Drug delivery device

Abstract

A drug delivery device comprises a housing having a proximal end, a distal end, and an opening at the distal end, a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening, a guard moveably positioned adjacent to the opening, a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, a biasing member, and a releaser member operably coupled to the plunger. The plunger is rotationally fixed relative to the housing. The releaser member is configured to rotate from a first rotational position to a second rotational position under a biasing force exerted by the biasing member.

Description

10885-W001-SEC DRUG DELIVERY DEVICE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 761,693, filed February 21, 2025.FIELD OF DISCLOSURE

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

[0003] Some individuals may not be comfortable with needles or their use in performing an injection. This general aversion to needles, along with other concerns related to health and safety, has prompted the development of drug delivery devices which conceal a needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer a variety of benefits as compared with traditional forms of drug delivery including, for example, delivery via a regular syringe.

[0004] Some drug delivery devices, including, for example, some autoinjectors, may include a spring biased guard to hide the needle prior to and / or after an injection. To uncover the needle, the user may press the guard against the skin at the injection site to move the guard upwards, which exposes the tip of the needle for insertion. The drug delivery device may, then, be activated to expel a drug through the needle of the drug delivery device. However, to properly activate the drug delivery device, some components of the drug delivery device may need to overcome various frictional forces within the drug delivery device without any additional help from the user, especially since various aspects of the drug delivery device is automated. For example, if the user does not exert enough force when pressing the guard against the skin at the injection site, some components may not be able to overcome various frictional forces, which could result in no activation or improper activation of the drug delivery device.

[0005] The present disclosure sets forth drug delivery devices and related methods to address one or one of the needs and challenges mentioned herein and other related needs and challenges.SUMMARY

[0006] One aspect of the present disclosure provides a drug delivery device comprising a housing having a proximal end, a distal end, and an opening at the distal end, a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening, a guard moveably positioned adjacent to the opening, a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, a biasing member, and a releaser member operably coupled to the plunger. The plunger is rotationally fixed relative to the housing. Additionally, the releaser member is configured to rotate from a first rotational position to a second rotational position under a biasing force exerted by the biasing member.

[0007] In some embodiments, the releaser member may be configured to restrict movement of the plunger in the distal direction when the releaser member is in the first rotational position and the releaser member may be configured to permit movement of the plunger in the distal direction when the releaser member is in the second rotational position. In some embodiments, the guard may have an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing. The releaser member may be prevented from rotating from the first rotational position to the second rotational position when the guard is in the extended position and the releaser member may be allowed to rotate from the first rotational position toward the second rotational position when the guard is in the retracted position. In some embodiments, movement of the guard from the extended position to the retracted position may allow the releaser member to rotate from the first rotational position to the second rotational position under the biasing force exerted by the biasing member.

[0008] In some embodiments, the plunger may include a cam, and the releaser member may include a cam follower. The biasing force of the biasing member may urge the cam follower against the cam to urge the releaser member to rotate from the first rotational position to the second rotational position. In some embodiments, the cam may be formed by at least one projection10885-W001-SEC extending radially outwardly from the plunger near a proximal end of the plunger. In some embodiments, the releaser member may comprise an annular wall having a proximal end and a distal end and at least one flange extending outwardly in a proximal direction near the proximal end of the annular wall, and the cam follower may be formed by a proximally facing surface of the at least one flange.

[0009] In some embodiments, the drug delivery device may further comprise a plunger guide fixed relative to the housing, and the plunger may be disposed at least partially within the plunger guide. The plunger guide may include an annular wall and an opening formed in the annular wall, and the opening may be configured to slidably receive the at least one projection after the releaser member rotates from the first rotational position to the second rotational position. In some embodiments, the opening may extend along a height of the annular wall of the plunger guide. In some embodiments, the drug delivery device may further comprise a first projection extending outwardly from the releaser member and a second projection extending outwardly from the plunger guide, and the first and second projections may engage one another to limit axial movement of the releaser member.

[0010] In some embodiments, the drug delivery device may further comprise a plunger biasing member disposed at least partially within the plunger. In other embodiments, the drug delivery device may further comprise a guard extension, and the releaser member may be disposed at least partially within the guard extension. The biasing member may be an extender biasing member positioned between the guard extension and the releaser member. In some embodiments, the drug delivery device may comprise a first projection extending outwardly from the releaser member and a third projection extending inwardly from the guard extension, and the first and third projections engage one another to retain the releaser member in the first rotational position. In some embodiments, the guard may have an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing, and movement of the guard from the extended position to the retracted position may cause movement of the guard extension in a proximal direction. In some embodiments, movement of the guard extension in the proximal direction may cause the third projection to slide out of engagement with the first projection to allow the releaser member to rotate from the first rotational position to the second rotational position.

[0011] Another aspect of the present disclosure provides a drug delivery device comprising a housing having a proximal end, a distal end, and an opening at the distal end, a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening, a guard moveably positioned adjacent to the opening, a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, a biasing member, and a releaser member operably coupled to the plunger. The plunger is rotationally fixed relative to the housing. The releaser member is configured to rotate relative to the plunger under a biasing force exerted by the biasing member, and the rotation of the releaser member is configured to generate an audible signal indicating a start of dose delivery.

[0012] In some embodiments, the releaser member may be configured to rotate from a first rotational position to a second rotational position under the biasing force exerted by the biasing member. The releaser member may be configured to restrict movement of the plunger in the distal direction when the releaser member is in the first rotational position, and the releaser member may be configured to permit movement of the plunger in the distal direction when the releaser member is in the second rotational position.

[0013] In some embodiments, the guard may have an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing. In some embodiments, the releaser member may be prevented from rotating relative to the plunger when the guard is in the extended position, and the releaser member may be allowed to rotate relative to the plunger when the guard is in the retracted position.

[0014] In some embodiments, the plunger may include a cam, and the releaser member may include a cam follower. The biasing force of the biasing member may urge the cam follower against the cam to urge the releaser member to rotate relative to10885-W001-SEC the plunger. In some embodiments, the cam may be formed by at least one projection extending radially outwardly from the plunger near a proximal end of the plunger. In some embodiments, the releaser member may comprise an annular wall having a proximal end and a distal end and at least one flange extending outwardly in a proximal direction near the proximal end of the annular wall, and the cam follower may be formed by a proximally facing surface of the at least one flange. In some embodiments, the drug delivery device may further comprise a plunger guide fixed relative to the housing, wherein the plunger is disposed at least partially within the plunger guide. The plunger guide may include an annular wall and an opening formed in the annular wall, and the opening may be configured to slidably receive the at least one projection after the releaser member rotates relative to the plunger.

[0015] In some embodiments, the drug delivery device may further comprise a plunger biasing member disposed at least partially within the plunger. In other embodiments, the drug delivery device may further comprise a guard extension, and the releaser member may be disposed at least partially within the guard extension. The biasing member may be an extender biasing member positioned between the guard extension and the releaser member. In some embodiments, the guard extension may be configured to selectively engage the releaser member to limit rotation of the releaser member and slide out of engagement with the releaser member to allow rotation of the releaser member.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily to scale.

[0017] Fig. 1A is a perspective view of an exemplary drug delivery device in accordance with various embodiments of the present disclosure.

[0018] Fig. 1 B is a perspective view of the drug delivery device in Fig. 1 A, in a pre-deli very state.

[0019] Fig. 1 C is a perspective view of the drug delivery device in Fig. 1 A, in a delivery state.

[0020] Fig. 2A is an exploded assembly view of a portion, namely a drive mechanism, of the drug delivery device in Fig. 1 A.

[0021] Fig. 2B is an exploded assembly view of the drug delivery device in Fig. 1A.

[0022] Fig. 3 is a perspective view of an exemplary plunger guide of the drug delivery device in Fig. 1A.

[0023] Fig. 4A is a side view of an exemplary releaser member of the drug delivery device in Fig. 1A.

[0024] Fig. 4B is a cross-sectional perspective view of the releaser member in Fig. 4A.

[0025] Fig. 5 is a perspective view of an exemplary guard extension of the drug delivery device in Fig. 1A.

[0026] Fig. 6 is a perspective view of an exemplary plunger of the drug delivery device in Fig. 1A.

[0027] Fig. 7A are perspective views of an exemplary plunger releasing arrangement of the drug delivery device in Fig. 1A. In the exemplary plunger releasing arrangement shown on the right in Fig. 7A, the guard extension is illustrated in dotted lines.

[0028] Fig. 7B is a perspective view of a top portion of the plunger releasing arrangement in Fig. 7A.

[0029] Fig. 70 is a top view of a portion of the plunger releasing arrangement in Fig. 7A.

[0030] Fig. 8A is a perspective view of the plunger releasing arrangement in Fig. 7A, where the releaser member is in a first rotational position. In Fig. 8A, the releaser member is illustrated in dotted lines. Also, the plunger biasing member and the extender biasing member are omitted for clarity.

[0031] Fig. 8B is a top view of a portion of the plunger releasing arrangement in Fig. 8A.

[0032] Fig. 9A is a perspective view of the plunger releasing arrangement in Fig. 7A, where the releaser member is in a second rotational position. In Fig. 9A, the releaser member is illustrated in dotted lines. Also, the plunger biasing member and the extender biasing member are omitted for clarity.10885-W001-SEC

[0033] Fig. 9B is a top view of a portion of the plunger releasing arrangement in Fig. 9A.

[0034] Fig. 10 is a perspective view of the plunger releasing arrangement in Fig. 7A, in a delivery state. In Fig. 10, the releaser member is illustrated in dotted lines. Also, the plunger biasing member and the extender biasing member are omitted for clarity.DETAILED DESCRIPTION

[0035] The present disclosure generally relates to drug delivery devices operable by a user for administering a drug, or in the case where a patient is the user, self-administering a drug. Various features are disclosed to facilitate safe and proper handling and activation of the drug delivery device. Such features include, but are not limited to, a plunger releasing arrangement that facilitates rotation of a releaser member to allow the plunger to overcome any frictional forces and move distally to expel a drug. These features and others work together and / or interact with one another in synergistic ways so as to facilitate safe and proper handling and activation of the drug delivery device, while limiting complexity of the drug delivery device. Furthermore, certain features described herein exploit a biasing force exerted by a plunger biasing member and / or an extender biasing member for actuation purposes, thereby reducing any force that must be applied by the user and / or alleviating a need to incorporate a dedicated energy source for implementing said feature. These and other advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.

[0036] Figs. 1A-1C, 2A, and 2B illustrate several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug product. The drug may be, but is not limited to, various biologicals such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the disclosure is not limited to a particular state.

[0037] Various implementations and configurations of the drug delivery device 10 are possible. The present embodiment of the drug delivery device 10 is configured as a single-use, disposable injector. In other embodiments, the drug delivery device 10 may be configured as multiple-use, reusable injector. The drug delivery device 10 is operable for self-administration by a patient or for administration by caregiver or a formally trained healthcare provider (e.g. , a doctor or nurse). The exemplary the drug delivery devices shown in the figures may take the form of an autoinjector or pen-type injector, and, as such, may be held in the hand of the user over the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and / or configurations.

[0038] The configuration of various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or dosing state, and a post-delivery state, although fewer or more states are also possible. For example, each state may have several sub-states or stages. The pre-delivery state may correspond to the configuration of the drug delivery device 10 subsequent to assembly and prior to activation by the user. In some embodiments, the pre-delivery state may exist in the time between when the drug delivery device 10 leaves a manufacturing facility and when a patient or user activates a drive mechanism 30 of the drug delivery device 10. This includes the moments in time after the user has removed the drug delivery device 10 from any secondary packaging and prior to positioning the drug delivery device 10 against the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as dosing, is in progress. The postdelivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is complete and / or when a stopper is arranged in an end-of-dose position in a drug storage container.

[0039] As shown in Figs. 1A-1C, the drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and dimensioned to enable a person to grasp the injector 10 in a single hand. The housing 12 may have a generally elongate shape, such as a cylindrical shape, and extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (Fig. 2B) may be formed at or near the distal end to permit an insertion end of a delivery member, such as a needle or cannula, to extend outside of the housing 12. The insertion end of the delivery member may include a sharpened tip or other pointed geometry to allow the insertion end to pierce the patient’s skin and subcutaneous tissue during10885-W001-SEC insertion of the delivery member. A transparent or semi-transparent inspection window 17 (Figs. 1A-1C) may be positioned in a wall of the housing 12 to permit a user to view component(s) inside the drug delivery device 10, including a drug storage container 20 (Fig. 2B). Viewing the drug storage container 20 through the window 17 may allow a user to confirm that drug delivery is in progress and / or complete. A removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10, and, in some embodiments, may including a gripper 13 (Fig. 2B) configured to assist with removing a sterile barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) mounted on the insertion end of the delivery member. The gripper 13 may include one or more inwardly protruding barbs or arms that frictionally or otherwise mechanically engage the sterile barrier 21 (Fig. 2B) to pull the sterile barrier 21 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 sterile barrier 21 from the delivery member.

[0040] Referring to Figs. 2A and 2B, the drive mechanism 30 may be disposed partially or entirely within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, upon or in response to activation of the drive mechanism 30 by the user, release or output that energy to drive the plunger 26 to expel a drug from the drug storage container 20 through the delivery member into the patient. In the present embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may be configured differently, for example, with the drive mechanism 30 storing electrical or chemical potential energy. Generally, upon activation of the drive mechanism 30, the drive mechanism 30 may convert the potential energy into kinetic energy for moving the plunger 26. As best illustrated in Fig. 2A, in one embodiment, the drive mechanism 30 includes the plunger biasing member 50, a plunger 26 including a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, the releaser member 52, a plunger guide 60, an extender biasing member 35, and a guard extension 37. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) which is initially retained in an energized state. In the energized state, the plunger biasing member 50 may be compressed such that its axial length is shorter than it would be in a natural or deenergized state. When released, the plunger biasing member 50 may try to expand to its natural axial length, and as a consequence, exert a biasing force pushing the plunger 26 in the distal direction.

[0041] In one embodiment, the housing 12 may include two separate and interconnected structures: a rear end cap 23 (e.g., a rear cover) at the proximal end of the drug delivery device 10; and a tubular housing 25 extending substantially completely 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, such as a two-piece tubular housing having front and rear portions. The tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical shape or a hollow cylindrical shape with an open end and a closed off end. In some embodiments, the rear end cap 23 and the tubular housing 25, and any components to be positioned therein, may be assembled together to define different sub-assemblies, such as the drive mechanism 30 (Fig. 2A). In some embodiments, the different sub-assemblies are assembled independently of each other and then later combined with one another, as well as with the drug storage container 20, to form the fully-assembled drug delivery device 10. In certain such embodiments, some or all of the foregoing phases of assembly may occur in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed in one piece, such that the housing 12 is defined by a single, monolithic structure that integrates a rear cap and tubular housing in a single component.

[0042] The drug storage container 20 is disposed within an interior space of the housing 12 and is configured to contain a drug. The drug storage container 20 may be pre-filled and shipped, e.g., by a manufacturer, to a location where the drug storage container 20 is combined with a remainder of the drug delivery device 10. For example, the drug may be distributed and / or provided to patients in more than one use case, such as a as a pre-filled syringe or as an autoinjector including a pre-filled syringe. By utilizing the same or similar syringe components in either case, at least some of above steps such as filling, labeling, packaging, shipping, and distribution may be streamlined or simplified for two different use cases. As another example, in the10885-W001-SEC event that multiple use cases utilize some or all of the same syringe components, some regulatory pathways to marketing and / or distributing the drug may be streamlined and / or simplified for at least one of the multiple use cases.

[0043] In one embodiment, the drug storage container 20 may be a pre-filled syringe and has a staked, hollow metal needle for the delivery member. Here, the needle is fixed relative to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a Luer Lock or other suitable connection. In yet other embodiments, the drug storage container 20 may be a needle-less cartridge, and, as such, initially may not be in fluid communication with the delivery member. In such embodiments, the drug storage container 20 may move toward a proximal end of the delivery member, or vice versa, during operation of the drug delivery device 10 such that the proximal end of the delivery member penetrates through a septum covering an opening in the drug storage container 20 thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member.

[0044] The housing 12 may be pre-loaded with the drug storage container 20, e.g., by a manufacturer, or alternatively, loaded with the drug storage container 20 by a user prior to use of the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal bore or reservoir. The wall may be made of glass or plastic. A stopper (not shown) may be moveably disposed in the drug storage container 20 such that it can move in a distal direction along the longitudinal axis A between proximal end and a distal end of the drug storage container 20. In some embodiments, the drug storage container 20 may be fixed relative to the housing 12 such that the drug storage container 20 does not move relative to the housing 12 once installed in the housing 12. As such, the insertion end of the delivery member may extend permanently through the opening 14 in the housing 12 in the pre-delivery, delivery, and post-delivery states. For example, the delivery member may extend beyond a distal end of the housing 12 that defines the opening 14. However, in the pre-delivery state, for example, the delivery member may be covered / protected by the sterile barrier 21 and a guard member 32 that surrounds the delivery member and protects against or reduces the likelihood of unintended or premature needle stick.

[0045] In some embodiments, a volume of the drug included in the reservoir of the drug storage container 20 may be equal to 1 mL, or equal to approximately (e.g., ±10%) 1 mL, or equal to 2.5 mL, or equal to approximately (e.g., ±10%) 2.5 mL, or equal to 3 mL, or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 1 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g., ±10%) 10 mL, or within a range between approximately (e.g., ±10%) 1 - 10 mL, or within a range between approximately (e.g., ±10%) 1 - 5 mL, or within a range between approximately (e.g., ±10%) 1 - 4 mL, or within a range between approximately (e.g., ±10%) 1 - 3 mL, or within a range between approximately (e.g., ±10%) 1 - 2.5 mL.

[0046] As shown in Fig. 2B, the drug delivery device includes a container holder 31 having a hollow and generally cylindrical or tubular shape centered about the longitudinal axis A, and the drug storage container 20 may be disposed partially or entirely within the container holder 31. The container holder 31 may be configured to support the drug storage container 20 therein and prevent distal movement of the drug storage container 20 during actuation of the plunger 26. In one embodiment, the container holder 31 secures and / or fixes the position of the drug storage container 20 within the housing 12.

[0047] As shown in Figs. 2A and 3, the plunger guide 60 of the drug delivery device 10 may have a hollow and generally cylindrical or tubular shape. The plunger guide 60 may also be centered about the longitudinal axis A and extend longitudinally from a proximal end thereof to a distal end thereof. At least a portion of the plunger guide 60 may be positioned radially between the plunger 26 and the releaser member 52. As such, the plunger 26 may be disposed at least partially within the plunger guide 60, and the plunger guide 60 may be disposed at least partially within the releaser member 52, as illustrated in Figs. 7A-7C, 8A-8B, 9A-9B, and 10. Further features and functions of the plunger guide 60 are discussed below. The plunger guide 60 may be10885-W001-SEC fixedly coupled with the housing 12 such that the plunger guide 60 is substantially and / or generally immovable relative to the housing 12. Accordingly, the plunger guide 60 may be rotationally and axially fixed relative to the housing 12.

[0048] The plunger 26, as best illustrated in Fig. 6, may have a hollow and generally cylindrical or tubular shape and may extend longitudinally from a proximal end thereof to a distal end thereof. The plunger 26 may include an annular wall 39 having an outer surface and an inner surface. The inner surface of the plunger 26 may define an interior space sized to receive a plunger biasing member 50 therein (as shown in Figs. 2A and 7A-7C). The plunger 26 may be configured to translate linearly relative to the housing 12 during operation of the drug delivery device 10. However, the plunger 26 is rotationally fixed relative to the housing 12 such that the plunger 26 cannot rotate relative to the housing. For example, the plunger 26 may be rotationally fixed to the plunger guide 60, which is fixed coupled with the housing 12, such that the plunger 26 cannot rotate relative to the housing 12.

[0049] As discussed in more detail below, the plunger guide 60 may include an annular wall 80 extending between a proximal end thereof and a distal end thereof. The plunger guide 60 may also include a longitudinal slot 86 formed in the annular wall 80 that extend along at least a portion of the height of the annular wall 80. As best illustrated in Figs. 7B, 8A, 9A, and 10, the longitudinal slot 86 may be configured to slidably receive the projections 48 of the top ring 45 of the plunger 26 and allow the top ring 45 (and the plunger 26) to travel axially in the distal direction (downward) relative to the plunger guide 60.

[0050] In some embodiments, the plunger 26 may be constructed of multiple, interconnected pieces, or alternatively, have a one-piece construction. In the present embodiment, as illustrated in Fig. 6, the plunger 26 is constructed of three separate and interconnected structures: a top ring 45 defining the proximal end of the plunger 26, a base 47 defining the distal end of the plunger 26, and a hollow rod 46 positioned between and rigidly connecting the top ring 45 and the base 47. The positions of the top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other such that these components are immoveable relative to each other. The top ring 45, the hollow rod 46, and the base 47 may each have an annular construction and be centered about the longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a respective central opening extending from end to end of the component to define an axial chamber; whereas, the base 47 may have a central opening extending through the proximal end of the base 47 but which is closed off at the distal end of the base 47. The closed off end of the base 47 may define seat or abutment surface for the plunger biasing member 50. In alternative embodiments, the central opening may extend through the base 47 from end to end. In such alternative embodiments, an inner diameter of the central opening of the base 47 may be smaller than an outer diameter of the plunger biasing member 50 such that the base 47 retains a distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is activated, the base 47 may be the portion of the plunger 46 that comes into contact with the stopper disposed within the drug storage container 20 to push the stopper in the distal direction and expel the drug from the drug storage container 20.

[0051] As illustrated in Fig. 6, the top ring 45 of the plunger 26 may include one or more flanges or projections 48, which extend radially outwardly from a central portion of the top ring 45. Each of the projections 48 may include a distally facing camming surface 49. As described below in more detail, the distally facing camming surface 49 may interact with a counterpart camming surface on a releaser member 52 in order to release the plunger 26. In some embodiments, the distally facing camming surface 49 may arranged at angle relative to, or is otherwise non-parallel to, an imaginary plane perpendicular to the longitudinal axis A. In other words, in some embodiments, the distally facing camming surface 49 may be slanted or sloped at an angle. The counterpart camming surface on the releaser member 52 may also be slanted or sloped at an angle to correspond to the slope of the distally facing camming surface 49 of the plunger 26.

[0052] In some embodiments, the top ring 45 and / or the base 47 may be constructed of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or the base 47 made be constructed of plastic whereas the hollow rod 46 may be constructed of metal. So configured, the plastic material used for the top ring 45 may facilitate the camming action described below by providing a relatively low coefficient of friction, and the plastic material used for the base 47 may help absorb or10885-W001-SEC attenuate any shock or vibrations associated with base 47 striking the stopper. The metal material used for the hollow rod 46 may provide sufficient rigidity to avoid buckling under the biasing force exerted by the plunger biasing member 50. In alternative embodiments, the top ring 45, hollow rod 46, and / or base 47 may be made of the same material, including, for example, metal or plastic. In certain such embodiments, the top ring 45, hollow rod 46, and base 47 may be integrally formed in one piece so as to define single, monolithic structure.

[0053] As discussed above, the plunger biasing member 50 may be disposed at least partially within the plunger 26. So that the plunger biasing member 50 may be received within the plunger 26, an outer diameter or other dimension of the plunger biasing member 50 may be equal to or less than an inner diameter of the top ring 45 and / or equal to or less than an inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut against a proximally facing inner surface of the base 47 of the plunger 26. Furthermore, as best illustrated in Fig. 2A, a proximal end 50a of the plunger biasing member 50 may abut against a distally facing surface 38a of the plunger biasing member seat 38. The plunger biasing member seat 38 may be fixedly attached to the rear housing such that the plunger biasing member seat 38 provides a stationary surface for the plunger biasing member 50 to push off of. The plunger biasing member 50, when released from the energized state, may expand in length with distal end of the plunger biasing member 50 moving in the distal direction away from the stationary proximal end of the plunger biasing member 50. This motion may push the plunger 26 is the distal direction, which, in turn, may push the stopper in the distal direction to expel the drug from the drug storage container 20.

[0054] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end of the delivery member when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a guard member 32 (Fig. 2B) moveably disposed at or near the distal end of the housing 12 adjacent to the opening 14. The guard member 32 may have a hollow and generally tubular-shaped or cylindrical portion 32a centered about the longitudinal axis A, and may have a pair of arms 32b extending proximally from the cylindrical portion 32a. The arms 32b may be substantially or completely received within the housing 12 such that no part thereof extends from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. For example, the guard member 32 may be configured to move relative to the housing 12 such that portions of the guard member 32 are received within the housing 12 in some stages / states and are extending from the housing 12 in other stages / states.

[0055] The guard member 32 may be configured to move relative to the housing 12 between an extended position where at least a portion of the cylindrical portion 32a of the guard member 32 extends through the opening 14 in the housing 12 and a retracted position wherein a shorter length of the cylindrical portion 32a or no part of the cylindrical portion 32a extends through the opening 14 in the housing 12. In other words, in the extended position, a length X of the cylindrical portion 32a extends from through the opening 14 in the housing 12 and in the retracted position, a length Y of the cylindrical portion 32a extends through the opening 14 in the housing 12, wherein X is a value greater than Y. The length X may be any suitable number such as 10 mm, 8 mm, 6 mm, 4mm, 2 mm, 1 mm, or another value. The length Y may be any suitable number that is less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. Fig. 1 B, for example, illustrates an exemplary pre-injected configuration or a pre-delivery state where the guard member 32 is in the extended position, and Fig. 1C illustrates an exemplary injection configuration or a delivery state where the guard member 32 is in the retracted position.

[0056] The guard member 32 may also be configured to move in the opposite direction, namely 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. In at least the extended position, the guard member 32 may extend beyond and surround the insertion end of the delivery member. As discussed above, moving the guard member 32 from the extended position to the retracted position, e.g., 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 of the delivery member being exposed and inserted into the patient’s skin at the injection site.10885-W001-SEC In some embodiments, the guard member 32 may be rotationally fixed or rotationally restricted relative to the housing 12.Therefore, although the guard member 32 may be able to translate linearly relative to the housing 12, the guard member 32 may be substantially or completely prevented from rotating relative to the housing 12.

[0057] As illustrated in Figs. 2A, 5, 7A, 8A, 9A, and 10, the drug delivery device 10 may further include an extender biasing member 35 and a guard extension 37. The guard extension 37 may be positioned proximal to the guard member 32, and the extender biasing member 35 shown in the figures may be positioned proximal to the guard extension 37. As shown in Fig. 5, the guard extension 37 may have a hollow and generally cylindrical or tubular shape centered about the longitudinal axis A. As a more specific example, the guard extension 37 may include a generally cylindrical body 37a. The guard extension 37 may also include a proximally facing surface 37b for receiving, supporting, and / or retaining a distal portion of the extender biasing member 35. Furthermore, the guard extension 37 may be moveable in a linear direction along the longitudinal axis A relative to the housing 12. In the present embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in alternative embodiments, the guard extension 37 and the guard member 32 may be integrally formed in one piece to define a single, monolithic structure. In such alternative embodiments, the proximal end of the guard member 32 may correspond to the guard extension 37. In some embodiments, the guard extension 37 and / or the guard member 32 may be injection molded.

[0058] Similar to the guard member 32, the guard extension 37 may be rotationally fixed relative to the housing 12. Therefore, although the guard extension 37 may be able to translate linearly relative to the housing 12, the guard extension 37 may be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, the guard extension 37 may cooperate with the plunger guide 60 to restrict or prevent rotation between the respective components 37, 60. As a result, and because the plunger guide 60 is fixedly connected with the housing 12, the guard extension 37 may be rotationally fixed to the housing 12 through the plunger guide 60.

[0059] As illustrated in Figs. 7A, 8A, 9A, and 10, the releaser member 52 is disposed at least partially within the guard extension 37. In Figs. 8A, 9A, and 10, the releaser member 52 is illustrated in dotted lines to help visualize the remaining components of the plunger releasing arrangement. In addition, in Figs. 8A, 9A, and 10, the plunger biasing member 50 and the extender biasing member 35 are omitted for clarity. In some embodiments, the guard extension 37 and / or the releaser member 52 may have axial travel limits that limit the distance they are able to travel in the distal direction. For example, as illustrated in Figs. 3 and 7A, the plunger guide 60 may include a longitudinal ridge 60c formed on the outer surface and positioned adjacent to a distal portion of the plunger guide 60. The releaser member 52 may also include a longitudinal ridge 54 having a distally facing surface 56, as shown in Figs. 4A and 7A. The distally facing surface 56 of the longitudinal ridge 54 of the releaser member 52 may abut a proximally facing surface 60d (Figs. 3 and 7A) defined by the longitudinal ridge 60c, thereby defining the distal-most point of travel for the releaser member 52. Additionally, the guard extension 37 may include one or more ridges 37c having a proximally facing surface 37e (as shown in Fig. 5). The proximally facing surface 37e of the one or more ridges 37c of the guard extension 37 may abut a distally facing surface 60b (Fig. 3) defined by the longitudinal ridge 60c, thereby defining the proximal-most point of travel for the guard extension 37.

[0060] As is best illustrated in Fig. 7A, in some embodiments, the extender biasing member 35 is positioned between and in contact with the guard extension 37 and a releaser member 52. In Fig. 7A, the guard extension 37 on the right is illustrated in dotted lines to help visualize the remaining components of the plunger releasing arrangement. The extender biasing member 35 may be configured to bias or urge the guard extension 37 in the distal direction and / or bias or urge the releaser member 52 in the proximal direction. In the pre-delivery or storage state, the extender biasing member 35 is initially in an energized state (e.g., compressed). In other words, when the device 10 is in the pre-delivery state, the extender biasing member 35 exerts a distal direction (downward) biasing force on the guard extension 37 and a proximal direction (upward) biasing force on the releaser member 52.10885-W001-SEC

[0061] During operation of the device, a user may cause the guard member 32 to translate (with respect to the housing 12) in the proximal direction by pressing the guard member 32 against the injection site. In doing so, the guard member 32 will move towards the guard extension 37 and push the guard extension 37 in the proximal direction. Accordingly, once the guard member 32 contacts the guard extension 37, the guard member 32 and the guard extension 37 move jointly in the proximal direction until, for example, the guard member 32 reaches the retracted position. When the injection is complete and the drug delivery device 10 is lifted off of the injection site, the extender biasing member 35 may urge the guard extension 37 so that the guard extension 37 and the guard member 32 move jointly in the distal direction. This motion returns the guard member 32 to the extended position, which has the effect of covering the insertion end of the delivery member after drug delivery is complete. In some embodiments, the extender biasing member 35 may include a compression spring (e.g., a helical compression spring). Furthermore, in embodiments where the plunger biasing member 50 also includes a compression spring, the extender biasing member 35 may disposed around and / or have a larger diameter than the plunger biasing member 50.

[0062] However, in some alternative embodiments, the extender biasing member 35 may be in non-energized (natural) state when the device is in a pre-delivery state. In these embodiments, the extender biasing member 35 may become compressed or energized upon deflection of the guard member 32 in the proximal direction.

[0063] Referring to Figs. 4A and 4B, the releaser member 52 may have a hollow and generally cylindrical or tubular shape, and may be centered about the longitudinal axis A. The releaser member 52 may extend longitudinally between a proximal end thereof and a distal end thereof. In some embodiments, the releaser member 52 may be injection molded. As best illustrated in Figs. 7A, 8A, 9A, and 10, the releaser member 52 may be radially positioned between the plunger guide 60 and the guard extension 37. Furthermore, as illustrated in Fig. 7A, the extender biasing member 35 may be axially positioned between the releaser member 52 and the guard extension 37 and may be radially arranged around the releaser member 52.

[0064] As illustrated in Figs. 4A and 4B, the releaser member 52 comprises an annular wall 52a having a proximal end and a distal end and at least one flange 55 extending outwardly in a proximal direction near the proximal end of the annular wall 52a. In the embodiments of the present disclosure, the releaser member 52 includes a pair of flanges 55 extending from opposite sides of the annular wall 52a. However, in alternative embodiments, the releaser member 52 may include one flange, three flanges, or four flanges. As best illustrated in Fig. 4B, each of the flanges 55 may include a proximally facing camming surface 51. As discussed in more detail below, the proximally facing camming surface 51 may interact with a counterpart distally facing camming surface 49 of the projections 48 of the top ring 45 of the plunger 26. In some embodiments, the proximally facing camming surface 51 may be arranged at an angle relative to, or is otherwise non-paral lei to, an imaginary plane perpendicular to the longitudinal axis A. In other words, in some embodiments, the proximally facing camming surface 51 may be slanted or sloped at an angle.

[0065] The releaser member 52 may further include channel surfaces 52b on an inner surface of the annular wall 52a. The channel surfaces 52b may be formed on opposite sides of the inner surface of the annular wall 52a. The channel surfaces 52b may each be configured to slidably receive the projections 48 of the top ring 45 and permit axial movement of the top ring 45 (and the plunger 26) in a distal direction (downward) with respect to the releaser member 52 but to resist or prevent rotational movement between the plunger 26 and the releaser member 52. As shown in Fig. 4B, the channel surfaces 52b may extend along the height of the annular wall 52a and may extend proximally past the proximal-most (e.g., top) surface of the annular wall 52a and extend axially into the flanges 55 of the releaser member 52. Accordingly, the channel surfaces 52b may provide a continuous path for the projections 48 of the top ring 45.

[0066] The releaser member 52 may be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. Rotation of the releaser member 52 associated with activation may be powered by the plunger biasing member 50 and / or the extender biasing member 35. Any linear translation of the releaser member 52 without rotation may be powered solely by the extender biasing member 35. In some embodiments,10885-W001-SEC the releaser member 52 may translate linearly only in the proximal direction; however, alternative embodiments may permit linear translation of the releaser member 52 in both the proximal and distal directions.

[0067] Having described the general configuration of the drug delivery device 10, a method of using the drug delivery device 10 to perform an 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. Also, as a preliminary step, the user may prepare the injection site, e.g., by rubbing the patient’s skin with an alcohol wipe. Next, the user may pull and detach the removable cap 19 from the housing 12. As a result of this motion, the gripper 13 may pull and detach the sterile barrier 21 from the drug storage container 20. This may uncover the insertion end of the delivery member, such as a needle or a cannula. Nevertheless, the insertion end of the delivery member will remain surrounded by the guard member 32 at this stage because the guard member 32 is arranged in the extended position. Next, the user may position the drug delivery device 10 over the injection site and then push the distal end of the guard member 32 against the injection site. The force applied by the user will overcome the biasing force of the extender biasing member 35, thereby causing the guard member 32 to retract into the opening 14 moving from the extended position to the retracted position in the proximal direction. When the guard member 32 is in the retracted position, the insertion end of the delivery member will be exposed and inserted into the patient’s skin at the injection site.

[0068] Retraction of the guard member 32 from the extended position to the retracted position will cause the guard member 32 to move axially in the proximal direction (upward) and come into contact with the distally facing surface of the guard extension 37 and urge the guard extension 37 in the proximal direction. After coming into contact with the guard extension 37, the guard member 32 and the guard extension 37 will move jointly in the proximal direction (upward) until at least the guard member 32 reaches the retracted position. As shown in Figs. 5 and 7A, the inner surface of the guard extension 37 annular wall includes a locking flange 37d that corresponds to the longitudinal ridge 54 on an outer surface of the annular wall 52a of the releaser member 52. When the device is in the pre-injection stage, the locking flange 37d of the guard extension 37 engages the longitudinal ridge 54 of the releaser member 52 to rotationally lock the releaser member 52 at a first rotational position. At this point in the sequence and as best illustrated in Figs. 7B, 7C, 8A, and 8B, the distally facing camming surfaces 49 of the projections 48 are abutting against the proximally facing camming surfaces 51 of the flanges 55 of the releaser member 52 such that the plunger 26 is restrained from axial travel due to this interaction between the plunger 26 and the releaser member 52. Because the distally facing camming surfaces 49 of the projections 48 are abutting against the proximally facing camming surfaces 51 of the flanges 55 (i.e., the distally facing camming surfaces 49 are directly on top of the proximally facing camming surfaces 51), in Figs. 7C and 7B, the proximally facing camming surfaces 51 of the flanges 55 cannot be seen from the top of the drug delivery device 10. The distally facing camming surface 49 and / or the proximally facing camming surface 51 includes a sloped surface to promote relative movement of the releaser member 52 in a clockwise direction. For example, the distally facing camming surface 49 and / or the proximally facing camming surface 51 has a slope of approximately 10 degrees but may have any suitable slope such as 9 to 11 degrees, 8 to 12 degrees, 7 to 13 degrees, 6 to 14 degrees, 5 to 15 degrees, 4 to 16 degrees, or any other suitable slope. The slope(s) on one or more of the respective surfaces 49, 51 may cause the axial force from the plunger biasing member 50 to generate a force in the transverse direction, thereby urging the releaser member 52 to rotate in the clockwise direction. However, as discussed above, the releaser member 52 is rotationally locked at its first rotational position due to the engagement between the locking flange 37d of the guard extension 37 and the longitudinal ridge 54 of the releaser member. As a result, as long as the guard extension 37 is rotationally locking the releaser member 52, then releaser member 52 will be prevented from rotating in the clockwise direction, and the projections 48 of the top ring 45 will remain axially locked by the proximally facing camming surfaces 51 of the flanges 55.

[0069] During the unlocking stage, the guard extension 37 translates in the proximal direction, thereby further compressing the extender biasing member 35. The guard extension 37 translates in the proximal direction until the locking flange 37d of the guard extension 37 no longer engages the longitudinal ridge 54 of the releaser member 52 and the releaser member 52 is no longer10885-W001-SEC rotationally locked. At this stage in the injection sequence, when the locking flange 37d slides out of engagement with the longitudinal ridge 54 of the releaser member 52, the extender biasing member 35 urges the releaser member 52 to rotate in the clockwise direction from the first rotational position to a second rotational position at least partially due to the sloped surfaces of the distally facing camming surface 49 and / or the proximally facing camming surface 51. As illustrated in Figs. 9A and 9 B, when the releaser member 52 rotates in the clockwise direction to the second rotational position, the proximally facing camming surface 51 of each flange 55 rotates in the clockwise direction and slides out of engagement with the distally facing camming surface 49 of each projection 48 of the top ring 45. The releaser member 52 rotates in the clockwise direction under the biasing force of the extender biasing member 35 until the projections 48 of the top ring 45 aligns with respective channel surfaces 52b on an inner surface of the releaser member 52. At this point, because the projections 48 are no longer axially locked by the proximally facing surfaces 51 of the flanges 55, the plunger biasing member 50 urges the top ring 45 in a distal direction (downward), as illustrated in Fig. 10. Accordingly, the plunger may function as a cam, and the releaser member 52 may function as a cam follower. The biasing force of the extender biasing member 35 and / or the biasing force of the plunger biasing member 50 may urge the proximally facing camming surface 51 of each flange 55 of the releaser member 52 (i.e., the cam follower) against the distally facing camming surface 49 of each projection 48 of the plunger 26 (i.e., the cam) to urge the releaser member 52 to rotate from the first rotational position to the second rotational position.

[0070] At this unlocked stage, the proximally facing camming surface 51 of the flanges 55 of the releaser member 52 has cleared the distally facing camming surfaces 49 of the top ring 45 such that the top ring 45 (and thus the plunger 26) is no longer axially restrained by the releaser member 52. As a result, the plunger biasing member 50 urges the plunger 26 axially in the distal direction, as illustrated in Fig. 10. During the downward stroke stage, the top ring 45 is still visible from the top of the releaser member 52 and the plunger guide 60. Once the top ring 45 is no longer axially restrained by the releaser member 52, the projections 48 of the top ring 45 will be slidably received in the longitudinal slot 86 formed in the plunger guide 60 and the channel surfaces 52b of the releaser member 52, and the top ring 45 (and the plunger 26) will travel axially in the distal direction (downward). During this stage, the top ring 45 of the plunger 26 is traveling along both the channel surfaces 52b of the releaser member 52 and the longitudinal slot 86 of the plunger guide 60, thereby preventing rotation between any of the three components (plunger 26, releaser member 52, and plunger guide 60). As a more specific example, because the plunger guide 60 is rotationally fixed with respect to the housing 12, while the projections 48 of the top ring 45 are positioned within both the channel surfaces 52b and the longitudinal slot 86, the releaser member 52 is unable to rotate. Also during this stage, as the plunger 26 travels distally, the base 47 of the plunger 26 will come into contact with the stopper in the drug storage container 20. The device 10 is designed such that plunger 26 is traveling with a force sufficient to drive the stopper in the distal direction within the drug storage container 20 to expel the drug. At the same time, the device 10 is also designed such as to reduce or eliminate the likelihood of glass breakage, undesirable forces acting on the patient, and / or undesirable impact vibration or sound due to interaction between the base 47 and the stopper. For example, the plunger biasing member 50 design parameters may be designed to meet these two sets of design goals. As another example, a damping component may be positioned between the base 47 and the stopper or in another location in the device 10 to dampen the forces between the base 47 and the stopper. For example, the base 47 may include an elastomeric component, section, or other damping feature. Additionally or alternatively, the stopper may be formed of an elastomeric material that includes inherent damping properties. Additionally or alternatively, the stopper may include an additional elastomeric component, section, or other damping feature.

[0071] In some embodiments, the camming action between the distally facing camming surfaces 49 of the projections 48 and the proximally facing camming surfaces 51 of the flanges 55 of the releaser member 52 may generate a signal indicating a start of dose delivery or a start of the injection process. More particularly, as the releaser member 52 rotates relative to the plunger 26, a sliding friction between these the two camming surfaces 49, 51 may generate an audible or a tactile signal indicating the start of dose or drug delivery.10885-W001-SEC

[0072] As discussed above, during the downward stroke stage, while the projections 48 of the top ring 45 are positioned within the channel surfaces 52b and the longitudinal slot 86, the releaser member 52 is unable to rotate with respect to the plunger guide 60. However, in the end-of-dose initiation stage, the projections 48 of the top ring 45 may exit the channel surfaces 52b, and the releaser member 52 may no longer be rotationally constrained by the top ring 45. In some embodiments, once the top ring 45 clears the releaser member 52, the releaser member 52 may rotate in a counter-clockwise direction back to its first rotational position, and this rotation in the counter-clockwise direction may generate an audible or tactile signal indicating an end of dose delivery.

[0073] Once the patient and / or health care provider hears the audible sound, he / she / they may be notified that the dose is complete. In some embodiments, the user may be informed of the significance of the audible signal by way of instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an Instructions for Use (IFU) pamphlet packaged together with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by watching movement of the stopper and / or plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by a vibration or other tactile feedback produced as a result of the rotation of the releaser member 52. The audible notification may be in the form of a click or slap sound, or any other suitable audible signal that is perceptible to the user. The audible signal may be generated simultaneously, or substantially simultaneously, with the stopper reaching the end-of-dose position. Once the user receives some assurance that drug delivery is complete, the user may then lift the drug delivery deice 10 off of the injection site. With nothing to resist it, the extender biasing member 35 may push the guard member 32 from the retracted position back to the extended position to cover the insertion end of the delivery member. In some embodiments, the guard member 32 may be locked at this stage by, for example, a lock ring 40 (Fig. 2B), to prevent subsequent retraction of the guard member 32.

[0074] From the foregoing, it can be seen that the present disclosure advantageously provides a streamlined design for a drug delivery device having automated features. Various mechanisms and components of the drug delivery device may interact with each other in synergistic ways so as to limit the number of moving parts required by the drug delivery device, thereby improving the reliability of the drug delivery device and saving costs, as well as providing other benefits and advantages.

[0075] As will be recognized, the devices and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0076] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0077] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0078] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF,10885-W001-SEC hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0079] 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, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0080] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti-IGF-1R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal lgG2 antibodies, including but not limited to fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, 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, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like; Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like,10885-W001-SEC including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta);Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti ™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1 A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1);OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human lgG1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5|31 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1 ) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1 R 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 receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor / hCGp mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa10885-W001-SEC antibody (I MC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0081] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin / Kexin Type 9 (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienXOlO; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with Bemarituzumab, a monoclonal antibody that inhibits fibroblast growth factor receptor 2b (FGFR2b) for the treatment of advanced Gastric and Gastroesophageal Junction (GEJ) cancers. Additionally, bispecific T cell engager (BiTE®) antibodies such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), anti-TNF a monoclonal antibody, biosimilar to 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 with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo- 1 H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used with Parsabiv7® (etelcalcetide HOI, KAI-4169) or another product containing etelcalcetide HOI for the treatment of secondary hyperparathyroidism (sHPT) such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 206 (nivolumab), a biosimilar candidate to OPDIVO®, or another product containing a monoclonal antibody that targets the PD-1 protein on T cells. In some embodiments, the drug delivery device may contain or be used with ABP 234 (pembrolizumab), a biosimilar candidate to KEYTRUDA®, or another product containing a monoclonal antibody that binds to the PD-1 protein on immune cells. In some embodiments, the drug delivery device may contain or be used with ABP 692 (ocrelizumab), a biosimilar candidate to OCREVUS®, or another product containing a humanized anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with daxdilimab, a human monoclonal antibody against ILT7 or another product. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug10885-W001-SEC delivery device may contain or be used with Pavblu®, a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2, fused to Fc domain of lgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein 05. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is 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 with Imdelltra® (tarlatamab-dlle), an anti-delta-like ligand 3 (DLL3) x anti-CD3 bispecific T cell engager (BITE) molecule, or another product containing tarlatamab-dlle for the treatment of small cell lung cancer. In some embodiments, the drug delivery device may contain or be used with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Lumakras® (sotorasib), a KRASG12Csmall molecule inhibitor, or another product containing a KRASG12Csmall molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezaspire® (tezepelumab-ekko), a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with Tavneos® (avacopan), a complement 5a receptor 1 (C5aR1) antagonist that inhibits the effects of 05a. In some embodiments, the drug delivery device can contain or be used with Tepezza® (teprotumumab-trbw), a human monoclonal antibody against insulin-like growth factor-1 receptor (IGF-1 R), or another product containing a human monoclonal antibody against IGF-1 R. In some embodiments, the drug delivery device can contain or be used with Uplizna® (inebilizumab-cdon), a humanized monoclonal antibody that binds to the B cell-specific surface antigen CD19, or another product containing a humanized monoclonal antibody that binds to the B cell-specific surface antigen CD19. In some embodiments, the drug delivery device may contain or be used with rocatinlimab (AMG 451), a human anti-OX40 monoclonal antibody that is expressed on activated T cells and blocks 0X40 to inhibit and / or reduce the number of 0X40 pathogenic T cells that are responsible for driving system and local atopic dermatitis inflammatory responses. In some embodiments, the drug delivery device may contain or be used with ordesekimab (AMG 714), a human monoclonal antibody that binds to Interleukin- 15 (IL-15) or another product containing a human monoclonal antibody that binds to Interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with olpasiran (AMG 890), a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with Wezlana® / Wezenla™ (human IgG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human lgG1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human lgG1), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human IgG 1. In some embodiments, the drug delivery device may contain or be used with AMG 104, or another product containing a human anti-TSLP Fab. In some embodiments, the drug delivery device may contain or be used with AMG 193, or another product containing a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. In some embodiments, the drug delivery device may contain or be used with AMG 329, or another product containing a human monoclonal antibody that binds and neutralizes the function of the FLT3-ligand. In some embodiments, the drug delivery device may contain or be used with AMG 732, or another product containing a monoclonal antibody against insulin-like growth factor-1 receptor (IGF-1 R). In some embodiments, the drug delivery device may contain or be used with AMG 305, or another product containing dual-targeting bispecific T cell engager (BITE) molecule against P-cadherin (CDH3), mesothelin (MSLN) and CD3. In some embodiments, the drug delivery device may contain or be used with AMG 355, or another product containing an anti-CCR8 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 378, or another product containing a small10885-W001-SEC molecule for the treatment of ulcerative colitis. In some embodiments, the drug delivery device may contain or be used with AMG 410, or another product containing a small molecule for the treatment of solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 513, or another product containing a molecule for the treatment of obesity. In some embodiments, the drug delivery device may contain or be used with AMG 691, or another product containing a monoclonal antibody for the treatment of asthma. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with MariTide™ (AMG 133), or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD- 1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the Interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti- Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 (xaluritamig) or another product containing a bivalent T-cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vl II (EGFRvll I) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Dazodalibep, a fusion protein binding CD40L on T cells to block their interaction with CD40-expressing B cells.10885-W001-SEC

[0082] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0083] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above-described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

10885-W001-SEC What is claimed is:

1. A drug delivery device comprising:a housing having a proximal end, a distal end, and an opening at the distal end;a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening;a guard moveably positioned adjacent to the opening;a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, the plunger being rotationally fixed relative to the housing;a biasing member; anda releaser member operably coupled to the plunger, wherein the releaser member is configured to rotate from a first rotational position to a second rotational position under a biasing force exerted by the biasing member.

2. The drug delivery device of claim 1, wherein the releaser member is configured to restrict movement of the plunger in the distal direction when the releaser member is in the first rotational position, and wherein the releaser member is configured to permit movement of the plunger in the distal direction when the releaser member is in the second rotational position.

3. The drug delivery device of claim 1, wherein the guard has an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing.

4. The drug delivery device of claim 3, wherein the releaser member is prevented from rotating from the first rotational position to the second rotational position when the guard is in the extended position, and wherein the releaser member is allowed to rotate from the first rotational position toward the second rotational position when the guard is in the retracted position.

5. The drug delivery device of any one of claims 3 to 4, wherein movement of the guard from the extended position to the retracted position allows the releaser member to rotate from the first rotational position to the second rotational position under the biasing force exerted by the biasing member.

6. The drug delivery device of any one of claims 1 to 5, wherein the plunger includes a cam and the releaser member includes a cam follower.

7. The drug delivery device of claim 6, wherein the biasing force of the biasing member urges the cam follower against the cam to urge the releaser member to rotate from the first rotational position to the second rotational position.

8. The drug delivery device of any one of claims 6 to 7, wherein the cam is formed by at least one projection extending radially outwardly from the plunger near a proximal end of the plunger.

9. The drug delivery device of any one of claims 6 to 8, wherein the releaser member comprises an annular wall having a proximal end and a distal end and at least one flange extending outwardly in a proximal direction near the proximal end of the annular wall, wherein the cam follower is formed by a proximally facing surface of the at least one flange.10885-W001-SEC 10. The drug delivery device of any one of claims 8 to 9, further comprising a plunger guide fixed relative to the housing, wherein the plunger is disposed at least partially within the plunger guide.

11. The drug delivery device of claim 10, wherein the plunger guide includes an annular wall and an opening formed in the annular wall, wherein the opening is configured to slidably receive the at least one projection after the releaser member rotates from the first rotational position to the second rotational position.

12. The drug delivery device of claim 11, wherein the opening extends along a height of the annular wall of the plunger guide.

13. The drug delivery device of claim 11, further comprising a first projection extending outwardly from the releaser member and a second projection extending outwardly from the plunger guide, wherein the first and second projections engage one another to limit axial movement of the releaser member.

14. The drug delivery device of any one of claims 1 to 13, further comprising a plunger biasing member disposed at least partially within the plunger.

15. The drug delivery device of any one of claims 1 to 14, further comprising a guard extension, wherein the releaser member is disposed at least partially within the guard extension, and wherein the biasing member is an extender biasing member positioned between the guard extension and the releaser member.

16. The drug delivery device of claim 15, further comprising a first projection extending outwardly from the releaser member and a third projection extending inwardly from the guard extension, wherein the first and third projections engage one another to retain the releaser member in the first rotational position.

17. The drug delivery device of claim 16, wherein the guard has an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing, and wherein movement of the guard from the extended position to the retracted position causes movement of the guard extension in a proximal direction.

18. The drug delivery device of claim 17, wherein movement of the guard extension in the proximal direction causes the third projection to slide out of engagement with the first projection to allow the releaser member to rotate from the first rotational position to the second rotational position.

19. A drug delivery device comprising:a housing having a proximal end, a distal end, and an opening at the distal end;a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening;a guard moveably positioned adjacent to the opening;a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, the plunger being rotationally fixed relative to the housing;a biasing member; and10885-W001-SEC a releaser member operably coupled to the plunger, wherein the releaser member is configured to rotate relative to the plunger under a biasing force exerted by the biasing member, wherein the rotation of the releaser member is configured to generate an audible signal indicating a start of dose delivery.

20. The drug delivery device of claim 19, wherein the releaser member is configured rotate from a first rotational position to a second rotational position under the biasing force exerted by the biasing member, wherein the releaser member is configured to restrict movement of the plunger in the distal direction when the releaser member is in the first rotational position, and wherein the releaser member is configured to permit movement of the plunger in the distal direction when the releaser member is in the second rotational position.

21. The drug delivery device of any one of claims 19 to 20, wherein the guard has an extended position where the guard extends at least partially through the opening in the housing and a retracted position where the guard is positioned away from the extended position toward the housing.

22. The drug delivery device of claim 21, wherein the releaser member is prevented from rotating relative to the plunger when the guard is in the extended position, and wherein the releaser member is allowed to rotate relative to the plunger when the guard is in the retracted position.

23. The drug delivery device of any one of claims 19 to 22, wherein the plunger includes a cam and the releaser member includes a cam follower.

24. The drug delivery device of claim 23, wherein the biasing force of the biasing member urges the cam follower against the cam to urge the releaser member to rotate relative to the plunger.

25. The drug delivery device of any one of claims 23 to 24, wherein the cam is formed by at least one projection extending radially outwardly from the plunger near a proximal end of the plunger.

26. The drug delivery device of any one of claims 23 to 25, wherein the releaser member comprises an annular wall having a proximal end and a distal end and at least one flange extending outwardly in a proximal direction near the proximal end of the annular wall, wherein the cam follower is formed by a proximally facing surface of the at least one flange.

27. The drug delivery device of any one of claims 25 to 26, further comprising a plunger guide fixed relative to the housing, wherein the plunger is disposed at least partially within the plunger guide.

28. The drug delivery device of claim 27, wherein the plunger guide includes an annular wall and an opening formed in the annular wall, wherein the opening is configured to slidably receive the at least one projection after the releaser member rotates relative to the plunger.

29. The drug delivery device of any one of claims 19 to 28, further comprising a plunger biasing member disposed at least partially within the plunger.10885-W001-SEC 30. The drug delivery device of any one of claims 19 to 29, further comprising a guard extension, wherein the releaser member is disposed at least partially within the guard extension, and wherein the biasing member is an extender biasing member positioned between the guard extension and the releaser member.

31. The drug delivery device of claim 30, wherein the guard extension is configured to selectively engage the releaser member to limit rotation of the releaser member and slide out of engagement with the releaser member to allow rotation of the releaser member.

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