Drug delivery device

Abstract

A drug delivery device is provided, comprising a housing, a drug storage container, and a removable cap. The housing includes a housing cam-action feature and a longitudinal axis, and includes an opening. The drug storage container includes a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The removable cap defines a cap cam-action feature and is configured to be removably coupled to the housing, such that the removable cap has a storage position and a removal position, in which the removable cap is coupled to the housing and at least partially covers the opening, and in which the removable cap is not coupled to the housing. The cap cam-action feature and the housing cam-action feature are configured to convert rotational motion into axial motion, such that during rotational movement of the removable cap, the cap cam-action feature and / or the housing cam-action feature pushes the removable cap along the longitudinal axis. The housing cam-action feature and the cap cam-action feature are each visible to a user of the drug delivery device to indicate the cam-action function of the housing cam-action feature and the cap cam-action feature by signaling.

Description

[Technical Field]

[0001] This disclosure relates to drug delivery devices, and more particularly to devices for automatically injecting drugs into a patient. [Previous Technology]

[0002] The widespread aversion to exposed needles, along with health and safety concerns, has spurred the development of drug delivery devices that conceal the needle or other insertion components before use and automate various aspects of the injection process. Such devices offer several advantages compared to conventional forms of drug delivery, including, for example, delivery via conventional syringes.

[0003] The drug delivery device can incorporate various mechanisms to achieve a variety of automated features. Such features may include automatically covering the needle before and / or after delivery, automatically inserting the needle and / or cannula into the patient, automatically activating the drive mechanism, automatically instructing the user to complete drug delivery, and other features. The device may also include additional needle covering features, such as a removable cap used when the device is in a stored state. The removable cap can be removed manually by the user, which may require a minimum size and / or a removal force in a specific direction.

[0004] Additionally, some users may not be familiar with all the features or functions of the drug delivery device. For example, some users may not easily understand that the cap should be removed before use or how the cap can / should be removed.

[0005] This disclosure describes drug delivery devices that embody advantageous alternatives to existing drug delivery devices and feature removable cap removal, and can address one or more of the challenges or needs mentioned herein. [Summary of the Invention]

[0006] One aspect of this disclosure provides a drug delivery device including a housing, a drug storage container, and a removable cap. The housing may include a housing cam-action feature and a longitudinal axis, and includes an opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The removable cap may define a cap cam-action feature and is configured to be removably coupled to the housing such that the removable cap has a storage position and a removal position, in which the removable cap is coupled to the housing and at least partially covers the opening, and in which the removable cap is not coupled to the housing. The cap cam-action feature and the housing cam-action feature are configured to convert rotational motion into axial motion, such that during rotational movement of the removable cap, the cap cam-action feature and / or the housing cam-action feature pushes the removable cap along the longitudinal axis. The housing cam-action feature and the cap cam-action feature are each visible to a user of the drug delivery device to signal the cam-action function of the housing cam-action feature and / or the cap cam-action feature.

[0007] The cover cam function may define a wavy shape. The removable cover may include a generally cylindrical body portion defining an annular front edge and an end wall generally perpendicular to the body portion, wherein the annular front edge defines a wavy shape. The annular front edge may define two wavy shapes.

[0008] The housing may define a generally cylindrical outer surface, and the housing cam-action feature may include a protrusion extending away from the generally cylindrical outer surface. When the removable cover is in the storage position, the protrusion may be aligned with the wavy shape of the cover cam-action feature. When the removable cover is in the storage position, the protrusion may abut against the wavy shape of the cover cam-action feature. The protrusion may define a wavy surface corresponding to the wavy shape of the cover cam-action feature.

[0009] The housing may include two protrusions, each extending away from a generally cylindrical outer surface. The housing cam-action feature and the cover cam-action feature may each be defined or positioned on the outer surface of the drug delivery device.

[0010] The housing cam function features and / or cover cam function features may include aspects for improving their visibility. For example, aspects for improving visibility may include bright colors.

[0011] The removable cover may include at least one rotational aid feature, such as fins.

[0012] Another aspect of this disclosure provides a drug delivery device including a housing, a drug storage container, and a removable cap. The housing may include a housing cam-action feature and a longitudinal axis, and includes an opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The removable cap may define a cap cam-action feature and is configured to be removably coupled to the housing, such that the removable cap has a storage position and a removal position, in which the removable cap is coupled to the housing and at least partially covers the opening, and in the removal position, the removable cap is not coupled to the housing. The cap cam-action feature and the housing cam-action feature are configured to convert rotational motion into axial motion, such that during rotational movement of the removable cap, the cap cam-action feature and / or the housing cam-action feature push the removable cap along the longitudinal axis. The housing cam-action feature and the cap cam-action feature may each be defined or positioned on an outer surface of the drug delivery device to signal the cam-action function of the housing cam-action feature and / or the cap cam-action feature.

Implementation Method

[0029] Cross-reference to related applications

[0030] This application claims priority to U.S. Provisional Patent Application No. 63 / 159,335, filed March 10, 2021, the entire contents of which are expressly incorporated herein by reference.

[0031] This disclosure generally relates to a drug delivery device that can be operated by a user to administer a drug or, in the case of a patient-user, to administer a drug independently. The device includes a housing having a housing cam-action feature and a longitudinal axis, and includes an opening. The device also includes a removable cover having a cover cam-action feature and configured to be removably coupled to the housing such that the removable cover has a storage position and a removal position, in which the removable cover is coupled to the housing and at least partially covers the opening, and in the removal position, the removable cover is not coupled to the housing. The cover cam-action feature and the housing cam-action feature are configured to convert rotational motion into axial motion, such that during rotational movement of the removable cover, the cover cam-action feature and / or the housing cam-action feature pushes the removable cover along the longitudinal axis. The housing cam-action feature and the cover cam-action feature are each visible to the user of the drug delivery device to indicate the cam-action function of the housing cam-action feature and the cover cam-action feature by signaling.

[0032] Several views of an embodiment of a drug delivery device 10 for delivery of a drug may also be referred to herein as an agent or a drug product. Drugs may be, but are not limited to, various biological agents, such as peptides, peptidomes, or antibodies. Drugs may be in fluid or liquid form, but the contents of this disclosure are not limited to specific states.

[0033] Various implementations and configurations of the drug delivery device 10 are possible. The current embodiment of the drug delivery device 10 is configured as a single-use disposable syringe. In other embodiments, the drug delivery device 10 may be configured as a reusable syringe for multiple uses. The drug delivery device 10 can be operated for patient self-administration or by a caregiver or a formally trained health care provider (e.g., a physician or nurse). The exemplary drug delivery device shown in the accompanying figures may take the form of an auto-injector or pen-type syringe and, therefore, may be held in the user's hand for the duration of the drug delivery, but may or alternatively be applicable to other drug delivery devices and / or configurations.

[0034] The configuration of various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10 . The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state can have several substates or stages. The storage state may correspond to the configuration of the drug delivery device 10 in FIGS. In some embodiments, a state of storage may be present during the time between when the drug delivery device 10 leaves the manufacturing plant and when the lid is removed by the patient or user. The pre-delivery stage may correspond to a configuration of the drug delivery device 10 after the removable cover has been removed but before the user activates the device. This may include moments after the user has removed the removable cover, when the user first positions the drug delivery device 10 against the injection site, but before the start of administration. The delivery state may correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is in progress. The post-delivery state may correspond to the configuration of the drug delivery device 10 after the completion of drug delivery and / or when the stopper is arranged at the end of administration position in the drug storage container.

[0035] As shown in Figures 1 to 5, the drug delivery device 10 includes a housing or casing 12. In some embodiments, the size and dimensions of the casing 12 may be configured to allow a person to grasp the syringe 10 with one hand. The casing 12 may have a generally elongated shape, such as a cylindrical shape, and extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (Figure 5) may be formed in the distal end to allow the insertion end 28 of the delivery member 16 to extend outside the casing 12. A transparent or translucent inspection window 17 may be positioned in the wall of the casing 12 to allow a user to view the components inside the drug delivery device 10, including the drug storage container 20. Viewing the drug storage container 20 through the window 17 allows the user to confirm that drug delivery is in progress and / or has been completed. The removable cap 19 can cover the opening 14 at the distal end of the device before use of the drug delivery device 10, and in some embodiments, may include a gripper 13 (FIG. 5) configured to remove a sterile barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) mounted on the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally engage or otherwise mechanically engage the sterile barrier 21 to pull the sterile barrier 21 with the removable cap 19 as the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0036] The device may include a drive mechanism configured to store energy and, when or in response to a user activating the drive mechanism, release or output the energy to drive a plunger to expel the drug from the drug storage container 20 through the delivery member 16 into the patient.

[0037] As best shown in Figures 1 and 2, in one embodiment, the housing 12 may include two separate and interconnected structures: a rear end cap 23 (e.g., a rear cover) at the proximal end of the drug delivery device 10; and a tubular housing 25 that extends substantially entirely along the length of the drug delivery device 10 and defines an opening 14. Alternatively or additionally, the housing 12 may include fewer or more components, such as a two-piece tubular housing having a front portion and a rear portion. The tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical shape or a hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25, as well as any components positioned therein, may be assembled together to define different sub-assemblies. In alternative embodiments, the housing 12 may be constructed as a single piece, such that the housing 12 is defined by a single integral structure integrating the rear end cap and the tubular housing into a single component.

[0038] The drug storage container 20 is disposed within the internal space of the housing 12 and configured to contain a drug. The drug storage container 20 may be pre-filled and, for example, transported by the manufacturer to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be dispensed and / or provided to a patient in more than one use case, such as as a pre-filled syringe or as an auto-injector including a pre-filled syringe. By utilizing the same or similar syringe components in either case, at least some of the above steps (such as filling, labeling, packaging, transporting, and dispensing) can be streamlined or simplified for two different use cases. As another example, where multiple use cases utilize some or all of the same syringe components, some administrative approaches to marketing and / or distributing the drug can be streamlined or simplified for at least one of the multiple use cases.

[0039] In some embodiments, the volume of the drug 22 included in the reservoir of the drug storage container 20 may be equal to 1 mL, or equal to about (e.g., ±10%) 1 mL, or equal to 2.5 mL, or equal to about (e.g., ±10%) 2.5 mL, or equal to 3 mL, or equal to about (e.g., ±10%) 3 mL, or less than or equal to about (e.g., ±10%) 1 mL, or less than or equal to about (e.g., ±10%) 2 mL, or less than or equal to about (e.g., ±10%) 3 mL, or less than or equal to about (e.g., ±10%) 4 mL, or less than about (e.g., ±10%) 5 mL, or less than or equal to about (e.g., ±10%) 10 mL, or in the range of about (e.g., ±10%) 1 to 10 mL, or in the range of about (e.g., ±10%) 1 to 5 mL, or in the range of about (e.g., ±10%) 1 to 4 mL. The range is between 1 and 3 mL, or between approximately (e.g., ±10%) 1 and 2.5 mL.

[0040] The delivery member 16 is connected or operatively configured to be in fluid communication with a reservoir of the drug storage container 20. A distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include other sharp tips with pointed geometries, thereby allowing the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and have internal passageways. One or more openings may be formed in the insertion end 28 to allow drug to flow from the delivery member 16 into the patient.

[0041] In one embodiment, the drug storage container 20 may be a pre-filled syringe and have a peg-type hollow metal needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In still other embodiments, the drug storage container 20 may be a needleless cartridge and therefore may not initially be in fluid communication with the delivery member 16. In such embodiments, the drug storage container 20 may be movable toward the proximal end of the delivery member 16 and vice versa during operation of the drug delivery device 10, such that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0042] The drug storage container 20 may include a body portion having a distal end 20a and a proximal end (not shown). The drug storage container 20 may be fixed relative to the housing 12 such that once installed in the housing 12, the drug storage container 20 does not move relative to the housing 12. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 in the housing 12. For example, as shown in FIG2, the delivery member 16 extends beyond the distal end of the housing 12 defining the opening 14. However, in some configurations, such as the storage configuration shown in FIG2, the delivery member 16 is covered / protected by a sterile barrier 21 and a protective member 32 that surrounds the delivery member 16 and protects against or reduces the possibility of unintentional or premature needlestick injuries.

[0043] The device may also include a container retainer 33 configured to secure the drug storage container 20 relative to the housing 12, such as by preventing distal movement of the drug storage container 20 during plunger actuation. The container retainer 33 may include a plurality of flanges 33c, each flange including an arcuate inclined surface 33a that substantially matches the arcuate shape of a shoulder portion of the drug storage container 20. As a more specific example, when the drug storage container 20 is inserted into the container retainer 33, the flanges 33c cooperate to support the shoulder portion and restrict the movement of the drug storage container 20 in the distal direction. The housing 12 may include a plurality of locking slots 12c, each locking slot receiving a corresponding flange 33c of the container retainer 33 to prevent and / or restrict relative movement between the corresponding components 12, 33. Thus, when fully assembled, the storage container 20, the container retainer 33, and the housing 12 are all substantially or completely secured relative to each other.

[0044] The device may also include a locking ring 40 configured to lock the protective member 32 in an extended position once the device has reached a certain state (such as an injection state or a post-injection state). The locking ring 40 shown in FIG5 is centered on and rotates about a longitudinal axis A. In some embodiments, the locking ring biasing member 51 may include a compression spring (e.g., a helical compression spring). The locking ring 40 may also be used to provide initial resistance to the movement of the protective member 32. For example, the initial resistance may be configured to facilitate the insertion of the delivery member 16 into the patient by using, utilizing, or otherwise utilizing inertial forces. In other words, the locking ring 40 and / or other components may provide initial resistance to the movement of the protective member 32 to accumulate the force input by the user.

[0045] These and other aspects of the operation of an exemplary drug delivery device are discussed in more detail in U.S. Application No. 17 / 035,851, filed on September 29, 2020, the entire contents of which are incorporated herein by reference.

[0046] As discussed above, the removable cap 19 may have a storage position (Figures 1, 2, and 5) and a removal position (Figure 4), in which the removable cap 19 is engaged with the housing 12, and in the removal position, the removable cap 19 is removed from the housing 12 and is not engaged with the housing. Also as discussed above, the device 10 may include a sterile barrier 21 that is removed from the delivery member 16 when the removable cap is removed from the housing 12. The sterile barrier 21 may have a relatively tight or relatively high-friction engagement with the drug storage container 20 to maintain the sterility of the delivery member 16 and / or prevent air from entering the drug storage container 20. For example, to reduce the possibility of contamination and / or blockage or evaporation of the drug, it may be desirable to prevent air from entering the drug storage container and / or the delivery member 16 or to reduce such possibility. Additionally or alternatively, it may be desirable to have a relatively tight or relatively high-friction engagement between the sterile barrier 21 and the drug storage container 20 to prevent accidental needle punctures or to reduce such possibility. For these or other reasons, a relatively tight or relatively high-friction fit between the removable cap 19 and the housing 12 may also be desired, or alternatively. The sterile barrier 21 and the removable cap 19 may also be coupled to their respective components (e.g., the drug storage container 20 and the housing 12) via other suitable features, such as connecting tabs / slots, fragile connections (e.g., perforated seals), threaded connections, or other features that achieve a relatively robust but removable connection between the respective components.

[0047] As a result of these connection forces, features, and / or other factors, some device users may experience difficulty or discomfort when removing the removable cover 19. For example, some device users may have difficulty removing the cover 19 by axial force only (along axis A). In other words, some device users may have difficulty pulling the cover 19 away from / away from the housing 12. The cover 19 shown in Figures 1 to 5 includes multiple ribs to help the user grip the surface of the cover when removing it.

[0048] The device 10 shown in Figures 1 to 5 also includes a cam action feature to convert rotational motion into axial motion, such that during rotational movement of the removable cover 19, the removable cover 19 is pushed away from the housing 12, thereby facilitating and / or making the removal of the cover 19 easier. For example, the housing 12 includes a housing cam action feature 12a and a cover cam action feature 19c. As a more specific example, in order to remove the cover 19 from the housing 12 solely by axial force / movement (e.g., "pull force"), it may be necessary for the user to apply 45 Newtons or less; approximately 40 to 45 Newtons; approximately 35 to 40 Newtons; approximately 30 to 35 Newtons; approximately 25 to 30 Newtons; approximately 20 to 25 Newtons; approximately 15 to 20 Newtons; approximately 10 to 15 Newtons; approximately 5 to 10 Newtons; or less than approximately 5 Newtons. In the device 10 shown in Figures 1 to 5, removing the cover 19 requires a pull force of approximately 10 to 15 Newtons.

[0049] The cover cam action feature 19c shown in Figures 1 to 5 defines a wavy shape, such as an arcuate surface. As a more specific example, the removable cover 19 shown in the figures includes a generally cylindrical body portion 19d and an end wall 19e that is generally perpendicular to the body portion 19d at the distal end of the cover 19. The body portion 19d defines a generally annular front edge 19f at the proximal end of the cover 19. The front edge 19f defines the wavy cover cam action feature 19c. As an even more specific example, the front edge 19f shown in the figures defines two wavy cam action surfaces 19c and two relatively flat surfaces 19c' extending between the wavy cam action surfaces 19c. In other words, the two wavy cam action surfaces 19c and the two relatively flat surfaces 19c' cooperate to define the front edge 19f. Alternatively, the front edge 19f may define a continuous wavy shape, such as a continuous sine wave or another continuous wavy shape. For the purposes of this application, the term "continuous" should be interpreted as meaning that the wavy pattern is continuous around the entire perimeter of the front edge, rather than alternating wavy and flat surfaces.

[0050] The housing cam action feature 12a shown in Figures 1 to 5 defines a wavy shape, such as an arcuate protrusion extending away from the outer surface 25 of the housing 12. As a more specific example, the housing cam action feature 12a is a protrusion shaped like a "smile" or a "crescent moon". As an even more specific example, the housing 12 shown in the figures defines two wavy cam action features 12a.

[0051] When the removable cover 19 is in the storage position 19a shown in Figures 1, 2, and 5, the cover cam action feature 19c engages or abuts the housing cam action feature 12a. Additionally, the corresponding cam action features 12a, 19c shown in the figures have matching or mirror shapes, such that the corresponding surfaces 12a, 19c slide smoothly / easily across each other. For example, when the removable cover 19 rotates relative to the housing 12 (clockwise or counterclockwise), the housing cam action features 12a, 19c rotate relative to each other and push the removable cover 19 away from the housing 12 along axis A. In other words, the cam action features 12a, 19c convert rotational motion into axial motion to remove or assist in removing the cover 19. As a more specific example, Figure 3A shows the distal portion of the device 10 after the removable cover 19 has been rotated relative to the housing 12, thereby pushing the removable cover 19 in the distal direction and away from the housing 12. The rotation system shown in Figure 3A exhibits a relatively small rotation (5 to 10 degrees about axis A), but it is still sufficient to overcome at least the initial coupling forces between the removable cap 19 and the housing 12 on one hand, and between the sterile barrier 21 and the drug storage container 20 on the other. Therefore, even a relatively small rotation can facilitate and / or facilitate the removal of the cap 19. Figure 3B shows the distal portion of the device 10 after the removable cap 19 has been rotated further, thus pushing the removable cap 19 further away from the housing 12 in the distal direction. The rotation system shown in Figure 3B exhibits a larger rotation (10 to 20 degrees about axis A) than that shown in Figure 3A, and is sufficient to separate the removable cap 19 and the housing 12 on one hand, and the sterile barrier 21 and the drug storage container 20 on the other. For example, in Figure 3B, the cap 19 has been rotated sufficiently such that the protective member 32 is visible between the cap 19 and the housing 12.

[0052] As discussed above, device 10 requires a direct pulling force of approximately 10 to 15 Newtons to move cap 19 from the storage position shown in FIG. 1 to the removal position shown in FIG. 4. In contrast, the rotational force (e.g., "rotational removal force") required to move cap from the storage position shown in FIG. 1 to the partial removal position shown in FIG. 3 is less than approximately 5 Newtons. As another example, the rotational removal force can be less than approximately 10 Newtons; less than approximately 8 Newtons; less than approximately 6 Newtons; less than approximately 4 Newtons; less than approximately 3 Newtons; less than approximately 2 Newtons; less than approximately 1.5 Newtons; less than approximately 1 Newton; less than or equal to approximately 0.5 Newtons; or approximately 0.5 Newtons. In device 10 shown in FIGS. 1 to 5, removing cap 19 requires a rotational removal force of approximately 0.5 Newtons.

[0053] The device may also include features that signal the cam action function of housing cam action feature 12a and / or lid cam action feature 19c. As an example, housing cam action feature 12a and / or lid cam action feature 19c may be visible to the user to signal the cam action function of cam action features 12a, 19c. As a more specific example, some users may easily understand that the removable lid 19 can / should be removed and / or the removable lid 19 can / should be rotated. For example, some users may not be familiar with all the features or functions of the drug delivery device. As a more specific example, some users may not easily understand how the lid should be removed before use or how it can / should be removed. The device will typically include an instruction manual (“IFU”), but visible cam action features can enhance the visual signal given to the user by the IFU and / or on or near the end cap 19. Therefore, the visibility of the cam action features can improve ease of use, reduce user errors, improve user comfort when using the device, reduce user complaints, and improve overall device compliance and user experience.

[0054] One or both of the cam-action features 12a, 19c may include additional aspects to improve their visibility. For example, one or both of the cam-action features 12a, 19c may be a bright color or highlighted with a bright color or be a different color from the surrounding features. As another example, the removable cover 19 may be translucent or transparent, and the housing may be opaque. In this embodiment, the protective member may be a bright color, such as yellow or green, so that it is visible through the translucent or transparent removable cover. As yet another example, one or both of the cam-action features 12a, 19c may include markings, such as arrows or other symbols, words or other markings, that encourage or instruct the user to rotate the removable cover. As another example, the housing 12 may be a light color, such as white, and the housing cam-action feature 12a may be a color that stands out from the rest of the housing 12 and the cover 19 (such as yellow, bright green, or bright orange).

[0055] As an additional or alternative example, one or both of the cam-action features 12a, 19c may be defined or positioned on the outer surface 25 of the drug delivery device 10 to signal the cam-action function of features 12a, 19c. As another example, one or both of the cam-action features 12a, 19c may include markings, such as arrows or other symbols, words or other markings, that encourage or instruct the user to rotate the removable cap. As another example, one of the cam-action features may be distinguished by a color scheme. Additionally or alternatively, the cam-action features 12a, 19c may be visually concentric and / or closely proximate to indicate the rotational cam-action function of the indicator features.

[0056] The cam-action function feature that indicates the housing cam-action feature and the cover cam-action feature by means of a signal may be advantageous or more desirable than a cam-action feature that is not visible to the user inside the device or otherwise. For example, if the cam-action feature is not visible, the user may not be able to easily view or understand the cam-action feature.

[0057] As discussed above, the design of the cam action features 12a and 19c can affect various aspects of cover removal, such as the rotational removal force, the degree to which the features signal the cam action function of the features 12a and 19c, the longitudinal distance the cover travels during rotation (e.g., "cover lifting"), and / or other aspects. For example, the coefficient of friction and / or cam angle of the cam action features 12a and 19c can affect the rotational removal force. As a more specific example, the coefficient of friction of the cam action features 12a and 19c shown in Figures 1 to 5 can be approximately 0.25. As another example, the coefficient of friction of the cam action features 12a and 19c can be between approximately 0.15 and 0.35; between approximately 0.15 and 0.5; between approximately 0.15 and 0.65; or between approximately 0.05 and 0.75. The coefficient of friction may be affected by the material constituting the cam action feature, surface roughness, and / or surface finish. It may be desirable to minimize the coefficient of friction of the desired material used in the device to minimize the rotational removal force.

[0058] The cam angle 19m shown in Figures 1 to 5 (e.g., the slope of the tangent 19n of the cover cam action feature 19c at the contact point between cam action features 12a and 19c) can be approximately 30 degrees. As another example, the cam angle 19m can be between approximately 25 and 35 degrees; between approximately 20 and 40 degrees; between approximately 15 and 45 degrees; between approximately 10 and 50 degrees; or between approximately 5 and 55 degrees. Generally, a higher cam angle can result in a larger cover lift and a higher rotational removal force. Conversely, a lower cam angle can result in a lower cover lift and a lower rotational removal force. Therefore, it may be advantageous to select a cam angle that results in the desired cover lift, cover rotation, and rotational removal force. For example, a 90-degree rotation of the cover 19 shown in Figures 1 to 5 can result in a cover lift of approximately 5 mm and a rotational removal force of 0.5 Nm. As another example, a 90-degree rotation of the lid 19 can cause a lid lift of approximately 4 to 6 mm and a rotational removal force of approximately 0.35 Nm to 0.65 Nm; a lid lift of approximately 5 to 7 mm and a rotational removal force of approximately 0.25 Nm to 0.75 Nm; a lid lift of approximately 3 to 8 mm and a rotational removal force of approximately 0.15 Nm to 0.85 Nm; or a lid lift of approximately 3 to 8 mm and a rotational removal force of less than approximately 1 Nm.

[0059] The cam angle can vary at different points of lid rotation. For example, the cam angle shown in Figure 3B can be different from the cam angle shown in Figure 3A. For example, the slope of the tangent of the lid cam action feature 19c can vary at different points along the lid cam action feature 19c, such as if the lid cam action feature 19c has a sinusoidal shape. The varying cam angle may be desirable to impart a varying force distribution curve to the device. For example, it may be desirable to have a lower cam angle at the trough of the wave (e.g., the low point) to minimize the initial rotational removal force while the sterile barrier is still intact. The lid cam action feature 19c can then have a higher cam angle at the midpoint of the wave to provide sufficient lid lift to separate the lid from the housing. Conversely, it may be desirable to have a higher cam angle at the trough of the wave to initially and quickly separate the lid from the housing to remove the sterile barrier. The lid cam action feature 19c can then have a lower cam angle at the midpoint of the wave to have a lower rotational removal force and indicate to the user that the lid is separating from the housing.

[0060] Figures 6 through 8 show views of components of another exemplary drug delivery device according to various embodiments. For example, Figures 6 and 7 show a housing 112 that can be coupled with other components to assemble a device (such as the device shown in Figures 1 through 5). The housing 112 includes many features among the same features as those shown in Figures 1 through 5, such as the viewing window 117, the outer surface 125 of the housing, and the housing cam action feature 112a. However, the housing cam action feature 112a has a smaller curvature than the housing cam action feature 12a shown in Figures 1 through 5. As discussed above, the cam action feature can have different shapes and sizes depending on desired characteristics and properties.

[0061] Additionally, the housing 112 includes a retaining feature 112b to illustrate securing the removable cover 119 to the housing 112. As a more specific example, the retaining feature 112b includes a recess or slot for receiving a retaining tab formed in the cover. Figure 8 shows a distal portion of the housing 112 positioned adjacent to the removable cover 119, which is configured to be removably coupled to the housing 112. For illustrative purposes, Figure 8 does not show all components of the operating device; only the housing 112 and the removable cover 119 are shown. The cover 119 includes a retaining tab 119g configured to fit within the recess 112b to aid in securing the removable cover 119 to the housing 112. The retaining features 112b and 119g help prevent unintentional cover separation / removal.

[0062] The retaining feature 112b can be configured to engage the retaining tab 119g to hold the removable cover 119 in a storage position. For example, the retaining tab 119g can receive the retaining feature 112b by a snap-fit ​​connection, which requires a baseline removal force to disengage the retaining tab 119g from the retaining feature 112b (and vice versa). As a more specific example, the retaining tab 119g can have size, shape, stiffness, and surface friction characteristics that require a removal force of 5 N to disengage the retaining tab 119g from the retaining feature 112b (and vice versa). Alternatively, the removal force can be between approximately 4 N and 6 N; between approximately 3 N and 7 N; between approximately 2 N and 8 N; between approximately 1 N and 9 N; between approximately 0 N and 10 N; or another suitable value or range.

[0063] As an additional or alternative example, fixing feature 112b can hold the removable cap 119 in a storage position regardless of whether the drug storage container is located within the housing and / or whether the drug storage container is coupled to the housing in a position where the drug can be delivered. For example, during the assembly phase, when the drug storage container is not yet located within the housing or when the drug storage container is positioned within the housing but not yet in its final position relative to the housing (as shown in FIG. 5), it may be desirable to secure the removable cap 119 with the housing. For this purpose, fixing features 112b, 119g can be configured to secure the removable cap 119 with the housing 112 without affecting or assisting other components (such as the sterile barrier 21 or other components connecting the removable cap and the drug storage container) (e.g., prior to the final assembly of the device).

[0064] The fixing features 112b and 119g may have alternative suitable configurations, such as protrusions on the removable cover 119 and receiving slots on the housing 112, or any other suitable features. The fixing features 112b and 119g may also have any suitable shape, such as curved, spiral, or circular button-like shapes. The shape, size, and other aspects of the fixing features may facilitate the removal of the cover in a particular direction or with a particular type of movement, such as rotational movement. For example, the fixing features shown in Figures 6 through 8 are generally horizontal (e.g., generally perpendicular to axis A) to facilitate separation as the removable cover 119 rotates. The size and shape of the fixing features 112b and 119g may also be designed in conjunction with the size and shape of the cam-acting features 112a and 119c. For example, the cam-acting features 112a and 119c may have relatively flat bottom / valley portions to facilitate relative rotational movement between the housing and the cover while minimizing relative translational movement until the fixing features 112b and 119g separate. In other words, the retaining features 112b and 119g rotate apart / separate from each other before the cap is axially translated away from the housing. To achieve this, the retaining features 112b and 119g separate with smooth movement, rather than with dragging resistance and / or giving the user a jerky / clamping sensation. Moreover, this configuration allows for a relatively low or negligible effect on rotational removal forces while simultaneously providing sufficient translational removal forces to hold the cap to the housing. In other words, the retaining features 112b and 119g prevent or minimize "stacked" removal forces.

[0065] The housing 112 and the removable cover 119 include cam-acting features to convert rotational motion into axial motion, such that during rotational movement of the removable cover 119, the removable cover 119 is pushed away from the housing 112, thereby facilitating and / or making the removal of the cover 119 easier. For example, the housing 112 includes a housing cam-acting feature 112a, and the removable cover 119 includes a cover cam-acting feature 119c.

[0066] The cover cam action feature 119c defines a wavy, such as arcuate, surface. As a more specific example, the removable cover 119 shown in the figures includes a generally cylindrical body portion 119d and an end wall 119e that is generally perpendicular to the body portion 119d at the distal end of the cover 119. The body portion 119d defines a generally annular front edge 119f at the proximal end of the cover 119. The front edge 119f defines the wavy cover cam action feature 119c. As an even more specific example, the front edge 119f shown in the figures defines two wavy cam action surfaces 119c.

[0067] The housing cam action feature 112a defines a wavy shape, such as an arcuate protrusion extending away from the outer surface of the housing 112. As a more specific example, the housing cam action feature 112a is a protrusion shaped like a slightly upturned mouth. As an even more specific example, the housing 112 shown in the figure defines two wavy cam action features 112a.

[0068] When the removable cover 119 is in the storage position 119a, the cover cam action feature 119c engages or abuts the housing cam action feature 112a. Additionally, the corresponding cam action features 112a, 119c shown in the figures have matching or mirror shapes, such that the corresponding surfaces 112a, 119c slide smoothly / easily across each other. For example, when the removable cover 119 rotates relative to the housing 112 (clockwise or counterclockwise), the housing cam action features 112a, 119c rotate relative to each other and push the removable cover 119 away from the housing 112 along axis A. In other words, the cam action features 112a, 119c convert rotational motion into axial motion to remove or assist in the removal of the cover 119. Similar to the devices shown in Figures 1 to 5, even relatively small rotations of the removable cover 119 can facilitate and / or facilitate the removal of the cover 119. The components shown in Figures 6 to 8 can generate similar direct pulling and rotational removal forces as those shown in Figures 1 to 5. As a more specific example, in order to remove the cap 119 from the housing 112 solely by axial force / movement (direct pull), the user may need to apply 45 Newtons or less; approximately 40 to 45 Newtons; approximately 35 to 40 Newtons; approximately 30 to 35 Newtons; approximately 25 to 30 Newtons; approximately 20 to 25 Newtons; approximately 15 to 20 Newtons; approximately 10 to 15 Newtons; approximately 5 to 10 Newtons; or less than approximately 5 Newtons. In the apparatus shown in Figures 6 to 8, removing the cap 119 requires a direct pull force of approximately 10 to 15 Newtons. In contrast, the rotational force required to remove the cap from Figures 6 to 8 can be less than approximately 10 Newtons; less than approximately 8 Newtons; less than approximately 6 Newtons; less than approximately 4 Newtons; less than approximately 3 Newtons; less than approximately 2 Newtons; less than approximately 1.5 Newtons; less than approximately 1 Newton; less than or equal to approximately 0.5 Newtons; or approximately 0.5 Newtons. In the components shown in Figures 6 to 8, removing the cover 119 requires a rotational removal force of approximately 0.5 Newtons.

[0069] Similar to Figures 1 to 5, the device may also include features that signal the cam function of housing cam function feature 112a and / or lid cam function feature 119c. For example, one or both of cam function features 112a, 119c may include additional aspects to improve their visibility. As an additional or alternative example, one or both of cam function features 112a, 119c may be defined by or positioned on the outer surface 125 of the device to signal the cam function of features 112a, 119c. As another example, one or both of cam function features 112a, 119c may include markings that encourage or instruct the user to rotate the removable lid.

[0070] FIG9 shows a view of the components of another exemplary drug delivery device according to various embodiments. For example, FIG9 shows a housing 212 and a removable cover 219 that can be connected to each other to assemble a device (such as the device shown in FIG1 to FIG5). The housing 212 includes many of the same features as the housing 12 shown in FIG1 to FIG5, such as the viewing window 217, the outer surface of the housing 225, and the housing cam action feature 212a.

[0071] The housing 212 and the end cap 219 include cam-acting features to convert rotational motion into axial motion, such that during rotational movement of the removable cap 219, the removable cap 219 is pushed away from the housing 212, thereby facilitating and / or making the cap 219 easy to remove. For example, the housing 212 includes a housing cam-acting feature 212a, and the removable cap 219 includes a cap cam-acting feature 219c.

[0072] The cover cam action feature 219c defines a wavy, such as arcuate, surface. As a more specific example, the removable cover 219 shown in the figures includes a generally cylindrical body portion 219d and an end wall 219e that is generally perpendicular to the body portion 219d at the distal end of the cover 219. The body portion 219d defines a generally annular front edge 219f at the proximal end of the cover 219. The front edge 219f defines the wavy cover cam action feature 219c. As an even more specific example, the front edge 219f shown in the figures defines two wavy cam action surfaces 219c.

[0073] The housing cam action feature 212a defines a wavy shape, such as an arcuate protrusion extending away from the outer surface of the housing 212. As a more specific example, the housing cam action feature 212a is a protrusion shaped like a smile or crescent moon. As an even more specific example, the housing 212 shown in the figure defines two wavy cam action features 212a.

[0074] When the removable cover 219 is in the storage position 219a, the cover cam action feature 219c engages or abuts the housing cam action feature 212a. Additionally, the corresponding cam action features 212a, 219c shown in the figures have matching or mirror-shaped forms, such that the corresponding surfaces 212a, 219c slide smoothly / easily across each other. For example, when the removable cover 219 rotates relative to the housing 212 (clockwise or counterclockwise), the housing cam action features 212a, 219c rotate relative to each other and push the removable cover 219 away from the housing 212 along axis A. In other words, the cam action features 212a, 219c convert rotational motion into axial motion to remove or assist in the removal of the cover 219. Similar to the devices shown in Figures 1 to 5, even relatively small rotations of the removable cover 219 can facilitate and / or facilitate the removal of the cover 219. The components shown in Figure 9 can result in similar direct pulling and rotational removal forces as those shown in Figures 1 to 5. As a more specific example, in order to remove the cap 219 from the housing 212 solely by axial force / movement (direct pull), the user may need to apply 45 Newtons or less; approximately 40 to 45 Newtons; approximately 35 to 40 Newtons; approximately 30 to 35 Newtons; approximately 25 to 30 Newtons; approximately 20 to 25 Newtons; approximately 15 to 20 Newtons; approximately 10 to 15 Newtons; approximately 5 to 10 Newtons; or less than approximately 5 Newtons. In the device shown in Figure 9, removing the cap 219 requires a direct pull force of approximately 10 to 15 Newtons. In contrast, the rotational force required to remove the cap from Figure 9 can be less than approximately 10 Newtons; less than approximately 8 Newtons; less than approximately 6 Newtons; less than approximately 4 Newtons; less than approximately 3 Newtons; less than approximately 2 Newtons; less than approximately 1.5 Newtons; less than approximately 1 Newton; less than or equal to approximately 0.5 Newtons; approximately 0.5 Newtons. In the component shown in Figure 9, removing the cover 219 requires a rotational removal force of approximately 0.5 Newtons.

[0075] The cover 219 shown in FIG. 9 may also include rotational aid features, such as fins 219h, 219j that increase the user's grip and / or increase the torque that the user can apply on the cover 219. The fins 219h, 219j shown in FIG. 9 may also be shaped, sized, and spaced apart, such as to ergonomically adapt to the user's hand or fingers. For example, fin 219j may adapt to the user's thumb and fin 219h may adapt to the user's index finger and / or middle finger. The fins may also have a size suitable for applying a desired amount of torque on the cover 219, such as a fin thickness sufficient to prevent the fins from breaking or warping and a fin height sufficient to generate a desired torque arm around the longitudinal axis of the cover.

[0076] The cover 219 shown in Figure 9 may also include gripping aids, such as ribs 219k that increase the user's gripping ability so that the user can apply longitudinal force on the cover 219. The ribs 219k shown in Figure 9 may also be shaped, sized, and spaced, such as to ergonomically adapt to the user's hand or fingers. For example, the ribs 219k may adapt to the user's thumb and forefinger. The ribs 219k may also have a size suitable for applying a desired amount of axial force on the cover 219, such as a rib thickness sufficient to prevent fin breakage or warping, and a rib orientation (slightly concave) that signals to the user that the cover should be pulled downward in the direction of the rib ends.

[0077] Similar to Figures 1 to 8, the device may also include features that signal the cam function of housing cam function feature 212a and / or lid cam function feature 219c. For example, one or both of cam function features 212a and 219c may include additional aspects to improve their visibility. As an additional or alternative example, one or both of cam function features 212a and 219c may be defined or positioned on the outer surface 225 of the device to signal the cam function of features 212a and 219c. As another example, one or both of cam function features 212a and 219c may include markings that encourage or instruct the user to rotate the removable lid.

[0078] FIG. 10 shows a view of the components of an additional exemplary drug delivery device according to various embodiments. For example, FIG. 10 shows a distal portion of a device 310 having a housing 312 and an end cap 319 that can be coupled to each other to assemble a device (such as the devices shown in FIG. 1 to FIG. 5). The device 310 in FIG. 10 includes many features among the same features as those of the devices shown in FIG. 1 to FIG. 5, such as viewing windows, outer surfaces of the housing, and housing cam action feature 312a. The end cap 319c includes a cam action feature to convert rotational motion into axial motion, such that during rotational movement of the removable cap 319, the removable cap 319 is pushed away from the housing 312, thereby facilitating and / or making the cap 319 easy to remove. For example, the housing 312 includes housing cam action feature 312a, and the removable cap 319 includes cap cam action feature 319c. The cap cam action feature shown in FIG. 10 is generally wavy, and the housing cam action feature 312a is a rounded or rounded protrusion. When the removable cover 319 is in the storage position 319a, the cover cam action feature 319c engages or abuts the housing cam action feature 312a. Additionally, the corresponding cam action features 312a, 319c shown in the figures have matching or mirror-shaped forms, such that the corresponding surfaces 312a, 319c slide smoothly / easily across each other. For example, when the removable cover 319 rotates relative to the housing 312 (clockwise or counterclockwise), the housing cam action features 312a, 319c rotate relative to each other and push the removable cover 319 away from the housing 312 along axis A. In other words, the cam action features 312a, 319c convert rotational motion into axial motion to remove or assist in removing the cover 319.

[0079] FIG11 shows a view of the components of yet another exemplary drug delivery device according to various embodiments. For example, FIG11 shows the distal portion of a device 410 having a housing 412 and an end cap 419 that can be coupled to each other to assemble a device (such as the devices shown in FIG1 to FIG5). The device 410 in FIG11 includes many of the same features as those in the devices shown in FIG1 to FIG5, such as viewing windows, outer surfaces of the housing, and housing cam action feature 412a. The end cap 419c includes a cam action feature to convert rotational motion into axial motion, such that during rotational movement of the removable cap 419, the removable cap 419 is pushed away from the housing 412, thereby facilitating and / or making the cap 419 easy to remove. For example, the housing 412 includes the housing cam action feature 412a, and the removable cap 419 includes the cap cam action feature 419c. The cap cam action feature shown in FIG11 is generally triangular in shape, and the housing cam action feature 412a is a triangular or rhomboid protrusion. When the removable cover 419 is in the storage position 419a, the cover cam action feature 419c engages or abuts the housing cam action feature 412a. Additionally, the corresponding cam action features 412a, 419c shown in the figures have matching or mirror-shaped forms, such that the corresponding surfaces 412a, 419c slide smoothly / easily across each other. For example, when the removable cover 419 rotates relative to the housing 412 (clockwise or counterclockwise), the housing cam action features 412a, 419c rotate relative to each other and push the removable cover 419 away from the housing 412 along axis A. In other words, the cam action features 412a, 419c convert rotational motion into axial motion to remove or assist in removing the cover 419.

[0080] FIG12 shows a view of the components of yet another exemplary drug delivery device according to various embodiments. For example, FIG12 shows the distal portion of a device 510 having a housing 512 and an end cap 519 that can be coupled to each other to assemble a device (such as the devices shown in FIG1 to FIG5). The device 510 in FIG12 includes many of the same features as those in the devices shown in FIG1 to FIG5, such as viewing windows, outer surfaces of the housing, and housing cam action feature 512a. The end cap 519c includes a cam action feature to convert rotational motion into axial motion, such that during rotational movement of the removable cap 519, the removable cap 519 is pushed away from the housing 512, thereby facilitating and / or making the cap 519 easy to remove. For example, the housing 512 includes housing cam action feature 512a, and the removable cap 519 includes cap cam action feature 519c. The cap cam action feature shown in FIG12 is generally wavy, i.e., a continuous or semi-continuous wavy shape extending around the circumference of the cap. The housing cam action feature 512a is generally wavy, that is, a continuous or semi-continuous wavy shape extending around the circumference of the cover. When the removable cover 519 is in the storage position 519a, the cover cam action feature 519c engages or abuts the housing cam action feature 512a. Additionally, the corresponding cam action features 512a, 519c shown in the figures have matching or mirror shapes, such that the corresponding surfaces 512a, 519c slide smoothly / easily across each other. For example, when the removable cover 519 rotates relative to the housing 512 (clockwise or counterclockwise), the housing cam action features 512a, 519c rotate relative to each other and push the removable cover 519 away from the housing 512 along axis A. In other words, the cam action features 512a, 519c convert rotational motion into axial motion to remove or assist in removing the cover 519.

[0081] FIG13 shows a view of the components of yet another exemplary drug delivery device according to various embodiments. For example, FIG13 shows the distal portion of a device 610 having a housing 612 and an end cap 619 that can be coupled to each other to assemble a device (such as the devices shown in FIG1 to FIG5). The device 610 in FIG13 includes many of the same features as those in the devices shown in FIG1 to FIG5, such as viewing windows, outer surfaces of the housing, and housing cam action feature 612a. The end cap 619c includes a cam action feature to convert rotational motion into axial motion, such that during rotational movement of the removable cap 619, the removable cap 619 is pushed away from the housing 612, thereby facilitating and / or making the cap 619 easy to remove. For example, the housing 612 includes housing cam action feature 612a, and the removable cap 619 includes cap cam action feature 619c. The cap cam action feature shown in FIG13 is generally wavy, i.e., a continuous or semi-continuous wavy shape extending around the circumference of the cap. The housing cam action feature 612a has multiple curved or wavy protrusions. When the removable cover 619 is in the storage position 619a, the cover cam action feature 619c engages or abuts the housing cam action feature 612a. Additionally, the corresponding cam action features 612a, 619c shown in the figures have matching or mirror-shaped shapes, such that the corresponding surfaces 612a, 619c slide smoothly / easily across each other. For example, when the removable cover 619 rotates relative to the housing 612 (clockwise or counterclockwise), the housing cam action features 612a, 619c rotate relative to each other and push the removable cover 619 away from the housing 612 along axis A. In other words, the cam action features 612a, 619c convert rotational motion into axial motion to remove or assist in removing the cover 619.

[0082] Figure 14 shows a view of a component (i.e., an end cap) of yet another exemplary drug delivery device according to various embodiments. For example, end cap 619 includes a cap cam action feature 619c defining a wavy shape, such as an arcuate surface. As a more specific example, the removable cap 619 shown in the figure includes a generally cylindrical body portion 619d and an end wall 619e that is generally perpendicular to the body portion 619d at the distal end of the cap 619. As an even more specific example, the leading edge 619f shown in the figure defines a continuous wavy cam action surface 619c, such as a sinusoidal wavy cam action surface 619c.

[0083] As can be seen from the above, this disclosure advantageously provides a streamlined design for a drug delivery device with automated features. The various mechanisms and components of the drug delivery device can interact with each other in a cooperative manner to limit the number of moving parts required by the drug delivery device, thereby improving the reliability of the drug delivery device and saving costs, as well as providing other benefits and advantages.

[0084] It will be appreciated that the apparatus and method according to this disclosure may have one or more advantages over conventional techniques, and any one or more of these advantages may be present in a particular embodiment that conforms to the features of this disclosure contained in that embodiment. Other advantages not specifically listed herein may also be appreciated.

[0085] The foregoing description describes various devices, components, parts, subsystems, and methods used in connection with a drug delivery device. Devices, components, parts, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to those drugs identified below and their class counterparts and biosimilar counterparts. As used herein, the term "drug" is used interchangeably with other similar terms and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and components, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and classifiers. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or in a form that can be reconstructed from a lyophilized form. The following exemplary list of drugs should not be considered as all-encompassing or restrictive.

[0086] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or prefilled with the medication for treatment. The master container may be a vial, cartridge, or prefilled syringe.

[0087] In some embodiments, the reservoir of the drug delivery device may be filled with a community-stimulating factor (such as granulocyte community-stimulating factor (G-CSF)), or the device may be used in conjunction with a community-stimulating factor. Such G-CSF agents include, but are not limited to, Neulasta® (pefilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pefilgrastim-cbqv), Ziextenzo® (LA-EP2006; pefilgrastim-bmez) or FULPHILA (pefilgrastim-bmez).

[0088] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulator (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin-stimulating proteins include, but are not limited to, Epogen® (epogen α), Aranesp® (dabepoetin α), Dynepo® (epogen δ), Mircera® (methoxy-polyethylene glycol-epogen β), Hematide®, MRK-2578, INS-22, Retacrit® (epogen ζ), Neorecormon® (epogen β), Silapo® (epogen ζ), Binocrit® (epogen α), epogen α Hexal, Abseamed® (epogen α), Ratioepo® (epogen θ), Eporatio® (epogen θ), Biopoin® (epogen θ), epogen α, epogen β, epogen ι, epogen ω, epogen δ, epogen ζ, epogen θ and epogen δ, pegylated erythropoietin, carbamolated erythropoietin, and their molecules or variants or analogues.

[0089] The specific illustrative proteins are the particular proteins described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (also known as RANKL-specific antibodies, peptides, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, especially fully humanized monoclonal antibodies; myostatin-binding proteins, peptides, related proteins, etc., including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, related proteins, etc., especially those inhibiting myostatin-binding proteins. And / or those that mediate IL-13 binding to its receptor; interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptides, related proteins, etc.; Ang2 specific antibodies, peptides, related proteins, etc.; NGF specific antibodies, peptides, related proteins, etc.; CD22 specific antibodies, peptides, related proteins, etc., especially human CD22 specific antibodies, such as, but not limited to, humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2. Dimers of the γ-chain linked to the human-mouse monoclonal hLL2 κ chain by disulfide, such as the fully humanized human CD22-specific antibody in epazuzumab, CAS Registry No. 501423-23-0; IGF-1 receptor-specific antibodies, peptides, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptides, and related proteins ("B7RP-1", also known as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies binding to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those inhibiting the interaction of B7RP-1 with its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptides, and related proteins, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as 145c7; IFN γ-specific antibodies, peptides, and related proteins, including but not limited to human IFN γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptides, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptides, and related proteins; thrombopoietin receptor ("TPO-R") specific antibodies, peptides, and related proteins; hepatocyte growth factor ("HGF") specific antibodies, peptides, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptides, and related proteins; activin A specific antibodies, peptides, and proteins; TGF-β specific antibodies, peptides, and related proteins; amyloid-β protein specific antibodies, peptides, and related proteins; c-Kit specific antibodies, peptides, and related proteins, including but not limited to proteins binding to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to proteins binding to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin. Hemopoietin [30-aspartic acid, 32-threonine, 87-valine, 88-aspartic acid, 90-threonine], dabepoetin α, novel erythropoietin-stimulating protein (NESP); Epogen® (eberphytin α, or erythropoietin); GLP-1, Avonex® (interferon β-1a); Bexxar® (tosimomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-β); Camppath® (alemumab, anti-CD52 monoclonal antibody); Dynepo® (eberphytin δ); Velcade® (bortezomib); MLN0002 (anti-β4β7) mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (ebertin α); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (growth hormone, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns), an anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (growth hormone, human growth hormone) Humira® (adalimumab); Vectibix® (panitumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistine), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)).Kineret® (analyzedin); Leukine® (saxaglastine, rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenepazolizumab, t-PA analog); Mircera® (methoxy-polyethylene glycol-epazolidin beta); Mylotarg® (gem-tuzumab-ozomicin); Raptiva® (efalizumab); Cimzia® (cetuzumab, CDP 870); Soliris™ (eculizumab); Pexazumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibuzumab); Panorex® (17-1A, ezolomide); Trabio® (lerdelimumab); TheraCim hR3 (Nimotuzumab); Omnitarg (Pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (Vencizumab); Cantuzumab Mertansine (huC242-DM1); NeoRecormon® (Ibertin β); Neumega® (Interleukin-11); Orthoclone OKT3® (Moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (Ibertin α); Remicade® (Infliximab, anti-TNF® monoclonal antibody); Reopro® (Abciximab, anti-GP IB / Ilia) Receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (baricuximab); Prexige® (romecoxib); Synagis® (palizumab); 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507); Tysabri® (natelizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the extracellular domain of the Fc region of human IgG1 and the IL-1 receptor components (type I receptor and receptor accessory protein)).VEGF trap (Ig domain of VEGFR1 fused with IgG1 Fc); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2R™ mAb); Zevalin® (teimomab); Zetia® (ezetimibe); Orencia® (asceticipeptide, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNF™ mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-5-1 integrin mAb); MDX-010 (iplimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1 and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF fibrinogen for stage I idiopathic pulmonary fibrosis (FG-3019); anti-CTLA4 mAb; anti-eosinophil chemokine 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO). 1275); Anti-IL13 mAb (CAT-354); Anti-IL2Ra mAb (HuMax-TAC); Anti-IL5 receptor mAb;Anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCG™ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFR™ antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0090] In some embodiments, the drug delivery device may include or be used with sclerosing protein antibodies, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) binding to human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may comprise or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumab, or similar drugs. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, or the device may be used with such an oncolytic HSV, including but not limited to OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may include or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may include Aimovig® (anovisumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for the treatment of migraine containing or being used with anovisumab. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, anovisumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets may also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agents (BiTE®) molecules (such as, but not limited to, BLINCYTO® (bonatumab)) may be used in or with the drug delivery device of this disclosure.In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device disclosed herein. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), an anti-TNF® monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may comprise or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylepoxyethylene-2-yl)-1-oxypentane-2-aminomethoxy)-2-phenylethyl)-2-((S)-2-(2-morpholinylacetamido)-4-phenylbutanoneamino)-4-methylpentylamine, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may comprise or be used with Otezla® (aplastrin), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product comprising aprerin for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may comprise Parsabiv™ (vilalaceptide HCl, KAI-4169), or another product comprising vilalaceptide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as for hemodialysis in patients with chronic kidney disease (KD). In some embodiments, the drug delivery device may comprise ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product comprising an anti-CD20 monoclonal antibody, or be used with it. In some embodiments, the drug delivery device may comprise or be used with a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (an Ig domain 2 from VEGFR1 fused to the Fc domain of IgG1 and an Ig domain 3 from VEGFR2)). In some embodiments, the drug delivery device may comprise or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product comprising or being used with a monoclonal antibody that specifically binds to complement protein C5.In some embodiments, the drug delivery device may comprise or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activities of ICOSL and BAFF. In some embodiments, the drug delivery device may comprise or be used with Omecamtiv mecarbil, a small-molecule selective myoglobin activator that directly targets the contractile mechanism of the heart, or a positive inotropic agent targeting sarcomeres (myotrope), or another product comprising or being used with a small-molecule selective myoglobin activator. In some embodiments, the drug delivery device may comprise or be used with sotorazib (formerly AMG 510), a KRASG12C small-molecule inhibitor, or another product comprising or being used with a KRASG12C small-molecule inhibitor. In some embodiments, the drug delivery device may comprise or be used with terzolidinedaline, a human monoclonal antibody that inhibits the activity of thymic stromal lymphopoietin (TSLP), or another product comprising or being used with a human monoclonal antibody that inhibits the activity of TSLP. In some embodiments, the drug delivery device may comprise, or be used with, AMG 714, a human monoclonal antibody that binds interleukin-15 (IL-15), or another product comprising, or being used with, a human monoclonal antibody that binds interleukin-15 (IL-15). In some embodiments, the drug delivery device may comprise, or be used with, AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a) (also known as Lp(a)), or another product comprising, or being used with, a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may comprise, or be used with, ABP 654 (human IgG1κ antibody), a biosimilar candidate of Stelara®, or another product comprising, or being used with, an IgG1κ antibody and / or the p40 subunit that binds the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (monoclonal antibody against TNF human IgG1), a biosimilar candidate of Humira®, or another product comprising or used with a human monoclonal antibody against TNF human IgG1. In some embodiments, the drug delivery device may comprise or be used with AMG 160 or another product comprising a half-life-extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate). In some embodiments, the drug delivery device may comprise or be used with AMG 119 or another product comprising or used with a delta-ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with AMG 119 or another product containing or using with a delta-ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133 or another product containing or using with a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing or using with a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing or using with a small molecule inhibitor of myeloid leukemia gene 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing or using with a half-life-extended (HLE) bispecific T-cell conjugate (BiTE®). In some embodiments, the drug delivery device may comprise, or be used with, AMG 256 or another product comprising an anti-PD-1 x IL21 mutant and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in planned cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may comprise, or be used with, AMG 330 or another product comprising an anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 404 or another product comprising a human anti-planned cell death-1 (PD-1) monoclonal antibody investigated for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may comprise, or be used with, AMG 427 or another product comprising a half-life-extended (HLE) anti-fms tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with another product comprising an anti-Jagged-1 monoclonal antibody, or in combination with it. In some embodiments, the drug delivery device may comprise or be used with another product comprising a multispecific FAP x 4-1BB targeting DARPin® biologic agent that is investigated to treat solid tumors, or in combination with it. In some embodiments, the drug delivery device may comprise or be used with another product comprising a bivalent T-cell binder and designed using XmAb® 2+1 technology, or in combination with it. In some embodiments, the drug delivery device may comprise or be used with another product comprising an anti-half-life extension (HLE) CD19 x CD3 BiTE® (bispecific T-cell binder) construct, or in combination with it.In some embodiments, the drug delivery device may comprise or be used with an IL-2 mutant fusion protein (Efavaleukin alfa) (formerly AMG 592) or another product comprising or using with an IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may comprise or be used with AMG 596 or another product comprising or using with a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell conjugate) molecule. In some embodiments, the drug delivery device may comprise or be used with AMG 673 or another product comprising or using with an anti-half-life extension (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 701 or another product comprising or using with an anti-half-life extension (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 757 or another product comprising, or being used with, an extended half-life (HLE) anti-δ-ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 910 or another product comprising, or being used with, an extended half-life (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T-cell conjugate) construct.

[0091] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. This detailed description is to be construed as exemplary only and does not describe every possible implementation of the present disclosure. Many alternative implementations may be carried out using current technology or technology developed after the date of this patent application, and such implementations still fall within the scope of the claims that define the invention disclosed herein.

[0092] Those skilled in the art will understand that various modifications, alterations and combinations can be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations and combinations can be regarded as being within the scope of the inventive concept. [Simplified Explanation of the Diagram]

[0013] It is believed that the present disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. To show other elements more clearly, some drawings may be simplified by omitting selected elements. In some drawings, the omission of such elements does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it can be clearly indicated in the corresponding written description. Furthermore, not all drawings need to be drawn to scale.

[0014] [Figure 1] is a perspective view of an exemplary drug delivery device according to various embodiments, wherein there is a device removable cover and the device removable cover is connected to the housing;

[0015] [Figure 2] is a front view of the drug delivery device in Figure 1;

[0016] [Figure 3A] is a perspective view of the distal portion of the drug delivery device in Figure 1, wherein the removable cover is in the process of being removed from the drug delivery device;

[0017] [Figure 3B] is a perspective view similar to Figure 3A, wherein the removable cover is rotated more than in Figure 3A to further separate the cover from the housing;

[0018] [Figure 4] is a perspective view of the distal portion of the drug delivery device in Figure 1, wherein the removable cover is removed from the drug delivery device;

[0019] [Figure 5] is a cross-sectional view of a portion of the drug delivery device in Figure 1, wherein a removable cover is present and the removable cover is connected to the housing;

[0020] [Figure 6] is a front view of the housing of another exemplary drug delivery device according to various embodiments;

[0021] [Figure 7] is a side view of the housing of the drug delivery device in Figure 6;

[0022] [Figure 8] is a perspective view of the distal portion of the housing in Figure 6 positioned adjacent to a removable cover configured to be removably coupled to the housing;

[0023] [Figure 9] is a perspective view of the distal portion of another exemplary drug delivery device according to various embodiments, wherein a device removable cover is provided and the device removable cover is coupled to the housing;

[0024] [Figure 10] is a perspective view of the distal portion of another exemplary drug delivery device according to various embodiments, wherein a device removable cover is provided and the device removable cover is connected to the housing;

[0025] [Figure 11] is a perspective view of the distal portion of another exemplary drug delivery device according to various embodiments, wherein a device removable cover is provided and the device removable cover is connected to the housing;

[0026] [Figure 12] is a perspective view of the distal portion of another exemplary drug delivery device according to various embodiments, wherein a device removable cover is present and the device removable cover is connected to the housing;

[0027] [Figure 13] is a perspective view of the distal portion of another exemplary drug delivery device according to various embodiments, wherein a device removable cover is present and the device removable cover is coupled to the housing; and

[0028] [Figure 14] is a perspective view of the distal portion of a removable cover of another exemplary drug delivery device according to various embodiments. [Biomaterial Storage]

[0094] None

Claims

1. A drug delivery device, comprising: A housing that defines a longitudinal axis and cam action features, the housing having an opening and an outer surface; A drug storage container, the drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; The device includes a removable cap that defines a cap cam action feature and is configured to be removably coupled to the housing, such that the removable cap has a storage position and a removal position, in which the removable cap is coupled to the housing and at least partially covers the opening, and in the removal position, the removable cap is not coupled to the housing; wherein the cap cam action feature and the housing cam action feature are configured to convert rotational motion into axial motion, such that during rotational movement of the removable cap, the cap cam action feature and / or the housing cam action feature pushes the removable cap along the longitudinal axis; wherein the housing cam action feature and the cap cam action feature are each visible to the user of the drug delivery device to signal the cam action function of the housing cam action feature and / or the cap cam action feature; and wherein the housing cam action feature includes at least one protrusion extending away from the outer surface of the housing, wherein the at least one protrusion includes a first end and a second end, the first end being configured to slidably engage a first portion of the cap cam action feature, and the second end being configured to slidably engage a second portion of the cap cam action feature.

2. The drug delivery device as claimed in claim 1, wherein, The cam's function is defined by a wave-like shape.

3. The drug delivery device as described in claim 2, wherein, The wave-shaped system is roughly sinusoidal in shape.

4. The drug delivery device as described in claim 3, wherein, The removable cover includes a generally cylindrical body portion defining an annular front edge and an end wall generally perpendicular to the body portion, wherein the annular front edge defines the wavy shape.

5. The drug delivery device as claimed in claim 2, wherein, The outer surface is generally cylindrical.

6. The drug delivery device as claimed in claim 5, wherein, When the removable cover is in the storage position, the at least one protrusion is aligned with the wave-shaped cam action feature of the cover.

7. The drug delivery device as claimed in claim 6, wherein, When the removable cover is in the storage position, the at least one protrusion is adjacent to the wavy shape of the cover cam action feature.

8. The drug delivery device as claimed in claim 7, wherein, The at least one protrusion defines a wavy surface corresponding to the wavy shape of the cover cam's function.

9. The drug delivery device as described in any one of claims 6 to 7, wherein, The housing includes two protrusions, each extending away from the generally cylindrical outer surface.

10. The drug delivery device as described in any one of claims 1 to 4, wherein, The housing defines a retaining feature configured to engage the removable cover and hold it in place in the storage position.

11. The drug delivery device as claimed in claim 10, wherein, The fixing feature is configured to retain the removable cap in the storage position regardless of whether the drug storage container is attached to the housing.

12. The drug delivery device as described in any one of claims 1 to 4, wherein, At least one of the housing cam function feature and / or the cover cam function feature includes aspects for improving its visibility.

13. The drug delivery device as claimed in claim 12, wherein, The aspect used to improve visibility includes bright colors.

14. The drug delivery device as described in any one of claims 1 to 4, wherein, The cover includes at least one rotational auxiliary feature.

15. The drug delivery device as claimed in claim 14, wherein, The at least one rotational auxiliary feature includes fins.

16. A drug delivery device, comprising: A housing that defines a longitudinal axis and cam action features, the housing having an opening and an outer surface; A drug storage container, the drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; And a removable cover, the removable cover defining a cover cam action feature and configured to be removably coupled to the housing, such that the removable cover has a storage position and a removal position, in the storage position the removable cover is coupled to the housing and at least partially covers the opening, and in the removal position the removable cover is not coupled to the housing; wherein the cover cam action feature and the housing cam action feature are configured to convert rotational motion into axial motion, such that during the rotational movement of the removable cover, the cover cam action feature and / or the housing cam action feature pushes the removable cover along the longitudinal axis; The housing cam function feature and the cover cam function feature are each defined or positioned on the outer surface of the drug delivery device to indicate the cam function of the housing cam function feature and / or the cover cam function feature by means of a signal; and wherein the housing cam function feature includes at least one protrusion extending away from the outer surface of the housing, wherein the at least one protrusion includes a first end and a second end, the first end being configured to slidably engage a first portion of the cover cam function feature, and the second end being configured to slidably engage a second portion of the cover cam function feature.

17. The drug delivery device as claimed in claim 16, wherein, The cam's functional characteristics define a wavy shape; Furthermore, the removable cover includes a generally cylindrical body portion defining an annular front edge and an end wall generally perpendicular to the body portion, wherein the annular front edge defines the wavy shape.

18. The drug delivery device as claimed in claim 17, wherein, The outer surface is generally cylindrical.

19. The drug delivery device as described in any one of claims 16 to 18, wherein, When the removable cover is in the storage position, the at least one protrusion is aligned with the wave-shaped cam action feature of the cover.

20. The drug delivery device as described in any one of claims 16 to 18, wherein, At least one of the housing cam function feature and / or the cover cam function feature includes aspects for improving its visibility.

21. The drug delivery device as described in any one of claims 16 to 18, wherein, The cover includes at least one rotational auxiliary feature.

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