Drug delivery device with shock absorber

Abstract

A drug delivery device is provided that includes a housing, a drug reservoir, a plunger, a plunger biasing member, a releaser, and a shock absorber. The housing defines a longitudinal axis and has an opening. The drug reservoir includes a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel. The delivery member is disposed at a distal end of the barrel and has an insertion end configured to extend at least partially through the opening during a delivery state. The plunger is movable toward the distal end of the drug reservoir to engage the stopper and release the drug from the drug reservoir through the delivery member. The plunger biasing member is coupled to the plunger and configured to bias the plunger toward the distal end of the drug reservoir. The releaser member has a first position in which the releaser member prevents the plunger from transitioning to the delivery state and a second position in which the releaser member does not prevent the plunger from transitioning to the delivery state. The shock absorber is configured to absorb impact forces to prevent unintended movement of the releaser member.

Description

[Technical Field]

[0001] Cross-Reference to Related Applications Priority is claimed to U.S. Provisional Patent Application No. 63 / 211,904 filed on June 17, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure generally relates to drug delivery devices, and more specifically to devices for automatically injecting a drug into a patient. [Background Art]

[0003] General aversion to exposed needles, as well as health and safety concerns, have led to the development of drug delivery devices that conceal needles or other insertion members before use and automate various aspects of the injection process. Such devices offer various advantages compared to conventional forms of drug delivery including, for example, delivery via a conventional syringe.

[0004] Drug delivery devices can incorporate various mechanisms for implementing various automated or semi-automated features. Among other features, such features include automatically covering a needle in pre-delivery and / or post-delivery conditions, automatically inserting a needle and / or cannula into a user, automatically activating a drive mechanism, automatically indicating to a user that drug delivery is completed, and locking a guard in a position covering the needle after drug delivery is completed. Certain such features are activated, for example, by application of an external force by a user. Such features may tend to activate prematurely or inadvertently if the drug delivery device is subjected to sudden unintended force or movement during manufacturing, transportation, storage, and / or other handling of the device.

[0005] For example, if a drug delivery device falls from a height and hits a stationary surface such as the ground, the device may experience a considerable impact force. This impact force could prematurely activate automated or semi-automated features and / or cause structural damage to the drug delivery device. The likelihood of such problems increases if the drug delivery device containing a particular drug has just been removed from the cryogenic storage required for such a device. At low temperatures, various components of a drug delivery device may be relatively brittle and therefore susceptible to breakage or damage as a result of a sudden impact.

[0006] This disclosure describes a drug delivery device that embodies a favorable alternative to existing drug delivery devices and device housing features and can address one or more of the challenges or needs described herein. [Overview of the Initiative] [Means for solving the problem]

[0007] One aspect of the present disclosure provides a drug delivery device comprising a housing, a drug storage container, a plunger, a plunger biasing member, a releaser, and a shock absorber. The housing may define a longitudinal axis and have an opening. The drug storage container may include a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel. The delivery member may be located at the distal end of the barrel and has an insertion end configured to extend at least partially through the opening during the delivery state. The plunger may be movable toward the distal end of the drug storage container to engage with the stopper and release a drug from the drug storage container through the delivery member. The plunger biasing member may be coupled with the plunger and configured to bias the plunger toward the distal end of the drug storage container. The releaser member may have a first position in which the releaser member prevents the plunger from transitioning to the delivery state, and a second position in which the releaser member does not prevent the plunger from transitioning to the delivery state. The impact absorber may be configured to absorb impact forces and prevent unintended movement of the release member.

[0008] The housing includes a tubular housing and a rear cap that are movably coupled to each other, and the shock absorber may include the rear cap. The rear cap may be movable relative to the tubular housing.

[0009] The shock absorber may include a snap ring configured to allow relative movement between the rear cap and the tubular housing.

[0010] The impact absorber may include annular projections configured to be received by a snap ring. The snap ring may include an inclined surface configured to allow the rear cap to move distally when an impact force is applied and to bias the rear cap to move proximally after the impact force has dissipated. The inclined surface may be defined by a plurality of longitudinal ribs.

[0011] The device may include a buffer gap between the rear cap and the tubular housing. The buffer gap may define the distance between the rear cap and the tubular housing.

[0012] The device may include a plunger guide configured to operably connect a rear cap and a tubular housing. The plunger guide may define an annular projection that is received by a snap ring of the rear cap, and the plunger guide may further define a second annular projection that is configured to be received by a second annular ring.

[0013] The plunger guide may be configured to operably connect the tubular housing and the rear cap, and the plunger guide may define an annular projection.

[0014] The drug delivery device may be an autoinjector, but is not limited to an autoinjector.

[0015] The tubular housing may be defined as having a substantially cylindrical shape. The tubular housing may also be defined as having a non-cylindrical shape, such as a substantially oval or elliptical shape.

[0016] The tubular housing and rear cap may be defined by a single monolithic structure, and the shock absorber may include a flexible or compressible portion connecting the tubular housing and the rear cap.

[0017] This disclosure is expected to be better understood by interpreting the following description in conjunction with the accompanying drawings. Some of the drawings have been simplified by omitting selected elements in order to more clearly illustrate other elements. Such omissions of elements in some drawings do not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless explicitly depicted in the corresponding descriptive description. Furthermore, none of the drawings are necessarily shown to exact scale. [Brief explanation of the drawing]

[0018] [Figure 1] This is a perspective view of exemplary drug delivery devices in various embodiments, equipped with shock absorbers configured to absorb impact forces. [Figure 2] Figure 1 is a cross-sectional view of a drug delivery device. [Figure 3A] Figure 1 is an enlarged cross-sectional view of a portion of a drug delivery device, where the shock absorber is located at a first position where the device is not affected by the shock event or its aftereffects. [Figure 3B] Figure 1 is an enlarged cross-sectional view of a portion of the drug delivery device, where the housing is in a second position during an impact event or its aftermath. [Figure 4A] Figure 1 is an exploded view of a part of the drug delivery device, specifically the drive mechanism. [Figure 4B] Figure 1 is an exploded view of the drug delivery device. [Figure 5] This is a cross-sectional view of a rear cap that can be used as part of a shock absorber in various embodiments of drug delivery devices. [Figure 6] It is a cross-sectional view of another rear cap that can be used as part of a shock absorber according to various aspects of a drug delivery device. [Figure 7] It is a cross-sectional view of yet another rear cap that can be used as part of a shock absorber according to various aspects of a drug delivery device. [Figure 8] It is a cross-sectional view of another rear cap that can be used as part of a shock absorber according to various aspects of a drug delivery device. [Figure 9A] It is a cross-sectional view of part of a housing and a plunger guide that can be used as part of a shock absorber according to various aspects of a drug delivery device, wherein the housing is in a first position not subjected to an impact event or the aftermath thereof. [Figure 9B] It is a cross-sectional view of part of the housing and plunger guide shown in FIG. 9A, wherein the housing is in a second position during an impact event or the aftermath thereof. DETAILED DESCRIPTION OF EMBODIMENTS FOR CARRYING OUT THE INVENTION

[0019] This disclosure relates, in general, to a drug delivery device that can be operated by a user to administer a drug, or, if the user is a patient, to self-administer a drug. The drug delivery device may include a housing, a drug storage container, a plunger, a plunger biasing member, a releaser, and a shock absorber. The housing may define a longitudinal axis and have an opening. The drug storage container may include a barrel, a stopper, and a delivery member, the stopper being movably disposed within the barrel. The delivery member may be located at the distal end of the barrel and has an insertion end configured to extend at least partially through the opening during the delivery state. The plunger may engage with the stopper and be movable toward the distal end of the drug storage container to release a drug from the drug storage container through the delivery member. The plunger biasing member may be coupled with the plunger and configured to bias the plunger toward the distal end of the drug storage container. The release member may have a first position in which it prevents the plunger from moving to the delivery state, and a second position in which it does not prevent the plunger from moving to the delivery state. The shock absorber may be configured to absorb the shock force and prevent unintended movement of the release member.

[0020] The shock absorber of the present disclosure may allow a cap or a specific portion thereof to move relative to other components of the device (e.g., a housing) to reduce or dampen at least a portion of the mechanical effect of an externally applied force, including reducing acceleration and / or deceleration caused by the externally applied force. Accordingly, the shock absorber may prevent or impede actuation of one or more automated or semi-automated features included in a drug delivery device comprising a releaser, a drive mechanism for expelling a drug, for example, in particular. In addition, the shock absorbing features of the present disclosure may prevent or impede damage to a drug delivery device including a cap that might otherwise result from an externally applied force. For example, the shock absorber may reduce the likelihood that fracture or cracking will form in the cap and / or other portions of the drug delivery device if a user accidentally drops the drug delivery device after removing the drug delivery device from a cold storage. These and other advantages will be apparent to those skilled in the art having the benefit of this disclosure.

[0021] Figures 1 to 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 an agent or a drug product. The drug may be various biologics such as, but not limited to, peptides, peptibodies, or antibodies. The drug may be in fluid or liquid form, but the present disclosure is not limited to a particular state.

[0022] Various realizations and configurations are possible for the drug delivery device 10. In this embodiment, 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 reusable injector for multiple uses. The drug delivery device 10 is operable for self-administration by the patient or administration by a caregiver or formally trained healthcare provider (e.g., a physician or nurse). The exemplary drug delivery device shown in the figure may take the form of an auto-injector or a pen-type injector, and can therefore be held in the user's hand for the duration of drug delivery, or alternatively, other drug delivery devices and / or configurations may be suitable.

[0023] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state may have several substates or stages. The storage state may correspond to the configuration of the drug delivery device 10 in Figures 1 to 3, in which the delivery device includes a removable cap in a storage position. In some embodiments, the storage state may exist in the time between when the drug delivery device 10 leaves the manufacturing facility and when a patient or other user removes the removable cap. The pre-delivery stage may correspond to the configuration of the drug delivery device 10 after the removable cap has been removed but before the user activates the drive mechanism. This may include the moment after the user has removed the removable cap, while the user is initially positioning the drug delivery device 10 relative to the injection site, but before administration begins. The delivery state may correspond to the 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 the configuration of the drug delivery device 10 after drug delivery is complete and / or when the stopper is placed in the end-of-dose position within the drug storage container.

[0024] Referring to Figures 1 to 4B, the drug delivery device 10 includes an external casing or housing 12. In some embodiments, the housing 12 may be sized and dimensional so that a person can grasp the injector 10 with one hand. The housing 12 may have a substantially 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 (Figure 2) may be formed at the distal end (bottom end in Figures 1 to 3) to allow the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be positioned in the wall of the housing 12 to allow the user to view the components inside the drug delivery device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window 17, the user may be able to confirm that drug delivery is in progress and / or completed. At the distal end of the device, a removable cap 19 may cover the opening 14 before use of the drug delivery device 10, and in some embodiments, a gripper 13 may be included, configured to assist in the removal of a removable sterile barrier 21 (e.g., a rigid needle shield (RNS), a 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 return portions or arms that frictionally or mechanically engage with the removable sterile barrier 21 to pull the removable sterile barrier 21 together with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the removable sterile barrier 21 from the delivery member 16.

[0025] In some embodiments, the housing 12 may include two separate interconnected structures, namely a rear end cap 23 (e.g., a rear cover) at the proximal end of the drug delivery device 10, and a tubular housing 25 extending substantially along the length of the drug delivery device 10 and defining the opening 14. Additionally or alternatively, the housing 12 may include fewer or more components, for example, a two-part tubular housing having a front portion and a rear portion. The tubular housing 25 may have a hollow, substantially cylindrical or tubular shape, and the rear end cap 23 may have a substantially hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25, and any components placed therein, may be assembled together to define different subassemblies. In alternative embodiments, the housing 12 may be assembled in one part such that the housing 12 is defined by a single monolithic structure that integrates the rear cap and the tubular housing into a single component. In such one-piece housing embodiments, the housing may include a flexible or compressible portion that acts as a shock absorber.

[0026] The drug storage container 20 is disposed within the internal space of the housing 12 and is configured to contain the drug. The drug storage container 20 may be pre-filled and transported, for example, by the manufacturer to a location where the drug storage container 20 will be combined with the rest of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to the patient in more than one use case, such as in a pre-filled syringe or an auto-injector containing a pre-filled syringe. In either case, by using the same or similar syringe components, at least some of the above steps, such as filling, labeling, packaging, shipping and delivery, may be made more efficient or simpler for two different use cases. As another example, if some or all of the same syringe components are used in multiple use cases, some regulatory channels for selling and / or delivering the drug may be made more efficient and / or simpler for at least one of the multiple use cases.

[0027] The drug storage container 20 may include a rigid wall defining an internal bore, i.e., a reservoir. The wall may be made of glass or plastic. The stopper 24 may be movably disposed within the drug storage container 20 so as to move 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 sealed contact with the inner surface 15 of the wall of the drug storage container 20 so as to prevent or prevent the drug 22 from leaking over the stopper 24 while the stopper 24 is moving. The distal movement of the stopper 24 releases the drug 22 from the reservoir of the drug storage container 20 to 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 positioned spaced apart by a gap 18. When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap 18 and come into contact with the stopper 24. The subsequent distal movement of the plunger 26 drives the stopper 24 distally, releasing the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially be in contact with or coupled to each other, for example, via a screw coupling, so that they move together from the start of the movement of the plunger 26. Once the stopper 24 has moved, it may continue to move distally until it comes into contact with the portion of the inner surface 15 of the wall of the drug storage container 20 that faces the proximal side. This position of the stopper 24 may be referred to as the end-of-dose or end-of-delivery position and may correspond to when the delivery of the drug 22 to the patient is complete or substantially complete.

[0028] In some embodiments, the volume of drug 22 contained in the reservoir of the drug storage container 20 may be equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.5 mL, or approximately (e.g., ±10%) equal to 2.5 mL, or equal to 3 mL, or approximately (e.g., ±10%) equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 1 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) less than or equal to 3 mL. It is fine, or it may be less than or about (e.g., ±10%) 4 mL, or less than or about (e.g., ±10%) 5 mL, or less than or about (e.g., ±10%) 10 mL, or it may be within the range of 1 to 10 mL, or it may be within the range of 1 to 5 mL, or it may be within the range of 1 to 4 mL, or it may be within the range of 1 to 3 mL, or it may be within the range of 1 to 2.5 mL, or about (e.g., ±10%).

[0029] The delivery member 16 is connected to or operable to be connected in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include other pointed sharp tips, allowing the insertion end 28 to puncture the patient's skin and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal pathway. One or more openings may be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 and enter the patient.

[0030] In one embodiment, the drug storage container 20 may be a pre-filled syringe having a fixed hollow metal needle for the delivery member 16. In this case, the needle may be fixed to the wall of the drug storage container 20 and permanently in fluid communication with the reservoir of the drug storage container 20. In another embodiment, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In yet another embodiment, the drug storage container 20 may be a needleless cartridge and therefore may not initially be in fluid communication with the delivery member 16. In such an embodiment, during the operation of the drug delivery device 10, the drug storage container 20 may move toward or toward the proximal end of the delivery member 16 so that the proximal end of the delivery member 16 penetrates the 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.

[0031] The device may also include a container holder 33 configured to secure the drug storage container 20 to the housing 12, for example, by preventing distal movement of the drug storage container 20 while the plunger is in operation. The container holder 33 may include a plurality of flanges 33c, each including an arc-shaped inclined surface 33a substantially matching the arc shape of the shoulder of the drug storage container 20. In a more specific example, when the drug storage container 20 is inserted into the container holder 33, the flanges 33c cooperate to support the shoulder and restrict distal movement of the drug storage container 20. The housing 12 may include a plurality of locking slots 12c, each receiving a flange 33c of the container holder 33, to prevent and / or restrict relative movement between the respective components 12, 33. As a result, when fully assembled, the storage container 20, container holder 33, and housing 12 are all substantially or completely fixed to each other.

[0032] The drug delivery device 10 may further include a guard mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an infusion. The guard mechanism may include a guard member 32 movably disposed at the distal end of the housing 12 adjacent to the opening 14. The guard member 32 may have a hollow, substantially cylindrical or tubular shape that is generally centered about the longitudinal axis A, and may have a proximal end that is received within the housing 12. The guard member 32 may be configured to move relative to the housing 12 between an extended position in which the distal end of the guard member 32 extends through the opening 14 in the housing 12, and a retracted position in which the distal end of the guard member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the guard member 32 may be configured to move from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 may translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 may translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond the insertion end 28 of the delivery member 16 and surround the insertion end 28. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 before delivery or in the storage state, moving the guard member 32 from the extended position to the retracted position by pressing the distal end of the guard member 32 against the patient's skin at the injection site may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin.

[0033] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be positioned proximal to the guard member 32, and the guard biasing member 35 may be positioned proximal to the guard extension 37. The guard extension 37 may have a hollow, substantially cylindrical or tubular shape centered about the longitudinal axis A. Furthermore, the guard extension 37 may be movable linearly along the longitudinal axis A relative to the housing 12. In this embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in an alternative embodiment, the guard extension 37 and the guard member 32 may be integrally formed as a single part to define a single monolithic structure. In such an alternative embodiment, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0034] The guard biasing member 35 may be positioned between the guard extension 37 and the release member 52, in contact with them. The guard biasing member 35 may be configured to bias or press the guard extension 37 distally and bias or press the release member 52 proximal. The guard biasing member 35 may initially be biased (e.g., compressed) to apply a biasing force to the guard extension 37 and the release member 52 in the pre-delivery state. In some embodiments, the distal end of the guard extension 37 is initially in contact with the proximal end of the guard member 32, as shown in Figure 2. As a result, the guard extension 37 transmits the biasing force of the guard biasing member 35 to the guard member 32 so that the guard biasing member 35 biases or presses the guard member 32 toward the extended position. The user can overcome the biasing force by pressing the guard member 32 against the injection site. In this manner, the guard member 32 and the guard extension 37 move together proximal to, for example, the guard member 32 until it reaches a retracted position. When the injection is complete and the drug delivery device 10 is lifted from the injection site, the guard biasing member 35 may press against the guard extension 37, thereby causing the guard extension 37 and the guard member 32 to move together distally. This action returns the guard member 32 to its extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the guard biasing member 35 may include a compression spring (e.g., a helical compression spring). Furthermore, in embodiments in which the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be arranged around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0035] After drug delivery is complete and the guard member 32 has been repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent subsequent user contact with the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. To these purposes, 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 in order to lock the guard member 32 in the extended position once the guard member 32 has moved from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered and rotates about the longitudinal axis A. As shown in Figure 3, the proximal end of the locking ring 40 may be in contact with the container holder 33, and the distal end of the locking ring 40 may be disposed at least partially within the guard member 32. A locking ring biasing member 51 may be axially positioned between the distal-facing surface of the locking ring 40 and the proximal-facing surface of the guard member 32. The lock ring biasing member 51 may initially be compressed or biased to bias the lock ring 40 and the guard member 32 away from each other. Thus, the lock ring biasing member 51 may apply a biasing force that pushes the guard member 32 toward the extended position, and may also apply a biasing force that pushes the proximal end of the lock ring 40 toward the container holder 33. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a helical compression spring). In some embodiments, rotation of the lock ring 40 may be achieved by a cam configuration between the lock ring 40 and the container holder 33.

[0036] The drug delivery device 10 may further include a drive mechanism 30 partially or completely disposed within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, at the time of or in response to activation of the drive mechanism 30 by the user, release or output that energy to drive the plunger 26 to release the drug 22 from the drug storage container 20 through the delivery member 16 into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, but alternative embodiments of the drive mechanism 30 may be configured in a different form, for example, so that the drive mechanism 30 stores electrical or chemical potential energy. Generally, at the time of activation of the drive mechanism 30, the drive mechanism 30 may convert the potential energy into kinetic energy to move the plunger 26.

[0037] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member seating surface 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 may include a compression spring (e.g., a helical compression 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 that of its natural or unbiased state. When released, the plunger biasing member 50 attempts to extend to its natural axial length, and as a result may apply a biasing force that pushes the plunger 26 distally.

[0038] The plunger biasing member 50 may be at least partially disposed within the plunger 26, and may have a distal end that abuts against the inner surface facing the proximal side of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. The outer diameter or other dimensions of the plunger biasing member 50 may be less than or equal to the inner diameter of the ring 45 and / or the inner diameter of the hollow rod 46, so that the plunger biasing member 50 can be received within the plunger 26. In some embodiments, the distal end of the plunger biasing member 50 may abut against the inner surface facing the proximal side of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut against the distal surface of the plunger biasing member seating surface 38. The plunger biasing member seating surface 38 may be fixedly attached to the tubular housing 25 so that the plunger biasing member seating surface 38 provides a stationary surface for pushing the plunger biasing member 50 away. With this configuration, when the plunger biasing member 50 is released from the biased state, its length may be extended by moving distally so that the distal end of the plunger biasing member 50 moves away from the stationary proximal end of the plunger biasing member 50. This movement may push the plunger 26 distally, which in turn may push the stopper 24 distally, releasing the drug 22 from the drug storage container 20 into the delivery member 16 and then into the patient.

[0039] The release member 52 may have a hollow, substantially cylindrical or tubular shape and may be centered around the longitudinal axis A. As shown in Figure 2, the release member 52 may be radially positioned between the distal end of the plunger guide 60 and the proximal end of the guard extension 37. Furthermore, the release member 52 may be positioned radially inward of the guard biasing member 35. Generally, the release member 52 is configured to operably couple the guard member 32 and the plunger 26 in the operating sequence and to generate an audible signal indicating the end of drug delivery. By being configured in this way, the release member 52 performs two distinct functions and is therefore used to reduce the number of moving parts required by the drug delivery device 10.

[0040] The release member 52 may be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the release member 52 related to the operation may be powered by the plunger biasing member 50 and / or the guard biasing member 35, while subsequent rotations of the release member 52 related to the generation of the end-of-dose signal may be powered solely by the guard biasing member 35. Any linear translational movement of the release member 52 without rotation may be powered solely by the guard biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction, but alternative embodiments may allow linear translational movement of the release member 52 in both the proximal and distal directions.

[0041] The ability of the release member 52 to rotate about the longitudinal axis A may be adjusted by the interaction between the outer portion of the annular wall of the release member 52 and the inner portion of the guard extension 37. The guard extension 37 may be prevented from rotating about the longitudinal axis A as a result of being coupled to the housing 12. This is achieved by the engagement of a contact structure (e.g., an outwardly extending projection) included in the outer portion of the release member 52 with a cooperating contact structure (e.g., an inwardly extending projection) included in the inner portion of the guard extension 37, which prevents the release member 52 from rotating about the longitudinal axis A. If the release member 52 cannot rotate, the outwardly extending projection of the plunger 26, which is received in a recess formed on the inner surface of the release member 52, also cannot rotate. If this projection of the plunger 26 cannot rotate, the projection cannot slide within the longitudinal opening of the plunger guide 60. If the projection cannot move in this way, the plunger 26 also cannot move. If the plunger 26 cannot move, the plunger biasing member 50 cannot extend and release the bias. Therefore, the release member 52 holds the plunger biasing member 50 in a biased state until the guard extension 37 moves to the axial position, in which state the cooperating contact structures on the outer portion of the release member 52 and the inner portion of the guard extension 37 are disengaged from each other, thereby allowing the release member 52 to rotate relative to the guard extension 37.

[0042] As described above, the removable cap 19 may have a storage position (Figures 1 and 3) in which the removable cap 19 is coupled to the housing 12, and a removal position in which the removable cap 19 is detached from the housing 12 and not coupled to the housing 12. Also as described above, the device 10 may include a removable sterile barrier 21 which is removed from the delivery member 16 when the removable cap 19 is removed from the housing 12. The removable sterile barrier 21 may have a relatively snug or relatively high-friction fit with the drug storage container 20 in order to maintain the sterility of the delivery member 16 and / or to prevent air from entering the drug storage container 20. For example, it may be desirable to prevent or reduce the possibility of air entering the drug storage container and / or delivery member 16 in order to reduce the possibility of contamination and / or blockage or evaporation of the drug. Additionally or alternatively, it may be desirable to have a relatively snug or relatively high-friction fit between the sterile barrier 21 and the drug storage container 20 in order to prevent or reduce the possibility of accidental needle stick injuries. For these or other reasons, and alternatively, it may be desirable to have a relatively tight or relatively high-friction fit between the removable cap 19 and the housing 12. The sterile barrier 21 and the removable cap 19 may also be coupled to their respective components (e.g., the drug storage container 20 and the housing 12) via other suitable features such as coupling tab / slot connections, breakable connections such as perforated seals, screw connections, or other features that achieve a relatively secure but removable connection between their respective components.

[0043] As a result of these bonding forces, characteristics, and / or other factors, some device users may find it difficult or uncomfortable to remove the removable cap 19. For example, some device users may find it difficult to remove the cap 19 by axial force alone (along the longitudinal axis A). In other words, some device users may find it difficult to pull the cap 19 out of the housing 12. The cap 19 shown in Figures 1 to 3 includes multiple ribs 19d to help the user grip the surface of the removable cap 19 when removing it.

[0044] The device 10 shown in Figures 1 to 3 also includes a cam feature for converting rotational motion into axial motion so that, during the rotational motion of the removable cap 19, the removable cap 19 is biased to move away from the housing 12, thereby facilitating and / or facilitating the removal of the cap 19. For example, the housing 12 includes a housing cam feature 12a and a cap cam feature 19c. As a more specific example, in order to remove the removable cap 19 from the housing 12 by axial force / movement only (e.g., a "straight pulling force"), the user may need to apply a force of 45 Newtons or less, about 40-45 Newtons, about 35-40 Newtons, about 30-35 Newtons, about 25-30 Newtons, about 20-25 Newtons, about 15-20 Newtons, about 10-15 Newtons, about 5-10 Newtons, or less than about 5 Newtons. In the device 10 shown in Figures 1 to 3, a straight pulling force of approximately 10 to 15 Newtons is required to remove the removable cap 19.

[0045] The cap cam feature portion 19c shown in Figures 1 to 3 defines a wave shape, such as an arc-shaped surface. As a more specific example, the removable cap 19 shown in the figure includes a substantially cylindrical body portion 19d and an end wall 19e that is substantially perpendicular to the body portion 19d at the distal end of the cap 19. The body portion 19d defines a substantially annular lead rim 19f at the proximal end of the cap 19. The lead rim 19f defines the wave-shaped cap cam feature portion 19c. As a further specific example, the lead rim 19f shown in the figure defines two wave-shaped cam surfaces 19c and two relatively flat surfaces 19c' extending between the wave-shaped cam surfaces 19c. In other words, the two wave-shaped cam surfaces 19c and the two relatively flat surfaces 19c' work together to define the lead rim 19f. Alternatively, the leading rim 19f may define a continuous waveform, such as a continuous sine wave or another continuous waveform. For the purposes of this application, the term “continuous” should be interpreted as meaning that the waveform continues along the entire circumference of the leading edge, rather than alternating between waveform and flat surfaces.

[0046] The housing cam feature portion 12a shown in Figures 1 and 2 defines a waveform, such as an arc-shaped projection extending away from the outer surface 25 of the housing 12. As a more specific example, the housing cam feature portion 12a is a projection that has a shape somewhat resembling a "smile" or a "crescent moon". As an even more specific example, the housing 12 shown in the figure defines two waveform cam feature portions 12a.

[0047] When the removable cap 19 is in the storage position 19a shown in Figures 1 and 2, the cap cam feature 19c engages with or abuts against the housing cam feature 12a. In addition, the respective cam features 12a and 19c shown in the figures have a matched or mirror-like shape such that their respective surfaces 12a and 19c slide smoothly / easily across each other. For example, when the removable cap 19 is rotated (either clockwise or counterclockwise) relative to the housing 12, the housing cam features 12a and 19c rotate relative to each other, biasing the removable cap 19 away from the housing 12 along axis A. In other words, the cam features 12a and 19c convert the rotational motion into an axial motion to remove or assist in removing the cap 19. In some embodiments, even a relatively small rotation can facilitate and / or make the removal of the cap 19 easier.

[0048] Having described the general configuration of the drug delivery device 10, a general method of using the drug delivery device 10 for injection will now be described. As a preliminary step, the user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or cardboard box. Similarly, as a preliminary step, the user may prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. Next, the user may pull off the removable cap 19 from the housing 12, as will be described in more detail below. As a result of this movement, the gripper 13 may pull off the removable sterile barrier 21 from the drug storage container 20. This may expose the insertion end 28 of the delivery member 16. Nevertheless, since the guard member 32 is in the extended position, at this stage the insertion end 28 of the delivery member 16 remains surrounded by the guard member 32. The user may then place the drug delivery device 10 over the injection site and then press the distal end of the guard member 32 against the injection site. The force applied by the user overcomes the biasing force of the guard biasing member 35 and the lock ring biasing member 51, causing the guard member 32 to move proximally from the extended position to the retracted position and retract into the opening 14. The delivery member 16 remains stationary relative to the housing 12 during the retraction of the guard member 32.

[0049] As the guard member 32 moves from the extended position to the retracted position, several actions may occur. Since the delivery member 16 remains stationary relative to the housing 12 while the guard member 32 is retracted, the insertion end 28 of the delivery member 16 extends through the opening at the distal end of the guard member 32, thereby puncturing the patient's skin at the injection site and entering the patient's subcutaneous tissue. In addition, the retraction of the guard member 32 may also activate the drive mechanism 30 to release the drug 22 from the drug storage container 20.

[0050] As the guard member 32 moves from the extended position to the retracted position, the guard member 32 may press the guard extension 37 in the proximal direction. During the proximal movement of the guard extension 37, the aforementioned cooperating contact structures on the outer portion of the release member 52 and the inner portion of the guard extension 37 may slide past each other until they no longer contact each other. When this occurs, the release member 52 may rotate freely about the longitudinal axis A. The rotation of the release member 52 at this stage is caused by the extension of the plunger biasing member 50, which pushes the distally facing cam surface included on the plunger 26 and slides along the proximal facing cam surface on the plunger guide 60. The resulting cam action may cause the plunger 26 to rotate, thereby causing the release member 52 to rotate along with it.

[0051] The joint rotation of the release member 52 and the plunger 26 may continue until the distal-facing cam surface included on the plunger 26 reaches the end of the proximal-facing cam surface on the plunger guide 60 and moves into a longitudinal slot formed in the plunger guide 60. The longitudinal slot does not hinder the linear motion of the plunger 26. As a result, the plunger 26 is driven to move linearly distally by the extending plunger biasing member 50. Consequently, the plunger 26 contacts the stopper 24 (if it has not already contacted the stopper 24), and then pushes the stopper 24 distally, releasing the drug 22 from the drug storage container 20 through the delivery member 16 and out of the insertion end 28 into the patient's tissue. Drug delivery may continue until the stopper 24 reaches the end of drug delivery position. At this point, the stopper 24 may abut against the proximal-facing portion of the inner surface 15 of the wall of the drug storage container 20. As a result, the plunger 26 stops moving distally.

[0052] After drug delivery is complete, the user may lift the drug delivery device 10 from the injection site. Since there is nothing to resist the guard biasing member 35, the guard biasing member 35 may push the guard member 32 from the retracted position to the extended position, covering the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 may rotate the lock ring 40 to a position that prevents further retraction of the guard member 32.

[0053] These and other exemplary embodiments of drug delivery devices are discussed in more detail in U.S. Patent Application No. 17 / 036,690, No. 17 / 035,851, No. 17 / 035,927, No. 17 / 036,129, No. 17 / 036,217, filed on September 29, 2020, and in a U.S. Provisional Patent Application entitled “DRUG DELIVERY DEVICE” filed by the applicant of this application on the same date as this application, the entirety of which is incorporated by reference.

[0054] As described above, it may be advantageous to incorporate one or more shock-absorbing features within the rear cap 23. If the drug delivery device 10 is accidentally dropped from a height such that the rear cap contacts the ground at a considerable speed, or if the removable cap collides with or is struck by an external object at a considerable speed in any other way, the rear cap may be subjected to a considerable impact force. Without the shock-absorbing features, such an impact force may be transmitted to other components within the device 10. Such a force may trigger the activation of automated or semi-automated features included in the drug delivery device 10 and / or cause damage to the drug delivery device 10. As an example, if the drug delivery device 10 is dropped with its longitudinal axis A parallel or substantially parallel to the direction of gravity and the rear cap 23 facing generally downward, the deceleration associated with the drug delivery device 10 hitting the ground will cause the release member 52 to move proximal (towards the rear cap 23, upward in Figure 2) and / or the guard member 32 to retract into the housing. Any or both of these exemplary movements could potentially trigger the drive mechanism 30, thereby causing unintended and / or premature injection. Additionally or alternatively, deceleration may cause the lock ring 40 to rotate or otherwise move to a position that prevents the guard member 32 from subsequently retracting. This would then cause the guard member 32 to lock out prematurely, thereby preventing the user from performing an injection using the drug delivery device 10.

[0055] As a more specific example of a potentially undesirable consequence of dropping the drug delivery device 10, if the device 10 is dropped with the rear cap 23 facing downwards, most or all of the components of the device 10 will move and accelerate at roughly the same speed. However, when the rear cap 23 hits the ground or another surface, the housing 12 will decelerate before or faster than other internal components such as the release member 52 and / or guard member 32. In other words, upon impact, the housing decelerates relatively significantly, abruptly stopping its fall, while some of the other internal components are still moving and / or accelerating toward the ground. As a result of a relatively large difference between the deceleration of the housing and the acceleration of the other internal components ("acceleration Δ"), upon or immediately after impact, the release member 52 and / or guard member 32 may move proximal (towards the rear cap 23, upward in Figure 2), thereby potentially triggering the injection sequence. However, the shock absorption function described herein may reduce the speed at which the housing decelerates during an impact, thereby reducing the acceleration Δ between the respective components, such as the housing 12 on the one hand and the release member 52 and / or guard member 32 on the other, and reducing the possibility of premature or unintended operation.

[0056] Another example of a potentially undesirable consequence of dropping the drug delivery device 10 is that if the drug delivery device 10 has just been removed from a cold storage facility (e.g., below 10°C, below 5°C, or below 0°C) before being dropped, there may be a risk of fracture or cracking of components of the drug delivery device 10 due to, for example, a decrease in the elasticity of certain materials at low temperatures. Such fracture or cracking may impair the proper functioning of the drug delivery device 10, or even if not, if they are visible to the user, they may lead the user to assume that the drug delivery device 10 is defective, and consequently, they may discard the drug delivery device 10, whether necessary or not.

[0057] The reaction force described above, when applied to the shock absorber, can cause a conversion of kinetic energy to another form of energy, such as thermal energy (e.g., heat), and prolong the impact time. This, in turn, may reduce the likelihood that the impact event will trigger the activation of automated or semi-automated features included in a drug delivery device, for example, a drive mechanism and / or a guard lock mechanism for drug release, and / or reduce the likelihood of structural damage to components of the drug delivery device, for example, a rear cap. In at least some scenarios, the rear cap may function as a spring and damper system and / or shock absorber during the impact event.

[0058] Referring now to Figure 3, an exemplary embodiment of the shock absorber described above will be explained. Device 10 includes a shock absorber 61 configured to absorb impact forces and prevent unintended movement of the release member 52. In the device shown in Figure 3, the shock absorber includes a rear cap 23 and a tubular housing 25 which are operably coupled to each other for purposes such as absorbing impact forces by allowing relative movement between the rear cap 23 and the tubular housing 25. In a more specific example, the shock absorber 61 includes a snap ring 62 configured to allow relative movement between the rear cap 23 and the tubular housing 25. In the device shown in Figure 3, the snap ring 62 is an annular ring defined by the inner wall portion of the rear cap 23. The snap ring may be concave, convex, or another suitable shape, but the snap ring 62 shown in Figure 3 is substantially concave for purposes such as operably coupling with an annular projection 63. The annular projection 63 shown in Figure 3 is defined by the outer wall portion of the plunger guide 60, but the annular projection 63 may be defined by other components such as the tubular housing 25, another component of the housing 12, or another suitable component. The snap ring 62 and the annular projection 63 are configured to have a first position 61a (shown in Figure 3A) when no external impact force is applied or its aftereffects are felt, such as when the device 10 is in its storage state, pre-delivery state, delivery or administration state, or post-delivery state. In this first position, the rear cap 23 is positioned apart from the tubular housing 25 along the longitudinal axis A by a buffer gap 64 that allows the rear cap 23 to move distally (downward in Figure 3A).

[0059] The rear cap 23 is defined by a substantially cylindrical side wall 23a and a substantially convex upper wall 23b. The side wall 23a shown in Figures 1 to 3 is flexible enough to allow it to flex radially outward during the application of the shock absorber. The side wall 23a of the snap ring 62 is further defined by first and second inclined surfaces 62a and 62b that interact with the annular projection 63 to maintain the rear cap 23 in a first position 61a, in the absence of an external force. As a more specific example, the first inclined surface 62a is a frustoconical surface facing distally, configured to allow the rear cap 23 to move distally (downward) when an impact force is applied, and then bias the rear cap 23 to move proximal (upward) when the impact force is removed. During this movement, the side wall 23a flexes radially outward like a spring and / or cushion. The shape and angle of the first inclined surface 62a are configured to allow the rear cap 23 to move distally (downward in Figure 3A) during an impact event, and then to bias the rear cap 23 proximal (upward in Figure 3A) after the impact and its aftershocks. In a more specific example, if the device is dropped or otherwise subjected to an impact, the snap ring 62 may be biased to a second position 61b (shown in Figure 3B), in which case the first inclined surface 62a may bias the rear cap 23 to return to the first position 61a when the impact force and its aftershocks have dissipated or ceased. In another more specific example, the rear cap 23 is configured to allow movement of the rear cap 23 without plastically deforming the rear cap 23 and / or fixing the rear cap 23 in the second position 61b. As a more specific example, the rear cap 23 may be configured to prevent or reduce the possibility that the release member 52 and / or guard member 32 will move a certain distance in the event of an impact sufficient to activate the device 10. The impact force may be similar to or the same as the force produced by a fall from a height of 0.5 to 0.7 meters, about 0.7 to 0.9 meters, about 0.9 to 1.0 meters, about 1.0 to 1.1 meters, about 1.1 to 1.2 meters, about 1.2 to 1.3 meters, about 1.3 to 1.4 meters, about 1.4 to 1.5 meters, about 1.5 to 1.7 meters, about 1.7 to 2.0 meters, or another suitable height.As another exemplary specification, the device may be activated when the release member 52 moves longitudinally by approximately 7-8 mm, 6-9 mm, 5-10 mm, 4-11 mm, 3-12 mm, 2-15 mm, or another appropriate distance. As another exemplary specification, the device may be activated when the guard member 32 moves longitudinally by approximately 10-11 mm, 9-12 mm, 8-13 mm, 7-14 mm, 6-15 mm, 5-16 mm, 3-18 mm, or another appropriate distance.

[0060] The rear cap 23 may be configured to have a side wall 23a that is flexible enough to move upon impact but rigid enough to spring back to a first position after the impact and its aftershocks. The second inclined surface 62b is a frustoconical surface facing proximal side, configured to allow the rear cap 23 to slide over the annular projection 63 during assembly and then prevent or deter the removal of the rear cap 23 after assembly.

[0061] The snap ring 62 may have a longitudinal height 62c that is approximately equal to the longitudinal height of the annular projection 63 in order to hold the components in a first position during normal use. The first inclined surface 62a may have a longitudinal height 62d that is approximately equal to the longitudinal height of the buffer gap 64.

[0062] The sidewall of the rear cap may be a continuous cylindrical shape, or it may have one or more discontinuities that allow or promote elastic deformation / flexing in the event of impact. For example, the sidewall may include one or more slits formed in the sidewall adjacent to its distal end. The slits may extend partially or completely through the sidewall, or extend along part of the wall or along its entire length. The slits may extend substantially parallel to the longitudinal axis or along another direction / orientation.

[0063] Referring here to Figure 5, the rear cap 23 is shown completely and independently (rather than attached to the device). The rear cap 23 includes the side wall 23a, the convex upper wall 23b, and the snap ring 62 as described above. The rear cap 23 also includes a plurality of longitudinal ribs 23c that provide rigid stoppers for the annular projection 63 shown in the previous figure. For example, the longitudinal ribs prevent or stop the rear cap 23 from moving distally beyond the point where the annular projection abuts the longitudinal ribs 23c. The longitudinal ribs may also provide strength or rigidity to the rear cap 23. The first inclined surface 62a forms an angle 23d with respect to the longitudinal axis A, and the angle 23d may be approximately 20 degrees, approximately 18-22 degrees, approximately 16-24 degrees, approximately 14-26 degrees, approximately 12-28 degrees, approximately 10-30 degrees, approximately 5-35 degrees, approximately 5-40 degrees, approximately 5-45 degrees, or another suitable angle.

[0064] As an alternative or additional form of shock absorption, the rear cap 23 may be radially deformable through interaction between the rear cap 23 and the plunger guide 60. As an example, the rear cap 23 shown in Figure 5 includes three ribs 23c such that the rear cap 23 can be deformed radially outward in the region near each rib 23c. As a result, the region between the ribs 23c may be deformed radially inward. In other words, the rear cap 23 shown in Figure 5 may be deformed into a more rounded triangular shape with three rounded triangular "points" aligned with the ribs 23c. If the rear cap 23 has a different number of ribs, such as two, four, five, six, or any other suitable number, the deformed shape may correspond accordingly.

[0065] Referring here to Figure 6, another embodiment of the rear cap 123 is described. The various elements of the rear cap 123 shown in Figure 6 may be similar or identical in structure, configuration, and / or function to the elements of the rear cap 123 described above in conjunction with Figures 1 to 5. Such elements are assigned the same reference numerals as those used in Figures 1 to 5, except that they increase by 100 or a multiple thereof. For the sake of brevity, the description of some of these elements has been simplified or omitted. The rear cap 123 includes the side wall 123a, the convex upper wall 123b, and the snap ring 162 as described above. The rear cap 123 also includes a plurality of longitudinal ribs 123c that provide rigid stoppers for the annular projection, similar to those shown in the earlier figures. For example, the longitudinal ribs prevent or stop the rear cap 123 from moving distally beyond the point where the annular projection abuts the longitudinal ribs 123c. The longitudinal ribs may also provide strength or rigidity to the rear cap 123. The first inclined surface 162a forms an angle 123d with respect to the longitudinal axis A, and the angle 123d may be about 10 degrees, about 8-12 degrees, about 6-14 degrees, about 4-16 degrees, about 3-18 degrees, about 3-20 degrees, about 3-25 degrees, about 3-30 degrees, about 3-35 degrees, or another suitable angle. The rear cap 123 also includes at least one rigid stopper, such as a plurality of rigid stoppers 123e that define the maximum distance the rear cap 123 can move relative to one or more components of the device, such as a plunger guide similar to that shown in the previous figure.

[0066] Referring here to Figure 7, another embodiment of the rear cap 223 is described. Various elements of the rear cap 223 shown in Figure 7 may be similar or identical in structure, configuration, and / or function to the elements of the rear cap described above. Such elements are assigned the same reference numerals as those used in Figures 1 to 6, except that they increase by 200 or a multiple thereof. For the sake of brevity, the description of some of these elements has been simplified or omitted. The rear cap 223 includes the side wall 223a, the convex upper wall 223b, and the snap ring 262 as described above. The rear cap 223 also includes a plurality of longitudinal ribs 223c that provide rigid stoppers for the annular projection, similar to those shown in the earlier figures. For example, the longitudinal ribs prevent or stop the rear cap 223 from moving distally beyond the point where the annular projection abuts the longitudinal ribs 223c. The longitudinal ribs may also provide strength or rigidity to the rear cap 223. The first inclined surface 262a forms an angle 223d with respect to the longitudinal axis A, and the angle 223d may be approximately 20 degrees, approximately 18–22 degrees, approximately 16–24 degrees, approximately 14–26 degrees, approximately 12–28 degrees, approximately 10–30 degrees, approximately 5–35 degrees, approximately 5–40 degrees, approximately 5–45 degrees, or another suitable angle. The rear cap 223 also includes at least one rigid stopper, such as a plurality of rigid stoppers 223e, which define the maximum distance that the rear cap 223 can move relative to one or more components of the device, such as a plunger guide similar to that shown in the earlier figures. The convex upper wall 223b of the rear cap defines a wall that is thinner than the corresponding upper wall in Figures 5 and 6. As a more specific example, the thickness of the convex upper wall 223b is approximately 0.5 mm, compared to the thickness of the upper wall shown in Figures 5 and 6, which is approximately 0.7 mm. The rear cap 223 also includes a flow leader 223f to improve the injection molding process.

[0067] Referring here to Figure 8, another embodiment of the rear cap 323 is described. Various elements of the rear cap 323 shown in Figure 8 may be similar or identical in structure, configuration, and / or function to the elements of the rear cap described above. Such elements are assigned the same reference numerals as those used in Figures 1 to 7, except that they increase by 300 or a multiple thereof. For the sake of brevity, the description of some of these elements has been simplified or omitted. The rear cap 323 includes the side wall 323a, the convex upper wall 323b, and the snap ring 362 as described above. The rear cap 323 also includes a plurality of longitudinal ribs 323c that cooperate to define the first inclined surface 362a. As a more specific example, a plurality of longitudinal ribs 323c are arranged radially apart from one another around the inner surface of the side wall 323a, and each or many of the ribs 323c have a similar or the same angle 323d with respect to the longitudinal axis A, such that the plurality of ribs define a path for receiving annular projections similar to those shown in Figures 1 to 5. The angle 323d may be about 20 degrees, about 18 to 22 degrees, about 16 to 24 degrees, about 14 to 26 degrees, about 12 to 28 degrees, about 10 to 30 degrees, about 5 to 35 degrees, about 5 to 40 degrees, about 5 to 45 degrees, or another suitable angle. The rear cap 323 also includes at least one rigid stopper, such as a plurality of rigid stoppers 323e, which define the maximum distance the rear cap 323 can move relative to one or more components of the device, such as plunger guides similar to those shown in the earlier figures. The convex upper wall 323b of the rear cap defines a wall that is thinner than the corresponding upper wall in Figures 5 and 6. As a more specific example, the thickness of the convex upper wall 323b is approximately 0.5 mm, while the thickness of the upper wall shown in Figures 5 and 6 is approximately 0.7 mm.

[0068] Referring here to Figures 9A and 9B, another embodiment of the shock absorber 461 for device 410 is described. Various elements of device 410 shown in Figures 9A and 9B may be similar or identical in structure, configuration, and / or function to the elements of the rear cap described above. Such elements are assigned the same reference numerals as those used in Figures 1 to 8, except that they increase by 400 or a multiple thereof. Some of these elements have been simplified or omitted for brevity. Device 410 includes a housing 412 with a proximal portion (including at least the rear cap 423 and the tubular housing section 425) defining a single monolithic structure, and the shock absorber 461 includes a flexible and compressible portion connecting the tubular housing 425 and the rear cap 423. As a more specific example, Figure 9A shows a section view of part of a housing and plunger guide that may be used as part of a shock absorber in various embodiments of a drug delivery device. Figure 9A shows the shock absorber 461 having a first position 461a (shown in Figure 9A) when the device 410 is in its storage state, pre-delivery state, delivery or administration state, or post-delivery state, and no external impact force is being applied or its aftereffects are not felt. In this first position, the rear cap 423 is positioned along the longitudinal axis A, spaced apart from the plunger holder 460 by a buffer gap 464 that allows the rear cap 423 to move distally (downward in Figure 9A), and the housing is in the first position when the device is not subjected to an impact event or its aftereffects, and in a second position 461b during an impact event or its aftereffects. The shock absorber 461 may act like a spring, allowing the housing 412 to compress axially upon impact and then return to a relaxed state (for example, in the second position 461b). The flexible or compressible portion of the shock absorber 461 may be made of a thermoplastic material, an elastomer material, a coil spring covered with another material, or any other suitable configuration.

[0069] Any or all of the shock absorbers described above may be used in devices having an outer label, such as a plastic film, containing information or labels related to the drug product and / or drug delivery device. The label may be placed on top of the shock absorber so that the patient or end user cannot easily see the shock absorber. In such cases, the label may wrinkle temporarily or permanently during an impact event.

[0070] All features disclosed herein with respect to any embodiment of the removable cap may be combined in any combination, except for any combination in which at least some of such features are mutually exclusive.

[0071] As should be understood, the devices and methods of this disclosure may have one or more advantages over the prior art, and one or more of these advantages may exist in particular embodiments according to the features of this disclosure included in those embodiments. Other advantages not specifically mentioned herein may also be understood in the same way.

[0072] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used with, drugs specified below, as well as their generic and biosimilar equivalents. As used herein, the term "drug" is interchangeable with other similar terms and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, dietary supplements, supplements, biologics, biological 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 list of exemplary drugs should not be considered exhaustive or limiting.

[0073] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container, which is either filled with the drug for treatment or pre-filled with the drug. The primary container can be a vial, cartridge, or pre-filled syringe.

[0074] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. 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).

[0075] In other embodiments, the drug delivery device may contain, or be used with, an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Examples of erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Examples of erythropoiesis-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), and Binocrit® (epoetin a). Examples include, but are not limited to, epoetin alpha (alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0076] Certain exemplary proteins, including their fusions, fragments, analogues, variants, or derivatives, are described below: fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies (also referred to as RANKL-specific antibodies, peptide bodies, etc.), OPGL-specific antibodies, peptide bodies, and related proteins; myostatin-specific peptide bodies, myostatin-binding proteins, peptide bodies, and related proteins; and in particular, the binding of IL-4 and / or IL-13 to their receptors. Antibodies that inhibit the activity mediated by the interaction of IL-4 receptors, such as IL-4 receptor-specific antibodies, peptide bodies, and related proteins; interleukin-1 receptor 1 ("IL1-R1")-specific antibodies, peptide bodies, and related proteins; Ang2-specific antibodies, peptide bodies, and related proteins; NGF-specific antibodies, peptide bodies, and related proteins; CD22-specific antibodies, peptide bodies, and related proteins, particularly those that inhibit the activity mediated by the interaction of human-mouse monoclonal hLL2 kappa chains and human-mouse monoclonal hLL2 gamma chain disulfides. Human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as epratuzumab (CAS registry number 501423-23-0) human CD22-specific fully humanized antibody; human CD22-specific antibodies, including but not limited to humanized and fully human monoclonal antibodies; humanized and fully human antibodies, including but not limited to human CD22-specific antibodies; IGF-1 receptor-specific antibodies, peptide bodies and related proteins, including but not limited to anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG This includes, but is not limited to, two antibodies, including, but not limited to, fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1, and those that inhibit the interaction between B7RP-1 and its native receptor ICOS on activated T cells, such as B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1" as well as B7H2, ICOSL, B7h, and CD275); for example, 145c7; and, but is not limited to, HuMax IL-15 antibodies and related proteins, particularly IL-15-specific antibodies, peptide bodies, and related proteins such as humanized monoclonal antibodies;IFN-gamma specific antibodies, peptide bodies, and related proteins, including but not limited to human IFN-gamma specific antibodies, and including but not limited to fully human anti-IFN-gamma antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as NAL antibodies; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-beta-specific antibodies, peptide bodies, and related proteins; amyloid-beta protein-specific antibodies, peptide bodies, and related proteins; and proteins that bind to c-Kit and / or other stem cell factor receptors, but is not limited to these. c-Kit-specific antibodies, peptide bodies, and related proteins, etc., not specified; OX40L-specific antibodies, peptide bodies, and related proteins, etc., including but not limited to proteins that bind to 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, novel erythropoiesis-stimulating agent Protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel (registered trademark) (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex (registered trademark) (epoetin alfa); Erbitux (registered trademark) (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin (registered trademark) (somatropin, human growth hormone); Herceptin (registered trademark) (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti (trademark) (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin (registered trademark) or other product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope (registered trademark) (somatropin, human growth hormone); Humira (registered trademark) (adalimumab); Vectibix (registered trademark) (Panitumumab), Xgeva (Denosumab), Prolia (Denosumab), Human immunoglobulin G2 monoclonal antibody against RANK ligand, Enbrel (Etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in solution; Infergen (Interferon Alphacon-1); Natrecor (Nesiritide; Recombinant human type B natriuretic peptide (hBNP); Kineret (Anakinra); Leukine (Sargamostim, rhuGM-CSF); LymphoCide (Epratuzumab, anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex(registered trademark) (17-1A, edrecolomab); Trabio(registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem(registered trademark) (IDM-1); OvaRex(registered trademark) (B43.13); Nuvion(registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon(registered trademark) (epoetin beta); Neumega(registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (epoetin alfa); Remicade(registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (absiximab, anti-GP) Ib / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanorimumab); Mvasi® (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark)-(interferon alpha-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); 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 (saltumumab); M200 (boroxiximab, 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 mAb 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); Adekatumumab; 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-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / F; lt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0077] In some embodiments, the drug delivery device may contain, or be used in conjunction with, sclerostin antibodies such as romosozumab, brosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), and other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, as well as, in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of 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, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with, or the device may be used with, IMLYGIC® (Tarimogene Laharpa Lepbec) 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 with, an endogenous tissue inhibitor (TIMP) of metalloproteinases, such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used with, another product containing Aimovig® (Erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or erenumab for the treatment of migraine. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including 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 device of this disclosure.In addition, bispecific T-cell engager (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to apelin or its analogues. In some embodiments, therapeutically effective amounts of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibodies may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with 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-morpholinoacetamide)-4-phenylbutanamide)-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-isoindole-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® (ethelcalcetide 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 in conjunction with, another product containing ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used in conjunction 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 condensed to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain, or be used in conjunction 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 in conjunction with, rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain, or be used in conjunction with, omecamutib mecarbir, small molecule selective cardiac myosin activator, or myotrope, or another product containing small molecule selective cardiac myosin activator that directly targets the cardiac contractile mechanism. In some embodiments, the drug delivery device may contain, or be used in conjunction with, sotrasib (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 together with, tezeperumab, a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (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 together with, AMG 714 that binds to interleukin-15 (IL-15), a human monoclonal antibody, 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 together with, AMG 890 that reduces lipoprotein (a), also known as Lp(a), a small interfering RNA (siRNA), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing human IgG1 kappa antibody and / or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing Amjevita® or Amgevita® (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 160, or another product containing the half-life extension (HLE) anti-prostate-specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 171, or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 199, or another product containing a half-life extension (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 256, or another product containing anti-PD-1 × IL-21 mutaine 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 in conjunction with, AMG 330, or another product containing the anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction 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 the long-lived (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × 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 the anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used with, AMG 506, or another product containing the multispecific FAP × 4-1 BB-targeted DARPin® biologic being studied 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 the long-lived (HLE) CD19 × CD3 BiTE. Another product containing the E(registered trademark) (bispecific T cell engager) construct may be contained or used in conjunction with it. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing efavavaluquin alfa (formerly AMG 592) or IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing AMG 596 or the CD3×epidermal growth factor receptor vIII (EGFRvIII)BiTE(registered trademark) (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing AMG 673 or the half-life extended (HLE) anti-CD33×anti-CD3BiTE(registered trademark) (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 the HLE (Hyperlife-Extended Epithelial) anti-B cell maturation antigen (BCMA) × 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 the HLE (Hyperlife-Extended Epithelial Tissue-Like Ligand 3 (DLL3) × 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 the HLE (Hyperlife-Extended Epithelial Tight Junction Constituent Protein Claudin 18.2 × CD3 BiTE® (bispecific T cell engager) construct.

[0078] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited to exemplary embodiments. The detailed descriptions should be interpreted merely as examples and do not describe all possible embodiments of this disclosure. Various alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments are still included within the claims defining the invention disclosed herein.

[0079] Those skilled in the art will understand that a variety of modifications, changes, and combinations of the above embodiments can be made without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations are to be interpreted as falling within the scope of the concept of the invention.

Claims

1. A drug delivery device, A housing having a defined longitudinal axis and an opening, comprising a rear cap and a tubular housing, A drug storage container comprising a barrel, a stopper, and a delivery member, wherein the stopper is movably disposed within the barrel, and the delivery member is located at the distal end of the barrel and has an insertion end configured to extend at least partially through the opening during the delivery process, A plunger that engages with the stopper and is movable toward the distal end of the drug storage container in order to release the drug from the drug storage container through the delivery member, A plunger biasing member coupled to the plunger and configured to bias the plunger toward the distal end of the drug storage container, The release member has a first position in which the release member prevents the plunger from moving to the delivery state, and a second position in which the release member does not prevent the plunger from moving to the delivery state, An impact absorber configured to absorb impact force and prevent unintended movement of the release member, wherein the impact absorber includes an annular ring configured to allow relative movement between the rear cap and the tubular housing, and Drug delivery devices, including those mentioned above.

2. The drug delivery device according to claim 1, wherein the rear cap and the tubular housing are operably coupled to each other, and the shock absorber includes the rear cap.

3. The drug delivery device according to claim 2, wherein the rear cap is movable relative to the tubular housing.

4. The drug delivery device according to any one of claims 1 to 3, further comprising an annular projection configured to be received by the annular ring, wherein the shock absorber further comprises an annular projection.

5. The drug delivery device according to any one of claims 1 to 3, wherein the annular ring includes an inclined surface configured to allow the rear cap to move distally when the impact force is applied and to bias the rear cap to move proximal after the impact force has dissipated.

6. The drug delivery device according to claim 5, wherein the inclined surface is defined by a plurality of longitudinal ribs.

7. The drug delivery device according to any one of claims 1 to 3, further comprising a buffer gap between the rear cap and the tubular housing.

8. The drug delivery device according to claim 7, wherein the buffer gap defines the distance between the rear cap and the tubular housing.

9. A drug delivery device according to any one of claims 1 to 3, further comprising a plunger guide configured to operably connect the tubular housing and the rear cap.

10. The drug delivery device according to claim 9, wherein the plunger guide defines the annular projection that is received by the annular ring of the rear cap, and the plunger guide further defines a second annular projection that is configured to be received by a second annular ring.

11. The drug delivery device according to claim 4, further comprising a plunger guide configured to operably connect the tubular housing and the rear cap, wherein the plunger guide defines the annular projection.

12. The drug delivery device according to any one of claims 1 to 3, wherein the drug delivery device is an autoinjector.

13. The drug delivery device according to any one of claims 1 to 3, wherein the tubular housing defines a substantially cylindrical shape.

14. The drug delivery device according to any one of claims 1 to 3, wherein the tubular housing defines a non-cylindrical shape, such as a substantially oval or substantially elliptical shape.

15. A drug delivery device, A housing having a defined longitudinal axis and an opening, comprising a rear cap and a tubular housing, A drug storage container comprising a barrel, a stopper, and a delivery member, wherein the stopper is movably disposed within the barrel, and the delivery member is located at the distal end of the barrel and has an insertion end configured to extend at least partially through the opening during the delivery process, A plunger that engages with the stopper and is movable toward the distal end of the drug storage container in order to release the drug from the drug storage container through the delivery member, A plunger biasing member coupled to the plunger and configured to bias the plunger toward the distal end of the drug storage container, The release member has a first position in which the release member prevents the plunger from moving to the delivery state, and a second position in which the release member does not prevent the plunger from moving to the delivery state, An impact absorber configured to absorb impact force and prevent unintended movement of the release member, wherein the tubular housing and the rear cap are defined by a single monolithic structure, and the impact absorber includes a flexible or compressible portion connecting the tubular housing and the rear cap. Drug delivery devices, including those mentioned above.

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