Drug delivery devices and related methods

Abstract

A drug delivery device and associated arrangement are disclosed. The drug delivery device may include a housing having an opening and a longitudinal axis; a drug storage container including a delivery member having an insertion end configured to at least partially extend through the opening when in a delivery state; a plunger movable tipwise along the longitudinal axis to release a drug from the drug storage container through the delivery member when in a delivery state; and 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, wherein a base biasing member may be configured to selectively bias the guard tipwise.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 585,949 filed on September 27, 2023, the entire content of which is incorporated herein by reference.

[0002] The present disclosure relates to drug delivery devices, and more specifically, to devices for automatically injecting a drug into a patient. BACKGROUND ART

[0003] Some individuals may experience anxiety regarding needles or their use when administering injections. This common aversion to needles, along with other health and safety concerns, has driven the development of drug delivery devices that conceal needles or other insertion members prior to use and automate various aspects of the injection process. Such devices offer various advantages compared to conventional forms of drug delivery, including for example, delivery via conventional syringes.

[0004] For example, some drug delivery devices, including some autoinjectors, may include a spring-loaded guard to conceal the needle before and / or after injection. To remove the needle cover, the user may press the guard against the skin at the injection site, moving the guard from an extended position to a retracted position so that the tip of the needle is exposed or can be exposed for insertion. During injection, the user continues to press the guard against the skin to hold it in the retracted position. To this end, the user needs to apply a force to counteract the biasing force of the guard spring throughout the course of injection. This can be difficult for at least some individuals, including, for example, those who are self-injecting and / or have limited knowledge about injections. In some cases, the force of the guard spring may cause or encourage the user to remove the device from the skin before the completion of drug delivery, potentially resulting in incomplete delivery of the drug dose. Furthermore, maintaining the counteracting force may cause the user to unintentionally move the needle laterally against the skin, which may cause discomfort to the patient. [Overview of the project] [Problems that the invention aims to solve]

[0005] This disclosure describes drug delivery devices and related methods for addressing one or more of the needs and challenges described herein and other related needs and challenges. [Means for solving the problem]

[0006] One aspect of the present disclosure provides a drug delivery device. The drug delivery device may include a housing, a drug storage container, a guard, 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 while in a delivery state. The plunger may be movable in the tip direction with respect to the longitudinal axis to release a drug from the drug storage container through the delivery member during a delivery state. The plunger biasing member may be configured to press the plunger in the tip direction. A guard 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 guard in the tip direction.

[0007] Another aspect of the present disclosure provides a method. The method may include providing a drug delivery device, which includes a housing having an opening and a longitudinal axis; a drug storage container having an insertion end configured to at least partially extend through the opening during a delivery state; a plunger movable tipwise along the longitudinal axis to release a drug from the drug storage container through a delivery member during a delivery state; a plunger biasing member configured to bias the plunger tipwise; a guard positioned adjacent to the opening and having a first axial position relative to the housing before a delivery state and a second axial position relative to the housing during a delivery state; and a base biasing member configured to selectively bias the guard tipwise. The method may further include moving the guard tipwise from the first axial position to the second axial position while the base biasing member is biasing the guard tipwise. Furthermore, the method may include holding the guard in the second axial position while the base biasing member at least temporarily stops or less biases the guard tipwise.

[0008] This disclosure will be better understood from the following description in conjunction with the accompanying drawings. Some of the drawings have been simplified by omitting selected elements for the purpose of more clearly illustrating other elements. Such omissions of elements in some of the drawings do not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless explicitly described in the corresponding description. Also, none of the drawings are necessarily drawn to a constant scale. [Brief explanation of the drawing]

[0009] [Figure 1A] This is a perspective view of drug delivery devices in storage conditions according to various embodiments. [Figure 1B] Figure 1A is a perspective view of the drug delivery device before injection. [Figure 1C] Figure 1A is a perspective view of the drug delivery device in the injection state. [Figure 2] Figure 1A is a cross-sectional view of the drug delivery device in its delivery state. [Figure 3A] Figure 1A is an exploded view of the drug delivery device. [Figure 3B] Figure 3A is an exploded view of the drive mechanism. [Figure 4A] Figure 3B is a perspective view of the plunger. [Figure 4B] Figure 4A is a top view of the plunger guide. [Figure 5A] Figure 3B is a perspective view of the release member. [Figure 5B] Figure 3B is a perspective view of the release member. [Figure 6A] Figure 3B is a perspective view of the rotatable member. [Figure 6B] Figure 3B is a perspective view of the rotatable member. [Figure 7A] Figure 3A shows a side view of the drug delivery device in its stored state, specifically the drive mechanism and guard. [Figure 7B] Figure 7A shows a side view of the plunger guide in the state shown, and a dashed line indicates a side view of a part of the rotatable member. [Figure 8A] shows a side view of the portion of the drug delivery device of Figure 3A, namely the drive mechanism and the guard, in the initial part of the delivery state, wherein the rotatable member in Figure 8A is shown as being translucent. [Figure 8B] shows a side view of the plunger guide in the state shown in Figure 8A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 9A] shows a side view of the portion of the drug delivery device of Figure 3A, namely the drive mechanism and the guard, in a part of the delivery state that is after a part of the delivery state of Figure 8A. [Figure 9B] shows a side view of the plunger guide in the state shown in Figure 9A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 10A] shows a side view of the portion of the drug delivery device of Figure 3A, namely the drive mechanism and the guard, in a part of the delivery state that is after a part of the delivery state of Figure 9A. [Figure 10B] shows a side view of the plunger guide in the state shown in Figure 10A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 11A] shows a side view of the portion of the drug delivery device of Figure 3A, namely the drive mechanism and the guard, in the post-delivery state, wherein Figure 8A is shown as being translucent. [Figure 11B] shows a side view of the plunger guide in the state shown in Figure 11A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 12A] is an exploded view of another embodiment of the drug delivery device. [Figure 12B] is an exploded view of the drive mechanism in Figure 12A. [Figure 13] is a perspective view of the release device of Figure 12B. [Figure 14A] is a perspective view of the rotatable member of Figure 12B. [Figure 14B] is a perspective view of the rotatable member of Figure 12B. [Figure 15] is a perspective view of the transmitter of Figure 12B. [Figure 16A]shows a side view of the portion of the drug delivery device of Figure 12A in the stored state, that is, the drive mechanism, the guard, the container holder, and the rear end cap. [Figure 16B] shows a side view of the plunger guide in the state shown in Figure 16A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 17A] shows a side view of the portion of the drug delivery device of Figure 12A in the initial part of the delivery state, that is, the drive mechanism, the guard, the container holder, and the rear end cap. [Figure 17B] shows a side view of the plunger guide in the state shown in Figure 17A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 18A] shows a side view of the portion of the drug delivery device of Figure 12A in a part of the delivery state subsequent to the part of the delivery state of Figure 17A, that is, the drive mechanism, the guard, the container holder, and the rear end cap. [Figure 18B] shows a side view of the plunger guide in the state shown in Figure 18A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 19] shows a side view of the portion of the drug delivery device of Figure 12A in a part of the delivery state subsequent to the part of the delivery state of Figure 18A, that is, the drive mechanism and the guard, wherein the rotatable member of the drive mechanism is shown as translucent in Figure 19. [Figure 20A] shows a side view of the portion of the drug delivery device of Figure 12A in the post-delivery state, that is, the drive mechanism, the guard, the container holder, and the rear end cap. [Figure 20B] shows a side view of the plunger guide in the state shown in Figure 20A, and also shows a side view of a portion of the rotatable member in broken lines. [Figure 21A] is an exploded view of another embodiment of the drug delivery device. [Figure 21B] is an exploded view of the drive mechanism of Figure 21A. [Figure 22A] is a perspective view of the rotatable member of Figure 21B. [Figure 22B] is a perspective view of the rotatable member of Figure 21B. [Figure 23]Figure 21A is a cutaway view of a portion of the housing. [Figure 24] Figure 21A shows a side view of the drug delivery device in storage, specifically the drive mechanism, guard, rotatable member engaging member of the housing, and container holder. [Figure 25] Figure 21A shows a side view of the drug delivery device in the initial stages of delivery, namely the drive mechanism, guard, rotatable member engaging member of the housing, and container holder. [Figure 26] Figure 25 shows a portion of the drug delivery device in a portion of the delivery state after the delivery state shown in Figure 21A, namely the drive mechanism, guard, rotatable member of the housing, engaging member, and container holder, as shown in a side view. [Figure 27] Figure 21A shows a side view of the drug delivery device in its initial post-delivery state, specifically the drive mechanism, guard, rotatable member engaging member of the housing, and container holder. [Figure 28] Figure 27 shows a side view of the portion of the drug delivery device shown in Figure 21A in the initial post-delivery state, namely the drive mechanism, guard, rotatable member engaging member of the housing, and container holder. [Modes for carrying out the invention]

[0010] This disclosure relates, in general, to drug delivery devices that can be operated by a user to administer a drug, or, if the user is a patient, to self-administer a drug. Various features are disclosed for simplifying, automating and / or facilitating certain aspects of drug delivery, such as those used in autoinjectors, on-body injectors, or other automatic or partially automatic drug delivery devices (collectively, autoinjectors or auto-injectors). For example, these features may include, among other things, automatically covering the needle in a pre-delivery and / or post-delivery state, automatically inserting the needle and / or cannula into the user's body, automatically activating a drive mechanism, and automatically indicating to the user that drug delivery is complete. One or more of these features may be powered by one or more springs that the user may need to compress by pressing a guard against the injection site, for example, to expose the tip of the needle for insertion into the injection site, or otherwise load. This disclosure provides various configurations and arrangements that reduce or assist in the user's need to maintain one or more of these springs in a compressed or unloaded state before, during, and / or after drug delivery. For example, these configurations and arrangements may reduce or eliminate the amount of force the user must apply to the drug delivery device to hold the guard in the retracted position during drug delivery. As a result, the operation of the drug delivery device may be simplified and more reliable for the user. Furthermore, the likelihood of the user removing the needle from the injection site during drug delivery due to, for example, the sensation of wanting to push the guard away from the skin may be low. Thus, the chances of successful and complete drug delivery are increased. Moreover, the reduced required holding force may reduce the likelihood of the user inadvertently moving the needle laterally from the injection site, potentially causing discomfort to the patient. These and other advantages will become apparent to those skilled in the art who consider this disclosure.

[0011] Figures 1 to 3 show some diagrams of embodiments of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological formulations such as peptides, peptide bodies, or antibodies. The drug may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0012] Various realizations and configurations are possible for the drug delivery device 10. In this embodiment, the drug delivery device 10 is configured as a single-use, disposable injector. In other embodiments, the drug delivery device 10 may be configured as a reusable injector for multiple uses. The drug delivery device 10 is operable for self-administration by the patient or administration by a caregiver or formally trained healthcare provider (e.g., a physician or nurse). The exemplary drug delivery device shown in the figure may take the form of an auto-injector or a pen-type injector, and can therefore be held in the user's hand for the duration of drug delivery, or alternatively, other drug delivery devices and / or configurations may be suitable.

[0013] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery state or administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state may have several substates or stages. The storage state may correspond to the configuration of the drug delivery device 10 in Figure 1A, in which the delivery device 10 includes a removable cap 19 in a storage position. In some embodiments, the storage state may exist in the time between when the drug delivery device 10 leaves the manufacturing facility and when a patient or other user removes the removable cap 19. Additionally or alternatively, the storage state may exist in the time between when a user removes the drug delivery device 10 from the secondary package and when a user removes the removable cap 19, and may be called the out-of-package state. The pre-delivery stage 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 moment after the user has removed the removable cap, as shown in Figure 1B, while the user is initially positioning the drug delivery device 10 relative to the injection site, but before drug administration begins. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as administration, is in progress, as shown in Figure 1C. The delivery state may additionally include the configuration of the drug delivery device 10 when the plunger biasing member is released, but before the plunger begins to release the drug from the drug delivery device 10. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is complete and / or when the stopper is placed in the end-of-administration position within the drug storage container.

[0014] As shown in Figures 1-3, the drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and sized so that a person can grasp the injector 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylinder, and may extend along a longitudinal axis A between a base end and a tip end. An opening 14 (Figure 2) may be formed at the tip end to allow the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be positioned in the wall of the housing 12 to allow the user to see the components inside the drug delivery device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window 17, the user may be able to confirm that drug delivery is in progress and / or completed. At the tip of the device, a removable cap 19 may cover the opening 14 before use of the drug delivery device 10, and in some embodiments, a gripper 13 (Figure 3A) may be included, configured to assist in the removal of a removable sterile barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting return portions or arms that frictionally or mechanically engage with 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. Thus, removing the removable cap 19 has the effect of removing the removable sterile barrier 21 from the delivery member 16.

[0015] In some embodiments, the housing 12 may include two separate interconnected structures, namely a rear end cap 23 (e.g., a rear cover) at the base end of the drug delivery device 10, and a tubular housing 25 extending substantially along the length of the drug delivery device 10 and defining an opening 14. Additionally or alternatively, the housing 12 may include fewer or more elements, such as a two-piece tubular housing having a front and a rear section. The tubular housing 25 may have a hollow, substantially cylindrical or tubular shape, and the rear end cap 23 may have a substantially hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25 and any components placed therein may be combined to define different subassemblies, such as a drive mechanism 30 (Figure 3B). In some embodiments, the different subassemblies are assembled independently of each other and then combined with each other and with the drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the assembly steps described above may be carried out in different manufacturing facilities or environments. In another embodiment, the housing 12 may be assembled from a single part such that the housing 12 is defined by a single monolithic structure that integrates the rear cap and the tubular housing into a single component.

[0016] The drug storage container 20 is located within the internal space of the housing 12 and is configured to contain the drug. The drug storage container 20 may be pre-filled and transported, for example, by the manufacturer to a location where the drug storage container 20 will be combined with the rest of the drug delivery device 10. For example, the drug 22 may be distributed and / or provided to the patient in two or more use cases, such as as a pre-filled syringe or as an auto-injector containing a pre-filled syringe. In either case, by using the same or similar syringe components, at least some of the above steps, such as filling, labeling, packaging, shipping and distribution, may be made more efficient or simpler for two different use cases. As another example, if some or all of the same syringe components are used in multiple use cases, some regulatory channels to the market trade and / or distribution of the drug may be made more efficient and / or simpler for at least one of the multiple use cases.

[0017] The housing 12 may be pre-loaded with the drug storage container 20, for example, by the manufacturer, or alternatively, the drug storage container 20 may be loaded by the user before use of the drug delivery device 10. The drug storage container 20 may include rigid walls defining an internal bore or reservoir. The walls may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 so as to move toward the tip along the longitudinal axis A between the base and tip of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may be in slidable sealing contact with the inner surface 15 of the wall of the drug storage container 20 so as to prevent or obstruct the drug 22 from leaking over the stopper 24 while the stopper 24 is moving. The tipping of the stopper 24 causes the drug 22 to be dispensed from the reservoir of the drug storage container 20 to the delivery member 16. The base end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 toward the tip. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by an axial gap. When the drive mechanism 30 is activated, the plunger 26 moves toward the tip, closing the axial gap and contacting the stopper 24. The subsequent tipward movement of the plunger 26 drives the stopper 24 toward the tip, dispensing the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or connected to each other, for example, via a screw coupling, so that they move together from the start of the plunger 26's movement. Once the stopper 24 is in motion, it can continue to move toward the tip until it contacts the base-facing portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may also be referred to as the end of drug administration or end of delivery position, and may correspond to the time when the delivery of drug 22 to the patient is completed or substantially completed.

[0018] In some embodiments, the volume of drug 22 contained in the reservoir of the drug storage container 20 may be equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.5 mL, or approximately (e.g., ±10%) equal to 2.5 mL, or equal to 3 mL, or approximately (e.g., ±10%) equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 1 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) less than or equal to 3 mL. It is fine, or it may be less than or about (e.g., ±10%) 4 mL, or less than or about (e.g., ±10%) 5 mL, or less than or about (e.g., ±10%) 10 mL, or it may be within the range of 1 to 10 mL, or it may be within the range of 1 to 5 mL, or it may be within the range of 1 to 4 mL, or it may be within the range of 1 to 3 mL, or it may be within the range of 1 to 2.5 mL, or about (e.g., ±10%).

[0019] The delivery member 16 is connected to or operable to be connected in fluid communication with the reservoir of the drug storage container 20. The tip of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include a sharp tip of any other pointed geometric shape, allowing the insertion end 28 to penetrate the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and have an internal passage. One or more openings may be formed in the insertion end 28 to allow the drug to exit the delivery member 16 and flow into the patient.

[0020] In one embodiment, the drug storage container 20 may be a pre-filled syringe and may have a fixed hollow metal needle for the delivery member 16. Here, the needle may be fixed to the wall of the drug storage container 20 and permanently in fluid communication with the reservoir of the drug storage container 20. In another embodiment, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In yet another embodiment, 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 such an embodiment, during operation of the drug delivery device 10, the drug storage container 20 may move toward or inversely toward the proximal end of the delivery member 16 so that the proximal end of the delivery member 16 penetrates the septum covering the opening of the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0021] Once the drug storage container 20 is placed inside the housing 12, it may be fixed to the housing 12 so as not to move relative to the housing 12. In this way, the insertion end 28 of the delivery member 16 may permanently extend through the opening 14 of the housing 12 in the pre-delivery, during-delivery, and post-delivery states. For example, as shown in Figure 2, the insertion end 28 of the delivery member 16 extends beyond the tip of the housing 12 defining the opening 14 in the delivery state. In certain other states, including the storage state shown in Figure 2, the insertion end 28 of the delivery member 16 may extend beyond the tip of the housing 12, but may be covered or protected by a removable cap 19, a sterile barrier 21, and / or a guard 32 surrounding the delivery member 16 to protect against or reduce the likelihood of unintentional or premature needle stick injuries.

[0022] The drug delivery device 10 may also include a container holder 31 configured to secure the drug storage container 20 to the housing 12, for example, by preventing the drug storage container 20 from moving toward the tip while the plunger 26 is in operation. The container holder 31 may have a hollow and substantially cylindrical or tubular shape centered about a longitudinal axis A, and the drug storage container 20 may be partially or entirely placed inside the container holder 31. The tip of the container holder 31 may include one or more inwardly projecting flanges 33, which abut the shoulder of the drug storage container 20, thereby preventing the drug storage container 20 from moving toward the tip while the plunger 26 is in operation. In some embodiments, each of the flanges 33 may include an arc-shaped inclined surface 33a that substantially matches the arc shape of the shoulder 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 of the drug storage container 20 and can restrict or prevent its movement toward the tip. The housing 12 may include a number of locking slots, each receiving one of the flanges 33 of the container holder 31, to prevent and / or restrict relative movement between the respective components 12 and 31. As a result, when fully assembled, the storage container 20, the container holder 31, and the housing 12 are all substantially or completely fixed to each other.

[0023] The drug delivery device 10 may further include a guard mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an infusion. The guard mechanism may include a guard 32 movably positioned adjacent to the opening 14 and at or near the tip of the housing 12. The guard 32 may have a hollow, substantially tubular or cylindrical portion 32a centered about a longitudinal axis A. The guard 32 may have a pair of longitudinally extending arms 32b and 32c extending from the cylindrical portion 32a toward the proximal end. The guard 32 may further include a tip portion 32d which may substantially include the cylindrical portion 32a and a proximal end portion 32e which may be defined by the longitudinally extending arms 32b and 32c. The longitudinally extending arms 32b and 32c may be substantially or completely receptive within the housing 12 such that no portion thereof extends from the housing 12. The cylindrical portion 32a can be received at least partially and / or selectively within the housing 12. For example, the guard 32 may be configured to move relative to the housing 12 such that in some stages / states multiple portions of the guard 32 are received within the housing 12 and in other stages / states they extend from the housing 12.

[0024] The guard 32 may 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. Further axial positions of the guard 32 relative to the housing 12 are possible. The first axial position of the guard 32 may be the tip relative to the second axial position of the guard 32. The guard 32 may be positioned in the first axial or extended position, for example, during the storage state and / or the pre-delivery state, and / or before the delivery state, including after the delivery state, for example, during the post-delivery state. The guard 32 may be positioned in the second axial or retracted position, for example, during part or all of the delivery state. In some embodiments, the guard 32 may be in the pre-delivery state when moving from the first axial position to the second axial position.

[0025] In the first axial position, the length X (see Figure 1B) of the cylindrical portion 32a of the guard 32 may extend through the opening 14 of the housing 12 such that at least this portion of the guard 32 is outside the housing 12. In the second axial position, the length Y (see Figure 1C) of the cylindrical portion 32a may extend through the opening 14 of the housing 12, where X is greater than Y. The length X may be any suitable number, including, for example, 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y may be any suitable number smaller than X, for example, 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. Figure 1B shows an example of a pre-delivery state where the guard 32 is in the first axial or extended position and the length X of the exposed portion of the guard 32 may be approximately 5 mm to 11 mm. Figure 1C shows an example of a delivery state in which the guard 32 is in a second axial or retracted position and the length Y of the exposed portion of the guard 32 is approximately 0 mm to 2 mm (so that the tip 32d of the guard 32 is coplanar or substantially coplanar 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 is operational before the guard becomes coplanar or substantially coplanar with the housing 12.

[0026] The guard 32 may 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 guard 32 may translate linearly toward the proximal end along the longitudinal axis A, and when moving from the second axial position to the first axial position, the guard 32 may translate linearly toward the tip along the longitudinal axis A. At least in the first axial position, the guard 32 may extend beyond and surround the insertion end 28 of the delivery member 16. In embodiments in which the insertion end 28 of the delivery member 16 extends from the opening 14 of the housing 12 before delivery or in storage, moving the guard 32 from the first axial position to the second axial position by pressing the tip of the guard 32 against the patient's skin 5 at the injection site may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin 5.

[0027] During the delivery process, the guard 32 may remain stationary relative to the user's skin 5, while the housing 12 and several components located within it move relative to the guard 32 and the skin 5. Nevertheless, this disclosure refers to the movement, retraction, translation, and indentation of the guard 32. These references and descriptions may be considered to refer to the relative motion between the guard 32 and the housing 12, regardless of which component (guard 32 or housing 12) is moving relative to the user's skin 5.

[0028] In some embodiments, the guard 32 may be rotationally fixed or its rotation may be restricted relative to the housing 12. Thus, even if the guard 32 may be able to translate linearly relative to the housing 12, its rotation relative to the housing 12 may be substantially or completely prevented.

[0029] In an alternative embodiment, the drug storage container 20 may be movably coupled to the housing 12 so that the drug storage container 20 can move relative to the housing 12 during the operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may be retracted inward into the opening 14 of the housing 12 in the pre-delivery state. Subsequently, during the operation of the injection device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 of the housing 12 for insertion into the patient. In some embodiments, this movement may result in the drug storage container 20 being driven forward relative to the housing 12.

[0030] The drive mechanism 30 may be located partially or entirely within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, when or in response to the user's operation of the drive mechanism 30, release or output that energy to drive the plunger 26 to release the drug 22 from the drug storage container 20 to the patient through the delivery member 16. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, but alternative embodiments of the drive mechanism 30 may be configured to store differently, for example, electrical or chemical potential energy or a combination of mechanical, electrical, and / or chemical potential energy. Generally, when the drive mechanism 30 is operated, the drive mechanism 30 may convert the potential energy into kinetic energy to move the plunger 26.

[0031] As shown in Figure 3B, 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 base biasing member 35, and a rotatable member 37. The plunger biasing member 50 may include a compression spring (e.g., a compression coil spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 may be compressed such that its axial length is shorter than in its natural or unbiased state, and as a result, the plunger biasing member 50 may apply a biasing force directed toward the tip to the plunger 26 and a biasing force directed toward the base to other components, which in some embodiments may include a release member 52. When released, the plunger biasing member 50 may attempt to expand to its natural axial length, thereby pushing the plunger 26 toward the tip and, in some embodiments, depending on the state of operation, pushing the release member 52 toward the base end.

[0032] The plunger guide 60 may have a hollow, substantially cylindrical or tubular shape and may be centered about the longitudinal axis A. The outer diameter of the base end of the plunger guide 60 or other external dimensions may be larger than the outer diameter of the tip end of the plunger guide 60 or other external dimensions. The plunger guide 60 may be fixedly coupled to the housing 12 such that the plunger guide 60 is substantially and / or generally immobile relative to the housing 12, or at least its rotation is fixed or locked relative to the housing 12. For example, the plunger guide 60 may include a locking tab or other projection, which is sized, shaped, and / or aligned to be received within a locking key or other mating structure formed within the housing 12. As another example, the plunger guide 60 and the housing 12 may each include a pair of components that cooperate to prevent relative rotation between the plunger guide 60 and the housing 12 so that the plunger guide 60's rotation is fixed or locked relative to the housing 12. Additionally or alternatively, annular protrusions formed on the outer surface of the plunger guide 60 can form a friction fit with the inner surface of the housing 12, thereby preventing or blocking rotation between the plunger guide 60 and the housing 12. Further features and functions of the plunger guide 60 are discussed below.

[0033] In some embodiments, as shown in Figures 2 and 3A, the plunger 26 may be at least partially located within the release member 52, and the release member 52 may be at least partially located within the plunger guide 60, so at least a portion of the release member 52 may be radially positioned between the plunger 26 and the plunger guide 60. In other embodiments, the plunger may be at least partially located within the plunger guide, and the plunger guide may be at least partially located within the release member, so at least a portion of the plunger guide may be radially positioned between the plunger and the release member.

[0034] The plunger 26 may have a hollow, substantially cylindrical or tubular shape, as shown in Figure 3B. 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. The annular wall 39 may be made of any suitable material, such as metal and / or plastic. To minimize the thickness of the annular wall 39, it may be advantageous to make the annular wall 39 out of a metal such as steel or aluminum.

[0035] As will be described in more detail below, for example, during the operation of the drug delivery device 10, including during the delivery state, the plunger 26 may be configured to selectively rotate relative to the housing 12 and to translate linearly relative to the housing 12.

[0036] The plunger 26 may consist of multiple interconnected parts, or it may have an integrated structure. In some embodiments, the plunger 26 consists of three separate interconnected structures: a top ring 45 defining the base end of the plunger 26, a base 47 defining the tip end of the plunger 26, and a hollow rod 46 positioned between the top ring 45 and the base 47 and rigidly connecting them. The positions of the top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other so that these components do not move relative to each other. The top ring 45, the hollow rod 46, and the base 47 may each have an annular structure and may be centered around a longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a central opening that extends from end to end of the component and defines an axial chamber, while the base 47 may have a central opening that extends through the base end of the base 47 but is closed at the tip of the base 47. The closed end of the base 47 may define a seat or contact surface for the plunger biasing member 50. In an alternative embodiment, the central opening may extend from end to end through the base 47. In such an alternative embodiment, the inner diameter of the central opening of the base 47 may be smaller than the outer diameter of the plunger biasing member 50 so that the base 47 holds the tip of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is actuated, the base 47 may be a portion of the plunger 26 that contacts the stopper 24 and pushes the stopper 24 toward the tip.

[0037] The top ring 45 may include one or more flanges or projections 48a and 48b extending radially outward from the central portion of the top ring 45. The flanges 48a and 48b may each include cam surfaces 49a and 49b (e.g., ramps) facing the tip. As will be described in more detail below, the tip-facing cam surfaces 49a and 49b may interact with the corresponding base-facing cam surfaces on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the tip-facing cam surfaces 49a and 49b may each be configured at an angle with respect to a virtual plane perpendicular to the longitudinal axis A, or non-parallel to this virtual plane.

[0038] In some embodiments, the top ring 45 and / or base 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or base 47 may be made of plastic, while the hollow rod 46 may be made of metal. With this configuration, the plastic material used for the top ring 45 can facilitate the cam operation described below by providing a relatively low coefficient of friction, and the plastic material used for the base 47 may help absorb or dampen any shocks or vibrations associated with the base 47 colliding with the stopper 24. The metal material used for the hollow rod 46 may provide sufficient rigidity to avoid buckling under the biasing force exerted 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 such particular embodiments, the top ring 45, hollow rod 46, and base 47 may be integrally formed into a single part to define a single monolithic structure.

[0039] The plunger biasing member 50 may be at least partially disposed within the plunger 26, and may have a tip that abuts against the inner surface of the base 47 of the plunger 26 facing the proximal end, and / or may be fixedly attached to the inner surface of the plunger 26. The outer diameter or other dimensions of the plunger biasing member 50 may be less than or equal to the inner diameter of the top ring 45 and / or the inner diameter of the hollow rod 46, so that the plunger biasing member 50 can be received within the plunger 26. In some embodiments, the tip of the plunger biasing member 50 may abut against the inner surface of the base 47 of the plunger 26 facing the proximal end. Furthermore, the proximal end of the plunger biasing member 50 may abut against the surface of the plunger biasing member seating surface 38 facing the tip. The plunger biasing member seating surface 38 may be fixedly attached to the tubular housing 25 so that the plunger biasing member seating surface 38 provides a stationary surface for pushing the plunger biasing member 50 away. With this configuration, when the plunger biasing member 50 is released from its biased state, its length may be extended by moving in the tip direction so that the tip of the plunger biasing member 50 moves away from the stationary base end of the plunger biasing member 50. This movement can push the plunger 26 in the tip direction, thereby further pushing the stopper 24 in the tip direction, allowing the drug 22 to be dispensed from the drug storage container 20 into the delivery member 16 and subsequently into the patient's body. However, in the embodiment shown in the figure, neither the release of the plunger biasing member 50 nor any other biasing member drives the delivery member 16 downward relative to the housing 12. Rather, the drug product container 20, and consequently the delivery member 16, are substantially or completely fixedly coupled to the housing 12. The delivery member 16 is driven toward the patient's skin 5 by an inertial force generated by a downward force from the patient (or healthcare provider or other person administering the dose).

[0040] As shown in Figure 2, the rotatable member 37 may be positioned on the base end side of the guard 32, and the base biasing member 35 may be positioned on the base end side of the rotatable member 37. The rotatable member 37 may be a separate structure from the guard 32, and in at least some embodiments, it may generally function as a guard extension or guard extension, and / or take the form of a guard extension or guard extension. The rotatable member 37 may have a hollow and substantially cylindrical or tubular shape centered about the longitudinal axis A. As an example, the rotatable member 37 may include a substantially cylindrical body 37a. The rotatable member 37 may also include an arm 37b for receiving, supporting, and / or holding the tip of the base biasing member 35. Furthermore, depending on the state or operating stage of the drug delivery device 10, the rotatable member 37 may be configured to move linearly along the longitudinal axis A relative to the housing 12, and / or rotate about the longitudinal axis A relative to the housing 12, as will be described in more detail below.

[0041] For example, prior to a delivery state, including a storage state and / or a pre-delivery state, the rotatable member 37 may be configured to move linearly along the longitudinal axis A, including in the proximal direction, relative to the housing 12, but rotation about the longitudinal axis A relative to the housing 12 may be prevented. In some embodiments, to achieve this effect, the rotatable member 37 may 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 to allow relative axial movement between the rotatable member 37 and the plunger guide 60. As a result, and because the plunger guide 60 is fixedly connected to the housing 12, the rotatable member 37 can be fixed to the housing 12 via the plunger guide 60. For example, as shown in Figures 4A and 4B, the outer portion of the plunger guide 60 may include a first rotatable member engaging member 60a, and the inner portion of the rotatable member 37 may include a plunger guide engaging member 37c. The first rotatable member engaging member 60a of the plunger guide 60 may include a projection (e.g., a longitudinally extending ridge or spline) extending radially outward and located near the tip of the plunger guide 60, and having at least one surface parallel or substantially parallel to the longitudinal axis A. The plunger guide engaging member 37c of the rotatable member 37 may include a projection extending radially inward and located near the base end of the rotatable member 37. The first rotatable member engaging member 60a may engage with the plunger guide engaging member 37c to prevent the rotatable member 37 from rotating relative to the plunger guide 60 and housing 12, while allowing the rotatable member 37 to move linearly relative to the plunger guide 60 and housing 12. For example, when the user pushes the guard 32 toward the base end to activate the drive mechanism 30 and / or removes the cover of the insertion end 28 of the delivery member 16, resulting in the rotatable member 37 moving linearly relative to the plunger guide 60, the plunger guide engaging member 37c may slide relative to the first rotatable member engaging member 60a. Additionally or alternatively, the rotatable member 37 may include a rotation-preventing feature that engages with a corresponding feature on the inner surface of the housing 12.

[0042] During at least the initial portion of the delivery state, the rotatable member 37 may be configured to rotate together with the release member 52 with respect 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 engaging member 52a, and the inner portion of the rotatable member 37 may include a release member engaging member 37d. The rotatable member engaging member 52a of the release member 52 may include a projection extending radially outward and located near the tip of the release member 52. The release member engaging member 37d may include a projection extending radially inward and located near the tip of the rotatable member 37. When the rotatable member 37 is not fixed to rotate with respect to the plunger guide 60 because the plunger guide engaging member 37c of the rotatable member 37 is disengaged from the first rotatable member engaging member 60a of the plunger guide 60, the rotatable member engaging member 52a of the release member 52 may be configured to engage with the release member engaging member 37d of the rotatable member 37 so that the rotatable member 37 (together with the release member 52) is rotated about the longitudinal axis A, for example, from a first rotation position to a second rotation position, by the rotation of the release member 52 (for example, caused by the extension of the plunger biasing member 50). Further features and functions of the rotatable member 37 will be described below.

[0043] As shown in Figure 2, in some embodiments, the base biasing member 35 may be positioned between the rotatable member 37 and the plunger guide 60 and in contact with them. The base biasing member 35 may be configured to bias the rotatable member 37 toward the tip (e.g., to urge) and, depending on the state of the drug delivery device 10, to bias the guard 32 toward the tip via the rotatable member 37. In other embodiments, such as those shown in Figures 12 to 28, the base biasing member may be positioned between the rotatable member and the release member and in contact with them. Furthermore, in some embodiments, the base biasing member may have a diameter larger than the diameter of the plunger biasing member and / or may be positioned radially outward of at least a portion of the plunger biasing member.

[0044] The base biasing member 35 may include a compression spring (e.g., a compression coil spring). In some embodiments, the base biasing member 35 may initially be held in a biased state (e.g., in storage), and in other embodiments, the base biasing member 35 may initially be in an unbiased or natural state (e.g., in storage). In the biased state, the base biasing member 35 can be compressed such that its axial length is shorter than when it is in the de-biased or natural state.

[0045] For example, if the guard 32 moves the rotatable member 37 in the proximal direction during the pre-delivery state, the proximal biasing member 35 may be compressed axially between the rotatable member 37 and the plunger guide 60 (or the release member 52 if the proximal end of the proximal biasing member 35 is seated against the release member 52 instead of the plunger guide 60). Compressing the proximal biasing member 35 may require the user to apply force to the drug delivery device 10, for example, by pressing the guard 32 against the injection site and moving the guard 32 in the proximal direction from a first axial position to a second axial position.

[0046] During operation of the drug delivery device 10, the user can translate the guard 32 in the proximal direction relative to the housing 12 by pressing the guard 32 against the injection site. In doing so, the guard 32 moves toward the rotatable member 37, closing the gap between them. Once the axial gap is eliminated, the guard 32 and the rotatable member 37 can move together in the proximal direction until, for example, the guard 32 reaches a second axial position. This movement can compress the proximal biasing member 35. In some embodiments, once drug delivery is complete and the drug delivery device 10 is removed from the injection site, the proximal biasing member 35 may extend from its compressed or biased state to push or assist in pushing the guard 32 toward the tip (via the rotatable member 37). This movement and / or the biasing force by the tip biasing member 51 return the guard 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), once drug delivery is complete and the drug delivery device 10 is removed from the injection site, the proximal biasing member 35 does not need to push the guard 32 toward the tip. Instead, the tip biasing member 51 may only be responsible for pushing the guard 32 toward the tip to a first axial position or an extended position.

[0047] After drug delivery is complete and the guard 32 has been repositioned to the extended position, it may be desirable to lock the guard 32 in the extended position to prevent the user from subsequently contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. To these purposes, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the guard 32 in order to lock the guard 32 in the extended position when the guard 32 moves from the retracted position to the extended position. The locking ring 40 may be centered and may rotate about a longitudinal axis A. The base end of the locking ring 40 may be in contact with the container holder 31, and the tip of the locking ring 40 may be at least partially disposed within the guard 32. The tip biasing member 51 may be axially positioned between the surface facing the tip of the locking ring 40 and the surface facing the base end of the guard 32. The tip biasing member 51 may initially be compressed or biased to bias the lock ring 40 and the guard 32 away from each other. Thus, the tip biasing member 51 may apply a biasing force that pushes the guard 32 toward the extended position, and may also apply a biasing force that pushes the base end of the lock ring 40 toward the container holder 31. In some embodiments, the tip biasing member 51 may include a compression spring (e.g., a compression coil spring). In some embodiments, rotation of the lock ring 40 may be achieved by a cam configuration between the lock ring 40 and the container holder 31. In alternative embodiments, the lock ring 40 may be omitted, and / or the rotatable member 37 may be configured to lock the guard 32 in the extended position when the guard 32 moves from the retracted position to the extended position.

[0048] The release member 52 may be hollow and substantially cylindrical or tubular in shape, and may be centered about the longitudinal axis A. As shown in Figure 2, the release member 52 may be radially positioned between the plunger guide 60 and the plunger 26. Also as shown in Figure 2, the release member 52 may also be radially positioned between the rotatable member 37 and the plunger 26. Furthermore, in some embodiments, the base end of the release member 52 may be coupled to the plunger biasing member seating surface 38 so that the plunger biasing member 50 can be configured to bias the release member 52 toward the base end. In general, the release member 52 may be configured to (1) operably couple the guard 32 and the plunger 26 in the operating sequence, and (2) generate an audible signal indicating the end of drug delivery. By being configured in this way, the release member 52 performs two distinct functions and is therefore utilized to reduce the number of moving parts required by the drug delivery device 10.

[0049] The release member 52 may be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the release member 52 related to operation may be powered by the plunger biasing member 50, while subsequent rotations of the release member 52 related to the generation of a drug delivery completion signal may be powered only 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 related to the generation of a delivery completion signal may be driven only by the base biasing member 50, but in the embodiments shown in Figures 12 to 28, the rotation of the release member 52 related to the generation of a delivery completion signal may be powered only by the base biasing member 35. In some embodiments, the release member 52 may translate linearly only in the base direction; however, alternative embodiments may allow linear translation of the release member 52 in both the base and tip directions.

[0050] In some embodiments, the ability of the release member 52 to rotate about the longitudinal axis A may be adjusted or controlled by the engagement or lack thereof between the rotatable member 37 and the plunger guide 60. For example, in storage and / or pre-delivery conditions, if the plunger guide engaging member 37c of the rotatable member 37 engages with the first rotatable member engaging member 60a of the plunger guide 60, the release member 52 may not be able to rotate about the longitudinal axis A. This is because the aforementioned engagement may prevent the rotation of the rotatable member 37, and as a result, the rotatable member 37 may prevent the release member 52 from rotating by 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.

[0051] If the release member 52 cannot rotate, the plunger 26 may also not rotate, as the outwardly extending flanges 48a and 48b of the top ring 45 of the plunger 26 are received in longitudinally extending openings or slots 52b and 52c formed in the annular wall of the release member 52. If the flanges 48a and 48b on the plunger 26 cannot rotate, the flanges 48a and 48b cannot slide in longitudinally extending recesses 60b and 60c (e.g., grooves, recesses, slots, and / or channels) formed on the inner surface of the plunger guide 60. If the flanges 48a and 48b cannot move in this way, the plunger 26 cannot move either. If the plunger 26 cannot move, the plunger biasing member 50 cannot extend to release the bias. Therefore, the release member 52 holds the plunger biasing member 50 in a biased state until the rotatable member 37 moves to an axial position in which the plunger guide engaging member 37c of the rotatable member 37 is disengaged from the first rotatable member engaging member 60a of the plunger guide 60, thereby allowing the rotatable member 37 and the release member 52 to rotate together.

[0052] As will be further explained here, the rotation of the rotatable member 37 and the release member 52 may be powered by the plunger biasing member 50 via a cam configuration. In storage and / or pre-delivery state, the cam surfaces 49a and 49b of the plunger 26 facing the tips of the flanges 48a and 48b of the top ring 45 may abut against the cam surfaces 60d and 60e (e.g., ramps) facing their respective base ends, formed by the interior of the plunger guide 60, and as a result, the plunger 26 is restrained from axial movement by this interaction. The cam surfaces 49a, 49b, 60d and / or 60e may each have an inclination to facilitate relative movement between the top ring 45 and the plunger guide 60. The inclination of the cam surfaces 49a, 49b, 60d, and / or 60e may convert or transform at least a portion of the axial biasing force from the plunger biasing member 50 into a force in a transverse direction with respect to the longitudinal axis A, thereby pushing the top ring 45 and the rest of the plunger 26 and causing them to rotate around the longitudinal axis A. However, the release member 52 may prevent or resist rotational movement between the release member 52 and the plunger 26 while the outwardly extending flanges 48a and 48b of the top ring 45 of the plunger 26 are received in the respective longitudinally extending openings 52b and 52c formed in the annular wall of the release member 52. As a result, as long as the rotatable member 37 locks the release member 52 in the rotational direction, the top ring 45 may remain locked in the rotational direction by the longitudinally extending openings 52b and 52c of the release member 52, and may remain locked in the axial direction by the cam surfaces 60d and 60e facing the base end of the plunger guide 60.

[0053] When the rotatable member 37 is translated in the proximal direction to a position where the plunger guide engaging member 37c of the rotatable member 37 does not engage with the first rotatable member engaging 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 the rotational direction. As a result, the plunger biasing member 50 begins to expand in the proximal direction, pushing the cam surfaces 49a and 49b facing the tips of the flanges 48a and 48b of the top ring 45 of the plunger 26, and sliding against the cam surfaces 60d and 60e facing the respective proximal ends formed by the internal portion of the plunger guide 60. The resulting cam action in this sliding interface can rotate the plunger 26, thereby rotating the release member 52 together with it, due to the outward-extending flanges 48a and 48b of the top ring 45 of the plunger 26 being received by the respective longitudinally extending openings 52b and 52c formed in the annular wall of the release member 52. The rotatable member 37 may rotate together with the release member 52 at this point 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.

[0054] The joint rotation of the release member 52, the rotatable member 37, and the plunger 26 may continue until the cam surfaces 49a and 49b facing the tip of the plunger 26 displace the ends of the cam surfaces 60d and 60e facing the respective base ends of the plunger guide 60 and move into the longitudinally extending recesses 60b and 60c of the plunger guide 60. The longitudinally extending recesses 60b and 60c do not have to prevent the linear movement of the plunger 26. As a result, the plunger 26 is driven to move linearly and translationally toward the tip by the extending plunger biasing member 50. Consequently, the plunger 26 contacts the stopper 24 (if it has not already contacted the stopper 24), and then pushes the stopper 24 toward the tip, releasing the drug 22 from the drug storage container 20 through the delivery member 16 and out of the insertion end 28 of the delivery member 16 into the patient's tissue. Drug delivery may continue until the stopper 24 reaches the end of drug delivery position. At this time, the stopper 24 may come into contact with the portion of the inner surface 15 of the wall of the drug storage container 20 that faces the proximal end. As a result, the plunger 26 may stop moving toward the tip.

[0055] During at least the initial portion of the plunger 26's tip movement, the flanges 48a and 48b of the plunger 26's top ring 45 may move 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 the three components. However, as the plunger 26 approaches the end-of-delivery position, the top ring 45 may pass the tip of the plunger guide 60, and therefore the plunger guide 60 no longer needs to restrict or prevent rotation of the plunger 26 and / or the release member 52. As a result, the plunger biasing member 50 may expand in the proximal direction, pushing against the proximal-facing cam surface of the release member 52 and sliding against the tip-facing surface of the plunger guide 60. The resulting cam action in this sliding interface may cause the surface of the release member 52 (e.g., the proximal end opposing surface) to strike the surface of another component, such as the plunger guide 60 (e.g., the tip opposing surface), and rotate the release member 52, moving it linearly in the proximal direction until a delivery completion or administration completion click or other audible signal is generated.

[0056] When a patient and / or healthcare provider hears an audible sound, they may be notified that the administration is complete. In some embodiments, the user may be informed of the importance of the audible signal by instructions provided with the drug delivery device 10. In some embodiments, these instructions may be in the form of an Instructions for Use (IFU) brochure packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by observing the movement of the stopper 24 and / or plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by vibration or other tactile feedback generated as a result of the release member 52 colliding with the plunger guide 60. The audible notification may be in the form of a click or slap or any other appropriate audible signal that the user can recognize. The audible signal may be generated simultaneously with or substantially simultaneously with the stopper 24 reaching the end-of-administration position.

[0057] In any case, once the user receives some confirmation that drug delivery is complete, the user can then lift the drug delivery device 10 from the injection site. The tip biasing member 51, which may be pre-compressed due to the movement of the guard 32 from a first axial or extended position to a second axial or retracted position due to the absence of any resistance, can push the guard 32 from the second axial or retracted position back to the first axial or extended position, thereby covering the insertion end 28 of the delivery member 16. In some embodiments, the tip biasing member 51 may move the guard 32 from the second axial or retracted position to the first axial or extended position independently of the base biasing member 35 (e.g., without the assistance of the base biasing member 35). In some embodiments, the movement of the guard 32 from the second axial or retracted position to the first axial or extended position may rotate the lock ring 40 to a position that prevents further retraction of the guard 32.

[0058] Generally, the drug delivery device 10 may be configured to eliminate or reduce the amount of downward or tip-directed force that the user must apply to the drug delivery device 10, for example, to hold the insertion end 28 of the delivery member 16 in the insertion position in the patient's tissue 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 and expose the insertion end 28 of the delivery member 16, the user may need to press the guard 32 against the skin of the injection site with enough force to overcome the tip-directed biasing force of the tip biasing member 51 and / or proximal biasing member 35 and thereby compress it within the tip biasing member 51 and / or proximal biasing member 35. In each of their compressed states, the tip biasing member 51 and / or proximal biasing member 35 may continue to act their tip-directed biasing force on any of the components holding them in their respective compressed states. If the guard 32 is one of these components, the user may need to counteract the biasing force directed towards the tips of the biasing members 51 and / or 35 in order to hold the guard 32 in a second axial or retracted position.

[0059] At least the proximal biasing member 35 may be configured to selectively (e.g., intermittently) bias the guard 32 toward the tip. Whether the proximal biasing member 35 biases the guard 32 toward the tip may depend, for example, on the operating state or substate of the drug delivery device 10. For example, the proximal biasing member 35 may be configured to bias the guard 32 toward the tip during at least a portion of the pre-delivery state (e.g., during at least a portion of the movement of the guard 32 from a first axial or extended position to a second axial or retracted position), but not bias the guard 32 toward the tip or to less bias the guard 32 during a portion or all of the delivery state (e.g., during at least a portion of the time the drug is released into the patient from the insertion end 28 of the delivery member 16). As a more specific example, the base biasing member 35 may be configured to selectively bias the guard 32 toward the tip when the guard 32 is in the second axial or retracted position, such that the base biasing member 35 biases the guard 32 toward the tip when the guard 32 is initially in the second axial or retracted position, but thereafter, while the guard 32 is still in the second axial or retracted position, the guard 32 is not biased toward the tip, or is biased toward the tip less than when the guard 32 was initially in the second axial or retracted position.

[0060] When the base biasing member 35 is not configured to bias the guard 32 toward the tip, the plunger guide 60 can withstand the biasing force of the base biasing member 35 toward the tip, for example, through an operable coupling with the rotatable member 37. For example, the rotatable member 37 may have a first rotational position that allows the base biasing member to bias the guard 32 toward the tip, and a second rotational position that prevents the base biasing member 35 from biasing the guard 32 toward the tip. Optionally, the rotatable member 37 may have a third rotational position different from the first and second rotational positions, for example, that allows the base biasing member 35 to bias the guard 32 toward the tip if the guard 32 comes into contact with the rotatable member 37 after the guard 32 has been lifted from the injection site after injection is complete.

[0061] Referring to Figures 7 to 11, here is an example illustrating how the rotatable member 37 can facilitate the reduction of retention force requirements (e.g., reduction of user retention force requirements) during at least some of the delivery states, among other features and functions. Figures 7 to 11 are ordered in chronological order and show the sequence of positions of the rotatable member 37 and other components of the drug delivery device 10 during various states and substates of operation of the drug delivery device 10. For visual clarity, the base biasing member 35 is omitted from Figures 7 to 11, but in practice, as shown in Figure 2, the base biasing member 35 is axially positioned between the base end of the rotatable member 37 and the base end of the plunger guide 60, and / or the tip of the base biasing member 35 is in contact with the base-facing surface of the base end of the rotatable member 37, and / or the base end of the base biasing member 35 is in contact with the tip-facing surface of the base end of the plunger guide 60. For example, other components of the drug delivery device 10, including the housing 12, drug storage container 20, container holder 31, and removable cap 19, are also omitted from Figures 7–11 for clarity. In Figures 7B, 8B, 9B, 10B, and 11B, the rotatable member 37 is omitted, but the position of the plunger guide engaging member 37c of the rotatable member 37 is indicated by a dashed rectangle.

[0062] Figures 7A and 7B show the drug delivery device 10 in storage. Here, the guard 32 may be positioned in its first axial or extended position such that the insertion end 28 of the delivery member 16 is covered by the guard 32, and the rotatable member 37 may be positioned in a first axial position and a first rotational position with respect to the longitudinal axis A. As shown in Figure 7A, the base end 32e of the guard 32, including the base end opposing end faces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32, may be positioned at an axial gap or distance from the tip of the rotatable member 37. The rotatable member 37 is biased toward the tip (along the longitudinal axis A) by a base biasing member 35 (for example, shown in Figure 2), and can also be biased clockwise (around the longitudinal axis A when viewed from above) by a plunger biasing member 50 (for example, shown in Figure 3B) via an 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. However, the rotatable member 37 may be prevented or inhibited from moving toward the tip and rotating clockwise by an engagement between the rotatable member 37 and the plunger guide 60. For example, as shown in Figure 7B, the plunger guide engaging member 37c of the rotatable member 37 may engage with the first rotatable member engaging member 60a of the plunger guide 60 to prevent or inhibit the rotatable member 37 from rotating clockwise. As a result, 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 prevents or restrains the release member 52, which is currently locked to the rotatable member 37 in the rotational direction, from rotating clockwise, thereby preventing the plunger biasing member 50 from expanding as described above. To prevent the rotatable member 37 from moving toward the tip, the plunger guide engaging member 37c of the rotatable member 37 may engage with a second rotatable member engaging member 60f of the plunger guide 60, as shown in Figure 7B. The second rotatable member engaging member 60f may include a projection that extends radially outward, is positioned toward the tip relative to at least a portion of the first rotatable member engaging member 60a, and has at least one surface perpendicular to or otherwise non-parallel to the longitudinal axis A.The first rotatable member engaging member 60a and the second rotatable member engaging member 60f may be separate protrusions with a gap between them, as shown in Figure 7B, or in other embodiments.

[0063] Figures 8A and 8B show the start or substantial start of the delivery state. Here, the user presses the guard 32 against the injection site and inserts the insertion end 28 of the delivery member 16 into the injection site, causing the guard 32 to move from its first axial or extended position to its second axial or retracted position in the direction of arrow 32f (corresponding to the base end direction). As the guard 32 moves from its first axial or extended position to its second axial or retracted position, it eliminates the initial axial gap between the guard 32 and the rotatable member 37, and then engages the rotatable member 37 in the direction of arrow 37e (corresponding to the base end direction), pushing it from its first axial position to its second axial position. The rotatable member 37 may compress the axial length of the base biasing member 35 as it moves from its first axial position to its second axial position. Furthermore, this axial movement of the rotatable member 37 may cause the plunger guide engaging member 37c of the rotatable member 37 to slide against the first rotatable member engaging member 60a of the plunger guide 60 until the plunger guide engaging member 37c passes the base end of the first rotatable member engaging member 60a, as shown in Figure 1. This is shown in Figure 8B. In this case, the plunger guide engaging member 37c of the rotatable member 37 no longer engages with the first rotatable member engaging member 60a of the plunger guide 60. As a result, the plunger guide 60 no longer prevents the rotation of the rotatable member 37 or the release member 52 around the longitudinal axis A. As described above, this allows the plunger biasing member 50 to begin expanding toward the tip, and the cam action between the plunger 26 and the plunger guide 60 rotates the release member 52 (see arrow 52d in Figure 9A), thereby rotating the rotatable member 37 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 37j in Figure 9A).

[0064] Figures 9A and 9B show a moment in the delivery state after the rotatable member 37 has been rotated clockwise from the first rotation position to the second rotation position by the release member 52. Upon reaching the second rotation position, the rotatable member 37 may stop rotating clockwise, as seen in Figure 9B, at least in part due to the engagement of the plunger guide engaging member 37c of the rotatable member 37 with the third rotatable member engaging member 60g of the plunger guide 60. The third rotatable member engaging member 60g of the plunger guide 60 may include a projection (e.g., a longitudinally extending ridge or spline) that extends radially outward and is located near the tip of the plunger guide 60, and has at least one surface parallel or substantially parallel to the longitudinal axis A. The engagement between the plunger guide engaging member 37c of the rotatable member 37 and the third rotatable member engaging member 60g of the plunger guide 60 allows for relative axial movement between the plunger guide engaging member 37c and the third rotatable member engaging member 60g, so as to prevent or restrict further clockwise rotation of the rotatable member 37 (see arrow 37j in Figure 9A).

[0065] By rotating the rotatable member 37 from a first rotation position to a second rotation position, the base end faces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32 may be slid against the tip end faces 37f and 37g of the rotatable member 37 until the base end faces 32g and 32h pass their respective tip end faces 37f and 37g, as shown in Figure 9A. Here, the rotatable member 37 may be disengaged from the guard 32, and the longitudinally extending arms 32b and 32c of the guard 32 may be aligned with the respective recesses 37h and 37i (e.g., grooves, depressions, slots, and / or channels) formed on the outer surface of the rotatable member 37. The radial depth of the recesses 37h and 37i may be greater than or equal to the radial thickness of the longitudinally extending arms 32b and 32c of the guard 32. As a result, the longitudinally extending arms 32b and 32c may be configured to slide into or otherwise accommodate recesses 37h and 37i formed on the outer surface of the rotatable member 37, respectively, when the rotatable member 37 is in a second rotation position. When the rotatable member 37 is in a second rotation position, the base biasing member 35 may continue to apply a biasing force directed toward the tip to the rotatable member 37. The longitudinally extending arms 32b and 32c are aligned with their respective recesses 37h and 37i, and when the rotatable member 37 is in a second rotation position, there is nothing to restrain the tip movement of the rotatable member 37, so the rotatable member 37 moves toward the tip along the longitudinal axis A under the influence of the biasing force directed toward the tip by the base biasing member 35 (see arrow 37k in Figure 10A).

[0066] Figures 10A and 10B show a moment in the delivery state after the rotatable member 37 has been moved linearly in the tip direction from a second axial position to a third axial position by the base biasing member 35. As the rotatable member 37 moves from the second axial position to the third axial position, the plunger guide engaging member 37c of the rotatable member 37 may slide against the third rotatable member engaging member 60g of the plunger guide 60. When the rotatable member 37 reaches the third axial position, as seen in Figure 10B, it may stop moving in the tip direction, at least in part due to the engagement of the plunger guide engaging member 37c of the rotatable member 37 with the fourth rotatable member engaging member 60h of the plunger guide 60. As the rotatable member 37 moves from the second axial position to the third axial position, the plunger guide engaging member 37c of the rotatable member 37 may engage with the fourth rotatable member engaging member 60h of the plunger guide 60 and cause impact. The impact between the plunger guide engaging member 37c of the rotatable member 37 and the fourth rotatable member engaging member 60h of the plunger guide 60 may generate an audible signal (administration start signal) indicating the commencement of dose delivery. In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal generated as a result of the plunger guide engaging member 37c contacting the fourth rotatable member engaging member 60h. The audible notification of dose commencement may be in the form of a click or slap or any other appropriate audible signal that the user can perceive. The audible signal may be generated simultaneously with or substantially simultaneously with the contact between the plunger guide engaging member 37c of the rotatable member 37 and the fourth rotatable member engaging member 60h of the plunger guide 60.

[0067] Figures 10A and 10B show an audible dosing start signal generated when the plunger guide engaging member 37c of the rotatable member 37 collides with the fourth rotatable member engaging member 60h of the plunger guide 60. In some embodiments, the dosing start signal may be generated when the rotatable member 37 collides with another component of the drug delivery device 10. For example, the dosing start signal may be generated when the longitudinally extending arms 32b and 32c of the guard 32 are fully received into recesses 37h and 37i formed on the outer surface of the rotatable member 37, respectively, and their respective proximal end faces 32g and 32h engage with at least a portion of the rotatable member 37. In other embodiments, the dosing start signal may be generated when the proximal end faces 37f and 37g of the rotatable member 37 collide with at least a portion of, for example, the container holder 31. In some embodiments, the dosing start signal may be generated when the rotatable member 37 collides with a portion of the housing 12 or another component of the drug delivery device 10 that remains fixed during operation. In yet another embodiment, the administration start signal may be generated when the proximal biasing member 35 is released and / or when the plunger biasing member 50 is released.

[0068] When the rotatable member 37 is in the second rotation position, the base biasing member 35 does not need to bias the guard 32 toward the tip. This is because, when the rotatable member 37 is in the second rotation position, the tip-facing surfaces of the rotatable member 37, including the tip-facing end faces 37f and 37g, do not contact the base-facing surfaces of the guard 32, including the base-facing end faces 32g and 32h of the longitudinally extending arms 32b and 32c, respectively. As a result, the rotatable member 37 does not need to transmit the biasing force directed toward the tip of the base biasing member 35 to the guard 32. Therefore, the user can completely or substantially completely reduce the need to apply a manual force to counteract the biasing force directed toward the tip of the base biasing member 35 when the rotatable member 37 is in the second rotation position, including part or all of the delivery state. Nevertheless, in embodiments including a tip biasing member 51, the user may be required to apply a manual force to counteract the biasing force directed toward the tip of the tip biasing member 51. However, it requires less effort, potentially substantially less effort, than it would be necessary to counteract both the biasing force directed towards the tip of the proximal biasing member 35 and the biasing force directed towards the tip of the tip biasing member 51. Therefore, the amount of force that the user must apply to hold the guard 32 in the second axial or retracted position during the delivery state can be reduced. This can reduce the likelihood that the user may lift the guard 32 from the skin prematurely before the end of the delivery state and / or withdraw the insertion end 28 of the delivery member 16 from the patient, which could potentially result in a suboptimal amount of drug being delivered or no drug being delivered at all. Furthermore, the reduction in required holding force can help the user hold the drug delivery device 10 firmly or stably during the delivery state, reducing the likelihood that the user may move the insertion end 28 of the delivery member 16 laterally against the surrounding tissue, causing discomfort to the patient. As shown in Figure 10B, the fourth rotatable member engaging member 60h of the plunger guide 60 may include a projection extending radially outward, positioned at the tip of the third rotatable member engaging member 60g, and having at least one cam surface 60i (e.g., ramp) positioned at an angle or inclination with respect to the third rotatable member engaging member 60g, or otherwise non-parallel to an imaginary plane perpendicular to the longitudinal axis A.When the rotatable member 37 is in the second rotational position and the third axial position, the base biasing member 35 can press the plunger guide engaging member 37c of the rotatable member 37 against the cam surface 60i, thereby allowing the plunger guide 60 to support the biasing force directed toward the tip of the base biasing member 35. The inclination of the cam surface 60i may convert or transform at least a portion of the axial biasing force from the base biasing member 35 into a transverse force with respect to the longitudinal axis A, thereby pushing the plunger guide engaging member 37c and the rest of the rotatable member 37 to rotate around the longitudinal axis A. However, the longitudinally extending arms 32b and 32c of the guard 32, as shown in Figure 10A, are positioned in recesses 37h and 37i on the outer surface of the rotatable member 37, respectively, so as to contact the circumferential surface of the rotatable member 37, thereby preventing the rotatable member 37 from rotating around the longitudinal axis A. As a result, the rotatable member 37 can remain locked in the rotational direction relative to the guard 32 and the housing 12, as long as the arms 32b and 32c extending in the longitudinal direction of the guard 32 are positioned in the recesses 37h and 37i on the outer surface of the rotatable member 37, respectively.

[0069] Figures 11A and 11B show the post-delivery state after the guard 32 has been moved away from the injection site and moved toward the tip (for example by the tip biasing member 51) to return to its first axial or extended position that covers the insertion end 28 of the delivery member 16. As a result of the guard 32 moving toward the tip 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 exit their respective recesses 37h and 37i on the outer surface of the rotatable member 37. Consequently, the rotatable member 37 can be freed to rotate about the longitudinal axis A. The base biasing member 35 can continuously apply a biasing force directed toward the tip to the rotatable member 37, so that the plunger guide engaging member 37c of the rotatable member 37 can be pressed against the cam surface 60i of the plunger guide 60, causing the plunger guide engaging member 37c to slide against the cam surface 60i, thereby rotating the rotatable member 37 counterclockwise around the longitudinal axis A from a second rotation position to a third rotation position (see arrow 37j in Figure 11A), and at the same time, it can move linearly toward the tip along the longitudinal axis A from a third axial position to a fourth axial position (see arrow 37n in Figure 11A). When the rotatable member 37 is positioned in the third rotation position, at least portions of the tip-opposing end faces 37f and 37g of the rotatable member 37 can be aligned in the rotational direction with at least portions of the base-opposing end faces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32. Furthermore, when the rotatable member 37 is positioned in the third rotation position, the base biasing member 35 may push the plunger guide engaging member 37c of the rotatable member 37 against the rotatable member engaging member 60h of the plunger guide 60 so that the plunger guide 60 supports the biasing force directed toward the tip of the base biasing member 35.

[0070] Furthermore, when the rotatable member 37 is positioned in the third rotation position, further rotational movement of the rotatable member 37 in the counterclockwise direction can be prevented by the fifth rotatable member engaging member 60k of the plunger guide 60. The fifth rotatable member engaging member 60k of the plunger guide 60 may include a projection that extends radially outward, is located near the tip of the plunger guide 60, and has at least one surface parallel or substantially parallel to the longitudinal axis A.

[0071] As shown in Figure 11B, when the rotatable member 37 is positioned in its third rotational position and fourth axial position, the plunger guide engaging member 37c of the rotatable member 37 is positioned toward the tip of the sixth rotatable member engaging member 60j of the plunger guide 60 and may be positioned directly adjacent to the rotatable member engaging member 60j. The sixth rotatable member engaging member 60j of the plunger guide 60 may include a projection that extends radially outward and is positioned near the tip of the plunger guide 60, and has at least one surface perpendicular or substantially perpendicular to the longitudinal axis A. If, after the guard 32 has been lifted from the injection site following injection, there is an attempt to move the guard 32 in the proximal direction from a first axial or extended position to a second axial or retracted position, the proximal end faces 32g and 32h of the longitudinally extending arms 32b and 32c of the guard 32 may contact or otherwise engage with the tip-opposite end faces 37f and 37g of the rotatable member 37, thereby biasing the rotatable member 37 in the proximal direction. However, such proximal movement of the guard 32 can be prevented or suppressed because the plunger guide engaging member 37c may contact or otherwise engage with the sixth rotatable member engaging member 60j to prevent the proximal movement of the rotatable member 37, and therefore also prevent the proximal movement of the guard 32. Therefore, when the rotatable member 37 is in its third rotational position and fourth axial position, the rotatable member 37 may lock the guard 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 separated from the injection site.

[0072] Although not specifically described above, the engaging members 37c, 37d, 52a, 60a, 60f, 60g, 60h, 60j, and / or 60k may each have a duplicate member or a mating member, which are identical assuming that their geometric shapes are mirrored across the longitudinal axis A, as shown in some figures.

[0073] Having described the configuration of the drug delivery device 10, a general method of using the drug delivery device 10 to perform an injection will now be described. As a preliminary step, the user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or cardboard box. Similarly, as a preliminary step, the user may prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. The user can then pull off the removable cap 19 from the housing 12. As a result of this action, the gripper 13 can pull off the removable sterile barrier 21 from the drug storage container 20. This may expose the insertion end 28 of the delivery member 16. Nevertheless, since the guard 32 is positioned in a first axial or extended position, the insertion end 28 of the delivery member 16 remains surrounded by the guard 32 at this stage. The user can then place the drug delivery device 10 over the injection site and then press the tip of the guard 32 against the injection site. The force applied by the user overcomes the biasing force directed towards the tip of the proximal biasing member 35 and (if included) the biasing force directed towards the tip of the tip biasing member 51, thereby retracting the guard 32 into the opening 14 and moving it proximal from a first axial or extended position to a second axial or retracted position. Since the delivery member 16 remains stationary relative to the housing 12 during this proximal movement of the guard 32, the insertion end 28 of the delivery member 16 extends through the opening at the tip of the guard 32, thereby puncturing the patient's skin at the injection site and penetrating the patient's subcutaneous tissue.

[0074] As the guard 32 moves from a first axial position or extended position to a second axial position or retracted position, the guard 32 may push the rotatable member 37 in the proximal direction from its first axial position to its second axial position. As described above, this movement of the rotatable member 37 may result in several actions, directly or indirectly, including, but not limited to, rotation of the rotatable member 37, rotation of the release member 52, release of the plunger biasing member 50, movement 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 completion signal.

[0075] After drug delivery is complete, the user may lift the guard 32 from the injection site. Since there is nothing to resist the distal biasing member 51, the distal biasing member 51 may push the guard 32 forward from the second axial or retracted position to the first axial or extended position, covering the insertion end 28 of the delivery member 16. As described above, this forward movement of the guard 32 may disengage the longitudinally extending arms 32b and 32c of the guard 32 from the rotatable member 37, thereby allowing the rotatable member 37 to move to a locked position that prevents further retraction of the guard 32 under the influence of the biasing force directed towards the tip of the proximal biasing member 35.

[0076] In the embodiments described above, the base biasing member 35 does not need to bias the guard 32 toward the tip when the delivery state is initiated or immediately after the delivery state is initiated, except when attempting to move the guard 32 toward the base after the injection is completed and the guard 32 has been removed from the injection site. In an alternative embodiment, once the delivery state is completed, the base biasing member returns to bias the guard toward the tip, for example, in the post-delivery state, moving the guard toward the tip from its second axial or retracted position to its first axial or extended position to cover the insertion end of the delivery member. Such embodiments will be described below with reference to Figures 12 to 20.

[0077] 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 the elements of the drug delivery device 10 described above in conjunction with Figures 1 to 11. Such elements are assigned the same reference numerals as those used in Figures 1 to 11, except that they are increased by 100. For the sake of brevity, the descriptions of some of these elements have been simplified or omitted. The details of structure, configuration, and / or function that distinguish the embodiments of the drug delivery device 110 shown in Figures 12 to 20 from the embodiments of the drug delivery device 10 in Figures 1 to 11 are the focus of the following discussion.

[0078] As shown in Figure 12A, the release member 152 may be positioned radially outward of the plunger guide 160. Also as shown in Figure 12A, at least a portion of the plunger guide 160 may be positioned radially between the release member 152 and the plunger 126. The release member 152, plunger guide 160, and plunger 126 generally release the plunger biasing member 150 and / or generate a delivery completion click sound when the guard 132 moves from a first axial or extended position to a second axial or retracted position, as shown in Figures 1-11 (except that the latter occurs as a result of the release member 152 striking the tip-opposite surface of the outer portion of the plunger guide 160).

[0079] Figure 13 shows that the rotatable member engaging member 152a of the release member 152 may be defined by a recess (e.g., groove, recess, slot and / or channel) formed on the radially outward-facing surface of the release member 152. In an alternative embodiment, the rotatable member engaging member 152a may be a projection extending radially outward. In any case, the rotatable member engaging member 152a of the rotatable member 137 may be configured to engage with the release member engaging member 137d of the rotatable member 137 so that when the rotatable member 137 is not fixed to rotate with the plunger guide 160 by the rotation of the release member 152 (e.g., caused by the expansion of the plunger biasing member 150), the rotatable member engaging member 152a of the rotatable member 137 is rotated together with the release member 152 around the longitudinal axis A, for example, from a first rotation position to a second rotation position. Further features and functions of the rotatable member 137 are described below.

[0080] Figures 14A and 14B show that the release member engaging member 137d may include a projection extending radially inward and located near the base end of the rotatable member 137, and that the plunger guide engaging member 137c may include a projection extending radially inward and located near the tip of the rotatable member 137. The plunger guide engaging member 137c may include: a contact surface 137ci parallel or substantially parallel to the longitudinal axis A and generally facing a first circumferential direction; and a cam surface 137cii (e.g., a ramp) positioned at an angle or inclination with respect to an imaginary plane perpendicular to the longitudinal axis A, or otherwise non-parallel. As shown in Figure 14B, the tip of the cam surface 137cii may be closer circumferentially to the contact surface 137ci than the base end of the cam surface 137cii. In another embodiment, the plunger guide engaging member 137c may be replaced with two separate plunger guide engaging members, each having a contact surface 137ci and a cam surface 137cii.

[0081] Figures 12A, 12B, and 15 show that the drug delivery device 110 may include a transmitter 170. The transmitter 170 may be hollow and substantially cylindrical or tubular or ring-shaped, and may be centered about the longitudinal axis A. The transmitter 170 may be axially positioned between the rotatable member 137 and the guard 132. The transmitter 170 may be configured to move linearly along the longitudinal axis A, but to be prevented from rotating about the longitudinal axis A. Thus, the transmitter 170 may be configured to move linearly with respect to the housing 112 and / or plunger guide 160, but to be substantially or completely prevented from rotating relative to the housing 112 and / or plunger guide 160. To achieve this effect, in some embodiments, the transmitter 170 may cooperate with the plunger guide 160 to prevent relative rotational movement between the transmitter 170 and the plunger guide 160, but to allow relative axial movement. For example, as shown in Figures 12B and 15, the outer portion of the plunger guide 160 may include a transmitter engaging member 160m, and the inner portion of the transmitter 170 may include a plunger guide engaging member 170a. The transmitter engaging member 160m may include a projection (e.g., a longitudinally extending ridge or spline) that extends radially outward, is located near the tip of the plunger guide 160, and has at least one surface parallel or substantially parallel to the longitudinal axis A. The plunger guide engaging member 170a may be defined by a recess (e.g., a groove, a depression, a slot, and / or channel) formed on the radially inward surface of the transmitter 170. The transmitter engaging member 160m may be configured to engage with the plunger guide engaging member 170a to prevent the transmitter 170 from rotating relative to the plunger guide 160 and housing 112, while allowing the transmitter 170 to move linearly relative to the plunger guide 160 and housing 112. For example, the plunger guide engaging member 170a may slide against the transmitter engaging member 160m when the transmitter 170 moves linearly relative to the plunger guide 160 as a result of the user pushing the guard 132 toward the base end to activate the drive mechanism 130 and / or exposing the insertion end 128 of the delivery member 116.As an addition or alternative, the transmitter 170 may include a rotation-retaining feature that mates with a corresponding feature on the inner surface of the housing 112.

[0082] Referring to Figures 16 to 20, here is an example of how the rotatable member 137 and the transmitter 170 may interact to eliminate or reduce the amount of tip-directed force applied to the guard 132 by the base biasing member 135 during part or all of the delivery state, and to partially or completely restore the amount of tip-directed force applied to the guard 132 by the base biasing member 135 after the delivery state.

[0083] Figures 16–20 are ordered in chronological order and show a series of positions of the rotatable member 137, the transmitter 170, and other components of the drug delivery device 110 during various states or substates of operation of the drug delivery device 110. For visual clarity, the base biasing member 135 is shown in Figures 16–20, but in practice, as shown in Figure 12A, the base biasing member 135 is axially positioned between the base end of the rotatable member 137 and the base end of the release member 152, and / or the tip of the base biasing member 135 is in contact with the base-facing surface of the base end of the rotatable member 137, and / or the base end of the base biasing member 135 is in contact with the tip-facing surface of the base end of the release member 152. 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 from Figures 16–20 for clarity. As shown in Figures 16B, 17B, 18B, and 20B, the rotatable member 137 is omitted, but the position of the plunger guide engaging member 137c of the rotatable member 137 is indicated by a dashed line.

[0084] Figures 16A and 16B show the drug delivery device 110 in storage. Here, the guard 132 may be positioned in its first axial or extended position such that the insertion end 128 of the delivery member 116 is covered by the guard 132, the rotatable member 137 may be positioned in a first axial position and a first rotational position with respect to the longitudinal axis A, and the transmitter 170 may be positioned in a first axial position. As seen in Figure 16A, the tip-facing surface of the transmitter 170 may engage with the base-facing surface of the container holder 131 to prevent the transmitter 170 from moving in the tip direction in storage. Furthermore, the tip-facing surface of the rotatable member 137 may engage with the base-facing surface of the transmitter 170 to prevent the rotatable member 137 from moving in the tip direction in storage (for example, under the influence of a biasing force directed toward the tip of the base biasing member 135).

[0085] Figure 16A further shows that the base end 132e of the guard 132, including the base end opposing end faces 132g and 132h of the longitudinally extending arms 132b and 132c of the guard 132, may be positioned at an axial gap or distance from the tip of the transmitter 170. The rotatable member 137 and the transmitter 170 may be biased toward the tip (along the longitudinal axis A) by the base biasing member 135. The rotatable member 137 may also be biased clockwise (about the longitudinal axis A when viewed from above) by the plunger biasing member 150 via the engagement between the release member engaging member 137d of the rotatable member 137 and the rotatable member engaging member 152a of the release member 152. However, the rotatable member 137 may be prevented or inhibited from rotating clockwise by the engagement between the rotatable member 137 and the plunger guide 160. As an example, as shown in Figure 16B, the plunger guide engaging member 137c of the rotatable member 137, in particular the contact surface 137ci of the plunger guide engaging member 137c (shown in Figures 14A and 14B), engages with the rotatable member engaging member 160a of the plunger guide 160, thereby preventing or suppressing the rotation of the rotatable member 137 in a clockwise direction. As a result, the engagement between the release member engaging member 137d of the rotatable member 137 and the rotatable member engaging member 152a of the release member 152 also prevents or suppresses the rotation of the release member 152, which is currently locked to the rotatable member 137 in the rotational direction, thereby preventing the plunger biasing member 150 from expanding as described above.

[0086] Figures 17A and 17B show the start or substantial start of the delivery state. Here, the user presses the guard 132 against the injection site and inserts the insertion end 128 of the delivery member 116 into the injection site, causing the guard 132 to move from its first axial or extended position to its second axial or retracted position in the direction of arrow 132f (corresponding to the base end direction). As the guard 132 moves from its first axial or extended position to its second axial or retracted position, it eliminates the initial axial gap between the guard 132 and the transmitter 170, and then engages the transmitter 170 in the direction of arrow 170b (corresponding to the base end direction), pushing it 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 base end direction). As the rotatable member 137 moves from its first axial position to its second axial position, the axial length of the base biasing member 135 may be compressed. Furthermore, this axial movement of the rotatable member 137 allows the plunger guide engaging member 137c of the rotatable member 137, in particular the contact surface 137ci of the plunger guide engaging member 137c, to slide against the rotatable member engaging member 160a of the plunger guide 160 until the contact surface 137ci passes the base end of the rotatable member engaging member 160a, as shown in Figure 17B. Here, the contact surface 137ci of the plunger guide engaging member 137c of the rotatable member 137 no longer engages with the rotatable member engaging member 160a of the plunger guide 160. As a result, the plunger guide 160 no longer prevents the rotation of the rotatable member 137 or the release member 152 around the longitudinal axis A. As described above, this allows the plunger biasing member 150 and the base biasing member 135 to begin expanding toward the tip, and the cam action between the plunger 126 and the plunger guide 160 rotates the release member 152 clockwise (see arrow 152d in Figure 18A), which in turn causes the rotatable member 137 to rotate clockwise (see arrow 137j in Figure 18A) due to the engagement between the release member engaging member 137d of the rotatable member 137 and the rotatable member engaging member 152a of the release member 152.The rotational motion of the rotatable member 137, at least partially powered by the proximal biasing member 135, is configured to generate an audible signal (administration start signal) indicating the start of dose delivery. In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal generated as a result of the rotational motion of the rotatable member 137. The administration start signal may be generated simultaneously with or substantially simultaneously with the rotational motion of the rotatable member 137. Additionally or alternatively, the release of the plunger biasing member 150 may generate an administration start signal. Thus, as the plunger biasing member 150 begins to extend toward the tip, the plunger biasing member 150 may simultaneously or substantially simultaneously generate an administration start signal. The administration start signal may be accompanied by tactile feedback or a tactile signal generated as a result of the release of the plunger biasing member 150. In other embodiments, cam action between the plunger 126 and the plunger guide 160 may generate an administration start signal.

[0087] Figures 18A and 18B show a moment in the delivery state after the rotatable member 137 has been rotated clockwise from a first rotation position to a second rotation position by the release member 152. As a result of moving from the first rotation position to the second rotation position, the rotatable member 137 is positioned such that the cam surface 137cii (shown in Figure 14A) of the plunger guide engaging member 137c of the transmitter 170 and the rotatable member 137 may contact or engage with the rotatable member engaging portion 160n of the plunger guide 160. The rotatable member engaging portion 160n may include a projection extending radially outward, positioned at the base end of the rotatable member engaging member 160a, and having at least one surface perpendicular to or otherwise non-parallel to the longitudinal axis A. The rotatable member engaging members 160a and 160n may be separate projections with a gap between them, as shown in Figure 18B, or in other embodiments.

[0088] When the rotatable member 137 is in the second rotation position, the base biasing member 135 does not need to bias the guard 132 toward the tip. This is because, when the rotatable member 137 is in the second rotation position, the tip-facing surface of the rotatable member 137 is not in contact with the base-facing surface of the transmitter 170. As a result, the transmitter 170 does not need to transmit the biasing force directed toward the tip of the base biasing member 135 to the guard 132. Instead, the contact between the cam surface 137cii of the plunger guide engaging member 137c of the rotatable member 137 and the rotatable member engaging portion 160n of the plunger guide 160 allows the plunger guide 160 to support the tip-direction biasing force of the base member 135 when the rotatable member 137 is in the second rotation position shown in Figure 18B. Therefore, the user can completely or substantially completely eliminate the need to apply a manual force to counteract the biasing force directed towards the tip of the base biasing member 135 when the rotatable member 137 is in a second rotational position, including part or all of the delivery state. Nevertheless, in embodiments including the tip biasing member 151, the user may be required to apply a manual force to counteract the biasing force directed towards the tip of the tip biasing member 151. However, this requires less effort, potentially substantially less effort, than it would be necessary to counteract both the biasing force directed towards the tip of the base biasing member 135 and the biasing force directed towards the tip of the tip biasing member 151. Thus, the amount of force that the user must apply to hold the guard 132 in a second axial or retracted position during the delivery state can be reduced.

[0089] As a result of the base biasing member 135 creating a cam interaction between the cam surface 137cii of the plunger guide engaging member 137c of the rotatable member 137 and the rotatable member engaging portion 160n of the plunger guide 160, the rotatable member 137 can continue to rotate clockwise, and thus the rotatable member 137 can be positioned in the second rotation position only momentarily. For example, the inclination of the cam surface 137cii may convert or transform at least a portion of the axial biasing force from the base biasing member 135 into a transverse force with respect to the longitudinal axis A, thereby pushing the cam surface 137cii of the plunger guide engaging member 137c and the rest of the rotatable member 137, causing it to rotate clockwise around the longitudinal axis A (see arrow 137k in Figure 19). In addition, while the rotatable member 137 is rotating, the base biasing member 135 may push the rotatable member 137 and move it linearly toward the tip (see arrow 137m in Figure 19). As a result, the rotatable member 137 can rotate clockwise to a third rotational position (shown in Figure 19) and toward the tip to a third axial position (shown in Figure 19). Here, the plunger guide engaging member 137c of the rotatable member 137 (shown translucently in Figure 19) can contact or engage with the rotatable member engaging member 170c of the transmitter 170, as shown in Figure 19. In this operating state, which may be in the delivery state, the plunger guide engaging member 137c of the rotatable member 137 may still be engaged with the rotatable member engaging portion 160n of the plunger guide 160. As a result, in this operating state, both the plunger guide 160 and the transmitter 170 can support the biasing force directed toward the tip of the base biasing member 135. In at least some embodiments, the plunger guide 160 may support a larger proportion of the biasing force directed toward the tip of the base biasing member 135 than the transmitter 170. For example, the plunger guide 160 may support most of the biasing force directed towards the tip of the base biasing member 135 (i.e., greater than 50%). Arms 132b and 132c extending longitudinally from the guard 132 may contact the transmitter 170 (as shown in Figure 10), and the transmitter 170 may transmit at least a portion of the biasing force directed towards the tip of the base biasing member 135 to the guard 132.Furthermore, since the cam surface 137cii may remain in contact with the rotatable member engagement portion 160n of the plunger guide 160, the resulting cam interaction may continue to encourage the rotatable member 137 to rotate clockwise when the rotatable member is in a third rotational position. However, due to the engagement with the rotatable member 137 and the rotation being fixed to the plunger guide 160, the transmitter 170 may prevent the rotatable member 137 from rotating further clockwise when it reaches its third rotational position.

[0090] Figures 20A and 20B show the post-delivery state after the guard 132 has been moved away from the injection site and moved toward the tip by the base biasing member 135 and / or tip biasing member 151 to return to its first axial or extended position to cover the insertion end 128 of the delivery member 116. As a result of the guard 132 moving toward the tip from its second axial or retracted position to its first axial or extended position, the transmitter 170 may also be loaded toward the tip (arrow 170d in Figure 20A) under the influence of the biasing force directed toward the tip of the base biasing member 135. This can create a gap for the plunger guide engaging member 137c to slip off or otherwise disengage from the rotatable member engaging portion 160n of the plunger guide 160, and as a result the transmitter 170 will be supported only by the rotatable member engaging member 170c. The rotatable member engaging member 170c may include a cam surface 170ci (e.g., a ramp) which is positioned at an angle to or inclined with respect to an imaginary plane perpendicular to the longitudinal axis A, or otherwise non-parallel. The inclination of the cam surface 170ci converts or transforms at least a portion of the axial biasing force from the base biasing member 135 (pushing the rotatable member 137 toward the tip) into a transverse force with respect to the longitudinal axis A, thereby pushing the rotatable member 137 to rotate counterclockwise around the longitudinal axis A to a fourth rotational position (see arrow 137m in Figure 20A). In addition, while the rotatable member 137 is rotating counterclockwise, the base biasing member 135 may push the rotatable member 137 linearly toward the tip to a fourth axial position (see arrow 137n in Figure 20A).

[0091] As shown in Figures 20A and 20B, 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 engaging member 137c of the rotatable member 137 may be positioned at the tip and directly adjacent to the rotatable member engaging member 160j of the plunger guide 160. The rotatable member engaging member 160j of the plunger guide 160 may include a projection that extends radially outward, is positioned at the tip of the rotatable member engaging member 160a, and has at least one surface perpendicular or substantially perpendicular to the longitudinal axis A. The rotatable member engaging members 160a and 160j may be separate projections with a gap between them, as shown in Figure 20B or in other embodiments.

[0092] If, after the guard 132 has been injected and separated from the injection site, an attempt is made to move the guard 132 in the proximal direction from a first axial or extended position to a second axial or retracted position, the proximal end faces 132g and 132h of the longitudinally extending arms 132b and 132c of the guard 132 may contact or otherwise engage with the tip-facing end faces of the transmitter 170, thereby pushing the transmitter 170 and the rotatable member 137 in the proximal direction. However, such proximal movement of the guard 132 can be prevented or suppressed because the proximal end face of the plunger guide engaging member 137c can contact or engage with the tip-facing surface of the rotatable member engaging member 160j of the plunger guide 160, thereby preventing the proximal movement of the rotatable member 137, and therefore the proximal movement of the transmitter 170 and the guard 132. Therefore, when the rotatable member 137 is in its fourth rotational position and fourth axial position, the rotatable member 137 may lock the guard 232 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 132 has been separated from the injection site.

[0093] Although not specifically described above, any one of the engaging members 137c, 137d, 152a, 160a, 160m, 160n and / or 160j may have a corresponding duplicate member or mating member whose geometric shape is the same, assuming that it is mirror-reversed across the longitudinal axis A, as shown in some figures.

[0094] In the embodiments described above, the rotation of the rotatable member may be achieved in various states through engagement between the rotatable member and the plunger guide and / or between the rotatable member and the transmitter. In alternative embodiments, the rotation of the rotatable member may be achieved in various states through engagement between the rotatable member and the housing. Such embodiments are described below in reference to Figures 21 to 28.

[0095] The various elements of the drug delivery device 210 shown in Figures 21 to 28 may be similar or identical in structure, configuration, function, and / or operation to the elements of the drug delivery device 110 described above in conjunction with Figures 12 to 20. Such components are assigned the same reference numerals as those used in Figures 12 to 20, except that they are increased by 100. For the sake of brevity, the descriptions of some of these elements have been simplified or omitted. The structural, configuration, and / or functional details that distinguish the embodiments of the drug delivery device 210 shown in Figures 21 to 28 from the embodiments of the drug delivery device 110 in Figures 12 to 20 are the focus of the following discussion.

[0096] Figure 21B shows that the rotatable member engaging member 252a of the release member 252 may be defined by a recess (e.g., groove, recess, slot and / or channel) formed on the radially outward-facing surface of the release member 252. In an alternative embodiment, the rotatable member engaging member 252a may be a projection extending radially outward. In any case, the rotatable member engaging member 252a of the release member 237 may be configured to engage with the release member engaging member 237d of the rotatable member 237 so that the rotation of the release member 252 (e.g., caused by the expansion of the plunger biasing member 250) rotates the rotatable member 237 (together with the release member 252) around the longitudinal axis A, for example, from a first rotation position to a second rotation position, when the rotatable member 237 is not fixed to the housing 212 because the housing engaging member 237f of the rotatable member 237 is disengaged from the rotatable member engaging member 212a of the housing 212, the rotatable member 237 is not fixed to the housing 212, and the rotation of the release member 252 (e.g., caused by the expansion of the plunger biasing member 250) rotates the rotatable member 237 (together with the release member 252) around the longitudinal axis A, for example from a first rotation position to a second rotation position. Further features and functions of the rotatable member 237 are described below.

[0097] Figures 22A and 22B show that the housing engagement member 237f of the rotatable member 237 may include a projection extending radially outward and positioned near the tip of the rotatable member 237. The housing engagement member 237f may include: a contact surface 237fi that is parallel or substantially parallel to the longitudinal axis A and generally faces a first circumferential direction; a cam surface 237fii (e.g., a ramp) that is positioned at an angle or inclination with an imaginary plane perpendicular to the longitudinal axis A, or otherwise non-parallel; and a contact surface 237fiii that is perpendicular or substantially perpendicular to the longitudinal axis A and generally faces towards the tip. As seen in Figures 22A and 22B, the base end of the cam surface 237fii may be closer circumferentially to the contact surface 237fi than the tip of the cam surface 237fii. In an alternative embodiment, the housing engagement member 237f may be replaced with three separate housing engagement members, each having a contact surface 237fi, a cam surface 237fii, and a contact surface 237fiii.

[0098] Figures 22A and 22B show that the rotatable member 237 may additionally include a housing engaging member 237m located at the base end of the housing engaging member 237f. The housing engaging member 237m may include a projection having a cam surface 237mi (e.g., a ramp) that extends radially outward, is located near the base end of the rotatable member 237, and is positioned at an angle or inclination with respect to an imaginary plane perpendicular to the longitudinal axis A, or otherwise non-parallel. As seen in Figures 22A and 22B, the tip of the cam surface 237mi may be closer to the housing engaging member 237f in the circumferential direction than the base end of the cam surface 237mi.

[0099] Figure 22B shows that the rotatable member 237 may additionally include a plunger guide engaging member 237p. The plunger guide engaging member 237p may include a projection that extends radially inward, is located near the tip of the rotatable member 237, and generally faces the proximal end, having at least one surface perpendicular or substantially perpendicular to the longitudinal axis A. As discussed below, in the post-delivery state, the plunger guide engaging member 237p may be configured to engage with the rotatable member engaging member 260p of the plunger guide 260 to prevent the guard 332 from moving in the proximal end after the guard 332 has been lifted from the injection seat after injection. As seen in Figure 21B, the rotatable member engaging member 260p of the plunger guide 260 may include a projection that extends radially outward, is located near the tip of the plunger guide 260, and has at least one surface perpendicular or substantially perpendicular to the longitudinal axis A and generally facing the proximal end.

[0100] Figure 23 shows that the rotatable member engaging member 212a of the housing 212 may include a projection (e.g., a longitudinally extending ridge or spline) which extends radially inward, is located near the base end of the housing 212, is parallel or substantially parallel to the longitudinal axis A, and has at least one surface facing generally a second circumferential direction (opposite to the first circumferential direction).

[0101] Referring to Figures 24-28, here is an example of how the rotatable member 237 and the housing 212 interact to eliminate or reduce the amount of tip-directed force applied to the guard 232 by the base biasing member 235 during part or all of the delivery state, and to partially or completely restore the amount of tip-directed force applied to the guard 232 by the base biasing member 235 after the delivery state.

[0102] Figures 24–28 are sequentially ordered and show a series of positions of the rotatable member 237 and other components of the drug delivery device 210 during various states or substates of operation of the drug delivery device 210. For visual clarity, the base biasing member 235 is omitted from Figures 24–28, but in practice, as shown in Figure 21A, the base biasing member 235 is axially positioned between the base end of the rotatable member 237 and the base end of the release member 252, and / or with its tip in contact with the base-facing surface of the base end of the rotatable member 237, and / or with its tip in contact with the tip-facing surface of the base end of the release member 252. Other components of the drug delivery device 210, including the drug storage container 210 and the removable cap 219, are also omitted from Figures 24–28 for clarity.

[0103] Figure 24 shows the drug delivery device 210 in storage. Here, the guard 232 may be positioned in its first axial or extended position such that the insertion end 228 of the delivery member 216 is covered by the guard 232, and the rotatable member 237 may be positioned in a first axial position and a first rotational position with respect to the longitudinal axis A. As shown in Figure 24, the tip-facing surface of the rotatable member 237 may engage with the base-facing surface of the container holder 231 to prevent the rotatable member 237 from moving in the tip direction (for example, under the influence of a biasing force directed toward the base end of the base biasing member 235) in storage.

[0104] Figure 24 further shows that the base end portion 232e of the guard 232, including the base end opposing end faces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard 232, may be positioned at an axial gap or distance from the tip of the rotatable member 237. The rotatable member 237 may be biased toward the tip (along the longitudinal axis A) by the base biasing member 235.

[0105] The rotatable member 237 may also be biased clockwise (around the longitudinal axis A when viewed from above) by the plunger biasing member 250 via 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. However, the rotatable member 237 may be prevented or inhibited from rotating clockwise by the engagement between the rotatable member 237 and the housing 12. As an example, as shown in Figure 24, the housing engaging member 237f of the rotatable member 237, in particular the contact surface 237fi of the housing engaging member 237f, may engage with the rotatable member engaging member 212a of the housing 212 to prevent or inhibit the rotatable member 237 from rotating clockwise. As a result, 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 prevents or restricts the release member 252, which is currently locked to the rotatable member 237 in the rotational direction, from rotating clockwise, thereby preventing the plunger biasing member 250 from expanding as described above.

[0106] Figure 25 shows the start or substantial start of the delivery state. Here, the user presses the guard 232 against the injection site and inserts the insertion end 228 of the delivery member 216 into the injection site, causing the guard 232 to move from its first axial or extended position to its second axial or retracted position in the direction of arrow 232f (corresponding to the base end direction). As the guard 232 moves from its first axial or extended position to its second axial or retracted position, it eliminates the initial axial gap between the guard 232 and the rotatable member 237, and then engages the rotatable member 237 in the direction of arrow 237e (corresponding to the base end direction), pushing it 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, the axial length of the base biasing member 235 may be compressed. Furthermore, this axial movement of the rotatable member 237 allows the housing engaging member 237f of the rotatable member 237, in particular the contact surface 237fi of the housing engaging member 237f, to slide against the rotatable member engaging member 212a of the housing 212 until it passes the base end of the housing engaging member 212a of the housing 212. At this point, the contact surface 237fi of the housing engaging member 237f of the rotatable member 237 no longer engages with the rotatable member engaging member 212a of the housing 212. As a result, the housing 212 no longer prevents the rotation of the rotatable member 237 or the release member 252 about the longitudinal axis A. As described above, this causes the plunger biasing member 250 to begin expanding toward the tip, and the cam action between the plunger 226 and the plunger guide 260 allows the release member 252 to rotate (see arrow 252d in Figure 26). This 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 237n in Figure 26).

[0107] In some embodiments, the release of the plunger biasing member 250 may generate an audible signal (administration start signal) indicating the commencement of dose delivery. In some embodiments, the audible signal may be accompanied by tactile feedback or a tactile signal that is produced as a result of the release of the plunger biasing member 250. As the plunger biasing member 250 begins to expand toward the tip, the plunger biasing member 250 may simultaneously or substantially simultaneously generate the administration start signal. In other embodiments, cam action between the plunger 226 and the plunger guide 260 may generate the administration start signal.

[0108] Figure 26 shows a moment in the delivery state after the rotatable member 237 has been rotated clockwise from a first rotation position to a second rotation position by the release member 252. The rotation of the rotatable member 237 from the first rotation position to the second rotation position linearly moves the rotatable member 237 toward the base end to a third axial position, thereby creating an axial gap between the tip of the rotatable member 237 and the base-end opposing end faces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard 232, respectively, as seen in Figure 26. As a result, the axial gap can prevent the rotatable member 237 from transmitting the biasing force directed toward the tip of the base biasing member 235 to the guard 232, so the base biasing member 235 does not have to bias the guard 232 toward the tip. In some embodiments, this axial gap may persist for the duration of the delivery state, for example, until a delivery completion signal or administration completion signal is generated.

[0109] The rotatable member 237 may move in the proximal direction when rotating from a first rotational position to a second rotational position as a result of the cam interaction between the cam surface 237fii of the housing engaging member 237f and the rotatable member engaging member 212a of the housing 212. For example, when the cam surface 237fii is sliding against the rotatable member engaging member 212a, the inclination of the cam surface 237fii may redirect or convert at least a portion of the rotational force from the release member 252 in the proximal direction, thereby pushing the cam surface 237fii of the housing engaging member 237f and the rest of the rotatable member 237, causing it to move linearly in the proximal direction along the longitudinal axis A (see arrow 237g in Figure 26). As a result, the rotatable member 237 can move to its proximal position in a third axial direction while rotating clockwise from its first rotational position to its second rotational position.

[0110] As shown in Figure 26, when the rotatable member 237 is in its third axial position and second rotational position, the contact surface 237fiii of the housing engaging member 237f of the rotatable member 237 may engage with the rotatable member engaging member 212a of the housing 212. This engagement can prevent the biasing force directed toward the tip of the base biasing member 235 from moving the rotatable member 237 toward the tip relative to the housing 212. As a result, when the rotatable member 237 is in its third axial position and second rotational position, the housing 212 (instead of the guard 232) can support the biasing force directed toward the tip of the base biasing member 235.

[0111] Figure 27 shows the configuration of the drug delivery device 210 at the time the delivery termination signal is generated. Here, the release member 252 is rotated clockwise (see arrow 252e) to the final or delivery termination position as a result of a cam interaction between the release member 252 and the plunger guide 260, driven by the expansion of the proximal biasing member 235 in the proximal direction. Due to the engagement between the rotatable member engaging member 252a of the release member 252 and the release member engaging member 237d of the rotatable member 237, the rotatable member 237 may rotate together with the release member 252 to a third rotation position (see arrow 237h). As a result of the rotatable member 237 rotating to the third rotation position, the contact surface 237fiii of the housing engaging member 237f of the rotatable member 237 can disengage from the rotatable member engaging member 212a of the housing 212. As a result of this disengagement, the rotatable member 237 can move freely and linearly toward the tip under the influence of the biasing force directed toward the tip of the base biasing member 235. Therefore, the base biasing member 235 may push the rotatable member 237 toward the tip (see arrow 237i) and return it, engaging with the base-facing end faces 232g and 232h of the longitudinally extending arms 232b and 232c of the guard 232 (thereby eliminating the axial gap shown in Figure 26). As a result, the base biasing member 235 may return to bias the guard 232 toward the tip via the rotatable member 237 in the post-delivery state. Therefore, the proximal biasing member 235 can cover the insertion end 228 of the delivery member 216 by assisting, or solely by, pushing the guard 232 from a second axial or retracted position to a first axial or extended position when the user lifts the guard 232 from the injection site after injection.

[0112] Figure 28 shows the post-delivery state after the guard 232 has been lifted from the injection site and moved tipwise by the base biasing member 235 and / or tip biasing member 251 to return to its first axial or extended position to cover the insertion end 228 of the delivery member 216. As a result of the guard 232 moving tipwise from its second axial or retracted position to its first axial or extended position, the rotatable member 237 may also move tipwise (arrow 237j in Figure 28) under the influence of the biasing force directed towards the tip of the base biasing member 235. As a result of this tipwise movement of the rotatable member 237, the housing engaging member 237m of the rotatable member 237, in particular the cam surface 237mi of the housing engaging member 237m, may engage with the rotatable member engaging member 212a of the housing 212. The inclination of the cam surface 237mi converts or transforms at least a portion of the axial biasing force from the base biasing member 235 (which pushes the rotatable member 235 toward the tip) into a lateral force with respect to the longitudinal axis A, thereby causing the rotatable member 237 to rotate around the longitudinal axis A to a fourth rotational position (see arrow 237k in Figure 28). In addition, while the rotatable member 237 is rotating clockwise, the base biasing member 235 may push the rotatable member 237 and move linearly toward the tip to a fourth axial position (see arrow 237j in Figure 28).

[0113] 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 engaging member 237p of the rotatable member 237 may be positioned at the tip of the rotatable member engaging member 260p of the plunger guide 260 and directly adjacent to it. After the guard 232 has been removed from the injection site after injection, if there is an attempt to move the guard 232 in the proximal direction from the first axial or extended position toward the second axial or retracted position, the proximal end faces 232b and 232h of the longitudinally extending arms 232g and 232c of the guard 232 may contact or otherwise engage with the tip-facing end faces of the rotatable member 237, thereby biasing the rotatable member 237 toward the proximal direction. However, the surface of the plunger guide engaging member 237p of the rotatable member 237 facing the base end can contact or engage with the surface of the plunger guide 260 facing the tip end of the rotatable member engaging member 260p, thereby preventing the movement of the rotatable member 237 toward the base end, and therefore the movement of the guard 232 toward the base end as well, thus preventing or suppressing such movement of the guard 232 toward the base end. Therefore, when the rotatable member 237 is in its fourth rotational position and fourth axial position, the rotatable member 237 may 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 removed from the injection site.

[0114] Although not specifically described above, any one of the engaging members 237d, 237f, 237m, 237p, 252a, and / or 260p may have identical copies or mating members, assuming that their geometric shapes are symmetrical across the longitudinal axis A, as shown in some figures.

[0115] All features described herein, including this specification, the claims, the abstract, and the drawings, as well as all steps in any method or process described herein, may be combined in any combination, except for any combination in which one or more of these features and / or steps are mutually exclusive.

[0116] As can be understood, the systems and methods described herein may have one or more advantages over the prior art, any one or more of which may exist in particular embodiments according to the features of the disclosure included in those embodiments. Other advantages not specifically mentioned herein may also be understood.

[0117] The above description relates to various devices, assemblies, components, subsystems, and methods used in connection with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, drugs specified below, including, but not limited to, their generic and biosimilar counterparts. As used herein, the term "drug" is interchangeable with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional medicines, dietary supplements, supplements, biologics, biological agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or in a form reconstituted from a lyophilized form. The following exemplary list of drugs should not be considered exhaustive or restrictive.

[0118] The drug is contained within a reservoir. In some cases, the reservoir is a primary container that is either filled with or pre-filled with the drug for therapeutic purposes. The primary container may be a vial, cartridge, or pre-filled syringe.

[0119] 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 such factors. Examples of such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0120] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Examples of erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Examples of erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin a). Examples include, but are not limited to, epoetin alpha (alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0121] Particularly noteworthy examples of specific proteins include the following, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies, peptide bodies, and related proteins (also referred to as RANKL-specific antibodies, peptide bodies, etc.), including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptide bodies, and related proteins, including myostatin-specific peptide bodies; IL-4 receptor-specific antibodies, peptide bodies, and related proteins, particularly those that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; and interleukin-1 receptors. Body 1 ("IL1-R1") specific antibodies, peptide bodies, related proteins, etc.; Ang2 specific antibodies, peptide bodies, related proteins, etc.; NGF specific antibodies, peptide bodies, related proteins, etc.; CD22 specific antibodies, peptide bodies, related proteins, etc., especially human CD22 specific antibodies, for example, but not limited to humanized and fully human antibodies, for example, but not limited to humanized and fully human monoclonal antibodies, especially, for example, but not limited to human CD22 specific IgG antibodies, for example human-mouse monoclonal antibodies Dimers of human-mouse monoclonal hLL2 gamma chain disulfide conjugated to a monoclonal hLL2 kappa chain, e.g., human CD22-specific fully humanized antibody of epratuzumab (CAS registry number 501423-23-0); IGF-1 receptor-specific antibodies, peptide bodies, and related proteins, e.g., anti-IGF-1R antibodies, but not limited to these; B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1," as well as B7H2, ICOSL, B7h, and CD275). For example, but not limited to, B7RP-specific fully human monoclonal IgG2 antibodies; for example, but not limited to, fully human IgG2 monoclonal antibodies that bind to the epitope of the initial immunoglobulin-like domain of B7RP-1; for example, but not limited to, those that inhibit the interaction between B7RP-1 and its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptide bodies, related proteins, etc., for example, particularly humanized monoclonal antibodies, for example, but not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7;IFN gamma-specific antibodies, peptide bodies, related proteins, etc., for example, but not limited to human IFN gamma-specific antibodies, for example, but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptide bodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptide bodies, related proteins, etc.; hepatocyte growth factor ("HGF") specific antibodies, peptide bodies, related proteins, etc., where HGF / SF is the hepatocyte growth factor / dispersion factor. This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins that target the HGF / SF:cMet axis (HGF / SF:c-Met) which neutralizes factor / scatter; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-beta-specific antibodies, peptide bodies, and related proteins; amyloid-beta protein-specific antibodies, peptide bodies, and related proteins; c-Kit-specific antibodies, peptide bodies, and related proteins, including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; and OX40L-specific antibodies, peptide bodies, and related proteins, including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor. Related proteins, etc.; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (aremutuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta);Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti® (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalim) Mab; Vectibix(registered trademark) (panitumumab), Xgeva(registered trademark) (denosumab), Prolia(registered trademark) (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel(registered trademark) (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate(registered trademark) (romiplostim), rilotumumab, ganitumumab, conatumumab, brodalumab, insulin in solution; Infergen(registered trademark) (interferon alphacon-1); Natrecor(registered trademark) (nesiritide; recombinant human type B natriuretic peptide (hBNP); Kineret(registered trademark) (anakinra); Leukine(registered trademark) (sargamostim, rhuGM-CSF); LymphoCide(registered trademark) (epratuzumab, anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870);Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab); Panorex (registered trademark) (17-1A, edrecolomab); Trabio (registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem (registered trademark) (IDM-1); OvaRex (registered trademark) (B43.13); Nuvion (registered trademark) (vizilizumab); cantuzumab meltansine (huC242-DM1); NeoRecormon (registered trademark) (epoetin beta); Neumega (registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (Muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (Epoetin alfa); Remicade(registered trademark) (Infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (Absiximab, anti-GP Ib / Ilia receptor monoclonal antibody); Actemra(registered trademark) (Anti-IL6 receptor mAb); Avastin(registered trademark) (Bevacizumab), HuMax-CD4 (Zanolimumab); Mvasi(trademark) (Bevacizumab-awwb); Rituxan(registered trademark) (Rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark)-(interferon alpha-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein));VEGF trap (VEGFR1 Ig domain fused with IgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1) mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (saltumumab); M200 (boroxiximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1)); anti-BR3 mAb; anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; Anti-GDF-8 human mAb (MYO-029); Anti-GM-CSF receptor mAb (CAM-3001); Anti-HepC mAb (HuMax HepC); Anti-IFNα mAb (MEDI-545, MDX-198); Anti-IGF1R mAb; Anti-IGF-1R mAb (HuMax-Inflam); Anti-IL12 mAb(ABT-874); Anti-IL12 / IL23 mAb(CNTO 1275); Anti-IL13 mAb (CAT-354);Anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-インテグリン receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-マンノース receptor / hCGβ mAb(MDX-1307);anti-MedsFv-PE38コンジュゲート(CAT-5001);anti-PD1mAb(MDX-1106(ONO-4538));anti-PDGFRα antibody(IMC-3G3);anti-TGFβ mAb(GC-1008);anti-TRAIL receptor-2ヒトmAb(; HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0122] In some embodiments, the drug delivery device may contain, or may be used with, sclerostin antibodies such as romosozumab, brosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), or other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or be used with IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors (TIMPs) of metalloproteinases, including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab, for the treatment of migraines. Antagonist antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to bispecific antibody molecules targeting erenumab, the CGRP receptor, and other headache targets, may also be delivered using the drug delivery device of this disclosure.Furthermore, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to Apelin or its analogues. In some embodiments, therapeutically effective doses of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibodies may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola® (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used with Parsabiv® (ethelcalcetide HCl, KAI-4169), or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis.In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF inhibitor such as a non-antibody VEGF inhibitor and / or a VEGF trap such as aflibercept (fused to the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2, and the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly known as AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamutib mecarbir, a small molecule selective cardiac myosin activator, i.e., a myotrope that directly targets the cardiac contractile mechanism, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotrasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with tezeperumab, a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrotizing factor (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP.In some embodiments, the drug delivery device may contain or be used with rocatinlimab (AMG 451), a human anti-OX40 monoclonal antibody expressed on activated T cells and blocking OX40, thereby inhibiting and / or reducing the number of OX40 pathogenic T cells that are responsible for the driving system and localized inflammatory responses in atopic dermatitis. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing human IgG1 kappa antibody and / or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita® or Amgevita® (formerly ABP501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product containing the half-life extension (HLE) anti-prostate-specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133 or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or another product containing a half-life extension (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing an anti-PD-1 × IL-21 mutaine and / or an IL-21 receptor agonist designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing an anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being studied as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing the half-life extension (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430, or another product containing the anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506, or another product containing the multispecific FAP × 4-1 BB-targeted DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. The drug delivery device may accommodate or be used in conjunction with AMG 562 or another product containing the HLE (Hyperlife Extension) CD19×CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may accommodate or be used in conjunction with Efavaleukin alfa (formerly AMG 592) or another product containing the IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may accommodate or be used in conjunction with AMG 596 or another product containing the CD3×epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may accommodate or be used in conjunction with AMG 673 or another product containing the HLE (Hyperlife Extension) anti-CD33×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701, or another product containing the HLE (Hyperlife-Extended) anti-B cell maturation antigen (BCMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757, or another product containing the HLE (Hyperlife-Extended) anti-delta-like ligand 3 (DLL3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910, or another product containing the HLE (Hyperlife-Extended) epithelial cell tight junction protein claudin 18.2 × CD3 BiTE® (bispecific T cell engager) construct.

[0123] While drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, these are not limited to exemplary embodiments. The detailed descriptions should be interpreted as illustrative only and do not describe all possible embodiments of the Disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but these embodiments still fall within the scope of the claims defining one or more inventions disclosed herein.

[0124] Those skilled in the art will understand that a variety of modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations will be construed as falling within the scope of the concept of the present invention.

Claims

1. A drug delivery device, A housing having an opening and a longitudinal axis, A drug storage container includes a delivery member having an insertion end configured to extend at least partially through the opening during the delivery process, To release the drug from the drug storage container through the delivery member during the delivery state, a plunger is provided that is movable in the tip direction along the longitudinal axis, A plunger biasing member configured to bias the plunger toward the tip, A guard is positioned adjacent to the opening, 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. A base biasing member configured to selectively bias the guard in the direction of the tip, Drug delivery devices, including those mentioned above.

2. The drug delivery device according to claim 1, wherein the base biasing member is configured not to bias the guard toward the tip during at least a portion of the delivery state.

3. The drug delivery device according to claim 1, wherein the base biasing member is configured to bias the guard toward the tip with a smaller force during at least a portion of the delivery state compared to before the delivery state.

4. The drug delivery device according to claim 1 or 2, wherein when the guard is in the second axial position, the base biasing member is configured to selectively bias the guard toward the tip.

5. A 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 enables the base biasing member to bias the guard toward the tip, and a second rotational position that prevents the base biasing member from biasing the guard toward the tip.

6. The drug delivery device according to claim 5, wherein the rotatable member has a third rotational position that enables the base biasing member to bias the guard toward the tip.

7. The drug delivery device according to claim 5 or 6, wherein the rotatable member is positioned along the longitudinal axis between at least a portion of the guard and at least a portion of the base biasing member.

8. A drug delivery device according to any one of claims 5 to 7, comprising a plunger guide whose rotation is fixed relative to the housing, wherein, prior to the delivery state, the rotatable member is operably coupled to the plunger guide to prevent the rotatable member from rotating from the first rotation position toward the second rotation position.

9. The drug delivery device according to claim 8, wherein for at least a portion of the delivery state, the rotatable member is operably coupled with the plunger guide such that the base biasing member prevents the guard from biasing the guard toward the tip.

10. The drug delivery device according to claim 9, wherein, after the delivery state, the rotatable member is operably coupled to the guard such that the base biasing member can bias the guard toward the tip.

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 engaging member, and the outer portion of the plunger guide includes a first rotatable member engaging member, and prior to the delivery state, the plunger guide engaging member of the rotatable member engages with the first rotatable member engaging member of the plunger guide to prevent the rotatable member from rotating from the first rotation position toward the second rotation position.

12. The drug delivery device according to claim 11, wherein the outer portion of the plunger guide includes a second rotatable member engaging member, and for at least a portion of the delivery state, the plunger guide engaging member of the rotatable member engages with the second rotatable member engaging member of the plunger guide to prevent the rotatable member from moving toward the tip and / or the base biasing member prevents the guard from biasing toward the tip.

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

14. The drug delivery device according to claim 12, wherein, after the delivery state, the plunger guide engaging member of the rotatable member is disengaged from the second rotatable member engaging member of the plunger guide, allowing the rotatable member to move toward the tip, and / or allowing the base biasing member to bias the guard toward the tip.

15. The drug delivery device according to any one of claims 8 to 14, wherein the guard is configured such that when the guard moves from the first axial position to the second axial position, it moves the rotatable member toward the base end, disengaging the plunger guide engaging member of the rotatable member from the first rotatable member engaging member of the plunger guide, thereby enabling the rotatable member to rotate from the first rotation position to the second rotation position.

16. The drug delivery device according to claim 15, wherein the guard is positioned at an axial gap from the rotatable member before moving toward the second axial position.

17. The drug delivery device according to claim 5, wherein the rotational motion of the rotatable member is configured to generate at least one of an audible signal or a tactile signal indicating the commencement of dose delivery.

18. A drug delivery device according to any one of claims 5 to 17, wherein during the initial portion of the delivery state, one or both cam surfaces of the plunger and the plunger guide convert or transform the axial force from the plunger biasing member into a transverse force, thereby rotating the plunger relative to the plunger guide.

19. A drug delivery device according to claim 18, 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 the rotatable member rotates from a first rotation position to a second rotation position by the rotation of the plunger during the initial portion of the delivery state.

20. The drug delivery device according to claim 19, wherein the inner portion of the rotatable member includes a release member engaging member, the outer portion of the release member includes a third rotatable member engaging member, and in the initial portion of the delivery state, the third rotatable member engaging member of the release member engages with the release member engaging member of the rotatable member, causing the rotatable member to rotate from the first rotation position to the second rotation position.

21. The drug delivery device according to any one of claims 5 to 9, wherein the rotatable member includes a tip-facing surface configured to engage with the base-end-facing surface of the guard when the rotatable member is in the first rotation position, and not to engage with the base-end-facing surface of the guard when the rotatable member is in the second rotation position.

22. The drug delivery device according to claim 21, wherein when the guard is in the second axial position and the rotatable member is in the second rotational position, the base biasing member is configured to move the rotatable member toward the tip to a position where at least a portion of the tip of the rotating body is positioned radially inward of at least a portion of the base end of the guard.

23. The drug delivery device according to any one of claims 5 to 7, wherein, prior to the delivery state, the rotatable member is operably coupled to the housing to prevent the rotatable member from rotating from the first rotation position toward the second rotation position.

24. The drug delivery device according to claim 23, wherein for at least a portion of the delivery state, the rotatable member is operably coupled to the housing to prevent the base biasing member from biasing the guard toward the tip.

25. The drug delivery device according to claim 24, wherein, after the delivery state, the rotatable member is operably coupled to the guard such that the base biasing member can bias the guard toward the tip.

26. The drug delivery device according to claim 24 or 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, and prior to the delivery state, the first housing engagement member of the rotatable member engages with the first rotatable member engagement member of the housing to prevent the rotatable member from rotating from a first rotation position toward a second rotation position.

27. The drug delivery device according to claim 26, wherein the outer portion of the rotatable member includes a second housing engagement member, and for at least a portion of the delivery state, the second housing engagement member of the rotatable member engages with the first rotatable member engagement member of the housing to prevent the rotatable member from moving toward the tip and / or the base biasing member prevents the guard from biasing toward the tip.

28. The drug delivery device according to claim 27, wherein, after the delivery state, the second housing engaging member of the rotatable member is disengaged from the first rotatable member engaging member of the housing, allowing the rotatable member to move toward the tip, and / or allowing the base biasing member to bias the guard toward the tip.

29. The drug delivery device according to any one of claims 26 to 28, wherein the guard is configured such that when the guard moves from the first axial position to the second axial position, it moves the rotatable member toward the base end, disengaging the first housing engaging member of the rotatable member from the first rotatable member engaging member of the housing, thereby enabling the rotatable member to rotate from the first rotation position to the second rotation position.

30. The drug delivery device according to claim 29, wherein the guard is positioned at an axial gap from the rotatable member before moving toward the second axial position.

31. A drug delivery device according to any one of claims 5 to 30, comprising a plunger guide fixed to rotate 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 claim 31, wherein, during the initial portion of the delivery state, one or both cam surfaces of the plunger and the plunger guide convert or transform the axial force from the plunger biasing member into a lateral force, thereby rotating the plunger relative to the plunger guide.

33. A drug delivery device according to claim 32, comprising a release member, wherein in the initial portion of the delivery state, the release member operably connects the plunger and the rotatable member, and the rotation of the plunger in the initial portion of the delivery state causes the rotatable member to rotate from a first rotation position to a second rotation position.

34. The drug delivery device according to claim 33, wherein the inner portion of the rotatable member includes a release member engaging member, the outer portion of the release member includes a second rotatable member engaging member, and in the initial portion of the delivery state, the second rotatable member engaging member of the release member engages with the release member engaging member of the rotatable member, causing the rotatable member to rotate from the first rotation position to the second rotation position.

35. The drug delivery device according to claim 34, wherein, after the delivery state, the second rotatable member engaging member of the release member engages with the release member engaging member of the rotatable member, thereby rotating the rotatable member from the second rotation position to the third rotation position.

36. It is a method, To provide a drug delivery device comprising: a housing having an opening and a longitudinal axis; a drug storage container having an insertion end configured to at least partially extend through the opening when in a delivery state; a plunger movable toward the tip along the longitudinal axis to release a drug from the drug storage container through the delivery member when in a delivery state; a plunger biasing member configured to bias the plunger toward the tip; 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 base biasing member configured to selectively bias the guard toward the tip. While the base biasing member is biasing the guard toward the tip, the guard is moved toward the base from the first axial position toward the second axial position, The base biasing member holds the guard in the second axial position while at least temporarily stopping or reducing the biasing of the guard toward the tip, Methods that include...

37. The method according to claim 36, wherein the base biasing member is configured not to bias the guard toward the tip for at least a portion of the delivery state.

38. The method according to claim 36, wherein the base biasing member is configured to bias the guard toward the tip with a smaller force during at least a portion of the delivery state compared to before the delivery state.

39. The method according to claim 36 or 37, wherein when the guard is in the second axial position, the base biasing member is configured to selectively bias the guard toward the tip.

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 base biasing member to bias the guard toward the tip, and a second rotational position that prevents the base biasing member from biasing the guard toward the tip.

41. The method according to claim 40, comprising a plunger guide whose rotation is fixed relative to the housing, wherein the rotatable member is operably coupled to the plunger guide to prevent the rotatable member from rotating from the first rotation position toward the second rotation position prior to the delivery state.

42. The method according to claim 41, wherein, after the delivery state, the rotatable member is operably coupled to the guard such that the base biasing member can bias the guard toward the tip.

43. The method according to any one of claims 36 to 41, wherein the rotatable member has a tip-facing surface and is configured to engage with the base-facing surface of the guard when the rotatable member is in the first rotation position, and not to engage with the base-facing surface of the guard when the rotatable member is in the second rotation position.

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

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