Drug delivery device having impact activated retention features

Abstract

A drug delivery device includes: a housing having a proximal end and a distal end, and a longitudinal axis extending therebetween; an injection assembly at least partially disposed within the housing, the injection assembly including a needle or cannula; a drive assembly operatively coupled to the injection assembly; a shield slidably coupled to the housing and operatively coupled to the drive assembly; and a retention mechanism. The drive assembly is engageable to deliver a drug via the injection assembly. The shield is positionable in an extended position and a retracted position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance, and in the retracted position, the proximal end of the housing protrudes beyond the proximal end of the shield by a distance. The shield is moved to the retracted position to engage with the drive assembly to deliver a drug via the injection assembly. The retention mechanism restricts movement of the drive assembly to constrain its engagement, thereby constraining the drive assembly to deliver a drug via the injection assembly.

Description

Technical Field

[0001] This disclosure relates generally to drug delivery devices, and more specifically to impact-activated retention features for drug delivery devices. Prior Technology

[0002] Drug delivery devices, such as infusion sets, are used to deliver liquid medications to patients. Upon activation, the device uses a needle, cannula, or other delivery mechanism to expel medication stored in an internal reservoir into the patient's body. Some drug delivery devices, such as pen-type autoinfusers, can be positioned close to the patient's skin to deliver medication over a period of time via an injection needle or other means. Drug delivery devices can also be positioned near tissues in the patient's abdomen, thigh, arm, or other parts of the body.

[0003] Some devices may have drawbacks. Specifically, users may experience fear due to the exposed injection needle or feel that they are inherently incapable of injection. Due to the need to avoid exposed needles and the potential health and safety issues involved, various types of injectors and other devices have been developed to conceal the needle from the user and automate injection tasks to assist users in injection, ensure reliable drug delivery, and ensure patient safety.

[0004] Typically, when administering medication to a patient using a hypodermic syringe, three tasks can be performed: 1) inserting the needle into the patient; 2) injecting the medication from the syringe into the patient; and 3) withdrawing the needle after injection. Generally, shield-activated devices use a manual needle insertion technique, allowing the user to simultaneously insert the needle and initiate medication administration by retracting the shield relative to the rest of the device. In these devices, the needle can be automatically inserted after manual activation. Push-button-activated devices typically employ an automatic needle insertion mechanism, which mechanically inserts the needle and automatically delays the release of the medication administration mechanism until the correct device state is achieved. Any or all of these devices can use a manual and / or automatic withdrawal mechanism to retract the needle and typically rely on a spring or other power source to generate the force required to perform the task. Sometimes, the user may unintentionally misoperate or drop the device before use. In such cases, if the device is dropped in a certain direction, inertial forces may cause internal components to move relative to each other, potentially leading to unintentional premature activation of the device. Such premature initiation could result in some or all of the expected medication not actually being delivered to the user, which could be wasteful and potentially harmful to the user and / or others.

[0005] This disclosure describes a drug delivery device that embodies an advantageous alternative to existing drug delivery devices and can address one or more of the challenges or needs mentioned herein. Summary of the Invention

[0006] According to a first aspect, a drug delivery device includes: a housing having a proximal end and a distal end, and a longitudinal axis extending therebetween; an injection assembly at least partially disposed within the housing and including a needle or cannula; a drive assembly operatively coupled to the injection assembly; a shield slidably coupled to the housing and operatively coupled to the drive assembly; and a retention mechanism. The drive assembly is engageable to deliver a drug via the injection assembly. The shield is positionable in an extended position and a retracted position, wherein in the extended position, at least the proximal end of the shield extends beyond the proximal end of the housing by a distance, and in the retracted position, the proximal end of the housing protrudes beyond the proximal end of the shield by a distance. The shield is moved to the retracted position to engage with the drive assembly to deliver a drug via the injection assembly. The retention mechanism restricts movement of the drive assembly to constrain its engagement, thereby constraining the drive assembly from delivering the drug via the injection assembly during accidental movement of the housing.

[0007] In some examples, the drive assembly may further include a trigger ring that engages with a shield. This trigger ring is movable between an initial position and a release position. In some of these pathways, the shield moves to a retracted position, advancing the trigger ring to the release position. In these and other examples, the shield may include an actuator portion that engages the trigger ring.

[0008] In some approaches, the shield may include an actuator portion that engages the trigger ring. Additionally, the retaining mechanism may include at least one arm carried by a nut. This at least one arm may engage a portion of the trigger ring to prevent the trigger ring from moving to the release position. In some examples, the device may further include a container holder operatively coupled to the injection assembly. The container holder may include an arm that engages the at least one arm during unintentional or accidental movement of the device. In some examples, the container holder may be fixedly coupled to the housing.

[0009] According to a second aspect, a drug delivery device may include: a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends of the housing; an injection assembly at least partially disposed within the housing at or near the proximal end of the housing; a drive assembly at least partially disposed within the housing and operatively coupled to the injection assembly; and a shield slidably coupled to the housing and operatively coupled to the drive assembly. The drive assembly may include a trigger ring and further include a nut at least partially disposed around the periphery of the trigger ring, the trigger ring being movable between an initial position and a release position to deliver a drug via the injection assembly. The shield may be positioned in an extended position and a retracted position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance, and in the retracted position, the proximal end of the housing protrudes beyond the proximal end of the shield by a distance. When the shield is moved to the retracted position, a portion of the shield advances the trigger ring to the release position to deliver a drug via the injection assembly. The container holder, the nut, and the trigger ring cooperate to form a retention mechanism to prevent the trigger ring from being activated and thus delivering the drug via the injection assembly. Simple Explanation of the Diagram

[0010] The above-mentioned requirements are at least partially met by providing the impact-activated retention features of the drug delivery device described in the following embodiments, particularly studied in conjunction with the accompanying drawings, in which:

[0011] [Figure 1] shows a perspective view of an exemplary drug delivery device according to various embodiments;

[0012] [Figure 2] shows a cross-sectional view of the exemplary drug delivery device of Figure 1 according to various embodiments;

[0013] [Figure 3A] shows a cross-sectional view of an exemplary rear sub-assembly of the exemplary drug delivery device of Figures 1 and 2 according to various embodiments;

[0014] [Figure 3B] shows a cross-sectional view of an exemplary drug storage container of the exemplary drug delivery apparatus of Figures 1 to 3A according to various embodiments;

[0015] [Figure 3C] shows a cross-sectional view of an exemplary front sub-assembly of the exemplary drug delivery device of Figures 1 to 3B according to various embodiments;

[0016] [Figure 4] shows a perspective view of an exemplary drive assembly of the exemplary drug delivery device of Figures 1 to 3C according to various embodiments;

[0017] [Figure 5] shows an exemplary drive assembly of the exemplary drug delivery device of Figures 1 to 4 in a pre-start state and before impact, according to various embodiments;

[0018] [Figure 6] shows a cross-sectional view of an exemplary drive assembly of the exemplary drug delivery device of Figures 1 to 5 according to various embodiments, in a pre-start state and during impact; and

[0019] [Figure 7] shows an exemplary drive component of the exemplary drug delivery device of Figures 1 to 6 according to various embodiments, in a pre-start state and after impact.

[0020] Those skilled in the art will understand that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figures may be enlarged relative to other elements to help improve the understanding of the various embodiments of the invention. Furthermore, commonly used but easily understood elements that are available or necessary in commercially viable embodiments are generally not shown to facilitate viewing of these various embodiments with less obstruction. It will also be understood that certain actions and / or steps may be described or depicted in a specific sequence of occurrence, while those skilled in the art will understand that such specificity in sequence is not actually necessary. It will also be understood that the terms and expressions used herein have the ordinary technical meaning consistent with those set forth above by those skilled in the art, except for any other specific meanings set forth herein. Implementation

[0021] [Cross-references to related applications]

[0022] This application claims priority to U.S. Provisional Patent Application No. 63 / 252,940, filed October 6, 2021, the entire contents of which are incorporated herein by reference.

[0023] Generally, according to those various embodiments, a drug delivery device is provided that prevents the device from being prematurely activated during and after unintentional shedding. The drug delivery device provided herein incorporates a retention mechanism that is used to start a component of the device in the event that a force associated with dropping may occur. When the falling device is stopped due to contact with a surface (e.g., floor, table, etc.), internal components usually move due to those inertial forces. However, the device part responsible for device initiation is prevented from moving to the same extent, and by using the relative difference in this movement, the retention mechanism can remove kinetic energy from the device. Upon impact, the internal component will return to its preset position and the device will function as intended.

[0024] Turning to the accompanying diagram, a drug delivery device for the delivery of a drug (which may also be referred to herein as an agent or a drug product) is provided 10 . Drugs may be, but are not limited to, various biological agents, such as peptides, peptidomes, or antibodies. Drugs may be in fluid or liquid form, but the contents of this disclosure are not limited to a specific state. In certain liquid preparations, the drug may have a viscosity between approximately (e.g., ± 10%) 1 - 13 centipoise (cP), approximately (e.g., ±10%) 1 - 30 cP, approximately (e.g., ± 10%) 1 - 60 cP, or other suitable viscosity profiles. Other examples are also possible.

[0025] Various implementations and configurations of drug delivery devices 10 are possible. For example, the present disclosure describes a drug delivery device 10 in the form of a disposable disposable injector. In other embodiments, the drug delivery device 10 may be configured as a reusable injector for multiple uses. The drug delivery device 10 may be operated for self-administration by the client or by a nurse or a formally trained health care provider (e.g., a physician or nurse). Additionally, in the illustrated example, the drug delivery device 10 takes the form of an auto-injector or pen-type injector, and such may be held in the user's hand during the drug delivery or administration period.

[0026] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, but fewer or more states are possible. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before it is activated by the user. In some embodiments, the pre-delivery state may exist between the time the drug delivery device 10 leaves the manufacturing facility and the time the patient or user activates the drive assembly of the drug delivery device 10. The delivery state may correspond to the configuration of the drug delivery device 10 during drug delivery. It should be understood that during the transition from the pre-delivery state and the delivery state, the user can remove the drug delivery device 10 from any secondary packaging and begin positioning the drug delivery device 10 at the injection site. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is positioned at the end-of-administration position in the drug storage container. For the purposes of this disclosure, only the pre-delivery state and partial delivery state will be described herein, as the braking mechanism described herein is used to maintain the drug delivery device 10 in the pre-delivery state in the event of accidental and / or unintentional drop or contact.

[0027] The drug delivery device 10 includes a housing or casing 12. In some embodiments, the size and dimensions of the casing 12 may be determined to allow a person to hold the injector 10 with one hand. The casing 12 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 12a and a distal end 12b. The drug delivery device 10 further includes an injection assembly 15 and a drive assembly 30. The injection assembly 15 and the drive assembly 30 may each be at least partially disposed within the casing 12. The injection assembly 15 includes a delivery member 16 in the form of a needle or cannula. An opening 14 may be formed in the proximal end 12a to allow the insertion end 16a of the delivery member 16 to extend outside the casing 12 (i.e., beyond the length of the casing).

[0028] A transparent or translucent inspection window 17 may be positioned within the wall of the housing 12 to allow a user to observe the internal components of the drug delivery device 10, including the drug storage container 23 (which is also part of the infusion assembly 15). Observing the drug storage container 23 through the window 17 allows the user to confirm that drug delivery is in progress and / or has been completed. A removable cap 18 may cover the opening 14 before use of the drug delivery device 10 and, in some embodiments, may include a gripper 21a configured to assist in removing a sterile barrier 21 (e.g., a rigid needle sheath (RNS), a flexible needle sheath (FNS), etc.) mounted on the insertion end 16a of the delivery member 16. The gripper 21a may include one or more inwardly projecting barbs or arms that, when the user separates the removable cap 18 from the housing 12, mechanically engage the sterile barrier 21 in a frictional or otherwise manner, pulling the sterile barrier 21 together with the removable cap 18. Therefore, removing the removable cover 18 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0029] The cover 18 is in the form of a generally hollow member that can be removably coupled to the housing 12 and / or the shield 32. More specifically, in the illustrated examples of Figures 2 and 3C, a portion of the cover 18 can be inserted into an opening 14 formed by the housing 12.

[0030] The housing 12 may be hollow and generally cylindrical or tubular in shape, and may include a rear cover having a generally hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the housing and any components to be housed therein may be assembled together to define various sub-assemblies (e.g., the rear sub-assembly shown in FIG. 2A and the front sub-assembly shown in FIG. 2C). In some embodiments, the rear and front sub-assemblies are assembled independently of each other and then combined with each other and with the drug storage container 23 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the above assembly stages may be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed as a single piece, such that the housing 12 is defined by a single integral structure.

[0031] A drug storage container 23 is disposed within the internal space of the housing 12 and configured to contain a drug 24. The drug storage container 23 may be pre-filled and transported by the manufacturer, for example, to a location where it will be combined with the rest of the drug delivery device 10. The housing 12 may be pre-loaded with the drug storage container 23 by the manufacturer, or alternatively, by the user before using the drug delivery device 10. The drug storage container 23 may include a rigid wall defining an internal orifice or reservoir. This wall may be made of glass or plastic. A stopper 25 may be movably disposed within the drug storage container 23 such that it can move axially along a longitudinal axis A between the distal and proximal ends of the drug storage container 23. The stopper 25 may be constructed of rubber or any other suitable material. The stopper 25 may slidably and sealingly contact the inner surface of the wall of the drug storage container 23 such that when the stopper 25 moves, leakage of the drug 24 through the stopper 25 is prevented or inhibited. Proximal movement of the stopper 25 displaces the drug 24 from the reservoir of the drug storage container 23 into the delivery member 16. The distal end of the drug storage container 23 may be open to allow the plunger 26 to extend into the drug storage container 23 and push the stopper 25 proximally. In this embodiment, the plunger 26 and the stopper 25 are initially spaced apart by a gap. Upon activation of the drive assembly 30, the plunger 26 moves proximally to close the gap and contact the stopper 25. Subsequent proximal movement of the plunger 26 drives the stopper 25 proximally. In an alternative embodiment, the stopper 25 and the plunger 26 may be connected to each other, for example via a threaded connection, so that they move together from the beginning of the movement of the plunger 26. Once the stopper 25 has moved, it may continue to move proximally until it contacts the distal portion of the inner surface of the wall of the drug storage container 23. This position of the stopper 25 may be referred to as the end-of-dose position and may correspond to the time when the delivery of the drug 24 to the patient is complete or substantially complete.

[0032] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 23. The proximal end of the delivery member 16 may define an insertion end 16a. The insertion end 16a may include sharp tips of other sharp geometries to allow the insertion end 16a to pierce the patient's skin and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and have internal passageways. One or more openings may be formed in the insertion end 16a to allow drug to flow out of the delivery member 16 and into the patient.

[0033] In this embodiment, the drug storage container 23 is a pre-filled syringe and has a posted hollow metal needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 23 and is in permanent fluid communication with the reservoir of the drug storage container 23. In other embodiments, the drug storage container 23 may be a needleless cartridge, thus initially not in fluid communication with the delivery member 16. In such embodiments, during operation of the drug delivery device 10, the drug storage container 23 may be moved toward the distal end of the delivery member 16, or conversely, such that the distal end of the delivery member 16 penetrates a diaphragm covering an opening in the drug storage container 23, thereby establishing fluid communication with the reservoir of the drug storage container 23.

[0034] The drug storage container 23 can be fixed relative to the housing 12 so that once installed in the housing 12, it will not move relative to the housing. Thus, in the pre-delivery, delivery, and post-delivery states, the insertion end 16a of the delivery member 16 can permanently extend through the opening 14 in the housing 12. In this embodiment, a container holder 42 secures the position of the drug storage container 23 within the housing 12. The container holder 42 can be hollow and generally cylindrical or tubular in shape, and the drug storage container 23 can be partially or completely disposed within the container holder 42. The proximal end of the container holder 42 may include an inwardly projecting flange 42a that abuts against the neck of the drug storage container 23, thereby preventing proximal movement of the drug storage container 23. In some, but not all, ways, the container holder 42 can be fixedly attached to the housing 12, preventing movement of the container holder 42 relative to the housing 12 during operation of the drug delivery device 10. In these and other examples, the container retainer 42 can be operatively attached to the housing 12 via other components, such as nuts (which will be described in further detail below). The distal end of the container retainer 42 may include a housing connector 44 and at least one arm 45. More specifically, the housing connector 44 is in the form of a plurality of tabs or protrusions sized to engage and operatively connect with a portion of the housing 12. As an example, and as shown in FIG. 4, the distal end 12b of the housing 12 may include an opening 13 and a slot 13a engaging the housing connector 44. This arrangement securely attaches the container retainer 42 to the housing 12 such that they can move together in the axial direction.

[0035] In alternative embodiments, the drug storage container 23 may be movably coupled to the housing 12, allowing the drug storage container 23 to move relative to the housing 12 during operation of the drug delivery device 10. In some such alternative embodiments, in a pre-delivery state, the insertion end 16a of the delivery member 16 may retract into the opening 14 in the housing 12. Subsequently, during operation of the injection device 10, the insertion end 16a of the delivery member 16 may be extended through the opening 14 in the housing 12 for insertion into the patient. In some embodiments, this movement may be a result of the drug storage container 23 being driven proximally relative to the housing 12.

[0036] The plunger 26 may be constructed from multiple interconnected parts, or alternatively, have a one-piece construction. In this embodiment, the plunger 26 includes a rod 65 having a threaded outer surface 66 and a washer or disc 68 rigidly attached to the proximal end of the rod 65. When the drive assembly 30 is activated, the disc 68 may strike and push the plunger 25. Therefore, in some embodiments, the disc 68 may have damping characteristics to reduce any impact or vibration associated with an impact event.

[0037] The drug delivery device 10 may further include a protective mechanism to prevent contact with the insertion end 16a of the delivery member 16 when the drug delivery device 10 is not used for administration. The protective mechanism may include a shield 32 movably disposed at the proximal end 12a of the housing 12, adjacent to the opening 14. The shield 32 may be hollow and generally cylindrical or tubular in shape. The shield 32 may have a distal end received within the housing 12 and may be configured to move relative to the housing 12 between an extended position and a retracted position, in which the proximal end of the shield 32 extends through the opening 14 in the housing 12, and in the retracted position, the proximal end of the shield 32 is fully or partially retracted into the opening 14 in the housing 12. At least in the extended position, the shield 32 may extend beyond and surround the insertion end 16a of the delivery member 16. In some embodiments, moving the shield 32 toward the retracted position may expose the insertion end 16a of the delivery member 16. Furthermore, in some embodiments, the shield 32 may be coupled to the housing 12 and / or the container holder 42 via, for example, a pin-slot arrangement, such that the shield 32 can translate in a linear direction relative to the housing 12 and / or the container holder 42, but is prevented from rotating relative to the housing 12 and / or the container holder 42.

[0038] The proximal end of the shield 32 may include a skin contact portion 36 (FIG. 2). Referring to FIG. 4, the distal end of the shield 32 may include an actuator portion 34. In some examples, the pawl actuator portion 34 and the skin contact portion 36 may be integrally formed to define a single integral structure. At least the skin contact portion 36 of the shield 32 may have a hollow and cylindrical or tubular shape, and in some embodiments may be centered on the longitudinal axis A of the drug delivery device 10. The actuator portion 34 of the shield may be a cut-out or recessed area, which will be discussed in further detail below.

[0039] The shield 32 can be moved from the extended position to the retracted position by pressing the skin contact portion 36 against the injection site on the patient's skin. In an example where the delivery member 16 protrudes from the opening 14 in the housing 12 before delivery or in a stored state, this movement allows the insertion end 16a of the delivery member 16 to be inserted into the patient's skin.

[0040] The protective mechanism may further include a protective biasing member 35. The protective biasing member 35 can bias or advance the protective member 32 toward the extended position by applying a biasing force in the proximal direction to the shield 32. In some examples, the protective biasing member 35 is in the form of a compression spring. In other examples (not shown), the protective biasing member 35 may be in the form of a torsion spring or other types of springs. In any event, the user can overcome this biasing force by pressing the shield 32 against the injection site. When injection is complete and the drug delivery device 10 is removed from the injection site, the protective biasing member 35 can return the shield 32 to the extended position, thereby covering the insertion end 16a of the delivery member 16. In some embodiments, the protective biasing member 35 may be axially positioned and in contact with both the distal inner surface of the shield 32 and the proximal inner or outer surface of the lock 40. In embodiments where the guard 32 is a compression spring, movement of the guard 32 in the distal direction can compress the protective bias member 35 between the guard 32 and the lock 40. In some embodiments, the protective bias member 35 can be partially compressed before the guard 32 retracts, and thus apply a biasing force to both the guard 32 and the lock 40 in the pre-delivery state.

[0041] As previously described, the drug delivery device 10 may further include a drive assembly 30, partially or completely disposed within the housing 12. Typically, the drive assembly 30 may be configured to store energy and, upon or in response to user activation of the drive assembly 30, release or output that energy to drive the injection assembly 15 (i.e., the delivery member 16, the drug storage container 23, the stopper 25, and the plunger 26) to expel the drug 24 from the drug storage container 23 through the delivery member 16 into the patient. In this example, the drive assembly 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive assembly 30 may be configured differently, for example, storing electrical or chemical potential energy. Upon activation of the drive assembly 30, the drive assembly 30 may convert the potential energy into kinetic energy for moving the plunger 26.

[0042] Typically, the drive assembly 30 may include a rotational bias member 50, a rotational bias member housing 52, a trigger ring 54, and a mechanical linkage 58. The rotational bias member 50 may be a torsion spring (e.g., a helical torsion spring, a spiral torsion spring, etc.) initially held in an energized state. In the energized state, the rotational bias member 50 may be twisted or wound by the trigger ring 54 via the mechanical linkage 58 and held in this twisted or wound configuration. When released, the rotational bias member 50 will attempt to return to its natural length or shape, thus applying a biasing force to rotate the mechanical linkage 58. The mechanical linkage 58 may then convert the rotational motion into linear motion to drive the plunger 26 proximally. In some embodiments, the mechanical linkage 58 may convert the rotational motion from the rotational bias member 50 into linear motion driving the plunger 26 proximally and rotational motion of the plunger 26 about the longitudinal axis A.

[0043] Alternative implementations may utilize energy sources other than the rotary bias member. Some alternative implementations may utilize, for example, a linear bias member (e.g., a helical compression spring, a helical extension spring, etc.) that, when released, outputs a force in the direction of travel of the plunger 26. Attached to or alternative to the bias member, other implementations may include any one or a combination of the following: an electromechanical arrangement including an electric motor and / or solenoid and a drivetrain or transmission coupled to the plunger 26; or an arrangement that generates or releases pressurized gas or fluid to propel the plunger 26; or an arrangement that acts directly on the stopper 25 to move the stopper 25 through the drug storage container 23 to expel the drug 24 therefrom. In implementations where the drug storage container 23 and / or delivery member 16 are movable relative to the housing 12, the drive assembly 30 may, upon activation, drive the drug storage container 23 and / or delivery member 16 proximally so that the insertion end 16a of the delivery member 16 is inserted into the patient. Therefore, in some embodiments, the drive assembly 30 can provide the power required to insert the delivery member 16 into the patient and to expel the drug 24 from the drug storage container 23.

[0044] As shown in Figure 4, the trigger ring 54 may include an arm opening 55. The arm opening 55 may be in the form of a cutout or groove formed in the body of the arm opening 55. The trigger ring 54 may additionally include an actuator portion 56. In the example shown, the actuator portion 56 is in the form of a tab located on the proximal end of the trigger ring 54.

[0045] The mechanical linkage 58 may include a plunger guide 60 and a nut 62. The plunger guide 60 may be hollow and generally cylindrical or tubular in shape. At least in the pre-delivery state, the distal end of the plunger 26 may be disposed inside the plunger guide 60. The distal end of the plunger guide 60 may extend through the center of the rotational biasing member 50 and may be coupled to the rotational biasing member 50 such that when the rotational biasing member 50 is released, the plunger guide 60 rotates together with the rotational biasing member 50. The inner surface of the plunger guide 60 is coupled to the outer surface of the plunger 26 such that when the rotational biasing member 50 is released, the plunger 26 rotates together with the plunger guide 60, while allowing axial movement of the plunger 26 relative to the plunger guide 60. The connection between the plunger guide 60 and the plunger 26 can be achieved, for example, via a spline arrangement, wherein a longitudinal protrusion on one of the inner surface of the plunger guide 60 or the outer surface of the plunger 26 is slidably received in a longitudinal slot on the other of the outer surface of the plunger 26 or the inner surface of the plunger guide 60.

[0046] Nut 62 may have a generally annular shape and may be positioned around the proximal end of plunger 26 in the pre-delivery state. Additionally, as shown in FIG. 4, a portion of nut 62 may at least partially surround a portion of trigger ring 54. Nut 62 may be fixedly mounted such that nut 62 cannot move relative to housing 12. Furthermore, nut 62 may have a threaded inner surface 64 that engages the threaded outer surface 66 of plunger 26. Due to this threaded engagement, rotation of plunger 26 relative to nut 62 can linearly drive plunger 26 proximally. This, in turn, causes plunger 26 to act on and push the plug proximally, thereby discharging medication 24 from storage container 23 into the patient via inserted delivery member 16. Nut 62 may further include at least one arm 63 extending distally from nut 62. In some examples, the at least one arm 63 may be in the form of a peak lever arm, which can generate a peak force during a predetermined activation. The at least one arm 63 may include a finger 63a at its distal end, which, in the pre-activation state, is positioned adjacent to the arm opening 55 of the trigger ring 54. In some examples, the at least one arm 63 may be made of an elastic and / or flexible material to be biased to a position that does not engage or contact a portion of the trigger ring 54. Furthermore, in some examples, and as shown in FIG. 4, in the pre-activation state, one or more arms 45 of the container holder 42 are positioned adjacent to the at least one or more arms 63.

[0047] The shield 32 can be configured to interact with the drive assembly 30 when it moves from an extended position to a retracted position. This interaction can activate the drive assembly 30 to output the energy required to drive the plunger 26 to expel the medication 24 from the medication storage container 23 and / or to insert the insertion end 16a of the delivery member 16 into the patient's skin. In this embodiment, the movement of the shield 32 from the extended position to the retracted position releases the rotational bias member 50 from an energized state, thereby allowing the rotational bias member 50 to be de-energized and to drive the plunger 26 via the mechanical linkage 58 to expel the medication 24 from the medication storage container 23. More specifically, in the pre-delivery state, the trigger ring 54 can be arranged in an initial position in which the trigger ring lockably engages the outer surface of the plunger guide 60, thereby preventing the plunger guide 60 from rotating under the biasing force of the rotational bias member 50. Thus, de-energization of the rotational bias member 50 is prevented. As the shield 32 moves from the extended position to the retracted position due to pressure against the patient's skin, the actuator portion 34 of the shield 32 engages the actuator portion 56 of the trigger ring to push the trigger ring 54 distally to the release position, where the trigger ring 54 disengages from the plunger guide 60. More specifically, in these and other examples, the recessed actuator portion 34 of the trigger ring may at least partially surround the tabular actuator portion 56 to form a tight-fitting connection between them. Therefore, the plunger guide 60 is able to rotate under the biasing force of the rotational biasing member 50 and drive the plunger 26 proximally via the threaded connection between the plunger 26 and the nut 62.

[0048] The rotational biasing member housing 52 may be disposed within the housing 12 and rigidly attached to the housing. The rotational biasing member housing 52 may have a hollow and generally cylindrical or tubular shape, and may fully or partially receive the rotational biasing member 50 such that the rotational biasing member housing 52 surrounds or partially surrounds the rotational biasing member 50. The rotational biasing member housing 52 may serve as a mounting or seat for the rotational biasing member 50 to be pushed away when it is released.

[0049] Having described the general configuration and operation of the drug delivery device 10, it should be understood that axial movement of the shield 32 toward the distal end 12b of the housing 12 is used to activate the drive assembly 30 to deliver the drug 24 via the infusion assembly 15. However, it is possible that at some point during the pre-activation state, the user may unintentionally drop or bump the drug delivery device 10, causing the housing and / or shield to be pushed toward the distal end 12b of the housing 12. As shown in Figures 4 and 5, in the pre-activation state, the finger 63a of at least one arm 63 of the nut 62 is positioned adjacent to the arm opening 55 of the trigger ring 54, while the arm 45 of the container holder 42 is positioned adjacent to at least one arm 63 of the nut 62. To prepare for drug delivery, the user can pull the cap 18 away from the device 10 in the proximal direction 12a to expose the skin contact portion 36 of the shield 32 to engage with the patient's skin.

[0050] Before the user decides to continue medication delivery (i.e., before or after removing the cap 18), the container holder 42, nut 62, and trigger ring 54 cooperate to form a retention mechanism that prevents the drive assembly 30 from being activated. More specifically, referring to Figures 5 through 7, in the event of an accidental drop and / or impact to the device 10, inertia and / or contact forces may cause the housing (and thus the container holder 42 connected thereto) to move axially toward the distal end 12b of the housing 12. As shown in Figure 6, in the event of such movement, the arm 45 of the container holder slidably engages at least one arm 63 of the nut 62 or otherwise advances the at least one arm radially toward the longitudinal axis A, which in turn advances the at least one arm radially toward the longitudinal axis A. The relative movement causes the finger 63a of the at least one arm 63 to engage with the arm opening 55 formed on the trigger ring 54 and be at least partially inserted therein, and in this way, the nut 62 and the container retainer 42 restrain or prevent the trigger ring 54 from traveling further axially toward the distal end 12b of the housing.

[0051] Referring to Figure 8, after a period of time, the internal components cease moving relative to each other, return to their default positions, and the arm 45 of the container holder, along with the at least one arm 63, disengages from the opening 55 formed on the trigger ring 54, thereby allowing the device 10 to be used as needed (i.e., remaining in the pre-activation state and / or removing the cap 18 to transition to the delivery or administration state). Here, the user can pull and remove the removable cap 18 from the housing 12. This exposes the insertion end 16a of the delivery member 16. However, the insertion end 16a of the delivery member 16 will remain surrounded by the shield 32 at this stage. The user can position the skin contact portion 36 of the shield 32 on the desired injection site and then push the skin contact portion 36 against the injection site. The force applied by the user will overcome the biasing force of the protective bias member 35, causing the shield 32 to retract into the opening 14, moving distally from the extended position to the retracted position. It is worth noting that when the device 10 is used as intended, the housing 12 and the container holder 42 are not engaged with the nut, thus allowing the shield 32 to move to advance the trigger ring 54. During the retraction movement of the shield 32, the delivery member 16 remains stationary relative to the housing 12.

[0052] Retraction of the shield 32 can cause any number of actions. Since the delivery member 16 remains stationary relative to the housing 12 during retraction of the shield 32, the insertion end 16a of the delivery member 16 protrudes through the opening in the skin contact portion 36 of the shield 32, thereby piercing the patient's skin at the injection site and penetrating the patient's subcutaneous tissue. As previously described, retraction of the shield 32 actuates the drive assembly 30. More specifically, retraction of the shield 32 can cause the actuator portion 34 to engage the arm opening 55 of the trigger ring 54 to move the trigger ring 54 distally to the release position (in the release position, the trigger ring 54 is disengaged from the plunger guide 60), thereby actuating the drive assembly 30 to deliver the drug 24 via the injection assembly 15.

[0053] In this configuration, the retention mechanism prevents the device from being accidentally activated upon drop. The arm 45 of the container holder pushes at least one arm 63 of the nut 62 inward and clamps onto the trigger ring 54 if the container holder 42 travels too far into the device 10 in a distal direction. This retention mechanism removes energy from the device to allow it to return to its preset pre-activation state.

[0054] The above description describes various devices, components, parts, subsystems, and methods used in connection with drug delivery devices. Devices, components, parts, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to those drugs identified below and their class counterparts and biosimilar counterparts. As used herein, the term "drug" is used interchangeably with other similar terms and can be used to refer to any type of pharmaceutical agent or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and components, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and classifiers. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or in a form that can be reconstructed from lyophilized form. The following exemplary list of drugs should not be considered as all-encompassing or restrictive.

[0055] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or pre-filled with the medication for treatment. This master container can be a vial, cartridge, or pre-filled syringe.

[0056] In some embodiments, the reservoir of the drug delivery device may be filled with a community-stimulating factor (such as granulocyte community-stimulating factor (G-CSF)), or the device may be used in conjunction with a community-stimulating factor. Such G-CSF agents include, but are not limited to, Neulasta® (pefilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pefilgrastim-cbqv), Ziextenzo® (LA-EP2006; pefilgrastim-bmez) or FULPHILA (pefilgrastim-bmez).

[0057] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulant (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin-stimulating proteins include, but are not limited to, Epogen® (epogenin α), Aranesp® (dabepoline α), Dynepo® (epogenin δ), Mircera® (methoxy-polyethylene glycol-epogenin β), Hematide®, MRK-2578, INS-22, Retacrit® (epogenin ζ), Neorecormon® (epogenin β), Silapo® (epogenin ζ), Binocrit® (epogenin α), epogenin α Hexal, Abseamed® (epogenin α), Ratioepo® (epogenin θ), Eporatio® (epogenin θ), Biopoin® (epogenin θ), epogenin α, epogenin β, epogenin ι, epogenin ω, epogenin δ, epogenin ζ, epogenin θ and epogenin δ, pegylated erythropoietin, carbamolylated erythropoietin, and their molecules or variants or analogues.

[0058] The specific illustrative proteins described below are the particular proteins, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, and related proteins (also known as RANKL-specific antibodies, peptides, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, especially fully humanized monoclonal antibodies; myostatin-binding proteins, peptides, and related proteins, including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, and related proteins, particularly those inhibiting the activity of IL-4 and / or IL-4 receptors. -13-mediated activities involving receptor binding; interleukin-1 receptor 1 (IL-R1) specific antibodies, peptides, and related proteins; Ang2 specific antibodies, peptides, and related proteins; NGF specific antibodies, peptides, and related proteins; CD22 specific antibodies, peptides, and related proteins, especially human CD22 specific antibodies, such as, but not limited to, humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2. Dimers of the γ-chain linked to the human-mouse monoclonal hLL2 κ chain by disulfide, such as the fully humanized human CD22-specific antibody in epazuzumab (CAS registry number 501423-23-0); IGF-1 receptor-specific antibodies, peptides, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptides, and related proteins ("B7RP-1", also known as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies binding to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those inhibiting the interaction of B7RP-1 with its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptides, and related proteins, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as 145c7; IFN-γ; and other related proteins. γ-specific antibodies, peptides, and related proteins, including but not limited to human IFN γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptides, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptides, and related proteins; thrombopoietin receptor ("TPO-R") specific antibodies, peptides, and related proteins; hepatocyte growth factor ("HGF") specific antibodies, peptides, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptides, and related proteins; activin A specific antibodies, peptides, and proteins; TGF-β specific antibodies, peptides, and related proteins; amyloid-β protein specific antibodies, peptides, and related proteins; c-Kit specific antibodies, peptides, and related proteins, including but not limited to proteins binding to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to proteins binding to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin. Hemopoietin [30-aspartic acid, 32-threonine, 87-valine, 88-aspartic acid, 90-threonine], dabepoetin α, novel erythropoietin-stimulating protein (NESP); Epogen® (eberphytin α, or erythropoietin); GLP-1, Avonex® (interferon β-1a); Bexxar® (tosimomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-β); Camppath® (alemumab, anti-CD52 monoclonal antibody); Dynepo® (eberphytin δ); Velcade® (bortezomib); MLN0002 (anti-α4β7) mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (ebertin α); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (growth hormone, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns), anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (growth hormone, human growth hormone) Humira® (adalimumab); Vectibix® (panitumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand-based immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistamine), ritumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP));Kineret® (analyzedin); Leukine® (rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belizumab, anti-BlyS mAb); Metalyse® (tenepazolizumab, t-PA analog); Mircera® (methoxy-polyethylene glycol-epazolidin β); Mylotarg® (geutzumab / ozomicin); Raptiva® (efalizumab); Cimzia® (cetuzumab, CDP 870); Soliris™ (eculizumab); Pexazumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibuzumab); Panorex® (17-1A, ezolomide); Trabio® (lerdelimumab); TheraCim hR3 (Nymotuzumab); Omnitarg (Pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (Vencizumab); Cantuzumab mertansine (huC242-DM1); NeoRecormon® (Ibertin β); Neumega® (Interleukin-11); Orthoclone OKT3® (Moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (Ibertin α); Remicade® (Infliximab, anti-TNFα monoclonal antibody); Reopro® (Abciximab, anti-GP) IL-6 receptor monoclonal antibody); Actemra® (anti-IL-6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon α-2a); Simulect® (baricuximab); Prexige® (romecoxib); Synagis® (palizumab); 145c7-CHO (anti-IL-15 antibody, see US Patent No. 7,153,507); Tysabri® (natelizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA) mAb); IL-1 trap (the extracellular domain of the Fc region of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (Ig domain of VEGFR1 fused with IgG1 Fc); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2Rα mAb); Zevalin® (teimomab); Zetia® (ezetimibe); Orencia® (asceticipeptide, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipramab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1 and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF fibrinogen for stage I idiopathic pulmonary fibrosis (FG-3019); anti-CTLA4 mAb; anti-eosinophil chemokine 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO) 1275); Anti-IL13 mAb (CAT-354); Anti-IL2Ra mAb (HuMax-TAC); Anti-IL5 receptor mAb;Anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0059] In some embodiments, the drug delivery device may include or be used with sclerosing protein antibodies, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) binding to the human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may comprise or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumab, or similar drugs. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, or the device may be used with such an oncolytic HSV, including but not limited to OncoVEX GALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may include or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may include Aimovig® (anovisumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for the treatment of migraine containing or being used with anovisumab. Needle-antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, anovisumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets may also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agents (BiTE®) molecules (such as, but not limited to, BLINCYTO® (bonatumab)) may be used in or with the drug delivery device of this disclosure.In some embodiments, the drug delivery device may include or be used with a large APJ agonist, such as, but not limited to, apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device disclosed herein. In some embodiments, the drug delivery device may include or be used with Avsola™ (infliximab-axxq), an anti-TNF α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing or using infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may comprise or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylepoxyethylene-2-yl)-1-oxopentane-2-ylaminomethoxy)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutamido)-4-methylpentylamine, or another product comprising carfilzomib. In some embodiments, the drug delivery device may comprise or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may comprise Parsabiv™ (vilacin HCl, KAI-4169) or another product containing vilacin HCl for the treatment of secondary hyperparathyroidism (sHPT), such as for hemodialysis in patients with chronic kidney disease (KD). In some embodiments, the drug delivery device may comprise or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product comprising or used with an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with a VEGF antagonist (e.g., a non-antibody VEGF antagonist) and / or a VEGF-Trap (e.g., aflibercept (a fusion of the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 with the Fc domain of IgG1)). In some embodiments, the drug delivery device may comprise or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product comprising or used with a monoclonal antibody that specifically binds to complement protein C5.In some embodiments, the drug delivery device may comprise or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activities of ICOSL and BAFF. In some embodiments, the drug delivery device may comprise or be used with omeprazole (a small molecule selective cardiac myosin activator), or myotrope which directly targets the cardiac contraction mechanism, or another product comprising or being used with a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may comprise or be used with sotorazib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product comprising or being used with a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may comprise or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product comprising or being used with a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may comprise, or be used with, AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product comprising, or being used with, a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may comprise, or be used with, AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a) (also known as Lp(a)), or another product comprising, or being used with, a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may comprise, or be used with, ABP 654 (human IgG1κ antibody), a biosimilar candidate of Stelara®, or another product comprising, or being used with, a human IgG1κ antibody and / or a product that binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (monoclonal antibody against TNF human IgG1), a biosimilar candidate of Humira®, or another product comprising or used with a human monoclonal antibody against TNF human IgG1. In some embodiments, the drug delivery device may comprise or be used with AMG 160, or another product comprising or used with a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 119, or another product comprising or used with delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171, or another product containing a growth differentiation factor 15 (GDF15) analogue. 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 leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or another product containing a long-lived (HLE) bispecific T-cell conjugate construct (BiTE®). In some embodiments, the drug delivery device may comprise or be used with AMG 256, which is designed to selectively activate the interleukin-21 (IL-21) pathway in planned cell death-1 (PD-1) positive cells, or another product containing anti-PD-1 x IL21 mutant protein and / or IL-21 receptor agonist. In some embodiments, the drug delivery device may comprise or be used with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product containing a human anti-planned cell death-1 (PD-1) monoclonal antibody. In some embodiments, the drug delivery device may comprise 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 conjugate) 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, which is being investigated for the treatment of solid tumors, or another product (containing a multispecific FAP x 4-1BB-targeting DARPin® biologic). In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T-cell conjugate, and is designed using XmAb® 2+1 technology.In some embodiments, the drug delivery device may comprise or be used with another product comprising or containing an extended-half-life (HLE) CD19 x CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with another product comprising or containing Efavaleukin α (formerly AMG 592) or an IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may comprise or be used with another product comprising or containing a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell conjugate) molecule. In some embodiments, the drug delivery device may comprise or be used with another product comprising or containing an extended-half-life (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 701 or another product comprising, an extended-life (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 757 or another product comprising, an extended-life (HLE) anti-δ-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 910 or another product comprising, an extended-life (HLE) claudin 18.2 x CD3 BiTE® (bispecific T cell conjugate) construct.

[0060] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. This detailed description is to be construed as exemplary only and does not describe every possible implementation of the invention disclosed herein. Many alternative implementations may be carried out using current technology or technology developed after the date of this patent application, and such implementations still fall within the scope of the claims that define the invention disclosed herein.

[0061] Those skilled in the art will understand that various modifications, alterations, and combinations can be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations can be considered to be within the scope of the inventive concept.

[0062] 10. Drug delivery device 12. Outer shell or enclosure 12a proximal 12b remote 15. Injecting Components 30 Driver Components 16 Delivery Components 14 Opening 16a Insertion end 17 Inspection Window 23. Drug storage containers 18 Removable lid 21a Clamping parts 21. Sterile Barrier 32 protective shields 24. Drugs 25 stoppers 26 plungers 42 Container Holder 42a Inwardly protruding flange 44 Housing connector 13 Opening 13a Slot 65 strokes 66 Threaded outer surface 68 discs 36. Skin contact area 34. Starter Section 35. Protective component offsetting member 40 locks 50 Rotational offset component 52 Rotational offset component housing 54 Triggering ring 58 Mechanical linkage components 55-arm opening 56. Starter Section 60 Plunger Guide 62 nuts 64 Threaded inner surface 63 At least one arm 63a Finger-shaped component 45 arms

[0063] none

Claims

1. A drug delivery device, comprising: A housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end of the housing; An injection assembly, including a needle or cannula, is at least partially disposed within the housing; a container holder, including an arm; a drive assembly, at least partially disposed within the housing and operatively coupled to the injection assembly, the drive assembly being engageable to deliver a drug via the injection assembly; a shield, slidably coupled to the housing and operatively coupled to the drive assembly, the shield being positionable in an extended position and a retracted position, wherein in the extended position at least a proximal end of the shield extends beyond the proximal end of the housing by a distance, and in the retracted position the proximal end of the housing protrudes beyond the proximal end of the shield by a distance, wherein moving the shield to the retracted position engages the drive assembly to deliver a drug via the injection assembly; and a nut, including at least one arm adapted to engage a portion of the drive assembly; The shield, container holder, and nut cooperate to form a retention mechanism adapted to restrict the movement of the drive assembly to constrain its engagement, thereby constraining the drive assembly to deliver the drug via the injection assembly during accidental movement of the housing. The arm of the container holder is adapted to engage the arm of the nut during unintentional movement of the device, thereby preventing movement of the drive assembly.

2. The drug delivery device as claimed in claim 1, wherein, The drive assembly includes a trigger ring that engages with the shield, wherein the trigger ring is movable between an initial position and a release position.

3. The drug delivery device as described in claim 2, wherein, The shield moves to the retracted position and advances the trigger ring to the release position.

4. The drug delivery device as described in claim 2 or 3, wherein, The shield includes an actuator portion adapted to engage the trigger ring.

5. The drug delivery device as described in claim 2 or 3, wherein, The retaining mechanism includes at least one arm carried by a nut, the arm being adapted to engage a portion of the trigger ring to prevent the trigger ring from moving to the release position.

6. A drug delivery device, comprising: A housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends of the housing; An injection assembly, at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or cannula, a drug storage container, and a container holder adapted to at least partially surround the drug storage container; a drive assembly at least partially disposed within the housing and operatively coupled to the injection assembly, the drive assembly including a trigger ring and a nut disposed at least partially around the periphery of the trigger ring, the trigger ring being movable between an initial position and a release position to deliver a drug via the injection assembly; and a shield slidably coupled to the housing and operatively coupled to the drive assembly; wherein the container holder includes an arm, and the nut has at least one arm formed on a portion of the nut; The shield can be positioned in an extended position and a retracted position. In the extended position, at least the proximal end of the shield extends beyond the proximal end of the housing by a certain distance. In the retracted position, the proximal end of the housing protrudes beyond the proximal end of the shield by a certain distance. When the shield is moved to the retracted position, a portion of the shield advances the trigger ring to the release position to deliver the drug via the injection assembly. The container holder, the nut, and the trigger ring cooperate to form a retention mechanism to prevent the trigger ring from being activated during accidental movement of the housing to deliver the drug via the injection assembly by engagement of the arm of the container holder with the arm of the nut.

7. The drug delivery device as claimed in claim 6, wherein, The retaining mechanism includes: an arm opening formed on the trigger ring adapted to receive at least a portion of the at least one arm; wherein, during accidental movement of the device, the arm of the container holder is adapted to engage the at least one arm such that at least a portion of the at least one arm enters the arm opening of the trigger ring to prevent the trigger ring from moving to the release position.

8. The drug delivery device as claimed in claim 7, wherein, The at least one arm is movable between an initial state and an engaged state, wherein, in the engaged state, at least a portion of the at least one arm moves toward the longitudinal axis in a radially inward direction.

9. The drug delivery device as claimed in claim 8, wherein, During accidental movement of the device, the arm of the container holder can slidably engage at least one arm to push the at least one arm toward the longitudinal axis and into the arm opening of the trigger ring.

10. The drug delivery device as described in claim 8 or 9, wherein, At least one arm is biased toward the initial state.

11. The drug delivery device as claimed in claim 10, wherein, When the at least one arm is in the initial state, the at least one arm is removed from the arm opening of the trigger ring, so that the trigger ring can be moved to the release position.

12. The drug delivery device as described in any one of claims 6 to 9, wherein, The nut is adapted to guide the movement of the drive assembly during drug delivery.

13. The drug delivery device as described in any one of claims 6 to 9, wherein, The shield includes an actuator portion adapted to engage the trigger ring.

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