Drug delivery device, subassembly for a drug delivery device, syringe holder, and method of assembly - Patents.com

Abstract

A syringe holder for a drug delivery device is provided. The syringe holder may include a proximal end, a distal end, and a hollow interior configured to accommodate at least a portion of a syringe. The syringe holder may further include a side opening distal to the proximal end and an outwardly extending protrusion proximal to the side opening. Upon assembly of the syringe holder into a housing of the drug delivery device, the outwardly extending protrusion may be configured to support the syringe holder at a first axial position or an intermediate position relative to a longitudinal axis of the housing of the drug delivery device. Also provided are a drug delivery device incorporating the syringe holder and a subassembly for a drug delivery device incorporating the syringe holder. Methods of assembling a syringe holder into a housing of a drug delivery device are also provided.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 159,356, filed March 10, 2021, the entire contents of which are expressly incorporated by reference herein.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to devices for automatically injecting drugs into a patient, and to the manufacture of such devices. [Background technology]

[0003] General aversion to exposed needles and 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 a variety of advantages over traditional forms of drug delivery, including, for example, delivery by a traditional syringe.

[0004] Many drug delivery devices include a housing and a syringe stored within the housing. During the manufacture of such devices, it may be necessary or desirable to inspect the syringe and / or the syringe holder used to mount the syringe within the housing. Inspecting the syringe and / or the syringe holder after it is assembled to the housing may not be feasible because the walls of the housing may block the syringe and / or the syringe holder from view. Certain housings include windows designed to allow a user to view a portion of the syringe before, during, and / or after operation of the drug delivery device. However, such windows typically reveal only a limited portion of the syringe and, as a result, may not allow inspection of certain portions of the syringe and / or the syringe holder within the housing. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure describes drug delivery devices, subassemblies for drug delivery devices, syringe holders for drug delivery devices, and related assembly methods that embody advantageous alternatives to existing drug delivery devices and may address one or more of the problems or needs noted herein. [Means for solving the problem]

[0006] One aspect of the present disclosure provides a syringe holder for a drug delivery device. The syringe holder may include a proximal end, a distal end, and a hollow interior configured to accommodate at least a portion of a syringe. The syringe holder may further include a side opening distal to the proximal end and an outwardly extending protrusion proximal to the side opening. Upon assembly of the syringe holder into a housing of the drug delivery device, the outwardly extending protrusion may be configured to support the syringe holder at a first axial position or an intermediate position relative to a longitudinal axis of the housing of the drug delivery device.

[0007] The outwardly extending protrusion may be configured to contact a first inner portion of the housing of the drug delivery device when the syringe holder is in a first rotational position relative to the housing of the drug delivery device to prevent the syringe holder from moving in a distal direction relative to the housing of the drug delivery device. The outwardly extending protrusion may be configured to allow movement of the syringe holder in a proximal direction relative to the housing of the drug delivery device when the syringe holder is in a first axial position. The outwardly extending protrusion may be configured to be rotationally offset from the first inner portion of the housing of the drug delivery device to allow movement of the syringe holder in a distal direction relative to the housing of the drug delivery device when the syringe holder is in a second rotational position relative to the housing of the drug delivery device. At least a portion of the syringe holder may be configured to contact a second inner portion of the housing of the drug delivery device when the syringe holder is in a second axial position or a final assembly position relative to the longitudinal axis of the housing of the drug delivery device to prevent the syringe holder from moving distally relative to the housing of the drug delivery device.

[0008] Another aspect of the present disclosure provides a subassembly for a drug delivery device. The subassembly may include a syringe holder and a housing. The syringe holder may include an outwardly extending protrusion. The housing may include a hollow interior configured to accommodate at least a portion of the syringe holder, a first inwardly extending protrusion, and a second inwardly extending protrusion distal to the first inwardly extending protrusion. Upon assembly, the syringe holder may be disposed in a first axial position relative to a longitudinal axis of the housing where the outwardly extending protrusion of the syringe holder contacts the first inwardly extending protrusion of the housing, and in a second axial position relative to the longitudinal axis of the housing where at least a portion of the syringe holder contacts the second inwardly extending protrusion of the housing.

[0009] A further aspect of the present disclosure provides a drug delivery device comprising a housing having an opening and a syringe including a needle having an insertion end configured to extend at least partially through the opening in a delivery state. The drug delivery device may further comprise a syringe holder as generally described above.

[0010] An additional aspect of the present disclosure provides a method of assembling a syringe holder within a housing of a drug delivery device. The method may include at least partially disposing the syringe holder within the housing of the drug delivery device at a first axial position relative to a longitudinal axis of the housing of the drug delivery device. The method may further include inserting a syringe into the syringe holder while the syringe holder is disposed at the first axial position within the housing of the drug delivery device. Additionally, the method may include moving the syringe holder and the syringe distally relative to the longitudinal axis of the housing of the drug delivery device to a second axial position within the housing of the drug delivery device.

[0011] Placing the syringe holder in a first axial position within the housing of the drug delivery device may include coupling the syringe holder to the housing of the drug delivery device to prevent the syringe from moving at least in a distal direction relative to the housing of the drug delivery device. Placing the syringe holder in a first axial position within the housing of the drug delivery device may include coupling the syringe holder to the housing of the drug delivery device to prevent the syringe from rotating relative to the housing of the drug delivery device. Prior to moving the syringe holder and the syringe to a second axial position within the housing of the drug delivery device, the method may include decoupling the syringe holder from the housing of the drug delivery device. Decoupling the syringe holder from the housing of the drug delivery device may include moving the syringe holder in a proximal direction relative to the housing of the drug delivery device and / or rotating the syringe holder from a first rotational position to a second rotational position relative to the housing of the drug delivery device. Decoupling the syringe holder from the housing may include moving the syringe holder proximally relative to the housing of the drug delivery device prior to rotating the syringe holder from the first rotational position to the second rotational position.

[0012] The present disclosure will be more fully understood when the following description is taken 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 the particular element in any of the illustrative embodiments, unless expressly depicted in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0013] [Figure 1] 1A-1D are perspective views of an exemplary drug delivery device according to various embodiments. [Diagram 2] FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1. [Diagram 3] 1A-1D are perspective views of an exemplary syringe holder and an exemplary syringe prior to assembly into a drug delivery device according to various embodiments. [Figure 4] FIG. 4 is an enlarged view of a portion of the syringe holder of FIG. [Diagram 5] 4 is a perspective view of a portion of the syringe holder of FIG. 3 and a portion of the syringe of FIG. 3 during and / or after assembly. [Figure 6] 1A-1C are cutaway perspective views of a proximal portion of a housing of a drug delivery device according to various embodiments. [Figure 7] FIG. 7 is a cutaway perspective view of a distal portion of the housing of FIG. 6. [Figure 8] FIG. 8 is a cutaway perspective view of the housing partially shown in FIGS. 6 and 7. [Figure 9] 9 is a cutaway perspective view of the syringe holder of FIGS. 3-5 disposed at a first axial position within the housing of FIGS. 6-8. FIG. [Figure 10-15] 1 illustrates steps of an exemplary method for assembling a syringe holder within a housing of a drug delivery device according to various embodiments. [Figure 11-13] 1 illustrates the syringe holder in a first axial position and a first rotational position. [Figure 14] 1 shows the syringe holder in a second rotational position. [Figure 15] 1 illustrates the syringe holder in a second axial position and a second rotational position. [Figure 16] 1A-1D are perspective views of an exemplary syringe holder according to various embodiments. [Figure 17] FIG. 17 is a perspective view of the syringe holder of FIG. 16. [Figure 18] 17 is another perspective view of the syringe holder of FIG. 16. [Figure 19] FIG. 17 is an enlarged view of a portion of the syringe holder of FIG. 16. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The present disclosure relates generally to a drug delivery device operable by a user to administer a drug or to self-administer a drug in a scenario in which the user is a patient, as well as subassemblies and components for the drug delivery device and a method of assembling the drug delivery device. A drug delivery device or subassembly thereof according to the present disclosure may include a syringe holder and a housing having a hollow interior configured to accommodate the syringe holder. The syringe holder may be mounted at different axial positions within the housing during different stages of an assembly sequence. For example, the syringe holder may be initially mounted at a first axial position within the housing and then later in the assembly sequence at a second axial position within the housing. The first axial position may facilitate a manufacturer's ability to inspect a syringe inserted into the syringe holder, the syringe holder itself, and / or other aspects of the drug delivery device while the syringe and / or syringe holder are housed within the housing. The second axial position may correspond, for example, to a final assembly position of the syringe holder and syringe within the housing. The ability to inspect the syringe and / or syringe holder when the syringe holder is in the first axial position may, for example, allow for checking whether the syringe is properly secured within the syringe holder, checking the drug contained within the syringe for particulates and / or contaminants, and / or checking the walls of the syringe for breaks and / or other damage, among other safety checks. Additionally, the ability to inspect the syringe and / or syringe holder after the syringe and / or syringe holder are inserted into the housing of the drug delivery device may facilitate manufacturing efficiencies and / or allow flexibility in the manufacturing process, for example, by giving the manufacturer greater freedom as to when and / or where the inspection process is performed and / or by freeing the manufacturer from assembling the syringe within the syringe holder outside the housing and then inspecting components while those components are outside the housing. These and other advantages will be apparent to those of skill in the art upon review of this disclosure.

[0015] 1-2 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug product. The drug may be, but is not limited to, various biologics such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the present disclosure is not limited to a particular state. The drug delivery device 10 shown in FIGS. 1 and 2 may be in a final assembled form and / or in a stored state prior to manipulation by a user.

[0016] Various implementations 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 multiple-use, reusable injector. The drug delivery device 10 is operable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). The exemplary drug delivery device shown in the figures may take the form of an auto-injector or pen injector and thus may be held in the hand of a user for the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and / or configurations.

[0017] The configuration of the various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery or dispensing state, and a post-delivery state, although fewer or more states are possible. For example, each state may have several sub-states or stages. The storage state may correspond to the configuration of the drug delivery device 10 of Figures 1 and 2, where the delivery device includes a removable cap in a storage position. In some embodiments, the storage state may exist at a time between when the drug delivery device 10 leaves the manufacturing facility and when the patient or other user removes the removable cap. The pre-delivery stage may correspond to a configuration of the drug delivery device 10 after the removable cap has been removed, but before the user activates the drive mechanism. This may include the moment after the user removes the removable cap while the user is initially positioning the drug delivery device 10 against an injection site, but before dispensing begins. The delivery state may correspond to a configuration of the drug delivery device 10 while drug delivery, also referred to herein as dispensing, is ongoing. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is placed in an end-of-dose position within the drug reservoir.

[0018] 1 and 2 , 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 hollow, generally elongated shape, such as a cylindrical shape, and may extend along a longitudinal axis A between a proximal end 62 and a distal end 63. As an example, the housing 12 may include a wall 25 having a generally annular shape (e.g., a tubular shape) that defines a hollow interior (e.g., an interior space or cavity) of the housing 12. As a more specific example, the wall 25 may surround the longitudinal axis A and / or be centered about the longitudinal axis A.

[0019] An axial opening 14 ( FIG. 2 ) may be formed in a distal end 63 of the housing 12 to allow an insertion end 28 of the delivery member 16 to extend outside the housing 12. An axial opening 64 may be formed in the proximal end 62 and may be partially or entirely covered by an end cap 23 when the drug delivery device is in a final assembled configuration. The end cap 23 may have a generally hemispherical shape or any other suitable shape. A side opening 65 may be formed in a wall 25 of the housing 12 and may be partially or entirely covered by a transparent or semi-transparent inspection window 17. The window 17 may allow a user, manufacturer, and / or other individual or machine to view components within the drug delivery device 10, including the drug reservoir 20. Viewing the drug reservoir 20 through the window 17 may allow a user to verify that drug delivery is in progress and / or is complete and / or to check the drug for color changes, turbidity, and / or other visual characteristics. A removable cap 19 may cover the axial opening 14 at the distal end 63 of the drug delivery device 10 prior to use of the drug delivery device 10 and may in some embodiments include a gripper 13 ( FIG. 2 ) configured to aid in removal of a removable sterility barrier 21 (e.g., rigid needle shield (RNS), 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 barbs or arms that frictionally or otherwise mechanically engage the removable sterility barrier 21 to pull the removable sterility barrier 21 along with the removable cap 19 when a user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the removable sterility barrier 21 from the delivery member 16.

[0020] In some embodiments, the housing 12 may be constructed as a single piece such that the housing 12 is defined by a single monolithic structure. In other embodiments, the housing 12 may be constructed of multiple interconnected structures.

[0021] The drug reservoir 20 may be disposed within the hollow interior of the housing 12 and may be configured to contain the drug 22. The drug reservoir 20 may be pre-filled with the drug 22 and shipped, for example, by a manufacturer, to a location where the drug reservoir 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to a patient in two or more use cases, for example, as a pre-filled syringe or as an autoinjector including a pre-filled syringe. By using the same or similar syringe components in each case, at least some of the above steps, such as filling, labeling, packaging, shipping and distribution, may be streamlined or simplified for the two different use cases. As another example, when using some or all of the same syringe components in the multiple use cases, some regulatory pathways for selling and / or distributing the drug may be streamlined and / or simplified for at least one of the multiple use cases.

[0022] The drug storage container 20 may include a rigid wall defining an internal bore, i.e., reservoir. The wall may be made of glass or plastic. The 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 be in slidable and sealing contact with the inner surface 15 of the wall of the drug storage container 20 to prevent or inhibit the drug 22 from leaking past the stopper 24 while the stopper 24 is moving. Distal movement of the stopper 24 releases the drug 22 from the reservoir of the drug storage container 20 into 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 by the gap 18. Upon actuation of the drive mechanism 30 of the drug delivery device 10, the plunger 26 moves distally to close the gap 18 and contact the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally to release the drug 22 from the drug reservoir 20. In alternative embodiments, the stopper 24 and the plunger 26 may initially be in contact with each other or may be coupled to each other, for example via a threaded connection, so that they move together from the start of the movement of the plunger 26. Once moved, the stopper 24 may continue to move distally until it contacts a proximally facing portion of the inner surface 15 of the wall of the drug reservoir 20. This position of the stopper 24 may be referred to as an end-of-dosing or end-of-delivery position and may correspond to when delivery of the drug 22 to the patient is complete or substantially complete.

[0023] In some embodiments, the volume of drug 22 contained within the reservoir of drug storage container 20 may be equal to 1 mL, or may be equal to about (e.g., ±10%) 1 mL, or may be equal to 2.5 mL, or may be equal to about (e.g., ±10%) 2.5 mL, or may be equal to 3 mL, or may be equal to about (e.g., ±10%) 3 mL, or may be equal to about (e.g., ±10%) 1 mL or less, or may be equal to about (e.g., ±10%) 2 mL or less, or may be equal to about (e.g., ±10%) 3 mL or less. or may be about (e.g., ±10%) 4 mL or less, or may be about (e.g., ±10%) less than 5 mL, or may be about (e.g., ±10%) 10 mL or less, or may be in the range of about (e.g., ±10%) 1 to 10 mL, or may be in the range of about (e.g., ±10%) 1 to 5 mL, or may be in the range of about (e.g., ±10%) 1 to 4 mL, or may be in the range of about (e.g., ±10%) 1 to 3 mL, or may be in the range of about (e.g., ±10%) 1 to 2.5 mL.

[0024] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include a sharp tip of other pointed shapes to enable the insertion end 28 to pierce the skin and subcutaneous tissue of the patient during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal passageway. One or more openings may be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 and into the patient.

[0025] In some embodiments, including the embodiment shown in FIG. 2, the drug reservoir 20 may be a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. In this case, the needle may be attached to the wall of the drug reservoir 20 and in permanent fluid communication with the reservoir of the drug reservoir 20. In other embodiments, the needle may be coupled to the drug reservoir 20 via a luer lock or other suitable connection. In still other embodiments, the drug reservoir 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 reservoir 20 may move toward or away from the proximal end of the delivery member 16 such that the proximal end of the delivery member 16 pierces a septum covering the opening of the drug reservoir 20, thereby establishing fluid communication between the reservoir of the drug reservoir 20 and the delivery member 16.

[0026] As described in more detail below, drug delivery device 10 may also include a container holder 33 configured to secure drug storage container 20 relative to housing 12, such as by preventing distal movement of drug storage container 20 relative to housing 12 during actuation of plunger 26 during the delivery state and / or during transportation and / or handling during the storage state and / or pre-delivery state. In embodiments in which drug storage container 20 is a syringe, container holder 33 may be referred to herein as a syringe holder.

[0027] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a guard member 32 movably disposed at a distal end of the housing 12 adjacent the opening 14. The guard member 32 may have a hollow, generally cylindrical or tubular shape centered generally about a longitudinal axis A and may have a proximal end housed within the housing 12. The guard member 32 may be configured to move relative to the housing 12 between an extended position in which the distal end of the guard member 32 extends through the opening 14 in the housing 12 and a retracted position in which the distal end of the guard member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the guard member 32 may be configured to move from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 may translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 may translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond and surround the insertion end 28 of the delivery member 16. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 pre-delivery or in the retracted state, moving the guard member 32 from the extended position to the retracted position may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin, for example, by pressing the distal end of the guard member 32 against the patient's skin at the injection site.

[0028] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be disposed proximally of the guard member 32, and the guard biasing member 35 may be disposed proximally of the guard extension 37. The guard extension 37 may have a hollow generally cylindrical or tubular shape centered about the longitudinal axis A. Furthermore, the guard extension 37 may be linearly movable along the longitudinal axis A relative to the housing 12. In this embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in alternative embodiments, the guard extension 37 and the guard member 32 may be integrally formed as one piece to define a single monolithic structure. In such alternative embodiments, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0029] The guard bias member 35 may be disposed between and in contact with the guard extension 37 and the release member 52. The guard bias member 35 may be configured to bias or urge the guard extension 37 in a distal direction and to bias or urge the release member 52 in a proximal direction. The guard bias member 35 may initially be in a biased (e.g., compressed) state to apply a biasing force to the guard extension 37 and a biasing force to the release member 52 in a pre-delivery state. In some embodiments, the distal end of the guard extension 37 is initially in contact with the proximal end of the guard member 32, as seen in FIG. 2. As a result, the guard extension 37 transmits the biasing force of the guard bias member 35 to the guard member 32 such that the guard bias member 35 biases or urges the guard member 32 toward the extended position. The user may overcome the biasing force by pressing the guard member 32 against the injection site. In doing so, the guard member 32 and the guard extension 37 move together in a proximal direction, for example, until the guard member 32 reaches a retracted position. Once the injection is completed and the drug delivery device 10 is lifted from the injection site, the guard biasing member 35 may press against the guard extension 37, causing the guard extension 37 and the guard member 32 to move together in a distal direction. This movement returns the guard member 32 to the extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the guard biasing member 35 may include a compression spring (e.g., a helical compression spring). Moreover, in embodiments in which the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be disposed around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0030] After drug delivery is completed and the guard member 32 is repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent subsequent user contact with the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. In accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the guard member 32 to lock the guard member 32 in the extended position once the guard member 32 moves from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered and rotates about the longitudinal axis A. As shown in FIG. 2, a proximal end of the locking ring 40 may contact the container holder 33 and a 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 a distal-facing surface of the locking ring 40 and a proximal-facing surface of the guard member 32. The lock ring biasing member 51 may be initially in a compressed or biased state to bias the lock ring 40 and the guard member 32 away from each other. As such, the lock ring biasing member 51 may apply a biasing force that urges the guard member 32 toward the extended position as well as a biasing force that urges the proximal end of the lock ring 40 against the container holder 33. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a helical compression spring). In some embodiments, rotation of the lock ring 40 may be accomplished by a cam arrangement between the lock ring 40 and the container holder 33.

[0031] The drug delivery device 10 may further include a drive mechanism 30 disposed partially or completely within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and upon or in response to actuation of the drive mechanism 30 by a user, release or output the energy to drive the plunger 26 to release the drug 22 from the drug reservoir 20 through the delivery member 16 and into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, although alternative embodiments of the drive mechanism 30 may be configured in different forms, for example, such that the drive mechanism 30 stores electrical or chemical potential energy. Generally, upon actuation of the drive mechanism 30, the drive mechanism 30 may convert potential energy into kinetic energy for moving the plunger 26.

[0032] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member seat 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 may be compressed such that its axial length is shorter than it is in a natural or unbiased state. When released, the plunger biasing member 50 may attempt to expand to its natural axial length, thereby exerting a biasing force to urge the plunger 26 in a distal direction.

[0033] The plunger biasing member 50 may be at least partially disposed within the plunger 26, may have a distal end abutting a proximally-facing inner surface of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. The outer diameter or other dimension of the plunger biasing member 50 may be equal to or smaller than the inner diameter of the ring 45 and / or the inner diameter of the hollow rod 46 such that the plunger biasing member 50 may be received within the plunger 26. In some embodiments, the distal end of the plunger biasing member 50 may abut a proximally-facing inner surface of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut a distal-facing surface of the plunger biasing member seating surface 38. The plunger biasing member seating surface 38 may be fixedly attached to the tubular housing 25 such that the plunger biasing member seating surface 38 provides a stationary surface for the plunger biasing member 50 to be pushed aside. So configured, when released from a biased state, the plunger biasing member 50 may expand in length by moving a distal end of the plunger biasing member 50 away from a stationary proximal end of the plunger biasing member 50. This movement may push the plunger 26 distally, which may in turn push the stopper 24 distally, releasing the drug 22 from the drug reservoir 20 into the delivery member 16 and thereafter into the patient.

[0034] The release member 52 may have a hollow, generally cylindrical or tubular shape and may be centered about the longitudinal axis A. As shown in FIG. 2, the release member 52 may be radially disposed between the distal end of the plunger guide 60 and the proximal end of the guard extension 37. Additionally, the release member 52 may be disposed radially inward of the guard biasing member 35. In general, the release member 52 is configured to operatively couple the guard member 32 and the plunger 26 in an actuation sequence and to generate an audible signal indicating the end of drug delivery. So configured, the release member 52 is utilized to perform two separate functions, thus reducing the number of moving parts required by the drug delivery device 10.

[0035] The release member 52 may be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12 depending on the operational stage of the drug delivery device 10. The initial rotation of the release member 52 associated with actuation may be powered by the plunger biasing member 50 and / or the guard biasing member 35, while subsequent rotations of the release member 52 associated with generating an end-of-dose signal may be powered solely by the guard biasing member 35. Any linear translational movement of the release member 52 that does not involve rotation may be powered solely by the guard biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction, although alternative embodiments may allow linear translational movement of the release member 52 in both the proximal and distal directions.

[0036] The ability of the release member 52 to rotate about the longitudinal axis A may be regulated by interaction between an outer portion of the annular wall of the release member 52 and an inner portion of the guard extension 37. The guard extension 37 may be prevented from rotating about the longitudinal axis A as a result of being coupled to the housing 12. This has the effect of preventing rotation of the release member 52 about the longitudinal axis A when an abutment structure (e.g., an outwardly extending protrusion) included on the outer portion of the release member 52 engages a cooperating abutment structure (e.g., an inwardly extending protrusion) included on the inner portion of the guard extension 37. If the release member 52 cannot rotate, then the outwardly extending protrusion of the plunger 26, which is received in a recess formed in the inner surface of the release member 52, cannot rotate either. If this protrusion on the plunger 26 cannot rotate, then the protrusion cannot slide into the longitudinal opening in the plunger guide 60. If the protrusion cannot move in this way, then the plunger 26 cannot move either. If the plunger 26 is unable to move, the plunger biasing member 50 cannot expand to release the bias. Thus, the release member 52 holds the plunger biasing member 50 in a biased state until the guard extension 37 is moved to an axial position where cooperating abutment structures on an outer portion of the release member 52 and an inner portion of the guard extension 37 disengage from one another, thereby allowing the release member 52 to rotate relative to the guard extension 37.

[0037] Having described the general configuration of the drug delivery device 10, a general method of using the drug delivery device 10 to perform an injection will now be described. As a preliminary step, the user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or a cardboard box. Also as a preliminary step, the user may prepare the injection site, for example by wiping the patient's skin with an alcohol wipe. The user may then pull and remove the removable cap 19 from the housing 12, as described in more detail below. As a result of this movement, the gripper 13 may pull and remove the removable sterility barrier 21 from the drug reservoir 20. This may expose the insertion end 28 of the delivery member 16. Nevertheless, at this stage, the insertion end 28 of the delivery member 16 remains enclosed by the guard member 32, since the guard member 32 is disposed in the extended position. The user may then place the drug delivery device 10 over the injection site and thereafter press the distal end of the guard member 32 against the injection site. The force applied by the user will overcome the biasing force of the guard bias member 35 and the biasing force of the lock ring bias member 51, causing the guard member 32 to move proximally from the extended position to the retracted position and retract into the opening 14. The delivery member 16 remains stationary relative to the housing 12 during the retraction movement of the guard member 32.

[0038] The movement of the guard member 32 from the extended position to the retracted position may result in several actions. Because the delivery member 16 remains stationary relative to the housing 12 during retraction of the guard member 32, the insertion end 28 of the delivery member 16 extends through an opening 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. In addition, retraction of the guard member 32 may also actuate the drive mechanism 30 to release the drug 22 from the drug reservoir 20.

[0039] As the guard member 32 moves from the extended position to the retracted position, it may urge the guard extension 37 in a proximal direction. During the proximal movement of the guard extension 37, the cooperating abutment structures described above on the outer portion of the release member 52 and the inner portion of the guard extension 37 may slide past one another until they no longer contact one another. When that occurs, the release member 52 may be free to rotate about the longitudinal axis A. Rotation of the release member 52 at this stage is caused by the plunger biasing member 50 extending, pushing against a distally facing cam surface included on the plunger 26 and sliding along a proximally facing cam surface on the plunger guide 60. The resulting camming action rotates the plunger 26, which may cause the release member 52 to rotate with it.

[0040] Rotation of the release member 52 and the plunger 26 together may continue until a distally facing cam surface included on the plunger 26 reaches the end of a proximally facing cam surface on the plunger guide 60 and moves into a longitudinal slot formed in the plunger guide. The longitudinal slot does not prevent linear movement of the plunger 26. As a result, the plunger 26 is driven to linearly translate distally by the expanding plunger biasing member 50. As a result, the plunger 26 contacts the stopper 24 (if it is not already contacting the stopper 24) and thereafter pushes the stopper 24 distally, expelling the drug 22 from the drug reservoir 20, through the delivery member 16, out the insertion end and into the patient's tissue 28. Drug delivery may continue until the stopper 24 reaches an end-of-dosage position. At this time, the stopper 24 may abut a proximally facing portion of the inner surface 15 of the wall of the drug reservoir 20. As a result, the plunger 26 stops moving distally.

[0041] After drug delivery is completed, the user may lift the drug delivery device 10 from the injection site. With nothing to resist the guard bias member 35, the guard bias member 35 may push the guard member 32 from the retracted position to the extended position to cover the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 may rotate the locking ring 40 into a position that prevents subsequent retraction of the guard member 32.

[0042] These and other aspects of exemplary drug delivery devices are described in more detail in U.S. Patent Application No. 17 / 036,690, filed September 29, 2020, U.S. Patent Application No. 17 / 035,851, filed September 29, 2020, U.S. Patent Application No. 17 / 035,927, filed September 29, 2020, U.S. Patent Application No. 17 / 036,129, filed September 29, 2020, and U.S. Patent Application No. 17 / 036,217, filed September 29, 2020, the entire contents of each of which are incorporated by reference.

[0043] Turning now to Figures 3-19, additional embodiments of components of the drug delivery device described above will now be described. The components shown in Figures 3-19 may be similar or identical in structure, configuration, and / or function to the components described above in connection with Figures 1-2. Such components are assigned the same reference numbers as those used in Figures 1 and 2, except increased by 100 or multiples thereof. Specific descriptions of these components have been simplified or omitted for the sake of brevity. Details of structure, configuration, and / or function that distinguish the components shown in Figures 3-19 from the components in Figures 1 and 2 are the focus of the following discussion.

[0044] As explained above, during assembly of the drug delivery device, it may be useful to position the syringe holder at different axial positions relative to the longitudinal axis of the housing. Figures 3-5 show a syringe holder 133 having features that facilitate this purpose, as well as other advantageous features.

[0045] Syringe holder 133 may have a hollow, generally elongated shape extending along a longitudinal axis between proximal end 166 and distal end 167. By way of example, syringe holder 133 may have a generally annular shape (e.g., a tubular shape) and include a wall 168 that defines a hollow interior (e.g., an interior space or cavity) of syringe holder 133. As a more specific example, wall 168 may surround the longitudinal axis of syringe holder 133 and / or may be centered about the longitudinal axis of syringe holder 133. The longitudinal axis of the syringe holder 133 may be parallel to the longitudinal axis A of the housing of the drug delivery device (e.g., housing 12 described above or housing 112 described below) when the syringe holder 133 is assembled to the housing of the drug delivery device, may be parallel to the longitudinal axis A but offset from the longitudinal axis A, and / or may be coaxial with the longitudinal axis A.

[0046] An axial opening 170 may be formed in a proximal end 166 of the syringe holder 133 to allow for insertion of the syringe 120 into the hollow interior of the syringe holder 133. An axial opening 171 may be formed in a distal end 167 of the syringe holder 133 to allow a removable sterility barrier 121 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) to extend partially or entirely outside the syringe holder 133 when the syringe is fully inserted into the syringe holder 133, as seen in FIG.

[0047] 3-5, one or more side openings may be formed in wall 168 of syringe holder 133 and may communicate with the hollow interior of syringe holder 133. One or more of these side openings may be located at least partially axially between axial opening 170 and axial opening 171. For example, syringe holder 133 may include side opening 172a and / or side opening 172b formed in wall 168 approximately midway along the length of the longitudinal axis of syringe holder 133. Side openings 172a and 172b may be located on opposite sides of the longitudinal axis of syringe holder 133 and each may have a generally oval or generally rectangular shape when viewed from the side. At least one of the side openings 172a and 172b may align with a side opening 165 formed in the housing 112 of the drug delivery device when the syringe holder 133 is disposed in a second axial position or a final assembly position, as described in more detail below with reference to Figures 9-14. Additionally or alternatively, the syringe holder 133 may include a side opening 174a and / or a side opening 174b, one or both of which may be partially or entirely distal to the side openings 172a and / or the side openings 172b. The side openings 174a and 174b may be located on opposite sides of a longitudinal axis of the syringe holder 133, and each may have a generally C- or U-shape when viewed from the side, as can be seen in Figures 3 and 5. 3 and 5, side openings 172a, 172b, 174a, and 174b may be disposed at respective circumferential positions about the longitudinal axis of syringe holder 133, such that, for example, treating the center of side opening 172a as corresponding to zero degrees and moving circumferentially, the center of side opening 174a may be located at approximately 90 degrees, the center of side opening 172b may be located at approximately 180 degrees, and the center of side opening 174b may be located at approximately 270 degrees. Each of side openings 174a and 174b may be at least partially formed in a distally facing end surface 175 of syringe holder 133, and may consequently divide at least a portion of wall 168 at distal end 167 of syringe holder 133 into a pair of axially extending arms 176a and 176b.

[0048] One or both of the axially extending arms 176a and 176b may be configured to bend (e.g., elastically deform) at least radially relative to a longitudinal axis of the syringe holder 133 during insertion of the syringe 120 into the syringe holder 133. For example, the axially extending arms 176a and 176b may bend radially outward when the removable sterility barrier 121 of the syringe 120 is pushed axially out of the space between the axially extending arms 176a and 176b. Once the removable sterility barrier 121 has passed the axially extending arms 176a and 176b and is generally located distal to the axially extending arms 176a and 176b (as seen in FIG. 5), the axially extending arms 176a and 176b may bend radially inward back to their original position, including, for example, snapping back to their original shape. Axially extending arms 176a and 176b and / or other portions or all of syringe holder 133 may be made of a resilient material to facilitate such bending during insertion of syringe 120.

[0049] An inner portion of axially extending arms 176a and / or 176b may be configured to cooperate with (e.g., contact, abut, secure, couple with, and / or grip) an outer portion of syringe 120 to support syringe 120 within syringe holder 133. By way of example, an inner portion of axially extending arms 176a and / or 176b may be configured to contact a generally distally facing surface 177 of syringe 120 to prevent movement of syringe 120 in a distal direction relative to syringe holder 133. As a more specific example, one or both of axially extending arms 176a and / or 176b may include an inwardly extending protrusion (e.g., a rib, tab, finger, flange, collar, lip, and / or any other suitable structure) having a proximal-facing surface configured to contact distal-facing surface 177 of syringe 120. This inwardly extending protrusion may extend generally radially inward relative to the longitudinal axis of syringe holder 133 and / or may extend inward in any direction that is not parallel to the longitudinal axis of syringe holder 133. As an even more specific example, distal-facing surface 177 of syringe 120 may be part of a neck of syringe 120, as shown in FIGS. 3 and 5. As a further example, the inner diameter or other inner dimension defined between the inwardly extending protrusion of axially extending arm 176a and the inwardly extending protrusion of axially extending arm 176b may be smaller than (a) the outer diameter or other outer dimension of a portion of the barrel of syringe 120 proximal to the neck of syringe 120, and / or (b) the outer diameter or other outer dimension of removable sterility barrier 121.

[0050] An outer portion of wall 168 of syringe holder 133 may be configured to cooperate with a first inner portion of housing 112 (e.g., by contacting, abutting, securing the first inner portion, coupling with the first inner portion, and / or gripping the first inner portion) to support syringe holder 133 at a first axial position (e.g., a proximal position or an intermediate position) and / or a first rotational position relative to housing 112, and / or to cooperate with a second inner portion of housing 112 (e.g., by contacting, abutting, securing the second inner portion, coupling with the second inner portion, and / or gripping the second inner portion) to support syringe holder 133 at a second axial position (e.g., a distal position or a final assembly position) and / or a second rotational position relative to housing 112. By way of example, syringe holder 133 may include outwardly extending protrusion 180a and / or outwardly extending protrusion 180b, as seen in Figures 3-5. Outwardly extending protrusions 180a and 180b may be disposed on opposite sides of a longitudinal axis of syringe holder 133. Outwardly extending protrusions 180a and 180b may each extend generally radially outward relative to the longitudinal axis of syringe holder 133, and / or may extend outward in any direction that is not parallel to the longitudinal axis of syringe holder 133. Outwardly extending protrusions 180a and / or 180b may each be configured as a rib, tab, finger, flange, lip, collar, and / or any other suitable structure. Outwardly extending protrusions 180a and 180b may have distally facing surfaces 180az and 180bz, respectively. As described in more detail below, distally facing surfaces 180az and 180bz may contact respective proximally facing surfaces of housing 112 to prevent movement of syringe holder 133 in at least a distal direction when syringe holder 133 is disposed in a first axial position within housing 112. By way of example, distally facing surfaces 180az and 180bz may abut respective proximally facing surfaces of housing 112 to prevent distal movement of syringe holder 133 relative to housing 112.

[0051] Outwardly extending protrusions 180a and 180b may have lengths L1a and L1b, respectively, measured generally circumferentially about syringe holder 133, as seen in Figures 4 and 5. By way of example, length L1a and / or length L1b may correspond to an arc length measured about a longitudinal axis of syringe holder 133. Alternatively, length L1a and / or length L1b may correspond to a linear distance.

[0052] In addition to or instead of outwardly extending protrusions 180a and 180b, syringe holder 133 may include outwardly extending protrusions 182a and 182b. Outwardly extending protrusions 182a and 182b may be disposed on opposite sides of a longitudinal axis of syringe holder 133. Outwardly extending protrusions 182a and 182b may each extend generally radially outward relative to the longitudinal axis of syringe holder 133 and / or may extend outward in any direction that is not parallel to the longitudinal axis of syringe holder 133. Outwardly extending protrusions 182a and / or 182b may each be configured as a rib, tab, finger, flange, lip, collar, and / or any other suitable structure. As can be seen in Figures 3-5, outwardly extending protrusion 182a may be adjacent to and distal to outwardly extending protrusion 180a, and outwardly extending protrusion 182b may be adjacent to and distal to outwardly extending protrusion 180b.

[0053] Outwardly extending protrusion 182a may have sides 182ax, 182ay, each of which may face in a generally circumferential direction. Similarly, outwardly extending protrusion 182b may have sides 182bx, 182by, each of which may face in a generally circumferential direction. As described in more detail below, one or more of sides 182ax, 182ay, 182bx, and 182by may contact respective circumferentially facing surfaces of an inner portion of housing 112 to prevent rotation of syringe holder 133 in one or more rotational directions when syringe holder 133 is disposed in a first axial position within housing 112.

[0054] Outwardly extending protrusions 182a and 182b may have lengths L2a and L2b, respectively, measured generally circumferentially about syringe holder 133, as seen in FIGS. 4 and 5. By way of example, length L2a and / or length L2b may correspond to arc lengths measured about a longitudinal axis of syringe holder 133. Alternatively, length L2a and / or length L2b may correspond to linear distances. In some embodiments, length L1a of outwardly extending protrusion 180a may be longer than length L2a of outwardly extending protrusion 182a, and / or length L1b of outwardly extending protrusion 180b may be longer than length L2b of outwardly extending protrusion 182b. The relative lengths of these outwardly extending protrusions may facilitate the ability of outwardly extending protrusions 180a and / or 180b to prevent distal movement of syringe holder 133 relative to housing 112, and / or the ability of outwardly extending protrusions 182a and / or 182b to prevent rotational movement of syringe holder 133 relative to housing 112 when syringe holder 133 is in a first axial position, as described in more detail below.

[0055] 6-9, embodiments of the housing 112 configured to cooperate in various ways with the syringe holder 133 will now be described. FIG. 6 shows a cut-away view of a proximal portion of the housing 112 prior to insertion of the syringe holder 133, and FIG. 7 shows a cut-away view of a distal portion of the housing 112 prior to insertion of the syringe holder 133. FIG. 8 shows another cut-away view of the housing 112 prior to insertion of the syringe holder 133. The syringe holder 133, the housing 112, the syringe 120, and / or other associated components may represent subassemblies of a drug delivery device.

[0056] As discussed above, an inner portion of wall 125 of housing 112 may be configured to cooperate with (e.g., contact, abut, secure, couple, and / or grip) one or more of outwardly extending protrusions 180a and 180b of syringe holder 133 to support syringe holder 133 at a first axial position relative to housing 112 and / or a first rotational position relative to housing 112. By way of example, housing 112 may include inwardly extending protrusion 184a, inwardly extending protrusion 185a, inwardly extending protrusion 184b, and inwardly extending protrusion 185b, as seen in FIGS. Inwardly extending protrusions 184a and 185a may be located on one side of a longitudinal axis of housing 112, and inwardly extending protrusions 184b and 185b may be located on the opposite side of the longitudinal axis of housing 112. Inwardly extending protrusions 184a, 185a, 184b, and / or 185b may be proximate side opening 165, as shown in Figures 6, 8, and 9. Inwardly extending protrusions 184a, 185a, 184b, and / or 185b may extend generally radially inward relative to the longitudinal axis of housing 112, and / or may extend inward in any direction that is not parallel to the longitudinal axis of housing 112. Inwardly extending protrusions 184a, 185a, 184b, and / or 185b may each be configured as a rib, tab, finger, flange, lip, collar, and / or any other suitable structure. Inwardly extending protrusions 184a, 185a, 184b, and 185b may have proximally facing surfaces 184az, 185az, 184bz, and 185bz, respectively.

[0057] When the syringe holder 133 has a first rotational position relative to the housing 112 and is inserted distally into the housing 112 through the axial opening 164 at the proximal end 162 of the housing 112, the distal-facing surface 180az of the outwardly extending protrusion 180a of the syringe holder 133 may contact and / or abut one or more of the proximal-facing surfaces 184az and 185az of the inwardly extending protrusions 184a and 185a, and / or the distal-facing surface 180bz of the outwardly extending protrusion 180b of the syringe holder 133 may contact and / or abut one or more of the proximal-facing surfaces 184bz and 185bz of the inwardly extending protrusions 184b and 185b, as can be seen in FIG. 9. These contact points may prevent further distal movement of the syringe holder 133 relative to the housing 112. This axial position of the syringe holder 133 (shown in FIG. 9 ) may correspond to a first axial position of the syringe holder 133. When the syringe holder 133 is in the first axial and rotational position, the outwardly extending protrusion 182b of the syringe holder 133 may be circumferentially disposed between the inwardly extending protrusions 184b and 185b, as seen in FIG. 9 . By way of example, the sides 182bx, 182by of the outwardly extending protrusion 182b may face, contact, and / or abut the sides of the inwardly extending protrusion 184b and the sides of the inwardly extending protrusion 185b, respectively. As an example, outwardly extending protrusion 182b, when disposed between inwardly extending protrusions 184b and 185b, may form an interference fit (e.g., a press fit, a friction fit, and / or a snap fit) with inwardly extending protrusions 184b and 185b. A similar arrangement may, but need not, exist for outwardly extending protrusion 182a and inwardly extending protrusions 184a and 185a. This configuration of outwardly extending protrusions 182a and / or 184b relative to inwardly extending protrusions 184a, 185b, 184b, and / or 185b when syringe holder 133 is in the first axial position may prevent syringe holder 133 from rotating relative to housing 112.This reduces the likelihood of syringe holder 133 being inadvertently moved from the first axial position and / or first rotational position due to, for example, jostling, vibration, and / or sudden movement during the manufacturing process, while still allowing syringe holder 133 to be intentionally moved proximally if desired. As described in more detail below, syringe holder 133 may be moved proximally and then rotated from the first rotational position to a second rotational position in which no portion of outwardly extending protrusion 180a is circumferentially aligned with inwardly extending protrusions 184a and 185a, and no portion of outwardly extending protrusion 180b is circumferentially aligned with inwardly extending protrusions 184b and 185b. As a result, when syringe holder 133 is in the second rotational position, it may be possible to move syringe holder 133 in a distal direction without distal movement being prevented by contact between outwardly extending protrusion 180a and inwardly extending protrusions 184a and 185a and / or contact between outwardly extending protrusion 180b and inwardly extending protrusions 184b and 185b.

[0058] At least a portion of the distal end 167 of the syringe holder 133 may be aligned with the side opening 165 of the housing 112 when the syringe holder 133 is in the first axial position. By way of example, a portion or all of the side opening 172b may be aligned with the side opening 165 of the housing 112 when the syringe holder 133 is in the first axial position. To achieve this configuration, some embodiments of the syringe holder 133 and the housing 112 may be dimensioned as follows: The syringe holder 133 may have a length L3 defined axially between a distal-facing surface 180bz of the outwardly extending protrusion 180b and a distal-facing end face 175 of the syringe holder 133, as seen in FIG. Housing 112 may have a length L4 defined axially between proximally facing surfaces 184bz, 185bz and the proximal-most end of side opening 165, as seen in FIG. 9. L3 may be greater than L4 such that, for example, a portion or all of distal end 167 of syringe holder 133, including a portion or all of side opening 172b of syringe holder 133, is aligned with side opening 165 of housing 112 when syringe holder 133 is in the first axial position. Similar dimensions may, but are not required to, be used for distal facing surface 180az of outwardly extending projection 180a and distal facing end surface 175 of syringe holder 133.

[0059] An inner portion of wall 125 of housing 112 may be configured to cooperate with (e.g., contact, abut, secure, mate with, and / or grip) distally facing end surface 175 of syringe holder 133 to support syringe holder 133 in an axial position (e.g., a distal or final assembly position) relative to housing 112 and / or in a second rotational position relative to housing 112. By way of example, housing 112 may include an inwardly extending protrusion 186, as seen in FIG. 7 . Inwardly extending protrusion 186 may be distal to side opening 165 and / or distal to inwardly extending protrusions 184a,b and 185a,b. The inwardly extending protrusions 186 may extend generally radially inward relative to the longitudinal axis of the housing 112 and / or may extend inward in any direction other than parallel to the longitudinal axis of the housing 112. The inwardly extending protrusions 186 may be configured as ribs, tabs, fingers, flanges, lips, collars, and / or any other suitable structure. The inwardly extending protrusions 186 may have a proximally facing surface 186a.

[0060] As described in more detail below, during the assembly process, the syringe holder 133 may be moved distally until the distally facing end surface 175 of the syringe holder 133 contacts and / or abuts the proximally facing surface 186a of the inwardly extending protrusion 186 of the housing 112. This contact may prevent further distal movement of the syringe holder 133 relative to the housing 112. This axial position of the syringe holder 133 may correspond to a second axial position of the syringe holder 133. In some embodiments, the second axial position may correspond to a final assembly position of the syringe holder 133. In embodiments in which the syringe holder 133 does not move relative to the housing 112 during operation of the drug delivery device, the syringe holder 133 may remain in the second axial position throughout the life of the drug delivery device. In embodiments in which the syringe holder 133 moves relative to the housing 112 during operation of the drug delivery device (e.g., distal movement to achieve needle insertion), the syringe holder 133 may not remain in the second axial position throughout the life of the drug delivery device. In some embodiments, the proximal-facing surface 186a of the inwardly extending protrusion 186 of the housing 112 may be configured to contact the distally-facing end surface 175 of the syringe holder 133 regardless of whether the syringe holder 133 is in the first rotational position or the second rotational position, whereas in other embodiments, the proximal-facing surface 186a of the inwardly extending protrusion 186 of the housing 112 may be configured to contact the distally-facing end surface 175 of the syringe holder 133 only when the syringe holder 133 is in the second rotational position.

[0061] When syringe holder 133 is in the second axial position, at least a portion of distal end 167 of syringe holder 133 may be distal to side opening 165 of housing 112. By way of example, a portion or all of side opening 172b may be distal to side opening 165 of housing 112 when syringe holder 133 is in the second axial position, as seen in FIG.

[0062] A method of assembling the syringe holder 133 in the housing 112 will now be described with reference to Figures 10 to 15. The process of assembling the syringe holder 133 in the housing 112 may be part or an aspect of an overall process of assembling a drug delivery device such as the drug delivery device 10 described above. Figures 10 to 15 show the respective steps or stages of the assembly method, arranged in chronological order. Some or all of the steps described below may be performed manually by a person and / or automatically by a machine.

[0063] 10 , an initial step may include placing the syringe holder 133 in a first rotational position (e.g., an intermediate rotational position) relative to the housing 112. By way of example, this step may include rotating the syringe holder 133 relative to the housing 112 prior to and / or substantially simultaneously with inserting the syringe holder 133 into the housing 112. The removable cap 119 may be coupled to the distal end 163 of the housing 112 prior to this step to cover an axial opening (e.g., axial opening 14 described above) at the distal end 163 of the housing 112.

[0064] After and / or substantially simultaneously with placing the syringe holder 133 in the first rotational position, the syringe holder 133 may be inserted into the hollow interior of the housing 112 and secured in the first axial position, as shown in FIG. 11. As an example, the syringe holder 133 may be moved distally along the longitudinal axis A of the housing 112 through an axial opening 164 in the proximal end 162 of the housing 112. As a more specific example, the distal end 167 of the syringe holder 133 may be the tip of the syringe holder 133 that enters the interior of the housing 112 through the axial opening 164. As an even more specific example, syringe holder 133 may be moved distally until distal-facing surface 180az of outwardly extending protrusion 180a of syringe holder 133 contacts and / or abuts one or more of proximally-facing surfaces 184az and 185az of inwardly-extending protrusions 184a and 185a of housing 112 and / or distal-facing surface 180bz of outwardly extending protrusion 180b of syringe holder 133 contacts and / or abuts one or more of proximally-facing surfaces 184bz and 185bz of inwardly-extending protrusions 184b and 185b. As a result of this contact, further distal movement of syringe holder 133 relative to housing 112 may be at least temporarily prevented.

[0065] Fixing the syringe holder 133 in the first axial position may optionally include disposing the outwardly extending protrusion 182a of the syringe holder 133 between the inwardly extending protrusions 184a and 185a of the housing 112 and / or disposing the outwardly extending protrusion 182b of the syringe holder 133 between the inwardly extending protrusions 184b and 185b of the housing 112. The outwardly extending protrusion 182a may be naturally disposed between the inwardly extending protrusions 184a and 185a when the syringe holder 133 is disposed in the first rotational position when the syringe holder 133 is distally inserted into the housing 112. The same applies to the outwardly extending protrusion 182a and the inwardly extending protrusions 184b, 185b. As an example, outwardly extending protrusion 182a may be inserted between inwardly extending protrusions 184a and 185a to form an interference fit (e.g., a press fit, a friction fit, and / or a snap fit) with inwardly extending protrusions 184a and 185a, and / or outwardly extending protrusion 182b may be inserted between inwardly extending protrusions 184b and 185b to form an interference fit (e.g., a press fit, a friction fit, and / or a snap fit) with inwardly extending protrusions 184b and 185b. As a result of these interference fits, syringe holder 133 may be relatively securely (but not necessarily permanently) retained in a first axial position and / or a first rotational position.

[0066] By placing syringe holder 133 in the first axial position and the first rotational position, side opening 172b of syringe holder 133 may be aligned with side opening 165 of housing 112, as seen in FIG. 11. Additionally or alternatively, side opening 172a of syringe holder 133 may be aligned with a side opening (not shown) of housing 112 that is opposite side of longitudinal axis A from side opening 165.

[0067] After the syringe holder 133 is secured in the first axial and rotational positions, the syringe 120 may be inserted into the hollow interior of the syringe holder 133, as shown in FIG. 12. As an example, the syringe 120 may be moved distally along the longitudinal axis A of the housing 112 and / or the syringe holder 133 and through the axial opening 170 at the proximal end 166 of the syringe holder 133 into the interior of the syringe holder 133. As a more specific example, the removable sterility barrier 121 attached to the distal end of the syringe 120 may be the first portion of the syringe 120 that enters the interior of the syringe holder 133. As an even more specific example, the syringe 120 may be moved distally until a distally facing surface 177 of the syringe 120 contacts and / or abuts an inwardly extending protrusion disposed at the distal end 167 of the syringe holder 133. Once this contact occurs, further distal movement of the syringe 120 relative to the syringe holder 133 is substantially impeded, but not necessarily prevented. As explained above, insertion of the removable sterility barrier 121 through the syringe holder 133 may cause the axially extending arms 176a and 176b to bend outwardly, and once the removable sterility barrier 121 moves distally past the axially extending arms 176a and 176b, the axially extending arms 176a and 176b may bend inwardly, e.g., due to their resiliency. During insertion of the syringe 120 into the syringe holder 133, the syringe holder 133 may not move axially and / or rotationally relative to the housing 112 (and therefore may remain stationary in a first axial position and / or a first rotational position) due at least in part to contact between the outwardly extending protrusions 180a,b and 182a,b of the syringe holder 133 and the inwardly extending protrusions 184a,b and 185a,b of the housing 112.

[0068] When the syringe holder 133 is positioned in a first axial position, the radially outward surface of each of the axially extending arms 176a and 176b may be spaced a radial distance from the radially inward surface of the housing 112 such that the axially extending arms 176a and 176b can bend radially outward to accommodate insertion of the removable sterility barrier 121 into the distal end 167 of the syringe holder 133. The radial distance between the radially outward surface of axially extending arms 176a and 176b and the radially inward surface of housing 112 may be substantially shortened or eliminated such that when syringe holder 133 is positioned in a second axial position (described below), the radially inward surface of housing 112 prevents axially extending arms 176a and 176b from bending radially outward, thereby preventing further distal movement of syringe 120 relative to syringe holder 133. As an example, when syringe holder 133 is positioned in a first axial position, the radially outward surface of one or both of axially extending arms 176a and 176b may not contact the radially inward surface of housing 112, whereas when syringe holder 133 is positioned in a second axial position, the radially outward surface of one or both of axially extending arms 176a and 176b may contact and / or abut the radially inward surface of housing 112.

[0069] 13 shows the syringe 120 after it has been fully inserted into and seated within the syringe holder 133. Here, a portion of the syringe 120 may be aligned with the side opening 172b of the syringe holder 133. By way of example, a portion of the medication within the syringe may be aligned with the side opening 172b, a portion of the neck of the syringe 120 may be aligned with the side opening 172b, and / or a portion of the distally facing surface 177 of the syringe 120 may be aligned with the side opening 172b. Additionally or alternatively, a portion of the removable sterility barrier 121 may be aligned with the side opening 172b of the syringe holder 133. Because side opening 172b of syringe holder 133 is aligned with side opening 165 of housing 112, the portion of syringe 120 aligned with side opening 172b and / or the portion of removable barrier 121 aligned with side opening 172b may be visible to an observer outside housing 112 looking inside housing 112 through side opening 165.

[0070] While the syringe holder 133 is disposed in a first axial position and a first rotational position and the syringe 120 is seated within the syringe holder 133 (as shown in FIG. 13 ), an inspection of the syringe 120, the syringe holder 133, the removable sterility barrier 121, and / or other components within the housing 112 may be performed. By way of example, the inspection may include inspecting at least a portion of the syringe 120 that is aligned with and / or visible through the side opening 165 of the housing 112, at least a portion of the syringe holder 133 that is aligned with and / or visible through the side opening 165 of the housing 112, and / or at least a portion of the removable sterility barrier 121 that is aligned with and / or visible through the side opening 165 of the housing 112. As a more specific example, the inspection may include inspecting a portion of the syringe 120 and / or the removable barrier 21 that is visible through the aligned portions of the side opening 172b of the syringe holder 133 and the side opening 165 of the housing 112. The inspection may be performed manually and / or mechanically. The inspection may be performed visually (e.g., optically), audibly, electrically, magnetically, chemically, and / or using any other suitable inspection means. Inspection may include, for example, checking whether syringe 120 and / or removable sterility barrier 121 are properly secured within syringe holder 133, checking whether syringe holder 133 is properly secured within housing 112, checking the drug within syringe 120 for particulates, contaminants, and / or other quality and / or safety measures, and / or checking, for example, for breaks, cracks, and / or other structural damage to syringe 120, removable sterility barrier 121, and / or syringe holder 133. By way of example, checking whether syringe 120 is properly secured within syringe holder 133 may include, for example, inspecting the angle, radial position, and / or axial position of axially extending arms 176a and / or 176b relative to the longitudinal axis of syringe holder 133.As a more specific example, axially extending arms 176a and / or 176b may be checked for bending (e.g., bending radially inward) back to their original shape. Additionally or alternatively, inspection may include checking other components within housing 112 that are aligned with and / or visible through side opening 165 and / or side opening 172b. To the extent housing 112 includes a side opening on the opposite side of longitudinal axis A from side opening 165, a similar visual inspection may also be performed through that side opening.

[0071] After the test is completed, the syringe holder 133 (including the syringe 120) may be moved proximally away from the first axial position, as seen in FIG. 14, and then rotated from the first axial position to a second rotational position (e.g., a final rotational position). By way of example, the syringe holder 133 may be moved distally to an axial position (proximal to the first axial position) where the outwardly extending protrusion 182a is no longer between the inwardly extending protrusions 184a and 185a and the outwardly extending protrusion 182b is no longer between the inwardly extending protrusions 184b and 185b. As a result, the syringe holder 133 may no longer be rotationally constrained by the inwardly extending protrusions 184a,b and 185a,b. The syringe holder 133 may then be rotated to the second rotational position. As an example, in the second rotational position, outwardly extending protrusion 180a may be misaligned circumferentially with inwardly extending protrusions 184a and 185a, and outwardly extending protrusion 180b may be misaligned circumferentially with inwardly extending protrusions 184b and 185b. Stated another way, in the second rotational position, outwardly extending protrusion 180a may be rotationally offset from inwardly extending protrusions 184a and 185a, and outwardly extending protrusion 180b may be rotationally offset from inwardly extending protrusions 184b and 185b. As a result, outwardly extending protrusion 180a may no longer contact inwardly extending protrusions 184a and 185a when syringe holder 133 is returned distally to or moved through the first axial position, and outwardly extending protrusion 180b may no longer contact inwardly extending protrusions 184b and 185b when syringe holder 133 is returned distally to or moved through the first axial position.

[0072] Next, while maintaining the syringe holder 133 in the second rotational position, the syringe holder 133 (including the syringe 120) may be moved distally to a second axial position within the housing 112, as shown in FIG. 13. By way of example, the syringe holder 133 may be moved distally until a distally facing end face 175 of the syringe holder 133 contacts and / or abuts a proximally facing surface 186a of an inwardly extending protrusion 186 of the housing 112. As a result of this contact, further distal movement of the syringe holder 133 relative to the housing 112 may be prevented. When in the second axial position, the syringe holder 133 may be said to be seated within the housing 112 and / or in its final assembly position. In some embodiments, by moving the syringe holder 133 to a second axial position, the removable sterility barrier 121 may be inserted into and / or grasped by a gripper (e.g., gripper 13 described above) positioned inside the removable cap 119.

[0073] Distally moving the syringe holder 133 from the first axial position to the second axial position may include applying a distally directed force to the proximal end 166 of the syringe holder 133. By way of example, the distally directed force may be applied directly to the axially extending arms 190 and 191 located at the proximal end 166 of the syringe holder 133. The distally directed force does not have to be applied directly to the syringe 120 to avoid distal movement of the syringe 120 relative to the syringe holder 133, which may be possible prior to disposing the syringe holder 133 in the second axial position because, as described above, the radially inward facing surface of the housing 112 does not prevent the axially extending arms 176a and 176b of the syringe holder 133 from bending radially outward until the syringe holder 133 is located in the second axial position.

[0074] After disposing syringe holder 133 in the second axial position, other components may be assembled within housing 112. For example, a drive mechanism (e.g., drive mechanism 30, described above) may be disposed within housing 112 at least partially proximal to syringe holder 133. Once all of the necessary components and / or mechanisms are assembled within housing 112, axial opening 164 at proximal end 162 of housing 112 may be closed with an end cap (e.g., end cap 23, described above).

[0075] 16-19, another embodiment of a syringe holder (shown as syringe holder 233) is described. Syringe holder 233 includes elements that are similar or identical in structure, configuration, and / or function to the elements of syringe holder 133 described above in connection with FIGS. 3-15. Such components are assigned the same reference numerals as used in FIGS. 3-15, except increased by 100. Specific descriptions of these components have been simplified or omitted for the sake of brevity.

[0076] As shown in FIGS. 16 and 19, the proximal end 266 of the syringe holder 233 may include an axially extending protrusion 290 and an axially extending protrusion 291. As an example, the axially extending protrusion 290 includes an inwardly facing surface 290a and an outwardly facing surface 290b, as shown in FIG. 19. As a more specific example, the inwardly facing surface 290a includes at least one rounded corner 290c adjacent the distal end of the axially extending protrusion 290. As an even more specific example, the inwardly facing surface 290a and the outwardly facing surface 290b each have a respective slope. The axially extending protrusion 291 may be located on the opposite side of the longitudinal axis of the syringe holder 233 from the axially extending protrusion 291 and may be configured similarly to the axially extending protrusion 290.

[0077] As will be appreciated, the devices and methods according to the present disclosure may have one or more advantages over the prior art, any one or more of which may be present in a particular embodiment and in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically recited herein may be appreciated as well.

[0078] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0079] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for the treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0080] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, pegfilgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0081] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin and molecules or variants or analogs thereof.

[0082] 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 humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, including myostatin-specific peptibodies; and myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; and myostatin-binding proteins, particularly those directed against the receptors for IL-4 and / or IL-13. inhibiting activity mediated by binding; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc.; 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., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g. Human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, particularly including but not limited to, human CD22-specific IgG antibodies, such as the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 antibodies. B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (also referred to as "B7RP-1", B7H2, ICOSL, B7h, and CD275), including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, 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 and the like, particularly humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as 145c7; human IFNIFN gamma specific antibodies, peptibodies, related proteins, etc., including but not limited to, gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; those targeting the hepatocyte growth factor / scatter factor (HGF / SF:c-Met) axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize HGF / SF. hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including; 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, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors. and the like; OX40L-specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP), Epo gen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), (panitumumab), 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 alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP), Kineret® (anakinra), Leukine® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (Lymphostat B, Belimumab, Anti-BlySmAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Mvasi™ (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon alpha-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-alpha4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (VEGFR1 Ig domain fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), 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-BR3 mAb, anti-Clostridium difficile toxin A and toxin BC mAbs 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).

[0083] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as but not limited to apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotorasibe (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor.In some embodiments, the drug delivery device may contain or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that includes the human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199, or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506, or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain AMG 562, or a half-life extended (HLE) CD19 x CD3. The drug delivery device may contain or be used with another product containing a BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing ephavalukin alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 596 or a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0084] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be construed as merely exemplary and does 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 still fall within the scope of the claims that define the invention disclosed herein.

[0085] Those skilled in the art will understand that numerous modifications, alterations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations are to be construed as falling within the scope of the inventive concept.

Claims

1. 1. A drug delivery device comprising: a housing having an opening and a longitudinal axis; a syringe including a needle having an insertion end configured to extend at least partially through the opening in a delivery state; A syringe holder, comprising: a proximal end and a distal end; a hollow interior configured to accommodate at least a portion of the syringe; a side opening distal to the proximal end; an outwardly extending protrusion proximate the side opening, the outwardly extending protrusion configured to support the syringe holder at a first axial position relative to the longitudinal axis of the housing upon assembly of the syringe holder within the housing; A syringe holder including:

13. A drug delivery device comprising:

2. 2. The drug delivery device of claim 1, wherein the outwardly extending protrusion is configured to contact the first inner portion of the housing when the syringe holder is in the first rotational position relative to the housing to prevent the syringe holder from moving distally relative to the housing.

3. 3. The drug delivery device of claim 2, wherein the outwardly extending protrusion is configured (a) to permit movement of the syringe holder in a proximal direction relative to the housing when the syringe holder is in the first axial position, and / or (b) to permit movement of the syringe holder in the distal direction relative to the housing when the syringe holder is in a second rotational position relative to the housing, wherein the outwardly extending protrusion is rotationally offset from the first inner portion of the housing to permit movement of the syringe holder in the distal direction relative to the housing.

4. A drug delivery device as described in any one of claims 1 to 3, wherein at least a portion of the syringe holder is configured to contact a second inner portion of the housing when the syringe holder is in a second axial position relative to the longitudinal axis of the housing to prevent the syringe holder from moving distally relative to the housing, and optionally, the at least a portion of the syringe holder includes a surface facing distally of the distal end of the syringe holder.

5. A drug delivery device as described in any one of claims 1 to 4, wherein the syringe holder includes a second outwardly extending protrusion distal to the outwardly extending protrusion, and optionally, at least one of the outwardly extending protrusion and the second outwardly extending protrusion contacts an inner portion of the housing when the syringe holder is in the first axial position to prevent the syringe holder from rotating in at least one rotational direction relative to the housing.

6. The drug delivery device of claim 5, wherein the second outwardly extending protrusion is configured to be received between two inwardly extending protrusions of the housing when the syringe holder is in the first axial position to prevent the syringe holder from rotating relative to the housing, and optionally, the second outwardly extending protrusion is configured to form a tight fit with the two inwardly extending protrusions of the housing.

7. A drug delivery device as described in any one of claims 1 to 6, wherein at least a portion of the side opening is configured to align with at least a portion of the side opening of the housing when the syringe holder is in the first axial position.

8. A syringe holder for a drug delivery device, comprising: a proximal end and a distal end; a hollow interior configured to accommodate at least a portion of a syringe; a side opening distal to the proximal end; an outwardly extending protrusion proximal to the side opening, the outwardly extending protrusion configured to support the syringe holder at a first axial position relative to a longitudinal axis of the housing of the drug delivery device upon assembly of the syringe holder into a housing of the drug delivery device; A syringe holder for a drug delivery device comprising:

9. A syringe holder as described in claim 8, wherein the outwardly extending protrusion is configured to contact a first inner portion of the housing of the drug delivery device when the syringe holder is in a first rotational position relative to the housing of the drug delivery device to prevent the syringe holder from moving in a distal direction relative to the housing of the drug delivery device.

10. A syringe holder as described in claim 9, wherein the outwardly extending protrusion is configured (a) to enable movement of the syringe holder in a proximal direction relative to the housing of the drug delivery device when the syringe holder is in the first axial position, and / or (b) to enable movement of the syringe holder in the distal direction relative to the housing of the drug delivery device when the syringe holder is in a second rotational position relative to the housing of the drug delivery device, such that the outwardly extending protrusion is rotationally displaced from the first inner portion of the housing of the drug delivery device to enable movement of the syringe holder in the distal direction relative to the housing of the drug delivery device.

11. A syringe holder as described in any one of claims 8 to 10, wherein at least a portion of the syringe holder is configured to contact a second inner portion of the housing of the drug delivery device when the syringe holder is in a second axial position relative to the longitudinal axis of the housing of the drug delivery device to prevent the syringe holder from moving in a distal direction relative to the housing of the drug delivery device, and optionally, the at least a portion of the syringe holder includes a surface facing distally of the distal end of the syringe holder.

12. A syringe holder as described in any one of claims 8 to 11, wherein the syringe holder includes a second outwardly extending protrusion distal to the outwardly extending protrusion, and optionally, at least one of the outwardly extending protrusion and the second outwardly extending protrusion contacts an inner portion of the housing of the drug delivery device when the syringe holder is in the first axial position to prevent the syringe holder from rotating in at least one rotational direction relative to the housing of the drug delivery device.

13. A syringe holder as described in claim 12, wherein the second outwardly extending protrusion is configured to be received between two inwardly extending protrusions of the housing of the drug delivery device when the syringe holder is in the first axial position to prevent the syringe holder from rotating relative to the housing of the drug delivery device, and optionally, the second outwardly extending protrusion is configured to form a tight fit with the two inwardly extending protrusions of the housing of the drug delivery device.

14. A syringe holder as described in any one of claims 8 to 13, wherein at least a portion of the side opening is configured to align with at least a portion of a side opening of the housing of the drug delivery device when the syringe holder is in the first axial position.

15. A subassembly for a drug delivery device, comprising: a syringe holder including an outwardly extending protrusion; A housing, a hollow interior configured to receive at least a portion of the syringe holder; a first inwardly extending projection; and a second inwardly extending protrusion distal to the first inwardly extending protrusion; and a housing and Including, during assembly, the syringe holder is in a first axial position relative to the longitudinal axis of the housing where the outwardly extending protrusion of the syringe holder contacts the first inwardly extending protrusion of the housing, and thereafter in a second axial position relative to the longitudinal axis of the housing where at least a portion of the syringe holder contacts the second inwardly extending protrusion of the housing; A subassembly for a drug delivery device.

16. The subassembly of claim 15, wherein the first inwardly extending protrusion is configured to prevent the syringe holder from moving distally relative to the housing when the syringe holder is in a first rotational position relative to the housing.

17. A subassembly as described in claim 16, wherein the first inwardly extending protrusion is configured to enable the syringe holder to move in the distal direction relative to the housing when the syringe holder is in a second rotational position relative to the housing, and optionally, the syringe holder is in the second rotational position when the syringe holder is in the second axial position.

18. A subassembly as described in any one of claims 15 to 17, wherein the syringe holder includes a second outwardly extending protrusion distal to the outwardly extending protrusion, and optionally, at least one of the outwardly extending protrusion and the second outwardly extending protrusion contacts the first inwardly extending protrusion when the syringe holder is in the first axial position to prevent the syringe holder from rotating in at least one rotational direction relative to the housing.

19. The subassembly of claim 18, wherein the housing includes a third inwardly extending protrusion adjacent the first inwardly extending protrusion, and the second outwardly extending protrusion of the syringe holder is disposed between the first inwardly extending protrusion of the housing and the third inwardly extending protrusion of the housing when the syringe holder is in the first axial position to prevent the syringe holder from rotating relative to the housing, and optionally, a tight fit is formed between the second outwardly extending protrusion of the syringe holder and the first inwardly extending protrusion and the third inwardly extending protrusion of the housing when the syringe holder is in the first axial position.

20. A subassembly as described in any one of claims 15 to 19, wherein the syringe holder includes a side opening, and the housing has a side opening distal to the first inwardly extending protrusion of the housing, and at least a portion of the side opening of the syringe holder is configured to align with at least a portion of the side opening of the housing when the syringe holder is in the first axial position and / or the first rotational position.

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