Drug delivery device with needle shield with visual feedback

Abstract

A drug delivery device includes a housing, a drug storage container, a plunger, and a guard. The housing has an opening, and the guard is disposed adjacent the opening and is movable relative to the housing between an extended position and a retracted position. The guard includes a first annular portion and a second annular portion disposed at a distal end of the first annular portion, the second annular portion having an outer diameter greater than an outer diameter of the first annular portion. The second annular portion is positioned a first distance from the distal end of the housing when the guard is in the extended position, and the second annular portion is positioned a second distance from the distal end of the housing when the guard is in the retracted position. The second distance is less than the first distance.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 518,266, filed August 8, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to drug delivery devices, and more particularly to devices for automatically injecting drugs into patients, having a needle protection mechanism that retracts to allow for needle insertion and dosage administration. Background Technology

[0004] The widespread aversion to exposed needles, along with health and safety concerns, has spurred the development of drug delivery devices that conceal the needle or other insertion components before use and automate various aspects of the injection process. For example, drug delivery devices (such as syringes and autoinjectors) can incorporate various health and safety features to protect the injection needle from exposure and prevent the risk of accidental needle jamming or dose delivery. Such features may include retractable needle protectors for covering the needle before and / or after delivery. Typically, such retractable needle protectors require user input force to expose the injection needle and achieve needle insertion. For example, after placing the needle protector in contact with the user's skin, the user may need to apply a certain amount of force to retract the needle protector, expose the injection needle, and achieve needle insertion.

[0005] However, users may often not know when to stop applying additional force to the needle protector (i.e., when the needle is fully inserted into the user's skin). Additionally, users may not know when to maintain the input force applied to the needle protector to ensure the needle is properly inserted into the user's skin throughout the injection duration. This can, in turn, make self-administering medication difficult and may increase the likelihood of inappropriate dosing. With the growing need for easier-to-use and safer drug delivery devices, finding ways to incorporate more features without unduly increasing the complexity of the drug delivery device presents various design and manufacturing challenges.

[0006] This disclosure describes advantageous alternatives to existing drug delivery devices and drug delivery devices that can address one or more of the challenges or needs mentioned herein. Summary of the Invention

[0007] One aspect of this disclosure provides a drug delivery device including a housing, a drug storage container, a plunger, and a protective member. The housing may define a longitudinal axis and may have an opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The plunger may be movable toward a distal end of the drug storage container to expel drug from the drug storage container through the delivery member. The protective member may be disposed adjacent to an opening on the housing and is movable relative to the housing between an extended position and a retracted position. In the extended position, the insertion end of the delivery member may be surrounded by the protective member, and in the retracted position, the insertion end may be at least partially exposed. The protective member may include a first annular portion and a second annular portion disposed at a distal end of the first annular portion, the outer diameter of the second annular portion being larger than the outer diameter of the first annular portion. When the protective member is in the extended position, the second annular portion may be positioned at a first distance from the distal end of the housing, and when the protective member is in the retracted position, the second annular portion may be positioned at a second distance from the distal end of the housing. The second distance may be smaller than the first distance.

[0008] In some embodiments, the second annular portion may be defined by an annular sidewall, a bottom wall configured to contact the user's skin, and a top wall opposite the bottom wall. In some embodiments, the top wall may include a first ramp surface, and the distal end of the housing may include a second ramp surface complementary to the first ramp surface. In other embodiments, the top wall may include a first stepped surface, and the distal end of the housing may include a second stepped surface complementary to the first stepped surface. In yet another embodiment, the top wall may include a first curved surface, and the distal end of the housing may include a second curved surface complementary to the first corrugated surface.

[0009] In some embodiments, at least a portion of the annular sidewall of the first annular portion may be configured to slide into the housing when the protector is in a retracted position. In some embodiments, the outer diameter of the second annular portion may be substantially the same as the outer diameter of the housing. In other embodiments, the outer diameter of the second annular portion may be smaller than the outer diameter of the housing. In some embodiments, the first annular portion of the protector may be at least partially defined by an annular sidewall, and the annular sidewall of the first annular portion may be configured to slide within the housing between an extended position and a retracted position. In some embodiments, the second annular portion may be coupled to the first annular portion. In other embodiments, the first and second annular portions may be defined by a single integral structure.

[0010] In some embodiments, the drug delivery device may further include a plunger guide fixed relative to the housing, and the plunger may be at least partially disposed within the plunger guide. The drug delivery device may further include a release member operatively coupled to the plunger and configured to selectively rotate relative to the housing. Each of the plunger and the plunger guide may be at least partially disposed within the release member. A protective member may be operatively coupled to the release member. In some embodiments, when the protective member is in an extended position, the release member is prevented from rotating in at least one rotational direction, and wherein when the protective member is in a retracted position, the release member is permitted to rotate in said at least one rotational direction. In some embodiments, moving the protective member from the extended position to the retracted position may allow the release member and the plunger to rotate together from a first rotational position toward a second rotational position under the action of a biasing force applied by a biasing member.

[0011] In some embodiments, the drug delivery device may further include a locking ring configured to rotate between a first rotational position and a second rotational position. The rotational position of the locking ring may be based on the axial position of the protective member. In some embodiments, the distal end of the locking ring may be at least partially disposed within the protective member. The drug delivery device may further include a locking ring biasing member positioned between the locking ring and the bottom wall of a second annular portion of the protective member. The locking ring biasing member may be positioned within a first annular portion of the protective member. In some embodiments, the locking ring biasing member may be a compression spring configured to apply a biasing force to the protective member to push the protective member toward an extended position.

[0012] According to another embodiment of this disclosure, a method for delivering a drug is provided. The method includes providing a drug delivery device comprising: a housing; a drug storage container having a delivery member with an insertion end; a plunger movable toward a distal end of the drug storage container to expel drug from the drug storage container through the delivery member; and a protective member movable relative to the housing between an extended position and a retracted position. The protective member may include a first annular portion and a second annular portion disposed at a distal end of the first annular portion, the outer diameter of the second annular portion being larger than the outer diameter of the first annular portion. The method further includes positioning the drug delivery device such that the second annular portion of the protective member abuts against an injection site, and applying a force toward the injection site to the housing to allow the protective member to move from the extended position to the retracted position. When the protective member is in the extended position, the second annular portion may be positioned at a first distance from the distal end of the housing, and when the protective member is in the retracted position, the second annular portion may be positioned at a second distance from the distal end of the housing, the second distance being smaller than the first distance. Attached Figure Description

[0013] This disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. To illustrate other elements more clearly, some drawings may be simplified by omitting selected elements. Such omission of elements in some drawings does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, except as can be clearly described in the corresponding written description. Furthermore, not all drawings need to be drawn to scale.

[0014] Figure 1A A three-dimensional diagram of a drug delivery device is shown.

[0015] Figure 1B Showing Figure 1A A perspective view of a drug delivery device, in which the cover has been removed from the drug delivery device.

[0016] Figure 1C Showing Figure 1A A three-dimensional view of the drug delivery device in its pre-injection configuration.

[0017] Figure 1D Showing Figure 1A A three-dimensional view of the drug delivery device in the injection configuration.

[0018] Figure 2 Showing Figures 1A to 1D A cross-sectional view of the drug delivery device in the image.

[0019] Figure 3A A front view of an exemplary drug delivery device in a pre-injection configuration according to different embodiments of the present disclosure is shown.

[0020] Figure 3B Different embodiments of the present disclosure are shown. Figure 3A A front view of an exemplary drug delivery device in injection configuration.

[0021] Figure 3C Different embodiments of the present disclosure are shown. Figure 3A A perspective view of an exemplary drug delivery device.

[0022] Figure 3D Different embodiments according to this disclosure are shown. Figure 3B A perspective view of an exemplary drug delivery device.

[0023] Figure 4A A front view of another exemplary drug delivery device in a pre-injection configuration, according to different embodiments of the present disclosure, is shown.

[0024] Figure 4B Different embodiments of the present disclosure are shown. Figure 4A A front view of an exemplary drug delivery device in injection configuration.

[0025] Figure 5 Two different views of exemplary needle guards according to different embodiments of the present disclosure are shown.

[0026] Figure 6A A front view of another exemplary drug delivery device in a pre-injection configuration, according to different embodiments of the present disclosure, is shown.

[0027] Figure 6B Different embodiments of the present disclosure are shown. Figure 6A A front view of an exemplary drug delivery device in injection configuration.

[0028] Figure 6C Different embodiments of the present disclosure are shown. Figure 6A Two different views of an exemplary needle shield of an exemplary drug delivery device.

[0029] Figure 7A A front view of another exemplary drug delivery device in a pre-injection configuration, according to different embodiments of the present disclosure, is shown.

[0030] Figure 7B Different embodiments of the present disclosure are shown. Figure 7A A front view of an exemplary drug delivery device in injection configuration.

[0031] Figure 7C Different embodiments of the present disclosure are shown. Figure 7A Two different views of an exemplary needle shield of an exemplary drug delivery device. Detailed Implementation

[0032] This disclosure generally relates to a drug delivery device that can be operated by a user to administer a drug or, in the case of a patient self-administering a drug, can be administered by the user. Various features are disclosed, such as a needle guard having one or more indicators for signaling to the user when to stop pressing the drug delivery device further against the user's skin and / or when to maintain the force applied by the user to the drug delivery device. These features, along with other features, work together and / or interact with each other to limit the complexity of the drug delivery device and ensure proper drug delivery. For example, the drug delivery device does not require or includes a separate component for signaling to the user when the user should stop pressing the drug delivery device against the user's skin, thereby reducing the mechanical complexity, durability, and / or cost of the device. These and other advantages will be apparent to those skilled in the art who review this disclosure. As used herein, the term "guard" generally refers to a guard for protecting the insertion end of a delivery member (e.g., a needle) and is used interchangeably with "needle shield" or "needle protector."

[0033] Figures 1A to 1D as well as Figure 2 Several views of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a pharmaceutical agent or pharmaceutical product, are shown. The drug may be, but is not limited to, various biological agents, 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.

[0034] Various implementations and configurations of the drug delivery device 10 are possible. The drug delivery device 10 can be configured as a disposable syringe. In other embodiments, the drug delivery device 10 can be configured as a reusable syringe for multiple uses. The drug delivery device 10 can be operable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a physician or nurse). The drug delivery device 10 can take the form of an auto-injector or a pen syringe and can therefore be held in the user's hand during drug delivery.

[0035] The configuration of the different components included in the drug delivery device 10 can depend on the operating state of the drug delivery device 10. The drug delivery device 10 can have a pre-injection or storage state ( Figures 1A to 1C As shown), injection or administration status (as shown) Figure 1D(As shown in the diagram) and the post-injection state, but fewer or more states are also possible. The pre-injection state may correspond to the configuration of the drug delivery device 10 after assembly and before it is activated by the user. In some embodiments, the pre-injection state may exist between the time when the drug delivery device 10 leaves the manufacturing facility and when the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the time after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 against the injection site. The injection state may correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is in progress. The post-injection state may correspond to the configuration of the drug delivery device 10 after drug delivery has been completed and / or when the stopper is positioned at the end-of-administration position in the drug storage container.

[0036] like Figure 1A and Figure 1B As shown, the drug delivery device 10 includes a housing or casing 12. In some embodiments, the size and dimensions of the casing 12 may be configured to allow a person to hold the syringe 10 with one hand. The casing 12 may have a generally elongated tubular shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between its proximal and distal ends. In some embodiments, the outer diameter of the casing 12 may be the same along the longitudinal axis A from its proximal to its distal end. In other embodiments, the outer diameter of the casing 12 may vary along the longitudinal axis A such that the outer diameter of the casing 12 near its distal end may be larger than the outer diameter of the casing 12 near its proximal end. An opening 14 may be formed at the distal end ( Figure 2 ) to allow the insertion end 28 of the delivery component 16 ( Figure 2 ) extends to the outside of housing 12. Transparent or semi-transparent inspection window 17 ( Figure 1A and Figure 1B The window 17 can be positioned within the wall of the housing 12 to allow the user to observe the components inside the drug delivery device 10 (including the drug storage container 20). Observing the drug storage container 20 through the window 17 allows the user to confirm that drug delivery is in progress and / or complete. A removable cover 19 can cover the opening 14 before use of the drug delivery device 10, and in some embodiments, may include a clamp 13. Figure 2 The gripper is configured to assist in removing a sterile barrier 21 (e.g., a rigid needle shield (RNS) or a non-rigid needle shield (nRNS)) mounted on the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally engage or otherwise mechanically engage the sterile barrier 21 to pull the sterile barrier 21 with the removable cap 19 as the user separates the removable cap 19 from the housing 12. Therefore, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0037] like Figure 2 As shown, the drive mechanism 30 may be partially or completely housed within the housing 12. Typically, the drive mechanism 30 may be configured to store energy and, upon or in response to user activation, release or output that energy to drive the plunger 26 (also referred to as the "plunger rod") to expel the drug 22 from the drug storage container 20 through the delivery member 16 into the patient. In the current embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may be configured differently, for example, where the drive mechanism 30 stores electrical or chemical potential energy. Typically, when activated, the drive mechanism 30 can convert potential energy into kinetic energy to move the plunger 26. 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 rod guide 60, an extended biasing member 35, and a protective extension 37. The plunger biasing member 50 may include a spring, such as a compression spring (e.g., a helical compression spring), initially held in a stored state. In the stored state, the plunger biasing member 50 can be compressed such that its axial length is shorter than its axial length in the unloaded or deloaded state. When released, the plunger biasing member 50 may attempt to extend to its unloaded axial length, and thus apply a biasing force pushing the plunger 26 in the distal direction. In other embodiments, the plunger biasing member 50 may include a torsion spring initially held in a stored state. When released, the plunger biasing member 50 may rotate, and thus cause the plunger 26 to rotate while translating distally.

[0038] like Figure 2As shown, the drug delivery device 10 may include a housing 12, which may include two separate and interconnected structures: a rear end cap 23 (e.g., a back cover) at the proximal end of the drug delivery device 10, and a tubular housing 25 extending substantially entirely 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 components. The tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical or hollow cylindrical shape, having an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25, along with any components to be positioned therein, may be assembled together to define different sub-assemblies, such as a drive mechanism 30. In some embodiments, the different sub-assemblies are assembled independently of each other and subsequently combined with each other and with a drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the above-described assembly stages may be performed in different manufacturing facilities or environments. In an alternative embodiment, the housing 12 may be constructed as a single piece, such that the housing 12 is defined by a single integral structure that integrates the rear cover 23 and the tubular housing 25 into a single component.

[0039] A drug storage container 20 is disposed within the internal space of the housing 12 and configured to contain a drug 22. The drug storage container 20 may be pre-filled and transported by the manufacturer, for example, to a location where it will be combined with the rest of the drug delivery device 10. For example, the drug 22 may be dispensed and / or provided to a patient in more than one use case, such as as a pre-filled syringe or as an automated injection device including a pre-filled syringe. By utilizing the same or similar syringe components in either case, at least one of the above steps (e.g., filling, labeling, packaging, transporting, and dispensing) can be streamlined or simplified for two different use cases. As another example, where multiple use cases utilize some or all of the same syringe components, some administrative approaches to marketing and / or distributing drugs can be streamlined or simplified for at least one of the multiple use cases.

[0040] The housing 12 may be pre-loaded with the drug storage container 20 by the manufacturer, or alternatively, by the user before using the drug delivery device 10. The drug storage container 20 may include a cylinder having a rigid wall defining an internal orifice or reservoir. This wall may be made of glass or plastic. A stopper 24 may be movably disposed within the cylinder of the drug storage container 20 such that the stopper is movable distally along the longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the inner surface 15 of the wall of the drug storage container 20, thereby preventing or inhibiting leakage of the drug 22 through the stopper 24 during movement. Distal movement of the stopper 24 displaces the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 may be open to allow a plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In the current embodiment, the plunger 26 and the plug 24 are initially separated by a gap 18 ( Figure 2 The plunger 26 and the stopper 24 are spaced apart from each other. When the drive mechanism 30 is activated, the plunger 26 moves distally to reduce the gap and contact the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally to displace the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially contact each other or be connected to each other, for example via a threaded connection, such that they move together from the moment the plunger 26 begins to move. Once the stopper 24 has moved, it may continue to move distally until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may be referred to as the end of dosing or delivery position and may correspond to the time when the delivery of the drug 22 to the patient is completed or substantially completed.

[0041] In some embodiments, the volume of drug 22 included in the reservoir of drug storage container 20 may be equal to 1 mL, or equal to about (e.g., ± 10%) 1 mL, or equal to 2.5 mL, or equal to about (e.g., ± 10%) 2.5 mL, or equal to 3 mL, or equal to about (e.g., ± 10%) 3 mL, or less than or equal to about (e.g., ± 10%) 1 mL, or less than or equal to about (e.g., ± 10%) 2 mL, or less than or equal to about (e.g., ± 10%) 3 mL, or less than or equal to about (e.g., ± 10%) 4 mL, or less than about (e.g., ± 10%) 5 mL, or less than or equal to about (e.g., ± 10%) 10 mL, or in the range of about (e.g., ± 10%) 1-10 mL, or in the range of about (e.g., ± 10%) 1-5 mL, or in the range of about (e.g., ± 10%) 1-4 ... The range is 1-3 mL (10%) or approximately 1-2.5 mL (e.g., ± 10%).

[0042] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. For example, the delivery member 16 may be positioned at the distal end of the cylinder of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 may include other sharp tips with pointed geometries, thereby allowing the insertion end 28 to pierce the patient's skin 5 during insertion of the delivery member 16. Figure 1C and Figure 1D The delivery member 16 may be hollow and have internal pathways. One or more openings may be formed in the insertion end 28 to allow the drug to flow from the delivery member 16 into the patient.

[0043] In one embodiment, the drug storage container 20 may be a pre-filled syringe with a peg-type hollow metal needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In still other embodiments, the drug storage container 20 may be a needleless cartridge and therefore may not initially be in fluid communication with the delivery member 16. In this embodiment, the drug storage container 20 may be moved toward the proximal end of the delivery member 16 during operation of the drug delivery device 10, or conversely, such that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening on the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0044] The drug storage container 20 may include a body portion 20g having a distal end 20e and a proximal end 20f. The drug storage container 20 may be fixed relative to the housing 12 such that once installed in the housing 12, it will not move relative to the housing 12. Thus, in the pre-injection state, the injection state, and the post-injection state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 on the housing 12. For example, as... Figure 2 As shown, the delivery member 16 extends beyond the distal end of the housing 12 defining the opening 14. However, in some configurations, such as Figure 2 In the storage configuration shown, the delivery member 16 is covered / protected by a sterile barrier 21 and a protective member 32 that surrounds the delivery member 16 and prevents or reduces the likelihood of accidental or premature needlestick injuries, as described in more detail below. As used herein, the term "body portion" of the drug storage container 20 refers to the generally cylindrical portion of the drug storage container 20.

[0045] like Figure 2 As shown, the plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end (which abuts against the proximal inner surface of the plunger 26) and / or may be fixedly attached to the inner surface of the plunger 26. Such that the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 may be equal to or less than the inner diameter of the top ring 45, and / or equal to or less than the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut against the proximal inner surface of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut against the distal surface 38a of the plunger biasing member seat 38. The plunger biasing member seat 38 may be fixedly attached to the rear housing 27 such that the plunger biasing member seat 38 provides a retaining surface to push the plunger biasing member 50 away. In this configuration, the plunger biasing member 50 can extend in length when released from the stored state, wherein the distal end of the plunger biasing member 50 moves in a distal direction away from the fixed proximal end of the plunger biasing member 50. This movement can push the plunger 26 in a distal direction, which in turn can push the stopper 24 in a distal direction to expel the drug 22 from the drug storage container 20 into the delivery member 16 and thereby into the patient.

[0046] The plunger rod guide 60 can be fixedly attached to the rear housing 27, such that the plunger rod guide 60 is immovable relative to the rear housing 27. The plunger rod guide 60 can have a hollow and generally cylindrical or tubular shape, and can be centered on the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger rod guide 60 can be larger than the outer diameter or other outer dimension of the distal end of the plunger rod guide 60. At least a portion of the distal end of the plunger rod guide 60 can be radially positioned between the plunger 26 and the release member 52. Thus, the plunger 26 can be at least partially disposed within the distal end of the plunger rod guide 60, and the distal end of the plunger rod guide 60 can be at least partially disposed within the release member 52, such as... Figure 2 As shown in the image.

[0047] The release member 52 may be hollow and generally cylindrical or tubular in shape, and may be centered on the longitudinal axis A. For example... Figure 2 As shown, the release member 52 can be positioned radially between the distal end of the plunger rod guide 60 and the proximal end of the protective extension 37. Furthermore, the release member 52 can be arranged radially inside the protective bias member 35. Typically, the release member 52 is configured to operatively engage the protective member 32 and the plunger 26 in the activation sequence and generate an audible signal indicating the end of drug delivery.

[0048] The release member 52 can be configured to rotate and / or translate linearly relative to the housing 12 according to the operational phase of the drug delivery device 10. The initial rotation of the release member 52 associated with activation can be powered by the plunger biasing member 50 and / or the protective biasing member 35; while subsequent rotation of the release member 52 associated with the generation of a dosing termination signal can be powered solely by the protective biasing member 35. Any linear translation of the release member 52 without rotation can be powered solely by the protective biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction; however, alternative embodiments may permit linear translation of the release member 52 in both the proximal and distal directions.

[0049] As described above, the drug delivery device 10 may further include a protective mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used for injection. The protective mechanism may include a protective member 32 movably disposed at the distal end of the housing 12 adjacent to the opening 14. The protective member 32 may have a hollow, generally cylindrical or tubular shape centered on the longitudinal axis A. The protective member 32 typically includes a cylindrical portion 32a, a distal end 32c, and a proximal end 32d. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. For example, the protective member 32 may be configured to move relative to the housing 12 such that portions of the protective member 32 are received within the housing 12 in some stages / states and extend from the housing 12 in other stages / states.

[0050] The protective member 32 can be configured to move relative to the housing 12 between an extended position and a retracted position. In the extended position, at least a portion of the cylindrical portion 32a of the protective member 32 extends through the opening 14 in the housing 12. In the retracted position, a shorter length of the cylindrical portion 32a extends through the opening 14 in the housing 12, or no portion of the cylindrical portion 32a extends through the opening 14 in the housing 12. In other words, in the extended position, length X of the cylindrical portion 32a extends through the opening 14 in the housing 12, and in the retracted position, length Y of the cylindrical portion 32a extends through the opening 14 in the housing 12, wherein the value of X is greater than the value of Y. Length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. Length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. Figure 1C and Figure 1D Demonstrates: Exemplary pre-injection configuration ( Figure 1C In the pre-injection configuration, the protective member 32 is in the extended position 32e, and the length X of the exposed portion of the protective member 32 can be approximately 5 mm to 11 mm; and the injection configuration ( Figure 1D In this injection configuration, the protective member 32 is in the retracted position 32f, and the exposed portion of the protective member 32 has a length Y of approximately 0 mm to 2 mm (such that the distal end 32c of the protective member 32 is flush with the opening 14 of the housing 12). In one embodiment, the distance Y is greater than 0 (e.g., 1 mm) to help ensure that the device 10 can be activated before the protective member is flush with the housing 12.

[0051] During operation of the device, the user can move the protective member 32 (relative to the housing 12) proximally by pressing it against the injection site. In doing so, the protective member 32 will move toward the protective extension 37 and close the gap 37g therebetween. Figure 2 Once the gap 37g is eliminated, the protective member 32 and the protective extension 37 move together in the proximal direction until, for example, the protective member 32 reaches the retracted position 32f. When the injection is completed and the drug delivery device 10 is lifted away from the injection site, the extension biasing member 35 can advance the protective extension 37, causing the protective extension 37 and the protective member 32 to move together in the distal direction. This movement (and / or the biasing force from the locking ring biasing member 51) returns the protective member 32 to the extended position 32e, which has the effect of covering the insertion end 28 of the delivery member 16.

[0052] However, users may not typically know when to stop applying force to the protective member 32 and press it against the injection site. Additionally, users may not know when to maintain the input force applied to the protective member 32 to ensure that the insertion end 28 of the delivery member 16 is correctly and adequately inserted into the injection site throughout the injection duration. This can further make self-administering medication difficult and may increase the likelihood of inappropriate dosage. With the growing demand for more convenient and safer drug delivery devices, it may be desirable to provide additional features to the drug delivery device 10 that instruct the user when to maintain the input force applied to the protective member 32 to ensure proper dosage administration.

[0053] For example, Figures 3A to 3D Different views of a drug delivery device 100 according to different embodiments of the present disclosure are shown. The drug delivery device 100 may include the same components that constitute the drug delivery device 10. For example, the drug delivery device 100 may include a drive mechanism 30, a drug storage container 20, a delivery member 16, a release member 52, and other components described above with respect to the drug delivery device 10.

[0054] like Figures 3A to 3D As shown, the drug delivery device 100 includes a housing or casing 112. Like the casing 12, the casing 112 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 112e and a distal end 112f. In some configurations, an opening 114 may be formed on the distal end 112f. Figure 3C and Figure 3DThe insertion end 128 of the delivery member 116 extends to the outside of the housing 112. A transparent or translucent inspection window 117 may be positioned on the wall of the housing 112 to allow the user to observe the components inside the drug delivery device 100, including the drug storage container 120 (similar to drug storage container 20). Although not shown, a removable cover (such as removable cover 19) may cover the opening 114 before use of the drug delivery device 100. The drug delivery device 100 may also include a rear end cover 123 (also referred to as a "rear cover") at the proximal end 112e of the drug delivery device 100.

[0055] The drug delivery device 100 may further include a protective mechanism to prevent contact with the insertion end 128 of the delivery member 116 when the drug delivery device 100 is not used for injection. The protective mechanism may include a protective member 132 movably disposed at or near the distal end 112f of the housing 112, adjacent to the opening 140. Figure 3C As shown in the diagram). As described in more detail below, the protective member 132 can be in an extended position relative to the housing 112 (as shown in the diagram). Figure 3A and Figure 3C ) and retraction position ( Figure 3B and Figure 3D The protective member 132 moves between the extended positions. Figure 3A and Figure 3C When the delivery member 116 is in the retracted position, the insertion end 128 of the delivery member 116 can be surrounded by the protective member 132, making the insertion end 128 of the delivery member 116 invisible to the user. When the protective member 132 is in the retracted position... Figure 3B and Figure 3D When the delivery member 116 is inserted, the insertion end 128 can be at least partially exposed, making it visible to the user operating the drug delivery device 100.

[0056] Similar to protective member 32, protective member 132 may be hollow and generally tubular. However, unlike protective member 32 of drug delivery device 100, protective member 132 of drug delivery device 100 may include a first annular portion 132a and a second annular portion 132b disposed at the distal end of the first annular portion 132a. The first annular portion 132a may be hollow and generally tubular, and may be a cylindrical portion centered on the longitudinal axis A. The second annular portion 132b may be disposed at the distal end of the first annular portion 132a, and may also be a generally cylindrical portion centered on the longitudinal axis A. In some embodiments, the second annular portion 132b may be coupled to the first annular portion 132a. For example, the second annular portion 132b may be glued to the first annular portion 132a, or coupled to the first annular portion 132a by a snap-fit ​​configuration or by other known mechanisms for coupling the second annular portion 132b to the first annular portion 132a. In other embodiments, the first annular portion 132a and the second annular portion 132b may be integrally formed and may define a single integral structure.

[0057] like Figures 3A to 3D As shown, the outer diameter of the second annular portion 132b can be larger than the outer diameter of the first annular portion 132b. In some embodiments, the outer diameter of the second annular portion 132b can be substantially equal to or at least similar to the outer diameter of the distal end 112f of the housing 112. Accordingly, when the protective member 132 is in the retracted position ( Figure 3B and Figure 3D When the second annular portion 132b is in the extended position, its outer diameter can match the outer diameter of at least the distal end 112f of the housing 112, such that the second annular portion 132b is flush with the distal end 112f of the housing 112. The outer diameter of the first annular portion 132a can be smaller than the outer diameter of the second annular portion 132b and at least the distal end 112f of the housing 112, such that the first annular portion 132a can slide into and out of the housing 112 between the extended position and the retracted position.

[0058] As indicated above, the protective member 132 can be configured to move relative to the housing 112 between an extended position and a retracted position. In the extended position, at least a portion of the first annular portion 132a extends through the opening 140 in the housing 112; in the retracted position, a shorter length of the first annular portion 132a, or no portion thereof, extends through the opening 140 in the housing 112. In other words, in the extended position, the length X of the first annular portion 132a is... Figure 3C As shown, it can extend through the opening 140 of the housing 112, and in the retracted position, the length Y of the first annular portion 132a (as shown) Figure 3D(As shown) can extend through opening 140, where X is a value greater than Y. Length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. Length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value.

[0059] When the protective component 132 is in the extended position ( Figure 3A and Figure 3C When the protective member 132 is in the retracted position, the second annular portion 132b can be positioned at a first distance from the distal end 112f of the housing 112, such that the first annular portion 132a and the second annular portion 132b can cover the insertion end 128 of the delivery member 116. The first distance can be equal to the length X of the first annular portion 132a extending through the opening 140 of the housing 112. When the protective member 132 is in the retracted position ( Figure 3B and Figure 3D When the protective member 132 is in the retracted position, the first annular portion 132a can move in the proximal direction, and at least a portion of the first annular portion 132a can slide into the distal end 112f of the housing 112, and the second annular portion 132b can also move in the proximal direction toward the proximal end 112e of the housing 112. Accordingly, when the protective member 132 is in the retracted position, the second annular portion 132b of the protective member 132 can be positioned at a second distance (less than the first distance) from the distal end 112f of the housing 112, thereby at least partially exposing the insertion end 128 of the delivery member 116. The second distance can be equal to the length Y of the first annular portion 132a extending through the opening 140 of the housing 112.

[0060] The protective member 132 can also be configured to move in the opposite distal direction, i.e., from a retracted position to an extended position. During the injection process, the protective member 132 can remain fixed relative to the user's skin, while the housing 112 and several components disposed therein (such as the drive mechanism and delivery member 116) move relative to the protective member 132 and the skin. In some embodiments, the protective member 132 may be fixed or restricted in a rotational sense relative to the housing 112. Accordingly, while the protective member 132 may be able to translate linearly relative to the housing 112, rotation of the protective member 132 relative to the housing 112 may be substantially or completely prevented. For example, a first annular portion 132a of the protective member 132 may include a protrusion 172 extending therefrom, which aligns with a corresponding feature on the inner surface of the housing 112, such as a groove, a ridge, or another component cooperating with the protrusion 172 to substantially or completely prevent rotation of the protective member 132. In some embodiments, the first annular portion 132a may include a plurality of protrusions 172, and the inner surface of the housing 112 may include a plurality of corresponding features.

[0061] As described above, the first annular portion 132a of the protective member 132 may be at least partially defined by an annular sidewall, and at least a portion of the annular sidewall of the first annular portion 132a may be configured to slide between an extended position and a retracted position within the housing 112. (Reference) Figures 3A to 3D The second annular portion 132b of the protective member 132 may be defined by an annular sidewall 151, a bottom wall 152 configured to contact the user's skin during operation of the drug delivery device 100, and a top wall 150 opposite the bottom wall 152. In some embodiments, such as Figures 3A to 3D As shown, the top wall 150 of the second annular portion 132b may include a first stepped surface, and the distal end 112f of the housing 112 may also include a second stepped surface complementary to the first stepped surface. Accordingly, when the protective member 132 moves from the extended position to the retracted position, the first stepped surface of the top wall 150 of the second annular portion 132b can match the second stepped surface of the distal end 112f of the housing 112 (e.g., ...). Figure 3B and Figure 3D (as shown in the diagram). In other embodiments, when the protective member 132 is in the retracted position, the first stepped surface of the top wall 150 of the second annular portion 132b may be flush with the second stepped surface of the distal end 112f of the housing 112.

[0062] The complementary stepped surfaces of the top wall 150 of the second annular portion 132b of the protective member 132 and the distal end 112f of the housing 112 can provide the user with the following visual indications or feedback regarding when the user should: (a) stop applying force to the protective member 132 and press the bottom wall 152 against the injection site, and (b) maintain the input force applied to the protective member 132 to ensure that the insertion end 128 of the delivery member 116 is correctly and adequately inserted into the injection site throughout the injection duration. Specifically, the user can be instructed to apply force to the protective member 132 by pressing the bottom wall 152 of the second annular portion 132b against the user's skin until a consistent length 170 of the first annular portion 132a can be seen around the protective member 132 (in...). Figure 3B (Seen in dashed lines). This, in turn, ensures that the user administers the appropriate dose. Additionally or alternatively, the drug delivery device 100 may be configured to provide tactile and / or auditory feedback to the user: informing the user when they should (a) stop applying force to the protective member 132 and press the bottom wall 152 against the injection site, and (b) maintain the input force applied to the protective member 132 to ensure that the insertion end 128 of the delivery member 116 is correctly and adequately inserted into the injection site throughout the injection duration.

[0063] Return to reference Figure 2 Similar to drug delivery device 10, drug delivery device 100 may also include an extension biasing member 35 and a protective extension 37. The protective extension 37 may be positioned near the protective member 132, and the extension biasing member 35 may be positioned near the protective extension 37. The protective extension 37 may have a hollow, generally cylindrical or tubular shape centered on a longitudinal axis A. The protective extension 37 may be a separate structure from the protective member 132. In other embodiments, the protective extension 37 may be integrally formed with the protective member 132 to define a single integral structure. The protective extension 37 may be fixed in a rotational sense relative to the housing 112. To achieve this effect, in some embodiments, the protective extension 37 may cooperate with a plunger guide (such as a plunger rod guide 60) to limit or prevent rotation.

[0064] In some embodiments, the extension biasing member 35 may be positioned between the protective extension 37 and the release member (e.g., release member 52) and in contact with both the protective extension and the release member. The extension biasing member 35 may be configured to bias or advance the protective extension 37 distally and / or bias or advance the release member 52 proximally. Figure 3A and Figure 3CIn the device 100 shown in the pre-delivery or extended position, the extension biasing member 35 is initially in a stored state (e.g., compressed). In other words, the extension biasing member 35 can apply a distal (downward) biasing force on the protective member extension 37 and a proximal (upward) biasing force on the release member 52. During operation of the device, the user can translate the protective member 132 proximal to the housing 112 by pressing the bottom wall 152 of the protective member 132, particularly the second annular portion 132b, against the injection site. In doing so, the protective member 132 can move toward the protective member extension 37 and close the gap 37g therebetween. Figure 2 (As shown in the diagram). Once the gap 37g is eliminated, the protective member 132 and the protective extension 37 can move together in the proximal direction until, for example, the protective member 132 reaches the retracted position (as shown in the diagram). Figure 3B and Figure 3D When the injection is completed and the drug delivery device 100 is lifted away from the injection site, the extension biasing member 35 can advance the protective extension 37 such that the protective extension 37 and the protective member 132 move together in a distal direction. This movement can return the protective member 132 to the extended position, and the protective member 132 can cover the insertion end 128 of the delivery member 116 to prevent the delivery member 116 from being accidentally injected into the user's skin after dose delivery. In some embodiments, the extension biasing member 35 may include a compression spring (e.g., a helical compression spring).

[0065] After drug delivery is completed and the protective member 132 has been re-extended to the extended position, it is desirable to lock the protective member 132 in the extended position to prevent subsequent users from contacting the insertion end 128 of the delivery member 116 and / or to prevent reuse of the drug delivery device 100. In some embodiments, the drug delivery device 100 may include a locking ring, such as a locking ring 40, configured to selectively rotate between a first rotational position and a second rotational position depending on the axial position of the protective member 132, so as to lock the protective member 132 in the extended position once it has moved from the retracted position back to the extended position. In some embodiments, the locking ring may be centered and may rotate about a longitudinal axis A. The proximal end of the locking ring may contact a portion of the housing 112, and the distal end of the locking ring may be at least partially disposed within the protective member 132.

[0066] In some embodiments, the drug delivery device 100 may further include a locking ring biasing member, such as locking ring biasing member 51. The locking ring biasing member may be positioned axially between the distally facing surface of the locking ring and the proximal facing surface of the bottom wall 152 of the second annular portion 132b of the protective member 132. In some embodiments, the locking ring biasing member may be positioned within the first annular portion 132a of the protective member 132. The locking ring biasing member may be a compression spring and may be configured to apply a biasing force to the protective member 132 to push the protective member 132 toward an extended position. The locking ring biasing member may also bias the locking ring and the protective member away from each other.

[0067] In some embodiments, the drug delivery device 100 may include a plunger guide, such as a plunger rod guide 60, fixed relative to the housing 112. A plunger (e.g., plunger 26) may be at least partially disposed within the plunger guide. As described above, a release member (e.g., release member 52) may be operatively coupled to the plunger and configured to selectively rotate relative to the housing. The plunger and plunger guide may be at least partially disposed within the release member, and a guard member 132 may be operatively coupled to the release member. When the guard member 132 is in the extended position, it prevents the release member from rotating in at least one rotational direction, and when the guard member 132 is in the retracted position, it allows the release member to rotate in at least one rotational direction. Specifically, when the guard member 132 moves from the extended position to the retracted position, this movement of the guard member 132 allows the release member and the plunger to rotate together from a first rotational position toward a second rotational position under the action of a biasing force applied by a biasing member (e.g., a spring).

[0068] Having described the general configuration of the drug delivery device 100, a method for administering an injection using the drug delivery device 100 will now be described. As a preliminary step, the user can remove a removable cap, such as removable cap 19, from the distal end 112f of the housing 112. This exposes the insertion end 128 of the delivery member 116. However, the insertion end 128 may still be surrounded by the protective member 132, as the protective member 132 is arranged in the extended position. Next, the user can position the drug delivery device 110 above the injection site, grasp the housing 112, and while grasping the housing 112, push the bottom wall 152 of the second annular portion 132b of the protective member 132 against the injection site. The user can push the bottom wall 152 against the injection site until a consistent line 170 (e.g., ...) can be seen around the first annular portion 132a of the protective member 132. Figure 3B and Figure 3D (As shown in the diagram). At this point, the user can stop pushing the bottom wall 152 further and can maintain the force applied to the injection site until the drug delivery is complete.

[0069] The force applied by the user overcomes the biasing forces of the extension biasing member and the locking ring biasing member, thereby retracting the protective member 132 into the opening 140, thus moving it from the extended position to the retracted position in a proximal direction. During the retraction movement of the protective member 132, the delivery member 116 remains fixed relative to the housing 112. Because the delivery member 116 remains fixed, the insertion end 128 of the delivery member 116 extends through the opening 114 on the bottom wall 152 of the second annular portion 132b of the protective member 132, thereby piercing the user's skin at the injection site and penetrating into the user's subcutaneous tissue.

[0070] In the pre-injection state, the plunger and release member can be positioned in their respective initial rotational positions. The plunger biasing member can also be in a storable compressed state. When the protective member 132 moves to the retracted position, this causes axial movement of the protective member extension, which unlocks the release member. Once the release member is unlocked, the plunger and plunger biasing member push the release member clockwise and allow the plunger to move axially in a distal direction (downward toward the distal end 112f of the housing 112). The plunger then pushes the plug distally, thereby ejecting the drug from the drug product container 120 and out of the delivery member 116. Once drug delivery is complete, the user can then remove the drug delivery device 100 from the injection site. Without any resistance, the extended biasing member can push the protective member 132 from the retracted position back to the extended position to cover the insertion end 128 of the delivery member 116. This movement of the protective member 132 can also cause the locking ring to rotate from the first rotational position to the second rotational position to lock the protective member 132 in the extended position and prevent the protective member 132 from subsequently retracting.

[0071] Now go to Figures 4A to 4B Another drug delivery device 200 according to different embodiments of the present disclosure is provided. The drug delivery device 200 may be similar to... Figures 3A to 3D The drug delivery device 100. For example, like the drug delivery device 100, the drug delivery device 200 includes a housing or casing 212. The casing 212 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 212e and a distal end 212f. In some configurations, an opening 214 may be formed on the distal end 212f to allow the insertion end 228 of the delivery member 216 to extend to the outside of the casing 212. A transparent or translucent inspection window 217 may be positioned on the wall of the casing 212 to allow a user to observe components inside the drug delivery device 200 (such as a drug storage container similar to the drug storage container 120). Although not shown, a removable cover (such as removable cover 19) may cover the opening 214 before use of the drug delivery device 200. The drug delivery device 200 may also include a rear end cover 223 at the proximal end 212e of the drug delivery device 200.

[0072] The drug delivery device 200 may further include a protective mechanism to prevent contact with the insertion end 228 of the delivery member 216 when the drug delivery device 200 is not used for injection. The protective mechanism may include a protective member 232 movably disposed at or near the distal end 212f of the housing 212, adjacent to the opening 240. Figure 4A As shown in the diagram). As described in more detail below, the protective member 232 can be in an extended position relative to the housing 212 (as shown in the diagram). Figure 4A ) and retraction position ( Figure 4B The protective member 232 moves between the extended positions. Figure 4A When the delivery member 216 is in the retracted position, the insertion end 228 can be surrounded by the protective member 232, making the insertion end 228 invisible to the user. Figure 4B When the insertion end 228 is at least partially exposed, the insertion end is visible to the user and the insertion end can pierce the user's skin at the injection site.

[0073] The protective member 232 may be hollow and generally tubular. The protective member 232 may include a first annular portion 232a and a second annular portion 232b disposed at the distal end of the first annular portion 232a. The first annular portion 232a may be hollow and generally tubular, and may be a cylindrical portion centered on a longitudinal axis A. The second annular portion 232b may be disposed at the distal end of the first annular portion 232a, and may also be a generally cylindrical portion centered on the longitudinal axis A. In some embodiments, the second annular portion 232b may be coupled to the first annular portion 232a. For example, the second annular portion 232b may be glued to the first annular portion 232a, or coupled to the first annular portion 232a by a snap-fit ​​configuration or by other known mechanisms for coupling the second annular portion 232b to the first annular portion 232a. In other embodiments, the first annular portion 232a and the second annular portion 232b may be integrally formed and may define a single integral structure.

[0074] like Figures 4A to 4BAs shown, the outer diameter of the second annular portion 232b may be larger than the outer diameter of the first annular portion 232b. In some embodiments, the outer diameter of the second annular portion 232b may be smaller than the outer diameter of the housing 212 near the distal end 212f, such that when the protective member 232 is in the retracted position, at least a portion of the second annular portion 232b can slide through an opening on the distal end 212f and slide within the housing 212. The outer diameter of the first annular portion 232a may be smaller than the outer diameter of the second annular portion 232b and at least the outer diameter of the distal end 212f of the housing 212, such that the first annular portion 232a can slide into and out of the housing 212 between the extended and retracted positions through an opening (e.g., opening 240) at the distal end 212f of the housing 212. In other embodiments, the outer diameter of the second annular portion 232b may be substantially equal to or at least similar to the outer diameter of the distal end 212f of the housing 212. In this configuration, when the protective member 232 is in the retracted position, the outer diameter of the second annular portion 232b can match the outer diameter of at least the distal end 212f of the housing 212, such that the second annular portion 232b is flush with the distal end 212f of the housing 212.

[0075] Like protective member 132, protective member 232 can be configured to move relative to housing 212 between an extended position and a retracted position. In the extended position, at least a portion of the first annular portion 232a extends through the opening 240 in housing 212; in the retracted position, a shorter length or no portion of the first annular portion 232a extends through the opening 240 in housing 212. In other words, in the extended position, the length X of the first annular portion 232a can extend through the opening 240 in housing 212, and in the retracted position, the length Y of the first annular portion 232a can extend through the opening 240, where X is a value greater than Y. The length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value.

[0076] When the protective component 232 is in the extended position ( Figure 4A When the protective member 232 is in the retracted position, the second annular portion 232b can be positioned at a first distance from the distal end 212f of the housing 212, such that the first annular portion 232a and the second annular portion 232b can cover the insertion end 228 of the delivery member 216. The first distance can be equal to the length X of the first annular portion 232a extending through the opening 240 of the housing 212. When the protective member 232 is in the retracted position ( Figure 4BWhen the protective member 232 is in the retracted position, the first annular portion 232a can move in the proximal direction, and at least a portion of the first annular portion 232a can slide into the distal end 212f of the housing 212, and the second annular portion 232b can also move in the proximal direction toward the proximal end 212e of the housing 212. Accordingly, when the protective member 232 is in the retracted position, the second annular portion 232b of the protective member 232 can be positioned at a second distance (less than the first distance) from the distal end 212f of the housing 212, thereby at least partially exposing the insertion end 228 of the delivery member 216. The second distance can be equal to the length Y of the first annular portion 232a extending through the opening 240 of the housing 212.

[0077] In some embodiments, when the protective member 232 is in the retracted position, at least a portion of the second annular portion 232b can slide through the opening 240 into the distal end 212f of the housing 212, making any part of the first annular portion 232a invisible. In this case, when the protective member 232 is in the retracted position, the first annular portion 232a is completely disposed within the housing 212, making any part of the first annular portion 232a invisible, and at least a portion of the second annular portion 232b is disposed within the housing 212. In yet another embodiment, when the protective member 232 is in the retracted position, the second annular portion 232b can be flush with the distal end 212f of the housing 212. In this configuration, the first annular portion 232a is completely disposed within the housing 212 such that no part of the first annular portion 232a is visible, and the second annular portion 232b is disposed 0 mm from the distal end 212f of the housing 212, and no part of the second annular portion 232b is disposed inside the housing 212 (i.e., in contact with the distal end 212f of the housing 212).

[0078] As described above, the first annular portion 232a of the protective member 232 may be at least partially defined by an annular sidewall, and at least a portion of the annular sidewall of the first annular portion 232a may be configured to slide between an extended position and a retracted position within the housing 212. The second annular portion 232b may be defined by an annular sidewall 251, a bottom wall 252 configured to contact the user's skin during operation of the drug delivery device 200, and a top wall 250 opposite to the bottom wall 252. In some embodiments, such as Figures 4A to 4B As shown, the top wall 250 of the second annular portion 232b may include a first stepped surface, and the distal end 212f of the housing 212 may also include a second stepped surface complementary to the first stepped surface. Accordingly, when the protective member 232 moves from the extended position to the retracted position, the first stepped surface of the top wall 250 of the second annular portion 232b can match the second stepped surface of the distal end 212f of the housing 212 (e.g., ...). Figure 4BAs shown in the figure, the first stepped surface of the top wall 250 can be flush with the second stepped surface of the distal end 212f of the housing 212.

[0079] The complementary stepped surfaces of the top wall 250 of the second annular portion 232b of the protective member 232 and the distal end 212f of the housing 212 can provide the user with the following visual indications or feedback regarding when the user should: (a) cease applying force to the protective member 232 and press the bottom wall 252 against the injection site, and (b) maintain the applied force on the protective member 232 to ensure that the insertion end 228 of the delivery member 216 is correctly and adequately inserted into the injection site throughout the injection duration. Specifically, the user can be instructed to apply force to the protective member 232 by pressing the bottom wall 252 of the second annular portion 232b against the user's skin until any part of the first annular portion 232a of the protective member 232 is no longer visible. This, in turn, ensures that the user administers the appropriate dosage. Additionally, the second annular portion 232b of the protective member 232 and the housing 212 may each include an indicator 280 for instructing the user when the user should: (a) cease applying force to the protective member 232 and press the bottom wall 252 against the injection site, and (b) maintain the input force applied to the protective member 232 to ensure that the insertion end 228 of the delivery member 216 is correctly and adequately inserted into the injection site throughout the injection duration. The indicator 280 may include an arrow (such as an arrowhead). Figures 4A to 4B (as shown) or any other geometric shape that can match each other. For example, such as Figure 5 As shown, the second annular portion 232b of the protective member 232 and the distal end 212f of the housing 212 may each include a linear indicator 380 instead of an arrow-shaped indicator 280. During operation of the drug delivery device 200, the user may apply force against the protective member 232 against their skin until (a) any part of the first annular portion 232a of the protective member 232 is no longer visible, and / or (b) the indicators 280, 380 (one on the second annular portion 232b of the housing 212 and the other on the distal end 212f) align with each other. The user may then maintain the force applied to the protective member 232 until drug delivery is complete.

[0080] Additionally or alternatively, the drug delivery device 200 may be configured to provide tactile and / or auditory feedback to the user: informing the user when they should (a) stop applying force to the protective member 232 and press the bottom wall 252 against the injection site, and (b) maintain the input force applied to the protective member 232 to ensure that the insertion end 228 of the delivery member 216 is properly and adequately inserted into the injection site throughout the injection duration.

[0081] Now go to Figures 6A to 6CAnother drug delivery device 400 according to different embodiments of the present disclosure is provided. The drug delivery device 400 includes a housing or casing 412. The casing 412 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 412e and a distal end 412f. In some configurations, an opening 414 may be formed in the distal end 412f to allow an insertion end 428 of a delivery member 416 to extend to the outside of the casing 412. A transparent or translucent inspection window 417 may be positioned on the wall of the casing 412 to allow a user to observe components inside the drug delivery device 400 (such as a drug storage container similar to drug storage container 120). Although not shown, a removable cap (such as removable cap 19) may cover the opening 414 before use of the drug delivery device 400. The drug delivery device 400 may also include a rear end cap 423 at the proximal end 412e of the drug delivery device 400.

[0082] The drug delivery device 400 may further include a protective mechanism to prevent contact with the insertion end 428 of the delivery member 416 when the drug delivery device 400 is not used for injection. The protective mechanism may include a protective member 432 movably disposed at or near the distal end 412f of the housing 412, adjacent to the opening 440. Figure 6A As shown in the diagram). As described in more detail below, the protective member 432 can be in an extended position relative to the housing 412 (as shown in the diagram). Figure 6A ) and retraction position ( Figure 6B The protective member 432 moves between the extended positions. Figure 6A When the delivery member 416 is in the retracted position, the insertion end 428 can be surrounded by the protective member 432, making the insertion end 428 invisible to the user. Figure 6B When the insertion end 428 is exposed, it can be at least partially exposed, making the insertion end visible to the user and allowing the insertion end to pierce the user's skin at the injection site.

[0083] The protective member 432 may be hollow and generally tubular. The protective member 432 may include a first annular portion 432a and a second annular portion 432b disposed at the distal end of the first annular portion 432a. The first annular portion 432a may be hollow and generally tubular, and may be a cylindrical portion centered on a longitudinal axis A. The second annular portion 432b may be disposed at the distal end of the first annular portion 432a, and may also be a generally cylindrical portion centered on the longitudinal axis A. In some embodiments, the second annular portion 432b may be coupled to the first annular portion 432a. For example, the second annular portion 432b may be glued to the first annular portion 432a, or coupled to the first annular portion 432a by a snap-fit ​​configuration or by other known mechanisms for coupling the second annular portion 432b to the first annular portion 432a. In other embodiments, the first annular portion 432a and the second annular portion 432b may be integrally formed and may define a single integral structure.

[0084] like Figures 6A to 6B As shown, the outer diameter of the second annular portion 432b can be larger than the outer diameter of the first annular portion 432b. In some embodiments, the outer diameter of the second annular portion 432b can be smaller than the outer diameter of the housing 412 near the distal end 412f, such that when the protective member 432 is in the retracted position, at least a portion of the second annular portion 432b can slide through the opening on the distal end 412f and slide within the housing 412. In other embodiments, the outer diameter of the second annular portion 432b can be substantially equal to or at least similar to the outer diameter of the distal end 412f of the housing 412. In this configuration, when the protective member 432 is in the retracted position, the outer diameter of the second annular portion 432b can match the outer diameter of at least the distal end 412f of the housing 412, such that the second annular portion 432b is flush with the distal end 412f of the housing 412. The outer diameter of the first annular portion 432a may be smaller than the outer diameter of the second annular portion 432b and at least the outer diameter of the distal end 412f of the housing 412, such that the first annular portion 432a can slide into and out of the housing 412 between the extended position and the retracted position through an opening (e.g., opening 440) at the distal end 412f of the housing 412.

[0085] The protective member 432 can be configured to move relative to the housing 412 between an extended position and a retracted position. In the extended position, at least a portion of the first annular portion 432a extends through the opening 440 in the housing 412. In the retracted position, a shorter length or no portion of the first annular portion 432a extends through the opening 440 in the housing 412. In other words, in the extended position, the length X of the first annular portion 432a can extend through the opening 440 in the housing 412, and in the retracted position, the length Y of the first annular portion 432a can extend through the opening 440, where X is a value greater than Y. The length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value.

[0086] When the protective component 432 is in the extended position ( Figure 6A When the protective member 432 is in the retracted position, the second annular portion 432b can be positioned at a first distance from the distal end 412f of the housing 412, such that the first annular portion 432a and the second annular portion 432b can cover the insertion end 428 of the delivery member 416. The first distance can be equal to the length X of the first annular portion 432a extending through the opening 440 of the housing 412. When the protective member 432 is in the retracted position ( Figure 6B When the protective member 432 is in the retracted position, the first annular portion 432a can move in the proximal direction, and at least a portion of the first annular portion 432a can slide into the distal end 412f of the housing 412, and the second annular portion 432b can also move in the proximal direction toward the proximal end 412e of the housing 412. Accordingly, when the protective member 432 is in the retracted position, the second annular portion 432b of the protective member 432 can be positioned at a second distance (less than the first distance) from the distal end 412f of the housing 412, thereby at least partially exposing the insertion end 428 of the delivery member 416. The second distance can be equal to the length Y of the first annular portion 432a extending through the opening 440 of the housing 412.

[0087] In some embodiments, when the protective member 432 is in the retracted position, at least a portion of the second annular portion 432b can slide through the opening 440 into the distal end 412f of the housing 412, making any portion of the first annular portion 432a invisible. In this case, when the protective member 432 is in the retracted position, the first annular portion 432a is completely disposed within the housing 412, making any portion of the first annular portion 432a invisible, and at least a portion of the second annular portion 432b is disposed within the housing 412. In yet another embodiment, and as Figure 6BAs shown, when the protective member 432 is in the retracted position, the second annular portion 432b can be flush with the distal end 412f of the housing 412. In this configuration, the first annular portion 432a is completely disposed within the housing 412, such that no part of the first annular portion 432a is visible, and the second annular portion 432b is disposed 0 mm from the distal end 412f of the housing 412, while no part of the second annular portion 432b is disposed inside the housing 412 (i.e., in contact with the distal end 412f of the housing 412).

[0088] As described above, the first annular portion 432a of the protective member 432 may be at least partially defined by an annular sidewall, and at least a portion of the annular sidewall of the first annular portion 432a may be configured to slide within the housing 412 between an extended position and a retracted position. The second annular portion 432b may be defined by an annular sidewall 451, a bottom wall 452 configured to contact the user's skin during operation of the drug delivery device 400, and a top wall 450 opposite the bottom wall 452. In some embodiments, such as Figures 6A to 6C As shown, the top wall 450 of the second annular portion 432b may include a first curved surface (e.g., a wavy surface), and the distal end 412f of the housing 412 may also include a second curved surface complementary to the first curved surface. Accordingly, when the protective member 432 moves from the extended position to the retracted position, the first curved surface of the top wall 450 of the second annular portion 432b may match the second curved surface of the distal end 412f of the housing 412 (e.g., a wavy surface). Figure 6B As shown in the figure, the first curved surface of the top wall 450 can be flush with the second curved surface of the distal end 412f of the housing 412.

[0089] The complementary curved surfaces of the top wall 450 of the second annular portion 432b of the protective member 432 and the distal end 412f of the housing 412 can provide the user with the following visual indications or feedback regarding when the user should: (a) cease applying force to the protective member 432 and press the bottom wall 452 against the injection site, and (b) maintain the applied force on the protective member 432 to ensure that the insertion end 428 of the delivery member 416 is correctly and adequately inserted into the injection site throughout the injection duration. Specifically, the user can be instructed to apply force to the protective member 432 by pressing the bottom wall 452 of the second annular portion 432b against the user's skin until any part of the first annular portion 432a of the protective member 432 is no longer visible. This, in turn, ensures that the user administers the appropriate dosage.

[0090] Additionally or alternatively, the drug delivery device 400 may be configured to provide tactile and / or auditory feedback to the user: informing the user when they should (a) stop applying force to the protective member 432 and press the bottom wall 452 against the injection site, and (b) maintain the input force applied to the protective member 432 to ensure that the insertion end 428 of the delivery member 416 is properly and adequately inserted into the injection site throughout the injection duration.

[0091] Now go to Figures 7A to 7C Another drug delivery device 500 according to different embodiments of the present disclosure is provided. The drug delivery device 500 includes a housing or casing 512. The casing 512 may have a generally elongated shape (e.g., a cylindrical shape) and extend along a longitudinal axis A between a proximal end 512e and a distal end 512f. In some configurations, an opening 514 may be formed on the distal end 512f to allow an insertion end 528 of a delivery member 516 to extend to the outside of the casing 512. A transparent or translucent inspection window 517 may be positioned on the wall of the casing 512 to allow a user to observe components inside the drug delivery device 500 (such as a drug storage container similar to drug storage container 120). Although not shown, a removable cover (such as removable cover 19) may cover the opening 514 before use of the drug delivery device 500. The drug delivery device 500 may also include a rear end cover 523 at the proximal end 512e of the drug delivery device 500.

[0092] The drug delivery device 500 may further include a protective mechanism to prevent contact with the insertion end 528 of the delivery member 516 when the drug delivery device 500 is not used for injection. The protective mechanism may include a protective member 532 movably disposed at or near the distal end 512f of the housing 512, adjacent to the opening 540. Figure 7A As shown in the diagram). As described in more detail below, the protective member 532 can be in an extended position relative to the housing 512 (as shown in the diagram). Figure 7A ) and retraction position ( Figure 7B The protective member 532 moves between the extended positions. Figure 7A When the delivery member 516 is in the retracted position, the insertion end 528 can be surrounded by the protective member 532, making the insertion end 528 invisible to the user. Figure 7B When the insertion end 528 is exposed, it can be at least partially exposed, making the insertion end visible to the user and allowing the insertion end to pierce the user's skin at the injection site.

[0093] The protective member 532 may be hollow and generally tubular. The protective member 532 may include a first annular portion 532a and a second annular portion 532b disposed at the distal end of the first annular portion 532a. The first annular portion 532a may be hollow and generally tubular, and may be a cylindrical portion centered on a longitudinal axis A. The second annular portion 532b may be disposed at the distal end of the first annular portion 532a, and may also be a generally cylindrical portion centered on the longitudinal axis A. In some embodiments, the second annular portion 532b may be coupled to the first annular portion 532a. For example, the second annular portion 532b may be glued to the first annular portion 532a, or coupled to the first annular portion 532a by a snap-fit ​​configuration or by other known mechanisms for coupling the second annular portion 532b to the first annular portion 532a. In other embodiments, the first annular portion 532a and the second annular portion 532b may be integrally formed and may define a single integral structure.

[0094] like Figure 7A As shown, the outer diameter of the second annular portion 532b can be larger than the outer diameter of the first annular portion 532b. In some embodiments, the outer diameter of the second annular portion 532b can be smaller than the outer diameter of the housing 512 near the distal end 512f, such that when the protective member 532 is in the retracted position, at least a portion of the second annular portion 532b can slide through the opening on the distal end 512f and slide within the housing 512. In other embodiments, the outer diameter of the second annular portion 532b can be substantially equal to or at least similar to the outer diameter of the distal end 512f of the housing 512. In this configuration, when the protective member 532 is in the retracted position, the outer diameter of the second annular portion 532b can match the outer diameter of at least the distal end 512f of the housing 512, such that the second annular portion 532b is flush with the distal end 512f of the housing 512. The outer diameter of the first annular portion 532a may be smaller than the outer diameter of the second annular portion 532b and at least the outer diameter of the distal end 512f of the housing 512, such that the first annular portion 532a can slide into and out of the housing 512 between the extended and retracted positions through an opening (e.g., opening 540) at the distal end 512f of the housing 512.

[0095] The protective member 532 can be configured to move relative to the housing 512 between an extended position and a retracted position. In the extended position, at least a portion of the first annular portion 532a extends through the opening 540 in the housing 512; in the retracted position, a shorter length or no portion of the first annular portion 532a extends through the opening 540 in the housing 512. In other words, in the extended position, the length X of the first annular portion 532a is... Figure 7AAs shown, it can extend through the opening 540 of the housing 512, and in the retracted position, the length Y of the first annular portion 532a is... Figure 7B (As shown) can extend through opening 540, where X is a value greater than Y. Length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. Length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value.

[0096] When the protective component 532 is in the extended position ( Figure 7A When the protective member 532 is in the retracted position, the second annular portion 532b can be positioned at a first distance from the distal end 512f of the housing 512, such that the first annular portion 532a and the second annular portion 532b can cover the insertion end 528 of the delivery member 516. The first distance can be equal to the length X of the first annular portion 532a extending through the opening 540 of the housing 512. When the protective member 532 is in the retracted position, the first annular portion 532a can move in the proximal direction, and at least a portion of the first annular portion 532a can slide into the distal end 512f of the housing 512, and the second annular portion 532b can also move in the proximal direction toward the proximal end 512e of the housing 512. Accordingly, when the protective member 532 is in the retracted position ( Figure 7B When the protective member 532 is in place, the second annular portion 532b can be positioned at a second distance (less than the first distance) from the distal end 512f of the housing 512, thereby at least partially exposing the insertion end 528 of the delivery member 516. The second distance can be equal to the length Y of the first annular portion 532a extending through the opening 540 of the housing 512.

[0097] In some embodiments, when the protective member 532 is in the retracted position, at least a portion of the second annular portion 532b can slide through the opening 540 into the distal end 512f of the housing 512, making any part of the first annular portion 532a invisible. In this case, when the protective member 532 is in the retracted position, the first annular portion 532a is completely disposed within the housing 512, making any part of the first annular portion 532a invisible, and at least a portion of the second annular portion 532b is disposed within the housing 512. In another embodiment, when the protective member 532 is in the retracted position, the second annular portion 532b can be flush with the distal end 512f of the housing 512. In this configuration, the first annular portion 532a is completely disposed within the housing 512 such that no part of the first annular portion 532a is visible, and the second annular portion 532b is disposed 0 mm from the distal end 512f of the housing 512, and no part of the second annular portion 532b is disposed inside the housing 512 (i.e., in contact with the distal end 512f of the housing 512).

[0098] As described above, the first annular portion 532a of the protective member 532 may be at least partially defined by an annular sidewall, and at least a portion of the annular sidewall of the first annular portion 532a may be configured to slide between an extended position and a retracted position within the housing 512. The second annular portion 532b may be defined by an annular sidewall 551, a bottom wall 552 configured to contact the user's skin during operation of the drug delivery device 500, and a top wall 550 opposite the bottom wall 552. In some embodiments, such as Figures 7A to 7C As shown, the top wall 550 of the second annular portion 532b may include a first ramp surface or an inclined surface, and the distal end 512f of the housing 512 may also include a second ramp surface complementary to the first ramp surface. Accordingly, when the protective member 532 moves from the extended position to the retracted position, the first ramp surface of the top wall 550 of the second annular portion 532b can match the second ramp surface of the distal end 512f of the housing 512, such that the first ramp surface of the top wall 550 can be flush with the second ramp surface of the distal end 512f of the housing 512.

[0099] The complementary ramp surfaces of the top wall 550 of the second annular portion 532b of the protective member 532 and the distal end 512f of the housing 512 can provide the user with the following visual indications or feedback regarding when the user should: (a) cease applying force to the protective member 532 and press the bottom wall 552 against the injection site, and (b) maintain the applied force on the protective member 532 to ensure that the insertion end 528 of the delivery member 516 is correctly and adequately inserted into the injection site throughout the injection duration. Specifically, the user can be instructed to apply force to the protective member 532 by pressing the bottom wall 552 of the second annular portion 532b against the user's skin until any part of the first annular portion 532a of the protective member 532 is no longer visible. This, in turn, ensures that the user administers the appropriate dosage.

[0100] Additionally or alternatively, the drug delivery device 500 may be configured to provide tactile and / or auditory feedback to the user: informing the user when they should (a) stop applying force to the protective member 532 and press the bottom wall 552 against the injection site, and (b) maintain the input force applied to the protective member 532 to ensure that the insertion end 528 of the delivery member 516 is properly and adequately inserted into the injection site throughout the injection duration.

[0101] As can be seen from the foregoing, this disclosure advantageously provides an improved design for a drug delivery device having a needle shield or guard that provides visual feedback to the user, instructing the user when to maintain pressure applied to the needle shield at the injection site to ensure correct dosage administration, and provides other benefits and advantages. All features disclosed herein with respect to any needle shield embodiment can be combined in any combination, except for combinations in which at least some of the features are mutually exclusive.

[0102] As will be appreciated, the apparatus and methods according to this disclosure may have one or more advantages over conventional techniques, and any one or more of these advantages may be present in specific embodiments based on the features of this disclosure contained in this embodiment. Other advantages not specifically listed herein may also be appreciated.

[0103] The above description describes various devices, components, parts, subsystems, and methods of use related to drug delivery devices. Devices, components, parts, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to those drugs identified below and their class and biosimilar counterparts. As used herein, the term "drug" may be used interchangeably with other similar terms and may refer to any type of pharmaceutical agent or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and class of substances. Non-therapeutic injectable materials are also covered. Drugs may be in liquid form, lyophilized form, or a form reconstituted from a lyophilized form. The following example list of drugs should not be considered as all-encompassing or restrictive.

[0104] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or prefilled with the medication for treatment. The master container can be a vial, cartridge, or prefilled syringe.

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

[0106] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulant (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin-stimulating proteins include, but are not limited to, Epogen® (epogen α), Aranesp® (dabepoetin α), Dynepo® (epogen δ), Mircera® (methoxy-polyethylene glycol-epogen β), Hematide®, MRK-2578, INS-22, Retacrit® (epogen ζ), Neorecormon® (epogen β), Silapo® (epogen ζ), Binocrit® (epogen α), epogen α Hexal, Abseamed® (epogen α), Ratioepo® (epogen θ), Eporatio® (epogen θ), Biopoin® (epogen θ), epogen α, epogen β, epogen ι, epogen Ω, epogen δ, epogen ζ, epogen θ and epogen δ, pegylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogues.

[0107] Among the specific display proteins are the specific proteins described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (also referred to as RANKL-specific antibodies, peptides, etc.), including fully humanized and human OPGL-specific antibodies, especially fully humanized monoclonal antibodies; myostatin-binding proteins, peptides, related proteins, etc., including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, related proteins, etc., especially those that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; interleukin-1 receptor 1 (“IL1-R1”)-specific antibodies, peptides, related proteins, etc.; Ang2-specific antibodies, peptides, related proteins, etc.; NGF-specific antibodies, peptides, related proteins, etc.; CD22-specific antibodies, peptides, related proteins, etc., especially human CD22-specific antibodies, such as, but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, especially including but not limited to, human CD22-specific IgG antibodies, such as those with human-mouse monoclonal hLL2. Dimers of human-mouse monoclonal hLL2 γ-chain disulfides linked by the κ chain, such as the fully humanized human CD22-specific antibody in epazolizumab (CAS registry number 501423-23-0); IGF-1 receptor-specific antibodies, peptides, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptides, and related proteins (“B7RP-1”, also known as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies binding to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those inhibiting the interaction of B7RP-1 with its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptides, and related proteins, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for example, 145c7; IFN γ-specific antibodies, peptides, and related proteins, including but not limited to human IFN γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptides, and related proteins, and other TALL-specific binding proteins; parathyroid hormone (“PTH”) specific antibodies, peptides, and related proteins; thrombopoietin receptor (“TPO-R”) specific antibodies, peptides, and related proteins; hepatocyte growth factor (“HGF”) specific antibodies, peptides, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptides, and related proteins; activin A specific antibodies, peptides, and proteins; TGF-β specific antibodies, peptides, and related proteins; amyloid-β protein specific antibodies, peptides, and related proteins; c-Kit specific antibodies, peptides, and related proteins, including but not limited to proteins binding to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to proteins binding to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin. Cytopoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], dabepoetin α, novel erythropoiesis-stimulating protein (NESP); Epogen® (eberphytin α, or erythropoietin); GLP-1, Avonex® (interferon β-1a); Bexxar® (tosimomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-β); Camppath® (alemumab, anti-CD52 monoclonal antibody); Dynepo® (eberphytin δ); Velcade® (bortezomib); MLN0002 (anti-α4β7) mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (ebertin α); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (growth hormone, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns), anti-HER2 monoclonal antibody, biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (growth hormone, human growth hormone) Humira® (adalimumab); Vectibix® (panitumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistine), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)).Kineret® (analyzedin); Leukine® (saxaglastine, rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlySmAb); Metalyse® (tenepazolizumab, t-PA analog); Mircera® (methoxy-polyethylene glycol-epazolidin beta); Mylotarg® (gem-tuzumab-ozomicin); Raptiva® (efalizumab); Cimzia® (cetuzumab, CDP 870); Soliris™ (eculizumab); Pexazumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibuzumab); Panorex® (17-1A, ezolomide); Trabio® (lerdelimumab); TheraCim hR3 (Nimotuzumab); Omnitarg (Pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (Vencizumab); Cantuzumab Mertansine (huC242-DM1); NeoRecormon® (Ibertin β); Neumega® (Interleukin-11); Orthoclone OKT3® (Moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (Ibertin α); Remicade® (Infliximab, anti-TNFα monoclonal antibody); Reopro® (Abciximab, anti-GP IIb / Ilia receptor monoclonal antibody); Actemra® (Anti-IL6 receptor mAb); Avastin® (Bevacizumab); HuMax-CD4 (Zanolimuab); Mvasi; TM(Bevacizumab - awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon α-2a); Simulect® (baliximab); Prexige® (romexicob); Synagis® (palizumab); 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507); Tysabri® (natelizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domain of the Fc portion of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory proteins)); VEGF trap (with IgG1) Fc fusion of VEGFR1 Ig domain); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2Rα mAb); Zevalin® (teimomab); Zetia® (ezetimibe); Orencia® (asceticipeptide, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipramab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1 and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb;Anti-CTGF fibrinogen for stage I idiopathic pulmonary fibrosis (FG-3019); Anti-CTLA4 mAb; Anti-eosinophil chemokine 1 mAb (CAT-213); Anti-FGF8 mAb; Anti-ganglioside GD2 mAb; Anti-ganglioside GM2 mAb; Anti-GDF-8 human mAb (MYO-029); Anti-GM-CSF receptor mAb (CAM-3001); Anti-HepC mAb (HuMax HepC); Anti-IFNα mAb (MEDI-545, MDX-198); Anti-IGF1R mAb; Anti-IGF-1R mAb (HuMax-Inflam); Anti-IL12 mAb (ABT-874); Anti-IL12 / IL23 mAb (CNTO 1275); Anti-IL13 mAb (CAT-354); Anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0108] In some embodiments, the drug delivery device may comprise or be used with sclerosing protein antibodies for the treatment of postmenopausal osteoporosis and / or fracture healing, such as, but not limited to, lomoxozimab, butozimab, or BPS 804 (Novartis), Evenity™ (lomoxozimab-aqqg), another product containing lomoxozimab, and in other embodiments, a monoclonal antibody (IgG) binding to the human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (aliculumab). In other embodiments, the drug delivery device may comprise or be used with any of the following: rituximab, bisalometabolum, trebananib, ganitamumab, kanamumab, motesanib diphosphate, brodamarab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, or the device may be used with such other oncolytic HSV, including but not limited to OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may comprise or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may comprise or be used with Aimovig® (erenumab-aooe) for the treatment of migraines, anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, errinumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets can also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agent (BiTE®) antibodies (such as, but not limited to, BLINCYTO®) can be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or an analogue thereof.In some embodiments, a therapeutically effective amount of anti-thymocyte stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may include Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), an anti-TNF α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab, or used therewith. In some embodiments, the drug delivery device may contain Kyprolis® (carfilzomib) for the treatment of multiple myeloma, (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylethyleneoxy-2-yl)-1-oxopentane-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamyl)-4-phenylbutamido)-4-methylpentanamide, or another product containing carfilzomib, or used therewith. In some embodiments, the drug delivery device may comprise or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory conditions. In some embodiments, the drug delivery device may comprise Parsabiv for the treatment of, for example, secondary hyperparathyroidism (sHPT) in dialysis patients with chronic kidney disease (KD). TM(Vicocineptide HCl, KAI-4169) or another product containing vecocineptide HCl or used therewith. In some embodiments, the drug delivery device may contain ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody or used therewith. In some embodiments, the drug delivery device may contain a VEGF antagonist (e.g., a non-antibody VEGF antagonist) and / or a VEGF-Trap (e.g., aflibercept (a fusion of the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 with the Fc domain of IgG1)) or used therewith. In some embodiments, the drug delivery device may contain ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5 or used therewith. In some embodiments, the drug delivery device may comprise or be used with Lobivup α (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activities of ICOSL and BAFF. In some embodiments, the drug delivery device may comprise or be used with omeprazole (a small molecule selective cardiac myosin activator), or myotrope which directly targets the cardiac contractile mechanism, or another product comprising or being used with a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may comprise sotoraraciab (formerly AMG 510), KRAS G12C Small molecule inhibitors, or those containing KRAS G12CAnother product containing or used with a small molecule inhibitor. In some embodiments, the drug delivery device may comprise or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing or used with a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may comprise or be used with rocatamumab (AMG-451), which is a human anti-OX40 monoclonal antibody that expresses and blocks OX40 on activated T cells to inhibit and / or reduce the number of OX40-pathogenic T cells responsible for driving systemic and local atopic dermatitis inflammatory responses. In some embodiments, the drug delivery device may comprise or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing or used with a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may comprise or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a) (also known as Lp(a)), or another product that comprises or is used with a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may comprise or be used with ABP 654 (human IgG1κ antibody), a biosimilar candidate of Stelara®, or another product that comprises or is used with a human IgG1κ antibody and / or binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise Amjevita. TM Or Amgevita TM(Previously ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing or used with a 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 a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) 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 inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may comprise or be used with AMG 171, or another product comprising a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may comprise or be used with AMG 176, or another product comprising a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise or be used with AMG 199, or another product comprising a bispecific T-cell conjugate with extended half-life (HLE) (BiTE®). In some embodiments, the drug delivery device may comprise or be used with AMG 256, or another product (comprising an anti-PD-1 x IL21 mutant protein and / or an IL-21 receptor agonist) designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may comprise or be used with AMG 330, or another product comprising an anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing or being used with an extended-life (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell binder) construct.In some embodiments, the drug delivery device may comprise or be used with AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with AMG 506, which is being investigated for the treatment of solid tumors, or another product comprising a multispecific FAP x 4-1BB-targeting DARPin® biologic. In some embodiments, the drug delivery device may comprise or be used with AMG 509 or another product comprising a bivalent T-cell conjugate and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may comprise or be used with AMG 562 or another product comprising a half-life-extended (HLE) CD19 x CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with Efavaleukin α (formerly AMG592) or another product comprising an IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may comprise or be used with AMG 596 or another product comprising or using with a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell conjugate) molecule. In some embodiments, the drug delivery device may comprise or be used with AMG 673 or another product comprising or using with a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG701 or another product comprising or using with a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG757 or another product comprising or using with a half-life extended (HLE) anti-δ-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may be used with AMG 910 or another product containing an extended half-life (HLE) claudin 18.2 x CD3 BiTE® (bispecific T-cell binding agent) construct.

[0109] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. The detailed descriptions are to be interpreted as exemplary only and do not describe every possible embodiment of this disclosure. Numerous alternative embodiments may be implemented using current technology or technology developed after the date of this patent application, and these embodiments will still fall within the scope of the claims defining the invention(s) disclosed herein.

[0110] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the embodiments described above without departing from the spirit and scope of the invention(s) disclosed herein, and such modifications, alterations, and combinations will be considered to be within the scope of the inventive concept(s).

Claims

1. A drug delivery device, comprising: A housing that defines a longitudinal axis and has an opening; A drug storage container, the drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; A plunger that can move toward the distal end of the drug storage container to expel the drug from the drug storage container through the delivery member; as well as A protective member is disposed adjacent to an opening in the housing and is movable relative to the housing between an extended position and a retracted position, wherein, in the extended position, the insertion end of the delivery member is surrounded by the protective member, and in the retracted position, the insertion end is at least partially exposed. The protective component includes a first annular portion and a second annular portion disposed at the distal end of the first annular portion. The outer diameter of the second annular portion is larger than the outer diameter of the first annular portion. When the protective member is in the extended position, the second annular portion is positioned at a first distance from the far end of the housing, and when the protective member is in the retracted position, the second annular portion is positioned at a second distance from the far end of the housing, the second distance being less than the first distance.

2. The drug delivery device as claimed in claim 1, wherein, The second annular portion is defined by an annular sidewall, a bottom wall configured to contact the user's skin, and a top wall opposite the bottom wall.

3. The drug delivery device as claimed in claim 2, wherein, The top wall includes a first sloping surface, and the distal end of the housing includes a second sloping surface that is complementary to the first sloping surface.

4. The drug delivery device as claimed in claim 2, wherein, The top wall includes a first stepped surface, and the distal end of the housing includes a second stepped surface that is complementary to the first stepped surface.

5. The drug delivery device as claimed in claim 2, wherein, The top wall includes a first curved surface, and the distal end of the housing includes a second curved surface that is complementary to the first curved surface.

6. The drug delivery device as claimed in claim 2, wherein, At least a portion of the annular sidewall of the first annular portion is configured to slide into the housing when the protective member is in the retracted position.

7. The drug delivery device as claimed in claim 1, wherein, The outer diameter of the second annular portion is substantially the same as the outer diameter of the housing.

8. The drug delivery device as claimed in claim 1, wherein, The outer diameter of the second annular portion is smaller than the outer diameter of the shell.

9. The drug delivery device as claimed in claim 1, wherein, The first annular portion of the protective member is at least partially defined by an annular sidewall, wherein the annular sidewall of the first annular portion is configured to slide within the housing between the extended position and the retracted position.

10. The drug delivery device as claimed in claim 1, wherein, The second annular portion is connected to the first annular portion.

11. The drug delivery device as claimed in claim 1, wherein, The first annular portion and the second annular portion are defined by a single integral structure.

12. The drug delivery device of claim 1, further comprising a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide.

13. The drug delivery device of claim 12, further comprising: A release member, operably coupled to the plunger and configured to selectively rotate relative to the housing, wherein each of the plunger and the plunger guide is at least partially disposed within the release member; and The protective element is operatively connected to the release member.

14. The drug delivery device of claim 13, wherein, When the protective member is in the extended position, the release member is prevented from rotating in at least one rotational direction, and wherein when the protective member is in the retracted position, the release member is allowed to rotate in the at least one rotational direction.

15. The drug delivery device of claim 14, wherein, Moving the protective member from the extended position to the retracted position allows the release member and the plunger to rotate together from the first rotational position toward the second rotational position under the biasing force applied by the biasing member.

16. The drug delivery device of claim 1, further comprising a locking ring configured to rotate between a first rotational position and a second rotational position, wherein, The rotational position of the locking ring is based on the axial position of the protective component.

17. The drug delivery device of claim 16, wherein, The distal end of the locking ring is at least partially located within the protective element.

18. The drug delivery device of claim 16, further comprising a locking ring biasing member positioned between the locking ring and the bottom wall of the second annular portion of the protective member.

19. The drug delivery device of claim 18, wherein, The locking ring biasing member is positioned within the first annular portion of the protective element.

20. The drug delivery device of claim 16, wherein, The locking ring biasing member is a compression spring configured to apply a biasing force to the guard to push the guard toward the extended position.

21. A method for delivering a drug, comprising: A drug delivery device is provided, comprising: a housing; a drug storage container having a delivery member with an insertion end; a plunger movable toward a distal end of the drug storage container to discharge drug from the drug storage container through the delivery member; and a protective member movable relative to the housing between an extended position and a retracted position, wherein the protective member includes a first annular portion and a second annular portion disposed at a distal end of the first annular portion, the second annular portion having an outer diameter larger than the outer diameter of the first annular portion; The drug delivery device is positioned such that the second annular portion of the protective member abuts against the injection site; and A force is applied to the housing toward the injection site to allow the protective member to move from the extended position to the retracted position. When the protective member is in the extended position, the second annular portion is positioned at a first distance from the far end of the housing, and when the protective member is in the retracted position, the second annular portion is positioned at a second distance from the far end of the housing, the second distance being less than the first distance.

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