Impact activated brake feature for drug delivery device

Abstract

A drug delivery device includes: a housing having a proximal end and a distal end, and a longitudinal axis extending between the proximal end and the distal end; an injection assembly at least partially disposed within the housing at or near the proximal end; a shield slidably coupled to the housing; a drive assembly operatively coupled to the injection assembly and the shield; and a cap. The injection assembly includes a needle or cannula. The shield can be positioned in an extended position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance. The drive assembly can be engaged to deliver a drug via the injection assembly. The cap is removably coupled to at least one of the shield or the housing and is adapted to restrict movement of the shield when coupled to the shield and / or the housing, such that the drive assembly is restricted from delivering the drug via the injection assembly.

Description

[Technical Field]

[0001] This disclosure generally relates to drug delivery devices, and more specifically to the impact-activated braking feature for drug delivery devices. [Previous Technology]

[0002] For example, drug delivery devices such as infusion syringes are used to deliver liquid medications to a patient. Upon activation, the drug delivery device dispenses medication stored in an internal reservoir into the patient via a needle, cannula, or other delivery component. 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 be positioned near tissues in the patient's abdomen, thigh, arm, or other part of the patient's 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 the injection task to assist the user 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 the injection is complete. Typically, shield-activated devices use a manual needle insertion technique, where the user can 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, where the needle is mechanically inserted and the release of the medication administration mechanism is automatically delayed 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. Occasionally, the user may unintentionally misoperate or drop the device before use. In such cases, if the device is dropped in a certain orientation, inertial forces may cause internal components to move relative to each other, which could lead to unintended premature device activation. Such premature initiation may result in some or all of the intended medication not actually being delivered to the user, which could lead to waste and potentially harm 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 between the proximal end and the distal end; an injection assembly at least partially disposed within the housing at or near the proximal end; a shield slidably coupled to the housing; a drive assembly operatively coupled to the injection assembly and the shield; and a cap. The injection assembly includes a needle or cannula. The shield can be positioned in an extended position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance. The drive assembly can be engaged to deliver a drug via the injection assembly. The cap is removably coupled to at least one of the shield or the housing and is adapted to restrict movement of the shield when coupled to the shield and / or the housing, such that the drive assembly is restricted from delivering the drug via the injection assembly.

[0007] In some examples, the shield may be further positionable in a retracted position, in which the proximal end of the housing protrudes beyond the proximal end of the shield by a distance. In such an example, moving the shield to the retracted position will engage the drive assembly to deliver the agent via the injection assembly.

[0008] In some embodiments, the cover may include a locking tab, and the shield may include a stop. At least a portion of the locking tab of the cover may be positionable within the stop. In such embodiments, positioning a portion of the locking tab within the stop prevents the shield from moving to the retracted position. Further, in these and other examples, the housing may include a ramp that advances the locking tab into the stop. In some examples, a gap is formed between the housing and the shield when the cover is removed from the shield and the housing to allow relative movement between the housing and the shield.

[0009] In any of these examples, the cover may further include a snap fastener to secure the cover to the cover.

[0010] According to a second aspect, a drug delivery device includes: a housing having a proximal end and a distal end, and a longitudinal axis extending between the proximal end and the distal end; an injection assembly at least partially disposed within the housing at or near the proximal end; a shield slidably coupled to the housing; a drive assembly operatively coupled to the injection assembly and the shield; and a cap. The injection assembly includes a needle or cannula. The shield can be positioned in an extended position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance. The drive assembly can be engaged to deliver a drug via the injection assembly. The housing, the shield, and the cap cooperate to form a braking mechanism to prevent the drive assembly from being activated to deliver the drug via the injection assembly.

[0011] According to a third aspect, a drug delivery device with a braking mechanism includes: a housing having a proximal end and a distal end, a longitudinal axis extending between the proximal end and the distal end, and a ramp member positioned at or near the proximal end; a shield slidably coupled to the housing; and a cover removably coupled to at least one of the shields of the housing. The shield is movable between 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 further includes a stop disposed along the length of the shield. The cover includes at least one locking tab. When the cover is coupled to at least one of the shield or the housing, as the shield moves toward the retracted position, the ramp member of the housing advances the at least one locking tab to engage with the stop of the shield to restrict movement of the shield to the retracted position.

Implementation Method

[0022] Cross-reference to related applications

[0023] This application claims priority to U.S. Provisional Patent Application No. 63 / 252,949, filed on October 6, 2021, the entire contents of which are incorporated herein by reference.

[0024] Generally, according to those different embodiments, a drug delivery device is provided that prevents premature activation of the device during and after unintentional shedding. The drug delivery device provided herein has a braking mechanism that holds a component used to activate the device in the event of a force related to dropping that may arise. When a falling device comes to a halt due to contact with a surface (e.g., floor, table, etc.), internal components usually move due to those inertial forces. However, the part of the device responsible for the activation of the device is prevented from traveling to the same extent, and by exploiting this relative difference in movement, the braking mechanism can remove kinetic energy from the device. After the impact, the internal components will return to their preset position and the device will function as intended.

[0025] Turning to the accompanying figure, a drug delivery device 10 for the delivery of a drug is provided, which may also be referred to herein as an agent or a drug product. 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 some 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.

[0026] Various implementations and configurations of the drug delivery device 10 are possible. For example, while FIGS. The drug delivery device 10 is in the form of a disposable throwable injector. In other embodiments, the drug delivery device 10 may be configured as a reusable injector for multiple uses. The drug delivery device 10 can be operated for patient self-administration or by a caregiver or a formally trained health care provider (e.g., a physician or nurse). Further, in the illustrated example, the drug delivery device 10 takes the form of an auto-injector or pen-type injector and may thus be held in the user's hand during the drug delivery or administration period.

[0027] 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 when the drug delivery device 10 leaves the manufacturing facility and when 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 to the delivery state, the user may remove the drug delivery device 10 from any secondary packaging and begin positioning the drug delivery device 10 against 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 a portion thereof 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.

[0028] 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 such that a person can hold the injector 10 with one hand. The casing 12 may have a generally elongated shape, such as 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, which is 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).

[0029] 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 shield (RNS), a flexible needle shield (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.

[0030] As shown in Figures 3 to 5, the cover 18 is in the form of a generally hollow member, which includes any number of locking tabs 19 positioned at its distal end. Further, the cover 18 includes an opening 20, which in some examples is positioned adjacent to the locking tabs 19. The cover 18 can be removably coupled to the housing 12 and / or (as described in further detail below) a shield 32. More specifically, in the examples shown in Figures 4 and 5, a portion of the cover 18 can be inserted into an opening 14 formed by the housing 12.

[0031] Referring particularly to Figures 4 and 5, the inner wall of the housing 12 includes any number of ramps 13 disposed at or near the proximal end 12a of the housing. In the example shown, the housing 12 includes two ramps 12 spaced apart on opposite sides of the inner wall, but other arrangements are possible. The ramps 13 are in the form of tapered or angled projections, such projections causing the inner diameter of the inner wall to decrease as it advances from the proximal end 12a toward the distal end 12b of the housing. In some examples, the ramps 13 may be integrally formed with the housing 12. In other examples, the ramps 13 may be operatively coupled to the housing 12 via any number of suitable means (e.g., adhesive, fusion welding, friction fit, etc.). Other examples are also possible.

[0032] 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, having an open end and a closed end. In some embodiments, the housing and any components to be housed in the housing may be assembled together to define individual 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.

[0033] 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 the stopper is axially movable along a longitudinal axis A between the proximal and distal 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 internal 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. The proximal movement of the stopper 25 displaces the drug 24 from the reservoir of the drug storage container 23 into the delivery member 16.

[0034] 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, such that the stopper and the plunger move together from the moment the plunger 26 begins to move. Once the stopper 25 has moved, it may continue to move proximally until it contacts the distally facing 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.

[0035] The delivery member 16 is connected to or operable to be connected to a reservoir in fluid communication with the drug storage container 23. The proximal end of the delivery member 16 may define an insertion end 16a of the delivery member 16. The insertion end 16a may include a sharp tip of other pointed geometry, thereby allowing 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 an internal passageway. One or more openings may be formed in the insertion end 16a to allow drug to flow from the delivery member 16 into the patient.

[0036] 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, and thus may not initially be in fluid communication with the delivery member 16. In such an embodiment, 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 vice versa, 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.

[0037] The drug storage container 23 can be fixed relative to the housing 12 such that once installed in the housing 12, the drug storage container 23 will not move relative to the housing 12. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 16a of the delivery member 16 extends permanently through the opening 14 in the housing 12. In this embodiment, the container holder 31 fixes the position of the drug storage container 23 within the housing 12. The container holder 31 may have a hollow and generally cylindrical or tubular shape, and the drug storage container 23 may be partially or completely disposed within the container holder 31. The proximal end of the container holder 31 may include an inwardly projecting flange 31a that abuts against the neck of the drug storage container 23, thereby preventing the drug storage container 23 from moving proximally. The container holder 31 can be fixedly attached to the housing 12 such that movement of the container holder 31 relative to the housing 12 is prevented during operation of the drug delivery device 10.

[0038] In an alternative embodiment, 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.

[0039] 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 impact and push the plunger 25. Therefore, in some embodiments, the disc 68 may have damping characteristics to reduce any impact or vibration associated with the impact event.

[0040] The drug delivery device 10 may further include a protective mechanism for preventing contact with the insertion end 16a of the delivery member 16 when the drug delivery device 10 is not being used for injection. 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 31 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 31, but is prevented from rotating relative to the housing 12 and / or the container holder 31.

[0041] As shown in Figures 5 and 6, the shield 32 includes a stop 33a. The stop 33a is positioned along the length of the shield 32 and defines a recess or cavity portion that can extend around all or part of the outer surface of the shield. Further, in some examples, the shield 32 includes a snap fastener 33b. Like the stop 33a, in some examples, the snap fastener 33b is positioned along the length of the shield 32. The stop 33b defines a protrusion or ridge that can extend around all or part of the outer surface of the shield 32. When viewed in Figures 5 and 6, the snap fastener 33b may be in the form of a member having an angled distal surface and a generally horizontal proximal surface. In the examples shown, the snap fastener 33b is positioned adjacent to the stop 33a and is disposed proximal to the stop. Other arrangements or configurations are possible.

[0042] The distal and proximal ends of the shield 32 may respectively include an actuator portion 34 and a skin contact portion 36 (FIG. 3). In some embodiments, the stop 33a, the latch 33b, the actuator portion 34, and the skin contact portion 36 may be integrally formed to define a single integral structure. In other embodiments, the stop 33a, the latch 33b, the actuator portion 34, and the skin contact portion 36 may be physically separate structures that are firmly attached to each other so as to be immovable relative to each other and / or move together during movement. At least the skin contact portion 36 of the shield 32 may have a hollow and generally cylindrical or tubular shape, and in some embodiments may be centered on the longitudinal axis A of the drug delivery device 10.

[0043] Moving the shield 32 from the extended position to the retracted position can be achieved by pressing the skin contact portion 36 against the patient's skin at the injection site. In embodiments where the delivery member 16 protrudes from the opening 14 in the housing 12 before delivery or in the storage state, this movement allows the insertion end 16a of the delivery member 16 to be inserted into the patient's skin.

[0044] 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 on the shield 32 in a proximal direction. In some examples (e.g., Figures 1 to 2C), the protective biasing member 35 is in the form of a compression spring. In other examples (e.g., Figures 4 and 5), the protective biasing member 35 may be in the form of a torsion member or other type of spring. In any case, the user can overcome this biasing force by pressing the shield 32 against the injection site. When the injection is complete and the drug delivery device 10 is lifted 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 positioned in the axial direction between and in contact with 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 cause the protective bias member 35 to be compressed 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.

[0045] 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, wherein the drive assembly 30 stores 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.

[0046] 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 56. 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 56 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, and thus apply a biasing force to rotate the mechanical linkage 56. The mechanical linkage 56 may then convert the rotational motion into linear motion for driving the plunger 26 in a proximal direction. In some embodiments, the mechanical linkage 56 may convert the rotational motion from the rotational bias member 50 into linear motion for driving the plunger 26 in a proximal direction and rotational motion of the plunger 26 about the longitudinal axis A.

[0047] Alternative embodiments may utilize energy sources other than the rotary bias member. Some alternative embodiments 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 embodiments 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 connected 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 discharge the drug 24 therefrom. In embodiments 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 in a proximal direction to insert the insertion end 16a of the delivery member 16 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.

[0048] The mechanical linkage 56 may include a plunger guide 60 and a nut 62. The plunger guide 60 may be hollow and generally cylindrical or tubular in shape. In at least 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 splined 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. The nut 62 may have a generally annular shape and may be positioned around the proximal end of the plunger 26 in the pre-delivery state. The nut 62 may be securely mounted such that it is immovable relative to the rear housing 27. Furthermore, the nut 62 may have a threaded inner surface 64 that engages with the threaded outer surface 66 of the plunger 26. Due to this threaded engagement, rotation of the plunger 26 relative to the nut 62 can linearly drive the plunger 26 proximally. This, in turn, causes the plunger 26 to act on and push the stopper proximally, thereby discharging the drug 24 from the storage container 23 into the patient via the inserted delivery member 16.

[0049] The shield 32 can be configured to interact with the drive assembly 30 when the shield 32 moves from the extended position to the retracted position. This interaction can activate the drive assembly 30 to output the energy required to drive the plunger 26 to dispensing the drug 24 from the drug 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 the energized state, thereby allowing the rotational bias member 50 to be de-energized and drive the plunger 26 via the mechanical linkage 56 to dispensing the drug 24 from the drug 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 being pressed against the patient's skin, the actuator portion 34 of the shield 32 pushes the trigger ring 54 distally to the release position, where the trigger ring 54 disengages from the plunger guide 60. Therefore, the plunger guide 60 can 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.

[0050] In an alternative embodiment, the trigger ring 54 can be omitted, and when the shield 32 is in the extended position, the actuator portion 34 of the shield 32 can lockably engage the outer surface of the plunger guide 60 to prevent its rotation. Therefore, in such an embodiment, the shield 32 can hold the rotational biasing member 50 in an energized state. When the shield 32 moves from the extended position to the retracted position, the actuator portion 34 of the shield 32 can disengage from the plunger guide 60, thereby releasing the plunger guide 60 from rotating under the biasing force of the biasing member 50.

[0051] 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.

[0053] Having described the overall configuration and operation of the drug delivery device 10, it should be understood that the axial movement of the shield 32 toward the distal end 12b of the housing 12 serves to activate the drive assembly 30 to deliver the drug 24 via the injection assembly 15. However, it is possible that at some point during the pre-activation state, the user may inadvertently drop or push the drug delivery device 10 in such a way that when the cover 18 is engaged with the device 10, the cover may push the shield 32 toward the distal end 12b of the housing 12. As shown in Figures 4 and 5, in the pre-activation state, the cover 18 at least partially surrounds a portion of the shield 32 and is at least partially disposed within the proximal end 12a of the housing 12. More specifically, in this configuration, the cover 18 can be removably engaged with the housing 12 and / or the shield 32. In this pre-activation state, the latch 33b of the shield 32 is positioned within the opening 20 formed in the cover 18 to maintain the engagement of the cover 18 with the housing 12 and / or the shield 32. In this arrangement, in preparation for drug administration, the user will pull the cap 18 away from the device 10 in a proximal direction 12a, thereby disengaging the opening 20 from the latch 33b. Notably, in this arrangement, the ramp 13 of the housing 12 is positioned adjacent to the locking tab 19 formed on the cap 18.

[0054] Before the user decides to continue medication administration, the housing 12, cover 18, and shield 32 cooperate to form a braking mechanism that prevents the drive assembly 30 from being activated. More specifically, if the cover 18 is connected to the housing 12 and / or shield 32, the interconnection of these components prevents the shield 32 from axially moving in a distal direction. Referring to FIG6, in the event of an accidental drop and / or push of the device 10, inertial forces and / or contact forces can cause the cover 18 to move axially toward the distal end 12b of the housing 12. When such movement occurs, the locking tab 19 engages the ramp 13 and slides along the ramp, which advances the locking tab 19 radially toward the longitudinal axis A. This relative movement causes the locking tab 19 to engage the stop 33a and at least partially insert into the stop, thus limiting or preventing the shield 32 from further axially advancing toward the distal end 12b of the housing. In some examples, the locking tab 19 may additionally engage the eaves 13a, which may help to hold and position the locking tab 19 within the stop 32a.

[0055] After a period of time, the internal components will cease moving relative to each other, return to their default positions, and the cover 18 and locking tab 19 will disengage from the stop 33a of the shield 32, thereby allowing the device 10 to be used as needed (i.e., remaining in the pre-activation state and / or removing the cover 18 to transition to the delivery or administration state). Here,

[0056] The user can pull the removable cap 18 away from the housing 12 with a force sufficient to overcome the holding force between the opening 20 and the latch 33b. As a result of this movement, the gripper 21a can pull the sterile barrier 21 away from the drug storage container 23. 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 biasing member 35, causing the shield 32 to retract into the opening 14 and move distally from the extended position to the retracted position. Notably, when the cover 18 is removed from the device 10, a gap is formed between the ramp 13 formed on the housing 12 and the shield 32, such that the ramp 13 does not contact or otherwise engage the shield 32, thereby allowing relative movement between the ramp and the shield. The delivery member 16 remains stationary relative to the housing 12 during the retraction movement of the shield 32.

[0057] Retraction of the shield 32 can cause any number of actions to occur. Because 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. Retraction of the shield 32 can also activate the drive assembly 30. More specifically, retraction of the shield 32 can cause the actuator portion 34 to engage the trigger ring 54 distally to a release position, in which the trigger ring 54 disengages from the plunger guide 60, thereby activating the drive assembly 30 to deliver the drug 24 via the injection assembly 15.

[0058] In this configuration, the braking mechanism prevents the device from being accidentally activated in the event of a fall. If the cover 18 and the shield 32 travel too far into the device 10 in a distal direction, the angled ramp 13 inside the housing 12 pushes the locking tab 19 of the cover inward and clamps it onto the shield 32. This braking mechanism removes energy from the shield, allowing the device to return to its preset pre-activation state.

[0059] The above description describes various devices, components, parts, subsystems, and methods used in connection with a drug delivery device. 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 a lyophilized form. The following exemplary list of drugs should not be considered as all-encompassing or restrictive.

[0060] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or prefilled with the medication for treatment. The master container may be a vial, cartridge, or prefilled syringe.

[0061] 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).

[0062] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulator (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 (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® (epogen α), Aranesp® (dabepoetin α), Dynepo® (epogen δ), Mircera® (methoxy-polyethylene glycol-epogen β), Hematide®, MRK-2578, INS-22, Retacrit® (epogen ζ), Neorecormon® (epogen β), Silapo® (epogen ζ), Binocrit® (epogen α), epogen α Hexal, Abseamed® (epogen α), Ratioepo® (epogen θ), Eporatio® (epogen θ), Biopoin® (epogen θ), epogen α, epogen β, epogen ι, epogen ω, epogen δ, epogen ζ, epogen θ and epogen δ, pegylated erythropoietin, carbamolated erythropoietin, and their molecules or variants or analogues.

[0063] The specific illustrative proteins are the particular proteins described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (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, related proteins, etc., including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, related proteins, etc., especially those inhibiting the binding of IL-4 and / or myostatin-binding proteins. Or those that mediate activity mediated by the binding of IL-13 to its receptor; interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptides, related proteins, etc.; Ang2 specific antibodies, peptides, related proteins, etc.; NGF specific antibodies, peptides, related proteins, etc.; CD22 specific antibodies, peptides, related proteins, etc., 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-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 that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to those that bind to OX40L and / or OX40 receptors. Other ligand proteins; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin [30-aspartic acid, 32-threonine, 87-valine, 88-aspartic acid, 90-threonine], dabepoetin α, novel erythropoietin-stimulating protein (NESP); Epogen® (epogenin 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® (epogenin 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), an 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® (panitumumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand-based immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistamine), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)); Kineret® (anaspirin); Leukine® (saxaglastine, rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS) mAb); Metalyse® (tenectiplase, t-PA analog); Mircera® (methoxy-polyethylene glycol-eberthene beta); Mylotarg® (gem-tuzumab-ozomicin); Raptiva® (efalizumab); Cimzia® (sertozumab, CDP 870); Soliris™ (eculizumab); Peroxyzumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibuzumab); Panorex® (17-1A, ezolizumab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertozumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vesizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (ibertin beta); Neumega® (human interleukin-11); Orthoclone OKT3® (moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (ibertin α); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib).Roferon-A® (interferon α-2a); Simulect® (baliximab); Prexige® (romexicob); Synagis® (palizumab); 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507); Tysabri® (natezumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domain of the Fc portion of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory proteins)); VEGF trap (Ig domain of VEGFR1 fused to 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 (iplimumab, 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;Antiganglioside 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-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).

[0064] 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 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 molecule 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 mechanisms of cardiac contraction, 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 sotorasirb (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 a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy.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 comprise or be used with AMG 133, or another product comprising a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may comprise or be used with AMG 171, or another product comprising a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may comprise or be used with AMG 176, or another product comprising a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise or be used with AMG 199, or another product comprising 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 an anti-PD-1 x IL21 mutant protein and / or an 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 comprise or be used with AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with AMG 506, which is being investigated for the treatment of solid tumors, or another product comprising a multispecific FAP x 4-1BB-targeting DARPin® biologic. In some embodiments, the drug delivery device may comprise or be used with AMG 509 or another product comprising 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-life (HLE) CD19 x CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with 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-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, 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, 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, another product comprising, an extended-life (HLE) claudin 18.2 x CD3 BiTE® (bispecific T cell conjugate) construct.

[0065] 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 interpreted as exemplary only and does not describe every possible implementation of the present disclosure. Many alternative implementations may be implemented 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.

[0066] 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 regarded as being within the scope of the inventive concept. [Simplified Explanation of the Diagram]

[0012] The above-mentioned requirements are at least partially met by providing the impact-activated braking feature of the drug delivery device described in the following embodiments, particularly studied in conjunction with the accompanying drawings, wherein:

[0013] [Figure 1] is a perspective view of an exemplary drug delivery device according to various embodiments;

[0014] [Figure 2] shows a cross-sectional view of the exemplary drug delivery device of Figure 1 according to various embodiments;

[0015] [Figure 3A] shows a cross-sectional view of an exemplary rear sub-component of the exemplary drug delivery device of Figures 1 and 2 according to various embodiments;

[0016] [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;

[0017] [Figure 3C] shows a cross-sectional view of an exemplary front sub-component of an exemplary drug delivery device of Figures 1 to 3B according to various embodiments;

[0018] [Figure 4] shows a cross-sectional view of an example cover of an exemplary drug delivery device of Figures 1 to 3C according to various embodiments;

[0019] [Figure 5] shows a cross-sectional view of exemplary braking features of the exemplary drug delivery device of Figures 1 to 4 in a pre-start state according to various embodiments; and

[0020] [Figure 6] shows a cross-sectional view of an exemplary braking feature of the exemplary drug delivery device of Figures 1 to 5 in a braking state according to various embodiments.

[0021] 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. Moreover, commonly used but easily understood elements that are available or necessary in commercially viable embodiments are generally not drawn to facilitate viewing the 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, and 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 different specific meanings set forth herein. [Biomaterial Storage]

[0068] None

Claims

1. A drug delivery device, comprising: A housing having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends of the housing, and a ramp; An injection assembly, at least partially disposed within the housing at or near the proximal end of the housing, the injection assembly including a needle or cannula; a shield, slidably coupled to the housing, the shield being positionable in an extended position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance, the shield including a stop; a drive assembly, at least partially disposed within the housing and operatively coupled to the injection assembly and the shield, the drive assembly being engageable to deliver a drug via the injection assembly; and a cap, removably coupled to at least one of the shield or the housing, the cap including a locking tab; wherein the ramp is adapted to advance at least a portion of the locking tab into the stop, such that the cap, when coupled to the shield and / or the housing, restricts movement of the shield to limit the delivery of the drug via the injection assembly by the drive assembly.

2. The apparatus as described in claim 1, wherein, The shield can be further positioned in a retracted position, in which the proximal end of the housing protrudes beyond the proximal end of the shield by a certain distance, wherein moving the shield to the retracted position will engage the drive assembly to deliver the drug via the injection assembly.

3. The apparatus as described in claim 1, wherein, Positioning a portion of the locking tab within the stop will prevent the guard from moving to the retracted position.

4. The apparatus as described in claim 1, wherein, When the cover is removed from the shield and the housing, a gap is formed between the housing and the shield to allow relative movement between the housing and the shield.

5. The apparatus as described in any one of claims 1 to 4, wherein, The cover further includes snaps to secure the cover to the cover.

6. A drug delivery device, comprising: A housing having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends of the housing, and a ramp member formed at or near the proximal end 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 shield, slidably coupled to the housing, the shield including a stop disposed along the length of the shield and capable of being positioned in an extended position, in which at least the proximal end of the shield extends beyond the proximal end of the housing by a distance; a drive assembly, at least partially disposed within the housing and operatively coupled to the injection assembly and the shield, the drive assembly capable of engaging to deliver a drug via the injection assembly; and a cap, removably coupled to at least one of the shield or the housing, the cap including a locking tab formed on a portion of the cap; The housing, the shield, and the cover cooperate to form a braking mechanism. When the shield initially moves toward the retracted position, the ramp member of the housing advances the locking tab to engage with the stop of the shield, thereby limiting the shield from moving further toward the retracted position. This prevents the drive assembly from being activated and delivering the drug via the injection assembly when the shield moves toward the retracted position.

7. The apparatus as described in claim 6, wherein, When the cover is removed from the shield and the housing, a gap is formed between the housing and the shield to allow relative movement between the housing and the shield.

8. The apparatus as described in claim 6 or 7, wherein, The cover further includes snaps to secure the cover to the cover.

9. A drug delivery device having a braking mechanism, the drug delivery device comprising: A housing having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends of the housing, and a ramp member positioned at or near the proximal end; A shield, slidably coupled to the housing, movable between 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 including a stop disposed along the length of the shield; a cover, removably coupled to at least one of the shield or the housing, the cover including at least one locking tab; wherein, when the cover is coupled to at least one of the shield or the housing, as the shield moves toward the retracted position, a ramp member of the housing advances the at least one locking tab to engage with the stop of the shield to restrict the movement of the shield to the retracted position.

10. The drug delivery device as claimed in claim 9, wherein, When the cover is removed from the shield and the housing, a gap is formed between the ramp and the shield to allow relative movement between the ramp and the shield.

11. The drug delivery device as claimed in claim 9 or 10, further comprising a drive assembly and an injection assembly, wherein, Moving the shield to the retracted position will engage the drive assembly to deliver the drug via the injection assembly.

12. The drug delivery device as claimed in claim 9 or 10, wherein, The cover further includes snaps to secure the cover to the cover.

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