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

Abstract

A device body for a drug delivery device is provided. The device body includes a needle cover positioning structure configured to fix the needle cover of the drug delivery device against axial movement relative to the device body by interacting with at least one corresponding fixed feature portion of the needle cover when the needle cover is in the needle cover position relative to the device body. The device body has a proximal end and a distal end. In the needle cover position, the needle cover protrudes distally beyond the device body. The device body further includes a first needle cover safety structure configured and positioned to prevent separation of the fixed feature portion from the needle cover positioning structure by interacting with the outer surface of the needle cover when the portion of the device body on which the needle cover positioning structure is located is deformed.

Description

Background Art

[0001] Drug delivery devices provide a convenient option for injecting drugs into users / patients. For example, drug delivery devices are safer against human error than conventional syringes. Due to the increasing demand, handheld drug delivery devices require mass production. Reducing manufacturing costs and improving manufacturing speed are ongoing challenges, where user safety plays an important role.

Summary of the Invention

Problems to be Solved by the Invention

[0002] The present disclosure relates to a device body for a drug delivery device. Further, the present disclosure relates to an assembly for a drug delivery device including the device body. Further, the present disclosure relates to a drug delivery device including the device body or the assembly.

[0003] The object of the present disclosure is to provide a device body for a drug delivery device, an assembly for a drug delivery device, and / or a drug delivery device that is easy to use, and / or can be used comfortably, and / or has as few components as possible.

Means for Solving the Problems

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

[0005] According to one embodiment, a device body for a drug delivery device is provided. The device body includes a needle cover positioning structure configured to fix the needle cover of the drug delivery device to axial movement relative to the device body by interacting with at least one corresponding fixed feature portion of the needle cover when the needle cover is in a needle cover position relative to the device body, for example, the first or last needle cover position. The device body includes a proximal end and a distal end. In the needle cover position, the needle cover protrudes distally beyond the device body, for example, distally beyond the distal end of the device body. The device body further includes a first needle cover safety structure configured and positioned to prevent separation of the fixed feature portion from the needle cover positioning structure by interacting with the outer surface of the needle cover when the portion of the device body on which the needle cover positioning structure is located is deformed.

[0006] The needle cover positioning structure may include a needle cover locking structure. Alternatively or additionally, the needle cover positioning structure may include a needle cover forward stopper.

[0007] The fixed feature portion may include at least one flexible arm (blocking means) of the needle cover. The at least one flexible arm may include one or more projections. One or more projections may protrude radially outward. Preferably, the fixed feature portion includes at least two flexible arms. The flexible arms may be distributed around the outer circumference of the needle cover with a 180-degree angular offset. In one embodiment, the fixed feature portion may include three or more flexible arms, preferably these arms are evenly distributed around the outer circumference of the needle cover.

[0008] At least one flexible arm may be configured to be pre-tensioned so that when the needle cover is inside the device body, at least one flexible arm is not completely relaxed. In other words, when the needle cover is inside the device body, at least one flexible arm may be configured to apply a radially outward force to any component, e.g., one or more protrusions, that it contacts on a radially outward surface. This may help ensure secure contact between at least one flexible arm and other components of the device, e.g., the needle cover positioning structure. Alternatively or additionally, the fixing feature may include at least one forward retaining slot for the needle cover.

[0009] In one embodiment, the needle cover locking structure may be configured to interact with at least one flexible arm. Alternatively or additionally, the needle cover forward stopper may be configured to interact with a forward stopper slot of the needle cover.

[0010] The first needle cover safety structure may include a needle cover lock release prevention structure.

[0011] In one embodiment, the first needle cover safety structure may include a projection extending radially inward from the inner surface of the device body, for example, the inner surface of the side wall of the device body. The radial inward extension of the projection may decrease proximal to the axial extension of the projection.

[0012] In one embodiment, the first needle cover safety structure extends along the axial direction of the device body, for example, from the proximal end of the needle cover positioning structure in a proximal direction.

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

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

[0015] In one embodiment, the outer surface of the needle cover may be the outer surface of the side region of the needle cover. The first needle cover safety structure may be positioned to interact with the outer surface of the side region, thereby supporting at least a portion, preferably the entire circumferential extension of the side region radially. Preferably, the first needle cover safety structure may be configured to interact with the side region in an appropriate manner, thereby ensuring that the force transmission of the contact force to the side region is at least unbiased, and preferably uniform, over the axial and / or circumferential extension of the side region or at least a portion of the axial and / or circumferential extension of the side region.

[0016] The deformable portion of the device body may be the distal portion of the device body. The distal portion may be offset distally from the drug window of the device body. Alternatively, the distal portion may be offset distally from the proximal end of the syringe when positioned at its most distal position relative to the device body. Alternatively, the distal portion may be distal to the needle cover front stopper.

[0017] The needle cover positioning structure may include at least one, at least two, or at least four projections (e.g., ribs) extending radially inward from the side wall of the device body. The needle cover positioning structure may include at least one, at least two, or at least four ramp-like structures having a radially inward inclination in the distal direction. The needle cover positioning structure may be formed on the distal half of the device body.

[0018] In one embodiment, protrusions, such as ramp-like structures, may be arranged at equal intervals in the circumferential direction of the device body. Alternatively, the protrusions or ramp-like structures may have different angular offsets between them. If a larger difference exists in the angular offset, two or more protrusions may be grouped together. In one embodiment, groups of protrusions may be arranged at equal intervals in the circumferential direction; for example, a group of two ramp-like structures may be angularly offset by 180 degrees in the circumferential direction from another group of two ramp-like structures.

[0019] In one embodiment, the device body may include at least one proximal stopper structure that determines the maximum proximal position of the needle cover relative to the device body. The proximal stopper structure may be configured to interact with a rear stopper feature of the needle cover when the needle cover is moved proximal to the device body. The proximal stopper structure may include a needle cover rear stopper. The needle cover rear stopper may include four ribs extending radially inward from the side wall of the device body. The angular offset between the ribs may be 30 to 150 degrees. The needle cover rear stopper feature may be formed by a proximal-facing surface between the lateral region of the needle cover and a flexible arm.

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

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

[0022] In one embodiment, the axial support front end may have a closed outer circumference. The axial support front end may include a radially inward projection. This projection may be configured to interact with the shoulder of the drug container. Alternatively or additionally, this projection may be configured to interact with the flexible arm of the container holder. The inner diameter of the axial support front end may decrease distally. Thus, the inner surface of the axial support front end may form a cone. This may be advantageous when a container holder having a flexible distal end, e.g., a flexible holder arm, is inserted into and connected to the device body. The conical, narrowing cross-section may provide radially outward support to the distal end of the container holder. In one embodiment, the axial support front end causes radially inward deflection of the flexible holder arm, thereby improving the connection between the drug container and the container holder.

[0023] The central support structure may be connected to the sidewall of the device body via at least one, preferably at least four, connecting elements. The connecting elements may be connecting ribs. The connecting elements may extend radially.

[0024] The connecting element may extend along at least 50% of the axial length of the central support structure. In one embodiment, the connecting element may extend along at least 75%, preferably at least 90%, of the axial length of the central support. Longer axial extensions may be advantageous because they can improve the stability of the central support structure by improving support at the side walls.

[0025] The radially inner portion of the connecting element may be shorter in the axial direction than the radially outer portion of the connecting element. Therefore, at least the distal surface of the radially outer portion may protrude distally more than the distal surface of the radially inner portion.

[0026] The radially inner portion can be the section of the connecting rib where the connecting rib is connected to the central support structure. In other words, the radially inner portion can be the section of the connecting rib that is located radially inward of the section that is connected to the inner surface of the side wall which is the radially outer portion. In other words, the radially outer portion is the outer section of the connecting rib where the connecting rib is connected to the inner surface of the side wall of the device body.

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

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

[0029] In one embodiment, the device body may further include a needle cover rotation prevention structure configured to prevent rotation of the needle cover relative to the device body by interaction with the rotation prevention feature of the needle cover when the needle cover is connected to the device body, for example, when assembled to the device body. The rotation prevention feature of the needle cover can be formed by at least one, preferably a plurality or all, of the edges of one or more side regions of the needle cover.

[0030] The needle cover anti-rotation structure may include at least one projection, such as a needle cover guide rib, extending circumferentially from at least one of the connecting elements. The projection may further extend radially. The projection may further extend axially and form an anti-rotation surface that interacts with the anti-rotation feature portion of the needle cover.

[0031] In one embodiment, the device body may further include a second needle cover safety structure configured to prevent separation of the anti-rotation feature portion and the anti-rotation structure. For example, the second needle cover safety structure may be configured to interact with the inner surface of the needle cover. The inner surface of the needle cover may be the inner surface of the lateral region of the needle cover. The interaction may be enhanced, for example, by deformation of the portion of the device body on which the needle cover positioning structure is located if the device body is dropped or compressed by the user / patient.

[0032] The second needle cover safety structure may include needle cover radial support ribs extending radially outward from the central support structure. The second needle cover safety structure may be positioned offset circumferentially from the first needle cover safety structure by less than 45 degrees, preferably less than 10 degrees. The second needle cover safety structure may at least partially, preferably completely, overlap the first needle cover safety structure in the axial direction. Alternatively or additionally, the second needle cover safety structure may at least partially, preferably completely, overlap the needle cover anti-rotation feature in the axial direction. Smaller angular offsets and / or axial overlaps may be advantageous in supporting the lateral region of the needle cover so that it does not detach from the device body.

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

[0034] In one embodiment, the device body may further include a cap rotation prevention structure configured to prevent rotation of the cap of the drug delivery device relative to the device body when the cap is connected to the device body, for example, when it is assembled. The cap rotation prevention structure may interact with a corresponding cap feature. The cap rotation prevention structure may include one or more cap grooves. The cap grooves may be formed on the inner surface of the side wall of the device body. The cap grooves may extend from the distal end of the inner surface in a proximal direction. In one embodiment, four cap grooves may be arranged along the inner surface of the side wall, with different angular offsets between them. Alternatively, the cap grooves may be arranged at equal intervals in the circumferential direction.

[0035] According to one embodiment of the present disclosure, an assembly for a drug delivery device is provided. The assembly includes a device body according to one of the embodiments described above. Furthermore, the assembly includes a needle cover. Preferably, the assembly includes a needle cover spring.

[0036] Alternatively or additionally, the assembly may include one or more caps, grabbers, and / or container holders (e.g., syringe holders).

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

[0038] Further details regarding the above features are described below with reference to the figures. Furthermore, details regarding the drug delivery device assembly or its components and subassemblies are described below with reference to the figures.

[0039] In a further embodiment, a method is provided for delivering a drug from a drug delivery device, which includes using a drug delivery device according to the present disclosure, for example, one of the embodiments described above.

[0040] In a further embodiment, a drug is provided for use in a method of treating a patient, the method comprising delivering the drug to the patient using a drug delivery device, for example, one of the embodiments described above, as provided in this disclosure.

[0041] The creation and use of this preferred embodiment will be discussed in detail below. However, it should be understood that this disclosure provides many applicable concepts that can be embodied in a variety of specific circumstances. The specific embodiments discussed are merely illustrative of specific ways of creating and using the disclosed concepts and do not limit the scope of the claims.

[0042] Furthermore, unless otherwise stated, the same reference numeral refers to the same technical feature. Where the phrase "may be" is used in this application, it means not only the actual technical implementation form but also the possibility of doing so. This concept of the disclosure will be described in a more specific context, namely drug delivery devices, particularly drug delivery devices for humans or animals, with respect to the following preferred embodiments. However, the disclosed concepts may also be applicable to other situations and / or configurations, such as other injectors, spray devices or inhalation devices.

[0043] The above provides a fairly broad overview of the features and technical advantages of the embodiments of this disclosure. Further features and advantages of the embodiments of this disclosure, for example with respect to the subject matter of the dependent claims, will be described below. It will be understood by those skilled in the art that the concepts and specific embodiments disclosed can be readily used as a basis for modifying or designing other structures or processes to realize concepts having the same or similar objectives as the concepts specifically discussed herein. It will also be recognized by those skilled in the art that equivalent configurations, such as those defined in the appended claims, will not deviate from the spirit and scope of this disclosure.

[0044] Herein, for a more detailed understanding of the concepts and advantages disclosed herein, refer to the following description in conjunction with the accompanying drawings. The drawings are not drawn to scale. The drawings show the following: [Brief explanation of the drawing]

[0045] [Figure 1] Figures 1A-1D are cross-sectional views of a drug delivery device in different operating states according to the first embodiment. [Figure 2] This is an exploded view of an example of a drug delivery device, with or without an optional separate syringe holder. [Figure 3A] Any cap and any cap cover. [Figure 3B] Any cap and any cap cover. [Figure 3C] Any cap and any cap cover. [Figure 3D] Any cap and any cap cover. [Figure 3E] Any cap and any cap cover. [Figure 3F] Any cap and any cap cover. [Figure 3G] Any cap and any cap cover. [Figure 3H] Any cap and any cap cover. [Figure 3I] Any cap and any cap cover. [Figure 4A] These are perspective views and cross-sectional views of an arbitrary graba, respectively. [Figure 4B] These are perspective views and cross-sectional views of an arbitrary graba, respectively. [Figure 4C] This is an exemplary embodiment of a single sheet capable of forming a grabber carrier. [Figure 4D] This is a grabber that engages with the syringe needle shield. [Figure 4E]This is a grabber that engages with the syringe needle shield. [Figure 4F] This is a cutaway view of the grabber from the previous embodiment, assembled inside the cap. [Figure 4G] This details the interaction between grabber-holding bosses, for example, between the boss of a cap and the opening of an exemplary grabber. [Figure 4H] This is a cross-sectional view of the front end of an injection device having a fitted cap and a grabber mounted on the cap that interacts with the needle shield. [Figure 5] This is any needle cover (needle shroud). [Figure 6A] This is the needle cover spring. [Figure 6B] This is a cross-sectional view of the needle cover spring assembled inside the drug delivery device in its pre-use state. [Figure 7A] This is the device itself. [Figure 7B] This is a cross-sectional view of the device itself. [Figure 7C] This is a perspective cross-sectional view of the distal end of the device body. [Figure 7D] This is a cross-sectional view of the central portion of the device body having a syringe holder. [Figure 7E] This is a perspective view of the syringe holder front stopper on the device body. [Figure 7F] This is a cross-sectional view of the distal end of the device body with the needle cover in the third cover position. [Figure 7G] This is a perspective view of the needle cover locking structure interacting with the flexible arm of the needle cover. [Figure 8A] Any syringe holder. [Figure 8B] A perspective view of any syringe holder. [Figure 8C] This is a detail diagram of a further exemplary embodiment of the flexible holder arm. [Figure 8D] This is an arbitrary syringe holder including the flexible holder arm shown in Figure 8C. [Figure 9] Any pre-filled syringe. [Figure 10] It's a plunger. [Figure 10A] This is the plunger release mechanism in its first state. [Figure 10B] This is the plunger release mechanism in its second state. [Figure 10C] This is the plunger release mechanism during the assembly of the drive subassembly. [Figure 10D] This is the plunger release mechanism during final assembly. [Figure 10E] This is a further state of the plunger release mechanism. [Figure 10F] This is a schematic diagram of the plunger release mechanism after the sleeve has been pushed into the retracted position. [Figure 10G] This is a schematic detail diagram of the plunger release mechanism after final assembly, before the sleeve is pushed in. [Figure 10H] This is a schematic detail diagram of the plunger release mechanism while the sleeve is being pushed in. [Figure 10I] This is a longitudinal rib located on the inside of the rigid arm of the drive spring holder. [Figure 10J] This is a perspective view of the plunger according to the second embodiment. [Figure 10K] This is a distal view of the plunger according to the second embodiment. [Figure 10L] This is a cross-sectional view along the radial direction through the shaft of the plunger according to the second embodiment. [Figure 10M] This is a cross-sectional view along the longitudinal direction through which the plunger shaft passes. [Figure 11A] This is a drive spring according to one embodiment of the present disclosure. [Figure 11B] This is the drive spring shown in Figure 11A, which is incorporated into the drug delivery device and operates the plunger. [Figure 11C] These are the drive springs shown in Figures 11A and 11B, which are incorporated into the drug delivery device before the plunger is activated. [Figure 12A] This is a perspective view of the drive spring holder. [Figure 12B] This is a perspective view of the drive spring holder. [Figure 12C] This is a syringe return prevention mechanism. [Figure 12D] This is a cross-sectional view of the proximal portion of the drive spring holder. [Figure 12E] This is a different embodiment of the flexible portion of the drive spring holder. [Figure 12F] This is a different embodiment of the flexible portion of the drive spring holder. [Figure 12G] This is a different embodiment of the flexible portion of the drive spring holder. [Figure 13A] It is any audible indicator (clicker). [Figure 13B] An example is an indicator holder included on a drive spring holder. [Figure 13C] This is a perspective view of the support structure at the distal end of the flexible support arm. [Figure 13D] This is a perspective view of the guide structure of the indicator holder. [Figure 13E] This is a cross-sectional view of the indicator holder, passing through the longitudinal axis of symmetry. [Figure 13F] This is the rear sub-assembly (RSA) after the audible indicator has been installed, but before priming the audible indicator. [Figure 13G] Preferably, this is the rear subassembly (RSA) of the audible indicator after priming using a priming tool. [Figure 13H] It is a priming tool. [Figure 13I] This image shows the RSA and front subassembly (FSA) in the final assembly stage, just before priming of the audible indicator. [Figure 14A] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14B] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14C] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14D]This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14E] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14F] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14G] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14H] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14I] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14J] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 14K] This is the process of assembling any syringe holder and pre-filled syringe into the device. [Figure 15A] This is a flowchart illustrating an exemplary feedback sequence during the use of a drug delivery device. [Figure 15B] The image shows different views from the drug window during the dose dispensing process. [Figure 15C] The image shows different views from the drug window during the dose dispensing process. [Figure 15D] The image shows different views from the drug window during the dose dispensing process. [Figure 16] These are the rear and front subassemblies of a drug delivery device. [Figure 17] These are the rear and front subassemblies of a drug delivery device. [Figure 18-1] This shows the extended structural formula, molecular formula, and molecular weight of physsilane (e.g., sodium form). [Figure 18-2] Continuation of Figure 18-1. [Modes for carrying out the invention]

[0046] As a general note, in this specification, “distal” is used to specify a direction, end, or surface that is or will be positioned to face or point toward or toward the dispensing end of a drug delivery device and / or point away from the proximal end, or that is positioned or faces away from the proximal end. On the other hand, “proximal” is used to specify a direction, end, or surface that is or will be positioned to face away from or toward the dispensing end and / or distal end of a drug delivery device or its components. The distal end may be the end closest to the dispensing end and / or furthest from the proximal end, and the proximal end may be the end furthest from the dispensing end. The proximal surface may face away from the distal end and / or toward the proximal end. The distal surface may face toward the distal end and / or face away from the proximal end. The dispensing end may be, for example, the needle end on which a needle is positioned, or on which a needle or needle unit is or will be attached to the device. The term "axial direction" can be used synonymously with "longitudinal direction."

[0047] The distal end DE may be the end closer to the needle compared to the proximal end PE. Specific embodiments of this disclosure are shown relating to injection devices, such as autoinjectors. The device may include a high-performance needle cover used as an activation element.

[0048] 1. Overview of drug delivery devices (Figures 1A-1D) Figures 1A to 1D show one embodiment of the drug delivery device 100. Device 100 may be suitable as a device in the drug delivery apparatus described in detail above and below. The drawings show device 100 in different states during operation.

[0049] Figure 1A shows the drug delivery device 100 in its initial or marketable state. The drug delivery device 100 may include a housing or device body 700. The device body 700 may be provided for and / or capable of holding a drug container, such as a pre-filled syringe 900, inside it. A drug, such as a liquid drug or drug Dr, may be placed inside the pre-filled syringe 900. Note that the following use of the term pre-filled syringe 900 does not limit the container design to a pre-filled syringe. Rather, containers other than pre-filled syringes may also be considered during implementation. The device body 700 may be provided for and / or capable of holding a needle 908 (see Figure 1C). In other words, the needle 908 may be placed inside the device body 700. The needle 908 may be permanently or removably connected to a pre-filled syringe 900 or an integral part of a container, such as the body of a drug container, or it may be separate from the drug container. In the first case, the drug container may be a syringe. In the second case, the drug container may be a cartridge. When a cartridge is used as a drug container, initially, the drug container and the needle may be fluidly separated, and fluid communication between the inside of the drug container and the needle 908 may only be established during the operation of the drug delivery device 100. Any drug container carrier, such as a syringe holder 800, may be used to support and / or hold the drug container within the device body 700.

[0050] A drive mechanism 101, provided for driving the drug delivery operation, may be conveniently located within 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 (not explicitly shown), such as a compression spring. The drive energy source may be configured to drive the plunger 1000 distally D relative to the drug container during the drug delivery operation. During this movement, a plunger stopper 910, which may be movably held within the drug container, i.e., a pre-filled syringe 900, and capable of sealing the drug container, is displaced toward the drug outlet of the drug container, allowing the drug Dr or drug held within the drug container to be dispensed through the outlet. The outlet may be formed or defined by a needle 908 (see Figure 1C).

[0051] Other potential drive energy sources, distinct from the drive spring 1100, include a power cell or battery for driving the plunger 1000 by a motor, or a reservoir suitable for providing gas pressure that can drive the drug delivery operation using gas pressure.

[0052] The drug delivery device 100 may be an auto-injector. The energy to drive the drug delivery operation in the auto-injector may be provided by components incorporated into the drug delivery device 100, and the user does not need to charge the device during operation, as is the case with many spring-driven pen-type variable-dose injectors where the user typically charges the spring with energy during the dose setting procedure.

[0053] The drug delivery device 100 may, for convenience, be a single-shot device, i.e., designed 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 use. The device 100 may be a pen-type device. The pre-filled syringe 900 and / or needle 908 may be fixed axially within the drug delivery device 100, for example, within the device body 700, or may be movable relative to the device body 700, for example, to puncture the skin. In the first case, the user may need to make a movement to puncture the skin with the needle 908. In the second case, puncture of the skin with the needle 908 may be driven by the needle insertion mechanism of the drug delivery device 100. Automatic needle retraction may also be used.

[0054] As shown in Figure 1A, the drug delivery device 100 may further include a cap 200. The cap 200 may be positioned at the distal end DE of the drug delivery device 100. The cap 200 may be detachably connected to the rest of the device 100, for example, the device body 700 and / or another component or member of the drug delivery device 100. The cap 200 may cover the distal end DE of the rest of the drug delivery device 100 and / or the needle passage opening from which the needle 908, for example, the distal needle tip, can protrude to puncture the skin for drug delivery. The cap 200 may include a needle shield remover, such as a grabber 400. The needle shield remover, such as a grabber 400, may engage with a rigid needle shield (RNS) 914. The rigid needle shield (RNS) 914 may cover the needle 908 such that, for example, when the cap 200 is removed or separated from the device 100, the RNS 914 is removed from the needle 908 together with the cap 200.

[0055] For convenience, the device body 700 may cover most of the length of the drug delivery device 100, for example, 60 percent, 70 percent or more of the total length of the drug delivery device 100 (with the cap 200 attached and / or with the cap 200 removed).

[0056] Figure 1B shows the drug delivery device 100 with the cap 200 removed. According to Figure 1B, the device 100 may be ready for operation, for example, ready to perform a drug delivery operation when a drug delivery operation is triggered. As shown, the drug delivery device 100 may further include a needle cover 500. The needle cover 500 may protrude distally from the device body 700 and / or be covered by the cap 200 if the cap 200 is still attached to the device body 700. The needle cover 500 may be movable relative to the device body 700 from an initial position or a first position to a second position or a trigger position. The needle cover 500 may be provided to extend beyond the distal tip of the needle 908 which may protrude from the device body 700 before a drug delivery operation is initiated. The needle cover 500 may be movable in the proximal direction P relative to the housing 102. During this movement, for example, before the needle cover 500 reaches the second position, the needle 908 may puncture the user's skin.

[0057] The needle cover 500 may function as a trigger member of the drug delivery device 100. As a trigger member, the needle cover 500 may automatically initialize the drug delivery operation when displaced proximal to a second position or trigger position (see Figure 1C) from an initial position or first position shown in Figure 1B, preferably when it is in the second position. The drug delivery operation may be initialized by releasing a mechanical lock preventing the movement of the plunger 1000 distally D, or by moving the plunger 1000 to release the mechanical lock via the movement of the needle cover 500. Alternatively, the needle cover 500 may only be able to trigger the drug delivery operation when it has moved from the first position to the second position, and for convenience, only when it is in the second position. In this case, a separate trigger member, such as a trigger button located at the proximal end PE of the device body 700, may be provided to initiate the drug delivery operation. Operating the trigger button to initiate the drug delivery operation may only be possible when the needle cover 500 is in the second position. In yet another alternative configuration, the needle cover 500 may be provided solely to prevent needle stick injuries before and / or after use of the drug delivery device 100. In this case, the needle cover 500 may be completely isolated from the drive mechanism 101 and / or may not be involved at all in triggering or enabling the drug delivery operation.

[0058] The needle cover 500 may be positioned to abut against the user's skin during injection. Therefore, the distal surface of the needle cover 500 may provide a support surface or skin contact surface 501. The skin contact surface 501 may define and / or extend around a needle passage opening provided in the needle cover 500. The skin contact surface 501 may be circumferentially closed, such as a ring, oval, elliptical, rectangular, or quadratic curve, and / or defined by an inward projection (e.g., its distal cylindrical portion) radially protruding from the inner wall of the needle cover 500. For convenience, the skin contact surface 501 may be the distal end face (e.g., the distal end face) of the needle cover 500. The syringe with the needle may be fixed axially within the device. Needle insertion into the skin is performed manually, for convenience, rather than by displacing the syringe relative to the device body 700.

[0059] Figure 1C shows the needle cover 500 in a second position relative to the device body. This is, for example, the position when the drug delivery operation is initiated, may be initiated, and / or when the needle 908 punctures the skin. The needle 908 may protrude axially from the skin contact surface 501 of the drug delivery device 100 (particularly through the needle passage opening of the needle cover 500) and may penetrate the skin by a distance beyond which the needle 908 protrudes beyond the skin contact surface 501 (skin is not shown in this figure). This distance may be characteristic of or equal to the injection depth. The device 100 may remain in contact with the skin until the drug delivery operation of the drug doctor is completed. Completion of the drug delivery operation of the drug doctor may be indicated by any audible, tactile, and / or visual indication or feedback provided by the drug delivery device 100.

[0060] After the drug delivery operation is complete, for example, after the plunger 1000 has moved distally, the device 100 can be removed from the skin (see Figure 1D). The needle cover 500 can be biased relative to the device body 700 toward a first position by a needle cover spring 600 (not shown). Thus, when the device 100 is removed from the skin, the needle cover 500 can be moved relative to the device body 700 toward the first position. The needle cover 500 can be moved distally, for example, beyond its first position, toward the device body 700 to a final, third, or locked position. In this position, the needle cover 500 can be axially locked relative to the device body 700 with respect to movement in the proximal direction P, for convenience, by a locking engagement between the locking feature of the needle cover 500 and the device body 700. Because the needle cover 500 is locked axially, it can no longer be displaced proximal to the second and / or first positions relative to the device body 700. This may protect the user from needle stick injuries after use. In this state, device 100 can be locked (see Figure 1D). The needle cover may protrude further from the device body at the third cover position Z than at the first cover position X.

[0061] List of drugs The terms “drug” or “pharmaceutical” are used herein as synonyms and refer to pharmaceutical preparations containing one or more pharmaceutically active ingredients or pharmaceutically acceptable salts or solvates thereof and optionally pharmaceutically acceptable carriers. A pharmaceutically active ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or pharmaceuticals are used to treat, cure, prevent or diagnose diseases, or otherwise to improve physical or mental health. Drugs or pharmaceuticals may be used over a limited period or, in the case of chronic diseases, regularly.

[0062] As described below, drugs or pharmaceuticals may contain at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes) having a molecular weight of 500 Da or less, carbohydrates and polysaccharides, as well as 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 may be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also possible.

[0063] Drugs or pharmaceuticals may be contained within a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a chamber suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, the chamber may be designed to store drugs for at least one day (e.g., one day to at least 30 days). The chamber may be designed to store drugs for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). The drug container may be or include a dual-chamber cartridge configured to store two or more components of the pharmaceutical preparation to be administered (e.g., an API and a diluent or two different drugs) separately, one in each chamber. In such a case, the two chambers of the dual-chamber cartridge may be configured to allow mixing of two or more components before and / or during administration to a human or animal. For example, the two chambers may be configured to be in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components before administration if desired. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are administered into the body of a human or animal.

[0064] Drugs or agents contained in drug delivery devices as described herein may be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic diabetes mellitus or diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in handbooks such as the Rote Liste 2014, for example, main group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0065] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications thereof include insulin, e.g., human insulin or insulin analogs or derivatives; glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors or pharmaceutically acceptable salts or solvates thereof or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having molecular structures that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or substituting at least one amino acid residue in the naturally occurring peptide and / or adding at least one amino acid residue. The amino acid residue added and / or substituted may be an encoding amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as “insulin receptor ligands.” In particular, the term "derivative" refers to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may be deleted and / or substituted with other amino acids, including non-coding amino acids, or amino acids, including non-coding amino acids, may be added to a naturally occurring peptide.

[0066] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glardine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala, and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0067] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0068] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), and HM-15211. CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Biador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, These include ZP-3022, ZP-DI-70, TT-401 (Pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Chilzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-XTEN.

[0069] Examples of oligonucleotides include mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia, or RG012, used for the treatment of Alport syndrome.

[0070] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0071] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0072] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms and / or pharmaceutically acceptable salts thereof. 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-F20 (Synvisc®) derived from sodium hyaluronate.

[0073] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind to antigens. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be able to immobilize complement. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant that does not support binding to Fc receptors, for example, with a mutated or deleted Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or bivariable region antibody-like binding proteins having crossover binding region orientation (CODVs).

[0074] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage sites of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or polyspecific antibody fragments, e.g., dispecific, trispecific, tetraspecific, and polyspecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or polyvalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and polyvalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0075] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "framework region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides, not the CDR sequence itself, primarily responsible for maintaining the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself is typically not directly involved in antigen binding, as is well known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0076] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0077] Further examples of APIs for the prevention of hemophilia A or B, with or without inhibitors, include antithrombin-targeted siRNAs. An example of an antithrombin-targeted siRNA is fitsilan. The terms “prevention” and “preventive measures” are used interchangeably herein.

[0078] Any pharmaceutically acceptable salt of any API described herein is intended for use with drugs or pharmaceuticals in drug delivery devices. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0079] Without departing from the full scope and spirit of the present invention, various modifications (additional and / or deletions) of the APIs, formulations, apparatus, methods, systems, and embodiments described herein may be made, and it will be understood by those skilled in the art that the present invention encompasses such modifications and all equivalents thereof.

[0080] Exemplary drug delivery devices may include needle-based injection systems, such as those 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 classified into multi-dose container systems and single-dose (partial or full-dose) container systems. Containers may be replaceable or integrated non-replaceable containers.

[0081] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user).

[0082] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based infusion device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (total discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (total discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0083] Fitsilan as a drug API within a device Phytsilane is a synthetically modified double-stranded small interfering RNA (siRNA) oligonucleotide that covalently binds to a three-branched N-acetyl-galactosamine (GalNAc) ligand targeting AT3 mRNA in the liver, thereby inhibiting antithrombin synthesis. See, for example, Pasi et al., N Engl J Med. (2017) 377(9):819-28. The nucleosides in each chain of phytsilane are linked by either 3'-5' phosphodiester or phosphorothioate bonds, forming the oligonucleotide's sugar-phosphate backbone.

[0084] The sense and antisense strands each contain 21 and 23 nucleotides, respectively. The 3' end of the sense strand is conjugated to a GalNAc-containing moiety (also referred to herein as L96) via a phosphodiester bond. The sense strand contains two consecutive phosphorothioate bonds at its 5' end. The antisense strand contains four phosphorothioate bonds, two at its 3' end and two at its 5' end. The 21 nucleotides of the sense strand hybridize with the complementary 21 nucleotides of the antisense strand to form 21 nucleotide base pairs and a two-base overhang at the 3' end of the antisense strand. See also U.S. Patent No. 9,127,274, U.S. Patent No. 11,091,759, U.S. Patent Application Publication No. 2020 / 0163987(A1), and International Publication No. 2019 / 014187. The entire contents of each of these are expressly incorporated herein by reference.

[0085] The two nucleotide strands of phytsilane are shown below: Sense chain: 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 Antisense chain: 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'(Sequence ID 2) Here, Af = 2'-deoxy-2'-fluoroadenosine Cf = 2'-deoxy-2'-fluorocytidine Gf = 2'-deoxy-2'-fluoroguanosine Uf = 2'-deoxy-2'-fluorouridine Am=2'-O-methyladenosine Cm=2'-O-methylcytidine Gm = 2'-O-methylguanosine Um=2'-O-methyluridine "-" (hyphen) = 3'-5' phosphodiester bonded sodium salt "-ps-" = 3'-5' phosphorothioate-bonded sodium salt And, L96 is expressed by the following formula: [ka] It has.

[0086] As used herein, the terms 2'-deoxy-2'-fluoroadenosine and 2'-fluoroadenosine may be used interchangeably.

[0087] As used herein, the terms 2'-deoxy-2'-fluorocytidine and 2'-fluorocytidine may be used interchangeably.

[0088] As used herein, the terms 2'-deoxy-2'-fluoroguanosine and 2'-fluoroguanosine may be used interchangeably.

[0089] As used herein, the terms 2'-deoxy-2'-fluorouridine and 2'-fluorouridine may be used interchangeably.

[0090] Figure 18 shows the extended structural formula, molecular formula, and molecular weight of phytsilane (e.g., sodium form).

[0091] The structure of physsilane is shown in the following diagram: [ka] (In the equation, X is O) It can also be expressed using .

[0092] In Figure 18, phytsilane is shown in its sodium salt form.

[0093] In some embodiments, the device delivers phytsilane in an aqueous solution at concentrations of about 40 to about 200 mg / mL (e.g., about 50 to about 150 mg / mL, about 80 to about 110 mg / mL, or about 90 to about 110 mg / mL). Intermediate values ​​of the ranges and values ​​described herein are also intended to be part of this disclosure. In addition, ranges of values ​​are intended to be used with any combination of the described values ​​as upper and / or lower limits. In further embodiments, the pharmaceutical formulation contains phytsilane in an aqueous solution at concentrations of about 40, about 50, about 75, about 100, about 125, about 150, or about 200 mg / mL. In certain embodiments, phytsilane is provided in an aqueous solution at a concentration of about 100 mg / mL.

[0094] The terms “deliver,” “delivers,” or “the act of delivering” are intended to mean “administer,” “administers,” or “the act of administering.”

[0095] Unless otherwise specified or the context makes clear, as used herein, the terms “approximately” or “about” mean a value within the tolerance range for a particular value determined by those skilled in the art, partly depending on how the measurement or determination is performed. For example, “approximately” or “about” could mean a range of up to 10% (i.e., ±10%). Thus, “approximately” or “about” 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%. Where a particular value is provided in this disclosure, unless otherwise specified, the meaning of “approximately” or “about” should be assumed to be within the tolerance range for that particular value.

[0096] In this specification, the weight of a fitting drug dose refers to the weight of fitting free acid (active moiety), while the administration of fitting to a patient as described herein refers to the administration of fitting sodium (API) provided in a pharmaceutically appropriate aqueous solution (e.g., phosphate-buffered saline at physiological pH). For example, about 100 mg / mL of fitting means about 100 mg of fitting free acid per mL (corresponding to about 106 mg of fitting sodium API). Unless otherwise indicated, the weight of fitting listed in this disclosure refers to the weight of fitting free acid (active moiety).

[0097] In some embodiments, the pharmaceutical formulation in the device comprises a phosphate-buffered saline solution containing a phytosilane. The phosphate concentration in the solution may be about 1 to about 10 mM (e.g., about 2, about 3, about 4, about 5, about 6, about 7, about 8, or about 9 mM) at a pH of about 6.0 to 8.0. The pharmaceutical formulations described herein may contain stabilizers such as EDTA. The pharmaceutical formulations may be preservative-free. In some embodiments, the phytosilane pharmaceutical formulation in the device is preservative-free and contains about 100 mg of a phytosilane per 1 mL of about 5 mM phosphate-buffered saline (PBS) solution, or consists of about 100 mg of a phytosilane per 1 mL of about 5 mM phosphate-buffered saline (PBS) solution, or essentially consists of about 100 mg of a phytosilane per 1 mL of about 5 mM phosphate-buffered saline (PBS) solution. In some embodiments, the phytosisran pharmaceutical formulation in the device contains, or comprises, or essentially consists of, phytosisran in a solution of approximately 5 mM phosphate-buffered saline (PBS), without any preservatives. The PBS solution consists of sodium chloride, dibasic sodium phosphate (heptahydrate), and monobasic sodium phosphate (monohydrate). Sodium hydroxide solution and dilute phosphoric acid may be used to adjust the pH of the formulation to approximately 7.0 or approximately 7.1.

[0098] In some embodiments, the in-device fittings for subcutaneous delivery contain fittings in 5 mM phosphate-buffered saline at pH 7.0 with 0.64 mM NaH2PO4, 4.36 mM Na2HPO4, and 84 mM NaCl. In specific embodiments, the formulation of the fittings for subcutaneous delivery is shown in Table 1 below.

[0099] [Table 1]

[0100] In some embodiments, the formulation of the phytsilane solution for subcutaneous delivery by the device can be described as shown in Table 2 below.

[0101] [Table 2]

[0102] In some embodiments, the device may be used to deliver a single dose of fitusilane, which comprises about 20 to about 80 mg of fitusilane (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 may be used to deliver a single dose of fitusilane, which comprises about 1 to about 30 mg of fitusilane (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0103] In one embodiment, the device may be used to deliver a single dose of approximately 80 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 50 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 20 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 30 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 10 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 5 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 2.5 mg of fitsiran. In one embodiment, the device may be used to deliver a single dose of approximately 1.25 mg of fitsiran.

[0104] In some embodiments, a single dose of fitsilane may be delivered in a delivery volume of about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL). Other delivery volumes described herein may also be used.

[0105] In one embodiment, the device may be used to deliver a single dose of approximately 80 mg of fitsiran in approximately 0.8 mL (approximately 100 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 50 mg of fitsiran in approximately 0.5 mL (approximately 100 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 20 mg of fitsiran in approximately 0.5 mL (approximately 40 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 30 mg of fitsiran in approximately 0.5 mL (approximately 60 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 10 mg of fitsiran in approximately 0.5 mL (approximately 20 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 5 mg of fitsiran in approximately 0.5 mL (approximately 10 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 2.5 mg of fitsiran in approximately 0.5 mL (approximately 5 mg fitsiran / mL). In one embodiment, the device may be used to deliver a single dose of approximately 1.25 mg of fitsiran in approximately 0.5 mL (approximately 2.5 mg fitsiran / mL).

[0106] In one embodiment, the device delivers a prophylactically effective dose of fitsiran to patients who require fitsiran (e.g., patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B) to prophylactically treat hemophilia (e.g., patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B). “Prophylactically effective dose” means the amount of fitsiran that helps patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B to achieve a desired clinical endpoint, such as a reduction in annual bleeding rate (ABR), annual joint bleeding rate (AjBR), annual spontaneous bleeding rate (AsBR), or frequency of bleeding episodes. Where used herein in relation to fitsiran, the terms “treat,” “to treat,” or “to cure” include prophylactic treatment of the disease and refer to the achievement of a desired clinical endpoint.

[0107] Patients with inhibitors in hemophilia A or B are those who have expressed alloantibodies against factors they previously received treatment for (for example, factor VIII in the case of hemophilia A patients or factor IX in the case of hemophilia B patients). Patients with inhibitors in hemophilia A or B may be refractory to replacement factor therapy. Patients without inhibitors are those who do not have such alloantibodies. This treatment method may be beneficial not only for patients with inhibitors in hemophilia B, but also for patients with inhibitors in hemophilia A.

[0108] As used herein, "inhibitor-containing or inhibitor-free hemophilia A or hemophilia B" means 1) a patient with inhibitor-containing hemophilia A, or 2) a patient with inhibitor-containing hemophilia B, 3) a patient with inhibitor-free hemophilia A, or 4) a patient with inhibitor-free hemophilia B. As used herein, "patient" means a human patient. "Patient" may also mean a human subject.

[0109] In some embodiments, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 50 mg of fitsiran every two months (or every eight weeks). In other embodiments, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 50 mg of fitsiran every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 80 mg of fitsiran every two months (or every eight weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 80 mg of fitsiran every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 20 mg of fitsiran every two months (or every eight weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 20 mg of fitsiran every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 10 mg of fitsiran every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 30 mg of fitsiran every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B by subcutaneously administering approximately 5 mg of fitsilan monthly (or every four weeks).In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 2.5 mg of fitsiran monthly (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 1.25 mg of fitsiran monthly (or every four weeks).

[0110] Accordingly, provided herein is a method for the prophylactic treatment of a patient with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, comprising subcutaneous delivery of a prophylactic effective dose of fitsiran to a patient requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once a month (or every 4 weeks) or every 2 months (or every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0111] As an example, a prophylactic treatment method for patients with hemophilia A or hemophilia B, with or without inhibitors, may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0112] Furthermore, provided herein is a method for reducing the frequency of bleeding episodes in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, comprising subcutaneous delivery of a prophylactic effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once a month (or every 4 weeks) or every 2 months (or every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0113] As an example, a method to reduce the frequency of bleeding episodes in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0114] Provided herein are methods for reducing ABR in patients with or without inhibitors of hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once a month (or every 4 weeks) or every 2 months (or every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0115] As an example, a method for reducing ABR in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0116] Provided herein are methods for reducing AjBR in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once a month (or every 4 weeks) or every 2 months (or every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0117] As an example, a method for reducing AjBR in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every 4 weeks) or every 2 months (or every 8 weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0118] Provided herein are methods for reducing AsBR in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once a month (or every 4 weeks) or every 2 months (or every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0119] As an example, a method for reducing AsBR in patients with hemophilia A or hemophilia B, with or without inhibitors, may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every 4 weeks) or every 2 months (or every 8 weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0120] In some embodiments, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 50 mg of fitsiran once every two months (or every eight weeks). In other embodiments, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 50 mg of fitsiran approximately every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 80 mg of fitsiran approximately every two months (or every eight weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 80 mg of fitsiran approximately every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 20 mg of fitsiran approximately every two months (or approximately every eight weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 20 mg of fitsiran approximately every month (or every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 10 mg of fitsiran approximately every month (or approximately every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering approximately 30 mg of fitsiran approximately every month (or approximately every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B by subcutaneously administering approximately 5 mg of fitsilan approximately every month (or approximately every four weeks).In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering about 2.5 mg of fitsiran approximately every month (or approximately every four weeks). In yet another embodiment, the device may be used to prophylactically treat patients with hemophilia A or hemophilia B, with or without inhibitors, by subcutaneously administering about 1.25 mg of fitsiran approximately every month (or approximately every four weeks).

[0121] Accordingly, provided herein is a method for the prophylactic treatment of a patient with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, comprising subcutaneous delivery of a prophylactic effective dose of fitsiran to a patient requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once approximately every month (or every four weeks) or every two months (or every eight weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0122] As an example, a prophylactic treatment method for patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran to patients requiring fitsiran, approximately monthly (or approximately every 4 weeks) or approximately every 2 months (or approximately every 8 weeks) using a device. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0123] Furthermore, provided herein is a method for reducing the frequency of bleeding episodes in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, comprising subcutaneous delivery of a prophylactic effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once approximately monthly (or about every 4 weeks) or about every 2 months (or about every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0124] As an example, a method to reduce the frequency of bleeding episodes in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitusilane to patients requiring fitusilane, approximately monthly (or every four weeks) or every two months (or every eight weeks) using a device. Approximately 50 mg of fitusilane may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitusilane / mL).

[0125] Provided herein are methods for reducing ABR in patients with or without inhibitors of hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once approximately every month (or every four weeks) or every two months (or every eight weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0126] As an example, a method for reducing ABR in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0127] Provided herein are methods for reducing AjBR in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once approximately monthly (or about every 4 weeks) or about every 2 months (or about every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0128] As an example, a method for reducing AjBR in patients with or without inhibitors of hemophilia A or hemophilia B may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0129] Provided herein are methods for reducing AsBR in patients with inhibitor-containing or inhibitor-free hemophilia A or hemophilia B, which also include subcutaneous delivery of a prophylactically effective dose of fitsiran to patients requiring fitsiran using a device. The prophylactic effective dose of fitsiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactic effective dose of fitsiran may 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 prophylactic effective dose of fitsiran may be delivered once approximately every month (or about every 4 weeks) or about every 2 months (or about every 8 weeks). Phytsilane can be delivered in a delivery volume of approximately 0.5 mL to approximately 1 mL (for example, approximately 0.5 mL, approximately 0.6 mL, approximately 0.7 mL, approximately 0.8 mL, approximately 0.9 mL, or approximately 1 mL).

[0130] As an example, a method for reducing AsBR in patients with hemophilia A or hemophilia B, with or without inhibitors, may include subcutaneous delivery of approximately 50 mg of fitsiran once a month (or every four weeks) or every two months (or every eight weeks) using a device to patients requiring fitsiran. Approximately 50 mg of fitsiran may be delivered in approximately 0.5 mL of PBS (at a concentration of approximately 100 mg fitsiran / mL).

[0131] 2. Examples of drug delivery devices with or without a separate syringe holder (Figures 1A-1D and 2) Figure 2 shows an exploded view of one example of a drug delivery device 100, with or without an optional separate syringe holder 800. The drug delivery device 100 may be an auto-injector suitable for automated drug injection. The injection process can be triggered manually, i.e., by the user.

[0132] The drug delivery device 100 may include the following: - Removable cap 200 and cap lid 300. The cap 200 with the cap lid 300 can prevent reattachment after use of the drug delivery device 100. Details of the cap 200 and cap lid 300 are described in Section 3 below. - A grabber 400, attached to the cap 200 and configured to remove the RNS914 or soft needle shield SNS914 from the pre-filled syringe 900. Details of the grabber 400 are described in Section 4 below. - A needle cover 500 that can be nested inside the device body 700. Details of the needle cover 500 are described in Section 5 below. - A needle cover spring 600 biases the needle cover 500 in the distal direction D. Details of the needle cover spring 600 are described in Section 6 below. - A device body 700 which is essentially cylindrical and may include a distal opening configured for inserting a needle cover 500 and a proximal opening configured for inserting a drive spring holder 1200 which may have the function of a rear case. Details of the device body 700 are described in Section 7 below. - Any syringe holder 800. The mounting of pre-filled syringes 900 without a syringe holder is described in more detail in Section 7 below. Details of the syringe holder 800 are described in Section 8 below. - Prefilled syringe 900. Details of the prefilled syringe 900 are described in Section 9 below. Alternatively, a cartridge configured to connect to a removable needle or any other drug container may be used. - Plunger 1000. Details of Plunger 1000 are described in Section 10 below. Plunger 1000 can be used to discharge drug Dr from pre-filled syringe 900. - Drive spring 1100. Details of the drive spring 1100 are described 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. - Drive spring holder 1200. Details of the drive spring holder 1200 are described in Section 12 below. The drive spring holder 1200 may be part of the housing, case, or device body 700, particularly the rear portion. The drive spring holder 1200 may be configured to hold the drive spring 1100 and to support the syringe flange 912 of a pre-filled syringe 900, for example, by two support arms extending distally from the proximal end plate of the drive spring holder 1200. - Clicker 1300. Details of Clicker 1300 are described in Section 13 below. Clicker may be an audible indicator and / or a tactile indicator, or may provide audible and / or tactile feedback indicating, for example, the completion of dose delivery or other events.

[0133] The control subassembly (or front subassembly) may include a needle cover 500, a needle cover spring 600, and a device body 700. The control subassembly may perform control of the pre-filled syringe 900.

[0134] The plunger 1000, drive spring 1100, drive spring holder 1200, and optional audible indicator or clicker 1300 may be included in the drive subassembly (or rear subassembly).

[0135] The drug delivery device 100 may include a case designed as a multi-part case. In particular, the case may include a device body 700 forming a front case and a rear case formed by, for example, a drive spring holder 1200. A portion of the drive spring holder 1200 may be enclosed along its longitudinal direction by the front case or the device body and fitted to close the open proximal end of the front case. The proximal portion of the drive spring holder may protrude from the proximal end of the device body. The case may be fitted to hold a pre-filled syringe 900 and the other parts of the auto-injector 100.

[0136] The pre-filled syringe 900 has a needle 908 located at the distal end, fixed, for example, to the neck of the syringe body. The pre-filled syringe 900 can be pre-assembled. Typically, a protective needle shield may be detachably coupled to the needle 908 of the pre-filled syringe 900. The protective needle shield may be a flexible needle shield (e.g., a rubber needle shield SNS) 914 or RNS 914, which may consist of an inner rubber material and a full or partial plastic shell. A plunger stopper 910 may be positioned to seal the pre-filled syringe 900 proximal and to displace the drug Dr or drug M contained within the pre-filled syringe 900 through the needle 908. In other exemplary embodiments, instead of the pre-filled syringe 900, a cartridge or container containing the drug Dr or drug M that engages with a detachable needle (e.g., by screw, snap, friction, Luer lock, etc.) may be used.

[0137] In exemplary embodiments, the cap 200 may be detachably positioned on the device body 700 or the distal end DE of the case. The cap 200 may include gripping elements (e.g., barbs, hooks, narrowing portions, etc.) of the grabber 400 positioned to engage with the protective needle shield RNS or SNS 914 of the prefilled syringe 900. The cap 200 may also engage with the needle cover 500 and / or the device body 700. The cap 200 may include gripping features to facilitate removal of the cap 200 (e.g., by twisting and / or pulling the cap 200 relative to the device body 700). Furthermore, the cap 200 may include visual and / or tactile indicators, such as arrows, indicating the direction in which to remove the cap 200 from the device body 700. The cap 200 may be a single piece 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.

[0138] In an exemplary embodiment, the needle cover spring 600 may be positioned to bias the needle cover 500 distally D relative to the device body 700.

[0139] In an exemplary embodiment, the drive spring 1100 may be located within the device body 700, for example, and may be attached to a drive spring holder 1200. The plunger 1000 may serve to transmit the force of the drive spring 1100 to a plunger stopper 910 in the pre-filled syringe 900 or in another drug container.

[0140] In an exemplary embodiment, the plunger 1000 may be hollow, and the drive spring 1100 may be located inside the plunger 1000 and bias the plunger 1000 distally D relative to the device body 700 and / or the drive spring holder 1200.

[0141] In another exemplary embodiment, the plunger 1000 may be solid, and the drive spring 1100 may engage with 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 into the pre-filled syringe 900.

[0142] In an exemplary embodiment, a plunger release mechanism may be provided to prevent the plunger 1000 from being released before the needle cover 500 retracts relative to the device body 700, and to release the plunger 1000 after the needle cover 500 has retracted sufficiently.

[0143] In exemplary embodiments, the pre-use needle cover locking mechanism may be arranged to prevent the needle cover 500 from retracting relative to the device body 700 when the cap 200 is in a predetermined position, thereby preventing unintended activation of the auto-injector, i.e., the drug delivery device 100 (e.g., if dropped, during transport, or during packaging).

[0144] Furthermore, a post-use needle cover locking mechanism may be provided to prevent the needle cover 500 from moving proximal after use of the drug delivery device 100.

[0145] When the cap 200 is attached to the drug delivery device 100, the axial movement of the cap 200 in the proximal direction P relative to the device body 700 can be limited by the cap 200 contacting the device body 700. When the cap 200 is pulled distally D relative to the device body 700, the grabber 400 of the cap 200 can capture the RNS or SNS 914 and may also allow the RNS or SNS 914 to be removed.

[0146] In the illustrated embodiment, the cap 200 may include a closable opening for inserting a front assembly tool. The cap 200 may be permanently closed at its distal end.

[0147] The drug delivery device 100 may include at least one clicker 1300 for generating audible and / or tactile feedback of the completion of delivery of drug Dr or drug M. In relation to the present invention, the clicker 1300 may also be called an audible indicator and / or tactile indicator. The audible indicator and / or tactile indicator 1300 may be formed, for example, as a monostable or bistable spring, for example, a leaf spring, and may be held in a drive spring holder 1200 or a rear case.

[0148] The drive spring holder 1200 or rear case may be adapted to prevent axial movement of the pre-filled syringe 900 after assembly, particularly during storage, transport, and normal use. In detail, the drive spring holder 1200 may include elastic arms, for example, two elastic arms, at its front end. The elastic arms may be formed as labyrinth arms to dampen impact forces. The elastic arms may be attached to more rigid arms of the drive spring holder 1200, for example, two rigid arms. The rigid arms may extend distally from the proximal end plate of the drive spring holder 1200. Both rigid arms may be arranged parallel to each other or essentially parallel. The drive spring holder 1200 may include a central pin for guiding the drive spring 1100. The central pin and the proximal end plate may be integral parts of the drive spring holder 1200 or separate parts thereof, for example, integrated into a single separate part with respect to the drive spring holder 1200.

[0149] In exemplary embodiments, the drug delivery device 100 may be formed from at least two subassemblies, for example, a control or front subassembly and a drive or rear subassembly, to allow flexibility in the time and place of manufacturing the subassemblies and final assembly with the prefilled syringe 900.

[0150] 3. Cap and cap cover (Figures 3A to 3I) Figure 3A shows an arbitrary cap 200 with an arbitrary cap cover 300 mounted on it, and the cap 200 and cap cover 300 are separated from the device body 700 and needle cover 500. The cap 200 may have a different color from the device body 700. The cap 200 shown in Figures 3A to 3I may correspond to or be identical to the cap 200 shown in Figures 4F, 4H and 6B. The material selected for the cap 200 and / or cap cover 300 may be Bayblend M850X, a medical-grade PC / ABS blend. PC / ABS may be selected primarily for its strength, flexibility and its strength at high temperatures, which reduces injection molding cycle time and thus allows for lower part costs. The cap 200 includes a cap body 201. The cap body 201 (for example, when viewed in a plan view) has a frustoconical shape in which the radial and / or circumferential dimensions of the cap body 201 increase distally D along the longitudinal axis A. This shape assists the user in grasping the cap 200 and pulling it distally D by, for example, pure axial movement relative to the device body. When viewed from above, i.e., along the longitudinal axis A, the cap body 201 may have an elliptical or rectangular shape with rounded corners. This shape can also assist the user in grasping the cap 200 and pulling it distally D. Furthermore, such a shape can prevent the drug delivery device 100 from rolling when the user places it down. To further facilitate handling by the user, especially when removing the cap 200, the cap 200 is provided with a gripping surface 202, for example, a side surface. The gripping surface 202 may have a ribbed, flared, or square geometric shape. As shown in Figure 3A, the cap 200 has at least one cap user indicator 203 on its surface. Preferably, the cap 200 has two cap user indicators 203 positioned on opposite sides of each other. In the illustrated embodiment, the cap user indicator 203 has the shape of an arrow pointing in the distal direction D. Proximal to where the arrow begins, the cap 200 may have a rectangular recess.Cap user indicator 203 and body user indicator 733 (as described in Section 7 below) may form a user indicator. Thus, the cap user indicator 203 indicates to the user which direction the cap 200 should be pulled when removing the cap 200 from the drug delivery device 100. The arrow is designed as a recess on the cap surface, so the arrow also supports a secure grip for the user when grasping and pulling the cap 200. Thus, the cap user indicator 203 provides the user with both visual and tactile assistance. Furthermore, the cap 200 includes at least one cap clip 204 for connecting or attaching the cap 200 to the needle cover 500 and therefore to the device body 700. As shown in Figures 3B, 3C, 3F, 3H and 3I, the cap clip 204 may be designed as an elastic element having a free end that engages with a corresponding portion of the needle cover 500 in the proximal direction. The corresponding portion of the needle cover 500 may be a cap clip window 504 as described below. The cap 200 preferably has two opposite cap clips 204. As shown in Figures 3B, 3C, 3F, 3H and 3I, the cap clips 204 are integral parts of the cap 200. The cap clips 204 have a proximal free end that defines the clip 204 in the proximal direction. This free end has a radially inward-facing hook or retaining element. The retaining element is designed to engage with the cap clip window 504 of the needle cover 500. The cap 200 has two diametrically opposite cap recesses 213. In the illustrated embodiment, the recesses 213 are on the same side as the arrows (see Figure 3I). Preferably, the recesses 213 have a trapezoidal shape (when viewed in plan). The width of each recess increases in the proximal direction.

[0151] In addition, the cap 200 includes at least one, preferably more than one, for example, four anti-rotation ribs 205. The anti-rotation ribs 205 may help enable the cap 200 to be mounted on the device body 700 in only one orientation so that the body user indicator 733 and the cap user indicator 203 are rotatably aligned and the combined indicators are axially oriented. When the cap 200 is mounted on the drug delivery device 100, the needle shield is rotatably locked relative to the cap for convenience, so the anti-rotation ribs 205 prevent accidental rotation of the cap 200 relative to the housing body 700, which could lead to damage or coring of the needle shield. For example, as seen in Figures 3A, 3H and 3I, the anti-rotation ribs 205 may be elongated bars extending proximal along the longitudinal axis of the cap 200 or the device. The anti-rotation ribs 205 may be integral projections 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.

[0152] The anti-rotation rib 205 may be designed as an elongated (for example, having its main extension range along the longitudinal axis A) locking lug that slides into a corresponding recess or cap groove 725 of the device body 700 when the cap 200 is joined to the device body 700. Thus, the cap 200 cannot be rotated relative to the device body 700, i.e., the drug delivery device 100. The cap user indicator 203 may be on the same plane as the anti-rotation rib 205 and the cap recess 213.

[0153] As shown in Figures 3B and 3C, the cap clips 204 can help implement drop protection, i.e., a drop protection mechanism. In the illustrated embodiment, the device 100 includes two cap clips 204. The drop protection mechanism conveniently prevents the drug delivery device 100 from being ejected if it is dropped. If this mechanism is not in place, if the drug delivery device 100 is dropped with the cap 200 facing upwards, the needle cover 500 could continue to move under its own inertia from a first cover position X (see Figure 1B) to a second cover position Y (see Figure 1C) when the drug delivery device 100 touches the ground, allowing the device 100 to be ejected. This is prevented by the cap clips 204. Figure 3B shows the drug delivery device 100 in its pre-use state, with the needle cover 500 in the first cover position X, biased forward by the needle cover spring 600. The cap clip 204 is located within the corresponding cap clip window 504 of the needle cover 500 and restricts the backward movement of the needle cover 500 in the proximal direction P, as shown in Figure 3C. Therefore, when the cap clip 204 is located within the corresponding cap clip window 504, the needle cover 500 cannot reach the second cover position Y. The cap clip 204 is constrained by the cap rib 727 of the device body 700 (see Figure 7F) and is prevented from deflecting outward. When the cap 200 is removed by the user, the cap 200 first moves forward, allowing the cap clip 204 to move to a wider portion of the device body 700 before the cap clip 204 contacts the needle cover 500, thus allowing the cap clip 204 to deflect outward and the cap 200 to be removed.

[0154] Figures 3D and 4F show the interior of the cap 200. The cap 200 has a cap opening 206 for receiving the grabber 400. The cap opening 206 extends distally to the cap case 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 located in the proximal end section of the cap tube 210. Multiple grabber retaining bosses 207 (e.g., two grabber retaining bosses 207) are arranged, for example, equidistant along the inner circumferential surface of the cap tube to prevent movement of the grabber 400 in the proximal direction P relative to the cap 200. The retaining bosses are located distal to the cap (tube) opening 206. For the interaction between the cap opening 206 and the grabber 400, see the description in Figures 4A to 4H. As seen in Figure 3D, the cap has several apertures, distal holes 208, or device priming holes in the longitudinal direction. These holes 208 may serve as access for tools to prime the device. Priming may involve making the device triggerable. Priming may involve moving the needle cover and is a process performed during assembly, for example, near the end of the device assembly (further described below).

[0155] Furthermore, the cap 200 includes at least one, preferably two, cap cover clips 209 for attaching the cap cover 300 to the cap 200. Preferably, the two cap cover clips 209 are positioned on opposite sides of each other. The cap 200 may have a surface 214 for tightening and fitting the cap cover 300. For example, as seen in Figures 2, 3A, 3B, 3C, 3E, and 3F, the cap cover 300 may be positioned in the distal end region of the cap 200. Figure 3E shows a side cross-sectional view of the cap cover 300. The cap cover 300 has an outer cap cover surface 301 that closes the cap 200 in the distal end region. Thus, the distal hole 208 of the cap 200 can be sealed (made inaccessible). Another function of the cap cover 300 is to protect the user from reapplying the cap to the drug delivery device 100 that is already in use, which is implemented using an anti-recapping mechanism. The cap cover 300 further includes an inner surface facing the proximal direction P. The inner surface has at least one cap cover spacer 302. Preferably, as shown in Figures 3E and 3F, the cap cover 300 includes two cap cover spacers 302. The cap cover spacers 302 are positioned opposite each other. Furthermore, the distance between the two end regions of the cap cover spacer 302 pointing in the proximal direction P corresponds at least essentially to and / or is adjusted to the distance between points on the skin contact surface 501 of the needle cover 500 (see Figure 5) that are opposite each other in the diametrical direction. In other words, the distance between the cap cover spacers may be between the inner diameter and outer diameter of the ring defining the ring-shaped skin contact surface. As shown in Figure 3F, after the device has been used or injected, when the drug delivery device 100 is removed from the injection site and the needle cover 500 is moved to its final locked position (see Figure 1D), the recapping prevention mechanism prevents the cap 200 from being placed back onto the used drug delivery device 100.Because the needle cover 500 protrudes further distally from the device body 700 after dispensing (see Figure 1D) than before dispensing (see Figure 1B), and because the distance between the cap lid spacers 302 is appropriately selected, when attempting to reattach the cap 200 to the device body 700, as shown in Figure 3F, direct contact occurs between the needle cover 500 and the cap lid 300 before the cap is connected to the rest of the device. This means that the cap lid 300, i.e., the cap lid spacer 302, comes into contact with the needle cover 500, i.e., the skin contact surface 501, before the cap 200 can fully seat on the device body 700. The appearance of the drug delivery device 100 with the cap 200 being replaced is also different because the recapping prevention mechanism prevents the cap 200 from being positioned on the drug delivery device 100 in the same way as by the cooperation of the initial needle cover and cap lid. Therefore, a used drug delivery device 100 having a cap 200 is visually and tactilely distinguishable from an unused drug delivery device 100 having a cap 200. An advantage is that the cap can no longer be placed on the device body at all, and is not in the position where the cap was originally located, i.e., before the cap was separated from the rest of the device in order to use the device.

[0156] As shown in Figure 3G, the cap cover 300 preferably has positioning structures or positioning arcs 303 located on two opposite sides. Preferably, each of the positioning arcs 303 has a positioning guide 303a within its end area, designed as an integral projection of the positioning arc. Thus, the cap cover 300 has four positioning guides 303a. The cap cover 300 preferably has interlocking ribs 303b in the middle of each positioning arc 303a. Preferably, each positioning arc 303 has three ribs 303b. The ribs 303b are configured to form an interlocking fit with the corresponding interlocking surface 214 of the cap 200. Furthermore, the cap cover 300 preferably has recesses 304 located on two opposite sides.

[0157] 4. Graba (Figures 4A-4H) Figures 4A to 4H show an arbitrary grabber 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 grabber 400 may be connected such that when the cap 200 is removed from the drug delivery device 100 together with the grabber 400, the needle shield 914 is removed from the needle 908. In other words, the grabber 400 may be coupled to the cap 200 such that when the cap 200 is removed, the needle shield 914 is also removed from the needle 908. The grabber may be locked axially to the cap.

[0158] Figures 4A and 4B show a perspective view and a cross-sectional view of an arbitrary grabber 400, respectively. The grabber 400 may be a thin sheet metal component located inside the cap 200 that removes the needle shield 914 from the pre-filled syringe 900 during cap removal. The needle shield 914 (for example, shown in Figure 9) may be a rigid needle shield (RNS) or a flexible needle shield (SNS).

[0159] In this example, the grabber 400 may be formed from a single piece, such as a sheet of metal or a sheet of metal alloy (see, for example, Figure 4C). The grabber 400 may include at least a body or a grabber carrier 402. The grabber carrier 402 may be bent or kinked multiple times along a plurality of longitudinal bends, kinks, or bends 404 to form a plurality of carrier portions 406. Each carrier portion 406 may have or include a planar outer surface area or an essentially planar outer surface area.

[0160] Furthermore, the planar outer surface region of the grabber carrier 402 can be bent or angled so that the outer carrier portion 406 partially overlaps with the overlap region 408. Thus, in the bent state, the grabber carrier 402 may have, for example, a pipe or tube shape with a polygonal cross-section. Other cross-sections, such as a circular cross-section, are also possible. The partial overlap region 408 in the bent state of the grabber carrier 402 may allow for compensation of manufacturing tolerances of the grabber 400. The grabber carrier 402 may have a free longitudinal end that can be positioned near the overlap region 408.

[0161] To grasp the needle shield 914, more than one of the carrier portions 406 may include notches or openings 410, from which each barb 412 may be bent and protrude inward from the inner surface of the grabber carrier 402 and thus the carrier portion 406. In the assembled state, the inwardly angled barbs 412 may extend distally D of the grabber 400 and thus the drug delivery device 100.

[0162] The barb 412 may be adapted to deflect and grip the needle shield 914 while the needle shield 914 is being assembled to the drug delivery device 100 (see, for example, Figures 4D, 4E, and 4H), and may be adapted to further grip the needle shield 914 when the cap 200 is removed from the drug delivery device 100.

[0163] The barb 412 may be designed as a hook or may have a prong configuration. In particular, the barb 412 may project inward from the inner surface of the carrier portion 406 and may include a prong 414 at its free end. The prong 414 may be fitted to abut or bite into the outer surface of the needle shield 914. The prong may be designed to form an interlocking fit and / or a morphing fit and / or a pressure fit during assembly, or to form a positive connection and / or a non-positive connection (see, for example, Figures 4D and 4E) at least during the removal of the needle shield 914 from the needle. In another embodiment, the prong 414 may be fitted so that it is already biting into the outer surface of the needle shield 914 when the grabber 400 is assembled to the needle shield 914. That is, a morphing fit or a positive fit may already be applied during the assembly process, rather than immediately after the start of the cap removal process.

[0164] According to this embodiment, the prongs 414 may be configured as double spikes positioned on each barb 412. This configuration can be achieved by a concave shape between each of the two prongs 414 for each barb 412. By controlling the concave shape, and therefore the distance between the prongs 414, the penetration depth into the surface of the needle shield 914 can be limited. This may be particularly important if the needle shield 914 is a rubber needle shield, as penetration beyond a certain limit could affect sterility by accessing the needle 908.

[0165] Each opening 410 having a barb 412 may be located in the distal portion D6 (e.g., the distal half) of the grab carrier 402, and the proximal portion D5 (e.g., the proximal half) of the grab carrier 402 may include any openings or grab portion 406 without barbs.

[0166] The proximal portion D5 and the distal portion D6 may be substantially the same length when viewed along the longitudinal direction. However, the proximal portion D5 may be longer than the distal portion D6. For example, the proximal portion D5 may be about 10 mm, and the distal portion may be 9 mm.

[0167] The sum of the lengths of the proximal D5 and distal D6 corresponds to the total length of the Graba 400 when viewed along its longitudinal direction.

[0168] The overall length of the grub could be, for example, 15mm to 25mm, or even 19mm.

[0169] The grabber 400 may have two opposite axial ends, a first end or anterior end 418 located at the distal D6 of the grabber carrier 402, and a second end or posterior end 420 located at the proximal D5 of the grabber carrier 402.

[0170] The first end 418 of the grabber 400, for example, the front end 418, may be the end that is first introduced into the cap opening 206 of the cap 200 during the assembly process. The grabber 400 may have an inclined surface region 422 located at the front end 418. The region 422 may be inclined and oriented away from the axis when viewed from the first end 418.

[0171] Region 422 may be designed to interact with a grabber retaining boss 207 that is to engage with the associated grabber interface feature portion 410b, for example, the opening 410b and / or the retaining slot 410b (see Figures 4F and 4E). The inclined surface region 422 may be angularly aligned with the grabber interface feature portion 410b and / or the grabber retaining boss 207 that it is to engage with when assembled to the cap 200. In the axial direction, the inclined surface region 422 is offset distally from the grabber interface feature portion 410b formed by the opening 410 in the embodiment shown in Figure 4A. As the grabber 400 is inserted into the cap opening 206, the grabber retaining boss 207 contacts the surface region 422, and the grabber 400 is further guided into the cap opening 206. This can increase the radial elastic deformation of the grabber 400 until, for example, the grabber interface feature (opening 410b / retaining slot 410b) engages with the grabber retaining boss 207 (see, for example, Figure 4F). Once engagement is established, the elastic bias of the grabber 400 can be reduced, for example, until the grabber 400 contacts the cap 200.

[0172] Figure 4A shows a notch forming a grabber orientation feature 416. The notch may have an inclined surface 424 that angularly defines the notch. The notch may be defined axially by the surface 426, as seen in the axial direction away from the first end 418 (e.g., proximal direction P). The angular spread of the notch may decrease or diminish with increasing distance from the first end 418. In other words, the notch may taper toward the second end 420 (e.g., toward proximal direction P). The surface 426 that axially defines the notch may extend perpendicular to axis A when the notch is viewed in a plan view or top view. The angle of the surface 424 with respect to the axis may be less than 90°, for example, 45° or less, when the notch is viewed in a plan view or top view.

[0173] The kinked, folded, or bent region 404 may extend along the longitudinal direction of the grabber 400, preferably along the entire axial extension range of the grabber 400. Thus, at the front end or leading edge 418, the kink, fold, or bend 404 may define a corner 428. Each corner may be an angled region of the edge of the grabber 400. The edge or corner 428 may be oriented axially, i.e., facing away from the cap opening 206.

[0174] The rear end 420 of the grabber carrier 402 may include at least one further notch 434. The notch 434 serves, for example, to help the assembly head maintain orientation during assembly of the grabber 400 with the cap.

[0175] The rear end portion 420 may also include small indentations 436, which are indentations formed during the production of the metal sheet later used to form the grabber 400.

[0176] Figure 4C shows an exemplary embodiment of a single sheet 430 that can form a grabber carrier 402. The metal sheet, and therefore the grabber 400, may include two groups of three openings 410a, 410b, and 410c, respectively. Each opening 410 may include its respective barb 412. The webs between the openings 410a, 410b, and 410c may be arbitrary, and for example, there may be common openings for several barbs 412. All barbs 412 may have the same length and / or shape. Alternatively, at least one of the barbs 412 may have a different shape and / or length compared to the shape and / or length of the other barbs 412.

[0177] The openings, for example, two groups 410a, 410b, and 410c, can be arranged on the metal sheet such that when the grabber carrier 402 is formed, the two groups of openings 410 and their respective barbs 412 can be positioned substantially opposite each other. Thus, the force applied to the needle shield (RNS or SNS) 914 by the barbs 412 during removal can be distributed more uniformly and / or symmetrically, and better removal of the needle shield can be achieved.

[0178] According to one aspect of this disclosure, the Graba 400 performs the following steps: - A step of preparing the grab carrier 402 in the form of a sheet 430, such as a metal sheet that has been stamped or punched (cut out), - A step of forming a plurality of barbs 412 on the grabber carrier 402 by cutting, punching, stamping or die stamping, - A step of bending or kinking the grabber carrier 402 multiple times along multiple longitudinal bends or lines 404 in order to form multiple carrier sections 406 such that more than one of the multiple carrier sections 406 may contain their respective barbs 412, - For example, as shown in Figures 4A and 4B, the process involves bending the barb 412 so that it protrudes from the inner surface of the associated carrier portion 406. It can be produced by [means].

[0179] The sheet 402 may be a single thin sheet metal that can be cut, for example, by punching or stamping, to form notches or openings 410 and barbs 412 within the notches or openings 410.

[0180] The sheet may include stainless steel, such as high-strength stainless steel, EN 1.4310.

[0181] The maximum outer diameter of the grabber 400 in the assembled state may depend on the transverse length l1 of the sheet. However, the maximum outer diameter of the grabber 400 in the assembled state may be smaller than the outer diameter of the folded sheet 430 when the two longitudinal edges of the sheet are in contact. This may be the case if there is an overlapping region 408 of the grabber 400 in the assembled state (see, for example, Figures 4A and 4B).

[0182] The opening 410 may have a substantially rectangular shape. The extended range of the opening 410 along the transverse axis of the sheet 420 may represent the width or area of ​​the opening 410, for example, 410a, 410b, and 410c.

[0183] The barbs 412 may have a width smaller than the openings 410 and may extend longitudinally along at least one-third of each opening 410.

[0184] In particular, the barb 412 may have a length along its longitudinal axis of 0.5 mm, 1 mm, or 2 mm or more, measured from its proximal end to the prong of the barb 412.

[0185] In particular, the barb 412 may have a length along its longitudinal axis of 3 mm, 2 mm, or 1 mm or less. In particular, the barb may have a width of 1 mm, 2 mm, or 3 mm.

[0186] Figures 4D and 4E show the grabber 400 in the engagement position with the needle shield 914 of the syringe 900. The body or barrel 902 and all other elements of the syringe 900, such as the cap 200, are not shown in these figures.

[0187] As can be seen, the grabber 400 may be positioned distal to the needle shield 914 such that at least the proximal portion D4 of the needle shield between the proximal end of the grabber 400, for example, the trailing edge 420, and the proximal end of the needle shield 914 is not covered.

[0188] Therefore, the length of the grabber 400 may be shorter than the length of the needle shield that the grabber 400 intends to grasp, such that the proximal portion of the needle shield 914 extends proximally beyond the proximal portion of the grabber 400.

[0189] The leading edge 418 of the grabber 400 can be aligned with the distal end of the needle shield 914 along a vertical plane, or can be essentially aligned with the distal end of the needle shield 914.

[0190] In the assembly position of the grabber 400 and the needle shield 914, the barb 412 is bent for convenience to penetrate the needle shield 914. As can be seen from Figure 4D, the point of contact of the barb 412 with the needle shield 914, for example, the penetration point, may be offset distally with respect to the longitudinal midpoint of the needle shield 914. In other words, the grabber 400 may grip the needle shield 914 at its distal portion. In further other words, the grabber 400 may interact with the needle shield 914 via the barb 412 over a substantially total distance given by portions D4 and D5 (and the length of the barb 412) from the proximal end of the needle shield 914.

[0191] The proximal D5 of the Graba 400 may have the advantage of stabilizing the needle shield 914 during removal of the cap 200, and therefore the needle 0 itself. Thus, the sterility of the needles 110 and 908 can be further maintained.

[0192] The required size of the Grava 400 depends on the drug delivery device, pre-filled syringe, and especially the needle shield used with certain drug delivery devices, and therefore may vary accordingly.

[0193] Figure 4F shows a cutaway view of the grabber 400 of the aforementioned embodiment assembled inside the cap 200.

[0194] As can be seen, the grabber 400 is inserted into the cap opening 206 (shown in Figure 3D), and the cap opening 206 is configured and / or sized to receive the grabber 400 when it is introduced. The cap opening 206 may be defined by a tubular or sleeve-shaped portion of the cap 200 which can be sized to receive the grabber 400 inside.

[0195] Furthermore, in order to ensure the grabber 400 is correctly oriented during assembly into the cap 200, the grabber 400 may include an orientation element 416 that indicates the assembly orientation. The orientation element 416 may be designed as a tactile indicator, a visual indicator, or a combination thereof. In particular, one of the front surfaces of the grabber carrier 402 may be profiled, for example, wavy or protruding. The orientation feature 416 may be a notch, as described in more detail above.

[0196] The cap 200 may further include at least two lugs, bosses, or grabber-retaining bosses 207 which can be designed to engage with one of the openings 410 in the group comprising three openings 410, preferably the intermediate opening 410b. In the assembled state, the grabber-retaining bosses 207 abut against the distal end 432 of each opening 410, and can hold the grabber 400 in place within the cap 200 (see Figure 4G).

[0197] In relation to this disclosure, “angle” may refer to an azimuthal direction, i.e., a direction defined by an azimuthal or rotational angle with respect to an axis, for example, with respect to a longitudinal axis passing through the cap opening 206.

[0198] The grabber 400 may be elastically deformed during the assembly process. Here, the grabber 400 is initially slightly elastically deformed, for example, because the cap opening 206 has a smaller diameter than the undeformed grabber 400 before the grabber 400 engages with the grabber retaining boss 207. Subsequently, the radial elastic deformation increases. Thus, a radially acting force may exist, which may tend to enlarge the diameter of the grabber 400 in one or more regions angularly offset from the grabber retaining boss 207.

[0199] In particular, as shown in Figure 3D, the cap 200 may include at least one, preferably four, grabber guide features 211 and an inner distal hole 212.

[0200] In embodiments suitable for reducing or preventing abrasion or flake formation, the sensitive area of ​​the cap 200 may include the inner distal hole 212.

[0201] The inner distal hole 212 may extend radially through a portion of the cap, for example, the cap case 210. The inner distal hole 212 may be defined during the molding of the cap 200.

[0202] The medial distal hole 212 may axially overlap with the grabber retaining boss 207.

[0203] The inner distal hole 212 may extend axially across the entire region distal to the grabber retaining boss 207 or offset away from the cap opening 206, preferably to the edge of the housing space of the cap case 210.

[0204] The opening may axially overlap with the grabber retaining boss 207. The use of the inner distal hole 212 has also proven particularly advantageous in terms of avoiding abrasion or flakes.

[0205] Since the sensitive area has an internal distal hole 212, please note that the sensitive area also has a grabber-free guide feature section 211.

[0206] The grabber-free guide feature 211 may be angularly offset from the medial distal hole 212 or sensitive area, as shown in the figure.

[0207] Therefore, despite the inner distal hole 212 within the sensitive area, the grabber guide feature 211 can still be provided, thereby guiding and engaging the interface feature of the gripper and cap during assembly.

[0208] Figure 4G shows in more detail the interaction between the grabber retaining boss 207 of the cap 200 and the opening 410b / retaining slot 410 of the exemplary grabber 400.

[0209] The grabber retaining boss 207 includes a gradient region or inclined portion 207a at its proximal end. The preferably planar surface of this portion or region may form or define an acute angle with the longitudinal axis A, for example, less than 45°. At its distal end, the grabber retaining boss 207 may be positioned to interact with a surface 432 of the grabber 400, for example, a surface 432 that distally defines the retaining slot 410b and / or opening 410b. The distal end face 207b of the grabber retaining boss 207 preferably defines or forms an angle with axis A that is greater than the angle defined by the proximal inclined portion 207a with axis A. For example, the end face 207b may be oriented perpendicular to axis A. The proximal inclined portion 207a and the end face 207b may be connected by a connecting region 207c that may extend substantially parallel to axis A.

[0210] In the assembly position, the end face 207b of the grabber retaining boss 207 may distally abut the surface 432 of the retaining slot 410b and / or opening 410b.

[0211] Figure 4H shows a cross-sectional view of the front end of the injection device 100, which has an attached cap 200 and a grabber 400 mounted thereon that interacts with the needle shield 914.

[0212] As shown in the figure, the barb grips the needle shield 914 and penetrates the needle shield 914 so that the needle shield 914 can be removed by removing the cap 200. The length of the barb 412 may be such that only the tip of the barb penetrates the needle shield 914 in order to maintain the sterility of the needle 908.

[0213] In this figure, the grabber guide feature 422 does not contact the needle shield 914 because the needle shield 914 has a smaller diameter at its front end, for example, its distal end, than at its proximal end. In embodiments where the needle shield 914 has a constant diameter from proximal to distal, the front edge 422 contacts the outer surface of the needle shield 914 and provides guidance assistance during the assembly of the grabber 400 into the injection device 100 for an injection needle containing an injection shield with a constant diameter.

[0214] 5. Needle cover (needle shroud) (Figure 5) As shown in Figures 1B to 1D, the drug delivery device 100 may further include a needle cover 500. The needle cover 500 is shown in more detail in Figure 5. The needle cover 500 may protrude distally from the device body 700 and / or be covered by the cap 200 if the cap 200 is attached to the device body 700. The needle cover 500 may be movable relative to the device body 700 from a first cover position X (see Figure 1B) to a second cover position Y (see Figure 1C).

[0215] The needle cover 500 may be provided to extend beyond the distal tip of the needle 908, which may protrude from the device body 700 before the drug delivery operation is initiated. The needle cover 500 may be movable in a proximal direction P relative to the device body 700. During this movement, for example, before the needle cover 500 reaches a second cover position Y, the needle 908 may puncture the user's skin. The needle cover 500 may act as a trigger member of the drug delivery device 100. As a trigger member, the needle cover 500 may, when displaced proximal to a second cover position Y from a first cover position X, automatically initialize the drug delivery operation, preferably when it is at the second cover position Y. The needle cover 500 may remain in contact with the skin until the drug delivery operation is completed, and the completion of the drug delivery operation may be indicated by an audible, tactile, and / or visual indication provided by the drug delivery device 100. After the drug delivery operation is complete, the needle cover 500 may be moved distally to a third cover position Z (see Figure 1D) relative to the device body 700 to cover the tip of the needle 908.

[0216] The drug delivery operation of the drug delivery device 100 can be initiated by removing a mechanical lock that prevents the distal movement of the plunger 1000, or by moving the plunger 1000 to release the mechanical lock via the movement of the needle cover 500. Alternatively, the needle cover 500 may be made triggerable only when it has moved from a first cover position X to a second cover position Y, and for convenience, when it is in the second cover position Y. In this case, a separate trigger member, such as a trigger button on the proximal end of the device body 700, may be provided to initiate the drug delivery operation. Operation of the trigger button to initiate the drug delivery operation may only be possible when the needle cover 500 is in the second cover position Y. In yet another alternative, the needle cover 500 may be provided solely to prevent needle stick injuries before and / or after use of the drug delivery device. In this case, the needle cover 500 may be completely isolated from the drive mechanism 101 and / or may not be involved at all in triggering or enabling the triggering of the drug delivery operation. In the devices described herein, the needle cover functions as a trigger member. Therefore, there is no need for a separate trigger member to be activated by the user.

[0217] As will be described in more detail below, the drug delivery device 100 may include a needle cover spring 600. The needle cover spring 600 may be operably coupled to the needle cover 500 to move the needle cover 500 distally D relative to the device body 700 when the drug delivery device 100 is removed from the skin. The force of the needle cover spring 600 must be overcome to move the needle cover 500 proximal P away from a first cover position X. After the drug delivery operation is complete, at the final or third cover position Z (see Figure 1D), the drug delivery device 100 is removed from the skin, the needle cover spring 600 displaces the needle cover 500 distally, and the needle cover 500 may be locked against proximal movement relative to the device body 700.

[0218] FIG. 5 shows an exemplary detailed view of the needle cover 500. The needle cover 500 may include a circular or other shaped skin contact surface 501, which is disposed at the cylindrical distal end 502 of the needle cover 500 and is designed to be disposed on the user's skin. The skin contact surface 501 may have an opening concentric with a circular shape that axially extends in the proximal direction through the cylindrical distal end, and this opening encloses the needle 908 in the assembled state of the delivery device 100 (when viewed in plan view). The needle cover 500 may have a side region 503 that extends in the proximal direction P starting from, for example, the cylindrical distal end 502. In the illustrated example, the needle cover 500 may have two side regions 503, but the needle cover 500 may have three or more, for example three or four side regions 503, and it should be noted that each side region 503 may have all of the features of the side region 503 described below. The two side regions 503 are disposed opposite to each other and are designed to enclose any syringe holder 800, prefilled syringe 900, plunger 1000 and / or drive spring 1100 that may be present when the drug delivery device 100 is assembled. The side region may be a leg.

[0219] Each of the two side regions 503 includes an inner side region surface 503a and an outer side region surface 503b. The inner side region surface 503a faces the longitudinal axis in the radial direction, and the outer side region surface 503b faces opposite to the longitudinal axis in the radial direction. The side region 503 includes two side edges 503.1. The side region 503 includes three recesses, a cap clip window 504, a front stop slot 505 and a plunger boss slot 506. In the illustrated embodiment, the front stop slot 505 may be disposed axially between the cap clip window 504 and the plunger boss slot 506, the cap clip window 504 may be offset distally from the front stop slot 505, and the plunger boss slot 506 may be offset proximally from the front stop slot 505.

[0220] The cap clip window 504 can be a (e.g., rectangular) recess into which the cap clip 204 can engage when the cap 200 is attached to the device body 700. The connection between the cap clip 204 and the cap clip window 504 can prevent the axial movement of the needle cover 500 relative to the device body 700. This connection can provide a safety function that can prevent accidental triggering of the dispensing mechanism, for example, if the user accidentally drops the drug delivery device 100.

[0221] The front stop slot 505 can be a (e.g., rectangular) rectangular recess located on the inner surface of the device body 700 that defines the maximum distal position of the needle cover relative to the device body 700 after operation of the drug delivery device, e.g., at the end of injection, and can interact with a needle cover front stop 724 and a boss 724, such as shown in FIG. 7C.

[0222] The plunger boss slot 506 can be a recess formed by an L-shaped recess, i.e., two rectangles of different sizes, i.e., a proximal slot 506a and a distal slot 506b arranged directly adjacent to each other. The proximal slot 506a can have a smaller angular width compared to the angular width of the distal slot 506b. The plunger boss slot 506 and at least one plunger boss 1040.2, 1040.3 of the plunger 1000 (see FIG. 10) can form a mechanical lock, e.g., a rotational lock. The needle cover 500 can remain in the first cover position X as long as the mechanical lock is established. The plunger boss slot 506 can be configured to allow relative movement of the needle cover 500 relative to the plunger 1000 when the needle cover 500 is moved from the first cover position X to the second cover position Y to release the mechanical lock. Here, by the plunger boss 1040.2 of the plunger 1000 (see FIG. 10), rotational movement of the plunger 1000 relative to the needle cover 500 can be prevented until the plunger bosses 1040.2, 1040.3 (see FIG. 10) axially move from the proximal slot 506a to the distal slot 506b.

[0223] The plunger boss slot 506 may include a slot rib 507 positioned on the side of the transition from the proximal slot 506a to the distal slot 506b, and the slot rib 507 may include a shoulder portion 507a for different rectangular sizes. The slot rib 507 may include a contact surface 507b on the inner side region surface 503a, and the contact surface 507b may be designed on which the plunger boss 1040.2 (see Figure 10) rests. The slot rib 507 may further include a plunger 1000 and an optional first ramp 507c and an optional second ramp 507d that can interact with, for example, the plunger boss 1040.3, as shown in Figures 10G and 10H. The optional first ramp 507c may be positioned in the transition from the proximal slot 506a to the distal slot 506b and can interact with the plunger boss 1040.3 (see Figures 10G and 10H). If the plunger 1000 does not rotate spontaneously (for example, when the needle cover is in the second position), the first ramp 507c may interact with the plunger boss 1040.3 (see Figures 10G and 10H) to additionally induce or initiate the rotation of the plunger 1000. The second ramp 507d may be located at the proximal end of the lateral region 503 and may be designed to facilitate the priming of the plunger 1000 by acting on the plunger boss 1040.3 during the final assembly of the drug delivery device 100, for example as shown in Figures 10G and 10H.

[0224] As shown in Figure 5, the needle cover 500 may include plunger guide ribs 508 on the inner side region surface 503a, which are designed to provide angular guidance to the plunger 1000 for, for example, one or both of bosses 1040.2 and 1040.3. Furthermore, the needle cover 500 may have grooves 509 on the outer side region surface 503b. The grooves may be provided to reduce warping of the molded product when manufacturing the needle cover 500 and / or during subsequent injection molding. Mechanical stability may also be improved by the grooves 509.

[0225] Figure 5 also shows that the needle cover 500 may have at least one needle cover blocking means 510. The needle cover blocking means 510 may be offset 90 degrees rotationally from each cap clip window 504. The needle cover blocking means 510 may be embodied as an elastically pivotable flexible arm 510 that is or can be biased radially away from the longitudinal axis in the assembled state of the device 100. The needle cover 500 may have several flexible arms 510. For example, the needle cover 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 perimeter of the needle cover 500. Furthermore, the flexible arms 510 may be positioned on opposite sides of each other. After the drug delivery operation is complete, the drug delivery device 100 may be removed from the user's skin. The needle cover 500 can be biased relative to the device body 700 toward a first cover position X by a needle cover spring 600. Thus, when the drug delivery device 100 is removed from the skin, the needle cover 500 can move toward, and beyond the first cover position X, for example, toward the first cover position X, toward a final, locked, or third cover position Z relative to the device body 700, as shown in Figure 1D. In the third cover position Z, the needle cover 500 can be axially locked relative to the device body 700 against proximal movement by a locking engagement between the flexible arm 510 of the needle cover 500 and the associated projection of the device body 700, for example, a needle cover lock structure 720 on the inner surface of the side wall 700a of the device body 700. The needle cover lock structure 720 may also be called a block element 720 or a ramp-shaped element 720. Since the needle cover 500 is locked in the axial direction, it can no longer be displaced proximal to the device body 700 to the second cover position and / or the first cover position. This can protect the user from needle stick injuries after use. In addition, features such as the flexible arm 510 and / or the cap 200, particularly on any cap cover 300, may make it impossible to reattach the cap 200 when the needle cover 500 is in the third cover position Z.

[0226] As shown in Figure 5, the flexible arm 510 may have a radial projection 510.1 at its proximal end region, for example, in the shape of a rectangular parallelepiped. The projection may extend radially from the flexible arm. This projection 510.1 forms the proximal end of the flexible arm 510. The projection may also be called a stopping surface. The projection 510.1 may extend further in the circumferential direction than the axial direction of the needle cover 500. Due to its rectangular parallelepiped shape and the difference in radial height relative to the rest of the flexible arm's outer surface, the flexible arm has edges in the distal and proximal directions. The projection 510.1 of the flexible arm 510 engages with a corresponding projection on the inner circumferential surface of the device body 700, allowing the needle cover 500 to be locked against axial movement relative to the device body 700 (for example, at a third cover position Z). In this disclosure, the first cover position X is also referred to as the intermediate position X, and the third cover position Z is also referred to as the initial position Z. For example, one of the surfaces of the projection 510.1, for example the surface pointing in the proximal direction P, may contact the distal surface of the needle cover locking structure 720 when the needle cover is in the third cover position Z. Therefore, the proximal movement of the needle cover 500 relative to the device body 700 is restricted. In other words, the projection 510.1 and the needle cover locking structure 720 provide a post-use needle cover locking mechanism that can prevent injury to the user by preventing exposure of the needle tip.

[0227] For example, the needle cover locking mechanism after use can prevent the needle cover 500 from moving proximal to the device body 700 if the proximal force applied to the needle cover 500 is less than 60N, preferably less than 50N, and more preferably less than 40N.

[0228] In this disclosure, the projection 510.1 may also be referred to as the stop surface 510.1. As shown in Figure 5, the flexible arm 510 may also have a web 510.2. In this disclosure, the web 510.2 may also be referred to as the projection 510.2. The web 510.2 may have a free end distal to the projection, which may be chamfered. The proximal end opposite the web may transition into the projection. The web 510.2 may have a height lower than or equal to the projection 510.1 in the radial direction. The web 510.2 may interact with the needle cover lock structure 720 of the device body 700 (see also Figure 4H). For example, the web 510.2 may interact with a recess of the needle cover lock structure 720 to prevent rotational movement of the needle cover 500 relative to the device body 700. Alternatively, or in addition, the interaction may reduce the inward deflection of the flexible arm 510 as it moves along the needle cover locking structure 720, for example, when the needle cover 500 moves from its second cover position Y to its third cover position Z relative to the device body 700. This reduces the load on the flexible arm.

[0229] As shown in Figure 5, the flexible arm 510 has a recess 510.3 at its joint with the rest of the needle cover 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 cover body. The area of ​​the needle cover adjacent to the flexible arm, for example, the distal end 502, may be a cylindrical sleeve-shaped area of ​​the needle cover. Preferably, at any one of the positions of the needle cover relative to the device body, only this area protrudes from the device body.

[0230] Furthermore, immediately after the cap 200 is removed, but before the needle cover 500 is positioned on the skin surface and before the energy of the plunger 1000 and drive spring 1100 is released, it may be possible to move the needle cover 500 slightly distally. In this case, the needle cover 500 slides slightly forward as the needle cover spring 600 is released and the plunger 1000 rotates to a usable position. This may be particularly true if the cap 200 is directly engaged with the device body 700 of the drug delivery device 100 or the device body 700 and contacts the cap before the needle cover (biased by the needle cover spring) is removed.

[0231] It should be noted that all features of the needle cover 500, namely the skin contact surface 501, distal end 502, lateral region 503, inner lateral region surface 503a, outer lateral region surface 503b, cap clip window 504, front retaining slot 505, plunger boss slot 506, proximal slot 506a, distal slot 506b, slot rib 507, shoulder portion 507a, contact surface 507b, first ramp 507c, second ramp 507d, plunger guide rib 508, groove 509, and flexible arm 510, may or may not be an integral part of the needle cover 500. Therefore, a needle cover 500 having all of its features may be an integral component. However, a needle cover 500 consisting of two or more parts may also be used.

[0232] 6. Needle cover spring (Figures 6A, 6B) Figures 6A and 6B show the needle cover spring 600. As shown in Figure 6B, the needle cover spring 600 may extend between the needle cover 500 and the device body 700 (described later). For example, the needle cover spring 600 may extend between the proximal opposing surface of the needle cover 500 and the distal opposing surface of the central support structure 701 of the device body 700. More specifically, the needle cover spring 600 may extend between the proximal opposing inner surface of the distal end 502 of the needle cover 500 and the needle cover spring support portion 708a of the device body 700, as described below.

[0233] In one embodiment, the needle cover spring 600, particularly its proximal end, may be supported radially outward by a needle cover retainer 721 (described later) of the device body 700. In other words, tilting of the needle cover spring 600 relative to the device body 700 and / or radially outward deflection of the needle cover spring 600 may be prevented by the needle cover retainer 721.

[0234] The needle cover spring 600 may be configured to provide force to the needle cover 500. This force biases the needle cover 500 distally D. The needle cover spring 600 may be configured such that when a force smaller than the force of the needle cover spring is applied to the needle cover in a 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, that force pushes the needle cover 500 distally. Furthermore, the needle cover spring 600 may be configured to ensure that the device 100 can only be activated when the needle cover 500 is pressed against the user's skin with a sufficiently large force. In other words, the drug delivery device 100 will not be activated / triggered unless the needle cover 500 is pressed against the injection site with a sufficiently large force. Therefore, the needle cover spring 600 may be configured to satisfy a minimum activation force requirement. For example, the minimum force required to activate the drug delivery device may be 1 N (Newton) to 50 N, preferably less than 20 N.

[0235] In one embodiment, the needle cover spring 600 may be made of high-strength stainless steel. For example, the needle cover spring 600 may be made of austenitic steel having sufficient elastic properties to allow elastic compression of the needle cover spring 600. In one embodiment, the needle cover spring 600 may be made of austenitic chromium-nickel steel. In one embodiment, the needle cover spring 600 may be made of DIN EN 1.4310 steel.

[0236] In one embodiment, the length of the needle cover spring 600 can be selected so as to achieve a flat force profile and avoid excessive starting force.

[0237] In one embodiment, the needle cover spring 600 can be made of a coiled wire. The wire diameter can be selected according to the stress generated when the needle cover spring 600 is compressed. Further, the wire can be a soap lubricated wire to assist in manufacturability.

[0238] In one embodiment, the needle cover spring 600 can have 5 to 50 coils, preferably 5 to 25 coils, more preferably 10 coils. The outer diameter of the coil can be selected according to the shape of the needle cover 500, particularly the flexible arm 510 of the needle cover 500, so as to avoid collision with the flexible arm 510 when the flexible arm 510 is deflected on the needle cover lock structure when the needle cover spring 600 surrounds the axial support front end 703 of the device body 700.

[0239] In one embodiment, the outer diameter of the coil can be 5 mm to 20 mm, preferably 10 mm to 15 mm, more preferably 12 mm to 14 mm, for example 13 mm. The inner diameter of the coil can be 5 mm to 20 mm, preferably 10 mm to 15 mm, more preferably 11 mm to 13 mm, for example 12 mm.

[0240] In one embodiment, the coiled wire can have double or triple windings 601 at its ends. The double or triple windings 601 can be formed by two or three coils that contact each other axially along their circumferences. The double or triple windings 601 can provide a contact surface for ensuring contact between the needle cover spring 600 and the needle cover 500 and the device body 700.

[0241] In one embodiment, the needle cover spring 600 can have a length of 30 mm to 100 mm. In one embodiment, the needle cover spring 600 can have a length of 50 mm to 80 mm. In one embodiment, the needle cover spring 600 can have a length of 60 mm to 70 mm, preferably 66 mm.

[0242] 7. Device Body (Figs. 7A - 7G) Figures 7A and 7B show a device body 700 according to one 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 space for housing some or all of the components of the drug delivery device 100.

[0243] The device body 700 may have a cylindrical shape. In other words, the device body may have a distal end and a proximal end connected to each other by a 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, the cross-sectional area may increase toward the distal end such that the cross-sectional area at the distal end may be larger than that at the proximal end.

[0244] In one embodiment, the cross-sectional area may increase within the side wall 700a, for example, from the intermediate drug window 710 (side wall window) to the distal end. The increase may be linear or nonlinear, for example, parabolic, so that the outer surface of the side wall 700a of the device body 700 can curve toward the distal end.

[0245] The device body 700 includes a proximal aperture 730 at its proximal end. The proximal aperture 730 can be defined by the proximal edge 732 of the side wall 700a.

[0246] The side wall 700a may provide a user gripping surface that allows the user to handle and / or operate the drug delivery device 100.

[0247] 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 located in the distal half of the side wall 700a, preferably in its fourth and / or fifth section, assuming that the axial length of the side wall 700a, measured from the proximal end, is divided into six equal long sections. The drug window 710 may be an elongated window that extends more axially than circumferentially. The side wall may further include a portion for labeling on its outer surface.

[0248] The user may be able to see the plunger stopper 910 of the syringe 900 (described later) and / or the plunger 1000 (described later) through the drug window 710. The user may also be able to see the drug Dr before and during injection through the drug window 710. For example, during the operation of the drug delivery device 100, the user can first see the drug Dr and the barrel 902 of the syringe 900 (described later), which may be a pre-filled syringe containing the drug Dr. During injection, the user can see the plunger stopper 910 and then the plunger 1000 moving distally D within the barrel 902.

[0249] The outer surface of the side wall 700a and / or the inner surface of the side wall may include interaction elements for supporting other components of the drug delivery device 100, such as the cap 200 and / or needle cover 500 and / or syringe holder 800 (described later) and / or drive spring holder 1200 (described later). The interaction elements may be mainly located 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 the other components of the drug delivery device 100.

[0250] 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 shown in Figure 7A, the recesses may be proximal notches 714. The proximal notches 714 may be offset proximal to the drug window 710 and located, for example, near the proximal end of the device body. For example, the proximal notches 714 may be located in the first 20 percent or first 10 percent of the length of the side wall 700a when measured from the proximal end. The proximal notches 714 may be offset 180 degrees from each other in the circumferential direction of the device body 700. At least one of the proximal notches 714 may overlap the drug window 710 in the circumferential direction.

[0251] As described below, for example in Section 12, the proximal notch 714 may interact with the snap projection 1203.2 of the snap arm 1203 of the drive spring holder 1200, for example when the drive spring holder is in the (first) drive spring holder position (closed position). Furthermore, as described below, the proximal notch 714 may interact with the retaining clip 806 of the syringe holder 800, for example when the syringe holder 800 is in the first syringe holder position (first container holder position).

[0252] The side wall 700a may further include an injection molding gate recess 712. The injection molding gate recess 712 may be formed on the outer surface of the side wall 700a. The injection molding gate recess 712 does not have to penetrate the side wall 700a. The injection molding gate recess 712 may be offset distally from the proximal notch 714. The injection molding gate recess 712 may be offset proximal to the drug window 710. In one embodiment, the injection molding gate recess 712 may be located near or in the middle of the side wall 700a in the axial direction of the device body 700.

[0253] In one embodiment, the side wall 700a may further include a second body connection structure. The second body connection structure may include at least one, preferably at least two, recesses. As shown in Figure 7A, the recesses may be distal notches 713. The distal notches 713 may be positioned offset proximal to the drug window 710. The distal notches 713 may be offset distally to the injection molding gate recess 712. The distal notches 713 may be offset distally to the proximal notches 714. In one embodiment, the distal notches 713 may be positioned midway or near midway in the axial direction of the side wall 700a. The distal notches 714 may be offset 180 degrees from each other.

[0254] The proximal notch 714 may be larger than the distal notch 713. In other words, the proximal notch 714 may extend further than the distal notch 713 in at least one spatial direction. In one embodiment, at least one of the distal notches 713 may be aligned with at least one proximal notch 714.

[0255] At least one, preferably all, of the distal notches 713 may overlap a corresponding number of proximal notches 714 in the circumferential direction. This overlap may be partial. Preferably, the proximal notches 714 completely overlap the distal notches 713 in the circumferential direction. Furthermore, at least one of the distal notches 713 may overlap with or be aligned with the drug window 710 in the circumferential direction.

[0256] As described below, the distal notch 713 may interact with the retaining clip 806 of the syringe holder 800. Thus, the syringe holder 800 may be fixed to the device body 700, for example, in a second syringe holder position (second container holder position).

[0257] The notches 713 and / or 714 may be offset from the centerline between the holder guide ribs 726 (described in more detail below). Alternatively, or in addition, the notches 713 and 714 may be offset from the longitudinal centerline of the axially extending drug window 710, as shown in Figures 7A and 17. Alternatively, or in addition, the notches 713 and / or 714 may be located midway, i.e., in the center, between the holder guide ribs 726.

[0258] The device body 700 may include a body user indicator 733 on the outer surface of the side wall 700a. The body user indicator 733 may be configured to show the user the position of the device body 700 relative to other components of the drug delivery device 100, such as the cap 200.

[0259] When a label is applied to the side wall 700a, the injection molding gate recess 712 and / or notches 713, 714 can be concealed by the label such that at least one, at least two, or all of these features are not visible to the user. This may provide comfort to the user.

[0260] The device body 700 may be formed from PC (polycarbonate) Makrolon 2258, medical-grade PC, or another material. PC may be selected primarily for its strength, flexibility, toughness, and high-temperature strength, which shortens injection molding cycle time and thus allows for a reduction in part cost.

[0261] As shown in Figure 7B, a feature of the device body 700 may form a syringe support mechanism. The syringe support mechanism may be formed inside the device body 700. The syringe support mechanism may be configured to position the syringe 900 inside the device body 700 so that needle extension requirements are met. Needle extension requirements may be, for example, that the distal end of the needle 908 of the syringe 900 extends beyond a certain length, for example, 4 mm to 8 mm, while withstanding the impact load caused by the impact of the plunger 1000 against the plunger stopper 910 of the syringe 900 at the start of injection.

[0262] In one embodiment, the syringe support mechanism is configured to support the syringe within the device body 700, for example, a pre-filled syringe 900, against distal movement relative to the device body 700. In one embodiment, the syringe support mechanism may be configured to support the shoulder portion 904 of the syringe 900. Thus, manufacturing tolerances can be better compensated compared to a design in which the syringe 900 is supported by its proximal flange 912. This leads to reduced variation in the extension of the distal needle end beyond the device body 700 when the syringe 900 is in its final assembled position within the device body 700.

[0263] Specific design of the assembly process may be required to ensure that the components reach their correct final positions and that the syringe 900 is properly supported.

[0264] As shown in Figure 7C, 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, for example, at the shoulder portion 904. In one embodiment, as shown in Figures 7D and 7E, the central support structure 701 may be configured to support the syringe holder 800.

[0265] 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 a syringe holder 800 (not shown). In one embodiment, the central tube 702 may have an open perimeter and may include, for example, at least one axial recess extending axially from the central tube 702. The central tube 702 may have an axial length greater than half or three-quarters of the axial length of the barrel 902 of the syringe 900, measured, for example, from the shoulder 904 to the distal surface of the syringe flange 912 (not shown).

[0266] The central support structure 701 may include an axial support front end 703 configured to support the syringe 900 axially, for example, against distal movement relative to the device body 700. The axial support front end 703 may be formed at the distal end of the central tube 702.

[0267] In one embodiment, the axial support front end 703 may include a projection 704 extending radially inward at its distal end. The axial support front end 703 and the radial projection 704 interact with the shoulder portion 904 of the syringe 900, thereby preventing distal movement of the syringe 900 beyond the axial support front end 703, and particularly beyond the projection 704. In other words, the axial support front end 703 can define the maximum distal position of the syringe 900 relative to the device body 700 and hold the syringe 900 at its desired axial position relative to the device body 700.

[0268] In one embodiment, the axial support front end 703 may have a closed perimeter. Thus, the axial support front end 703 may surround the shoulder portion 904. The closed perimeter may allow for a uniform distribution of force across the entire contact surface. The closed perimeter may further allow the axial support front end 703 to withstand higher loads and impacts in the distal and / or radial directions.

[0269] In embodiments not shown in the figures, the axial support front end may have an open perimeter, interrupted, for example, by at least one recess extending in the axial direction. In this embodiment, the axial support front end 703 may be thickened more radially so that it can withstand the forces of the drug delivery device 100, for example, the force of the drive spring 600, during assembly and / or operation.

[0270] In one embodiment, the radially inward projection 704 may have an inner diameter 704ID smaller than the outer diameter 902OD of the barrel 902. For example, the inner diameter 704ID may be at least 2 percent, at least 5 percent, at least 10 percent, or at least 20 percent smaller than the outer diameter 902OD.

[0271] In embodiments such as that shown in Figure 7C, the outer diameter 914OD of the needle shield 914 (described later) is smaller than the inner diameter 704ID of the projection 704, thereby allowing the needle shield 914 to move distally beyond the projection 704. For example, the outer diameter 914OD may be at least 2 percent, at least 5 percent, at least 10 percent, or at least 20 percent smaller than the inner diameter 704ID of the projection 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 900 are provided in Section 9 below.

[0272] In the embodiment shown in Figure 7D, the outer diameter 914OD of the needle shield 914 may be larger than the outer diameter 902OD of the barrel 902, for example, by at least 2 percent, at least 5 percent, at least 10 percent, or at least 20 percent. This may necessitate the use of a syringe holder 800 to enable the assembly of the syringe 900 within the drug delivery device 100, particularly within the device body 700. However, the syringe holder 800 may also be used when the outer diameter 914OD of the needle shield 914 is equal to the outer diameter 902OD of the barrel 902, or when the outer diameter 914OD of the needle shield 914 is smaller than the outer diameter 902OD of the barrel 902.

[0273] In one embodiment, the axial support front end 703 may be configured to axially support the syringe holder 800 relative to the device body 700 (see Figure 7D). For example, the axial support front end 703 may be configured to fix the syringe holder 800 to distal movement relative to the device body 700. In particular, the axial support front end 703 may be configured to surround the flexible holder arm 801 of the syringe holder 800. Radially inward projections 704 may form a contact surface for the holder projection 803. The axial support front end 703 may have a closed perimeter. Thus, the axial support front end 703 may surround the holder arm 801. The axial support front end 703 may have a conical inner surface 703.1 whose diameter decreases in the distal direction D. The conical inner surface 703.1 may be configured to interact with the holder arm 801 when the syringe holder 800 moves distally relative to the device body 700. Therefore, the conical inner surface 703.1 can restrict the radially outward movement of the holder arm 801, or further deflect the holder arm 801 radially inward. With regard to further details of the specific interaction between the device body 700 and the syringe holder 800, the above-described interaction between the device body 700 and the syringe 900 applies, and vice versa, where possible from a technical standpoint.

[0274] The central support structure 701, in particular its central tube 702, may include at least one central support window 709 (see Figure 7E). The central support window 709 may be aligned with or at least partially overlap with the drug window 710 to allow inspection of the syringe 900, the drug in the syringe 900, the plunger stopper 910, and / or the plunger 1000, for example, during assembly and / or injection. If a syringe holder 800 is used within the drug delivery device 100, the central support window 709 may be aligned with or at least partially overlap with the holder window 808 (described later).

[0275] 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 axially along the device body 700. For example, the connecting rib 708 may extend along at least 50 percent, at least 60 percent, or at least 75 percent of the axial length of the central support structure 701. The connecting rib 708 may extend distally to the distal end of the axial support front end 703.

[0276] In one embodiment, there may be several connecting ribs 708, for example, at least two, at least three, or at least four connecting ribs 708. The connecting ribs 708 may be arranged equidistant from each other in the circumferential direction of the device body 700. Alternatively, as shown in Figure 7C, 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 by the proximal and / or distal surfaces of the drug window 710 and extend 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, for example less than 80 degrees, less than 70 degrees, or less than 50 degrees. As a result, the angular offset between two connecting ribs 708 that are not connected by the proximal and / or distal surfaces of the drug window 710 may be greater than 90 degrees, for example greater than 100 degrees, greater than 110 degrees, or greater than 130 degrees. The connected configurations described are for illustrative purposes only. Even if the connecting ribs 708 are not connected to each other, a similar angular offset of the connecting ribs 708 is possible.

[0277] Therefore, contact between the needle cover 500 and the device body 700 may be improved, and the axial stability and / or rotational stability of the needle cover 500 within the device body 700 may be improved.

[0278] In the radially inner section, at least one, preferably all, connecting ribs 708 may form a needle cover spring support portion 708a. In this regard, the radially inner section is the section of connecting ribs 708 connected to the central support structure 701. In other words, the radially inner section is a section further radially inner than the section connected to the inner surface of the side wall 700a. The needle cover spring support portion 708a may interact with the needle cover spring 600, for example, its proximal end, to support the needle cover spring 600 axially.

[0279] The illustrated embodiment includes four connecting ribs 708 that extend axially from 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 percent of its axial length.

[0280] In embodiments not shown, the syringe support mechanism may include, instead of a central tube 702, at least two, at least three, or at least four support arms extending axially from the device body 700. The support arms may be arranged equidistant from or at different angular offsets around the central support structure 701. In the circumferential direction, the support arms may extend over a variety of 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 around 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 details of this axial support end may be the same as those described above with respect to embodiments having a central tube 702 with an axial support end 703.

[0281] In one embodiment, the proximal notch 714 is configured to form a space that can deflect the snap projection 1203.2 of the snap arm 1203 of the drive spring holder 1200 when it is aligned with the proximal notch 714. In other words, the snap arm 1203 and the notch 714 can form a case snap mechanism.

[0282] The case snap mechanism secures the drive spring holder 1200 to the device body 700 and can prevent the drug delivery device 100 from being disassembled by the user or under the impact load of the drive spring 1100 at the start of injection, for example, when the plunger 1000 contacts the plunger stopper 910. In particular, when the snap arm 1203 interacts with the proximal notch 714, the axial movement of the drive spring holder 1200 relative to the device body 700 can be limited, preferably avoided. Thus, the drive spring holder 1200 can be in a first drive spring holder position which may be the closed position. Alternatively or in addition, when the snap arm 1203 interacts with the proximal notch 714, the rotational movement of the drive spring holder 1200 relative to the device body 700 can be limited, preferably avoided. In other words, in the closed position, the drive spring holder 1200 can be fixed to the device body 700 against axial and / or rotational movement.

[0283] In one embodiment, when the device body 700 is used in a drug delivery device 100 having a syringe holder 800, the proximal notch 714 may interact with the retaining clip 806 of the syringe holder 800 when the syringe holder 800 is moved distally into the device body 700, for example, through the proximal aperture 730 from the proximal end.

[0284] As described below, when the retaining clip 806 and the proximal notch 714 are aligned, the retaining clip 806 deflects radially outward into the proximal notch 714, securing the syringe holder 800 to the device body in a first container holder position. The first container holder position can be a first engagement position of the syringe holder 800, as described below. In other words, the proximal notch 714 provides space for the retaining clip 806 during assembly of the syringe holder 800 to the device body 700.

[0285] When a distal force is applied to the syringe holder 800, the retaining clip 806 is deflected radially inward by interaction with the inner surface of the side wall 700a, thereby disengaging from the proximal notch 714. Thus, the syringe holder 800 can move freely further distally within the device body 700. When the retaining clip 806 is aligned with the distal notch 713, the retaining clip 806 is deflected radially outward into the space provided by the distal notch 713, thereby locking the syringe holder 800 against the device body 700 in a second container holder position. The second container holder position may be a second engagement position of the syringe holder 800, as described below.

[0286] In one embodiment, the device body 700 may include a needle cover positioning structure. The needle cover positioning structure may include at least one needle cover front stopper 724. The needle cover front stopper 724 may include at least one projection projecting radially inward from the inner surface of the side wall 700a of the device body 700. The needle cover front stopper 724 may include a ramp-shaped portion 724.1 and a rectangular parallelepiped portion 724.2 (see Figure 7F) having a radially inward inclination in the proximal direction P. The rectangular parallelepiped portion 724.2 may be positioned proximal to the ramp-shaped portion 724.1. The rectangular parallelepiped portion 724.2 may project radially inward to the same extent as the proximal end of the ramp-shaped portion 724.1. Alternatively, the rectangular parallelepiped portion 724.2 may project radially inward to a slightly greater extent than the ramp-shaped portion 724.1.

[0287] The needle cover front stopper 724 may be configured to interact with a corresponding fixed feature portion of the needle cover 500. The fixed feature portion may be a front stopper slot 505 of the needle cover 500. In particular, the distal opposing surface of the front stopper slot 505 may abut the proximal opposing surface of the rectangular parallelepiped portion 724.2 when the needle cover 500 is moved distally relative to the device body 700, for example from a second cover position Y to a third cover position Z, as described above. Thus, the needle cover front stopper 724 is configured to provide a limit to the distal movement of the needle cover 500 relative to the device body 700. In other words, the maximum distal extension range of the needle cover 500 beyond the distal end of the device body 700 is defined by the interaction between the front stopper slot 505 and the needle cover front stopper 724 when the needle cover 500 is in its final position relative to the device body 700, for example after use.

[0288] The ramp-shaped portion 724.1 may be configured to deflect the lateral region 503 of the needle cover 500 radially inward when the needle cover 500 is inserted into the device body 700, thereby enabling the assembly of the needle cover 500 into the device body 700. The rectangular parallelepiped portion 724.2 may provide additional axial strength to the needle cover front retainer 724, thereby improving the stability of the device body 700. For example, this may be beneficial in withstanding the distal force applied to the needle cover 500 by the needle cover spring 600.

[0289] In one embodiment, the device body 700 may include a needle cover retainer 721. The needle cover retainer 721 may be formed at the distal end of at least one connecting rib 708. As shown in Figure 7C, the needle cover retainer 721 may be located on the 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 cover retainer 721 includes a distal surface that may extend to the distal end of the axial support front end 703. The distal surface may interact with the needle cover 500 and the proximal opposing surface of the recess between, for example, the lateral region 503 and the flexible arm 510 when the needle cover 500 moves proximal to the device body 700, for example when the skin contact surface 501 is pressed against the user's skin with sufficient force, as described above. Thus, the needle cover retainer 721 may define the maximum proximal position of the needle cover 500 relative to the device body 700.

[0290] The embodiments shown in Figures 7C and 7F include, as described above, four connecting ribs 708, each having a needle cover retainer 721. The needle cover retainer 721 extends distally from the connecting rib 708 beyond the needle cover spring support portion 708a to, for example, the projection 704 (see also Figure 6B). Alternatively, the needle cover retainer 721 may extend further distally or not extend as far.

[0291] In one embodiment, the device body 700 may include a needle cover lock structure 720. The needle cover lock structure 720 may include at least one projection, for example, one or more ramp-shaped elements 720 (see Figures 7B, 7C, and 7F), projecting radially inward from the inner surface of the side wall 700a of the device body 700. The ramp-shaped elements 720 may have a radially inward inclination in the distal direction D.

[0292] The needle cover lock structure 720 may be located near the distal end of the device body 700, for example, within the last 30 percent, last 20 percent, or last 10 percent of the axial length of the device body 700, when measured from the edge 732 to the distal end. The needle cover lock structure 720 may be circumferentially aligned with the drug window 710. The needle cover lock structure 720 may be distal to the drug window 710. The needle cover lock structure 720 may interact with the flexible arm 510 on the needle cover 500 (as described above and below). This interaction may limit, preferably avoid, proximal movement of the needle cover 500 relative to the device body 700, for example, after injection when the needle cover 500 is distal to the device body 700. In other words, the interaction may provide termination of the dose lockout function.

[0293] In the embodiments shown in Figures 7B, 7C, and 7F, the needle cover lock structure 720 may include at least one ramp-shaped element 720. The ramp-shaped element 720 may be axially offset from the needle cover front stopper 724. Preferably, the ramp-shaped element 720 may be offset distally from the needle cover front stopper 724.

[0294] Due to the radially inward inclination of the ramp-shaped element 720 in the distal direction D, the needle cover 500 moves distally to the device body 700, and when the flexible arm 510 is proximal to the ramp-shaped element 720, the flexible arm 510 is deflected radially inward. After passing the ramp-shaped element 720, the flexible arm 510 can return to its relaxed state by deflecting radially outward. Thus, the proximal surface of the rectangular projection 510.1 interacts with the distal surface 720a of the ramp-shaped element 720. For example, when a force P is applied to the needle cover 500, the distal surface 720a of the ramp-shaped element 720 can be perpendicular to the axial direction or only slightly inclined with respect to the axial direction so as to restrict the sliding of the rectangular projection 510.1 along the distal surface. In other words, the needle cover 500 is locked against proximal movement relative to the device body 700 by the interaction between its rectangular projection 510.1 and the distal surface of the ramp-shaped element 720.

[0295] In the embodiment shown in Figure 7G, the needle cover lock structure 720 includes four ramp-shaped elements 720 grouped into two pairs. In other words, the needle cover lock structure 720 includes two double ramps, each consisting of two ramp-shaped elements 720. The ramp-shaped elements 720 may be offset distally from the drug window 710 (see Figure 7F). Each pair of ramp-shaped elements 720 may be aligned circumferentially with the drug window 710. The two ramp-shaped elements 720 of a pair may be positioned such that the angle between them circumferentially is less than 90 degrees, preferably less than 45 degrees. A space may be formed between the two ramp-shaped elements of a pair. Circumferentially, each pair may be aligned with the flexible arm 510 of the needle cover 500 such that when the needle cover 500 moves distally relative to the device body 700, the web 510.2 of the needle cover 500 is guided between the two ramp-shaped elements (as described above). Furthermore, the extension of the web 510.2 into the space between the ramp-shaped elements 720 reduces the inward deflection of the radially flexible arm 510 when it slides along the ramp-shaped elements 720.

[0296] The two pairs of ramp-shaped elements 720 may be offset from each other by, for example, 180 degrees. Furthermore, these two pairs may be offset from the needle cover front stopper 724 by, for example, 90 degrees.

[0297] After the rectangular projection 510.1 passes the distal end of the ramp-shaped element 720, the flexible arm 510 is deflected radially outward. Therefore, the proximal surface of the rectangular projection 510.1 interacts with the distal surface of the ramp-shaped element 720 when a proximal force is applied to the needle cover 500 after use (see Figure 7G). This interaction prevents the needle cover 500 from moving proximal to the device body 700, i.e., the needle cover locking mechanism after use.

[0298] In the embodiments shown in Figures 7B, 7C, 7F, and 7G, the device body 700 includes two needle cover front stops 724, and the needle cover locking structure 720 is formed by four ramp-shaped elements 720. However, there may be more or fewer than two needle cover front stops 724 and more or fewer than four ramp-shaped elements 720. The needle cover front stops 724 may be angularly offset from the ramp-shaped elements 720 by, for example, more or less than 90 degrees, depending on the shape of the needle cover 500 and / or the number of ramp-shaped elements 720 and / or the number of front stops 724. The ramp-shaped elements 720 may be grouped into pairs, for example, so that pairs of ramp-shaped elements 720 are angularly offset from each other in the circumferential direction, preferably so that the pairs are equidistant in the circumferential direction. For example, the angle between two pairs may be 180 degrees. Each pair of ramp-shaped elements 720 may be 90 degrees circumferentially offset from each needle cover front stop 724. Therefore, the pair of ramp-shaped elements 720 and the needle cover front stopper 724 can be arranged equidistant from each other around the inner surface of the side wall 700a. For example, there may be two pairs of ramp-shaped structures 720 that are angularly offset by 90 degrees from the needle cover front stopper 724, while the front stops are angularly offset by 180 degrees from each other. The needle cover front stopper 724 may be positioned proximal to the ramp-shaped elements 720.

[0299] In one embodiment, the needle cover front stopper 724 may be positioned at a 90-degree angle offset from the drug window 710. The needle cover front stopper 724 may at least partially overlap the drug window 710 in the axial direction (see Figure 7D).

[0300] In one embodiment, the device body 700 may include a needle cover release prevention structure 720.1. The needle cover release prevention structure 720.1 may include a projection, such as a rib 720.1, that protrudes radially inward from the inner surface of the side wall 700a and extends along the longitudinal direction of the device body 700 (see Figure 7C). The needle cover release prevention structure 720.1 is configured to limit the deformation of the needle cover 500 relative to the device body 700 when the needle cover 500 is interacting with the needle cover lock structure 720 and / or the needle cover front stopper 724. This limits the risk that the needle cover 500, particularly the rectangular parallelepiped projection 510.2 or slot 505 of the flexible arm 510, may disengage from the needle cover lock structure 720 or the front stopper 724 if the device body 700 deforms relative to the needle cover 500, for example, due to the body being dropped or gripped tightly by a user. In addition, the needle cover lock release prevention structure 720.1 can provide rigidity to the side wall 700a.

[0301] As shown in Figures 7C and 7F, the needle cover release prevention structure 720.1 may include eight elements, for example, eight ribs 720.1, arranged at different angular offsets on the side wall 700a. The ribs 720.1 may be arranged such that pairs of ribs 720.1 can be angularly offset from two single ribs 720.1. For example, pairs of ribs 720.1 may be circumferentially surrounded by two single ribs 720.1 on each half of the perimeter of the side wall 700a. The ribs 720.1 may extend proximal from the proximal end of the ramp-like element 720. In embodiments not shown, the ribs 720.1 may axially overlap with the ramp-like structure 720 and / or the forward stop 724.

[0302] In the proximal direction, the rib 720.1 may have a radially inward extension range that decreases from the side wall 700a. In one embodiment, the rib 720.1 may transition to the inner surface of the side wall 700a in the portion that axially overlaps with the central support window 709, for example. For example, the radially inward extension range from the side wall 700a may be zero at an axial position corresponding to the proximal end of the central support window 709 or the proximal end of the needle cover front stopper 724.

[0303] In one embodiment, the device body 700 may include at least one needle cover guide rib 723 (see Figure 7C). The needle cover guide rib 723 may be configured to prevent rotation of the needle cover 500 relative to the device body 700. For example, the needle cover guide rib 723 may interact with the side region 503 of the needle cover and, for example, the side edge 503.1 of the side region 503, thereby preventing rotational movement of the needle cover 500 relative to the device body 700. The needle cover guide rib 723 may be formed on at least one of the connecting ribs 708, some of the connecting ribs 708, or all of the circumferentially opposing surfaces of the connecting ribs 708. The needle cover guide rib 723 may extend axially from the central support structure 701. For example, the needle cover guide rib 723 may extend axially from the proximal end of the axial support front end 703 to the distal end of the holder guide rib 726 (described later). Other axial extensions are possible, for example, with respect to the central support window 709, as long as the needle cover guide rib 723 is positioned to interact with the needle cover along the entire axial movement of the needle cover 500 relative to the device body 700 and to provide rotational support to the needle cover. The needle cover guide rib 723 may have a triangular cross-section such that the surface of the needle cover guide rib 723 extending mainly in the circumferential direction may be shorter than the surface of the needle cover guide rib extending mainly in the radial direction. Thus, a larger interaction surface may be formed for interaction with the side edge portion 503.1 of the side region 503. This may be beneficial in preventing disengagement of the side edge portion 503.1 from the needle cover guide rib 723.

[0304] In one embodiment, the needle cover guide rib 723 is formed on the circumferential surface (lateral side) of the connecting rib 708, for example, facing the needle cover radial support rib 722 (described later), and / or on the circumferential surface facing one of the ribs 720.1 of the needle cover lock release prevention structure.

[0305] In one embodiment, the device body 700 may further include at least one needle cover radial support rib 722 (see Figure 7C). The needle cover radial support rib 722 may be configured to support the lateral region 503 of the needle cover 500 so as to prevent the lateral region 503 from deflecting radially inward. This may be particularly relevant when the device body 700 is deformed, for example, when it is squeezed. In this case, a portion of the needle cover 500 extending into the interior of the device body 700 may also be deformed. This may cause disengagement of the lateral edge 503.1 from the needle cover guide rib 723 or disengagement of the rectangular projection 510.1 from the needle cover lock structure 720, both of which are potentially dangerous to the user or to the proper functioning of the drug delivery device.

[0306] As shown in the figure, the needle cover radial support rib 722 may extend radially outward from the central support structure 701. In the axial direction, the needle cover radial support rib 722 may extend along the same length as the needle cover guide rib 723. In the axial direction, the needle cover radial support rib 722 may at least partially overlap the needle cover guide rib 723. Preferably, the needle cover radial support rib 722 and the needle cover guide rib 723 overlap over the entire axial length of the shorter of the two ribs. As shown in Figure 7C, the device body 700 may include four needle cover radial support ribs 722, for example, one for each connecting rib 708. In the circumferential direction, the needle cover radial support ribs 722 may be positioned to support the lateral region 503 of the needle cover 500 along their circumferential extension range. Preferably, in the circumferential direction, the needle cover radial support rib 722 may be positioned such that the outermost section of the lateral region 503 of the needle cover 500 is supported against radially inward deflection.

[0307] In one embodiment, the needle cover radial support rib 722 may be positioned to circumferentially overlap the needle cover lock-removal prevention structure, e.g., rib 720.1. Alternatively, the angular offset between the needle cover radial support rib 722 and the needle cover lock-removal prevention rib 720.1 may be small, e.g., less than 45 degrees, less than 20 degrees, less than 10 degrees, or less than 5 degrees. A small offset may be advantageous because it can improve the support of the needle cover 500 in both radial directions. In other words, the lateral region 503 can be fixed against radial movement by having the needle cover radial support rib 722 extend radially inward and the needle cover lock-removal prevention rib 720.1 extend radially outward.

[0308] In one embodiment, the device body 700 may further include a syringe holder front stop 705 (see Figures 7D and 7E). The syringe holder front stop 705 may be formed on the distal half of the central tube 702, for example, on the proximal end of the axial support front end 703. The syringe holder front stop 705 may be formed by the proximal opposing 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, the syringe holder forward stopper 705 may interact with the stopping feature portion 809 (described later) of the syringe holder 800 when the syringe holder 800 moves distally to the device body 700 during assembly of the syringe holder 800 to the device body 700. As shown in Figure 7E, the axial centerline of the syringe holder forward stopper 705, which is parallel to the axial direction of the central support structure 701, may be offset by 90 degrees from the axial centerline of the central support window 709 and / or drug window 710.

[0309] In one embodiment, the device body 700 may include at least one cap groove 725. The cap groove 725 may be formed on the inner surface of the side wall 700a. The cap groove 725 may extend axially from the distal end of the device body 700 in the proximal direction P. In the circumferential direction, the extension of the cap groove 725 may occupy at least 1 percent of the perimeter. The cap groove 725 is configured to interact with the anti-rotation rib 205 of the cap 200, thereby preventing rotation of the cap 200 relative to the device body 700 when the cap 200 is connected to the device body 700 as described above. As shown in Figures 7B and 7C, the device body 700 may include at least four cap grooves 725. The cap grooves 725 may be arranged equidistantly around the inner surface of the side wall 700a. Alternatively, the cap grooves 725 may be arranged with different angular offsets in the circumferential direction.

[0310] 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 may include four holder guide ribs 726. The holder guide ribs 726 may extend radially inward from the side wall 700a. The holder guide ribs 726 may extend distally from the proximal end of the device body 700, for example, from the aperture 730 to about half the length of the central support structure 701. For example, the holder guide ribs 726 may extend distally from the proximal end of the device body 700 to the proximal end of the needle cover guide rib 723 and / or to the proximal end of the needle cover radial support rib 722. Alternatively, or in addition, the holder guide rib 726 may extend distally from the proximal end of the device body 700 to at least the proximal end of the needle cover release prevention structure 720.1, for example, to an axial position where the radially inward extension range of the rib 720.1 from the side wall 700a is zero.

[0311] The holder guide ribs 726 may have a triangular cross-section or a rectangle, such as a square, with triangles on its radially inner surface, such that the vertices of the triangles point toward 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 with respect to a first adjacent holder guide rib may be less than the offset with respect to a second adjacent holder guide rib. In one embodiment, the holder guide ribs 726 may be arranged equidistant from each other in the circumferential direction.

[0312] In one embodiment, the holder guide rib 726 may be configured to interact with the syringe holder 800. For example, the holder guide rib 726 may be configured to interact with the guide feature portion 811 of the syringe holder 800 during and / or after assembly of the syringe holder 800, as described below. For example, the holder guide rib 726 may prevent the syringe holder 800 from rotating relative to the device body 700, thereby defining the spatial orientation of the syringe holder 800 relative to the device body 700, for example, during and / or after assembly of the syringe holder 800 to the device body 700.

[0313] Alternatively, or in addition, the holder guide rib 726 may be configured to interact with the drive spring holder 1200 (described later). For example, the holder guide rib 726 may be configured to interact with the guide rib 1202.1 of the drive spring holder 1200 during and / or after assembly of the drive spring holder 1200 to the device body 700, as will be described in more detail in Section 12 below. For example, the holder guide rib 726 may prevent the drive spring holder 1200 from rotating relative to the device body 700, thereby defining the spatial orientation of the drive spring holder 1200 relative to the device body 700, for example, during and / or after assembly of the drive spring holder 1200 to the device body 700.

[0314] 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 inward 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 radially outward movement of the cap clip 204, thereby preventing disengagement of the cap clip 204 from the cap clip window 504 of the needle cover 500. As shown in Figure 12F, the device body 700 may include two groups, each having three cap ribs 727. The groups may be offset from each other by 180 degrees.

[0315] The cap ribs 727 within each group may be arranged at equidistant distances in the circumferential direction. Each group of cap ribs 727 may be formed at substantially the same axial position as the needle cover locking element 720, with a 90-degree angular offset from the needle cover locking element 720. In other words, the group of cap ribs 727 may be aligned circumferentially with the needle cover front stopper 724. The cap ribs 727 may be positioned distal to the needle cover front stopper 724.

[0316] 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, connected to, or directly incorporated into the side wall 700a. The label may prevent the user from seeing the injection molding gate recess 712 and / or the notches 713, 714. This may provide comfort to the user. The label may include information about the drug delivery device 100, such as information about the drug Dr administered by the drug delivery device 100 or the manufacturing date of the drug delivery device 100.

[0317] In one embodiment, the label includes an NFC (Near Field Communication) tag. The NFC tag may be a passive NFC tag configured to direct the user to a website or app, for example. Alternatively, or in addition, the NFC tag may be an active NFC tag that can function as a sensor. For example, the NFC tag may be an RFID (Radio Frequency Identification) tag.

[0318] 8. Syringe holder (Figures 8A-8D) Figures 8A and 8B show an optional syringe holder 800 to enable precise support of the pre-filled syringe 900 during and after assembly. In certain embodiments, the drug delivery device may include a syringe holder 800, e.g., a container holder. The syringe holder 800 may be adapted to assemble and hold the pre-filled syringe 900, e.g., a drug container, within the device body 700, which will be described in more detail below.

[0319] In particular, syringe 900 may be a 1.0 ml pre-filled syringe 900 having a rigid protective needle shield 914 (RNS). Typically, syringe 900 and / or protective needle shield 914 (also called “needle shield”) may have dimensional variations, such as length and / or diameter. Despite these variations, in order to enable accurate support of the pre-filled syringe 900 in the mounting position, the design of the syringe holder 800 and the device body 700 (front case) may be adapted to displace and position the needle shield 914 in a predetermined position during assembly, providing sufficient clearance to support the pre-filled syringe 900 at its reference point in the mounting position. The reference point may be the distal shoulder of the syringe barrel. Alternatively, or in addition, the radial diameter of the syringe shoulder may be smaller than one of the needle shields, which is often the case, for example, with a 1 ml syringe, so as to facilitate the syringe holder providing access to the syringe shoulder.

[0320] Therefore, the syringe holder 800 may include a flexible holder arm 801 adapted to engage with the syringe 900 and / or to position the syringe 900 and / or to hold the syringe 900 in a mounting position. The flexible holder arm 801 may protrude inward in a relaxed state. Alternatively, the flexible holder arm 801 may protrude outward in a relaxed state. Other configurations of the arm in a relaxed state are also possible.

[0321] The syringe holder 800 may include a holder housing 800a, for example, a main body portion, adapted to receive a pre-filled syringe 900, and at least two flexible holder arms 801, for example, four flexible holder arms 801, adapted to connect with the pre-filled syringe 900 at the mounting position. The holder housing 800a may be formed as a hollow cylinder or a cylindrical portion.

[0322] The flexible holder arm 801 may extend distally from the axial holder front end 802 of the holder housing 800a, for example, the distal end 802, and may project inward in a relaxed state, for example, be formed inward, and for example, be angled. The flexible holder arm 801 may include a holder projection 803 at its distal end that may be radially oriented, for example, inward.

[0323] The flexible holder arm 801 may have the same width throughout its entire extension range. That is, the width of one flexible holder arm at the front end 802 of the syringe holder corresponds to the width of the flexible holder arm at its distal end (see Figure 8A).

[0324] The holder projection 803 may include a ramp (best seen in Figure 8B) on its radially inward opposing surface that increases in height in the proximal direction, assisting the assembly process as described later in Figures 14B to 14E.

[0325] The holder projection 803 may have the function of stabilizing the connection between the syringe holder 800 and the prefilled syringe 900 at the mounting position of the prefilled syringe 900 and / or the syringe holder. The holder projection 813 may be adapted to engage in particular with the space between the proximal end of the needle shield 914 and the shoulder of the prefilled syringe 900.

[0326] To support the final assembly of the pre-filled syringe 900 to the syringe holder 800, at least two flexible holder arms 801 may be fitted to the pre-filled syringe 900 at the mounting position, for example, between the rigid needle shield 914 and the shoulder portion 904 of the pre-filled syringe 900, such that the outwardly prestressed flexible holder arms 801 return to a relaxed or springy state radially inward. The flexible holder arms 801 may return to a relaxed state due to relative movement of the syringe holder 800 with respect to the syringe 900, for example, distal movement of the syringe holder. This relative movement may be caused by an axial force acting on the syringe holder 800, for example, the rear end portion 804 of the holder.

[0327] Furthermore, the device body 700 (front case) can be adapted to suppress outward deflection of the flexible holder arm 801 when the syringe 900 is in the mounting position. This secures the syringe within the syringe holder.

[0328] The syringe holder 800 may include a holder rear end 804, i.e., a proximal end, opposite to the holder front end 802. At the holder rear end 804, the holder 800 may include a holder flange portion 805 containing a retaining clip 806 for intermittently and releasably holding the syringe holder 800 relative to the device body 700.

[0329] The holder flange portion 805 can form a housing space 818 into which the prefilled syringe 900 is distally inserted into the hollow cylinder formed by the holder body 800a.

[0330] The holder flange portion 805 may be non-circular, for example, including two rounded portions 813 of the holder flange portion 805 that are arranged on opposite sides of each other, for example, in the diametrically opposite direction, and two radially inward recessed portions 812 that are flatter than the rounded portions 813. Thus, the two rounded portions extend circumferentially as semicircles. The two recessed portions may be located on the other opposite side of the holder flange portion 805, for example, the diametrically opposite end and on the opposite side of the holder flange portion 805 from the rounded portions 813. The two recessed portions 812 may define a recessed outer flange surface.

[0331] The two rounded portions 813 can be circumferentially aligned with the window 814 of the syringe holder 800. This is possible because the notch 714 described with respect to the body 700 can be circumferentially aligned with the drug window 710 of the device body 700. The recessed portion 812 can be circumferentially offset by 90 degrees from the window 814 of the syringe holder 800 and can be circumferentially aligned with the rib 807 in particular, which will be described in detail later.

[0332] The axial extension range of the recessed portion 812 in the proximal direction may be smaller than the axial extension range of the rounded portion 813 in the proximal direction, as shown by length l2 in Figure 8B. In other words, the proximal end 813a of the rounded portion 813 may be even more proximal than the proximal end 812a of the recessed portion 812.

[0333] Therefore, the two rounded portions 813 that extend further axially in the proximal direction may define a receiving space for the syringe flange of the pre-filled syringe 900 when attached to the syringe holder 800.

[0334] Once installed, the pre-filled syringe 900 can be rotatably locked relative to the syringe holder 800 and / or the device body 700. Specifically, the rounded portion 813 may include internal ribs 819, which can prevent the installed pre-filled syringe 900 from rotating in the assembled state.

[0335] However, in embodiments where such rotation is considered necessary or advantageous, the pre-filled syringe 900 may also be rotatable relative to the syringe holder 800 and / or the device body 700.

[0336] The two recessed portions 812 may be recesses 812 of the holder flange portion 805, extending axially across the entire holder flange portion 805. The edge between the rounded portion 813 of the holder flange portion 805 and the flat recess of the holder flange portion 805 may also include or form a guide feature portion 811 to assist in positioning the syringe holder 800 onto the body during assembly. In other words, the syringe holder 800 may include a guide feature portion 811 extending along the longitudinal axis of the holder flange portion 805, the guide feature portion 811 positioned on the side wall of the holder flange portion 805 defining the space defined by the recessed portions 812.

[0337] The flat recessed portion can, for example, form a housing space for a needle cover arm during the assembly process or within the device.

[0338] Each recess may further include at least one, for example, two ramp-shaped projections 810 whose height increases toward the rear end 804 of the syringe holder, for example, the proximal end 804. The ramp-shaped projections 810 may function as guide features for the needle cover arm during the assembly process of inserting the prefilled syringe 900 and syringe holder 800 into the device body 700.

[0339] The ramp-shaped projection 810 may be positioned proximal to the recessed portion 812 such that the proximal end of the ramp-shaped projection 810 lies substantially in the same plane as the proximal end 812a of the recessed portion 812.

[0340] The two ramp-shaped protrusions 810 may be positioned at an angle to opposite ends of the recessed outer flange surface. In the case of two ramp-shaped protrusions, they may define a channel located centrally between them, which is configured to allow the passage of a portion of the needle cover's ribs during the assembly of the drug delivery device and / or at the mounting position of the container holder.

[0341] The recessed portion 812 may be defined radially by the surface of the holder flange portion 805. The holder flange portion 805 may be a rounded portion 813 in the proximal end region of the holder body. The recessed portion 812 may define a space angularly defined by the side wall of the holder flange portion 805, and the recessed portion 812 may be open at the distal and proximal ends.

[0342] The space defined by the recessed portion 812 can be adapted to engage with and / or accommodate a portion of the needle cover of the drug delivery device at the mounting position of the container holder 800. The space defined by the recessed portion 812 has a radially inward depth that decreases in the proximal direction. This is particularly useful when assembling the drug delivery device 100, as it allows for deflection of the needle cover side region, e.g., the leg portion, as needed during the assembly of the drug delivery device. The space defined by the recessed portion 812 has a radially inward depth that does not change.

[0343] 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 is substantially axially extended and radially deflectable. The retaining clip 806 may be positioned on a rounded portion 813 of the holder flange portion 805. The retaining clip 806 may be positioned circumferentially offset from the midpoint of each rounded portion 813 on which the retaining clip 806 is positioned. The retaining clips 806 may be circumferentially opposite each other.

[0344] The retaining clip 806, particularly its flexible portion, may extend further axially from the distal end of the holder flange portion 805 toward the proximal end of the holder flange portion 805. The retaining clip 806 may be configured not to extend over the entire axial extension of the holder flange portion 805. In particular, the retaining clip 806 may extend proximal over the same length as a receding portion, such as a recessed portion 812. In other words, the retaining clip 806 may extend less proximal to the holder flange portion 805.

[0345] The proximal end of the retaining clip 806 may be oriented radially outward to engage with notches 713, 714 of the device body 700. In one embodiment, the proximal end may have a bevel having a radially outward inclination in the proximal direction P. In one embodiment, the syringe holder 800 may include two retaining clips 806 positioned opposite each other. Instead of notches, the device body 700 may include an inner support for releasably holding the retaining clips 806. In particular, the inner support may be formed as an inner groove.

[0346] The retaining clip 806 is configured such that, in a first engagement position of the syringe holder, the retaining clamp 806 interacts with a slot, for example, a proximal notch 714 of the device body 700. In the first engagement position, the syringe holder 800 can be moved distally relative to the device body 700, but can also be moved proximal and thereby prevented from coming out of the device body 700. For example, this can be achieved by a sloped distal surface of the retaining clip 806, for example, a ramp whose height increases in the proximal direction. Furthermore, in the first engagement position, the syringe holder 800 can be prevented from rotating relative to the device body 700.

[0347] The retaining clip 806 is configured to disengage from the notch 714 when the syringe holder 800 is moved distally, for example during its assembly process. Further distal movement of the syringe holder 800 re-biases the retaining clip 806 radially inward until it aligns with a distal slot, for example, the distal notch 713 of the device body 700. Once aligned, the retaining clip 806 interacts with the notch 713 by deflecting radially outward into the space formed by the notch 713. This is a second engagement position for the syringe holder 800. The interaction between the retaining clip 806 and the notch 713 prevents proximal and rotational movement of the syringe holder 800 relative to the device body 700.

[0348] At least one arbitrary longitudinal rib 807 may be located on the holder housing 800a, or, for example, two ribs may be located on opposite sides. The longitudinal rib 807 may be used to position the syringe holder 800 axially with respect to the device body 700. The longitudinal rib 807 may include a stop feature 809 positioned toward the front end 802 of the holder at the end of the longitudinal rib 807. The stop feature 809 is configured to abut against each element of the device body, as illustrated and described with respect to Figure 7E. This can restrict distal movement of the syringe holder relative to the device body. The stop feature may be wider than the longitudinal rib 807.

[0349] Furthermore, the holder housing 800a may include at least one elongated holder window 808 to allow visual inspection of the amount of drug Dr in the pre-filled syringe 900 when the syringe 900 is mounted inside the syringe holder 800. The holder housing 800a may include two elongated holder windows 808 on sides opposite to each other.

[0350] The holder window 808 may be configured to be larger than the drug window 710 of the main body 700, for example, to reduce visibility, or to conceal the holder housing 800a when viewed through the drug window 710 of the main body 700. This improves user confidence, for example, the patient, because it provides an unobstructed view of the prefilled syringe 900 through the holder window 808 and the drug window 710 of the main body 700, without facing any internal components of the drug delivery device.

[0351] The inner surface of the holder housing 800a may further include longitudinal ribs, such as support ribs 814, that substantially extend along the inner surface of the holder housing 800a. The support ribs 814 may extend more proximal to the holder housing 800a, for example, on the inner surface of a recessed portion 812.

[0352] The support rib 804 can function as a support for the syringe barrel 902 when the pre-filled syringe 900 is inserted into the syringe holder 800. The support rib 814, when inserted into the syringe holder 800, further has the function of centering the pre-filled syringe 900, 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 preferably centered relative to the periphery defined by the body of the drug delivery device, axially parallel to the axial extension range of the drug delivery device. This ensures a more accurate injection process.

[0353] Figure 7D shows the arrangement of the syringe holder 800 within the device body 700. The essentially cylindrical central syringe support 701 may be shorter than half the length of the barrel 902 of the syringe 900, or even shorter than a quarter of the length of the barrel 902 of the syringe 900, for example, to save plastic material. Therefore, an elongated window may not be necessary and may not be present within the central syringe support 701.

[0354] The outer diameter of the needle shield 914 may be essentially equal to the outer diameter of the barrel 902 of the syringe 900. Thus, the distal end of the flexible holder arm 801, for example, a holder projection 803 extending radially inward, may be positioned between the shoulder 904 and the proximal end of the needle shield 914. The needle shield 914 can thereby be moved a small distance in the distal direction D. However, the sterility of the needle 908 can still be ensured. Removal of the cap 200 and the needle shield 914 can be facilitated by creating a gap between the proximal end of the needle shield 914 and the shoulder 904. In other embodiments, the needle shield may not be movable.

[0355] As shown in Figures 3A and 7A, to further facilitate user handling, particularly when removing the cap 200, the device body 700 includes a body user indicator 733 on its outer surface. The body user indicator 733 may be a gripping surface. Preferably, the device body 700 has two body user indicators 733 positioned opposite each other. The body user indicator 733 has the shape of three rectangles located at the distal end of the device body 700, the size of the area of ​​the three rectangles increasing in the distal direction D, and the rectangles adjacent to each other in the axial direction A. The cap user indicator 203 (as described in Section 3 above) and the body user indicator 733 may form a user indicator. Thus, the body user indicator 733 indicates to the user which direction the cap 200 should be pulled when removing it from the drug delivery device 100. Since the rectangles are formed as recesses in the device body 700, the rectangles also support a secure grip for the user when gripping the device 100. Therefore, the main body user indicator 733 provides the user with both visual and tactile assistance. The main body user indicator 733 is located distal to the drug window along the longitudinal axis of the device body 700. The main body user indicator 733 may have three rectangular recesses. The rectangular side lines extending transversely to the longitudinal axis may have the same length, and the rectangular side lines extending along the longitudinal axis may increase in length distally. Furthermore, the most distally located recess of the main body user indicator 733 may be positioned directly relative to the opening of the device body. The cap user indicator 203 may have two recesses, the first recess having an arrow shape, and the second recess having a rectangular or trapezoidal shape. The recess having the arrow may be located distal to the recess having the trapezoidal or rectangular shape.

[0356] Figure 8C shows exemplary embodiments of possible alternative or additional shapes for at least one flexible holder arm 801 of the syringe holder 800.

[0357] The flexible holder arm 801 of this embodiment may include a distal portion 816 configured to have a wider width than the proximal portion 817 of the flexible holder arm 801.

[0358] The distal portion 816 of the flexible arm 801 in Figure 8C is wider than the distal portion 816 of the flexible holder arm 801 in Figure 8A. In other words, the width of the flexible arm decreases proximally when viewed circumferentially. Having a wider distal portion 816 also widens the holder projection 803 which is oriented radially inward and located at the distal end of the flexible holder arm 801, thereby increasing the contact surface of the holder projection with the prefilled syringe 900, for example, with the barrel 902 of the prefilled syringe 900 (see, for example, Figures 14a to 14K).

[0359] This improves the holding stability of the syringe holder 800 over the prefilled syringe 900. In particular, it has proven advantageous as it provides additional stability against distal movement of the prefilled syringe caused by, for example, the spring-driven plunger first colliding with the syringe plunger stopper during the injection process, or by the prefilled syringe 900 colliding with the flexible holder arm 801.

[0360] Figure 8D shows a further exemplary embodiment of the syringe holder 800 in which the flexible holder arms 801 of Figure 8C are mounted on all four flexible holder arms 801 of the syringe holder 800. Other features of the syringe holder 800 in Figure 8D are similar to those of the syringe holder 800 in Figures 8A and 8B.

[0361] 9. Pre-filled syringe (Figure 9) Figure 9 shows an arbitrary pre-filled syringe 900. In particular, the syringe 900 may be a 1.0 ml pre-filled syringe 900 having an RNS 914 or SNS 914 covering a hollow needle 908. Other volumes of drug Dr are also possible. Typically, the pre-filled syringe 900 and needle shield 914 may have variations in dimensions, e.g., length and / or diameter. The needle shield 914 may be configured to cover the needle 908 and the conical portion 906 at the front end of the pre-filled syringe 900, e.g., a portion of the distal end. The needle shield 914 may be further configured such that, in the mounting position, a space is left between the proximal end of the needle shield 914 and the shoulder portion 904 of the pre-filled syringe 900. The pre-filled syringe 900 may further include a syringe flange 912 at its proximal end.

[0362] The pre-filled syringe 900 further comprises a barrel 902 containing, for example, a drug Dr, particularly drug M, to be injected into a patient or user.

[0363] Before initiating the injection, the needle shield 914 must be removed to expose the needle 908. This can be achieved by removing the cap 200 with the grabber 400 of the drug delivery device 100, as described above with respect to the grabber 400 and cap 200. During injection, the plunger stopper 910 inserted into the barrel 902 is pushed toward the distal end of the barrel 902, for example toward the needle 908, and can push, for example, drug Dr, for example drug M, from the needle 908 into the injection area toward the distal end of the pre-filled syringe 900. The plunger stopper 910 prevents drug Dr from exiting the barrel 902 from the proximal direction, but may be configured to slide along the barrel 902 toward the distal direction, for example toward the needle 908, when a force acts on the plunger stopper 910.

[0364] Examples of pre-filled syringes 900 include the BD (Becton Dickinson) Neopak 1 ml long pre-filled syringe (with a 27 gauge special thin-walled needle) and the Ompi EZ-Fill 1 ml long pre-filled syringe (with a 27 gauge thin-walled needle). Both of these syringes contain RNS and West2340 Flurotec Plunger Stopper. Other syringes or drug containers, particularly those with different drug Dr capacities and / or different needle diameters, especially outer diameters, may also be used.

[0365] According to at least one embodiment, the dose volume may be in the range of 0.5 to 1.14 ml (milliliters), and the viscosity of the drug may be 1 to 25 cP (centipoise).

[0366] Further examples of pre-filled syringes include the BD (Becton Dickinson) Neopak 2ml long pre-filled syringe (with a 27-gauge special thin-walled needle) and the Ompi EZ-Fill 2ml long pre-filled syringe (with a 27-gauge thin-walled needle), both of which feature a rigid needle shield (RNS) and a West2340 Flurotec Plunger Stopper.

[0367] According to at least one embodiment, the dose volume may be in the range of 1.15 to 2.25 ml, and the drug may have a viscosity of 1 to 25 cP.

[0368] 10. Plunger (Figures 10-10M) Figure 10 shows a plunger 1000. The plunger 1000 may include an elongated, preferably cylindrical, plunger shaft 1010. The plunger shaft 1010 may be hollow to provide, for example, assembly space for a drive spring 1100 and an optional spring support arm / pin 1230. On its inner surface, the plunger shaft 1010 may have at least one longitudinal rib 1060.1-1060.4 for guiding the drive spring 1100. The distal portion D of the plunger 1000 may be closed by a cylindrical end portion having a diameter smaller than the diameter of the plunger shaft 1010, for example, to connect to a complementary or essentially complementary recess of the plunger stopper 910.

[0369] The proximal end of plunger 1000 has several radial projections, for example, at least two or at least three projections, or at least two or at least three projections each: - A first plunger boss 1040.1 configured to interact with the profiled slot 1221.1 of the drive spring holder 1200 (see, for example, Figures 10A to 10F and Figure 10I), - A second plunger boss 1040.2 configured to interact with the plunger boss slot 506 of the needle cover 500 (see, for example, Figures 10G and 10H), and - Angled plunger rib 1040.3 It may include two groups, including the one that contains the specified value.

[0370] The purpose of the distal edge (plane) 1040.1d of the first plunger boss 1040.1 will be described in more detail in the explanation of Figure 10I below. The purpose of the proximal end (plane) 1040.9 of the first plunger boss 1040.1 will be described in more detail in the explanation of Figure 12D below.

[0371] Furthermore, optional plunger slots 1020, 1022, etc., may be located at the proximal end P of the plunger 1010. Slots 1020, 1022 may be used to provide triggering for the clicker 1300, independently of the length of the plunger 1000, for example, directly or indirectly via a flexible arm having projections that support the clicker 1300 in its biased state and are adapted to engage with slots 1020, 1022. There may be at least one plunger slot 1020 or at least two plunger slots 1020, 1022, for example, a pair of plunger slots, adapted to engage with at least one projection or a pair of projections of the flexible arm supporting the clicker 1300. Optionally, at least one additional slot may be located on the lower side of the plunger 1000, for example, to provide a symmetrical design and to facilitate assembly of the plunger 1000.

[0372] Figure 10A shows the plunger release mechanism 1025 in the first state. The following elements of the drive spring holder 1200: - Proximal region 1221, - Profiled slot 1221.1, - First angled surface 1221.2 of profiled slot 1221.1, - The wall 1221.3 of the profiled slot 1221.1, the wall 1221.3 may essentially extend in the axial direction of the drug delivery device 100 and may be located between the first angled surface 1221.2 and the second angled surface 1221.4. - The second angled surface 1221.4 of the profiled slot 1221.1, and - Longitudinal edges 1234 of profiled slots 1221.1 that may be radially positioned within the region to avoid interaction with the first plunger boss 1040.1 (see also Figures 12A and 12B) This may be related.

[0373] The plunger release mechanism 1025 may include a first plunger boss 1040.1 positioned on the plunger 1000 and a profiled slot 1221.1 in the proximal region 1221 of the drive spring holder 1200 (the rear portion of the device body 700). The profiled slot 1221.1 may include a first angled surface 1221.2 adapted to engage with the first plunger boss 1040.1 to induce a torque on the plunger 1000 in a first rotational direction R1, and a wall 1221.3 for restricting the movement of the first plunger boss 1040.1 in the first rotational direction R1 when engaged with the first angled surface 1221.2. Furthermore, the profiled slot 1221.1 may include a second angled surface 1221.4 adapted to engage with the first plunger boss 1040.1 to induce a torque in a first rotational direction R1 on the plunger 1000.

[0374] The first angled surface 1221.2 and / or the second angled surface 1221.4 may have an inclination angle in the range of 30° to 70° with respect to a perpendicular line on the longitudinal axis A of the drug delivery device 100, which may also be the longitudinal axis of the plunger 1000. In other words, the first angled surface 1221.2 may have an inclination angle in the range of 30° to 70° with respect to the circumferential direction.

[0375] In the first state shown in Figure 10A, the first plunger boss 1040.1 engages with the first angled surface 1221.2. The drive spring 1100 acting on the plunger 1000 presses the first plunger boss 1040.1 distally D against the first angled surface 1221.2, inducing a torque in the first rotational direction R1 on the plunger 1000, causing the first plunger boss 1040.1 to slide along the first angled surface 1221.2 until it contacts the wall 1221.3, stopping the rotation of the plunger 1000 in the first rotational direction R1. The first state can be used to assemble the drive subassembly.

[0376] Optionally, a recess 1221.15 may be provided on the proximal face of the profiled slot 1221.1. As described below, this recess may be used as a drop protection feature and / or as a guide feature for guiding the first plunger boss (rib) 1040.1 in a rotational direction opposite to the rotational direction R1.

[0377] Figure 10B shows the plunger release mechanism 1025 in the second state. Starting from the first state, the plunger 1000 has moved in the proximal direction P by a distance at least the same length as the wall 1221.3 such that the wall 1221.3 no longer restricts the movement of the first plunger boss 1040.1 in the first rotational direction R1. The plunger 1000 is then rotated further in the first rotational direction R1, for example by using the needle cover 500, such that the first plunger boss 1040.1 engages with the second angled surface 1221.4. A drive spring 1100 acting on the plunger 1000 presses the first plunger boss 1040.1 against the second angled surface 1221.4 in a distal direction D, inducing a torque in a first rotational direction R1 on the plunger 1000, causing the first plunger boss 1040.1 to slide along the second angled surface 1221.4. Unless the plunger 1000 is prevented from rotating further, the first plunger boss 1040.1 may slide along the second angled surface 1221.4 until it disengages, allowing the plunger 1000 to advance distally D and displace drug Dr or drug M from the pre-filled syringe 900. However, this only occurs afterward, i.e., when the drug delivery device 100 is triggered, for example, when the needle cover 500 is used and pressed against the user's skin.

[0378] In an exemplary embodiment, the movement of the plunger 1000 from the first state to the second angled surface 1221.4 in the proximal direction P can be achieved by the needle cover 500 (proximal sleeve portion 513) interacting with the plunger 1000, for example, by engaging with the plunger boss or rib of the plunger 1000. This can be done during final assembly, i.e., during the assembly of the control subassembly and the drive subassembly. Furthermore, this may differ from triggering the device 100 for drug delivery.

[0379] Alternatively, for this purpose, other parts of the drug delivery device 100, such as the end plate of the drive spring holder 1200 including a suitable projection, may be used so that the first angled surface 1221.2 can be inclined in the opposite direction compared to the direction shown in Figures 10A to 10F, without using a different shape, such as a wall 1221.3. In this embodiment, the plunger rib / projection 1040.3 may be omitted or not present.

[0380] Exemplary embodiments of the plunger release mechanism 1025 are shown in detail in Figures 10C, 10D, 10E and 10F. Figure 10C shows the plunger release mechanism 1025 during the final assembly of the control subassembly and the drive subassembly. The needle cover 500 includes a proximal sleeve portion 513. The proximal sleeve portion 513 is - A slot rib 507 including a longitudinal extension, for example, a slot rib 507 (see Figure 5), and a circumferential extension, for example, a second ramp 507d (see Figure 5), for example, an angled slot rib 507, - For example, the proximal surface 513.2 on the circumferential extension (second ramp 507d), - For example, distal surface 513.3 on the circumferential extension (second ramp 507d), - For example, on the longitudinal extension, for example, the contact surface 507b on the slot rib 507, and - Any first ramp 507c (see Figure 10H) It may include.

[0381] The proximal sleeve portion 513 may include a plunger boss slot 506 (see Figures 10G and 10H). The plunger boss slot 506 is described in more detail in Section 5 above and includes, for example, a proximal slot 506a and a distal slot 506b.

[0382] To prevent component jamming and provide smooth operation of the drug delivery device 100, there may be pairs of proximal sleeve portions 513 that interact with the groups of plunger protrusions 1040.2 and / or plunger protrusions 1040.3, respectively, in order to have symmetrical forces acting on, for example, protrusions 1040.2 and / or protrusions 1040.3 and other parts.

[0383] The plunger release mechanism 1025 can essentially have two functions. a) During the assembly of the control subassembly and the drive subassembly, the plunger 1000 is moved from its first state to a second state, i.e., the needle cover 500 is stationary relative to the device body 700, but the device body 700, including the needle cover 500, is moved axially relative to the drive spring holder 1200 or vice versa (see Figures 10C and 10D). As described above, for this purpose, the needle cover 500 or other parts, such as other parts of the device 100, may be used. b) When the needle cover 500 is pressed against the patient's skin, i.e., the plunger 1000 is released during the relative movement of the needle cover 500 relative to the device body 700 (front portion of the housing) and the drive spring holder 1200 (rear portion of the housing) (see Figure 10F).

[0384] 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 only axially with respect to each other, for example, parallel to or along the longitudinal axis A with respect to each other, while the plunger 1000 can move parallel to the longitudinal axis A and can rotate around the longitudinal axis A (see rotational directions R1 and R2). The components of the plunger release mechanism 1025 may be inherently rigid and may not require deformation to function properly.

[0385] The plunger 1000, the proximal region 1221 and the components positioned to engage with the proximal sleeve portion 513 are, - Plunger 1000, first plunger boss 1040.1, - Plunger 1000, second plunger boss 1040.2, - Angled plunger rib 1040.3 of plunger 1000, - Profiled slot 1221.1 in the proximal region 1221, adapted to interact with the first plunger boss 1040.1, - The slot rib 507 of the proximal sleeve portion 513, the proximal surface 513.2 of the plunger boss slot 506 adapted to interact with the angled plunger rib 1040.3, the distal surface 513.3 of the plunger boss slot 506, and the contact surface 507b of the plunger boss slot 506 adapted to interact with the second plunger boss 1040.2 It may include.

[0386] Figure 10C shows a gap 1030 that reveals the possibility of a rotational offset between the two parts shown in the figure. However, the three projections of the plunger 1000 may have fixed positions relative to each other (see dashed line 1032).

[0387] The profiled slot 1221.1 may include a first angled surface 1221.2 adapted to engage with a first plunger boss 1040.1 to induce a torque in a first rotational direction R1 on the plunger 1000, and a wall 1221.3 for restricting the movement of the first plunger boss 1040.1 in the first rotational direction R1 when engaged with the first angled surface 1221.2. Furthermore, the profiled slot 1221.1 may include a second angled surface 1221.4 adapted to engage with the first plunger boss 1040.1 to induce a torque in a first rotational direction R1 on the plunger 1000.

[0388] As described above, during the assembly of the drive subassembly, the plunger 1000, which has the drive spring 1100, is inserted into the proximal region 1221. When the plunger 1000 reaches the proximal position, the first plunger boss 1040.1 is axially aligned with the profiled slot 1221.1. By rotating the plunger 1000 by an angle of approximately 30° in a second rotational direction R2, the first plunger boss 1040.1 is moved into the profiled slot 1221.1. In this position, the first angled surface 1221.2 moves the first plunger boss 1040.1 relative to the wall 1221.3 by inducing a torque in the first rotational direction R1 on the plunger 1000, as the drive spring 1100 biases the plunger 1000 in the distal direction D.

[0389] To finally assemble the drug delivery device 100, the syringe 900 may be inserted into a control subassembly which may include the device body 700 (the front portion of the housing).

[0390] Subsequently, the drive subassembly is inserted distally D into the control subassembly. The proximal region 1221 and the device body 700 may include snap connections to lock them together when assembled. During the final assembly of the drug delivery device 100, the needle cover 500 and its associated proximal sleeve portion 513 may be partially pushed in, for example by an assembly jig (not shown) or by a different method, to enable the plunger release mechanism 1025 to initiate from a first state to a second state. The initiation is distinct from the triggering of the plunger release mechanism 1025.

[0391] Figure 10D shows the plunger release mechanism 1025 during final assembly. Exemplarily, the slot rib 507, particularly the proximal surface 513.2, proximal to the angled plunger rib 1040.3, thereby inducing a torque in a first rotational direction R1 to the plunger 1000, pushing the plunger 1000 in the proximal direction P, and the first plunger boss 1040.1 moves along the wall 1221.3 until it disengages from the wall 1221.3. This action is the priming of the device. Due to the induced torque, the first plunger boss 1040.1 moves in the first rotational direction R1 and engages with the second angled surface 1221.4. The indentation of the needle cover 500 and its associated proximal sleeve portion 513 can be stopped, and the plunger 1000 can rotate further in the first rotational direction R1 as the first plunger boss 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.

[0392] The needle cover 500 and consequently the proximal sleeve portion 513 are not further compressed and can move distally D relative to the device body 700, for example, under the action of a needle cover spring 600 (sleeve spring, not shown). This movement can be limited by the second plunger boss 1040.2 contacting the distal surface 513.3 of the slot rib 507. Further rotation of the plunger 1000 in the first rotational direction R1 can be prevented by the second plunger boss 1040.2 contacting the longitudinal surface of the slot rib 507. The load of the drive spring 1100 can be relieved in the proximal region 1221 by the first plunger boss 1040.1 engaging with the profiled slot 1221.1. This state of the plunger release mechanism 1025, i.e., the second state, is shown in Figure 10E.

[0393] The sequence of operations of the drug delivery device 100 may be as follows:

[0394] The user removes the cap 200 and cap cover 300 by pulling them distally D away from the device body 700. When the cap 200 and cap cover 300 are removed, the protective needle shield 914 (e.g., a rigid needle shield or a flexible needle shield) can also be removed from the needle 908.

[0395] The needle cover 500 may be in an extended position that protrudes distally D from the device body 700. The extended position may be defined by a second plunger boss 1040.2 that proximal abuts the distal surface 513.3 of the slot rib 507.

[0396] Subsequently, the user may press the drug delivery device 100, which has the needle cover 500 in the front, against the injection site, for example, the patient's skin, thereby moving the needle cover 500 from the extended position to the retracted position against the biasing force of the needle cover spring 600.

[0397] Figure 10F is a schematic diagram of the plunger release mechanism 1025 after the needle cover 500 has been pushed into the retracted position. As the needle cover 500 moves from the extended position toward the retracted position, the second plunger boss 1040.2 is guided along the contact surface 507b of the slot rib 507 and moves distally D relative to the needle cover 500 (starting from the position shown in Figure 10E).

[0398] In exemplary embodiments, the contact surface 507b of the slot rib 507 may include a break or bump feature (not shown) to generate an increased force necessary to further push the needle cover 500. This may be used to indicate to the user that needle insertion is initiated by further pushing of the needle cover 500 and its associated proximal sleeve portion 513. Up to this point, the user can freely remove the drug delivery device 100 from the injection site and reposition it as the needle cover 500 extends back to its initial position under the force of the needle cover spring 600.

[0399] As the user continues to press the drug delivery device 100 against the injection site, the needle cover 500 moves to a retracted position, exposing the needle 908 and inserting it into the injection site.

[0400] As the needle cover 500 is pushed into the retracted position and the needle 908 is inserted, the second plunger boss 1040.2 is moved distally beyond the slot rib 507 so that the plunger 1000 is no longer prevented from rotating in the first rotational direction R1 by the torque induced by the drive spring 1100, and the first plunger boss 1040.1 engages with the second angled surface 1221.4 on the profiled slot 1221.1. The plunger 1000 rotates in the first rotational direction R1 by this torque, and the first plunger boss 1040.1 leaves the profiled slot 1221.1 and is guided along the inner longitudinal rib 1236 (see Figure 10I). Thus, the plunger 1000 is released, advancing the plunger stopper 910 distally D and displacing drug Dr or drug M from the syringe 900 through the needle 908. The release of the first or second plunger boss 1040.1, 1040.2 may provide audible feedback that drug delivery has commenced.

[0401] Figure 10G is a schematic detail view of the plunger release mechanism 1025 after final assembly and before the needle cover 500 and its associated proximal sleeve portion 513 are pushed in, i.e., when the plunger 1000 is in the second state. Figure 10G is a view of the interior of the proximal portion of the elongated arm of the needle cover 500, in particular the interior of the proximal sleeve portion 513. Movement of the needle cover 500 relative to the device body 700 in the distal direction D can be limited by the second plunger boss 1040.2 contacting the distal surface 513.3 of the slot rib 507. Further rotation of the plunger 1000 in the first rotation direction R1 can be prevented by the second plunger boss 1040.2 contacting the contact surface 507b of the slot rib 507.

[0402] Figure 10H is a schematic detail view of the plunger release mechanism 1025 during the pushing in of the needle cover 500 and its associated proximal sleeve portion 513. Figure 10H is a view of the interior of the proximal portion of the elongated arm of the needle shroud 500, in particular the interior of the proximal sleeve portion 513. As the proximal sleeve portion 513 moves in the proximal direction P from the extended position to the retracted position, the second plunger boss 1040.2 is guided along the contact surface 507b of the slot rib 507 and moves distally D relative to the needle cover 500 (starting from the position shown in Figure 9).

[0403] As the user continues to press the drug delivery device 100 against the injection site, the needle cover 500 moves to a retracted position, exposing the needle 908 and inserting it into the injection site.

[0404] As the needle cover 500 is pushed into the retracted position and the needle 908 is inserted, the second plunger boss 1040.2 is moved distally beyond the slot rib 507 so that the plunger 1000 is no longer prevented from rotating in the first rotational direction R1 by the torque induced by the drive spring 1100, and the first plunger boss 1040.1 engages with the second angled surface 1221.4 on the profiled slot 1221.1. The plunger 1000 rotates in the first rotational direction R1 by this torque, and the first plunger boss 1040.1 disengages from the profiled slot 1221.1. Thus, the plunger 1000 is released, advancing the plunger stopper 910 distally in direction D and displacing the drug / medicine Dr / M from the syringe 900 through the needle 908.

[0405] In another embodiment of the plunger release mechanism 1025, in addition to the above embodiment, a first ramp 507c is provided on the proximal sleeve portion 513. As the proximal sleeve portion 513 approaches the retracted position, the first ramp 507c engages with a rib or boss on the plunger 1000, for example, an angled plunger rib 1040.3, and actively rotates the plunger 1000 in a first rotational direction R1. If the plunger 1000 should not rotate spontaneously due to the features of the above embodiment, the additional first ramp 507c induces the rotation of the plunger 1000.

[0406] During normal use, the plunger 1000 is released as in the embodiment described above. The first ramp 507c is positioned to interact with the angled plunger rib 1040.3 only when the plunger 1000 is not spontaneously rotating near the end of the indentation of the needle cover 500 and the associated proximal sleeve portion 513. Those skilled in the art will readily understand that the embodiment functions similarly when only one of the ribs or bosses of the plunger 1000, for example, the angled plunger rib 1040.3 or the first ramp 507c, is inclined or angled. The same applies to the proximal surface 513.3.

[0407] Another advantage of a further embodiment, namely the use of the first ramp 507c, is that it provides additional guidance for the movement of the plunger 1000 when the plunger 1000 is in operation.

[0408] In another exemplary embodiment, engaging the first ramp 507c with a rib or boss of the plunger 1000, such as the angled plunger rib 1040.3, may be the only method for disengaging the plunger 1000 from the profiled slot 1221.1 and rotating it. For example, the profiled slot 1221.1 may not have an angled surface that disengages the plunger 1000 from the profiled slot 1221.1 and rotates it in a first rotational direction R1. In an exemplary embodiment, the profiled slot 1221.1 may have only a transverse surface oriented transversely with respect to the longitudinal axis A toward the distal direction D. The transverse surface may have a stopper or bump. In another exemplary embodiment, the profiled slot 1221.1 may have only an angled surface that rotates the plunger in a second rotational direction R2 to maintain the first plunger boss 1040.1 engaged within the profiled slot 1221.1.

[0409] In exemplary embodiments, the drug delivery device 100 may be an auto-injector.

[0410] Figure 10I shows an internal longitudinal rib 1236 located inside at least one syringe support arm 1202 of the drive spring holder 1200 (see also Figures 12A and 12B). In other words, the internal longitudinal rib 1236 may be located on radially inward opposing surfaces of the arms 1202 of the drive spring holder 1200. The distal edge / face 1040.1.d of the first plunger boss 1040.1 abuts against the proximal surface 1239 of the sliding surface 1238 on the longitudinal rib 1236 in the second state of the plunger 1000, and for example, the rib 1236 may have a retaining function for holding the plunger 1000 against the biasing force of the drive spring 1100. The proximal surface 1239 may be inclined to allow further rotation of the plunger 1000 in the absence of additional support. However, the second plunger bosses 1040.2, 1040.2a and 1040.2b are supported on the rib 507a, and therefore further rotation of the plunger 1000 is prevented unless the drug delivery device 100 is injected. When the plunger release mechanism 1025 is triggered for injection by moving the needle cover 500 proximal to the device body 700 and the drive spring holder 1200, the plunger 1000 is allowed to rotate in the direction R1 of the second plunger boss 1040.2, i.e., to rotate freely (see Figure 10H), and the first plunger boss 1040.1 can slide distally through the sliding surface 1238. Further distal movement of the plunger 1000 can be guided by using the guide rib, for example, by guiding the first plunger boss 1040.1.

[0411] Therefore, the longitudinal edge portion 1234 may not interfere with the first plunger boss 1040.1. In other words, the longitudinal edge portion 1234 may be positioned radially further outward than the positions of the first angled surface 1221.2, the second angled surface 1221.4, and the inner edges of the first plunger boss 1040.1, so that the plunger boss 1040.1 does not come into contact with the longitudinal edge portion 1234.

[0412] Figure 10J shows a perspective view of the plunger 1000 according to a second embodiment. The plunger 1000 may be used to discharge the drug Dr, M from the drug container 900. The plunger 1000 may include, for example, an elongated shaft 1010, such as an elongated plunger rod 1010, which forms the main body of the plunger, extending from the proximal end 1011p of the plunger 1000 to the distal end 1011d of the plunger 1000. The distal end 1011d may be configured to transmit force during the discharge of the drug Dr, M.

[0413] Optionally, at least one trigger feature TF may be located within or on the shaft 1010. The trigger feature TF may be configured to allow the release of the plunger 1000 from the rest of the drug delivery device 100 to begin dispensing the drug Dr, M from the drug container 900, for example, a pre-filled syringe 900. In a second embodiment of the plunger 1000, similar to the first embodiment shown, for example, in Figure 10, two pairs of plunger ribs 1042a, 1042b may be used as the trigger feature TF. At least one common rib CR may be used as a base for positioning the two pairs of plunger ribs 1042a, 1042b on the plunger 1000, for example, on the plunger shaft 1010. However, as will be described in more detail below, optionally, additional radially extending ribs 1046-1049 and / or support ribs SR including, for example, rounded support feature RF may be used to reinforce the trigger feature TF.

[0414] Optionally, the plunger 1000 may include at least one interaction feature IF configured to interact with a drive source that generates a force for ejecting the drug Dr, M. In a second embodiment, a drive spring 1100 may similarly be used as the drive force. The interaction feature IF may include an inner elongated cavity 1059 within the plunger 1000, more specifically within the shaft 1010. Furthermore, the interaction feature IF may include inner longitudinal ribs 1060.1-1060.4, an inclined surface 1075, and other optional features as described in more detail below (see Figures 10L and 10M and their corresponding descriptions).

[0415] In addition or alternatively, the plunger 1000 may include at least one group 1050a, 1050b comprising at least one auxiliary structure AS or at least two auxiliary structures AS. Groups 1050a, 1050b comprising at least one auxiliary structure AS or at least two auxiliary structures AS may be configured to enable automatic recognition 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 comprising the plunger 1000. Preferably, at least one auxiliary structure AS may be a circumferentially extending auxiliary structure that extends at least partially, preferably, around the shaft 1010, and preferably around at least approximately one-quarter of the shaft 1010. However, other types of auxiliary structures, such as axially extending structures, may also be used. Group 1050a may include grooves 1051.1a, groove 1051.2a, and groove 1051.3a, from distal to proximal. Group 1050b may include grooves 1051.1b, 1051.2b, and 1051.3b, running from distal to proximal.

[0416] Grooves 1051.1a, etc., may have several functions in addition to their testing function, such as the visual feedback function described later.

[0417] A batch testing method for a drug delivery device 100 including a plunger 1000 with an appropriate auxiliary structure AS or any other plunger is: - Preferably, a batch of plungers 1000 and / or drug delivery devices 100 is produced using at least one injection molding die, - Assembling the drug delivery device 100, - Testing the drug delivery device 100, which may include using a camera (e.g., using a high-speed camera and / or shutter) to detect the auxiliary structure AS during dose (drug Dr, M) dispensing and / or at the end of dose (drug Dr, M) delivery, and preferably automatically recognize the position of the plunger 1000. - Quality control must be conducted based on the results of at least one test. It may include.

[0418] A batch may contain several parts produced using the same machine / mold and / or cavity, etc. A batch may contain a number of parts ranging from 10 to 1000 or from 100 to 500.

[0419] Quality control can be statistical quality control, which, for example, defines how many devices need to be tested during production to ensure quality, and preferably defines when and how many devices need to be tested according to an approved test plan.

[0420] Preferably, auxiliary structures AS, such as grooves 1051a, 1051.2a, etc., are positioned at angular locations on the shaft 1010 that allow the auxiliary structures AS to be viewed through at least one side wall window 710 of the drug delivery device 100. However, other arrangements are also possible, for example, if appropriate radiation, such as radiation passing through the housing or body 700, is used to recognize the plunger position / movement.

[0421] Optionally, the plunger 1000 may include at least one lateral opening 1052.1a, 1053 or at least two lateral openings 1052.1a, 1052.1b, preferably on the lateral side opposite the shaft 1010. At least one lateral opening 1052.1a, 1053 or at least two lateral openings 1052.1a, 1052.1b may be configured to allow the removal of at least one auxiliary component of the mold used to produce the plunger 1000. At least one auxiliary component may be configured to laterally hold, for example, a rod or pin, or an elongated auxiliary component consisting of a rod or pin, during the injection of plastic into the mold. The further auxiliary component (e.g., a rod or pin) may be an elongated component that can define the inner contour or at least a portion of the elongated cavity 1059 inside the plunger 1000. The inner contour / cavity 1059 of the plunger 1000 may preferably include an inner elongated cavity, particularly an essentially cylindrical cavity, which includes a slight draft angle that facilitates the removal of further auxiliary molded parts (e.g., rods or pins) after a suitable cooling time following the injection of the plastic material into the mold.

[0422] According to the second embodiment, two pairs of molding slots, 1052a and 1052b, may be used. Pair 1052a may include slots 1052.1a and 1052.2a. Pair 1052b may include slots 1052.1b and 1052.2b. However, it is also possible to use only one of the pairs of molding slots 1052a and 1052b, or only one slot on each side of the plunger 1000, for example, only two molding slots in total. Thus, it is possible to use only slots 1052.1a and 1052.1b, or to use slots 1052.2a and 1052.2b. Slots 1052.2a and 1052.2b will be described in more detail below (see Figure 10L and the corresponding description).

[0423] Preferably, the lateral opening 1052.1a, etc., 1053 is positioned at an angular position on the shaft 1010 such that the lateral opening 1052.1a, etc., 1053 is not visible within at least one side wall window 710 (drug viewing window) of the drug delivery device 100. However, other positions are also possible, such as the opening 1053 being at the same angular position as the upper auxiliary structure AS, 1050a, 1051.1a, etc., on the top surface of the shaft 1010 (see Figure 10J).

[0424] A method for producing plunger 1000 or any other plunger may include the following: - To provide a mold for producing at least one plunger 1000 or more plungers 1000, wherein the mold comprises two main components configured to press against each other during molding, and the two main components define at least one outer contour of the plunger 1000. The inner contour of the elongated cavity 1059 inside the plunger 1000 may be defined by an elongated first auxiliary molding component (e.g., including or consisting of a rod or pin) preferably positioned on a first slider which is part of the mold. The mold may preferably include at least one second auxiliary molding component at the free end and / or middle of the elongated first auxiliary molding component, configured to hold the elongated first auxiliary molding component (e.g., a pin or rod) laterally during injection of the plastic material 1090 into the mold. At least one second auxiliary molding part may be preferably integrally positioned on the mold, i.e., in this case a separate slider may not be used, but instead, a second slider may be used. However, each slider may complicate the mold and thus production. - Closing two main components of the mold before, during, or after sliding a first slider (and a second slider, if optionally present) into its molding position, thereby closing at least one second auxiliary molding component so as to hold the first auxiliary molding component (e.g., a rod or pin) laterally. - Injecting plastic material 1090 into a mold to form at least one plunger 1000, wherein the plunger 1000 includes at least one molding slot 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. - To optionally cool the mold by force, for example, by using a liquid cooling medium in the cooling cavity of the mold, or freely, preferably by primarily or solely by heat conduction, without using a separate cooling medium different from, for example, ambient air. - Open the two main components of the mold and slide the first slider (and the second slider, if present) back to a position that allows at least one plunger 1000 to be ejected from the mold. - After opening the two main components, eject at least one plunger 1000 from the mold.

[0425] The precision of the plunger 1000 can be improved, for example, by using a second auxiliary molding part that holds a first auxiliary molding part (e.g., a rod or pin) in particular at its free end, in order to prevent displacement during injection of the high-temperature plastic material 1090 into the mold under high pressure.

[0426] Optionally, the plunger 1000 or any other plunger may include at least one retaining structure 1043, 1040.1, preferably a rib 1040.1 comprising a proximal axial extension 1045 and a distal support 1044 having an angular width greater than the width of the axial extension 1045. The retaining structure 1043 may be configured to interact with a further retaining structure 1221.1 (profiled slot) on a portion of the drug delivery device 100 so that the plunger 1000 is securely held in the further retaining structure 1221.1 (profiled slot) while biased by the drive spring 1100. Preferably, the axial length of the axial extension 1045 is greater than the axial length of the distal support 1045, for example, twice or three times greater, preferably less than 10 times as the axial length of the axial extension 1045.

[0427] Optionally, the plunger 1000 may include the trigger feature section TF described above. The trigger feature section TF may consist of or include at least one group 1042a, 1042b, for example, at least one pair 1042a, 1042b of at least two outward-facing ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, 1040.3b. Pair 1042a may include rib 1040.2a and rib 1040.3a. Pair 1042b may include rib 1040.2b and rib 1040.3b.

[0428] Each of the ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, and 1040.3b of at least one group (e.g., a pair) 1042a, 1042b may be positioned at the same angular location or with an angular offset of less than 10 degrees from each other. Each of the ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, and 1040.3b of at least one group 1042a, 1042b may have different axial positions within a distance of less than 15 mm or less than 10 mm. Each of the ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, and 1040.3b may also extend axially. Each of the ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, and 1040.3b may have a smaller angular or circumferential extension range compared to their radial extension range and / or their axial extension range.

[0429] At least two outward-facing ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, and 1040.3b of at least one group 1042a, 1042b may be positioned on their respective common ribs CR, CRa, and CRb, which may extend axially with respect to the longitudinal axis of the shaft 1010.

[0430] Preferably, at least one support rib SR may be positioned on each of the common ribs CR, CRa, CRb. The support rib SR may extend obliquely in the axial direction to at least two outward-facing ribs 1040.2, 1040.2a, 1040.2b, 1040.3, 1040.3a, 1040.3b of one adjacent group from at least two groups 1042a, 1042b, preferably including an angle of 80 to 100 degrees, for example, about 90 degrees or 90 degrees, with respect to the more proximal rib 1040.3a and / or 1040.3b located in P.

[0431] Preferably, at least one support rib SR may include a rounded support feature RF having a curved shape that extends from an axial position equal to the axial position of the proximal end of a first rib of at least one group 1042a, 1042b, e.g., a distal rib (e.g., 1040.2a, 1040.2b), to an axial position equal to the axial position of the proximal end of one second rib of each of the at least one group 1042a, 1042b, e.g., a proximal rib (e.g., 1040.3a, 1040.3b).

[0432] For example, the following radially extending ribs may be used for reinforcement purposes. - Preferably, rib 1046 at the distal end of common ribs CR, CRa, CRb, which terminates at the distal portion of ribs 1040.2a, 1040.2b, - Preferably terminating at the proximal portions of ribs 1040.2a and 1040.2b, rib 1047 is located in the middle of the common ribs CR, CRa, and CRb, and the rounded support feature RF may begin from here. - Rib 1048, which is on the opposite side of the common ribs CR, CRa, CRb, and ribs 1046 and 1047, which are preferably located on the side where ribs 1046 and 1047 are located, terminating at the distal portions of the angled ribs 1040.3a, 1040.3b, and - Rib 1049 and rounded support feature RF may terminate here, on the opposite side of the common ribs CR, CRa, CRb, compared to the side where ribs 1046 and ribs 1047 are located, preferably terminating at the proximal portions of the angled ribs 1040.3a, 1040.3b.

[0433] Corresponding ribs may be used on the pair of plunger ribs 1040.2b and 1040.3b on 1042b. In general, rotational symmetry of the plunger 1000 may be preferred to facilitate production (e.g., less warping during molding) and / or assembly, and there are no further details regarding, for example, the mounting direction.

[0434] Optionally, the plunger 1000 may or may consist of 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 PA66. The glass-filled material may have glass or glass fiber portions in the range of 23 to 43 mass percent or 30 to 36 mass percent, for example, in the range of 33 mass percent. Preferably, DuPont Zytel FGFE5171, in particular FGFE5171NC010C containing 33 mass percent of glass or glass fiber, may be used. Alternatively, volume percentages may be used instead of mass percentages in the above ranges or values. Other materials, such as PA(polyamide, nylon)6, may also be used. PA(polyamide, nylon)66 is also suitable for use in the food industry and therefore may be particularly well suited as a material for medical devices, especially the plunger 1000 which is part of medical device 100. Furthermore, it has excellent moldability.

[0435] Optionally, the plunger 1000 may include at least one axially extended notch (e.g., slot) 1020a, 1022a, 1020b, 1022b or at least two longitudinal notches (e.g., slots) 1020a, 1020b. At least one axially extended notch 1020a, 1020b or at least two longitudinal notches 1020a, 1022a, 1020b, 1022b may be located within the proximal portion of the shaft 1010. Preferably, at least one axially extending notch 1020a, 1022a, 1020b, 1022b or at least two longitudinal notches 1020a, 1022a, 1020b, 1022b may be configured to interact with the support arm 1241, as will be described in more detail below (see, for example, Figures 13B to 13E and the corresponding description). In particular, the support arm, e.g., support arm 1241, may be configured to interact with and / or trigger the audible and / or indicator 1300 of the drug delivery device 100 (see, for example, Figure 13A and the corresponding description).

[0436] A pair of notches may be used. The first pair may include notches 1020a, 1022a. The second pair may include notches 1020b, 1022b. If only one audible and / or indicator 1300 is used, only one pair may be used to trigger the audible and / or indicator 1300. Other pairs may or may not be present to provide rotational symmetry, for example, to the plunger 1000, in particular to the shaft 1010. Alternatively, only one inward-facing rib may be used on the flexible support arm 1241 or the flexible mounting support arm 1241. In this case, only one notch may be used that interacts with a single radially inward-facing rib on the support arm 1241. Further notches may be located on the other side of the shaft 1010. Alternatively, only one notch may be used.

[0437] The notches 1020a, 1020b, 1022a, and 1022b may be longitudinally extending notches (slots). For example, to prevent the use of a slider, the inclination of the sides of a pair of first notches may differ from the inclination of the sides of a pair of second notches.

[0438] The features of plunger 1000 described above can enable multiple functions. Therefore, plunger 1000 can be a multifunctional part of drug delivery device 100, especially if all functions are realized. As will be explained below with reference to Figures 10K to 10M, synergistic technical effects may exist from combining these functions, especially when further functions are considered.

[0439] Figure 10K shows a distal view of the plunger 1000 according to a second embodiment. The plunger 1000 may preferably include at least one identification mark 1080 comprising 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 distal opposing surface 1014 of the shaft 1010.

[0440] The plunger 1000 may include at least two, at least three, or at least four identification marks 1080.1 to 1080.4 on the distal surface 1014 of the shaft 1010, preferably on the distal surface 1014 which is outwardly bounded by the distal end of the shaft 1010 and inwardly bounded by the proximal portion of the tip portion 1012 of the plunger 1000.

[0441] In this embodiment, four marks 1080.1 to 1080.4 are arranged on the annular surface 1016. The four marks 1080.1 to 1080.4 may have equidistant spaces between marks that are angularly adjacent to each other. The identifier "600X" may be indicated by marks 1080.1 to 1080.4 to indicate, for example, a special mold and / or a special mold set (e.g., for all parts of the drug delivery device 100) and / or a special cavity within the mold. The value of the identifier "600X" may, to give just one example, indicate that a sixth cavity was used to produce that part.

[0442] At least one additional marking 1082 may be placed on other parts, for example, on the drive spring holder 1200, and in particular on the base 1202 of the drive spring holder 1200. The same value or the same marking may be used on several parts of the same drug delivery device 100 to indicate that a dedicated cavity and / or mold was used to produce the parts of the drug delivery device 100 (see, for example, the marking "600X"). Thus, it is optional to combine only parts produced in the sixth cavity of a mold of a dedicated mold set, for example. Alternatively, to give a further example, a plunger 1000 produced in the first cavity of a plurality of cavities for producing the plunger 1000 can always be combined with a drive spring holder 1200 produced in the second cavity of a plurality of cavities for producing the drive spring holder 1200.

[0443] Using markings can enable better production control, such as better statistical control, compared to, for example, randomly assembling parts within a single drug delivery device. Specific molds, such as a mold dedicated to a plunger and another mold dedicated to a different part, may be used for a particular part. Alternatively, different types of parts, such as the plunger 1000 and the drive spring holder 1200 or other parts of the drug delivery device, may be produced within a single mold.

[0444] The method for marking a plunger, for example, plunger 1000, is: - To provide a mold for producing at least one plunger 1000 or more plungers 1000, wherein the mold may include at least one cavity for producing at least one plunger 1000 or each cavity for producing more plungers 1000. - Marking at least one cavity by using at least one groove or projection to print at least one letter, number or other symbol, preferably different marks 1080.1 to 1080.4 for different cavities, preferably, at least a portion of the marks 1080.1 to 1080.4 indicates or is an identifier of the mold and / or cavity, or at least one mark includes an identifier of the mold and / or cavity of the mold. - Use a mold to produce at least one plunger 1000, - Preferably, tracing the mold and / or cavity used to produce at least one plunger 1000 of the produced plunger 1000, for example as part of a quality control method, preferably including storing digital data related to marks or markings. It may include.

[0445] Interchangeable inserts may be used to facilitate the manufacture of molds and markings, and / or to change markings in an easy manner as needed, or to omit markings as appropriate.

[0446] For marking devices (any mechanically operating devices, housings, etc.), particularly for marking parts of drug delivery devices 100, - Preferably, to provide at least two molds for producing at least two different components of the drug delivery device 100, including the plunger 1000, wherein each mold may include at least one cavity for producing at least one of each component. - Marking at least one cavity by using at least one of grooves and protrusions to print at least one letter, number or other symbol on at least one part, preferably different marks 1080.1, 1080.4 for different cavities and / or different marks 1080.1, 1080.4 for different molds, preferably, at least a portion of each mark 1080.1, 1080.4 may indicate or may be a mold identifier, or at least one mark may include an identifier for the mold and / or the mold cavity. - Using a mold to produce at least one drug delivery device 100, - Assembling the drug delivery device 100, - Preferably, trace the mold and / or cavity used to produce at least one of the generated devices 100 as part of a quality control method, thereby preferably storing digital data related to the marking or marking. Similar methods, including those mentioned above, may be used.

[0447] Figure 10K shows a preferred tool splitting plane (TPP), i.e., a plane in which 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 located on the distal surface 1014 of the plunger tip 1012 or at any other suitable location on the plunger 1000.

[0448] In an alternative embodiment, additional marks may be placed on the distal surface 1014 of the plunger tip 1012, for example, if the injection point is not located on this distal surface 1014. According to a further embodiment, at least one mark may be placed on the distal surface of the plunger tip 1012, but not on the annular surface 1016.

[0449] Figure 10L shows a cross-sectional view of the plunger 1000 along the radial direction RD passing through the shaft 1010 according to the second embodiment. The circumferential direction CD is also shown in Figure 10L.

[0450] Furthermore, optionally, as described above, the interaction feature IF may consist of or include an elongated cavity 1059 within the shaft 1010. The elongated cavity 1059 may be configured to interact with the drive spring 1100, preferably with a compression spring. Furthermore, the elongated cavity 1059 may be configured to hold a spring support arm / pin 1230 (see, for example, Figure 12A).

[0451] The plunger 1000 may include at least two, at least three, or at least four inner ribs 1060.1 to 1060.4 extending along at least one-quarter, one-half, or three-quarters of the elongated cavity 1059 or along the entire axial length. At least two ribs 1060.1 to 1060.4 may be positioned at equidistant angular positions from adjacent ribs 1060.1 to 1060.4. In the illustrated embodiment, four inner ribs 1060.1 to 1060.4 are positioned inside the shaft 1010. The proximal end of rib 1060.1 may be positioned between notches 1020a and 1020b or at another suitable location. The proximal end of rib 1060.3 may be positioned between notches 1022a and 1022b or at another suitable location. All inner ribs may form a group of inner ribs 1060.

[0452] The lateral opening 1052.2a is - A strongly inclined surface 1055, - A surface 1056 that is moderately inclined relative to the inclination angle of the inclined surface 1055, - Side 1057 (not shown in Figure 10L; see, for example, Figure 10J), and - Side 1058 It may include.

[0453] The radial RD may be used to define the inclination angles of the inclined surfaces 1055 and 1056, thereby the radial direction being used at the inner boundary or edge of each of the inclined surfaces 1055 and 1056.

[0454] The arrangement of faces 1055 and 1056, as is evident in Figure 10L considering the tool (mold) splitting plane TPP, may allow the use of mold components to form the lateral opening 1052.2a without additional sliders, for example, both faces 1055 and 1056 can be produced without causing undercuts with respect to the tool closing and tool opening directions perpendicular to the tool (mold) splitting plane TPP. This is possible even if each mold component has rounded features that interact with mold pins or mold rods used to define or form the inner cavity 1059. The same may apply to sides 1057 and 1058. However, the use of additional sliders is also possible, for example, if the tool (mold) splitting plane TPP is located elsewhere.

[0455] Preferably, all other lateral openings, such as 1052.1a, 1052.1b, and 1052.2b, may have the same features as lateral opening 1052.2a.

[0456] Figure 10M shows a cross-sectional view of the plunger 1000 along its longitudinal direction through the shaft 1010.

[0457] The plunger 1000, for example, the shaft 1010, may include at least one or all of the following features in a cross-section from the proximal end 1011p to the distal end 1011d, preferably in the order described, and particularly inside the shaft 1010. - Preferably a first rounded edge portion 1074, - Preferably, an inclined surface 1075 that is inclined with respect to the outer surface 1071 and / or inner main surface 1077 of the shaft 1010, - Preferably a second rounded edge portion 1076, and / or - Plunger 1000, more specifically the inner surface 1077 of shaft 1010.

[0458] In particular, the inclined surface 1075 can have a significant impact on the generation of noise sound wave components that occur when the drive spring 1100 is released. The inclination angle of the inclined surface 1075 with respect to the longitudinal axis or the outer surface 1071 may be in the range of 30 to 60 degrees, so as to generate noise containing a small number of noise components, thereby making it comfortable for the user.

[0459] Furthermore, it has the following features: - Outer surface 1071 of shaft 1010, - The outer edge portion 1072 of the shaft 1010, and - Proximal surface 1073 oriented towards the proximal side This is shown.

[0460] Additionally or alternatively, the radii of the first rounded edge 1074 and the second rounded edge 1076 may have an effect on noise generation. Therefore, edges 1074 and / or edges 1076 may preferably have a smaller curvature, for example, a larger radius, compared to the radii of other edges of the shaft 1010, such as edges 1072 and / or edges 1074.

[0461] The drug delivery device 100 is - A plunger 1000 as described in any one of the embodiments described above, - A drug container, particularly a pre-filled syringe 900 or a holding space configured to hold a drug container (e.g., syringe 900), wherein the drug container (900) is capable of storing a drug (Dr, M) or can be configured to store a drug (Dr, M), and It may include.

[0462] The rear subassembly (RSA) (see, for example, Figure 13I) is: - A drive spring holder (1200) configured to hold the drive spring (1100), - Drive spring (1100), - A plunger (1000) as described in any one of the embodiments described above and It may include.

[0463] Therefore, the effects described above may also apply to the drug delivery device 100 or the rear subassembly (RSA).

[0464] Neither the plunger 1000 according to the first embodiment (see, for example, Figure 10) nor the plunger 1000 according to the second embodiment contains threads. Therefore, production is not as complicated as production of plungers that also contain at least one thread or a reverse thread.

[0465] 11. Drive spring (Figures 11A-11C) Figure 11A shows the drive spring 1100. The drive spring 1100 may be configured, as described in sections 10 and 12, to provide an actuation force to the plunger 1000 to move the plunger 1000 distally to the syringe 900 (not shown) when, for example, the first plunger boss 1040.1 of the plunger 1000 disengages from the profiled slot 1221.1 of the drive spring holder 1200.

[0466] The spring mechanism may provide the force to empty the syringe 900. In particular, the spring mechanism may include a drive spring 1100 that can interact with the plunger 1000 and cause distal movement of the plunger 1000 relative to the device body 700 and / or the drive spring holder 1200 and / or the syringe 900. This may cause distal movement of the plunger stopper 910 within the syringe 900 when the plunger 1000 comes into contact with the stopper 910. Thus, the drug can be discharged from the barrel 902 of the syringe 900. In other words, the drive spring 1100 may provide the force for discharging and injecting the drug.

[0467] As shown in Figures 11B and 11C, the drive spring 1100 may surround the drive spring support arm / pin 1230 of the drive spring holder 1200 and may extend distally D from the base 1201 of the drive spring holder 1200. The distal end of the drive spring 1100 may abut against the proximal opposing inner surface of the plunger 1000. In other words, the drive spring 1100 may be configured to extend into the interior of the plunger 1000.

[0468] The drive spring support arm / pin 1230 may have an essentially circular cross-section or a circular cross-section. Preferably, at least two longitudinal guide ribs may be arranged along the outer surface of the drive spring support arm / pin 1230. The longitudinal guide ribs may be configured to support the drive spring 1100 against radially inward movement. Preferably, there may be at least two ribs, at least three ribs, or at least four ribs arranged equidistantly around the drive spring support arm / pin 1230.

[0469] Inside the plunger 1000, the drive spring 1100 may be guided by at least one inner rib of the plunger 1000, which is formed on the inner surface of the plunger shaft 1010 and extends in the axial / longitudinal direction of the plunger 1000. In one embodiment, the drive spring 1100 may be guided inside the plunger 1000 by at least four of the above inner ribs. The inner ribs may be arranged equidistantly around the inner circumference of the plunger shaft 1010. The inner ribs may extend along at least a portion of the axial length of the plunger shaft 1010, preferably along the entire axial length of the plunger shaft 1010. Alternatively, the inner ribs may have different angular offsets between them. In one embodiment, the inner ribs may extend from the inclined surface 1075 of the plunger 1000 to the inner distal surface of the plunger 1000. Further details are described, for example, in Section 10.

[0470] In one embodiment, the drive spring 1100 may be made of high-strength stainless steel. For example, the drive spring 1100 may be made of austenitic steel having sufficient elastic properties to allow elastic compression of the drive spring 1100. In one embodiment, the drive spring 1100 may be made of austenitic chromium-nickel steel. In one embodiment, the drive spring 1100 may be made of DIN EN1.4310 steel.

[0471] In one embodiment, the drive spring 1100 may be made of a coiled wire. The wire diameter may be selected according to the stress generated when the drive spring 1100 is compressed, for example, when fully compressed, before the drug delivery device 100 is activated. In one embodiment, the wire may be a soap-lubricated wire to aid in manufacturability.

[0472] In one embodiment, the drive spring 1100 may have 10 to 150 coils or windings. In one embodiment, the drive spring 1100 may have 20 to 120 coils or windings. In one embodiment, the drive spring 1100 may have 40 to 100 coils or windings, for example, 80 coils or windings.

[0473] The coil diameter can be selected according to the shape of the plunger 1000 and the drive spring support arm / pin 1230 of the drive spring holder 1200.

[0474] In one embodiment, the inner diameter of the drive spring 1100 (inner diameter of the coil) may be 1.5 mm to 6 mm, preferably 2.0 mm to 4.0 mm, for example, 2.5 mm.

[0475] In one embodiment, the outer diameter (outer diameter of the coil) of the drive spring 1100 may be 2.0 mm to 8.0 mm, preferably 3.0 mm to 6.0 mm, for example, 4.0 mm.

[0476] The length of the drive spring 1100 and / or the wire diameter of the wire wound to form the drive spring 1100 and / or the number of coils may be selected to allow for easy assembly while ensuring the drive spring provides a flat force profile. In other words, the details of the drive spring 1100 may be adapted to minimize the impact load at the start of injection and / or to minimize the forces acting on the support device components during storage.

[0477] Furthermore, the details of the drive spring 1100 can be adapted so that the drive spring 1100 provides sufficient starting force to meet injection time requirements. Such requirements may include the ability to empty the syringe 900 in less than 30 seconds, preferably less than 20 seconds. In one embodiment, a preferred injection time requirement may be less than 15 seconds. Furthermore, the details of the drive spring 1100 can be selected according to force requirements, such as the maximum operating force that can be applied to the plunger.

[0478] In one embodiment, in the unbiased state, the drive spring 1100 may have a length of 50 mm to 200 mm, preferably 100 mm to 200 mm, for example, 110 mm.

[0479] In one embodiment, the drive spring 1100 may be configured to provide an operating force of 2N (Newtons) to 60N depending on its compression state. In one embodiment, the drive spring 1100 may be configured to provide an operating force of 3N to 50N, preferably 3N to 40N, depending on its compression state. In one embodiment, the drive spring 1100 may be configured to provide an operating force of 3N to 24N depending on its compression state.

[0480] 12. Drive spring holder (Figures 12A to 12G) Figures 12A and 12B show the drive spring holder 1200. The drive spring holder 1200 may be configured to support the drive spring 1100 and plunger 1000 relative to the device body 700. The drive spring holder 1200 may be configured to withstand the load of the drive spring 1100 before priming of the plunger 1000, for example, during storage of the rear subassembly (RSA). The drive spring holder 1200 may further be configured to compensate for variations in the length of the syringe 900 and to prevent proximal movement of the syringe 900 within the drug delivery device 100. The drive spring holder 1200 may further be configured to support an audible indicator and / or a tactile indicator, such as a clicker 1300 (not shown), as described below.

[0481] The drive spring holder 1200 may have a base 1201 at its proximal end that defines a proximal end surface 1201.1 that can define the proximal (rear) end face of the drug delivery device 100 in its assembled state.

[0482] The drive spring holder 1200 may further include one or more syringe support arms 1202 extending distally from the base 1201 (opposite to the proximal direction indicated by arrow P). The syringe support arms 1202 may be positioned radially inward of the device body 700 when the drive spring holder 1200 is assembled with the device body 700. The syringe support arms 1202 may be rigid so as not to deform due to forces generated during assembly, use, or accidental dropping of the drug delivery device 100.

[0483] The base 1201 may have a diameter similar to or larger than the outer diameter of the proximal end of the device body 700, so that the base 1201 of the drive spring holder 1200 cannot move distally within the device body 700. In other words, the base 1201 of the drive spring holder 1200 may come into contact with the edge 732 of the proximal aperture 730 of the device body 700 when the drive spring holder 1200 is moved distally within the device body 700.

[0484] The drive spring holder 1200 may further include a case lock formed by one or more deflectable snap arms 1203. The snap arms 1203 may be located distal to the base 1201 at the proximal end of the drive spring holder 1200. As shown in Figure 12D, the snap arms 1203 may include a flexible portion 1203.1 extending axially, for example proximal, of the drug delivery device 100. Alternatively, the flexible portion 1203.1 may extend axially and radially such that it may have a radially outward inclination in the proximal direction. The case snap arms 1203 may further include a snap projection 1203.2 projecting radially outward from the flexible portion 1203.1. The snap arm 1203 may be pre-tensioned, i.e., biased outward, so that when the drive spring holder 1200 is assembled into the device body 700 (not shown), and the drive spring holder 1200 is moved distally inside the device body 700, tension is initially applied to the snap arm 1203 by an inward deflection caused by contact with the inner surface of the device body 700. When aligned with the proximal notch 714 of the device body 700, the snap arm 1203 returns to its relaxed state, thereby moving the snap projection 1203.2 radially outward to engage with or latch to the proximal notch 714 in order to securely fix the drive spring holder 1200 to the device body 700 in the first drive spring holder position (closed position). In other words, the snap arm 1203 may be configured to form a snap-fit ​​connection with the notch 714. In the first drive spring holder position, the axial movement of the drive spring holder 1200 relative to the device body 700 can be limited / prevented by the interaction between the snap projection 1203.2 and the proximal notch 714. Furthermore, in the first drive spring holder position, the rotational movement of the drive spring holder 120 relative to the device body 700 can be limited / prevented.

[0485] 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 radially support the drive spring 1100 and plunger 1000. In other words, the drive spring support pin 1230 centers the drive spring 1100 and / or plunger 1000 relative to the drive spring holder 1200 during assembly and before the drug delivery device 100 is activated. For example, there may be at least two, at least three, or at least four longitudinal ribs arranged on the outer surface of the drive spring support pin 1230. The longitudinal ribs may be arranged equidistant in the circumferential direction. The longitudinal ribs can support the drive spring 1100 and / or plunger 1000 against radially inward movement relative to the drive spring support pin 1230.

[0486] After the drug delivery device 100 is activated (or triggered), i.e., when the plunger 1000 is disengaged from the profiled slot 1221.1 of the drive spring holder 1200 as described in Section 10 above, the drive spring support arm / pin 1230 may be configured to guide the axial movement of the drive spring 1100 and the plunger 1000. The arm / pin 1230 may extend from the base 1201 along at least a portion of the axial length of the drive spring holder 1200, for example, along at least 50 percent or at least 70 percent of the axial length of the drive spring holder 1200.

[0487] In one embodiment, the drive spring support arm / pin 1230 may have a cylindrical shape along the axial direction. Alternatively, or in addition, the drive spring support arm / pin 1230 may have a conical shape along the axial direction. In particular, the outer diameter of the pin 1230 may decrease distally, for example, to allow release from the mold.

[0488] In one embodiment, the drive spring support arm / pin 1230 may be configured to guide the drive spring 1100 and / or plunger 1000 during assembly and / or use, i.e., when the drive spring 1100 is released.

[0489] In one embodiment, the profiled slot 1221.1 may be formed distal to the base 1201 at the proximal end of at least one syringe support arm 1202. The profiled slot 1221.1 may be formed circumferentially adjacent to at least one snap arm 1203 (see Figures 12A and 12B). Thus, the profiled slot 1221.1 and the snap arm 1203 may overlap at least partially axially. The profiled slot 1221.1 may be configured to interact with the plunger 1000 when the plunger is connected to the drive spring holder, as described in this disclosure.

[0490] The drive spring holder 1200 may include longitudinal ribs 1236, as shown in Figures 12A and 12B, for interaction with the plunger 1000, as described in Section 10 above.

[0491] As shown in Figures 12A and 12B, the drive spring holder 1200 may further include a clicker support structure 1240. The clicker support structure 1240 may be positioned on at least one of the syringe support arms 1202. The clicker support structure 1240 may be positioned offset distally from the profiled slot 1221.1. The clicker support structure 1240 may define a recess into which a clicker 1300 (not shown) may be inserted, as described below, for example, in Section 13.

[0492] In one embodiment, the clicker support structure 1240 may include a clicker support arm 1241, at least one clicker tab restraint portion 1242, and a clicker rear support portion 1243 (see Figures 12A and 12B).

[0493] In one embodiment, the clicker support structure 1240 may further include at least one clicker mounting groove 1244.

[0494] The clicker support structure 1240 is configured to support the clicker 1300, and when the plunger 1000 overlaps the clicker support arm 1241 and the drive spring support arm 1230 in the axial direction, it can support the clicker 1300 in a radially outward direction.

[0495] The clicker support arm 1241 may preferably be flexible and / or elastic and / or deflectable and / or movable substantially radially of the drive spring holder 1200. The clicker support arm 1241 may be positioned at the distal end of the clicker support structure 1240, distal to the clicker rear support portion 1243 and the clicker tab restraint portion 1242.

[0496] The clicker support arm 1241 may include at least one outward-facing ramp-shaped projection 1241.1. The outward-facing ramp-shaped projection 1241.1 may extend radially outward from a radially outward-facing opposing surface of the syringe support arm 1202. The ramp-shaped projection 1241.1 may have a radially outward inclination in the distal direction D. In one embodiment, the outward-facing ramp-shaped projection 1241.1 may include two outward-facing ramps / ribs, with a recess between the two outward-facing ramps / ribs.

[0497] The clicker support arm 1241 may further include at least one inward-facing ramp-shaped projection 1241.2 (see Figures 12A and 12B). The inward-facing ramp-shaped projection 1241.2 may extend radially inward from the inward-facing opposing surface of the syringe support arm 1202. The ramp-shaped projection 1241.2 may have a radially inward inclination in the distal direction D. In one embodiment, the inward-facing ramp-shaped projection 1241.2 may include two inward-facing ramps / ribs with a recess between the two inward-facing ramps / ribs.

[0498] The clicker support arm 1241 can be radially supported by the outer surface of the plunger 1000, for example, insofar as there is an axial overlap between these components, and can be held in a radial position. In particular, the inward-facing ramp-shaped projection 1241.2 can abut against the outer surface of the plunger 1000 so as to restrict, preferably prevent, radially inward movement of the flexible support arm 1241.

[0499] After the proximal end or notches 1020, 1022 of the plunger 1000 pass the inwardly curved projections 1241.2, and for example, after the plunger 1000 has disengaged from the contact surface 507b and moved distally, the clicker support arm 1241 may deflect and / or move radially inward, thereby no longer supporting the clicker 1300 in the radially outward direction. Thus, the clicker 1300 may return to its relaxed state (S1), as outlined in Section 13 below, thereby generating an audible and / or tactile signal indicating the completion of drug Dr, M delivery.

[0500] In one embodiment, the inwardly curved projection 1241.2 may be complementary to the notches / slots 1020, 1022 of the plunger 1000. In this embodiment, the clicker support arm 1241 may be deflected and / or moved radially inward when the notches 1020, 1022 are aligned with the curved projection 1241.2. This may reduce the distal movement required of the plunger 1000 relative to the drive spring holder 1200. Furthermore, different plunger lengths 1000 may be used with different drug delivery devices 100 without changing the trigger mechanism of the clicker 1300. The length of the plunger may determine the amount of drug Dr,M discharged during drug infusion.

[0501] In one embodiment, the clicker rear support 1243 may be positioned offset proximal to the clicker support arm 1241 and at least one clicker tab restraint 1242. The clicker rear support 1243 may include one or more ramp-like projections extending radially outward from the outer surface of the drive spring holder 1200, preferably from the bottom surface of the support arm 1202, for example, the upper support arm 1202 that supports the audible indicator 1300 (clicker) as shown in Figure 12A. One or more ramp-like projections may have a radially outward inclination in the proximal direction P. The clicker rear support 1243 may be configured to support the proximal section of the clicker 1300 radially outward when the audible indicator 1300 is biased and / or during assembly / priming of the audible indicator 1300. This will be described in more detail in Section 13 below.

[0502] The clicker support structure 1240 shown in Figures 12A and 12B may include two clicker tab restraints 1242. The clicker tab restraints 1242 may be configured to engage with the support tabs 1303a and 1303b (see, for example, Figure 13A) of the elastic force member 1301 (see, for example, Figure 13A) of the clicker 1300 (see, for example, F...

Claims

1. A device body (700) for a drug delivery device (100), A needle cover positioning structure (720, 724) is configured to fix the needle cover (500) of a drug delivery device to axial movement relative to the device body (700) by interacting with at least one corresponding fixing feature portion (505, 510) of the needle cover (500) when the needle cover (500) is in the needle cover position (Z) relative to the device body (700). Includes, It has a proximal end and a distal end, At the needle cover position (Z), the needle cover (500) protrudes distally beyond the device body (700). The device body (700) further includes a first needle cover safety structure (720.1) configured and positioned to prevent separation of the fixed feature portion (505, 510) and the needle cover positioning structure (720, 724) by interacting with the outer surface of the needle cover (500) when the portion of the device body (700) on which the needle cover positioning structure (720, 724) is located is deformed.

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

3. The device body (700) according to claim 2, wherein the radial inward extension of the projection decreases in the proximal direction (P) along the axial extension of the projection.

4. The first needle cover safety structure (720.1) extends axially from the proximal end of the needle cover positioning structure (720, 724) in the proximal direction (P), and is the device body (700) according to any one of claims 1 to 3.

5. The device body (700) according to any one of claims 1 to 4, wherein the portion of the device body (700) is the distal portion of the device body (700).

6. The device body (700) according to any one of claims 1 to 5, wherein the first needle cover safety structure (720.1) is configured to restrict the radial movement of the outer surface of the needle cover (500) relative to the inner surface of the device body (700).

7. The device body (700) according to any one of claims 1 to 6, wherein the needle cover positioning structure (720, 724) includes at least one, preferably at least four, ribs extending radially inward from the inner surface of the device body (700), for example, the side wall.

8. The device body (700) according to any one of claims 1 to 7, further comprising at least one proximal stopper structure (721) that interacts with a rear stopper feature of the needle cover (500) to determine the maximum proximal position of the needle cover (500) relative to the device body (700) when the needle cover (500) is moved in a proximal direction relative to the device body (700).

9. The device body (700) according to any one of claims 1 to 8, further comprising a central support structure (701) configured to support a drug container (900), for example, a pre-filled syringe (900) and / or a container holder (800), for example, a syringe holder (800).

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

11. The device body (700) according to claim 10, wherein the radially inner portion of the connecting element (708) is shorter in the axial direction than the radially outer portion of the connecting element (708), and as a result, at least the distal surface of the radially outer portion protrudes distally beyond the distal surface of the radially inner portion.

12. A device body (700) according to any one of claims 1 to 11, further comprising a holder guide structure (726), for example, at least one holder guide rib (726), preferably four holder guide ribs (726), configured to interact with the container holder (800) and / or the body closure (1200) of the drug delivery device (100) to restrict the rotational movement of the container holder (800) and / or the body closure (1200) relative to the device body (700).

13. The device body (700) according to claim 12, further comprising a needle cover rotation prevention structure (723) configured to prevent the rotation of the needle cover (500) relative to the device body (700) by interaction with the rotation prevention feature portion of the needle cover (500).

14. The device body (700) according to claim 13, wherein the needle cover rotation prevention structure (723) includes projections extending circumferentially and radially from at least one of the connecting elements (708), thereby forming an anti-rotation surface for interacting with the anti-rotation feature portion of the needle cover (500).

15. The device body (700) according to claim 13 or 14, further comprising a second needle cover safety structure (722) configured and positioned to prevent the rotation-preventing feature from detaching from the rotation-preventing structure (723) by interacting with the inner surface of the needle cover (500).

16. The device body (700) according to any one of claims 1 to 15, wherein the needle cover position is the first or last needle cover position.

17. An assembly for a drug delivery device, A device body (700) according to any one of claims 1 to 16, Needle cover (500) and Needle cover spring (600) and An assembly that includes this.

18. A device body (700) according to any one of claims 1 to 16 or an assembly according to claim 17, A drug container (900) for containing the drug (Dr) and A drug delivery device (100) including the drug.

19. A drug delivery device (100) according to claim 18, which is an auto-injector and / or a pen-type device.

20. A method for delivering a drug from a drug delivery device, comprising using the drug delivery device (100) according to claim 18 or 19.

21. A drug for use in a method of treating a patient, the method comprising delivering the drug to the patient using a drug delivery device (100) according to claim 18 or 19.

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