Drug delivery devices and related methods

Abstract

A drug delivery device and related methods are disclosed. The drug delivery device may include a housing having an opening and a longitudinal axis; a drug storage container comprising a delivery member having an insertion end configured to at least partially extend through the opening during a delivery condition; a plunger movable in a distal direction along the longitudinal axis to expel medicament from the medicament storage container through the delivery member during the delivery condition; a plunger biasing member configured to bias the plunger in the distal direction; a guard positioned adjacent to the opening and having a first axial position relative to the housing prior to the delivery state and a second axial position relative to the housing during the delivery state; and a proximal biasing member, which may be configured to selectively bias the guard in the distal direction.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 585,949, filed September 27, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to drug delivery devices, and more specifically to devices for automatically injecting drugs into patients. Background Technology

[0003] Some people may feel uncomfortable with needles or when using needles for injections. This widespread aversion to needles, along with other health and safety concerns, has spurred the development of drug delivery devices that conceal the needle or other insertion component before use and automate various aspects of the injection process. Such devices offer several advantages compared to traditional forms of drug delivery, including, for example, delivery via conventional syringes.

[0004] Some drug delivery devices (including, for example, some autoinjection devices) may include a spring-biased guard to conceal the needle before and / or after injection. To expose the needle, the user presses the guard against the skin at the injection site to move it from an extended position to a retracted position, exposing or making the needle tip exposed for insertion. During injection, the user continues to press the guard against the skin to hold it in the retracted position. This requires the user to apply a force to counteract the biasing force of the guard's spring during injection. This can be challenging for at least some people, including those performing self-injection and / or those with limited familiarity with injection. In some cases, the force of the guard's spring can cause or prompt the user to lift the device off the skin before the drug delivery is complete, potentially resulting in incomplete drug delivery. Furthermore, maintaining the counteracting force may cause the user to unintentionally move the needle laterally relative to the skin, which can cause patient discomfort.

[0005] This disclosure describes drug delivery devices and related methods for addressing one or more of the needs and challenges mentioned herein, as well as other related needs and challenges. Summary of the Invention

[0006] One aspect of this disclosure provides a drug delivery device. The drug delivery device may include a housing, a drug storage container, a protective element, a plunger, a plunger biasing member, and a proximal biasing member. The housing may have an opening and a longitudinal axis. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The plunger may be distally movable along the longitudinal axis to expel drug from the drug storage container through the delivery member during a delivery state. The plunger biasing member may be configured to bias the plunger distally. The protective element is positioned adjacent to the opening and has a first axial position relative to the housing before the delivery state and a second axial position relative to the housing during the delivery state. The proximal biasing member may be configured to selectively bias the protective element distally.

[0007] Another aspect of this disclosure provides a method. This method may include providing a drug delivery device comprising: a housing having an opening and a longitudinal axis; a drug storage container having an insertion end configured to extend at least partially through the opening during a delivery state; a plunger movable distally along the longitudinal axis to expel drug from the drug storage container via a delivery member during the delivery state; a plunger biasing member configured to bias the plunger distally; a guard positioned adjacent to the opening and having a first axial position relative to the housing before the delivery state and a second axial position relative to the housing during the delivery state; and a proximal biasing member configured to selectively bias the guard distally. The method may further include: moving the guard proximally from the first axial position to the second axial position when the proximal biasing member biases the guard distally. In addition, the method may include holding the guard in a second axial position when the proximal biasing member stops at least temporarily or biases the guard to a lesser extent toward the distal direction. Attached Figure Description

[0008] We believe that this disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. To illustrate other elements more clearly, some drawings may be simplified by omitting selected elements. In some drawings, such omission of elements does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it can be clearly indicated in the corresponding written description. Furthermore, not all drawings need to be drawn to scale.

[0009] Figure 1A This is a perspective view of a drug delivery device in a storage state according to different embodiments.

[0010] Figure 1B yes Figure 1A A three-dimensional view of the drug delivery device in the pre-delivery state.

[0011] Figure 1C yes Figure 1A A three-dimensional view of the drug delivery device in delivery mode.

[0012] Figure 2 yes Figure 1A A cross-sectional view of the drug delivery device in the delivery state.

[0013] Figure 3A yes Figure 1A A disassembled and assembled view of the drug delivery device.

[0014] Figure 3B yes Figure 3A The disassembled and assembled view of the drive mechanism in the image.

[0015] Figure 4A yes Figure 3B A three-dimensional view of the plunger guide in the middle.

[0016] Figure 4B yes Figure 4A A top view of the plunger guide in the middle.

[0017] Figure 5A and Figure 5B yes Figure 3B A three-dimensional view of the release component.

[0018] Figure 6A and Figure 6B yes Figure 3B A three-dimensional view of the rotatable component.

[0019] Figure 7A Showing Figure 3A A side view of a portion of the drug delivery device (i.e., the drive mechanism and protective components) in its stored state.

[0020] Figure 7B Showing the status Figure 7A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0021] Figure 8A Showing Figure 3A A side view of a portion of the drug delivery device (i.e., the drive mechanism and protective components) in the initial delivery state. Figure 8A The rotatable components are shown as being semi-transparent.

[0022] Figure 8B Showing the status Figure 8A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0023] Figure 9A Showing Figure 3A A portion of the drug delivery device (i.e., the drive mechanism and protective components) is located in Figure 8A The side view of the delivery state section after the delivery state section.

[0024] Figure 9B Showing the status Figure 9A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0025] Figure 10A Showing Figure 3A A portion of the drug delivery device (i.e., the drive mechanism and protective components) is located in Figure 9A The side view of the delivery state section after the delivery state section.

[0026] Figure 10B Showing the status Figure 10A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0027] Figure 11A Showing Figure 3A A side view of the various parts of the drug delivery device (i.e., the drive mechanism and the protective components) in the post-delivery state. Figure 8A The rotatable components are shown as being semi-transparent.

[0028] Figure 11B Showing the status Figure 11A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0029] Figure 12A This is an exploded assembly view of another embodiment of the drug delivery device.

[0030] Figure 12B yes Figure 12A The disassembled and assembled view of the drive mechanism in the image.

[0031] Figure 13 yes Figure 12B A three-dimensional view of the release component.

[0032] Figure 14A and Figure 14B yes Figure 12B A three-dimensional view of the rotatable component.

[0033] Figure 15 yes Figure 12B A 3D view of the transmitter.

[0034] Figure 16AShowing Figure 12A A side view of the various parts of the drug delivery device (i.e., the drive mechanism, protective components, container holder, and rear end cap) in the storage state.

[0035] Figure 16B Showing the status Figure 16A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0036] Figure 17A Showing Figure 12A A side view of the drug delivery device in the initial stage of delivery, showing the various parts (i.e., drive mechanism, protective components, container holder, and rear cover) in the delivery state.

[0037] Figure 17B Showing the status Figure 17A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0038] Figure 18A Showing Figure 12A The various parts of the drug delivery device (i.e., the drive mechanism, protective components, container holder, and rear end cap) are in Figure 17A The side view of the delivery state section after the delivery state section.

[0039] Figure 18B Showing the status Figure 18A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0040] Figure 19 Showing Figure 12A The various parts of the drug delivery device (i.e., the drive mechanism and protective components) are in Figure 18A The side view of the delivery state portion after the delivery state portion. The rotatable component of the drive mechanism in... Figure 19 It is described as being semi-transparent.

[0041] Figure 20A Showing Figure 12A A side view of the various parts of the drug delivery device (i.e., the drive mechanism, protective components, container holder, and rear end cap) in the post-delivery state.

[0042] Figure 20B Showing the status Figure 20A A side view of the plunger guide and a portion of the rotatable component (shown in dashed lines) in the indicated state.

[0043] Figure 21A This is an exploded assembly view of another embodiment of the drug delivery device.

[0044] Figure 21B yes Figure 21A The disassembled and assembled view of the drive mechanism in the image.

[0045] Figure 22A and Figure 22B yes Figure 21B A three-dimensional view of the rotatable component.

[0046] Figure 23 yes Figure 21A A cross-sectional view of a portion of the shell.

[0047] Figure 24 Showing Figure 21A A side view of the various parts of the drug delivery device (i.e., the drive mechanism, protective components, rotatable components of the housing, and container holders) in the storage state.

[0048] Figure 25 Showing Figure 21A A side view of the drug delivery device in the initial stage of delivery, showing the various parts (i.e., the drive mechanism, protective components, rotatable components of the housing, and container holder) in the delivery state.

[0049] Figure 26 Showing Figure 21A The various parts of the drug delivery device (i.e., the drive mechanism, protective components, rotatable components of the housing, and container holders) are in Figure 25 The side view of the delivery state section after the delivery state section.

[0050] Figure 27 Showing Figure 21A A side view of the drug delivery device in its initial post-delivery state, comprising the drive mechanism, protective components, rotatable engagement components of the housing, and container holder.

[0051] Figure 28 Showing Figure 21A The various parts of the drug delivery device (i.e., the drive mechanism, protective components, rotatable components of the housing, and container holders) are in Figure 27 A side view of the post-delivery state after the initial part of the post-delivery state. Detailed Implementation

[0052] This disclosure generally relates to drug delivery devices that can be operated by a user to administer medication or, in the case of a patient, self-administer medication. Different features are disclosed to simplify, automate, and / or facilitate certain aspects of drug injection, such as features used in automated injection devices, intravitreal injection devices, or other automated or partially automated drug delivery devices (collectively, automated injection devices). For example, these features may include features such as automatically covering the needle in a pre- and / or post-delivery state, automatically activating the drive mechanism, and automatically informing the user that drug delivery has been completed. One or more of these features may be powered by one or more springs that the user may need to compress or otherwise charge by pressing the guard against the injection site, for example, to expose the distal end of the needle for insertion into the injection site. This disclosure provides different configurations and arrangements that reduce the burden on the user of maintaining or helping to maintain one or more of these springs in a compressed or charged state before, during, and / or after drug delivery. For example, these configurations and arrangements may reduce or eliminate the amount of force that the user must exert on the drug delivery device to hold the guard in the retracted position during drug delivery. Therefore, the operation of the drug delivery device can be simplified and made more reliable for the user. Furthermore, because the user can, for example, feel the protective device pushing against the skin, the likelihood of removing the needle from the injection site midway through drug delivery is reduced. This increases the probability of successful and complete drug delivery. In addition, the reduced retention force requirement decreases the possibility that the user may unintentionally move the needle laterally relative to the injection site, potentially causing patient discomfort. These and other advantages will be apparent to those skilled in the art who review this disclosure.

[0053] Figures 1 through 3 illustrate several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a pharmaceutical agent or drug product. The drug product may be, but is not limited to, various biological agents, such as peptides, peptide bodies, or antibodies. The drug product may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0054] Different implementations and configurations of the drug delivery device 10 are possible. The current embodiment of the drug delivery device 10 is configured as a disposable injection device. In other embodiments, the drug delivery device 10 may be configured as a reusable injection device for multiple uses. The drug delivery device 10 is operable for self-administration by a patient or by a caregiver or a formally trained healthcare provider (e.g., a physician or nurse). The example drug delivery device shown in the figures may take the form of an automated injection device or a pen-type injection device, and thus can be held in the user's hand for the duration of drug delivery, and may also be or alternatively adapted to other drug delivery devices and / or configurations.

[0055] The configuration of the different components included in the drug delivery device 10 can depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state may have several sub-states or stages. The storage state may correspond to... Figure 1A The configuration of the drug delivery device 10 includes a removable cap 19 in a storage position. In some embodiments, the storage state may exist between the time the drug delivery device 10 leaves the manufacturing plant and the time the patient or other user removes the removable cap 19. Alternatively or additionally, the storage state may correspond to the time between the user removing the drug delivery device 10 from the secondary packaging and the user removing the removable cap 19, and may be referred to as the unpacking state. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after the removable cap has been removed but before the user activates the drive mechanism. This may include the time after the user has removed the removable cap (including when the user first places the drug delivery device 10 against the injection site) but before the start of drug administration, such as... Figure 1B As seen in the diagram. The delivery state can correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is in progress, such as... Figure 1C The delivery state may additionally include the configuration of the drug delivery device 10 before the plunger begins to expel the drug from the drug delivery device 10, even after the plunger biasing member has been released. The post-delivery state may correspond to the configuration of the drug delivery device 10 when drug delivery is completed and / or when the stopper is positioned at the end of delivery or end of administration position in the drug storage container.

[0056] As shown in Figures 1 to 3, the drug delivery device 10 may include a housing or casing 12. In some embodiments, the size and dimensions of the casing 12 may be configured to allow a person to hold the injection device 10 with one hand. The casing 12 may have a generally elongated shape, such as a cylindrical shape, and extend along the longitudinal axis A between the proximal and distal ends. Opening 14 ( Figure 2 An insertion end 28 of the delivery member 16 may be formed at the distal end to allow the delivery member 16 to extend to the exterior of the housing 12. A transparent or translucent inspection window 17 may be positioned on the wall of the housing 12 to allow the user to view the components inside the drug delivery device 10, including the drug storage container 20. Observing the drug storage container 20 through the window 17 allows the user to confirm that drug delivery is in progress and / or has been completed. Before using the drug delivery device 10, a removable cover 19 may cover the opening 14 at the distal end of the device, and in some embodiments, the removable cover may include a gripper 13. Figure 3AThe gripper is configured to assist in removing a removable sterile barrier 21 (e.g., a rigid needle protector (RNS), a non-rigid needle protector (nRNS), etc.) mounted on the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally engage or otherwise mechanically engage the removable sterile barrier 21 to pull the removable sterile barrier 21 together with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Therefore, removing the removable cap 19 has the effect of removing the removable sterile barrier 21 from the delivery member 16.

[0057] In some embodiments, housing 12 may include two separate and interconnected structures: a rear end cap 23 (e.g., a rear seal) at the proximal end of drug delivery device 10; and a tubular housing 25 that extends substantially entirely along the length of drug delivery device 10 and defines an opening 14. Alternatively or additionally, housing 12 may include fewer or more components, such as a two-piece tubular housing having a front and a rear portion. Tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and rear end cap 23 may have a generally hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, rear end cap 23 and tubular housing 25, along with any components to be positioned therein, may be assembled together to define different sub-assemblies, such as drive mechanism 30 (…). Figure 3B In some embodiments, the different sub-components are assembled independently of each other and 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-described assembly stages may be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed as a single piece, such that the housing 12 is defined by a single integral structure integrating the rear cover and the tubular housing into a single component.

[0058] A drug storage container 20 is disposed within the internal space of the housing 12 and configured to contain a drug. The drug storage container 20 may be pre-filled by the manufacturer and transported to a location where it will be combined with the rest of the drug delivery device 10. For example, the drug 22 may be dispensed and / or provided to a patient in more than one use case, such as as a pre-filled syringe or as an automated injection device including a pre-filled syringe. By utilizing the same or similar syringe components in either case, at least one of the above steps (e.g., filling, labeling, packaging, transporting, and dispensing) can be streamlined or simplified for two different use cases. As another example, where multiple use cases utilize some or all of the same syringe components, some administrative approaches to marketing and / or distributing drugs can be streamlined or simplified for at least one of the multiple use cases.

[0059] The housing 12 may be pre-loaded with the drug storage container 20 by the manufacturer, or alternatively, by the user before using the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal orifice or reservoir. This wall may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 such that it can move distally along a longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be constructed of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the inner surface 15 of the wall of the drug storage container 20, thereby preventing or inhibiting leakage of the drug 22 through the stopper 24 during movement. Distal movement of the stopper 24 displaces 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 a plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, plunger 26 and stopper 24 are initially spaced apart from each other with an axial clearance. Upon actuation of drive mechanism 30, plunger 26 moves distally to close the axial clearance and contact stopper 24. Subsequent distal movement of plunger 26 drives stopper 24 distally to dispense drug 22 from drug storage container 20. In an alternative embodiment, stopper 24 and plunger 26 may initially contact each other or be connected to each other, for example via a threaded connection, such that they move together from the moment plunger 26 begins to move. Once stopper 24 has moved, it may continue to move distally until it contacts the proximal portion of the inner surface 15 of the wall of drug storage container 20. This position of stopper 24 may be referred to as the end of dosing or delivery end position and may correspond to the time when drug 22 is delivered to the patient and is essentially completed.

[0060] In some embodiments, the volume of drug 22 included in the reservoir of drug storage container 20 may be equal to 1 mL, or equal to about (e.g., ± 10%) 1 mL, or equal to 2.5 mL, or equal to about (e.g., ± 10%) 2.5 mL, or equal to 3 mL, or equal to about (e.g., ± 10%) 3 mL, or less than or equal to about (e.g., ± 10%) 1 mL, or less than or equal to about (e.g., ± 10%) 2 mL, or less than or equal to about (e.g., ± 10%) 3 mL, or less than or equal to about (e.g., ± 10%) 4 mL, or less than about (e.g., ± 10%) 5 mL, or less than or equal to about (e.g., ± 10%) 10 mL, or in the range of about (e.g., ± 10%) 1-10 mL, or in the range of about (e.g., ± 10%) 1-5 mL, or in the range of about (e.g., ± 10%) 1-4 mL. The range is between 1 mL, or between approximately (e.g., ±10%) 1-3 mL, or between approximately (e.g., ±10%) 1-2.5 mL.

[0061] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28. The insertion end 28 may include other sharp tips with pointed geometries, thereby allowing 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 may be hollow and have internal passageways. One or more openings may be formed in the insertion end 28 to allow drug to flow from the delivery member 16 into the patient.

[0062] In one embodiment, the drug storage container 20 may be a pre-filled syringe with a peg-type hollow metal needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In still other embodiments, the drug storage container 20 may be a needleless cartridge and therefore may not initially be in fluid communication with the delivery member 16. In this embodiment, the drug storage container 20 may be moved toward the proximal end of the delivery member 16 during operation of the drug delivery device 10, or conversely, such that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0063] The drug storage container 20 can be fixed relative to the housing 12 so that once installed in the housing 12, it will not move relative to the housing 12. Thus, in the pre-delivery, delivery, and post-delivery states, the insertion end 28 of the delivery member 16 can permanently extend through the opening 14 in the housing 12. For example, as... Figure 2 As shown, in the delivery state, the insertion end 28 of the delivery member 16 extends beyond the distal end of the housing 12 that defines the opening 14. In some other states, including Figure 2 In the storage configuration shown, the insertion end 28 of the delivery member 16 may extend beyond the distal end of the housing 12, but is covered or protected by a removable cap 19, a sterile barrier 21, and / or a protective element 32 that surround the delivery member 16 and prevent or reduce the possibility of accidental or premature needle puncture.

[0064] The drug delivery device 10 may further include a container holder 31 configured to secure the drug storage container 20 relative to the housing 12, for example, by preventing distal movement of the drug storage container 20 during plunger 26 actuation. The container holder 31 may have a hollow, generally cylindrical or tubular shape centered on a longitudinal axis A, and the drug storage container 20 may be partially or completely disposed within the container holder 31. The distal end of the container holder 31 may include one or more inwardly projecting flanges 33 that abut against a shoulder portion of the drug storage container 20, thereby preventing distal movement of the drug storage container 20 during plunger 26 actuation. In some embodiments, each of the flanges 33 may include an arcuate inclined surface 33a that substantially matches the arcuate shape of the shoulder portion of the drug storage container 20. As a more specific example, when the drug storage container 20 is inserted into the container holder 31, the flanges 33 cooperate to support the shoulder portion of the drug storage container 20, thereby limiting or preventing the drug storage container 20 from traveling distally. The housing 12 may include a plurality of locking slots, each receiving a corresponding flange of the flanges 33 of the container holder 31 to prevent and / or limit relative movement between the respective components 12 and 31. Thus, when fully assembled, the storage container 20, the container holder 31, and the housing 12 are all substantially or completely fixed relative to each other.

[0065] The drug delivery device 10 may further include a protective mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used for injection. The protective mechanism may include a protective member 32 movably disposed at or near the distal end of the housing 12, adjacent to the opening 14. The protective member 32 may have a hollow and generally tubular or cylindrical portion 32a centered on a longitudinal axis A. The protective member 32 may also have a pair of longitudinally extending arms 32b and 32c extending proximally from the cylindrical portion 32a. The protective member 32 may further include a distal end 32d and a proximal end 32e, the distal end typically including the cylindrical portion 32a, the proximal end being defined by the longitudinally extending arms 32b and 32c. The longitudinally extending arms 32b and 32c may be substantially or completely received within the housing 12 such that neither portion protrudes from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. For example, the protective member 32 may be configured to move relative to the housing 12 such that portions of the protective member 32 are received within the housing 12 in some states and extend out of the housing 12 in other states.

[0066] The protective member 32 can be configured to move along the longitudinal axis A, having at least a first axial position or extended position relative to the housing 12 and a second axial position or retracted position relative to the housing 12. Additional axial positions of the protective member 32 relative to the housing 12 are possible. The first axial position of the protective member 32 may be located distal to the second axial position of the protective member 32. The protective member 32 may be positioned in the first axial or extended position before a delivery state (including, for example, during a storage state and / or a pre-delivery state) and / or after a delivery state (including, for example, during a post-delivery state). The protective member 32 may be positioned in the second axial or retracted position, for example, during a portion of or the entire delivery state. In some embodiments, the protective member 32 may be in the pre-delivery state when moving from the first axial position to the second axial position.

[0067] In the first axial position, the length X of the cylindrical portion 32a of the protective member 32 (see...) Figure 1B The cylindrical portion 32 can extend through the opening 14 on the housing 12, such that at least this portion of the protective member 32 is located outside the housing 12. In the second axial position, the length Y of the cylindrical portion 32a (see...) Figure 1C The length X can extend through the opening 14 on the housing 12, where the value of X is greater than that of Y. The length X can be any suitable value, including, for example, 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or other values. The length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or other values. Figure 1BAn example of a pre-delivery state is shown, in which the protective member 32 is in a first axial or extended position, and the length X of the exposed portion of the protective member 32 can be approximately 5 mm to 11 mm. Figure 1C An example of a delivery configuration is shown, in which the protective member 32 is in a second axial or retracted position, and the length Y of the exposed portion of the protective member 32 is approximately 0 mm to 2 mm (such that the distal end 32d of the protective member 32 is flush or substantially flush with the opening 14 of the housing 12). In some embodiments, the distance Y is greater than 0 (e.g., 1 mm) to help ensure that the device 10 can be activated before the protective member is flush or substantially flush with the housing 12.

[0068] The protective member 32 can also be configured to move in the opposite direction, i.e., from a second axial position to a first axial position. When moving from the first axial position to the second axial position, the protective member 32 can be linearly translated proximally along the longitudinal axis A; and when moving from the second axial position to the first axial position, the protective member 32 can be linearly translated distally along the longitudinal axis A. At least in the first axial position, the protective member 32 can extend beyond and around the insertion end 28 of the delivery member 16. In embodiments where the insertion end 28 of the delivery member 16 extends through the opening 14 on the housing 12 in a pre-delivery state and / or storage state, moving the protective member 32 from the first axial position to the second axial position (e.g., by pressing the distal end of the protective member 32 against the patient's skin 5 at the injection site) allows the insertion end 28 of the delivery member 16 to be inserted into the patient's skin 5.

[0069] During delivery, the protective element 32 may remain stationary relative to the user's skin 5, while the housing 12 and / or components disposed therein may move relative to the protective element 32 and the skin 5. However, this disclosure relates to movement, retraction, translation, and pressing of the protective element 32. These references and descriptions may be understood to refer to relative movement between the protective element 32 and the housing 12, regardless of which component (the protective element 32 or the housing 12) moves relative to the user's skin 5.

[0070] In some embodiments, the protective member 32 may be fixed or restricted in a rotational sense relative to the housing 12. Thus, while the protective member 32 may be able to translate linearly relative to the housing 12, the protective member 32 may be substantially or completely prevented from rotating relative to the housing 12.

[0071] In alternative embodiments, the drug storage container 20 may be movably coupled to the housing 12, allowing the drug storage container 20 to move relative to the housing 12 during operation of the drug delivery device 10. In some such alternative embodiments, in a pre-delivery state, the insertion end 28 of the delivery member 16 may retract into the opening 14 in the housing 12. Subsequently, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 in the housing 12 for insertion into the patient. In some embodiments, this movement may result from the drug storage container 20 being driven distally relative to the housing 12.

[0072] The drive mechanism 30 may be partially or completely housed within the housing 12. Typically, the drive mechanism 30 may be configured to store energy and, upon or in response to user activation of the drive mechanism 30, release or output the stored energy to drive the plunger 26 to expel the drug 22 through the delivery member 16 from the drug storage container 20 into the patient. 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, storing electrical or chemical potential energy, or a combination of mechanical, electrical, and / or chemical potential energy. Typically, upon activation, the drive mechanism 30 can convert potential energy into kinetic energy to move the plunger 26.

[0073] like Figure 3B As shown, in some embodiments, the drive mechanism 30 may include a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, a release member 52, a plunger guide 60, a proximal biasing member 35, and a rotatable member 37. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) initially held in a stored state. In the stored state, the plunger biasing member 50 can be compressed such that its axial length is shorter than its axial length in its natural or non-stored state, thus applying a distal biasing force to the plunger 26 and a proximal biasing force to one or more other components (which may include the release member 52 in some embodiments). When released, the plunger biasing member 50 may attempt to extend to its natural axial length and thus push the plunger 26 distally, and in some embodiments, push the release member 52 proximally depending on the operating state.

[0074] The plunger guide 60 may have a hollow and generally cylindrical or tubular shape, and may be centered on a longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger guide 60 may be larger than the outer diameter or other outer dimension of the distal end of the plunger guide 60. The plunger guide 60 may be fixedly coupled to the housing 12 such that the plunger guide 60 is substantially and / or generally immovable relative to the housing 12, or at least fixed or locked in a rotational sense relative to the housing 12. For example, the plunger guide 60 may include a locking tab or other protrusion whose size and shape are configured and / or aligned to be received within a locking key or other mating structure formed in the housing 12. As another example, both the plunger guide 60 and the housing 12 may include a pair of corresponding components that cooperate to prevent relative rotation between the plunger guide 60 and the housing 12, such that the plunger guide 60 is fixed or locked in a rotational sense relative to the housing 12. Alternatively or additionally, an annular ridge formed on the outer surface of the plunger guide 60 may form a frictional engagement with the inner surface of the housing 12 to resist or prevent rotation between the plunger guide 60 and the housing 12. Additional features and functions of the plunger guide 60 are discussed below.

[0075] In some embodiments, at least a portion of the release member 52 may be radially positioned between the plunger 26 and the plunger guide 60, such that the plunger 26 may be at least partially disposed within the release member 52, and the release member 52 may be at least partially disposed within the plunger guide 60, as... Figure 2 and Figure 3A As seen in the previous embodiment. In other embodiments, at least a portion of the plunger guide may be radially positioned between the plunger and the release member, such that the plunger may be at least partially disposed within the plunger guide and the plunger guide may be at least partially disposed within the release member.

[0076] like Figure 3B As seen, the plunger 26 can have a hollow and generally cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space sized to accommodate the plunger biasing member 50 therein. The annular wall 39 can be made of any suitable material, such as metal or plastic. It may be advantageous to make the annular wall 39 of a metal (such as steel or aluminum) to, for example, minimize the thickness of the annular wall 39.

[0077] As described in more detail below, the plunger 26 can be configured to selectively rotate relative to the housing 12 and translate linearly relative to the housing 12 during operation of the drug delivery device 10, including, for example, during delivery.

[0078] The plunger 26 may be constructed from multiple interconnected components or alternatively have a one-piece construction. In some embodiments, the plunger 26 is constructed from three separate and interconnected structures: a top ring 45 defining the proximal end of the plunger 26; a base 47 defining the distal end of the plunger 26; and a hollow rod 46 located between the top ring 45 and the base 47 and rigidly connecting the two. The top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other, such that these components are immovable relative to each other. The top ring 45, the hollow rod 46, and the base 47 all have annular construction and may be centered on a longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a corresponding central opening extending from one end of the component to the other to define an axial chamber; while the base 47 may have a central opening extending through the proximal end of the base 47 but closed at the distal end of the base 47. The closed end of the base 47 may define a seat or abutment surface of the plunger biasing member 50. In an alternative embodiment, the central opening may extend through the base 47 from one end to the other. In such an alternative embodiment, the inner diameter of the central opening of the base 47 may be smaller than the outer diameter of the plunger biasing member 50, such that the base 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is activated, the base 47 may be the portion of the plunger 26 that contacts the plug 24 to push the plug 24 distally.

[0079] The top ring 45 may include one or more flanges or protrusions 48a and 48b extending radially outward from a central portion of the top ring 45. The flanges 48a and 48b may each include distally facing cam-acting surfaces 49a and 49b (e.g., ramps). As described in more detail below, each of the distally facing cam-acting surfaces 49a and 49b may interact with a proximal facing mating cam-acting surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, both the distally facing cam-acting surfaces 49a and 49b may be arranged at an angle or slope to, or not parallel to, an imaginary plane perpendicular to the longitudinal axis A.

[0080] In some embodiments, the top ring 45 and / or base 47 may be made of a material different from that of the hollow rod 46. In some embodiments, the top ring 45 and / or base 47 may be made of plastic, while the hollow rod 46 may be made of metal. This configuration allows the plastic material for the top ring 45 to facilitate the cam action described below by providing a relatively low coefficient of friction, and the plastic material for the base 47 to help absorb or dampen any impacts or vibrations associated with the base 47 striking the plug 24. The metal material for the hollow rod 46 may provide sufficient stiffness to prevent buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, hollow rod 46, and / or base 47 may be made of the same material, including, for example, metal or plastic. In some such embodiments, the top ring 45, hollow rod 46, and base 47 may be integrally formed in one piece to define a single, monolithic structure.

[0081] A plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end abutting against the proximal inner surface of the base 47 of the plunger 26, and / or may 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 may be equal to or less than the inner diameter of the ring 45 and / or equal to or less than the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut against the proximal inner surface of the base 47 of the plunger 26. Furthermore, the distal end of the plunger biasing member 50 may abut against the distal surface of the plunger biasing member seat 38. The plunger biasing member seat 38 may be fixedly attached to the tubular housing 25 such that the plunger biasing member seat 38 provides a retaining surface from which the plunger biasing member 50 disengages. In this configuration, the plunger biasing member 50 can extend in length when released from the stored state, with the distal end of the plunger biasing member 50 moving distally away from the fixed proximal end of the plunger biasing member 50. This movement can push the plunger 26 distally, which in turn can push the stopper 24 distally to expel the drug 22 from the drug storage container 20 into the delivery member 16 and thereby into the patient. However, in the embodiment shown in the figures, releasing the plunger biasing member 50 or other biasing members does not drive the delivery member 16 downward relative to the housing 12. Instead, the drug container 20, and therefore the delivery member 16, is substantially or completely fixed relative to the housing 12. The delivery member 16 is driven into the patient's skin 5 by the inertial force generated by the downward force of the patient (or healthcare provider or other person administering the drug).

[0082] like Figure 2As shown, the rotatable member 37 can be positioned proximal to the protective member 32, and the proximal biasing member 35 can be positioned proximal to the rotatable member 37. The rotatable member 37 can be a separate structure from the protective member 32, and in at least some embodiments, it can generally function as an extension of the protective member or take the form of an extension of the protective member or a protective member extension. The rotatable member 37 can have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A. As an example, the rotatable member 37 can include a generally cylindrical body 37a. The rotatable member 37 can also include a groove 37b for receiving, supporting, and / or retaining the distal portion of the proximal biasing member 35. Furthermore, depending on the operating state or stage of the drug delivery device 10, the rotatable member 37 can be configured to move in a straight direction relative to the housing 12 along the longitudinal axis A and / or rotate relative to the housing 12 about the longitudinal axis A, as described in more detail below.

[0083] Prior to the delivery state, including, for example, in the storage and / or pre-delivery state, the rotatable member 37 can be configured to move linearly (including proximalally) relative to the housing 12 along the longitudinal axis A, but rotation about the longitudinal axis A relative to the housing 12 can be prevented. To achieve this effect, in some embodiments, the rotatable member 37 can cooperate with the plunger guide 60 to prevent relative rotational movement between the rotatable member 37 and the plunger guide 60 prior to the delivery state, but allow relative axial movement between them. Thus, since the plunger guide 60 is fixedly coupled to the housing 12, the rotatable member 37 can be fixed to the housing 12 in a rotational sense via the plunger guide 60. For example, as Figure 4A and Figure 4BAs shown, the outer portion of the plunger guide 60 may include a first rotatable member engagement member 60a, and the inner portion of the rotatable member 37 may include a plunger guide engagement member 37c. The first rotatable member engagement member 60a of the plunger guide 60 may include a protrusion (e.g., a longitudinally extending ridge or spline) extending radially outward, disposed near the distal end of the plunger guide 60, and having at least one surface parallel to or substantially parallel to the longitudinal axis A. The plunger guide engagement member 37c of the rotatable member 37 may include a protrusion extending radially inward and disposed near the proximal end of the rotatable member 37. The first rotatable member engagement member 60a may be configured to engage the plunger guide engagement member 37c to prevent rotation of the rotatable member 37 relative to the plunger guide 60 and the housing 12, while allowing linear movement of the rotatable member 37 relative to the plunger guide 60 and the housing 12. As an example, when the rotatable member 37 moves linearly relative to the plunger guide 60 due to the user pushing the protective member 32 proximally to activate the drive mechanism 30 and / or expose the insertion end 28 of the delivery member 16, the plunger guide engagement member 37c can slide against the first rotatable member engagement member 60a. Alternatively or additionally, the rotatable member 37 may include an anti-rotation feature that engages with a corresponding feature disposed on the inner surface of the housing 12.

[0084] During at least the initial portion of the delivery state, the rotatable member 37 can be configured to rotate together with the release member 52 relative to the plunger guide 60 and the housing 12. In some embodiments, to achieve this effect, the outer portion of the release member 52 may include a rotatable member engagement member 52a, and the inner portion of the rotatable member 37 may include a release member engagement member 37d. The rotatable member engagement member 52a of the release member 52 may include a protrusion extending radially outward and disposed near the distal end of the release member 52. The release member engagement member 37d may include a protrusion extending radially inward and disposed near the distal end of the rotatable member 37. The rotatable member engagement member 52a of the release member 52 can be configured to engage the release member engagement member 37d of the rotatable member 37, such that when the rotatable member 37 is not fixed to the plunger guide 60 in a rotational sense due to the disengagement of the plunger guide engagement member 37c of the rotatable member 37 from the first rotatable member engagement member 60a of the plunger guide 60, the release member 52 rotates (e.g., caused by the extension of the plunger biasing member 50) causing the rotatable member 37 (together with the release member 52) to rotate about the longitudinal axis A, for example, from a first rotational position to a second rotational position. Further features and functions of the rotatable member 37 are discussed below.

[0085] like Figure 2As shown, in some embodiments, the proximal biasing member 35 may be positioned between and in contact with the rotatable member 37 and the plunger guide 60. The proximal biasing member 35 may be configured to bias (e.g., push) the rotatable member 37 in a distal direction and, depending on the state of the drug delivery device 10, bias the guard 32 distally via the rotatable member 37. In other embodiments, such as those shown in Figures 12 to 13, the proximal biasing member 35 may be positioned between and in contact with the rotatable member 37. Figure 28 As shown, the proximal biasing member can be positioned between and in contact with the rotatable member and the release member. Furthermore, in some embodiments, the proximal biasing member can have a diameter larger than the diameter of the plunger biasing member and / or can be disposed radially outward of at least a portion of the plunger biasing member.

[0086] The proximal bias member 35 may include a compression spring (e.g., a helical compression spring). In some embodiments, the proximal bias member 35 may initially (e.g., in a stored state) remain in a stored state; however, in other embodiments, the proximal bias member 35 may initially (e.g., in a stored state) be in an unstored or unstored state. In the stored state, the proximal bias member 35 may be compressed such that its axial length is shorter than its axial length in the unstored or unstored state.

[0087] When the protective member 32 moves the rotatable member 37 proximally during, for example, a pre-delivery state, the proximal biasing member 35 can be compressed axially between the rotatable member 37 and the plunger guide 60 (or the release member 52, when the proximal end of the proximal biasing member 35 is positioned against the release member 52 instead of the plunger guide 60). Compression of the proximal biasing member 35 may require the user to apply force to the drug delivery device 10, for example, by pushing the protective member 32 against the injection site so that the protective member 32 moves proximally from a first axial position toward a second axial position.

[0088] During operation of the drug delivery device 10, the user can translate the protective member 32 proximally relative to the housing 12 by pressing it against the injection site. In doing so, the protective member 32 will move toward the rotatable member 37 and close the axial gap between them. Once the axial gap is eliminated, the protective member 32 and the rotatable member 37 can move together proximally until, for example, the protective member 32 reaches a second axial position. This movement can compress the proximal biasing member 35. In some embodiments, when drug delivery is complete and the drug delivery device 10 is lifted away from the injection site, the proximal biasing member 35 can expand from its compressed or stored state to push or assist in pushing the protective member 32 distally (via the rotatable member 37). This movement and / or the distal biasing force from the distal biasing member 51 can return the protective member 32 to a first axial position or extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In other embodiments (including those shown in Figures 1 to 11), when drug delivery is completed and the drug delivery device 10 is lifted away from the injection site, the proximal bias member 35 may not push the guard 32 in the distal direction. Instead, the distal bias member 51 may be solely responsible for pushing the guard 32 in the distal direction to the first axial position or extended position.

[0089] After drug delivery is completed and the protective member 32 has been redeployed to the extended position, it may be desirable to lock the protective member 32 in the extended position to prevent subsequent users from contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. For these purposes, at least some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate according to the axial position of the protective member 32 so as to lock the protective member 32 in the extended position once it has been moved from the retracted position to the extended position. The locking ring 40 may be centered on and rotate about a longitudinal axis A. The proximal end of the locking ring 40 may be in direct contact with the container holder 31, and the distal end of the locking ring 40 may be at least partially disposed within the protective member 32. A distal biasing member 51 may be axially positioned between the distally facing surface of the locking ring 40 and the proximal facing surface of the protective member 32. The distal biasing member 51 may initially be in a compressed or stored state such that it biases the locking ring 40 and the protective member 32 away from each other. Therefore, the distal biasing member 51 can apply a biasing force to push the guard 32 toward the extended position and a biasing force to push the proximal end of the locking ring 40 against the container holder 31. In some embodiments, the distal biasing member 51 may include a compression spring (e.g., a helical compression spring). In some embodiments, rotation of the locking ring 40 can be achieved by a cam action arrangement between the locking ring 40 and the container holder 31. In alternative embodiments, the locking ring 40 may be omitted and / or the rotatable member 37 may be configured to lock the guard 32 in the extended position once it has been moved from the retracted position to the extended position.

[0090] The release member 52 may be hollow and generally cylindrical or tubular in shape, and may be centered on the longitudinal axis A. For example... Figure 2 As shown, the release member 52 can be radially positioned between the plunger guide 60 and the plunger 26. Also as... Figure 2 As shown, the release member 52 can be radially positioned between the rotatable member 37 and the plunger 26. Furthermore, in some embodiments, the proximal end of the release member 52 can be coupled to the plunger biasing member seat 38, such that the plunger biasing member 50 can be configured to bias the release member 52 proximally. Typically, the release member 52 can be configured to: (1) operably engage the guard 32 with the plunger 26 in an activation sequence; and (2) generate an audible signal indicating the end of drug delivery. With this configuration, the release member 52 performs two separate functions, and thus reduces the number of moving parts required in the drug delivery device 10.

[0091] The release member 52 can be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12 depending on the operating state or stage of the drug delivery device 10. The initial rotation of the release member 52 associated with activation can be powered by the plunger biasing member 50; while subsequent rotation of the release member 52 associated with the generation of a delivery end signal can be powered by the plunger biasing member 50 and / or the guard biasing member 35. In the embodiments shown in Figures 1 to 11, the rotation of the release member 52 associated with the generation of a delivery end signal can be powered solely by the proximal biasing member 50; while in Figures 12 to... Figure 28 In the illustrated embodiment, the rotation of the release member 52 associated with the generation of the delivery end signal may be powered solely by the proximal bias 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.

[0092] In some embodiments, the ability of the release member 52 to rotate about the longitudinal axis A can be adjusted or controlled by engagement or disengagement between the rotatable member 37 and the plunger guide 60. For example, in a pre-storage and / or delivery state, when the plunger guide engagement member 37c of the rotatable member 37 engages the first rotatable member engagement member 60a of the plunger guide 60, the release member 52 is unable to rotate about the longitudinal axis A. This is because the aforementioned engagement prevents the rotatable member 37 from rotating, and therefore, due to the engagement between the release member engagement member 37d of the rotatable member 37 and the rotatable member engagement member 52a of the release member 52, the rotatable member 37 can prevent the release member 52 from rotating.

[0093] If the release member 52 cannot rotate, the plunger 26 also cannot rotate because the outwardly extending flanges 48a and 48b of the top ring 45 of the plunger 26 are received in corresponding longitudinally extending openings or slots 52b and 52c formed on the annular wall of the release member 52. If the flanges 48a and 48b on the plunger 26 cannot rotate, they cannot slide into the corresponding longitudinally extending recesses 60b and 60c (e.g., grooves, pits, slots, and / or channels) formed in the inner surface of the plunger guide 60. If the flanges 48a and 48b cannot move in this manner, the plunger 26 also cannot move. If the plunger 26 cannot move, the plunger biasing member 50 cannot extend to de-energize. Therefore, the release member 52 holds the plunger biasing member 50 in an energy-storing state until the rotatable member 37 moves to an axial position where the plunger guide engagement member 37c of the rotatable member 37 disengages from the first rotatable member engagement member 60a of the plunger guide 60, thereby allowing the rotatable member 37 and the release member 52 to rotate together.

[0094] The rotation of the rotatable member 37 and the release member 52 can be powered by the plunger biasing member 50 via a cam-acting arrangement, as will now be described further. In the pre-storage and / or delivery state, the distally facing cam-acting surfaces 49a and 49b of the flanges 48a and 48b of the top ring 45 of the plunger 26 can abut against corresponding proximally facing cam-acting surfaces 60d and 60e (e.g., ramps) formed by the inner portion of the plunger guide 60, such that the axial travel of the plunger 26 is restricted by this interaction. The cam-acting surfaces 49a, 49b, 60d, and / or 60e can all have a slope to facilitate relative movement between the top ring 45 and the plunger guide 60. The slope of the cam-acting surfaces 49a, 49b, 60d, and / or 60e can transform or convert at least a portion of the axial biasing force of the plunger biasing member 50 into a force in the transverse direction relative to the longitudinal axis A, thereby driving the top ring 45 and the remaining portion of the plunger 26 to rotate about the longitudinal axis A. However, when the outwardly extending flanges 48a and 48b of the top ring 45 of the plunger 26 are received in corresponding longitudinally extending openings 52b and 52c formed on the annular wall of the release member 52, the release member 52 can prevent or resist rotational movement between the release member 52 and the plunger 26. Therefore, as long as the rotatable member 37 locks the release member 52 in a rotational sense, the top ring 45 can remain rotationally locked through the longitudinally extending openings 52b and 52c of the release member 52 and axially locked through the proximal cam-acting surfaces 60d and 60e of the plunger guide 60.

[0095] When the rotatable member 37 is translated proximally to a position where the plunger guide engagement member 37c of the rotatable member 37 no longer engages with the first rotatable member engagement member 60a of the plunger guide 60, the rotatable member 37 and the release member 52 are no longer locked to the plunger guide 60 in a rotational sense. Therefore, the plunger biasing member 50 can begin to extend distally, thereby pushing the distally facing cam action surfaces 49a and 49b of the flanges 48a and 48b of the top ring 45 of the plunger 26 against the corresponding proximally facing cam action surfaces 60d and 60e formed by the inner portion of the plunger guide 60. Since the outwardly extending flanges 48a and 48b of the top ring 45 of the plunger 26 are received in corresponding longitudinally extending openings 52b and 52c formed on the annular wall of the release member 52, the cam action generated at this sliding interface can cause the plunger 26 to rotate, which in turn can cause the release member 52 to rotate together. At this time, due to the engagement between the release member engagement member 37d of the rotatable member 37 and the rotatable member engagement member 52a of the release member 52, the rotatable member 37 can rotate together with the release member 52.

[0096] The co-rotation of the release member 52, the rotatable member 37, and the plunger 26 can continue until the distally facing cam action surfaces 49a and 49b of the plunger 26 exit the ends of the corresponding proximal facing cam action surfaces 60d and 60e of the plunger guide 60 and move into the corresponding longitudinally extending recesses 60b and 60c of the plunger guide 60. The longitudinally extending recesses 60b and 60c do not inhibit the linear movement of the plunger 26. Therefore, the plunger 26 can be driven by the extended plunger biasing member 50 to translate linearly distally, for example, during the downward stroke. Thus, the plunger 26 can contact the stopper 24 (if the plunger has not yet contacted the stopper 24) and push the stopper 24 distally to expel the drug 22 through the delivery member 16 from the drug storage container 20 and beyond the insertion end 28 of the delivery member 16 into the patient's tissue. Drug delivery can continue until the stopper 24 reaches the delivery end position. Here, the stopper 24 can abut against the proximal portion of the inner surface 15 of the wall of the drug storage container 20. Therefore, the plunger 26 can stop moving in the distal direction.

[0097] During at least the initial portion of the distal movement of the plunger 26, the flanges 48a and 48b of the top ring 45 of the plunger 26 can travel along both the longitudinally extending openings 52b and 52c of the release member 52 and the longitudinally extending recesses 60b and 60c of the plunger guide 60, thereby preventing rotation between any of these three components. However, as the plunger 26 approaches the delivery end position, the top ring 45 can disengage from the distal end of the plunger guide 60, so the plunger guide 60 can no longer restrict or prevent rotation of the plunger 26 and / or the release member 52. Therefore, the plunger biasing member 50 can extend proximally, thereby pushing the proximal-facing cam-acting surface of the release member 52 against the distal-facing surface of the plunger guide 60. The cam action generated at the sliding interface causes the release member 52 to rotate and move linearly in the proximal direction until the surface of the release member 52 (e.g., the proximal surface) strikes the surface of another component (e.g., the distal surface) of the plunger guide 60, thereby generating a delivery end or drug administration end click or other audible signal.

[0098] Once the patient and / or healthcare provider hears the delivery end signal, he / she / they can be informed that medication administration is complete. In some embodiments, the user may be informed of the importance of the sound signal through instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an instruction for use (IFU) booklet packaged with the drug delivery device 10. In some embodiments, the user may receive additional confirmation of drug delivery completion by observing the movement of the stopper 24 and / or plunger 26 through the window 17. In some embodiments, the sound signal may be accompanied by vibration or other tactile feedback or tactile signal generated by the release member 52 striking the plunger guide 60. The sound notification may be in the form of a click or tap, or any other suitable sound signal perceptible to the user. The sound signal may occur simultaneously or substantially simultaneously with the stopper 24 reaching the delivery end position.

[0099] In any case, once the user receives some form of confirmation that drug delivery is complete, the user can lift the drug delivery device 10 away from the injection site. Since there is no obstruction, the distal biasing member 51, pre-compressed by the movement of the guard 32 from the first axial or extended position to the second axial or retracted position, can push the guard 32 from the second axial or retracted position to the first axial or extended position to cover the insertion end 28 of the delivery member 16. In some embodiments, the distal biasing member 51 can move the guard 32 from the second axial or retracted position to the first axial or extended position independently of the proximal biasing member 35 (e.g., without the assistance of the proximal biasing member). In some embodiments, moving the guard 32 from the second axial or retracted position to the first axial or extended position can cause the locking ring 40 to rotate to a position that prevents the guard 32 from subsequently retracting.

[0100] Typically, the drug delivery device 10 can be configured to eliminate or reduce the amount of downward or distal force that the user must apply to the drug delivery device 10 in order to hold the insertion end 28 of the delivery member 16 in the insertion position within the patient's tissue, for example, during the delivery state. As described above, in order to move the guard 32 from a first axial or extended position to a second axial or retracted position to expose the insertion end 28 of the delivery member 16, the user may need to press the guard 32 against the skin at the injection site with sufficient force to overcome the distal biasing force of the distal biasing member 51 and / or the proximal biasing member 35, thereby compressing the distal biasing member 51 and / or the proximal biasing member 35. In their respective compressed states, the distal biasing member 51 and / or the proximal biasing member 35 may continue to apply a distal biasing force to the component holding it in its respective compressed state. If the guard 32 is one of these components, the user may need to counteract the distal biasing force of the biasing members 51 and / or 35 in order to hold the guard 32 in the second axial or retracted position.

[0101] At least the proximal biasing member 35 can be configured to selectively (e.g., intermittently) bias the protector 32 distally. Whether the proximal biasing member 35 biases the protector 32 distally can depend on, for example, the operating state or sub-state of the drug delivery device 10. As an example, the proximal biasing member 35 can be configured to bias the protector 32 distally during at least a portion of the pre-delivery state (e.g., during at least a portion of the movement of the protector 32 from a first axial or extended position to a second axial or retracted position), but not bias the protector 32 distally or bias it to a lesser extent during a portion or all of the delivery state (e.g., during at least a portion of the time the drug is expelled from the insertion end 28 of the delivery member 16 into the patient). As a more specific example, the proximal biasing member 35 may be configured to selectively bias the guard 32 in a distal direction when the guard 32 is in the second axial or retracted position, such that when the guard 32 is initially in the second axial or retracted position, the proximal biasing member 35 biases the guard 32 in a distal direction, but subsequently, when the guard 32 is still in the second axial or retracted position, the proximal biasing member does not bias the guard 32 in a distal direction or biases the guard 32 to a lesser extent than when the guard 32 is initially in the second axial or retracted position.

[0102] When the proximal biasing member 35 is not configured to bias the guard 32 distally, the plunger guide 60 can withstand the distal biasing force of the proximal biasing member 35 via, for example, an operable connection with the rotatable member 37. As an example, the rotatable member 37 may have a first rotational position that allows the proximal biasing member to bias the guard 32 distally and a second rotational position that prevents the proximal biasing member 35 from biasing the guard 32 distally. Alternatively, if the guard 32 contacts the rotatable member 37, for example, after the guard 32 has been lifted away from the injection site following injection, the rotatable member 37 may have a third rotational position different from the first and second rotational positions, thereby allowing the proximal biasing member 35 to bias the guard 32 distally.

[0103] Referring now to Figures 7 through 11, examples will be described of how the rotatable member 37 can help reduce holding force requirements (e.g., reduce user holding force requirements) and other features and functions during at least a portion of the delivery state. Figures 7 through 11 are arranged chronologically and show a series of positions of the rotatable member 37 and other components of the drug delivery device 10 during different operating states and sub-states of the drug delivery device 10. For clarity, the proximal biasing member 35 is omitted in Figures 7 through 11, but in practice, as shown... Figure 2As shown, the proximal biasing member 35 is axially positioned between the proximal end of the rotatable member 37 and the proximal end of the plunger guide 60, and / or the distal end of the proximal biasing member 35 contacts the proximal-facing surface of the proximal end of the rotatable member 37, and / or the proximal end of the proximal biasing member 35 contacts the distal-facing surface of the proximal end of the plunger guide 60. For clarity, other components of the drug delivery device 10, including, for example, the housing 12, the drug storage container 20, the container holder 31, and the removable cap 19, are also omitted in Figures 7 through 11. Figure 7B , Figure 8B , Figure 9B , Figure 10B and Figure 11B In the image, the rotatable member 37 is omitted, but the position of the plunger guide engagement member 37c of the rotatable member 37 is shown as a dashed rectangle.

[0104] Figure 7A and Figure 7B The storage state of the drug delivery device 10 is shown. Here, the protective member 32 can be positioned in its first axial or extended position, such that the insertion end 28 of the delivery member 16 is covered by the protective member 32, and the rotatable member 37 can be positioned relative to the longitudinal axis A in the first axial position and the first rotational position. Figure 7A As seen, the proximal end 32e of the protective member 32 (including the corresponding proximal-facing end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c of the protective member 32) can be spaced apart axially from the distal end of the rotatable member 37 by a clearance or distance. The rotatable member 37 can be offset by a proximal biasing member 35 (e.g., Figure 2 As shown, it is biased in the distal direction (along the longitudinal axis A) and biased by the plunger biasing member 50 (e.g., via the engagement between the release member engagement member 37d of the rotatable member 37 and the rotatable member engagement member 52a of the release member 52). Figure 3B As shown, it is offset in a clockwise direction of rotation (around the longitudinal axis A, when viewed from above). However, the engagement between the rotatable member 37 and the plunger guide 60 prevents or inhibits movement of the rotatable member 37 in the distal direction and rotation in the clockwise direction. As an example, such as Figure 7BAs shown, the plunger guide engagement member 37c of the rotatable member 37 can engage the first rotatable member engagement member 60a of the plunger guide 60 to prevent or inhibit rotation of the rotatable member 37 in the clockwise direction. Therefore, the release member 52, currently locked in a rotational sense with the rotatable member 37 due to the engagement between the release member engagement member 37d of the rotatable member 37 and the rotatable member engagement member 52a of the release member 52, is also prevented or inhibited from rotating clockwise, as described above, this prevents the plunger bias member 50 from expanding. To limit the movement of the rotatable member 37 in the distal direction, the plunger guide engagement member 37c of the rotatable member 37 can engage the second rotatable member engagement member 60f of the plunger guide 60, as... Figure 7B As shown. The second rotatable member engagement member 60f may include a protrusion extending radially outward, disposed distal to at least a portion of the first rotatable member engagement member 60a, and having at least one surface perpendicular to or not parallel to the longitudinal axis A. The first rotatable member engagement member 60a and the second rotatable member engagement member 60f may define a continuous protrusion (e.g., Figure 7B As shown in the figure, or in other embodiments, it may be a separate protrusion with a gap therebetween.

[0105] Figure 8A and Figure 8B This demonstrates the beginning or essentially the beginning of the delivery process. Here, as the user presses the protective member 32 against the injection site, the protective member 32 has moved from its first axial or extended position to its second axial or retracted position in the direction of arrow 32f (corresponding to the proximal direction), causing the insertion end 28 of the delivery member 16 to be inserted into the injection site. As the protective member 32 moves from its first axial or extended position to its second axial or retracted position, the initial axial gap between the protective member 32 and the rotatable member 37 is eliminated, and then the rotatable member 37 is engaged in the direction of arrow 37e (corresponding to the proximal direction), pushing the rotatable member from its first axial position to its second axial position. As the rotatable member 37 moves from its first axial position to its second axial position, it can compress the axial length of the proximal biasing member 35. Furthermore, this axial movement of the rotatable member 37 can cause the plunger guide engagement member 37c of the rotatable member 37 to slide against the first rotatable member engagement member 60a of the plunger guide 60 until the plunger guide engagement member 37c moves away from the proximal end of the first rotatable member engagement member 60a, such as... Figure 8BAs seen here, the plunger guide engagement member 37c of the rotatable member 37 no longer engages the first rotatable member engagement member 60a of the plunger guide 60. Therefore, the plunger guide 60 no longer prevents or inhibits rotation of the rotatable member 37 or the release member 52 about the longitudinal axis A. As described above, this allows the plunger biasing member 50 to begin extending in the distal direction and for the release member 52 to rotate via the cam action between the plunger 26 and the plunger guide 60 (see...). Figure 9A (See arrow 52d in the image), which in turn causes the rotatable member 37 to rotate due to the engagement between the release member engaging member 37d of the rotatable member 37 and the rotatable member engaging member 52a of the release member 52 (see arrow 52d in the image). Figure 9A (Arrow 37j in the image).

[0106] Figure 9A and Figure 9B This illustrates a moment during the delivery state after the rotatable member 37 has rotated clockwise from the first rotational position to the second rotational position via the release member 52. Upon reaching the second rotational position, the rotatable member 37 stops rotating clockwise, at least in part, due to the engagement of the plunger guide engagement member 37c of the rotatable member 37 with the third rotatable member engagement member 60g of the plunger guide 60. Figure 9B As seen in the diagram. The third rotatable member engagement member 60g of the plunger guide 60 may include a protrusion (e.g., a longitudinally extending ridge or spline) that extends radially outward, is located near the distal end of the plunger guide 60, and has at least one surface parallel to or substantially parallel to the longitudinal axis A. The engagement between the plunger guide engagement member 37c of the rotatable member 37 and the third rotatable member engagement member 60g of the plunger guide 60 can prevent or inhibit further clockwise rotation of the rotatable member 37 (see [reference]). Figure 9A (arrow 37j in the image), but allows relative movement in the axial direction between the plunger guide engagement member 37c and the third rotatable member engagement member 60g.

[0107] Rotating the rotatable member 37 from a first rotational position to a second rotational position causes the corresponding proximal-facing end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c of the protective member 32 to slide against the distal-facing end surfaces 37f and 37g of the rotatable member 37, respectively, until the proximal-facing end surfaces 32g and 32h move away from their respective distal-facing end surfaces 37f and 37g. Figure 9AAs seen here, the rotatable member 37 can be disengaged from the protective member 32, and the longitudinally extending arms 32b and 32c of the protective member 32 can be aligned with corresponding recesses 37h and 37i (e.g., grooves, pits, slots, and / or channels) formed in the outer surface of the rotatable member 37. The radial depth of each of the recesses 37h and 37i can be equal to or greater than the radial thickness of each of the longitudinally extending arms 32b and 32c of the protective member 32. Therefore, the longitudinally extending arms 32b and 32c can be configured to slide into or be received in the recesses 37h and 37i formed in the outer surface of the rotatable member 37, respectively, when the rotatable member 37 is in the second rotational position. When the rotatable member 37 is in the second rotational position, the proximal biasing member 35 can continue to apply a distal biasing force to the rotatable member 37. Since the longitudinally extending arms 32b and 32c are aligned with the corresponding recesses 37h and 37i, and when the rotatable member 37 is in the second rotational position, no component restricts the rotatable member 37 from moving distally, the rotatable member 37 moves distally along the longitudinal axis A under the influence of the distal biasing force of the proximal biasing member 35 (see...). Figure 10A (Arrow 37k in the image).

[0108] Figure 10A and Figure 10B This illustrates a moment during the delivery state after the rotatable member 37 has linearly moved distally from the second axial position to the third axial position via the proximal bias member 35. As the rotatable member 37 moves from the second axial position to the third axial position, the plunger guide engagement member 37c of the rotatable member 37 can slide against the third rotatable member engagement member 60g of the plunger guide 60. Upon reaching the third axial position, the rotatable member 37 stops moving distally, at least in part, due to the engagement of the plunger guide engagement member 37c of the rotatable member 37 with the fourth rotatable member engagement member 60h of the plunger guide 60. Figure 10BAs the rotatable member 37 moves from the second axial position to the third axial position, the plunger guide engagement member 37c of the rotatable member 37 can engage and impact the fourth rotatable member engagement member 60h of the plunger guide 60. The impact between the plunger guide engagement member 37c of the rotatable member 37 and the fourth rotatable member engagement member 60h of the plunger guide 60 can generate an audible signal indicating the start of drug delivery (drug delivery start signal). In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal generated by the impact of the plunger guide engagement member 37c on the fourth rotatable member engagement member 60h. The drug delivery start audible signal may be in the form of a click or tapping sound, or any other suitable audible signal perceptible to the user. The audible signal may be generated simultaneously or substantially simultaneously with the contact of the plunger guide engagement member 37c of the rotatable member 37 with the fourth rotatable member engagement member 60h of the plunger guide 60.

[0109] Although Figure 10A and Figure 10B An audible signal indicating drug administration initiation is shown when the plunger guide engagement member 37c of the rotatable member 37 strikes the fourth rotatable member engagement member 60h of the plunger guide 60. However, in some embodiments, the drug administration initiation signal may be generated when the rotatable member 37 strikes another component of the drug delivery device 10. For example, after the longitudinally extending arms 32b and 32c are fully received in recesses 37h and 37i formed on the outer surface of the rotatable member 37, respectively, the drug administration initiation signal may be generated when the corresponding proximal end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32 engage at least a portion of the rotatable member 37. In other embodiments, the drug administration initiation signal may be generated when the distal end surfaces 37f and 37g of the rotatable member 37 strike, for example, at least a portion of the container holder 31. In some embodiments, the drug administration initiation signal may be generated when the rotatable member 37 strikes a portion of the housing 12 or another component of the drug delivery device 10 that remains fixed during activation. In yet another embodiment, a dosing initiation signal may be generated when the proximal bias member 35 is released and / or when the plunger bias member 50 is released.

[0110] When the rotatable member 37 is in the second rotational position, the proximal biasing member 35 may not bias the protective member 32 in the distal direction. This is because, when the rotatable member 37 is in the second rotational position, the distal-facing surface of the rotatable member 37 (including the distal-facing end surfaces 37f and 37g) may not contact the proximal-facing surface of the protective member 32 (including the corresponding proximal-facing end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c). Therefore, the rotatable member 37 may not transmit the distal biasing force of the proximal biasing member 35 to the protective member 32. Thus, when the rotatable member 37 is in the second rotational position (including part or all of the delivery state), the user may be completely or substantially completely free from having to apply manual force to counteract the distal biasing force of the proximal biasing member 35. However, in embodiments including the distal biasing member 51, the user may still need to apply manual force to overcome the distal biasing force of the distal biasing member 51. However, this reduces, and potentially significantly reduces, the required force compared to the need to counteract the distal biasing force of the proximal biasing member 35 and the distal biasing force of the distal biasing member 51. Therefore, the amount of force that the user must apply during delivery to hold the guard 32 in the second axial or retracted position can be reduced. This reduces the possibility that the user might prematurely lift the guard 32 off the skin and / or withdraw the insertion end 28 of the delivery member 16 from the patient before the delivery state ends, potentially resulting in suboptimal drug delivery or no delivery at all. Furthermore, the reduced holding force requirement helps the user smoothly or stably hold the drug delivery device 10 during delivery, thereby reducing the likelihood of the user causing discomfort to the patient by laterally moving the insertion end 28 of the delivery member 16 relative to surrounding tissue. Figure 10BAs seen, the fourth rotatable member engagement member 60h of the plunger guide 60 may include a protrusion extending radially outward, disposed distal to the third rotatable member engagement member 60g, and having at least one cam-acting surface 60i (e.g., a ramp) arranged at an angle or slope relative to an imaginary plane perpendicular to the longitudinal axis A, or not parallel to the imaginary plane. When the rotatable member 37 is in the second rotational position and the third axial position, the proximal biasing member 35 can push the plunger guide engagement member 37c of the rotatable member 37 against the cam-acting surface 60i, thereby subjecting the plunger guide 60 to a distal biasing force from the proximal biasing member 35. The slope of the cam-acting surface 60i can convert or transform at least a portion of the axial biasing force from the proximal biasing member 35 into a force in the transverse direction relative to the longitudinal axis A, thereby causing the plunger guide engagement member 37c and the remainder of the rotatable member 37 to rotate about the longitudinal axis A. However, the longitudinally extending arms 32b and 32c of the protective member 32 are respectively positioned in the recesses 37h and 37i on the outer surface of the rotatable member 37, such as Figure 10A As can be seen, this allows the rotatable member 37 to abut against the circumferentially facing surface, thereby preventing the rotatable member 37 from rotating about the longitudinal axis A. Therefore, as long as the longitudinally extending arms 32b and 32c of the guard 32 are positioned in the recesses 37h and 37i on the outer surface of the rotatable member 37, the rotatable member 37 can be kept in a rotationally locked relative to the guard 32 and the housing 12.

[0111] Figure 11A and Figure 11B The diagram illustrates the post-delivery state after the guard 32 has been lifted away from the injection site and moved distally (e.g., by the distal bias member 51) back to its first axial or extended position to cover the insertion end 28 of the delivery member 16. As the guard 32 moves distally from its second axial or retracted position to its first axial or extended position, the longitudinally extending arms 32b and 32c of the guard 32 can be removed from their respective recesses 37h and 37i on the outer surface of the rotatable member 37. Therefore, the rotatable member 37 can rotate freely about the longitudinal axis A. Since the proximal bias member 35 can continue to apply a distal biasing force to the rotatable member 37, it can push the plunger guide engagement member 37c of the rotatable member 37 against the cam action surface 60i of the plunger guide 60, causing the plunger guide engagement member 37c to slide against the cam action surface 60i, and thereby causing the rotatable member 37 to rotate counterclockwise (see [link to diagram]). Figure 11A Arrow 37j in the diagram rotates from the second rotational position to the third rotational position around the longitudinal axis A, and simultaneously moves linearly from the third axial position in the distal direction along the longitudinal axis A (see [reference]). Figure 11AArrow 37n) to the fourth axial position. When the rotatable member 37 is positioned in the third rotational position, at least a portion of the distal end surfaces 37f and 37g of the rotatable member 37 can be aligned in the rotational direction with at least a portion of the proximal end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard member 32, respectively. Furthermore, when the rotatable member 37 is positioned in the third rotational position, the proximal biasing member 35 can push the plunger guide engagement member 37c of the rotatable member 37 against the rotatable member engagement member 60h of the plunger guide 60, such that the plunger guide 60 is subjected to a distal biasing force from the proximal biasing member 35.

[0112] Furthermore, when the rotatable member 37 is positioned in the third rotational position, the fifth rotatable member engagement member 60k of the plunger guide 60 can prevent further rotational movement of the rotatable member 37 in the counterclockwise direction. The fifth rotatable member engagement member 60k of the plunger guide 60 may include a protrusion extending radially outward, disposed near the distal end of the plunger guide 60, and having at least one surface parallel to or substantially parallel to the longitudinal axis A.

[0113] like Figure 11B As seen, when the rotatable member 37 is positioned in its third rotational position and fourth axial position, the plunger guide engagement member 37c of the rotatable member 37 can be positioned distal to and adjacent to the sixth rotatable member engagement member 60j of the plunger guide 60. The sixth rotatable member engagement member 60j of the plunger guide 60 may include a protrusion extending radially outward, disposed near the distal end of the plunger guide 60, and having at least one surface perpendicular to or substantially perpendicular to the longitudinal axis A. If, after injection, an attempt is made to move the guard 32 proximally from the first axial or extended position to the second axial or retracted position after the guard 32 has been lifted away from the injection site, the proximally facing end surfaces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32 can abut or otherwise engage the distally facing end surfaces 37f and 37g of the rotatable member 37, thereby pushing the rotatable member 37 proximally. However, such proximal movement of the protective member 32 can be prevented or suppressed because the plunger guide engagement member 37c can abut or otherwise engage the sixth rotatable member engagement member 60j to prevent proximal movement of the rotatable member 37 and thus also prevent proximal movement of the protective member 32. Therefore, when the rotatable member 37 is in its third rotational position and fourth axial position, the rotatable member 37 can lock the protective member 32 in the first axial or extended position to cover the insertion end 28 of the delivery member 16 in the post-delivery state after the drug delivery device 10 has been lifted away from the injection site.

[0114] Although not specifically mentioned above, any of the joining members 37c, 37d, 52a, 60a, 60f, 60g, 60h, 60j and / or 60k may have corresponding replicas or mating members with the same geometry but mirrored about the longitudinal axis A, as shown in some of the accompanying drawings.

[0115] Having described the configuration of the drug delivery device 10, a general method for performing an injection using the drug delivery device 10 will now be described. As a preparatory step, the user can remove the drug delivery device 10 from any secondary packaging (such as a plastic bag and / or cardboard box). Additionally, as a preparatory step, the user can prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. Next, the user can pull the removable cap 19 and remove it from the housing 12. As a result of this movement, the gripper 13 can pull the removable sterile barrier 21 and detach it from the drug storage container 20. This exposes the insertion end 28 of the delivery member 16. However, the insertion end 28 of the delivery member 16 will remain surrounded by the protective member 32 at this stage, as the protective member 32 is positioned in a first axial or extended position. Next, the user can position the drug delivery device 10 above 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 distal biasing force of the proximal biasing member 35 and (if included) the distal biasing force of the distal biasing member 51, thereby causing the guard 32 to retract into the opening 14, moving proximally from a first axial or extended position to a second axial or retracted position. During this proximal movement of the guard 32, the delivery member 16 can remain stationary relative to the housing 12, thus causing the insertion end 28 of the delivery member 16 to extend through the opening at the distal end of the guard 32, thereby piercing the patient's skin at the injection site and penetrating into the patient's subcutaneous tissue.

[0116] When the protective member 32 moves from the first axial or extended position to the second axial or retracted position, the protective member 32 can push the rotatable member 37 proximally from its first axial position to its second axial position. As described above, this movement of the rotatable member 37 can directly or indirectly cause several actions, including but not limited to rotation of the rotatable member 37, rotation of the release member 52, release of the plunger biasing member 50, removal of the drug from the drug storage container 20 into the patient via the insertion end 28 of the delivery member 16, and / or generation of a delivery termination signal.

[0117] After drug delivery is complete, the user can then lift the protective member 32 away from the injection site. With no obstruction, the distal biasing member 51 can push the protective member 32 distally from the second axial or retracted position to the first axial or extended position to cover the insertion end 28 of the delivery member 16. As discussed above, this distal movement of the protective member 32 causes the longitudinally extending arms 32b and 32c of the protective member 32 to disengage from the rotatable member 37, thereby allowing the rotatable member 37 to move to a locked position under the influence of the distal biasing force of the proximal biasing member 35, which prevents the protective member 32 from subsequently retracting.

[0118] In the above embodiments, once the delivery state has begun or shortly thereafter, the proximal biasing member 35 cannot bias the protector 32 distally unless an attempt is made to move the protector 32 proximally after injection is completed and the protector 32 is removed from the injection site. In an alternative embodiment, once the delivery state is complete, the proximal biasing member can return to biasing the protector distally, for example, moving the protector distally from its second axial or retracted position to its first axial or extended position, thereby covering the insertion end of the delivery member in the post-delivery state. Such embodiments are described below with reference to Figures 12 to 20.

[0119] The various elements of the drug delivery device 110 shown in Figures 12 to 20 may be similar or identical in structure, configuration, function, and / or operation to those of the drug delivery device 10 described above in conjunction with Figures 1 to 11. These components are given the same reference numerals as used in Figures 1 to 11, but with an addition of 100. For brevity, the description of some of these elements has been simplified or omitted. The details of the structure, configuration, and / or function that distinguish the embodiments of the drug delivery device 110 shown in Figures 12 to 20 from those shown in Figures 1 to 11 are the focus of the following discussion.

[0120] like Figure 12A As shown, the release member 152 can be positioned radially outward of the plunger guide 160. Also as... Figure 12A As shown, at least a portion of the plunger guide 160 may be radially positioned between the release member 152 and the plunger 126. The release member 152, the plunger guide 160, and the plunger 126 may generally interact in a manner similar to the embodiments described above in conjunction with Figures 1 to 11 to release the plunger biasing member 150 and / or generate a delivery end click when the guard 132 moves from a first axial or extended position to a second axial or retracted position, except that the delivery end click is generated by the release member 152 striking the distally facing surface of the outer portion of the plunger guide 160.

[0121] Figure 13 The rotatable member engagement member 152a of the release member 152 can be defined by a recess (e.g., groove, pit, slot, and / or channel) formed on a radially outward surface of the release member 152. In an alternative embodiment, the rotatable member engagement member 152a can be a radially outwardly extending protrusion. In any case, the rotatable member engagement member 152a of the release member 152 can be configured to engage the release member engagement member 137d of the rotatable member 137 such that when the rotatable member 137 is not fixed to the plunger guide 160 in a rotational sense due to the disengagement of the plunger guide engagement member 137c of the rotatable member 137 from the rotatable member engagement member 160a of the plunger guide 160, the rotation of the release member 152 (e.g., caused by the extension of the plunger biasing member 150) causes the rotatable member 137 to rotate together with the release member 152 about the longitudinal axis A, for example, from a first rotational position to a second rotational position. The following section discusses additional features and functions of the rotatable component 137.

[0122] Figure 14A and Figure 14B The diagram shows that the release member engagement member 137d may include a radially inwardly extending protrusion disposed near the proximal end of the rotatable member 137, and the plunger guide engagement member 137c may include a radially inwardly extending protrusion disposed near the distal end of the rotatable member 137. The plunger guide engagement member 137c may include: an abutment surface 137ci, which is parallel to or substantially parallel to the longitudinal axis A and generally faces upward in a first circumferential direction; and a cam-acting surface 137cii (e.g., a ramp), which is arranged at an angle or slope relative to an imaginary plane perpendicular to the longitudinal axis A, or is not parallel to the imaginary plane. Figure 14B As can be seen, the distal end of the cam actuating surface 137cii may be closer to the abutment surface 137cii in the circumferential direction than the proximal end of the cam actuating surface 137cii. In an alternative embodiment, the plunger guide engagement member 137c may be replaced by two separate plunger guide engagement members having the abutment surface 137cii and the cam actuating surface 137cii, respectively.

[0123] Figure 12A , Figure 12B and Figure 15The drug delivery device 110 shown may include a launcher 170. The launcher 170 may be hollow and generally cylindrical or tubular in shape, or annular in shape, and may be centered on a longitudinal axis A. The launcher 170 may be axially positioned between a rotatable member 137 and a protective member 132. The launcher 170 may be configured to move linearly along the longitudinal axis A, but is prevented from rotating about the longitudinal axis A. Therefore, the launcher 170 may be configured to move linearly relative to the housing 112 and / or the plunger guide 160, but is substantially or completely prevented from rotating relative to the housing 112 and / or the plunger guide 160. To achieve this effect, in some embodiments, the launcher 170 may cooperate with the plunger guide 160 to prevent relative rotational movement between the launcher 170 and the plunger guide 160, but permit relative axial movement between them. For example, as Figure 12B and Figure 15 As shown, the outer portion of the plunger guide 160 may include a launcher engagement member 160m, and the inner portion of the launcher 170 may include a plunger guide engagement member 170a. The launcher engagement member 160m may include a protrusion (e.g., a longitudinally extending ridge or spline) extending radially outward, positioned near the distal end of the plunger guide 160, and having at least one surface parallel to or substantially parallel to the longitudinal axis A. The plunger guide engagement member 170a may be defined by a recess (e.g., a groove, pit, slot, and / or channel) formed on a radially inwardly facing surface of the launcher 170. The launcher engagement member 160m may be configured to engage the plunger guide engagement member 170a to prevent rotation of the launcher 170 relative to the plunger guide 160 and the housing 112, while allowing linear movement of the launcher 170 relative to the plunger guide 160 and the housing 112. As an example, when a user pushes the protective member 132 proximally to activate the drive mechanism 130 and / or exposes the insertion end 128 of the delivery member 116, causing the launcher 170 to move linearly relative to the plunger guide 160, the plunger guide engagement member 170a can slide against the launcher engagement member 160m. Alternatively or additionally, the launcher 170 may include an anti-rotation feature that engages with a corresponding feature provided on the inner surface of the housing 112.

[0124] Referring now to Figures 16 through 20, examples, as well as other features and functions, will be described of how the rotatable member 137 and the transmitter 170 can interact to eliminate or reduce the amount of distal force applied to the protector 132 by the proximal bias member 135 during part or all of the delivery state, and to partially or fully restore the amount of distal force applied to the protector 132 by the proximal bias member 135 after the delivery state.

[0125] Figures 16 through 20 are arranged chronologically and show a series of positions of the rotatable member 137, the transmitter 170, and other components of the drug delivery device 110 during different operating states and sub-states. For clarity, the proximal biasing member 135 is omitted in Figures 16 through 20, but in reality, as shown... Figure 12A As shown, the proximal biasing member 135 is axially positioned between the proximal end of the rotatable member 137 and the proximal end of the release member 152, and / or the distal end of the proximal biasing member 135 contacts the proximal-facing surface of the proximal end of the rotatable member 137, and / or the proximal end of the proximal biasing member 135 contacts the distal-facing surface of the proximal end of the release member 152. For clarity, other components of the drug delivery device 110, including, for example, the housing 112, the drug storage container 120, and the removable cap 119, are also omitted in Figures 16 to 20. Figure 16B , Figure 17B , Figure 18B and Figure 20B In the image, the rotatable member 137 is omitted, but the position of the plunger guide engagement member 137c of the rotatable member 137 is shown by dashed lines.

[0126] Figure 16A and Figure 16B The storage state of the drug delivery device 110 is shown. Here, the protective member 132 can be positioned in its first axial or extended position, such that the insertion end 128 of the delivery member 116 is covered by the protective member 132, the rotatable member 137 can be positioned relative to the longitudinal axis A in the first axial position and the first rotational position, and the transmitter 170 can be positioned in the first axial position. Figure 16A As shown, the distal surface of the transmitter 170 can engage the proximal surface of the container holder 131 to prevent the transmitter 170 from moving distally in the storage state. Furthermore, the distal surface of the rotatable member 137 can engage the proximal surface of the transmitter 170, thereby preventing the rotatable member 137 from moving distally in the storage state (e.g., under the influence of the distal biasing force of the proximal biasing member 135).

[0127] Figure 16AFurther illustration shows that the proximal end 132e of the protective member 132 (including the corresponding proximal-facing end surfaces 132g and 132h of the longitudinally extending arms 132b and 132c of the protective member 132) can be spaced apart axially from the distal end of the launcher 170 by a clearance or distance. The rotatable member 137 and the launcher 170 can be biased distally (along the longitudinal axis A) by the proximal biasing member 135. The rotatable member 137 can also be biased clockwise (around the longitudinal axis A, when viewed from above) by the plunger biasing member 150 via the engagement between the release member engagement member 137d of the rotatable member 137 and the rotatable member engagement member 152a of the release member 152. However, clockwise rotation of the rotatable member 137 can be prevented or inhibited by the engagement between the rotatable member 137 and the plunger guide 160. As an example, such as Figure 16B As shown, the plunger guide engagement member 137c of the rotatable member 137, and in particular the abutment surface 137ci of the plunger guide engagement member 137c (in Figure 14A and Figure 14B (As shown in the diagram) a rotatable member engagement member 160a of the plunger guide 160 can engage to prevent or inhibit rotation of the rotatable member 137 in the clockwise direction. Therefore, the release member 152, which is currently locked in a rotational sense to the rotatable member 137 due to the engagement between the release member engagement member 137d of the rotatable member 137 and the rotatable member engagement member 152a of the release member 152, is also prevented or inhibited from rotating clockwise, as described above, which prevents the plunger bias member 150 from expanding.

[0128] Figure 17A and Figure 17BThis demonstrates the beginning or essentially the beginning of the delivery process. Here, as the user presses the protective member 132 against the injection site, the protective member 132 has moved from its first axial or extended position to its second axial or retracted position in the direction of arrow 132f (corresponding to the proximal direction), causing the insertion end 128 of the delivery member 116 to be inserted into the injection site. As the protective member 132 moves from its first axial or extended position to its second axial or retracted position, the initial axial gap between the protective member 132 and the transmitter 170 is eliminated, and then the transmitter 170 is engaged in the direction of arrow 170b (corresponding to the proximal direction), pushing the transmitter from its first axial position to its second axial position. This axial movement of the transmitter 170 causes the rotatable member 137 to move from its first axial position to its second axial position in the direction of arrow 137e (corresponding to the proximal direction). As the rotatable member 137 moves from its first axial position to its second axial position, it can compress the axial length of the proximal biasing member 135. Furthermore, this axial movement of the rotatable member 137 can cause the plunger guide engagement member 137c of the rotatable member 137, and in particular the abutment surface 137ci of the plunger guide engagement member 137c, to slide against the rotatable member engagement member 160a of the plunger guide 160 until the abutment surface 137ci moves away from the proximal end of the rotatable member engagement member 160a, such as... Figure 17B As seen here, the abutment surface 137ci of the plunger guide engagement member 137c of the rotatable member 137 no longer engages the rotatable member engagement member 160a of the plunger guide 160. Therefore, the plunger guide 160 no longer prevents or inhibits the rotation of the rotatable member 137 or the release member 152 about the longitudinal axis A. As described above, this allows the plunger biasing member 150 and the proximal biasing member 135 to begin extending in the distal direction, and the release member 152 to rotate clockwise via the cam action between the plunger 126 and the plunger guide 160 (see...). Figure 18A (See arrow 152d in the image), which in turn causes the rotatable member 137 to rotate clockwise due to the engagement between the release member engagement member 137d of the rotatable member 137 and the rotatable member engagement member 152a of the release member 152 (see arrow 152d in the image). Figure 18AThe arrow 137j in the diagram rotates. Rotational movement of the rotatable member 137, at least partially powered by the proximal biasing member 135, is configured to generate an audible signal indicating the start of drug delivery (drug delivery start signal). In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal generated due to the rotational movement of the rotatable member 137. The drug delivery start signal may be generated simultaneously or substantially simultaneously with the rotational movement of the rotatable member 137. Alternatively or additionally, release of the plunger biasing member 150 may generate the drug delivery start signal. Thus, when the plunger biasing member 150 begins to extend distally, the plunger biasing member 150 may generate the drug delivery start signal simultaneously or substantially simultaneously. The drug delivery start signal may be accompanied by tactile feedback or a tactile signal generated due to the release of the plunger biasing member 150. In other embodiments, cam action between the plunger 126 and the plunger guide 160 may generate the drug delivery start signal.

[0129] Figure 18A and Figure 18B This illustrates a moment during the delivery state after the rotatable member 137 has been rotated clockwise from the first rotational position to the second rotational position via the release member 152. The rotatable member 137 can disengage from the launcher 170 due to its movement from the first rotational position to the second rotational position, and the plunger guide of the rotatable member 137 engages the cam action surface 137cii of the engagement member 137c (in... Figure 14A (As shown in the diagram) can contact or engage with the rotatable member engagement 160n of the plunger guide 160. The rotatable member engagement member 160n may include a protrusion extending radially outward, disposed proximal to the rotatable member engagement member 160a, and having at least one surface perpendicular to or not parallel to the longitudinal axis A. The rotatable member engagement members 160a and 160n may define a continuous protrusion (as shown in the diagram). Figure 18B As shown in the figure, or in other embodiments, it may be a separate protrusion with a gap therebetween.

[0130] When the rotatable member 137 is in the second rotational position, the proximal biasing member 135 does not bias the protective member 132 in the distal direction. This is because, when the rotatable member 137 is in the second rotational position, the distal-facing surface of the rotatable member 137 does not contact the proximal-facing surface of the transmitter 170. Therefore, the transmitter 170 does not transmit the distal biasing force of the proximal biasing member 135 to the protective member 132. Instead, when the rotatable member 137 is in the second rotational position... Figure 18BIn the second rotational position shown, due to the contact between the cam action surface 137cii of the plunger guide engagement member 137c of the rotatable member 137 and the rotatable member engagement 160n of the plunger guide 160, the plunger guide 160 can withstand the distal biasing force of the proximal member 135. Therefore, when the rotatable member 137 is in the second rotational position (including part or all of the delivery state), the user can be completely or substantially completely freed from the manual force required to counteract the distal biasing force of the proximal biasing member 135. However, in embodiments including the distal biasing member 151, the user may still need to apply manual force to counteract the distal biasing force of the distal biasing member 151. However, this is a reduction, potentially a substantial reduction, in the required force compared to both the distal biasing force of the proximal biasing member 135 and the distal biasing force of the distal biasing member 151. Therefore, the amount of force that the user must apply to keep the guard 132 in the second axial or retracted position during delivery can be reduced.

[0131] Because the proximal biasing member 135 causes cam interaction between the cam action surface 137cii of the plunger guide engagement member 137c of the rotatable member 137 and the rotatable member engagement 160n of the plunger guide 160, the rotatable member 137 can continue to rotate clockwise, thus allowing the rotatable member 137 to be temporarily positioned in the second rotational position. As an example, the slope of the cam action surface 137cii can convert or transform at least a portion of the axial biasing force from the proximal biasing member 135 into a force in the transverse direction relative to the longitudinal axis A, thereby causing the cam action surface 137cii of the plunger guide engagement member 137c and the remainder of the rotatable member 137 to rotate clockwise about the longitudinal axis A (see [link to relevant documentation]). Figure 19 (See arrow 137k in the image). Additionally, when the rotatable member 137 rotates, the proximal biasing member 135 can push the rotatable member 137 to move linearly in the distal direction (see [reference]). Figure 19 (See arrow 137m). Therefore, the rotatable member 137 can rotate clockwise to the third rotation position (…). Figure 19 (depicted in the middle) and moved to the third axial position on the far side ( Figure 19 (Depicted in the middle). Here, the plunger guide of the rotatable member 137 engages with the member 137c (in Figure 19 (As shown in the image, it is semi-transparent) and can contact or engage with the rotatable component engagement component 170c of the transmitter 170, such as... Figure 19As depicted. In this operating state (which may be during the delivery state), the plunger guide engagement member 137c of the rotatable member 137 can still engage with the rotatable member engagement 160n of the plunger guide 160. Therefore, in this operating state, both the plunger guide 160 and the launcher 170 can withstand the distal biasing force of the proximal biasing member 135. In at least some embodiments, the plunger guide 160 can withstand a larger share of the distal biasing force of the proximal biasing member 135 than the launcher 170. For example, the plunger guide 160 can withstand most (i.e., greater than 50%) of the distal biasing force of the proximal biasing member 135. Since the longitudinally extending arms 132b and 132c of the guard 132 can contact the launcher 170 (as seen in FIG. 10), the launcher 170 can transfer at least a portion of its share of the distal biasing force of the proximal biasing member 135 to the guard 132. Furthermore, since the cam action surface 137cii can remain in contact with the rotatable member engagement 160n of the plunger guide 160, the resulting cam interaction can continue to cause the rotatable member 137 to rotate clockwise when the rotatable member is in the third rotational position. However, since the launcher engages with the rotatable member 137 and is fixed to the plunger guide 160 in a rotational sense, the launcher 170 can prevent the rotatable member 137 from rotating further clockwise when it has reached its third rotational position.

[0132] Figure 20A and Figure 20B This illustrates the post-delivery state after the protective member 132 has been lifted away from the injection site and moved distally back to its first axial or extended position by the proximal bias member 135 and / or the distal bias member 151 to cover the insertion end 128 of the delivery member 116. Because the protective member 132 has moved distally from its second axial or retracted position to its first axial or extended position, the transmitter 170 can also move distally under the influence of the distally biasing force of the proximal bias member 135. Figure 20A(arrow 170d) moves. This can create a gap for the plunger guide engagement member 137c to slide off or otherwise disengage from the rotatable member engagement 160n of the plunger guide 160, so that it is supported only by the rotatable member engagement member 170c of the launcher 170. The rotatable member engagement member 170c may include a cam-acting surface 170ci (e.g., a ramp) arranged at an angle or slope relative to an imaginary plane perpendicular to the longitudinal axis A or not parallel to that imaginary plane. The slope of the cam-acting surface 170ci can transform or convert at least a portion of the axial biasing force from the proximal bias member 135 (pushing the rotatable member 137 in a distal direction) into a force in the lateral direction relative to the longitudinal axis A, thereby causing the rotatable member 137 to rotate counterclockwise about the longitudinal axis A (see... Figure 20A (See arrow 137m) rotates to the fourth rotation position. Additionally, when the rotatable member 137 rotates counterclockwise, the proximal biasing member 135 can push the rotatable member 137 in the distal direction (see...). Figure 20A The arrow (137n) moves linearly to the fourth axial position.

[0133] like Figure 20A and Figure 20B As depicted, when the rotatable member 137 is positioned in the fourth rotational position and the fourth axial position, at least a portion of the plunger guide engagement member 137c of the rotatable member 137 can be positioned distal to and adjacent to the rotatable member engagement member 160j of the plunger guide 160. The rotatable member engagement member 160j of the plunger guide 160 may include a protrusion extending radially outward, disposed distal to the rotatable member engagement member 160a, and having at least one surface perpendicular to or substantially perpendicular to the longitudinal axis A. The rotatable member engagement members 160a and 160j may define a continuous protrusion (e.g., Figure 20B As shown in the figure, or in other embodiments, it may be a separate protrusion with a gap therebetween.

[0134] If, after injection, an attempt is made to move the protective member 132 proximally from a first axial or extended position to a second axial or retracted position after the protective member 132 has been lifted away from the injection site, the proximally facing end surfaces 132g and 132h of the longitudinally extending arms 132b and 132c of the protective member 132 can abut or otherwise engage the distally facing end surface of the transmitter 170, thereby pushing the transmitter 170 and the rotatable member 137 proximally. However, such proximal movement of the protective member 132 can be prevented or suppressed because the proximally facing end surface of the plunger guide engagement member 137c can abut or otherwise engage the distally facing surface of the rotatable member engagement member 160j of the plunger guide 160 to prevent proximal movement of the rotatable member 137, and thus also prevent proximal movement of the transmitter 170 and the protective member 132. Therefore, when the rotatable member 137 is in its fourth rotational position and fourth axial position, the rotatable member 137 can lock the guard 132 in the first axial or extended position to cover the insertion end 128 of the delivery member 116 in the post-delivery state after the guard 232 has been lifted away from the injection site.

[0135] Although not specifically mentioned above, any of the joining members 137c, 137d, 152a, 160a, 160m, 160n and / or 160j may have corresponding replicas or mating members with the same geometry but mirrored about the longitudinal axis A, as shown in some of the figures.

[0136] In the above embodiments, the rotation of the rotatable member can be achieved in various states via engagement between the rotatable member and the plunger guide and / or between the rotatable member and the launcher. In alternative embodiments, the rotation of the rotatable member can be achieved in various states via engagement between the rotatable member and the housing. Referring below to Figures 21 to... Figure 28 Such an embodiment is described.

[0137] Figure 21 to Figure 28 The various components of the drug delivery device 210 shown may be similar or identical in structure, configuration, function, and / or operation to the components of the drug delivery device 110 described above in conjunction with Figures 12 to 20. These components are given the same reference numerals as used in Figures 12 to 20, but with an addition of 100. For brevity, the description of some of these components has been simplified or omitted. Figures 21 to... Figure 28 The details of the structure, configuration and / or function that distinguish the embodiment of drug delivery device 210 shown in Figures 12 to 20 from the embodiment of drug delivery device 110 shown in Figures 12 to 20 are the focus of the discussion below.

[0138] Figure 21BThe rotatable member engagement member 252a of the release member 252 is shown to be defined by a recess (e.g., groove, pit, slot, and / or channel) formed in a radially outward surface of the release member 252. In an alternative embodiment, the rotatable member engagement member 252a may be a radially outwardly extending protrusion. In any case, the rotatable member engagement member 252a of the release member 252 may be configured to engage the release member engagement member 237d of the rotatable member 237 such that when the rotatable member 237 is not fixed to the housing 212 in a rotational sense due to the disengagement of the housing engagement member 237f of the rotatable member 237 from the rotatable member engagement member 212a of the housing 212, the rotation of the release member 252 (e.g., caused by the extension of the plunger biasing member 250) causes the rotatable member 237 (together with the release member 252) to rotate about the longitudinal axis A, for example, from a first rotational position to a second rotational position. Further features and functions of the rotatable member 237 are discussed below.

[0139] Figure 22A and Figure 22B The housing engagement member 237f, showing the rotatable member 237, may include a protrusion extending radially outward and positioned near the distal end of the rotatable member 237. The housing engagement member 237f may include: an abutment surface 237fi, which is parallel or substantially parallel to the longitudinal axis A and generally faces upward in a first circumferential direction; a cam-acting surface 237fii (e.g., a ramp), which is arranged at an angle or slope relative to an imaginary plane perpendicular to the longitudinal axis A, or is not parallel to the imaginary plane; and an abutment surface 237fiii, which is perpendicular or substantially perpendicular to the longitudinal axis A and generally faces downward in a distal direction. Figure 22A and Figure 22B As can be seen, the proximal end of the cam action surface 237fii may be closer to the abutment surface 237fi in the circumferential direction than the distal end of the cam action surface 237fii. In an alternative embodiment, the housing engagement member 237f may be replaced by three separate housing engagement members having the abutment surface 237fi, the cam action surface 237fii, and the abutment surface 237fiii, respectively.

[0140] Figure 22A and Figure 22BThe rotatable member 237 may additionally include a housing engagement member 237m located proximal to the housing engagement member 237f. The housing engagement member 237m may include a protrusion extending radially outward, positioned near the proximal end of the rotatable member 237, and having a cam-acting surface 237mi (e.g., a ramp) arranged at an angle or slope relative to an imaginary plane perpendicular to the longitudinal axis A, or not parallel to the imaginary plane. Figure 22A and Figure 22B As can be seen, the distal end of the cam action surface 237mi can be closer to the housing engagement member 237f in the circumferential direction than the proximal end of the cam action surface 237mi.

[0141] Figure 22B It is shown that the rotatable member 237 may additionally include a plunger guide engagement member 237p. The plunger guide engagement member 237p may include a protrusion extending radially inward, disposed near the distal end of the rotatable member 237, and having at least one surface perpendicular to or substantially perpendicular to the longitudinal axis A and generally facing proximally. As discussed below, in the post-delivery state, the plunger guide engagement member 237p may be configured to engage the rotatable member engagement member 260p of the plunger guide 260 to prevent the protector 332 from moving proximally after the post-injection protector 332 has been lifted away from the injection site. Figure 21B As seen, the rotatable member engagement member 260p of the plunger guide 260 may include a protrusion that extends radially outward, is located near the distal end of the plunger guide 260, and has at least one surface that is perpendicular or substantially perpendicular to the longitudinal axis A and generally faces the distal direction.

[0142] Figure 23 The rotatable member engagement member 212a of the housing 212 may include a protrusion (e.g., a longitudinally extending ridge or spline) that extends radially inward, is located near the proximal end of the housing 212, and has at least one surface that is parallel or substantially parallel to the longitudinal axis A and generally faces a second circumferential direction (opposite to the first circumferential direction).

[0143] refer to Figures 24 to 28 Examples and other features will now be described of how the rotatable member 237 and the housing 212 can interact to eliminate or reduce the amount of distal force applied to the protector 232 by the proximal bias member 235 during part or all of the delivery state, and to partially or fully restore the amount of distal force applied to the protector 232 by the proximal bias member 235 after the delivery state.

[0144] Figures 24 to 28Arranged chronologically, this diagram shows a series of positions of the rotatable member 237 and other components of the drug delivery device 210 during different operating states or sub-states. For clarity, Figures 24 to 28 The proximal offset member 235 is omitted, but in reality, as shown in the figure... Figure 21A As shown, the proximal biasing member 235 is axially positioned between the proximal end of the rotatable member 237 and the proximal end of the release member 252, and / or the distal end of the proximal biasing member 235 contacts the proximal-facing surface of the proximal end of the rotatable member 237, and / or the proximal end of the proximal biasing member 235 contacts the distal-facing surface of the proximal end of the release member 252. For clarity, Figures 24 to 28 Other components of the drug delivery device 210, such as the drug storage container 210 and the removable cap 219, are also omitted.

[0145] Figure 24 The storage state of the drug delivery device 210 is shown. Here, the protective member 232 can be positioned in its first axial or extended position, such that the insertion end 228 of the delivery member 216 is covered by the protective member 232, and the rotatable member 237 can be positioned relative to the longitudinal axis A in the first axial position and the first rotational position. Figure 24 As can be seen, the distal surface of the rotatable member 237 can engage the proximal surface of the container holder 231 to prevent the rotatable member 237 from moving in the distal direction in the storage state (e.g., under the influence of the proximal biasing force of the proximal biasing member 235).

[0146] Figure 24 It is further shown that the proximal end 232e of the protective member 232 (including the corresponding proximal-facing end surfaces 232g and 232h of the longitudinally extending arms 232b and 232c of the protective member 232) can be spaced apart axially from the distal end of the rotatable member 237 by a clearance or distance. The rotatable member 237 can be biased distally (along the longitudinal axis A) by the proximal biasing member 235.

[0147] The rotatable member 237 can also be biased by the plunger biasing member 250 in a clockwise direction of rotation (around the longitudinal axis A, when viewed from above) via the engagement between the release member engagement member 237d of the rotatable member 237 and the rotatable member engagement member 252a of the release member 252. However, the engagement between the rotatable member 237 and the housing 12 can prevent or suppress the clockwise rotation of the rotatable member 237. As an example, such as Figure 24As shown, the housing engagement member 237f of the rotatable member 237, and particularly the abutment surface 237fi of the housing engagement member 237f, can engage the rotatable member engagement member 212a of the housing 212 to prevent or inhibit the rotatable member 237 from rotating in the clockwise direction. Therefore, the release member 252, which is currently locked in a rotational sense with the rotatable member 237 due to the engagement between the release member engagement member 237d of the rotatable member 237 and the rotatable member engagement member 252a of the release member 252, is also prevented or inhibited from rotating in the clockwise direction, as described above, which prevents the plunger bias member 250 from expanding.

[0148] Figure 25 This demonstrates the start or essentially start of the delivery process. Here, as the user presses the protective member 232 against the injection site, the protective member 232 has moved from its first axial or extended position to its second axial or retracted position in the direction of arrow 232f (corresponding to the proximal direction), causing the insertion end 228 of the delivery member 216 to be inserted into the injection site. As the protective member 232 moves from its first axial or extended position to its second axial or retracted position, the initial axial gap between the protective member 232 and the rotatable member 237 is eliminated, and then the rotatable member 237 is engaged in the direction of arrow 237e (corresponding to the proximal direction), pushing the rotatable member from its first axial position to its second axial position. As the rotatable member 237 moves from its first axial position to its second axial position, it can compress the axial length of the proximal biasing member 235. Furthermore, this axial movement of the rotatable member 237 can cause the housing engagement member 237f of the rotatable member 237, particularly the abutment surface 237fi of the housing engagement member 237f, to slide against the rotatable member engagement member 212a of the housing 212 until the abutment surface 237fi leaves the proximal end of the rotatable member engagement member 212a of the housing 212. Here, the abutment surface 237fi of the housing engagement member 237f of the rotatable member 237 no longer engages with the rotatable member engagement member 212a of the housing 212. Therefore, the housing 212 no longer prevents or inhibits the rotation of the rotatable member 237 or the release member 252 about the longitudinal axis A. As described above, this allows the plunger biasing member 250 to begin extending distally and the release member 252 to rotate via the cam action between the plunger 226 and the plunger guide 260 (see...). Figure 26 (See arrow 252d in the image), which in turn causes the rotatable member 237 to rotate due to the engagement between the release member engaging member 237d of the rotatable member 237 and the rotatable member engaging member 252a of the release member 252 (see arrow 252d in the image). Figure 26 (Arrow 237n in the image).

[0149] In some embodiments, release of the plunger biasing member 250 may generate an audible signal indicating the start of drug delivery (drug delivery start signal). In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal generated due to the release of the plunger biasing member 250. The plunger biasing member 250 may generate the drug delivery start signal simultaneously or substantially simultaneously as it begins to extend distally. In other embodiments, a cam action between the plunger 226 and the plunger guide 260 may generate the drug delivery start signal.

[0150] Figure 26 This illustrates a moment during the delivery state after the rotatable member 237 has been rotated clockwise from a first rotational position to a second rotational position by the release member 252. Rotation of the rotatable member 237 from the first rotational position to the second rotational position causes it to move linearly proximally to a third axial position, thereby creating an axial clearance between the distal end of the rotatable member 237 and the corresponding proximally facing end surfaces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard member 232, as shown. Figure 26 As can be seen. Therefore, the proximal biasing member 235 may not bias the protective member 232 distally because the axial clearance prevents the rotatable member 237 from transmitting the distal biasing force of the proximal biasing member 235 to the protective member 232. In some embodiments, this axial clearance may be maintained for the duration of the delivery state until, for example, a delivery end signal or drug administration end signal is generated.

[0151] Due to the cam interaction between the cam action surface 237fii of the housing engagement member 237f and the rotatable member engagement member 212a of the housing 212, the rotatable member 237 can move proximally when rotating from a first rotational position to a second rotational position. As an example, when the cam action surface 237fii slides against the rotatable member engagement member 212a, the slope of the cam action surface 237fii can transform or convert at least a portion of the rotational force from the release member 252 into a linear force proximally, thereby causing the cam action surface 237fii of the housing engagement member 237f and the remainder of the rotatable member 237 to move linearly proximally along the longitudinal axis A (see [link to relevant documentation]). Figure 26 (See arrow 237g in the image). Therefore, the rotatable member 237 can move proximally to its third axial position as it rotates clockwise from its first rotational position to its second rotational position.

[0152] like Figure 26As shown, when the rotatable member 237 is in its third axial position and second rotational position, the abutment surface 237fiii of the housing engagement member 237f of the rotatable member 237 can engage the rotatable member engagement member 212a of the housing 212. This engagement prevents the rotatable member 237 from moving distally relative to the housing 212 due to the distal biasing force of the proximal biasing member 235. Therefore, when the rotatable member 237 is in its third axial position and second rotational position, the housing 212 (instead of the protective member 232) can withstand the distal biasing force of the proximal biasing member 235.

[0153] Figure 27 The configuration of the drug delivery device 210 at the point of delivery termination is shown. Here, due to the cam interaction between the release member 252 and the plunger guide 260, powered by the proximal extension of the proximal bias member 235, the release member 252 has rotated clockwise (see arrow 252e) to the final or delivery termination position. Due to the engagement between the rotatable member engagement member 252a of the release member 252 and the release member engagement member 237d of the rotatable member 237, the rotatable member 237 can rotate together with the release member 252 (see arrow 237h) to a third rotation position. As the rotatable member 237 rotates to the third rotation position, the abutment surface 237fiii of the housing engagement member 237f of the rotatable member 237 can disengage from the rotatable member engagement member 212a of the housing 212. Due to this disengagement, the rotatable member 237 can move freely linearly in the distal direction under the influence of the distal biasing force of the proximal bias member 235. Therefore, the proximal biasing member 235 can push the rotatable member 237 in a distal direction (see arrow 237i) back into contact with the corresponding proximal-facing end surfaces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard member 232 (thereby eliminating) Figure 26 (The axial clearance shown). Therefore, in the post-delivery state, the proximal biasing member 235 can return to bias the guard 232 distally via the rotatable member 237. Thus, the proximal biasing member 235 can assist or solely be responsible for pushing the guard 232 distally from the second axial or retracted position to the first axial or extended position to cover the insertion end 228 of the delivery member 216 when the user lifts the guard 232 away from the injection site after injection.

[0154] Figure 28This illustrates the post-delivery state after the protective member 232 has been lifted away from the injection site and moved distally back to its first axial or extended position by the proximal biasing member 235 and / or the distal biasing member 251 to cover the insertion end 228 of the delivery member 216. Because the protective member 232 has moved distally from its second axial or retracted position to its first axial or extended position, the rotatable member 237 can also move distally under the influence of the distally biasing force of the proximal biasing member 235. Figure 28 Arrow 237j in the diagram moves. Due to this distal movement of the rotatable member 237, the housing engagement member 237m of the rotatable member 237, and in particular the cam action surface 237mi of the housing engagement member 237m, can engage the rotatable member engagement member 212a of the housing 212. The slope of the cam action surface 237mi can transform or convert at least a portion of the axial biasing force from the proximal biasing member 235 (pushing the rotatable member 235 distally) into a force in the transverse direction relative to the longitudinal axis A, thereby causing the rotatable member 237 to rotate clockwise around the longitudinal axis A (see...). Figure 28 (See arrow 237k) rotates to the fourth rotation position. Additionally, when the rotatable member 237 rotates clockwise, the proximal biasing member 235 can push the rotatable member 237 in the distal direction (see...). Figure 28 Arrow 237j in the diagram moves linearly to the fourth axial position.

[0155] When the rotatable member 237 is positioned in the fourth rotational position and the fourth axial position, at least a portion of the plunger guide engagement member 237p of the rotatable member 237 can be positioned distal to and adjacent to the rotatable member engagement member 260p of the plunger guide 260. If, after injection, an attempt is made to move the guard 232 proximally from the first axial or extended position to the second axial or retracted position after the guard 232 has been lifted away from the injection site, the corresponding proximally facing end surfaces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard 232 can abut against or otherwise engage the distally facing end surface of the rotatable member 237, thereby pushing the rotatable member 237 proximally. However, such proximal movement of the guard 232 can be prevented or suppressed because the proximal-facing surface of the plunger guide engagement member 237p of the rotatable member 237 can abut against or otherwise engage the distal-facing surface of the rotatable member engagement member 260p of the plunger guide 260, preventing proximal movement of the rotatable member 237 and thus also preventing proximal movement of the guard 232. Therefore, when the rotatable member 237 is in its fourth rotational and fourth axial positions, the rotatable member 237 can lock the guard 232 in a first axial or extended position to cover the insertion end 228 of the delivery member 216 in a post-delivery state after the guard 232 has been lifted away from the injection site.

[0156] Although not specifically mentioned above, any of the joining members 237d, 237f, 237m, 237p, 252a and / or 260p may have corresponding replicas or mating members with the same geometry but mirrored about the longitudinal axis A, as shown in some of the figures.

[0157] All features described herein (including in the specification, claims, abstract and drawings) and all steps in any method or process described herein may be combined in any combination except where one or more of the features and / or steps are mutually exclusive.

[0158] It will be appreciated that the systems and methods according to this disclosure may have one or more advantages over conventional techniques, and any one or more of these advantages may be present in specific embodiments conforming to the features of this disclosure contained in this embodiment. Other advantages not specifically listed herein may also be appreciated.

[0159] The above description describes various devices, components, parts, subsystems, and methods used in connection with drug delivery devices. Devices, components, parts, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to those drugs identified below and their class counterparts and biosimilar counterparts. As used herein, the term "drug" is used interchangeably with other similar terms and can be used to refer to any type of pharmaceutical agent or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and classifiers. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or in a form that can be reconstructed from lyophilized form. The following exemplary list of drugs should not be considered as all-encompassing or restrictive.

[0160] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or prefilled with the medication for treatment. This master container can be a vial, cartridge, or prefilled syringe.

[0161] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors (such as granulocyte colony-stimulating factor (G-CSF)), or the device may be used in conjunction with colony-stimulating factors. Such G-CSF agents include, but are not limited to, Neulasta® (pefragiltin, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pefragiltin-cbqv), Ziextenzo® (LA-EP2006; pefragiltin-bmez) or FULPHILA (pefragiltin-bmez).

[0162] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulant (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (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. Erythropoietin-stimulating proteins include, but are not limited to, Epogen® (epogen α), Aranesp® (dabepoetin α), Dynepo® (epogen δ), Mircera® (methoxy-polyethylene glycol-epogen β), Hematide®, MRK-2578, INS-22, Retacrit® (epogen ζ), Neorecormon® (epogen β), Silapo® (epogen ζ), Binocrit® (epogen α), epogen α Hexal, Abseamed® (epogen α), Ratioepo® (epogen θ), Eporatio® (epogen θ), Biopoin® (epogen θ), epogen α, epogen β, epogen ι, epogen ω, epogen δ, epogen ζ, epogen θ and epogen δ, pegylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogues.

[0163] The specific illustrative proteins are those described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (also known as RANKL-specific antibodies, peptides, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, especially fully humanized monoclonal antibodies; myostatin-binding proteins, peptides, related proteins, etc., including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, related proteins, etc., particularly those inhibiting the activity of IL-4 and / or IL-4 receptors. -13-mediated activities involving receptor binding; interleukin-1 receptor 1 ("IL1-R1") specific antibodies, peptides, and related proteins; Ang2 specific antibodies, peptides, and related proteins; NGF specific antibodies, peptides, and related proteins; CD22 specific antibodies, peptides, and related proteins, especially human CD22 specific antibodies, such as, but not limited to, humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2. Dimers of the γ-chain linked to the human-mouse monoclonal hLL2 κ chain by disulfide, such as the fully humanized human CD22-specific antibody in epazuzumab (CAS Registry No. 501423-23-0); IGF-1 receptor-specific antibodies, peptides, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptides, and related proteins (“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 binding to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those inhibiting the interaction of B7RP-1 with its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptides, and related proteins, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as 145c7; IFN. γ-specific antibodies, peptides, and related proteins, including but not limited to human IFN γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptides, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone (“PTH”) specific antibodies, peptides, and related proteins; thrombopoietin receptor (“TPO-R”) specific antibodies, peptides, and related proteins;Hepatocyte growth factor (“HGF”) specific antibodies, peptides, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersive protein (HGF / SF); TRAIL-R2 specific antibodies, peptides, and related proteins; activin A specific antibodies, peptides, and proteins; TGF-β specific antibodies, peptides, and related proteins; amyloid-β protein specific antibodies, peptides, and related proteins; c-Kit specific antibodies, peptides, and related proteins, including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to proteins that bind to OX40L and / or OX40 receptors. Other ligand proteins; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], dabepoetin α, novel erythropoiesis-stimulating protein (NESP); Epogen® (epogenetin α, or erythropoietin); GLP-1, Avonex® (interferon β-1a); Bexxar® (tosimomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-β); Camppath® (alemumab, anti-CD52 monoclonal antibody); Dynepo® (epogenetin δ); Velcade® (bortezomib); MLN0002 (anti-α4β7) mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (ebertin α); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (growth hormone, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns), an anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (growth hormone, human growth hormone); Humira® (adalimumab).Vectibix® (panitumumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistamine), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)); Kineret® (anaspirin); Leukine® (saxaglastine, rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat) B, Belimumab (anti-BlySmAb); Metalyse® (tenectase, t-PA analog); Mircera® (methoxy-polyethylene glycol-edeotinib); Mylotarg® (gem-tuzumab-ozomicin); Raptiva® (efalizumab); Cimzia® (sertozumab, CDP 870); Soliris™ (eculizumab); Pexazumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibumab); Panorex® (17-1A, ezolizumab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vesizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (ibertin beta); Neumega® (interleukin-11); Orthoclone OKT3® (moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (ibertin α); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP IIb / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib).Roferon-A® (interferon α-2a); Simulect® (baliximab); Prexige® (romecoxib); Synagis® (palizumab); 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507); Tysabri® (natezumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domain of the Fc portion of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory proteins)); VEGFtrap (Ig domain of VEGFR1 fused to IgG1 Fc); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2Rα) mAb); Zevalin® (teimomab); Zetia® (ezetimibe); Orencia® (asceticipeptide, 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 (iplimumab, anti-CTLA-4) mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-Clostridium difficile toxin A and toxin BC mAb 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 fibrinogen for stage I idiopathic pulmonary fibrosis (FG-3019); anti-CTLA4 mAb; anti-eosinophil chemokine 1 mAb (CAT-213); anti-FGF8 mAb;Antiganglioside GD2 mAb; Antiganglioside 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).

[0164] In some embodiments, the drug delivery device may comprise or be used with sclerosing protein antibodies, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to the human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may comprise or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumab, or similar drugs. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, or the device may be used with such other oncolytic HSV, including but not limited to OncoVEX GALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may 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 may include Aimovig® (anovisumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for the treatment of migraine containing or being used with anovisumab. Needle-antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, anovisumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets may also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agents (BiTE®) molecules (such as, but not limited to, BLINCYTO® (bonatumab)) may be used in or with the drug delivery device of this disclosure.In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymocyte stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), an anti-TNF α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may comprise Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylepoxyethylene-2-yl)-1-oxopentane-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamyl)-4-phenylbutamido)-4-methylpentanamide, or another product containing carfilzomib, or used therewith, for the treatment of multiple myeloma. In some embodiments, the drug delivery device may comprise Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast, or used therewith, for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may comprise or be used with Parsabiv™ (vilalaceptide HCl, KAI-4169) or another product containing vilalaceptide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as for hemodialysis in patients with chronic kidney disease (KD). In some embodiments, the drug delivery device may comprise or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (a fusion of the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 with the Fc domain of IgG1)). In some embodiments, the drug delivery device may comprise or be used with ABP959 (eculizumab), a biosimilar candidate of Soliris®, or another product comprising or used with a monoclonal antibody that specifically binds to complement protein C5.In some embodiments, the drug delivery device may comprise or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activities of ICOSL and BAFF. In some embodiments, the drug delivery device may comprise or be used with omeprazole (a small molecule selective cardiac myosin activator), or myotrope which directly targets the cardiac contraction mechanism, or another product comprising or being used with a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may comprise or be used with sotorasibi (formerly AMG 510), a KRASG12C small molecule inhibitor, or another product comprising or being used with a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may comprise or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product comprising or being used with a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may comprise or be used with rocatamumab (AMG-451), a human anti-OX40 monoclonal antibody that expresses on activated T cells and blocks OX40 to inhibit and / or reduce the number of OX40-pathogenic T cells responsible for driving systemic and local atopic dermatitis inflammatory responses. In some embodiments, the drug delivery device may comprise or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product comprising or being used with a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may comprise or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a) (also known as Lp(a)), or another product comprising or being used with a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may comprise or be used with ABP 654 (human IgG1 κ antibody), a biosimilar candidate of Stelara®, or another product comprising or binding to the p40 subunits of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (monoclonal antibody against TNF human IgG1), a biosimilar candidate of Humira®, or another product comprising or being used with human monoclonal antibody against TNF human IgG1.In some embodiments, the drug delivery device may comprise, or be used with, AMG 160, or another product comprising, or being used with, an extended-life (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise, or be used with, AMG 119, or another product comprising, or being used with, delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy. In some embodiments, the drug delivery device may comprise, or be used with, AMG 119, or another product comprising, or being used with, delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy. In some embodiments, the drug delivery device may comprise, or be used with, AMG 133, or another product comprising, or being used with, a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may comprise, or be used with, AMG 171, or another product comprising, or being used with, a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may comprise or be used with AMG 176 or another product comprising a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise or be used with AMG 199 or another product comprising a bispecific T-cell conjugate with extended half-life (HLE) (BiTE®). In some embodiments, the drug delivery device may comprise or be used with AMG 256 or another product (comprising anti-PD-1 x IL21 mutant protein and / or an IL-21 receptor agonist) designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may comprise or be used with AMG 330 or another product comprising an anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing an extended-life (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell binder) construct. In some embodiments, the drug delivery device may contain or be used with AMG430, or another product containing an anti-Jagged-1 monoclonal antibody.In some embodiments, the drug delivery device may contain or be used with AMG 506, which is being investigated for the treatment of solid tumors, or another product containing a multispecific FAP x4-1BB-targeting DARPin® biologic. In some embodiments, the drug delivery device may contain or be used with AMG 509, or another product containing a bivalent T-cell binder, and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562, or another product containing an extended half-life (HLE) CD19 xCD3 BiTE® (bispecific T-cell binder) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin α (formerly AMG 592), or another product containing an IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596, or another product containing a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell binder) molecule. In some embodiments, the drug delivery device may comprise or be used with AMG 673 or another product comprising or containing an extended-life (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 701 or another product comprising or containing an extended-life (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 757 or another product comprising or containing an extended-life (HLE) anti-δ-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 910 or another product comprising or containing an extended-life (HLE) claudin 18.2 x CD3 BiTE® (bispecific T-cell conjugate) construct.

[0165] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. This detailed description is to be interpreted as exemplary only and does not describe every possible embodiment of this disclosure. Many alternative embodiments can be implemented using current technology or technology developed after the date of this patent application, and these embodiments still fall within the scope of the claims defining the invention disclosed herein.

[0166] Those skilled in the art will understand that various modifications, alterations, and combinations can be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations are considered to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: A housing having an opening and a longitudinal axis; A drug storage container, the drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; A plunger, which is movable distally along the longitudinal axis, to expel the drug through the delivery member from the drug storage container during the delivery state; A plunger biasing member configured to bias the plunger in the distal direction; A protective element is positioned adjacent to the opening and has a first axial position relative to the housing before the delivery state, and a second axial position relative to the housing during the delivery state; as well as A proximal biasing member configured to selectively bias the protective member in the distal direction.

2. The drug delivery device as claimed in claim 1, wherein, The proximal biasing member is configured to not bias the protective member in the distal direction during at least a portion of the delivery state.

3. The drug delivery device as claimed in claim 1, wherein, The proximal biasing member is configured to bias the guard in the distal direction to a lesser extent during at least a portion of the delivery state compared to before the delivery state.

4. The drug delivery device as claimed in any one of claims 1 or 2, wherein, The proximal biasing member is configured to selectively bias the protective member in the distal direction when the protective member is in the second axial position.

5. The drug delivery device according to any one of claims 1 to 4, comprising a rotatable member that is movable along the longitudinal axis and has a first rotational position that allows the proximal biasing member to bias the protective member in the distal direction and a second rotational position that prevents the proximal biasing member from biasing the protective member in the distal direction.

6. The drug delivery device as claimed in claim 5, wherein, The rotatable member has a third rotational position that allows the proximal biasing member to bias the protective member in the distal direction.

7. The drug delivery device as claimed in any one of claims 5 or 6, wherein, The rotatable member is positioned along the longitudinal axis between at least a portion of the protective member and at least a portion of the proximal biasing member.

8. The drug delivery device according to any one of claims 5 to 7, comprising a plunger guide fixed in a rotational sense relative to the housing, wherein prior to the delivery state, the rotatable member is operatively coupled to the plunger guide to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

9. The drug delivery device as claimed in claim 8, wherein, During at least a portion of the delivery state, the rotatable member is operatively engaged with the plunger guide to prevent the proximal biasing member from biasing the guard in the distal direction.

10. The drug delivery device as claimed in claim 9, wherein, After the delivery state, the rotatable member is operatively coupled to the protective member to allow the proximal biasing member to bias the protective member in the distal direction.

11. The drug delivery device according to any one of claims 8 to 10, wherein, The inner portion of the rotatable member includes a plunger guide engagement member, and the outer portion of the plunger guide includes a first rotatable member engagement member, wherein, prior to the delivery state, the plunger guide engagement member of the rotatable member engages the first rotatable member engagement member of the plunger guide to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

12. The drug delivery device of claim 11, wherein, The outer portion of the plunger guide includes a second rotatable member engagement member, wherein, during at least a portion of the delivery state, the plunger guide engagement member of the rotatable member engages the second rotatable member engagement member of the plunger guide to prevent the rotatable member from moving in the distal direction and / or to prevent the proximal biasing member from biasing the guard in the distal direction.

13. The drug delivery device of claim 12, wherein, The engagement between the plunger guide engagement member of the rotatable member and the second rotatable member engagement member of the plunger guide is configured to generate at least one of an audible signal or a tactile signal indicating the start of drug delivery.

14. The drug delivery device of claim 12, wherein, After the delivery state, the plunger guide engagement member of the rotatable member disengages from the second rotatable member engagement member of the plunger guide to allow the rotatable member to move in the distal direction and / or allow the proximal biasing member to bias the guard in the distal direction.

15. The drug delivery device according to any one of claims 8 to 14, wherein, The protective member is configured such that when the protective member moves from the first axial position to the second axial position, it causes the rotatable member to move in the proximal direction, so that the plunger guide engagement member of the rotatable member disengages from the first rotatable member engagement member of the plunger guide, thereby allowing the rotatable member to rotate from the first rotational position to the second rotational position.

16. The drug delivery device of claim 15, wherein, The protective component is spaced axially from the rotatable member before moving to the second axial position.

17. The drug delivery device as claimed in claim 5, wherein, The rotational movement of the rotatable component is configured to generate at least one of an audible signal or a tactile signal indicating the start of drug delivery.

18. The drug delivery device according to any one of claims 5 to 17, wherein, A cam-acting surface located on one or both of the plunger and the plunger guide converts or transforms the axial force from the plunger biasing member into a lateral force that causes the plunger to rotate relative to the plunger guide during the initial portion of the delivery state.

19. The drug delivery device of claim 18, further comprising a release member, wherein, During the initial portion of the delivery state, the release member operably connects the plunger and the rotatable member such that rotation of the plunger during the initial portion of the delivery state causes the rotatable member to rotate from the first rotational position to the second rotational position.

20. The drug delivery device of claim 19, wherein, The inner portion of the rotatable member includes a release member engagement member, and the outer portion of the release member includes a third rotatable member engagement member, wherein, during the initial portion of the delivery state, the third rotatable member engagement member of the release member engages the release member engagement member of the rotatable member to cause the rotatable member to rotate from the first rotational position to the second rotational position.

21. The drug delivery device according to any one of claims 5 to 9, wherein, The rotatable member includes a distal surface configured to engage the proximal surface of the protective member when the rotatable member is in the first rotational position, and not engage the proximal surface of the protective member when the rotatable member is in the second rotational position.

22. The drug delivery device of claim 21, wherein, When the protective member is in the second axial position and the rotatable member is in the second rotational position, the proximal biasing member is configured to move the rotatable member in the distal direction such that at least a portion of the distal end of the rotatable member is positioned radially inward of at least a portion of the proximal end of the protective member.

23. The drug delivery device according to any one of claims 5 to 7, wherein, Prior to this delivery state, the rotatable member is operably connected to the housing to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

24. The drug delivery device of claim 23, wherein, During at least a portion of the delivery state, the rotatable member is operatively coupled to the housing to prevent the proximal biasing member from biasing the protective member toward the distal direction.

25. The drug delivery device of claim 24, wherein, After the delivery state, the rotatable member is operatively coupled to the protective member to allow the proximal biasing member to bias the protective member in the distal direction.

26. The drug delivery device according to any one of claims 24 to 25, wherein, The outer portion of the rotatable member includes a first housing engagement member, and the inner portion of the housing includes a first rotatable member engagement member, wherein, prior to the delivery state, the first housing engagement member of the rotatable member engages the first rotatable member engagement member of the housing to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

27. The drug delivery device of claim 26, wherein, The outer portion of the rotatable member includes a second housing engagement member, wherein, during at least a portion of the delivery state, the second housing engagement member of the rotatable member engages the first rotatable member engagement member of the housing to prevent the rotatable member from moving in the distal direction and / or to prevent the proximal biasing member from biasing the protective member in the distal direction.

28. The drug delivery device of claim 27, wherein, After the delivery state, the second housing engagement member of the rotatable member disengages from the first rotatable member engagement member of the housing to allow the rotatable member to move in the distal direction and / or allow the proximal biasing member to bias the protective member in the distal direction.

29. The drug delivery device according to any one of claims 26 to 28, wherein, The protective member is configured such that when the protective member moves from the first axial position to the second axial position, it causes the rotatable member to move in the proximal direction, so that the first housing engagement member of the rotatable member disengages from the first rotatable member engagement member of the housing, thereby allowing the rotatable member to rotate from the first rotational position to the second rotational position.

30. The drug delivery device of claim 29, wherein, The protective component is spaced axially from the rotatable member before moving to the second axial position.

31. The drug delivery device according to any one of claims 5 to 30, comprising a plunger guide fixed in a rotational sense relative to the housing, wherein at least a portion of the plunger is positioned within the plunger guide prior to the delivery state.

32. The drug delivery device according to any one of claims 31, wherein, A cam-acting surface located on one or both of the plunger and the plunger guide converts or transforms the axial force from the plunger biasing member into a lateral force that causes the plunger to rotate relative to the plunger guide during the initial portion of the delivery state.

33. The drug delivery device of any one of claims 32, comprising a release member, wherein, During the initial portion of the delivery state, the release member operably engages the plunger with the rotatable member such that rotation of the plunger during the initial portion of the delivery state causes the rotatable member to rotate from the first rotational position to the second rotational position.

34. The drug delivery device as claimed in claim 33, wherein, The inner portion of the rotatable member includes a release member engagement member, and the outer portion of the release member includes a second rotatable member engagement member, wherein, during the initial portion of the delivery state, the second rotatable member engagement member of the release member engages the release member engagement member of the rotatable member to cause the rotatable member to rotate from the first rotational position to the second rotational position.

35. The drug delivery device of claim 34, wherein, After the delivery state, the second rotatable member engagement member of the release member engages with the release member engagement member of the rotatable member, so that the rotatable member rotates from the second rotation position to the third rotation position.

36. A method comprising: A drug delivery device is provided, comprising: a housing having an opening and a longitudinal axis; a drug storage container having an insertion end configured to extend at least partially through the opening during a delivery state; a plunger movable distally along the longitudinal axis to discharge drug through the delivery member from the drug storage container during the delivery state; a plunger biasing member configured to bias the plunger distally; a guard positioned adjacent to the opening and having a first axial position relative to the housing before the delivery state and a second axial position relative to the housing during the delivery state; and a proximal biasing member configured to selectively bias the guard distally. When the proximal biasing member biases the protective member in the distal direction, the protective member moves in the proximal direction from the first axial position to the second axial position; and When the proximal biasing member stops at least temporarily or biases the guard to a lesser extent toward the distal direction, the guard is held in the second axial position.

37. The method of claim 36, wherein, The proximal biasing member is configured to not bias the protective member in the distal direction during at least a portion of the delivery state.

38. The method of claim 36, wherein, The proximal biasing member is configured to bias the guard in the distal direction to a lesser extent during at least a portion of the delivery state compared to before the delivery state.

39. The method of any one of claims 36 or 37, wherein, The proximal biasing member is configured to selectively bias the protective member in the distal direction when the protective member is in the second axial position.

40. The method according to any one of claims 36 to 39, wherein, The drug delivery device includes a rotatable member that is movable along the longitudinal axis and has a first rotational position that allows the proximal biasing member to bias the protective member in the distal direction and a second rotational position that prevents the proximal biasing member from biasing the protective member in the distal direction.

41. The method of any one of claims 40, comprising a plunger guide fixed in a rotational sense relative to the housing, wherein prior to the delivery state, the rotatable member is operatively coupled to the plunger guide to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

42. The method of any one of claims 41, wherein, After the delivery state, the rotatable member is operatively coupled to the protective member to allow the proximal biasing member to bias the protective member in the distal direction.

43. The method according to any one of claims 36 to 41, wherein, The rotatable member has a distal surface that is configured to engage the proximal surface of the protective member when the rotatable member is in the first rotational position, and not engage the proximal surface of the protective member when the rotatable member is in the second rotational position.

44. The method according to any one of claims 36 to 40, wherein, Prior to this delivery state, the rotatable member is operably connected to the housing to prevent the rotatable member from rotating from the first rotational position to the second rotational position.

Images