Drug Delivery Devices

Abstract

The drug delivery device may include a housing defining a longitudinal axis and having an opening; a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel, the delivery member being disposed at a distal end of the barrel, and a drug storage container having an insertion end configured to extend at least partially through the opening during a delivery state. The device may also include a plunger movable toward the distal end of the drug storage container to engage the stopper and expel the drug from the drug storage container through the delivery member, the plunger including a body portion and a shock absorbing portion. The device may further include a plunger biasing member coupled with the plunger and configured to bias the plunger toward the distal end of the drug storage container.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 166,080, filed March 25, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to drug delivery devices, and more particularly, to devices for injecting drugs into a patient. [Background technology]

[0003] A general aversion to exposed needles, as well as health and safety concerns, have led to the development of drug delivery devices that hide the needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer various advantages over traditional forms of drug delivery, including, for example, delivery via a traditional syringe.

[0004] Many injector systems use coils and other spring structures to provide actuation energy for functions such as needle insertion and / or fluid delivery. The use of springs can offer the advantages of simplicity and low cost, but can have certain limitations. For example, there is a linear relationship between force and the displacement of the spring actuator. When initiating drug delivery, an excessive amount of energy may be input into the system to provide enough energy for drug delivery at the end of the plunger stroke. As another example, the spring force required may increase when more viscous drugs are delivered by the autoinjector. A spring with a higher spring constant may impart more force to the drug product and primary container. Various physical properties of the spring, such as the spring wire diameter, the spring center diameter, the number of turns of the spring, and the spring material, may affect the spring constant and therefore the spring force. However, as the spring force increases, the possibility of other components being damaged and / or broken may increase. Therefore, it may be desirable and / or advantageous to include device components that allow for flexible spring designs and / or facilitate the use of springs with different physical properties than the remaining device components.

[0005] The present disclosure describes a drug delivery device that embodies an advantageous alternative to existing drug delivery devices and that may address one or more of the problems or needs set forth herein. Summary of the Invention [Means for solving the problem]

[0006] One aspect of the present disclosure provides a drug delivery device having a housing defining a longitudinal axis and having an opening; a drug storage container including a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel, the delivery member being disposed at a distal end of the barrel, the drug storage container having an insertion end configured to extend at least partially through the opening during a delivery state. The device may also include a plunger movable toward the distal end of the drug storage container to engage the stopper and expel the drug from the drug storage container through the delivery member, the plunger including a body portion and a shock absorbing portion. The device may further include a plunger biasing member coupled with the plunger and configured to bias the plunger toward the distal end of the drug storage container.

[0007] The shock absorbing portion may include a foldable portion, which may include at least one foldable leg, at least two foldable legs, or at least four foldable legs.

[0008] The shock absorbing portion may include a foot portion coupled to the foldable portion, the foot may define a distal end of the plunger configured to engage the stopper, and the foldable portion is disposed between the foot and the plunger body portion, operatively coupling the foot and the plunger body portion.

[0009] The shock absorbing portion can have an extended position defining a first distance between the foot and the plunger body portion and a collapsed position defining a second distance between the foot and the plunger body, the first distance being greater than the second distance.

[0010] The shock absorbing portion may include a hard stop that defines a folded position. The hard stop may include a pair of protrusions that extend toward one another along the longitudinal axis. The hard stop may include two pairs of protrusions that each extend toward one another along the longitudinal axis.

[0011] The body portion of the plunger may have a hollow tubular shape. The body portion may comprise a non-metallic material, such as a thermoplastic material.

[0012] Another aspect of the present disclosure provides a plunger configured for use in a drug delivery device, the plunger may include a body portion having a proximal end and a distal end, and a shock absorbing portion disposed adjacent the distal end of the body portion, the shock absorbing portion including at least one foldable leg.

[0013] The present disclosure will be more fully understood when taken in conjunction with the following description and the accompanying drawings, some of which may be simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omission of elements in some of the drawings does not indicate the presence or absence of a particular element in any of the exemplary embodiments, unless expressly indicated in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0014] [Figure 1] 1A-1D are perspective views of an exemplary drug delivery device according to various embodiments. [Diagram 2] FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1. [Diagram 3] 3 is a cross-sectional view of the drug delivery device of FIG. 1 similar to the view of FIG. 2 but focusing on a portion of the device showing the distal end of the plunger rod and the stopper. [Figure 4] 13 is a front view of a distal portion of another embodiment of a plunger rod in accordance with various embodiments, the plunger rod being in an extended configuration. [Diagram 5] FIG. 4 is a front view of the distal portion of the plunger rod shown in FIG. 3, the plunger rod being in a folded configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The present disclosure generally relates to drug delivery devices operable for a user to administer a drug or for self-administration of a drug when the patient is the user. Various features are disclosed to streamline, simplify, automate and / or facilitate certain aspects of drug delivery, such as those used in autoinjectors, on-body injectors, or other automatic or partially automatic drug delivery devices (collectively, autoinjectors or auto-injectors). For example, these features may include automatically covering the needle in pre-delivery and / or post-delivery states, automatically inserting the needle and / or cannula into the user's body, automatically activating a drive mechanism, and automatically indicating to the user that drug delivery is complete, among other features. While known drug delivery devices incorporate separate or singly operable mechanisms to achieve each of their automated features, the present disclosure includes eliminating and / or combining at least some of these features and / or providing device components that allow for flexible device design. For example, the device may include components that allow for flexible spring designs and / or facilitate the use of springs with different physical properties than the remaining device components. As another example, the device may include components that reduce part count, part complexity, total device weight, and / or overall device complexity. For example, the present disclosure may include a plunger movable toward a distal end of the drug storage container to expel the drug from the drug storage container through a delivery member, the plunger including a body portion and a shock absorbing portion. The present disclosure may also include a plunger biasing member configured to bias the plunger toward the distal end of the drug storage container.

[0016] 1-3 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug product. The drug may be, but is not limited to, various biological agents such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the present disclosure is not limited to a particular condition.

[0017] Various implementations and configurations of the drug delivery device 10 are possible. This embodiment of the drug delivery device 10 is configured as 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). The illustrated exemplary drug delivery device may take 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, but may also or alternatively be suitable for other drug delivery devices and / or configurations.

[0018] The configuration of various 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-delivery or storage state, a delivery or administration state, and a post-delivery state, although fewer or more states are possible. For example, each state may have several sub-states or stages. The pre-delivery state may correspond to a configuration of the drug delivery device 10 after assembly and before activation by a user. In some embodiments, the pre-delivery state may exist in the time between when the drug delivery device 10 leaves the manufacturing facility and when the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the moment after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 relative to an injection site. The delivery state may correspond to a configuration of the drug delivery device 10 while drug delivery, also referred to herein as administration, is in progress. The post-delivery state may correspond to a configuration of the drug delivery device 10 after completion of drug delivery and / or when a stopper is placed in an end-of-administration position in a drug storage container.

[0019] As shown in Figures 1 and 2, 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 grip the injector 10 in 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 and a distal end. An opening 14 may be formed at the distal end to allow an insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be disposed in a wall of the housing 12 to allow a user to view components within the drug delivery device 10, including the drug storage container 20. Viewing the drug storage container 20 through the window 17 may allow a user to verify that drug delivery is in progress and / or is complete. A removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10 and, in some embodiments, may include a gripper 13 configured to aid in the removal of a sterility barrier 21 (e.g., rigid needle shield (RNS), non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the sterility barrier 21 and pull the sterility barrier 21 along with the removable cap 19 when a user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterility barrier 21 from the delivery member 16. 1, the removable cap 19 and / or housing 12 may include cap cam features, such as cap cam feature 19c, and housing cam feature 12a configured to translate rotational motion of the removable cap 19 into longitudinal motion of the removable cap 19, thereby facilitating cap removal. As a more specific example, upon rotation of the removable cap 19, the relative motion of cam features 12a, 19c urges the removable cap 19 distally (downward in FIG. 2) along the longitudinal axis A.

[0020] As shown in FIG. 2, the drive mechanism 30 may be partially or entirely disposed within the housing 12. In general, the drive mechanism 30 may be configured to store energy and, upon or in response to activation of the drive mechanism 30 by a user, release or output the energy to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 and into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, although alternative embodiments of the drive mechanism 30 may be configured in different forms, for example, such that the drive mechanism 30 stores electrical or chemical potential energy. In general, upon activation of the drive mechanism 30, the drive mechanism 30 may convert potential energy into kinetic energy to move the plunger 26. As best shown in FIG. 2, in one embodiment, the drive mechanism 30 includes a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, a releaser member 52, a plunger guide 60, an extender biasing member 35, and a guard extension 37. The plunger biasing member 50 may include a compression spring (e.g., a compression coil spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 may be compressed such that its axial length is shorter than when in a natural or de-energized state. When released, the plunger biasing member 50 attempts to expand to its natural axial length, thereby exerting a biasing force that may push the plunger 26 in a distal direction. The plunger 26 may also include a top ring 45 that defines a proximal end of the plunger 26. The top ring 45 may include one or more flanges or protrusions extending radially outward from a central portion of the top ring 45 to facilitate the locking and release configuration of the plunger.

[0021] As best shown in Figures 1-2, in one embodiment, the device 10 includes a housing 12, which may include two separate, interconnected structures: a rear end cap 23 (e.g., rear cover) at the proximal end of the drug delivery device 10, and a tubular housing 25 that extends substantially the entire length of the drug delivery device 10 and defines an opening 14. The housing 12 shown in Figure 2 also includes a guard member 32 that surrounds the delivery member 16 and protects against or reduces the possibility of an unintended or premature needle stick. Additionally or alternatively, the housing 12 may include fewer or more components, for example, a two-piece tubular housing having a front portion and a rear portion. The tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the end cap 23 and the tubular housing 25 and any components disposed therein may be combined to define different subassemblies, such as the drive mechanism 30. In some embodiments, the different subassemblies are assembled independently of one another and then combined with one another and with the drug storage container 20 to form the fully assembled drug delivery device 10. In certain such embodiments, some or all of the aforementioned assembly steps may occur in different manufacturing facilities or environments. In another embodiment, the housing 12 may be assembled in one piece such that the housing 12 is defined by a single monolithic structure that integrates the end cap and the tubular housing into a single component.

[0022] The drug storage container 20 is disposed within the interior space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 may be pre-filled, for example by a manufacturer, and shipped to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to a patient in more than one use case, such as as a pre-filled syringe or an auto-injector including a pre-filled syringe. By using the same or similar syringe components in both cases, at least some of the above steps, such as filling, labeling, packaging, shipping and distribution, may be streamlined or simplified for the two different use cases. As another example, when some or all of the same syringe components are used in the multiple use cases, some regulatory pathways for selling and / or distributing the drug may be streamlined and / or simplified for at least one of the multiple use cases.

[0023] The housing 12 may be preloaded with the drug storage container 20, e.g., by a manufacturer, or alternatively, the drug storage container 20 may be loaded by a user prior to use of the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal bore or reservoir. The wall may be made of glass or plastic. The stopper 24 may be movably disposed within the drug storage container 20 such that the stopper 24 may be moved 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 be in slidable and sealing contact with the inner surface 15 of the wall of the drug storage container 20 to prevent or inhibit leakage of the drug 22 past the stopper 24 while the stopper 24 is being moved. Distal movement of the stopper 24 expels 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 the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by a gap 18 (FIG. 2). Upon actuation of the drive mechanism 30, the plunger 26 moves distally to close the gap and abut the stopper 24. As the plunger 26 then moves distally, the stopper 24 is driven distally to expel the drug 22 from the drug storage container 20. In another embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or may be coupled to each other, for example via a threaded connection, so that they move together from the start of the movement of the plunger 26. Once the stopper 24 is in a displaced state, the stopper can continue to move distally until it contacts a proximally facing 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 an end-of-dose or end-of-delivery position and may correspond to when delivery of the medication 22 to the patient is complete or substantially complete.

[0024] The plunger 26 may generally include a body portion 39 and a shock absorbing portion 44 configured to dampen or absorb impact forces when the plunger 26 impacts the stopper 24 during actuation of the device 10. The plunger 26 may also include a foot 47 that defines a distal end of the plunger and is configured to engage the stopper 24 during actuation of the device 10.

[0025] The body portion 39 of the plunger 26 may have a hollow, generally cylindrical or tubular shape, such as a hollow rod 46. As a more specific example, the hollow rod 46 may have an inner surface 43 that may define an interior space sized to receive the plunger biasing member 50 therein. In general, to maximize the inner diameter of the plunger 26, it is desirable to minimize the thickness of the hollow rod 46 to the extent possible and without compromising the integrity of the plunger 26. This allows a larger diameter plunger biasing member 50 to fit within the interior space of the plunger 26, which in turn allows the plunger biasing member 50 to be stronger. As a more specific example, the hollow rod 46 may have a thickness less than 2 mm. As another more specific example, the hollow rod may have a thickness less than 1 mm. As another more specific example, the hollow rod may have a thickness less than 0.6 mm. As another more specific example, the hollow rod may have a thickness less than 0.3 mm. As another more specific example, the hollow rod may have a thickness less than 0.2 mm. As another more specific example, the thickness of the hollow rod can be less than 0.1 mm.As another more specific example, the thickness of the hollow rod can be less than 0.05 mm.

[0026] Additionally or alternatively, the hollow rod 46 may facilitate and / or provide greater flexibility in spring design. For example, it may be desirable or advantageous to use devices with different springs depending on the drug properties and / or the desired drug delivery profile. For example, a more viscous drug may require a spring with a higher spring constant and / or spring force, and therefore it may be desirable or advantageous to have flexibility in the physical properties of the spring. As a more specific example, various physical properties of the spring, such as the wire diameter of the spring (generally, increasing the wire diameter increases the spring constant), the center diameter of the spring (generally, increasing the center diameter decreases the spring constant), the number of turns of the spring (generally, increasing the number of turns increases the spring constant), and the material of the spring, may affect the spring constant and therefore the spring force. These physical properties may be adjusted to provide different spring constants, while also, in some cases, adjusting the thickness of hollow rod 46 to maintain a constant or relatively constant outer diameter of the overall plunger 26 and to keep the remaining components of the device constant, such as plunger guide 60 and stopper 24. Additionally or alternatively, hollow rod 46 may promote and / or provide greater longitudinal stability of plunger biasing member 50, such as by preventing or reducing buckling or other transverse movement.

[0027] The body portion 39 shown in the figures includes a metallic hollow rod 46 made of metal and a thermoplastic overmolding 48. Alternatively, the body portion 39 may be made of any suitable material, such as metal and / or plastic. To minimize the thickness of the hollow rod 46, it may be advantageous to make the hollow rod 46 out of a metal, such as steel or aluminum. For example, a metallic hollow rod 46 may have sufficient axial strength and / or buckling resistance for use in a device if the annular wall thickness is greater than 0.05 mm. Conversely, a plastic annular wall 39 may have sufficient axial strength and / or buckling resistance for use in a device if the annular wall thickness is greater than 1 mm. The metallic hollow rod 46 and thermoplastic overmolding 48 may enable the plunger 26 to have sufficient axial strength, while also providing the plunger 26 with a desirable surface finish that minimizes friction between the plunger 26 and the drug storage container 20. Additionally or alternatively, the thermoplastic overmolding material may facilitate the manufacture and / or performance of other features of the plunger rod 26 , such as the shock absorbing portion 44 and / or the foot 47 .

[0028] As shown in FIGS. 2-3, the shock absorbing portion 44 includes a foldable portion that dampens and / or absorbs forces due to a collision between the plunger rod 26 and the stopper 24. As a more specific example, the foldable portion shown in FIGS. 2-3 includes a pair of foldable legs 44a, 44b each having a generally "U" shape when in a first (extended) position and a "flat U" shape when in a second (folded) position. The foldable legs 44a, 44b may elastically deform to absorb the force. Additionally or alternatively, the foldable legs 44a, 44b may plastically deform to absorb the force. Additionally or alternatively, the foldable legs 44a, 44b may deform such that some are elastically deformed and some are plastically deformed. The foldable portion may have any suitable number of legs, such as one, two, three, four or more. The foldable legs may have any suitable shape, such as a "V" shape, a "W" shape, a coil spring shape, a leaf spring shape, or any suitable shape.

[0029] The shock absorbing portion 44 may be made of any suitable material, such as thermoplastic, other types of plastic, rubber, metal, or any suitable material. As noted above, the shock absorbing portion 44 may be an integral part of an overmolded section that surrounds a hollow metal rod, or may be formed by a thermoplastic molding process. The thickness, shape, and material of the components of the shock absorbing portion 44 affect its stiffness, which allows for the distribution of the amount of force absorbed by the shock absorbing portion, as described in more detail below.

[0030] Additionally or alternatively, the shock absorbing portion 44 may be formed of an elastomeric material that includes inherent damping properties. In such an example, the shock absorbing portion 44 may have a diameter and profile similar to the body portion 39 of the plunger 26, such as an elastomeric disk or cylinder at the distal end of the plunger 26.

[0031] As noted above, the plunger 26 may include a foot 47 that defines a distal end of the plunger 26. The foot 47 may be configured to engage the stopper 24 such that the foldable portion 44 is disposed between the foot 47 and the plunger body portion 39 of the plunger 26 to operatively couple the foot 47 and the plunger body portion 39 of the plunger 26. The foot may also be an integral part of an overmolded portion that surrounds the hollow metal rod or may be formed by a thermoplastic molding process. The foot may be generally cylindrical, e.g., resembling a disk shape, to properly engage the stopper 24 upon actuation of the device 10.

[0032] As a more specific example, during actuation of the device 10, as the plunger 26 moves distally, the gap 18 between the foot 47 of the plunger 26 and the stopper 24 closes rapidly and the foot 47 contacts the stopper 24. The device 10 is designed so that the plunger 26 moves with sufficient force to drive the stopper 24 distally and push the drug 22 out of the delivery member 16. At the same time, the device 10 is also designed to reduce or eliminate the possibility of, for example, glass breakage, undesirable forces acting on the patient, and / or undesirable shock vibrations or sounds due to the interaction between the base portion 47 and the stopper 24. For example, the design parameters of the plunger biasing member 50 can be designed to meet these two sets of design goals. As another example, the shock absorbing portion 44 can dampen the force between the foot 47 and the stopper 24. As a result, the speed of the plunger 26 can be slowed during initial contact between the plunger 26 and the stopper 24, thereby reducing the impact force between the respective components and reducing the possibility of structural damage to the medication storage container 20 and / or providing a more comfortable injection for the user.

[0033] In some embodiments, the volume of drug 22 contained within the reservoir of drug storage container 20 may be equal to 1 mL, or may be equal to about (e.g., ±10%) 1 mL, or may be equal to 2.5 mL, or may be equal to about (e.g., ±10%) 2.5 mL, or may be equal to 3 mL, or may be equal to about (e.g., ±10%) 3 mL, or may be equal to about (e.g., ±10%) 1 mL or less, or may be equal to about (e.g., ±10%) 2 mL or less, or may be equal to about (e.g., ±10%) 3 mL or less. or may be about (e.g., ±10%) 4 mL or less, or may be about (e.g., ±10%) less than 5 mL, or may be about (e.g., ±10%) 10 mL or less, or may be in the range of about (e.g., ±10%) 1 to 10 mL, or may be in the range of about (e.g., ±10%) 1 to 5 mL, or may be in the range of about (e.g., ±10%) 1 to 4 mL, or may be in the range of about (e.g., ±10%) 1 to 3 mL, or may be in the range of about (e.g., ±10%) 1 to 2.5 mL.

[0034] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. A distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include a sharp tip or other pointed shape that allows the insertion end 28 to pierce the skin 5 and subcutaneous tissue of the 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 28 to allow drug to flow from the delivery member 16 to the patient.

[0035] In one embodiment, the drug storage container 20 may be a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. In this case, the needle may be fixed against 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 yet other embodiments, the drug storage container 20 may be a needleless cartridge and thus may not initially be in fluid communication with the delivery member 16. In such an embodiment, the drug storage container 20 may move toward or away from the proximal end of the delivery member 16 during operation of the drug delivery device 10 such that the proximal end of the delivery member 16 pierces a septum covering the opening of the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0036] The container holder 31 may have a hollow, generally cylindrical or tubular shape centered about a longitudinal axis A, and the medication storage container 20 may be partially or entirely disposed within the container holder 31. The distal end of the container holder 31 may include an inwardly protruding flange 33 that abuts against a shoulder 20a of the medication storage container 20, thereby preventing distal movement of the medication storage container 20 during actuation of the plunger 26. The container holder 31 may include two flanges 33, each of which includes an arcuate inclined surface 33a that substantially matches the arcuate shape of the shoulder of the medication storage container. The housing 12 may include a plurality of locking slots 12c, each of which receives a respective locking ridge 33c of the container holder 31 to prevent and / or limit relative movement between the respective components 12, 31.

[0037] After drug delivery is completed and the guard member 32 is repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent a user from subsequently contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. In accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the guard member 32 to lock the guard member 32 in the extended position as the guard member 32 moves from the retracted position to the extended position. The device may also include a locking ring biasing member 51 that biases the guard member 32 in an outward (distal) direction to facilitate movement of the guard member 32 to the extended position, thereby covering the insertion end 28 of the delivery member 16.

[0038] More information regarding these and other features disclosed in the present disclosure is shown and described in more detail in U.S. patent application Ser. No. 62 / 960,996, filed Sep. 29, 2020, and U.S. patent application Ser. No. 17 / 035,851, which claims priority to U.S. patent application Ser. No. 62 / 960,996, each of which is incorporated herein by reference.

[0039] 4 and 5 show another plunger rod 126 according to various embodiments. In FIG. 4, the plunger rod 126 is shown in an extended configuration 126a, and in FIG. 5, the plunger rod 126 is shown in a folded configuration 126b. The plunger rod shown in FIGS. 4-5 includes a body portion 139 having a metallic hollow rod and a thermoplastic overmolding 148. The plunger rod also includes a shock absorbing portion 144 that dampens and / or absorbs forces due to a collision between the plunger rod 126 and the stopper. As a more specific example, the foldable portion shown in FIGS. 4-5 includes a pair of foldable legs 144a, 144b each having a generally "U" shape when in the first (extended) position 126a and a "flat U" shape when in the second (folded) position 126b. The foldable legs 144a, 144b may elastically deform to absorb forces. Additionally or alternatively, the foldable legs 144a, 144b may plastically deform to absorb forces. The foldable legs may have any suitable shape, such as a "V" shape, a "W" shape, a coil spring shape, a leaf spring shape, or any suitable shape.

[0040] The shock absorbing portion 144 shown in Figures 4-5 includes at least one hard stop 153 that defines the collapsed position 126b. As a more specific example, the shock absorbing portion 144 includes two pairs of opposing protrusions 153a, 153b, 153c, 153d that each extend toward one another along the longitudinal axis. When the plunger rod 126 is in the collapsed configuration 126b, the hard stops 153a, 153b, 153c, 153d contact one another to prevent further compression, thereby defining the collapsed portion.

[0041] The shock absorbing portion may reduce the impact energy of the plunger / stopper interaction by about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 8%, about 10%, about 12%, about 15%, or any suitable amount. As a more specific example, for a 20N spring with a free height of 3 mm (i.e., when the gap 18 shown in FIG. 2 is 3 mm), the plunger will impact the stopper with 0.06 Joules (3 mm*20N=0.06 Joules) without the shock absorbing portion. However, the shock absorbing portion may reduce the impact energy by about 10% (e.g., about 0.006 Joules). As another example, for a 20N spring with a free height of 15 mm (i.e., when the gap 18 shown in FIG. 2 is 15 mm), the plunger will impact the stopper with 0.3 Joules (15 mm*20N=0.3 Joules) without the shock absorbing portion. However, the shock absorbing portion can reduce the impact energy by about 2% (e.g., about 0.006 Joules). The shock absorbing portion may be constructed with different parameters to provide more or less energy reduction capabilities, as desired, such as by increasing or decreasing the stiffness of the foldable legs.

[0042] From the above, it can be seen that the present disclosure advantageously provides a streamlined design of a drug delivery device having automated features, where the various mechanisms and components of the drug delivery device interact synergistically to limit the number of moving parts required in the drug delivery device, thereby improving the reliability of the drug delivery device, saving costs, as well as providing other benefits and advantages.

[0043] It will be appreciated that devices and methods according to the present disclosure may have one or more advantages over the prior art, any one or more of which may be present in a particular embodiment and in accordance with the features of the present disclosure included in that embodiment, and other advantages not specifically recited herein may be appreciated as well.

[0044] The above description describes various devices, assemblies, elements, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, elements, subsystems, methods, or drug delivery devices may also include or be used with drugs, including but not limited to the drugs identified below, as well as their generic and biosimilar counterparts. The term drug, as used herein, may be used interchangeably with other similar terms and may be used to refer to any type of pharmaceutical or therapeutic material, including conventional and non-conventional pharmaceuticals, nutraceuticals, supplements, biologics, bioactive substances and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid, lyophilized, or reconstituted from lyophilized form. The following exemplary list of drugs should not be considered exhaustive or limiting.

[0045] The drug is contained in 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 can be a vial, cartridge, or pre-filled syringe.

[0046] 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 filgastrim, 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).

[0047] 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, the 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 alpha, 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.

[0048] Particularly exemplary proteins include the specific proteins listed 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., in particular a dimer 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, 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, human CD22-specific fully humanized antibodies of HuMax; IGF-1 receptor-specific antibodies, peptibodies and related proteins, including but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, 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, a B7RP-specific fully human monoclonal IgG2 antibody, including but not limited to, a fully human IgG2 monoclonal antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1; 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, etc., including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as monoclonal antibodies; TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-beta specific antibodies, peptibodies, related proteins, etc.; amyloid-beta protein specific antibodies, peptibodies, related proteins, etc.; 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® (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 alfa); 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, 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 mAb; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugate (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 1 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-mannos receptor / hCGβ mAb (MDX-1307); anti-methelin 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 mAb (HGS-ETR2); anti-TWEA; K mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0049] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, 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, a monoclonal antibody (IgG) that binds 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 in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, 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 migraine. 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-TNF alpha 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 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) on 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 omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS. G12C Small molecule inhibitors or KRAS G12CIt may contain or be used with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or a 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 Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product that contains a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160 or another product that contains 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 in conjunction with another product containing AMG 119 or 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 AMG 199, or a product containing 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 house or be used in conjunction with another product containing AMG 427 or 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 FAPx4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used 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 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 efavalukin alpha (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. may be used in conjunction with this. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 596 or another product containing CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecules. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 701 or another product containing 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 in conjunction with AMG 757 or another product containing 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 contain or be used in conjunction with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0050] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be construed as merely an example, and does not describe all possible embodiments of the present disclosure. Various alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0051] 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. 1. A drug delivery device comprising: a housing defining a longitudinal axis and having an opening; a drug storage container including a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel, the delivery member being disposed at a distal end of the barrel, the drug storage container having an insertion end configured to extend at least partially through the opening during a delivery state; a plunger movable toward the distal end of the medication storage container to engage the stopper and expel medication from the medication storage container through the delivery member, the plunger including a body portion and a shock absorbing portion; a plunger biasing member coupled to the plunger and configured to bias the plunger toward the distal end of the medication storage container; A drug delivery device comprising:

2. The drug delivery device of claim 1 , wherein the shock absorbing portion comprises a foldable portion.

3. The drug delivery device of claim 2 , wherein the foldable portion includes at least one foldable leg, at least two foldable legs, or at least four foldable legs.

4. The drug delivery device according to any one of claims 2 to 3, wherein the shock absorbing portion comprises a foot portion coupled to the foldable portion.

5. 5. The drug delivery device of claim 4, wherein the foot defines a distal end of the plunger configured to engage the stopper, and the foldable portion is disposed between the foot and the plunger body portion and operatively couples the foot and the plunger body portion.

6. 6. The drug delivery device of claim 5, wherein the shock absorbing portion has an extended position defining a first distance between the foot and the plunger body portion and a folded position defining a second distance between the foot and the plunger body, the first distance being greater than the second distance.

7. The drug delivery device of claim 6 , wherein the shock absorbing portion includes a hard stop that defines the collapsed position.

8. The drug delivery device of claim 7 , wherein the hard stop includes at least one pair of protrusions extending toward each other along the longitudinal axis.

9. The drug delivery device of any one of claims 1 to 8, wherein the body portion has a hollow tubular shape.

10. The drug delivery device of any one of claims 1 to 9, wherein the body portion comprises a non-metallic material and the shock absorbing portion is defined by the non-metallic material.

11. The drug delivery device of claim 10 , wherein the non-metallic material is a thermoplastic material.

12. 1. A plunger configured for use in a drug delivery device, comprising: a body portion having a proximal end and a distal end; a shock absorbing portion disposed adjacent the distal end of the body portion, the shock absorbing portion including at least one foldable leg; The plunger comprises:

13. The plunger of claim 12 , wherein the shock absorbing portion includes a foot coupled to the at least one foldable leg.

14. 14. The plunger of claim 13, wherein the foot is disposed at the distal end of the body portion, and the at least one foldable leg is disposed between the foot and a remainder of the body portion, operatively coupling the foot and the remainder of the body portion.

15. 15. The plunger of claim 14, wherein the shock absorbing portion has an extended position defining a first distance between the foot and the remainder of the body portion and a folded position defining a second distance between the foot and the remainder of the body portion, the first distance being greater than the second distance.

16. The plunger of claim 15, wherein the shock absorbing portion includes a hard stop that defines the collapsed position.

17. 17. The plunger of claim 16, wherein the hard stop includes at least one pair of projections extending toward one another along the longitudinal axis.

18. A plunger according to any one of claims 12 to 17, wherein the body portion has a hollow tubular shape.

19. A plunger according to any one of claims 12 to 18, wherein the body portion comprises a non-metallic material, and the shock absorbing portion is defined by the non-metallic material.

20. 20. The plunger of claim 19, wherein the non-metallic material is a thermoplastic material.

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