Impact-activated braking mechanism for drug delivery devices - Patents.com

Abstract

The 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 disposed at least partially within the housing at or near the proximal end, a shield slidably coupled to the housing, a drive assembly operably coupled to the injection assembly and the shield, and a cap. The injection assembly includes a needle or cannula. The shield is positionable in an extended position in which at least a proximal end of the shield extends a distance beyond the proximal end of the housing. The drive assembly is engageable to deliver a medicament via the injection assembly. The cap is removably coupled to at least one of the shield or the housing and adapted to limit movement of the shield when coupled to the shield and / or the housing such that the drive assembly is inhibited from delivering a medicament via the injection assembly.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 252,949, filed October 6, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to impact-activated braking mechanisms for drug delivery devices. [Background technology]

[0003] Drug delivery devices, such as injectors, are used to deliver liquid medication to a patient. When actuated, the drug delivery device expels a drug stored in an internal reservoir through a needle, cannula, or other delivery member into the patient. Some drug delivery devices, such as pen-type autoinjectors, may be positioned adjacent to the patient's skin to deliver the drug through an injection needle or other means over a period of time. The drug delivery device may be positioned near tissue in the patient's abdomen, thigh, arm, or other part of the patient's body.

[0004] Some devices may have drawbacks. In particular, users may be afraid of exposed injection needles or may feel essentially unable to perform an injection. Due to the aversion to exposed needles, as well as the health and safety issues that may be involved, various types of injectors and other devices have been developed to hide the needle from the user and automate the injection process to assist users in performing injections, ensure reliable delivery of medication, and ensure patient safety.

[0005] Typically, three operations may be performed when injecting a drug into a patient with a hypodermic syringe: 1) inserting the needle into the patient, 2) injecting the drug from the syringe into the patient, and 3) removing the needle after the injection is complete. Shield-activated devices generally use manual needle insertion techniques, whereby the user inserts the needle and initiates administration simultaneously through the action of retracting the shield relative to the rest of the device. In these devices, the needle may be inserted automatically upon manual activation of the device. Typically, button-activated devices use automated needle insertion mechanisms, whereby the needle is mechanically inserted and automatically delays release by the administration mechanism until the correct device state is achieved. Any or all of these devices may use manual and / or automatic removal mechanisms to retract the needle and typically rely on a spring or other power source to generate the force required to perform the operation. Occasionally, a user may carelessly handle or drop the device prior to use. In such a situation, if the device is dropped in a certain orientation, inertial forces may cause internal components to move relative to each other, which may result in inadvertent premature activation of the device. Such premature actuation may actually result in some or all of the desired medication being delivered to the user, which may be wasteful and potentially harmful to the user and / or others.

[0006] The present disclosure describes a drug delivery device that embodies an advantageous alternative to existing drug delivery devices and that may address one or more of the problems or needs set forth herein. Summary of the Invention [Means for solving the problem]

[0007] According to a first aspect, the 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 disposed at least partially within the housing at or near the proximal end, a shield slidably coupled to the housing, a drive assembly operably coupled to the injection assembly and the shield, and a cap. The injection assembly includes a needle or cannula. The shield is positionable in an extended position in which at least its proximal end extends a distance beyond the proximal end of the housing. The drive assembly is engageable to deliver a medicament via the injection assembly. The cap is removably coupled to at least one of the shield or the housing and adapted to limit movement of the shield when coupled to the shield and / or the housing such that the drive assembly is inhibited from delivering a medicament via the injection assembly.

[0008] In some examples, the shield may be further positionable in a retracted position in which the proximal end of the housing projects a distance beyond the proximal end of the shield, in such examples, moving the shield to the retracted position engages the drive assembly to deliver the medicament via the injection assembly.

[0009] In some approaches, the cap may include a locking tab and the shield may include a detent. At least a portion of the locking tab of the cap may be positionable within the detent. In such approaches, positioning a portion of the locking tab within the detent may prevent the shield from moving to the retracted position. Further, in these and other examples, the housing may include a ramp that biases the locking tab into the detent. In some examples, removal of the cap from the shield and housing forms a gap between the housing and the shield to allow relative movement between the housing and the shield.

[0010] In any of these examples, the shield may further include a snap for securing the cap to the shield.

[0011] 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 disposed at least partially within the housing at or near the proximal end, a shield slidably coupled to the housing, a drive assembly operably coupled to the injection assembly and the shield, and a cap. The injection assembly includes a needle or cannula. The shield is positionable in an extended position in which at least its proximal end extends a distance beyond the proximal end of the housing. The drive assembly is engageable to deliver a medicament via the injection assembly. The housing, shield, and cap cooperate to form a brake mechanism for preventing the drive assembly from being actuated to deliver a medicament via the injection assembly.

[0012] According to a third aspect, a drug delivery device having 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 near the proximal end and the proximal end, a shield slidably coupled to the housing, and a cap detachably coupled to at least one of the shield or the housing. The shield is movable between an extended position in which at least the proximal end of the shield extends a distance beyond the proximal end of the housing, and a retracted position in which the proximal end of the housing projects a distance beyond the proximal end of the shield. The shield further includes a detent disposed along its length. The cap can include at least one locking tab. When the cap 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 biases the at least one locking tab to engage the detent of the shield to inhibit the shield from moving to the retracted position.

[0013] The above needs are met, at least in part, by the provision of an impact-activated braking mechanism for a drug delivery device as described in the following detailed description, particularly when studied in conjunction with the drawings. [Brief description of the drawings]

[0014] [Figure 1] 1 illustrates a perspective view of an exemplary drug delivery device according to various embodiments. [Diagram 2] 2 illustrates a cross-sectional view of the exemplary drug delivery device of FIG. 1 in accordance with various embodiments. [Figure 3A] 3 shows a cross-sectional view of an exemplary rear subassembly of the exemplary drug delivery device of FIGS. 1 and 2 in accordance with various embodiments. FIG. [Figure 3B] 1-3A in accordance with various embodiments. FIG. [Figure 3C] 1A-3C show cross-sectional views of an exemplary front sub-assembly of the exemplary drug delivery device of FIGS. 1-3B according to various embodiments. [Figure 4] 1-3C according to various embodiments. FIG. [Diagram 5] 5 illustrates a cross-sectional view of the exemplary braking mechanism of the exemplary drug delivery device of FIGS. 1-4 in a pre-actuated state, according to various embodiments. FIG. [Figure 6] 6 shows a cross-sectional view of the exemplary braking mechanism of the exemplary drug delivery device of FIGS. 1-5 in a braking state, according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Those skilled in the art will appreciate that the elements in the figures are depicted for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to not overly distract from the illustrations of these various embodiments. Furthermore, it will be appreciated that certain acts and / or steps may be described or shown in a particular sequence of occurrence, although those skilled in the art will appreciate that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meanings, as set forth above, that would be given to such terms and expressions by those skilled in the art, unless a different specific meaning is explained herein.

[0016] Generally speaking, in accordance with these various embodiments, a drug delivery device is provided that prevents premature activation of the device both during and after an inadvertent drop. The drug delivery device provided herein incorporates a braking mechanism that holds the components used to activate the device when a drop-related force may occur. When a dropped device comes to a halt due to contact with a surface (e.g., floor, table, etc.), internal components typically move due to these inertial forces. However, the device components involved in the device's activation are prevented from moving to the same extent, and using this relative difference in movement, the braking mechanism may remove kinetic energy from the device. After impact, the internal components return to a predefined position and the device functions as intended.

[0017] Turning to the figures, a drug delivery device 10 is provided for delivering a drug, sometimes referred to herein as a medicament or pharmaceutical. The drug may be various biological substances, such as, but not limited to, a peptide, a peptibody, or an antibody. The drug may be in a fluid or liquid form, although the disclosure is not limited to a particular state. In certain liquid formulations, the drug may have a viscosity of 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 profile. Other examples are possible.

[0018] Various implementations and configurations of the drug delivery device 10 are possible. For example, although FIGS. 1-3C show a first exemplary device 10, the described braking mechanism features may be incorporated into any number of alternative delivery devices having different configurations. The drug delivery device 10 is in the form of a single-use disposable injector. In other embodiments, the drug delivery device 10 may be configured as a multiple-use reusable injector. The drug delivery device 10 is operable for self-administration by the patient or for administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). Furthermore, in the illustrated example, the drug delivery device 10 takes the form of an auto-injector or pen injector, and thus may be held in the user's hand for the duration of drug delivery or administration.

[0019] The configuration of the various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, although fewer or more states are possible. The pre-delivery state may correspond to the configuration of the drug delivery device 10 following assembly and prior to actuation by a user. In some embodiments, the pre-delivery state may exist at a time between when the drug delivery device 10 leaves the manufacturing facility and when the patient or user actuates the drive assembly of the drug delivery device 10. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery is in progress. It is recognized that during the transition from the pre-delivery and delivery states, the user removes the drug delivery device 10 from any secondary packaging and begins positioning the drug delivery device 10 relative to the injection site. The post-delivery state may correspond to the configuration of the drug delivery device 10 after completion of drug delivery and / or when the stopper is placed in an end-of-administration position in the drug reservoir. For purposes of this disclosure, only a portion of the pre-delivery and delivery states are described herein, as the braking mechanisms described herein function to maintain the drug delivery device 10 in the pre-delivery state in the event of an accidental and / or unintentional drop or contact.

[0020] The drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and dimensioned to allow a person to grasp the injector 10 with one hand. The housing 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 housing 12. The injection assembly 15 includes a delivery member 16 in the form of a needle or cannula. An opening 14 may be formed at the distal end to allow an insertion end 16a of the delivery member 16 to extend outside the housing 12 (i.e., beyond the length of the housing 12).

[0021] A transparent or translucent inspection window 17 may be positioned in the wall of the housing 12 to allow a user to view components within the drug delivery device 10, including the drug reservoir 23 (also part of the injection assembly 15). Viewing the drug reservoir 23 through the window 17 may allow a user to verify that drug delivery is in progress and / or completed. A removable cap 18 may cover the opening 14 prior to use of the drug delivery device 10 and may include a gripper 21a configured in some embodiments to aid in the removal of a sterility 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 frictionally or otherwise mechanically engage the sterility barrier 21 to pull the sterility barrier 21 along with the removable cap 18 when the user separates the removable cap 18 from the housing 12. Thus, removing the removable cap 18 has the effect of removing the sterility barrier 21 from the delivery member 16 .

[0022] As shown in Figures 3-5, cap 18 is in the form of a generally hollow member including any number of locking tabs 19 positioned at a distal end thereof. Additionally, cap 18, in some examples, includes openings 20 positioned adjacent locking tabs 19. Cap 18 may be removably coupled to housing 12 and / or shield 32, as described in more detail below. More specifically, in the illustrated example of Figures 4 and 5, a portion of cap 18 is insertable into opening 14 formed by housing 12.

[0023] With particular reference to Figures 4 and 5, the inner wall of the housing 12 includes any number of ramps 13 disposed at or near its proximal end 12a. In the illustrated example, the housing 12 includes two ramps 13 spaced apart on either side of the inner wall, although other arrangements are possible. The ramps 13 are in the form of tapered or angled protrusions that reduce the inner diameter of the inner wall as one progresses from the proximal end 12a of the housing 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 operably coupled to the housing 12 by any number of suitable techniques, such as, for example, adhesive, fusion, friction fit coupling, etc. Other examples are possible.

[0024] The housing 12 may have a hollow generally cylindrical or tubular 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 contained within the housing may be assembled together to define various subassemblies (e.g., a rear subassembly as shown in FIG. 2A and a front subassembly as shown in FIG. 2C). In some embodiments, the rear and front subassemblies are assembled independently of each other and then combined with each other and with the drug reservoir 23 to form the fully assembled drug delivery device 10. In certain such embodiments, some or all of the assembly steps described above may be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed in a single piece such that the housing 12 is defined by a single monolithic structure.

[0025] The drug storage container 23 is disposed within the interior space of the housing 12 and is configured to contain the drug 24. The drug storage container 23 may be pre-filled, for example, by a manufacturer and shipped to a location where the drug storage container 23 is assembled with the remainder of the drug delivery device 10. The housing 12 may be pre-loaded with the drug storage container 23, for example, by a manufacturer, or loaded with the drug storage container 23 by a user prior to use of the drug delivery device 10. The drug storage container 23 may include a rigid wall defining an interior bore or reservoir. The wall may be made of glass or plastic. The stopper 25 may be movably disposed within the drug storage container 23 such that it may move axially along the longitudinal axis A between the distal and proximal ends of the drug storage container 23. The stopper 25 may be made of rubber or any other suitable material. The stopper 25 may slidably and sealingly contact an inner surface of the wall of the drug storage container 23 to prevent or inhibit leakage of the drug 24 past the stopper 25 when the stopper 25 is moving. Proximal movement of the stopper 25 expels the drug 24 from the reservoir of the drug storage container 23 into the delivery member 16 .

[0026] The distal end of the drug reservoir 23 may be open to allow the plunger 26 to extend into the drug reservoir 23 and push the stopper 25 proximally. In this embodiment, the plunger 26 and the stopper 25 are initially spaced apart from one another by a gap. Upon actuation 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 in the proximal direction. In an alternative embodiment, the stopper 25 and the plunger 26 may be coupled to one another, for example, via a threaded coupling, such that they move in unison from the start of the movement of the plunger 26. Once moved, the stopper 25 may continue to move proximally until it contacts a distally facing portion of the inner surface of the wall of the drug reservoir 23. This position of the stopper 25 may be referred to as an end-of-dose position and may correspond to when delivery of the drug 24 to the patient is complete or substantially complete.

[0027] 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 defines an insertion end 16a of the delivery member 16. The insertion end 16a may include a sharp tip of other pointed shape to enable the insertion end 16a to pierce the skin and subcutaneous tissue of the patient during insertion of the delivery member 16. The delivery member 16 may be hollow and have an internal passageway. One or more openings may be formed in the insertion end 16a to allow the drug to flow out of the delivery member 16 and into the patient.

[0028] In this embodiment, the drug reservoir 23 is a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. Here, the needle is fixed against the wall of the drug reservoir 23 and is in permanent fluid communication with the reservoir of the drug reservoir 23. In other embodiments, the drug reservoir 23 may be a needleless cartridge and thus may not initially be in fluid communication with the delivery member 16. In such embodiments, the drug reservoir 23 may move towards the distal end of the delivery member 16 or vice versa during operation of the drug delivery device 10 such that the distal end of the delivery member 16 penetrates a septum covering the opening of the drug reservoir 23, thereby establishing fluid communication with the reservoir of the drug reservoir 23.

[0029] The drug storage container 23 may be fixed relative to the housing 12 so that it does not move relative to the housing 12 once the drug storage container 23 is installed therein. Thus, the insertion end 16a of the delivery member 16 permanently extends through the opening 14 of the housing 12 in pre-delivery, delivery, and post-delivery states. 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, generally cylindrical or tubular shape, and the drug storage container 23 may be partially or entirely 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 proximal movement of the drug storage container 23. The container holder 31 may be fixedly attached to the housing 12 so that the container holder 31 is prevented from moving relative to the housing 12 during operation of the drug delivery device 10.

[0030] In alternative embodiments, the drug reservoir 23 may be movably coupled to the housing 12 such that the drug reservoir 23 is capable of moving relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 16a of the delivery member 16 may be retracted inside the opening 14 of the housing 12 in a pre-delivery state. Then, during operation of the injection device 10, the insertion end 16a of the delivery member 16 may be deployed through the opening 14 of the housing 12 for insertion into a patient. This movement may be the result of the drug reservoir 23 being driven proximally relative to the housing 12 in some embodiments.

[0031] Plunger 26 may be constructed of multiple interconnected parts, or alternatively, may have a one-piece configuration. In this embodiment, plunger 26 includes a rod 65 having a threaded outer surface 66 and a washer or disk 68 rigidly attached to the proximal end of rod 65. Disk 68 may impact and push against stopper 25 when drive assembly 30 is actuated. Thus, in some embodiments, disk 68 may have dampening properties that dampen any shock or vibration associated with an impact event.

[0032] The drug delivery device 10 may further include a guard mechanism to prevent contact with the insertion end 16a of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a shield 32 movably disposed at the proximal end 12a of the housing 12 adjacent the opening 14. The shield 32 may have a hollow generally cylindrical or tubular shape. The shield 32 may have a distal end housed within the housing 12 and may be configured to move relative to the housing 12 between an extended position in which the proximal end of the shield 32 extends through the opening 14 of the housing 12 and a retracted position in which the proximal end of the shield 32 is fully or partially retracted into the opening 14 of 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, the insertion end 16a of the delivery member 16 may be exposed by moving the shield 32 toward the retracted position. Further, in some embodiments, the shield 32 may be coupled to the housing 12 and / or container holder 31, for example, via a pin and slot arrangement, such that the shield 32 can move in a linear direction relative to the housing 12 and / or container holder 31, but is prevented from rotating relative to the housing 12 and / or container holder 31.

[0033] As shown in FIGS. 5 and 6, the shield 32 includes a detent 33a. The detent 33a is positioned along the length of the shield 32 and defines a groove or cavity that may extend around all or a portion of its outer surface. Additionally, in some examples, the shield 32 includes a snap 33b. Similar to the detent 33a, in some examples, the snap 33b is positioned along the length of the shield 32. The detent 33b defines a protrusion or ridge that may extend around all or a portion of the outer surface of the shield 32. The snap 33b may be in the form of a member having an angled distal surface and a generally horizontal proximal surface, as shown in FIGS. 5 and 6. In the illustrated example, the snap 33b is positioned adjacent to the detent 33a while being disposed proximally relative to the detent 33a. Other arrangements or configurations are possible.

[0034] The distal and proximal ends of the shield 32 may each include an activator portion 34 and a skin-contacting portion 36 (FIG. 3). In some embodiments, the detents 33a, snaps 33b, activator portion 34, and skin-contacting portion 36 may be integrally formed to define a single monolithic structure. In other embodiments, the detents 33a, snaps 33b, activator portion 34, and skin-contacting portion 36 may be physically separate structures fixedly attached to one another to prevent movement with respect to one another and / or to move in unison when moved. At least the skin-contacting portion 36 of the shield 32 may have a hollow, generally cylindrical or tubular shape and, in some embodiments, may be centered about the longitudinal axis A of the drug delivery device 10.

[0035] Movement of the shield 32 from the extended position to the retracted position may be accomplished by pressing the skin contacting portion 36 against the patient's skin at the injection site. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 pre-delivery or in the storage state, this movement may result in insertion of the insertion end 16a of the delivery member 16 into the patient's skin.

[0036] The guard mechanism may further include a guard biasing member 35. The guard biasing member 35 may bias or urge the guard 32 toward the extended position by exerting a proximal biasing force on the shield 32. In some examples (e.g., FIGS. 1-2C), the guard biasing member 35 is in the form of a compression spring. In other examples (e.g., FIGS. 4 and 5), the guard biasing member 35 may be in the form of a torsion spring or other form of spring. In either case, the user may overcome this biasing force by pressing the shield 32 against the injection site. Once the injection is completed and the drug delivery device 10 is moved away from the injection site, the guard biasing member 35 may return the shield 32 to the extended position, thereby covering the insertion end 16a of the delivery member 16. In some embodiments, the guard biasing member 35 may be axially positioned between and in contact with both the distally facing inner surface of the shield 32 and the proximally facing inner or outer surface of the stop 40. In embodiments in which the shield 32 is a compression spring, movement of the shield 32 in the distal direction may cause the guard bias member 35 to compress between the shield 32 and the lock 40. In some embodiments, the guard bias member 35 may be partially compressed prior to retraction of the shield 32, thereby exerting a biasing force against both the shield 32 and the lock 40 in the pre-delivery state.

[0037] As previously mentioned, the drug delivery device 10 may further include a drive assembly 30 disposed partially or completely within the housing 12. Generally, the drive assembly 30 may be configured to store energy and, upon or in response to actuation of the drive assembly 30 by a user, release or output the energy to drive the injection assembly 15 (i.e., the delivery member 16, the drug reservoir 23, the stopper 25, and the plunger 26) to expel the drug 24 from the drug reservoir 23 through the delivery member 16 to the patient. In this example, the drive assembly 30 is configured to store mechanical potential energy, but alternative embodiments of the drive assembly 30 may be configured differently, for example, the drive assembly 30 stores electrical or chemical potential energy. Upon actuation of the drive assembly 30, the drive assembly 30 may convert the potential energy into kinetic energy for moving the plunger 26.

[0038] Generally, the drive assembly 30 may include a rotary biasing member 50, a rotary biasing member housing 52, a triggering ring 54, and a mechanical linkage 56. The rotary biasing member 50 may be a torsion spring (e.g., a spiral torsion spring, a helical torsion spring, etc.) that is initially held in a biased state. In the biased state, the rotary biasing member 50 may be twisted or wound and held in the twisted or wound configuration by the triggering ring 54 via the mechanical linkage 56. When released, the rotary biasing member 50 will attempt to return to its natural length or shape, resulting in a biasing force that rotates the mechanical linkage 56. Furthermore, the mechanical linkage 56 may convert the rotational motion into linear motion to drive the plunger 26 in a proximal direction. In some embodiments, the mechanical linkage 56 may convert rotational motion from the rotary biasing member 50 into linear motion to drive the plunger 26 proximally and into rotational motion of the plunger 26 about the longitudinal axis A.

[0039] Alternative embodiments may utilize a different energy source than a rotary biasing member. Certain alternative embodiments may utilize, for example, a linear biasing member (e.g., a helical compression spring, a helical extension spring, etc.) that outputs a force in the direction of movement of the plunger 26 when released. In addition to or instead of a biasing member, other embodiments may include any one or combination of an electromechanical arrangement including an electric motor and / or solenoid coupled to the plunger 26 and a drive train or transmission, or an arrangement that produces or releases a pressurized gas or fluid that propels the plunger 26 or acts directly on the stopper 25 to move the stopper 25 through the drug reservoir 23 and expel the drug 24 therefrom. In embodiments in which the drug reservoir 23 and / or the delivery member 16 are movable relative to the housing 12, the drive assembly 30 may drive the drug reservoir 23 and / or the delivery member 16 in a proximal direction upon actuation such that the insertion end 16a of the delivery member 16 is inserted into the patient. Thus, in certain embodiments, the drive assembly 30 may provide the driving force necessary to both insert the delivery member 16 into the patient and expel the drug 24 from the drug reservoir 23 .

[0040] The mechanical linkage 56 may include a plunger guide 60 and a nut 62. The plunger guide 60 may have a hollow generally cylindrical or tubular shape. The proximal end of the plunger 26 may be disposed within the plunger guide 60 at least in the pre-delivery state. The distal extension of the plunger guide 60 may extend through a center of the rotary biasing member 50 and may be coupled to the rotary biasing member 50 such that the plunger guide 60 rotates in concert with the rotary biasing member 50 when the rotary biasing member 50 is released. The inner surface of the plunger guide 60 is coupled to the outer surface of the plunger 26 to permit axial movement of the plunger 26 relative to the plunger guide 60 while the plunger 26 rotates in concert with the plunger guide 60 when the rotary biasing member 50 is released. The coupling between the plunger guide 60 and the plunger 26 may be achieved, for example, via a spline mechanism, with a longitudinal protrusion on one of the inner surface of the plunger guide 60 or the outer surface of the plunger 26 being 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 disposed around the proximal end of the plunger 26 in the pre-delivery state. The nut 62 may be fixedly mounted such that the nut 62 does not move 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. As a result of this threaded engagement, rotation of the plunger 26 relative to the nut 62 may linearly drive the plunger 26 in the proximal direction. This, in turn, causes the plunger 26 to act on and push the stopper in the proximal direction to expel the drug 24 from the reservoir 23 to the patient via the inserted delivery member 16.

[0041] The shield 32 may be configured to interact with the drive assembly 30 when the shield 32 moves from the extended position to the retracted position. This interaction may actuate the drive assembly 30 to output the energy required to drive the plunger 26 to expel the drug 24 from the drug reservoir 23 and / or 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 rotary biasing member 50 from the biased state, thereby allowing the rotary biasing member 50 to de-energize and drive the plunger 26 via the mechanical linkage 56 to expel the drug 24 from the drug reservoir 23. More specifically, in the pre-delivery state, the trigger ring 54 may be disposed in an initial position where it engages with an outer surface of the plunger guide 60, thereby preventing the plunger guide 60 from rotating under the biasing force of the rotary biasing member 50. As a result, the rotary biasing member 50 is prevented from de-energizing. When the shield 32 moves from the extended position to the retracted position as a result of being pressed against the patient's skin, the activator portion 34 of the shield 32 pushes the trigger ring 54 distally to a release position where the trigger ring 54 disengages from the plunger guide 60. As a result, the plunger guide 60 can rotate under the biasing force of the rotary biasing member 50 and drive the plunger 26 proximally due to the threaded connection between the plunger 26 and the nut 62.

[0042] In alternative embodiments, the trigger ring 54 may be omitted, and the activator portion 34 of the shield 32 may lockingly engage an outer surface of the plunger guide 60 when the shield 32 is in the extended position to prevent it from rotating. Thus, the shield 32 may retain the rotatable biasing member 50 in a biased state in such an embodiment. When the shield 32 moves from the extended position to the retracted position, the activator portion 34 of the shield 32 may disengage from the plunger guide 60, thereby releasing the plunger guide 60 to rotate under the biasing force of the biasing member 50.

[0043] The rotary biasing member housing 52 may be disposed within and rigidly attached to the housing 12. The rotary biasing member housing 52 may have a hollow generally cylindrical or tubular shape and may fully or partially house the rotary biasing member 50 such that the rotary biasing member housing 52 surrounds or partially surrounds the rotary biasing member 50. The rotary biasing member housing 52 may act as a support or seat for pushing the rotary biasing member 50 out when released.

[0044] Having described the general configuration and operation of the drug delivery device 10, it is recognized that axial movement of the shield 32 toward the distal end 12b of the housing 12 may function to actuate the drive assembly 30 to deliver the drug 24 via the injection assembly 15. However, occasionally, at some point during the pre-actuated state, the user may inadvertently drop or push the drug delivery device 10 such that the cap 18, when coupled with the device 10, may urge the shield 32 toward the distal end 12b of the housing 12. As shown in FIGS. 4 and 5, in the pre-actuated state, the cap 18 is at least partially disposed within the proximal end 12a of the housing 12 while at least partially surrounding a portion of the shield 32. More specifically, in this configuration, the cap 18 may be releasably coupled with the housing 12 and / or the shield 32. In this pre-actuated state, the snaps 33b of the shield 32 are positioned within the openings 20 formed in the cap 18 to maintain the coupling of the cap 18 with the housing 12 and / or the shield 32. In this arrangement, to prepare for drug administration, the user pulls cap 18 in proximal direction 12a, away from device 10, disengaging opening 20 from snap 33b. Notably, in this arrangement, angled portion 13 of housing 12 is positioned adjacent locking tab 19 formed on cap 18.

[0045] The housing 12, cap 18, and shield 32 cooperate to form a damping mechanism that prevents the drive assembly 30 from being actuated before the user decides to begin drug administration. More specifically, when the cap 18 is coupled to the housing 12 and / or shield 32, the interconnection of these components prevents the shield 32 from moving axially in a distal direction. With reference to FIG. 6, in the event of an accidental dropping and / or jostling of the device 10, inertial and / or contact forces may cause the cap 18 to move axially toward the distal end 12b of the housing 12. When such movement occurs, the locking tabs 19 engage and slide along the ramps 13, urging the locking tabs 19 radially inward toward the longitudinal axis A. This relative movement causes the locking tabs 19 to engage and at least partially insert into the detents 33a, such that the locking tabs 19 inhibit or prevent the shield 32 from further axial advancement toward the distal end 12b of the housing. In some examples, the locking tab 19 may additionally engage a ledge 13a that may help retain and position the locking tab 19 within the detent 32a.

[0046] After a period of time, the internal components stop moving relative to one another and return to their default positions, and the cap 18 and locking tab 19 disengage from the detents 33a of the shield 32, thereby allowing the device 10 to be used as desired (i.e., remain in the pre-activation state and / or remove the cap 18 to transition to a delivery or administration state).

[0047] The user may pull and remove the removable cap 18 from the housing 12 with sufficient force to overcome the retention force between the opening 20 and the snap 33b. As a result of this movement, the gripper 21a may pull and remove the sterility barrier 21 from the drug reservoir 23. This may expose the insertion end 16a of the delivery member 16, which nevertheless remains surrounded by the shield 32 at this stage. The user may position the skin contacting portion 36 of the shield 32 over the desired injection site and then press the skin contacting portion 36 against the injection site. The force applied by the user will overcome the biasing force of the guard biasing member 35, causing the shield 32 to move distally from the extended position to the retracted position and retract into the opening 14. In particular, when cap 18 is removed from device 10, a gap is formed between ramp 13 formed on housing 12 and shield 32 such that ramp 13 does not contact or otherwise engage shield 32, thereby allowing relative movement between ramp 13 and shield 32. Delivery member 16 remains stationary relative to housing 12 during retraction movement of shield 32.

[0048] Retraction of the shield 32 may result in any number of actions. 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 may be caused to protrude through an opening in the skin contacting 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 may also actuate the drive assembly 30. More specifically, retraction of the shield 32 may cause the activator portion 34 to distally engage the trigger ring 54 to a release position where the trigger ring 54 disengages from the plunger guide 60, thereby actuating the drive assembly 30 to deliver the medication 24 via the injection assembly 15.

[0049] So configured, the damping mechanism serves to prevent inadvertent activation of the device if it is dropped. The inner angled ramp 13 of the housing 12 biases the cap's locking tabs 19 inwardly and clamps onto the shield 32 if the cap 18 and shield 32 are driven too far distally into the device 10. Such a damping mechanism removes energy from the shield, allowing the device to return to its default pre-activated state.

[0050] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. The term drug, as used herein, may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. The drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0051] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is either filled or pre-filled for the treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0052] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0053] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin, and variants, analogs, or derivatives thereof, which bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0054] Among the specific exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and proteins that specifically bind to the receptors for IL-4 and / or IL-13. interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., particularly dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, For example, human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, specifically including but not limited to, human CD22-specific IgG antibodies, such as the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 anti B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (also referred to as "B7RP-1" and B7H2, ICOSL, B7h, and CD275), including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, which inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins and the like, particularly humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, e.g., 145c7;IFN gamma specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as antibodies; TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; Activin A specific antibodies, peptibodies, proteins, etc.; TGF-beta specific antibodies, peptibodies, related proteins, etc.; Amyloid-beta protein specific antibodies, peptibodies, related proteins, etc.; including, but not limited to, proteins that bind c-Kit and / or other stem cell factor receptors. c-Kit specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, a new erythropoiesis-stimulating protein Protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered trademark (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388; anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3; mAb (HuMax-ZP3).

[0055] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, including but not limited to romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used with, an endogenous tissue inhibitor of metalloproteinases (TIMP), including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain, or be used with, Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to erenumab, and bispecific antibody molecules targeting the human CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as but not limited to apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, or another product containing a small molecule selective cardiac myosin activator that directly targets the contractile machinery of the heart. In some embodiments, the drug delivery device may contain or be used with sotorasibe (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor.In some embodiments, the drug delivery device may contain or be used with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that includes the human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199, or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506, or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device comprises AMG 562, or a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell). In some embodiments, the drug delivery device may contain or be used with another product containing an anti-CD33×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing ephavalukin alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 596, or a CD3×epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673, or a half-life extended (HLE) anti-CD33×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0056] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to the exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe all possible embodiments of the present disclosure. Various alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0057] Those skilled in the art will understand that various modifications, changes and combinations can be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and that such modifications, changes and combinations are to be construed as falling within the scope of the concept of the present invention.

Claims

1. 1. A drug delivery device comprising: a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end; an injection assembly disposed at least partially within the housing at or near the proximal end thereof, 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 a proximal end of the shield extends a distance beyond the proximal end of the housing; a drive assembly disposed at least partially within the housing and operably coupled with the injection assembly and the shield, the drive assembly engageable to deliver a medicament through the injection assembly; a cap detachably coupled to at least one of the shield or the housing; Including, the cap is adapted to limit movement of the shield when coupled with the shield and / or the housing such that the drive assembly is inhibited from delivering the medicament through the injection assembly. Drug delivery devices.

2. 10. The device of claim 1, wherein the shield is further positionable in a retracted position in which the proximal end of the housing protrudes a distance beyond the proximal end of the shield, and wherein moving the shield to the retracted position engages the drive assembly to deliver the medication through the injection assembly.

3. The device of claim 1 or 2, wherein the cap includes a locking tab and the shield includes a detent, and at least a portion of the locking tab of the cap is adapted to be positionable within the detent of the shield.

4. The device of claim 3 , wherein the shield is prevented from moving to the retracted position by positioning the portion of the locking tab within the detent.

5. The device of claim 3 , wherein the housing includes a ramp adapted to bias the locking tab into the detent.

6. The device of claim 5 , wherein removal of the cap from the shield and the housing forms a gap between the housing and the shield to allow relative movement between the housing and the shield.

7. The device of claim 1 or 2, wherein the shield further comprises a snap for securing the cap to the shield.

8. 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; an injection assembly disposed at least partially within the housing at or near the proximal end thereof, 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 a proximal end of the shield extends a distance beyond the proximal end of the housing; a drive assembly disposed at least partially within the housing and operably coupled with the injection assembly and the shield, the drive assembly engageable to deliver a medicament through the injection assembly; a cap detachably coupled to at least one of the shield or the housing; Including, the housing, the shield, and the cap cooperate to form a braking mechanism for preventing the drive assembly from actuating to deliver the medication through the injection assembly. Drug delivery devices.

9. The braking mechanism is a ramp member formed at or near the proximal end of the housing; detents disposed along the length of the shield; a locking tab formed on a portion of the cap; Including, when the cap is coupled with at least one of the shield or the housing, as the shield moves toward the retracted position, the ramped member of the housing biases the at least one locking tab into engagement with the detent of the shield to inhibit the shield from moving to the retracted position. The drug delivery device of claim 8.

10. 10. The device of claim 9, wherein removal of the cap from the shield and the housing forms a gap between the housing and the shield to allow relative movement between the housing and the shield.

11. The device of any one of claims 8 to 10, wherein the shield further comprises a snap for securing the cap to the shield.

12. 1. 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 end and the distal end, and a ramp member positioned at or near the proximal end; a shield slidably coupled to the housing, the shield being movable between an extended position in which at least a proximal end of the shield extends a distance beyond the proximal end of the housing and a retracted position in which the proximal end of the housing projects a distance beyond the proximal end of the shield, the shield including detents disposed along a length of the shield; a cap removably coupled to at least one of the shield or the housing, the cap including at least one locking tab; Including, when the cap is coupled with at least one of the shield or the housing, as the shield moves toward the retracted position, the ramped member of the housing biases the at least one locking tab into engagement with the detent of the shield to inhibit the shield from moving to the retracted position. Drug delivery devices.

13. 13. The drug delivery device of claim 12, wherein when the cap 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.

14. 14. The drug delivery device of claim 12 or 13, further comprising a drive assembly and an injection assembly, wherein moving the shield to the retracted position engages the drive assembly to deliver a medication through the injection assembly.

15. 14. The drug delivery device of claim 12 or 13, wherein the shield further comprises a snap for securing the cap to the shield.

Images