Depth-adjustable autoinjector

Abstract

The drug delivery device includes a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends, an injection assembly at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or cannula, a shield slidably coupled to the housing, a drive assembly at least partially disposed within the housing, and a depth adjuster operably coupled to the shield and / or the housing. The shield is positionable in an extended position, where at least the proximal end extends a distance beyond the proximal end of the housing, and a retracted position. The drive assembly is operably coupled to the injection assembly and the shield, and is engageable to deliver a medicament through the injection assembly. When coupled to the shield and / or the housing, the depth adjuster is adapted to prevent or inhibit the shield from being positionable in the retracted position.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 319,049, filed March 11, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to adjustable features of drug delivery devices. [Background technology]

[0003] To deliver a liquid drug to a patient, a drug delivery device such as an injector is used. When actuated, the drug delivery device expels a drug stored in an internal reservoir, such as a pre-filled syringe ("PFS"), through a needle, cannula, or other delivery member into the patient. Some drug delivery devices, such as a pen autoinjector or an on-body injector, can be placed adjacent to the patient's skin to deliver the drug over a period of time through an injection needle or some other means. The drug delivery device can be placed near tissue in the patient's abdomen, thigh, arm, or some other part of the patient's body.

[0004] When using such devices, the delivery member is inserted at a desired depth to achieve subcutaneous or intramuscular drug delivery. As children and other patients continue to grow, the appropriate delivery depth of a particular drug may change. For example, children's skin is often thinner than adults, so the subcutaneous depth is not as deep. Devices that accommodate children of various ages and sizes are not typically used, in part due to high development costs and the need for a variety of devices to accommodate children's changing sizes as they grow. Furthermore, adult devices are often not used with pediatric patients, as their increased needle penetration depth may cause the device to deliver drugs to an undesirable depth in some cases. Thus, children are typically administered drugs with prefilled syringes rather than devices such as autoinjectors that may incorporate more patient-friendly features. Summary of the Invention [Means for solving the problem]

[0005] The present disclosure describes an adjustable depth autoinjector and corresponding techniques that embody advantageous alternatives to existing devices and techniques and that may address one or more of the problems or needs noted herein.

[0006] According to a first aspect, a drug delivery device is provided that includes a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, an injection assembly at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or cannula, a shield slidably coupled to the housing, a drive assembly at least partially disposed within the housing, and a depth adjuster operably coupled to the shield and / or the housing. The shield is positionable in an extended position, where at least the proximal end extends a distance beyond the proximal end of the housing, and a retracted position. The drive assembly is operably coupled to the injection assembly and the shield, and is engageable to deliver a medicament via the injection assembly. When coupled to the shield and / or the housing, the depth adjuster is adapted to prevent or inhibit the shield from being positionable in the retracted position.

[0007] In some examples, the depth adjuster includes a collar having an opening for receiving a portion of the shield and a body. The body of the collar can engage a portion of the shield and a portion of the housing to prevent or inhibit relative movement between the shield and the housing. In some examples, a proximal end of the shield includes a ridge that engages a portion of the collar. Further, in some examples, the body can have a thickness of about 1 mm to about 5 mm. In some approaches, the depth adjuster is selectable between a plurality of depth adjusters having different thicknesses.

[0008] In these and other examples, the depth adjuster includes a rotatable knob that selectively engages a portion of the shield. Further, the rotatable knob can be disposed on a threaded member of the housing. In some examples, the rotatable knob can include at least one linear step for adjusting the point of engagement with the portion of the shield.

[0009] According to a second aspect, a drug delivery device is provided that includes a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends, an injection assembly at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or cannula, and a drive assembly at least partially disposed within the housing and operably coupled to the injection assembly. The drive assembly is engageable to deliver a medicament through the injection assembly. The housing is adapted to slidably receive at least one of 1) a first shield having a first configuration, or 2) a second shield having a second configuration different from the first configuration of the first shield. The first shield is adapted to have the needle or cannula extend a first length from its proximal end, and the second shield is adapted to have the needle or cannula extend a second length from its proximal end.

[0010] According to a third aspect, there is provided a platform system for assembling a drug delivery device, the platform system including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, an injection assembly at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or a cannula, and a drive assembly at least partially disposed within the housing and operably coupled to the injection assembly. The drive assembly is engagable to deliver a medicament through the injection assembly. The system further includes a selectable depth adjustment component group adapted to couple with a portion of the drug delivery device to at least partially limit movement of the portion of the injection assembly. The drug delivery device is assembled by identifying and selecting a first depth adjustment component from the selectable depth adjustment component group using at least one desired characteristic of the drug delivery device, and coupling the first depth adjustment component with at least one of the housing, the injection assembly, or the drive assembly.

[0011] The above needs are met, at least in part, through the provision of an adjustable depth autoinjector as described in the detailed description below, particularly when considered in conjunction with the drawings. [Brief description of the drawings]

[0012] [Figure 1] 1 illustrates a cross-sectional view of an exemplary drug delivery device according to various embodiments. [Diagram 2] 2 illustrates the exemplary drug delivery device of FIG. 1 coupled with an exemplary depth adjuster, according to various embodiments. [Diagram 3] 3 illustrates the exemplary drug delivery device of FIG. 2 in accordance with various embodiments. [Figure 4] 4 illustrates the exemplary drug delivery device of FIGS. 2 and 3 coupled with several different exemplary depth adjusters, according to various embodiments. [Diagram 5] 5 illustrates a front view of the exemplary depth adjuster of FIGS. 2-4 in accordance with various embodiments. FIG. [Figure 6] 6 illustrates an exemplary side view of the exemplary depth adjuster of FIGS. 2-5 in accordance with various embodiments. [Figure 7] 14 illustrates a front view of another exemplary depth adjuster according to various embodiments. [Figure 8] 8 illustrates an exemplary side view of another exemplary depth adjuster of FIG. 7 in accordance with various embodiments. [Figure 9] 1 illustrates an exemplary drug delivery device having an alternative depth adjuster in the form of a knob, according to various embodiments. [Figure 10] 10 shows a cross-sectional view of the exemplary drug delivery device of FIG. 9 in accordance with various embodiments. [Figure 11] 10 shows a cross-sectional view of the exemplary drug delivery device of FIG. 9 having another depth adjuster in the form of a knob having a different configuration, according to various embodiments. [Figure 12] 1 illustrates an exemplary drug delivery device having a first exemplary depth adjustment mechanism in the form of a shield having a first feature, according to various embodiments. [Figure 13]13 shows a cross-sectional view of the exemplary drug delivery device of FIG. 12 in accordance with various embodiments. [Figure 14] 13A-13C show cross-sectional views of an exemplary drug delivery device having a second exemplary depth adjustment mechanism in the form of a shield having a second characteristic, according to various embodiments. [Figure 15] 13A-13C show cross-sectional views of an exemplary drug delivery device having a third exemplary depth adjustment mechanism in the form of a shield having a third feature, according to various embodiments. [Figure 16] 13A-13C show cross-sectional views of an exemplary drug delivery device having a fourth exemplary depth adjustment mechanism in the form of a shield having a fourth feature, according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Those skilled in the art will appreciate that the elements in the figures are depicted for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to not overly distract from the illustrations of these various embodiments. Furthermore, it will be appreciated that certain acts and / or steps may be described or shown in a particular order of occurrence, although those skilled in the art will appreciate that such specificity with respect to the order is not actually required. It will also be appreciated that the terms and expressions used herein have the ordinary technical meaning that those skilled in the art of the above-mentioned art would recognize for such terms and expressions, unless a different specific meaning is otherwise expressly stated herein.

[0014] Generally, in accordance with these various embodiments, systems and techniques are provided for adjusting the insertion depth of a drug delivery device, such as, for example, an autoinjector. The systems and techniques described herein may provide insertion depth adjustability ranging from about 1 mm to about 15 mm. Furthermore, in some examples, such systems may be provided as kits in which several depth adjustment components may be provided that a user can quickly select based on a desired drug administration profile (e.g., based on the patient's age, weight, body mass index, and / or other factors). Such systems may advantageously not require significant redesign and / or modification of components, and therefore may be easily and quickly retrofitted to existing drug delivery devices as desired.

[0015] The drug delivery device delivers a drug, which may be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological substances, such as peptides, peptibodies, or antibodies. The drug may be in fluid or liquid form, although the present disclosure is not limited to a particular state. Various implementations and configurations of the drug delivery device are possible. For example, the present disclosure describes a drug delivery device in the form of a single-use disposable injector. In other embodiments, the drug delivery device may be configured as a multiple-use reusable injector. The drug delivery device may be operable for self-administration by the patient or administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). Additionally, the drug delivery device may take the form of an auto-injector or pen-type injector, and thus may be held in the user's hand for the duration of the drug delivery or administration.

[0016] With reference to the figures, and in particular to FIGS. 1-7, a drug delivery device 10 is provided for delivering a drug, which may also be referred to herein as a medicament or formulation. The drug may be various biological substances, such as, but not limited to, a peptide, a peptibody, or an antibody. The drug may be in a fluid or liquid form, although the disclosure is not limited to a particular state. In a particular liquid formulation, the drug may have a viscosity of approximately (e.g., ±10%) 1-13 centipoise (cP), approximately (e.g., ±10%) 1-30 cP, approximately (e.g., ±10%) 1-60 cP, or other suitable viscosity profile. Other examples are possible.

[0017] Various implementations and configurations of the drug delivery device 10 are possible. For example, the present disclosure describes the drug delivery device 10 in the form of a single-use, disposable injector. In other embodiments, the drug delivery device 10 may be configured as a multiple-use, reusable injector. The drug delivery device 10 is operable for self-administration by a patient or administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). Furthermore, in the illustrated example, the drug delivery device 10 takes the form of an auto-injector or pen injector, and thus may be held in the hand of a user for the duration of drug delivery or administration.

[0018] The drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and dimensioned to allow a person to grasp the injector 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylindrical shape, and may extend along a longitudinal axis "A" between a proximal end 12a and a distal end 12b. The drug delivery device 10 further includes an injection assembly 15 and a drive assembly 30. The injection assembly 15 and the drive assembly 30 may each be at least partially disposed within the housing 12. The injection assembly 15 includes a delivery member 16 in the form of a needle or cannula. An opening 14 may be formed in the proximal end 12a to allow an insertion end 16a of the delivery member 16 to extend outside of (i.e., beyond the length of) the housing 12.

[0019] The injection assembly 15 may further include a drug reservoir 23, which may be disposed within the interior space of the housing 12 and configured to contain a drug 24. The drug reservoir 23 may, for example, be pre-filled by a manufacturer and shipped to a location where the drug reservoir 23 is assembled with the remainder of the drug delivery device 10. The housing 12 may, for example, be pre-loaded with the drug reservoir 23 by a manufacturer, or alternatively, may be loaded with the drug reservoir 23 by a user prior to use of the drug delivery device 10. The drug reservoir 23 may include a rigid wall defining an internal bore or reservoir. The wall may be made of glass or plastic. Proximal movement of a stopper or similar device may expel the drug 24 from the reservoir of the drug reservoir 23 into the delivery member 16. The distal end of the drug reservoir 23 may be open to allow a plunger to extend into the drug reservoir 23 and push the stopper proximally. Actuation of the drive assembly 30 may cause the plunger to move proximally, driving the stopper proximally.

[0020] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 23. The proximal end of the delivery member 16 may define an insertion end 16a of the delivery member 16. The insertion end 16a may include a sharp tip of other pointed shape that allows the insertion end 16a to pierce the skin and subcutaneous tissue of a patient during insertion of the delivery member 16. The delivery member 16 may be hollow and have an internal passageway. One or more openings may be formed in the insertion end 16a to allow the drug to flow out of the delivery member 16 and into the patient.

[0021] In this embodiment, the drug reservoir 23 is a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. Here, the needle is fixed against the wall of the drug reservoir 23 and is in permanent fluid communication with the reservoir of the drug reservoir 23. In other embodiments, the drug reservoir 23 may be a needle-less cartridge and thus may not be in fluid communication with the delivery member 16 initially. In such an embodiment, the drug reservoir 23 may move toward or away from the distal end of the delivery member 16 during operation of the drug delivery device 10 such that the distal end of the delivery member 16 penetrates a septum covering the opening of the drug reservoir 23, thereby establishing fluid communication with the reservoir of the drug reservoir 23.

[0022] Once the drug storage container 23 is installed in the housing 12, the drug storage container 23 may be fixed relative to the housing 12 so that it does not move relative to the housing 12. In this manner, the insertion end 16a of the delivery member 16 may permanently extend through the opening 14 of the housing 12 in the pre-delivery, delivery and post-delivery states. In alternative embodiments, the drug storage container 23 may be movably coupled to the housing 12 such that the drug storage container 23 is capable of moving relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 16a of the delivery member 16 may be retracted inside the opening 14 of the housing 12 in the pre-delivery state. Subsequently, during operation of the injection device 10, the insertion end 16a of the delivery member 16 may be deployed through the opening 14 of the housing 12 for insertion into the patient. This movement may be the result of the drug storage container 23 being driven proximally relative to the housing 12 in some embodiments.

[0023] As previously mentioned, the drug delivery device 10 may further include a drive assembly 30 disposed partially or completely within the housing 12. In general, the drive assembly 30 may be configured to store energy and, upon or in response to actuation of the drive assembly 30 by a user, release or output the energy to drive the injection assembly 15 (i.e., the delivery member 16, the drug reservoir 23, etc.) to expel the drug 24 from the drug reservoir 23 through the delivery member 16 to the patient. In this example, the drive assembly 30 is configured to store mechanical potential energy, although alternative embodiments of the drive assembly 30 may be configured differently, for example, the drive assembly 30 may store electrical or chemical potential energy. Upon actuation of the drive assembly 30, the drive assembly 30 may convert the potential energy into kinetic energy for moving the plunger and other components.

[0024] In some examples, the drive assembly 30 may include a biasing member, such as a rotary biasing member, and additional components used to engage the biasing member and release its mechanical potential energy. In some implementations, the rotary biasing member may be a torsion spring (e.g., a spiral torsion spring, a helical torsion spring, etc.) that is initially held in a biased state. In the biased state, the rotary biasing member may be twisted or wound and held in the twisted or wound configuration by such additional components. Upon release, the rotary biasing member may attempt to return to its natural length or shape, thereby exerting a biasing force that rotates the component, and thus may convert the rotational motion into a linear motion to drive the plunger in a proximal direction. Alternative embodiments may utilize a different energy source than the rotary biasing member. Certain alternative embodiments may utilize, for example, a linear biasing member (e.g., a helical compression spring, a helical extension coil spring, etc.) that upon release outputs a force in the direction of the plunger movement. In addition to or in lieu of a biasing member, other embodiments may include any one or combination of these configurations: an electromechanical configuration including an electric motor and / or solenoid coupled to the plunger and a drive train or power transmission; or a configuration that generates or releases a pressurized gas or fluid to propel the plunger or act directly on the stopper to move the stopper through the drug reservoir 23 and expel the drug 24 therefrom. In embodiments in which the drug reservoir 23 and / or the delivery member 16 are movable relative to the housing 12, the drive assembly 30, upon actuation, may drive the drug reservoir 23 and / or the delivery member 16 in a proximal direction such that the insertion end 16a of the delivery member 16 is inserted into the patient. Thus, in certain embodiments, the drive assembly 30 may provide the driving force necessary to both insert the delivery member 16 into the patient and expel the drug 24 from the drug reservoir 23.

[0025] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 16a of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a shield 60 movably disposed at the proximal end 12a of the housing 12 adjacent the opening 14. The shield 60 may have a hollow, generally cylindrical or tubular shape. The shield 60 may have a distal end housed within the housing 12 and may be configured to move relative to the housing 12 between an extended position in which the proximal end 60a of the shield 60 extends through the opening 14 of the housing 12 and a retracted position in which the proximal end of the shield 60 is fully or partially retracted into the opening 14 of the housing 12. At least in the extended position, the shield 60 may extend beyond and surround the insertion end 16a of the delivery member 16. In some embodiments, the shield 60 may be moved toward the retracted position to expose the insertion end 16a of the delivery member 16. Further, in some embodiments, the shield 60 may be coupled to the housing 12 and / or the drive mechanism 30 such that the shield 60 can translate in a linear direction relative to the housing 12 .

[0026] The proximal end of the shield 60 may include a skin-contacting portion 62. The distal end of the shield 60 may include an activator portion or engagement portion 64. In some examples, the activator portion 64 and the skin-contacting portion 62 may be integrally formed to define a single monolithic structure. At least the skin-contacting portion 62 of the shield 60 may have a hollow generally cylindrical or tubular shape and, in some embodiments, may be centered about the longitudinal axis A of the drug delivery device 10. The activator portion 64 of the shield 60 may be a cut-out or recessed area.

[0027] Movement of the shield 60 from the extended position to the retracted position may be accomplished by pressing the skin contacting portion 62 against the patient's skin at the injection site. In instances where the delivery member 16 protrudes from the opening 14 of the housing 12 pre-delivery or in a storage state, this movement may result in insertion of the insertion end 16a of the delivery member 16 into the patient's skin.

[0028] It will be appreciated that the device 10 may include any number of additional components, such as, for example, a guard biasing member (not shown) that may exert a biasing force on the shield 60 in a proximal direction, thereby biasing or urging the shield 60 toward the extended position. In some examples, the guard biasing member is in the form of a compression spring. In other examples, the guard biasing member may be in the form of a torsion spring or other form of spring. In either case, the user may overcome this biasing force by pressing the shield 60 against the injection site with sufficient force. Once the injection is completed and the drug delivery device 10 is removed from the injection site, the guard biasing member may return the shield 60 to the extended position, thereby covering the insertion end 16a of the delivery member 16.

[0029] The shield 60 may be configured to interact with the drive assembly 30 as the shield 60 moves from the extended position to the retracted position. This interaction may actuate the drive assembly 30 to output the energy necessary to drive the plunger to expel the drug 24 from the drug reservoir 23 and / or insert the insertion end 16a of the delivery member 16 into the patient's skin. In some embodiments, the movement of the shield 60 from the extended position to the retracted position releases the rotary biasing member from a biased state, thereby allowing the rotary biasing member to de-energize and drive the plunger to expel the drug 24 from the drug reservoir 23. When the shield 60 moves from the extended position to the retracted position as a result of being pressed against the patient's skin, the activator portion 64 of the shield 60 engages the drive assembly 30 to release the rotary biasing member and drive the plunger in a proximal direction.

[0030] In particular, when the shield 60 is fully moved to the retracted position, the delivery member 16 extends and / or protrudes a maximum distance from the skin contacting portion 62. In some instances, this distance may be between about 10 mm and 15 mm, although other instances are possible. However, the desired delivery site for some patients (e.g., children) may be at a depth less than this maximum (e.g., between about 3 mm and 8 mm).

[0031] To achieve drug delivery at a relatively shallow depth, the drug delivery device 10 further includes a depth adjuster 70. In the illustrated example of FIGS. 2-8, the depth adjuster 70 is in the form of a collar having an opening 72 and a body 74. The body 74 of the depth adjuster 70 can have any number of desired thicknesses, such as, for example, about 1 mm to 15 mm. The opening 72 of the collar 70 can operably engage and / or receive a portion of the shield 60, such that the depth adjuster 70 can move relative to the housing 12. In other examples (not shown), the depth adjuster 70 can be operably coupled to the housing 12. As shown in FIGS. 5-8, the depth adjuster 70 can have any number of cross-sectional shapes (e.g., a generally circular member, a C-shaped member, etc.).

[0032] The shield 60 may further define an abutment surface or ridge 68 that may engage and / or retain the body 74 of the collar 70. Additionally, the opposite end of the body 74 may engage the proximal end 12a of the housing 12. So positioned, the collar 70 acts as a wedge to prevent or block the shield 60 from moving completely to the retracted position, as shown in FIG. 2. By preventing or blocking the shield 60 from moving completely to the retracted position, less than the full length of the delivery member 16 may be exposed and inserted into the patient, and thus the delivery member 16 extends to a shallower depth within the patient. This may be desirable for certain patients, such as children. In these and other implementations, the thickness of the body 74 of the collar 70 directly correlates to the reduction in the depth that the delivery member 16 may reach. For example, if the body 74 of the collar 70 is approximately 5 mm thick, the resulting insertable length of the delivery member 16 is reduced by approximately 5 mm.

[0033] As previously mentioned, the depth adjuster 70 may have any number of configurations and / or thicknesses. In some examples, a kit or system may include the device 10 including multiple depth adjusters 70 having different thicknesses. For example, the kit may include a first depth adjuster 70 having a thickness of about 1 mm, a second depth adjuster 70 having a thickness of about 2 mm, a third depth adjuster 70 having a thickness of about 3 mm, and so on. In some examples, each different depth adjuster 70 may have a different visual feature, such as color, texture, lettering, etc., to allow a user to quickly identify the thickness of the depth adjuster 70. Configured in this manner, a user (e.g., a primary care physician or other person responsible for administration of the device 10) may select the desired one or more depth adjusters 70 from the kit that are suitable for properly administering the device 10 to the desired delivery depth of the patient. As shown in FIG. 4, in some examples, the multiple depth adjusters 70 may be combined as desired with the shield 60 to reduce the overall distance that the delivery member 16 may extend.

[0034] 9-11, another depth adjuster 170 for use with the drug delivery device 10 may be provided. In these examples, the depth adjuster 170 is in the form of a rotatable knob having several steps 172. The rotatable knob 170 may be coupled to the housing 12 or may be otherwise disposed on the housing 12. For example, the housing 12 may include a cutout through which a portion of the rotatable knob 170 may extend. In some examples, the housing 12 may include a threaded region that engages with a corresponding threaded portion of the rotatable knob 170. As shown in FIGS. 10 and 11, a portion of the shield 60 (e.g., the engagement portion 64) may be disposed at a distance from the rotatable knob 170 while the shield 60 is in the extended position. However, when the skin contact portion 62 of the shield 60 is pressed against the skin of the user to initiate the drug administration process, the engagement portion 64 of the shield 60 may contact the rotatable knob and the designated steps 172, thus limiting the axial movement of the shield 60. As a result, a reduced length of delivery member 16 is exposed, and therefore extends to a shallower depth within the patient when delivering drug.

[0035] A user may selectively rotate the rotatable knob 170 to engage different steps 172 with the shield during drug administration. As shown in Fig. 10, the steps 172 are arranged in a generally concave arrangement, and in Fig. 11, which shows an alternative rotatable knob 170', the steps 172' are arranged in a generally convex arrangement. In some examples (not shown), the rotatable knob 170 may include several different visual indicators to assist in identifying the depth to which the delivery member 16 is inserted.

[0036] 12-14, the drug delivery device 10 includes yet another alternative mechanism for adjusting the insertion depth of the delivery member 16. In these examples, another shield 260, 260' is provided. These shields 260, 260' may have similar features as the shield 60 and will not be described in detail. Each of the shields 260, 260' may have a different configuration that allows the delivery member 16 to be inserted to a different depth. More specifically, the shield 260 shown in FIG. 13 includes a lip 266 having a first thickness, and the shield 260' shown in FIG. 14 includes a lip 266' having a second thickness. These lips 266, 266' allow the delivery member 16 to extend at different lengths from each shield 260, 260'. In particular, the lip 266 shown in Figure 13 is relatively wide and therefore reduces the insertion depth of the delivery member 16 by a greater amount from the maximum value as compared to the relatively narrow lip 266' shown in Figure 14 which reduces the insertion depth of the delivery member 16 by a lesser amount from the maximum value. As with the depth adjuster 70, it will be appreciated that kits or systems having any number of shields having lips of different thicknesses may be provided.

[0037] 15 and 16, the drug delivery device 10 includes yet another alternative mechanism for adjusting the insertion depth of the delivery member 16. In these examples, another shield 360, 360' is provided. These shields 360, 360' may have similar features as the shields 60, 260, 260' and will not be described in detail. Each of the shields 360, 360' may have a different configuration that allows the delivery member 16 to be inserted to a different depth. More specifically, the shield 360 shown in FIG. 15 has a first overall length and the shield 360' shown in FIG. 16 has a second overall length. These different lengths allow the delivery member 16 to extend at different lengths from each shield 360, 360'. In particular, the length of the shield 360 shown in Figure 15 is relatively long, and thus the shield 360 reduces the insertion depth of the delivery member 16 by a greater amount from the maximum value, as compared to the relatively short shield 360' shown in Figure 16, which reduces the insertion depth of the delivery member 16 by a lesser amount from the maximum value. As with the depth adjuster 70 and shields 260, 260', it will be appreciated that a kit or system may be provided having any number of shields having different lengths.

[0038] In some examples, a platform system or kit for assembling the drug delivery device 10 may be provided. The platform system includes a group of selectable depth adjustment components that couple with the device 10 to limit relative movement of a portion of the injection assembly. The device 10 is assembled by identifying and selecting a first desired depth adjustment component from the group of selectable depth adjustment components using any number of desired characteristics of the drug delivery device (e.g., a desired injection depth, etc.) and coupling the first depth adjustment component with at least one of the housing, the injection assembly, or the drive assembly. For example, the group of selectable depth adjustment components may include different depth adjusters 70, different rotatable knobs 170, and / or different shields 260, 260', 360, 360'. In examples where the desired depth adjustment component is one of the depth adjusters 70 and / or the rotatable knobs 170, it will be understood that the device 10 further includes a shield 60, but in examples where the desired depth adjustment component is one of the shields 260, 260', 360, 360', these shields replace the shield 60 in the device. It is understood that any combination of depth adjustment components may be used together as desired, and configured in this manner allows a user (e.g., a primary care physician or other person responsible for administering device 10) to select the desired depth adjuster 70 that is appropriate for properly administering device 10 to a patient.

[0039] In some examples, the depth adjustment components described herein may also be coupled with components that limit the movement of the storage unit and may be located at different locations within the device 12. For example, the depth adjustment components may also limit the plunger depth. In such examples, various plunger rods having different lengths may be provided as needed.

[0040] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. The term drug, as used herein, may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following exemplary list of drugs should not be considered exhaustive or limiting.

[0041] The drug is contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is filled or pre-filled for treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0042] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez) or FULPHILA (pegfilgrastim-bmez).

[0043] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin 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 Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin and molecules or variants or analogs thereof.

[0044] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which particularly inhibit activities mediated by binding of IL-4 and / or IL-13 to its receptor; Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., epratuzumab (CAS Registry Number 501423-23-0). 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, including, but not limited to, human CD22 specific IgG antibodies, particularly including, but not limited to, the human CD22 specific fully humanized antibody of HuMax; IGF-1 receptor specific antibodies, including, but not limited to, anti-IGF-1R antibodies, peptibodies and related proteins; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like, including, but not limited to, those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including, but not limited to, the B7RP specific fully human monoclonal IgG2 antibody, including, but not limited to, the fully human IgG2 monoclonal antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1 (also referred to as "B7RP-1" and B7H2, ICOSL, B7h and CD275); e.g., 145c7, HuMax IL-15 specific antibodies, such as humanized monoclonal antibodies, peptibodies, related proteins, and the like, including, but not limited to, IL-15 antibodies and related proteins;IFN gamma specific antibodies, including but not limited to, human IFN gamma specific antibodies, including but not limited to, fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, and the like; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, and the like; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as monoclonal antibodies; TRAIL-R2 specific antibodies, peptibodies, related proteins, and the like; activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; and proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, including, but not limited to, c-Kit specific antibodies, peptibodies, related proteins, etc.; OX40L specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, stimulating de novo erythropoiesis Protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered ® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs 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 idiopathic pulmonary fibrosis stage I fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 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-VE; GFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0045] In some embodiments, the drug delivery device may contain or be used with sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell-engaging (BiTE®) molecules, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with an APJ large molecule agonist, such as, but not limited to, apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169), or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis.In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a new bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile mechanism of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotorasibe (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15).In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or another product that contains small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with another product, including Amjevita™ or Amgevita™ (formerly ABP501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or a mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 160 or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119 or a 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 another product containing AMG 119 or a 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 another product containing AMG 133 or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171 or a growth differentiation factor 15 (GDF15) analog.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176 or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199 or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein 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 contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may house or be used in conjunction with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 562 or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with ephavalukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 596 or a CD3xEpidermal Growth Factor Receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager). In some embodiments, the drug delivery device may contain or be used with another product containing a half-life extended (HLE) anti-human CD33 x anti-anti-human CD3 BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or a half-life extended (HLE) anti-human CD33 x anti-anti-human CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 757 or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may house or be used in conjunction with AMG 910 or another product containing the half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0046] The drug delivery devices, assemblies, components, subsystems and methods have been described in terms of, but not limited to, exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0047] Those skilled in the art will understand that various modifications, alterations and combinations may be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and that such modifications, alterations and combinations are to be construed as falling within the scope of the concept of the present invention.

Claims

1. A housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end of the housing, An injection assembly located at least partially within the housing at or near the proximal end of the housing, comprising an injection assembly including a needle or cannula, A shield slidably coupled to the housing, wherein the shield can be positioned in an extended position where at least its proximal end extends beyond the proximal end of the housing by a certain distance, and in a retracted position, A drive assembly, at least partially disposed within the housing and operably coupled with the injection assembly and the shield, the drive assembly being engageable to deliver a drug through the injection assembly, A depth adjuster operably coupled to at least one of the shield or the housing. A drug delivery device comprising a depth adjuster, wherein when the depth adjuster is coupled to at least one of the shield or the housing, the depth adjuster is adapted to prevent or prevent the shield from being positioned in the retracted position.

2. The drug delivery device according to claim 1, wherein the depth adjuster includes a collar having an opening for receiving a portion of the shield and a body, the body of the collar being fitted to engage with a portion of the shield and a portion of the housing to prevent or block relative movement between the shield and the housing.

3. The drug delivery device according to claim 2, wherein the proximal end of the shield includes a raised portion that engages with a part of the collar.

4. The drug delivery device according to claim 2 or 3, wherein the main body has a thickness of approximately 1 mm to approximately 5 mm.

5. The drug delivery device according to any one of claims 1 to 3, wherein the depth adjuster is selectable from a plurality of depth adjusters having different thicknesses.

6. The drug delivery device according to claim 1, wherein the depth adjuster includes a rotatable knob that selectively engages with a portion of the shield.

7. The drug delivery device according to claim 6, wherein the rotatable knob is positioned on a threaded member of the housing.

8. The drug delivery device according to claim 6 or 7, wherein the rotatable knob includes at least one linear step for adjusting the point of engagement with the portion of the shield.

9. A housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end of the housing, An injection assembly, at least partially disposed within the housing at or near the proximal end of the housing, comprising an injection assembly including a needle or cannula, A drive assembly, at least partially located within the housing and operably coupled to the injection assembly, is a drive assembly that can be engaged to deliver a drug through the injection assembly. A drug delivery device including, The housing is adapted to slidably receive at least one of 1) a first shield having a first configuration, or 2) a second shield having a second configuration different from the first configuration of the first shield. A drug delivery device in which the first shield is fitted to allow the needle or cannula to extend from its proximal end by a first length, and the second shield is fitted to allow the needle or cannula to extend from its proximal end by a second length.

10. The drug delivery device according to claim 9, wherein the first shield has a first overall length, and the second shield has a second overall length different from the first overall length.

11. The drug delivery device according to claim 9, wherein the first shield includes a proximal end having a lip having a first thickness, and the second shield includes a proximal end having a lip having a second thickness different from the first thickness.

12. A platform system for assembling drug delivery devices, A housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end of the housing, An injection assembly located at least partially within the housing at or near the proximal end of the housing, comprising an injection assembly including a needle or cannula, A drive assembly, at least partially disposed within the housing and operably coupled to the injection assembly, the drive assembly being engageable to deliver a drug through the injection assembly, A group of selectable depth-adjusting components adapted to couple with a portion of the drug delivery device, in order to at least partially restrict the relative movement of a portion of the injection assembly. A platform system comprising the drug delivery device, wherein the drug delivery device is assembled by identifying and selecting a first depth adjustment component from the selectable depth adjustment component group using at least one desired characteristic of the drug delivery device, and coupling the first depth adjustment component with at least one of the housing, the injection assembly, or the drive assembly.

13. The platform system according to claim 12, wherein the at least one desired characteristic includes a desired injection depth.

14. The platform system according to claim 12 or 13, wherein the selectable depth adjustment component group includes a plurality of shields, each of which has a different configuration.

15. The platform system according to claim 14, wherein each of the plurality of shields has a different overall length.

16. The platform system according to claim 14, wherein each of the plurality of shields includes a lip adapted to engage with a portion of the housing, and each lip of the plurality of shields has a different thickness.

17. The platform system according to claim 12 or 13, wherein the selectable depth adjustment components include a plurality of depth adjusters operably coupled to a part of the device.

18. The platform system according to claim 17, wherein each of the plurality of depth adjusters includes a collar having a body of a different thickness.

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