Drug delivery devices

Abstract

A drug delivery device may include a housing with an opening and a drug storage container, the drug storage container including a delivery member with an insertion end, the insertion end being configured to extend at least partially through the opening. The biasing member may initially remain in an energized state and may be released to drive a plunger to discharge the drug from the drug storage container. The plunger may be configured to selectively rotate from an initial rotational position to a second rotational position under the biasing force applied by the biasing member, and to translate linearly in a distal direction to drive the stopper through the drug storage container after the initial rotational position is rotated to the second rotational position. The release member may have an initial position and a second position, in which the release member maintains the biasing member in the energized state, and in which the release member generates an audible end-of-drug signal.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 908,504, filed on September 30, 2019, entitled “Drug Delivery Device,” which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to drug delivery devices, and more particularly to devices for automatically infusing a drug into a patient. Background Art

[0004] The general aversion to exposed needles, as well as health and safety concerns, has led to the development of drug delivery devices that conceal the needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer a variety of benefits over traditional forms of drug delivery, including, for example, delivery via conventional syringes.

[0005] Drug delivery devices can be combined with various mechanisms to implement various automated features. Such features include automatically covering the needle in the pre-delivery and / or post-delivery state, providing the user with an interface to enable the drive mechanism, indicating to the user that drug delivery has been completed, and other features. Typically, drug delivery devices are combined with separate or independently operable mechanisms to implement each of their automated features. Therefore, as each function is added, the mechanical complexity of the device tends to increase. This in turn may increase the size of the device, which may make it cumbersome for the user to handle, and increase manufacturing costs and time. With the growing demand for easier-to-use and safer drug delivery devices, finding a way to combine more automated features without excessively increasing the complexity of the drug delivery device has various design and manufacturing challenges.

[0006] The present disclosure sets forth drug delivery devices that represent advantageous alternatives to existing drug delivery devices and that may address one or more of the challenges or needs noted herein. Summary of the invention

[0007] 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 operably connected to the plunger biasing member. The drug storage container may include an inner surface and a plug 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 applied by the biasing member, and (ii) linearly translate in a distal direction after the initial rotational position is rotated to the second rotational position to drive the plug through the drug storage container.

[0008] Another aspect of the present disclosure provides a drug delivery device, which includes a housing having an opening, a drug storage container, a shield 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, the insertion end being configured to extend at least partially through the opening. The plunger may move in a distal direction to discharge the drug from the drug storage container through the delivery member. The release member may be operably coupled to the shield and the plunger. In addition, the release member may be configured to rotate from an initial rotational position to a second rotational position under the biasing force applied by the plunger biasing member.

[0009] Another aspect of the present disclosure provides a drug delivery device, which includes a housing, a drug storage container, a plunger, a plunger biasing member initially maintained in an energized state, and an indicator. The drug storage container may include a delivery member having an insertion end, the insertion end having a member configured to extend at least partially through the opening. Releasing the plunger biasing member can drive the plunger in a distal direction to discharge the drug from the drug storage container through the delivery member. The indicator can have an initial position and a second position, in which the indicator maintains the plunger biasing member in an energized state, and in the second position, the indicator generates an audible signal indicating the end of drug delivery.

[0010] 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, the insertion end being configured to extend at least partially through the opening. The plunger may have an inner surface defining an axial chamber. The plunger biasing member may be at least partially arranged in the axial chamber of the plunger and may be initially maintained in an energized state. Releasing the plunger biasing member may drive the plunger in a distal direction to discharge the drug from the drug storage container through the delivery member.

[0011] Other aspects of the present disclosure provide a housing having an opening, a medicine storage container, a shield positioned movably adjacent to the opening, a plunger, a plunger biasing member, and a release member. The medicine storage container may include a delivery member having an insertion end, the insertion end being configured to extend at least partially through the opening. The medicine storage container may be coupled to the housing to resist relative movement therebetween. The plunger may move in a distal direction to discharge medicine from the medicine storage container through the delivery member. The release member may be operably coupled to the shield and the plunger. In addition, the release member may be configured to utilize an inertial force from a user to drive the housing and the medicine storage container toward the injection site of the user.

[0012] Another aspect of the present disclosure provides a drug delivery device, which includes a housing with an opening, a drug storage container, a plunger, a plunger biasing member, and a brake 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, the insertion end being configured to extend at least partially through the opening during a delivery state. The plunger can move in a distal direction to discharge the drug from the drug storage container through the delivery member. The plunger biasing member can be configured to advance the plunger in a distal direction. The brake member can be operably connected to the plunger. The movement of the plunger in a distal direction can cause the plunger and / or the brake member to rotate around the longitudinal axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] It is believed that the present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings. Some drawings may be simplified by omitting selected elements in order to more clearly show other elements. The omission of these elements in certain drawings does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it may be clearly indicated in the corresponding written description. Moreover, all drawings are not necessarily drawn to scale.

[0014] Figure 1 is a perspective view of a drug delivery device according to an embodiment of the present disclosure.

[0015] Figure 2 yes Figure 1 Cross-sectional view of a drug delivery device.

[0016] Figure 3 yes Figure 2 Exploded assembly view of a drug delivery device.

[0017] Figure 4 and Figure 5 yes Figure 2 Different perspective views of the plunger guide are shown.

[0018] Figure 6 and Figure 7 yes Figure 2 Different perspective views of the release member are depicted.

[0019] Figure 8 yes Figure 2 A partial perspective view of the plunger, plunger biasing member, and plunger guide is shown.

[0020] Fig.9A It is along Fig. 9B A cross-sectional view taken along line ZZ of FIG.

[0021] Fig. 9B is a perspective view of the plunger retention arrangement before the guard member is retracted. Fig. 9BIn , the release member is shown as translucent. And in Fig. 9B In the drawings, the guard extension and the guard biasing member are omitted for clarity.

[0022] Fig. 9C yes Fig. 9B A perspective view of the distal end of the plunger retention arrangement. Fig. 9C In FIG. 1 , the guard and the guard extension are each shown as being translucent. Fig. 9C , the guard biasing member, plunger, and plunger guide are omitted for clarity.

[0023] Fig.9D It is along Fig. 9C A cross-sectional view taken along line YY.

[0024] Fig.9E yes Fig. 9B A stereoscopic view of the proximal end of the retention arrangement. Fig.9E In the example, the release members are shown as semi-transparent. Fig.9E In the drawings, the guard biasing member is omitted for clarity.

[0025] Fig. 10A It is along Fig. 10B A cross-sectional view taken along line XX.

[0026] Fig. 10B is a perspective view of the plunger retention arrangement moments after the guard member has moved to the retracted position. Fig. 10B In , the release member is shown as translucent. And in Fig. 10B In the drawings, the guard extension and the guard biasing member are omitted for clarity.

[0027] Fig. 10C yes Fig. 10B A perspective view of the distal end of the plunger retention arrangement. Fig. 10C In FIG. 1 , the guard and the guard extension are each shown as being translucent. Fig. 10C , the guard biasing member, plunger, and plunger guide are omitted for clarity.

[0028] Fig. 10D It is along Fig. 10C A cross-sectional view taken along line WW.

[0029] Fig.11A It is along Fig. 11B A cross-sectional view taken along line VV of FIG.

[0030] Fig. 11B is a perspective view of the plunger retention arrangement at the start of drug delivery. Fig. 11B In , the release member is shown as translucent. And in Fig. 11B In the drawings, the guard extension and the guard biasing member are omitted for clarity.

[0031] Fig. 11C yes Fig. 11B A perspective view of the distal end of the plunger retention arrangement. Fig. 11C In FIG. 1 , the guard and the guard extension are each shown as being translucent. Fig. 11C , the guard biasing member, plunger, and plunger guide are omitted for clarity.

[0032] Fig.11D It is along Fig. 11C A cross-sectional view taken along line UU.

[0033] Fig.11E yes Fig. 11B A stereoscopic view of the proximal end of the retention arrangement. Fig.11E In FIG, the release member is shown as semi-transparent. Fig.11E In the drawings, the guard biasing member is omitted for clarity.

[0034] Fig. 12A It is along Fig. 12B A cross-sectional view taken along line TT.

[0035] Fig. 12B is a perspective view of the plunger retention arrangement at the end of drug delivery. Fig. 12B In , the release member is shown as translucent. And in Fig. 12B In the drawings, the guard extension and the guard biasing member are omitted for clarity.

[0036] Fig. 12C yes Fig. 12B A perspective view of the distal end of the plunger retention arrangement. Fig. 12C In FIG. 1 , the guard and the guard extension are each shown as being translucent. Fig. 12C , the guard biasing member, plunger, and plunger guide are omitted for clarity.

[0037] Fig.12D It is along Fig. 12C A cross-sectional view taken along line SS.

[0038] Fig.12E yes Fig. 12B A stereoscopic view of the proximal end of the retention arrangement. Fig.12E In FIG, the release member is shown as semi-transparent. Fig.12E In the drawings, the guard biasing member is omitted for clarity.

[0039] Fig.13 is a perspective view of a drug delivery device according to another embodiment of the present disclosure.

[0040] Fig.14 yes Fig.13 A perspective view of a drug delivery device with a removable cover removed.

[0041] Fig.15 and Fig.16 yes Fig.13 Different side views of a drug delivery device.

[0042] Fig.17A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0043] Fig. 17B yes Fig.17A An enlarged view of the proximal end of the drug delivery device is shown.

[0044] Fig.18A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0045] Fig.18B yes Fig.18A An enlarged view of the proximal end of the drug delivery device is shown.

[0046] Fig.19A is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0047] Fig.19B yes Fig.19A An enlarged view of the proximal end of the drug delivery device is shown.

[0048] Fig. 20 is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure.

[0049] Fig.21 is a cross-sectional view of a drug delivery device according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0050] The present disclosure generally relates to a drug delivery device that can be operated by a user to deliver a drug, or that delivers the drug by itself when the patient is the user. Various features are disclosed to promote the safety 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 sending a signal that drug delivery is complete to the user, and a drive mechanism that can be enabled by pressing the drug delivery device against the injection site of the patient's skin. These features and other features work together and / or interact with each other in a collaborative manner to limit the number and / or complexity of moving parts of the drug delivery device. In addition, some features described herein are actuated using a biasing force applied by a plunger biasing member and / or a guard biasing member, thereby reducing any force that must be applied by the user, and / or reducing the need to implement the features in conjunction with a dedicated energy source. These and other advantages are clear to those of ordinary skill in the art who read this disclosure.

[0051] Figures 1 to 3 Several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug, are shown. The drug may be, but is not limited to, various biological agents, such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, but the disclosure is not limited to a particular state.

[0052] 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 disposable injector for single use. In other embodiments, the drug delivery device 10 can be configured as a reusable injector for multiple uses. The drug delivery device 10 is operable for self-administration by the patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a doctor or nurse). The current embodiment of the drug delivery device 10 takes the form of an automatic injector or a pen-type injector, and thus can be held in the user's hand for the duration of drug delivery.

[0053] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery 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 may correspond to the configuration of the drug delivery device 10 after being assembled and before being activated by the user. In some embodiments, the pre-delivery state may exist between the time when the drug delivery device 10 leaves the manufacturing facility and the time when the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the moment after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 at the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is ongoing. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is arranged in the end-of-dose position in the drug storage container.

[0054] The drug delivery device 10 includes a housing and a shell 12. In some embodiments, the size and dimensions of the shell 12 can be determined so that people can hold the injector 10 in one hand. The shell 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 allow the insertion end 28 of the delivery member 16 to extend outside the shell 12. A transparent or translucent inspection window 17 can be positioned in the wall of the shell 12 to allow the user to view the (multiple) 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 cover 19 can cover the opening 14 before the drug delivery device 10 is used, and in some embodiments, a grip 13 can be included, which is configured to assist in removing a sterile barrier 21 (e.g., a rigid needle cover (RNS) or a flexible needle cover (FNS), etc.) mounted on the insertion end 28 of the delivery member 16. The grip 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the sterile barrier 21 to pull the sterile barrier 21 along with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0055] In the current embodiment, the housing 12 is defined by three separate and interconnected structures: a rear 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 rear end cap 23 and the front housing 25 and rigidly connecting the two. The front housing 25 and the rear housing 27 can each have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 can have a generally hemispherical shape or a hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23, and the rear housing 27 and any components to be positioned therebetween can be assembled together to define a rear subassembly. At the same time, the front housing 25 and any components to be positioned therebetween can be assembled together to define a front subassembly. In some embodiments, the front subassembly and the rear subassembly are assembled independently of each other and are subsequently combined with each other and with the drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the above-mentioned assembly stages can be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed in one piece such that the housing 12 is defined by a single unitary structure.

[0056] The medicine storage container 20 is arranged in the inner space of the housing 12 and is configured to hold medicine 22. The medicine storage container 20 can be pre-filled and transported to a place where the medicine storage container 20 is combined with the rest of the drug delivery device 10, for example, by a manufacturer. The housing 12 can be pre-loaded with the medicine storage container 20, for example, by a manufacturer, or alternatively loaded with the medicine storage container 20 by a user before using the drug delivery device 10. The medicine storage container 20 can include a rigid wall that defines an internal hole or a reservoir. The wall can be made of glass or plastic. The stopper 24 can be movably arranged in the medicine storage container 20 so that it can move in a distal direction between the proximal end and the distal end of the medicine storage container 20 along the longitudinal axis A. The stopper 24 can be made of rubber or any other suitable material. The stopper 24 can slidably and sealingly contact the inner surface 15 of the wall of the medicine storage container 20 so that when the stopper 24 moves, the medicine 22 will be prevented or suppressed from leaking through the stopper 24. 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 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 in the distal direction. In the current embodiment, the plunger 26 and the stopper 24 are initially spaced apart from each other by a certain gap. When the drive mechanism 30 is enabled, the plunger 26 moves in the distal direction to reduce the gap and contact the stopper 24. The subsequent distal movement of the plunger 26 drives the stopper 24 in the distal direction to discharge the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially contact each other or be coupled to each other, for example, via a threaded connection, so that they can move together from the start of the plunger 26. Once the stopper 24 moves, it can continue to move in the distal direction until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20. This position of stopper 24 may be referred to as an end-of-dose or end-of-delivery position and may correspond to complete or substantially complete delivery of drug 22 to the patient.

[0057] In some embodiments, the volume of drug 22 contained in the reservoir of drug storage container 20 can 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 or equal to approximately (e.g., ± 10%) 5 mL, or less than or equal to approximately (e.g., ± 10%) 10 mL, or in a range between approximately (e.g., ± 10%) 1-10 mL, or in a range between approximately (e.g., ± 10%) 1-5 mL, or in a range between approximately (e.g., ± 10%) 1-4 mL, or in a range between approximately (e.g., ± 10%) 1-3 mL, or in a range between approximately (e.g., ± 10%) 1-2.5 mL.

[0058] The delivery member 16 is or can be operatively connected in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery member 16 can define an insertion end 28 of the delivery member 16. The insertion end 28 can include a sharp tip having other sharp geometric shapes to allow the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 can be hollow and have an internal passageway. One or more openings can be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 into the patient's body.

[0059] In the current embodiment, the drug storage container 20 is a pre-filled syringe and has a hollow metal stake needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and is permanently in fluid communication with the reservoir of the drug storage container 20. In other embodiments, the drug storage container 20 may be a needle-free cartridge and thus may not initially be in fluid communication with the delivery member 16. In such embodiments, the drug storage container 20 may be moved toward the proximal end of the delivery member 16 or vice versa during operation of the drug delivery device 10, so that the proximal end of the delivery member 16 penetrates the septum covering the opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0060] The drug storage container 20 may be fixed relative to the housing 12, such that the drug storage container 20 cannot move relative to the housing 12 after being installed in the housing 12. In this way, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 in the housing 12 in the pre-delivery state, the delivery state, and the post-delivery state. In the current embodiment, the container holder 31 fixes the position of the drug storage container 20 in the housing 12. The container holder 31 may have a hollow and generally cylindrical or tubular shape, and the drug storage container 20 may be partially or completely arranged in the container holder 31. The distal end of the container holder 31 may include an inwardly protruding flange 33, which abuts the neck of the drug storage container 20, thereby preventing the drug storage container 20 from moving distally. The container holder 31 may 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.

[0061] In alternative embodiments, the drug storage container 20 may be movably coupled to the housing 12 such that the drug storage container 20 can move relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may 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 may be deployed through the opening 14 in the housing 12 for insertion into the patient. In some embodiments, this movement may be the result of the drug storage container 20 having been driven in a distal direction relative to the housing 12.

[0062] The plunger 26 may have a hollow and generally cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an interior space sized to receive a 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 to maximize the inner diameter of the plunger 26. This allows a larger diameter plunger biasing member 50 to fit within the interior space of the plunger 26, which in turn allows a more powerful plunger biasing member 50 to be achieved. As described in more detail below, the plunger 26 may 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.

[0063] The plunger 26 may be constructed of multiple interconnected pieces, or alternatively have a one-piece construction. 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 so 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 on the longitudinal axis A. The top ring 45 and the hollow rod 46 can each have a corresponding central opening extending from one end of the component to the other end to define an axial chamber; while 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 from one end to the other through the base 47. In such an alternative embodiment, the inner diameter of the central opening of the base 47 can be smaller than the outer diameter of the plunger biasing member 50, so that the base 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is actuated, the base 47 can be the portion of the plunger 46 that contacts the stopper 24 to push the stopper 24 in the distal direction.

[0064] The top ring 45 may include one or more flanges or protrusions 48 extending radially outward from a central portion of the top ring 45. Each of these protrusions 48 may include a distally facing cam surface 49. As described in more detail below, the distally facing cam surface 49 may interact with a mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distally facing cam surface 49 may be arranged at an angle to, or non-parallel to, an imaginary plane perpendicular to the longitudinal axis A.

[0065] In some embodiments, the top ring 45 and / or the base 47 may be constructed of a material different from the hollow rod 46. In some embodiments, the top ring 45 and / or the base 47 are constructed of plastic, while the hollow rod 46 may be constructed of metal. This configuration allows the plastic material used for the top ring 45 to facilitate the camming action described below by providing sliding friction, and the plastic material used 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 used for the hollow rod 46 can provide sufficient rigidity to avoid buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, the hollow rod 46, and / or the base 47 can be made of the same material (including, for example, metal or plastic). In some such embodiments, the top ring 45, the hollow rod 46, and the base 47 can be integrally formed in one piece to define a single, integral structure.

[0066] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used to perform an injection. The guard mechanism may include a guard member 32 that is movably disposed at the distal end of the housing 12, adjacent the opening 14. The guard 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 guard member 32 may be configured to move relative to the housing 12 between an extended position and a retracted position, in which the distal end of the guard member 32 extends through the opening 14 in the housing 12, and in which the distal end of the guard member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the guard member 32 may be configured to move from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 can translate linearly in the proximal direction; and when moving from the retracted position to the extended position, the guard member 32 can translate linearly in the distal direction. At least in the extended position, the guard member 32 can extend beyond and surround the insertion end 28 of the delivery member 16. 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 guard member 32 from the extended position to the retracted position (e.g., by pressing the distal end of the guard member 32 against the patient's skin at an injection site) can cause the insertion end 28 of the delivery member 16 to be inserted into the patient's skin.

[0067] For example, the delivery device 10 can utilize an inertial drive design rather than a spring design to insert the needle into the patient's subcutaneous tissue. As a more specific example, when the patient presses the distal end of the protective member 32 against the injection site of 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 presses down with a predetermined force, the delivery device 10 achieves a quick release to utilize the energy stored in the patient's muscles while compressing the needle sleeve and its spring to a defined release point. The release mechanism is designed so that the needle insertion speed obtained exceeds the patient's reaction speed, and the combination of this speed and the mass of the device allows the needle to quickly and completely 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, more robust design.

[0068] In some embodiments, the guard member 32 may be rotationally fixed relative to the housing 12. Thus, while the guard member 32 may be able to translate linearly relative to the housing 12, the guard member 32 may be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 61 may be formed in the wall of the guard member 32 and parallel to the longitudinal axis A. Each longitudinal slot 61 may be sized to fit or snugly receive a protrusion or pin 63 extending radially inward from the front housing 25. When the guard member 32 translates linearly along the longitudinal axis A relative to the front housing 25, each pin 63 may slidably engage a surface defining a corresponding one of the longitudinal slots 61. However, the pin 63 abuts the same surface to prevent rotation of the guard member 32 relative to the front housing 25 when any rotational force is applied to the guard member 32. In an alternative embodiment, the pin and slot arrangement may be reversed, such that the guard member 32 has one or more radially outwardly extending pins, and the front housing 25 has one or more slots or other recesses to fit or snugly receive the one or more pins.

[0069] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be positioned proximal to the guard member 32; and the guard biasing member 35 may be positioned proximal to the guard extension 37. The guard extension 37 may have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A. In addition, the guard extension 37 may be movable relative to the housing 12 in a linear direction along the longitudinal axis A. In the current embodiment, the guard extension 37 is a structure separate from the guard member 32. However, in an alternative embodiment, the guard extension 37 and the guard member 32 may be integrally formed in one piece to define a single integral structure. In such an alternative embodiment, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0070] Similar to the guard member 32, the guard extension 37 can be fixed in a rotational sense relative to the housing 12. Therefore, although the guard extension 37 may be able to translate linearly relative to the housing 12, the guard extension 37 can be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 71 can be formed in the wall of the guard extension 37 and can be parallel to the longitudinal axis A. Each longitudinal slot 71 can be sized to fit or snugly receive a protrusion or pin (not shown) extending radially inward from the housing 12 (e.g., the rear housing 23 and / or the front housing 25). When the guard extension 37 is linearly translated along the longitudinal axis A relative to the housing 12, each pin can slidably engage the surface defining the corresponding longitudinal slot 71. However, the pin abuts the same surface to prevent rotation of the guard extension 37 relative to the housing 12 when any rotational force is applied to the guard extension 37. In alternative embodiments, the pin and slot arrangement may be reversed such that the guard extension 37 has one or more radially outwardly extending pins and the housing 12 has one or more slots or other recesses to matingly or snugly receive the one or more pins.

[0071] The shield biasing member 35 can be positioned between and in contact with the shield extension 37 and the release member 52. The shield biasing member 35 can be configured to bias or urge the shield extension 37 in a distal direction and to bias or urge the release member 52 in a proximal direction. The shield biasing member 35 can initially be in an energized (e.g., compressed) state such that in a pre-delivery state, it applies a biasing force to the shield extension 37 and a biasing force to the release member 52. In some embodiments, the distal end of the shield extension 37 initially contacts the proximal end of the shield member 32, see Figure 2. Thus, the shield extension 37 transmits the biasing force of the shield biasing member 35 to the shield member 32, so that the shield biasing member 35 biases or pushes the shield member 32 toward the extended position. The user can overcome the biasing force by pressing the shield member 32 against the injection site. In doing so, the shield member 32 and the shield extension 37 move together in the proximal direction until, for example, the shield member 32 reaches the retracted position. When the injection is completed and the drug delivery device 10 is lifted off the injection site, the shield biasing member 35 can push the shield extension 37 so that the shield extension 37 and the shield member 32 move together in the distal direction. This movement returns the shield 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 shield biasing member 35 may include a compression spring (e.g., a helical compression spring). Furthermore, in embodiments where the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be disposed about the plunger biasing member 50 and / or have a larger diameter than the plunger biasing member.

[0072] In an alternative embodiment, the distal end of the guard extension 37 may initially be spaced apart from the proximal end of the guard member 32 by a gap in the proximal direction. Therefore, in the pre-delivery state, the guard biasing member 35 may not bias the guard member 32 toward the extended position. When the guard member 32 is retracted in the proximal direction and contacts the guard extension 37, only then does the guard biasing member 35 apply a biasing force to the guard member 32 to urge it toward the extended position. In such an alternative embodiment, in the pre-delivery state, only the locking ring biasing member 51 described below may be used to bias the guard member 32 toward the extended position.

[0073] 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 a user from subsequently contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. In accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 that is configured to selectively rotate 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 current embodiment, the locking ring 40 is centered on and rotates about the longitudinal axis A. Figure 2As shown, the proximal end of the locking ring 40 can be in contact with the container holder 31, and the distal end of the locking ring 40 can be at least partially disposed within the guard member 32. The locking ring biasing member 51 can be positioned between the distally facing surface of the locking ring 40 and the proximally facing surface of the guard member 32 in the axial direction. The locking ring biasing member 51 can initially be in a compressed or energized state, thereby biasing the locking ring 40 and the guard member 32 away from each other. In this way, the locking ring biasing member 51 can apply a biasing force to push the guard member 32 toward 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).

[0074] The 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 may include one or more cam surfaces 53, which are configured to slidably engage with 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 on the longitudinal axis A and can be a radially inward cantilever of the annular outer wall 59 of the front housing 25, so 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 guard 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 a radial direction from the longitudinal axis A, the cam surfaces 53 of the locking ring 40 can have a generally sawtooth appearance. In addition, the cam surfaces 53 can be arranged around the longitudinal axis A so that each cam surface 53 is positioned at a different angular position around the longitudinal axis A. Similarly, the cam surfaces 55 on the container holder 31 may have a generally sawtooth appearance when viewed in a radial direction from the longitudinal axis A. Furthermore, the cam surfaces 55 may be arranged about the longitudinal axis A such that each cam surface 55 is located at a different angular position about the longitudinal axis A.

[0075] 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 in the proximal direction 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. During the entire movement of the locking ring 40, the annular inner wall 57 of the front housing 25 remains stationary relative to the rest of the front housing 25. In this configuration, the annular inner wall 57 of the front housing 25 acts as a cam, and the locking ring 40 acts as a cam follower.

[0076] 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. Therefore, the locking ring 40 is continuously advanced to rotate around the longitudinal axis A. However, the locking ring 40 may not be able to rotate, depending on the relative positions of the 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 with each other to allow the locking ring 40 to rotate. In some embodiments, the locking ring 40 can be rotated to a final rotational position when the guard member 32 moves from the retracted position to the extended position. In the final rotational position, the distal-facing surface of one or more abutment structures included on the locking ring 40 can be rotationally aligned with and arranged opposite to the proximal-facing surface of one or more matching abutment structures included on the guard member 32. Therefore, by engaging the distal surfaces of the abutment structures included on the locking ring 40 with the proximal-facing surfaces of the abutment structures included on the protective member 32, any subsequent movement of the protective member 32 in the proximal direction can be prevented.

[0077] The drug delivery device 10 may further include a drive mechanism 30 partially or completely disposed within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and 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 the patient's body when or in response to the user activating the drive mechanism 30. In the current embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may be configured differently, for example, wherein the drive mechanism 30 stores electrical potential energy or chemical potential energy. Generally, when the drive mechanism 30 is activated, the drive mechanism 30 can convert the potential energy into kinetic energy to move the plunger 26.

[0078] In the current 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 may include a compression spring (e.g., a helical compression spring) that is initially maintained in an energized state. In the energized state, the plunger biasing member 50 may be compressed so that its axial length is shorter than its length in a natural or unenergized state. When released, the plunger biasing member 50 may attempt to expand to its natural axial length and thus apply a biasing force to push the plunger 26 in a distal direction.

[0079] The plunger biasing member 50 can be at least partially disposed within the plunger 26 and can have a distal end that abuts the proximally 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 stem 46. In some embodiments, the distal end of the plunger biasing member 50 can abut the proximally facing inner surface of the base 47 of the plunger 26. In addition, the proximal end of the plunger biasing member 50 can abut the distally 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 for pushing the plunger biasing member 50 away. The plunger biasing member 50 is configured so that when released from the energized state, it can expand in length by the distal end of the plunger biasing member 50 moving in a distal direction away from the stationary proximal end of the plunger biasing member 50. This movement can push the plunger 26 in the distal direction, which in turn can push the stopper 24 in the distal direction to expel the drug 22 from the drug storage container 20 into the delivery member 16 and then into the patient's body.

[0080] The plunger guide 60 can be fixedly attached to the rear housing 27 such that the plunger guide 60 is not movable relative to the rear housing 27. The plunger guide 60 can have a hollow and generally cylindrical or tubular shape and can be centered on the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger guide 60 can be greater than the outer diameter or other outer dimension 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 shown in FIG. Figure 2 shown.

[0081] refer to Figure 4 , Figure 5 ,and Figure 8, the distal end of the plunger guide 60 may include an annular wall 80 formed with various surfaces and openings to interact with and control 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 may be sized to receive a protrusion 48 extending outwardly from the top ring 45 of the plunger 26. The annular wall 80 may include a proximal-facing cam surface 84 that defines a portion of the periphery of the first opening 82. The cam surface 84 may be tilted downward to form an angle with, or not parallel to, an imaginary plane perpendicular to the longitudinal axis A. In the pre-delivery state, the proximal-facing cam surface 84 of the plunger guide 60 may contact the distal-facing cam surface 49 of the top ring 45 of the plunger 26. Here, the biasing force of the plunger biasing member 50 may press the distal-facing cam surface 49 of the top ring 45 against the proximal-facing cam surface 84 of the plunger guide 60. Thus, the distally facing cam surface 49 of the top ring 45 can 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 can cause the plunger 26 to rotate and linearly translate relative to the stationary plunger guide 60. Accordingly, the plunger guide 60 can act as a cam, and the top ring 45 acts as a cam follower. In the pre-delivery state, the engagement between the protrusion 48 and the release member 52 can 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 acts to prevent linear translation of the plunger 26 in the distal direction. Therefore, the plunger guide 60 can assist in maintaining the plunger biasing member 50 in the energized state before the guard member 32 is retracted. In some embodiments, an opening similar to the first opening 82 may be formed on an opposing side of the plunger guide 60 and may be configured to receive a different one of the protrusions 48 of the top ring 45 .

[0082] Continue to refer 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. 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 second opening 86 can be sized to receive one protrusion 48 of the top ring 45 and can permit the protrusion 48 to slide linearly in the distal direction through the second opening 86. After the protrusion 48 has rotated beyond the end of the cam surface 84, the protrusion 48 can be received in the second opening 86 and then linearly translated in the distal direction through the second opening 86 without further rotating the protrusion 48 relative to the plunger guide 60, as shown. Figure 8 In some embodiments, an opening similar to the second opening 86 can be formed on an opposite side of the plunger guide 60 and can be configured to receive a different one of the protrusions 48 of the top ring 45 .

[0083] The annular wall 80 of the plunger guide 60 may further include a distally facing cam surface 88. Figure 4 and Figure 5 As depicted, the distally facing cam surface 88 can be part of a helical protrusion extending outwardly from the remainder of the annular wall 80. The distally facing cam surface 88 can be tilted upward to be at an angle to, or non-parallel to, an imaginary 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. Thus, the proximally facing cam surface of the release member 52 can be biased to slide along the distally facing cam surface 88 of the plunger guide 60, generally 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. Accordingly, the plunger guide 60 can act as a cam, and the release member 52 acts as a cam follower. In some embodiments, a distally facing cam surface similar to distally facing cam surface 88 can be formed on an opposite side of plunger guide 60 and configured to engage a different proximally facing cam surface on release member 52 .

[0084] Reference now Figure 2 , Figure 3 , Figure 6 ,and Figure 7 5 to describe the configuration of the release member 52. The release member 52 may have a hollow and generally cylindrical or tubular shape and may be centered on a longitudinal axis A. Figure 2As shown, the release member 52 can be positioned in the radial direction between the distal end of the plunger guide 60 and the proximal end of the guard extension 37. In addition, the release member 52 can be arranged radially inward of the guard biasing member 35. Generally, the release member 52 is configured to operably couple the guard member 32 and the plunger 26 in an activation sequence and generate an audible signal indicating the end of drug delivery. Such a configuration allows the release member 52 to be used to perform these two separate functions and thus reduce the number of moving parts required for the drug delivery device 10.

[0085] The release member 52 may be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the release member 52 associated with activation may be powered by the plunger biasing member 50 and / or the guard biasing member 35; whereas the subsequent rotation of the release member 52 associated with the generation of the end-of-dose signal may be powered solely by the guard biasing member 35. Any linear translation of the release member 52 without rotation may be powered solely by the guard biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction; however, alternative embodiments may permit the release member 52 to translate linearly in both the proximal and distal directions.

[0086] The release member 52 may have an annular wall 90 having a distal end and a proximal end. Typically, the distal end of the annular wall 90 is configured to assist in activating the drive mechanism 30, while the proximal end of the annular wall 90 is configured to generate an audible end-of-dose signal. Figure 2 As depicted, a distally facing ledge or surface 91 formed on an outer portion of the annular wall 90 can abut the proximal end of the guard biasing member 35. In this manner, the guard biasing member 35 can apply a biasing force to the release member 52 to urge the release member 52 in a proximal direction.

[0087] refer to Figure 6, a recess 92 may be formed on the 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 so that its length or longest dimension is parallel to the longitudinal axis A. In addition, the size of the recess 92 may be determined to fit or snugly receive one protrusion 48 of the top ring 45. The recess 92 may be configured to permit the protrusion 48 to slide linearly relative to the release member 52 parallel to the longitudinal axis A, but to prevent the protrusion 48 from rotating relative to the release member 52 about the longitudinal axis A. This can be achieved by forming the width of the recess 92 to be slightly larger than the width of the protrusion 48, so that there is almost no play between the recess 92 and the protrusion 48 in the rotational direction. Due to the mating engagement between the protrusion 48 and the recess 92, the release member 52 and the plunger 26 can be locked to each other in a rotational sense. Thus, when protrusion 48 is received in recess 92, release member 52 may rotate in conjunction with plunger 26, and when protrusion 48 is not received in recess 92, release member 52 may be able to rotate independently of plunger 26. In some embodiments, a recess similar to recess 92 may be formed on the opposite side of release member 52, and the recess may be configured to receive a different one of protrusions 48 of top ring 45.

[0088] 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 guard extension 37. More specifically, the biasing force of the plunger biasing member 50 can continuously press the cam surface 49 of the protrusion 48 against the cam surface 84 of the plunger guide 90, thereby urging the protrusion 48 to rotate about the longitudinal axis A. Since the protrusion 48 is cooperatively received in the recess 92, 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 guard biasing member 35, via the cam arrangement between the proximal end of the release member 52 and the plunger guide 60. Despite these biasing forces, in the pre-delivery state, the release member 52 is 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 guard extension 37. Depending on the relative axial positions of the abutment structures, the abutment structures may engage with each other to prevent the release member 52 from rotating relative to the guard extension 37, or disengage from each other to allow the release member 52 to rotate relative to the guard extension 37. In the current embodiment, the cooperating abutment structures may take the form of one or more protrusions 94 extending outwardly from the release member 52 and one or more corresponding protrusions 96 extending inwardly from the guard extension 37, which protrusions slidably engage with each other to permit relative movement in a linear direction along the longitudinal axis A and simultaneously abuttly engage with each other to prevent relative rotational movement about the longitudinal axis A. In certain alternative embodiments, the cooperating abutment structures may take the form of one or more recesses formed in the outer surface of the release member 52 and one or more corresponding protrusions extending inwardly from the guard extension 37, which recesses and corresponding protrusions slidably engage with each other to permit relative movement in a linear direction along the longitudinal axis A and simultaneously abuttly engage with each other to prevent relative rotational movement about the longitudinal axis A. In certain other alternative embodiments, these cooperative abutment structures can take the following form: one or more protrusions extending outward from the release member 52 and one or more corresponding grooves formed in the inner surface of the guard extension 37, which are slidably engaged with each other to allow relative movement in a linear direction along the longitudinal axis A and at the same time abut against each other to prevent relative rotational movement around the longitudinal axis A.

[0089] As described above, the guard extension 37 is prevented from rotating about the longitudinal axis A due to its coupling to the housing 12. This has the effect that when the protrusion 94 on the outer portion of the release member 52 engages the protrusion 96 on the inner portion 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, then the protrusion 48 received in the recess 92 formed in the inner surface of the release member 52 cannot rotate either. If the protrusion 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 protrusion 48 cannot move in this manner, then the plunger 26 cannot move either. If the plunger 26 cannot move, then the plunger biasing member 50 cannot expand without being energized. Thus, the release member 52 maintains the plunger biasing member 50 in an energized state until the guard extension 37 moves to an axial position in which the cooperating abutment structures on the outer portion of the release member 52 and the abutment structures on the inner portion of the guard extension 37 disengage from each other and thereby permit the release member 52 to rotate relative to the guard extension 37.

[0090] In addition to this securing 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 is not required to have this indicator function. In the current embodiment, the proximal end of the release member 52 defines the indicator. Therefore, in the current embodiment, the indicator and the release member 52 are the same component. In an alternative embodiment, the indicator can be defined by a structure that is separate from the release member 52 but rigidly attached thereto.

[0091] Initially, there may be a gap between the proximal end surface 97 of the release member 52 and the distally facing abutment surface 98 of the proximal end of the plunger guide 60. In order to generate an audible signal, the release member 52 may be driven in the proximal direction by the guard biasing member 35 to reduce this gap, and thereby cause the proximal end surface 97 of the release member 52 to impact or hit the distally facing abutment surface 98 of the proximal end of the plunger guide 60. This impact may produce a click or a slapping sound, or any other suitable audible signal that the user can perceive. The audible signal may be generated simultaneously or substantially simultaneously with the stopper 24 reaching the end position of the drug administration. Accordingly, the audible signal may indicate to the user that the drug delivery or administration is completed. In some embodiments, the user may be informed of the importance of the audible signal by instructions provided by the drug delivery device 10. In some embodiments, these instructions may take the form of an IFU booklet packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that the drug delivery is completed by observing the stopper 24 and / or the plunger 26 moving through the window 17. In some embodiments, the audible signal may be accompanied by a vibration or other tactile feedback resulting from the release member 52 striking the plunger guide 60 .

[0092] In some embodiments, the movement of the release member 52 to generate an audible signal may involve both rotation of the release member 52 about the longitudinal axis A and linear translation of the release member 52 in the proximal direction. This may be achieved by a cam arrangement between the release member 52 and the plunger guide 60. In the current 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 may press the proximally facing cam surface 99 of the release member 52 against the distally facing cam surface 88 of the plunger guide 60. Thus, the proximally facing cam surface 99 of the release member 52 may 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 motion may cause the release member 52 to rotate and linearly translate relative to the plunger guide 60. Accordingly, the plunger guide 60 may act as a cam, and the release member 52 may act as a cam follower. In some embodiments, a proximally facing cam surface similar to proximally facing cam surface 99 can be formed on an opposite side of release member 52 and configured to engage a different distally facing cam surface on plunger guide 60 .

[0093] Although the guard biasing member 35 can continuously urge the proximally facing cam surface 99 of the release member 52 to slide along the distally 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 in the recess 92 and the plunger 26 and the release member 52 are thus configured to rotate together, rotation of the plunger 26 can allow the proximally facing cam surface 99 of the release member 52 to slide along the distally facing cam surface 88 of the plunger guide 60, which in turn rotates the release member 52 about the longitudinal axis A and causes the release member 52 to linearly translate in the proximal direction. Conversely, when the projection 48 is received in the recess 92 and the projection 48 cannot rotate, for example, because the projection 48 is received in the second opening 86 formed in the plunger guide 60, the proximal-facing cam surface 99 of the release member 52 cannot slide along the distal-facing cam surface 88 of the plunger guide 60. As described below, when the stopper 24 reaches the end-of-dose position, the projection 48 can slide away from the distal end of the recess 92. Therefore, the release member 52 can freely rotate about the longitudinal axis A. This allows the guard biasing member 35 to push the proximally facing cam surface 99 of the release member 52 to slide along the distally facing cam surface 88 of the plunger guide 60, which in turn narrows the gap between the proximally facing end surface 97 of the release member 52 and the distally facing abutment surface 98 of the proximal end of the plunger guide 60, and ends with the proximally facing end surface 97 striking the distally facing abutment surface 98 or otherwise contacting it to produce an audible signal indicating the end of drug delivery.

[0094] Although the above embodiment uses the guard biasing member 35 to provide the actuation energy required to generate the end-of-dose signal, alternative embodiments can utilize a biasing member separate from the guard biasing member 35 to achieve this purpose. In some such embodiments, this additional biasing member can have a distal end fixed relative to the housing 12, and a proximal end against the distal surface of the release member 52. In this way, the biasing member can be pushed away from the housing 12 to apply a biasing force to the release member 52 in the proximal direction. In addition, this biasing member can operate independently of the plunger biasing member 50 and the guard biasing member 35.

[0095] Having described the general configuration of the drug delivery device 10, reference will now be made to 9A to 12E1 to describe a method of injecting using the drug delivery device 10. As a preliminary step, the user can remove the drug delivery device 10 from any secondary packaging (such as a plastic bag and / or a cardboard box). Moreover, as a preliminary step, the user can prepare the injection site, for example, by wiping the patient's skin with alcohol. Next, the user can pull down and remove the removable cover 19 from the front housing 25. As a result of this movement, the grip 13 can pull and remove the sterile barrier 21 from the drug storage container 20. This can 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 because the protective member 32 is arranged in the extended position. Next, the user can 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 protective member biasing member 35 and the biasing force of the locking ring biasing member 51, thereby 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 guard member 32 , the delivery member 16 remains stationary relative to the housing 12 .

[0096] The movement of the guard member 32 from the extended position to the retracted position may cause several actions to occur. Because the delivery member 16 remains stationary relative to the housing 12 during the retraction of the guard member 32, the insertion end 28 of the delivery member 16 is extended through the opening in the distal end of the guard member 32, thereby piercing the patient's skin and penetrating the patient's subcutaneous tissue at the injection site. In addition, the retraction of the guard member 32 can also activate the drive mechanism 30 to discharge the drug 22 from the drug storage container 20, as described below.

[0097] In the pre-delivery state before the needle guard 32 is retracted, the plunger 26 and the release member 52 may each be arranged in a respective initial rotational position, such as 9A to 9E 8, and the plunger 26 is in a state of being urged toward the distal end of the plunger 26. The plunger 26 is in a state of being urged toward the proximal ... Fig.9A and Fig.9EIn some embodiments, the plunger 26 can also be urged to rotate due to the guard biasing member 35 pushing the proximally facing cam surface 99 of the release member 52 against the distally facing cam surface 88 of the plunger guide 60. Despite these (multiple) biasing forces, in the pre-delivery state, neither the release member 52 nor the plunger 26 can rotate. This is because Fig.9D As 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 in 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 translate linearly in the distal direction. Accordingly, the release member 52, the plunger guide 60, the guard extension 37, and the housing 12 work in conjunction with each other to maintain the plunger biasing member 50 in an energized state prior to retracting the guard member 32.

[0098] When the guard member 32 moves from the extended position to the retracted position, the guard member 32 can move the guard extension 37 from the Fig. 9C Push proximally to the position shown Fig. 10C During the proximal movement of the guard extension 37, the projections 96 and 98 can slide past each other until finally the projections 96 and 98 no longer contact each other ( Fig. 10C and Fig. 10D ). At this point, the release member 52 can rotate freely about the longitudinal axis A. At this stage, the rotation of the release member 52 is caused by the plunger biasing member 50 expanding and pushing the distally facing cam surface 49 of the protrusion 48 to slide along the proximally facing cam surface 84 of the plunger guide 60, as shown in FIG. Fig. 10A and Fig. 10B92. The resulting camming action rotates the protrusion 48, which in turn rotates the release member 52 together due to the protrusion 48 being received in the recess 92. During this rotational movement, the plunger 26 translates linearly in the distal direction, and the release member 52 translates linearly in the proximal direction. The distal translation of the plunger 26 is due to the downwardly inclined angle of the proximally facing cam surface 84 of the plunger guide 60, along which the protrusion 48 of the plunger 26 slides under 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 applied to the release member 52 by the guard biasing member 35. In some embodiments, during the proximal translation of the release member 52, the proximally facing cam surface 99 of the release member 52 can slide on the distally facing cam surface 88 of the plunger guide 60.

[0099] In some embodiments, the camming action between the distally facing cam surface 49 on the protrusion 48 and the proximally facing cam surface 84 of the plunger guide 60 can provide a damping effect. More specifically, the sliding friction between these two surfaces can be selected to slow the initial expansion of the plunger biasing member 50. Thus, the speed of the plunger 26 can be reduced during the initial expansion of the plunger biasing member 50 compared to an uninhibited expansion of the plunger biasing member 50. The reduced speed of the plunger 26 can cause the plunger 26 to strike the stopper 24 with less 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.

[0100] The combined rotation of the release member 52 and the plunger 26 can continue until the projection 48 slides away from the proximally facing cam surface 84 of the plunger guide 60, see Fig.11A and Fig. 11B . Here, the projection 48 has moved away from the first opening 82 into the second opening 86. The sidewalls of the second opening 86 can slidably and snugly receive the projection 48 so that there is little or no rotational play therebetween. Accordingly, when the projection 48 is received in the second opening 86, the projection 48 and the rest of the plunger 26 can be prevented from rotating. Since the end of the projection 48 is still received in the recess 92 of the release member 52, the release member 52 can also be prevented from rotating at this stage. The second opening 86 does not inhibit the linear movement of the projection 48. Accordingly, the projection 48 and the rest of the plunger 26 are driven by the expanded plunger biasing member 50 to translate linearly in the distal direction. Therefore, the base 47 of the plunger 26 contacts the stopper 24 and thereafter pushes the stopper 24 in the distal direction to discharge the drug 22 from the drug storage container 20 through the delivery member 16 and out of the insertion end 28 into the patient's tissue.

[0101] Drug delivery can continue until the stopper 24 reaches the end-of-dose position. At this point, the stopper 24 can abut the proximal-facing portion of the inner surface 15 of the wall of the drug storage container 20. As a result, the plunger 26 stops moving in the distal direction. Simultaneously or substantially simultaneously with the stopper 24 reaching the end-of-dose position, the projection 48 can slide away from the recess 92 on the release member 52, as shown in FIG. Fig. 12B As shown. Therefore, the release member 52 can now rotate freely about the longitudinal axis A. At this stage, the rotation of the release member 52 is caused by the guard biasing member 35 expanding and pushing 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 camming action causes the release member 52 to rotate and translate linearly in the proximal direction. This movement can continue until the proximally facing end surface 97 of the release member 52 hits the distally facing abutment surface 98 ( Fig.12E ). This impact can produce an audible signal to indicate to the user that drug delivery is complete.

[0102] With some confirmation that drug delivery is complete, the user can then 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 being subsequently retracted.

[0103] From the above, it can be seen that the present disclosure advantageously provides a streamlined design for a drug delivery device having an automated feature. 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.

[0104] The drug delivery devices described herein may have a wide 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 having the same or similar internal components as the drug delivery device 10 described above, but having 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.

[0105] The drug delivery device 110 includes a housing or shell 112 having a generally elongated shape extending along a longitudinal axis. At most or all positions along the longitudinal axis, the shell 112 may have a circular cross-section so that the shell 112 has a generally cylindrical shape. A recess having a transparent or translucent inspection window 117 may be positioned in the wall of the shell 112 to permit a user to view the (multiple) components (including, for example, a drug storage container) inside the drug delivery device 110. At the distal end of the shell 112, a removable cover 119 may cover an opening in the shell 112. The interior of the removable cover 119 may include a grip configured to assist in removing a sterile barrier (e.g., a rigid needle cover (RNS) or a flexible needle cover (FNS), etc.) from a delivery member (e.g., a needle) when the removable cover 119 is removed from the shell 112, as described above. Shell 112 and removable cover 119 can each have a plurality of ribs 105 and 107 formed on its outer surface, respectively, to improve the ability of the user to grasp these parts when shell and removable cover are pulled apart.Each rib can extend completely or partially around the periphery of shell 112 or removable cover 119.

[0106] The circular cross-section of housing 112 may make it easy for it to roll on a surface when placed on its side. To inhibit or prevent such rolling, a portion or all of removable cover 119 may have a non-circular cross-section. Figures 13 to 16 In the embodiment shown, the removable cover 119 has a distal end with a non-circular cross section and a proximal end with a circular cross section. In this way, when moving from the proximal end of the removable cover 119 to the distal end of the removable cover 119, the cross section of the removable cover 119 gradually changes from a circular cross section to a non-circular cross section. In the embodiment shown, the distal end of the removable cover 119 generally takes the form of a square. In other embodiments, the non-circular cross section can be a rectangle, a triangle, or any other polygonal or partially polygonal shape, as long as one or more sides of the removable cover 119 are flat or substantially flat to suppress or prevent rolling. In addition, the size of the non-circular cross section of the distal end of the removable cover 119 can gradually increase as it moves toward the distal direction, so that the distalmost part of the distal end of the removable cover 119 has a larger cross-sectional area than the most proximal part of the distal end of the removable cover 119. This configuration makes the distal end of the removable cover 119 have a flared shape, which in turn can help the user to grasp the removable cover 119 and pull it away from the housing 112.

[0107] In some embodiments, the housing 112 and the removable cover 119 may each include respective anti-rotation features. When the removable cover 119 is in the storage position, these anti-rotation features may engage with each other to prevent or inhibit the removable cover 119 from rotating relative to the housing 112, such as Fig.13In some embodiments, the anti-rotation feature of the housing 112 can be adjacent to and substantially aligned with the anti-rotation feature of the removable cover 119 when the removable cover 119 is in the storage position. Figures 13 to 16 In the illustrated embodiment, the anti-rotation feature of the removable cover 119 is provided by an opening 108 formed in the tubular wall of the removable cover 119 at the proximal end of the removable cover 119; and the anti-rotation feature of the housing 112 is provided by an axial protrusion 109 extending in the distal direction from the distal end of the housing 112. The size of the opening 108 can be determined to accommodate the radial axial protrusion 109 when the removable cover 119 is in the storage position. Due to this mating engagement, the removable cover 119 may not be able to rotate relative to the housing 112. This may be advantageous if the user attempts to twist the removable cover 119 when pulling the removable cover 119 away from the housing 112. In some cases, the rotation of the removable cover 119 may rotate the sterile barrier, such as the RNS or FNS, which in turn may cause the needle tip to penetrate into the sealing member in the RNS or FNS. Therefore, at least during the initial moment of cover removal, arranging the axial protrusion 109 in the opening 108 can prevent the penetration of the needle. In alternative embodiments, the opening 108 may be formed in the wall of the housing 112 , and the axial projection 109 may extend in a proximal direction from the proximal end of the removable cap 119 .

[0108] Steering FIG. 17A to FIG. 21 , a number of different embodiments of drug delivery devices incorporating a braking member will now be described. FIG. 17A to FIG. 21 The various elements of the drug delivery device shown are similar in function and / or structure to those described above in conjunction with Figures 1 to 12E 1. Such elements are designated with reference to the elements of the drug delivery device 10. Figures 1 to 12E The same reference numerals are used, but increased by 100 or multiples thereof. FIG. 17A to FIG. 21 The embodiments shown are Figures 1 to 12E Details of the structure and / or function of the embodiments described herein. FIG. 17A to FIG. 21 Although not shown, components of the drug delivery device 10 or variations of these components may be included in the combination FIG. 17A to FIG. 21 The various drug delivery devices described are described unless the design of a particular drug delivery device prevents the inclusion of these components or variations thereof.

[0109] The inclusion of a stop member is advantageous at least in drug delivery devices where, before delivery or in a storage state, the distal end of the plunger is spaced apart from the proximal end of the stopper by a gap. As an example, Fig.17AShown is a drug delivery device 210 in a pre-delivery or storage state, wherein the distal end of the plunger 226 is spaced apart from the proximal end of the stopper 224 by a certain gap (e.g., axial distance). The gap may be, for example, a result of a drug storage container being filled with a certain volume of medicine, design tolerances, and / or manufacturing considerations. Due to the gap, the plunger may be allowed to accelerate to a significant speed and impact the stopper with significant force when the plunger biasing member is released. This in turn may produce a pulse or shock wave, which may destroy or damage the wall of the drug storage container that may be made of glass, and / or scare the user in some cases. In addition, in an embodiment where the plunger biasing member is a spring, the output force of the plunger biasing member may be maximum at the initial moment after it is released. Therefore, the plunger may reach a significant speed before impacting the stopper.

[0110] The embodiments described below incorporate a brake member configured to resist the movement of the plunger in a distal direction at least during the time period when the plunger moves to reduce the initial gap between the plunger and the stopper. Due to the resistance provided by the brake member, the speed of the plunger can be reduced during the initial expansion of the plunger biasing member compared to the speed of the plunger when the plunger biasing member is allowed to expand freely without hindrance. The reduction in the speed of the plunger has the following effects: limiting the amount of force with which the plunger strikes the stopper, which in turn reduces the possibility of structural damage to the drug storage container and can also promote a more comfortable injection for the user or patient. In some embodiments, the brake member can stop resisting the movement of the plunger at or almost at the same time as the plunger strikes the stopper; while in other embodiments, the brake member can continue to resist the movement of the plunger in a distal direction after the plunger strikes the stopper (including, for example, the entire plunger stroke process). In some embodiments, the brake member can be operably (e.g., interactively) coupled to the plunger so that the movement of the plunger in the distal direction causes the plunger and / or the brake member to rotate around 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 brake member and to initiate 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. So configured, the brake member can operate like a damper because the brake member dissipates the kinetic energy associated with the movement of the plunger in the distal direction. In some embodiments, the brake member can convert the linear motion of the plunger into heat and / or other forms of energy in addition to the rotational motion.

[0111] Fig.17A and Fig. 17BA drug delivery device 210 is shown that includes a brake member 270 operably 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 the longitudinal axis A. The operable 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 threadingly engage 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 Fig. 17B By requiring the plunger 226 to rotate the brake member 270 when the plunger 226 moves in the distal direction, the brake member 270 can resist the 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 the 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 the 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 in which the plunger 226 reduces the gap between the plunger 226 and the stopper 224.

[0112] In order 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. Although the spline connection can prevent the plunger 226 from rotating, it can permit axial movement of the plunger 226. As an example, the splines 274 can be formed on the outer surface of the proximal end of the plunger 226 and can cooperate with splines formed on the inner surface of the housing 212, or a component that is fixed in rotation relative to the housing 212.

[0113] In the pre-delivery or storage state, the brake member 270 can be prevented from rotating, and therefore, 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 brake member 270. As an example, the drug delivery device 210 may include a lock 272 that selectively prevents the brake member 270 from rotating relative to the plunger 226 and / or the housing 212. As a more specific example, the drug delivery device 210 may include a lock 272 that has an initial position and a second position. In the initial position, the lock 272 prevents the brake member 270 from rotating (see Fig.17A and Fig. 17B ), when in the second position, the lock 272 does not prevent the brake member 270 from rotating. In some embodiments, the lock 272 can be a rotation lock. In some embodiments, the lock 272 can move in the proximal direction when moving from the initial position to the second position. Additionally or alternatively, the lock 272 can deflect outwardly in a radial direction when moving from the initial position to the second position. In some embodiments, such deflection can be achieved by constructing the lock 272 with a resilient (e.g., elastic) material that naturally returns to its original shape after removing a separate blocking component, and / or bends due to the camming 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.

[0114] In some embodiments, the lock 272 can be operably connected to the guard member 232 such that movement of the guard member 232 from the extended position to the retracted position causes the lock 272 to move from the initial position to the second position, thereby unlocking the rotation of the brake member 270 and thereby allowing the plunger biasing member 250 to expand axially to drive the plunger 226 in the distal direction, thereby expelling the drug from the drug storage container 220.

[0115] According to some embodiments, the drug delivery device 210 can operate as follows. Initially (e.g., before delivery or in a storage state), the lock 272 can be arranged in its initial position so that the lock 272 prevents the brake member 270 from rotating. At this time, the plunger biasing member 250 can advance the plunger 226 in the distal direction; however, due to the threaded engagement between the plunger 226 and the brake member 270 that is currently rotationally locked, the plunger 226 can be prevented from moving in the distal direction. Subsequently, the user can press the distal end of the protective member 232 against the injection site of the skin. This can cause the protective member 232 to retract into the housing 212 and move from the extended position to the retracted position. Due to this movement, the protective member 232 can push the lock 272 in the proximal direction so that the lock 272 moves from the initial position to the second position. In the second position, the lock 272 can be disengaged from the brake member 270 so that the brake member 270 is free to rotate. Next, 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 plunger 226 translates distally to rotate the brake member 270, 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. Therefore, at least at the moment when the distal end of the plunger 226 hits the proximal end of the stopper 224, the speed of the plunger 226 in the distal direction is less than that without the brake member 270. After contacting the stopper 224, the plunger biasing member 250 can push the plunger 226 in a distal direction, thereby causing the stopper 224 to move the drug out of the drug storage container 220, through the delivery member (e.g., needle) and into the patient's body. The brake member 270 can continue to rotate after the plunger 226 contacts the stopper 224, but this is not required.

[0116] Fig.18A and Fig.18B An embodiment of a drug delivery device 310 is shown that is similar in structure and / or function to Fig.17A and Fig. 17B The drug delivery device 210 in FIG. 2 is discussed below. Fig.18A and Fig.18B The drug delivery device 310 in Fig.17A and Fig. 17B Details of the structure and / or function of the drug delivery device 210 in FIG.

[0117] The drug delivery device 310 includes a plunger 326 and a brake member 370, which are operably coupled to each other so that the brake member 370 rotates the plunger 326 when the plunger 326 moves in the distal direction. As an example, the brake member 370 can have a threaded inner surface 370a that engages a threaded outer surface 326a at the proximal end of the plunger 326, see Fig.18B The brake member 370 can 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 can be a part of the housing 312, such as a rear cover 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. Therefore, the speed of the plunger 326 in the distal direction is less than if the brake member 370 is not included. After the plunger 326 has moved a certain distance in the distal direction, the threaded outer surface 326a of the plunger 326 can no longer contact the threaded inner surface 370a of the brake member 370. Once this occurs, the plunger 326 can stop rotating. In some embodiments, the axial length of the threaded inner surface 370a of the stopper 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. Therefore, the plunger 326 may stop rotating simultaneously or almost simultaneously when the plunger 326 hits the stopper 324.

[0118] In some embodiments, the plunger biasing member 350 can rotate with the plunger 326. In such embodiments, the proximal end of the plunger biasing member base 338 (which can be in contact with the proximal end of the plunger biasing member 350) can be configured as a bearing. For example, the proximal end of the plunger biasing member base 338 can be rotatably coupled to the brake member 370 and / or the rear housing 327 so that the plunger biasing member base 338 can rotate relative to the brake member 370 and / or the rear housing 327. Accordingly, the plunger biasing member 350, the plunger 326, and the plunger biasing member base 338 can rotate together in unison when the plunger 326 rotates due to the threaded connection between the plunger 326 and the brake member 370.

[0119] The stop member 370 can be coupled to the proximal end of the guard biasing member 335. As an example, the proximal end of the guard biasing member 335 can be seated against the stop member 370, see Fig.18B As a more specific example, the guard biasing member 335 can surround the distal end of the brake member 370, and the guard biasing member 335 can have a proximal end that seats against a flange extending radially outward from the brake member 370, see Fig.18B .

[0120] 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 Fig.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.

[0121] Fig.19A and Fig.19B An embodiment of a drug delivery device 410 is shown that is similar in structure and / or function to Fig.18A and Fig.18B The drug delivery device 310 in FIG. Fig.19A and Fig.19B The drug delivery device 410 and Fig.18A and Fig.18B Details of the structure and / or function of the drug delivery device 310 are provided.

[0122] 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 Fig.19B The inner surface of this flange may define a threaded inner surface 470 a of the brake member 470 .

[0123] 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 Fig.19B .

[0124] Although combined FIG. 17A to FIG. 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 Fig. 20 and Fig.21The described embodiments utilize a brake member that engages with the inner part of the plunger. Depending on the design of the drug delivery device, a brake member of this configuration may be advantageous. For example, in an embodiment where the plunger is hollow and the plunger biasing member is at least partially disposed within the plunger, configuring the brake member to engage with the inner part of the plunger may allow the plunger to be designed to have a larger diameter than would otherwise be possible. This in turn may allow a larger diameter spring to be used for the plunger biasing member. A larger diameter spring may output more force when driving the plunger to discharge the drug, which may be advantageous for example in delivering viscous drugs, such as certain biological drugs. In addition, a larger diameter spring may allow the axial length of the spring to be reduced without compromising the force output of the spring. A shorter axial length spring may facilitate a smaller and more compact design of the drug delivery device, which may be desirable for handling, transporting and / or storing purposes or other purposes.

[0125] Fig. 20 An embodiment of a drug delivery device 510 is shown that is similar in structure and / or function to Fig.19A and Fig.19B The drug delivery device 410 in FIG. 4 is discussed below. Fig. 20 The drug delivery device 510 and Fig.19A and Fig.19B Details of the structure and / or function of the drug delivery device 410 are provided.

[0126] The drug delivery device 500 may include a plunger 526 having a generally hollow tubular shape defining an axial chamber. In some embodiments, the axial chamber may extend through the entire plunger 526, such that the proximal and distal ends of the plunger 526 each have an opening communicating with the interior space of the plunger 526; while in other embodiments, the axial chamber may extend through a limited portion of the plunger 526, such that, for example, the distal end of the plunger 526 is closed.

[0127] The interior of the plunger 526 can be configured to accommodate the plunger biasing member 550 and also interface with the 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. Fig. 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 a proximally 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 proximally facing surface 578 of the nut 576 and can be configured to allow the plunger 526 to rotate 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 be in direct contact with the proximally facing surface 578 of the nut 576. The nut 576 can have a threaded inner surface 526a that threadably engages a threaded outer surface 570a of the brake member 570, as described in more detail below. Fig. 20 In the illustrated embodiment, the distal end of the nut 576 has an opening. In some embodiments, the plug can be disposed in this opening and can have a distal end configured to be received in a recess formed in the proximal end of the plug.

[0128] In some embodiments, the guide 574 and the nut 576 can be integrally formed to define a single one-piece structure. In other embodiments, the guide 574 and the nut 576 can be separate structures fixed to each other. In some 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, and 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.

[0129] The brake member 570 can be operably 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 elongated member having a proximal end fixed to the rear housing 527 and a distal end threadedly engaged with 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 threadedly engaged with the threaded inner surface 526a of the nut 576, see Fig. 20Due to the threaded coupling between the brake member 570 and the nut 576 of the plunger 526, the brake member 570 can rotate the plunger 526 about the longitudinal axis A as the plunger 526 moves in the distal direction. By requiring the plunger 526 to rotate, the brake member 570 can resist the movement of the plunger 526 in the distal direction and thereby reduce the speed of the plunger 526 in the distal direction compared to if the brake member 570 were omitted.

[0130] Before delivery or in storage (see Fig. 20 ), the plunger 526 may 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 may include a lock 572 having an initial position ( Fig. 20 ) and a second position, in which the lock 572 prevents the plunger 526 from moving in the distal direction when in the initial position, and in which the lock 572 does not prevent the plunger 526 from moving in the distal direction when in the second position. As a more specific example, the lock 572 may include one or more generally radially inwardly extending arms 582, which are received in one or more corresponding recesses 584 formed in the outer surface of the plunger 526 before delivery or in the storage state. The one or more radially inwardly extending arms 582 may be prevented from radially outwardly deflecting by a trigger ring 586, which surrounds the radially inwardly extending arms 582 before delivery or in the storage state. The trigger ring 586 may be operably coupled to a guard member (e.g., guard member 32) such that when the guard 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 may be achieved by forming radially inwardly extending arms 582 from a resilient (e.g., elastic) material that moves away from the trigger ring 586. Fig. 20 The trigger ring 586 naturally returns to its original shape when in the blocking position shown, and / or bends when the plunger 526 is moved in the distal direction by the plunger biasing member 550 due to the camming action between the radially inwardly extending arms 582 and the corresponding recesses 584 of the plunger 526. In some embodiments, the trigger ring 586 can be part of the guard member; while in other embodiments, the trigger ring 586 can be separate from the guard member.

[0131] According to some embodiments, drug delivery device 510 can operate as follows. Initially (e.g., before delivery or in storage), lock 572 can be arranged in its initial position so that radially inwardly extending arms 582 are received in corresponding recesses 584 in plunger 526 and are prevented from radially outwardly deflecting by trigger ring 586, as shown in FIG. Fig. 20As shown. In this configuration, the lock 572 can prevent the plunger 526 from moving in the distal direction under the biasing force of the plunger biasing member 550. Subsequently, the user can press the distal end of the protective member against the injection site of the skin. This can cause the protective member to retract into the housing in the proximal direction, and thereby push the trigger ring 586 away from its initial blocking position in the proximal direction. Therefore, the radially inwardly extending arms 582 can be radially biased outward, leaving their corresponding recesses 584. Subsequently or simultaneously, the plunger 526 can begin to translate in the distal direction 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 speed at which the plunger 526 moves in the distal direction is less than the situation when the plunger does not need to rotate due to the interaction between the plunger 526 and the brake member 570. 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, the plunger 526 can continue to rotate. In some embodiments, the rotation of the plunger 526 can be stopped simultaneously or nearly simultaneously when the plunger 526 hits the stopper disposed in the drug delivery container 520.

[0132] exist Fig. 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 so that the nut 576 is disposed within the interior space of the guide 574 together with the plunger biasing member 550. This can reduce the overall 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 seat for the distal end of the plunger biasing member 550.

[0133] Fig.21 An embodiment of a drug delivery device 610 is shown that is similar in structure and / or function to Fig. 20 The drug delivery device 510 in FIG. 1 is discussed below. Fig.21 The drug delivery device 610 in Fig. 20 Details of the structure and / or function of the drug delivery device 510 are provided.

[0134] about Fig.21In the illustrated embodiment, the plunger 626 may include a guide 674 and a center rod 690. The guide 674 may have a hollow tubular shape, the proximal end of which is open and the distal end of which is closed by a transverse wall 692. The transverse wall 692 may be perpendicular or substantially perpendicular to the longitudinal axis A and may define a seat for the distal end of the plunger biasing member 650. The center rod 690 may have a distal end fixed to the transverse wall 692 so that the center rod 690 and the guide 674 translate and rotate together. The center rod 690 may extend from the transverse wall 692 in a proximal direction through the interior space of the guide 674. The proximal end of the center rod 690 may be disposed adjacent to an opening in the proximal end of the guide 674, and in some embodiments, may 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.

[0135] like Fig.21 As shown, the brake member 670 can be fixed to the rear housing 627. The brake member 670 can have a generally annular shape and can surround the proximal end of the center rod 690. In addition, the threaded inner surface 670a of the brake member 670 can threadably engage the threaded outer surface 626a of the proximal end of the center rod 690. Due to this threaded connection, the movement of the plunger 626 (including its center rod 690) in the distal direction can cause the plunger 626 to rotate. As long as the threaded outer surface 626a of the center rod 690 remains in contact with the threaded inner surface 670a of the brake member 670, the plunger 626 can continue to rotate. In some embodiments, the rotation of the plunger 626 can stop at or about the same time as the plunger 626 hits the stopper in the drug storage container 620.

[0136] Before delivery or in storage (see Fig.21 ), the plunger 626 may 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 may include a lock 672 having an initial position ( Fig.21) and a second position, in which the lock 672 prevents the plunger 626 from moving in the distal direction when in the initial position, and in which the lock 672 does not prevent the plunger 626 from moving in the distal direction when in the second position. As a more specific example, the lock 672 may 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 which the distal end is secured to the proximal end of the guide 674 in the initial position, thereby preventing the plunger 626 from moving distally, and in which the distal end does not contact the proximal end of the guide 674 in the second position, thereby permitting the plunger 626 to move distally. The distal end of the lock 672 may be operably coupled to the guard member 632, so that when the guard member 632 is retracted in the proximal direction, the guard member 632 may directly or indirectly act on the distal end of the lock 672 to cause it to translate from the initial position to the second position. In some embodiments, such movement of the distal end of the lock 672 can be the result of a camming action between the distal end of the lock 672 and the proximal end of the guard member 632. When the lock 672 is in the second position, the plunger biasing member 650 can be allowed to expand, thereby driving the plunger 626 in a distal direction, which in turn causes the plunger 626 to rotate during at least a portion of the plunger stroke due to the threaded coupling between the plunger 626 and the brake member 670.

[0137] Although the above combined FIG. 17A to FIG. 21 The described embodiments use a threaded connection between the plunger and the brake member to produce relative rotation between the plunger and the brake member during the axial translation of the plunger, but other embodiments can achieve this via other means. For example, the plunger and the brake member may include one or more cooperating cam surfaces that interact with each other to convert relative axial movement into a combination of relative axial movement and relative rotational movement. In addition, in some embodiments, resistance to the distal movement of the plunger can be achieved via an air damper operably connected to the plunger. In some such embodiments, the plunger may not rotate when moving in the distal direction.

[0138] It will be appreciated that the apparatus and method according to the present disclosure may have one or more advantages over conventional techniques, any one or more of which may be present in a specific embodiment that conforms to the features of the present disclosure included in the embodiment. Other advantages not specifically listed herein may also be appreciated.

[0139] The above description describes various devices, assemblies, parts, subsystems and methods used in relation to drug delivery devices. Devices, assemblies, parts, subsystems, methods or drug delivery devices may further include or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also included. The drug can be in liquid form, in lyophilized form or in a form that can be reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0140] The drug will be contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug to be used for treatment. The primary container can be a vial, a cartridge, or a pre-filled syringe.

[0141] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor (such as granulocyte colony stimulating factor (G-CSF)), or the device can 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).

[0142] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. ESA is any molecule that stimulates erythropoiesis. In some embodiments, 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 to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include but are not limited to (Epoetin α), (darbepoetin alfa), (Epoetine δ), (methoxy polyethylene glycol-epoetin beta), MRK-2578, INS-22, (Epoetin ζ), (Epoetin β), (Epoetin ζ), (Epoetin α), Epoetin α Hexal, (Epoetin α), (Epoetine θ), (Epoetine θ), (Epoetin theta), Epoetin alpha, Epoetin beta, Epoetin iota, Epoetin omega, Epoetin delta, Epoetin zeta, Epoetin theta and Epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0143] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully humanized 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 activity mediated by 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 CD 22-specific IgG antibodies, such as a disulfide-linked dimer of a human-mouse monoclonal hLL2γ-chain and a human-mouse monoclonal hLL2κ chain, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS Registry No. 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, ICOSL, B7h and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies 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 targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (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 OX40 receptors; (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 alpha); (cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Somatropin, human growth hormone); (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti for the treatment of breast or gastric cancer TM (Trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of trastuzumab or another product containing trastuzumab; (Somatropin, human growth hormone); (adalimumab); (panitumumab), (Dinosutumab), (Dinosutumab), immunoglobulin G2 human monoclonal antibody 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); (epatuzumab, anti-CD22 mAb); Benlysta TM (lymphostat B, belimumab, anti-BlyS mAb); (tenecteplase, a t-PA analog); (methoxypolyethylene glycol-epoetin beta); (gemtuzumab ozogamicin); (efalizumab); (certolizumab pegol, 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); (viciluzumab); cantuzumab mertansine (huC242-DM1); (Epoetin beta); (Opreleukin, 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 alfa-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-anthrax protective antigen mAb); ABthrax TM ; (omalizumab); ETI211 (anti-MRSA mAb); IL-1trap (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 monoclonal antibody (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). ;

[0144] In some embodiments, the drug delivery device may contain or be used 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 (Lomosozumab-aqqg), another product comprising lomosozumab, and in other embodiments, comprising 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 contain or be used with rituximab, bixalomer, trebananib, ganitazumab, canatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with a drug for treating melanoma or other cancers. (talimogene laherparepvec) or another oncolytic HSV, or the device can be used with it, the other oncolytic HSV includes but is not limited to OncoVEXGALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device can include or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device can include a (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab or used together with it. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptor (such as but not limited to erenumab) and bispecific antibody molecules targeting CGRP receptor and other headache targets can also be delivered using the drug delivery device of the present disclosure. In addition, bispecific T cell engagers Antibodies (such as but not limited to (blinatumomab)) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with an APJ macromolecular agonist, such as but not limited to apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), anti-TNFα monoclonal antibody, In some embodiments, the drug delivery device may include a biosimilar of infliximab (Janssen Biotech, Inc.) or another product containing infliximab or used together with it. (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutyramido)-4-methylpentanamide, or another product comprising or for use with carfilzomib. In some embodiments, the drug delivery device may comprise a drug for treating various inflammatory diseases. (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast or used together with it. In some embodiments, the drug delivery device can contain Parsabiv for treating secondary hyperparathyroidism (sHPT) in chronic kidney disease (KD) dialysis patients. TM (Vicositriptyline HCl, KAI-4169) or another product comprising Vicositriptyline HCl or used together with it. In some embodiments, the drug delivery device may comprise ABP 798 (rituximab), / MabThera TM In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate of, or another product comprising an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)). In some embodiments, the drug delivery device may contain ABP 959 (eculizumab), In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate, or another product comprising a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecadimecarb (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile mechanism, or another product comprising a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotolacib (formerly AMG 510), KRAS G12C Small molecule inhibitors, or KRAS G12C In some embodiments, the drug delivery device may contain or be used with another product that is a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product that contains a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product that contains a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein (a) (also known as Lp(a)), or another product that contains a small interfering RNA (siRNA) that lowers lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1κ antibody), In some embodiments, the drug delivery device may contain Amjevita TM or Amgevita TM (formerly ABP 501) (mab anti-TNF human IgG1), In some embodiments, the drug delivery device may contain AMG 160, or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 (bispecific T cell engager) construct or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 133 or another product containing gastric inhibitory peptide receptor (GIPR) antagonists and GLP-1R agonists or use it together. In some embodiments, the drug delivery device may include AMG 171 or another product containing growth differentiation factor 15 (GDF15) analogs or use it together. In some embodiments, the drug delivery device may include AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) or use it together. In some embodiments, the drug delivery device may comprise AMG 199 or a bispecific T cell engager construct comprising a half-life extended (HLE) In some embodiments, the drug delivery device may contain or be used with another product designed to selectively turn on the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells, or another product (comprising anti-PD-1 x IL21 mutant protein and / or IL-21 receptor agonist). In some embodiments, the drug delivery device may contain or be used with AMG 330 or a product comprising anti-CD33 x anti-CD3 In some embodiments, the drug delivery device may contain or be used with another product of a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product (comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody) being studied for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 In some embodiments, the drug delivery device may contain or be used with another product comprising a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product (comprising a multispecific FAP x 4-1BB-targeting In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager, and the use 2+1 technology design. In some embodiments, the drug delivery device may contain AMG 562 or contain half-life extended (HLE) CD19 x CD3 In some embodiments, the drug delivery device may contain or be used with another product comprising a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product comprising Efavaleukin alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product comprising a CD3x epidermal growth factor receptor vIII (EGFRvIII) In some embodiments, the drug delivery device may comprise AMG 673 or comprise anti-CD33 x anti-CD3 with extended half-life (HLE). In some embodiments, the drug delivery device may comprise AMG 701 or comprise half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 757 or comprise half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 910 or comprise a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 Another product of the (bispecific T cell engager) construct is used together with it.

[0145] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, which still fall within the scope of the claims defining the invention disclosed herein.

[0146] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes and combinations are deemed to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: case; a drug storage container fixed relative to the housing and comprising an inner surface and a plug slidable along the inner surface; offset member; a plunger operably coupled to the biasing member and configured to: selectively rotates from an initial rotational position to a second rotational position under the biasing force applied by the biasing member, and After rotating from the initial rotational position to the second rotational position, linearly translating in a distal direction to drive the stopper through the medicinal storage container; and a plunger guide fixedly coupled to the housing and having an annular wall, the plunger being at least partially disposed within the plunger guide, wherein the plunger comprises a cam follower and the plunger guide comprises a cam formed by a proximally facing surface of the annular wall, and The biasing force of the biasing member urges the cam follower against the cam to urge the plunger to rotate from the initial rotational position toward the second rotational position.

2. The drug delivery device of claim 1, the biasing member being at least partially disposed within the plunger.

3. The drug delivery device of claim 2, the biasing member comprising a compression spring.

4. The drug delivery device according to any one of claims 2 or 3, wherein: The plunger is configured to translate linearly in the distal direction when rotated from the initial rotational position to the second rotational position.

5. The drug delivery device according to any one of claims 1 to 3, wherein: The plunger is rotationally fixed relative to the housing after being rotated from the initial rotational position to the second rotational position.

6. The drug delivery device according to any one of claims 1 to 3, wherein: The cam follower is formed by at least one projection extending outwardly from the plunger.

7. The drug delivery device of claim 6, wherein: An opening is formed in the annular wall distal to the proximally facing surface, and wherein the opening slidably receives the projection after the plunger is rotated from the initial rotational position to the second rotational position.

8. The drug delivery device according to any one of claims 1 to 3, 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; as well as A guard is movably positioned adjacent the opening in the housing and operably coupled to the release member.

9. The drug delivery device of claim 8, wherein: The guard has an extended position in which the guard at least partially extends through the opening in the housing and a retracted position in which the guard is positioned away from the extended position toward the housing.

10. The drug delivery device of claim 9, wherein: The release member is prevented from rotating in at least one rotational direction when the guard is in the extended position, and wherein the release member is permitted to rotate in the at least one rotational direction when the guard is in the retracted position.

11. The drug delivery device according to any one of claims 9 or 10, wherein: Moving the guard from the extended 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 applied by the biasing member.

12. The drug delivery device of any one of claims 1 to 3, comprising an indicator configured to generate an audible signal indicating end of drug delivery, the indicator being configured to rotate with the plunger from the initial rotational position to the second rotational position.

13. The drug delivery device of claim 12, wherein: The indicator is configured to translate linearly in a proximal direction when rotated from the initial rotational position toward the second rotational position.

14. The drug delivery device of claim 13, wherein: The indicator is configured to rotate from the second rotational position to a third rotational position independently of the plunger.

15. The drug delivery device of claim 14, wherein: The indicator is configured to translate linearly in the proximal direction when rotated from the second rotational position toward the third rotational position.

16. The drug delivery device of any one of claims 14 or 15, wherein: The indicator contacts the housing or a structure fixed relative to the housing to generate an audible signal after reaching the third rotational position.

17. The drug delivery device of claim 16, wherein: The indicator contacts a distally facing surface of the housing or a structure fixed relative to the housing in the third rotational position to generate the audible signal.

18. The drug delivery device of any one of claims 1 to 3, wherein: The housing includes an opening, and wherein the medicinal storage container includes a delivery member having an insertion end configured to extend at least partially through the opening.

19. The drug delivery device of claim 18, further comprising a guard movably positioned adjacent the opening.

20. The drug delivery device of claim 19, wherein: The guard has an extended position in which the guard at least partially extends through the opening in the housing and a retracted position in which the guard is positioned away from the extended position toward the housing.

21. The drug delivery device of claim 20, comprising a guard biasing member configured to bias the guard toward the extended position.

22. The drug delivery device of claim 21, comprising an indicator operably coupled to the guard biasing member and configured to generate an audible signal indicating the end of drug delivery.

23. The drug delivery device of claim 22, comprising a second cam and a second cam follower, wherein: The indicator includes a second cam follower.

24. The drug delivery device of claim 23, wherein: The biasing force of the guard biasing member urges the second cam follower against the second cam to urge the indicator to rotate relative to the housing.

25. The drug delivery device of claim 24, wherein: The indicator is configured to rotate with the plunger from the initial rotational position to the second rotational position and to rotate independently of the plunger from the second rotational position to a third rotational position.

26. The drug delivery device of claim 25, wherein: The indicator contacts the housing or a structure fixed relative to the housing to generate an audible signal after reaching the third rotational position.

27. The drug delivery device of any one of claims 1 to 3, wherein the drug storage container is filled or pre-filled with a drug, and wherein, The drug includes one of the following: a drug containing human IgG1κ antibody, a drug containing small interfering RNA (siRNA) that reduces lipoprotein (a), Efavaleukin α, Eloumab, and a drug containing a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist.

28. The drug delivery device of claim 7, wherein: After the protrusion is received in the opening, the protrusion is configured to translate linearly in a distal direction through the opening.

29. The drug delivery device of any one of claims 1 to 3, wherein: The plunger guide includes an opening formed in the annular wall, and wherein the proximally facing surface defines a portion of a circumference of the opening.

30. The drug delivery device of any one of claims 1 to 3, wherein: The proximally facing surface is inclined, and wherein the biasing force of the biasing member urges the cam follower to slide along the proximally facing surface to urge the plunger to rotate from the initial rotational position toward the second rotational position.

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