Drug delivery device with back cover for improved drop resistance robustness

Abstract

A drug delivery device includes a housing, a drug storage container, a plunger, a release member, and a back cover. The housing defines a longitudinal axis and has an opening at a distal end thereof. A drug storage container includes a barrel, a stopper, and a delivery member. The plunger is movable toward the distal end of the drug storage container to expel the drug. The release member has a first position in which the release member prevents the plunger from moving to the delivery state and a second position in which the release member does not prevent the plunger from moving to the delivery state. The rear cover is coupled to the housing at a proximal end thereof and is asymmetric about the longitudinal axis to convert a portion of the impact force on the rear cover into a rotational acceleration of the drug delivery device.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 584,978, filed September 25, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to drug delivery devices, and more specifically to a device for automatically injecting drugs into a patient, having a back cover configured to improve drop resistance. Background Technology

[0004] The widespread aversion to exposed needles, along with health and safety concerns, has spurred the development of drug delivery devices, such as syringes and autoinjectors, that conceal the needle or other insertion components before use and automate or semi-automate various aspects of the injection process. These devices offer several advantages compared to traditional forms of drug delivery, including, for example, delivery via conventional syringes.

[0005] Drug delivery devices can incorporate various mechanisms to achieve a range of automated or semi-automated features. These features may include automatic needle covering before and / or after delivery, automatic activation of the drive mechanism, automatic notification to the user that drug delivery is complete, and other features. Some of these features are activated by the application of external force, such as by the user. Such features may be prone to premature or unintentional activation should the drug delivery device be subjected to sudden, unintended forces or movements during manufacturing, transportation, storage, and / or other manipulations of the device.

[0006] For example, if a drug delivery device is dropped from a height and impacts a stationary surface (such as the ground), it may be subjected to considerable impact force. This impact could prematurely activate automated or semi-automated features, causing displacement of one or more components of the drug delivery device, and / or structural damage. The likelihood of this problem increases if the drug delivery device has recently been removed from refrigeration (essential for drug delivery devices containing certain medications). In a cold state, the various components of the drug delivery device may be relatively brittle and therefore susceptible to breakage or damage from sudden impacts. Therefore, there is a need for an improved drug delivery device that enhances drop resistance and reduces the likelihood of unintentional activation, component displacement, and structural damage when subjected to the impact force of a drop.

[0007] This disclosure describes a drug delivery device that implements advantageous alternatives and device housing features to existing drug delivery devices and can address one or more of the challenges or needs mentioned herein. Summary of the Invention

[0008] One aspect of this disclosure provides a drug delivery device including a housing, a drug storage container, a plunger, a release member, and a rear cover. The housing may define a longitudinal axis and have an opening at its distal end. The drug storage container may include a cylinder, a stopper, and a delivery member. The stopper may be movably positioned within the cylinder, and the delivery member may be positioned at the distal end of the cylinder and may have an insertion end configured to extend at least partially through the opening during a delivery state. The plunger may be movable toward the distal end of the drug storage container to engage the stopper and expel drug from the drug storage container through the delivery member. The release member may have a first position and a second position, in which the release member prevents the plunger from moving into the delivery state, and in the second position, the release member does not prevent the plunger from moving into the delivery state. The rear cover is coupled to the housing at its proximal end, and the rear cover is asymmetrical about the longitudinal axis of the housing to convert a portion of the impact force on the rear cover into rotational acceleration of the drug delivery device.

[0009] In some embodiments, the housing may include a tubular housing, and the back cover may be defined at least partially by annular sidewalls and a top surface. In some embodiments, at least a portion of the top surface of the back cover may be generally tilted at a predefined angle relative to a transverse axis perpendicular to the longitudinal axis. In some embodiments, the predefined angle may be between about 5° and about 30° relative to the transverse axis. In other embodiments, the predefined angle may be between about 10° and about 25° relative to the transverse axis. In some embodiments, at least a portion of the top surface may be a linear surface. In other embodiments, at least a portion of the top surface may be a concave surface. In yet another embodiment, at least a portion of the top surface may be a convex surface. In some embodiments, the back cover may include a chamfer connecting the annular sidewalls and the top surface. In some embodiments, the portion of the top surface that is generally tilted at a predefined angle may define a first portion of the top surface, and the top surface may further include a second portion defined by a flat surface parallel to the transverse axis.

[0010] In some embodiments, the top surface of the back cover may be a linear surface. In other embodiments, the top surface of the back cover may be a convex surface. In some embodiments, the back cover may include a protrusion on the top surface, and the protrusion may be offset from the longitudinal axis. The protrusion may generally project away from the top surface of the back cover along the longitudinal axis.

[0011] In some embodiments, the drug delivery device may further include a plunger guide configured to operatively engage the housing and the rear cover. In some embodiments, the plunger may be configured to rotate while translating toward the distal end of the drug storage container.

[0012] In some embodiments, the tubular housing may define a generally cylindrical shape. In other embodiments, the tubular housing may define a non-cylindrical shape, and the outer diameter of the tubular housing may vary along the longitudinal axis. In some embodiments, the housing and the rear cover may be defined by a single integral structure. In some embodiments, the drug delivery device may be an autoinjector.

[0013] Another aspect of this disclosure provides a drug delivery device including a housing, a drug storage container, a plunger, a release member, and a rear cover. The housing may define a longitudinal axis and have an opening at its distal end. The drug storage container may include a cylinder, a stopper, and a delivery member. The stopper may be movably positioned within the cylinder, and the delivery member may be positioned at the distal end of the cylinder and may have an insertion end configured to extend at least partially through the opening during a delivery state. The plunger may be movable toward the distal end of the drug storage container to engage the stopper and expel drug from the drug storage container through the delivery member. The release member may have a first position and a second position, in which the release member prevents the plunger from moving into the delivery state, and in the second position, the release member does not prevent the plunger from moving into the delivery state. The proximal end of the rear cover is coupled to the housing, and the rear cover is asymmetrical about the longitudinal axis of the housing to facilitate or cause rotation of the drug delivery device. Attached Figure Description

[0014] This disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. To illustrate other elements more clearly, some drawings may be simplified by omitting selected elements. Such omission of elements in some drawings does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, except as can be clearly described in the corresponding written description. Furthermore, not all drawings need to be drawn to scale.

[0015] Figure 1A A three-dimensional diagram of a drug delivery device is shown.

[0016] Figure 1B Showing Figure 1A A perspective view of a drug delivery device, in which the needle cap has been removed from the drug delivery device.

[0017] Figure 2 Showing Figure 1A and Figure 1B A cross-sectional view of the drug delivery device in the image.

[0018] Figure 3 The contact points and center of gravity of a drug delivery device with a dome-shaped rear cover and an exemplary drug delivery device with an asymmetrical rear cover according to different embodiments of the present disclosure are shown.

[0019] Figure 4A A perspective view of an exemplary drug delivery device with an exemplary rear cover according to different embodiments of the present disclosure is shown.

[0020] Figure 4B Different embodiments of the present disclosure are shown. Figure 4A Right side view of an exemplary drug delivery device.

[0021] Figure 4C Different embodiments of the present disclosure are shown. Figure 4A and Figure 4B A perspective view of an exemplary back cover.

[0022] Figure 5A A perspective view of an exemplary drug delivery device having another exemplary rear cover according to different embodiments of the present disclosure is shown.

[0023] Figure 5B Different embodiments of the present disclosure are shown. Figure 5A Right side view of an exemplary drug delivery device.

[0024] Figure 5C Different embodiments of the present disclosure are shown. Figure 5A and Figure 5B A perspective view of an exemplary back cover.

[0025] Figure 6A A perspective view of an exemplary drug delivery device having another exemplary rear cover according to different embodiments of the present disclosure is shown.

[0026] Figure 6B Different embodiments of the present disclosure are shown. Figure 6A Right side view of an exemplary drug delivery device.

[0027] Figure 6C Different embodiments of the present disclosure are shown. Figure 6A and Figure 6B A perspective view of an exemplary back cover.

[0028] Figure 7A A perspective view of an exemplary drug delivery device having another exemplary rear cover according to different embodiments of the present disclosure is shown.

[0029] Figure 7B Different embodiments of the present disclosure are shown. Figure 7A Right side view of an exemplary drug delivery device.

[0030] Figure 7C Different embodiments of the present disclosure are shown. Figure 7A and Figure 7B A perspective view of an exemplary back cover.

[0031] Figure 8A A perspective view of an exemplary drug delivery device having another exemplary rear cover according to different embodiments of the present disclosure is shown.

[0032] Figure 8B Different embodiments of the present disclosure are shown. Figure 8A Right side view of an exemplary drug delivery device.

[0033] Figure 8C Different embodiments of the present disclosure are shown. Figure 8A and Figure 8B A perspective view of an exemplary back cover.

[0034] Figure 9A A perspective view of an exemplary drug delivery device having another exemplary rear cover according to different embodiments of the present disclosure is shown.

[0035] Figure 9B Different embodiments of the present disclosure are shown. Figure 9A Right side view of an exemplary drug delivery device.

[0036] Figure 9C Different embodiments of the present disclosure are shown. Figure 9A and Figure 9B A perspective view of an exemplary back cover.

[0037] Figure 10 The graphs show the relative displacement between the release member and the protective extension after a vertical drop impact, according to different embodiments of the present disclosure, over time.

[0038] Figure 11 A front view of an exemplary drug delivery device having another exemplary rear cover, according to different embodiments of the present disclosure, is shown.

[0039] Figure 12 A front view of an exemplary drug delivery device having another exemplary rear cover, according to different embodiments of the present disclosure, is shown. Detailed Implementation

[0040] 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, self-administer a drug. Various features are disclosed, such as an asymmetrical rear cover, which is used to convert the linear velocity of the drug delivery device into rotation of the device after a vertical drop. The asymmetrical rear cover is configured to create a distance between the point of contact of the rear cover due to the drop and the center of gravity of the device (also referred to as the “axis center”), in order to convert a portion of the linear velocity into rotational acceleration of the device. These features, along with other features, work together and / or interact with each other to reduce any displacement of one or more components in the drug delivery device after a drop impact, and thus increase the robustness of the drug delivery device. These and other advantages will be apparent to those skilled in the art upon review of this disclosure. As used herein, the terms “rear cover” and “rear end cap” are used interchangeably.

[0041] The currently disclosed back cover converts the linear momentum and impact force generated by a drop of the drug delivery device into rotational acceleration, thereby causing the device to rotate. Additionally, upon a drop, the currently disclosed back cover creates a distance between the contact point of the back cover and the center of gravity of the device. Accordingly, these features of the currently disclosed back cover can prevent or inhibit the activation of one or more automatic or semi-automatic features included in the drug delivery device (e.g., including a drive mechanism for discharging the drug, a release device, etc.). Furthermore, these features of the currently disclosed back cover can prevent or inhibit damage to the drug delivery device that would otherwise be caused by externally applied forces due to a drop. For example, in the event of an accidental drop by a user, the back cover can reduce the likelihood of breakage or cracking in the cover and / or other parts of the drug delivery device. Additionally, these features of the currently disclosed back cover can reduce displacement of one or more components of the drug delivery device due to externally applied forces. These and other advantages will be apparent to those skilled in the art upon review of this disclosure.

[0042] Figures 1A to 1B as well as Figure 2 Several views of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a pharmaceutical agent or pharmaceutical product, are shown. The drug may be, but is not limited to, various biological agents, such as peptides, peptide bodies, or antibodies. The drug may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0043] Various implementations and configurations of the drug delivery device 10 are possible. The drug delivery device 10 can be configured as a disposable syringe. In other embodiments, the drug delivery device 10 can be configured as a reusable syringe for multiple uses. The drug delivery device 10 can be operable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a physician or nurse). The drug delivery device 10 can take the form of an auto-injector or a pen syringe and can therefore be held in the user's hand during drug delivery.

[0044] The configuration of the different components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a pre-injection or storage state, an injection or administration state, and a post-injection state, but fewer or more states are also possible. The pre-injection state may correspond to the configuration of the drug delivery device 10 after assembly and before it is activated by the user. In some embodiments, the pre-injection state may exist between the time the drug delivery device 10 leaves the manufacturing facility and the time the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the time after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 against the injection site. The injection 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-injection state may correspond to the configuration of the drug delivery device 10 after drug delivery has been completed and / or when the stopper is positioned at the end-of-administration position in the drug storage container.

[0045] like Figure 1A and Figure 1B As shown, 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 hold the syringe 10 with one hand. The casing 12 may have a generally elongated tubular shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between the proximal and distal ends of the casing 12. In some embodiments, the casing 12 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. An opening 14 may be formed at the distal end ( Figure 2 ) to allow the insertion end 28 of the delivery component 16 ( Figure 2 ) extends to the outside of housing 12. Transparent or semi-transparent inspection window 17 ( Figure 1A and Figure 1BThe device 10 can be positioned within the wall of housing 12 to allow a user to observe the internal components of the drug delivery device 10, including the drug storage container 20. Observing the drug storage container 20 through window 17 allows the user to confirm that drug delivery is in progress and / or complete. A removable cover 19 can cover opening 14 before use of the drug delivery device 10, and in some embodiments, may include a clamp 13. Figure 2 The gripper is configured to assist in removing a sterile barrier 21 (e.g., a rigid needle shield (RNS) or a non-rigid needle shield (nRNS)) 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. Therefore, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0046] like Figure 2 As shown, the drive mechanism 30 may be partially or completely housed within the housing 12. Typically, the drive mechanism 30 may be configured to store energy and, upon or in response to user activation, release or output that energy to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 into the patient. In the current embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may be configured differently, for example, where the drive mechanism 30 stores electrical or chemical potential energy. Typically, when activated, the drive mechanism 30 can convert potential energy into kinetic energy to move the plunger 26. The drive mechanism 30 may include a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, a release member 52, a plunger guide 60, an extended biasing member 35, and a protective extension 37. The plunger biasing member 50 may include a spring, such as a compression spring (e.g., a helical compression spring), initially held in a stored state. In the stored state, the plunger biasing member 50 can be compressed such that its axial length is shorter than its axial length in the unloaded or deloaded state. When released, the plunger biasing member 50 may attempt to extend to its unloaded axial length, and thus apply a biasing force pushing the plunger 26 in the distal direction. In other embodiments, the plunger biasing member 50 may include a torsion spring initially held in a stored state. When released, the plunger biasing member 50 may rotate, and thus cause the plunger 26 to rotate while translating distally.

[0047] like Figure 2As shown, the drug delivery device 10 may include a housing 12, which may include two separate and interconnected structures: a rear end cap 23 (e.g., a back cover) at the proximal end of the drug delivery device 10, and a tubular housing 25 extending substantially entirely along the length of the drug delivery device 10 and defining an opening 14. Additionally or alternatively, the housing 12 may include fewer or more components. 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 or hollow cylindrical shape with an open end and a closed end. In some embodiments, the housing 25 and / or the rear end cap 23 may have a non-cylindrical shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In some embodiments, the rear end cap 23 and the tubular housing 25, along with any components to be positioned therein, may be assembled together to define different sub-assemblies, such as a drive mechanism 30. In some embodiments, the different sub-assemblies are assembled independently of each other and subsequently combined with each other and with a drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the assembly stages described above can be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 can be constructed as a single piece, such that the housing 12 is defined by a single integral structure that integrates the rear cover 23 and the tubular housing 25 into a single component.

[0048] A drug storage container 20 is disposed within the internal space of the housing 12 and configured to contain a drug 22. The drug storage container 20 may be pre-filled and transported by the manufacturer, for example, to a location where it will be combined with the rest 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 automated injection device including a pre-filled syringe. By utilizing the same or similar syringe components in either case, at least one of the above steps (e.g., filling, labeling, packaging, transporting, and dispensing) can be simplified or streamlined 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 drugs can be simplified or streamlined for at least one of the multiple use cases.

[0049] The housing 12 may be pre-loaded with the drug storage container 20 by the manufacturer, or alternatively, by the user before using the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal orifice or reservoir. This wall may be made of glass or plastic. A stopper 24 may be movably disposed in the drug storage container 20 such that the stopper is movable distally along the longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the inner surface 15 of the wall of the drug storage container 20, thereby preventing or inhibiting leakage of the drug 22 through the stopper 24 during movement. Distal movement of the stopper 24 displaces the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 may be open to allow a plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In the current embodiment, the plunger 26 and the plug 24 are initially separated by a gap 18 ( Figure 2 The plunger 26 and the stopper 24 are spaced apart from each other. When the drive mechanism 30 is activated, the plunger 26 moves distally to reduce the gap and contact the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally to displace the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially contact each other or be connected to each other, for example via a threaded connection, such that they move together from the moment the plunger 26 begins to move. Once the stopper 24 has moved, it may continue to move distally until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may be referred to as the end of dosing or delivery position and may correspond to the time when the delivery of the drug 22 to the patient is completed or substantially completed.

[0050] In some embodiments, the volume of drug 22 included in the reservoir of 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%) 1-10 mL, or in the range of about (e.g., ± 10%) 1-5 mL, or in the range of about (e.g., ± 10%) 1-4 mL. The range is between 1 and 3 mL, or between approximately (e.g., ±10%) 1 to 2.5 mL.

[0051] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28. The insertion end 28 may include other sharp tips with pointed geometries, thereby allowing the insertion end 28 to pierce the patient's skin 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.

[0052] In one embodiment, the drug storage container 20 may be a pre-filled syringe with 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 this embodiment, the drug storage container 20 may be moved toward the proximal end of the delivery member 16 during operation of the drug delivery device 10, or conversely, such that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening on the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0053] The drug storage container 20 may include a body portion 20g having a distal end 20e and a proximal end 20f. The drug storage container 20 may be fixed relative to the housing 12 such that once installed in the housing 12, it will not move relative to the housing 12. Thus, in the pre-injection state, the injection state, and the post-injection state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 on the housing 12. For example, as... Figure 2 As shown, the delivery member 16 extends beyond the distal end of the housing 12 defining the opening 14. However, in some configurations, such as Figure 2 In the storage configuration shown, the delivery member 16 is covered / protected by a sterile barrier 21 and a protective member 32 that surrounds the delivery member 16 and prevents or reduces the likelihood of accidental or premature needlestick injuries, as described in more detail below. As used herein, the term "body portion" of the drug storage container 20 refers to the generally cylindrical portion of the drug storage container 20.

[0054] like Figure 2 As shown, the plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end (which abuts against the proximal inner surface of the plunger 26) and / or may be fixedly attached to the inner surface of the plunger 26. Such that the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 may be equal to or less than the inner diameter of the top ring 45, and / or equal to or less than the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut against the proximal inner surface of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut against the distal surface 38a of the plunger biasing member seat 38. The plunger biasing member seat 38 may be fixedly attached to the rear housing 27 such that the plunger biasing member seat 38 provides a retaining surface to push the plunger biasing member 50 away. In this configuration, the plunger biasing member 50 can extend in length when released from the stored state, wherein the distal end of the plunger biasing member 50 moves in a distal direction away from the fixed proximal end of the plunger biasing member 50. This movement can push the plunger 26 in a distal direction, which in turn can push the stopper 24 in a distal direction to expel the drug 22 from the drug storage container 20 into the delivery member 16 and thereby into the patient.

[0055] The plunger guide 60 can be fixedly attached to the rear housing 27 such that the plunger guide 60 is immovable relative to the rear housing 27. The plunger guide 60 can have a hollow and generally cylindrical or tubular shape, and can be centered on the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger guide 60 can be larger than the outer diameter or other outer dimension of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 can be radially positioned between the plunger 26 and the release member 52. Thus, the plunger 26 can be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 can be at least partially disposed within the release member 52, such as... Figure 2 As shown.

[0056] The release member 52 may be hollow and generally cylindrical or tubular in shape, and may be centered on the longitudinal axis A. For example... Figure 2 As shown, the release member 52 can be positioned radially between the distal end of the plunger guide 60 and the proximal end of the protective extension 37. Furthermore, the release member 52 can be arranged radially inside the protective bias member 35. Typically, the release member 52 is configured to operatively engage the protective member 32 and the plunger 26 in an activation sequence and generate an audible signal indicating the end of drug delivery.

[0057] The release member 52 can be configured to rotate and / or translate linearly relative to the housing 12 according to the operational phase of the drug delivery device 10. Initial rotation of the release member 52 associated with activation can be powered by the plunger biasing member 50 and / or the protective biasing member 35; while subsequent rotation of the release member 52 associated with the generation of an end-of-dosing signal can be powered solely by the protective biasing member 35. Any linear translation of the release member 52 without rotation can be powered solely by the protective biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction; however, alternative embodiments may permit linear translation of the release member 52 in both the proximal and distal directions.

[0058] As described above, the drug delivery device 10 may further include a protective mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used for injection. The protective mechanism may include a protective member 32 movably disposed at the distal end of the housing 12 adjacent to the opening 14. The protective member 32 may have a hollow, generally cylindrical or tubular shape centered on the longitudinal axis A. The protective member 32 typically includes a cylindrical portion 32a, a distal end 32c, and a proximal end 32d. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. For example, the protective member 32 may be configured to move relative to the housing 12 such that portions of the protective member 32 are received within the housing 12 in some stages / states and extend from the housing 12 in other stages / states.

[0059] The protective member 32 can be configured to move relative to the housing 12 between an extended position and a retracted position. In the extended position, at least a portion of the cylindrical portion 32a of the protective member 32 extends through the opening 14 on the housing 12. In the retracted position, a shorter length of the cylindrical portion 32a extends through the opening 14 on the housing 12, or no portion of the cylindrical portion 32a extends through the opening on the housing.

[0060] During operation of the device, the user can move the protective member 32 (relative to the housing 12) proximally by pressing it against the injection site. In doing so, the protective member 32 will move toward the protective extension 37 and close the gap 37g therebetween. Figure 2 Once the gap 37g is eliminated, the protective member 32 and the protective extension 37 move together in a proximal direction until, for example, the protective member 32 reaches a retracted position. When the injection is completed and the drug delivery device 10 is lifted away from the injection site, the extension biasing member 35 can advance the protective extension 37, causing the protective extension 37 and the protective member 32 to move together in a distal direction. This movement (and / or the biasing force from the locking ring biasing member 51) returns the protective member 32 to the extended position, which has the effect of covering the insertion end 28 of the delivery member 16.

[0061] like Figure 2As shown, the drug delivery device 10 may include a rear end cap 23 (e.g., a back cover) at the proximal end of the drug delivery device 10. The rear end cap 23 may be centered about the longitudinal axis A and be dome-shaped, such that the rear end cap 23 is symmetrical about the longitudinal axis A. However, such a dome-shaped back cover (such as the rear end cap 23 of the drug delivery device 10) may not be robust enough, and when dropped from a vertical height, the dome-shaped back cover may cause the impact force to be transmitted to various components within the device 10. Accordingly, when dropped, the drug delivery device 10 with the dome-shaped rear end cap 23 may be prone to damage to components of the device 10 and / or unintentional activation of the device. As an example, the drug delivery device 10 being dropped with the longitudinal axis A parallel or substantially parallel to the direction of gravity and the rear end cap 23 generally facing downwards may cause the release member 52 to move proximally (towards the rear end cap 23) due to the deceleration associated with the drug delivery device 10 impacting the ground. Figure 2 (In the upward direction) and / or retract the protective member 32 into the housing 12. Any one or both of these exemplary movements could potentially trigger the drive mechanism 30, resulting in unintended and / or premature injection. Additionally or alternatively, deceleration could cause the locking ring 40 to rotate or otherwise move to a position that prevents the protective member 32 from subsequently retracting. This could then prematurely lock the protective member 32, thereby preventing the user from using the drug delivery device 10 to perform the injection.

[0062] As a more specific example of the potential adverse consequences of the drug delivery device 10 falling, if the device 10 falls with the rear cover 23 facing down, most or all of the components of the device 10 travel and accelerate at approximately the same rate. However, when the rear cover 23 impacts the ground or other surface, the housing 12 will decelerate before or at a faster rate than other internal components (such as the release member 52 and / or the protective member 32). In other words, upon impact, the housing will stop falling abruptly with a relatively large deceleration, while some of the other internal components will still travel and / or accelerate toward the ground. Due to the relatively large difference (“acceleration difference”) between the deceleration of the housing and the acceleration of the other internal components, the release member 52 and / or the protective member 32 may move proximally (towards the rear cover 23) within the housing 12 at or immediately after impact. Figure 2 The device moves in an upward direction, potentially triggering an injection sequence. Therefore, it may be advantageous to provide a back cover that provides enhanced drop resistance, such that in the event that the drug delivery device 10 is accidentally dropped from a height and the back cover hits the ground at a considerable speed, the back cover can prevent or inhibit activation of one or more features within the device 10 and / or prevent or inhibit damage to one or more components of the device 10.

[0063] In one embodiment, it may be advantageous to provide a rear end cap that is asymmetrical about the longitudinal axis A. For example, Figure 3 The differences between a drug delivery device 10 with a dome-shaped rear cover 23 according to different embodiments of the present disclosure and a drug delivery device 100 with a rear cover 123 that is asymmetrical about the longitudinal axis A are illustrated. (Refer to the above text) Figures 1A to 1B and Figure 2 The discussed drug delivery device 10 includes a housing 12, a rear cover 23 disposed at the proximal end of the housing 12, and a removable cover 19 disposed at the distal end of the housing 12. According to different embodiments of the present disclosure, the drug delivery device 100 includes a housing 112, a rear cover 123 disposed at the proximal end 112e of the housing 112, and a removable cover 119 disposed at the distal end 112f of the housing 112.

[0064] like Figure 3 As shown, when the drug delivery device 10 is accidentally dropped from a certain height and the rear cover 23 contacts the ground 70 at point P1 with a considerable speed, the contact point P1 is aligned with the center of gravity C1 of the drug delivery device 10. Accordingly, the impact force of the impact on the ground 70 is directly transmitted through the center of gravity C1 of the drug delivery device 10. On the other hand, when the drug delivery device 100 with the asymmetrical rear cover 123 is accidentally dropped from a certain height and the rear cover 123 contacts the ground 70 at point P2 with a considerable speed, the contact point P2 moves outward toward the outer diameter of the device 100 compared to the contact point P1 of the device 10. Accordingly, the impact force is transmitted toward the outer diameter of the drug delivery device 100, rather than directly through the center of gravity C2 of the device 100. In addition, a portion of the impact force is converted into rotational acceleration or torque T of the drug delivery device 100, causing the drug delivery device 100 to rotate after impacting the ground 70.

[0065] Tests were conducted to determine whether the asymmetrical rear cover 123 of the drug delivery device 100, compared to the dome-shaped rear cover 23 of the drug delivery device 10, reduced the likelihood of damage to one or more components of the drug delivery device 100 and / or accidental activation. Regarding the test setup, a drop tester was used to assess the devices' ability to withstand impact forces. Five drug delivery devices 10 and five drug delivery devices 100 were each dropped from heights of 1.3 m, 1.45 m, 1.6 m, and 1.75 m onto a granite surface (the maximum height of the drop tester was 1.75 m). Based on the drop test results, the dome-shaped rear cover (such as the rear cover 23 of the drug delivery device 10) failed even at a low height of 1.3 m, while the angled or asymmetrical rear cover (such as the rear cover 123) could withstand repeated drops from all heights (i.e., 1.3 m, 1.45 m, 1.6 m, and 1.75 m).

[0066] Now go to Figures 4A to 4CThe drug delivery device 100 with an asymmetrical rear cover 123 will be described in more detail below. The drug delivery device 100 may include the components described above. Figures 1A to 1B as well as Figure 2 The same components constituting the drug delivery device 10 are discussed. For example, the drug delivery device 100 may include a drive mechanism 30, a drug storage container 20, a delivery member 16, a release member 52, and other components described above with respect to the drug delivery device 10.

[0067] like Figures 4A to 4C As shown, the drug delivery device 100 includes a housing or casing 112. Like the casing 12, the casing 112 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 112e and a distal end 112f. In some embodiments, the casing 112 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 112 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 112e and a distal end 112f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 117 may be positioned on the wall of the casing 112 to allow a user to observe components inside the drug delivery device 100, including a drug storage container 120 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 132 prior to use of the drug delivery device 100. As discussed above, the drug delivery device 100 may also include a rear end cap 123 (also referred to as a “rear cap”) at the proximal end 112e of the drug delivery device 100. The rear cap 123 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 123 may be assembled with the housing 112 to define the drug delivery device 100. In some embodiments, the rear cap 123 may be removably coupled to the housing 112 at the proximal end 112e of the housing 112. In other embodiments, the rear cap 123 and the housing 112 may be integrally formed to define a single, monolithic structure.

[0068] The rear cover 123 may be defined by a generally annular or cylindrical sidewall 125 and a top surface 124 (also referred to as "top wall"). In some embodiments, the rear cover 123 may further include a chamfer 126 connecting the annular sidewall 125 and the top surface 124. In other embodiments, the rear cover 123 may include a rounded edge connecting the annular sidewall 125 and the top surface 124. Unlike the rear cover 23, the rear cover 123 may be about the longitudinal axis A of the housing 112 ( Figure 4B(As shown) is asymmetrical, such that at least a portion of the top surface 124 of the rear cover 123 is generally inclined, sloped, or beveled. For example, the top surface 124 may be generally relative to the transverse axis B perpendicular to the longitudinal axis A (…). Figure 4B (As shown) a predefined angle "a" is tilted. The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. Additionally, at least a portion of the top surface 124 of the rear cover 123 may be a non-linear surface. For example, as... Figures 4A to 4C As shown, the top surface 124 can be a convex surface.

[0069] The asymmetrical, generally inclined shape and angle of the top surface 124 of the rear cover 123 can be configured to allow the rear cover 123 to convert at least a portion of the impact force on the rear cover 123 into rotational speed or acceleration of the drug delivery device 100. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of the top surface 124 of the rear cover 123 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 100, causing the device 100 to rotate to one side after the initial impact with the ground 70. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 100, such that not all of the impact force is directly transmitted through the center of gravity C2 of the device 100 (e.g., ...). Figure 3 (As shown). Accordingly, even if the drug delivery device 100 is accidentally dropped, the asymmetrical rear cover 123 can prevent or inhibit the accidental activation of one or more components (such as the drive mechanism 30) within the device 100, reduce the relative displacement between one or more components within the device 100, and prevent or inhibit structural damage to the device 100. In addition, the generally convex shape of the top surface 124 can increase the comfort of the user when holding the device 100 during injection.

[0070] Figures 5A to 5CAnother exemplary drug delivery device 200 with a different asymmetrical rear cover 223 according to various embodiments of the present disclosure is shown. The drug delivery device 200 includes a housing or casing 212. The casing 212 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 212e and a distal end 212f. In some embodiments, the casing 212 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 212 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 212e and a distal end 212f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 217 may be positioned on the wall of the casing 212 to allow a user to observe components inside the drug delivery device 200, including a drug storage container 220 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 232 prior to use of the drug delivery device 200. As discussed above, the drug delivery device 200 may also include a rear end cap 223 (also referred to as a “rear cap”) at the proximal end 212e of the drug delivery device 200. The rear cap 223 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 223 may be assembled with the housing 212 to define the drug delivery device 200. In some embodiments, the rear cap 223 may be removably coupled to the housing 212 at the proximal end 212e of the housing 212. In other embodiments, the rear cap 223 and the housing 212 may be integrally formed to define a single, monolithic structure.

[0071] The rear cover 223 may be defined by a generally annular or cylindrical sidewall 225 and a top surface 224 (also referred to as "top wall"). In some embodiments, the rear cover 223 may further include a rounded edge 226 connecting the annular sidewall 225 and the top surface 224. In other embodiments, the rear cover 223 may further include a chamfer (similar to chamfer 126) connecting the annular sidewall 225 and the top surface 224. The rear cover 223 may be defined about the longitudinal axis A of the housing 212 ( Figure 5B As shown, the top surface 224 of the rear cover 223 is asymmetrical, such that at least a portion of it is generally inclined, sloped, or beveled. For example, the top surface 224 may be generally inclined relative to the transverse axis B perpendicular to the longitudinal axis A. Figure 5B(As shown) tilted at a predefined angle "a". The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. Additionally, at least a portion of the top surface 224 of the rear cover 223 may be a non-linear surface. For example, as... Figures 5A to 5C As shown, the top surface 224 can be a concave surface.

[0072] The asymmetrical, generally inclined shape and angle of the top surface 224 of the rear cover 223 can be configured to allow the rear cover 223 to convert at least a portion of the impact force on the rear cover 223 into rotational speed or acceleration of the drug delivery device 200. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of the top surface 224 of the rear cover 223 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 200, causing the device 200 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 200, so that not all impact force is transmitted directly through the center of gravity of the device 200. Accordingly, even when the drug delivery device 200 is accidentally dropped, the asymmetrical rear cover 223 can prevent or suppress accidental activation of one or more components within the device 200 (such as the drive mechanism 30), reduce relative displacement between one or more components within the device 200, and prevent or suppress structural damage to the device 200. In addition, the overall concave shape of the top surface 224 can increase the user's comfort when holding the device 200 during injection.

[0073] Figures 6A to 6CAnother exemplary drug delivery device 300 with a different asymmetrical rear cover 323 according to various embodiments of the present disclosure is shown. The drug delivery device 300 includes a housing or casing 312. The casing 312 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 312e and a distal end 312f. In some embodiments, the casing 312 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 312 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 312e and a distal end 312f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 317 may be positioned on the wall of the casing 312 to allow a user to observe components inside the drug delivery device 300, including a drug storage container 320 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 332 prior to use of the drug delivery device 300. As discussed above, the drug delivery device 300 may also include a rear end cap 323 (also referred to as a “rear cap”) at the proximal end 312e of the drug delivery device 300. The rear cap 323 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 323 may be assembled with the housing 312 to define the drug delivery device 300. In some embodiments, the rear cap 323 may be removably coupled to the housing 312 at the proximal end 312e of the housing 312. In other embodiments, the rear cap 323 and the housing 312 may be integrally formed to define a single, monolithic structure.

[0074] The rear cover 323 may be defined by a generally annular or cylindrical sidewall 325 and a top surface 324 (also referred to as "top wall"). In some embodiments, the rear cover 323 may further include a rounded edge 326 connecting the annular sidewall 325 and the top surface 324. In other embodiments, the rear cover 323 may further include a chamfer (similar to chamfer 126) connecting the annular sidewall 325 and the top surface 324. The rear cover 323 may be positioned relative to the longitudinal axis A of the housing 312 ( Figure 6B As shown, the top surface 324 of the rear cover 323 is asymmetrical, such that at least a portion of it is generally inclined, sloped, or beveled. For example, the top surface 324 may be generally inclined relative to the transverse axis B perpendicular to the longitudinal axis A (as shown). Figure 6B(As shown) tilted at a predefined angle "a". The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. Additionally, at least a portion of the top surface 324 of the back cover 323 may be a non-linear surface. For example, as... Figures 6A to 6C As shown, the top surface 324 can be a convex surface.

[0075] The asymmetrical, generally inclined shape and angle of the top surface 324 of the rear cover 323 can be configured to allow the rear cover 323 to convert at least a portion of the impact force on the rear cover 323 into rotational speed or acceleration of the drug delivery device 300. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of the top surface 324 of the rear cover 323 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 300, causing the device 300 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 300, so that not all impact force is transmitted directly through the center of gravity of the device 300. Accordingly, even when the drug delivery device 300 is accidentally dropped, the asymmetrical rear cover 323 can prevent or suppress accidental activation of one or more components within the device 300 (such as the drive mechanism 30), reduce relative displacement between one or more components within the device 300, and prevent or suppress structural damage to the device 300. In addition, the overall convex shape of the top surface 324 can increase the user's comfort when holding the device 300 during injection.

[0076] Figures 7A to 7CAnother exemplary drug delivery device 400 with a different asymmetrical rear cover 423 according to various embodiments of the present disclosure is shown. The drug delivery device 400 includes a housing or casing 412. The casing 412 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 412e and a distal end 412f. In some embodiments, the casing 412 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 412 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 412e and a distal end 412f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 417 may be positioned on the wall of the casing 412 to allow a user to observe components inside the drug delivery device 400, including a drug storage container 420 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 432 prior to use of the drug delivery device 400. As discussed above, the drug delivery device 400 may also include a rear end cap 423 (also referred to as a “rear cap”) at the proximal end 412e of the drug delivery device 400. The rear cap 423 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 423 may be assembled with the housing 412 to define the drug delivery device 400. In some embodiments, the rear cap 423 may be removably coupled to the housing 412 at the proximal end 412e of the housing 412. In other embodiments, the rear cap 423 and the housing 412 may be integrally formed to define a single, monolithic structure.

[0077] The rear cover 423 may be defined by a generally annular or cylindrical sidewall 425 and a top surface 424 (also referred to as "top wall"). In some embodiments, the rear cover 423 may further include a rounded edge 426 connecting the annular sidewall 425 and the top surface 424. In other embodiments, the rear cover 423 may further include a chamfer (similar to chamfer 126) connecting the annular sidewall 425 and the top surface 424. The rear cover 423 may be positioned relative to the longitudinal axis A of the housing 412 ( Figure 7B (As shown) Asymmetry, such that at least a portion of the top surface 424 of the rear cover 423 is generally inclined, sloped, or beveled. For example... Figures 7A to 7C As shown, in some embodiments, the top surface 424 of the rear cover 423 may include a first portion 424a and a second portion 424b. The first portion 424a of the top surface 424 may be generally inclined, sloped, or beveled. For example, the first portion 424a of the top surface 324 may be relative to the transverse axis B perpendicular to the longitudinal axis A ( Figure 7B(As shown) is generally tilted at a predefined angle "a". The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. The second portion 424b of the top surface 424 may be flat and parallel to the lateral axis B. Although Figures 7A to 7C A top surface 424 comprising two portions 424a and 424b is shown, but in other embodiments, the top surface 424 may be divided into more than two portions, such as three, four, five, six, seven, eight, nine, or ten portions. In some embodiments, such as Figures 7A to 7C As shown, the first portion 424a and the second portion 424b of the top surface 424 can be generally flat and linear. In other embodiments, at least a portion of the top surface 424 can be a non-linear surface. For example, at least a portion of the top surface 424 (such as the first portion 424a and / or the second portion 424b) can be concave or convex.

[0078] The asymmetrical, generally inclined shape and angle of at least a first portion 424a of the top surface 424 of the rear cover 423 can be configured to allow the rear cover 423 to convert at least a portion of the impact force on the rear cover 423 into rotational speed or acceleration of the drug delivery device 400. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of at least a first portion 424a of the top surface 424 of the rear cover 423 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 400, causing the device 400 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed toward the outer diameter of the drug delivery device 400, such that not all the impact force is transmitted directly through the center of gravity of the device 400. Accordingly, even if the drug delivery device 400 is accidentally dropped, the asymmetrical rear cover 423 can prevent or suppress the accidental activation of one or more components (such as the drive mechanism 30) within the device 400, reduce the relative displacement between one or more components within the device 400, and prevent or suppress structural damage to the device 400.

[0079] Figures 8A to 8CAnother exemplary drug delivery device 500 with a different asymmetrical rear cover 523 according to various embodiments of the present disclosure is shown. The drug delivery device 500 includes a housing or casing 512. The casing 512 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 512e and a distal end 512f. In some embodiments, the casing 512 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 512 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 512e and a distal end 512f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 517 may be positioned on the wall of the casing 512 to allow a user to observe components inside the drug delivery device 500, including a drug storage container 520 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 532 prior to use of the drug delivery device 500. As discussed above, the drug delivery device 500 may also include a rear end cap 523 (also referred to as a “rear cap”) at the proximal end 512e of the drug delivery device 500. The rear cap 523 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 523 may be assembled with the housing 512 to define the drug delivery device 500. In some embodiments, the rear cap 523 may be removably coupled to the housing 512 at the proximal end 512e of the housing 512. In other embodiments, the rear cap 523 and the housing 512 may be integrally formed to define a single, monolithic structure.

[0080] The rear cover 523 may be defined by a generally annular or cylindrical sidewall 525 and a top surface 524 (also referred to as "top wall"). In some embodiments, the rear cover 523 may further include a rounded edge 526 connecting the annular sidewall 525 and the top surface 524. In other embodiments, the rear cover 523 may further include a chamfer (similar to chamfer 126) connecting the annular sidewall 525 and the top surface 524. The rear cover 523 may be positioned relative to the longitudinal axis A of the housing 512 ( Figure 8B (As shown) asymmetry, such that at least a portion of the top surface 524 of the rear cover 523 is generally inclined, sloped, or beveled. For example, the top surface 524 may be generally relative to the transverse axis B perpendicular to the longitudinal axis A (…). Figure 8B(As shown) tilted at a predefined angle "a". The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. Additionally, at least a portion of the top surface 524 of the rear cover 523 may be a non-linear surface. For example, as... Figures 8A to 8C As shown, the top surface 524 can be a concave surface.

[0081] The asymmetrical, generally inclined shape and angle of the top surface 524 of the rear cover 523 can be configured to allow the rear cover 523 to convert at least a portion of the impact force on the rear cover 523 into rotational speed or acceleration of the drug delivery device 500. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of the top surface 524 of the rear cover 523 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 500, causing the device 500 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 500, so that not all impact force is transmitted directly through the center of gravity of the device 500. Accordingly, even when the drug delivery device 500 is accidentally dropped, the asymmetrical rear cover 523 can prevent or suppress accidental activation of one or more components within the device 500 (such as the drive mechanism 30), reduce relative displacement between one or more components within the device 500, and prevent or suppress structural damage to the device 500. In addition, the overall concave shape of the top surface 524 can increase the user's comfort when holding the device 500 during injection.

[0082] Figures 9A to 9CAnother exemplary drug delivery device 600 with a different asymmetrical rear cover 623 according to various embodiments of the present disclosure is shown. The drug delivery device 600 includes a housing or casing 612. The casing 612 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 612e and a distal end 612f. In some embodiments, the casing 612 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 612 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 612e and a distal end 612f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 617 may be positioned on the wall of the casing 612 to allow a user to observe components inside the drug delivery device 600, including a drug storage container 620 (similar to drug storage container 20). Although not shown, a removable cap (such as removable cap 19) may cover the needle shield 632 prior to use of the drug delivery device 600. As discussed above, the drug delivery device 600 may also include a rear end cap 623 (also referred to as a “rear cap”) at the proximal end 612e of the drug delivery device 600. The rear cap 623 may have a hollow cylindrical shape having an open end and a closed end. The rear cap 623 may be assembled with the housing 612 to define the drug delivery device 600. In some embodiments, the rear cap 623 may be removably coupled to the housing 612 at the proximal end 612e of the housing 612. In other embodiments, the rear cap 623 and the housing 612 may be integrally formed to define a single, monolithic structure.

[0083] The rear cover 623 may be defined by a generally annular or cylindrical sidewall 625 and a top surface 624 (also referred to as the "top wall"). The rear cover 623 may be defined relative to the longitudinal axis A of the housing 612. Figure 9B As shown, the top surface 624 of the rear cover 623 is asymmetrical, such that at least a portion of it is generally inclined, sloped, or beveled. For example, the top surface 624 may be generally inclined relative to the transverse axis B perpendicular to the longitudinal axis A (as shown). Figure 9B (As shown) tilted at a predefined angle "a". The predefined angle "a" may be between about 5° and about 50° relative to the lateral axis B. In some embodiments, the predefined angle "a" may be between about 5° and about 30° relative to the lateral axis B. In other embodiments, the predefined angle "a" may be between about 10° and about 25° relative to the lateral axis B. In some embodiments, at least a portion of the top surface 624 of the back cover 623 may be a linear surface. For example, the top surface 624 may be a generally flat and linear surface.

[0084] The asymmetrical, generally inclined shape and angle of the top surface 624 of the rear cover 623 can be configured to allow the rear cover 623 to convert at least a portion of the impact force on the rear cover 623 into rotational speed or acceleration of the drug delivery device 600. As a more specific example, in the event of a fall from a height, the generally inclined shape and angle of the top surface 624 of the rear cover 623 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 600, causing the device 600 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 600, so that not all impact force is transmitted directly through the center of gravity of the device 600. Accordingly, even when the drug delivery device 600 is accidentally dropped, the asymmetrical rear cover 623 can prevent or suppress accidental activation of one or more components within the device 600 (such as the drive mechanism 30), reduce relative displacement between one or more components within the device 600, and prevent or suppress structural damage to the device 600.

[0085] Now go to Figure 10 The diagram shows a graph illustrating the change over time in the relative displacement between a release member (e.g., release member 52) and a protective extension (e.g., protective extension 37) after the drug delivery devices 10, 100, 200, 300, 400, 500, and 600 have been vertically dropped from the same drop height. Figure 10 Comparative analysis shows that all drug delivery devices 100, 200, 300, 400, 500, and 600, with asymmetrical rear covers 123, 223, 323, 423, 523, and 623 respectively, provided better performance than drug delivery device 10 with dome-shaped rear cover 23 during drop tests. That is, when all devices are dropped from the same height, each of drug delivery devices 100, 200, 300, 400, 500, and 600 exhibits less relative displacement between the release member and the protective extension within the housing than drug delivery device 10. Comparative analysis shows that the height (also known as the "drop height") required to induce sufficient relative displacement within the housing to activate the device for drug delivery devices 100, 200, 300, 400, 500, and 600 is greater than that for drug delivery device 100. Therefore, Figure 10 Comparative analysis shows that when the device is accidentally dropped from a certain vertical height, drug delivery devices 100, 200, 300, 400, 500 and 600, which have asymmetrical rear covers 123, 223, 323, 423, 523 and 623 respectively, can reduce the possibility of unintentional activation due to the relative displacement of one or more components within the housing, compared with drug delivery device 10, which has a dome-shaped symmetrical rear cover 23.

[0086] In some embodiments, the back cover may include a protrusion, lip, or any similar feature on the top surface of the back cover such that the back cover is asymmetrical about the longitudinal axis A. For example, Figure 11 A drug delivery device 700 with a dome-shaped rear end cap 723, including a protrusion 730, is shown according to different embodiments of the present disclosure. The drug delivery device 700 includes a housing or casing 712. The casing 712 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 712e and a distal end 712f. In some embodiments, the casing 712 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 712 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 712e and a distal end 712f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 717 may be positioned within the wall of the casing 712 to allow a user to observe components inside the drug delivery device 700, including a drug storage container 720. A removable cap 719 can cover a needle shield, such as needle shield 32, before use of the drug delivery device 700. As discussed above, the drug delivery device 700 may also include a rear end cap 723 (also referred to as a "rear cover") at the proximal end 712e of the drug delivery device 700. The rear cover 723 may have a hollow cylindrical shape having an open end and a closed end. The rear cover 723 may be assembled with the housing 712 to define the drug delivery device 700. In some embodiments, the rear cover 723 may be removably coupled to the housing 712 at the proximal end 712e of the housing 712. In other embodiments, the rear cover 723 and the housing 712 may be integrally formed to define a single integral structure.

[0087] The rear cover 723 may be defined by generally annular or cylindrical sidewalls 725 and a dome-shaped or convex top surface 724 (also referred to as the "top wall"). Figure 11 As shown, even though the rear cover 723 is dome-shaped, it is asymmetrical about the longitudinal axis A because it includes a protrusion 730 on one side. The protrusion 730 may be offset from the longitudinal axis A and may generally protrude upwards along the longitudinal axis and away from the rear cover 723. The protrusion 730 on the rear cover 723 can be configured to shift the contact point with a hard surface toward the outer edge of the drug delivery device 700 and away from its axial center or center of gravity when the drug delivery device 700 is unintentionally dropped from a certain height, thereby achieving drop-resistant robustness. Although Figure 11A single protrusion 730 on the rear cover 723 is shown, but the rear cover 723 may include multiple protrusions 730 for defining an asymmetrical rear cover 723. In other embodiments, the protrusion 730 may be a lip or any similar feature that may be configured to displace the point of contact with the surface toward the outer edge of the drug delivery device 700 if the device 700 is accidentally dropped.

[0088] The protrusion 730 on the rear cover 723 can be configured to allow the rear cover 723 to convert at least a portion of the impact force on the rear cover 723 into rotational speed or acceleration of the drug delivery device 700. As a more specific example, in the event of a fall from a height, the protrusion 730 on the rear cover 723 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 700, causing the device 700 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 700, so that not all impact force is transmitted directly through the center of gravity of the device 700. Accordingly, even when the drug delivery device 700 is accidentally dropped, the asymmetrical rear cover 723 can prevent or suppress accidental activation of one or more components within the device 700 (such as the drive mechanism 30), reduce relative displacement between one or more components within the device 700, and prevent or suppress structural damage to the device 700.

[0089] Figure 12A drug delivery device 800 with a flat rear end cap 823, including a protrusion 830, is shown according to different embodiments of the present disclosure. The drug delivery device 800 includes a housing or casing 812. The casing 812 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 812e and a distal end 812f. In some embodiments, the casing 812 may have a generally elongated non-tubular shape, such as a rectangular shape, a triangular shape, or other non-cylindrical geometry. In other embodiments, the casing 812 may be a tubular casing and may have a generally elongated shape extending along a longitudinal axis A between a proximal end 812e and a distal end 812f, but the tubular casing may define a non-cylindrical shape. That is, in some embodiments, the outer diameter of the tubular casing may vary along the longitudinal axis A. A transparent or translucent inspection window 817 may be positioned within the wall of the casing 812 to allow a user to observe components inside the drug delivery device 800, including a drug storage container 820. A removable cap 819 can cover a needle shield, such as needle shield 32, before use of the drug delivery device 800. As discussed above, the drug delivery device 800 may also include a rear end cap 823 (also referred to as a "rear cover") at the proximal end 812e of the drug delivery device 800. The rear cover 823 may have a hollow cylindrical shape having an open end and a closed end. The rear cover 823 may be assembled with a housing 812 to define the drug delivery device 800. In some embodiments, the rear cover 823 may be removably coupled to the housing 812 at the proximal end 812e of the housing 812. In other embodiments, the rear cover 823 and the housing 812 may be integrally formed to define a single, monolithic structure.

[0090] The back cover 823 may be defined by generally annular or cylindrical sidewalls 825 and a linear, flat top surface 824 (also referred to as the "top wall"). Figure 12 As shown, even though the rear cover 823 is flat at the top, it is asymmetrical about the longitudinal axis A because it includes a protrusion 830 on one side. The protrusion 830 may be offset from the longitudinal axis A and may generally protrude upwards along the longitudinal axis and away from the rear cover 823. The protrusion 830 on the rear cover 823 can be configured to shift the contact point with a hard surface toward the outer edge of the drug delivery device 800 and away from the axial center or center of gravity of the device 800 when the drug delivery device 800 is unintentionally dropped from a height, thereby achieving drop-resistant robustness. Although Figure 12A single protrusion 830 on the rear cover 823 is shown, but the rear cover 823 may include multiple protrusions 830 for defining an asymmetrical rear cover 823. In other embodiments, the protrusion 830 may be a lip or any similar feature that may be configured to displace the point of contact with the surface toward the outer edge of the drug delivery device 800 if the device 800 is accidentally dropped.

[0091] The protrusion 830 on the rear cover 823 can be configured to allow the rear cover 823 to convert at least a portion of the impact force into the rotational speed or acceleration of the drug delivery device 800. As a more specific example, in the event of a fall from a height, the protrusion 830 on the rear cover 823 can be configured to convert at least a portion of the impact energy into rotational acceleration or torque of the device 800, causing the device 800 to rotate to one side after the initial impact with the ground. In this way, at least a portion of the impact force can be distributed towards the outer diameter of the drug delivery device 800, so that not all the impact force is transmitted directly through the center of gravity of the device 800. Accordingly, even when the drug delivery device 800 is accidentally dropped, the asymmetrical rear cover 823 can prevent or suppress the accidental activation of one or more components within the device 800 (such as the drive mechanism 30), reduce the relative displacement between one or more components within the device 800, and prevent or suppress structural damage to the device 800. Although Figure 11 and Figure 12 Dome-shaped back cover 723 and flat back cover 823 are shown respectively. However, it should be noted that tilted back covers (such as back covers 123, 223, 323, 423, 523 and 623) may also include protrusions, lips or similar features (such as protrusions 730 and 830) to offset the contact point with the surface toward the outer edge of the device and away from the axial center of the device when the drug delivery device is dropped.

[0092] As can be seen from the foregoing, this disclosure advantageously provides an improved design for a drug delivery device having a rear end cover configured to improve drop resistance and provide other benefits and advantages by preventing or inhibiting accidental activation of one or more components (such as a drive mechanism) within the drug delivery device, preventing or inhibiting relative displacement of one or more components within the drug delivery device after impact with a hard surface, and reducing the likelihood of damage to one or more components of the drug delivery device. All features disclosed herein with respect to any rear end cover embodiment can be combined in any combination, except for combinations in which at least some of such features are mutually exclusive.

[0093] As will be appreciated, the apparatus and methods 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 specific embodiments based on the features of this disclosure contained in this embodiment. Other advantages not specifically listed herein may also be appreciated.

[0094] The above description describes various devices, components, parts, subsystems, and methods of use related to drug delivery devices. 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 and biosimilar counterparts. As used herein, the term "drug" may be used interchangeably with other similar terms and may refer to any type of pharmaceutical agent or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and class of substances. Non-therapeutic injectable materials are also covered. Drugs may be in liquid form, lyophilized form, or a form reconstituted from a lyophilized form. The following example list of drugs should not be considered as all-encompassing or restrictive.

[0095] 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 can be a vial, cartridge, or prefilled syringe.

[0096] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors (e.g., granulocyte colony-stimulating factor (G-CSF)), or the device may be used in conjunction with these colony-stimulating factors. 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).

[0097] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulant (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the 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, carbamylated erythropoietin, and their molecules or variants or analogues.

[0098] Among the specific display proteins are the specific proteins described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (also referred to as RANKL-specific antibodies, peptides, etc.), including fully humanized 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 that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; 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, especially including but not limited to, human CD22-specific IgG antibodies, such as those with human-mouse monoclonal hLL2. Dimers of human-mouse monoclonal hLL2 γ-chain disulfides linked by the κ chain, such as the fully humanized human CD22-specific antibody in epazolizumab (CAS registry number 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, for example, 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, and 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. Cytopoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], dabepoetin α, novel erythropoiesis-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-α4β7) 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), anti-HER2 monoclonal antibody, 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-TNFα monoclonal antibody); Reopro® (Abciximab, anti-GP IIb / Ilia receptor monoclonal antibody); Actemra® (Anti-IL6 receptor mAb); Avastin® (Bevacizumab); HuMax-CD4 (Zanolimuab); Mvasi; TM(Bevacizumab - awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon α-2a); Simulect® (baliximab); Prexige® (romexicob); 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 (extracellular domain of the Fc portion of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory proteins)); VEGF trap (with IgG1) Fc fusion of VEGFR1 Ig domain); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2Rα 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-TNFα mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipramab, 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 / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα 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).

[0099] In some embodiments, the drug delivery device may comprise or be used with sclerosing protein antibodies for the treatment of postmenopausal osteoporosis and / or fracture healing, such as, but not limited to, lomoxozimab, butozimab, or BPS 804 (Novartis), Evenity™ (lomoxozimab-aqqg), another product containing lomoxozimab, and in other embodiments, a monoclonal antibody (IgG) binding to the human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (aliculumab). In other embodiments, the drug delivery device may comprise or be used with any of the following: rituximab, bisalometabolum, trebananib, ganitamumab, kanamumab, motesanib diphosphate, brodamarab, vidupiprant, or panitumumab. 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 other 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 comprise 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 comprise or be used with Aimovig® (erenumab-aooe) for the treatment of migraines, anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, errinumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets can also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agent (BiTE®) antibodies (such as, but not limited to, BLINCYTO®) can 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-thymocyte stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may include Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), an anti-TNF α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab, or used therewith. In some embodiments, the drug delivery device may contain Kyprolis® (carfilzomib) for the treatment of multiple myeloma, (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylethyleneoxy-2-yl)-1-oxopentane-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamyl)-4-phenylbutamido)-4-methylpentanamide, or another product containing carfilzomib, or used therewith. In some embodiments, the drug delivery device may comprise or be used with Otezla® (apremilast), 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 containing apremilast for the treatment of various inflammatory conditions. In some embodiments, the drug delivery device may comprise Parsabiv for the treatment of, for example, secondary hyperparathyroidism (sHPT) in dialysis patients with chronic kidney disease (KD). TM(Vicocineptide HCl, KAI-4169) or another product containing vecocineptide HCl or used therewith. In some embodiments, the drug delivery device may contain ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody or used therewith. In some embodiments, the drug delivery device may contain a VEGF antagonist (e.g., a non-antibody VEGF antagonist) and / or a VEGF-Trap (e.g., aflibercept (a fusion of the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 with the Fc domain of IgG1)) or used therewith. In some embodiments, the drug delivery device may contain ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5 or used therewith. In some embodiments, the drug delivery device may comprise or be used with Lobivup α (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 omeprazole (a small molecule selective cardiac myosin activator), or myotrope which directly targets the cardiac contractile mechanism, or another product comprising or being used with a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may comprise sotoraraciab (formerly AMG 510), KRAS G12C Small molecule inhibitors, or those containing KRAS G12CAnother product containing or used with a small molecule inhibitor. In some embodiments, the drug delivery device may comprise or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing or being used with a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may comprise or be used with rocatamumab (AMG-451), which is a human anti-OX40 monoclonal antibody that expresses and blocks OX40 on activated T cells to inhibit and / or reduce the number of OX40-pathogenic T cells responsible for driving systemic and local atopic dermatitis inflammatory responses. In some embodiments, the drug delivery device may comprise or be used with AMG714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing or being used with a human monoclonal antibody that binds to 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 that comprises or is 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 that comprises or is used with a human IgG1κ antibody and / or binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise Amjevita. TM Or Amgevita TM(Previously ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing or used with human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product containing a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing delta-like 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 delta-like 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 AMG133, or another product containing a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may comprise or be used with AMG 171, or another product comprising a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may comprise or be used with AMG 176, or another product comprising a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise or be used with AMG 199, or another product comprising a bispecific T-cell conjugate with extended half-life (HLE) (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 protein and / or an IL-21 receptor agonist) designed to selectively activate the interleukin-21 (IL-21) pathway in programmed 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 contain or be used with AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing or being used with an extended-life (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell binder) construct.In some embodiments, the drug delivery device may comprise or be used with AMG430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with AMG 506, which is being investigated for the treatment of solid tumors, or another product comprising a multispecific FAP x4-1BB-targeting DARPin® biologic. In some embodiments, the drug delivery device may comprise or be used with AMG 509 or another product comprising a bivalent T-cell conjugate and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may comprise or be used with AMG 562 or another product comprising an extended half-life (HLE) CD19 xCD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with Efavaleukin α (formerly AMG 592) or another product comprising 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 a half-life extended (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 a half-life extended (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 using with a half-life extended (HLE) anti-δ-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may be used with AMG 910 or another product containing an extended half-life (HLE) claudin 18.2 x CD3 BiTE® (bispecific T-cell binding agent) construct.

[0100] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. The detailed descriptions are to be interpreted as exemplary only and do not describe every possible embodiment of this disclosure. Numerous alternative embodiments may be implemented using current technology or technology developed after the date of this patent application, and these embodiments will still fall within the scope of the claims defining the invention(s) disclosed herein.

[0101] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the embodiments described above without departing from the spirit and scope of the invention(s) disclosed herein, and such modifications, alterations, and combinations will be considered to be within the scope of the inventive concept(s).

Claims

1. A drug delivery device, comprising: A housing that defines a longitudinal axis and has an opening at its distal end; A drug storage container includes a cylinder, a stopper, and a delivery member, the stopper being movably positioned within the cylinder, the delivery member being positioned at a distal end of the cylinder and having an insertion end configured to extend at least partially through the opening during delivery. A plunger that can move toward the distal end of the drug storage container to engage the stopper and discharge the drug from the drug storage container through the delivery member; A release member having a first position and a second position, wherein in the first position the release member prevents the plunger from moving to the delivery state, and in the second position the release member does not prevent the plunger from moving to the delivery state; as well as A rear cover, which is attached to the housing at the proximal end of the housing, wherein the rear cover is asymmetrical about the longitudinal axis of the housing to convert a portion of the impact force on the rear cover into rotational acceleration of the drug delivery device.

2. The drug delivery device as claimed in claim 1, wherein, The housing includes a tubular housing, wherein the rear cover is at least partially defined by annular sidewalls and a top surface.

3. The drug delivery device as claimed in claim 2, wherein, At least a portion of the top surface of the back cover is generally tilted at a predefined angle from a transverse axis perpendicular to the longitudinal axis.

4. The drug delivery device as claimed in claim 3, wherein, The predefined angle is between approximately 5° and approximately 30° from the lateral axis.

5. The drug delivery device as claimed in claim 3, wherein, The predefined angle is between approximately 10° and approximately 25° from the lateral axis.

6. The drug delivery device as claimed in claim 3, wherein, At least that portion of the top surface is a linear surface.

7. The drug delivery device as claimed in claim 3, wherein, At least that portion of the top surface is a concave surface.

8. The drug delivery device as claimed in claim 3, wherein, At least that portion of the top surface is a convex surface.

9. The drug delivery device as claimed in claim 2, wherein, The back cover includes a chamfer connecting the annular sidewall and the top surface.

10. The drug delivery device as claimed in claim 3, wherein, The portion of the top surface that is generally inclined at the predefined angle defines a first portion of the top surface, and wherein the top surface further includes a second portion defined by a flat surface parallel to the transverse axis.

11. The drug delivery device as claimed in claim 2, wherein, The top surface is a linear surface.

12. The drug delivery device as claimed in claim 2, wherein, The top surface is a convex surface.

13. The drug delivery device as claimed in claim 2, wherein, The back cover includes a protrusion on the top surface, wherein the protrusion is offset from the longitudinal axis, and wherein the protrusion generally protrudes away from the top surface along the longitudinal axis.

14. The drug delivery device of claim 1, further comprising a plunger guide configured to operatively connect the housing and the rear cover.

15. The drug delivery device as claimed in claim 1, wherein, The plunger is configured to rotate while translating toward the distal end of the drug storage container.

16. The drug delivery device as claimed in claim 2, wherein, The tubular shell defines a generally cylindrical shape.

17. The drug delivery device as claimed in claim 2, wherein, The tubular shell defines a non-cylindrical shape, and the outer diameter of the tubular shell varies along the longitudinal axis.

18. The drug delivery device as claimed in claim 1, wherein, The housing and the rear cover are defined by a single integral structure.

19. The drug delivery device as claimed in claim 1, wherein, The drug delivery device is an automated injector.

20. A drug delivery device, comprising: A housing that defines a longitudinal axis and has an opening at its distal end; A drug storage container includes a cylinder, a stopper, and a delivery member, the stopper being movably positioned within the cylinder, the delivery member being positioned at a distal end of the cylinder and having an insertion end configured to extend at least partially through the opening during delivery. A plunger that can move toward the distal end of the drug storage container to engage the stopper and discharge the drug from the drug storage container through the delivery member; A release member having a first position and a second position, wherein in the first position the release member prevents the plunger from moving to the delivery state, and in the second position the release member does not prevent the plunger from moving to the delivery state; as well as A rear cover, which is attached to the housing at the proximal end of the housing, wherein the rear cover is asymmetrical about the longitudinal axis of the housing to facilitate or cause rotation of the drug delivery device.

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