Drug delivery devices

Abstract

The drug delivery device may include a housing having an opening and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening. The biasing member may be initially held in a biased state and may be released to drive the plunger and expel the drug from the drug storage container. The plunger may be configured to selectively rotate from an initial rotational position to a second rotational position under a biasing force applied by the biasing member and to linearly translate distally after rotation from the initial rotational position to the second rotational position to drive the stopper through the drug storage container. The release member may have an initial position in which the release member holds the biasing member in the biased state and a second position in which the release member generates an audible end-of-dosage signal.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 908,504, filed on September 30, 2019, entitled "Drug Delivery Device", which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to drug delivery devices, and more particularly to devices for automatically injecting drugs into a patient.

Background Art

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

[0004] Drug delivery devices can incorporate various mechanisms to achieve various automated functions. Such functions include, among other things, automatically covering the needle in the pre - delivery and / or post - delivery state, providing an interface to the user for actuating the drive mechanism, and indicating to the user that drug delivery has been completed. Typically, drug delivery devices incorporate separate or independently operable mechanisms to achieve each of their automated functions. As a result, each additional function tends to increase the mechanical complexity of the device. This can increase the size of the device, make it cumbersome for the user to handle, and in addition, increase manufacturing costs and time frames. As the demand for more user - friendly and safer drug delivery devices grows, finding ways to incorporate more automated functions without adding excessive complexity to the drug delivery device presents various design and manufacturing challenges.

[0005] This disclosure describes a drug delivery device that embodies a favorable alternative to existing drug delivery devices and addresses one or more of the challenges or needs described herein. [Overview of the Initiative] [Means for solving the problem]

[0006] One aspect of the present disclosure provides a drug delivery device comprising a housing, a drug delivery container fixed to the housing, a biasing member, and a plunger operably coupled to the plunger biasing member. The drug storage container may include an inner surface and a stopper slidable along the inner surface. The plunger is configured to (i) selectively rotate from an initial rotational position to a second rotational position under a biasing force applied by the biasing member, and (ii) after rotating from the initial rotational position to the second rotational position, linearly translate distally to drive the stopper through the drug storage container.

[0007] Another aspect of the present disclosure provides a drug delivery device comprising a housing having an opening, a drug storage container, a guard, a plunger, a plunger biasing member, and a release member movably positioned adjacent to the opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening. The plunger may be distally movable to release a drug from the drug storage container through the delivery member. The release member may be operably coupled to the guard and the plunger. Furthermore, the release member may be configured to rotate from an initial rotation position to a second rotation position under a biasing force applied by the plunger biasing member.

[0008] Additional aspects of the present disclosure provide a drug delivery device comprising a housing, a drug storage container, a plunger, a plunger biasing member initially held in a biased state, and an indicator. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through an opening. By releasing the plunger biasing member, the plunger may be driven distally, thereby releasing the drug from the drug storage container through the delivery member. The indicator may have an initial position in which the indicator holds the plunger biasing member in a biased state, and a second position in which the indicator generates an audible signal indicating the end of drug delivery.

[0009] Another aspect of the present disclosure provides a housing having an opening, a drug storage container, a plunger, and a plunger biasing member. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening. The plunger may have an inner surface defining an axial chamber. The plunger biasing member may be located at least partially within the axial chamber of the plunger and may be initially held in a biased state. By releasing the plunger biasing member, the plunger may be driven distally, thereby releasing the drug from the drug storage container through the delivery member.

[0010] Additional aspects of the present disclosure provide a housing having an opening, a drug storage container, a guard, a plunger, a plunger biasing member, and a release member movably positioned adjacent to the opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening. The drug storage container may be coupled to the housing so that relative movement between them is resisted. The plunger may be distally movable to release the drug from the drug storage container through the delivery member. The release member may be operably coupled to the guard and the plunger. Furthermore, the release member may be configured to utilize inertial force from the user to drive the housing and drug storage container toward the user's injection site.

[0011] Further aspects of the present disclosure provide a drug delivery device comprising a housing having an opening, a drug storage container, a plunger, a plunger biasing member, and a brake member. The drug storage container may include a body portion defining a longitudinal axis and a delivery member having an insertion end configured to extend at least partially through the opening during delivery. The plunger may be movable distally to release a drug from the drug storage container through the delivery member. The plunger biasing member may be configured to press the plunger distally. The brake member may be operably coupled to the plunger. By moving the plunger distally, the plunger and / or the brake member may rotate about the longitudinal axis.

[0012] This disclosure is expected to be better understood by interpreting the following description in conjunction with the accompanying drawings. Some of the drawings have been simplified by omitting selected elements in order to more clearly illustrate other elements. Such omissions of elements in some drawings do not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless explicitly described in the corresponding documentation. Furthermore, none of the drawings are necessarily shown to exact scale. [Brief explanation of the drawing]

[0013] [Figure 1] This is a perspective view of a drug delivery device according to one embodiment of the present disclosure. [Figure 2] Figure 1 is a cross-sectional view of a drug delivery device. [Figure 3] Figure 2 is an exploded view of a drug delivery device. [Figure 4] Figure 2 shows different perspective views of the plunger guide. [Figure 5] Figure 2 shows different perspective views of the plunger guide. [Figure 6] Figure 2 shows different perspective views of the release member. [Figure 7]Figure 2 shows different perspective views of the release member. [Figure 8] Figure 2 is a partial perspective view of the plunger, plunger biasing member, and plunger guide shown. [Figure 9A] This is a cross-sectional view along line ZZ in Figure 9B. [Figure 9B] This is a perspective view of the plunger holding configuration before the guard member is retracted. In Figure 9B, the release member is shown as semi-transparent. Also, in Figure 9B, the guard extension and guard biasing member are omitted for clarity. [Figure 9C] Figure 9B is a perspective view of the distal end of the plunger holding configuration. In Figure 9C, the guard and guard extension are shown as semi-transparent. Also, in Figure 9C, the guard biasing member, plunger, and plunger guide are omitted for clarity. [Figure 9D] This is a cross-sectional view along line YY in Figure 9C. [Figure 9E] Figure 9B is a perspective view of the proximal end of the retaining configuration. In Figure 9E, the release member is shown as semi-transparent. Also, in Figure 9E, the guard biasing member is omitted for clarity. [Figure 10A] This is a cross-sectional view along line XX in Figure 10B. [Figure 10B] This is a perspective view of the plunger holding configuration at the moment after the guard member has moved to the retracted position. In Figure 10B, the release member is shown as semi-transparent. Also, in Figure 10B, the guard extension and guard biasing member are omitted for clarity. [Figure 10C] Figure 10B is a perspective view of the distal end of the plunger holding configuration. In Figure 10C, the guard and guard extension are shown as semi-transparent. Also, in Figure 10C, the guard biasing member, plunger, and plunger guide are omitted for clarity. [Figure 10D] This is a cross-sectional view along line WW in Figure 10C. [Figure 11A] Figure 11B is a cross-sectional view along line VV. [Figure 11B]It is a perspective view of the plunger holding configuration at the start of drug delivery. In FIG. 11B, the release member is shown as translucent. Also, in FIG. 11B, for clarity, the guard extension and the guard biasing member are omitted. [Figure 11C] It is a perspective view of the distal end of the plunger holding configuration of FIG. 11B. In FIG. 11C, each of the guard and the guard extension is shown as translucent. Also, in FIG. 11C, for clarity, the guard biasing member, the plunger, and the plunger guide are omitted. [Figure 11D] It is a cross-sectional view taken along line U-U of FIG. 11C. [Figure 11E] It is a perspective view of the proximal end of the holding configuration of FIG. 11B. In FIG. 11E, the release member is shown as translucent. Also, in FIG. 11E, for clarity, the guard biasing member is omitted. [Figure 12A] It is a cross-sectional view taken along line T-T of FIG. 12B. [Figure 12B] It is a perspective view of the plunger holding configuration at the end of drug delivery. In FIG. 12B, the release member is shown as translucent. Also, in FIG. 12B, for clarity, the guard extension and the guard biasing member are omitted. [Figure 12C] It is a perspective view of the distal end of the plunger holding configuration of FIG. 12B. In FIG. 12C, each of the guard and the guard extension is shown as translucent. Also, in FIG. 12C, for clarity, the guard biasing member, the plunger, and the plunger guide are omitted. [Figure 12D] It is a cross-sectional view taken along line S-S of FIG. 12C. [Figure 12E] It is a perspective view of the proximal end of the holding configuration of FIG. 12B. In FIG. 12E, the release member is shown as translucent. Also, in FIG. 12E, for clarity, the guard biasing member is omitted. [Figure 13] It is a perspective view of a drug delivery device according to another embodiment of the present disclosure. [Figure 14] It is a perspective view of the drug delivery device of FIG. 13 with the removable cap removed. [Figure 15] Figure 13 shows different side views of a drug delivery device. [Figure 16] Figure 13 shows different side views of a drug delivery device. [Figure 17A] This is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. [Figure 17B] Figure 17A is a magnified view of the proximal end of the drug delivery device shown. [Figure 18A] This is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. [Figure 18B] Figure 18A is a magnified view of the proximal end of the drug delivery device shown. [Figure 19A] This is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. [Figure 19B] Figure 19A is a magnified view of the proximal end of the drug delivery device shown. [Figure 20] This is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. [Figure 21] This is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. [Modes for carrying out the invention]

[0014] This disclosure relates to a user-operable drug delivery device for administering a drug, or for self-administering a drug if the user is a patient. Various features are disclosed to facilitate the safe and proper handling of the drug delivery device, including handling the drug delivery device after it has been used to deliver its payload. Such features include, but are not limited to, an indicator for notifying the user that drug delivery is complete, and a drive mechanism that can be activated by pressing the drug delivery device against the patient's skin at the injection site. These and other features work together and / or interact synergistically to limit the number of moving parts and / or the complexity of the drug delivery device. Furthermore, certain features described herein reduce any force that must be applied by the user and / or reduce the need to incorporate a dedicated energy source to implement the feature by utilizing the biasing force applied by a plunger biasing member and / or a guard biasing member for the purpose of operation. These and other advantages will become apparent to those skilled in the art who consider this disclosure.

[0015] Figures 1 to 3 show some drawings of one embodiment of a drug delivery device 10 for delivering a drug, also referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological formulations such as peptides, peptide bodies, or antibodies. The drug may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0016] Various realizations and configurations are possible for the drug delivery device 10. In this embodiment of the drug delivery device 10, it is configured as a single-use, disposable syringe. In other embodiments, the drug delivery device 10 may be configured as a reusable syringe for multiple uses. The drug delivery device 10 is operable for self-administration by the patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a doctor or nurse). This embodiment of the drug delivery device 10 may take the form of an auto-injector or a pen-type injector and thus be held in the user's hand throughout the period of drug delivery.

[0017] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have pre-delivery or storage state, delivery or administration state, and post-delivery state, but fewer or more states are also possible. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before operation by the user. In some embodiments, the pre-delivery state may exist in the time from when the drug delivery device 10 leaves the manufacturing facility until a patient or user operates the drive mechanism 30 of the drug delivery device 10. This includes the time from when the user removes the drug delivery device 10 from some secondary package until the drug delivery device 10 is placed at the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 during drug delivery, also referred to herein as administration. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is complete and / or when the stopper is placed at the end of administration position in the drug storage container.

[0018] The drug delivery device 10 includes an external casing or housing 12. In some embodiments, the housing 12 may be sized and configured to allow a person to grasp the syringe 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylinder, and may extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 may be formed at the distal end to allow the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be placed in the wall of the housing 12 to allow the user to view the components inside the drug delivery device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window 17, the user can confirm that drug delivery is in progress and / or completed. Before use of the drug delivery device 10, a removable cap 19 may cover the opening 14, and in some embodiments, a gripper 13 may be included to assist in the removal of a sterile barrier 21 (e.g., a rigid needle shield (RNS), a flexible needle shield (FNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting return portions or arms that frictionally or mechanically engage with the sterile barrier 21 to pull the sterile barrier 21 together with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0019] In this embodiment, the housing 12 is defined by three separate interconnected structures: a rear end cap 23 located at the proximal end of the drug delivery device 10; a front housing 25 located at the distal end of the drug delivery device 10 and including an opening 14; and a rear housing 27 positioned between the rear end cap 23 and the front housing 25, and rigidly connecting them. The front housing 25 and the rear housing 27 may each have a hollow, substantially cylindrical or tubular shape, and the rear end cap 23 may have a substantially hemispherical shape or a hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the rear housing 27, and any components placed therein, may be assembled together to define a rear subassembly. Alternatively, the front housing 25 and any components placed therein may be assembled together to define a front subassembly. In some embodiments, the rear and front subassemblies are assembled independently of each other and then combined with each other, and with the drug storage container 20, to form a fully assembled drug delivery device 10. In certain such embodiments, some or all of the assembly steps described above may be carried out in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed as a single unit such that the housing 12 is defined by a single monolithic structure.

[0020] The drug storage container 20 is positioned within the internal space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 may be pre-filled and shipped, for example, by the manufacturer, to a location where it will be combined with the rest of the drug delivery device 10. The housing 12 may be pre-loaded with the drug storage container 20, for example, by the manufacturer, or alternatively, the drug storage container 20 may be loaded by the user before use of the drug delivery device 10. The drug storage container 20 may include rigid walls defining an internal bore, i.e., a reservoir. The walls may be made of glass or plastic. A stopper 24 may be movably positioned within the drug storage container 20 so as to 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 airtight contact with the inner surface 15 of the wall of the drug storage container 20 to prevent or stop the drug 22 from leaking over 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 to the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by a gap. When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap and contact the stopper 24. Subsequently, as the plunger 26 moves distally, the stopper 24 is driven distally, releasing the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or connected to each other, for example, via a screw coupling, so that they move together from the start of the plunger 26's movement. Once the stopper 24 is in a moving state, it can continue to move distally until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20.This position on the stopper 24 may be called the end-of-dose position or end-of-delivery position, and may correspond to when the delivery of the drug 22 to the patient is complete or substantially complete.

[0021] In some embodiments, the volume of drug 22 contained in the reservoir of the drug storage container 20 may be equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.5 mL, or approximately (e.g., ±10%) equal to 2.5 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) less than or equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 4 mL, or approximately (e.g., ±10%) less than or equal to 5 mL, or approximately (e.g., ±10%) less than or equal to 10 mL, or approximately (e.g., ±10%) within the range of 1 to 10 mL, or approximately (e.g., ±10%) within the range of 1 to 5 mL, or approximately (e.g., ±10%) within the range of 1 to 4 mL, or approximately (e.g., ±10%) within the range of 1 to 3 mL, or approximately (e.g., ±10%) within the range of 1 to 2.5 mL.

[0022] The delivery member 16 is fluidly connected to or operable to be connected to the reservoir of the drug storage container 20. The distal end of the delivery member 16 may define the insertion end 28 of the delivery member 16. The insertion end 28 may include other pointed or sharp tips to allow the insertion end 28 to puncture the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal pathway. 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.

[0023] In this embodiment, the drug storage container 20 is a pre-filled syringe having a fixed, hollow metal needle for the delivery member 16. Here, the needle is fixed to the wall of the drug storage container 20 and is in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the drug storage container 20 may be a cartridge without a needle and therefore may not be in fluid communication with the delivery member 16 initially. In such embodiments, during operation of the drug delivery device 10, the drug storage container 20 may move toward the proximal end of the delivery member 16 or vice versa, so that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0024] Once the drug storage container 20 is placed in the housing 12, it may be fixed to the housing 12 so that it does not move relative to the housing 12. Therefore, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 of the housing 12 in the pre-delivery, during-delivery, and post-delivery states. In this embodiment, a container holder 31 fixes the position of the drug storage container 20 within the housing 12. The container holder 31 may have a hollow, substantially cylindrical or tubular shape, and the drug storage container 20 may be partially or entirely positioned within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33 that abuts against the neck of the drug storage container 20, thereby preventing distal movement of the drug storage container 20. The container holder 31 may be fixedly attached to the housing 12 so that it is prevented from moving relative to the housing 12 during operation of the drug delivery device 10.

[0025] In alternative embodiments, the drug storage container 20 may be movably coupled to the housing 12 so that the drug storage container 20 can move relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may be retracted inward into the opening 14 of the housing 12 in the pre-delivery state. Subsequently, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 of the housing 12 for insertion into the patient. In some embodiments, this movement may result from the drug storage container 20 being driven distally relative to the housing 12.

[0026] The plunger 26 may have a hollow, substantially cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space sized to accommodate the plunger biasing member 50 therein. It is generally desirable to minimize the thickness of the annular wall 39 as much as possible without compromising the integrity of the plunger 26, in order to maximize the inner diameter of the plunger 26. This makes it possible to fit a plunger biasing member 50 of a larger diameter into the internal space of the plunger 26, thereby making the plunger biasing member 50 stronger. As will be described in more detail below, the plunger 26 may be configured to selectively rotate relative to the housing 12 and to translate linearly relative to the housing 12 during operation of the drug delivery device 10.

[0027] The plunger 26 may consist of multiple interconnected parts, or it may have an integrated structure. In this embodiment, the plunger 26 consists of three separate interconnected structures: a top ring 45 defining the proximal end of the plunger 26, a base 47 defining the distal end of the plunger 26, and a hollow rod 46 positioned between the top ring 45 and the base 47 and rigidly connecting them. The positions of the top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other so that these components do not move relative to each other. The top ring 45, the hollow rod 46, and the base 47 may each have an annular structure and may be centered around a longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a central opening that extends from end to end of the component and defines an axial chamber, while the base 47 may have a central opening that extends through the proximal end of the base 47 but is closed at the distal end of the base 47. The closed end of the base 47 may define a seating or contact surface for the plunger biasing member 50. In an alternative embodiment, the central opening may extend from end to end through the base 47. In such an alternative embodiment, the inner diameter of the central opening of the base 47 may be smaller than the outer diameter of the plunger biasing member 50 so that the base 47 holds the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is actuated, the base 47 may be a portion of the plunger 46 that contacts the stopper 24 and pushes the stopper 24 distally.

[0028] The top ring 45 may include one or more flanges or projections 48 extending radially outward from the central portion of the top ring 45. Each of the projections 48 may include a distally facing cam surface 49. As will be described in more detail below, the distally facing cam surface 49 may interact with a corresponding cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distally facing cam surface 49 may be configured at an angle to a virtual plane perpendicular to the longitudinal axis A, or non-parallel to this virtual plane.

[0029] In some embodiments, the top ring 45 and / or base 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or base 47 may be made of plastic, while the hollow rod 46 may be made of metal. By such configuration, the plastic material used for the top ring 45 may facilitate the cam action described below by providing sliding friction, and the plastic material used for the base 47 may help absorb or dampen shocks or vibrations associated with the base 47 striking the stopper 24. The metal material used for the hollow rod 46 can provide sufficient rigidity to avoid buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, hollow rod 46, and / or base 47 may be made of the same material, including, for example, metal or plastic. In certain such embodiments, the top ring 45, hollow rod 46, and / or base 47 may be integrally formed as a single piece to define a single monolithic structure.

[0030] The drug delivery device 10 may further include a guard mechanism to prevent 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 positioned at the distal end of the housing 12 adjacent to the opening 14. The guard member 32 may have a hollow, substantially cylindrical or tubular shape centered 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. In addition 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 before delivery or in storage, moving the guard member 32 from the extended position to the retracted position by pressing the distal end of the guard member 32 against the patient's skin at the injection site may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin.

[0031] For example, the delivery device 10 may utilize an inertial design rather than a spring-driven design to insert the needle into the patient's subcutaneous tissue. In a more specific example, when the patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 may advance toward the injection site. When the patient pushes down a predetermined distance or with a predetermined force, the delivery device 10 is rapidly released using the energy stored in the patient's muscles, while compressing the needle cover and its spring to a predetermined release point. The release mechanism is designed such that the resulting needle insertion speed exceeds the patient's reaction speed, and this speed, combined with the mass of the device, allows the needle to penetrate the skin and reach subcutaneous depth quickly and completely. Compared to known syringes in which the entire primary container moves forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing, thus providing a simplified, more robust design.

[0032] In some embodiments, the guard member 32 may be fixed from rotation relative to the housing 12. Therefore, the guard member 32 may be able to translate linearly relative to the housing 12, but rotation relative to the housing 12 may be prevented. To achieve this effect, in some embodiments, one or more longitudinal slots 61 may be formed in the wall of the guard member 32 and may be parallel to the longitudinal axis A. Each longitudinal slot 61 may be dimensioned to engage with or snugly accommodate a projection or pin 63 extending radially inward from the front housing 25. Each pin 63 may slidably engage with a surface defining a corresponding one of the longitudinal slots 61 when the guard member 32 translates linearly along the longitudinal axis A relative to the front housing 25. However, the pins 63 abut against the same surface to prevent rotation of the guard member 32 relative to the front housing 25 when some rotational force is applied to the guard member 32. In an alternative embodiment, the pin and slot configuration may be reversed, with the guard member 32 having one or more radially outward-extending pins, and the front housing 25 having one or more slots or other recesses for mating or snugly accommodating one or more pins.

[0033] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be positioned proximal to the guard member 32, and the guard biasing member 35 may be positioned proximal to the guard extension 37. The guard extension 37 may have a hollow, substantially cylindrical or tubular shape centered about the longitudinal axis A. Furthermore, the guard extension 37 may be movable linearly 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 an alternative embodiment, the guard extension 37 and the guard member 32 may be integrally formed as a single part to define a single monolithic structure. In such an alternative embodiment, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0034] Similar to the guard member 32, the guard extension 37 may be fixed from rotation relative to the housing 12. Therefore, the guard extension 37 may be able to translate linearly relative to the housing 12, but rotation relative to the housing 12 may be prevented. To achieve this effect, in some embodiments, one or more longitudinal slots 71 may be formed in the wall of the guard extension 37 and may be parallel to the longitudinal axis A. Each longitudinal slot 71 may be dimensioned to fit or snugly accommodate a projection or pin (not shown) extending radially inward from the housing 12, for example, from the rear housing 23 and / or the front housing 25. Each pin may slidably engage with a surface defining the corresponding longitudinal slot 71 when the guard extension 37 translates linearly relative to the housing 12 along the longitudinal axis A. However, the pins abut the same surface to prevent rotation of the guard extension 37 relative to the housing 12 when any rotational force is applied to the guard extension 37. In an alternative embodiment, the pin and slot configuration may be reversed so that the guard extension 37 has one or more radially outward-extending pins, and the housing 12 has one or more slots or other recesses to fit or snugly accommodate one or more pins.

[0035] The guard biasing member 35 may be positioned between the guard extension 37 and the release member 52, in contact with them. The guard biasing member 35 may be configured to bias or press the guard extension 37 distally and bias or press the release member 52 proximal. The guard biasing member 35 may initially be in a biased (e.g., compressed) state so as to apply a biasing force to the guard extension 37 and the release member 52 in the 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 shown in Figure 2. As a result, the guard extension 37 transmits the biasing force of the guard biasing member 35 to the guard member 32 so that the guard biasing member 35 biases or presses the guard member 32 toward the extended position. The user can overcome the biasing force by pressing the guard member 32 against the injection site. In this manner, the guard member 32 and the guard extension 37 move together proximal to a position, for example, until the guard member 32 reaches a retracted position. When the injection is complete and the drug delivery device 10 is lifted from the injection site, the guard biasing member 35 may press against the guard extension 37, thereby causing the guard extension 37 and the guard member 32 to move together distally. This movement returns the guard member 32 to an 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). Furthermore, in embodiments in which the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be positioned around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0036] In an alternative embodiment, the distal end of the guard extension 37 is initially positioned proximal to the proximal end of the guard member 32 by a gap. As a result, the guard biasing member 35 may not bias the guard member 32 toward the extended position in the pre-delivery state. Only when the guard member 32 retracts proximal and contacts the guard extension 37 can the guard biasing member 35 apply a biasing force to the guard member 32, pressing it toward the extended position. In such an alternative embodiment, biasing the guard member 32 toward the extended position in the pre-delivery state can only be achieved by relying on the lock ring biasing member 51, which is described below.

[0037] After drug delivery is complete and the guard member 32 has been repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent further user contact with the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. To these purposes, 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 in order to lock the guard member 32 in the extended position once the guard member 32 has moved from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered and rotates about a longitudinal axis A. As shown in Figure 2, the proximal end of the locking ring 40 may be in contact with the container holder 31, and the distal end of the locking ring 40 may be located at least partially within the guard member 32. The locking ring biasing member 51 may be axially positioned between the distal surface of the locking ring 40 and the proximal surface of the guard member 32. The lock ring biasing member 51 may be initially compressed or biased so as to bias the lock ring 40 and the guard member 32 toward each other. Thus, the lock ring biasing member 51 may apply a biasing force that pushes the guard member 32 toward the extended position, and may also apply a biasing force that pushes the proximal end of the lock ring 40 toward the container holder 31. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a helical compression spring).

[0038] The rotation of the lock ring 40 can be achieved by a cam configuration between the lock ring 40 and the container holder 31. In some embodiments, the proximal end of the lock ring 40 may include one or more cam surfaces 53 configured to slidably engage with one or more corresponding cam surfaces 55 included in the inner annular wall 57 of the front housing 25. The inner annular wall 57 of the front housing 25 may be centered about the longitudinal axis A and may be supported by a cantilever radially inward from the outer annular wall 59 of the front housing 25 such that an annular gap exists between the inner annular wall 57 and the outer annular wall 59 of the front housing 25. This configuration may allow the guard member 32 to slide into the annular gap between the inner wall 57 and the outer wall 59 during retraction. In some embodiments, the cam surfaces 53 of the lock ring 40 may have a generally serrated appearance when viewed radially from the longitudinal axis A. Furthermore, the cam surfaces 53 may be positioned around the longitudinal axis A such that each cam surface 53 is positioned at a different angular position with respect to the longitudinal axis A. Similarly, the cam surfaces 55 on the container holder 31 may have a generally sawtooth appearance when viewed radially from the longitudinal axis A. Furthermore, the cam surfaces 55 may be positioned around the longitudinal axis A such that each cam surface 55 is positioned at a different angular position with respect to the longitudinal axis A.

[0039] The cam surfaces 53 and 55, when pressed against each other, can convert linear motion into a combination of rotational and linear motion. More specifically, as the lock ring 40 moves proximal along the longitudinal axis A, each of the cam surfaces 53 can slide relative to each of the cam surfaces 55. This interaction can convert the proximal linear motion of the lock ring 40 into a combination of rotational motion of the lock ring 40 about the longitudinal axis A and proximal linear motion of the lock ring 40 along the longitudinal axis A. Throughout the entire movement of the lock ring 40, the inner annular wall 57 of the front housing 25 remains stationary relative to the rest of the front housing 25. In this configuration, the inner annular wall 57 of the front housing 25 functions as a cam, and the lock ring 40 functions as a cam follower.

[0040] The biasing force of the guard biasing member 35 can continuously press the cam surface 53 of the lock ring 40 against the cam surface 55 of the inner annular wall 57. As a result, the lock ring 40 is continuously promoted to rotate about the longitudinal axis A. However, the lock ring 40 may not rotate depending on the relative positions of the various cooperating contact structures contained outside the lock ring 40 and inside the guard member 32. Depending on the axial position of the guard member 32, these cooperating contact structures may engage and / or disengage from each other to enable the rotation of the lock ring 40. In some embodiments, the lock ring 40 may rotate to a final rotation position when the guard member 32 moves from a retracted position to an extended position. In the final rotation position, the distally facing surfaces of one or more contact structures contained in the lock ring 40 may be aligned in the rotational direction with and facing the proximal facing surfaces of one or more corresponding contact structures contained in the guard member 32. As a result, any subsequent proximal movement of the guard member 32 can be prevented by the distal surface of the contact structure included in the lock ring 40, which engages with the proximal surface of the contact structure included in the guard member 32.

[0041] The drug delivery device 10 may further include a drive mechanism 30 partially or completely located within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, at the time of or in response to activation of the drive mechanism 30 by the user, release or output that energy to drive the plunger 26 to release the drug 22 from the drug storage container 20 through the delivery member 16 into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, but alternative embodiments of the drive mechanism 30 may be configured in a different form, for example, so that the drive mechanism 30 stores electrical or chemical potential energy. Generally, at the time of activation of the drive mechanism 30, the drive mechanism 30 may convert the potential energy into kinetic energy to move the plunger 26.

[0042] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member seating surface 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 can be compressed such that its axial length is shorter than that in the natural or unbiased state. When released, the plunger biasing member 50 attempts to extend to its natural axial length, thereby applying a biasing force to press the plunger 26 distally.

[0043] The plunger biasing member 50 may be at least partially located within the plunger 26, and may have a distal end that abuts against the proximal inner surface of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. To accommodate the plunger biasing member 50 within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 may be less than or equal to the inner diameter of the top ring 45 and / or the inner diameter 46 of the hollow rod. In some embodiments, the distal end of the plunger biasing member 50 may abut against the proximal inner surface of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut against the distal surface of the plunger biasing member seating surface 38. The plunger biasing member seating surface 38 may be fixedly attached to the rear housing 27 so as to provide a stationary surface against which the plunger biasing member 50 presses as it extends. With this configuration, the plunger biasing member 50 may extend in length when released from the biased state, by moving distally so that the distal end of the plunger biasing member 50 moves away from the stationary proximal end of the plunger biasing member 50. This movement pushes the plunger 26 distally, thereby pushing the stopper 24 distally, allowing the drug 22 to be released from the drug storage container 20 into the delivery member 16 and then into the patient.

[0044] The plunger guide 60 may be fixedly attached to the rear housing 27 so as not to move relative to the rear housing 27. The plunger guide 60 may have a hollow, substantially cylindrical or tubular shape and may be centered around the longitudinal axis A. The outer diameter or other external dimensions of the proximal end of the plunger guide 60 may be larger than the outer diameter or other external dimensions of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 may be radially positioned between the plunger 26 and the release member 52. Therefore, as shown in Figure 2, the plunger 26 may be at least partially positioned within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 may be at least partially positioned within the release member 52.

[0045] As shown in Figures 4, 5, and 8, the distal end of the plunger guide 60 may include an annular wall 80 formed of various surfaces and openings for interacting with the plunger 26 and the release member 52 and controlling their movement. More specifically, a first opening 82 may be formed in the annular wall 80 and may be dimensioned to accommodate one of the outwardly extending projections 48 from the upper ring 45 of the plunger 26. The annular wall 80 may include a proximal-facing cam surface 84 defining a portion of the periphery of the first opening 82. The cam surface 84 may be inclined downward at some angle with respect to a virtual plane perpendicular to the longitudinal axis A, or may be non-parallel. In the pre-delivery state, the proximal-facing cam surface 84 of the plunger guide 60 may be in contact with the distal-facing cam surface 49 of the top ring 45 of the plunger 26. Here, the biasing force of the plunger biasing member 50 may press the distally facing cam surface 49 of the top ring 45 against the proximal facing cam surface 84 of the plunger guide 60. As a result, the distally facing cam surface 49 of the top ring 45 may be facilitated to slide along the proximal facing cam surface 84 of the plunger guide 60, generally following a helical path. If permitted, this sliding motion may result in rotation and linear translation of the plunger 26 relative to the stationary plunger guide 60. Accordingly, the plunger guide 60 can function as a cam and the top ring 45 can function as a cam follower. In the pre-delivery state, any rotation of the plunger 26 relative to the plunger guide 60 may be prevented by the engagement between the projection 48 and the release member 52, as described below. When there is no sliding motion between the distally facing cam surface 49 of the top ring 45 and the proximal facing cam surface 84 of the plunger guide 60, the annular wall 80 of the plunger guide 60 acts to prevent linear translational movement of the plunger 26 distally. Thus, the plunger guide 60 can help hold the plunger biasing member 50 in a biased state before retracting the guard member 32. In some embodiments, an opening similar to the first opening 82 may be formed on the opposite side of the plunger guide 60 and may be configured to accommodate one of the different projections 48 of the top ring 45.

[0046] Referring again to Figures 4, 5, and 8, the second opening 86 may be formed in the annular wall 80 of the plunger guide 60 and may be located at least partially distal to the first opening 86. As shown in Figures 4 and 5, the second opening 86 generally takes the form of a longitudinal slot parallel to the longitudinal axis A. The second opening 86 may be dimensioned to accommodate one of the projections 48 of the top ring 45 and may allow the projection 48 to slide linearly distally through the second opening 86. After the projection 48 has rotated beyond the end of the cam surface 84, the projection 48 may be housed in the second opening 86, as shown in Figure 8, and subsequently, the projection 48 may move linearly distally through the second opening 86 without further rotation relative to the plunger guide 60. In some embodiments, an opening similar to the second opening 86 may be formed on the opposite side of the plunger guide 60 and may be configured to accommodate one different projection 48 of the top ring 45.

[0047] The annular wall 80 of the plunger guide 60 may further include a distally facing cam surface 88. As shown in Figures 4 and 5, the distally facing cam surface 88 may be part of a helical projection extending outward from the rest of the annular wall 80. The distally facing cam surface 88 may be inclined upward at some angle with respect to a virtual plane perpendicular to the longitudinal axis A, or it may be non-parallel. As will be described in more detail below, the biasing force of the guard biasing member 35 can press the proximal facing cam surface of the release member 52 against the distally facing cam surface 88 of the plunger guide 60. As a result, the proximal facing cam surface of the release member 52 may be biased and slide along the distally facing cam surface 88 of the plunger guide 60, generally following a helical path. Where permitted, this sliding motion may result in rotational and linear translational movement of the release member 52 relative to the stationary plunger guide 60. Accordingly, the plunger guide 60 can function as a cam, and the release member 52 can function as a cam follower. In some embodiments, a distally facing cam surface similar to the distally facing cam surface 88 may be formed on the opposite side of the plunger guide 60 and may be configured to engage with different proximal facing cam surfaces on the release member 52.

[0048] The configuration of the release member 52 will now be described with reference to Figures 2, 3, 6, and 7. The release member 52 may have a hollow, substantially cylindrical or tubular shape and may be centered around the longitudinal axis A. As shown in Figure 2, the release member 52 may be radially positioned between the distal end of the plunger guide 60 and the proximal end of the guard extension 37. Furthermore, the release member 52 may be positioned radially inward of the guard biasing member 35. Generally, the release member 52 is configured to operably couple the guard member 32 and the plunger 26 in the operating sequence and to generate an audible signal indicating the end of drug delivery. By being configured in this way, the release member 52 performs two distinct functions and is therefore used to reduce the number of moving parts required by the drug delivery device 10.

[0049] 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 operating stage of the drug delivery device 10. The initial rotation of the release member 52 related to operation may be powered by the plunger biasing member 50 and / or the guard biasing member 35, while subsequent rotations of the release member 52 related to the generation of a drug delivery completion signal may be powered solely by the guard biasing member 35. Any linear translational movement of the release member 52 without 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, but alternative embodiments may allow linear translational movement of the release member 52 in both the proximal and distal directions.

[0050] The release member 52 may have an annular wall 90 having a distal end and a proximal end. Generally, the distal end of the annular wall 90 is configured to assist in the operation of the drive mechanism 30, and the proximal end of the annular wall 90 is configured to generate an audible medication completion signal. As shown in Figure 2, a distally facing projection or surface 91 formed on the outer portion of the annular wall 90 may abut against the proximal end of the guard biasing member 35. Thus, the guard biasing member 35 may apply a biasing force to the release member 52, pressing it in the proximal direction.

[0051] Referring to Figure 6, a recess 92 may be formed in the inner portion of the annular wall 90 of the release member 52. In this embodiment, the recess 92 takes the form of a groove formed in the inner surface of the annular wall 90. In other embodiments, the recess 92 may take the form of a through hole, opening, or slot extending between the inner and outer surfaces of the annular wall 90. The recess 92 may be positioned such that its length or longest dimension is parallel to the longitudinal axis A. Furthermore, the recess 92 may be dimensioned to fit or snugly accommodate one of the projections 48 of the top ring 45. The recess 92 may allow the projection 48 to slide linearly relative to the release member 52 parallel to the longitudinal axis A, but may be configured to prevent the projection 48 from rotating about the longitudinal axis A relative to the release member 52. This can be achieved by forming the recess 92 with a width slightly greater than the width of the projection 48 so that there is little rotational play between the recess 92 and the projection 48. Due to the mating engagement between the projection 48 and the recess 92, the release member 52 and the plunger 26 can be locked to each other in the rotational direction. Therefore, when the projection 48 is housed in the recess 92, the release member 52 may rotate together with the plunger 26, and when the projection 48 is not housed in the recess 92, the release member 52 may rotate independently of the plunger 26. In some embodiments, a recess similar to the recess 92 may be formed on the opposite side of the release member 52 and may be configured to house one of the different projections 48 of the top ring 45.

[0052] The ability of the release member 52 to rotate about the longitudinal axis A may be regulated by the interaction between the outer portion of the annular wall 90 of the release member 52 and the inner portion of the guard extension 37. More specifically, the biasing force of the plunger biasing member 50 may continuously press the cam surface 49 of the projection 48 against the cam surface 84 of the plunger guide 90, thereby causing the projection 48 to rotate about the longitudinal axis A. Since the projection 48 is fitted and housed in the recess 92, the release member 52 may also be facilitated to rotate under the biasing force of the plunger biasing member 50. In addition, in some embodiments, the release member 52 may be facilitated to rotate by the biasing force of the guard biasing member 35 via a cam arrangement between the proximal end of the release member 52 and the plunger guide 60. Despite these biasing forces, in the pre-delivery state, the release member 52 is prevented from rotating by various cooperating contact structures included in the outer portion of the annular wall 90 of the release member 52 and the inner portion of the guard extension 37. Depending on the relative axial position of these contact structures, the contact structures may engage with each other to prevent the release member 52 from rotating relative to the guard extension 37, or the contact structures may disengage from each other to allow the release member 52 to rotate relative to the guard extension 37. In this embodiment, these cooperating contact structures may take the form of one or more projections 94 extending outward from the release member 52 and one or more corresponding projections 96 extending inward from the guard extension 37, which are slidably engaged with each other to allow relative linear movement along the longitudinal axis A, and simultaneously engage with each other to prevent relative rotational movement about the longitudinal axis A. In certain alternative embodiments, the cooperating contact structure may take the form of one or more recesses formed on the outer surface of the release member 52 and one or more corresponding projections extending inward from the guard extension 37, which engage slidably with each other to allow relative linear movement along the longitudinal axis A, and simultaneously engage and abut each other to prevent relative rotational movement about the longitudinal axis A.In certain other alternative embodiments, the cooperating contact structure may take the form of one or more projections extending outward from the release member 52 and one or more corresponding grooves formed on the inner surface of the guard extension 37, which are slidably engaged with each other to allow relative linear movement along the longitudinal axis A, and simultaneously engage in contact with each other to prevent relative rotational movement about the longitudinal axis A.

[0053] As described above, the guard extension 37 is prevented from rotating about the longitudinal axis A as a result of being coupled to the housing 12. This has the effect of preventing the release member 52 from rotating about the longitudinal axis A when the projection 94 on the outer portion of the release member 52 engages with the projection 96 on the inner portion of the guard extension 37. If the release member 52 cannot rotate, the projection 48 housed in the recess 92 formed on the inner surface of the release member 52 cannot rotate either. If the projection 48 cannot rotate, the projection cannot slide out of the first opening 82 and enter the second opening 86 in the plunger guide 60. If the projection 48 cannot move in this way, the plunger 26 cannot move either. If the plunger 26 cannot move, the plunger biasing member 50 cannot extend and release the bias. Therefore, until the guard extension 37 moves to the axial position, the release member 52 holds the plunger biasing member 50 in a biased state, in which case the cooperating contact structure on the outer part of the release member 52 and the contact structure on the inner part of the guard extension 37 are disengaged from each other, thereby allowing the release member 52 to rotate relative to the guard extension 37.

[0054] In addition to this holding function, the release member 52 may also be used to generate an audible signal to indicate to the user that drug delivery or administration is complete, although it is not essential that the release member 52 has this indicator function. In this embodiment, the proximal end of the release member 52 defines the indicator. Therefore, in this embodiment, the indicator and the release member 52 are the same component. In an alternative embodiment, the indicator is defined by a structure that is separated from the release member 52 but is securely attached to the release member 52.

[0055] Initially, a gap may exist between the proximal end face 97 of the release member 52 and the distal contact surface 98 of the proximal end of the plunger guide 60. To generate an audible signal, the release member 52 may be driven proximal by the guard biasing member 35 to close this gap, and thus the proximal end face 97 of the release member 52 may collide with or strike the distal contact surface 98 of the proximal end of the plunger guide 60. This impact may generate a click or slap, or other appropriate audible signal that the user can recognize. The audible signal may be generated simultaneously with or substantially simultaneously with the stopper 24 reaching the end of drug delivery position. Accordingly, the audible signal may indicate to the user that drug delivery or drug delivery is complete. In some embodiments, the user may be informed of the importance of the audible signal by instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an IFU brochure packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by monitoring the movement of the stopper 24 and / or plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by vibration or other tactile feedback generated as a result of the release member 52 striking the plunger guide 60.

[0056] In some embodiments, the movement of the release member 52 to generate an audible signal may involve both rotation of the release member 52 about the longitudinal axis A and linear translational movement of the release member 52 in the proximal direction. This may be achieved by a cam configuration between the release member 52 and the plunger guide 60. In this embodiment, the proximal end of the release member 52 includes a proximal-facing cam surface 99 that slidably engages with a distal-facing cam surface 88 on the annular wall 80 of the plunger guide 60. The biasing force of the guard biasing member 35 may press the proximal-facing cam surface 99 of the release member 52 against the distal-facing cam surface 88 of the plunger guide 60. As a result, the proximal-facing cam surface 99 of the release member 52 may be facilitated to slide along the distal-facing cam surface 88 of the plunger guide 60, generally following a helical path. If permitted, this sliding motion can result in rotational and linear translational movement of the release member 52 relative to the stationary plunger guide 60. Accordingly, the plunger guide 60 can function as a cam and the release member 52 can function as a cam follower. In some embodiments, a proximal-facing cam surface similar to the proximal-facing cam surface 99 may be formed on the opposite side of the release member 52 and may be configured to engage with different distal-facing cam surfaces on the plunger guide 60.

[0057] The guard biasing member 35 may continuously press the cam surface 99 facing the proximal end of the release member 52 to slide along the cam surface 88 facing the distal end of the plunger guide 60, but such movement may be limited by the interaction between the projection 48 of the plunger 26 and the recess 92 formed in the release member 52. More specifically, when the projection 48 is housed in the recess 92 and thus configured to rotate together, the rotation of the plunger 26 may allow the cam surface 99 facing the proximal end of the release member 52 to slide along the cam surface 88 facing the distal end of the plunger guide 60, thereby resulting in rotation of the release member 52 about the longitudinal axis A and linear translational movement of the release member 52 in the proximal direction. Conversely, if, for example, the projection 48 is housed in the second opening 86 formed in the plunger guide 60, and the projection 48 is housed in the recess 92 and cannot rotate, the cam surface 99 facing the proximal end of the release member 52 cannot slide along the cam surface 88 facing the distal end of the plunger guide 60. As will be explained below, when the stopper 24 reaches the end of drug dispensing position, the projection 48 may slide out from the distal end of the recess 92. As a result, the release member 52 can rotate freely about the longitudinal axis A. As a result, the guard biasing member 35 pushes the cam surface 99 facing the proximal end of the release member 52, allowing it to slide along the cam surface 88 facing the distal end of the plunger guide 60. This closes the gap between the end surface 97 facing the proximal end of the release member 52 and the adjacent distal surface 98 of the proximal end of the plunger guide 60, causing the end surface 97 to strike or contact the contact surface 98 facing the distal end, generating an audible signal indicating the end of drug delivery and terminating the process.

[0058] While the above-described embodiment utilizes the guard biasing member 35 to provide the operating energy necessary to generate a drug completion signal, an alternative embodiment may utilize a biasing member separate from the guard biasing member 35 for this purpose. In certain such embodiments, this additional biasing member may have a distal end fixed to the housing 12 and a proximal end that abuts the distally facing surface of the release member 52. Thus, the biasing member can press against the housing 12 and extend, applying a biasing force proximal to the release member 52. Furthermore, this biasing member can be operated independently of the plunger biasing member 50 and the guard biasing member 35.

[0059] Having described the general configuration of the drug delivery device 10, the method of administering an injection using the drug delivery device 10 will now be described with reference to Figures 9A to 12E. As a preliminary step, the user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or cardboard box. Alternatively, as a preliminary step, the user may prepare the injection site by, for example, rubbing the patient's skin with an alcohol wipe. Next, the user may pull off the removable cap 19 from the front housing 25. As a result of this movement, the gripper 13 may pull off the sterile barrier 21 from the drug storage container 20. This may expose the insertion end 28 of the delivery member 16. However, since the guard member 32 is still in the extended position, the insertion end 28 of the delivery member 16 remains surrounded by the guard member 32 at this stage. Next, the user may place the drug delivery device 10 over the injection site and then press the distal end of the guard member 32 against the injection site. The force applied by the user overcomes the biasing force of the guard biasing member 35 and the lock ring biasing 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 of the guard member 32.

[0060] As the guard member 32 moves from the extended position to the retracted position, several actions may occur. Since the delivery member 16 remains stationary relative to the housing 12 while the guard member 32 is retracted, the insertion end 28 of the delivery member 16 extends through the opening at the distal end of the guard member 32, thereby penetrating the patient's skin at the injection site and entering the patient's subcutaneous tissue. In addition, the retraction of the guard member 32 may also actuate the drive mechanism 30 to release the drug 22 from the drug storage container 20, as described below.

[0061] In the pre-delivery state before the needle guard 32 retracts, the plunger 26 and the release member 52 may be positioned in their corresponding initial rotational positions, as shown in Figures 9A to 9E. Here, the projection 48 of the top ring 45 of the plunger 26 may extend through the first opening 82 in the plunger guide 60, or it may be housed in the recess 92 of the release member 52. Also, before the needle guard retracts, the plunger biasing member 50 may be in a biased state. As a result, the plunger biasing member 50 may apply a distally directed biasing force to the plunger 26, which presses the distally facing cam surface 49 against the projection 48, causing it to slide along the proximal facing cam surface 84 of the plunger guide 60. The resulting cam action may promote the rotation of the plunger 26 in the clockwise direction in Figures 9A and 9E. In some embodiments, the plunger 26 may also rotate as a result of the guard biasing member 35 pressing the cam surface 99 facing the proximal end of the release member 52 against the cam surface 88 facing the distal end of the plunger guide 60. Despite these biasing forces, neither the release member 52 nor the plunger 26 rotates in the pre-delivery state. This is because, as shown in Figure 9D, each of the radially outward-extending projections 94 on the outer portion of the releaser 50 abuts against a corresponding radially inward-extending projection 96 on the inner portion of the guard extension 37. Since the guard biasing member 37 is fixed to rotate relative to the housing 12, the abutment engagement of the projections 94 and 96 prevents the release member 52 from rotating. This prevents the plunger 26 from rotating due to the projection 48 being housed in the recess 92 of the release member 52. The inability of the plunger 26 to rotate means that the projection 48 cannot slide out of the first opening 82 and enter the second opening 86, where it cannot freely translate linearly in the distal direction. Accordingly, the release member 52, the plunger guide 60, the guard extension 37, and the housing 12 operate in conjunction with each other to hold the plunger biasing member 50 in a biased state before the guard member 32 retracts.

[0062] As the guard member 32 moves from the extended position to the retracted position, the guard member 32 may press the guard extension 37 proximal from the position shown in Figure 9C to the position shown in Figure 10C. During the proximal movement of the guard extension 37, the projections 96 and 98 may slide away from each other until they eventually no longer come into contact with each other (Figures 10C and 10D). When this occurs, the release member 52 can rotate freely around the longitudinal axis A. The rotation of the release member 52 at this stage is caused by the extension of the plunger biasing member 50, as shown in Figures 10A and 10B, which pushes the distally facing cam surface 49 on the projection 48 and slides along the proximal facing cam surface 84 of the plunger guide 60. The resulting cam action causes the projection 48 to rotate, and as a result, the release member 52 rotates along with it, due to the projection 48 being housed in the recess 92. During this rotational movement, the plunger 26 translates linearly distally, and the release member 52 translates linearly proximal. The distal translation of the plunger 26 is due to the downward inclined angle of the proximal-facing cam surface 84 of the plunger guide 60, along which the projection 48 of the plunger 26 slides under the distal biasing force of the plunger biasing member 50. The proximal translation of the release member 52 is due to the proximal biasing force applied to the release member 52 by the guard biasing member 35. In some embodiments, during the proximal translation of the release member 52, the proximal-facing cam surface 99 of the release member 52 may slide against the distal-facing cam surface 88 of the plunger guide 60.

[0063] In some embodiments, the cam action between the distally facing cam surface 49 on the projection 48 and the proximal facing cam surface 84 on the plunger guide 60 may provide a damping effect. More specifically, the sliding friction between these two surfaces may be selected to delay the initial extension of the plunger biasing member 50. As a result, the velocity of the plunger 26 may decrease during the initial extension of the plunger biasing member 50 compared to the free, unrestricted extension of the plunger biasing member 50. A decrease in the velocity of the plunger 26 may cause the plunger 26 to collide with the stopper 24 with less force, thereby reducing the possibility of structural damage to the drug storage container 20 and / or facilitating a more comfortable injection for the user.

[0064] The joint rotation of the release member 52 and the plunger 26 can continue until the projection 48 slides away from the cam surface 84 facing the proximal side of the plunger guide 60, as can be seen in Figures 11A and 11B. At this point, the projection 48 exits the first opening 82 and enters the second opening 86. The side walls of the second opening 86 slide the projection 48 in and securely accommodate it, so that there is little to no rotational play between them. Accordingly, while the projection 48 is housed in the second opening 86, rotation between the projection 48 and the rest of the plunger 26 can be prevented. The end of the projection 48 is still housed in the recess 92 of the release member 52, so the release member 52 can also be prevented at this stage. The second opening 86 does not prevent the linear movement of the projection 48. Accordingly, the projection 48, along with the rest of the plunger 26, moves linearly in the distal direction, driven by the extending plunger biasing member 50. As a result, the base 47 of the plunger 26 comes into contact with the stopper 24, which then pushes the stopper 24 distally, releasing the drug 22 from the drug storage container 20, which then passes through the delivery member 16 and out the insertion end into the patient's tissue 28.

[0065] Drug delivery may continue until the stopper 24 reaches the end-of-dose position. At this time, the stopper 24 may abut against the proximal portion of the inner surface 15 of the wall of the drug storage container 20. As a result, the plunger 26 stops moving distally. As shown in Figure 12B, simultaneously with or substantially simultaneously with the stopper 24 reaching the end-of-dose position, the projection 48 may slide out of the recess 92 in the release member 52. As a result, the release member 52 now rotates freely about the longitudinal axis A. The rotation of the release member 52 at this stage is caused by the extension of the guard biasing member 35, which pushes the proximal cam surface 99 of the release member 52 and slides against the distal cam surface 88 of the plunger guide 60. The resulting cam action causes the release member 52 to rotate and translate linearly in the proximal direction. This movement may continue until the proximal end face 97 of the release member 52 strikes the distal contact surface 98 of the proximal end of the plunger guide 60 (Figure 12E). This impact may generate an audible signal to indicate to the user that drug delivery is complete.

[0066] With some degree of assurance that drug delivery is complete, the user may then lift the drug delivery device 10 from the injection site. Since there is nothing to resist the guard biasing member 35, the guard biasing member 35 can push the guard member 32 from the retracted position to the extended position, covering the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 may rotate the lock ring 40 to a position that prevents further retraction of the guard member 32.

[0067] From the foregoing, it can be seen that this disclosure conveniently provides a streamlined design for drug delivery devices having automated features. The various mechanisms and components of the drug delivery device interact synergistically to limit the number of moving parts required for the drug delivery device, thereby improving the reliability of the drug delivery device, saving costs, and providing other benefits and advantages.

[0068] For example, various external morphological factors are possible for the drug delivery devices described herein, depending on the needs and / or preferences of the user and / or manufacturer. Figures 13 to 16 show embodiments of drug delivery devices 110 having the same or similar internal components as drug delivery device 10 described above, but with different external morphological factors. Features of drug delivery device 110 that are functionally similar to those included in drug delivery device 10 are assigned the same reference numbers, but increased by 100.

[0069] The drug delivery device 110 includes an external casing or housing 112 having a generally elongated shape extending along the longitudinal axis. At most or all positions along the longitudinal axis, the housing 112 may have a circular cross-section such that the housing 112 has a substantially cylindrical shape. Transparent or translucent recesses 117 may be provided in the walls of the housing 112 to allow the user to see the components inside the drug delivery device 110, such as a drug storage container. At the distal end of the housing 112, a removable cap 119 may cover the opening of the housing 112. The interior of the removable cap 119 may include a gripper configured to help remove a sterile barrier (e.g., a rigid needle shield (RNS), a flexible needle shield (FNS), etc.) from a delivery member such as a needle when the removable cap 119 is removed from the housing 112, as described above. The housing 112 and the removable cap 119 may each have a number of ribs 105 and 107 formed on their outer surfaces to improve the user's ability to grasp these components when pulling them apart. Each of the ribs may extend all or partially around the periphery of the housing 112 or the removable cap 119.

[0070] The circular cross-section of the housing 112 may be prone to rolling and moving on its surface when placed with its side facing down. To prevent or stop such rolling, part or all of the removable cap 119 may have a non-circular cross-section. In the embodiments shown in Figures 13 to 16, the removable cap 119 has a distal end with a non-circular cross-section and a proximal end with a circular cross-section. Thus, the cross-section of the removable cap 119 gradually transitions from a circular cross-section to a non-circular cross-section as it moves from the proximal end to the distal end. In the illustrated embodiments, the non-circular cross-section of the distal end of the removable cap 119 is generally square in shape. In other embodiments, the non-circular cross-section may be rectangular, triangular, or any other polygon or partially polygonal in shape, as long as one or more faces of the removable cap 119 are flat or substantially flat, in order to prevent or stop rotation. Furthermore, the non-circular cross-section of the distal end of the removable cap 119 may gradually increase in size as it moves distally, such that the most distal portion of the distal end of the removable cap 119 has a larger cross-section than the most proximal portion of the distal end of the removable cap 119. This configuration may result in a flared shape at the distal end of the removable cap 119, thereby assisting the user in grasping the removable cap 119 and pulling it away from the housing 112.

[0071] In some embodiments, the housing 112 and the removable cap 119 may each include corresponding anti-rotation mechanisms. These anti-rotation mechanisms may engage with each other when the removable cap 119 is in a storage position as shown in Figure 13 to prevent or restrict the removable cap 119 from rotating relative to the housing 112. In some embodiments, the anti-rotation function of the housing 112 may be adjacent to and substantially collinear with the anti-rotation function of the removable cap 119 when the removable cap 119 is in a storage position. In the embodiments shown in Figures 13 to 16, the anti-rotation function of the removable cap 119 is provided by an opening 108 formed in the tubular wall of the removable cap 119 at its proximal end, and the anti-rotation function of the housing 112 is provided by an axial projection 109 extending distally from the distal end of the housing 112. The opening 108 may be dimensioned to fit and accommodate the axial projection 109 when the removable cap 119 is in a storage position. As a result of this mating engagement, the removable cap 119 may not be able to rotate relative to the housing 112. This may be beneficial if the user attempts to twist the removable cap 119 when pulling it away from the housing 112. In certain cases, rotation of the removable cap 119 may rotate a sterile barrier such as an RNS or FNS, thereby causing the tip of a needle to cor into the sealing member within the RNS or FNS. Therefore, coring of the needle can be prevented by positioning the axial projection 109 within the opening 108, at least during the initial moments of cap removal. In an alternative embodiment, the opening 108 may be formed in the wall of the housing 112, and the axial projection 109 may extend proximal from the proximal end of the removable cap 119.

[0072] Here, with reference to Figures 17A to 21, various embodiments of drug delivery devices incorporating brake members are described. The various elements of the drug delivery devices shown in Figures 17A to 21 may be functionally and / or structurally similar to the elements of drug delivery device 10 described in relation to Figures 1 to 12E. Such elements are assigned the same reference numerals as those used in Figures 1 to 12E, but increased by 100 or a multiple thereof. The structural and / or functional details that distinguish the embodiments shown in Figures 17A to 21 from the embodiments in Figures 1 to 12E are the focus of the following discussion. Components of drug delivery device 10 or variations thereof, which may not be shown in Figures 17A to 21, may be included in the various drug delivery devices described in relation to Figures 17A to 21, provided that this does not prevent the design of a particular drug delivery device from including these components or variations thereof.

[0073] The inclusion of a braking member is advantageous, at least in drug delivery devices where the distal end of the plunger is spaced apart from the proximal end of the stopper by a gap, either before delivery or in storage. As an example, Figure 17A shows a drug delivery device 210 in a pre-delivery or storage state where the distal end of the plunger 226 is spaced apart from the proximal end of the stopper 224 by a gap (e.g., axial distance). The gap may be, for example, a result of the drug storage container being filled with a specific amount of drug, design tolerances, and / or manufacturing considerations. Because of the gap, when the plunger biasing member is released, the plunger can be accelerated to very high speeds and strike the stopper with very high force. This may generate an impact or shock wave, which may, in some cases, shatter or damage the wall of a glass drug storage container and / or startle the user. In addition, in embodiments where the plunger biasing member is a spring, the output force of the plunger biasing member may be maximum at the first moment after the release of the plunger biasing member. As a result, the plunger can reach extremely high speeds before hitting the stopper.

[0074] The embodiments described below incorporate a braking member configured to resist distal movement of the plunger while the plunger is moving to close the initial gap between the plunger and the stopper. As a result of the resistance provided by the braking member, the velocity of the plunger during the initial extension of the plunger biasing member may be reduced compared to the velocity of the plunger when the plunger biasing member is able to extend freely without obstruction. This reduction in plunger velocity has the effect of limiting the amount of force with which the plunger strikes the stopper, thereby reducing the possibility of structural damage to the drug storage container and further promoting a more comfortable injection for the user or patient. In some embodiments, the braking member may cease resisting the movement of the plunger at or near the same time as the plunger strikes the stopper, while in other embodiments, the braking member may continue to resist distal movement of the plunger after the plunger has struck the stopper, for example, over the entire stroke of the plunger. In some embodiments, the brake member may be operably (e.g., interactively) coupled to the plunger such that the plunger and / or brake member rotate about the longitudinal axis of the housing of the drug storage container and / or drug delivery device as the plunger moves distally. The force required to overcome the rotational inertia of the plunger and / or brake member when stationary and to initiate rotation may reduce the amount of force available to drive the plunger distally, and thus may limit the distal velocity of the plunger. Configured in this way, the brake member can act like a damper in that it dissipates the kinetic energy associated with the distal movement of the plunger. In some embodiments, the brake member can convert the linear motion of the plunger into heat and / or other forms of energy, in addition to rotational motion.

[0075] Figures 17A and 17B show a drug delivery device 210 including a brake member 270 operably coupled to a plunger 226. The brake member 270 may surround at least a portion of the plunger 226 and may have an annular shape, such as a ring or a hollow tube. In some embodiments, the annular shape of the brake member 270 may be centered along the longitudinal axis A. The operable coupling between the brake member 270 and the plunger 226 may be such that the brake member 270 rotates as the plunger 226 moves distally along the longitudinal axis A. As an example, the brake member 270 may screw-engage to the plunger 226 such that relative axial movement between the plunger 226 and the brake member 270 causes rotation of the brake member 270 about the longitudinal axis A. As a more specific example, as can be seen in Figure 17B, the brake member 270 may have a threaded inner surface 270a that engages with the threaded outer surface 226a of the plunger 226. The brake member 270 may resist the distal movement of the plunger 226 by requiring the plunger 226 to rotate the brake member 270 as the plunger 226 moves distally. In some embodiments, the axial length of the threaded inner surface 270a of the brake member 270 and / or the threaded outer surface 226a of the plunger 226 may be such that the brake member 270 resists the distal movement of the plunger 226 over the entire or substantially entire stroke of the plunger 226. In other embodiments, the axial length of the threaded inner surface 270a of the brake member 270 and / or the threaded outer surface 226a of the plunger 226 may be such that the brake member 270 resists distal movement of the plunger 226 only over a limited portion of the stroke of the plunger 226, for example, over a portion of the stroke over which the plunger 226 closes the gap between the plunger 226 and the stopper 224.

[0076] A spline connection may be formed between the plunger 226 and the housing 212 to prevent the plunger 226 from rotating about the longitudinal axis A as a result of its interaction with the brake member 270. The spline connection may prevent the rotation of the plunger 226, while allowing axial movement of the plunger 226. For example, the spline 274 may be formed on the outer surface of the proximal end of the plunger 226 and may be mated with a spline formed on the inner surface of the housing 212 or on a component whose rotation relative to the housing 212 is fixed.

[0077] Before delivery or in storage, the brake member 270 may be prevented from rotating, and as a result, the plunger 226 may be prevented from moving distally under the biasing force of the plunger biasing member 250 due to its screw connection with the brake member 270. As an example, the drug delivery device 210 may include a lock 272 that selectively prevents the rotation of the brake member 270 relative to the plunger 226 and / or housing 212. In a more specific example, the drug delivery device 210 may include a lock 272 having an initial position in which the lock 272 prevents the rotation of the brake member 270 (as seen in Figures 17A and 17B) and a second position in which the lock 272 does not prevent the rotation of the brake member 270. In some embodiments, the lock 272 may be a rotary lock. In some embodiments, the lock 272 may move proximal when moving from the initial position to the second position. In addition, or instead, the lock 272 may deflect radially outward as it moves from an initial position to a second position. In some embodiments, such deflection can be achieved by constructing the lock 272 from an elastic (e.g., resilient) material, which, after a separate blocking component has been removed, naturally returns to its original shape and / or bends as a result of a cam action between the lock 272 and the plunger 226 moving distally under the biasing force of the plunger biasing member 250.

[0078] In some embodiments, the lock 272 is operably coupled to the guard member 232, and as a result, moving the guard member 232 from an extended position to a retracted position causes the lock 272 to move from an initial position to a second position, thereby releasing the rotation of the brake member 270 and thus allowing the plunger biasing member 250 to extend axially, driving the plunger 226 distally to release the drug from the drug storage container 220.

[0079] According to some embodiments, the drug delivery device 210 may operate as follows: Initially (for example, before delivery or in storage), the lock 272 may be positioned in an initial position so that the lock 272 prevents the brake member 270 from rotating. At this point, the plunger biasing member 250 may press the plunger 226 distally. However, the plunger 226 may be prevented from moving distally due to a screw-like engagement between the plunger 226 and the brake member 270, which is currently locked to rotate. Subsequently, the user may press the distal end of the guard member 232 against the skin at the injection site. This may cause the guard member 232 to move from an extended position to a retracted position and retract into the housing 212. As a result of this movement, the guard member 232 may press the lock 272 proximal so that the lock 272 moves from an initial position to a second position. In the second position, the lock 272 may be disengaged from the brake member 270 so that the brake member 270 can rotate freely. Next, the plunger biasing member 250 begins to extend, pressing the plunger 226 distally and closing the gap between the plunger 226 and the stopper 224. Due to the screw connection between the plunger 226 and the brake member 270, while the plunger 226 moves to close the gap between the plunger 226 and the stopper 224, the distal translational movement of the plunger 226 rotates the brake member 270. The rotation of the brake member 270 absorbs a portion of the kinetic energy output by the plunger biasing member 250, reducing the kinetic energy required to drive the plunger 226 distally. As a result, the distal velocity of the plunger 226 is slower than the velocity without the brake member 270, at least at the moment when the distal end of the plunger 226 strikes the proximal end of the stopper 224. After the plunger biasing member 250 contacts the stopper 224, it presses the plunger 226 distally, thereby causing the stopper 224 to dispense the drug from the drug storage container 220 and deliver it into the patient's body through a delivery member (e.g., a needle). After the plunger 226 contacts the stopper 224, the brake member 270 may continue to rotate, but this is not mandatory.

[0080] Figures 18A and 18B show embodiments of a drug delivery device 310 whose structure and / or function are similar to the drug delivery device 210 in Figures 17A and 17B. Details of the structure and / or function that distinguish the drug delivery device 310 in Figures 18A and 18B from the drug delivery device 210 in Figures 17A and 17B are described below.

[0081] The drug delivery device 310 includes a plunger 326 and a brake member 370 operably coupled to each other, such that when the plunger 326 moves distally, the brake member 370 rotates the plunger 326. For example, the brake member 370 may have a threaded inner surface 370a that threadlessly engages with a threaded outer surface 326a at the proximal end of the plunger 326, as shown in Figure 18B. The brake member 370 may be fixed in rotation relative to the housing 312 so as to prevent the brake member 370 from rotating about the longitudinal axis A. In some embodiments, the brake member 370 may be a part of the housing 312, for example, a rear cover of the housing 312. Since the brake member 370 does not rotate, the threaded coupling between the brake member 370 and the plunger 326 rotates the plunger 326 when the plunger 326 moves distally. The rotation of the plunger 326 absorbs a portion of the kinetic energy output by the plunger biasing member 350, reducing the kinetic energy required to drive the plunger 326 distally. As a result, the distal speed of the plunger 326 is slower than if the brake member 370 were not included. After the plunger 326 has traveled a certain distance distally, the threaded outer surface 326a of the plunger 326 may no longer contact the threaded inner surface 370a of the brake member 370. When this occurs, the plunger 326 may stop rotating. In some embodiments, the axial length of the threaded inner surface 370a of the brake 370 may be equal to or substantially equal to the axial length of the initial gap between the distal end of the plunger 326 and the stopper 324. As a result, the plunger 326 may stop rotating at the same time as, or almost simultaneously with, the plunger 326 hitting the stopper 324.

[0082] In some embodiments, the plunger biasing member 350 may rotate together with the plunger 326. In such embodiments, the proximal end of the plunger biasing member seat 338, which may be in contact with the proximal end of the plunger biasing member 350, may be configured as a bearing. For example, the proximal end of the plunger biasing member seat 338 may be rotatably coupled to the brake member 370 and / or the rear housing 327 so that the plunger biasing member seat 338 can rotate relative to the brake member 370 and / or the rear housing 327. Accordingly, the plunger biasing member 350, the plunger 326, and the plunger biasing member seat 338 may rotate together when the plunger 326 rotates as a result of the screw coupling between the plunger 326 and the brake member 370.

[0083] The brake member 370 may be coupled to the proximal end of the guard biasing member 335. For example, as can be seen in Figure 18B, the proximal end of the guard biasing member 335 may be seated in contact with the brake member 370. As a more specific example, as can be seen in Figure 18B, the guard biasing member 335 may surround the distal end of the brake member 370, and the guard biasing member 335 may have a proximal end that is seated in contact with a flange extending radially outward from the brake member 370.

[0084] The drug delivery device 310 may further include a lock 370. The lock 370 may be similar to the lock 270 described above, except that it prevents the plunger 326 from rotating before delivery or in storage. If the plunger 326 is unable to rotate, the plunger 326 may be prevented from moving distally due to a screw connection between the plunger 326 and the brake member 370. Accordingly, the lock 370 may prevent drug delivery until the lock 370 is disengaged from the plunger 326, which may occur in response to the retraction of the guard member 332. The lock 370 may be positioned between a guard biasing member 335 and a guard member 332, as shown in Figure 18B. The guard biasing member 335 can press the lock 370 distally, and the lock 370 can then press the guard member 332 toward the extended position.

[0085] Figures 19A and 19B show embodiments of a drug delivery device 410 whose structure and / or function are similar to the drug delivery device 310 in Figures 18A and 18B. Details of the structure and / or function that distinguish the drug delivery device 410 in Figures 19A and 19B from the drug delivery device 310 in Figures 18A and 18B are described below.

[0086] The drug delivery device 410 may include a brake member 470 which is part of the rear housing 427 of the drug delivery device 410. For example, the brake member 470 may be defined by an annular flange extending radially inward from the proximal end of the rear housing 427, as shown in Figure 19B. The inner surface of this flange may define the threaded inner surface 470a of the brake member 470.

[0087] The brake member 470 may be coupled to the proximal end of the guard biasing member 435. For example, as can be seen in Figure 19B, the proximal end of the guard biasing member 435 may be seated in contact with the distal end face of the brake member 470.

[0088] The embodiments described above in relation to Figures 17A to 19B utilize a brake member that engages with the outer portion of the plunger, whereas the embodiments described below in relation to Figures 20 and 21 utilize a brake member that engages with the inner portion of the plunger. Depending on the design of the drug delivery device, this configuration of the brake member may be advantageous. For example, in embodiments where the plunger is hollow and the plunger biasing member is at least partially located inside the plunger, configuring the brake member to engage with the inner portion of the plunger may allow the plunger to be designed with a larger diameter than would otherwise be possible. This may allow the use of a spring with a larger diameter for the plunger biasing member. A larger spring diameter allows for greater force to be output when driving the plunger to release the drug, which is beneficial for delivering viscous drugs, such as certain biological drugs. Furthermore, a larger spring diameter may allow for a shorter axial length of the spring without compromising the force output by the spring. A shorter axial length of the spring may facilitate the design of smaller and more compact drug delivery devices, which may be desirable for handling, transport, and / or storage purposes, or for other purposes.

[0089] Figure 20 shows an embodiment of a drug delivery device 510 whose structure and / or function are similar to the drug delivery device 410 in Figures 19A and 19B. Details of the structure and / or function that distinguish the drug delivery device 510 in Figure 20 from the drug delivery device 410 in Figures 19A and 19B are described below.

[0090] The drug delivery device 500 may include a plunger 526 having a substantially hollow tubular shape that defines an axial chamber. In some embodiments, the axial chamber may extend through the entire plunger 526 such that the proximal and distal ends of the plunger 526 each have openings communicating with the internal space of the plunger 526, while in other embodiments, the axial chamber may extend through a limited portion of the plunger 526 such that, for example, the distal end of the plunger 526 is closed.

[0091] The interior of the plunger 526 may house a plunger biasing member 550 and, in addition, interface with a brake member 570. For example, the proximal end of the plunger 526 may define a guide 574, and the distal end of the plunger 526 may define a nut 576. As shown in Figure 20, the guide 574 may have an inner diameter or other dimensions larger than the inner diameter or other dimensions of the nut 576. The plunger biasing member 550 may be at least partially located within the guide 574 and may have a distal end that seats and / or presses against a proximal surface 578 of the nut 576. An annular bearing 580 may be located between the distal end of the plunger biasing member 550 and the proximal surface 578 of the nut 576 and may be configured to allow the plunger 526 to rotate relative to the plunger biasing member 550 during axial extension of the plunger biasing member 550. In some embodiments, the annular bearing 580 may include a washer. In other embodiments, the annular bearing 580 may be omitted, and the distal end of the plunger biasing member 550 may be in direct contact with the proximal surface 578 of the nut 576. The nut 576 may have a threaded inner surface 526a, which screw-engages with the threaded outer surface 570a of the brake member 570, as will be described in more detail below. In the embodiment shown in Figure 20, the distal end of the nut 576 has an opening. In some embodiments, the plug may be located within this opening and may have a distal end configured to be housed in a recess formed at the proximal end of the stopper.

[0092] In some embodiments, the guide 574 and the nut 576 may be integrally formed to define a single, integrated structure. In other embodiments, the guide 574 and the nut 576 may be separate structures fixed to each other. In certain such embodiments, the guide 574 and the nut 576 may be made of different materials. For example, the guide 574 may be made of metal and the nut 576 may be made of plastic, or vice versa. In some embodiments, the entire plunger 526, including the guide 574 and the nut 576, may be made of a single material, such as metal, plastic, or any other suitable material.

[0093] The brake member 570 may be operably coupled to the nut 576 so that the brake member 570 resists distal movement of the plunger 526 during at least the initial portion of the stroke of the plunger 526. As an example, the brake member 570 may include a rod or other elongated member having a proximal end fixed to the rear housing 527 and a distal end threaded to the nut 576. In a more specific example, as shown in Figure 20, the brake member 570 may extend through the axial chamber of the plunger 526 and have a distal end including a threaded outer surface 570a that threaded to the threaded inner surface 526a of the nut 576. As the plunger 526 moves distally as a result of the threaded coupling between the brake member 570 and the nut 576 of the plunger 526, the brake member 570 may rotate the plunger 526 about the longitudinal axis A. By requiring the plunger 526 to rotate, the brake member 570 can resist the distal movement of the plunger 526, and therefore the distal speed of the plunger 526 can be reduced compared to when the brake member 570 is omitted.

[0094] Before delivery or in storage (as shown in Figure 20), the plunger 526 is prevented from moving distally under the biasing force of the plunger biasing member 550. As an example, the drug delivery device 510 may include a lock 572, which has an initial position (Figure 20) in which the lock 572 prevents distal movement of the plunger 526, and a second position in which the lock 572 does not prevent distal movement of the plunger 526. In a more specific example, the lock 572 may include one or more arms 582 extending generally radially inward, which are housed in one or more corresponding recesses 584 formed on the outer surface of the plunger 526 before delivery or in storage. One or more radially inwardly extending arms 582 may be prevented from being deflected radially outward by a trigger ring 586 surrounding the radially inwardly extending arms 582 before delivery or in storage. The trigger ring 586 may be operably coupled to a guard member (e.g., guard member 32), so that when the guard member retracts proximally, the trigger ring 586 also moves proximally, and as a result, the radially inward-extending arm 582 is no longer prevented from deflecting outward. In some embodiments, such deflection may be achieved by constructing the radially inward-extending arm 582 from an elastic (e.g., resilient) material, and the arm may naturally return to its original shape and / or deflection as a result of a cam action between the radially inward-extending arm 582 and the corresponding recess 584 of the plunger 526 when the plunger 526 is moved distally by the plunger biasing member 550 after the trigger ring 586 has disengaged from the closed position shown in Figure 20. In some embodiments, the trigger ring 586 may be part of the guard member, while in other embodiments, the trigger ring 586 may be separate from the guard member.

[0095] According to some embodiments, the drug delivery device 510 may operate as follows: Initially (for example, before delivery or in storage), as shown in Figure 20, the arm 582 extending radially inward is housed in the corresponding recess 584 of the plunger 526, and the lock 572 may be positioned in its initial position such that the trigger ring 586 prevents it from bending radially outward. In this configuration, the lock 572 can prevent the plunger 526 from moving distally under the biasing force of the plunger biasing member 550. Subsequently, the user may press the distal end of the guard member against the skin at the injection site. This causes the guard member to retract proximal into the housing, and as a result, the trigger ring 586 may be pushed proximal out of its initial occlusion position. Thus, the arm 582 extending radially inward can bend radially outward and exit its corresponding recess 584. Subsequently or simultaneously, the plunger 526 may begin to translate distally under the biasing force of the plunger biasing member 550. Due to the threaded connection between the plunger 526 and the brake member 570, the distal translation of the plunger 526 can cause the plunger 526 to rotate. As a result of this rotation, the plunger 526 may move distally at a slower speed than it would have if it did not need to rotate, as a result of its interaction with the brake member 570. The rotation of the plunger 526 can continue as long as the threaded outer surface 526a of the plunger 526 remains in contact with the threaded inner surface 570a of the lock 572. In some embodiments, the rotation of the plunger 526 may stop simultaneously or almost simultaneously with the plunger 526 striking a stopper located in the drug delivery container 520.

[0096] In the embodiment shown in Figure 20, the proximal end of the nut 576 is fixed to the distal end of the guide 574. In an alternative embodiment, the distal end of the nut 576 may be fixed to the distal end of the guide 574 such that the nut 576 is positioned within the internal space of the guide 574 together with the plunger biasing member 550. This may shorten the overall axial length of the plunger 526. In such an alternative embodiment, the distal end of the guide 574 may include a transverse wall perpendicular or substantially perpendicular to the longitudinal axis A. In addition to being fixed to the distal end of the nut 576, the transverse wall may define a seating surface for the distal end of the plunger biasing member 550.

[0097] Figure 21 shows an embodiment of a drug delivery device 610 having similarities in structure and / or function to the drug delivery device 510 in Figure 20. Details of the structure and / or function that distinguish the drug delivery device 610 in Figure 21 from the drug delivery device 510 in Figure 20 are discussed below.

[0098] In the embodiment shown in Figure 21, the plunger 626 may include a guide 674 and a central rod 690. The guide 674 may have a hollow tubular shape, open at its proximal end and closed at its distal end by a transverse wall 692. The transverse wall 692 may be perpendicular or substantially perpendicular to the longitudinal axis A and may define a seating surface for the distal end of the plunger biasing member 650. The central rod 690 may have a distal end fixed to the transverse wall 692 so that the central rod 690 and the guide 674 translate and rotate together. The central rod 690 may extend proximal from the transverse wall 692 through the internal space of the guide 674. The proximal end of the central rod 690 may be positioned adjacent to the opening at the proximal end of the guide 674, and in some embodiments may extend outside the opening formed at the proximal end of the guide 674, or instead may be positioned inside the proximal end of the guide 674.

[0099] As shown in Figure 21, the brake member 670 may be fixed to the rear housing 627. The brake member 670 may have a substantially annular shape and may surround the proximal end of the central rod 690. Furthermore, the threaded inner surface 670a of the brake member 670 may screw-engage with the threaded outer surface 626a of the proximal end of the central rod 690. As a result of this screw-engagement, the plunger 626 can be rotated by moving distally, including its central rod 690. The rotation of the plunger 626 can continue as long as the threaded outer surface 626a of the central rod 690 remains in contact with the threaded inner surface 670a of the brake member 670. In some embodiments, the rotation of the plunger 626 may stop simultaneously with or approximately simultaneously with the plunger 626 striking the stopper of the drug storage container 620.

[0100] Before delivery or in storage (as seen in Figure 21), the plunger 626 is prevented from moving distally under the biasing force of the plunger biasing member 650. As an example, the drug delivery device 610 may include a lock 672, which has an initial position (Figure 21) in which the lock 672 prevents distal movement of the plunger 626, and a second position in which the lock 672 does not prevent distal movement of the plunger 626. In a more specific example, the lock 672 may include a proximal end fixed to a rear housing 627 and a distal end, which has an initial position in which the distal end is fixed to the proximal end of a guide 674, thereby preventing distal movement of the plunger 626, and a second position radially outward from the initial position in which the distal end does not contact the proximal end of the guide 674, thereby allowing distal movement of the plunger 626. The distal end of the lock 672 may be operably coupled to the guard member 632 such that, when the guard member 632 retracts proximal, the guard member 632 acts directly or indirectly on the distal end of the lock 672, moving it from an initial position to a second position. In some embodiments, this movement of the distal end of the lock 672 may be the result of a cam action between the distal end of the lock 672 and the proximal end of the guard member 632. When the lock 672 is in the second position, the plunger biasing member 650 may be extendable, thereby driving the plunger 626 distally, resulting in the plunger 626 rotating over at least a portion of the plunger stroke due to the screw coupling between the plunger 626 and the brake member 670.

[0101] In the embodiments described above in relation to Figures 17A to 21, a screw coupling between the plunger and the brake member is used to generate relative rotation between the plunger and the brake member during the axial translational movement of the plunger, whereas other embodiments may achieve this rotation by other means. For example, the plunger and the brake member may include one or more cooperating cam surfaces that interact with each other to convert relative axial movement into a combination of relative axial movement and relative rotational movement. Furthermore, in some embodiments, resistance to distal movement of the plunger may be achieved via an air damper operably coupled to the plunger. In certain such embodiments, the plunger does not need to rotate when moving distally.

[0102] As should be understood, the devices and methods of this disclosure may have one or more advantages over the prior art, and one or more of these advantages may exist in particular embodiments according to the features of this disclosure included in those embodiments. Other advantages not specifically mentioned herein may also be understood in the same way.

[0103] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, the drugs specified below, and their generic and biosimilar equivalents, but not limited to those drugs. As used herein, the term "drug" is interchangeable with other similar terms and may be used to refer to any type of drug or therapeutic substance, including traditional and non-traditional medicines, dietary supplements, supplements, biological preparations, biological activators and compositions, large molecules, biosimilars, bioequivalents, 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 lyophilized form. The following list of exemplary drugs should not be considered exhaustive or restrictive.

[0104] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container, which is either filled with the drug for treatment or pre-filled with it. The primary container may be a vial, cartridge, or pre-filled syringe.

[0105] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0106] In other embodiments, the drug delivery device may contain, or be used with, an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing dimerization of the receptor. Examples of erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Examples of erythropoiesis-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), and Binocrit® (epoetin alfa). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0107] Certain exemplary proteins, including their fusions, fragments, analogs, variants, or derivatives, are described below: fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies, including OPGL-specific antibodies, peptide bodies, and related proteins (also referred to as RANKL-specific antibodies, peptide bodies, etc.); myostatin-binding proteins, peptide bodies, and related proteins, including myostatin-specific peptide bodies; and in particular, IL-4 receptor-specific antibodies, peptide bodies, and related proteins that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; Interleukin 1 receptor 1 ("IL1-R1") specific antibodies, peptide bodies, and related proteins; Ang2 specific antibodies, peptide bodies, and related proteins; NGF specific antibodies, peptide bodies, and related proteins; CD22 specific antibodies, peptide bodies, and related proteins, in particular, dimers of human-mouse monoclonal hLL2γ chain disulfide conjugated to human-mouse monoclonal hLL2κ chain, for example, human C22 epratuzumab (CAS registry number 501423-23-0). Human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as D22-specific fully humanized antibodies; including but not limited to humanized and fully human monoclonal antibodies; including but not limited to anti-IGF-1R antibodies; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins; including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies; including but not limited to fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; including but not limited to antibodies that suppress the interaction between B7RP-1 and ICOS, the natural receptor of B7RP-1 on activated T cells; B-7-related protein 1-specific antibodies, peptide bodies, and related proteins ("B7RP-1", but also referred to as B7H2, ICOSL, B7h, and CD275); for example, HuMax such as 145c7; IL-15 specific antibodies, peptide bodies, and related proteins, including but not limited to IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies;IFN γ-specific antibodies, peptide bodies, and related proteins, including but not limited to human IFN γ-specific antibodies, and fully human anti-IFN γ antibodies; TALL-1-specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R")-specific antibodies, peptide bodies, and related proteins; and HGF / SF:cMet axis targeting antibodies such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-β-specific antibodies, peptide bodies, and related proteins; amyloid-β protein-specific antibodies, peptide bodies, and related proteins; and c-Kit-specific antibodies, peptide bodies, and related proteins, including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors. etc; OX40L-specific antibodies, peptide bodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); Epo gen(registered trademark) (epoetin alfa, or erythropoietin); GLP-1; Avonex(registered trademark) (interferon β-1a); Bexxar(registered trademark) (tositumomab, anti-CD22 monoclonal antibody); Betaseron(registered trademark) (interferon-β); Campath(registered trademark) (aremtuzumab, anti-CD52 monoclonal antibody); Dynepo(registered trademark) (epoetin delta); Velcade(registered trademark) (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti® (trastuzumab-anns) anti-HER2 humanized monoclonal antibody, biosimilar of Herceptin®, or other products containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (Registered Trademark) (Panitumumab), Xgeva (Registered Trademark) (Denosumab), Prolia (Registered Trademark) (Denosumab), Immunoglobulin G2 Human Monoclonal Antibody against RANK Ligand, Enbrel (Registered Trademark) (Etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate (Registered Trademark) (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution; Infergen (Registered Trademark) (Interferon Alfacon-1); Natrecor (Registered Trademark) (Nesiritide, Recombinant Human Type B Natriuretic Peptide (hBNP)); Kineret (Registered Trademark) (Anakinra); Leukine (Registered Trademark) (Sargamostim, RhuGM-CSF); LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524);Lucentis (registered trademark) (ranibizumab); Panorex (registered trademark) (17-1A, edrecolomab); Trabio (registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem (registered trademark) (IDM-1); OvaRex (registered trademark) (B43.13); Nuvion (registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon (registered trademark) (epoetin beta); Neumega (registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (Muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (Epoetin alfa); Remicade(registered trademark) (Infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (Absiximab, anti-GP Ib / Ilia receptor monoclonal antibody); Actemra(registered trademark) (Anti-IL6 receptor mAb); Avastin(registered trademark) (Bevacizumab), HuMax-CD4 (Zanolimumab); Mvasi™ (Bevacizumab-awwb); Rituxan(registered trademark) (Rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark) (interferon α-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (saltumumab); M200 (boroxiximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1)); anti-BR3 mAb; Anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388); Anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); Anti-CD25 mAb (HuMax-TAC); Anti-CD3 mAb (NI-0401); Adekatumumab; Anti-CD30 mAb (MDX-060); MDX-1333 (Anti-IFNAR); Anti-CD38 mAb (HuMax CD38); Anti-CD40L mAb; Anti-Cripto mAb; Anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); Anti-CTLA4 mAb; Anti-eotaxin 1 mAb (CAT-213); Anti-FGF8 mAb; Anti-ganglioside GD2 mAb; Anti-ganglioside GM2 mAb; Anti-GDF-8 human mAb (MYO-029); Anti-GM-CSF receptor mAb (CAM-3001); Anti-HepC mAb (HuMax HepC); Anti-IFNα mAb (MEDI-545, MDX-198); Anti-IGF1R mAb; Anti-IGF-1R mAb (HuMax-Inflam); Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannos receptor / hCGβ mAb (MDX-1307); anti-mesotrelin 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 nitrile mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0108] The drug delivery device may contain, or be used in conjunction with, sclerostin antibodies such as romosozumab, brosozumab, BPS804 (Novartis), Evenity® (romosozumab-aqqg), etc., other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, etc., and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain, or be used with, rilotumumab, bixalomer, trevananib, ganitumumab, conatumumab, motesanib diphosphate, brodalumab, vidupiplant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with, or be used with, IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used with, endogenous metalloproteinase tissue inhibitors (TIMPs), including 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 migraines. Erenumab, as well as antagonist antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as but not limited to bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery device of the Disclosure.In addition, bispecific T cell induction (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to Apelin or its analogues. In some embodiments, a therapeutically effective amount of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibody may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola® (infliximab-axxq), an anti-TNF monoclonal antibody, Remicade® (infliximab) (a biosimilar of 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-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or a 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-isoindole-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® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT) 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 condensed to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Rozibafusp alpha (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 in conjunction with, omecamutib mecarbir, a small molecule selective cardiac myosin activator that directly targets the cardiac contractile mechanism, i.e., myotrope, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain, or be used in conjunction with, sotrasib (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 in conjunction with, tezeperumab, a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (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 in conjunction 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 in conjunction 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 in conjunction with, ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Sterara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Amjevita® or Amgevita® (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG160, or another product containing an extended half-life (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell induction) structure. In some embodiments, the drug delivery device may contain AMG119, or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy, or may be used in conjunction with these.In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG119, or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG171, or another product containing a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG199, or another product containing an extended half-life (HLE) bispecific T cell inducing structure (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 mutant protein and / or an IL-21 receptor agonist designed to selectively turn on the programmed cell death-1 (PD-1) positive cell interleukin-21 (IL-21) pathway. 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 induction) structure. 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 studied as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 427, or another product comprising a long-lived (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell induction) structure.In some embodiments, the drug delivery device may contain AMG430, or another product containing an anti-Jagged-1 monoclonal antibody, or may be used in conjunction with these. In some embodiments, the drug delivery device may contain AMG506, or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being studied as a treatment for solid tumors, or may be used in conjunction with these. In some embodiments, the drug delivery device may contain AMG 509, or another product containing a bivalent T cell derivative and designed using XmAb® 2 + 1 technology, or may be used in conjunction with these. In some embodiments, the drug delivery device may contain AMG 562, or an extended half-life (HLE) CD19 x CD3 BiTE® (bispecific T cell inducer). The drug delivery device may contain, or be used in conjunction with, another product containing the (delivery) structure. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Efavaleukin alpha (formerly AMG 592), or another product containing the IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG596, or another product containing the CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell induction) molecule. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 673, or another product containing the extended half-life (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell induction) structure. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 701, or another product containing the extended half-life (HLE) anti-B cell maturation antigen (BCMA) anti-CD3 BiTE® (bispecific T cell induction) structure. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 757, or another product comprising an extended half-life (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell induction) structure. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG910, or another product comprising an extended half-life (HLE) epithelial cell tight junction constituent protein claudin 18.2 x CD3 BiTE® (bispecific T cell induction) structure.

[0109] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The embodiments for carrying out the invention should be interpreted merely as examples and do not describe all possible embodiments of the disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments are still included within the scope of the claims defining the invention as disclosed herein.

[0110] Those skilled in the art will understand that a wide variety of modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations will be interpreted as falling within the scope of the concept of the present invention.

Claims

1. Housing and A drug storage container comprising a stopper fixed to the housing and slidable on and along the inner surface, A biasing member and A plunger operably coupled to the biasing member, Under the biasing force applied by the biasing member, it selectively rotates from the initial rotation position to the second rotation position. A plunger is configured to rotate from the initial rotation position to the second rotation position, and then move linearly and translationally in the distal direction to drive the stopper through the drug storage container. A plunger guide fixedly coupled to the housing and having an annular wall, wherein the plunger is at least partially disposed within the plunger guide, A release member configured to be operably coupled to the plunger and selectively rotate relative to the housing, wherein the plunger and the plunger guide are each at least partially located within the release member. A drug delivery device equipped with the following features.

2. The drug delivery device according to claim 1, wherein the biasing member is at least partially disposed within the plunger.

3. The drug delivery device according to claim 2, wherein the biasing member comprises a compression spring.

4. The drug delivery device according to claim 2 or 3, wherein the plunger is configured to move linearly in the distal direction while rotating from the initial rotation position toward the second rotation position.

5. The drug delivery device according to claim 1, wherein one of the plunger and the plunger guide is provided with a cam, and the other of the plunger and the plunger guide is provided with a cam follower.

6. The drug delivery device according to claim 5, wherein the biasing force of the biasing member presses the cam follower against the cam, causing the plunger to rotate from the initial rotation position toward the second rotation position.

7. The drug delivery device according to claim 6, wherein the plunger includes the cam follower, the plunger guide includes the cam, and the cam follower is formed by at least one projection extending outward from the plunger.

8. The drug delivery device according to claim 7, wherein the cam is formed by a surface facing the proximal side of the annular wall.

9. A drug delivery device according to any one of claims 1 to 8, comprising a guard that is movably disposed adjacent to an opening in the housing and operably coupled to the release member.

10. The drug delivery device according to claim 9, wherein the guard has an extended position in which the guard extends at least partially through the opening in the housing, and a retracted position in which the guard is positioned away from the extended position toward the housing.

11. The drug delivery device according to claim 10, wherein the release member is prevented from rotating in at least one rotational direction when the guard is in the extended position, and the release member is capable of rotating in at least one rotational direction when the guard is in the retracted position.

12. The drug delivery device according to claim 10 or 11, wherein by moving the guard from the extended position to the retracted position, the release member and the plunger can rotate together from the initial rotation position to the second rotation position under the biasing force applied by the biasing member.

13. The drug delivery device according to claim 8, wherein the opening is formed in the annular wall distal to the proximal surface, and the opening slidably receives the projection after the plunger has rotated from the initial rotation position to the second rotation position.

14. A drug delivery device according to any one of claims 1 to 12, comprising an indicator configured to generate an audible signal indicating the completion of drug delivery, wherein the indicator is configured to rotate together with the plunger from the initial rotation position to the second rotation position.

15. The drug delivery device according to claim 14, wherein the indicator is configured to move linearly in the proximal direction while rotating from the initial rotation position toward the second rotation position.

16. The drug delivery device according to claim 15, wherein the indicator is configured to rotate independently of the plunger from the second rotation position to the third rotation position.

17. The drug delivery device according to claim 16, wherein the indicator is configured to move linearly in the proximal direction while rotating from the second rotation position to the third rotation position.

18. The drug delivery device according to any one of claims 16 or 17, wherein the indicator, upon reaching the third rotational position, contacts the housing or a structure fixed to the housing to generate the audible signal.

19. The drug delivery device according to claim 18, wherein the indicator contacts a distally facing surface of the housing or a structure fixed to the housing at the third rotational position to generate the audible signal.

20. The drug delivery device according to any one of claims 1 to 8, wherein the housing has an opening, and the drug storage container comprises a delivery member having an insertion end configured to extend at least partially through the opening provided by the housing.

21. The drug delivery device according to claim 20, wherein the guard is movably positioned adjacent to the opening.

22. The drug delivery device according to claim 21, wherein the guard has an extended position in which the guard extends at least partially through the opening in the housing, and a retracted position in which the guard is positioned away from the extended position toward the housing.

23. The drug delivery device according to claim 22, further comprising a guard biasing member configured to bias the guard toward the extended position.

24. The drug delivery device according to claim 23, further comprising an indicator operably coupled to the guard biasing member and configured to generate an audible signal indicating the completion of drug delivery.

25. The drug delivery device according to claim 24, wherein the plunger guide includes a second cam, the indicator includes a second cam follower, and the biasing force of the guard biasing member presses the second cam follower against the second cam, causing the indicator to rotate relative to the housing.

26. The drug delivery device according to claim 25, wherein the indicator is configured to rotate together with the plunger from the initial rotation position to the second rotation position, and to rotate independently of the plunger from the second rotation position to the third rotation position.

27. The drug delivery device according to claim 26, wherein the indicator, upon reaching the third rotational position, contacts the housing or a structure fixed to the housing to generate the audible signal.

28. The drug storage container is filled with or pre-filled with a drug, the drug comprising one of the following: a drug containing a human IgG1 kappa antibody, a small interfering RNA (siRNA) that reduces lipoprotein (a), a drug containing efavaloikin alfa, a drug containing evolocumab, a gastric suppressor polypeptide receptor (GIPR) antagonist, and a drug containing a GLP-1R agonist, according to any one of claims 1 to 27.

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