Drug delivery device

Abstract

A 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 retained in an energized state and may be released to drive the plunger to expel medication from the medication 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 linearly translate in a distal direction after rotation of the initial rotational position to the second rotational position to drive the stopper through the medicament storage container. The release member may have an initial position in which the release member holds the biasing member in the energized state, and a second position in which the release member generates an audible end-of-administration signal.

Description

[0001] This is a divisional application, the parent application of which has an application number of 202080068292.6, an international filing date of September 29, 2020, and an invention title of Drug Delivery Device.

[0002] Cross - reference to related applications

[0003] This application claims the priority of U.S. Provisional Application No. 62 / 908,504, entitled "Drug Delivery Device", filed on September 30, 2019, which is incorporated herein by reference. Technical field

[0004] This disclosure relates to drug delivery devices, and more particularly to devices for automatically injecting a drug into a patient. Background art

[0005] The general aversion to exposed needles, as well as health and safety concerns, have led to the development of drug delivery devices that hide the needle or other insertion member before use and automate various aspects of the injection process. Such devices offer a variety of benefits compared to traditional forms of drug delivery, such as delivery via a conventional syringe.

[0006] Drug delivery devices can incorporate various mechanisms to implement various automated features. Such features include automatically covering the needle in the pre - and / or post - delivery states, providing an interface for the user to enable the drive mechanism, indicating to the user that drug delivery has been completed, and the like. Typically, drug delivery devices incorporate separate or independently operable mechanisms to implement each of their automated features. Thus, as each function is added, the mechanical complexity of the device tends to increase. This may in turn increase the size of the device, which may make it cumbersome for the user to handle, as well as increase the manufacturing cost and time period. With the growing demand for more user - friendly and safer drug delivery devices, there are various design and manufacturing challenges in finding a way to incorporate more automated features without unduly increasing the complexity of the drug delivery device.

[0007] This disclosure describes drug delivery devices that embody advantageous alternatives to existing drug delivery devices and that can address one or more of the challenges or needs mentioned herein. Summary of the invention

[0008] One aspect of the present disclosure provides a drug delivery device, the drug delivery device comprising a housing, a drug delivery container fixed relative to the housing, a biasing member, and a plunger operatively 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 may be configured to: (i) selectively rotate from an initial rotational position to a second rotational position under the biasing force exerted by the biasing member, and (ii) linearly translate in a distal direction after rotating from the initial rotational position to the second rotational position to drive the stopper through the drug storage container.

[0009] Another aspect of the present disclosure provides a drug delivery device, the drug delivery device comprising a housing having an opening, a drug storage container, a guard movably positioned adjacent to the opening, a plunger, a plunger biasing member, and a release member. The drug storage container may include a delivery member having an insertion end configured to at least partially extend through the opening. The plunger may be moved in a distal direction to expel the drug from the drug storage container through the delivery member. The release member may be operatively coupled to the guard and the plunger. Additionally, the release member may be configured to rotate from an initial rotational position to a second rotational position under the biasing force exerted by the plunger biasing member.

[0010] A further aspect of the present disclosure provides a drug delivery device, the drug delivery device comprising a housing, a drug storage container, a plunger, a plunger biasing member initially held in an actuated state, and an indicator. The drug storage container may include a delivery member having an insertion end configured to at least partially extend through the opening. Releasing the plunger biasing member may drive the plunger in a distal direction to expel the drug from the drug storage container through the delivery member. The indicator may have an initial position and a second position, in the initial position, the indicator holds the plunger biasing member in the actuated state, and in the second position, the indicator generates an audible signal indicating the end of drug delivery.

[0011] 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 at least partially extend through the opening. The plunger may have an inner surface defining an axial chamber. The plunger biasing member may be at least partially disposed within the axial chamber of the plunger and may be initially held in an actuated state. Releasing the plunger biasing member may drive the plunger in a distal direction to expel the drug from the drug storage container through the delivery member.

[0012] Another aspect of the present disclosure provides a housing having an opening, a drug storage container, a guard member movably positioned adjacent to the opening, a plunger, a plunger biasing member, and a release member. 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 to resist relative movement therebetween. The plunger may be moved in a distal direction to expel a drug from the drug storage container through the delivery member. The release member may be operably coupled to the guard member and the plunger. Additionally, the release member may be configured to drive the housing and the drug storage container toward a user's injection site using inertial force from the user.

[0013] Another aspect of the present disclosure provides a drug delivery device including a housing having an opening, a drug storage container, a plunger, a plunger biasing member, and a braking member. The drug storage container may include a delivery member and a body portion defining a longitudinal axis, the delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The plunger may be moved in a distal direction to expel a drug from the drug storage container through the delivery member. The plunger biasing member may be configured to urge the plunger in the distal direction. The braking member may be operably coupled to the plunger. Movement of the plunger in the distal direction may cause the plunger and / or the braking member to rotate about the longitudinal axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] It is believed that the present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings. To more clearly show other elements, some of the drawings may be simplified by omitting selected elements. In some of the drawings, the omission of these elements does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it can be clearly stated in the corresponding written description. Moreover, all of the drawings are not necessarily drawn to scale.

[0015] Figure 1 is a perspective view of a drug delivery device according to an embodiment of the present disclosure.

[0016] Figure 2 is Figure 1 a cross-sectional view of the drug delivery device.

[0017] Figure 3 is Figure 2 an exploded assembly view of the drug delivery device.

[0018] Figure 4 and Figure 5 is Figure 2 different perspective views of the plunger guide shown.

[0019] Figure 6 and Figure 7Yes Figure 2 Different perspective views of the depicted release member.

[0020] Figure 8 Yes Figure 2 Partial perspective view of the depicted plunger, plunger biasing member, and plunger guide.

[0021] Figure 9A Is a cross-sectional view taken along line Figure 9B Z-Z.

[0022] Figure 9B Is a perspective view of the plunger retention arrangement before the protective member is retracted. In Figure 9B , the release member is shown as translucent. And in Figure 9B , for clarity, the protective member extension and protective member biasing member are omitted.

[0023] Figure 9C Yes Figure 9B Perspective view of the distal end of the plunger retention arrangement of Figure 9C . In Figure 9C , the protective member and the protective member extension are each shown as translucent. And, in

[0024] Figure 9D Is a cross-sectional view taken along line Figure 9C Y-Y.

[0025] Figure 9E Yes Figure 9B Perspective view of the proximal end of the retention arrangement of Figure 9E . In Figure 9E , the release members are shown as translucent. In

[0026] Figure 10A Is a cross-sectional view taken along line Figure 10B X-X.

[0027] Figure 10B Is a perspective view of the plunger retention arrangement at the instant after the protective member has moved to the retracted position. In Figure 10B , the release member is shown as translucent. And in Figure 10B , for clarity, the protective member extension and protective member biasing member are omitted.

[0028] Figure 10C Yes Figure 10B Perspective view of the distal end of the plunger retention arrangement of Figure 10C . In Figure 10CFor clarity, the guard offset member, the plunger, and the plunger guide are omitted.

[0029] Figure 10D is a cross-sectional view taken along line W-W of Figure 10C .

[0030] Figure 11A is a cross-sectional view taken along line V-V of Figure 11B .

[0031] Figure 11B is a perspective view of the plunger retention arrangement at the start of drug delivery. In Figure 11B , the release member is shown as translucent. And in Figure 11B , for clarity, the guard extension and the guard offset member are omitted.

[0032] Figure 11C is Figure 11B a perspective view of the distal end of the plunger retention arrangement. In Figure 11C , the guard and the guard extension are each shown as translucent. And, in Figure 11C , for clarity, the guard offset member, the plunger, and the plunger guide are omitted.

[0033] Figure 11D is a cross-sectional view taken along line U-U of Figure 11C .

[0034] Figure 11E is Figure 11B a perspective view of the proximal end of the retention arrangement. In Figure 11E , the release member is shown as translucent. In Figure 11E , for clarity, the guard offset member is omitted.

[0035] Figure 12A is a cross-sectional view taken along line T-T of Figure 12B .

[0036] Figure 12B is a perspective view of the plunger retention arrangement at the end of drug delivery. In Figure 12B , the release member is shown as translucent. And in Figure 12B , for clarity, the guard extension and the guard offset member are omitted.

[0037] Figure 12C is Figure 12B a perspective view of the distal end of the plunger retention arrangement. In Figure 12C , the guard and the guard extension are each shown as translucent. And, in Figure 12C , for clarity, the guard offset member, the plunger, and the plunger guide are omitted.

[0038] Figure 12D is a cross-sectional view taken along line S-S of Figure 12C .

[0039] Figure 12E is Figure 12B a perspective view of the proximal end of the retention arrangement of Figure 12E . In Figure 12E , the release member is shown as translucent. In

[0040] Figure 13 is a perspective view of a drug delivery device according to another embodiment of the present disclosure.

[0041] Figure 14 is Figure 13 a perspective view of the drug delivery device of

[0042] Figure 15 and Figure 16 are Figure 13 different side views of the drug delivery device of

[0043] Figure 17A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0044] Figure 17B is Figure 17A an enlarged view of the proximal end of the drug delivery device shown in

[0045] Figure 18A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0046] Figure 18B is Figure 18A an enlarged view of the proximal end of the drug delivery device shown in

[0047] Figure 19A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0048] Figure 19B is Figure 19A an enlarged view of the proximal end of the drug delivery device shown in

[0049] Figure 20 is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0050] Figure 21 is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0051] This disclosure generally relates to a drug delivery device that can be operated by a user to deliver a drug, or in the case where the patient is the user, to self - deliver a drug. 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 a payload. Such features include, but are not limited to, an indicator for signaling to the user the completion of drug delivery, and a drive mechanism that can be enabled by pressing the drug delivery device against an injection site on the patient's skin. These features and other features work together and / or interact with each other in a synergistic manner to limit the number and / or complexity of the moving parts of the drug delivery device. Additionally, certain features described herein utilize a biasing force exerted by a plunger biasing member and / or a guard biasing member for actuation, thereby reducing any force that must be exerted by the user and / or reducing the need to incorporate a dedicated energy source to implement the feature. These and other advantages will be apparent to those of ordinary skill in the art who read this disclosure.

[0052] Figures 1 to 3 Several views are shown of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or pharmaceutical. The drug can be, but is not limited to, various biologics such as peptides, peptidomimetics, or antibodies. The drug can be in fluid or liquid form, but this disclosure is not limited to a particular state.

[0053] Various embodiments and configurations of the drug delivery device 10 are possible. The current embodiment of the drug delivery device 10 is configured as a single - use disposable injector. In other embodiments, the drug delivery device 10 can be configured as a multi - use reusable injector. The drug delivery device 10 is operable for self - administration by a patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a doctor or a nurse). The current embodiment of the drug delivery device 10 takes the form of an auto - injector or a pen - type injector and can thus be held in the user's hand for the duration of drug delivery.

[0054] The configuration of the various components included in the drug delivery device 10 can depend on the operating state of the drug delivery device 10. The drug delivery device 10 can have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. The pre-delivery state can correspond to the configuration of the drug delivery device 10 after assembly and before being enabled by the user. In some embodiments, the pre-delivery state can exist between the time when the drug delivery device 10 leaves the manufacturing facility and the time when the user enables the drive mechanism 30 of the drug delivery device 10. This includes the moment after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 at the injection site. The delivery state can correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is in progress. The post-delivery state can correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is disposed at the end-of-dose position in the drug storage container.

[0055] The drug delivery device 10 includes a housing and a housing 12. In some embodiments, the size and dimensions of the housing 12 can be determined such that a person can hold the injector 10 with one hand. The housing 12 can have a generally elongated shape, such as a cylindrical shape, and extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 can be formed in the distal end to permit the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 can be positioned in the wall of the housing 12 to permit the user to view the components (including the drug storage container 20) inside the drug delivery device 10. Viewing the drug storage container 20 through the window 17 can allow the user to confirm that drug delivery is in progress and / or completed. A removable cap 19 can cover the opening 14 before use of the drug delivery device 10, and in some embodiments, can include a grip 13 that is configured to assist in removing a sterile barrier 21 (e.g., a rigid needle sheath (RNS) or a flexible needle sheath (FNS), etc.) mounted on the insertion end 28 of the delivery member 16. The grip 13 can include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the sterile barrier 21 when the user separates the removable cap 19 from the housing 12, pulling the sterile barrier 21 together with the removable cap 19. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0056] In the present embodiment, the housing 12 is defined by three separate and interconnected structures: a back end cap 23 at the proximal end of the drug delivery device 10; a front housing 25 at the distal end of the drug delivery device 10 and including an opening 14; and a rear housing 27 located between the back end cap 23 and the front housing 25 and rigidly connecting the two. The front housing 25 and the rear housing 27 may each have a hollow and generally cylindrical or tubular shape, and the back end cap 23 may have a generally hemispherical shape or a hollow cylindrical shape with an open end and a closed end. In some embodiments, the back end cap 23, and the rear housing 27 and any components to be positioned therebetween may be assembled together to define a rear sub-assembly. Meanwhile, the front housing 25 and any components to be positioned therebetween may be assembled together to define a front sub-assembly. In some embodiments, the front sub-assembly and the rear sub-assembly 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 above assembly stages may be carried out in different manufacturing facilities or environments. In an alternative embodiment, the housing 12 may be of one-piece construction such that the housing 12 is defined by a single integral structure.

[0057] The drug storage container 20 is arranged within the interior space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 can, for example, be pre-filled by the manufacturer and transported to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. The housing 12 can, for example, be pre-loaded by the manufacturer with the drug storage container 20, or alternatively be loaded by the user with the drug storage container 20 prior to using the drug delivery device 10. The drug storage container 20 can include a rigid wall defining an internal bore or reservoir. The wall can be made of glass or plastic. A stopper 24 can be movably arranged within the drug storage container 20 such that it can move in a distal direction between the proximal and distal ends of the drug storage container 20 along the longitudinal axis A. The stopper 24 can be constructed of rubber or any other suitable material. The stopper 24 can slidably and sealingly contact the internal surface 15 of the wall of the drug storage container 20 such that when the stopper 24 moves, leakage of the drug 22 past the stopper 24 will be prevented or inhibited. The distal movement of the stopper 24 discharges the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 can be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 in a distal direction. In the current embodiment, the plunger 26 and the stopper 24 are initially spaced apart from each other by a gap. When the drive mechanism 30 is activated, the plunger 26 moves in a distal direction to reduce the gap and contact the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 in a distal direction to discharge the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 can initially be in contact with each other or be coupled to each other, for example, via a threaded connection, such that they can move together starting from the movement of the plunger 26. Once the stopper 24 moves, it can continue to move in a distal direction until it contacts the proximal-facing portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 can be referred to as the end-of-dose or end-of-delivery position and can correspond to the completion or substantially completion of the delivery of the drug 22 to the patient.

[0058] In some embodiments, the volume of the medicament 22 contained in the reservoir of the medicament storage container 20 may be equal to 1 mL, or equal to approximately (e.g., ±10%) 1 mL, or equal to 2.5 mL, or equal to approximately (e.g., ±10%) 2.5 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g., ±10%) 10 mL, or in the range between approximately (e.g., ±10%) 1 - 10 mL, or in the range between approximately (e.g., ±10%) 1 - 5 mL, or in the range between approximately (e.g., ±10%) 1 - 4 mL, or in the range between approximately (e.g., ±10%) 1 - 3 mL, or in the range between approximately (e.g., ±10%) 1 - 2.5 mL.

[0059] The delivery member 16 is or is operable to be fluidly connected in communication with the reservoir of the medicament storage container 20. The distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include a sharp tip having other sharp geometries to allow the insertion end 28 to pierce the skin 5 and subcutaneous tissue of the patient during insertion of the delivery member 16. The delivery member 16 may be hollow and have an internal passageway. One or more openings may be formed in the insertion end 28 to allow the medicament to flow out of the delivery member 16 into the patient's body.

[0060] In the present embodiment, the medicament storage container 20 is a pre-filled syringe and has a hollow metal stud needle for the delivery member 16. Here, the needle is fixed relative to the wall of the medicament storage container 20 and is permanently fluidly connected in communication with the reservoir of the medicament storage container 20. In other embodiments, the medicament storage container 20 may be a needleless cartridge and thus may not initially be fluidly connected in communication with the delivery member 16. In such an embodiment, the medicament storage container 20 may move towards the proximal end of the delivery member 16 or vice versa during operation of the medicament delivery device 10 such that the proximal end of the delivery member 16 penetrates a septum covering an opening in the medicament storage container 20, thereby establishing fluid communication between the reservoir of the medicament storage container 20 and the delivery member 16.

[0061] The drug storage container 20 can be fixed relative to the housing 12 such that once the drug storage container 20 is installed in the housing 12, it cannot move relative to the housing 12. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 in the housing 12. In the present embodiment, the container holder 31 secures the position of the drug storage container 20 within the housing 12. The container holder 31 can have a hollow and generally cylindrical or tubular shape, and the drug storage container 20 can be partially or fully disposed within the container holder 31. The distal end of the container holder 31 can include an inwardly projecting flange 33 that abuts the neck of the drug storage container 20, thereby preventing the drug storage container 20 from moving distally. The container holder 31 can be fixedly attached to the housing 12 such that during operation of the drug delivery device 10, the container holder 31 is prevented from moving relative to the housing 12.

[0062] In an alternative embodiment, the drug storage container 20 can be movably coupled to the housing 12 such that the drug storage container 20 can move relative to the housing 12 during operation of the drug delivery device 10. In some such alternative embodiments, the insertion end 28 of the delivery member 16 can be retracted into the opening 14 in 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 can be deployed through the opening 14 in the housing 12 for insertion into a patient. In some embodiments, this movement can be the result of the drug storage container 20 having been driven distally relative to the housing 12.

[0063] The plunger 26 can have a hollow and generally cylindrical or tubular shape. The plunger 26 can include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 can define an internal space sized to receive the plunger biasing member 50 therein. It is generally desirable to minimize the thickness of the annular wall 39 to the extent possible without compromising the integrity of the plunger 26 in order to maximize the inner diameter of the plunger 26. This allows a larger diameter plunger biasing member 50 to be fitted within the internal space of the plunger 26, which in turn allows for a more forceful plunger biasing member 50. As described in more detail below, the plunger 26 can be configured to selectively rotate relative to the housing 12 and translate linearly relative to the housing 12 during operation of the drug delivery device 10.

[0064] The plunger 26 can be constructed of multiple interconnected pieces or alternatively have a one-piece configuration. In the current embodiment, the plunger 26 is constructed of three separate and interconnected structures: a top ring 45 that defines the proximal end of the plunger 26; a base 47 that defines the distal end of the plunger 26; and a hollow rod 46 that is located between the top ring 45 and the base 47 and rigidly connects the two. The positions of the top ring 45, the hollow rod 46, and the base 47 can be fixed relative to each other such that these components can be immovable relative to each other. The top ring 45, the hollow rod 46, and the base 47 each have an annular configuration and can be centered about a longitudinal axis A. The top ring 45 and the hollow rod 46 can each have a respective central opening that extends from one end of the component to the other end to define an axial chamber; and the base 47 can 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 can define a seat or abutment surface for the plunger biasing member 50. In an alternative embodiment, the central opening can extend through the base 47 from one end to the other end. In such an alternative embodiment, the inner diameter of the central opening of the base 47 can be less than the outer diameter of the plunger biasing member 50 such that the base 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the actuation drive mechanism 30 is actuated, the base 47 can be the portion of the plunger 46 that contacts the plug 24 to push the plug 24 in the distal direction.

[0065] The top ring 45 can include one or more flanges or protrusions 48 that extend radially outward from the central portion of the top ring 45. Each of these protrusions 48 can include a distally facing cam surface 49. As described in more detail below, the distally facing cam surface 49 can interact with a mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distally facing cam surface 49 can be arranged at an angle to or non-parallel with a hypothetical plane perpendicular to the longitudinal axis A.

[0066] In some embodiments, the top ring 45 and / or the base 47 may be made of a material different from that of the hollow stem 46. In some embodiments, the top ring 45 and / or the base 47 are made of plastic, while the hollow stem 46 may be made of metal. Configured in this way, the plastic material for the top ring 45 can facilitate the cam action described below by providing sliding friction, and the plastic material for the base 47 can help absorb or attenuate any shock or vibration associated with the base 47 hitting the plug 24. The metal material for the hollow stem 46 can provide sufficient stiffness to avoid buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, the hollow stem 46, and / or the base 47 may be made of the same material (including, for example, metal or plastic). In certain such embodiments, the top ring 45, the hollow stem 46, and the base 47 may be integrally formed in one piece to define a single integral structure.

[0067] The drug delivery device 10 may further include a protective mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used for performing an injection. The protective mechanism may include a protective member 32 movably disposed at the distal end of the housing 12, adjacent to the opening 14. The protective member 32 may have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A and may have a proximal end received within the housing 12. The protective member 32 may be configured to move relative to the housing 12 between a protruding position and a retracted position, in the protruding position, the distal end of the protective member 32 extends through the opening 14 in the housing 12, and in the retracted position, the distal end of the protective member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the protective member 32 may be configured to move from the retracted position to the protruding position. When moving from the protruding position to the retracted position, the protective member 32 may linearly translate in the proximal direction; and when moving from the retracted position to the protruding position, the protective member 32 may linearly translate in the distal direction. At least in the protruding position, the protective member 32 may extend beyond the insertion end 28 of the delivery member 16 and surround the insertion end. In embodiments where the delivery member 16 protrudes from the opening 14 in the housing 12 in a pre-delivery or storage state, moving the protective member 32 from the protruding position to the retracted position (e.g., by pressing the distal end of the protective member 32 against the injection site on the patient's skin) may cause the insertion end 28 of the delivery member 16 to be inserted into the patient's skin.

[0068] For example, the delivery device 10 can utilize an inertial drive design rather than a spring design to insert the needle into the subcutaneous tissue of the patient. As a more specific example, when the patient presses the distal end of the protective member 32 against the injection site on the patient's skin, the housing 12 of the delivery device 10 can be advanced toward the injection site. When the patient presses down a predetermined distance or with a predetermined force, the delivery device 10 effects a rapid release to utilize the energy stored in the patient's muscle while compressing the needle sleeve and its spring to a defined release point. The release mechanism is designed such that the resulting needle insertion speed exceeds the patient's reaction speed, and the combination of this speed and the mass of the device causes the needle to quickly and fully penetrate the skin to a subcutaneous depth. Compared to known injectors in which the entire main container moves forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing and thus provides a simplified and more robust design.

[0069] In some embodiments, the protective member 32 can be rotationally fixed relative to the housing 12. Thus, while the protective member 32 may be able to translate linearly relative to the housing 12, the protective member 32 can be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 61 can be formed in the wall of the protective member 32 and can be parallel to the longitudinal axis A. The size of each longitudinal slot 61 can be determined to cooperatively or snugly receive a projection or pin 63 that extends radially inward from the front housing 25. When the protective member 32 translates linearly along the longitudinal axis A relative to the front housing 25, each pin 63 can slidably engage the surface that defines a corresponding one of the longitudinal slots 61. However, the pin 63 abuts against the same surface to prevent rotation of the protective member 32 relative to the front housing 25 when any rotational force is applied to the protective member 32. In an alternative embodiment, the pin and slot arrangement can be reversed such that the protective member 32 has one or more radially outwardly extending pins and the front housing 25 has one or more slots or other recesses to cooperatively or snugly receive the one or more pins.

[0070] The protection mechanism can further include a protection member biasing member 35 and a protection member extension 37. The protection member extension 37 can be positioned proximal to the protective member 32; and the protection member biasing member 35 can be positioned proximal to the protection member extension 37. The protection member extension 37 can have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A. Additionally, the protection member extension 37 can be movable relative to the housing 12 in a linear direction along the longitudinal axis A. In the present embodiment, the protection member extension 37 is a structure separate from the protective member 32. However, in an alternative embodiment, the protection member extension 37 and the protective member 32 can be integrally formed in one piece to define a single integral structure. In such an alternative embodiment, the proximal end of the protective member 32 can correspond to the protection member extension 37.

[0071] Similar to the protective member 32, the protective member extension 37 can be fixed relative to the housing 12 in a rotational sense. Thus, while the protective member extension 37 may be able to translate linearly relative to the housing 12, the protective member extension 37 can be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 71 can be formed in the wall of the protective member extension 37 and can be parallel to the longitudinal axis A. The dimensions of each longitudinal slot 71 can be determined to cooperatively or snugly receive a projection or pin (not shown) that extends radially inward from the housing 12 (such as the rear housing 23 and / or the front housing 25). When the protective member extension 37 translates linearly relative to the housing 12 along the longitudinal axis A, each pin can slidably engage the surface that defines the corresponding longitudinal slot 71. However, the pin abuts against the same surface to prevent rotation of the protective member extension 37 relative to the housing 12 when any rotational force is applied to the protective member extension 37. In alternative embodiments, the pin and slot arrangement can be reversed such that the protective member extension 37 has one or more radially outwardly extending pins and the housing 12 has one or more slots or other recesses to cooperatively or snugly receive the one or more pins.

[0072] The protective member biasing member 35 can be positioned and in contact between the protective member extension 37 and the release member 52. The protective member biasing member 35 can be configured to bias or urge the protective member extension 37 in the distal direction and to bias or urge the release member 52 in the proximal direction. The protective member biasing member 35 can initially be in an energized (e.g., compressed) state such that, in the pre-delivery state, it exerts a biasing force on the protective member extension 37 and a biasing force on the release member 52. In some embodiments, the distal end of the protective member extension 37 is initially in contact with the proximal end of the protective member 32, see Figure 2Thus, the guard extension 37 transfers the biasing force of the guard biasing member 35 to the guard member 32 such that the guard biasing member 35 biases or urges the guard member 32 towards the extended position. The user can overcome this biasing force by pressing the guard member 32 against the injection site. In doing so, the guard member 32 and the guard extension 37 move together in the proximal direction until, for example, the guard member 32 reaches the retracted position. When the injection is complete and the drug delivery device 10 is lifted away from the injection site, the guard biasing member 35 can push the guard extension 37 such that the guard extension 37 and the guard member 32 move together in the distal direction. This movement returns the guard member 32 to the extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the guard biasing member 35 can comprise a compression spring (e.g., a helical compression spring). Additionally, in embodiments where the plunger biasing member 50 also comprises a compression spring, the guard biasing member 35 can be arranged around the plunger biasing member 50 and / or have a larger diameter than the plunger biasing member.

[0073] In an alternative embodiment, the distal end of the guard extension 37 can initially be spaced apart from the proximal end of the guard member 32 in the proximal direction by a gap. Thus, in the pre-delivery state, the guard biasing member 35 cannot bias the guard member 32 towards the extended position. Only when the guard member 32 is retracted in the proximal direction and contacts the guard extension 37 does the guard biasing member 35 then apply a biasing force to the guard member 32 to urge it towards the extended position. In such an alternative embodiment, in the pre-delivery state, only the lock ring biasing member 51 described below can be used to bias the guard member 32 towards the extended position.

[0074] After drug delivery is complete and the guard member 32 has been redeployed to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent the user from subsequently accessing the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. For these purposes, some embodiments of the drug delivery device 10 can include a lock ring 40 that is configured to rotate selectively depending on the axial position of the guard member 32 so as 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 the present embodiment, the lock ring 40 rotates about and is centered on the longitudinal axis A. As Figure 2As shown, the proximal end of the locking ring 40 can contact the container holder 31, and the distal end of the locking ring 40 can be at least partially disposed within the protective member 32. The locking ring biasing member 51 can be axially positioned between the distally facing surface of the locking ring 40 and the proximally facing surface of the protective member 32. The locking ring biasing member 51 can initially be in a compressed or energized state, thereby biasing the locking ring 40 and the protective member 32 away from each other. In this way, the locking ring biasing member 51 can apply a biasing force to push the protective member 32 to the extended position and apply a biasing force to push the proximal end of the locking ring 40 against the container holder 31. In some embodiments, the locking ring biasing member 51 can include a compression spring (e.g., a helical compression spring).

[0075] Rotation of the locking ring 40 can be achieved by a cam arrangement between the locking ring 40 and the container holder 31. In some embodiments, the proximal end of the locking ring 40 can include one or more cam surfaces 53 that are configured to slidably engage one or more corresponding cam surfaces 55 included on the annular inner wall 57 of the front housing 25. The annular inner wall 57 of the front housing 25 can be centered about the longitudinal axis A and can be a radially inward cantilever of the annular outer wall 59 of the front housing 25, such that there is an annular gap between the annular inner wall 57 and the annular outer wall 59 of the front housing 25. This configuration can allow the protective member 32 to slide into the annular gap between the inner wall 57 and the outer wall 59 during retraction. In some embodiments, when viewed in the radial direction from the longitudinal axis A, the cam surfaces 53 of the locking ring 40 can have a generally serrated appearance. Additionally, the cam surfaces 53 can be arranged about the longitudinal axis A such that each cam surface 53 is positioned at a different angular position about the longitudinal axis A. Similarly, when viewed in the radial direction from the longitudinal axis A, the cam surfaces 55 on the container holder 31 can have a generally serrated appearance. Additionally, the cam surfaces 55 can be arranged about the longitudinal axis A such that each cam surface 55 is positioned at a different angular position about the longitudinal axis A.

[0076] When pressed against each other, the cam surfaces 53 and 55 can convert linear motion into a combination of rotational motion and linear motion. More specifically, when the locking ring 40 moves proximally along the longitudinal axis A, each cam surface 53 can slide against a corresponding one of the cam surfaces 55. This interaction can convert the proximal linear movement of the locking ring 40 into a combination of rotational movement of the locking ring 40 about the longitudinal axis A and proximal linear movement of the locking ring 40 along the longitudinal axis A. Throughout the movement of the locking ring 40, the annular inner wall 57 of the front housing 25 remains stationary relative to the remainder of the front housing 25. Configured in this way, the annular inner wall 57 of the front housing 25 serves as a cam, and the locking ring 40 serves as a cam follower.

[0077] The biasing force of the guard biasing member 35 can continuously press the cam surface 53 of the locking ring 40 against the cam surface 55 of the annular inner wall 57. Accordingly, the locking ring 40 is continuously urged to rotate about the longitudinal axis A. However, the locking ring 40 may not be able to rotate, depending on the relative positions of various cooperating abutment structures included on the exterior of the locking ring 40 and the interior of the guard member 32. Depending on the axial position of the guard member 32, these cooperating abutment structures can engage and / or disengage from each other to allow the locking ring 40 to rotate. In some embodiments, the locking ring 40 can rotate to a final rotational position as the guard member 32 moves from a retracted position to an extended position. In the final rotational position, the facing distal surfaces of one or more abutment structures included on the locking ring 40 can be rotationally aligned and oppositely disposed relative to the facing proximal surfaces of one or more mating abutment structures included on the guard member 32. Accordingly, any subsequent movement of the guard member 32 in the proximal direction can be prevented by engaging the facing proximal surfaces of the one or more abutment structures included on the guard member 32 with the facing distal surfaces of the one or more abutment structures included on the locking ring 40.

[0078] The drug delivery device 10 can further include a drive mechanism 30 that is partially or fully disposed within the housing 12. Generally, the drive mechanism 30 can be configured to store energy and, when the drive mechanism 30 is enabled by a user or in response to the user enabling the drive mechanism, release or output energy to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 into a patient's body. In the present embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 can be configured differently, for example, where the drive mechanism 30 stores electrical potential energy or chemical potential energy. Generally, when the drive mechanism 30 is enabled, the drive mechanism 30 can convert the potential energy into kinetic energy to move the plunger 26.

[0079] In the present embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member base 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 can include a compression spring (e.g., a helical compression spring) that is initially held in an energized state. In the energized state, the plunger biasing member 50 can be compressed such that its axial length is shorter than its length in its natural or unenergized state. When released, the plunger biasing member 50 can attempt to expand to its natural axial length and, accordingly, apply a biasing force to push the plunger 26 in the distal direction.

[0080] The plunger biasing member 50 can be at least partially disposed within the plunger 26 and can have a distal end that abuts the proximal-facing inner surface of the plunger 26 and / or can be fixedly attached to the inner surface of the plunger 26. Such that the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 can be equal to or less than the inner diameter of the top ring 45 and / or equal to or less than the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 can abut the proximal-facing inner surface of the base 47 of the plunger 26. Additionally, the proximal end of the plunger biasing member 50 can abut the distal-facing surface of the plunger biasing member base 38. The plunger biasing member base 38 can be fixedly attached to the rear housing 27 such that the plunger biasing member base 38 provides a stationary surface to push the plunger biasing member 50 away. Configured in this way, such that when released from the actuated state, the plunger biasing member 50 can expand in length by moving in a distal direction away from the stationary proximal end of the plunger biasing member 50 by the distal end of the plunger biasing member 50. This movement can push the plunger 26 in the distal direction, which in turn can push the plug 24 in the distal direction to discharge the medicament 22 from the medicament storage container 20 into the delivery member 16 and then into the patient's body.

[0081] The plunger guide 60 can be fixedly attached to the rear housing 27 such that the plunger guide 60 is immovable relative to the rear housing 27. The plunger guide 60 can have a hollow and generally cylindrical or tubular shape and can be centered about a longitudinal axis A. The outer diameter or other outer dimensions of the proximal end of the plunger guide 60 can be greater than the outer diameter or other outer dimensions of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 can be radially positioned between the plunger 26 and the release member 52. In this way, the plunger 26 can be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 can be at least partially disposed within the release member 52, as Figure 2 shown.

[0082] Reference Figure 4 、 Figure 5 、and Figure 8, the distal end of the plunger guide 60 may include an annular wall 80 that is formed to have various surfaces and openings for interacting with and controlling the movement of the plunger 26 and the release member 52. More specifically, a first opening 82 may be formed in the annular wall 80, and its size may be determined to receive a projection 48 extending outward from the top ring 45 of the plunger 26. The annular wall 80 may include a proximally facing cam surface 84 that defines a portion of the perimeter of the first opening 82. The cam surface 84 may be angled downward at an angle to, or non-parallel with, an imaginary plane perpendicular to the longitudinal axis A. In the pre-delivery state, the proximally facing cam surface 84 of the plunger guide 60 may contact the distally 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 proximally facing cam surface 84 of the plunger guide 60. Accordingly, the distally facing cam surface 49 of the top ring 45 may be urged to slide along the proximally facing cam surface 84 of the plunger guide 60, generally following a helical path. If permitted, this sliding motion may cause the plunger 26 to rotate and linearly translate relative to the stationary plunger guide 60. Accordingly, the plunger guide 60 may act as a cam, and the top ring 45 as a cam follower. In the pre-delivery state, the engagement between the projection 48 and the release member 52 may prevent any rotation of the plunger 26 relative to the plunger guide 60, as described below. In the absence of sliding motion between the distally facing cam surface 49 of the top ring 45 and the proximally facing cam surface 84 of the plunger guide 60, the annular wall 80 of the plunger guide 60 serves to prevent linear translation of the plunger 26 in the distal direction. Accordingly, the plunger guide 60 may assist in maintaining the plunger biasing member 50 in an energized state until the protective member 32 is retracted. In some embodiments, an opening similar to the first opening 82 may be formed on the opposite side of the plunger guide 60, and the opening may be configured to receive a different projection 48 of the top ring 45.

[0083] Continuing reference Figure 4 、 Figure 5 、and Figure 8 , a second opening 86 may be formed in the annular wall 80 of the plunger guide 60, and the second opening may be at least partially disposed distally of the first opening 86. As Figure 4 and Figure 5As shown, the second opening 86 generally takes the form of a longitudinal slot parallel to the longitudinal axis A. The size of the second opening 86 can be determined to receive a projection 48 of the top ring 45 and can permit the projection 48 to linearly slide in the distal direction through the second opening 86. After the projection 48 has rotated beyond the end of the cam surface 84, the projection 48 can be received in the second opening 86 and then linearly translated in the distal direction through the second opening 86 without further rotation of the projection 48 relative to the plunger guide 60, as Figure 8 depicted. In some embodiments, an opening similar to the second opening 86 can be formed on the opposite side of the plunger guide 60, and the opening can be configured to receive a different projection 48 of the top ring 45.

[0084] The annular wall 80 of the plunger guide 60 can further include a distally facing cam surface 88. As Figure 4 and Figure 5 depicted, the distally facing cam surface 88 can be part of a helical protrusion extending outward from the remainder of the annular wall 80. The distally facing cam surface 88 can be tilted upward at an angle to or not parallel to a hypothetical plane perpendicular to the longitudinal axis A. As described in more detail below, the biasing force of the guard biasing member 35 can press the proximally facing cam surface of the release member 52 against the distally facing cam surface 88 of the plunger guide 60. Accordingly, the proximally facing cam surface of the release member 52 can be biased to slide generally along the distally facing cam surface 88 of the plunger guide 60 following a helical path. If permitted, this sliding motion can cause the release member 52 to rotate and linearly translate relative to the stationary plunger guide 60. Correspondingly, the plunger guide 60 can act as a cam while the release member 52 acts as a cam follower. In some embodiments, a distally facing cam surface similar to the distally facing cam surface 88 can be formed on the opposite side of the plunger guide 60, and the distally facing cam surface is configured to engage a different proximally facing cam surface on the release member 52.

[0085] Now referring to Figure 2 、 Figure 3 、 Figure 6 、and Figure 7 to describe the configuration of the release member 52. The release member 52 can have a hollow and generally cylindrical or tubular shape and can be centered on the longitudinal axis A. As Figure 2As shown, the release member 52 can be positioned radially between the distal end of the plunger guide 60 and the proximal end of the shield extension 37. Additionally, the release member 52 can be disposed radially inward of the shield biasing member 35. Generally, the release member 52 is configured to operatively couple the shielding member 32 and the plunger 26 in an enabling sequence and generate an audible signal indicating the end of drug delivery. Being configured in this way enables the release member 52 to perform these two separate functions and thus reduces the number of moving parts required for the drug delivery device 10.

[0086] Depending on the operating phase of the drug delivery device 10, the release member 52 can be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12. The initial rotation of the release member 52 associated with enabling can be powered by the plunger biasing member 50 and / or the shield biasing member 35; while the subsequent rotation of the release member 52 associated with the generation of the end-of-dose signal can be powered only by the shield biasing member 35. Any linear translation of the release member 52 without rotation can be powered only by the shield biasing member 35. In some embodiments, the release member 52 can translate linearly only in the proximal direction; however, alternative embodiments can permit the release member 52 to translate linearly in both the proximal and distal directions.

[0087] The release member 52 can 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 enabling the drive mechanism 30, while the proximal end of the annular wall 90 is configured to generate an audible end-of-dose signal. As Figure 2 depicted, a distally facing rung or surface 91 formed on the outer portion of the annular wall 90 can abut the proximal end of the shield biasing member 35. In this way, the shield biasing member 35 can apply a biasing force to the release member 52 to urge the release member 52 in the proximal direction.

[0088] Reference Figure 6, a recess 92 may be formed on an inner portion of the annular wall 90 of the release member 52. In the current 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, an opening, or a slot extending between the inner and outer surfaces of the annular wall 90. The recess 92 may be arranged such that its length or longest dimension is parallel to the longitudinal axis A. Further, the size of the recess 92 may be determined to snugly or closely receive a projection 48 of the top ring 45. The recess 92 may be configured to permit the projection 48 to linearly slide relative to the release member 52 parallel to the longitudinal axis A, but to prevent the projection 48 from rotating relative to the release member 52 about the longitudinal axis A. This may be achieved by forming the width of the recess 92 to be slightly greater than the width of the projection 48 such that there is little to no play between the recess 92 and the projection 48 in the rotational direction. Due to the mating engagement between the projection 48 and the recess 92, the release member 52 and the plunger 26 may be locked to each other in a rotational sense. Thus, when the projection 48 is received within the recess 92, the release member 52 may rotate jointly with the plunger 26; and when the projection 48 is not received within the recess 92, the release member 52 may be able to rotate independently of the plunger 26. In some embodiments, a recess similar to the recess 92 may be formed on an opposite side of the release member 52, and the recess may be configured to receive a different projection 48 of the top ring 45.

[0089] The ability of the release member 52 to rotate about the longitudinal axis A can be adjusted by the interaction between the outer portion of the annular wall 90 of the release member 52 and the inner portion of the shield extension 37. More specifically, the biasing force of the plunger biasing member 50 can continuously press the cam surface 49 of the projection 48 against the cam surface 84 of the plunger guide 90, thereby urging the projection 48 to rotate about the longitudinal axis A. Since the projection 48 is received in the recess 92 in a mating manner, the release member 52 can also be urged to rotate under the biasing force of the plunger biasing member 50. In addition, in some embodiments, the release member 52 can be rotated by the biasing force of the shield biasing member 35 via a cam arrangement between the proximal end of the release member 52 and the plunger guide 60. Although there are these biasing forces, in the pre-delivery state, the release member 52 is still prevented from rotating by various cooperating abutment structures included on the outer portion of the annular wall 90 of the release member 52 and the inner portion of the shield extension 37. Depending on the relative axial positions of these abutment structures, these abutment structures can engage with each other to prevent the release member 52 from rotating relative to the shield extension 37, or disengage from each other to allow the release member 52 to rotate relative to the shield extension 37. In the current embodiment, these cooperating abutment structures can 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 shield extension 37, which are slidably engaged with each other to permit relative movement in a linear direction along the longitudinal axis A and at the same time are engaged with each other in an abutting manner to prevent relative rotational movement about the longitudinal axis A. In certain alternative embodiments, these cooperating abutment structures can take the form of one or more recesses formed in the outer surface of the release member 52 and one or more corresponding projections extending inward from the shield extension 37, which are slidably engaged with each other to permit relative movement in a linear direction along the longitudinal axis A and at the same time are engaged with each other in an abutting manner to prevent relative rotational movement about the longitudinal axis A. In certain other alternative embodiments, these cooperating abutment structures can take the form of one or more projections extending outward from the release member 52 and one or more corresponding grooves formed in the inner surface of the shield extension 37, which are slidably engaged with each other to permit relative movement in a linear direction along the longitudinal axis A and at the same time are engaged with each other in an abutting manner to prevent relative rotational movement about the longitudinal axis A.

[0090] As described above, the guard extension 37 is prevented from rotating about the longitudinal axis A due to its connection to the housing 12. This has the effect that when the projection 94 on the outer part of the release member 52 engages the projection 96 on the inner part of the guard extension 37, the release member 52 is prevented from rotating about the longitudinal axis A. If the release member 52 cannot rotate, the projection 48 received in the recess 92 formed in the inner surface of the release member 52 also cannot rotate. If the projection 48 cannot rotate, it cannot slide out of the first opening 82 and into the second opening 86 in the plunger guide 60. If the projection 48 cannot move in this way, the plunger 26 also cannot move. If the plunger 26 cannot move, the plunger biasing member 50 cannot expand when unactuated. Accordingly, the release member 52 holds the plunger biasing member 50 in the actuated state until the guard extension 37 moves to an axial position where the cooperating abutment structure on the outer part of the release member 52 and the abutment structure on the inner part of the guard extension 37 are disengaged from each other and thereby permit the release member 52 to rotate relative to the guard extension 37.

[0091] In addition to this fixing function, the release member 52 can also be used to generate an audible signal to indicate to the user that drug delivery or administration is complete, but the release member 52 does not need to have this indicator function. In the present embodiment, the proximal end of the release member 52 defines an indicator. Accordingly, in the present embodiment, the indicator and the release member 52 are the same component. In an alternative embodiment, the indicator can be defined by a structure separate from, but rigidly attached to, the release member 52.

[0092] Initially, there may be a gap between the proximally facing end surface 97 of the release member 52 and the distally facing abutment surface 98 at the proximal end of the plunger guide 60. To generate an audible signal, the release member 52 can be driven in the proximal direction by the guard biasing member 35 to reduce this gap and thereby cause the proximally facing end surface 97 of the release member 52 to impact or strike the distally facing abutment surface 98 at the proximal end of the plunger guide 60. This impact can produce a clicking or slapping sound, or any other suitable audible signal perceptible to the user. The audible signal can be generated simultaneously with or substantially simultaneously with the stopper 24 reaching the end-of-dose position. Accordingly, the audible signal can indicate to the user that drug delivery or administration is complete. In some embodiments, the user can be informed of the significance of the audible signal through instructions provided with the drug delivery device 10. In some embodiments, these instructions can take the form of an IFU booklet packaged with the drug delivery device 10. In some embodiments, the user can obtain additional confirmation of drug delivery completion by observing the stopper 24 and / or the plunger 26 moving through the window 17. In some embodiments, the audible signal can be accompanied by a vibration or other tactile feedback resulting from the release member 52 striking the plunger guide 60.

[0093] In some embodiments, the movement of the release member 52 that generates an audible signal can involve both rotation of the release member 52 about the longitudinal axis A and linear translation of the release member 52 in the proximal direction. This can be achieved by a cam arrangement between the release member 52 and the plunger guide 60. In the present embodiment, the proximal end of the release member 52 includes a proximally facing cam surface 99 that slidably engages a distally facing cam surface 88 on the annular wall 80 of the plunger guide 60. The biasing force of the guard biasing member 35 can press the proximally facing cam surface 99 of the release member 52 against the distally facing cam surface 88 of the plunger guide 60. Accordingly, the proximally facing cam surface 99 of the release member 52 can be urged to slide along the distally facing cam surface 88 of the plunger guide 60, generally following a helical path. If permitted, this sliding movement can cause the release member 52 to rotate and linearly translate relative to the plunger guide 60. Correspondingly, the plunger guide 60 can act as a cam, and the release member 52 can act as a cam follower. In some embodiments, a proximally facing cam surface similar to the proximally facing cam surface 99 can be formed on the opposite side of the release member 52 and is configured to engage a different distally facing cam surface on the plunger guide 60.

[0094] Although the shield biasing member 35 may continuously urge the proximal-facing cam surface 99 of the release member 52 to slide along the distal-facing cam surface 88 of the plunger guide 60, such movement may be limited by the interaction between the protrusion 48 of the plunger 26 and the recess 92 formed in the release member 52. More specifically, when the protrusion 48 is received within the recess 92 and thus the plunger 26 and the release member 52 are configured to rotate together, rotation of the plunger 26 may allow the proximal-facing cam surface 99 of the release member 52 to slide along the distal-facing cam surface 88 of the plunger guide 60, which in turn causes the release member 52 to rotate about the longitudinal axis A and causes the release member 52 to linearly translate in the proximal direction. In turn, when the protrusion 48 is received within the recess 92 and the protrusion 48 cannot rotate, for example because the protrusion 48 is received within a second opening 86 formed in the plunger guide 60, the proximal-facing cam surface 99 of the release member 52 may not slide along the distal-facing cam surface 88 of the plunger guide 60. As described below, when the plug 24 reaches the end-of-dose position, the protrusion 48 may slide out of the distal end of the recess 92. Accordingly, the release member 52 may freely rotate about the longitudinal axis A. This allows the shield biasing member 35 to push the proximal-facing cam surface 99 of the release member 52 along the distal-facing cam surface 88 of the plunger guide 60, which in turn reduces the gap between the proximal-facing end surface 97 of the release member 52 and the distal-facing abutment surface 98 of the proximal end of the plunger guide 60 and ends with the proximal-facing end surface 97 striking or otherwise contacting the distal-facing abutment surface 98 to produce an audible signal indicative of the end of drug delivery.

[0095] Although the above embodiments use the shield biasing member 35 to provide the actuation energy required to generate an end-of-dose signal, alternative embodiments may utilize a biasing member separate from the shield biasing member 35 to achieve this purpose. In some such embodiments, this additional biasing member may have a distal end fixed relative to the housing 12 and a proximal end abutting the distal-facing surface of the release member 52. Thus, the biasing member may push away from the housing 12 to apply a biasing force to the release member 52 in the proximal direction. Additionally, this biasing member may operate independently of the plunger biasing member 50 and the shield biasing member 35.

[0096] The general configuration of the drug delivery device 10 has been described and will now be referred to Figures 9A to 12EA method of injection using the drug delivery device 10 will be described. As a preparatory step, the user may remove the drug delivery device 10 from any secondary packaging (such as a plastic bag and / or cardboard box). Also, as a preparatory step, the user may prepare the injection site, for example, by wiping the patient's skin with alcohol. Next, the user may pull down and remove the removable cap 19 from the front housing 25. As a result of this movement, the gripper 13 may pull and remove the sterile barrier 21 from the drug storage container 20. This may expose the insertion end 28 of the delivery member 16. However, at this stage, the insertion end 28 of the delivery member 16 will remain surrounded by the protective member 32, since the protective member 32 is arranged in the extended position. Next, the user may position the drug delivery device 10 on the injection site and then push the distal end of the protective member 32 against the injection site. The force applied by the user will overcome the biasing force of the guard biasing member 35 and the biasing force of the lock ring biasing member 51, causing the protective member 32 to retract into the opening 14 and move from the extended position to the retracted position in the proximal direction. During the retraction movement of the protective member 32, the delivery member 16 remains stationary relative to the housing 12.

[0097] The movement of the protective member 32 from the extended position to the retracted position may cause several actions to occur. Since the delivery member 16 remains stationary relative to the housing 12 during the retraction of the protective member 32, the insertion end 28 of the delivery member 16 is extended through the opening in the distal end of the protective member 32, piercing the patient's skin at the injection site and penetrating into the patient's subcutaneous tissue. Additionally, the retraction of the protective member 32 may also enable the drive mechanism 30 to expel the drug 22 from the drug storage container 20, as described below.

[0098] In the pre-delivery state before retracting the needle guard 32, the plunger 26 and the release member 52 may each be arranged in their respective initial rotational positions, as Figures 9A to 9E shown. Here, the protrusion 48 of the top ring 45 of the plunger 26 may extend through the first opening 82 in the plunger guide 60 and may be received in the recess 92 in the release member 52. Also, before the needle guard is retracted, the plunger biasing member 50 may be in an energized state. Thus, the plunger biasing member 50 may apply a distally directed biasing force to the plunger 26 to advance the distally facing cam surface 49 on the protrusion 48 along the proximally facing cam surface 84 of the plunger guide 60. The resulting cam action may advance the plunger 26 towards Figure 9A and Figure 9EClockwise rotation. In some embodiments, the plunger 26 can also be advanced in rotation due to the guard biasing member 35 pushing the proximal-facing cam surface 99 of the release member 52 against the distal-facing cam surface 88 of the plunger guide 60. Despite these (multiple) biasing forces, neither the release member 52 nor the plunger 26 can rotate in the pre-delivery state. This is because as Figure 9D shown, each radially outwardly extending protrusion 94 on the outer portion of the release member 50 abuts a corresponding radially inwardly extending protrusion 96 on the inner portion of the guard extension 37. Since the guard biasing member 37 is rotationally fixed relative to the housing 12, the abutting engagement of the protrusions 94 and 96 prevents the release member 52 from rotating. Since the protrusion 48 is received within the recess 92 of the release member 52, this in turn prevents the plunger 26 from rotating. The inability of the plunger 26 to rotate means that the protrusion 48 cannot slide out of the first opening 82 into the second opening 86, in which the protrusion 48 is free to linearly translate in the distal direction. Accordingly, the release member 52, the plunger guide 60, the guard extension 37, and the housing 12 cooperate with each other to hold the plunger biasing member 50 in the actuated state before retracting the guard member 32.

[0099] When the guard member 32 moves from the extended position to the retracted position, the guard member 32 can push the guard extension 37 from the Figure 9C position shown in the proximal direction to the Figure 10C position shown. During the proximal movement of the guard extension 37, the protrusions 96 and 98 can slide past each other until finally the protrusions 96 and 98 no longer contact each other ( Figure 10C and Figure 10D ). At this time, the release member 52 can freely rotate about the longitudinal axis A. At the current stage, the rotation of the release member 52 is caused by the plunger biasing member 50 expanding and pushing the distal-facing cam surface 49 of the protrusion 48 along the proximal-facing cam surface 84 of the plunger guide 60, as Figure 10A and Figure 10Bas shown. The resulting cam action causes the projection 48 to rotate, which in turn causes the release member 52 to rotate together as the projection 48 is received within the recess 92. During this rotational movement, the plunger 26 linearly translates in the distal direction and the release member 52 linearly translates in the proximal direction. The distal translation of the plunger 26 is due to the downwardly angled cam surface 84 of the proximally facing cam surface of the plunger guide 60 along which the projection 48 of the plunger 26 slides under the action of the distally directed biasing force of the plunger biasing member 50. The proximal translation of the release member 52 is due to the proximally directed biasing force exerted on the release member 52 by the guard biasing member 35. In some embodiments, during the proximal translation of the release member 52, the proximally facing cam surface 99 of the release member 52 may slide on the distally facing cam surface 88 of the plunger guide 60.

[0100] In some embodiments, the cam action between the distally facing cam surface 49 on the projection 48 and the proximally facing cam surface 84 of the plunger guide 60 may provide a damping effect. More specifically, the sliding friction between these two surfaces may be selected to slow the initial expansion of the plunger biasing member 50. Accordingly, the velocity of the plunger 26 may be reduced during the initial expansion of the plunger biasing member 50 compared to the unconstrained expansion of the plunger biasing member 50. The reduced velocity of the plunger 26 may cause the plunger 26 to strike the stopper 24 with a lesser force, which reduces the chance of structural damage to the drug storage container 20 and / or contributes to a more comfortable injection for the user.

[0101] The combined rotation of the release member 52 and the plunger 26 may continue until the projection 48 slides out of engagement with the proximally facing cam surface 84 of the plunger guide 60, see Figure 11A and Figure 11B . Here, the projection 48 has moved out of the first opening 82 and into the second opening 86. The sidewalls of the second opening 86 may slidably and snugly receive the projection 48 such that there is little or no rotational play therebetween. Accordingly, when the projection 48 is received within the second opening 86, the projection 48 and the remainder of the plunger 26 may be prevented from rotating. Since the end of the projection 48 is still received within the recess 92 of the release member 52, the release member 52 may also be prevented from rotating at the current stage. The second opening 86 does not inhibit the linear movement of the projection 48. Accordingly, the projection 48 and the remainder of the plunger 26 are driven in the distal direction linearly by the expanded plunger biasing member 50. Accordingly, the base 47 of the plunger 26 contacts the stopper 24 and thereafter pushes the stopper 24 in the distal direction to expel the drug 22 from the drug storage container 20 through the delivery member 16 and out of the insertion tip 28 into the tissue of the patient.

[0102] Drug delivery can continue until the plug 24 reaches the end-of-dose position. Here, the plug 24 can abut the inner surface 15 of the wall of the drug storage container 20 facing the proximal portion. Accordingly, the plunger 26 stops moving in the distal direction. Simultaneously or substantially simultaneously with the plug 24 reaching the end-of-dose position, the projection 48 can slide out of the recess 92 in the release member 52, as Figure 12B shown. Accordingly, the release member 52 can then rotate freely about the longitudinal axis A. At the current stage, the rotation of the release member 52 is caused by the expansion of the guard biasing member 35 and the pushing of the proximally facing cam surface 99 of the release member 52 to slide on the distally facing cam surface 88 of the plunger guide 60. The resulting cam action causes the release member 52 to rotate in the proximal direction and translate linearly. This movement can continue until the proximally facing end surface 97 of the release member 52 impacts the distally facing abutment surface 98 of the proximal end of the plunger guide 60( Figure 12E ). This impact can generate an audible signal to indicate to the user that drug delivery is complete.

[0103] In the case of some confirmation of the completion of drug delivery, the user can lift the drug delivery device 10 away from the injection site. In the absence of any resistance, the guard biasing member 35 can push the guard member 32 from the retracted position to the extended position to cover the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 can cause the locking ring 40 to rotate to a position that will prevent the guard member 32 from subsequently retracting.

[0104] From the above, it can be seen that the present disclosure advantageously provides a streamlined design for a drug delivery device with automated features. The various mechanisms and components of the drug delivery device can interact with each other in a synergistic manner to limit the number of moving parts required for the drug delivery device, thereby improving the reliability of the drug delivery device and saving costs, as well as providing other benefits and advantages.

[0105] The drug delivery device described herein can have a variety of external form factors, depending on, for example, the needs and / or preferences of the user and / or manufacturer. Figures 13 to 16 An embodiment of a drug delivery device 110 is shown that has the same or similar internal components as the drug delivery device 10 described above, but has a different external form factor. Features of the drug delivery device 110 that are functionally similar to those included in the drug delivery device 10 are assigned the same reference numerals, but increased by 100.

[0106] The drug delivery device 110 includes a housing or casing 112 having a generally elongated shape extending along a longitudinal axis. At most or all positions along the longitudinal axis, the casing 112 may have a circular cross-section such that the casing 112 has a generally cylindrical shape. A recess having a transparent or translucent inspection window 117 may be located in the wall of the casing 112 to permit a user to view the components (including, for example, a drug storage container) inside the drug delivery device 110. At the distal end of the casing 112, a removable cap 119 may cover an opening in the casing 112. The interior of the removable cap 119 may include a gripping member configured to assist in removing a sterile barrier (e.g., a rigid needle sheath (RNS) or a flexible needle sheath (FNS), etc.) from a delivery member (such as a needle) when the removable cap 119 is removed from the casing 112, as described above. The casing 112 and the removable cap 119 may each respectively have a plurality of ribs 105 and 107 formed on their outer surfaces to improve a user's ability to grip these components when pulling the casing and the removable cap apart. Each rib may extend completely or partially around the periphery of the casing 112 or the removable cap 119.

[0107] The circular cross-section of the casing 112 may cause it to roll easily on a surface when placed on its side. To inhibit or prevent such rolling, a portion or all of the removable cap 119 may have a non-circular cross-section. In Figures 13 to 16 the illustrated embodiment, the removable cap 119 has a distal end with a non-circular cross-section and a proximal end with a circular cross-section. Thus, as moving from the proximal end of the removable cap 119 to the distal end of the removable cap 119, the cross-section of the removable cap 119 gradually changes from a circular cross-section to a non-circular cross-section. In the illustrated embodiment, the distal end of the removable cap 119 generally takes the form of a square. In other embodiments, the non-circular cross-section may be rectangular, triangular, or any other polygonal or partially polygonal shape, provided that one or more sides of the removable cap 119 are flat or substantially flat to inhibit or prevent rolling. Additionally, the size of the non-circular cross-section of the distal end of the removable cap 119 may gradually increase as moving in the distal direction such that the farthest side portion of the distal end of the removable cap 119 has a larger cross-sectional area than the nearest side portion of the distal end of the removable cap 119. This configuration gives the distal end of the removable cap 119 a flared shape, which in turn may help a user grip the removable cap 119 and pull it away from the casing 112.

[0108] In some embodiments, the casing 112 and the removable cap 119 may each include corresponding anti-rotation features. When the removable cap 119 is in a storage position, these anti-rotation features may engage with each other to prevent or inhibit rotation of the removable cap 119 relative to the casing 112, as Figure 13As shown. In some embodiments, when the removable cap 119 is in the storage position, the anti-rotation feature of the housing 112 can be adjacent to and generally aligned with the anti-rotation feature of the removable cap 119. In Figures 13 to 16 the illustrated embodiment, the anti-rotation feature of the removable cap 119 is provided by an opening 108 formed in the tubular wall of the removable cap 119 at the proximal end of the removable cap 119; and the anti-rotation feature of the housing 112 is provided by an axial protrusion 109 extending distally from the distal end of the housing 112. The size of the opening 108 can be determined to cooperatively receive the radially-axially projecting portion 109 when the removable cap 119 is in the storage position. Due to this mating engagement, the removable cap 119 may not be able to rotate relative to the housing 112. This can be advantageous if a user attempts to twist the removable cap 119 when pulling it away from the housing 112. In some cases, rotation of the removable cap 119 may rotate a sterile barrier, such as an RNS or FNS, which in turn may cause the needle tip to pierce a seal member within the RNS or FNS. Thus, disposing the axial protrusion 109 within the opening 108 can prevent needle penetration, at least during the initial moments of cap removal. In alternative embodiments, the opening 108 can be formed in the wall of the housing 112, and the axial protrusion 109 can extend proximally from the proximal end of the removable cap 119.

[0109] Turning Figures 17A to 21 now, a number of different embodiments of a drug delivery device incorporating a braking member will be described. Figures 17A to 21 The various elements of the illustrated drug delivery device are similar in function and / or structure to the elements of the drug delivery device 10 described above in connection with Figures 1 to 12E The same reference numerals are assigned to such elements as Figures 1 to 12E used, but incremented by 100 or multiples thereof. The details of the structure and / or function that distinguish the Figures 17A to 21 illustrated embodiments from the Figures 1 to 12E embodiments in Figures 17A to 21 are discussed in detail below. Although they may not be shown in Figures 17A to 21 the components of the drug delivery device 10 or variants of these components can be included in the various drug delivery devices described in connection with

[0110] It is advantageous to include a braking member in at least a drug delivery device, where the distal end of the plunger is spaced from the proximal end of the stopper in a pre-delivery or storage state. As an example, Figure 17AShows 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., an axial distance). This gap may be, for example, the result of the drug storage container being filled with a certain volume of drug, design tolerances, and / or manufacturing considerations. Due to this gap, the plunger can be allowed to accelerate to a significant speed and impact the stopper with a significant force when the plunger biasing member is released. This can in turn generate a pulse or shock wave, which in some cases may damage or break the wall of the drug storage container, which may be made of glass, and / or startle the user. Additionally, in embodiments where the plunger biasing member is a spring, the output force of the plunger biasing member may be greatest at the initial moment after its release. Thus, the plunger can reach a significant speed before impacting the stopper.

[0111] The embodiments described below incorporate a braking member that is configured to resist movement of the plunger in the distal direction at least during a period of time when the plunger moves to reduce the initial gap between the plunger and the stopper. Compared to the speed of the plunger when the plunger biasing member is allowed to expand freely without obstruction, the speed of the plunger can be reduced during the initial expansion of the plunger biasing member due to the resistance provided by the braking member. The reduction in the speed of the plunger has the effect of limiting the amount of force with which the plunger impacts the stopper, which in turn reduces the likelihood of structural damage to the drug storage container and can also facilitate a more comfortable injection for the user or patient. In some embodiments, the braking member can stop resisting movement of the plunger at the same time or almost at the same time as the plunger impacts the stopper; while in other embodiments, the braking member can continue to resist movement of the plunger in the distal direction after the plunger impacts the stopper (including, for example, throughout the entire plunger stroke). In some embodiments, the braking member can be operatively (e.g., interactively) coupled to the plunger such that movement of the plunger in the distal direction causes the plunger and / or the braking member to rotate about the longitudinal axis of the drug storage container and / or the housing of the drug delivery device. The force required to overcome the remaining rotational inertia of the plunger and / or the braking member and start the rotation can reduce the amount of force available to drive the plunger in the distal direction and thus can limit the speed of the plunger in the distal direction. Configured in this way, the braking member can operate like a damper because the braking member dissipates the kinetic energy associated with movement of the plunger in the distal direction. In some embodiments, the braking member can convert the linear movement of the plunger into heat and / or other forms of energy in addition to rotational movement.

[0112] Figure 17A and Figure 17BShows a drug delivery device 210 that includes a brake member 270 operatively coupled to a plunger 226. The brake member 270 can surround at least a portion of the plunger 226 and can have an annular shape, such as a ring, a hollow tube, etc. In some embodiments, the annular shape of the brake member 270 can be centered along a longitudinal axis A. The operative coupling between the brake member 270 and the plunger 226 can be such that movement of the plunger 226 in a distal direction along the longitudinal axis A causes the brake member 270 to rotate. As an example, the brake member 270 can be threadedly engaged with the plunger 226 such that relative axial movement between the plunger 226 and the brake member 270 causes the brake member 270 to rotate about the longitudinal axis A. As a more specific example, the brake member 270 can have a threaded inner surface 270a that engages a threaded outer surface 226a of the plunger 226, see Figure 17B . By requiring the plunger 226 to rotate the brake member 270 as the plunger 226 moves in the distal direction, the brake member 270 can resist movement of the plunger 226 in the distal direction. 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 can be such that the brake member 270 resists distal movement of the plunger 226 during the entire or substantially the 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 can be such that the brake member 270 resists distal movement of the plunger 226 during a limited portion of the stroke of the plunger 226, such as only during the portion of the stroke where the plunger 226 reduces the gap between the plunger 226 and the stopper 224.

[0113] To prevent the plunger 226 from rotating about the longitudinal axis A due to its interaction with the brake member 270, a spline connection can be formed between the plunger 226 and the housing 212. While the spline connection can prevent the plunger 226 from rotating, it can permit axial movement of the plunger 226. As an example, splines 274 can be formed on the outer surface of the proximal end of the plunger 226 and can mate with splines formed on the inner surface of the housing 212, or a component that is rotationally fixed relative to the housing 212.

[0114] Before delivery or in a stored state, the braking member 270 can be prevented from rotating, and thus, the plunger 226 can be prevented from moving in the distal direction under the biasing force of the plunger biasing member 250 due to its threaded connection with the braking member 270. As an example, the drug delivery device 210 can include a lock 272 that selectively prevents the braking member 270 from rotating relative to the plunger 226 and / or the housing 212. As a more specific example, the drug delivery device 210 can include a lock 272 that has an initial position and a second position, in the initial position, the lock 272 prevents the braking member 270 from rotating (see Figure 17A and Figure 17B ), in the second position, the lock 272 does not prevent the braking member 270 from rotating. In some embodiments, the lock 272 can be a rotary lock. In some embodiments, the lock 272 can travel in the proximal direction when moving from the initial position to the second position. Additionally or alternatively, the lock 272 can deflect radially outward when moving from the initial position to the second position. In some embodiments, such deflection can be achieved by constructing the lock 272 from an elastic (e.g., resilient) material that naturally returns to its original shape after removal of a separate blocking member and / or bends due to a cam action between the lock 272 and the plunger 226 when the plunger moves in the distal direction under the biasing force of the plunger biasing member 250.

[0115] In some embodiments, the lock 272 can be operably coupled to the protective member 232 such that movement of the protective member 232 from the extended position to the retracted position moves the lock 272 from the initial position to the second position, thereby unlocking the rotation of the braking member 270 and thus permitting the plunger biasing member 250 to expand axially to drive the plunger 226 in the distal direction to expel the drug from the drug storage container 220.

[0116] According to some embodiments, the drug delivery device 210 may operate as follows. Initially (e.g., prior to delivery or in a stored state), the lock 272 may be disposed in its initial position such that the lock 272 prevents the brake member 270 from rotating. At this time, the plunger biasing member 250 may urge the plunger 226 in the distal direction; however, due to the threaded engagement between the plunger 226 and the currently rotationally locked brake member 270, the plunger 226 may be prevented from moving in the distal direction. Subsequently, the user may press the distal end of the protective member 232 against the injection site of the skin. This may cause the protective member 232 to retract into the housing 212, moving from the extended position to the retracted position. Due to this movement, the protective member 232 may push the lock 272 in the proximal direction such that the lock 272 moves from the initial position to the second position. In the second position, the lock 272 may disengage from the brake member 270 such that the brake member 270 is free to rotate. Then, the plunger biasing member 250 begins to expand, thereby pushing the plunger 226 in the distal direction to reduce the gap between the plunger 226 and the stopper 224. Due to the threaded connection between the plunger 226 and the brake member 270, the distal translation of the plunger 226 causes the brake member 270 to rotate while the plunger 226 moves to reduce the gap between the plunger 226 and the stopper 224. The rotation of the brake member 270 absorbs a portion of the kinetic energy output by the plunger biasing member 250, leaving less kinetic energy to drive the plunger 226 in the distal direction. Thus, at least at the moment when the distal end of the plunger 226 impacts the proximal end of the stopper 224, the speed of the plunger 226 in the distal direction is less than the case where the brake member 270 is not included. After contact with the stopper 224, the plunger biasing member 250 may push the plunger 226 in the distal direction, whereby the stopper 224 moves the drug out of the drug storage container 220, through the delivery member (e.g., the needle), and into the patient's body. The brake member 270 may continue to rotate after the plunger 226 contacts the stopper 224, but this is not necessary.

[0117] Figure 18A and Figure 18B An embodiment of a drug delivery device 310 is shown, which is similar in structure and / or function to Figure 17A and Figure 17B the drug delivery device 210 in Figure 18A and Figure 18B Details of the structure and / or function that distinguish the drug delivery device 310 in Figure 17A and Figure 17B from the drug delivery device 210 in

[0118] The drug delivery device 310 includes a plunger 326 and a brake member 370, which are operatively coupled to each other such that when the plunger 326 moves in the distal direction, the brake member 370 causes the plunger 326 to rotate. As an example, the brake member 370 may have an internal threaded surface 370a that engages an external threaded surface 326a at the proximal end of the plunger 326, see Figure 18B . The brake member 370 may be rotationally fixed relative to the housing 312 such that the brake member 370 is prevented from rotating about the longitudinal axis A. In some embodiments, the brake member 370 may be part of the housing 312, such as a rear cover member of the housing 312. Since the brake member 370 does not rotate, the threaded connection between the brake member 370 and the plunger 326 causes the plunger 326 to rotate when the plunger 326 moves in the distal direction. The rotation of the plunger 326 absorbs a portion of the kinetic energy output by the plunger biasing member 350, leaving less kinetic energy to drive the plunger 326 in the distal direction. Accordingly, the speed of the plunger 326 in the distal direction is less than in the case where the brake member 370 is not included. After the plunger 326 has moved a certain distance in the distal direction, the external threaded surface 326a of the plunger 326 can no longer contact the internal threaded surface 370a of the brake member 370. Once this occurs, the plunger 326 can stop rotating. In some embodiments, the axial length of the internal threaded 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. Accordingly, the plunger 326 can stop rotating at the same time or almost at the same time as the plunger 326 impacts the stopper 324.

[0119] In some embodiments, the plunger biasing member 350 may rotate with the plunger 326. In such embodiments, the proximal end of the plunger biasing member base 338 (which may contact 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 base 338 may be rotatably coupled to the brake member 370 and / or the rear housing 327 such that the plunger biasing member base 338 is capable of rotating 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 base 338 may rotate together as a unit when the plunger 326 rotates due to the threaded connection between the plunger 326 and the brake member 370.

[0120] The brake member 370 may be coupled to the proximal end of the shield biasing member 335. As an example, the proximal end of the shield biasing member 335 may be seated against the brake member 370, see Figure 18B . As a more specific example, the shield biasing member 335 may surround the distal end of the brake member 370, and the shield biasing member 335 may have a proximal end that is seated against a flange that extends radially outward from the brake member 370, seeFigure 18B .

[0121] The drug delivery device 310 can further include a lock 370. The lock 370 can be similar to the lock 270 described above, except that the lock 370 prevents the plunger 326 from rotating before delivery or in a storage state. In the absence of rotation, the plunger 326 can be prevented from moving in a distal direction due to the threaded connection between the plunger 326 and the brake member 370. Accordingly, the lock 370 can prevent drug delivery until the lock 370 is disengaged from the plunger 326, which can occur in response to the retraction of the guard member 332. The lock 370 can be disposed between the guard biasing member 335 and the guard member 332, see Figure 18B The guard biasing member 335 can urge the lock 370 in the distal direction, and the lock 370 can in turn urge the guard member 332 toward the extended position.

[0122] Figure 19A and Figure 19B An embodiment of a drug delivery device 410 is shown that is similar in structure and / or function to Figure 18A and Figure 18B The drug delivery device 310 in FIG. Figure 19A and Figure 19B The drug delivery device 410 and Figure 18A and Figure 18B Details of the structure and / or function of the drug delivery device 310 are provided.

[0123] The drug delivery device 410 may include a stop member 470 that is part of the rear housing 427 of the drug delivery device 410. As an example, the stop member 470 may be defined by an annular flange extending radially inwardly from the proximal end of the rear housing 427, see Figure 19B The inner surface of this flange may define a threaded inner surface 470 a of the brake member 470 .

[0124] The stop member 470 can be coupled to the proximal end of the guard biasing member 435. As an example, the proximal end of the guard biasing member 435 can be seated against the distally directed end surface of the stop member 470, see Figure 19B .

[0125] Although combined Figures 17A to 19B The above described embodiments utilize a brake member that engages with the outer portion of the plunger, but the following embodiments are combined with Figure 20 and Figure 21The described embodiments utilize a brake member that engages an interior portion of the plunger. Depending on the design of the drug delivery device, a brake member in this configuration can be advantageous. For example, in embodiments where the plunger is hollow and the plunger biasing member is at least partially disposed within the plunger, configuring the brake member to engage the interior portion of the plunger can allow the plunger to be designed with a larger diameter than might otherwise be possible. This can in turn allow for the use of a spring with a larger diameter for the plunger biasing member. A spring with a larger diameter can output more force when driving the plunger to expel the drug, which is advantageous for delivering viscous drugs, such as certain biologic drugs. Additionally, a spring with a larger diameter can allow for a reduction in the axial length of the spring without sacrificing the force output of the spring. A spring with a shorter axial length can facilitate a smaller and more compact design of the drug delivery device, which is desirable for handling, transportation, and / or storage purposes or other purposes.

[0126] Figure 20 An embodiment of a drug delivery device 510 is shown, which is structurally and / or functionally similar to Figure 19A and Figure 19B the drug delivery device 410 in Figure 20 The details of the structure and / or function that distinguish the drug delivery device 510 in Figure 19A and Figure 19B from the drug delivery device 410 in

[0127] The drug delivery device 500 can include a plunger 526 having a generally hollow tubular shape that defines an axial chamber. In some embodiments, the axial chamber can extend through the entire plunger 526 such that the proximal and distal ends of the plunger 526 each have an opening that communicates with the interior space of the plunger 526; while in other embodiments, the axial chamber can extend through a limited portion of the plunger 526 such that, for example, the distal end of the plunger 526 is closed.

[0128] The interior of the plunger 526 can be configured to receive the plunger biasing member 550 and also interface with a brake member 570. As an example, the proximal end of the plunger 526 can define a guide 574, while the distal end of the plunger 526 can define a nut 576. As Figure 20As shown, the inner diameter or other dimension of the guide 574 can be greater than the inner diameter or other dimension of the nut 576. The plunger biasing member 550 can be at least partially disposed within the guide 574 and have a distal end that seats and / or pushes against the proximal-facing surface 578 of the nut 576. An annular bearing 580 can be disposed between the distal end of the plunger biasing member 550 and the proximal-facing surface 578 of the nut 576 and can be configured to permit rotation of the plunger 526 relative to the plunger biasing member 550 during axial expansion of the plunger biasing member 550. In some embodiments, the annular bearing 580 can include a washer. In other embodiments, the annular bearing 580 can be omitted and the distal end of the plunger biasing member 550 can contact the proximal-facing surface 578 of the nut 576 directly. The nut 576 can have a threaded inner surface 526a that, as described in more detail below, threadedly engages the threaded outer surface 570a of the brake member 570. In Figure 20 the illustrated embodiment, the distal end of the nut 576 has an opening. In some embodiments, a plug can be disposed in this opening and can have a distal end that is configured to be received in a recess formed in the proximal end of the plug.

[0129] In some embodiments, the guide 574 and the nut 576 can be integrally formed to define a single unitary structure. In other embodiments, the guide 574 and the nut 756 can be separate structures that are fixed to each other. In certain such embodiments, the guide 574 and the nut 576 can be made of different materials. For example, the guide 574 can be made of metal while the nut 576 can be made of plastic, or vice versa. In some embodiments, the entire plunger 526 (including the guide 574 and the nut 576) can be made of a single material, such as metal, plastic, or any other suitable material.

[0130] The brake member 570 can be operatively coupled to the nut 576 such that the brake member 570 resists movement of the plunger 526 in the distal direction during at least an initial portion of the stroke of the plunger 526. As an example, the brake member 570 can include a rod or other elongate member having a proximal end fixed to the rear housing 527 and a distal end that threadedly engages the nut 576. As a more specific example, the brake member 570 can extend through the axial chamber of the plunger 526 and have a distal end that includes a threaded outer surface 570a that threadedly engages the threaded inner surface 526a of the nut 576, see Figure 20Due to the threaded connection between the braking member 570 and the nut 576 of the plunger 526, when the plunger 526 moves in the distal direction, the braking member 570 can cause the plunger 526 to rotate about the longitudinal axis A. By requiring the plunger 526 to rotate, the braking member 570 can resist the movement of the plunger 526 in the distal direction and thus reduce the speed of the plunger 526 in the distal direction compared to when the braking member 570 is omitted.

[0131] Prior to delivery or in the stored state (see Figure 20 ), the plunger 526 can be prevented from moving in the distal direction under the biasing force of the plunger biasing member 550. As an example, the drug delivery device 510 can include a lock 572 having an initial position ( Figure 20 ) and a second position, in which the lock 572 prevents the plunger 526 from moving in the distal direction, and in the second position, the lock 572 does not prevent the plunger 526 from moving in the distal direction. As a more specific example, the lock 572 can include one or more arms 582 that generally extend radially inwardly, which are received in one or more corresponding recesses 584 formed in the outer surface of the plunger 526 prior to delivery or in the stored state. The one or more radially inwardly extending arms 582 can be prevented from deflecting radially outwardly by a trigger ring 586 that surrounds the radially inwardly extending arms 582 prior to delivery or in the stored state. The trigger ring 586 can be operatively coupled to a protective member (e.g., protective member 32) such that when the protective member is retracted in the proximal direction, the trigger ring 586 also moves in the proximal direction and thus no longer prevents the radially inwardly extending arms 582 from deflecting outwardly. In some embodiments, such deflection can be achieved by forming the radially inwardly extending arms 582 from an elastic (e.g., elastomeric) material that naturally returns to its original shape when the trigger ring 586 moves away from Figure 20 the shown blocking position and / or bends due to the cam action between the radially inwardly extending arms 582 and the corresponding recesses 584 of the plunger 526 when the plunger 526 is moved in the distal direction by the plunger biasing member 550. In some embodiments, the trigger ring 586 can be part of the protective member; while in other embodiments, the trigger ring 586 can be separate from the protective member.

[0132] According to some embodiments, the drug delivery device 510 can be operated as follows. Initially (e.g., prior to delivery or in the stored state), the lock 572 can be arranged in its initial position such that the radially inwardly extending arms 582 are received in the corresponding recesses 584 in the plunger 526 and are prevented from deflecting radially outwardly by the trigger ring 586, as Figure 20As shown. 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 can press the distal end of the guard member against the injection site on the skin. This can cause the guard member to retract proximally into the housing and thereby push the trigger ring 586 proximally away from its initial blocking position. Accordingly, the radially inwardly extending arm 582 can be radially outwardly biased out of its respective recess 584. Subsequently or simultaneously, the plunger 526 can 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. Due to this rotation, the plunger 526 moves distally at a slower speed than would be the case if the rotation of the plunger 526 were not required due to the interaction between the plunger 526 and the brake member 570. The plunger 526 can continue to rotate 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 can stop simultaneously with or almost simultaneously with the plunger 526 hitting the stopper disposed in the drug delivery container 520.

[0133] In Figure 20 In the illustrated embodiment, 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 can be fixed to the distal end of the guide 574 such that the nut 576 is disposed within the internal space of the guide 574 together with the plunger biasing member 550. This can reduce the total axial length of the plunger 526. In such an alternative embodiment, the distal end of the guide 574 can include a transverse wall that is 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 can define a base for the distal end of the plunger biasing member 550.

[0134] Figure 21 An embodiment of a drug delivery device 610 is shown that is structurally and / or functionally similar to Figure 20 the drug delivery device 510 of Figure 21 Details of the structure and / or function that distinguish the drug delivery device 610 of Figure 20 from the drug delivery device 510 of

[0135] Regarding Figure 21In the illustrated embodiment, the plunger 626 can include a guide 674 and a central rod 690. The guide 674 can have a hollow tubular shape with an open proximal end and a distal end closed by a transverse wall 692. The transverse wall 692 can be perpendicular or substantially perpendicular to the longitudinal axis A and can define a base for the distal end of the plunger biasing member 650. The central rod 690 can have a distal end fixed to the transverse wall 692 such that the central rod 690 and the guide 674 translate together and rotate together. The central rod 690 can extend proximally from the transverse wall 692 through the interior space of the guide 674. The proximal end of the central rod 690 can be arranged adjacent to the opening in the proximal end of the guide 674 and, in some embodiments, can extend beyond the opening formed in the proximal end of the guide 674 or alternatively be disposed within the proximal end of the guide 674.

[0136] As Figure 21 shown, the braking member 670 can be fixed to the rear housing 627. The braking member 670 can have a generally annular shape and can surround the proximal end of the central rod 690. Additionally, the threaded inner surface 670a of the braking member 670 can threadedly engage the threaded outer surface 626a of the proximal end of the central rod 690. Due to this threaded connection, movement of the plunger 626 (including its central rod 690) in the distal direction can cause the plunger 626 to rotate. As long as the threaded outer surface 626a of the central rod 690 remains in contact with the threaded inner surface 670a of the braking member 670, the plunger 626 can continue to rotate. In some embodiments, rotation of the plunger 626 can stop simultaneously or almost simultaneously with the plunger 626 striking the stopper in the drug storage container 620.

[0137] Prior to delivery or in the stored state (see Figure 21 ), the plunger 626 can be prevented from moving in the distal direction under the biasing force of the plunger biasing member 650. As an example, the drug delivery device 610 can include a lock 672 that has an initial position ( Figure 21) and a second position. In the initial position, the lock 672 prevents the plunger 626 from moving in the distal direction. In the second position, the lock 672 does not prevent the plunger 626 from moving in the distal direction. As a more specific example, the lock 672 can include: a proximal end fixed to the rear housing 627; and a distal end having an initial position and a second position radially outward of the initial position. In the initial position, the distal end is secured to the proximal end of the guide 674, thereby preventing the plunger 626 from moving distally. In the second position, the distal end does not contact the proximal end of the guide 674, thereby allowing the plunger 626 to move distally. The distal end of the lock 672 can be operatively coupled to the protective member 632 such that when the protective member 632 is retracted in the proximal direction, the protective member 632 can act directly or indirectly on the distal end of the lock 672 to translate it from the initial position to the second position. In some embodiments, this movement of the distal end of the lock 672 can be the result of a cam action between the distal end of the lock 672 and the proximal end of the protective member 632. When the lock 672 is in the second position, the plunger biasing member 650 can be allowed to expand, thereby driving the plunger 626 in the distal direction, which in turn causes the plunger 626 to rotate during at least a portion of the plunger stroke due to the threaded connection between the plunger 626 and the brake member 670.

[0138] While the embodiments described above in connection with Figures 17A to 21 use a threaded connection between the plunger and the brake member to create relative rotation between the plunger and the brake member during axial translation of the plunger, other embodiments can achieve this via other means. For example, the plunger and the brake member can 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. Additionally, in some embodiments, resistance to distal movement of the plunger can be achieved via an air damper operatively coupled to the plunger. In certain such embodiments, the plunger may not rotate when moving in the distal direction.

[0139] It will be appreciated that the apparatus and methods according to the present disclosure can have one or more advantages over conventional techniques, any one or more of which can be present in a particular embodiment that complies with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein can also be appreciated.

[0140] The foregoing description has described various devices, components, parts, subsystems, and methods for use in connection with a drug delivery device. The device, component, part, subsystem, method, or drug delivery device may further include a drug or be used with a drug, which drugs include but are not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including conventional and non-conventional drugs, nutraceuticals, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generics. Also included are non-therapeutic injectable materials. The drug may be in liquid form, in lyophilized form, or in a form that can be reconstituted from a lyophilized form. The following exemplary drug list should not be considered inclusive or restrictive.

[0141] The drug will be contained in a reservoir. In some cases, the reservoir is the primary container, which is filled or pre-filled with the drug for treatment. The primary container may be a vial, a cartridge, or a pre-filled syringe.

[0142] In some embodiments, the reservoir of the drug delivery device may be filled with a colony-stimulating factor (such as granulocyte colony-stimulating factor (G-CSF)), or the device may be used with a colony-stimulating factor. Such G-CSF agents include but are not limited to (pegfilgrastim, pegylated filgrastim, pegylated G-CSF, pegylated hu-Met-G-CSF) and (filgrastim, G-CSF, hu-MetG-CSF), (pegfilgrastim-cbqv), (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0143] In other embodiments, the drug delivery device may contain an erythropoiesis-stimulating agent (ESA) or be used with it, and the erythropoiesis-stimulating agent 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 (e.g., by binding and causing dimerization of the receptor). Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind and activate the erythropoietin receptor; antibodies that bind and activate the erythropoietin receptor; or peptides that bind and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include but are not limited to (epoetin alfa), Darbepoetin alfa Epoetin delta Methoxy polyethylene glycol-epoetin beta MRK-2578, INS-22 Epoetin zeta Epoetin beta Epoetin zeta Epoetin alfa, epoetin alfa Hexal Epoetin alfa Epoetin theta Epoetin theta Epoetin theta, epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0144] Specific illustrative proteins are the specific proteins described below, including their fusions, fragments, analogs, variants or derivatives: OPGL-specific antibodies, peptibodies, related proteins, etc. (also known as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully human monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that inhibit the activities mediated by the binding of IL-4 and / or IL-13 to the receptor; interleukin 1-receptor 1 (“IL1-R1”)-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly human CD22-specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22-specific IgG antibodies, such as the dimer of human-mouse monoclonal hLL2 γ-chain and human-mouse monoclonal hLL2 κ-chain linked by disulfide bonds, for example, the fully humanized antibody specific for human CD22 in epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor-specific antibodies, peptibodies and related proteins, etc., including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, etc. (“B7RP-1”, also known as B7H2, ICOS-L, B7h and CD275), including but not limited to fully human monoclonal IgG2 antibodies specific for B7RP, including but not limited to fully human IgG2 monoclonal antibodies that bind to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., such as particularly humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibody and related proteins, such as for example 145c7; IFNγ-specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone (“PTH”)-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor (“TPO-R”)-specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor (“HGF”)-specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF);TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; Activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; Amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; (Alteplase, tPA); (Darbepoetin alfa) Erythropoietin [30 - asparagine, 32 - threonine, 87 - valine, 88 - asparagine, 90 - threonine], darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); (Epoetin alfa, or erythropoietin); GLP-1, (Interferon beta-1a); (Tositumomab, anti-CD22 monoclonal antibody); (Interferon-β); (Alemtuzumab, anti-CD52 monoclonal antibody); (Epoetin delta); (Bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); (Etanercept, TNF receptor / Fc fusion protein, TNF blocker); (Epoetin alfa); (Cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Growth hormone, human growth hormone); (Trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti for the treatment of breast cancer or gastric cancer TM (Trastuzumab-anns) Anti-HER2 monoclonal antibody, biosimilar or another product containing trastuzumab; (Growth hormone, human growth hormone); (Adalimumab); (Panitumumab), (Denosumab), (Denosumab), human monoclonal antibody of immunoglobulin G2 against RANK ligand, (Etanercept, TNF-receptor / Fc fusion protein, TNF blocker), (Romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; (Interferon alfacon-1); (Nesiritide; Recombinant human B-type natriuretic peptide (hBNP)); (Anakinra); (Sargramostim, rhuGM-CSF); (Epratuzumab, anti-CD22 mAb); Benlysta TM (Lymphostat B, Belimumab, anti-BlyS mAb); (Tenecteplase, t-PA analog); (Methoxy polyethylene glycol-epoetin beta); (Gemtuzumab ozogamicin); (Efalizumab); (Certolizumab, CDP 870); Soliris TM (Eculizumab); Pexelizumab (anti-C5 complement); (MEDI-524); (Ranibizumab); (17-1A, Edrecolomab); (Lerdelimumab); TheraCim hR3 (Nimotuzumab); Omnitarg (Pertuzumab, 2C4); (IDM-1); (B43.13); (Visilizumab); Cantuzumab mertansine (huC242-DM1); (Epoetin beta); (Oprelvekin, human interleukin-11); Orthoclone (Muromonab-CD3, anti-CD3 monoclonal antibody); (Epoetin alpha); (Infliximab, anti-TNFα monoclonal antibody); (Abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); (Anti-IL6 receptor mAb); (Bevacizumab), HuMax-CD4 (Zanolimumab); Mvasi TM (Bevacizumab-awwb); (Rituximab, anti-CD20 mAb); (Erlotinib); (Interferon α-2a); (Basiliximab); (Lumiracoxib); (Palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); (Natalizumab, anti-α4 integrin mAb); (MDX-1303, anti-Bacillus anthracis protective antigen mAb); ABthrax TM ; (Omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); (Daclizumab); (Daclizumab, anti-IL-2Rα mAb); (Ibritumomab tiuxetan); (Ezetimibe); (atacicept, TACI-Ig); anti-CD80 mAb (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001);Anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).;

[0145] In some embodiments, the drug delivery device may comprise or be used in combination with a sclerostin antibody for treating osteoporosis and / or fracture healing in postmenopausal women, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity TM (romosozumab-aqqg), another product comprising romosozumab, and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include but are not limited to (evolocumab) and (alirocumab). In other embodiments, the drug delivery device may comprise rituximab, bixalomer, trebananib, ganitumab, canakinumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab or be used in combination therewith. In some embodiments, the reservoir of the drug delivery device may be filled with (talimogene laherparepvec) or another oncolytic HSV, or the device may be used in combination therewith, and such other oncolytic HSVs include but are not limited to OncoVEXGALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may comprise or be used in combination with an endogenous tissue inhibitor of metalloproteinase (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may comprise (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product comprising erenumab or used therewith. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as but not limited to erenumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets can also be delivered using the drug delivery devices disclosed herein. In addition, bispecific T cell engagers antibodies (such as but not limited to (blinatumomab)) can be used in or with the drug delivery devices disclosed herein. In some embodiments, the drug delivery device can comprise or be used with an APJ macromolecule agonist, such as but not limited to apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery devices disclosed herein. In some embodiments, the drug delivery device can comprise or be used with AvsolaTM (infliximab-axxq), an anti-TNFα monoclonal antibody, a (infliximab) (Janssen Biotech, Inc.) biosimilar or another product comprising infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device can comprise or be used with (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxirane-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamide)-4-methylpentanamide, or another product comprising carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device can comprise or be used with (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product comprising apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device can comprise or be used with Parsabiv TM (etelcalcetide HCl, KAI-4169) or another product comprising etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device can comprise ABP 798 (rituximab), / MabThera TM a biosimilar candidate drug, or another product containing an anti-CD20 monoclonal antibody or used therewith. In some embodiments, the drug delivery device may comprise a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or VEGF-Trap (such as aflibercept (the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)) or used therewith. In some embodiments, the drug delivery device may comprise ABP 959 (eculizumab), a biosimilar candidate drug, or another product containing a monoclonal antibody that specifically binds to complement protein C5 or used therewith. In some embodiments, the drug delivery device may comprise rozibafusp alfa (previously AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOS-L and BAFF activities, or used therewith. In some embodiments, the drug delivery device may comprise omecamtiv mecarbil (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile mechanism, or another product containing a small molecule selective cardiac myosin activator or used therewith. In some embodiments, the drug delivery device may comprise sotorasib (previously known as AMG 510), a KRAS G12C small molecule inhibitor, or another product containing a KRAS G12C small molecule inhibitor or used therewith. In some embodiments, the drug delivery device may comprise tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP or used therewith. In some embodiments, the drug delivery device may comprise 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) or used therewith. In some embodiments, the drug delivery device may comprise 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) or used therewith. In some embodiments, the drug delivery device may comprise ABP 654 (a human IgG1κ antibody), a biosimilar candidate drug, or another product containing a human IgG1κ antibody and / or that binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23 or used therewith. In some embodiments, the drug delivery device may comprise AmjevitaTM or Amgevita TM (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate drug, or another product comprising human mab anti-TNF human IgG1 or used therewith. In some embodiments, the drug delivery device can comprise AMG 160, or another product comprising a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 (bispecific T cell engager) construct or used therewith. In some embodiments, the drug delivery device can comprise AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or used therewith. In some embodiments, the drug delivery device can comprise AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or used therewith. In some embodiments, the drug delivery device can comprise AMG 133, or another product comprising a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist or used therewith. In some embodiments, the drug delivery device can comprise AMG 171 or another product comprising a growth differentiation factor 15 (GDF15) analogue or used therewith. In some embodiments, the drug delivery device can comprise AMG 176 or another product comprising a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) or used therewith. In some embodiments, the drug delivery device can comprise AMG199 or another product comprising a half-life extended (HLE) bispecific T cell engager construct or used therewith. In some embodiments, the drug delivery device can comprise AMG 256, which is designed to selectively turn on the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells, or another product (comprising an anti-PD-1xIL21 mutant protein and / or an IL-21 receptor agonist) or used therewith. In some embodiments, the drug delivery device can comprise AMG 330 or another product comprising an anti-CD33 x anti-CD3 (bispecific T cell engager) construct or used therewith. In some embodiments, the drug delivery device can comprise AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product (comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody) or used therewith. In some embodiments, the drug delivery device can comprise AMG 427 or another product comprising a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 Another product of the (bispecific T cell engager) construct or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 506 or another product (comprising a multispecific FAP x 4-1BB-targeting biological agent) or used in combination therewith that is being investigated for the treatment of solid tumors. In some embodiments, the drug delivery device may comprise AMG 509 or another product comprising a bivalent T cell engager or used in combination therewith, and is designed using the 2+1 technology. In some embodiments, the drug delivery device may comprise AMG 562 or another product comprising a half-life extended (HLE) CD19 xCD3 (bispecific T cell engager) construct or used in combination therewith. In some embodiments, the drug delivery device may comprise Efavaleukin α (formerly AMG 592) or another product comprising an IL-2 mutant protein Fc fusion protein or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 596 or another product comprising a CD3 x epidermal growth factor receptor vIII (EGFRvIII) (bispecific T cell engager) molecule or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 673 or another product comprising a half-life extended (HLE) anti-CD33 x anti-CD3 (bispecific T cell engager) construct or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 701 or another product comprising a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 (bispecific T cell engager) construct or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 757 or another product comprising a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 (bispecific T cell engager) construct or used in combination therewith. In some embodiments, the drug delivery device may comprise AMG 910 or another product comprising a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 (bispecific T cell engager) construct used in combination therewith.

[0146] Although drug delivery devices, components, parts, subsystems, and methods have been described in accordance with exemplary embodiments, they are not limited thereto. This detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the disclosure. Many alternative embodiments can be implemented using current technology or technology developed after the filing date of this patent application, and such embodiments still fall within the scope of the claims defining the invention disclosed herein.

[0147] Those of ordinary skill in the art will appreciate that various modifications, changes, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and such modifications, changes, and combinations are considered to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: a housing having an opening; a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening; a guard member movably positioned adjacent to the opening; a plunger movable in a distal direction to expel drug from the drug storage container through the delivery member; a plunger biasing member; and a release member operatively coupled to the guard member and the plunger, wherein the release member is configured to rotate from an initial rotational position to a second rotational position under a biasing force applied by the plunger biasing member.

2. The drug delivery device according to claim 1, wherein The guard member has an extended position and a retracted position, in which the guard member at least partially extends through the opening in the housing, and in which the guard member is positioned away from the extended position towards the housing.

3. The drug delivery device according to claim 2, wherein, When the guard member is in the extended position, the release member is prevented from rotating from the initial rotational position towards the second rotational position, and wherein when the guard member is in the retracted position, the release member is allowed to rotate from the initial rotational position towards the second rotational position.

4. The drug delivery device according to any one of claims 2 or 3, wherein Moving the guard member from the extended position to the retracted position allows the release member and the plunger to rotate together from the initial rotational position to the second rotational position under a biasing force applied by the plunger biasing member.

5. The drug delivery device according to any one of claims 2 to 4, comprising a guard extension, wherein, The release member is at least partially disposed within the guard member extension.

6. The drug delivery device according to claim 5, comprising a first protrusion extending outwardly from the release member and a second protrusion extending inwardly from the shield extension, wherein, The first protrusion and the second protrusion engage with each other to retain the release member in the initial rotational position.

7. The drug delivery device according to claim 6, wherein, When the guard member is in the retracted position, the second protrusion slides out of engagement with the first protrusion to allow the release member to rotate away from the initial rotational position towards the second rotational position.

8. The drug delivery device according to any one of claims 5 to 7, wherein, The guard member extension is separate from the guard member, and when the guard member moves from the extended position to the retracted position, the guard member acts on the guard member extension.

9. The drug delivery device according to any one of claims 1 to 8, wherein, The release member is configured to linearly translate in a proximal direction when rotating from the initial rotational position to the second rotational position.

10. The drug delivery device according to any one of claims 1 to 9, wherein, The release member is configured to selectively rotate from the second rotational position to a third rotational position.

11. The drug delivery device according to claim 10, wherein, The release member and the plunger rotate together from the initial rotational position towards the second rotational position, and wherein the release member rotates independently of the plunger from the second rotational position towards the third rotational position.

12. The drug delivery device according to any one of claims 10 or 11, wherein The release member is configured to linearly translate in the proximal direction when rotating from the second rotational position towards the third rotational position.

13. The drug delivery device according to any one of claims 10 to 12, wherein, The release member contacts the housing or a structure fixed relative to the housing after reaching the third rotational position to generate an audible signal.

14. The drug delivery device according to any one of claims 1 to 13, comprising a third protrusion extending outwardly from the plunger and received in a recess formed in the release member.

15. The drug delivery device according to claim 14, wherein, When the release member is in the initial rotational position, the third protrusion is prevented from sliding through the recess, and wherein when the release member is in the second rotational position, the third protrusion is allowed to slide through the recess in the distal direction.

16. The drug delivery device according to any one of claims 1 to 15, comprising a plunger guide fixed relative to the housing, wherein, The plunger is at least partially disposed within the plunger guide.

17. The drug delivery device according to claim 16, wherein, One of the plunger and the plunger guide includes a cam, and the other of the plunger and the plunger guide includes a cam follower.

18. The drug delivery device according to claim 17, wherein, The biasing force of the plunger biasing member biases the cam follower against the cam to urge the plunger to rotate from the initial rotational position towards the second rotational position.

19. The drug delivery device according to claim 18, wherein, The plunger includes the cam follower, and the plunger guide includes the cam, and wherein the cam follower is formed by at least one protrusion extending outward from the plunger.

20. The drug delivery device according to claim 19, wherein, The plunger guide includes an annular wall, and wherein the cam is formed by a surface of the annular wall facing proximally.

21. The drug delivery device according to claim 20, wherein, An opening is formed in the annular wall, away from the proximally facing surface, and wherein after the plunger rotates from the initial rotational position to the second rotational position, the opening slidably receives the protrusion.

22. The drug delivery device according to any one of claims 1 to 21, wherein, The plunger biasing member is at least partially disposed within the plunger.

23. The drug delivery device according to claim 22, wherein, The plunger biasing member includes a compression spring.

24. A drug delivery device, comprising: A housing having an opening; A drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening; A plunger; A plunger biasing member initially held in an actuated state, wherein releasing the plunger biasing member drives the plunger in a distal direction to expel drug from the drug storage container through the delivery member; And An indicator having an initial position and a second position, at the initial position, the indicator holds the plunger biasing member in the actuated state, and at the second position, the indicator generates an audible signal indicating the end of drug delivery.

25. The drug delivery device according to claim 24, wherein, The second position is close to the initial position.

26. The drug delivery device according to any one of claims 24 or 25, wherein, The indicator contacts the housing or a structure fixed relative to the housing after reaching the second position to generate an audible signal.

27. The drug delivery device according to any one of claims 24 to 26, comprising an indicator biasing member configured to bias the indicator in the proximal direction.

28. The drug delivery device according to claim 27, comprising a cam and a cam follower, wherein, The indicator includes the cam follower.

29. The drug delivery device according to claim 28, wherein, The biasing force of the indicator biasing member biases the cam follower against the cam to urge the indicator to rotate relative to the housing.

30. The drug delivery device according to claim 29, wherein, The indicator rotates relative to the housing and linearly translates in the proximal direction when moving from the initial position to the second position.

31. The drug delivery device according to any one of claims 28 to 30, wherein, The indicator is configured to rotate from the initial position to an intermediate position at least under the biasing force of the plunger biasing member.

32. The drug delivery device according to claim 31, wherein, When the indicator is in the initial position, the plunger is prevented from moving in the distal direction, and when the indicator is in the intermediate position, the plunger is allowed to move in the distal direction.

33. The drug delivery device according to any one of claims 31 or 32, wherein, The plunger rotates with the indicator from the initial position to the intermediate position.

34. The drug delivery device according to any one of claims 31 to 33, wherein, The indicator is configured to rotate from the intermediate position to the second position at least under the biasing force of the indicator biasing member.

35. The drug delivery device according to claim 34, wherein, The indicator is configured to rotate from the intermediate position to the second position independently of the plunger.

36. The drug delivery device according to claim 35, wherein, The indicator is configured to linearly translate in the proximal direction when rotating from the intermediate position towards the second position.

37. The drug delivery device according to any one of claims 24 to 36, comprising a shield movably positioned adjacent to the opening.

38. The drug delivery device according to claim 37, wherein, The shield has an extended position and a retracted position. In the extended position, the shield at least partially extends through the opening in the housing. In the retracted position, the shield is positioned away from the extended position towards the housing.

39. The drug delivery device according to claim 38, wherein, Moving the shield from the extended position to the retracted position allows the indicator to move at least partially from the initial position towards the second position.

40. A drug delivery device according to any one of claims 38 or 39, comprising a guard extension, wherein, The indicator is at least partially disposed within the shield extension.

41. The drug delivery device according to claim 40, comprising a first protrusion extending outwardly from the indicator and a second protrusion extending inwardly from the shield extension, wherein, The first protrusion and the second protrusion engage with each other to retain the indicator in the initial position.

42. The drug delivery device according to claim 41, wherein, When the shield is in the retracted position, the second protrusion slides out of engagement with the first protrusion to allow the indicator to rotate away from the initial position towards the second position.

43. The drug delivery device according to claim 42, comprising a shield biasing member configured to bias the shield in the distal direction and bias the indicator in the proximal direction.

44. A drug delivery device, comprising: a housing having an opening; a drug storage container including a delivery member having an insertion end configured to at least partially extend through the opening; a plunger having an inner surface defining an axial chamber; and a plunger biasing member at least partially disposed within the axial chamber of the plunger, the plunger biasing member being initially held in an energized state, wherein releasing the plunger biasing member drives the plunger in the distal direction to expel the drug from the drug storage container through the delivery member.

45. The drug delivery device according to claim 44, wherein, At least a portion of the plunger has a hollow tubular shape.

46. The drug delivery device according to any one of claims 44 or 45, wherein, The plunger has a proximal end and a distal end, the proximal end having at least one radially outwardly extending flange.

47. The drug delivery device according to claim 46, wherein, The distal end of the plunger has an inner surface defining a base for the plunger biasing member.

48. The drug delivery device according to any one of claims 46 or 47, wherein, The plunger has an intermediate portion between the proximal end and the distal end, wherein at least the intermediate portion is made of metal.

49. The drug delivery device according to any one of claims 48, wherein, The distal end of the plunger is made of a non-metallic material.

50. The drug delivery device according to any one of claims 44 to 49, wherein, The plunger is rotatable relative to the housing.

51. The drug delivery device according to any one of claims 44 to 50, wherein, The plunger is configured to: selectively rotate from an initial rotational position to a second rotational position under the biasing force applied by the plunger biasing member; and after rotating from the initial rotational position to the second rotational position, linearly translate in the distal direction under the biasing force applied by the plunger biasing member to expel the drug from the drug storage container.

52. The drug delivery device according to claim 51, wherein, The plunger is configured to linearly translate in the distal direction when rotating from the initial rotational position to the second rotational position.

53. The drug delivery device according to any one of claims 51 or 52, wherein, The plunger is rotationally fixed relative to the housing after rotating from the initial rotational position to the second rotational position.

54. The drug delivery device according to any one of claims 51 to 53, comprising a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide.

55. The drug delivery device according to claim 54, wherein, One of the plunger and the plunger guide includes a cam, and the other of the plunger and the plunger guide includes a cam follower.

56. The drug delivery device according to claim 55, wherein, The biasing force of the plunger biasing member biases the cam follower against the cam to urge the plunger to rotate from the initial rotational position toward the second rotational position.

57. The drug delivery device according to claim 56, wherein, The plunger includes the cam follower, and the plunger guide includes the cam, and wherein the cam follower is formed by at least one flange extending radially outward from the plunger.

58. The drug delivery device according to claim 57, wherein, The plunger guide includes an annular wall, wherein the cam is formed by the proximal-facing surface of the annular wall.

59. The drug delivery device according to claim 58, wherein, An opening is formed in the annular wall, remote from the proximal-facing surface, and wherein, after the plunger rotates from the initial rotational position to the second rotational position, the opening slidably receives the flange.

60. A drug delivery device according to any one of claims 54 to 59, comprising: A release member operably coupled to the plunger and configured to selectively rotate relative to the housing, wherein each of the plunger and the plunger guide is at least partially disposed within the release member; And A guard member movably positioned adjacent to an opening in the housing and operably coupled to the release member.

61. The drug delivery device according to claim 60, wherein, The guard member has a protruded position and a retracted position, in the protruded position, the guard member at least partially extends through the opening in the housing, and in the retracted position, the guard member is positioned away from the protruded position toward the housing.

62. The drug delivery device according to claim 61, wherein, When the guard member is in the protruded position, the release member is prevented from rotating in at least one rotational direction, and wherein, when the guard member is in the retracted position, the release member is allowed to rotate in the at least one rotational direction.

63. The drug delivery device according to any one of claims 60 to 62, wherein, Moving the guard member from the protruded position to the retracted position allows the release member and the plunger to rotate together from the initial rotational position toward the second rotational position under the biasing force exerted by the biasing member.

64. A drug delivery device according to any one of claims 44 to 63, wherein the drug reservoir is fixed relative to the housing.

65. A drug delivery device according to any one of claims 44 to 64, wherein the plunger biasing member comprises a compression spring.

66. A drug delivery device, comprising: A housing having an opening; A drug reservoir comprising a delivery member having an insertion end configured to at least partially extend through the opening, the drug reservoir being coupled to the housing to resist relative movement therebetween; A guard member movably positioned adjacent to the opening; A plunger movable in a distal direction to expel drug from the drug reservoir through the delivery member; A plunger biasing member; And A release member operably coupled to the guard member and the plunger, wherein the release member is configured to drive the housing and the drug reservoir toward the user's injection site using inertial force from the user.

67. A drug delivery device, comprising: A housing having an opening; A drug reservoir comprising a delivery member and a body portion defining a longitudinal axis, the delivery member having an insertion end configured to at least partially extend through the opening during a delivery state; A plunger that is movable in a distal direction to expel a drug from a drug storage container through the delivery member; A plunger biasing member configured to urge the plunger in the distal direction; And A braking member operably coupled to the plunger, wherein movement of the plunger in the distal direction causes at least one of the plunger and the braking member to rotate about the longitudinal axis.

68. The drug delivery device according to claim 67, wherein, The braking member surrounds at least a portion of the plunger and includes a radially inward-facing surface that threadedly engages a radially outward-facing surface of the plunger.

69. The drug delivery device according to claim 68, wherein, The plunger includes a central rod and an annular wall surrounding at least a portion of the central rod, the central rod having a radially outward-facing surface that threadedly engages the radially inward-facing surface of the braking member.

70. The drug delivery device according to claim 67, wherein, The plunger surrounds at least a portion of the braking member and includes a radially inward-facing surface that threadedly engages a radially outward-facing surface of the braking member.

71. The drug delivery device according to claim 70, wherein, The braking member includes a rod having a distal end and a proximal end coupled to the housing, the distal end having a radially outward-facing surface that threadedly engages a radially inward-facing surface of the plunger.

72. The drug delivery device according to claim 71, wherein, The rod is fixedly secured to the housing such that the rod does not move relative to the housing during operation of the drug delivery device.

73. The drug delivery device according to any one of claims 67 to 72, wherein, The braking member is operably coupled to the plunger such that movement of the plunger in the distal direction causes the braking member to rotate.

74. The drug delivery device according to any one of claims 67 to 72, wherein, The braking member is operably coupled to the plunger such that movement of the plunger in the distal direction causes the plunger to rotate.

75. The drug delivery device according to any one of claims 67 to 74, comprising a lock having an initial position and a second position, in the initial position, the lock prevents at least one of the plunger and the braking member from rotating, and in the second position, the lock does not prevent the at least one of the plunger and the braking member from rotating.

76. The drug delivery device according to claim 75, wherein, The lock is configured to move in a proximal direction when moving from the initial position to the second position.

77. A drug delivery device according to any one of claims 75 or 76, comprising a protective member movably positioned adjacent to the opening, wherein, The protective member has a protruding position and a retracted position, in the protruding position, the protective member at least partially extends through an opening in the housing, and in the retracted position, the protective member is positioned away from the protruding position towards the housing.

78. The drug delivery device according to claim 77, wherein Moving the protective member from the extended position to the retracted position causes the lock to move from the initial position to the second position.

79. The drug delivery device according to any one of claims 67 to 88, wherein, The plunger biasing member includes at least one compression spring.

80. The drug delivery device according to any one of claims 67 to 79, wherein, The plunger has a hollow tubular shape, and the plunger biasing member is at least partially disposed within the plunger.

81. The drug delivery device according to claim 80, wherein, The distal end of the plunger has an inner surface, and the plunger biasing member applies an axial biasing force to the inner surface.

82. The drug delivery device according to claim 81, comprising a bearing arranged between the plunger biasing member and the inner surface of the plunger, wherein, The bearing allows relative rotation between the plunger and the plunger biasing member.

83. A drug delivery device according to any one of claims 67 to 82, comprising a stopper movably arranged within the drug storage container, wherein, The distal end of the plunger is initially spaced apart from the proximal end of the stopper by a gap.

84. The drug delivery device according to claim 83, wherein, In the delivery state, the plunger biasing member moves the plunger in the distal direction to reduce the gap between the distal end of the plunger and the proximal end of the stopper, and then the plunger moves the stopper through the drug storage container to expel the drug from the drug storage container.

85. The drug delivery device according to claim 84, wherein, When the plunger moves in the distal direction to reduce the gap between the distal end of the plunger and the proximal end of the stopper, at least one of the plunger and the braking member rotates about the longitudinal axis.

86. The drug delivery device according to any one of claims 84 or 85, wherein When the plunger moves the stopper through the drug storage container to discharge the drug from the drug storage container, at least one of the plunger and the braking member rotates about the longitudinal axis.

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