Drug delivery device and method of delivering a drug

Abstract

The drug delivery device and method of using the same may include a housing having an opening and a drug reservoir including a delivery member having an insertion end configured to extend at least partially through the opening. The drug reservoir may be coupled to the housing, such as to substantially prevent relative motion between the drug reservoir and the housing. A guard may be disposed adjacent to the opening and operatively coupled to the plunger biasing member such that relative motion between the guard and the housing enables release of the plunger biasing member, urging the plunger to expel the drug from the drug reservoir. The locking component may be configured to prevent relative motion between the guard and the housing until the locking component is released by a user force. The user force then drives the housing and drug reservoir toward the injection site.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 908,504, entitled "Drug Delivery Device", filed on September 30, 2019; U.S. Provisional Patent Application No. 62 / 960,996, entitled "Drug Delivery Device and Methods of Delivering a Drug", filed on January 14, 2020; and U.S. Provisional Patent Application No. 62 / 962,042, entitled "Drug Delivery Device and Methods of Delivering a Drug", filed on January 16, 2020, each of which is hereby incorporated by reference herein.

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

Background Art

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

[0004] A drug delivery device can incorporate various mechanisms for implementing various automation features. Such features include, among others, automatically covering the needle in the pre-delivery and / or post-delivery state, automatically inserting the needle and / or cannula into the user, automatically activating the drive mechanism, and automatically indicating to the user that drug delivery has been completed. Typically, a drug delivery device incorporates separate or individually operable mechanisms to implement each of its automation features. As a result, with each additional feature, the mechanical complexity of the device tends to increase. This can further increase the size of the device, which can make it cumbersome for the user to handle, as well as increase the manufacturing cost and time frame. As the demand for drug delivery devices with improved ease of use and safety grows, finding ways to incorporate more automation features without adding excessive complexity to the drug delivery device presents various design and manufacturing challenges.

[0005] The present disclosure describes a drug delivery device that embodies advantageous alternatives to existing drug delivery devices and can address one or more of the problems or needs described herein. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEMS

[0006] One aspect of the present disclosure provides a drug delivery device including a drug storage container defining a longitudinal axis and having a housing with an opening, and a delivery member having an insertion end configured to extend at least partially through the opening, the drug storage container being coupled to the housing to substantially prevent relative movement between the drug storage container and the housing. The device may further include a plunger movable distally relative to the drug storage container to expel drug from the drug storage container through the delivery member, and a plunger biasing member configured to push the plunger distally. The device may also include a guard disposed adjacent the opening of the housing, the guard being operatively coupled to the plunger biasing member such that relative movement between the guard and the housing along the longitudinal axis allows release of the plunger biasing member. The device may further include a locking component configured to prevent relative movement between the guard and the housing until the locking component is released by a user force. The resistance by the locking component allows the user to increase the user force, and upon release of the locking component, the housing and the drug storage container may be driven toward the injection site by the user force. In at least some embodiments, release of the locking component may allow the housing and the drug storage container to be driven toward the injection site by utilizing inertial forces due to the user force.

[0007] The locking component may include a lock ring rotatable relative to the housing about the longitudinal axis. The lock ring may have a first position in which the lock ring prevents relative movement between the guard and the housing, and a second position in which the lock ring does not prevent relative movement between the guard and the housing. Additionally or alternatively, the lock ring may include a lock arm having a base portion and a deflectable end, deflection of the deflectable end allowing the lock ring to rotate between the first position and the second position. The lock arm may also include a lock ridge.

[0008] The guard may include inertia ribs, which are configured to engage with the locking ring and prevent rotational movement of the locking ring relative to the housing. The guard may further include inertia ribs, which are configured to engage with the deflectable end of the locking arm and prevent movement of the locking ring from a first position to a second position. The guard may include cam ribs, which are configured to engage with the cam surface of the locking ring and push the locking ring towards the second position.

[0009] The locking ring may include a cam surface configured to engage with the guard and push the locking ring towards a third position. The locking ring may also include stop ridges configured to selectively engage with the guard and restrict or prevent relative movement between the guard and the locking ring along the longitudinal axis when the locking ring is in the third position.

[0010] The guard may include a proximal opposing cam surface, and the housing may include a distal opposing cam surface. The locking ring may include a distal opposing cam surface and a proximal opposing cam surface, which are configured to engage with the proximal opposing cam surface of the guard and the distal opposing cam surface of the housing, respectively, when the locking ring is in the first position, and prevent proximal movement of the guard. During proximal movement of the guard, one or more of the proximal opposing cam surface of the guard and the distal opposing cam surface of the housing may be able to rotate the locking ring from the first position towards the second position. When the locking ring rotates to the second position, the distal opposing cam surface of the locking ring may be configured to disengage from the proximal opposing cam surface of the guard.

[0011] The locking ring may include radially outwardly extending protrusions, which may include a distal opposing cam surface. The guard may include radially inwardly extending protrusions, which may include a first proximal opposing cam surface.

[0012] Hereinafter, any two or a combination of, namely, the proximal opposing cam surface of the guard, the distal opposing cam surface of the housing, the distal opposing cam surface of the lock ring, and the proximal opposing cam surface of the lock ring, are parallel to each other.

[0013] Another aspect of the present disclosure provides a drug delivery device including a drug storage container defining a longitudinal axis and having a housing with an opening, and a delivery member having an insertion end configured to extend at least partially through the opening, the drug storage container being coupled to the housing to substantially prevent relative movement between the drug storage container and the housing. The device may further include a plunger movable distally relative to the drug storage container for discharging the drug from the drug storage container through the delivery member, and a plunger biasing member configured to push the plunger distally. The device may also include a guard disposed adjacent the opening such that the housing has a first position relative to the guard where the plunger biasing member is locked and a second position relative to the guard where the plunger biasing member is unlocked. The device may further include a locking component configured to maintain the housing in the first position until the locking component is released by a user's force. The user may increase the user's force due to the resistance of the locking component, and when the locking component is released, the housing and the drug storage container may be driven toward the injection site by the user's force. In at least some embodiments, the release of the locking component may enable the use of the inertial force by the user's force to drive the housing and the drug storage container toward the injection site.

[0014] Another aspect of the present disclosure is a method of delivering a drug to a user, the method comprising providing a drug delivery device including a housing, a drug reservoir coupled to the housing and having a delivery member and configured to substantially prevent relative movement between the housing and the drug reservoir, a plunger movable relative to the drug reservoir for expelling the drug from the drug reservoir through the delivery member, a plunger biasing member configured to push the plunger in a distal direction, a guard coupled to the housing, and a locking component configured to prevent relative movement between the guard and the housing. Another step may include positioning the drug delivery device in contact with the user such that the guard surrounds the injection site of the user. Yet another step may include applying to the housing, toward the injection site, a user force sufficient to overcome the resistance of the locking component, enabling relative movement between the housing and the guard, thereby driving the housing and the drug reservoir toward the injection site. In at least some embodiments, overcoming the resistance of the locking component enables driving the housing and the drug reservoir toward the injection site by utilizing inertial forces due to the user's force.

[0015] The present disclosure is considered to be more fully understood by interpreting the following description in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, except as specifically described in the corresponding written specification. Further, the drawings are not necessarily drawn to scale.

Brief Description of the Drawings

[0016]

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[0017] The present disclosure generally relates to a drug delivery device operable for a user to administer a drug or, if the patient is the user, for self - administration of the drug. Among other features, various features are disclosed such as automatically covering the needle in a pre - delivery and / or post - delivery state, automatically inserting the needle and / or cannula into the user, automatically activating a drive mechanism, and automatically indicating to the user that drug delivery has been completed. Known drug delivery devices incorporate separate or individually operable mechanisms to achieve each of their automation features, whereas the present disclosure includes eliminating and / or combining at least some of these features. For example, the present disclosure includes not only a fixed or substantially fixed relationship between a housing and a drug storage container, but also a locking component that is released by the user's force, thereby preventing relative movement between a guard and the housing until, for example, the housing and the drug storage container are driven towards the injection site by utilizing inertial forces due to the user's force. As a result, the delivery device does not require or include a separate component for automatically inserting the needle and / or cannula into the user, thereby reducing the mechanical complexity, durability, and / or cost of the device. These and other advantages will be apparent to those skilled in the art upon consideration of the present disclosure.

[0018] Figures 1 - 3 show some views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or a drug product. The drug may be various biological agents such as peptides, peptibodies, or antibodies, but is not limited thereto. The drug may be in a fluid or liquid form, but the present disclosure is not limited to a particular state.

[0019] A variety of embodiments and configurations of the drug delivery device 10 are possible. This embodiment of the drug delivery device 10 is configured as a single-use disposable injector. In other embodiments, the drug delivery device 10 may be configured as a reusable injector for multiple uses. The drug delivery device 10 is operable for self-administration by a patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a physician or a nurse). The exemplary drug delivery device shown in the figures can take the form of an auto-injector or a pen-type injector and can thus be held by the user's hand over the duration of drug delivery, or alternatively, may be suitable for other drug delivery devices and / or configurations.

[0020] 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 i.e., storage state, a delivery i.e., administration state, and a post-delivery state, although fewer or more states are also possible. For example, each state may have several sub-states or stages. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before activation by the user. In some embodiments, the pre-delivery state may exist within the time between when the drug delivery device 10 leaves the manufacturing facility and when the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the moment after the user removes the drug delivery device 10 from any secondary packaging and the moment before positioning the drug delivery device 10 relative to the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as dosing, is in progress. The 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 at the end-of-dose position within the drug storage container.

[0021] As shown in FIGS. 1A and 1B, 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 may extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (FIG. 3B) may be formed at the distal end to allow the insertion end 28 of the delivery member 16 (FIG. 2) to extend outside the housing 12. A transparent or translucent inspection window 17 (FIGS. 1A-1B) may be disposed in the wall of the housing 12 to allow the user to view the internal components of the drug delivery device 10, including the drug reservoir 20. By viewing the drug reservoir 20 through the window 17, the user can confirm that drug delivery is in progress and / or has been completed. A removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10, and in some embodiments, includes a gripper 13 (FIG. 2) configured to assist in removing a sterilization barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting reverse spines or arms that frictionally or otherwise mechanically engage the sterilization barrier 21 and pull the sterilization barrier 21 along with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterilization barrier 21 from the delivery member 16.

[0022] As shown in FIG. 2, the drive mechanism 30 can be disposed partially or entirely within the housing 12. Generally, the drive mechanism 30 stores energy and releases or outputs that energy upon activation of the drive mechanism 30 by a user or in response to activation of the drive mechanism 30 by a user, driving the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 to the patient. In the present embodiment, the drive mechanism 30 is configured to store mechanical potential energy, although alternative embodiments of the drive mechanism 30 may be configured differently. For example, the drive mechanism 30 may store electrical or chemical potential energy. Generally, upon activation of the drive mechanism 30, the drive mechanism 30 can convert the potential energy into kinetic energy for moving the plunger 26. As best shown in FIG. 3A, in one embodiment, the drive mechanism 30 includes a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, a releaser member 52, a plunger guide 60, an extender biasing member 35, and a guard extension 37. The plunger biasing member 50 may include a compression spring (e.g., a compression coil spring) initially held in a biased state. In the biased state, the plunger biasing member 50 can be compressed such that its axial length is shorter than when in its natural or relaxed state. When released, the plunger biasing member 50 attempts to expand to its natural axial length, and as a result, can exert a biasing force to push the plunger 26 in the distal direction.

[0023] As best shown in FIGS. 2 and 3B, in one embodiment, device 10 includes a housing 12, which can include two separate, interconnected structures, namely a rear end cap 23 (e.g., a rear cover) at the proximal end of drug delivery device 10 and a tubular housing 25 that extends substantially throughout the length of drug delivery device 10 and defines an opening 14. Additionally or alternatively, housing 12 may include fewer or more components, such as a two-piece tubular housing having a front portion and a rear portion. Tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and rear end cap 23 may have a generally hemispherical shape or a hollow cylindrical shape having an open end and a closed end. In some embodiments, rear end cap 23, tubular housing 25, and any components disposed therein may be combined to define different subassemblies, such as drive mechanism 30 (FIG. 3A). In some embodiments, the different subassemblies are assembled independently of one another and then combined with one another and with drug reservoir 20 to form a fully assembled drug delivery device 10. In such particular embodiments, some or all of the foregoing assembly steps may be performed in different manufacturing facilities or environments. In another embodiment, housing 12 may be assembled in one piece such that housing 12 is defined by a single monolithic structure that integrates the rear cap and the tubular housing into a single component.

[0024] The drug storage container 20 is disposed within the interior space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 may be pre-filled and transported, for example, by a manufacturer, to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be dispensed and / or provided to a patient in more than one use case, such as in a pre-filled syringe or an auto-injector including a pre-filled syringe. By using the same or similar syringe components in any case, at least some of the above steps, such as filling, labeling, packaging, shipping, and dispensing, may be made more efficient or simplified for two different use cases. As another example, if some or all of the same syringe components are used in multiple use cases, some of the regulatory pathways for selling and / or dispensing the drug may be made more efficient and / or simplified for at least one of the multiple use cases.

[0025] The housing 12 may be pre-loaded, for example, by the manufacturer with the drug storage container 20, or alternatively, the drug storage container 20 may be loaded by the user prior to use of the drug delivery device 10. The drug storage container 20 may include a rigid wall that defines an internal bore or reservoir. The wall may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 such that it can move distally along the longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the inner surface 15 of the wall of the drug storage container 20 so as to prevent or inhibit leakage of the drug 22 past the stopper 24 when the stopper 24 is moving. Distal movement of the stopper 24 causes the drug 22 to be discharged from the reservoir of the drug storage container 20 to the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart from each other by a gap 18 (FIG. 2). When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap and abuts the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally, discharging the drug 22 from the drug storage container 20. In another embodiment, the stopper 24 and the plunger 26 may initially be in contact with or coupled to each other, for example, via a screw connection, so as to move together from the start of movement of the plunger 26. Once the stopper 24 moves, it may continue to move distally until it contacts the proximal facing portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may also be referred to as the end-of-dose or end-of-delivery position and may correspond when the delivery of the drug 22 to the patient is complete or substantially complete.

[0026] In some embodiments, the volume of the drug 22 contained within the reservoir of the drug storage container 20 may be equal to 1 mL, or may be equal to approximately (e.g., ±10%) 1 mL, or may be equal to 2.5 mL, or may be equal to approximately (e.g., ±10%) 2.5 mL, or may be equal to 3 mL, or may be equal to approximately (e.g., ±10%) 3 mL, or may be less than or equal to approximately (e.g., ±10%) 1 mL, or may be less than or equal to approximately (e.g., ±10%) 2 mL, or may be less than or equal to approximately (e.g., ±10%) 3 mL, or may be less than or equal to approximately (e.g., ±10%) 4 mL, or may be less than approximately (e.g., ±10%) 5 mL, or may be less than or equal to approximately (e.g., ±10%) 10 mL, or may be within the range of approximately (e.g., ±10%) 1 to 10 mL, or may be within the range of approximately (e.g., ±10%) 1 to 5 mL, or may be within the range of approximately (e.g., ±10%) 1 to 4 mL, or may be within the range of approximately (e.g., ±10%) 1 to 3 mL, or may be within the range of approximately (e.g., ±10%) 1 to 2.5 mL.

[0027] The delivery member 16 is operably connected or connectable in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery member 16 may define the insertion end 28 of the delivery member 16. The insertion end 28 can include a sharp tip of other prior pointed geometric shapes, enabling the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 can be hollow and can have an internal passageway. One or more openings may be formed in the insertion end 28 to allow the drug to flow out from the delivery member 16 to the patient.

[0028] In one embodiment, the drug storage container 20 can be a prefilled syringe and has a fixed hollow metal needle for the delivery member 16. In this case, the needle is attached to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a luer lock or other suitable connection. In still other embodiments, the drug storage container 20 may be a needleless cartridge and thus may not initially be in fluid communication with the delivery member 16. In such embodiments, during operation of the drug delivery device 10, the drug storage container 20 may move towards or away from the proximal end of the delivery member 16 such that the proximal end of the delivery member 16 penetrates a septum covering the opening of the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0029] The drug storage container 20 may include a body portion 20g having a distal end 20e and a proximal end 20f. The drug storage container 20 may be attached to the housing 12 such that the drug storage container 20 does not move relative to the housing 12 once the drug storage container 20 is installed within the housing 12. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 of the housing 12. For example, as shown in FIG. 2, the delivery member 16 extends beyond the distal end of the housing 12 that defines the opening 14. However, in some configurations, such as the storage configuration shown in FIG. 2, the delivery member 16 is covered / protected by a sterilization barrier 21 and a guard member 32 that surround the delivery member 16 and prevent or reduce the likelihood of unintentional or premature needle sticks.

[0030] The container holder 31 may have a hollow and generally cylindrical or tubular shape centered about the longitudinal axis A, and the drug storage container 20 may be disposed partially or entirely within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33, and the inwardly projecting flange 33 abuts against the shoulder 20a of the drug storage container 20, thereby preventing distal movement of the drug storage container 20 during operation of the plunger 26.

[0031] In one embodiment, the container holder 31 positions and / or secures the drug storage container 20 within the housing 12. For example, the container holder 31 is configured to support the drug storage container 20 relative to the housing 12 at least proximally to at least a portion (e.g., including proximally to the entire distal end of the body portion of the drug storage container 20) of the distal end of the body portion of the drug storage container 20 such that the resultant force acting on the drug storage container 20 from the plunger biasing member 50 is at least substantially fully supported by the distal end of the body portion of the drug storage container 20.

[0032] As used herein, the term "body portion" of the drug storage container 20 is the generally cylindrical portion of the drug storage container 20. For example, the body portion 20g of the drug storage container 20 shown in FIG. 4A extends from the distal side of the flange 20c to the proximal side of the shoulder 20a. As a more specific example, the body portion 20g of the drug storage container 20 shown in FIG. 4A has a relatively constant inner diameter and / or a relatively constant outer diameter along its length. As shown in FIGS. 4A and 2, the drug storage container 20 defines a shoulder 20a proximally to the distal end 20e of the body portion 20g. The delivery member 16 extends distally from the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the drug storage container 20 further includes a neck portion 20g disposed distally to the shoulder 20a and configured to support a delivery member 16 such as a fixation needle.

[0033] The term "resultant force" refers to the force that pushes the drug storage container 20 along the axis A during and after the injection state, during the operation of the plunger biasing member 50 and due to the operation of the plunger biasing member 50. For example, when the plunger 26 is actuated and driven distally along the axis A, the plunger 26 pushes the stopper 24 distally. As a result of this direct contact between the plunger 26 and the stopper 24, the frictional force between the stopper 24 and the drug storage container 20, and the force required to push the drug 22 through the delivery member 16 with a relatively small diameter, the drug storage container 20 is pushed distally even if the plunger 26 cannot directly contact, abut, or engage the body portion of the drug storage container 20. As a result, the drug storage container 20 may experience a relatively high resultant force during the injection process, more specifically, during the actuation of the plunger 26.

[0034] The concentration of the resultant force acting on the drug storage container 20 during plunger actuation is greatest at the portion of the drug storage container 20 that resists distal movement. For example, in the device shown in the figure, the concentration of the force is greatest proximal to at least a portion of the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the concentration of the force is greatest at the shoulder 20a where the drug storage container 20 is supported by the container holder 31. As an even more specific example, the concentration of the force is at least substantially completely supported by the shoulder 20a of the drug storage container 20. The term "substantially completely" may mean more than 50%, more than 70%, more than 75%, more than 80%, more than 80%, more than 85%, more than 90%, more than 95%, more than 98%, or any other suitable number.

[0035] During plunger operation, the concentration of the resultant force acting on the drug storage container 20 is preferably not well supported by the outwardly protruding flange 20d of the drug storage container 20. For example, since the force is substantially completely supported by the distal portion 20e of the body portion 20g of the drug storage container 20, the concentration of the force at and near the outwardly protruding flange 20d is relatively small. As a more specific example, the proportion of the resultant force acting on the entire drug storage container 20 supported by the outwardly protruding flange 20d may be less than 20%, or less than 15%, or less than 10%, or less than 5%, or less than 3%, or less than 2%, or less than 1%, or about 0%.

[0036] As shown in FIGS. 2 and 4B, the container holder 31 includes a plurality of flanges 33 each including an arcuate inclined surface 33a that substantially conforms to the arcuate shape of the shoulder 20a of the drug storage container 20. As a more specific example, when the drug storage container 20 is inserted into the container holder 31, the flanges 33 cooperate to support the shoulder 20a and limit the distal movement of the drug storage container 20. As will be described in more detail below, the flanges 33 are separated from each other by a gap 33b (FIG. 3b) to allow for bending of the flanges 33. The container holder 31 shown in FIGS. 4A-4C includes four flanges 33, but any suitable number of flanges may be used as will be described below with respect to another exemplary design shown in FIG. 4D.

[0037] The container holder 31 can have an open position 29a (FIG. 4B) in which the container holder 31 can receive the drug storage container 20 during assembly, and a closed position 29b (FIG. 4C) in which the container holder 31 can support or at least partially support the drug storage container 20. As a more specific example, the container holder 31 includes a pair of arms 31a, 31b that extend axially from an annular ring 31c, and the arms 31a, 31b can bend away from each other or toward each other so as to transition between the open position 29a and the closed position 29b. The annular ring 31c in the figure is disposed near the distal end of the container holder 31, so that when the container holder 31 is in the open position 29a, the proximal portions of the arms 31a, 31b can extend away from each other. The container holder 31 further includes mating connectors 31d, 31e adjacent to the top (proximal) portion of the container holder 31 that are configured to snap fit together when the container holder is in the closed position 29b. As a more specific example, when the mating connectors 31d, 31e are engaged with each other, the container holder 31 is held in the closed position 29b by a friction fit between the components.

[0038] The container holder 31 shown in the figure also includes a pair of inwardly projecting flanges 31f, 31g disposed adjacent to the proximal end of the container holder 31. When the container holder 31 is in the open position 29a, the inwardly projecting flanges 31f, 31g are spaced apart from each other such that a radially outwardly projecting flange 20b on the drug storage container 20 can be disposed within the container holder 31 (by insertion in the distal direction). In other words, when the container holder 31 is in the open position 29a, the outwardly projecting flange 20b on the drug storage container 20 can eliminate the gap between the inwardly projecting flanges 31f, 31g. When the drug storage container 20 is fully inserted into the container holder 31 (e.g., such that the shoulder 20a of the drug storage container 20 contacts the inwardly projecting flange 33), the container holder arms 31a, 31b can move to the closed position 29b, where the inwardly projecting flanges 31f, 31g prevent the drug storage container 20 from exiting the container holder 31 in the proximal direction. In other words, when the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, the drug storage container 20 is held within the container holder 31 by an inwardly projecting flange 33 near the distal end of the container holder 31 and by inwardly projecting flanges 31f, 31g near the proximal end of the container holder 31.

[0039] As shown in FIGS. 4B and 4C, the container holder 31 includes opposing surfaces 31i, 31h that define an opening 31j for receiving the flange 20b of the drug storage container 20. For example, the container holder 31 shown in the figure includes two distal opposing surfaces 31i and two proximal opposing surfaces 31h, which cooperate to define two openings 31j that respectively receive opposite portions of the flange 20b. The opposing surfaces 31h, 31i define a lower boundary and an upper boundary for positioning the flange 20b when the drug storage container 20 is disposed within the container holder 31 in the closed position 29b. This range from the lower boundary and the upper boundary can provide flexibility for drug storage containers 20 of various lengths and / or a range of tolerances in the length of the drug storage container 20. However, as described in more detail below, when the drug storage container 20 / container holder 31 assembly is within the housing 12, additional components of the device 10 may further secure the drug storage container 20 in the vicinity of the flange 20b. The opening 31j can also prevent and / or limit the rotational movement of the drug storage container 20. For example, the opposite rounded sections 20c of the flange 20b can each extend at least partially through the opening 31j, and the opposite straight sections 20d of the flange 20b can each abut against the side walls that define the opening 31j, preventing and / or limiting the rotational movement between the respective components 20, 31.

[0040] As shown in FIG. 4B, the container holder 31 may include additional fitting connectors 31k, 31m disposed distally of the fitting connectors 31d, 31e. Each pair of fitting connectors 31d, 31e; 31k, 31m functions together to provide a snap fit between each arm 31a, 31b of the container holder 31 and can secure the container holder 31 in the closed position 29b.

[0041] The annular ring 31c may desirably be disposed on substantially opposite sides of the fitting connectors 31d, 31e (along the axis A) to facilitate opening and closing of the container holder arms 31a, 31b. For example, when the container holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly projecting flanges 31f, 31g may be proportional to the clearance gap between the inwardly projecting flanges 31f, 31g. Thus, the distance between the annular ring 31c and the inwardly projecting flanges 31f, 31g (e.g., the effective length of the arms 31a, 31b) may be maximized to maximize the gap between the inwardly projecting flanges 31f, 31g when the container holder 31 is in the open position 29a. Further, when the container holder 31 is in the open position 29a, the thickness, height, and material properties of the annular ring 31c may each affect the bending of the arms 31a, 31b and / or the gap between the inwardly projecting flanges 31f, 31g. As described above, the gap 33b between the flanges may also facilitate and / or define the amount of bending of the arms 31a, 31b and / or the gap between the inwardly projecting flanges 31f, 31g as the container holder 31 transitions to the open position 29a. For example, as the arms 31a, 31b bend outwardly, the flanges 33 may move inwardly.

[0042] The container holder 31 shown in the drawing may include alignment ridges 31n that abut against the inner surface of the housing 12 in order to radially align the container holder 31 within the housing 12 during assembly and to prevent and / or limit radial movement between the respective components 12, 31. As an example, the housing 12 may include slots 12a formed on the inner surface of the housing to receive the alignment ridges 31n. The housing 12 may include a plurality of slots, and the container holder 31 may include a plurality of alignment ridges for radially aligning the respective components 12, 31. For example, the container holder 31 shown in the figure includes two alignment ridges 31n, and the housing 12 includes two slots 12a. The slots 12a are spaced apart from each other and are sized to receive the respective alignment ridges 31n, for example, when the container holder 31 is inserted into the housing 12. The slots 12 shown in the figure are defined by a substantially annular collar 12d portion integral with the housing 12 (however, alternatively, the collar portion may be one or more components coupled to or attached to the housing). The annular collar 12d need not extend across the entire inner surface of the housing 12. Instead, it has cutouts or gaps to allow a portion of the guard member 32 to extend between each portion of the annular collar 12d. Alternatively, the annular collar 12d may be spaced radially inwardly from the inner surface of the housing 12 at at least one or more locations to facilitate a portion of the guard member extending beyond the collar 12d.

[0043] The annular collar 12d may further define inclined surfaces 12e on both sides of each lock slot 12c to further assist in the alignment between the container holder 31 and the housing 12.

[0044] The components shown in FIGS. 4A, 4B, and 4C include an alignment ridge 31n disposed at the distal end of the support ridge 31o. For example, the support ridge 31o has a height (measured perpendicular to the outer surface of the container holder 31) lower than that of the alignment ridge 31n such that rather than the support ridge 31o, only the alignment ridge 31n is received within the alignment slot 12a. Alternatively, as described below with respect to another exemplary design shown in FIG. 4D, the alignment ridge may extend substantially or completely along the axial length of the container holder 31.

[0045] During operation of the drug delivery device 10, the drug storage container 20 can be further or more securely coupled to the container holder 31 (and as a result, to the housing 12) such that movement of the drug storage container 20 and the container holder 31 relative to the housing 12 is prevented. For example, as shown in FIGS. 4B and 4C, the container holder 31 may include a plurality of locking ridges 33c on the flange 33 that form a friction fit with a portion of the housing 12. As a more specific example and as shown in FIGS. 2 and 3B, the housing 12 includes a plurality of lock slots 12c that each receive a respective locking ridge 33c of the container holder 31 to prevent and / or limit relative movement between the respective components 12, 31. As a more specific example, each of the locking ridges 33c extends radially from the outer surface of the flange 33. The container holder 31 may include, for example, one, two, three, four, or any suitable number more than that of locking ridges 33c. The lock slots 12c shown in the figures are defined by an annular collar 12d, but alternatively, these may be defined by another component. The lock slots 12c are spaced apart from each other and are sized to receive, for example, each locking ridge 33c when the drug storage container is disposed within the container holder 31. As a more specific example, for example, to secure the container holder 31 and as a result, the drug product container 20 within the housing 12, the locking ridges 33c are snap-fitted into the lock slots 12c by a friction fit. As an even more specific example, when the locking ridges 33c are snap-fitted into the lock slots 12c, the flange 33 may be slightly pushed inwards to form a more secure fit between the container holder 31 and the drug product container 20.

[0046] The inner surface of the container holder 31 may include a compressible component such as an elastomeric component disposed between the inner surface of the container holder 31 and the drug product container 20. As a more specific example, the elastomeric component may be a rubber ring. Alternatively or additionally, the natural flexure of the flange 33 may function as a compressible component.

[0047] The locking projection 33c can provide audible and / or tactile feedback to the user or assembler when the user or assembler snaps it into the corresponding lock slot 12c, thereby indicating to the assembler that the respective components 12, 31 are arranged as desired. Further, each component can be sized and arranged such that feedback occurs only when the drug product container 20 is also arranged as desired. For example, if the drug product container 20 is arranged much more distally relative to the container holder 31 such that the body of the drug product container 20, rather than the shoulder 20a, is aligned with the flange 33, the locking projection 33c may not be pushed radially in far enough for the locking projection 33c to fit within the lock slot 12c. Conversely, if the drug product container 20 is not inserted far enough distally relative to the container holder 31 such that the sterilization barrier 21, rather than the shoulder 20a, is aligned with the flange 33, the locking projection 33c can be pushed radially inward to the extent that the locking projection 33c can slide radially inwardly within the lock slot 12c, or the locking projection 33c can enter the lock slot 12c but not generate enough radially outward force to produce audible and / or tactile feedback. Audible and / or tactile feedback can be advantageous during manual assembly of the container holder 31, although the assembly of the container holder 31 need not be performed manually and, in some embodiments, may be performed in part or in whole by manufacturing equipment.

[0048] The above-described housing 12, container holder 31, and their respective components provide numerous advantages. For example, by securely coupling the drug product container 20 to the housing 12 via the shoulder 20a (rather than the flange portion), the device 10 may have a reduced incidence of glass breakage or other damage. As a more specific example, drug product containers such as syringes often have shoulders that are more robust and / or capable of handling greater forces compared to flange portions. In other words, the shoulder is more robust and can withstand breakage better than the flange, so the concentration of force on the drug product container may advantageously be higher at the shoulder than at the flange.

[0049] Another potential advantage of this configuration is that by securely coupling the drug product container 20 to the housing 12 via the distal portion (e.g., shoulder 20a), the device 10 may have a more predictable, repeatable, and / or consistent injection depth compared to designs that secure the drug product container 20 via a flange (e.g., a "suspended" design). For example, since the barrel length of the drug product container 20 can vary significantly more than the shoulder length of the barrel, the distance between the shoulder 20a and the delivery member 16 of the syringe is typically more predictable and / or has smaller manufacturing tolerances compared to the distance between the flange 20b and the delivery member 16. Additionally or alternatively, the distance between the flange 20b and the delivery member 16 includes any tolerances / variations in the distance between the shoulder 20a and the delivery member 16, so any tolerances / variations are "stacked".

[0050] As shown in FIG. 4C, when the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, a portion of the drug storage container 20 extends beyond the distal end of the container holder 31. As shown in FIGS. 4C and 4F and as described in more detail below, for example, the sterilization barrier 21 is disposed substantially or completely outside of the container holder 31 to facilitate removal of the sterilization barrier 21 during use of the device 10. Further, the delivery member 16 extends beyond the distal end of the container holder 31 (as described above).

[0051] Figure 4D shows another exemplary container holder 131 that has some features similar in function to those included in container holder 31, and each of them is assigned the same reference numeral except that 100 is added. For example, container holder 131 includes a pair of arms 131a, 131b; an annular ring 131c connecting arms 131a, 131b; each set of mating connectors 131d, 131e, 131k, 131m for selectively fixing the arms to the closed position 129b; a pair of inwardly projecting flanges 131f, 131g; a pair of opposing surfaces 131h, 131i that define the lower and upper limits of movement of the flange of the drug storage container; and an opening 131j for receiving the flange of the drug storage container. Container holder 131 also includes a plurality of flanges 133, and the plurality of flanges 133 are disposed at the distal end of container holder 131 and are configured to support the drug storage container. For example, container holder 131 includes two flanges 133, each of which includes an arcuate inclined surface 133a that substantially matches the arcuate shape of the shoulder of the drug storage container. The container holder 131 shown in Figure 4D has two flanges 133 as opposed to the four flanges 33 shown on container holder 31 shown in Figures 4A - 4C. Thus, each of the flanges 133 preferably has a greater perimeter than the flanges 33. Container holder 131 also includes an alignment ridge 131n that is received within an alignment slot 12a formed in the inner surface of housing 12 in order to properly align container holder 131 within housing 12 during assembly and to prevent and / or limit rotational movement between each component 12, 131. The alignment ridge 131n shown in Figure 4D extends substantially completely along the axial length of container holder 131 in contrast to alignment ridge 31n.

[0052] Similar to the container holder 31 shown in FIGS. 4B - 4C, the container holder 131 may include a plurality of locking ridges 133c on the flange 133 that form a friction fit with a portion of the housing 12. As a more specific example and as shown in FIGS. 4D and 4E, the housing 12 includes a plurality of lock slots 12c that each receive a respective locking ridge 133c of the container holder 131 to prevent and / or limit relative movement between the respective components 12, 131. The locking ridges 133c can also provide audible and / or tactile feedback to the user or assembler when the user or assembler snaps the corresponding locking ridges 133c into the lock slots 12c, thereby indicating to the assembler that the respective components 12, 131 are arranged as desired. Further, the container holder 131 may provide the same or similar advantages as those described above with respect to the container holder 31.

[0053] In yet another exemplary design, the container holder may have a fixed state rather than having an opening and closing arm. As a more specific example, the container holder may have a proximal opening sized to allow for the reception of a syringe. The container holder may further have a distally located flange for receiving and securing the shoulder of the syringe, particularly when the container holder is coupled to the injector housing.

[0054] Figures 4F and 5A show the distal portion (Figure 4F) and proximal portion (Figure 5A) of the drug product container 20 and its interaction with various other components of the device 10. For example, Figure 4F shows a partial cross-sectional view of the distal portion of the drug product container 20 disposed within the container holder 31, where the shoulder 20a is supported by the flange 33. As another example, Figure 5A shows a cross-sectional view of the proximal portion of the drug product container 20 disposed within the container holder 31 such that the drug product container flange 20b is disposed between the opposing surfaces 31h, 31i and within the opening 31j. The drug product container 20 shown in Figure 5A is further supported by a plunger guide 60, such as the flexible arm 60a of the plunger guide 60. As a more specific example, the flexible arm 60a extends generally distally and slightly radially inwardly from the distal portion of the plunger guide 60. As an even more specific example, the plunger guide 60 shown in Figure 5A includes a distal surface 60b that abuts against the inwardly projecting flanges 31f, 31g of the container holder 31, and the flexible arm 60a extends from the distal surface 60b between the inwardly projecting flanges 31f, 31g.

[0055] The flexible arm 60a can have a size, shape, and material type that promotes and / or enables the deflection of the flexible arm 60a. As a more specific example, when the drug product container 20 and the plunger guide 60 are inserted into the housing, the flexible arm 60a is preferably radially flexible such that the flexible arm 60a is aligned with the flange 20b and applies at least a gentle radial force (inwardly in the radial direction) to the drug product container 20. In this configuration, the drug product container 20 is first supported at its distal portion (e.g., shoulder 20a) by the container holder 31 and at least secondarily supported at its proximal portion (e.g., flange portion 20b) by the plunger guide 60. As a more specific example, the flexible arm 60a can provide radial support to the flange portion 20b and prevent and / or inhibit lateral movement of the drug product container 20 relative to the housing 12. Such a configuration can reduce or eliminate rattling noise from the device 10 and / or facilitate proper alignment of the drug product container 20 during assembly. As another more specific example, the flexible arm 60a can provide axial support (e.g., in the distal direction) to prevent unwanted axial movement of the drug product container 20 relative to the housing 12. The device 10 can have, for example, one, two, three, four, or any suitable number more than that of flexible arms 60a.

[0056] The container holder 31 may also include at least one support flange 31r having a size, shape, and type of material that facilitates and / or enables its deflection. As a more specific example, when the drug product container 20 and the container holder 31 are inserted into the housing, the support flange 31r is aligned with the body portion 20g of the drug product container, and it is preferable that the support flange 31r is radially flexible so as to apply at least a gentle radial force (inward in the radial direction) to the drug product container 20. In this configuration, the drug product container 20 is first supported by the container holder 31 at its distal portion (e.g., shoulder 20a), and also at least secondarily supported by the container holder 31 at the center or proximal region of the body portion 20g. As a more specific example, the support flange 31r can provide radial support for the drug product container 20 and prevent and / or inhibit the lateral movement of the drug product container 20 with respect to the housing 12. Such a configuration can reduce or eliminate rattling noise from the device 10 and / or facilitate proper alignment of the drug product container 20 during assembly. As another more specific example, the support flange 31r can provide axial support (e.g., in the distal direction) to prevent unwanted axial movement of the drug product container 20 with respect to the housing 12, although this is not necessary. The device 10 may have, for example, one, two, three, four, or any suitable number more than that of support flanges 31r. The container holder 31 shown in the figure includes four support flanges 31r arranged at equal intervals around it.

[0057] The flexible arm 60a and / or the support flange 31r shown in the figure provide at least some degree of support for the drug storage container 20. However, as described above, the container holder substantially completely supports the drug storage container 20 with respect to the housing 12 by the distal end of the body portion 20g of the drug storage container 20. As a more specific example, the flexible arm 60a and / or the support flange 31r may provide little or no support along the longitudinal axis A and may provide support only in a direction transverse to the axis A. As an even more specific example, the container holder 31 substantially completely supports the drug storage container 20 with respect to the housing 12 by the distal end of the body portion 20g of the drug storage container 20 with respect to forces along the axis A, for example, forces received during the injection process.

[0058] As shown above, the plunger guide 60 shown in FIG. 5A includes a distal surface 60b that abuts against flanges 31f, 31g protruding inwardly of the container holder 31. This configuration can help reduce or prevent the radial movement of the container holder 31 within the housing 12. For example, as shown in FIG. 5A, the container holder includes an annular wall 31p, which cooperates with the inwardly protruding flanges 31f, 31g to define an annular seat for the distal surface 60b of the plunger guide 60. The annular wall 31p can center the plunger guide 60 relative to the container holder 31 and the drug product container 20. Thus, the plunger 26 is similarly aligned with these components 31, 20. The annular wall 31p can also reduce or prevent the radial movement of the plunger guide 60 relative to the housing 12. This configuration can also help reduce or prevent the axial movement of the container holder 31 within the housing 12. For example, as shown in FIG. 2, the plunger guide 60 extends from the rear end cap 23 to an intermediate point of the device 10 (where the plunger guide 60 abuts the container holder 31). As a result, the container holder 31 is restricted from moving axially upward (i.e., proximally) by the plunger guide 60 in FIG. 2. Further, for example, if the distal surface 60b is not in contact with the inwardly protruding flanges 31f, 31g, the rear end cap 23 may not be attachable unless the plunger guide 60 is properly axially and radially aligned with the container holder 31.

[0059] As shown in FIGS. 5B and 5C, the plunger guide 60 may have a hollow and substantially cylindrical or tubular shape and may be centered about the longitudinal axis A. The outer diameter or other outer dimensions of the proximal end of the plunger guide 60 may be larger than the outer diameter or other outer dimensions of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 may be disposed radially between the plunger 26 and the release member 52. Thus, as shown in FIG. 2, the plunger 26 may be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 may be at least partially disposed within the release member 52. Further features and functions of the plunger guide 60 will be described below.

[0060] As shown in FIG. 2, the plunger guide 60 may be fixedly coupled to the housing such that the plunger guide 60 is substantially and / or nearly non-movable relative to the housing 12. For example, as shown in FIGS. 1C and 5B as well, the plunger guide includes a lock tab 60f sized, shaped, and positioned to be received within a lock key 12f formed within the housing 12. As a more specific example, the plunger guide 60 and the housing 12 each include a pair of respective components 60f, 12f, and the pair of respective components 60f, 12f cooperate to prevent relative rotation between the plunger guide 60 and the housing 12. Additionally or alternatively, an annular ridge 60g formed on the outer surface of the plunger guide 60 may form a friction fit with the inner surface of the housing and may prevent or inhibit rotation between the respective components 12, 60.

[0061] The plunger 26 (best shown in FIGS. 2 and 3A) may have a hollow and generally cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space sized to receive the plunger biasing member 50. Generally, to maximize the inner diameter of the plunger 26, it is desirable to minimize the thickness of the annular wall 39 to the extent possible and without compromising the integrity of the plunger 26. This allows a larger diameter plunger biasing member 50 to be received within the internal space of the plunger 26, which in turn allows for a more robust plunger biasing member 50. As a more specific example, the thickness of the annular wall 39 may be less than 2 mm. As another more specific example, the thickness of the annular wall may be less than 1 mm. As another more specific example, the thickness of the annular wall may be less than 0.6 mm. As another more specific example, the thickness of the annular wall may be less than 0.3 mm. As another more specific example, the thickness of the annular wall may be less than 0.2 mm. As another more specific example, the thickness of the annular wall may be less than 0.1 mm. As another more specific example, the thickness of the annular wall may be less than 0.05 mm. The annular wall 39 may be made of any suitable material such as metal or plastic. To minimize the thickness of the annular wall 39, it may be advantageous to make the annular wall 39 of a metal such as steel or aluminum. For example, a metal annular wall 39 may have sufficient axial strength and / or buckling resistance for use in the device if the thickness of the annular wall 39 is greater than 0.05 mm. In contrast, a plastic annular wall 39 may have sufficient axial strength and / or buckling resistance for use in the device if the thickness of the annular wall 39 is greater than 1 mm.

[0062] Additionally or alternatively, the hollow rod 46 can facilitate and / or provide greater flexibility of the spring design. For example, depending on the properties of the drug and / or the desired drug delivery profile, it may be desirable or advantageous to use devices with different springs. For example, for more viscous drugs, a spring with a higher spring constant and / or spring force may be required, and thus it may be desirable or advantageous to have flexibility in the physical properties of the spring. As a more specific example, various physical properties of the spring, such as the wire diameter of the spring (generally, as the wire diameter increases, the spring constant increases), the mean diameter of the spring (generally, as the mean diameter increases, the spring constant decreases), the number of turns of the spring (generally, as the number of turns increases, the spring constant increases), and the material of the spring, can affect the spring constant and thus the spring force. These physical properties can be adjusted to provide different spring constants, while also, in some cases, adjusting the thickness of the hollow rod 46 to maintain a constant or relatively constant outer diameter of the overall plunger 26 and keep the remaining components of the device, such as the plunger guide 60 and the stopper 24, constant. Additionally or alternatively, the hollow rod 46 can facilitate and / or provide greater longitudinal stability of the plunger biasing member 50, such as by preventing or reducing buckling or other transverse movement.

[0063] The plunger biasing member 50 shown in the figure can include the following dimensions, namely, a wire diameter of 0.65 mm, an outer diameter of the spring of 5.40 mm, and a number of turns of 80 - 86 (depending on the pitch), although other suitable spring characteristics may be used. The plunger biasing member 50 shown in the figure can be formed of stainless steel with a strength of 2300 n / mm, although other suitable materials may be used. The hollow rod 46 shown in the figure can include the following dimensions and material, namely, a length of 63 mm, an outer diameter of 6 mm, a wall thickness of 0.20 mm, and a stainless steel material with a strength of 600 - 750 n / mm, although other suitable dimensions and materials may be used.

[0064] As will be described in more detail below, during operation of the drug delivery device 10, the plunger 26 can be configured to rotate selectively relative to the housing 12 and to translate linearly relative to the housing 12.

[0065] The plunger 26 may be made of a plurality of interconnected parts or, alternatively, may have a one-piece structure. In the present embodiment, the plunger 26 is made of three separate, interconnected structures, namely, a top ring 45 that defines the proximal end of the plunger 26, a base portion 47 that defines the distal end of the plunger 26, and a hollow rod 46 that is disposed between the top ring 45 and the base portion 47 and rigidly connects them. The positions of the top ring 45, the hollow rod 46, and the base portion 47 can be fixed relative to each other such that these components cannot move relative to each other. The top ring 45, the hollow rod 46, and the base portion 47 may each have an annular structure and may be centered about the longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a respective central opening that extends from end to end of the respective component and defines an axial chamber. On the one hand, the base portion 47 may have a central opening that penetrates the proximal end of the base portion 47 but is closed at the distal end of the base portion 47. The closed end of the base portion 47 may define a seat or abutment surface for the plunger biasing member 50. In another embodiment, the central opening may extend through the base portion 47 from end to end. In such an alternative embodiment, the inner diameter of the central opening of the base portion 47 may be smaller than the outer diameter of the plunger biasing member 50 such that the base portion 47 holds the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is activated, the base portion 47 can become the portion of the plunger 26 that abuts the stopper 24 and pushes the stopper 24 in the distal direction.

[0066] The top ring 45 may include one or more flanges or protrusions 48 that extend radially outward from the central portion of the top ring 45. Each protrusion 48 may include a distal opposing cam surface 49. As will be described in more detail below, the distal opposing cam surface 49 may interact with a mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distal opposing cam surface 49 may be angled or otherwise non-parallel with respect to an imaginary plane perpendicular to the longitudinal axis A.

[0067] In some embodiments, the top ring 45 and / or the base portion 47 may be made of a material different from the hollow rod 46. In some embodiments, the top ring 45 and / or the base portion 47 may be made of plastic, while the hollow rod 46 may be made of metal. Configured in this way, the plastic material used for the top ring 45 may facilitate the cam operation described below by providing a relatively low coefficient of friction. The plastic material used for the base portion 47 may help absorb or dampen any shock or vibration associated with the base portion 47 colliding with the stopper 24. The metal material used for the hollow rod 46 may provide sufficient rigidity to avoid buckling under the biasing force exerted by the plunger biasing member 50. In another embodiment, the top ring 45, the hollow rod 46, and / or the base portion 47 may be made of the same material, including, for example, metal or plastic. In such a particular embodiment, the top ring 45, the hollow rod 46, and the base portion 47 may be integrally formed in one piece so as to define a single monolithic structure.

[0068] The drug delivery device 10 may further include a guard mechanism for preventing contact between the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used for injection administration. The guard mechanism may include a guard member 32 movably disposed adjacent to the opening 14 at or near the distal end of the housing 12. The guard member 32 may have a hollow and generally tubular or cylindrical portion 32a centered about the longitudinal axis A, and may have a pair of arms 32b extending proximally from the cylindrical portion 32a. The guard member 32 further includes a distal end 32c that may generally include the cylindrical portion 32a, and a proximal end 32d that may be defined by the arms 32b. The arms 32b may be substantially or completely received within the housing 12 such that a portion of them does not extend from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. As will be described in more detail below, for example, the guard member 32 may be configured to move relative to the housing 12 such that in one stage / state, a portion of the guard member 32 is received within the housing 12 and in another stage / state, it extends from the housing 12.

[0069] As one exemplary configuration shown in FIGS. 2, 4E, and 6, the arms 32b of the guide member 32 are radially spaced from each other along the periphery 32g of the guard 32 such that the arms 32b can slide between the protrusions of the annular collar 12d formed on the inner surface of the housing 12. For example, the arc length between each edge of the arm 32b is at least slightly longer than the arcuate length of the protrusion of the annular collar 12d. Thus, the arms can slide axially between the protrusions of the annular collar 12d without contacting the collar.

[0070] As shown above, the guard member 32 can be configured to move relative to the housing 12 between an extended position in which at least a portion of the cylindrical portion 32a of the guard member 32 extends through the opening 14 of the housing 12 and a retracted position in which a shorter length of the cylindrical portion 32a extends through the opening 14 of the housing 12 or no portion of the cylindrical portion 32a extends through the opening 14 of the housing 12. In other words, in the extended position, a cylindrical portion 32a of length X extends through the opening 14 of the housing 12, and in the retracted position, a cylindrical portion 32a of length Y extends through the opening 14 of the housing 12, where X is a value greater than Y. The length X can be any suitable number, for example, 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y can be any suitable number less than X, for example, 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. FIGS. 1C and 1D show an exemplary pre-injection configuration (FIG. 1C) in which the guard member 32 is in the extended position 32e and the length X of the exposed portion of the guard member 32 can be about 5 mm to 11 mm, and an injection configuration (FIG. 1D) in which the guard member 32 is in the retracted position 32f and the length Y of the exposed portion of the guard member 32 is about 0 mm to 2 mm (the distal end 32c of the guard member 32 is flush with the opening 14 of the housing 12). In one embodiment, the distance Y is greater than 0 (e.g., 1 mm) to help ensure that the device 10 can be activated before the guard member becomes flush with the housing 12.

[0071] The guard member 32 may also be configured to move in the opposite direction, i.e., from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 can translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 can translate linearly in the distal direction. At least in the extended position, the guard member 32 extends beyond the insertion end 28 of the delivery member 16 and may surround the insertion end 28 of the delivery member 16. As a further illustration, FIGS. 1C and 2 show the guard member 32 in the extended position (covered in FIG. 2 by the removable cap 19). As described above, for example, when the guard member 32 is moved from the extended position to the retracted position by pressing the distal end of the guard member 32 against the patient's skin at the injection site, the insertion end 28 of the delivery member 16 may be inserted into the patient's skin.

[0072] During the injection process, the guard member 32 can remain stationary relative to the user's skin 5, while the housing 12 and some of the components disposed therein move relative to the guard member 32 and the skin 5. Nevertheless, the present disclosure refers to the movement, retraction, translation, and pushing of the guard member 32. These references and descriptions can be considered to refer to the relative movement between the guard member 32 and the housing 12, regardless of which component (the guard member 32 or the housing 12) is moving relative to the user's skin 5.

[0073] The delivery device 10 may utilize an inertial drive design rather than a spring-driven design to insert a needle into the subcutaneous tissue of a patient. As a more specific example, when a patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 may advance toward the injection site. When the patient presses down with a predetermined distance or force, the delivery device 10 compresses the needle cover and its spring to a predetermined release point while performing a rapid release to utilize the energy stored in the patient's muscle. The release mechanism is designed such that the resulting needle insertion speed exceeds the patient's reaction speed, and the combination of this speed and the mass of the device causes the needle to quickly and completely penetrate the skin to a subcutaneous depth. This embodiment prevents relative movement between the drug storage container 20 and the housing, as compared to known injectors where the entire primary container moves forward relative to the housing, and thus may provide a simplified and more robust design.

[0074] In another embodiment, the drug storage container 20 may be movably coupled to the housing 12 such that the drug storage container 20 can move relative to the housing 12 during operation of the drug delivery device 10. In such a particular alternative embodiment, the insertion end 28 of the delivery member 16 may be retracted into the opening 14 of the housing 12 in the pre-delivery state. Thereafter, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be deployed through the opening 14 of the housing 12 for insertion into the patient. In some embodiments, this movement may be the result of the drug storage container 20 being driven distally relative to the housing 12.

[0075] In some embodiments, the guard member 32 may be rotatably fixed or rotatably restricted with respect to the housing 12. Thus, even though the guard member 32 may be capable of translating linearly with respect to the housing 12, the guard member 32 may be substantially or completely prevented from rotating with respect to the housing 12. As a more specific example, the cylindrical portion 32a of the guard member 32 may include a protrusion extending therefrom, such as a ridge 32h that is aligned with a corresponding feature on the inner surface of the housing 12. For example, the inner surface of the housing adjacent the distal end of the housing 12 may include a slot, a pair of adjacent ridges, or another component or set of components that cooperate with the ridge 32h to substantially or completely prevent rotation of the guard member 32. This configuration may also serve to align the respective components 32, 12 with each other during assembly.

[0076] The device 10 may further include an extender biasing member 35 and a guard extender 37. The guard extender 37 may be disposed proximal to the guard member 32, and the extender biasing member 35 shown in the figure is disposed proximal to the guard extender 37. The guard extender 37 may have a hollow and generally cylindrical or tubular shape that is centered about the longitudinal axis A. As a more specific example, the guard extender 37 may include a generally cylindrical body 37a. The guard extender 37 may also include an arm 37b for receiving, supporting, and / or holding the distal portion of the extender biasing member 35. Further, the guard extender 37 may be movable linearly along the longitudinal axis A with respect to the housing 12. In this embodiment, the guard extender 37 is a separate structure from the guard member 32. However, in another embodiment, the guard extender 37 and the guard member 32 may be integrally formed as one piece to define a single monolithic structure. In such another embodiment, the proximal end of the guard member 32 may correspond to the guard extender 37.

[0077] Similar to the guard member 32, the guard extension 37 can be rotatably fixed to the housing 12. Thus, even though the guard extension 37 may be able to translate linearly relative to the housing 12, the guard extension 37 can be prevented from rotating relative to the housing 12. In some embodiments, to achieve this effect, the guard extension 37 can cooperate with the plunger guide 60 to limit or prevent rotation between the respective components 37, 60. As a result, and because the plunger guide 60 is fixedly connected to the housing 12, the guard extension 37 can be rotatably fixed to the housing 12 via the plunger guide 60. For example, the plunger guide 60 may include a longitudinal ridge 60c in the vicinity of the distal portion of the plunger guide 60. The ridge can be received within a longitudinal channel on the inner surface of the guard extension 37 and / or within a pair or corresponding features that cooperate to receive the ridge 60c. In another embodiment, the arrangement of the ridge and slot can be reversed such that the guard extension 37 has one or more radially inwardly extending ridges and the plunger guide has one or more slots or other recesses for snugly or precisely receiving the one or more ridges. As yet another alternative, the guard extension 37 may include anti-rotation features that mate with corresponding features on the inner surface of the housing 12.

[0078] The guard extension 37 and / or the releaser member 52 may have an axial movement limit that restricts the distance they can move in the distal direction. For example, as shown in FIG. 6C, the plunger guide 60 may include an axial ridge 60c that is formed on the outer surface and disposed adjacent to the distal portion of the plunger guide 60. The distal facing surface 52j of the releaser member 52 may abut against the proximal facing surface 60d defined by the axial ridge 60c, thereby defining the farthest point of movement of the releaser member 52. The releaser member 52 may also include a lock flange 52a that further restricts the distal movement of the guard extension 37. For example, the lock ridge 52a may abut against the annular collar 37d of the guard extension 37, thereby defining the farthest point of movement of the guard extension 37. The axial ridge 60c and the lock ridge 52a shown in the figure do not necessarily restrict the movement of the releaser member 52 and the guard extension 37 in the proximal direction, but only restrict the movement in the distal direction.

[0079] As best shown in FIG. 2, the extender biasing member 35 is disposed between and in contact with the guard extension 37 and the releaser member 52. The extender biasing member 35 may be configured to bias or push the guard extension 37 in the distal direction and / or to bias or push the releaser member 52 in the proximal direction. In the device 10 shown in FIG. 2 before delivery, i.e., in the stored state, the extender biasing member 35 is initially in a biased state (e.g., compressed). In other words, as shown in FIG. 2, when the device 10 is in the pre-delivery state, the extender biasing member 35 applies a distal (downward) biasing force to the guard extension 37 and a proximal (upward) biasing force to the releaser member 52.

[0080] During operation of the device, the user can translate the guard member 32 proximally (with respect to the housing 12) by pressing the guard member 32 against the injection site. By doing so, the guard member 32 moves towards the guard extension 37, closing the gap 37g (Figure 2) therebetween. When the gap 37g is removed, the guard member 32 and the guard extension 37 move together proximally, for example, until the guard member 32 reaches the retracted position 32f. When the injection is complete and the drug delivery device 10 is removed from the injection site, the extender biasing member 35 can push the guard extension 37 so that the guard extension 37 and the guard member 32 move together distally. This movement (and / or the biasing force by the lock ring biasing member 51) causes the guard member 32 to return to the extended position 32e. This has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the extender biasing member 35 may include a compression spring (e.g., a compression coil spring). Further, in embodiments where the plunger biasing member 50 also includes a compression spring, the extender biasing member 35 may be disposed around the plunger biasing member 50 and / or may have a diameter larger than the plunger biasing member 50.

[0081] However, in some alternative embodiments, the extender biasing member 35 may be in an un-biased (natural) state when the device is in the pre-delivery state. In these embodiments, the biasing member 35 can be compressed or biased when the guard member 32 is deflected proximally.

[0082] After drug delivery is complete and the guard member 32 is redeployed to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent the next user from contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. As will be described in more detail below, in accordance with these objectives, some embodiments of the drug delivery device 10 may include a lock ring 40 configured to selectively rotate according to the axial position of the guard member 32 to lock the guard member 32 in the extended position when the guard member 32 moves from the retracted position to the extended position.

[0083] As described above, the plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end that abuts against the proximal opposing inner surface of the plunger 26 and / or may be firmly attached to the inner surface of the plunger 26. Since the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 can be less than or equal to the inner diameter of the top ring 45 and / or less than or equal to the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 can abut against the proximal opposing inner surface of the base portion 47 of the plunger 26. Further, as best shown in FIGS. 2 and 3A, the proximal end 50a of the plunger biasing member 50 can abut against the distal opposing surface 38a of the plunger biasing member seat 38. The plunger biasing member seat 38 can be firmly attached to the rear housing 27 such that the plunger biasing member seat 38 provides a stationary surface for the plunger biasing member 50 to push against. For example, as shown in FIGS. 3A and 5B, the plunger seat 38 may include a flange 38b, and the flange 38b is received within an opening 60h formed in the proximal portion of the plunger guide, thereby firmly coupling the plunger seat to the plunger guide 60. Configured in this way, when the plunger biasing member 50 is released from the biased state, the length of the plunger biasing member 50 can be extended by the distal end of the plunger biasing member 50 moving distally away from the stationary proximal end of the plunger biasing member 50. This movement can push the plunger 26 in the distal direction, which in turn can push the stopper 24 in the distal direction, allowing the drug 22 to be delivered from the drug storage container 20 to the delivery member 16 and then to the patient. However, in the embodiments shown in the figures, the release of the plunger biasing member 50 or the release of any other biasing member does not drive the delivery member 16 downward relative to the housing 12. On the contrary, the drug product container 20, and as a result the delivery member 16, are substantially or completely fixedly coupled to the housing 12. Rather, the delivery member 16 is driven towards the patient's skin 5 by inertial forces generated by a downward force applied by the patient (or a healthcare provider or other person administering the dose).

[0084] Referring to FIGS. 7A and 7B, the releaser member 52 may have a hollow and generally cylindrical or tubular shape and may be centered about the longitudinal axis A. As shown in FIG. 2, the releaser member 52 may be disposed radially between the plunger guide 60 and the guard extension 37. Also, as shown in FIG. 2, the releaser member 52 is also disposed radially between the guard extension 37 and the plunger guide 60. Further, the extender biasing member 35 may be disposed axially between the releaser member 52 and the guard extension 37 and may be disposed radially about the releaser member 52. Generally, the releaser member 52 is configured to (1) operatively couple the guard member 32 and the plunger 26 in an operating sequence and (2) generate an audible signal indicating the end of drug delivery. By being configured in this way, the releaser member 52 is used to perform two separate functions, and thus the number of moving parts required for the drug delivery device 10 is reduced.

[0085] The channel surfaces 52b each receive the protrusions 48 of the top ring 45 and are configured to allow axial movement of the plunger 26 relative to the releaser member 52 while preventing or inhibiting rotational movement between the plunger 26 and the releaser member 52. As shown in the figures, the channel surfaces 52b extend adjacent to the inner surface of the releaser member 52, but the channel surfaces 52b do not have an arcuate shape. Instead, they have a shape that is divided into generally rectangular segments (as best shown in FIGS. 7B and 10A).

[0086] The releaser member 52 includes channel surfaces 52b that extend proximally beyond the proximal (e.g., top) surface of the tubular body of the releaser member 52. For example, the releaser member 52 includes proximal opposing contact surfaces 52d (which will be described in more detail below) for end-of-dose notification and the channel surfaces 52b, and the channel surfaces 52b each provide a continuous path to the top ring 45 while also allowing sufficient clearance between the proximal opposing contact surfaces 52d and the corresponding surfaces involved in end-of-dose notification to extend beyond the contact surface 52.

[0087] The releaser member 52 can be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12 depending on the stage of operation of the drug delivery device 10. The first rotation of the releaser member 52 associated with activation can be driven by the plunger biasing member 50 and / or the extender biasing member 35, while the subsequent rotation of the releaser member 52 associated with the generation of an administration end signal can be driven by the extender biasing member 35 only. Any linear translation of the releaser member 52 without rotation can be driven by the extender biasing member 35 only. In some embodiments, the releaser member 52 can translate linearly only in the proximal direction. However, another embodiment may allow for linear translation of the releaser member 52 in both the proximal and distal directions.

[0088] Although the general configuration of the drug delivery device 10 has been described, here, with reference to FIGS. 9A to 12C, a method of using the drug delivery device 10 to perform an injection will be described. As a preliminary step, the user can remove the drug delivery device 10 from any secondary package such as a plastic bag and / or a cardboard box. Also, as a preliminary step, the user can prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. Next, the user can pull and remove the removable cap 19 from the front housing 25. As a result of this movement, the gripper 13 can pull and remove the sterile barrier 21 from the drug storage container 20. Thereby, the insertion end 28 of the delivery member 16 can be exposed. Nevertheless, since the guard member 32 is disposed in the extended position, at this stage, the insertion end 28 of the delivery member 16 remains surrounded by the guard member 32. Next, the user can place the drug delivery device 10 on the injection site and then press the distal end of the guard member 32 against the injection site. The force applied by the user overcomes the biasing force of the extender biasing member 35 and the biasing force of the lock ring biasing member 51, thereby pulling the guard member 32 into the opening 14 and moving it proximally from the extended position to the retracted position. During the retraction movement of the guard member 32, the delivery member 16 remains stationary relative to the housing 12.

[0089] Some of the components of the device include various features, surfaces, and apertures for interaction with the plunger 26 and for controlling the release movement (e.g., injection sequence) of the plunger 26. Generally, the injection sequence is initiated by the retraction / axial movement of the guard member 32 in the proximal direction (upward in FIG. 2), which causes the axial movement of the guard extension 37 and unlocks the releaser member 52. When the releaser member 52 is unlocked (e.g., the first stage of movement), the plunger 26 and the plunger biasing member 50 push the releaser member 52 so as to rotate clockwise, enabling the axial movement of the plunger 26 in the distal direction (downward in FIG. 2). Thereafter, the plunger pushes the stopper 24 in the distal direction, thereby extruding the drug 22 from the drug product container 20 and from the delivery member 16. When the plunger reaches a particular point along the axial length of the device, the movement of the releaser member 52 is further unlocked (e.g., the second stage of movement), and the releaser moves in the proximal direction (upward in FIG. 2) and contacts the plunger guide 60, thereby generating an end-of-administration indication (such as an audible click). Here, the injection sequence will be described in more detail.

[0090] FIGS. 2, 9A, 10, and 11A show the pre-injection stage. The movement of the guard member 32 from the extended position to the retracted position can cause several operations. During the retraction of the guard member 32, since the delivery member 16 remains stationary relative to the housing 12, the insertion end 28 of the delivery member 16 extends through the aperture at the distal end of the guard member 32, thereby piercing the patient's skin at the injection site and penetrating into the patient's subcutaneous tissue. Further, as will be described in more detail below, the retraction of the guard member 32 can also activate the drive mechanism 30 and discharge the drug 22 from the drug storage container 20.

[0091] As shown in FIGS. 9A, 10, and 11A, in the pre-delivery state before the needle guard 32 retracts, the plunger 26 and the releaser member 52 can each be disposed in their respective first rotational positions. The plunger biasing member 50 can be in a biased state. As a result, the plunger biasing member 50 can act on the plunger 26 with a distally-directed biasing force that pushes the distal opposing cam surface 49 against the proximal opposing cam surface 60j. The resulting cam action can rotate the plunger 26 in a clockwise direction. Despite these biasing forces, neither the releaser member 52 nor the plunger 26 rotates in the pre-delivery state. This is because the releaser member 52 and the plunger are rotatably fixed in the pre-injection state. Thus, as will be described in more detail herein, before the guard member 32 retracts, the releaser member 52, the plunger guide 60, the guard extension 37, and the housing 12 operate in cooperation with each other to keep the plunger biasing member 50 in a biased state.

[0092] As best shown in FIG. 2, when the guard member 32 moves in the proximal direction (upward in FIG. 2), the proximal end 32d of the guard member 32 contacts the distal opposing surface of the guard extension 37 and pushes the guard extension in the proximal direction. As shown in FIGS. 6B and 7A, the inner surface of the annular wall of the guard extension 37 includes a lock flange 37c, and the outer annular surface of the releaser member 52 includes a corresponding lock flange 52a. As shown in FIGS. 2, 9A, 10A, and 11A, when the device is in the pre-injection stage, the lock flange 37c of the guard extension 37 engages the lock flange 52a of the releaser member 52, thereby rotatably locking the releaser member 52 (as best shown in FIG. 11A). At this point in the sequence, the distal opposing cam surface 49 of the top ring 45 of the plunger 26 abuts the proximal opposing cam surface 60j of the plunger guide 60, and this interaction inhibits the axial movement of the plunger 26 (best shown in FIGS. 9A and 10A). The distal opposing cam surface 49 and / or the proximal opposing cam surface 60j include inclined surfaces for facilitating the relative movement of the top ring 45 of the plunger 26 in the direction of arrow 60k (clockwise) in FIGS. 9A and 10A. For example, the distal opposing cam surface 49 has a gradient 60m of about 10 degrees (best shown in FIGS. 9B and 9C), but may have any suitable gradient such as 9 - 11 degrees, 8 - 12 degrees, 7 - 13 degrees, 6 - 14 degrees, 5 - 15 degrees, 4 - 16 degrees, or any other suitable gradient. Additionally or alternatively, the distal opposing cam surface 49 of the top ring 45 may have a gradient 49a of about 10 degrees, but may have any suitable gradient such as 9 - 11 degrees, 8 - 12 degrees, 7 - 13 degrees, 6 - 14 degrees, 5 - 15 degrees, 4 - 16 degrees, or any other suitable gradient. The gradient of one or more of each surface 60j, 49 creates a lateral force against the axial force by the plunger biasing member 50, thereby pushing the top ring 45 of the plunger 26 in the clockwise direction 60k. However, as described above, while the top ring 45 is disposed within and / or in contact with the channel surface 52b, the releaser member 52 prevents or inhibits rotational movement between the releaser member 52 and the plunger.As a result, as long as the guard extension 37 rotatably locks the releaser member 52 (as shown in FIGS. 2, 9A, 10A, and 11A), the top ring 45 remains rotatably locked by the channel surface 52b and axially locked by the proximal opposing cam surface 60j.

[0093] The unlocking stage is shown in FIG. 11B. At this stage, the locking flange 37c of the guard extension 37 disengages from the locking flange 52a of the releaser member 52, and the guard extension 37 translates proximally until the releaser is no longer rotatably locked. At this stage of the injection sequence, the following two things occur simultaneously or almost simultaneously. (1) The inner surface of the releaser member 52 (substantially aligned with the reference numeral 52c shown in FIGS. 9C and 7B, but rather the inner surface and not the outer surface denoted by reference numeral 52c of the releaser member 52), or the outer surface of the plunger guide 60 (such as rib 60n (FIG. 5B)) on one or both of the cam surfaces that convert the axial force by the guard biasing member 35 into a lateral (clockwise) force, rotate the releaser member 52 clockwise and move it upward (proximally), and (2) the cam action between the surfaces 49, 60j of the plunger 26 and the plunger guide 60 causes the plunger biasing member 50 to push the top ring 45 clockwise and downward (distally), thereby moving the plunger 26 clockwise and slightly downward along the inclined surface 60j. In other words, both the releaser member 52 and the top ring 45 of the plunger 26 rotate clockwise by the forces from the respective biasing members 35, 50 simultaneously or substantially simultaneously. This sliding motion between the surfaces 49, 60j of the plunger 26 and the plunger guide 60 results in rotation and linear translation (similar to a helical path). Thus, the plunger guide 60 can function as a cam, and the plunger rod 26 can function as a cam follower.

[0094] The unlocking stage is shown in FIGS. 9B, 10B, and 11C. At this stage, the distal opposing cam surface 49 of the top ring 45 releases the proximal opposing cam surface 60j of the plunger guide 60 so that the top ring 45 (and thus the plunger 26) is no longer axially constrained by the plunger guide 60. As a result, the plunger biasing member 50 axially pushes the plunger 26 in the distal direction.

[0095] The downward stroke phase is shown in FIGS. 9C, 10C, and 12A. At this point in FIGS. 9C, 10C, and 12A, the top ring 45 can still be seen near the proximal portion of the plunger guide 60, but quickly moves along the longitudinal slot 86 formed in the plunger guide 60 and the channel surface 52b. During this phase, the top ring 45 of the plunger 26 moves along both the channel surface 52b of the releaser member 52 and the longitudinal slot 86 of the plunger guide 60, thereby preventing rotation between any of the three components (26, 52, 60). As a more specific example, while the plunger guide 60 is rotatably attached to the housing 12, the top ring 45 is disposed both within the channel surface 52b and within the longitudinal slot 86, so the releaser member 52 cannot rotate. Also, during this phase, as the plunger 26 moves distally, the gap 18 between the base portion 47 of the plunger 26 and the stopper 24 decreases, and the base portion 47 contacts the stopper 24. The device 10 is designed such that the plunger 26 moves with sufficient force to drive the stopper 24 distally and extrude the drug 22 from the delivery member 16. At the same time, the device 10 is also designed to reduce or eliminate, for example, the possibility of glass breakage, unwanted forces acting on the patient, and / or unwanted shock vibrations or sounds due to the interaction between the base portion 47 and the stopper 24. For example, the design parameters of the plunger biasing member 50 can be designed to meet these two sets of design goals. As another example, damping components can be disposed between the base portion 47 and the stopper 24 or at another location within the device 10 to damp the force between the base portion 47 and the stopper 24. For example, the base portion 47 may include an elastomeric component, part, or other damping feature. Additionally or alternatively, the stopper 24 may be formed of an elastomeric material having inherent damping properties. Additionally or alternatively, the stopper 24 may include additional elastomeric components, parts, or other damping features.

[0096] In some embodiments, the cam action between the distal opposing cam surface 49 on the projection 48 and the proximal opposing cam surface 60j of the plunger guide 60 can provide a damping effect. More specifically, the sliding friction between these two surfaces can be selected to delay the initial expansion of the plunger biasing member 50. As a result, during the initial expansion of the plunger biasing member 50, the speed of the plunger 26 can be reduced compared to an unobstructed expansion of the plunger biasing member 50. The reduced speed of the plunger 26 allows the plunger 26 to impact the stopper 24 with a smaller force, thereby reducing the potential for structural damage to the drug storage container 20 and / or facilitating a more comfortable injection for the user.

[0097] The administration end stage is shown in FIGS. 12B and 12C. As described above, during the downward stroke stage, while the top ring 45 is disposed within the channel surface 52b and the longitudinal slot 86, the releaser member 52 cannot rotate relative to the plunger guide 60. However, in the administration end start stage shown in FIG. 12B, the top ring 45 can, in some embodiments, release the distal end of the releaser member 52 and no longer restrict or prevent the rotation of the releaser member 52. As a more specific example, as shown at the bottom of FIG. 12B, as the top ring 45 exits the channel surface 52b and / or the distal surface 52d of the releaser, the releaser member 52 is no longer rotationally constrained by the top ring 45 and the releaser member 52 is pushed upward by the guard biasing member 35. By the upward force of the guard biasing member 35 and the cam surface, the releaser member 52 rotates clockwise while moving upward within the helical path, and the proximal opposing surface 52d of the releaser member 52 contacts the distal opposing surface 60p of the plunger guide 60, thereby making an audible click sound. As a more specific example, FIG. 12B shows the gap 90 between each surface 52d, 60p, which gap 90 is then removed as the releaser member 52 moves proximally as shown in FIG. 12C. The lengths of the channel surface 52b and the plunger 26 can be designed such that the top ring 45 exits the channel surface 52b when the stopper 24 reaches a desired movement location within the drug storage container 20, such as its moving end near the distal end of the drug storage container 20.

[0098] As a more specific example of the cam surface configuration between the release member 52 and the plunger guide 60, and as described above, the rib 60n of the plunger guide 60 is aligned with the inner surface of the release member 52 (but rather the inner surface rather than the outer surface indicated by reference numeral 52c) shown by reference numeral 52c in FIGS. 7A and 7B. The rib 60n has an inclined surface so as to help facilitate and / or promote relative rotation between the components 52, 60. More specifically, the biasing force of the guard biasing member 35, in combination with the inclined surface of the rib 60n, generates a rotational force (e.g., torque) to rotate the release member 52 relative to the plunger guide 60. During the first stage of rotation of the release member 52 (e.g., the unlocking stage shown in FIG. 11B), the rib 60n moves along a first section of the internal cam surface 52c of the release member 52, e.g., the first section 52f shown in FIG. 7B. During the second stage of rotation of the release member 52 (e.g., the end-of-dose stage shown in FIGS. 12B and 12C), the rib 60n moves along a second section of the internal cam surface 52c of the release member 52, e.g., the second section 52g shown in FIG. 7B. As seen in FIG. 7B, the second section 52g includes a pocket 52h that can receive the rib 60n and allows the release member 52 to quickly move proximally towards the plunger guide 60 and generate an audible click sound at the end of dosing. In summary, at the end-of-dose stage, the top ring 45 releases the channel surface 52b of the release member 52, the guard biasing member 35 and the rib 60n rotate and move the release member 52 upward, and the release member 52 quickly moves upward (proximally) as the rib 60n moves into the pocket 52h and contacts the plunger guide 60 to end.

[0099] When the patient and / or healthcare provider hears an audible sound, they may be notified that the administration is complete. In some embodiments, the user may be informed of the importance of the audible signal by instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an instruction for use (IFU) pamphlet packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by observing the movement of the stopper 24 and / or the plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by vibrations or other tactile feedback generated as a result of the release member 52 colliding with the plunger guide 60. The audible notification may be in the form of a click sound or a slap sound or any other suitable audible signal that can be recognized by the user. The audible signal may be generated at or substantially simultaneously with the stopper 24 reaching the administration end position.

[0100] As described above, in addition to its retaining function, the release member 52 can also be used to generate an audible signal indicating to the user that drug delivery, i.e., administration, is complete. By virtue of this dual-functional role, the number of components and / or the complexity of the design can be reduced. Alternatively, the release member 52 need not have this indicator function. In another embodiment, the indicator can be defined by a structure that is separate from but firmly attached to the release member 52.

[0101] In the foregoing description, the extender biasing member 35 can be used to provide the operating energy required for generating the administration end signal, but in another embodiment, a biasing member separate from the extender biasing member 35 may be used for this purpose. In such a particular embodiment, this additional biasing member may have a distal end fixed to the housing 12 and a proximal end that abuts against the distal opposing surface of the release member 52. Thus, the biasing member can push aside the housing 12 and act on the release member 52 with a biasing force in the proximal direction. Further, this biasing member may operate independently of the plunger biasing member 50 and the extender biasing member 35.

[0102] In any case, when the user receives some confirmation that drug delivery has been completed, the user can then lift the drug delivery device 10 from the injection site. With nothing obstructing the extender biasing member 35, the extender biasing member 35 can push the guard member 32 from the retracted position to the extended position and cover the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 can rotate a locking ring 40 to a position that prevents the guard member 32 from retracting thereafter.

[0103] For example, as described above, in some embodiments of the drug delivery device 10, when the guard member 32 moves from the retracted position to the extended position, it may include a locking ring 40 configured to lock the guard member 32 in the extended position. In this embodiment, the locking ring 40 is centered about the longitudinal axis A and rotates about the longitudinal axis A. As shown in FIG. 2, the proximal end of the locking ring 40 may contact a portion of the housing 12, and the distal end of the locking ring 40 may be at least partially disposed within the guard member 32. A locking ring biasing member 51 may be axially disposed between the distal opposing surface of the locking ring 40 and the proximal opposing surface of the guard member 32. The locking ring biasing member 51 may initially be in a compressed or biased state so as to bias the locking ring 40 and the guard member 32 away from each other. Thus, the locking ring biasing member 51 can not only exert a biasing force that pushes the guard member 32 towards the extended position, but also exert a biasing force that pushes the proximal end of the locking ring 40 against a portion of the housing 12 such as the annular collar 12d. In some embodiments, the locking ring biasing member 51 may include a compression spring (e.g., a compression coil spring).

[0104] The locking ring 40 may also function to provide an initial resistance to the movement of the guard member 32. As described above, the device 10 can be inserted into a patient using, leveraging, or otherwise utilizing inertial forces. As described in more detail below, the locking ring 40 and / or other components may provide an initial resistance to the movement of the guard member 32 to accumulate the force input by the user.

[0105] FIG. 13 shows a perspective view of the locking ring 40. In the example shown in FIG. 13, the locking ring 40 includes a cam surface 40a, and the cam surface 40a is configured to convert the translational movement of the shield guard 32 into rotational movement of the locking ring 40, rather than being parallel to the axis A. As a more specific example, the cam surface 40a shown in FIG. 13 has an angle 40d with respect to the axis A of approximately -30 degrees. Any suitable angle such as -10 to -80 degrees, -20 to -70 degrees, -20 to -60 degrees, -20 to -50 degrees, -20 to -40 degrees, -25 to -35 degrees, or any other suitable angle may be used. The angle 40d may be a positive number (such that the angled surface is inverted about the axis A), but such a configuration rotates the locking ring 40 in the opposite direction. In such a case, any suitable angle such as 10 to 80 degrees, 20 to 70 degrees, 20 to 60 degrees, 20 to 50 degrees, 20 to 40 degrees, 25 to 35 degrees, or any other suitable angle may be used.

[0106] In the example shown in FIG. 13, the locking ring 40 may include a locking arm 40b that can be a substantially cantilevered arm extending from the body portion of the locking ring 40 (along the perimeter of the locking ring 40). The locking arm 40b may include a protrusion 40c that extends in a transverse direction with respect to the body portion of the locking ring 40 (i.e., outwardly and non-parallel to the axis A).

[0107] FIG. 14 shows the locking ring 40 along with various other components of the device at the pre - deflection stage (e.g., before the guard member 32 is axially deflected in the proximal direction). For example, FIG. 14 shows a distal portion of the housing 12 (partial cross - sectional view for illustration), the guard member 32 (in a translucent form and partial cut - away view for illustration), the locking ring 40, and a portion of the inner housing collar 12d. The guard member 32 includes a plurality of ribs formed on its annular inner surface. These ribs are shown in FIG. 14, although a portion of the annular surface itself has been cut away for illustration. Similarly, a portion of the housing 12 has been cut away for illustration, but the annular collar 12d formed on the inner surface of the housing 12 can be seen in FIG. 14. When the device 10 is in the pre - deflection stage (as shown in FIG. 14), the protrusion 40c is adjacent to the inertia rib 32k formed on the inner annular surface of the guard member 32. As a more specific example, when the device 10 is in the pre - deflection stage, the protrusion 40c is positioned to the left of the inertia rib 32k such that the locking ring 40 generally prevents rotation (thereby preventing axial deflection of the guard member 32) until the protrusion 40c can move beyond (i.e., pass through) the inertia rib 32k. This configuration will be described in more detail below.

[0108] FIGS. 15A and 15B show views from different angles (offset from each other by approximately 90 degrees) of the device when it is in the initial deflection stage immediately after the guard member 32 has been released from engagement with the locking arm 40b. As a more specific example, the locking ring 40 is rotating such that the protrusion 40c has just passed through the locking rib 32k, thereby allowing the guard member 32 to deflect more freely (in the proximal direction). At this point in the sequence, it appears that the injection sequence has not been initiated. For example, the plunger biasing member 50 has not yet been released because the housing 12 has not yet moved distally far enough for the delivery member 16 to pierce the user's tissue.

[0109] For the components of the device to transition from the stage shown in FIG. 14 to the stages shown in FIGS. 15A and 15B, two main events, namely, the initial rotation of the locking ring 40 and the release from the locking arm 40b, occur almost simultaneously with each other. Regarding the initial rotation, as shown in FIG. 15B, the locking ring cam surface 40a is generally aligned with the cam rib 32j in order to convert the translational movement of the shield guard 32 into the rotational movement of the locking ring 40. As a more specific example, when the shield guard is retracted, the proximal opposing top surface of the cam rib 32j applies an axially upward force to the cam surface 40a. As a more specific example, due to the angle of the cam surface 40a with respect to the axis A, the upward force by the cam rib 32j has an axial component (along the axis A) and a rotational component (transverse to the axis A), whereby the locking ring 40 rotates. In other words, in both the stage shown in FIG. 14 and the stages shown in FIGS. 15A and 15B, the rotation of the locking ring 40 is caused by the deflection (retraction) of the guard member 32. The cam rib 32j biases the locking ring 40 to rotate to the right (i.e., counterclockwise as viewed from above in FIG. 15B), and at the same time, the locking arm 40b can substantially prevent such movement. For example, when the guard member 32 is pushed, the guard member 32 moves from the position shown in FIG. 14 to the positions shown in FIGS. 15A and 15B. As a more specific example, when the device 10 is in the position shown in FIG. 14, the raised portion 40c is disposed on the left side of the inertial rib 32k so that the locking ring 40 cannot rotate beyond a specific point until the raised portion 40c can pass through the inertial rib 32k. As shown in FIG. 15A, the raised portion 40c may be able to pass through the inertial rib 32k due to the radially inward deflection of the locking arm 40b. In such a design, the bending of the locking arm 40b at least partially determines the force required for the raised portion 40c to pass through the inertial rib 32k. In other words, the bending of the locking arm 40b at least partially determines the force required to sufficiently deflect the guard member 32 to initiate the injection process. The angle of the raised portion 40c with respect to the circumference of the locking ring 40 may also partially determine the force required to sufficiently deflect the guard member 32 to initiate the injection process.Furthermore, the degree of rotation that the locking ring 40 must undergo for the raised portion 40c to pass through the inertia rib 32k at least partially determines the distance that the guard member 32 translates (in the axial direction) before the locking arm 40b "releases" the guard member 32.

[0110] During operation, when the patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 can advance toward the injection site by a relatively small distance (e.g., 2 - 4 mm). Thereafter, the patient may feel resistance between the inertia rib 32k and the raised portion 40c. When the patient presses down with additional force, the raised portion 40c passes through the inertia rib 32k, and the delivery device 10 compresses the needle cover and its spring to a predetermined release point while effecting a rapid release to utilize the energy stored in the patient's muscle. The release mechanism such as the bending of the above-described locking arm 40b, the degree of rotation required to pass through the inertia rib 32k, and other parameters are such that when the raised portion 40c passes through the inertia rib 32k, the resulting needle insertion speed exceeds the patient's reaction speed, and the combination of this speed and the mass of the device can be designed to quickly and fully penetrate the skin to a subcutaneous depth. In other words, when the guard member 32 reaches the position shown in FIGS. 15A and 15B, the resistance to pushing the guard member is significantly reduced, so that the needle is inserted before the patient can stop the insertion process. As a more specific example, at this stage of the insertion process, the main resistance to the deflection of the guard member 32 due to the components at the distal portion of the device is by the locking ring biasing member 51, but this resistance is significantly smaller than the resistance provided by the locking arm 40b. Also, the user may still feel resistance to the deflection of the guard member 32, which should be noted as being due to other sub-components of the device, such as the activation of the drive mechanism 30. From this point forward, the insertion process is carried out very quickly, but the subsequent stages will be discussed in detail in the figures and the following chapter.

[0111] Figures 16A and 16B show views from different angles (offset from each other by approximately 90 degrees) when the device is in a continuous downward movement stage (at a point after FIGS. 15A and 15B where the housing has moved further distally and the guard member 32 has retracted further). At the point in the sequence shown in FIGS. 16A and 16B, the injection sequence may or may not have started, depending on desired release parameters such as the length of the needle, the desired insertion depth, and the distance between the guard member 32 and the tip of the needle.

[0112] As shown in FIG. 16A, at this point in the sequence, the cam rib 32j of the guard member 32 is passing or attempting to pass through the cam surface 40a such that the guard member 32 can deflect without rotating the lock ring 40. Additionally or alternatively, the inclined surface 40e of the lock ring 40 can engage the inclined surface 12g of the housing 12 (which can be defined by the annular collar 12d and is similar or identical to the inclined surface 412g of FIG. 25). This interaction between each surface 40e, 12g can also facilitate rotation of the lock ring 40 until it reaches the points shown in FIGS. 16A and 16B. Additionally or alternatively, at this stage of insertion, the stop ridge 40f of the lock ring 40 engages the stop rib 32n to limit rotation of the lock ring 40. However, as described above, at this stage, the guard member 32 can deflect without requiring or causing further rotation of the lock ring 40. More specifically, as shown in FIGS. 16B and 17, since the adjacent ribs (stop rib 32n and cam rib 32j) extend between adjacent components of the lock ring 40 (stop ridge 40f and cam surface 40a), the guard member 32 deflects relative to the housing 12.

[0113] FIG. 17 shows the device at the final insertion stage when the guard member is fully or nearly fully retracted. At this point in the sequence, the injection sequence appears to be activated. For example, the plunger biasing member 50 appears to be released and the delivery member 16 is inserted into the user's tissue. Further, at this point in the sequence, the guard member 32 is at or approaching its fully retracted position relative to the housing 12 and the device 10 is still pressed against the patient's skin. The user preferably holds the device 10 in this position at least until the drug delivery process is complete (i.e., when the total dose of the drug 22 has been delivered to the patient) and until an administration end notification indicates that the administration is complete. For purposes of illustration, the guard member 32 shown in FIG. 17 has a cutaway portion and it should be noted that FIG. 17 does not show the housing 12 (including the annular collar) or the drug reservoir 20.

[0114] FIGS. 18A and 18B show the device 10 in a lockout configuration when the guard member 32 is in its fully extended position (FIG. 18A) or nearly fully extended position (FIG. 18B). As a more specific example, the stop rib 32n and the cam rib 32j of the guard member 32 are aligned with the stop ridge 40f to limit and / or prevent deflection of the guard member 32 in the proximal direction. As another more specific example, the guard member 32 can only move proximally in the axial direction a distance indicated by the gap 91 in FIG. 18A, such that the guard member 32 cannot move proximally in the axial direction a sufficient distance to expose the delivery member 16. In other words, the guard member 32 is locked in a guard position that annularly surrounds the needle and minimizes or prevents inadvertent needle sticks.

[0115] In some embodiments, prior to removing the removable cap 19, the gripper 13 can be configured to prevent deflection of the locking arm 40b. As an example, the outer surface of the gripper 13 can be configured to abut the inner surface of the locking arm 40b to prevent the radially inward deflection of the locking arm 40b prior to removal of the removable cap 19. This configuration can reduce the possibility of unintentional lockout due to vibration or sudden movement during transportation or storage of the drug delivery device 10 before use. When the removable cap 19 is removed together with the gripper 13, the locking arm 40b can be deflected as described above.

[0116] The lock ring 40 and the housing 12 each have a stop surface, and the respective stop surfaces abut each other to prevent rotation between the lock ring 40 and the housing 12. For example, the lock ring 40 may have stop surfaces 40g and 40h (FIGS. 18A and 13) that abut the stop surfaces 12j, 12k (FIG. 18A) of the annular collar 12d. Each stop surface 40g, 40h of the lock ring 40 and each stop surface 12j, 12k of the annular collar 12d may be stepped surfaces to prevent or inhibit rotation between the lock ring 40 and the housing 12. The lock ring biasing member 51 can push the lock ring 40 in the proximal direction and / or the guard member 32 in the distal direction to hold the lock ring 40 in a predetermined position as shown in FIGS. 18A and 18B, i.e., in contact with the annular collar 12d.

[0117] Due to the circular cross-section of the housing 12, there is a possibility that the housing 12 may roll easily on the surface when the housing 12 is laid horizontally. To prevent or avoid such rolling, a part or all of the removable cap 19 may have a non-circular cross-section. In the illustrated embodiment, the removable cap 19 has a distal end with a non-circular cross-section and a proximal end with a circular cross-section. Thus, the cross-section of the removable cap 19 gradually transitions from a circular cross-section to a non-circular cross-section as it moves from the proximal end of the removable cap 19 to the distal end of the removable cap 19. In the illustrated embodiment, the non-circular cross-section of the distal end of the removable cap 19 takes the form of a substantially square. In other embodiments, the non-circular cross-section may be rectangular, triangular, or any other polygon or partial polygon as long as one or more surfaces of the removable cap 19 are flat or substantially flat to prevent or avoid rolling. Further, the non-circular cross-section of the distal end of the removable cap 19 may gradually increase in size as it moves distally such that the most distal portion of the distal end of the removable cap 19 has a larger cross-sectional area than the most proximal portion of the distal end of the removable cap 19. This configuration provides a flare shape to the distal end of the removable cap 19, which may further assist a user in gripping the removable cap 19 to remove it from the housing 12.

[0118] In some embodiments, the housing 12 and the removable cap 19 may each include respective anti-rotation features. These anti-rotation features may engage with each other to prevent or inhibit rotation of the removable cap 19 relative to the housing 12 when the removable cap 19 is in the storage position. In some embodiments, when the removable cap 19 is in the storage position, the anti-rotation feature of the housing 12 may be adjacent to and substantially aligned with the anti-rotation feature of the removable cap 19. For example, the radial protrusion 9 shown in FIG. 1A is disposed adjacent to the distal end of the housing 112. As shown in FIG. 1B, the removable cap 19 may include an opening 8 sized to snugly receive the radial protrusion 9 when the removable cap 19 is in the storage position. As a result of this mating engagement, the removable cap 19 may not be able to rotate relative to the housing 12. This can be beneficial when a user attempts to twist the removable cap 19 off the housing 12. In some cases, rotation of the removable cap 19 can cause a sterilization barrier such as an RNS or FNS to rotate, which in turn can cause the tip of the needle to enter the RNS or FNS of the seal member. Thus, by positioning the radial protrusion 9 within the opening 8 at least at the initial moment of cap removal, the core ring of the needle can be prevented. In another embodiment, the opening 8 may be formed in the wall of the housing 12, and the radial protrusion 9 may extend proximally from the proximal end of the removable cap 19.

[0119] In other embodiments, the removable cap may be and / or may be intended to be rotatable relative to the housing. For example, the removable cap may include features that convert the rotational movement of the removable cap into an axial assisting force that aids in separating the cap from the housing. As a more specific example, the removable cap and / or the housing may have a cam surface, such as a wavy surface, that converts the rotational movement of the removable cap relative to the housing into an axial distal movement of the removable cap relative to the housing. The axial assisting force provided by such a configuration can be beneficial to various users, including, for example, users with limited dexterity and / or muscle strength due to illness.

[0120] Figures 19A - 19B each show an exemplary force profile during the injection process of an exemplary drug delivery device, where the relative displacement amount between the device housing and the guard member is plotted along the x - axis (millimeters) and the resistance is plotted along the y - axis (Newtons). For example, the displacement (along the x - axis) represents the relative axial displacement amount between the guard member 32 and the housing 12 along axis A. As described above, this relative axial displacement amount can be understood to refer to the translational movement of the housing 12 relative to the guard member 32 (e.g., when the user pushes the housing distally towards the user's injection site while the user's tissue prevents the guard member 32 from moving in the same direction), or the translational movement of the guard member 32 relative to the housing 12 (e.g., when the housing 12 is held in place and the user pushes the guard member 32 proximally). In any case, the x - axis (horizontal) of the graph in Figure 19 represents the relative displacement amount between the guard member 32 and the housing 12. The y - axis (vertical) of the graph in Figure 19 represents the resistance force at various points in time of the relative displacement amount between the guard member 32 and the housing 12. For example, the resistance force that the user experiences when the guard member 32 and the housing 12 produce a relative displacement amount of about 2 mm is about 7.75 N in the force profile shown in Figure 19A. Even more specifically, the resistance force may refer to the force that the user experiences due to the mechanical interaction between the components of the device. For example, when initially pushing the housing 12 towards the injection site in the pre - injection state shown in Figure 14, the resistance force is approximately equal to the force required to compress the spring 51 and the force required to push the inertial rib 32k over the raised portion 40c. The force profiles in Figures 19A - 19B show several exemplary, potential desired force and displacement values, and thus it is understood that these values can vary depending on the design of the aforementioned interactions.

[0121] Nevertheless, as shown in the exemplary force profile of FIG. 19A, the initial resistance force is relatively small during the first approximately 1 mm of movement between the guard member 32 and the housing, after which, at point 202, the resistance force rapidly increases (mainly due to the force required to push the inertial rib 32k over the raised portion 40c), reaching a peak resistance force at point 204. When the inertial rib 32k passes over the raised portion 40c (FIG. 15A), the resistance force rapidly decreases to point 206. At this point, the resistance force is mainly due to the force required to compress the spring 51 (FIG. 14), the force required to compress the spring 35 (FIG. 11B), and the frictional forces between various movable components within the device. At point 208, the needle is inserted into the user's tissue, and at point 210, the injection phase begins and the drug 22 is injected into the user's tissue. When the user overcomes the peak resistance force at point 204, the housing and the drug reservoir can be driven towards the injection site by the user's inertia, facilitating needle insertion. This injection phase (between point 204 and point 208) can occur in a relatively short time due to the user's inertia, increasing the likelihood that the needle is fully inserted rather than partially inserted, and reducing the likelihood that the user stops the movement of the device before or during partial needle insertion. In other words, when the user clears the peak resistance force at point 204, the user can "focus" on the needle insertion and / or injection process.

[0122] FIG. 19B shows another exemplary force profile in which the peak force (point 304) is less than the corresponding point (204) in FIG. 19A, such that the user requires a smaller initial force to focus on the insertion. This force profile may reduce the likelihood that the user stops the process, such as prematurely removing the device from the tissue, during the initial push (point 302). However, it may be desirable to have a peak force 304 that is high enough to reduce the likelihood that the user stops the injection between the peak force 304 and the needle insertion 308. In other words, the vertical distance (along the y-axis) between point 304 and point 308 should be large enough to cause this injection phase to occur in a relatively short time.

[0123] Figures 20A - 20G show the distal portion of another design of device 400, mainly showing housing 412, guard member 432, lock ring 440, and lock ring biasing member 451. As shown in FIGS. 20A and 22, guard member 432 includes an annular base portion 432a, a pair of longitudinally extending arms 432b, a raised portion 432h, a plurality of internal ribs (described in more detail below), and at least one opening 432x (also called a hole in some of the figure annotations) formed in at least one of the ribs and walls of the guard member. The opening 432x does not have to be an opening formed throughout the wall of the guard member 432. For example, the opening may be merely a discontinuity within a long rib or protruding section having a lower height, rather than a cutout in a portion of the wall and ribs of the guard member 432. The internal ribs of the guard member 432 include a first rib that is preferably longer than other ribs (also known as long rib 432r), and a pair of short ribs 432s, 432t. The opening 432x is formed within the long rib 432r and is sized to be aligned with and, as further described below, selectively receive components of the lock ring 440. As shown in FIGS. 20A and 23, lock ring 440 includes a plurality of stop surfaces 440g, 440h, a U - shaped projection 440w (configured to be received within the opening 432x), and a plurality of proximal opposing cam surfaces 440x, 440y. However, the lock ring 440 shown in FIGS. 20A and 23 does not have a distal opposing cam surface corresponding to surface 40a in the design shown in FIG. 13. As shown in FIG. 20A, during the pre - injection, non - deflected state of device 400, each of the two U - shaped projections 440w is not initially received within the opening 432x. Rather, at this point, for example, the proximal portion of the long rib 432r (i.e., the portion of the long rib proximal to the opening 432x) is received within the U - shaped projection 440w to prevent, for example, the lock ring from moving upward (proximally) relative to the guard member.As shown in FIG. 20B, as the housing 412 moves downward (distally) and / or the guard member 432 moves upward (proximally), the lock ring 440 can move upward (proximally) from the spring 451, thereby bringing the cam surface of the housing 412 into contact with the lock ring cam surfaces 440x, 440y and rotatably pushing the lock ring. At the stage shown in FIG. 20B, the lock ring 440 cannot rotate because the proximal portion of the long rib 432r is aligned with the U-shaped protrusion 440w / received within the U-shaped protrusion 440w. Also, as shown in FIG. 20B, the housing cam surface 412x engages the lock ring cam surface 440y. However, as the relative movement between the guard member and the housing progresses to the state shown in FIG. 20C, the engagement between the housing cam surface 412x and the lock ring cam surface 440y, combined with further relative movement between the guard member and the housing, results in the following, namely, (1) the upward movement of the lock ring is stopped by the engagement between the housing cam surface 412x and the lock ring cam surface 440y, and the proximal portion of the long rib 432r can be disengaged from the alignment / engagement with the U-shaped protrusion 440w, where the U-shaped protrusion 440w is aligned with the opening 432x, and (2) the lock ring 440 is rotated by the engagement of each cam surface 412x, 440y. As shown in FIG. 20D, the lock ring rotates until the point (approximately two-thirds of its full rotation) where it is rotatably constrained by the short ribs 432s, 432t of the guard member (more specifically, the stop surface 440v shown in FIG. 23 engages the short ribs 432s, 432t). In the state shown in FIG. 20E, the guard member arm 432b moves sufficiently relative to the housing 412 such that the injection sequence can begin. As shown in FIG. 20F, when the user releases the pressure on the housing, allowing relative proximal movement of the housing and / or distal movement of the guard member, the lock ring is rotatably constrained until the stop surface 440v passes the short ribs 432s, 432t and the lock ring rotates to the lockout configuration shown in FIG. 20G.

[0124] Figures 26A - 26D show another alternative design of device 600 mainly showing housing 612, guard member 632, lock ring 640, and lock ring biasing member 651. As shown in Figure 26B, guard member 632 includes an annular base portion 632a, a pair of longitudinally extending arms 632b, a raised portion 632h, a plurality of internal ribs (described in more detail below), and at least one opening 632x (also referred to herein as a hole) formed in at least one of the ribs and walls of the guard member. Each rib of guard member 632 may be configured as a radially inwardly extending protrusion. Opening 632x need not be an opening formed throughout the wall of guard member 632. For example, opening 632x may be merely a discontinuity within a long rib or protrusion section having a lower height rather than a notch in a portion of the wall and ribs of guard member 632. Opening 632x is formed within rib 632r and is sized to be aligned with and selectively receive components of lock ring 640 as further described below. As shown in Figures 26A, 26B, and 26D, lock ring 640 includes a plurality of stop surfaces 640g, 640h, at least one tab - shaped protrusion 640w (configured to be received within opening 632x), and a plurality of proximal opposing cam surfaces 640y. As shown in Figure 26A, each tab - shaped protrusion 640w may be configured as a radially outwardly extending protrusion and may include a proximal opposing cam surface 640z. As shown in Figure 26D, during the pre - injection, partially deflected state of device 600, each of the two tab - shaped protrusions 640w is not initially received within opening 632x. Rather, at this point, the proximal opposing cam surface 612x of housing 612 is engaged with the distal opposing cam surface 640y of lock ring 640, preventing or inhibiting lock ring 640 from moving upwardly (proximally) relative to guard member 632. At the same time, each tab - shaped protrusion 640w is engaged with a respective pair of ramp surfaces 632y (also referred to herein as proximal opposing cam surfaces 632y).At this stage of the injection, the guard member 632 is partially deflected (such as in Figure 20B), but the lock ring 640 has not yet rotated, and the guard member 632 has not yet moved upward a sufficient distance to start the injection sequence. At this point, the user feels resistance to further movement of the injector housing 612 due to each of the above-described engagements, namely, the proximal opposing cam surface 612x of the housing 612 and the distal opposing cam surface 640y of the lock ring 640, and the proximal opposing cam surface 640z of the tab-shaped protrusion 640w of the lock ring 640 and the guard member ramp surface 632y. This resistance can or may prompt the user to push down on the injector with sufficient force to overcome the resistance (i.e., the peak resistance of the injector). The peak resistance is generated by the aforementioned interactions (the distal opposing cam surface 612x of the housing 612 and the proximal opposing cam surface 640y of the lock ring 640, and the distal opposing cam surface 640z of the tab-shaped protrusion 640w of the lock ring 640 and the guard member ramp surface 632y), and when the user's force is sufficient such that the tab-shaped protrusion 640w of the lock ring 640 slides along the inclined surface 632y of the guard member and the proximal opposing cam surface 640y of the lock ring 640 slides along the distal opposing cam surface 612x of the housing 612 (to the left in Figure 26D), the peak resistance is overcome (i.e., released). In other words, the lock ring 640 rotates in the direction of arrow 601 and moves slightly downward (distally) (as shown in Figure 26D). When the lock ring 640 has rotated sufficiently for the tab-shaped protrusion 640w of the lock ring to pass through the inclined surface 632y of the guard member, the guard member 632 can move axially upward (proximally). At this point, the following two things occur: (1) the guard member 632 translates proximally a sufficient distance, for example, to start the injection sequence, and (2) the tab-shaped protrusion 640w of the lock ring is axially aligned with the opening 632x of the guard member (Figure 26C), thereby enabling the lock ring 640 to rotate in the direction of arrow 602 (Figure 26D) and slightly upward (proximally) due to the interaction between the proximal opposing cam surface 640y of the lock ring 640 and the distal opposing cam surface 612x of the housing 612.Similar to the other embodiments described above, after injection is initiated, the lock ring 640 is in a position where it can lock out the shield. The injector 600 may be designed such that events (1) and (2) occur simultaneously such that when the guard member translates a sufficient distance to initiate injection, the lock ring rotates through an angle sufficient to initiate the lockout sequence. This may be desirable to substantially or completely prevent the user from attempting multiple injections. This may also be desirable to substantially or completely prevent the lockout sequence from being initiated without the injection sequence also being initiated. In other words, the above configuration can reduce the likelihood that the user has a locked out injector with an undelivered dose.

[0125] To facilitate rotation of the lock ring 640 relative to the housing 612 and / or the guard member 632, any two or combination of the following, namely, the distal opposing cam surface 612x of the housing 612, the proximal opposing cam surface 632y of the guard member 632, the distal opposing cam surface 640z of the lock ring 640, and the proximal opposing cam surface 640y of the lock ring 640, may be parallel to each other.

[0126] Figures 21A - 21F show the distal portion of another alternative design of device 500, mainly showing housing 512, guard member 532, lock ring 540, and lock ring biasing member 551. The components of device 500 are similar to those of device 400, except that lock ring 540 has only a pair of parallel protrusions 540w instead of U - shaped protrusion 440w and does not have a horizontal protrusion connecting them. In other words, protrusion 540w has the "sides" of a U - shape but no "bottom" of the U - shape. In the state shown in Figure 21A, protrusion 540w is received within the long rib of guard member 532 to prevent rotational movement of the lock ring. Due to relative movement between the guard member and the housing, as shown in Figure 21B, protrusion 540w is aligned with the opening of the guard member, thereby allowing rotational movement of the lock ring with respect to the guard member (and being pushed by the cam surface of the housing). As shown in the state of Figure 21C, thereafter, the lock ring rotates until stop surface 440v engages the short rib of the guard member. Figure 21D shows the distal components of the device during injection startup. Figure 21E shows the state of the distal components where the user releases pressure and the guard member can move (extend distally) relative to the housing. Figure 21F shows the lockout configuration.

[0127] FIG. 24 provides a graph for comparing the force profiles shown in FIGS. 19A and 19B with the force profiles by the drug delivery device 400 shown in FIGS. 20A-20G and the drug delivery device 500 shown in FIGS. 21A-21F. Similar to FIGS. 19A and 19B, FIG. 24 plots the resistance force received by the user against the displacement of the shield (e.g., shield guard 32). Further, FIG. 24 reveals where in each force profile the lock point associated with the locking ring is designed to occur. FIG. 24 shows that the lock points of the force profiles in FIGS. 19A and 19B occur at the same shield displacement amount when the user receives the peak resistance. In contrast, the lock points of the force profiles associated with the drug delivery device 400 and the drug delivery device 500 do not coincide with the shield displacement amount corresponding to the peak resistance received by the user. The device 600 shown in FIGS. 26A-26D can be designed such that the lock point occurs simultaneously with or immediately after the user receives the peak resistance. Although the force profile of the device 600 is not shown in FIG. 24, the force profile may appear similar to those in FIGS. 19A and 19B. That is, it has a relatively sharp peak and a decrease. However, the force profile of the device 600 can shift to the right such that the peak occurs closer to the needle insertion point (a displacement amount of 5-6 mm in FIG. 24).

[0128] Continuing to refer to FIG. 24, the force profile associated with the drug delivery device 400 is similar to the force profiles of FIGS. 19A and 19B in that, prior to needle insertion, the user experiences a sharp increase in resistance due to displacement of the shield. Unlike the force profiles of FIGS. 19A and 19B, the resistance experienced by the user of the drug delivery device 400 may continue to increase (to the activation point) after this increase. FIG. 24 shows that the user of the drug delivery device 500 may not experience a sharp increase in resistance during displacement of the shield and, rather, may experience a resistance that gradually increases to the activation point. A manufacturer may select one of the force profiles shown in FIG. 24 or a different force profile, for example, according to a desired user experience, the physical and / or mental capabilities of the intended user or patient population, considerations of mechanical safety, and / or additional considerations.

[0129] From the above, it can be seen that the present disclosure advantageously provides an optimized design for drug delivery devices having automated features. The various mechanisms and components of the drug delivery device can interact synergistically with each other to limit the number of moving parts required by the drug delivery device, thereby not only improving the reliability of the drug delivery device and saving costs, but also providing other benefits and advantages.

[0130] Of course, the devices and methods according to the present disclosure can have one or more advantages over the prior art, and any one or more of them may exist in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. The same may be understood for other advantages not specifically mentioned herein.

[0131] The foregoing description has been directed to 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 specified below, as well as their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and is used to refer to any kind of agent or therapeutic material, including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biological agents, biologically active agents and compositions, macromolecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic pharmaceuticals. Non-therapeutic injectable materials are also included. The drug may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0132] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0133] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device can be used with them. 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, pegylated filgrastim-bmez), or FULPHILA (pegylated filgrastim-bmez).

[0134] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA) formulation, which can be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that, for example, binds to a receptor and directly or indirectly causes activation of the erythropoietin receptor by causing dimerization of the receptor. Examples of erythropoiesis stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include Epogen® (epoetin alpha), Aranesp® (darbepoetin alpha), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogs, but are not limited thereto.

[0135] Among certain 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, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully human monoclonal antibodies; Myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that inhibit activities mediated by binding 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 humanized and fully human monoclonal antibodies, including but not limited to human CD22-specific IgG antibodies, such as the dimer of human-mouse monoclonal hLL2γ chain disulfide bound to the human-mouse monoclonal hLL2κ chain, for example, the human CD22-specific fully humanized antibody of epratuzumab (CAS registration number 501423-23-0); Humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, such as human CD22-specific antibodies; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, etc. (also referred to as 「B7RP-1」, B7H2, ICOS-L, B7h, and CD275), including but not limited to fully human monoclonal IgG2 antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., including but not limited to HuMax IL-15 antibody and related proteins, such as 145c7, particularly humanized monoclonal antibodies; Human IFNIFN-γ specific antibodies, peptibodies, related proteins, etc., including but not limited to those containing γ-specific antibodies and fully human anti-IFN-γ antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., and other TALL specific binding proteins; parathyroid hormone (「PTH」) specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor (「TPO-R」) specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor (「HGF」) specific antibodies, peptibodies, related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon β-1a), Bexxar® (tositumomab, anti-CD22 monoclonal antibody), Betaseron® (interferon-β), Campath® (alemtuzumab, anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-α4β7mAb), 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 cancer or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), Vectibix® (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 alfa-con-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP), Kineret® (anakinra), Leukine® (sargramostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphotstat-B, belimumab, anti-BlySmAb), Metalyse (registered trademark) (tenecteplase, t-PA analog), Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta), Mylotarg (registered trademark) (gemtuzumab ozogamicin), Raptiva (registered trademark) (efalizumab), Cimzia (registered trademark) (certolizumab pegol, CDP870), Soliris (trademark) (eculizumab), pexelizumab (anti-complement C5), Numax (registered trademark) (MEDI-524), Lucentis (registered trademark) (ranibizumab), Panorex (registered trademark) (17-1A, edrecolomab), Trabio (registered trademark) (lerdelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem (registered trademark) (IDM-1), OvaRex (registered trademark) (B43.13), Nuvion (registered trademark) (visilizumab), canzumab mertansine (huC242-DM1), NeoRecormon (registered trademark) (epoetin beta), Neumega (registered trademark) (oprelvekin, human interleukin-11), Orthoclone OKT3 (registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit (registered trademark) (epoetin alpha), Remicade (registered trademark) (infliximab, anti-TNFα monoclonal antibody), Reopro (registered trademark) (abciximab, anti-GP IIb / IIia receptor monoclonal antibody), Actemra (registered trademark) (anti-IL6 receptor mAb), Avastin (registered trademark) (bevacizumab), HuMax-CD4 (zanilimumab), Mvasi (trademark) (bevacizumab-awwb), Rituxan (registered trademark) (rituximab, anti-CD20mAb), Tarceva (registered trademark) (erlotinib), Roferon-A (registered trademark) (interferon α-2a), Simulect (registered trademark) (basiliximab), Prexige (registered trademark) (lumiracoxib), Synagis (registered trademark) (palivizumab), 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507), Tysabri (registered trademark) (natalizumab, anti-α4 integrin mAb), Valortim (registered trademark) (MDX-1303, anti-anthrax protective antigen mAb), ABthrax (trademark), Xolair (registered trademark) (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (Ig domain of VEGFR1 fused to IgG1's Fc), Zenapax (registered trademark) (daclizumab), Zenapax (registered trademark) (daclizumab, anti-IL-2Rα mAb), Zevalin (registered trademark) (ibritumomab tiuxetan), Zetia (registered trademark) (ezetimibe), Orencia (registered trademark) (abatacept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (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 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3mAb, anti-Clostridium difficile toxin A and toxin B C mAb MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMaxCD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF Idiopathic Pulmonary Fibrosis Phase 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 (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 Receptor mAb, anti-Integrin Receptor mAb (MDX-018, CNTO95), 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).

[0136] In some embodiments, the drug delivery device is a sclerostin antibody such as, but not limited to, BPS804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing. In other embodiments, the drug delivery device may contain or be used with 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 with rilotumumab, voxelotor, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. 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, including, but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042, or the device may be used with these. In some embodiments, the drug delivery device may contain or be used with an endogenous metalloproteinase tissue inhibitor (TIMP) such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets, but not limited to these, may also be delivered using the drug delivery device of the present disclosure.In addition, bispecific T cell engager (BiTE®) antibodies, 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 with an APJ macro-agonist, such as but not limited to apelin or an analog 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 devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxirane-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used 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 with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as patients with chronic kidney disease (CKD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF inhibitor, such as a non-antibody VEGF inhibitor, and / or a VEGF trap (Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2, fused to the Fc domain of IgG1), such as aflibercept. In some embodiments, the drug delivery device may contain or be used with ABP959 (eculizumab), a biosimilar candidate for 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 rozibafusp alfa (formerly AMG570), a novel bispecific antibody-peptide conjugate that simultaneously inhibits the activity of ICOS-L and BAFF. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil (a small molecule selective cardiac myosin activator) or myotrope (targeting the contractile mechanism of the heart) or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotrasib (formerly known as AMG510), KRAS. G12C a small molecule inhibitor, or KRAS G12CAnother product containing a small molecule inhibitor may be contained or used together therewith. In some embodiments, the drug delivery device may contain or be used together 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 together with another product containing AMG714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used together with another product containing AMG890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used together with another product containing ABP654 (human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used together with another product containing Amjevita™ or Amgevita™ (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product that includes a human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used together with another product containing AMG160, or 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 together with another product containing AMG119, 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 AMG119, or another product containing a delta-like ligand 3 (DLL3) chimeric antigen receptor T cell (CAR T cell) therapy. In some embodiments, the drug delivery device may contain or be used with AMG133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a glucagon-like peptide-1 receptor (GLP-1R) agonist. In some embodiments, the drug delivery device may contain or be used with AMG171, or another product containing a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG176, or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG199, or another product containing a half-life extended (HLE) bispecific T cell engager (BiTE®) construct. In some embodiments, the drug delivery device may contain or be used with AMG256, or another product containing an anti-PD-1xIL21 mutein and / or an interleukin-21 (IL-21) receptor agonist designed to selectively turn on the IL-21 pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG330, or another product containing an anti-CD33x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody that is being studied as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG427, 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 AMG430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG506, or another product containing a multispecific FAPx4-1BB target DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG509, or another product containing a bivalent T cell derivative and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG562, or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with efalokin alfa (formerly AMG592), or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device... S may contain or be used with another product containing AMG596, or a CD3x 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 AMG673, or a half-life extended (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG701, or 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 another product containing AMG757, or 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 another product containing AMG910, or a half-life extended (HLE) epithelial cell adhesion molecule Claudin 18.2xCD3 BiTE® (bispecific T cell engager) construct.

[0137] The drug delivery devices, assemblies, components, subsystems, and methods have been described from the perspective of exemplary embodiments, but they are not limited to the exemplary embodiments. The embodiments for carrying out the invention should be construed merely as examples and do not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments are still within the scope of the claims that define the invention disclosed herein.

[0138] Those skilled in the art will understand that various modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed in this specification, and such modifications, changes, and combinations are construed to be within the scope of the concept of the present invention.

Claims

1. A drug storage container including a housing defining a longitudinal axis and having an opening, and a delivery member having an insertion end configured to at least partially extend through the opening in a delivery state, wherein the drug storage container is coupled to the housing to substantially prevent relative movement between the drug storage container and the housing, a plunger movable distally relative to the drug storage container for discharging drug from the drug storage container through the delivery member, a plunger biasing member configured to push the plunger in the distal direction, a guard disposed adjacent to the opening, the guard being operatively coupled to the plunger biasing member such that relative movement between the guard and the housing along the longitudinal axis enables release of the plunger biasing member, and a locking component configured to prevent the relative movement between the guard and the housing until released by a user's force, wherein the resistance by the locking component causes the user to increase the user's force, and when the locking component is released, the user's force drives the housing and the drug storage container toward an injection site. The drug delivery device includes, at least a portion of the locking component is rotatable relative to the housing about the longitudinal axis, and at least a portion of the locking component has a first position where at least a portion of the locking component prevents the relative movement between the guard and the housing and a second position where at least a portion of the locking component does not prevent the relative movement between the guard and the housing or provides less resistance to the relative movement between the guard and the housing.

2. The drug delivery device according to claim 1, wherein at least a portion of the locking component includes a locking ring.

3. The drug delivery device according to claim 2, wherein the locking ring includes a locking arm having a base portion and a deflectable end, and deflection of the deflectable end enables the locking ring to rotate between the first position and the second position.

4. ​ The deflectable end portion includes a locking ridge, the drug delivery device according to claim 3.

5. The guard includes an inertial rib, the inertial rib is configured to engage with the locking ring and prevent rotational movement of the locking ring relative to the housing, the drug delivery device according to any one of claims 3 or 4.

6. The inertial rib is configured to engage with the deflectable end portion of the locking arm and prevent movement of the locking ring from the first position to the second position, the drug delivery device according to claim 5.

7. The guard further includes a cam rib, the cam rib is configured to engage with a first cam surface of the locking ring and push the locking ring towards the second position, the drug delivery device according to claim 6.

8. The locking ring has a second cam surface configured to engage with the guard and push the locking ring towards a third position, and a stop ridge configured to selectively engage with the guard and limit or prevent relative movement between the guard and the locking ring along the longitudinal axis when the locking ring is in the third position, the drug delivery device according to claim 7.

9. The guard includes a first proximal opposing cam surface, the housing includes a first distal opposing cam surface, the locking ring includes a second distal opposing cam surface and a second proximal opposing cam surface, the second distal opposing cam surface and the second proximal opposing cam surface are configured to engage with the first proximal opposing cam surface of the guard and the first distal opposing cam surface of the housing, respectively, when the locking ring is in the first position, and prevent proximal movement of the guard, the drug delivery device according to claim 2.

10. During proximal movement of the guard, one or more of the first proximal opposing cam surface of the guard and the first distal opposing cam surface of the housing rotate the locking ring from the first position towards the second position, the drug delivery device according to claim 9.

11. When the locking ring rotates to the second position, the second distal opposing cam surface of the locking ring is configured to disengage from the first proximal opposing cam surface of the guard, the drug delivery device according to claim 10.

12. The drug delivery device according to any one of claims 9 to 11, wherein any two or a combination of the following, namely, the first proximal opposing cam surface of the guard, the first distal opposing cam surface of the housing, the second distal opposing cam surface of the lock ring, and the second proximal opposing cam surface of the lock ring, are parallel to each other.

13. The drug delivery device according to any one of claims 9 to 12, wherein the lock ring includes a radially outwardly extending protrusion, and the radially outwardly extending protrusion includes the second distal opposing cam surface.

14. The drug delivery device according to any one of claims 9 to 13, wherein the guard includes a radially inwardly extending protrusion, and the radially inwardly extending protrusion includes the first proximal opposing cam surface.

15. A drug storage container including a housing that defines a longitudinal axis and has an opening, and a delivery member having an insertion end configured to at least partially extend through the opening in a delivery state, the drug storage container being coupled to the housing to substantially prevent relative movement between the drug storage container and the housing, a plunger movable distally relative to the drug storage container for discharging drug from the drug storage container through the delivery member, a plunger biasing member configured to push the plunger in the distal direction, a guard disposed adjacent to the opening such that the housing has a first position relative to the guard at which the plunger biasing member is locked and a second position relative to the guard at which the plunger biasing member is unlocked, a locking component configured to maintain the housing in the first position until the locking component is released by a user's force, the user increasing the user's force due to the resistance of the locking component, and when the locking component is released, the housing and the drug storage container being driven toward an injection site by the user's force, comprising At least a portion of the locking component is rotatable relative to the housing about the longitudinal axis, and at least a portion of the locking component has a first position where at least a portion of the locking component prevents relative movement between the guard and the housing, and a second position where at least a portion of the locking component does not prevent relative movement between the guard and the housing or provides less resistance to relative movement between the guard and the housing. A drug delivery device.

16. The drug delivery device according to claim 15, wherein at least a portion of the locking component includes a locking ring.

17. The drug delivery device according to claim 16, wherein the locking ring includes a locking arm having a base portion and a deflectable end portion, and deflection of the deflectable end portion enables the locking ring to rotate between the first position and the second position.

18. The drug delivery device according to claim 17, wherein the deflectable end portion includes a locking ridge.

19. The drug delivery device according to any one of claims 17 or 18, wherein the guard includes an inertia rib, and the inertia rib is configured to engage with the locking ring and prevent rotational movement of the locking ring relative to the housing.

20. The drug delivery device according to claim 19, wherein the inertia rib is configured to engage with the deflectable end portion of the locking arm and prevent movement of the locking ring from the first position to the second position.

21. The drug delivery device according to claim 20, wherein the guard further includes a cam rib, and the cam rib is configured to engage with a first cam surface of the locking ring and push the locking ring towards the second position.

22. The locking ring includes a second cam surface configured to engage with the guard and push the locking ring towards a third position, a stop ridge configured to selectively engage with the guard and limit or prevent relative movement between the guard and the locking ring along the longitudinal axis when the locking ring is in the third position. The drug delivery device according to claim 21, further including.

23. The guard includes a first proximal opposing cam surface, The housing includes a first distal opposing cam surface, The lock ring includes a second distal opposing cam surface and a second proximal opposing cam surface, and when the lock ring is in the first position, the second distal opposing cam surface and the second proximal opposing cam surface engage with the first proximal opposing cam surface of the guard and the first distal opposing cam surface of the housing, respectively, and are configured to prevent proximal movement of the guard. The drug delivery device according to claim 16. **Claim 24** During proximal movement of the guard, one or more of the first proximal opposing cam surface of the guard and the first distal opposing cam surface of the housing rotate the lock ring from the first position toward the second position. The drug delivery device according to claim 23. **Claim 25** When the lock ring rotates to the second position, the second distal opposing cam surface of the lock ring is configured to disengage from the first proximal opposing cam surface of the guard. The drug delivery device according to claim 24. **Claim 26** Any two or combinations of the following, namely, the first proximal opposing cam surface of the guard, the first distal opposing cam surface of the housing, the second distal opposing cam surface of the lock ring, and the second proximal opposing cam surface of the lock ring, are parallel to each other. The drug delivery device according to any one of claims 23 to 25. **Claim 27** The lock ring includes a radially outwardly extending protrusion, and the radially outwardly extending protrusion includes the second distal opposing cam surface. The drug delivery device according to any one of claims 23 to 26. **Claim 28** The guard includes a radially inwardly extending protrusion, and the radially inwardly extending protrusion includes the first proximal opposing cam surface. The drug delivery device according to any one of claims 23 to 27. **Claim 29** The drug storage container is filled or pre-filled with a drug, and the drug includes one of a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that reduces lipoprotein (a), a drug containing eculizumab, etanercept, tezepelumab, efalovikin alpha, evolocumab, a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. The drug delivery device according to claim 1. **Claim 30** The drug storage container is filled or pre-filled with a drug, and the drug includes one of a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that reduces lipoprotein (a), eculizumab, etanercept, tezepelumab, efalovikin alpha, a drug containing evolocumab, a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist, according to the drug delivery device of claim 15.

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