Drug delivery device with two-part user indicator

Abstract

An assembly for a drug delivery device (100), the assembly comprising: a cap (200) having a first indicia (203) on an outer surface of the cap; and a device body (700) having a second marker (733) on an outer surface of the device body, where the first marker (203) and the second marker (733) form a continuous marker extending from the device body (700) to the cap (200), where the cap (200) has a first axial position relative to the device body (700), where the cap (200) has a second axial position relative to the device body (700). When the cap (200) is not in the first axial position relative to the device body (700), the cap can be in the first axial position relative to the device body (700) only when the first marking (203) and the second marking (733) form a continuous marking.

Description

Background Art

[0001] A handheld drug delivery device requires a simple and understandable design both in terms of operation by a patient or medical staff and in terms of manufacturing the device. In particular, it is advantageous if the external form or the individual components forming the external form already have features that intuitively show the user the structure and function of the device. Unfortunately, the operation of conventional drug delivery devices remains too complex, especially under time pressure, both during manufacturing and especially during the process of drug dispensing in an emergency situation. Summary of the Invention

[0002] The object of the present disclosure is to facilitate improvements associated with drug delivery devices, such as improvements in handling safety, manufacturing costs, ease of use, and the ability to deliver drugs within a short period of time.

[0003] This object is achieved by the subject matter disclosed herein, for example by the subject matter defined in the appended independent claims. Advantageous improvements and extensions are subject to the dependent claims and / or are set forth in the following description.

[0004] One aspect of the present disclosure relates to a component for a drug delivery device. The drug delivery device may include the component.

[0005] A drug delivery device can be configured to dispense a drug or medicament. The drug delivery device can be a hand-held drug delivery device. The drug delivery device can be an auto-injector. The drug delivery device can have a drive energy source, such as a drive spring or another type of energy source (such as a gas reservoir), for providing energy for the drug delivery operation. The drug delivery device is configured to perform the drug delivery operation, for example, using the energy obtainable from the drive energy source. The assembly includes a cap that can be attached to the device to cover the distal opening of the device. The cap has a first marking located on the outer surface of the cap. The outer surface of the cap is preferably the surface that is touched by the user during manipulation of the cap. The assembly further includes a device body, i.e., a housing. The device body can form the outer surface of the drug delivery device and can isolate the drug delivery device from the surroundings. The surroundings of the drug delivery device can be anything outside the device body and not physically connected to the device body. When using the drug delivery device, the user can directly hold the device body with a hand. The drug delivery device can have a medicament container for receiving the drug and a needle associated with the respective medicament container. The container can be pre-filled with the drug. The needle can be integrated into the container. The needle is suitably configured to pierce the skin of the user. The drug can be administered to the user through the needle, for example, into the tissue of the user. The energy of the drive energy source can be used to drive a drive member (such as a plunger and a plunger rod) of the drug delivery device to dispense the drug from the medicament container. For the drug delivery operation, the drive member can be displaced in a distal direction relative to the device body by the energy provided by the drive energy source. The device body can be a body that encloses the components of the drug delivery device (such as a needle shield, a needle shield spring, an optional syringe holder, a medicament container (such as a pre-filled syringe), a plunger, a drive spring, a drive spring holder, and / or an audible indicator (such as a rattle)). The device body has a second marking located on the outer surface of the device body. The first marking and the second marking form a continuous marker that extends from the device body to the cap. That is, when the first marking and the second marking are adjacent to each other, the first marking and the second marking together form a single marker that can be perceived by the user, for example, haptically and / or visually, as a single continuous marker. The continuous marker can guide the user to the area where the cap is located. The cap of the assembly has a first axial position relative to the device body. The first axial position can be the position that the cap has relative to the device body when the cap is connected to the device body. The cap can have a second position or axial position relative to the device body, in which the cap is not directly or indirectly connected to the device body. In the first axial position, the cap can be indirectly connected to the device body, for example, through the connection between the cap and the needle shield, or directly connected to the device body through the connection between the cap and the device body.

[0006] In an embodiment, if the cap is not in a first axial position relative to the device body, for example if the cap is not attached to the device body, the cap can be brought into the first axial position relative to the device body only when the first mark and the second mark are aligned to form a continuous marker (e.g., rotationally aligned such that the cap moves axially towards the device body to form a continuous marker). Thus, if the first mark and the second mark are not aligned (e.g., rotationally offset), the cap may not be able to move axially to the first axial position relative to the body because one or more cap features engage with one or more device body features to prevent the cap from reaching the first axial position relative to the device body. In the present disclosure, the first mark will also be referred to as the user indicator on the cap, the second mark will also be referred to as the user indicator on the body, and the continuous marker will also be referred to as the user indicator.

[0007] By configuring the assembly such that the cap can be attached to the device body only when the first mark and the second mark form a continuous marker, incorrect assembly of the drug delivery device can be avoided. Thus, this arrangement helps to prevent incorrect assembly and thus potentially prevents non-functional devices from reaching the patient or user. Since incorrect assembly is pre-empted, the manufacturing process can also be carried out more efficiently, in particular faster and more cost-effectively.

[0008] In an embodiment, the continuous marker forms a user indicator. The user indicator can be a single user indicator. The user indicator can have information on how to manipulate the drug delivery device or the assembly during use. Additionally, the first mark and / or the second mark can form the user indicator.

[0009] In an embodiment, the continuous marker extends along the longitudinal axis of the cap and / or the device body.

[0010] In an embodiment, the user indicator points in the drug delivery direction. The drug delivery direction can be the direction in which the needle of the device ejects the drug. Thus, the user can immediately identify how to hold the device when dispensing the drug.

[0011] In an embodiment, the user indicator points in the distal direction.

[0012] In an embodiment, the first mark has the shape of an arrow. The arrow tip can point in the distal direction. The arrow tip can indicate the delivery direction. Additionally, the arrow tip can indicate the direction in which the cap must be pulled from the device body or the device if the cap is to be removed.

[0013] In an embodiment, the second mark has the shape of an arrow. The arrow tip can point in the distal direction and thus indicate the delivery direction.

[0014] In an embodiment, the continuous marker has the shape of an arrow. In this case, the first mark can include the arrow tip.

[0015] In an embodiment, the first marking and / or the second marking may be a haptically perceptible marking. The haptic marker can further improve the manipulation speed and safety. In this context of the present disclosure, haptic or haptically means that the user can detect the marking or marker by touching it. Thus, the first marking and / or the second marking may be implemented as at least one contour, recess, roughness, or for example an orifice. For example, the first marking and / or the second marking may include at least one recess. It should be noted that the term "recess" as used in the present disclosure is synonymous with the terms "contour", "roughness", or "opening", and thus can be easily interchanged with these terms.

[0016] In an embodiment, the first marking and / or the second marking may be a visually perceptible marking. In this context of the present disclosure, visually means that the user can detect the marking or marker with visual perception. Thus, additionally or alternatively, the first marking and / or the second marking may be implemented by a color marking.

[0017] In an embodiment, the first marking and / or the second marking may have more than one haptically and / or visually perceptible marking or structure. The first marking and / or the second marking may have at least two recesses. The recesses may be obliquely oriented with respect to the longitudinal axis of the cap and / or the device body.

[0018] In an embodiment, one or more recesses of the first marking and / or the second marking may have a rectangular shape. Additionally, the shorter side length of each rectangle may extend along the longitudinal axis of the device body and / or the cap.

[0019] In an embodiment, the recesses of the first marking and / or the second marking have different sizes. The sizes of the recesses of the first marking and / or the second marking may increase in the distal direction along the longitudinal axis.

[0020] In an embodiment, the number of recesses of the first marking on the cap is different from the number of recesses of the second marking on the device body. The first marking may include two recesses. The second marking may include three recesses.

[0021] In an embodiment, the second marking may have three rectangular recesses, the side edges of the rectangles extending transversely to the longitudinal axis having the same length, and the side edges of the rectangles extending along the longitudinal axis increasing in length in the distal direction. Additionally, the recess disposed furthest distally of the second marking may be positioned directly adjacent to the opening of the device body.

[0022] In an embodiment, the first marker may have two recesses, wherein the first recess has the shape of an arrow and the second recess has the shape of a rectangle or a trapezoid. The recess having the arrow shape may be located distally with respect to the recess having the trapezoid or rectangle shape. In particular, the arrow shape may provide a larger gripping surface for the user, thereby further improving the manipulation of the cap.

[0023] In an embodiment, the color of the cap and the device body is different.

[0024] In an embodiment, the second marker is located distally with respect to the drug window along the longitudinal axis of the device body. The drug window may be provided in the device body.

[0025] In an embodiment, the second marker is located at the distal portion of the device body.

[0026] In an embodiment, the cap includes at least one anti-rotation rib and the device body includes at least one cap groove. The anti-rotation rib may extend along the longitudinal direction of the cap. The cap groove may extend along the longitudinal direction of the device body. The cap groove may be configured to interact with the anti-rotation rib of the cap such that the cap can be connected to the device body only when the anti-rotation rib slides into the cap groove. Once connected (i.e., in the first axial position), the rib and the groove may cooperate to prevent the cap from rotating relative to the device body. Thus, the cap groove helps to ensure that the cap can be connected to the device body only at a specific position relative to the device body.

[0027] In an embodiment, the first marker and the second marker form a continuous marker only when the anti-rotation rib engages with the cap groove.

[0028] In an embodiment, when the first marker and the second marker form a continuous marker, the cap is rotationally fixed to the device body.

[0029] In an embodiment, the cap includes two first markers which are arranged on opposite sides of the outer surface of the cap. The device body may include two second markers which are arranged on opposite sides of the outer surface of the device body. The two first markers and the two second markers form two continuous markers which are arranged on opposite sides and extend from the device body along the longitudinal axis to the cap.

[0030] In an embodiment, when the cap is not in the first axial position relative to the device body, the cap can be brought into the first axial position relative to the device body only when the two first markers and the two second markers form two continuous markers.

[0031] In an embodiment, the two first marks have the same shape. The two second marks may also have the same shape. Additionally, the two consecutive markers may have the same shape. Preferably, the two first marks may each have some or all of the features disclosed above with respect to the first mark. Further, the two second marks may each have some or all of the features disclosed above with respect to the second mark. Moreover, the two consecutive markers may each have some or all of the features disclosed above with respect to the consecutive marker. That is, the first and second marks described above and thus the consecutive markers may be arranged twice on the device body and the cap, respectively, particularly opposite to each other. For example, the two first marks and the two second marks form consecutive markers only when the anti-rotation rib engages with the cap groove.

[0032] In the present invention, for ease of reading the specification and claims, singular expressions such as "a recess", "a mark" are used. However, since the components according to the present invention "include" or "have" the corresponding parts or features, such singular expressions do not limit the number of the parts or features involved. Instead, unless the context indicates otherwise, such singular expressions are intended to be understood as "at least one recess", "at least one mark", etc.

[0033] According to another aspect, there is provided a method of delivering a drug from a drug delivery device, the method comprising using a drug delivery device according to the present disclosure, such as according to any one of the above embodiments.

[0034] According to another aspect, there is provided a drug for use in a method of treating a patient, wherein the method comprises using a drug delivery device according to the present disclosure, such as according to any one of the above embodiments, to deliver the drug to the patient.

[0035] 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.

[0036] Furthermore, unless otherwise specified, the same reference numerals refer to the same technical features. As for "may" and "might" used in this application, it indicates the possibility of doing so as well as the actual technical implementation. The present concepts of the disclosure will be described below in a more specific context, namely a drug delivery device, particularly a drug delivery device for humans or animals, with respect to the preferred embodiments. However, the disclosed concepts can also be applied to other situations and / or arrangements, such as other syringes, spray devices or inhalation devices.

[0037] The features and technical advantages of embodiments of the present disclosure have been outlined above rather extensively. Additional features and advantages of 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 constructions 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

[0038] To more fully understand the concepts of the present disclosure 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:

[0039] Figures 1A to 1D A cross-section of a drug delivery device according to a first embodiment and in different operating states is shown,

[0040] Figure 2 An exploded view of an example of a drug delivery device without or with an optional separate syringe holder is shown,

[0041] FIG. 3A to FIG. 3I An optional cap and an optional cap cover are shown, and

[0042] Figure 4A and Figure 4B A perspective view and a cross-section of an optional gripper are shown respectively,

[0043] Figure 4C An exemplary embodiment of a single-piece sheet that can form a gripper support is shown,

[0044] Figure 4D and Figure 4E A gripper in an engaged position with the needle guard of a syringe is shown,

[0045] Figure 4F A cross-sectional view of the gripper of the previous embodiment assembled within a cap is shown,

[0046] Figure 4G The interaction between a gripper retaining boss (e.g., a boss of a cap) and an opening of an exemplary gripper is shown in detail,

[0047] Figure 4H A cross-section of the front end of an injection device is shown, on which a cap and a gripper mounted on the cap and interacting with the needle guard are installed,

[0048] Figure 5 An optional needle shield (needle cannula) is shown,

[0049] Fig. 6AShows the needle shield spring,

[0050] Figure 6B Shows a cross-sectional view of the needle shield spring assembled in a drug delivery device in the pre-use state of the drug delivery device,

[0051] Fig. 7A Shows the device body,

[0052] Figure 7B Shows a cross-sectional view of the device body,

[0053] Figure 7C Shows a three-dimensional cross-sectional view of the distal end of the device body,

[0054] Fig.7D Shows a cross-sectional view of the central part of the device body with a syringe holder,

[0055] Fig. 7E Shows a three-dimensional view of the syringe holder front stop of the device body,

[0056] Figure 7F Shows a cross-sectional view of the distal end of the device body, where the needle shield is in the third shield position,

[0057] Figure 7G Shows a three-dimensional view of the interaction between the needle shield locking structure and the flexible arm of the needle shield,

[0058] Fig. 8A Shows an optional syringe holder,

[0059] Figure 8B Shows a three-dimensional view of the optional syringe holder,

[0060] Figure 8C Shows a detailed view of another exemplary embodiment of the flexible holder arm,

[0061] Fig.8D Shows including Figure 8C The flexible holder arm of the optional syringe holder,

[0062] Fig. 9 Shows an optional pre-filled syringe,

[0063] Fig.10 Shows the plunger,

[0064] Fig. 10A Shows the plunger release mechanism in the first state,

[0065] Fig. 10B Shows the plunger release mechanism in the second state,

[0066] Fig. 10CShows the plunger release mechanism during the assembly of the drive sub-assembly,

[0067] Fig. 10D Shows the plunger release mechanism during final assembly,

[0068] Fig. 10E Shows another state of the plunger release mechanism,

[0069] Fig.10F Shows a schematic view of the plunger release mechanism after the sleeve has been pressed into the retracted position,

[0070] Figure 10G Shows a schematic detail view of the plunger release mechanism after final assembly and before the sleeve is pressed in,

[0071] Fig. 10H Shows a schematic detail view of the plunger release mechanism during the pressing in of the sleeve,

[0072] Fig.10I Shows the longitudinal rib on the inner side of the rigid arm of the drive spring retainer,

[0073] Fig.10J Shows a perspective view of the plunger according to the second embodiment,

[0074] Figure 10K Shows a distal view of the plunger according to the second embodiment,

[0075] Fig.10L Shows a cross-section of the shaft of the plunger along the radial direction according to the second embodiment

[0076] Figure 10M Shows a cross-section of the shaft of the plunger along the longitudinal direction.

[0077] Fig.11A Shows the drive spring according to an embodiment of the present disclosure,

[0078] Fig. 11B Shows, during actuation of the plunger, the Fig.11A drive spring assembled in the drug delivery device,

[0079] Fig. 11C Shows, before actuation of the plunger, the Fig.11A and Fig. 11B drive spring assembled in the drug delivery device,

[0080] Fig. 12A and Fig. 12B Shows a perspective view of the drive spring retainer,

[0081] Fig. 12C Shows the syringe rear stop mechanism,

[0082] Fig.12D Shows a cross-sectional view of the proximal portion of the drive spring holder,

[0083] FIG. 12E to FIG. 12G shows different embodiments of the flexible portion of the drive spring holder,

[0084] Fig.13A shows an optional auditory indicator (clicker),

[0085] Fig. 13B shows an indicator holder exemplary included on the drive spring holder,

[0086] Fig. 13C shows a perspective view of the support structure on the distal end of the flexible support arm,

[0087] Fig.13D shows a perspective view of the guiding structure of the indicator holder,

[0088] Fig.13E shows a cross-section through the longitudinal symmetry axis of the indicator holder,

[0089] Fig.13F shows the rear sub-assembly (RSA) after the auditory indicator has been assembled but before activating the auditory indicator,

[0090] Figure 13G shows the rear sub-assembly (RSA) after activating the auditory indicator (preferably using an activation tool),

[0091] Fig.13H shows the activation tool,

[0092] Fig.13I shows the state of the RSA and the front sub-assembly (FSA) during final assembly shortly before activating the auditory indicator,

[0093] FIG. 14A to FIG. 14J shows the steps for assembling an optional syringe holder and a pre-filled syringe into the device,

[0094] Fig.15A shows a flowchart of an exemplary feedback sequence during use of the drug delivery device,

[0095] FIG. 15B to FIG. 15D shows different views of the drug window during the dose dispensing process, and

[0096] Fig.16 and Fig.17 shows the rear sub-assembly and the front sub-assembly of the drug delivery device.

[0097] Figure 18 shows the expanded structural formula, molecular formula and molecular weight of tocilizumab (e.g., the sodium form). Detailed Description

[0098] Generally, "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".

[0099] The distal end DE can be the end closer to the needle compared to the proximal end PE.

[0100] Certain embodiments of the present disclosure are shown with respect to an injection device (e.g., an auto-injector). The device can include an advanced needle shield that serves as an enabling element.

[0101] 1. General description of the drug delivery device( Figures 1A to 1D )

[0102] Figures 1A to 1D An embodiment of a drug delivery device 100 is shown. The device 100 can be suitable as the device in the drug delivery arrangement further described above and below. These figures show different states of the device 100 during its operation.

[0103] Figure 1A The drug delivery device 100 is shown in an initial state or as it comes out of the factory. The drug delivery device 100 can include a housing or device body 700. The device body 700 can be configured to and / or can hold a medicament container (e.g., a pre-filled syringe 900) inside it. A medicament (e.g., a liquid medicament or drug Dr) can 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. Instead, containers other than pre-filled syringes can also be considered. The device body 700 can be configured to hold and / or can hold the needle 908, see Figure 1CIn other words, the needle 908 may be disposed or may be disposed within the device body 700. The needle 908 may be an integral part of a pre-filled syringe 900 or container (e.g., permanently or releasably attached 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.

[0104] 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 within the medicament container (i.e., the pre-filled syringe 900) and that 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 。

[0105] Other possible drive energy sources different from the drive spring 1100 include an electric battery cell or battery for driving the plunger 1000 by an electric motor, or (in cases where gas pressure can be used to drive a drug delivery operation) a reservoir suitable for providing gas pressure.

[0106] The drug delivery device 100 may be an auto-injector. The energy for driving the drug delivery operation in the auto-injector may be provided by the components of the drug delivery device 100, without the need for the user to load the energy into the device 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 a dose setting procedure.

[0107] The drug delivery device 100 may suitably be a single-dose device, i.e., it is arranged to dispense only one dose. The drug delivery device 100 may be a disposable drug delivery device 100, i.e., a device 100 that is discarded after its use. The device 100 may be a pen-shaped device. The pre-filled syringe 900 and / or the needle 908 may be axially fastened within the drug delivery device 100 (e.g., within the device body 700), or may 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 may be driven by a needle insertion mechanism of the drug delivery device 100. Automatic needle retraction may also be used.

[0108] As Figure 1A Depicted, the drug delivery device 100 may further include a cap 200. The cap 200 may be arranged at the distal end DE of the drug delivery device 100. The cap 200 may be detachably connected to the remainder of the device 100, e.g., to the device body 700 and / or to another part or component of the drug delivery device 100. The cap 200 may cover the distal end DE of the remainder of the drug delivery device 100 and / or the needle channel opening through which the needle 908 (e.g., the distal needle tip) may project to pierce the skin for a drug delivery operation. The cap 200 may include a needle shield remover, such as a gripper 400, which may engage a rigid needle shield (RNS) 914 that may 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.

[0109] The device body 700 may 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).

[0110] Figure 1B The drug delivery device 100 with the cap 200 removed is shown. According to Figure 1B, the device 100 can be in a state of being ready for operation, for example, a state of being ready to perform a drug delivery operation when the operation is triggered. As depicted in the figure, 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 is still attached to the device body 700. The needle shield 500 can move from an initial position or a first position to a second position or a trigger position relative to the device body 700. The needle shield 500 can be arranged to extend beyond the distal tip 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.

[0111] 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, when displaced proximally from Figure 1B the depicted initial position or first position to the second position or trigger 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. It is only possible to operate the trigger button 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 only be arranged 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.

[0112] 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 radially projecting 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.

[0113] Figure 1C The needle shield 500 is shown in a second position relative to the device body. For example, this is the position when the drug delivery operation has been initiated, can be initiated, and / or when the needle 908 pierces the skin. The needle 908 can project axially 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 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.

[0114] 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 the 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 the locking features 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.

[0115] Drug list

[0116] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation that comprises 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 an 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.

[0117] As described hereinbelow, a drug or medicament can include at least one API or a combination thereof in different types of formulations for the treatment of 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.

[0118] A drug or medicament can be contained in a primary packaging or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir, or other rigid or flexible vessels that are 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 an 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 the 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 an animal body.

[0119] The drugs or medicaments 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.

[0120] 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 their pharmaceutically acceptable salts or solvates; 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.

[0121] 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, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0122] 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.

[0123] 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.

[0124] Examples of oligonucleotides are, for example: mipomersen sodium ( ), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0125] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, degliptin, saxagliptin, berberine.

[0126] 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, gonadotrophin), somatotropin (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0127] Examples of polysaccharides include glucosaminoglycans, 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.

[0128] 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 antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a cross-over binding domain orientation (CODV).

[0129] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments can include cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, tribodies, tetrabodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, tetravalent, and multivalent antibodies), minibodies, chelating recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and antibodies containing VHHs. Additional examples of antigen-binding antibody fragments are known in the art.

[0130] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although framework regions typically do not directly participate in antigen binding as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0131] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0132] Additional examples of APIs for preventing hemophilia A or B (with or without inhibitors) include siRNAs that target antithrombin. An example of an siRNA that targets antithrombin is fitusiran. The terms "prevent" and "preventive treatment" are used interchangeably herein.

[0133] Also contemplated is the use of pharmaceutically acceptable salts of any of the APIs described herein in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0134] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, instruments, methods, systems, and embodiments of the APIs described herein without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

[0135] Example drug delivery devices can relate to needle-based injection systems 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 fully emptied) container systems. The container can be a replaceable container or an integral non-replaceable container.

[0136] As further described in ISO 11608-1:2014(E), a multi-dose container system can relate to a needle-based injection device having a replaceable container. In such a system, each container holds multiple doses, and the size of these doses can be fixed or variable (predetermined by the user). Another multi-dose container system can relate to a needle-based injection device having an integral non-replaceable container. In such a system, each container holds multiple doses, and the size of these doses can be fixed or variable (predetermined by the user).

[0137] As further described in ISO 11608-1:2014(E), a single-dose container system can involve a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, where the entire deliverable volume is expelled (fully emptied). In another example, each container holds a single dose, where a portion of the deliverable volume is expelled (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can involve a needle-based injection device with an integral non-replaceable container. In one example of such a system, each container holds a single dose, where the entire deliverable volume is expelled (fully emptied). In another example, each container holds a single dose, where a portion of the deliverable volume is expelled (partially emptied).

[0138] Fitusiran as the API of the medicament in the device

[0139] Fitusiran is a synthetic, chemically modified double-stranded small interfering RNA (siRNA) oligonucleotide that is covalently linked to a trivalent N-acetyl-galactosamine (GalNAc) ligand targeting AT3 mRNA in the liver, thereby inhibiting the synthesis of antithrombin. See, e.g., Pasi et al., N Engl J Med. [The New England Journal of Medicine] (2017) 377(9):819-28. The nucleosides in each strand of fitusiran are linked by 3'-5' phosphodiester or phosphorothioate linkages to form the sugar-phosphate backbone of the oligonucleotide.

[0140] The sense strand and the antisense strand contain 21 and 23 nucleotides, respectively. The 3' end of the sense strand is conjugated via a phosphodiester linkage to a GalNAc-containing moiety (referred to herein as L96). The sense strand contains two consecutive phosphorothioate linkages at its 5' end. The antisense strand contains four phosphorothioate linkages, two at the 3' end and two at the 5' end. The 21 nucleotides of the sense strand hybridize with the complementary 21 nucleotides of the antisense strand, thus forming 21 base pairs and a two-base overhang at the 3' end of the antisense strand. See also U.S. Patent 9,127,274, U.S. Patent 11,091,759, US2020 / 0163987A1, and WO 2019 / 014187, the entire contents of each of which are hereby expressly incorporated by reference.

[0141] The two nucleotide strands of fitusiran are shown below:

[0142] 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

[0143] 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),

[0144] wherein

[0145] Af = 2’-deoxy-2’-fluoroadenosine

[0146] Cf = 2’-deoxy-2’-fluorocytidine

[0147] Gf = 2’-deoxy-2’-fluoroguanosine

[0148] Uf = 2’-deoxy-2’-fluorouridine

[0149] Am = 2’-O-methyladenosine

[0150] Cm = 2’-O-methylcytidine

[0151] Gm = 2’-O-methylguanosine

[0152] Um = 2’-O-methyluridine

[0153] “-” (hyphen) = 3’-5’ phosphodiester bond-linked sodium salt

[0154] “-ps-” = 3’-5’ phosphorothioate bond-linked sodium salt

[0155] and wherein L96 has the following formula:

[0156]

[0157] As used herein, the terms “2’-deoxy-2’-fluoroadenosine” and “2’-fluoroadenosine” may be used interchangeably.

[0158] As used herein, the terms “2’-deoxy-2’-fluorocytidine” and “2’-fluorocytidine” may be used interchangeably.

[0159] As used herein, the terms “2’-deoxy-2’-fluoroguanosine” and “2’-fluoroguanosine” may be used interchangeably.

[0160] As used herein, the terms “2’-deoxy-2’-fluorouridine” and “2’-fluorouridine” may be used interchangeably.

[0161] The expanded structural formula, molecular formula, and molecular weight of fetuceran (e.g., the sodium form) are shown in Figure 18.

[0162] The structure of fetuceran can also be described by the following figure, where X is O:

[0163]

[0164] Fetuceran is shown in Figure 18 in the sodium salt form.

[0165] In some embodiments, the device delivers fetuceran in an aqueous solution, wherein the concentration of fetuceran 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 fetuceran 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, fetuceran is provided at a concentration of about 100 mg / mL in an aqueous solution.

[0166] The term "deliver / delivers / delivering" is intended to mean "administer / administers / administering".

[0167] Unless specifically stated or otherwise apparent from the context, as used herein, the term "about" or "approximately" refers to a value within an acceptable error range of a particular value as determined by a person of ordinary skill in the art, and a portion of this range will depend on how the measurement or determination is made. For example, "about" or "approximately" can mean a range of up to 10% (i.e., ±10%). Thus, "about" or "approximately" can be understood as 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.

[0168] While the non-tozilalan dose weights described herein refer to the weight of non-tozilalan free acid (the active moiety), administration of non-tozilalan to a patient herein refers to administration of sodium non-tozilalan (the drug substance) provided in a pharmaceutically suitable aqueous solution (e.g., phosphate buffered saline at physiological pH). For example, about 100 mg / mL non-tozilalan means that each mL contains about 100 mg of non-tozilalan free acid (equivalent to about 106 mg of sodium non-tozilalan, the drug substance). Unless otherwise indicated, the non-tozilalan weights recited in this disclosure are the weights of non-tozilalan free acid (the active moiety).

[0169] In some embodiments, the pharmaceutical formulation in the device comprises non-tozilalan in phosphate buffered saline. The phosphate concentration in the solution can be from about 1 to about 10 mM (e.g., about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, or about 9 mM), and the pH is from about 6.0 - 8.0. The pharmaceutical formulations herein can include stabilizers such as EDTA. The pharmaceutical formulations can be preservative-free. In some embodiments, the non-tozilalan pharmaceutical formulation in the device is preservative-free and each mL of about 5 mM phosphate buffered saline (PBS) solution contains about 100 mg of non-tozilalan, consists of or consists essentially of about 100 mg of non-tozilalan. In some embodiments, the non-tozilalan pharmaceutical formulation in the device is preservative-free and contains non-tozilalan, consists of or consists essentially of non-tozilalan in about 5 mM phosphate buffered saline (PBS) solution. The PBS solution consists 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 diluted phosphoric acid.

[0170] In some embodiments, the non-tozilalan formulation in the device for subcutaneous delivery contains non-tozilalan in 5 mM phosphate buffered saline at pH 7.0, and the phosphate buffered saline has 0.64 mM Na 2 PO 4 、4.36 mM Na 2 HPO 4 and 84 mM NaCl. In certain embodiments, the formulation of the non-tozilalan solution for subcutaneous delivery is shown in Table 1 below:

[0171] Table 1. Exemplary Non-tozilalan Formulations

[0172]

[0173] *q.s.: quantity sufficient

[0174] In some embodiments, the formulation of the non-tozilalan solution for subcutaneous delivery using a device can be described as shown in Table 2 below.

[0175] Table 2. Exemplary Fostamatinib Formulations

[0176]

[0177]

[0178] In some embodiments, the device can be used to deliver a single dose of fostamatinib, wherein the single dose comprises from about 20 mg to about 80 mg of fostamatinib (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 fostamatinib, wherein the single dose comprises from about 1 mg to about 30 mg of fostamatinib (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0179] In one embodiment, the device can be used to deliver a single dose of about 80 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 50 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 20 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 30 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 10 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 5 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 2.5 mg of fostamatinib. In one embodiment, the device can be used to deliver a single dose of about 1.25 mg of fostamatinib.

[0180] In some embodiments, a single dose of fostamatinib 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). Other delivery volumes described herein can also be used.

[0181] In one embodiment, the device can be used to deliver a single dose of approximately 80 mg of fitusiran (approximately 100 mg 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 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 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 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 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 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 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 fitusiran / mL) in approximately 0.5 mL.

[0182] In one embodiment, the device delivers fitusiran in a prophylactically effective amount for 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), annualized joint bleeding rate (AjBR), annualized spontaneous bleeding rate (AsBR), or 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.

[0183] A patient with hemophilia A or B with inhibitors is a patient who has developed an alloantibody against a factor they have previously received (e.g., factor VIII for a patient with hemophilia A or factor IX for a patient with hemophilia B). A patient 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 as well as patients with hemophilia B with inhibitors.

[0184] As used herein, a patient having "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.

[0185] In some embodiments, the device can be used to prophylactically treat patients having 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 having 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 having 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 having 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 having 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 having 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 having 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 having 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 having 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 having 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 having hemophilia A or B (with or without inhibitor) with approximately 1.25 mg of fitusiran subcutaneously every month (or every four weeks).

[0186] 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 subcutaneously delivering 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 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).

[0187] As an example, a method for prophylactic treatment of a patient with hemophilia A or hemophilia B (with or without inhibitors) can comprise subcutaneously delivering 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. 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).

[0188] Further, the present invention provides a method for reducing the frequency of bleeding episodes in a patient with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering 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 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).

[0189] 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 subcutaneously delivering 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. 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).

[0190] In addition, the present disclosure provides a method for reducing ABR in a patient with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering 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).

[0191] As an example, a method for reducing ABR in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneously delivering 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). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0192] In addition, the present disclosure provides a method for reducing AjBR in a patient with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering 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).

[0193] As an example, a method for reducing AjBR in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneously delivering 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). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0194] In addition, the present disclosure provides a method of reducing AsBR in a patient with hemophilia A or B, with or without inhibitors, the method comprising subcutaneous delivery, using the device, of a prophylactically effective amount of fitusiran to a patient in need thereof. 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).

[0195] As an example, the method of reducing AsBR in a patient with hemophilia A or B, with or without inhibitors, can comprise subcutaneous delivery, using the device, 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). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0196] In some embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 50 mg of subcutaneous doses of fitusiran approximately once every two months (or approximately every eight weeks). In other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 50 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 80 mg of subcutaneous doses of fitusiran approximately once every two months (or approximately every eight weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 80 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 20 mg of subcutaneous doses of fitusiran approximately once every two months (or approximately every eight weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 20 mg of subcutaneous doses of fitusiran approximately once a month (or every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 10 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 30 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 5 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 2.5 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with approximately 1.25 mg of subcutaneous doses of fitusiran approximately once a month (or approximately every four weeks).

[0197] Accordingly, the present disclosure 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 about monthly (or about every four weeks) or about every two months (or about every eight weeks). Fitusiran can be delivered at 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).

[0198] 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 about monthly (or about every four weeks) or about every two months (or about 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] Further, the present disclosure provides a method for reducing the frequency of bleeding episodes in a patient 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 about monthly (or about every four weeks) or about every two months (or about every eight weeks). Fitusiran can be delivered at 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).

[0200] 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 about monthly (or about every four weeks) or about every two months (or about 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 addition, the present disclosure provides a method for reducing ABR in patients with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering a prophylactically effective amount of fitusiran to a patient in need 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 about monthly (or about every four weeks) or about every two months (or about every eight weeks). Fitusiran can be delivered at 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).

[0202] As an example, a method for reducing ABR in a patient with hemophilia A or B (with or without inhibitors) can include subcutaneously delivering about 50 mg of fitusiran to a patient in need using the device about monthly (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0203] In addition, the present disclosure provides a method for reducing AjBR in patients with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering a prophylactically effective amount of fitusiran to a patient in need 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 about monthly (or about every four weeks) or about every two months (or about every eight weeks). Fitusiran can be delivered at 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).

[0204] As an example, a method for reducing AjBR in a patient with hemophilia A or B (with or without inhibitors) can include subcutaneously delivering about 50 mg of fitusiran to a patient in need using the device about monthly (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0205] In addition, the present disclosure provides a method of reducing AsBR 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 of the doses 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 about monthly (or about every four weeks) or about every two months (or about every eight weeks). Fitusiran can be delivered at 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).

[0206] As an example, the method of reducing AsBR in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneously delivering about 50 mg of fitusiran to a patient in need using the device about monthly (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0207] 2. Examples of drug delivery devices without or with a separate syringe holder ( Figures 1A to 1D and Figure 2 )

[0208] Figure 2 FIG. 14 shows an exploded view of an example of a drug delivery device 100 without or with an optional separate syringe holder 800. The drug delivery device 100 can be an autoinjector suitable for automatically injecting a drug Dr. The triggering of the injection process can be done manually, i.e., by the user.

[0209] The drug delivery device 100 can comprise:

[0210] - A removable cap 200 and a cap cover 300. After using the drug delivery device 100, reattachment of the cap 200 to the cap cover 300 can be prevented. Details of the cap 200 and the cap cover 300 will be explained in Section 3 below.

[0211] - A gripper 400, which is mounted on the cap 200 and is configured to remove the RNS 914 or the soft needle shield SNS 914 of the prefilled syringe 900. Details of the gripper 400 will be explained in Section 4 below.

[0212] - A needle shield 500, which is telescopically arranged within the device body 700. Details of the needle shield 500 will be explained in Section 5 below.

[0213] - A needle shield spring 600 that biases the needle shield 500 in the distal direction D. Details of the needle shield spring 600 will be explained in Section 6 below.

[0214] - A device body 700 that is generally cylindrical and may include a distal opening configured to receive the needle shield 500 and a proximal opening configured to receive a drive spring holder 1200 that may function as a rear housing. Details of the device body 700 will be explained in Section 7 below.

[0215] - An 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. Details of the syringe holder 800 will be explained in Section 8 below.

[0216] - A pre-filled syringe 900. Details of the pre-filled syringe 900 will be explained in Section 9 below. Alternatively, a cartridge or any other drug container configured to connect to a removable needle may be used.

[0217] - A plunger 1000. Details of the plunger 1000 will be explained in Section 10 below. The plunger 1000 may be used to expel a drug Dr from the pre-filled syringe 900.

[0218] - A drive spring 1100. Details of the drive spring 1100 will be explained in Section 11 below. The drive spring 1100 may supply mechanical energy for automatic drug injection. Alternatively, other drive sources such as pneumatic energy or electrical energy may be used.

[0219] - A drive spring holder 1200. Details of the drive spring holder 1200 will be explained in Section 12 below. The drive spring holder 1200 may be a housing, shell, or part of the device body 700, particularly the rear portion. The drive spring holder 1200 may be configured to hold the drive spring 1100 and perform other functions, such as supporting a syringe flange 912 of the pre-filled syringe 900 via two support arms extending distally from a proximal plate of the drive spring holder 1200.

[0220] - A clicker 1300. Details of the clicker 1300 will be explained in Section 13 below. The clicker may be an auditory indicator and / or a tactile indicator or provide auditory feedback and / or tactile feedback, such as indicating the end of dose delivery or other events.

[0221] The control subassembly (or front subassembly) may include the needle shield 500, the needle shield spring 600, and the device body 700. The control subassembly may control the pre-filled syringe 900.

[0222] The plunger 1000, drive spring 1100, drive spring retainer 1200, and optional audible indicator or clicker 1300 may be included in the drive subassembly (or rear subassembly).

[0223] The drug delivery device 100 may include a housing designed as a multi-part housing. In particular, the housing may include a device body 700 forming a front housing and a rear housing formed, for example, by the drive spring retainer 1200. A portion of the drive spring retainer 1200 may be surrounded by the front housing or the device body in a longitudinal direction and is adapted to close the open proximal end of the front housing. The proximal portion of the drive spring retainer may protrude from the proximal end of the device body. The housing may be adapted to hold the pre-filled syringe 900 and other parts of the auto-injector 100.

[0224] The pre-filled syringe 900 is provided with a needle 908 at the distal end, for example, the needle is staked to the neck of the syringe body. The pre-filled syringe 900 may be pre-assembled. Typically, a protective needle shield may be removably coupled to the needle 908 of the pre-filled syringe 900. The protective needle shield may be a soft needle shield (e.g., rubber needle shield SNS) 914 or an RNS 914 that may consist of an inner rubber material and a fully or partially plastic housing.

[0225] A plunger stopper 910 may be arranged to seal the pre-filled syringe 900 from the proximal side and to displace the drug Dr or medicament M contained in the pre-filled syringe 900 through the needle 908. In other exemplary embodiments, a cartridge or container may be used instead of the pre-filled syringe 900, the cartridge or container containing the drug Dr or medicament M and engaging a removable needle (e.g., by thread, snap, friction, luer lock, etc.).

[0226] In an exemplary embodiment, a cap 200 may be removably provided at the distal end DE of the device body 700 or the housing. The cap 200 may include a gripping element of the gripper 400 (e.g., including barbs, hooks, constricted sections, etc.), the gripper being arranged to engage the protective needle shield RNS or SNS 914 of the pre-filled syringe 900. The cap 200 may also engage the needle shield 500 and / or the device body 700. The cap 200 may include gripping features facilitating 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 may include a visual and / or tactile indication of the direction for removing the cap 200 from the device body 700, such as an arrow. The cap 200 may be a single part integrally formed, for example, by injection molding. Alternatively, the cap 200 may include several parts, such as a cap body 201 and a cap cover 300.

[0227] In an exemplary embodiment, a needle shield spring 600 may be arranged to bias the needle shield 500 in a distal direction D against the device body 700.

[0228] In an exemplary embodiment, the drive spring 1100 may be disposed within the device body 700, for example, mounted on the drive spring holder 1200. The plunger 1000 may be used to transfer the force of the drive spring 1100 to the plunger stop 910 within the pre-filled syringe 900 or another drug container.

[0229] In an exemplary embodiment, the plunger 1000 may be hollow, and the drive spring 1100 may 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 holder 1200.

[0230] In another exemplary embodiment, the plunger 1000 may be solid, and the drive spring 1100 may engage the proximal end of the plunger 1000. Similarly, the drive spring 1100 may be wound around the outer diameter of the plunger 1000 and / or extend within the pre-filled syringe 900.

[0231] In an exemplary embodiment, a plunger release mechanism may be arranged to prevent release of the plunger 1000 before the needle shield 500 is retracted relative to the device body 700, and to release the plunger 1000 once the needle shield 500 is fully retracted.

[0232] In an exemplary embodiment, a pre-use needle shield locking mechanism may be arranged to prevent retraction of the needle shield 500 relative to the device body 700 when the cap 200 is in place, thereby avoiding accidental activation of the auto-injector (i.e., the drug delivery device 100) (e.g., if dropped during transportation or packaging, etc.).

[0233] In addition, a post-use needle shield locking mechanism may be present to prevent proximal movement of the needle shield 500 after use of the drug delivery device 100.

[0234] When the cap 200 is attached to the drug delivery device 100, axial movement of the cap 200 relative to the device body 700 in the proximal direction P may be restricted 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 may grip the RNS or SNS 914 and may also allow removal of the RNS or SNS 914.

[0235] In the illustrated embodiment, the cap 200 may include a closable opening for insertion of a front assembly tool. The cap 200 may be permanently closed at its distal end.

[0236] The drug delivery device 100 may include at least one clicker 1300 for generating an auditory feedback and / or a tactile feedback when the delivery of the drug Dr or the medicament 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 held in the drive spring holder 1200 or the rear housing.

[0237] The drive spring holder 1200 or the rear housing may be adapted to prevent the pre-filled syringe 900 from axially moving after assembly (in particular during storage, transportation and normal use). In detail, the drive spring holder 1200 may include resilient arms at its front end, such as two resilient arms. The resilient arms may be formed as labyrinth arms to attenuate the impact force. The resilient arms may be mounted on more rigid arms of the drive spring holder 1200, such as two rigid arms. The rigid arms may extend in a distal direction from the proximal plate of the drive spring holder 1200. The two rigid arms may be arranged parallel to each other or substantially parallel to each other. The drive spring holder 1200 may include a central pin for guiding the drive spring 1100. The central pin and the proximal plate may be an integral part of the drive spring holder 1200 or may be separate parts thereof, such as integrated into a single part separate from the drive spring holder 1200.

[0238] In an exemplary embodiment, the drug delivery device 100 may be formed of at least two sub-assemblies, such as a control sub-assembly or a front sub-assembly and a drive sub-assembly or a rear sub-assembly, to allow flexibility in terms of the manufacturing time and location of the sub-assemblies and the final assembly time and site with respect to the pre-filled syringe 900.

[0239] 3. Cap and Cap Cover ( FIG. 3A to FIG. 3I )

[0240] Figure 3A The optional cap 200 is shown, on which the optional cap cover 300 is mounted, wherein the cap 200 and the cap cover 300 are separated from the device body 700 and the needle shield 500. The cap 200 may have a different color from the device body 700. FIG. 3A to FIG. 3I The cap 200 shown in Figure 4F 、 Figure 4H and Figure 6BThe cap 200 shown in the figure 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 temperatures, thus allowing for a shorter injection molding cycle time and therefore allowing for a reduction in part cost. The cap 200 includes a cap body 201. The cap body 201 (for example, when viewed in a planar view) has the shape of a frustum of a cone, where the radial and / or circumferential dimensions of the cap body 201 increase in the distal direction D along the longitudinal axis A. This shape supports the user in gripping the cap 200 and pulling off the cap in the distal direction D, for example, by a pure axial movement relative to the device body. When viewed from above, that is, 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 in gripping the cap 200 and pulling off the cap in the distal direction D. In addition, this shape can prevent the drug delivery device 100 from rolling away when it is put down by the user. To further facilitate the user's manipulation, especially when removing the cap 200, the cap 200 is characterized by a gripping surface 202, such as the side surface of the cap 200. The gripping surface 202 can have a ribbed, flared, square geometry. As Figure 3A shown, the cap 200 has at least one on-cap user indicator 203 on its surface. Preferably, the cap 200 has two on-cap user indicators 203, which are arranged opposite to each other. In the depicted embodiment, the on-cap user indicator 203 has the shape of an arrow pointing in the distal direction D. Along the proximal direction, before the start of the arrow, the cap 200 can have a rectangular recess. The on-cap user indicator 203 and the on-body user indicator 733 (described in Section 7 below) can form a user indicator. Thus, the on-cap user indicator 203 indicates to the user in which direction the cap 200 must be pulled when removing it 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 gripping and pulling the cap 200. Thus, the on-cap user indicator 203 provides both visual and tactile assistance to the user. In addition, the cap 200 includes at least one cap clip 204 to connect or mount the cap 200 to the needle shield 500 and thus connect or mount to the device body 700. As Figure 3B , Figure 3C , Figure 3F , Figure 3H and Fig. 3I depicted, the cap clip 204 can be designed as elastic members that have free ends in the proximal direction, and these free ends engage with corresponding parts of the needle shield 500. The corresponding parts of the needle shield 500 can be the cap clip windows 504 as described below. The cap 200 preferably has two opposite cap clips 204. As Figure 3B , Figure 3C , Figure 3F , Figure 3H and Fig. 3I As depicted in Fig. 3I , the cap clip 204 is an integral part of the cap 200. The cap clip 204 has a proximal free end that defines the clip 204 in the proximal direction. The free end has an inwardly directed hook or retaining element 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 recesses 213 have a trapezoidal shape (when viewed in a plan view). The width of the respective recesses increases in the proximal direction.

[0241] In addition, the cap 200 includes at least one, preferably more than one, such as 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 such 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 rotating accidentally relative to the housing body 700, and since the needle shield is properly rotationally locked to the cap, accidental rotation of the cap could cause damage or perforation of the needle shield. As can be seen, for example, in Figure 3A , Figure 3H and Fig. 3I , the anti-rotation ribs 205 can be elongate bars extending in the proximal direction along the longitudinal axis of the cap 200 or the device. The anti-rotation ribs 205 can be integral protrusions of the cap 200. Each anti-rotation rib 205 can be chamfered at its proximal end such that the anti-rotation rib 205 has a ramp at its proximal end.

[0242] The anti-rotation ribs 205 can be designed as elongate (e.g., with their major extent along the longitudinal axis A) locking lugs which, when the cap 200 is coupled to the device body 700, slide into corresponding recesses or cap grooves 725 in 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 user indicator 203 on the cap can be on the same face as the anti-rotation ribs 205 and the cap recess 213. It should be noted that the anti-rotation ribs 205 are also replaceable. For example, the cap 200 can have an oval cross-sectional shape in the outer surface of that part of it which is inserted into the body 700. In this case, the body 700 can have a corresponding oval cross-sectional shape in a part of its circumferential inner surface such that the cap 200 can only be inserted into the body 700 in two different positions which are offset 180° relative to the body. Further, any conceivable shaping of a part of the cap 200 and the corresponding part of the body 700 can be used to ensure that the cap can only be coupled to the body when a first marker (i.e., the user indicator on the cap) 203 and a second marker (i.e., the user indicator on the body) 733 form a continuous marker extending from the device body to the cap.

[0243] As Figure 3B and Figure 3C shown, the cap clips 204 can assist in implementing drop protection, i.e., a drop protection mechanism. In the depicted embodiment, the device 100 includes two cap clips 204. The drop protection mechanism suitably prevents the drug delivery device 100 from being fired in the event of it being dropped. In the absence of such a mechanism in place, if the cap 200 of the drug delivery device 100 drops upwards, then when the drug delivery device 100 impacts the ground from a first hood position X (see Figure 1B ) to a second hood position Y (see Figure 1C ), the needle shield 500 may continue to move under its own inertia, thus allowing the device 100 to be fired. The cap clips 204 prevent this. Figure 3B Figure 13 shows the drug delivery device 100 in its pre-use state, wherein the needle shield 500 is in a first hood position X which is biased forward by the needle shield spring 600. The cap clips 204 are located in corresponding cap clip windows 504 of the needle shield 500 and, as Figure 3C depicted, restrict the backward movement of the needle shield 500 in the proximal direction P. Thus, if the cap clips 204 are located in the corresponding cap clip windows 504, the needle shield 500 cannot reach the second hood position Y. The cap clips 204 are constrained by cap ribs 727 on the device body 700 (see Figure 7F ) to prevent the cap clips from deflecting outwards. When the user removes the cap 200, the cap 200 first moves forward, thus allowing the cap clips 204 to move into a wider section of the device body 700 before the cap clips 204 contact the needle shield 500, such that the cap clips 204 can deflect outwards and the cap 200 can be removed.

[0244] Figure 3D and Figure 4F shows the interior of the cap 200. The cap 200 has a cap opening 206 for receiving the gripper 400. The cap opening 206 extends distally into the cap shell or cap tube 210. The cap tube 210 may have a cylindrical shape. The cap opening 206 may be defined by the cap tube 6. The cap opening 206 may be at the proximal section of the cap tube 210. A plurality of gripper retaining bosses 207 (e.g., two gripper retaining bosses 207) are arranged equidistantly, for example, along the circumferential inner surface of the cap tube to prevent the gripper 400 from moving in the proximal direction P relative to the cap 200. The retaining bosses are positioned distally of the cap (tube) opening 206. Regarding the interaction between the cap opening 206 and the gripper 400, reference is made to 4A to 4H for a description. As can be seen in Figure 3D , the cap has a number of apertures in the longitudinal direction, namely distal holes 208 or device activation holes. These holes 208 may serve as channels for tools for activating the device. Activation may involve bringing the device into a state in which the device can be triggered. Activation may involve the movement of the needle shield and is a step carried out during assembly, for example, towards the end of the assembly of the device (which will be described further below).

[0245] Furthermore, the cap 200 includes at least one, but preferably two, cap lid clips 209 for connecting the cap lid 300 to the cap 200. Preferably, the two cap lid clips 209 are arranged opposite to each other. The cap 200 may have a surface 214 that has an interference fit with the cap lid 300. As can be seen, for example, in Figure 2 , Figure 3A , Figure 3B , Figure 3C , Figure 3E and Figure 3F , the cap lid 300 may be arranged in the distal region of the cap 200. Figure 3E shows a lateral cross-sectional view of the cap lid 300. The cap lid 300 has a cap lid outer surface 301 that closes the cap 200 in the distal region. Thus, the distal holes 208 of the cap 200 may be sealed (such that they are not accessible). Another function of the cap lid 300 is to prevent the user from reapplying the cap to a drug delivery device 100 that has already been used, where this is implemented by means of an anti-reapplication mechanism. The cap lid 300 further includes an inner surface facing the proximal direction P. This inner surface has at least one cap lid spacer 302. Preferably, as depicted in Figure 3E and Figure 3F , the cap lid 300 includes two cap lid spacers 302. The cap lid spacers 302 are arranged opposite to each other. Furthermore, the distance between the two end regions of the cap lid spacers 302 that point 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) The distance between two diametrically opposed points on []. In other words, the distance between the cap spacers can be between the inner diameter and the outer diameter of the ring defining the annular skin contact surface. As Figure 3F shown, 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 after the device has been used or fired (see Figure 1D ), the anti-reclosure mechanism prevents the cap 200 from being placed back onto the used drug delivery device 100. Since the needle shield 500 protrudes further distally from the device body 700 after dispensing (see Figure 1D ) than before dispensing (see Figure 1B ), and due to the distance between the cap spacers 302 being appropriately selected, attempting to reattach the cap 200 to the device body 700 (as Figure 3F shown) 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 spacers 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-reclosure mechanism prevents the cap 200 from being placed on the drug delivery device 100 in the same way as it was initially through the cooperation of the needle shield and the cap, the appearance of the drug delivery device 100 with the cap 200 being attempted to be repositioned 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 back onto the device body at all, at least not in the position it initially had (i.e., before the cap was separated from the rest of the device for use).

[0246] As Figure 3G depicted, the cap 300 preferably has two oppositely disposed 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. Thus, 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 ribs 303b are 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 disposed recesses 304.

[0247] 4. Grasper ( 4A to 4H )

[0248] 4A to 4HShows an optional gripper 400. The cap 200 may be adapted to form part of a needle shield remover or removal assembly. For this purpose, the cap 200 and the gripper 400 may be connected in such a way that when the cap 200 and the gripper 400 are removed together from the drug delivery device 100, the needle shield 914 is removed from the needle 908. In other words: the gripper 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 gripper may be axially locked to the cap.

[0249] Figure 4A and Figure 4B respectively show a perspective view and a cross-section of the optional gripper 400. The gripper 400 may be a sheet metal part that is located inside the cap 200 and removes the needle shield 914 from the pre-filled syringe 900 during cap removal. The needle shield 914 (shown, for example, in Fig. 9 ) may be a rigid needle shield (RNS) or a soft needle shield (SNS).

[0250] In this example, the gripper 400 may be formed from a single piece, such as a sheet, for example a metal sheet or a metal alloy sheet (see, for example, Figure 4C ). The gripper 400 may at least include a body or gripper support 402. The gripper support 402 may be bent or kinked multiple times along a plurality of longitudinal fold edges, kinks or bends 404 to form a plurality of support portions 406. The respective support portions 406 may have or include a planar outer surface area or a substantially planar outer surface area.

[0251] Furthermore, the planar outer surface area of the gripper support 402 may be bent or angled in such a way that the outer support portions 406 partially overlap in the overlapping area 408. Thus, in the bent state, the gripper support 402 may have the form of a tube or a tubular shape with, for example, a polygonal cross-section. Other cross-sections are possible, for example a circular cross-section. The partially overlapping area 408 in the bent state of the gripper support 402 may allow for compensation of the manufacturing tolerances of the gripper 400. The gripper support 402 may have longitudinal free ends that may be arranged close to the overlapping area 408.

[0252] In order to grip the needle shield 914, more than one of the plurality of support portions 406 may include a cut or opening 410 from which respective barbs 412 may be bent and may project inwards from the inner surface of the gripper support 402 and thus from the inner surface of the support portion 406. In the assembled state, the inwardly angled barbs 412 may extend in the distal direction D of the gripper 400 and thus in the distal direction of the drug delivery device 100.

[0253] The barb 412 can be adapted to deflect and grip the needle shield 914 during assembly of the needle shield 914 into the drug delivery device 100 (see, for example Figure 4D , Figure 4E and Figure 4H ), and can be adapted to further grip the needle shield 914 when the cap 200 is being removed from the drug delivery device 100.

[0254] The barb 412 can be designed as a hook or can have a pronged form. In particular, the barb 412 can project inwards from the inner surface of the support part 406 and can include a prong 414 at its free end. The prong 414 can be adapted to abut or penetrate into the outer surface of the needle shield 914. The prong can be designed to form an interference fit and / or a form fit and / or a press fit during assembly, or at least 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 prong 414 can be adapted to have penetrated into the outer surface of the needle shield 914 when the gripper 400 is being assembled to the needle shield 914. That is, the form fit or the forced fit may already be applied during the assembly process, and not only after the start of the cap removal process.

[0255] According to the present embodiment, the prong 414 can be configured as a double spike arranged on each barb 412 respectively. This configuration can be achieved by a concave shape between the two prongs 414 of each barb 412. Due to the concave shape and thus the control of the distance between the prongs 414, the penetration depth into the surface of the needle shield 914 can be limited. This can be particularly important when the needle shield 914 is a rubber needle shield, where penetration beyond a certain limit may affect sterility due to contact with the needle 908.

[0256] The opening 410 with the corresponding barb 412 can be arranged on the distal part D6 (e.g., on the distal half) of the gripper support 402, while the proximal part D5 (e.g., the proximal half) of the gripper support 402 can include a gripper part 406 without any openings or barbs.

[0257] Viewed along the longitudinal direction, the proximal part D5 and the distal part D6 can have substantially the same length. However, the proximal part D5 can also be longer than the distal part D6. The proximal part D5 can be, for example, about 10 mm, and the distal part can be 9 mm.

[0258] The sum of the lengths of the proximal part D5 and the distal part D6 corresponds to the total length of the gripper 400 viewed along the longitudinal direction.

[0259] The total length of the gripper can be, for example, between 15 mm and 25 mm, for example 19 mm.

[0260] The gripper 400 can have two opposite axial ends, namely a first end or leading edge end 418 located on the distal portion D6 of the gripper bracket 402 and a second end or trailing edge end 420 located on the proximal portion D5 of the gripper bracket 402.

[0261] The first end 418 of the gripper 400 (e.g., the leading edge end 418) can be the end that is first introduced into the cap opening 206 of the cap 200 during assembly. The gripper 400 can have a skewed surface area 422 provided at the leading edge end 418. As viewed from the first end 418, the area 422 can be inclined and away from the axis.

[0262] The area 422 can be designed to interact with the gripper retaining bosses 207, and these gripper retaining bosses should engage with the associated gripper interface features 410b, such as the opening 410b and / or the retaining groove 410b (see Figure 4F and Figure 4E ). When assembled to the cap 200, the skewed surface area 422 can be angularly aligned with the gripper interface features 410b and / or the gripper retaining bosses 207 that should engage with the gripper interface features. Axially, the skewed surface area 422 is offset towards the distal end relative to the gripper interface features 410b. In the Figure 4A illustrated embodiment, the gripper interface feature is formed by the opening 410. When the gripper retaining bosses 207 contact the surface area 422 during 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 features (opening 410b / retaining groove 410b) engage with the gripper retaining bosses 207 (e.g., see Figure 4F ). When the engagement is established, the elastic bias of the gripper 400 can decrease, for example until the gripper 400 abuts against the cap 200.

[0263] In Figure 4A , a cutout forming the gripper orientation feature 416 is shown. The cutout can have skewed side surfaces 424 that angularly define the cutout. Axially, as viewed along the axial direction away from the first end 418 (e.g., in the proximal direction P), the cutout can be defined by the surface 426. The angular extent of the cutout can decrease or reduce as the distance from the first end 418 increases. In other words, the cutout can taper towards the second end 420 (e.g., towards the proximal direction P). When the cutout is viewed in a plan view or top view, the surface 426 that axially defines the cutout can extend perpendicular to the axis A. When the cutout is viewed in a plan view or top view, the angle of the surface 424 relative to the axis can be less than 90°, for example 45 degrees or less.

[0264] The kink, fold or bend region 404 may extend along the longitudinal direction of the gripper 400, preferably along the entire axial extent of the gripper 400. Accordingly, at the leading edge end or leading edge 418, the kink, fold or bend 404 may define a corner 428. The corresponding 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.

[0265] The trailing edge end 420 of the gripper support 402 may include at least one additional notch 434. The notch 434 has the function of assisting in maintaining the orientation of the assembly head during assembly (e.g., the assembly of the gripper 400 and the cap).

[0266] The trailing edge end 420 may also include smaller recesses 436, which are recesses formed during the production of the metal sheet for later forming the gripper 400. ……

[0267] Figure 4C An exemplary embodiment of a single-piece sheet 430 from which the gripper support 402 may be formed is shown. The metal sheet and thus the gripper 400 may include two sets of three openings 410a, 410b, 410c each. Each opening 410 may include a corresponding barb 412. The webs between the openings 410a, 410b, 410c may be optional, e.g., there may be a common opening for several barbs 412. All barbs 412 may have the same length and / or shape. Alternatively, the shape and / or length of at least one of the barbs 412 may be different from the shape and / or length of the other barbs 412.

[0268] The two sets of openings, e.g., 410a, 410b, 410c, are arranged on the metal sheet such that when the gripper support 402 is formed, the two sets of openings 410 and their corresponding barbs 412 may be positioned substantially opposite each other. In this way, during the removal of the needle guard (RNS or SNS) 914, the force exerted by the barbs 412 on the needle guard is more evenly and / or symmetrically distributed, and the needle guard can be removed better.

[0269] According to one aspect of the present disclosure, the gripper 400 may be produced by the following steps:

[0270] - Providing a gripper support 402 in the form of a sheet 430, such as a metal sheet, e.g., a stamped or punched (blanked) metal sheet;

[0271] - Forming a plurality of barbs 412 on the gripper support 402 by cutting, stamping, embossing or molding;

[0272] - The gripper support 402 is bent or kinked multiple times along multiple longitudinal folding edges or lines 404 to form multiple support portions 406 in such a way that more than one of the multiple support portions 406 can include respective barbs 412;

[0273] - The barb 412 is bent in such a way that the barb 412 protrudes from the inner surface of the associated support portion 406, for example, as shown in Figure 4A and Figure 4B .

[0274] The sheet 402 can be a single-piece sheet metal, which can be cut, for example, by stamping or embossing to form incisions or openings 410 and barbs 412 in the incisions or openings 410.

[0275] The sheet can include stainless steel, such as EN 1.4310, a high-strength stainless steel.

[0276] The maximum outer diameter of the gripper 400 in the assembled state can 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 can be smaller than the outer diameter of the sheet. This may be because there is an overlapping region 408 in the gripper 400 in its assembled state (see, for example, Figure 4A and Figure 4B ).

[0277] The opening 410 can have a generally rectangular form. The amount of extension of the opening 410 along the transverse axis of the sheet 420 can represent the width or breadth of the opening 410 (e.g., 410a, 410b, and 410c).

[0278] The barb 412 can have a smaller width than the opening 410 and can extend longitudinally along at least one-third of the respective opening 410.

[0279] 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, and this length is measured from the proximal end of the barb 412 to the distal end of its prong

[0280] 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.

[0281] Figure 4D and Figure 4E shows the gripper 400 in an engaged position with the needle guard 914 of the syringe barrel 900. All other elements, such as the body or barrel 902 of the syringe barrel 900 and the cap 200, are not depicted in this figure.

[0282] As can be seen, the gripper 400 can be arranged on the distal part of the needle guard 914 such that at least the proximal part D4 of the needle guard between the proximal end (e.g., the trailing edge 420) of the gripper 400 and the proximal end of the needle guard 914 is not covered.

[0283] Accordingly, the length of the gripper 400 can be shorter than the length of the needle guard it is intended to grip, such that the proximal part of the needle guard 914 extends proximally beyond the proximal part of the gripper 400.

[0284] The leading edge 418 of the gripper 400 can be aligned with the distal end of the needle guard 914 along a vertical plane, or it can be substantially aligned with the distal end of the needle guard 914.

[0285] In the assembled position of the gripper 400 and the needle guard 914, the barbs 412 are properly bent and penetrate the needle guard 914. As can be seen from Figure 4D the contact point (e.g., the penetration point) of the barbs 412 with the needle guard 914 can be offset distally relative to the longitudinal midpoint of the needle guard 914. In other words, the gripper 400 can grip the needle guard 914 at the distal part of the needle guard 914. In other words, the gripper 400 can interact with the needle guard 914 via the barbs 412 at a position approximately the sum of the part D4 and the part D5 (and the length of the barbs 412) from the proximal end of the needle guard 914.

[0286] The advantage of the proximal part D5 of the gripper 400 can be that it keeps the needle guard 914 stable during removal of the cap 200 and thus removal of the needle 0 itself. In this way, the sterility of the needles 110, 908 can be further maintained.

[0287] The required size of the gripper 400 depends on the drug delivery device, the prefilled syringe, and in particular on the needle guard used in a particular drug delivery device, and can thus vary accordingly.

[0288] Figure 4F A cross-sectional view of the gripper 400 of the previous embodiment assembled within the cap 200 is shown.

[0289] As can be seen, the gripper 400 is inserted into the cap opening 206 ( Figure 3D as shown), which is configured and / or sized to receive the gripper 400 when the gripper 400 is introduced. The cap opening 206 can be defined by a tubular or sleeve-like part of the cap 200, the size of which can be set to receive the gripper 400 therein.

[0290] In addition, in order to correctly orient the gripper 400 during assembly within the cap 200, the gripper 400 may include an orientation element 416 indicating the assembly orientation. The orientation element 416 may be designed as a tactile indicator or a visual indicator or a combination thereof. In particular, one front surface of the gripper bracket 402 is shaped, for example, wavy or prong-shaped. The orientation feature 416 may be a notch as described in more detail above.

[0291] The cap 200 may further include at least two lugs, bosses or gripper retaining bosses 207, which may be designed to engage with one of a set of three openings 410, preferably the middle opening 410b. In the assembled state, the gripper retaining boss 207 may abut against the corresponding distal end 432 of the opening 410 and hold the gripper 400 in its position within the cap 200, see Figure 4G .

[0292] In the context of the present disclosure, "angular" may refer to an azimuthal direction, i.e., a direction defined by an azimuth angle or a rotation angle relative to an axis (e.g., relative to a longitudinal axis extending through the cap opening 206).

[0293] The gripper 400 may be elastically deformed during assembly. Here, before the gripper 400 engages with the gripper retaining boss 207, the gripper 400 is first slightly elastically deformed, for example, because the diameter of the cap opening 206 is smaller than the diameter of the undeformed gripper 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 gripper 400 in one or more regions angularly offset relative to the gripper retaining boss 207.

[0294] In particular as Figure 3D depicted, the cap 200 may include at least one, preferably four, gripper guiding features 211 and an inner distal hole 212.

[0295] In embodiments suitable for reducing or preventing scratching or generating debris, the sensitive area of the cap 200 may include the inner distal hole 212.

[0296] The inner distal hole 212 may extend radially through a section of the cap, such as the cap shell 210. The inner distal hole 212 may be defined during the molding of the cap 200.

[0297] The inner distal hole 212 may axially overlap with the gripper retaining boss 207.

[0298] The inner distal hole 212 can extend axially in a region offset distally or away from the cap opening 206 relative to the gripper retaining boss 207, preferably in the entire region up to the end of the receiving space of the cap housing 210.

[0299] The opening can be axially overlapped with the gripper retaining boss 207. It has been proven that the use of the inner distal hole 212 is also particularly advantageous in avoiding scratches or debris.

[0300] It should be noted that due to the presence of the inner distal hole 212 in the sensitive area, there is no gripper guiding feature 211 in this area.

[0301] As depicted, the absence of the gripper guiding feature 211 can be angularly offset relative to the inner distal hole 212 or the sensitive area.

[0302] Therefore, despite the presence of the inner distal hole 212 in the sensitive area, a gripper guiding feature 211 can still be established, which guides the engagement of the interface features of the gripper and the cap during assembly.

[0303] In Figure 4G the interaction between the gripper retaining boss 207 of the cap 200 and the opening 410b / holding groove 410 of the exemplary gripper 400 is shown in more detail.

[0304] The gripper retaining boss 207 includes an inclined area or ramp section 207a at its proximal end. The preferably planar surface of this section or area can 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 can be arranged to interact with the surface 432 of the gripper 400 (such as the surface 432 that distally defines the holding groove 410b and / or the opening 410b). The distal 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 and the axis A. For example, the end surface 207b can be oriented perpendicular to the axis A. The proximal ramp section 207a and the end surface 207b can be connected by a connecting area 207c, which can extend substantially parallel to the axis A.

[0305] In the assembled position, the end surface 207b of the gripper retaining boss 207 can abut against the surface 432 of the holding groove 410b and / or the opening 410b distally.

[0306] Figure 4H A cross-section of the front end of the injection device 100 is shown, on which the cap 200 is mounted and the gripper 400 is mounted on the cap and interacts with the needle guard 914.

[0307] As shown, the barb penetrates the needle shield 914 to grasp the needle shield and enable removal of the needle shield 914 by removing the cap 200. The length of the barb 412 can be such that only the tip of the barb penetrates the needle shield 914 to maintain the sterility of the needle 908.

[0308] In this illustration, the gripper guiding 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 the diameter at its proximal end. In an embodiment where the needle shield 914 has a constant diameter from proximal to distal, the leading edge 422 will contact the outer surface of the needle shield 914 and provide guiding assistance during assembly of the gripper 400 onto the injection device 100 including a needle shield with a constant diameter.

[0309] 5. Needle shield (needle cannula) ( Figure 5 )

[0310] As Figures 1B to 1D depicted, the drug delivery device 100 may further include a needle shield 500. The needle shield 500 is shown in more detail in Figure 5 . The needle shield 500 may project 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 move relative to the device body 700 from a first shield position X (see Figure 1B ) to a second shield position Y (see Figure 1C ).

[0311] The needle shield 500 may be arranged to extend beyond the distal tip of the needle 908, which may project from the device body 700 before the start of the drug delivery operation. The needle shield 500 may 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 may pierce the user's skin. The needle shield 500 may serve as a trigger member for the drug delivery device 100. The needle shield 500, as a trigger member, preferably when it is in the second shield position Y, may automatically initialize the drug delivery operation when displaced proximally from the first shield position X to the second shield position Y. The needle shield 500 may be maintained in contact with the skin until the drug delivery operation has been completed, which may be indicated by audible, tactile, and / or visual indications provided by the drug delivery device 100. After completion of the drug delivery operation, the needle shield 500 may move distally relative to the device body 700 to a third shield position Z (see Figure 1D ) to cover the tip of the needle 908.

[0312] The drug delivery operation of the drug delivery device 100 can be initialized by moving the needle shield 500 to remove a mechanical lock that prevents the plunger 1000 from moving in the distal direction or by moving the plunger 1000 to unlock the mechanical lock. Alternatively, the needle shield 500 can be configured to trigger the drug delivery operation only when moving from a first shield position X to a second shield position Y and, appropriately, when 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 initiate the drug delivery operation. The trigger button can be operated to initiate the drug delivery operation only when the needle shield 500 is in the second shield position Y. In yet another alternative, the needle shield 500 can be configured to prevent needle stick injuries only 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 at all in triggering the drug delivery operation or effectuating the triggering of the drug delivery operation. In the currently described device, the needle shield acts as a trigger member. Thus, the user does not need to actuate a separate trigger member.

[0313] As described in more detail below, the drug delivery device 100 can include a needle shield spring 600. The needle shield spring 600 can be operatively coupled to the needle shield 500 so as to move the needle shield 500 in the distal direction D relative to the device body 700 when the drug delivery device 100 is removed from the skin. To move the needle shield 500 in the 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 and the drug delivery device 100 is in a final or third shield position Z (see Figure 1D ), where the drug delivery device 100 has been removed from the skin and the needle shield spring 600 has displaced the needle shield 500 distally, the needle shield 500 can be locked against proximal movement relative to the device body 700.

[0314] Figure 5Shows a detailed exemplary illustration of the needle shield 500. The needle shield 500 may include a skin contact surface 501 having a circular shape or other shape, which is disposed at the cylindrical distal portion 502 of the needle shield 500 and is designed to be placed on the skin of the user. The skin contact surface 501 may have an opening concentric with the circular shape, which axially extends in the proximal direction through the cylindrical distal portion, wherein, in the assembled state of the drug delivery device 100 (when viewed in a plan view), the opening encloses the needle 908. Starting from, for example, the cylindrical distal portion 502, the needle shield 500 may have a side region 503 extending in the proximal direction P. In the illustrated example, 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. These two side regions 503 are arranged opposite to each other and are designed to enclose the optional syringe holder 800 (if present), the pre-filled 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.

[0315] Each of these 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 a cap clip window 504, a front stop groove 505, and a plunger boss groove 506. In the depicted embodiment, the front stop groove 505 may be located axially between the cap clip window 504 and the plunger boss groove 506, wherein the cap clip window 504 may 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.

[0316] The cap clip window 504 may be a recess (e.g., rectangular), 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 the axial movement of the needle shield 500 relative to the device body 700. This connection may provide a safety feature, for example, if the drug delivery device 100 is accidentally dropped by the user, this safety feature may prevent the dispensing mechanism from being accidentally triggered.

[0317] The front stop groove 505 may be a (e.g., rectangular) rectangular recess, which may cooperate with the needle shield front stop 724 (e.g., Figure 7CThe bosses 724 shown on the inner surface of the device body 700 interact to define the maximum distal position of the needle shield relative to the device body 700 after operation of the drug delivery device (e.g., at the end of an injection).

[0318] The plunger boss groove 506 can be an L-shaped recess, i.e., a recess formed by two rectangles of different sizes, namely a proximal groove 506a and a distal groove 506b placed directly adjacent to each other. The angular width of the proximal groove 506a can be smaller than the angular width of the distal groove 506b. The plunger boss groove 506 and at least one of the plunger bosses 1040.2, 1040.3 of the plunger 1000 (see Fig.10 ) can form a mechanical lock, e.g., a rotational lock. As long as the mechanical lock is established, the needle shield 500 can be held in the first shield position X. The plunger boss groove 506 can be configured to allow the needle shield 500 to move relative to the plunger 1000 when the needle shield 500 moves from the first shield position X to the second shield position Y in order to release the mechanical lock. Here, due to the plunger boss 1040.2 of the plunger 1000 (see Fig.10 ), rotational movement of the plunger 1000 relative to the needle shield 500 can be prevented until the plunger bosses 1040.2, 1040.3 (see Fig.10 ) move axially from the proximal groove 506a into the distal groove 506b.

[0319] The plunger boss groove 506 can include a groove rib 507 located on one side of the transition from the proximal groove 506a to the distal groove 506b, and due to the different rectangle sizes, the groove rib can include a shoulder 507a. The groove rib 507 can include a contact surface 507b on the inner surface 503a of the side region, wherein the contact surface 507b can be designed for the plunger boss 1040.2 (see Fig.10 ) to rest against. The groove rib 507 can further include an optional first ramp 507c and an optional second ramp 507d, and the first ramp and the second ramp can interact with the plunger 1000, e.g., with the plunger boss 1040.3, as shown in Figure 10G and Fig. 10H . The optional first ramp 507c can be located at the transition from the proximal groove 506a to the distal groove 506b and can interact with the plunger boss 1040.3, see Figure 10G and Fig. 10H . In the unlikely case that the plunger 1000 does not rotate spontaneously (e.g., when the needle shield is in the second position), the first ramp 507c can interact with the plunger boss 1040.3, see Figure 10G and Fig. 10H, so as to additionally prompt or initiate the rotation of the plunger 1000. The second ramp 507d may be located at the proximal end of the side region 503 and may be designed to facilitate the starting of the plunger 1000 during the final assembly of the drug delivery device 100, for example by acting on the plunger boss 1040.3, as Figure 10G and Fig. 10H shown.

[0320] As can be seen in Figure 5 , the needle shield 500 may include plunger guide ribs 508 on the inner surface 503a of the side region, which are designed to provide angular guidance to the plunger 1000, for example, for one or both of the bosses 1040.2 and 1040.3. In addition, the needle shield 500 may have grooves 509 on the outer surface 503b of the side region. These grooves may be provided to reduce part warping during and / or after injection molding during the manufacture of the needle shield 500. The mechanical stability may also be improved by the grooves 509.

[0321] Figure 5 It is also shown that the needle shield 500 may have at least one needle shield blocking device 510. The needle shield blocking device 510 may be offset 90 degrees relative to each cap clip window 504 in the rotational direction. The needle shield blocking device 510 may be embodied as an elastically pivotable flexible arm 510, which is biased or may be biased radially away from the longitudinal axis in the assembled state of the device 100. The needle shield 500 may have a plurality of flexible arms 510. For example, the needle shield 500 may have one, two, three, four, five, six, seven, eight or more flexible arms 510. The flexible arms 510 may be evenly distributed along the circumference of the needle shield 500. In addition, the flexible arms 510 are arranged opposite to each other. After the drug delivery operation has been completed, the drug delivery device 100 may be removed from the user's skin. The needle shield 500 may be biased relative to the device body 700 towards the first shield position X by the needle shield spring 600. Thus, when the drug delivery device 100 is removed from the skin, the needle shield 500 may move relative to the device body 700 towards the first shield position X, for example, beyond its first shield position X, into the final locked or third shield position Z, as Figure 1DAs shown. In the third cannula position Z, the cannula 500 can be axially locked relative to the device body 700 against movement in the proximal direction by a locking engagement between the flexible arm 510 of the cannula 500 and an associated protrusion of the device body 700 (e.g., the cannula locking structure 720 on the inner surface of the side wall 700a of the device body 700). The cannula locking structure 720 can also be referred to as a blocking element 720 or a ramp-shaped element 720. Since the cannula 500 is axially locked, the cannula can no longer be displaced proximally relative to the device body 700 to the second and / or first cannula positions of the cannula 500. This can protect the user from needle stick injuries after use. Additionally, when the cannula 500 is in the third cannula position Z, it may no longer be possible to reattach the cap 200, for example due to the flexible arm 510 and / or due to features on the cap 200 (especially features on the optional cap cover 300).

[0322] As Figure 5 As shown, the flexible arm 510 can have a (e.g., cuboid-shaped) bulge 510.1 in the radial direction at its proximal region. The bulge can project radially from the flexible arm. The bulge 510.1 forms the proximal end of the flexible arm 510. The bulge can also be referred to as a stop surface. In the circumferential direction, the bulge 510.1 can extend further than in the axial direction of the cannula 500. Due to the cuboid shape and the height difference in the radial direction relative to the rest of the outer surface of the flexible arm, the flexible arm has edges in the distal and proximal directions. The bulge 510.1 of the flexible arm 510 can engage with a corresponding protrusion at the inner circumferential surface of the device body 700 to lock the cannula 500 against axial movement relative to the device body 700 (e.g., in the third cannula position Z). It should be noted that in this disclosure, the first cannula position X is also referred to as the intermediate position X, and the third cannula position Z is also referred to as the initial position Z. For example, when the cannula is in the third cannula position Z, one surface of the bulge 510.1 (e.g., the surface pointing in the proximal direction P) can abut against the distal surface of the cannula locking structure 720. Thus, the proximal movement of the cannula 500 relative to the device body 700 is restricted. In other words, the bulge 510.1 and the cannula locking structure 720 provide a post-use cannula locking mechanism, which can prevent user injury by preventing the needle tip from being exposed.

[0323] For example, if the proximal force applied to the cannula 500 is less than 60 N, preferably less than 50 N, more preferably less than 40 N, the post-use cannula locking mechanism can prevent the cannula 500 from moving proximally relative to the device body 700.

[0324] In this disclosure, the bulge 510.1 can also be referred to as the stop surface 510.1. The flexible arm 510 can also have a web 510.2, as Figure 5As shown. In this disclosure, the web 510.2 may also be referred to as the protrusion 510.2. The web 510.2 may have a free end in the distal direction, and the free end may be chamfered. The relatively proximal end of the web may transition to a bulge. The height of the web 510.2 in the radial direction may be lower than or the same as the height of the bulge 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 the recess of the needle shield locking structure 720 to prevent the needle shield 500 from rotating relative to the device body 700. Alternatively or additionally, due to this interaction, 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, the degree of inward deflection required for the flexible arm 510 may be reduced. This reduces the load on the flexible arm.

[0325] As Figure 5 shown, 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 may be a circular material recess. The material recess provides a hinge 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) may be a cylindrical sleeve-like area of the needle shield. Preferably, at any position of the needle shield relative to the device body, only this area protrudes from the device body.

[0326] In addition, the needle shield 500 may move slightly in the distal direction immediately after the cap 200 is removed, but this movement occurs 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 rotates to the 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 when the device body 700 and the needle shield (biased by the needle shield spring) abut against the cap before the cap is removed.

[0327] 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 regions 503, the inner surface 503a of the side regions, the outer surface 503b of the side regions, 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 recess 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-piece or multi-piece needle shield 500 can also be used.

[0328] 6. Needle shield spring( Fig. 6A 、 Figure 6B )

[0329] Fig. 6A and Figure 6B shows the needle shield spring 600. As Figure 6B 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 particularly, 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.

[0330] In one embodiment, the needle shield spring 600, in particular its proximal end, can be supported by the needle shield rear stop 721 (described below) of the device body 700 in the radially outward direction. In other words, the needle shield spring 600 can be prevented from tilting relative to the device body 700 and / or deflecting radially outward by the needle shield rear stop 721.

[0331] The cannula spring 600 can be configured to provide a force to the cannula 500. This force biases the cannula 500 in the distal direction D. The cannula spring 600 can be configured such that when a force less than the cannula spring force is applied to the cannula 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 cannula spring force can push the cannula 500 distally. Additionally, the cannula spring 600 can be configured to ensure that the device 100 can only be enabled if the cannula 500 is pressed against the user's skin with a sufficient force. In other words, if the user does not press the cannula 500 against the injection site with a sufficient force, the drug delivery device 100 is not enabled / triggered. Thus, the cannula spring 600 can be configured to meet a minimum enabling force requirement. For example, the minimum force required to enable the drug delivery device can be between 1 N (Newton) and 50 N, preferably less than 20 N.

[0332] In one embodiment, the cannula spring 600 can be made of high-strength stainless steel. For example, the cannula spring 600 can be made of austenitic steel with sufficient elasticity to allow the cannula spring 600 to be elastically compressed. In one embodiment, the cannula spring 600 can be made of austenitic chromium-nickel steel. In one embodiment, the cannula spring 600 can be made of DIN EN 1.4310 steel.

[0333] In one embodiment, the length of the cannula spring 600 can be selected such that a smooth force curve can be obtained and excessive enabling forces can be avoided.

[0334] In one embodiment, the cannula spring 600 can be made of coiled wire. The wire diameter can be selected according to the stress endured when the cannula spring 600 is compressed. Further, the wire can be soap-lubricated wire to aid manufacturability.

[0335] In one embodiment, the cannula spring 600 can have 5 to 50 coils, preferably 5 to 25 coils, and more preferably 10 coils. The outer coil diameter can be selected according to the geometry of the cannula 500, in particular the flexible arm 510 of the cannula 500, such that when the flexible arm 510 deflects on the cannula locking structure while the cannula spring 600 surrounds the axial support front end 703 of the device body 700, collisions with the flexible arm 510 can be avoided.

[0336] In one embodiment, the outer coil diameter can be between 5 mm and 20 mm, preferably between 10 mm and 15 mm, more preferably between 12 mm and 14 mm, for example 13 mm. The inner coil diameter can be between 5 mm and 20 mm, preferably between 10 mm and 15 mm, more preferably between 11 mm and 13 mm, for example 12 mm.

[0337] In one embodiment, the coiled wire may have a double or triple coil winding 601 at its end. The double or triple coil winding 601 may be formed by two or three coils that are axially in contact with each other along their circumferences. The double or triple coil winding 601 may provide a contact surface for firmly contacting the needle shield spring 600 with the needle shield 500 and the device body 700.

[0338] 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.

[0339] 7. Device body( FIG. 7A to FIG. 7G )

[0340] Fig. 7A and Figure 7B shows a device body 700 according to an embodiment of the present disclosure. The device body 700 may be the 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.

[0341] The device body 700 may have a cylindrical shape. In other words, the device body may have a distal end and a proximal end that are connected to each other by a side wall 700a. The side wall 700a defines the 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, towards the distal end, the cross-sectional area may increase such that the cross-sectional area at the distal end may be larger than the cross-sectional area at the proximal end.

[0342] In one embodiment, the cross-sectional area may increase from a drug window 710 (side wall window) in the side wall 700a, for example from its middle to the distal end. This increase may be linear or non-linear (e.g., parabolic), such that the outer surface of the side wall 700a of the device body 700 may curve towards the distal end.

[0343] At its proximal end, the device body 700 includes a proximal orifice 730. The proximal orifice 730 may be defined by a proximal edge 732 of the side wall 700a.

[0344] The side wall 700a may provide a user gripping surface that allows a user to manipulate and / or operate the drug delivery device 100.

[0345] The side wall 700a of the device body 700 may include at least one opening. The opening may be a drug window 710. The drug window 710 may be arranged in the distal half of the side wall 700a, preferably in its fourth and / or fifth section when the axial length of the side wall 700a measured from the proximal end is divided into six equal-length sections. The drug 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 attaching a label.

[0346] Through the drug window 710, the user may be able to see the plunger stop 910 of the syringe 900 (described below) and / or the plunger 1000 (described below). Through the drug window 710, the user may further see the drug Dr before and during injection. For example, during the operation of the drug delivery device 100, the user may first see the drug Dr and the barrel 902 of the syringe 900 (described below), which may be a pre-filled syringe containing the drug Dr. During injection, the user may see the plunger stop 910 and then see the plunger 1000 moving distally in the barrel 902.

[0347] 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 other components being, for example, 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 mainly 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.

[0348] 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. As Fig. 7A shown, the recesses may be proximal incisions 714. The proximal incisions 714 may be arranged to be proximally offset relative to the drug window 710, for example near the proximal end of the device body. For example, when measured from the proximal end, the proximal incisions 714 may be arranged in the first 20% or the first 10% of the length of the side wall 700a. The proximal incisions 714 may be offset from each other by 180 degrees in the circumferential direction of the device body 700. At least one of the proximal incisions 714 may overlap the drug window 710 in the circumferential direction.

[0349] As described below, for example in Section 12, the proximal incision 714 can interact with the latching protrusion 1203.2 of the latching arm 1203 of the drive spring retainer 1200, for example when the drive spring retainer is in the (first) drive spring retainer position (closure position). Further, as described below, the proximal incision 714 can interact with the retaining clip 806 of the syringe retainer 800, for example when the syringe retainer 800 is in the first syringe retainer position (first container retainer position).

[0350] The side wall 700a can further include an injection molding gate recess 712. The injection molding gate recess 712 can be formed at the outer surface of the side wall 700a. The injection molding gate recess 712 does not penetrate through the side wall 700a. The injection molding gate recess 712 can be offset distally relative to the proximal incision 714. The injection molding gate recess 712 can be offset proximally relative to the drug window 710. In one embodiment, the injection molding gate recess 712 can be arranged near the middle or in the middle of the side wall 700a along the axial direction of the device body 700.

[0351] In one embodiment, the side wall 700a can further include a second body connection structure. The second body connection structure can include at least one, preferably at least two recesses. As Fig. 7A shown, the recess can be the distal incision 713. The distal incision 713 can be arranged to be offset proximally relative to the drug window 710. The distal incision 713 can be offset distally relative to the injection molding gate recess 712. The distal incision 713 can be offset distally relative to the proximal incision 714. In one embodiment, the distal incision 713 can be arranged in the middle or near the middle of the side wall 700a along the axial direction. The distal incisions 714 can be angularly offset from each other by 180 degrees.

[0352] The proximal incision 714 can be larger than the distal incision 713. In other words, the proximal incision 714 can extend further than the distal incision 713 in at least one spatial direction. In one embodiment, at least one of the at least one distal incision 713 can be aligned with at least one proximal incision 714.

[0353] At least one, preferably all, of the distal incisions 713 can overlap with a corresponding number of proximal incisions 714 in the circumferential direction. The overlap can be a partial overlap. Preferably, the proximal incisions 714 completely overlap the distal incisions 713 in the circumferential direction. Further, at least one of the distal incisions 713 can overlap or be aligned with the drug window 710 in the circumferential direction.

[0354] As described below, the distal incision 713 can interact with the retaining clip 806 of the syringe holder 800. Thus, the syringe holder 800 can be fastened to the device body 700, for example, in a second syringe holder position (second container holder position).

[0355] The incision 713 and / or 714 can be arranged to be offset relative to the centerline between the retaining ribs 726 (described in more detail below). Alternatively or additionally, the incisions 713, 714 can be offset relative to the longitudinal centerline extending in the axial direction of the drug window 710, as Fig. 7A and Fig.17 shown. Alternatively or additionally, the incision 713 and / or 714 can be arranged intermediate the retaining ribs 726, i.e., centered.

[0356] The device body 700 can include an on-body user indicator 733 at the outer surface of the sidewall 700a. The on-body user indicator 733 can be configured to indicate to the user the position of the device body 700 relative to other components of the drug delivery device 100 (such as the cap 200).

[0357] When the sidewall 700a is labeled, the injection molding gate recess 712 and / or the incisions 713, 714 can be hidden by the label such 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 can provide comfort to the user.

[0358] The device body 700 can be formed of polycarbonate (PC) Makrolon 2258 (a medical grade PC) or other materials. PC can be selected mainly considering its strength, flexibility, toughness, and its strength at high temperatures, thus allowing for a shortened injection molding cycle time and thus allowing for a reduced part cost.

[0359] As Figure 7B shown, 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 within the device body 700 such that a 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 the distal end of the device body by a certain length, for example, between 4 millimeters (mm) and 8 mm, while withstanding the impact load caused by the impact of the plunger 1000 on the plunger stop 910 of the syringe 900 at the start of injection.

[0360] In one embodiment, the syringe support mechanism is configured to support a syringe (e.g., a pre-filled syringe 900) in the device body 700, e.g., resisting distal movement relative to the device body 700. In one embodiment, the syringe support mechanism may be configured to support the shoulder 904 of the syringe 900. Thus, manufacturing tolerances can be better compensated compared to designs that support the proximal flange 912 of the syringe 900. This results in less variability in the amount by which the distal end of the needle extends beyond the device body 700 when the syringe 900 is in its final assembled position in the device body 700.

[0361] A specific designed assembly process may be required to ensure that the components reach their correct final positions and that the syringe 900 is properly supported.

[0362] As Figure 7C shown, the syringe support mechanism may include a central support structure 701 formed inside the device body 700. In one embodiment, the central support structure 701 may be configured to support the barrel 902 of the syringe 900, e.g., supporting the shoulder 904. In one embodiment, as Fig.7D and Fig. 7E shown, the central support structure 701 may be configured to support the syringe holder 800.

[0363] The central support structure 701 may include a central tube 702 configured to radially support the barrel 902 of the syringe 900 (see Figure 7C ) or the syringe holder 800 (not shown). In one embodiment, the central tube 702 may have an open circumference, e.g., 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 (e.g., when measured from the shoulder 904 to the distal surface of the syringe flange 912 (not shown)).

[0364] The central support structure 701 may include an axial support front end 703 configured to axially support the syringe 900, e.g., resisting 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.

[0365] 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 barrel 900, thereby preventing the syringe barrel 900 from moving distally beyond the axial support front end 703, and in particular beyond the protrusion 704. In other words, the axial support front end 703 may define the maximum distal position of the syringe barrel 900 relative to the device body 700 and hold the syringe barrel 900 relative to the device body 700 in its desired axial position.

[0366] In one embodiment, the axial support front end 703 may have a closed circumference. Thus, the axial support front end 703 may surround the shoulder 904. The closed circumference may enable the force to be evenly distributed over the entire contact surface. The closed circumference may also enable the axial support front end 703 to withstand higher loads and impacts in the distal and / or radial directions.

[0367] In one embodiment not shown in the drawings, the axial support front end may have an open 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 in order 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.

[0368] In one embodiment, the inner diameter 704ID of the radially inward protrusion 704 may be smaller than the outer diameter 902OD of the barrel 902. For example, the inner diameter 704ID may be at least 2%, at least 5%, at least 10% or at least 20% smaller than the outer diameter 902OD.

[0369] In one embodiment as Figure 7C shown, the outer diameter 914OD of the needle shield 914 (described below) may 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 may 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 may be smaller than the outer diameter 902OD of the barrel 902. Further details regarding the syringe barrel 900 are described in Section 9 below.

[0370] In one embodiment as Fig.7DIn one illustrated embodiment, the outer diameter 914OD of the needle shield 914 can be greater than the outer diameter 902OD of the barrel 902, such as at least 2%, at least 5%, at least 10% or at least 20% greater. This may require the use of a syringe holder 800 in order to be able to assemble the syringe 900 in the drug delivery device 100, in particular in the device body 700. However, the syringe holder 800 can be used even 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 less than the outer diameter 902OD of the barrel 902.

[0371] In one embodiment, the axially supporting front end 703 can be configured to axially support the syringe holder 800 relative to the device body 700 (see Fig.7D ). For example, the axially supporting 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 axially supporting front end 703 can be configured to surround the flexible holder arm 801 of the syringe holder 800. The radially inwardly projecting portion 704 can form an abutment surface for the holder projection 803. The axially supporting front end 703 can have a closed circumference. Thus, the axially supporting front end 703 can surround the holder arm 801. The axially supporting front end 703 can have a tapered inner surface 703.1, the diameter of which decreases in 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. Thus, the tapered inner surface 703.1 can limit the radially outward movement of the holder arm 801 or even cause the holder arm 801 to deflect radially inwardly. Regarding 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.

[0372] The central support structure 701 (in particular its central tube 702) can 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 in order to allow, for example, inspection of the syringe 900, the drug within the syringe 900, the plunger stop 910 and / or the plunger 1000 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).

[0373] 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.

[0374] 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. Only the connection configuration is 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.

[0375] Therefore, the contact between the needle shield 500 and the device body 700 can be improved, so that the axial and / or rotational stability of the needle shield 500 inside the device body 700 can be improved.

[0376] 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 a 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.

[0377] The illustrated embodiment includes four connecting ribs 708 that extend in the axial direction of the central support structure 701, for example, 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.

[0378] 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 less than 90 degrees of the circumference 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 the axial support front end as described above. All 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.

[0379] 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.

[0380] 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 the closed 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 closed position, the drive spring holder 1200 may be fastened to the device body 700 to resist axial and / or rotational movement.

[0381] In one embodiment, if the device body 700 is used for a drug delivery device 100 having a syringe holder 800, when the syringe holder 800 is moved distally into the device body 700 from the proximal end (e.g., through the proximal orifice 730), the proximal incision 714 may interact with the retaining clip 806 of the syringe holder 800.

[0382] 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.

[0383] 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.

[0384] 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 slopes radially inward 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.

[0385] 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 distally facing surface of the front stop groove 505 can abut against the proximally facing surface of the cubic 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.

[0386] 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 cubic 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.

[0387] 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 proximally 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.

[0388] Figure 7C and Figure 7F the illustrated embodiment includes four connecting ribs 708, and as previously described, each connecting rib has a needle shield rear stop 721. 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.

[0389] 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 inclined radially inward in the distal direction D.

[0390] The needle shield locking structure 720 may be disposed near the distal end of the device body 700, for example, 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 aligned with the drug window 710 in the circumferential direction. 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.

[0391] In Figure 7B , Figure 7C and Figure 7F the embodiment shown, the needle shield locking structure 720 may include at least one ramp-shaped element 720. The ramp-shaped element 720 may be offset in the axial direction relative to the needle shield front stop 724. Preferably, the ramp-shaped element 720 may be offset distally relative to the needle shield front stop 724.

[0392] Since the ramp-shaped element 720 is inclined radially inward 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.

[0393] 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 composed of 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.

[0394] 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.

[0395] 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.

[0396] 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 pairs of ramp-shaped elements 720 are angularly offset relative to each other in the circumferential direction, preferably such that the pairs are equidistantly arranged 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 pairs of ramp-shaped elements 720 and the needle shield front stoppers 724 may be equidistantly arranged 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.

[0397] 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 ).

[0398] 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.

[0399] 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 an 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.

[0400] 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.

[0401] 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 (e.g., 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 (e.g., 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.

[0402] In one embodiment, the needle shield guiding rib 723 is formed on the circumferential surface (lateral side) of the connecting rib 708, for example, 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-disengagement structure.

[0403] 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 bulge 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.

[0404] 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, for example, 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 extension. 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.

[0405] In one embodiment, the needle shield radial support rib 722 may be arranged to overlap with the needle shield locking anti-disengagement structure (e.g., rib 720.1) in the circumferential direction. Alternatively, the angular offset between the needle shield radial support rib 722 and the needle shield locking anti-disengagement rib 720.1 may be small, such as less than 45 degrees, less than 20 degrees, less than 10 degrees or less than 5 degrees. A smaller offset may be advantageous because it can 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-disengagement rib 720.1 extends in the radially outwards direction, the side region 503 can be fastened against radial movement.

[0406] 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 centerline of the central support window 709 and / or the drug window 710.

[0407] 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 sidewall 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 extent of the cap groove 725 may cover 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 equidistantly arranged around the circumference of the inner surface of the sidewall 700a. Alternatively, the cap grooves 725 may be arranged with different angular offsets in the circumferential direction.

[0408] 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 inward 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 of 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 inward from the sidewall 700a becomes zero.

[0409] 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 its radially inner surface, 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.

[0410] 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.

[0411] 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.

[0412] 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.

[0413] 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.

[0414] 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 using the drug delivery device 100 or the manufacturing date of the drug delivery device 100.

[0415] 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 an 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.

[0416] 8. Syringe Holder ( FIG. 8A to FIG. 8D )

[0417] Fig. 8A And Figure 8B An optional syringe holder 800 is shown to allow for 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 the pre-filled syringe 900 (e.g., a medicament container) within the device body 700, which will be further explained in more detail below.

[0418] In particular, the syringe 900 can be a 1.0 ml prefilled syringe 900 with a rigid protective needle shield 914 (RNS). Generally, the dimensions (such as 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 prefilled syringe 900 to be accurately supported in the mounting position despite these variations, the syringe holder 800 and the design of 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 prefilled syringe 900 at its reference at the mounting position. The reference 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 (such as is typically the case for a 1 ml syringe), such that the syringe holder facilitates access to the syringe shoulder.

[0419] Accordingly, 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 a relaxed state. Alternatively, the flexible holder arms 801 can project outwardly in a relaxed state. Other configurations of the arms in the relaxed state are possible.

[0420] The syringe holder 800 can include a holder housing 800a (such as a body portion) adapted to receive the prefilled syringe 900 and at least two flexible holder arms 801 (such as four flexible holder arms 801) adapted to couple to the prefilled syringe 900 at the mounting position. The holder housing 800a can be formed as a hollow cylinder or a cylindrical portion.

[0421] The flexible holder arms 801 can extend distally from the axial holder front end 802 (such as the distal end 802) of the holder housing 800a and can project inwardly in a relaxed state, such as be formed inwardly, such as at an angle. The flexible holder arms 801 can include holder protrusions 803 at their distal ends, which can point radially (such as inwardly).

[0422] The flexible holder arms 801 can have the same width throughout their entire extent, that is, 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 ).

[0423] 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 .

[0424] The holder 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 holder 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.

[0425] To support the final assembly of the pre-filled syringe 900 into the syringe holder 800, at least two flexible holder 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 holder 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 holder arms 801 can return to the relaxed state. This relative movement can be caused by an axial force acting on the syringe holder 800 (e.g., on the holder rear end 804).

[0426] Furthermore, when the syringe 900 is in the installation position, the device body 700 (front shell) can be adapted to restrain the flexible holder arms 801 from deflecting outwardly. This secures the syringe in the syringe holder.

[0427] The syringe holder 800 can include a holder rear end 804 opposite to the holder front end 802, i.e., the proximal end. At the holder rear end 804, the holder 800 can include a holder flange portion 805 that includes a retaining clip 806 for releasably and intermittently holding the syringe holder 800 relative to the device body 700.

[0428] The holder 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 holder body 800a.

[0429] The holder flange portion 805 can be non-circular, for example including two rounded sections 813 of the holder flange portion 805 arranged opposite to each other (e.g., diametrically opposite), and two radially inwardly recessed sections 812 that are flatter than the rounded sections 813. In this way, 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 holder flange portion 805 and are arranged on opposite sides of the holder flange portion 805 relative to the rounded sections 813. The two recessed sections 812 can define a recessed outer flange surface.

[0430] Two rounded sections 813 can 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, can be circumferentially aligned with the drug window 710 of the device body 700. The recessed section 812 can be arranged to be offset 90 degrees circumferentially relative to the window 814 of the syringe holder 800 and can in particular be circumferentially aligned with the rib 807 described in more detail later.

[0431] The axial extension of the recessed section 812 in the proximal direction can 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 can be closer to the proximal side than the proximal end 812a of the recessed section 812.

[0432] In this way, the two rounded sections 813 that further axially extend outward in the proximal direction can define a receiving space for receiving the syringe flange when the syringe flange of the prefilled syringe 900 is mounted on the syringe holder 800.

[0433] Once installed, the prefilled syringe 900 can be rotationally locked relative to the syringe holder 800 and / or relative to the device body 700. Specifically, the rounded section 813 can include ribs 819 on the inner surface, which can prevent the installed prefilled syringe 900 from rotating in the assembled state.

[0434] However, in embodiments where such rotation is considered necessary or advantageous, the prefilled syringe 900 can also be rotated relative to the syringe holder 800 and / or the device body 700.

[0435] The two recessed sections 812 can 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 can also 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 can 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.

[0436] The flat recessed section can form a receiving space for the needle shield arm, for example, during the assembly process or in the device.

[0437] Each recess may further include at least one, e.g., 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.

[0438] 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.

[0439] 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 mounting position of the container holder.

[0440] 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.

[0441] 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 mounting 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 regions (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.

[0442] 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.

[0443] The holding clip 806, particularly its flexible portion, can further axially extend 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).

[0444] In other words, the proximal extension of the holding clip 806 can be less than the proximal extension of the holder flange portion 805.

[0445] The proximal end of the holding clip 806 can point radially outward to engage with the cutouts 713, 714 of the device body 700. In one embodiment, the proximal end can have an inclined surface that is radially outwardly inclined in the proximal direction P. In an embodiment, the syringe holder 800 can include two holding clips 806 arranged opposite to each other. Instead of cutouts, 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.

[0446] 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 cutout 714 of the device body 700). In the first engagement position, the syringe holder 800 can move 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 in its proximal direction). Further, in the first engagement position, the syringe holder 800 can be prevented from rotating relative to the device body 700.

[0447] The holding clip 806 is configured such that when the syringe holder 800 moves distally, such as during its assembly, the holding clip 806 disengages from the cutout 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 cutout 713 of the device body 700). Upon alignment, the holding clip 806 interacts with the cutout 713 by deflecting radially outward into the space formed by the cutout 713. This is the second engagement position of the syringe holder 800. The interaction between the holding clip 806 and the cutout 713 prevents the syringe holder 800 from moving proximally and rotating relative to the device body 700.

[0448] 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 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.

[0449] 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 pre-filled 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.

[0450] 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) as they do not have to face any internal parts of the drug delivery device and enables them to unobstructedly view the pre-filled syringe 900 through the holder window 808 and the drug window 710 of the body 700.

[0451] The inner surface of the holder housing 800a may further include longitudinal ribs, such as support ribs 814 extending 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.

[0452] Once the pre-filled syringe 900 is inserted into the syringe holder 800, the support rib 804 may provide support for the syringe barrel 902. The support rib 814 further has the function of centering the pre-filled syringe 900 once it is inserted into the syringe holder 800, thereby ensuring that the pre-filled syringe 900 is centered inside the holder body 800a. By centering the pre-filled syringe 900 with the support rib 804, the needle of the pre-filled syringe 900 is axially parallel to the axially extending 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.

[0453] Fig.7DShows the syringe holder 800 arranged 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.

[0454] The outer diameter of the needle guard 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 projection 803 extending radially inwards, may be arranged between the shoulder 904 and the proximal end of the needle guard 914. Thereby, the needle guard 914 can be moved a small distance in the distal direction D. However, the sterility of the needle 908 can still be ensured thereby. The cap 200 and the needle guard 914 can be easily removed by providing a gap between the proximal end of the needle guard 914 and the shoulder 904. In other embodiments, the needle guard may not move.

[0455] As Figure 3A and Fig. 7A As shown in [relevant reference], 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 can 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 can 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 can have three rectangular recesses. The lengths of the side edges of the rectangles extending transversely to the longitudinal axis can be the same, and the lengths of the side edges of the rectangles extending along the longitudinal axis can increase in the distal direction. In addition, the recess arranged most distally of the on-body user indicator 733 can be located directly next to the opening of the device body. The on-cap user indicator 203 can 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 can be located distally relative to the recess with the trapezoidal or rectangular shape.

[0456] Figure 8C An exemplary embodiment showing a possible alternative or additional shape of at least one flexible holder arm 801 of the syringe holder 800 is presented.

[0457] In this embodiment, the flexible holder arm 801 may include a distal portion 816 that is configured to be wider in width than the proximal portion 817 of the flexible holder arm 801.

[0458] 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 between the holder protrusion and the pre-filled syringe 900 (e.g., with the barrel 902 of the pre-filled syringe 900) (see, for example, FIGS. 14a to

[0459] ).

[0460] Fig.8D Another exemplary embodiment of the syringe holder 800 is shown, in which Figure 8C The flexible holder arms 801 of Fig.8D The other features of the syringe holder 800 of Fig. 8A and Figure 8B are similar to the features in the syringe holder 800 of

[0461] 9. Pre-filled syringe ( Fig. 9 )

[0462] Fig. 9Shows an optional prefilled syringe 900. In particular, the syringe 900 can be a 1.0 ml prefilled 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 (such as length and / or diameter) of the prefilled 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 (such as the distal end) of the prefilled 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 prefilled syringe 900. The prefilled syringe 900 can further include a syringe flange 912 at its proximal end.

[0463] The prefilled 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.

[0464] Before the start of 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 injection, a plunger stop 910 inserted into the barrel 902 can be pushed towards the distal end of the barrel 902 (such as towards the needle 908) to push the drug Dr (such as the medicament M) towards the distal end of the prefilled syringe 900 and out of the needle 908 into the injection area. The plunger stop 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 (such as towards the needle 908).

[0465] Examples of the prefilled syringe 900 are the Neopak 1 ml long prefilled syringe (with a special thin-walled needle of size 27) from Becton Dickinson (BD) and the Ompi EZ-Fill 1 ml long prefilled syringe (with a thin-walled needle of size 27). Both syringes include RNS and West 2340 Flurotec plunger stops. 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.

[0466] According to at least one embodiment, the dose volume can range between 0.5 milliliters (ml) and 1.14 ml, and the viscosity of the drug is between 1 centipoise (cP) and 25 cP.

[0467] 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.

[0468] 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.

[0469] 10. Plunger ( Figures 10 to 10M )

[0470] Fig.10 The plunger 1000 is shown. The plunger 1000 may include an elongated, preferably cylindrical plunger shaft 1010. The plunger shaft 1010 may be hollow, for example, to provide an assembly space for the drive spring 1100 and an optional spring support arm / pin 1230. On the inner surface, the plunger shaft 1010 may 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 may 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.

[0471] The proximal end of the plunger 1000 may include a number of radially protruding portions, for example, at least two or at least three protruding portions or two groups each including at least two or at least three protruding portions:

[0472] - 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 ,

[0473] - 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

[0474] - An angled plunger rib 1040.3.

[0475] 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.

[0476] Furthermore, optional plunger grooves 1020, 1022, etc. may be arranged 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 a protrusion 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 lower side of the plunger 1000, for example in order to provide a symmetric design and ease of assembly of the plunger 1000.

[0477] 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:

[0478] - The proximal region 1221,

[0479] - The profiled groove 1221.1,

[0480] - The first angled surface 1221.2 of the profiled groove 1221.1,

[0481] - 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,

[0482] - The second angled surface 1221.4 of the profiled groove 1221.1, and

[0483] - The longitudinal edge 1234 of the profiled groove 1221.1 (see also Fig. 12A and Fig. 12B ), which may be radially positioned in a region that does not interact with the first plunger boss 1040.1.

[0484] 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 (the rear part 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 it engages with the first angled surface 1221.2. In addition, 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.

[0485] The inclination angle of the first angled surface 1221.2 and / or the second angled surface 1221.4 with respect to the perpendicular 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°.

[0486] In Fig. 10A the first state shown, the first plunger lug 1040.1 engages 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 subassembly.

[0487] Optionally, a recess 1221.15 may be disposed on the proximal face of the irregular groove 1221.1, which may be used 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, as described below.

[0488] 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 rotation, 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 medicament Dr or agent M from the pre-filled syringe 900. However, this will only occur later, i.e., when the drug delivery device 100 is triggered by pressing it, for example using the needle shield 500, against the user's skin.

[0489] In an exemplary embodiment, the movement of the plunger 1000 from the first state in the proximal direction P onto 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 when the triggering device 100 delivers the drug.

[0490] 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.

[0491] 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:

[0492] - A groove rib 507 (such as an angled groove rib 507), including a longitudinally extending portion (such as groove rib 507, see Figure 5 ), and a circumferentially extending portion (such as a second ramp 507d, see Figure 5 ):

[0493] - A proximal side surface 513.2, for example, on the circumferentially extending portion (second ramp 507d),

[0494] - A distal side surface 513.3, for example, on the circumferentially extending portion (second ramp 507d),

[0495] - An abutment surface 507b, for example, on the longitudinally extending portion, such as on groove rib 507, and

[0496] - An optional first ramp 507c, see Fig. 10H .

[0497] 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.

[0498] There may be a pair of proximal sleeve portions 513, each of which interacts 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 the parts from jamming and enabling the smooth operation of the drug delivery device 100.

[0499] The plunger release mechanism 1025 may basically have two functions:

[0500] 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.

[0501] 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 .

[0502] 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, for example, move relative to each other parallel to or along the longitudinal axis A, while the plunger 1000 may move parallel to the longitudinal axis A and rotate about the longitudinal axis A, see the rotation 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.

[0503] The parts arranged for engaging with the plunger 1000, the proximal region 1221, and the proximal sleeve portion 513 may include:

[0504] - A first plunger boss 1040.1 on the plunger 1000,

[0505] - A second plunger boss 1040.2 on the plunger 1000,

[0506] - An angled plunger rib 1040.3 on the plunger 1000,

[0507] - An irregular groove 1221.1 in the proximal region 1221, which is adapted to interact with the first plunger boss 1040.1,

[0508] - 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 abutting surface 507b of the plunger boss groove 506 adapted to interact with the second plunger boss 1040.2.

[0509] In Figure 10C a clearance 1030 is shown, which clearly indicates that there may be a rotational offset between the 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.

[0510] The irregular 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 rotation direction R1; a wall 1221.3 for restricting the movement of the first plunger boss 1040.1 in the first rotation direction R1 when it engages with the first angled surface 1221.2. In addition, the irregular 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 rotation direction R1.

[0511] 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 through an 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 to the plunger 1000 in the first rotational direction R1.

[0512] 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).

[0513] 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 the plunger release mechanism 1025 to be activated from the first state to the second state, for example, by an assembly jig (not shown) or in a different way. The activation of the plunger release mechanism 1025 is different from triggering.

[0514] Figure 10D The plunger release mechanism 1025 during final assembly is shown. Exemplarily, the groove rib 507, in particular the proximal face 513.2, abuts the angled plunger rib 1040.3 proximally, thereby applying a torque to the plunger 1000 in the first rotational direction R1 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.

[0515] 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 (a 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.

[0516] The operating sequence of the drug delivery device 100 can be as follows:

[0517] 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.

[0518] The needle shield 500 can be in an 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.

[0519] 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 moving the needle shield 500 from the extended position towards the retracted position.

[0520] 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.

[0521] In an exemplary embodiment, the abutment surface 507b of the groove rib 507 can include interruptions 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 the 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.

[0522] 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.

[0523] Once the needle shield 500 has been pressed into the retracted position and the needle 908 has been inserted, the second plunger boss 1040.2 has moved distally beyond the groove rib 507 such that there is no longer any prevention of the plunger 1000 from rotating in the first rotational direction R1 due to the torque exerted by the drive spring 1100 and the engagement of the first plunger boss 1040.1 with the second angled surface 1221.4 on the profiled groove 1221.1. 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 Thus, 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 can provide an audible feedback that the medicament delivery has started.

[0524] 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 restricted by the second plunger boss 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 boss 1040.2 abutting against the abutment surface 507b of the groove rib 507.

[0525] 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 Figure 9 position shown in), and is guided along the abutment surface 507b of the groove rib 507.

[0526] 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.

[0527] 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 such that the rotation of the plunger 1000 in the first rotational direction R1 due to the torque applied by the drive spring 1100 and 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. Accordingly, the plunger 1000 is released and advances the plunger stopper 910 in the distal direction D, thereby displacing the drug / agent Dr / M from the syringe barrel 900 through the needle 908.

[0528] 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 a rib or boss (such as the 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 foregoing embodiments, the additional first ramp 507c will rotate the plunger 1000.

[0529] During normal use, the plunger 1000 will be released as in the foregoing embodiments. The first ramp 507c is positioned to interact with the angled plunger rib 1040.3 only if the plunger 1000 does not rotate spontaneously when the pressing of the needle shield 500 together with the proximal sleeve portion 513 is near the end. It should be readily understood by those skilled in the art that the embodiments will work equally well if only one of the rib or boss (such as the angled plunger rib 1040.3) on the plunger 1000 or the first ramp 507c is ramped or angled. This also applies to the proximal face 513.3.

[0530] Another benefit of another embodiment (i.e., the use of the first ramp 507c) is that it provides additional guidance for the movement of the plunger when the plunger 1000 is enabled.

[0531] In another exemplary embodiment, the engagement of the first ramp 507c with a rib or 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 profiled groove 1221.1. For example, the profiled groove 1221.1 may not have an angled surface that causes the plunger 1000 to rotate in a first rotational direction R1 out of engagement with the profiled groove 1221.1. In an exemplary embodiment, the profiled groove 1221.1 may only have a transverse surface that faces in the distal direction D and is oriented transversely with respect to the longitudinal axis A. The transverse surface may have a pawl or a bulge. In another exemplary embodiment, the profiled groove 1221.1 may only have an angled surface that causes the plunger to rotate in a second rotational direction R2 to maintain the engagement of the first plunger boss 1040.1 within the profiled groove 1221.1.

[0532] In an exemplary embodiment, the drug delivery device 100 can be an autoinjector.

[0533] Figure 10I An internal longitudinal rib 1236 is shown, which is arranged on 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 plunger 1000 from rotating further as long as the drug delivery device 100 has not been fired. If the plunger release mechanism 1025 is triggered for injection by moving the needle shield 500 proximally relative to the device body 700 and relative to the drive spring holder 1200, the plunger 1000 is allowed to rotate, i.e., 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 plunger 1000 to move further distally, for example, by guiding the first plunger boss 1040.1.

[0534] Therefore, the longitudinal edge 1234 will not interfere with the first plunger boss 1040.1. In other words, the longitudinal edge 1234 can be arranged at a position radially more outward 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.

[0535] 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 elongated shaft 1010, such as an elongated plunger rod 1010, which forms the body of the plunger, for example, 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.

[0536] 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 start expelling the drug Dr, M from the drug container 900 (such as a pre-filled syringe 900). In the second embodiment of the plunger 1000, two pairs of plunger ribs 1042a, 1042b can be used as the trigger feature TF, for example, the same 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.

[0537] 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, the drive spring 1100 can also be used as the driving force. The interaction feature IF can include an internal elongated 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, inclined surfaces 1075, and other optional features, as described in more detail below, see Figure 10L and Figure 10M and the corresponding description.

[0538] 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.

[0539] In addition to the testing function, the grooves 1051.1a, etc. may also have several functions, such as a visual feedback function described later.

[0540] 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:

[0541] - Preferably using at least one injection molding die to produce a batch of plungers 1000 and / or drug delivery devices 100,

[0542] - Assembling the drug delivery device 100,

[0543] - 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,

[0544] - Performing quality control based on at least one result of the testing.

[0545] 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.

[0546] The quality control may be statistical quality control, such as defining how many devices must be tested during production to ensure quality, such as when to test and how many devices must be tested preferably according to an approved test plan.

[0547] 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 possible, for example if appropriate radiation is used to identify the plunger position / movement, such as radiation passing through the housing or body 700.

[0548] 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 used to produce the plunger 1000. The at least one auxiliary molding part may be configured to laterally hold an additional auxiliary molding part that is elongated 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 elongated part that may define the internal profile or at least part of the internal profile of the internal elongated cavity 1059 of the plunger 1000. The internal profile / cavity 1059 of the plunger 1000 may include an internal elongated 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.

[0549] 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, for example 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.

[0550] 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 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.

[0551] A method for producing the plunger 1000 or any other plunger may include:

[0552] - 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 (e.g., 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 (e.g., 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, i.e., 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.

[0553] - 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 (e.g., a rod or a pin).

[0554] - 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 a position defined by at least one second auxiliary molding part,

[0555] - Optionally, cooling is performed, for example, by forced cooling using a liquid cooling medium in the cooling cavity of the mold, or free cooling (e.g., without using a separate cooling medium other than ambient air), preferably mainly using or only using heat conduction within the mold.

[0556] - 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,

[0557] - Ejecting at least one plunger 1000 from the mold after opening the two main parts.

[0558] 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.

[0559] 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 supporting portion 1044. The distal supporting 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 supporting portion 1045, for example, 2 times greater or 3 times greater, preferably less than 10 times.

[0560] Optionally, the plunger 1000 may include the above-described 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.

[0561] 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 extension and / or axial extension.

[0562] At least two outwardly directed ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b in at least one of the sets 1042a, 1042b may be arranged on corresponding common ribs CR, CRa, CRb, which may extend axially relative to the longitudinal axis of the shaft 1010.

[0563] Preferably, at least one support rib SR may be arranged on the corresponding common ribs CR, CRa, CRb. The support rib SR may 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 sets of the at least two sets 1042a, 1042b, preferably at an angle within the range of 80 degrees to 100 degrees, for example about 90 degrees or 90 degrees, with respect to the ribs 1040.3a and / or 1040.3b arranged closer to the proximal side P.

[0564] Preferably, at least one support rib SR may 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 (e.g., the distal rib (e.g., 1040.2a, 1040.2b)) in at least one of the sets 1042a, 1042b to an axial position equal to the proximal axial position of the second rib (e.g., the proximal rib (e.g., 1040.3a, 1040.3b)) in the corresponding set of the at least one of the sets 1042a, 1042b.

[0565] The following radially extending ribs may be used, for example for reinforcement purposes:

[0566] - Rib 1046, which is at the distal end of the common ribs CR, CRa, CRb and preferably terminates at the distal portion of the ribs 1040.2a, 1040.2b,

[0567] - Rib 1047, which is at the middle portion of the common ribs CR, CRa, CRb and preferably terminates at the proximal portion of the ribs 1040.2a, 1040.2b; the rounded support feature RF may start from here,

[0568] - 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 portion of the angled ribs 1040.3a, 1040.3b, and

[0569] - 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.

[0570] Corresponding ribs can be used on a pair 1042b including plunger ribs 1040.2b and 1040.3b. Generally, 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 mounting direction).

[0571] Optionally, the plunger 1000 can comprise 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 percent to 43 mass percent, or in the range of 30 mass percent to 36 mass percent, for example 33 mass percent. Preferably, Zytel FGFE5171 from DuPont, especially FGFE5171NC010C, which contains 33 mass percent of glass or glass fiber, can be used. Alternatively, volume percent can be used instead of mass percent 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 which is part of the medical device 100, because it is also suitable for the food industry. Additionally, the molding characteristics are excellent.

[0572] 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.

[0573] 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 auditory indicator and / or indicator 1300 is used, only one pair may be used to trigger the auditory indicator and / or indicator 1300. The other pair may be absent or may be present, for example 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.

[0574] The incisions 1020a, 1020b, 1022a, 1022b may be longitudinally extending incisions (slots). The slope of the sides of the first incision in a pair may be different from the slope of the sides of the second incision in the pair, for example to avoid using a slider.

[0575] 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 the functions are implemented. 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.

[0576] 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.

[0577] 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.

[0578] 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 specific mold and / or a specific mold set (e.g., all parts for the drug delivery device 100) and / or a specific 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.

[0579] 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, thus indicating the dedicated cavities and / or molds for producing the respective parts of the drug delivery device 100, see for example the marker "600X". Thus, it is possible to select only the combination of parts that are, for example, produced in the sixth cavity of the molds in a dedicated mold set. Alternatively, as another example, the plunger 1000 that is always produced in the first cavity of the plurality of cavities for producing the plunger 1000 may always be assembled with the drive spring holder 1200 that is produced in the second cavity of the plurality of cavities for producing the drive spring holder 1200.

[0580] Compared to a random combination of the respective parts within, for example, one drug delivery device, the use of markers enables better control of production, for example enabling better statistical control. A specific mold may be used for a specific 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 may be produced within one mold, such as the plunger 1000 and the drive spring holder 1200 or other parts of the drug delivery device.

[0581] A method for marking a plunger (e.g., the plunger 1000) may include:

[0582] - 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,

[0583] - Marking at least one cavity by using at least one of a groove or a protrusion to print at least one letter, number 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 part of the markings 1080.1 to 1080.4 indicates or is an identifier of the mold and / or the cavity, or wherein at least one marking includes an identifier of the mold and / or the cavity of the mold.

[0584] - Using the mold to produce at least one plunger 1000, and

[0585] - For at least one of the produced plungers 1000, preferably tracing the mold and / or the 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.

[0586] 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 to omit the marker when appropriate.

[0587] 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:

[0588] - Preparing at least two different 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.

[0589] - Marking at least one cavity by using at least one of a groove and a protrusion to print at least one letter, number 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 part 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 the cavity of the mold.

[0590] - Using these molds to produce at least one drug delivery device 100.

[0591] - Assembling the drug delivery device 100, and

[0592] -For at least one of the produced devices 100, preferably trace the mold and / or the cavity used to produce the device 100, for example as part of a quality control method, whereby preferably store digital data related to a mark or marker.

[0593] 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 face 1014 of the plunger tip portion 1012 or at any other suitable position on the plunger 1000.

[0594] In an alternative embodiment, for example if the injection point is not arranged on the distal face 1014, additional marks can be arranged on the distal face 1014 of the plunger tip 1012. According to another embodiment, at least one mark can be arranged on the distal face of the plunger tip 1012, but not on the annular face 1016.

[0595] 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.

[0596] 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 .

[0597] 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 set of 1060 internal ribs.

[0598] The lateral opening 1052.2a can include:

[0599] - The extremely inclined surface 1055,

[0600] - The surface 1056 that is moderately inclined with respect to the inclination angle of the inclined surface 1055,

[0601] - The side surface 1057 ( Figure 10L not shown in, see for example Figure 10J ), and

[0602] - The side surface 1058.

[0603] 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.

[0604] 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 in Figure 10L in view of the tool (die) parting plane TPP. For example, with respect to the tool closing direction and the tool opening direction (perpendicular to the tool (die) parting plane TPP), neither the surface 1055 nor the surface 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 plane TPP is arranged at another position, the use of additional sliders is also possible.

[0605] Preferably, all other lateral openings, such as 1052.1a, 1052.1b, 1052.2b, may include the same features as those of the lateral opening 1052.2a.

[0606] Figure 10M A cross-section of the shaft 1010 of the plunger 1000 along the longitudinal direction is shown.

[0607] The plunger 1000 (such as the shaft 1010) may 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:

[0608] - Preferably, the first rounded edge 1074,

[0609] - 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,

[0610] - Preferably, the second rounded edge 1076, and / or

[0611] - The plunger 1000, more specifically the inner surface 1077 of the shaft 1010.

[0612] 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 with respect to the longitudinal axis or with respect 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 users to accept.

[0613] In addition, the following features are shown:

[0614] - The outer surface 1071 of the shaft 1010,

[0615] - The outer edge 1072 of the shaft 1010, and

[0616] - The proximal surface 1073 pointing proximally.

[0617] 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, for example a larger radius, may be used on the edge 1074 and / or the edge 1076, preferably with respect to the radii on other edges of the shaft 1010 (for example on the edge 1072 and / or on the edge 1074).

[0618] The drug delivery device 100 may include:

[0619] - The plunger 1000 according to any one of the foregoing embodiments, and

[0620] - 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).

[0621] The rear sub-assembly (RSA) (see for example Figure 13I ) may include:

[0622] - A drive spring holder (1200) configured to hold the drive spring (1100),

[0623] - The drive spring (1100), and

[0624] - The plunger (1000) according to any one of the above embodiments.

[0625] Therefore, the above effects may also apply to the drug delivery device 100 or the rear sub-assembly (RSA).

[0626] 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.

[0627] 11. Driving spring ( Figures 11A to 11C )

[0628] 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 as described in Sections 10 and 12 disengages from the shaped groove 1221.1 of the driving spring holder 1200, so as to move the plunger 1000 in the distal direction relative to the syringe barrel 900 (not shown).

[0629] 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. Therefore, 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.

[0630] 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.

[0631] The driving spring support arm / pin 1230 can have a substantially circular cross-section or a circular cross-section. Preferably, at least two longitudinal guide ribs can be arranged along the outer surface of the driving spring support arm / pin 1230. The longitudinal guide 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.

[0632] Inside the plunger 1000, the drive spring 1100 can be guided by at least one internal rib of the plunger 1000, the at least one internal rib being formed at the inner surface of the plunger shaft 1010 and extending 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 the 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.

[0633] 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.

[0634] In one embodiment, the drive spring 1100 can be made of coiled wire. The wire diameter can be selected according to the stress that the drive spring 1100 is subjected to when compressed (e.g., fully compressed before the drug delivery device 100 is enabled). In one embodiment, the wire can be a soap-lubricated wire to facilitate manufacturability.

[0635] In one embodiment, the drive spring 1100 can have 10 to 150 coils or turns. In one embodiment, the drive spring 1100 can have 20 to 120 coils or turns. In one embodiment, the drive spring 1100 can have 40 to 100 coils or turns, for example 80 coils or turns.

[0636] The coil diameter can be selected according to the geometries of the plunger 1000 and the drive spring support arm / pin 1230 of the drive spring holder 1200.

[0637] 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, for example 2.5 mm.

[0638] 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, for example 4.0 mm.

[0639] 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.

[0640] In addition, the specific characteristics of the drive spring 1100 can be adapted such that the drive spring 1100 provides sufficient actuation force to meet the injection time requirements. Such requirements can be that the syringe 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. In addition, 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.

[0641] In one embodiment, in the un-biased 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.

[0642] In one embodiment, the drive spring 1100 can be configured to provide an actuation force between 2 N (Newtons) and 60 N according to its compression 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, according to its compression state. In one embodiment, the drive spring 1100 can be configured to provide an actuation force between 3 N and 24 N according to its compression state.

[0643] 12. Drive spring holder ( Figures 12A to 12G )

[0644] Figure 12A and Figure 12B shows the 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 900 and to prevent the syringe 900 from moving proximally within the drug delivery device 100. The drive spring holder 1200 can further be configured to support an audible indicator and / or a tactile indicator, such as the rattle 1300 (not shown) as described below.

[0645] The drive spring holder 1200 may have a base 1201 at its proximal end defining 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.

[0646] The drive spring holder 1200 may further include one or more syringe support arms 1202 extending 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 forces exerted during the assembly, use or accidental dropping of the drug delivery device 100.

[0647] The diameter of the base 1201 may be similar to or greater 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.

[0648] 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 latch 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 axial and radial directions such that the flexible portion 1203.1 may be radially outwardly inclined in the proximal direction. The housing latch arm 1203 may further include a latch protrusion 1203.2 that protrudes radially outwardly from the flexible portion 1203.1. The latch 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 latch 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 latch arm 1203 returns to its relaxed state, thereby moving the latch 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 latch 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 of the latch protrusion 1203.2 with 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.

[0649] 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 radial inward movement relative to the drive spring support pin 1230.

[0650] 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).

[0651] 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.

[0652] 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).

[0653] 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 snap arms 1203 (see Figure 12A and Figure 12B ). Thus, the profiled groove 1221.1 and the snap 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.

[0654] 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.

[0655] 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.

[0656] 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 ).

[0657] In one embodiment, the flapper support structure 1240 may further include at least one flapper mounting groove 1244.

[0658] The flapper support structure 1240 is configured to support the flapper 1300, and when the plunger 1000 overlaps with 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.

[0659] The flapper support arm 1241 may be flexible and / or 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.

[0660] The flapper support arm 1241 may include at least one outwardly directed ramp-shaped protrusion 1241.1. The outwardly directed ramp-shaped protrusion 1241.1 may extend radially outward from the radially facing outer surface of the syringe support arm 1202. The ramp-shaped protrusion 1241.1 may be radially outwardly inclined in the distal direction D. In one embodiment, the outwardly directed ramp-shaped protrusion 1241.1 may include two outwardly directed ramps / ribs with a recess therebetween.

[0661] The flapper support arm 1241 may further include at least one inwardly directed ramp-shaped protrusion 1241.2 (see Figure 12A and Figure 12B ). The inwardly directed ramp-shaped protrusion 1241.2 may extend radially inward from the inwardly facing surface of the syringe support arm 1202. The ramp-shaped protrusion 1241.2 may be radially inwardly inclined in the distal direction D. In one embodiment, the inwardly directed ramp-shaped protrusion 1241.2 may include two inwardly directed ramps / ribs with a recess therebetween.

[0662] As long as there is axial overlap between the flapper support arm 1241 and the plunger 1000, the outer surface of the plunger may radially support the flapper support arm, for example, keeping it in a radial position. In particular, the inwardly directed ramp-shaped protrusion 1241.2 may abut against the outer surface of the plunger 1000 such that the flexible support arm 1241 is restricted, preferably prevented, from moving radially inward.

[0663] After the proximal end of the plunger 1000 or the cutouts 1020, 1022 have passed the inwardly directed ramp-shaped protrusion 1241.2, for example when the plunger 1000 moves distally after disengaging from the abutment surface 507b, the rattle support arm 1241 can deflect and / or move radially inwards, thereby no longer supporting the rattle 1300 in the radially outwards direction. Thus, the rattle 1300 can return to its relaxed state (S1), as outlined in section 13 below, thereby generating an audible and / or tactile signal indicating the end of drug Dr, M delivery.

[0664] In one embodiment, the inwardly directed ramp-shaped protrusion 1241.2 can be complementary to one or more cutouts / grooves 1020, 1022 of the plunger 1000. In this embodiment, when the cutouts 1020, 1022 are aligned with the ramp-shaped protrusion 1241.2, the rat...

Claims

1. A component for a drug delivery device (100), the component comprising: a cap (200) having a first marker (203) on an outer surface of the cap, and a device body (700) having a second marker (733) on an outer surface of the device body, wherein the first marker (203) and the second marker (733) form a continuous marker extending from the device body (700) to the cap (200), wherein the cap (200) has a first axial position relative to the device body (700), wherein when the cap (200) is not in the first axial position relative to the device body (700), the cap can be brought into the first axial position relative to the device body (700) only when the first marker (203) and the second marker (733) are aligned to form the continuous marker.

2. The component according to claim 1, wherein the continuous marker forms a user indicator, and wherein the user indicator points in the drug delivery direction.

3. The component according to any one of the preceding claims, wherein the first marker (200) has the shape of an arrow.

4. The component according to any one of the preceding claims, wherein the continuous marker has the shape of an arrow.

5. The component according to any one of the preceding claims, wherein the first marker (203) and / or the second marker (733) is a haptically and / or visually perceptible marker.

6. The component according to any one of the preceding claims, wherein the first marker (203) and / or the second marker (733) includes at least two recesses, and wherein the at least two recesses are obliquely oriented relative to a longitudinal axis of the cap (200) and / or the device body (700).

7. The component according to claim 6, wherein the recesses of the first marker (203) have different sizes.

8. The component according to any one of claims 6 and 7, wherein the recesses of the second marker (733) have different sizes.

9. The component according to any one of claims 6 to 8, wherein the sizes of the recesses of the first marker and / or the second marker increase in a distal direction along the longitudinal axis.

10. The component according to any one of the preceding claims, wherein the cap (200) and the housing body (700) have different colors.

11. The component according to any one of the preceding claims, wherein the second marker (733) is distal to a drug window (710) along a longitudinal axis of the device body (700).

12. The component according to any one of the preceding claims, wherein the second marker (733) is located at a distal portion of the device body (700).

13. The component according to any one of the preceding claims, wherein the first marker (203) is arranged on opposite sides of the cap (200), and the second marker (733) is arranged on opposite sides of the device body (700).

14. A component for a drug delivery device (100), the component comprising: a cap (200) having a first marker (203) on an outer surface of the cap, and a device body (700) having a second marker (733) on an outer surface of the device body, wherein the first marker (203) and the second marker (733) form a continuous marker that extends from the device body (700) to the cap (200), wherein the cap (200) has a first axial position relative to the device body (700), wherein when the cap (200) is not in the first axial position relative to the device body (700), the cap can be brought into the first axial position relative to the device body (700) only when the first marker (203) and the second marker (733) are aligned to form the continuous marker, wherein the continuous marker forms a user indicator, and wherein the user indicator points in the drug delivery direction, wherein the continuous marker has the shape of an arrow, and wherein the first marker (203) and the second marker (733) include at least one recess.

15. A drug delivery device (100) comprising the component according to any one of the preceding claims.

16. The drug delivery device (100) according to claim 15, comprising a container, wherein the container is pre-filled with a drug.

17. A method of delivering a drug from a drug delivery device, the method comprising using the drug delivery device according to claim 15 or 16.

18. A drug for use in a method of treating a patient, wherein the method comprises using the drug delivery device according to claim 15 or 16 to deliver the drug to the patient.

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