Drug delivery device

Abstract

To provide a device for automatically injecting a drug into a patient.SOLUTION: A drug delivery device may include a housing defining a longitudinal axis and having an opening and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The device may also include plunger moveable toward the distal end of the drug storage container to expel a drug from the drug storage container through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness. The device may further include a plunger biasing member disposed at least partially within the axial chamber, the plunger biasing member configured to urge the plunger toward the distal end of the drug storage container.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 908,504, entitled "Drug Delivery Device," filed September 30, 2019, and U.S. Provisional Patent Application No. 62 / 961,031, entitled "Drug Delivery Device," filed January 14, 2020, each of which is incorporated herein by reference.

[0002] The present disclosure relates to drug delivery devices, and more particularly to devices for automatically injecting drugs into patients. [Background technology]

[0003] The general aversion to exposed needles and health and safety concerns have led to the development of drug delivery devices that conceal the needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer various advantages over traditional forms of drug delivery, including, for example, delivery by a traditional syringe.

[0004] Many injector systems use a coil spring structure to provide actuation energy for functions such as needle insertion and / or fluid delivery. While the use of springs can offer advantages of simplicity and low cost, it can have certain limitations. For example, there is a linear relationship between force and spring actuator displacement. When initiating drug delivery, an excessive amount of energy may be input into the system to provide enough energy for drug delivery at the end of the plunger stroke. As another example, when more viscous drugs are delivered by an autoinjector, increased spring force may be required. A spring with a higher spring constant may impart more force to the drug product and primary container. Various physical properties of the spring, such as the spring wire diameter, spring center diameter, number of spring turns, and spring material, can affect the spring constant and, therefore, the spring force. Therefore, it may be desirable and / or advantageous to include device components that allow for flexible spring design and / or facilitate the use of springs with different physical properties than the remaining device components.

[0005] The present disclosure describes a drug delivery device that embodies an advantageous alternative to existing drug delivery devices and that can address one or more of the problems or needs set forth herein. Summary of the Invention [Means for solving the problem]

[0006] One aspect of the present disclosure provides a drug delivery device including a housing defining a longitudinal axis and having an opening, and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening in a delivery state. The device may further include a plunger movable toward a distal end of the drug storage container to expel the drug from the drug storage container through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness. The device may also include a plunger biasing member disposed at least partially within the axial chamber and configured to urge the plunger toward the distal end of the drug storage container.

[0007] The plunger body portion may have a hollow tubular shape. The plunger body portion may be metallic or non-metallic.

[0008] The plunger may be configured to selectively rotate from an initial rotational position to a second rotational position under a biasing force exerted by a plunger biasing member, and to translate linearly toward the distal end of the drug storage container after rotating from the initial rotational position to the second rotational position under a biasing force exerted by the plunger biasing member.

[0009] The device may further include a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide. One of the plunger and the plunger guide may include a cam, and the other of the plunger and the plunger guide may include a cam follower.

[0010] The plunger may include a cam follower, the plunger guide may include a cam, and the cam follower may be formed by at least one flange extending radially outward from the plunger.

[0011] The plunger body thickness may be less than 0.6 millimeters, less than 0.4 millimeters, less than 0.3 millimeters, less than 0.2 millimeters, less than 0.1 millimeters, or less than 0.05 millimeters.

[0012] Another aspect of the present disclosure provides a drug delivery device including a housing defining a longitudinal axis and having an opening, and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening in a delivery state. The device may further include a plunger movable toward a distal end of the drug storage container to expel the drug from the drug storage container through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness of less than 0.6 millimeters. The device may also include a plunger biasing member coupled to the plunger and configured to urge the plunger toward the distal end of the drug storage container.

[0013] The present disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily indicate the presence or absence of the particular element in any of the illustrative embodiments, unless expressly described in the corresponding written specification. Additionally, none of the drawings are necessarily drawn to scale. [Brief explanation of the drawings]

[0014] [Figure 1A] 1A-1D are perspective views of an exemplary drug delivery device according to various embodiments. [Figure 1B] FIG. 1B is a perspective view of the drug delivery device of FIG. 1A with the cap removed. [Figure 1C] FIG. 1B is a perspective view of the drug delivery device of FIG. 1A in a pre-injection configuration. [Figure 1D] FIG. 1B is a perspective view of the drug delivery device of FIG. 1A in an injection configuration. [Figure 2] FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1. [Figure 3A] FIG. 3 is an exploded view of a portion of the drug delivery device of FIG. 2, namely the drive mechanism. [Figure 3B] FIG. 3 is an exploded view of the drug delivery device of FIG. 2. [Figure 4A] 1 is a perspective view of an exemplary drug reservoir for use with a drug delivery device according to various embodiments. [Figure 4B] 1 is a perspective view of an exemplary container holder for use with a drug delivery device according to various embodiments, the container holder being in an open position. [Figure 4C] 4B coupled with the medication storage container of FIG. 4A, with the container holder in a closed position. [Figure 4D] 1 is a perspective view of an exemplary container holder for use with a drug delivery device according to various embodiments, the container holder being in a closed position. [Figure 4E] 1 is a perspective view of an exemplary housing for use with a drug delivery device according to various embodiments. [Figure 4F] 4F is a partial cross-sectional view of the container holder and medication reservoir taken along line 4F-4F of FIG. 4C. [Figure 5A] 5A is a partial cross-sectional view of the vial holder, the drug reservoir, and a distal portion of an exemplary plunger guide coupled with the vial holder and the drug reservoir, taken along line 5A-5A of FIG. 4C. [Figure 5B] 1 is a perspective view of an exemplary plunger guide according to various embodiments. [Figure 5C] FIG. 5C is a perspective partial cross-sectional view of the plunger guide of FIG. 5B. [Figure 6A] 1 is a perspective view of an exemplary guard member according to various embodiments. [Figure 6B] 1 is a perspective view of an exemplary guard extension according to various embodiments. [Figure 6C] FIG. 10 is a perspective partial cross-sectional view of the guard extension, releaser, and plunger guide with the components in a pre-injection position. [Figure 7A] 1 is a perspective view of an exemplary releaser member according to various embodiments; FIG. [Figure 7B] FIG. 7B is another perspective view of the releaser member of FIG. 7A. [Figure 8] 7A and 7B are perspective views of the plunger guide of FIG. 5B, the releaser member of FIG. 7A, and the plunger 26 shown in FIG. 2, with the guide member shown in semi-transparent form for purposes of illustration. [Figure 9A] FIG. 1 is a perspective view of an exemplary plunger guide, an exemplary releaser member, and an exemplary plunger, with a portion of the guide member shown in cutaway form for illustrative purposes, and with the drug delivery device in a pre-injection position. [Figure 9B] FIG. 9B is a perspective view of the component of FIG. 9A with the plunger in a released position prior to axial movement by the plunger. [Figure 9C] 9B is a perspective view of the component of FIG. 9A after the plunger has begun axial movement and is in a released position. [Figure 10A] FIG. 9B is a top view of the components of FIG. 9A, with the drug delivery device in a pre-injection position. [Figure 10B] FIG. 9C is a top view of the component of FIG. 9B with the plunger in a released position prior to axial movement by the plunger. [Figure 10C] FIG. 9D is a top view of the component of FIG. 9C with the plunger in a released position after the plunger has begun axial movement. [Figure 11A] FIG. 9B is a perspective view of the components of FIG. 9A and additional components, such as an exemplary guard extension, with the drug delivery device in a pre-injection position. [Figure 11B] FIG. 11B is a perspective view of the components of FIG. 11A with the guard extension moved proximally but the plunger not released. [Figure 11C] FIG. 11B is a perspective view of the components of FIG. 11A with the guard extension moved further proximally and the plunger released but not yet moved axially. [Figure 12A]9B is a perspective view of the components of FIG. 9A and an exemplary guard bias member with the plunger in a released position after axial movement by the plunger has begun, with some of the components shown in cutaway form for illustrative purposes. FIG. [Figure 12B] FIG. 12B is a perspective view of the components of FIG. 12A and a more distal view of the device with the guard extension member and guard bias member removed for illustrative purposes, and with the plunger at or near the end-of-dose position but the releaser member not yet in the end-of-dose position. [Figure 12C] FIG. 12B is a perspective view of the components of FIG. 12A with the releaser member in an end-of-dose position. [Figure 13] 1A-1C are perspective views of an exemplary locking ring according to various embodiments. [Figure 14] 1A-1C are perspective views of a distal portion of an exemplary device according to various embodiments, with the guard member in a pre-injection, pre-deflected state and with a portion of the housing shown in cut-away form for illustrative purposes. [Figure 15A] 15 is a perspective view of the distal portion of the device shown in FIG. 14, with the guard member in an initial deflection stage. [Figure 15B] 15B is a perspective view of the same device and the same stage as FIG. 15A, taken at approximately 90 degrees from that shown in FIG. 15A. [Figure 16A] 15B is a perspective view of the distal portion of the device shown in FIG. 14 with the guard member deflected further distally from the stage shown in FIG. 15A. [Figure 16B] 16B is a perspective view of the same device and the same stage as FIG. 16A, taken at approximately 90 degrees from that shown in FIG. 16A. [Figure 17] 15 is a perspective view of the distal portion of the device shown in FIG. 14 with the guard member in a fully deflected or nearly fully deflected position relative to the housing, such as during an injection phase. [Figure 18A] FIG. 15 is a perspective view of the distal portion of the device shown in FIG. 14 with the guard member in a fully retracted and locked position relative to the housing and the device in a post-injection stage. [Figure 18B]FIG. 15 is a perspective view of the distal portion of the device shown in FIG. 14 with the guard member in a nearly fully retracted and locked position relative to the housing and the device in a post-injection stage. [Figure 19A] 1 is a graph showing an exemplary force profile during an injection process of an exemplary drug delivery device, with the relative displacement between the device housing and the guard member plotted along the x-axis (millimeters) and resistance plotted along the y-axis (Newtons). [Figure 19B] 19B is another exemplary force profile during an injection process of an exemplary drug delivery device, similar to that of FIG. 19A. [Figure 20A] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20B] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20C] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20D] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20E] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20F] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 20G] 1 illustrates another exemplary drug delivery device according to various embodiments. [Figure 21A] 1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 21B] 1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 21C] 1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 21D] 1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 21E] 1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 21F]1 illustrates yet another exemplary drug delivery device according to various embodiments. [Figure 22] 20A to 20G and 21A to 21F show the guard members shown in FIG. [Figure 23] 20A to 20G show the lock ring shown in FIG. [Figure 24] Two of the force profiles are shown in Figures 19A and 19B, respectively, showing the force profiles of various devices, one force profile (shown as a dashed line) attributable to device 400 shown in Figures 20A-20G, and another force profile (shown as a dotted line) attributable to device 500 shown in Figures 21A-21F. [Figure 25] 1 illustrates a perspective view of an exemplary housing according to various embodiments. [Figure 26A] 26A and 26B show different perspective views of a locking ring of a drug delivery device, FIG. 26C shows a perspective view of a guard member of the drug delivery device, and FIG. 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device according to various embodiments. [Figure 26B] 26A and 26B show different perspective views of a locking ring of a drug delivery device, FIG. 26C shows a perspective view of a guard member of the drug delivery device, and FIG. 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device according to various embodiments. [Figure 26C] 26A and 26B show different perspective views of a locking ring of a drug delivery device, FIG. 26C shows a perspective view of a guard member of the drug delivery device, and FIG. 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device according to various embodiments. [Figure 26D] 26A and 26B show different perspective views of a locking ring of a drug delivery device, FIG. 26C shows a perspective view of a guard member of the drug delivery device, and FIG. 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0015] The present disclosure generally relates to drug delivery devices operable for a user to administer a drug, or for a patient to self-administer a drug if the user is a patient. Various features are disclosed to simplify, simplify, automate, and / or facilitate certain aspects of drug delivery, such as those used in autoinjectors, on-body injectors, or other automatic or partially automatic drug delivery devices (collectively, autoinjectors or auto-injectors). For example, these features include automatically covering the needle to a pre-delivery and / or post-delivery state, automatically inserting the needle and / or cannula into the user, automatically activating a drive mechanism, and automatically indicating to the user that drug delivery is complete, among other features. While known drug delivery devices incorporate separate or independently operable mechanisms to achieve each of their automated features, the present disclosure includes eliminating and / or combining at least some of these features and / or providing device components that allow for flexible device design. For example, the device may include components that enable a flexible spring design and / or facilitate the use of springs with different physical properties than the remaining device components. As another example, the device may include components that reduce part count, part complexity, total device weight, and / or overall device complexity. For example, the present disclosure may include a plunger movable toward a distal end of a drug reservoir to expel a drug from the drug reservoir through a delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness. The present disclosure may also include a plunger biasing member disposed at least partially within the axial chamber, the plunger biasing member configured to urge the plunger toward the distal end of the drug reservoir.

[0016] 1-3 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug product. The drug may be, but is not limited to, various biologics such as a peptide, peptibody, or antibody. The drug may be in fluid or liquid form, although the present disclosure is not limited to any particular condition.

[0017] Various implementations and configurations of drug delivery device 10 are possible. This embodiment of drug delivery device 10 is configured as a single-use, disposable injector. In other embodiments, drug delivery device 10 may be configured as a multiple-use, reusable injector. Drug delivery device 10 is operable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). The exemplary drug delivery device shown in the figures can take the form of an auto-injector or pen injector and, therefore, can be held in the user's hand for the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and / or configurations.

[0018] The configuration of various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, although fewer or more states are possible. For example, each state may have several sub-states or phases. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before activation by a user. In some embodiments, the pre-delivery state may exist during the time between 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 moment after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 relative to an injection site. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as dosing, is in progress. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when a stopper is placed in an end-of-dose position in the drug reservoir.

[0019] As shown in FIGS. 1A and 1B, the drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and dimensioned to allow a person to grasp the injector 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylindrical shape, and may extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (FIG. 3B) may be formed at the distal end to allow an insertion end 28 of the delivery member 16 (FIG. 2) to extend outside the housing 12. A transparent or translucent inspection window 17 (FIGS. 1A-1B) may be disposed in a wall of the housing 12 to allow a user to view the internal components of the drug delivery device 10, including the drug reservoir 20. Viewing the drug reservoir 20 through the window 17 can allow a user to confirm that drug delivery is in progress and / or has been completed. A removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10 and, in some embodiments, may include a gripper 13 ( FIG. 2 ) configured to assist in the removal of a sterility barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the sterility barrier 21 and pull the sterility barrier 21 along with the removable cap 19 when a user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 effectively removes the sterility barrier 21 from the delivery member 16.

[0020] As shown in FIG. 2 , the drive mechanism 30 may be partially or entirely disposed within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, upon or in response to activation of the drive mechanism 30 by a user, release or output that energy to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 and into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, although alternative embodiments of the drive mechanism 30 may be configured differently; for example, the drive mechanism 30 may store electrical or chemical potential energy. Generally, upon activation of the drive mechanism 30, the drive mechanism 30 may convert the potential energy into kinetic energy to move the plunger 26. As best shown in FIG. 3A , in one embodiment, drive mechanism 30 includes plunger biasing member 50, hollow rod 46 for supporting plunger biasing member 50, plunger biasing member seat 38, releaser member 52, plunger guide 60, extender biasing member 35, and guard extension 37. Plunger biasing member 50 may include a compression spring (e.g., a compression coil spring) that is initially held in a biased state. In the biased state, plunger biasing member 50 may be compressed such that its axial length is shorter than in its natural or de-energized state. When released, plunger biasing member 50 attempts to expand to its natural axial length, thereby exerting a biasing force that may push plunger 26 distally.

[0021] As best shown in FIGS. 2 and 3B , in one embodiment, device 10 includes housing 12, which may include two separate, interconnected structures: a rear end cap 23 (e.g., a rear cover) at the proximal end of drug delivery device 10; and a tubular housing 25 extending substantially the entire length of drug delivery device 10 and defining opening 14. Additionally or alternatively, housing 12 may include fewer or more components, e.g., a two-piece tubular housing having a front portion and a rear portion. Tubular housing 25 may have a hollow, generally cylindrical or tubular shape, and rear end cap 23 may have a generally hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, rear end cap 23 and tubular housing 25, as well as any components disposed therein, may be combined to define different subassemblies, such as drive mechanism 30 ( FIG. 3A ). In some embodiments, different subassemblies are assembled independently of one another and then combined with one another and with the drug reservoir 20 to form the fully assembled drug delivery device 10. In certain such embodiments, some or all of the aforementioned assembly steps may occur in different manufacturing facilities or environments. In another embodiment, the housing 12 may be assembled in one piece such that the housing 12 is defined by a single monolithic structure that integrates the rear cap and tubular housing into a single component.

[0022] The drug storage container 20 is disposed within the interior space of the housing 12 and is configured to contain a drug 22. The drug storage container 20 may be pre-filled and shipped, for example, by a manufacturer, to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to a patient in more than one use case, such as as a pre-filled syringe or an auto-injector including a pre-filled syringe. By using the same or similar syringe components in both cases, at least some of the above-described processes, such as filling, labeling, packaging, shipping, and distribution, may be streamlined or simplified for the two different use cases. As another example, when some or all of the same syringe components are used in multiple use cases, some regulatory pathways for selling and / or distributing the drug may be streamlined and / or simplified for at least one of the multiple use cases.

[0023] The housing 12 may be preloaded with the drug storage container 20, e.g., by a manufacturer, or alternatively, the drug storage container 20 may be loaded by a user prior to use of the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal bore or reservoir. The wall may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 such that the stopper 24 can move 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 to prevent or inhibit leakage of the drug 22 past the stopper 24 as the stopper 24 is moved. Distal movement of the stopper 24 expels the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug reservoir 20 may be open to allow the plunger 26 to extend into the drug reservoir 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by a gap 18 ( FIG. 2 ). When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap and abut the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally, expelling the drug 22 from the drug reservoir 20. In another embodiment, the stopper 24 and the plunger 26 may initially contact or be coupled to each other, for example, via a threaded connection, so that they move together from the start of the movement of the plunger 26. Once the stopper 24 moves, it may continue to move distally until it contacts a proximally facing portion of the inner surface 15 of the wall of the drug reservoir 20. This position of the stopper 24 may be referred to as the end-of-dose or end-of-delivery position and may correspond to when delivery of the medication 22 to the patient is complete or substantially complete.

[0024] In some embodiments, the volume of drug 22 contained within the reservoir of drug storage container 20 may be equal to 1 mL, or may be equal to about (e.g., ±10%) 1 mL, or may be equal to 2.5 mL, or may be equal to about (e.g., ±10%) 2.5 mL, or may be equal to 3 mL, or may be equal to about (e.g., ±10%) 3 mL, or may be equal to or less than about (e.g., ±10%) 1 mL, or may be equal to or less than about (e.g., ±10%) 2 mL, or may be equal to or less than about (e.g., ±10%) 3 mL. The volume may be about (e.g., ±10%) 4 mL or less, or about (e.g., ±10%) less than 5 mL, or about (e.g., ±10%) 10 mL or less, or about (e.g., ±10%) in the range of 1 to 10 mL, or about (e.g., ±10%) in the range of 1 to 5 mL, or about (e.g., ±10%) in the range of 1 to 4 mL, or about (e.g., ±10%) in the range of 1 to 3 mL, or about (e.g., ±10%) in the range of 1 to 2.5 mL.

[0025] The delivery member 16 is connected or operable to be connected in fluid communication with the reservoir 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 a sharp tip of other pointed geometry that allows the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal passageway. One or more openings may be formed in the insertion end 28 to allow the drug to flow from the delivery member 16 to the patient.

[0026] In one embodiment, the drug storage container 20 may be a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. In this case, the needle may be attached to the wall of the drug storage container 20 and 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 such embodiments, during operation of the drug delivery device 10, the drug storage container 20 may move toward or away from the proximal end of the delivery member 16 such that the proximal end of the delivery member 16 pierces a septum covering the opening of the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0027] 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 attached to the housing 12 such that the drug storage container 20 does not move relative to the housing 12 once placed therein. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 of the housing 12. For example, as shown in FIG. 2 , the delivery member 16 extends beyond the distal end of the housing 12 that defines the opening 14. However, in some configurations, such as the storage configuration shown in FIG. 2 , the delivery member 16 is covered / protected by a sterility barrier 21 and a guard member 32 that surround the delivery member 16 and prevent or reduce the likelihood of an unintentional or premature needle stick.

[0028] The container holder 31 may have a hollow, generally cylindrical or tubular shape centered about a longitudinal axis A, and the drug storage container 20 may be partially or wholly disposed within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33 that abuts a shoulder 20a of the drug storage container 20, thereby preventing distal movement of the drug storage container 20 during actuation of the plunger 26.

[0029] In one embodiment, the container holder 31 secures and / or fixes the position of the drug storage container 20 within the housing 12. For example, the container holder 31 may be configured to support the drug storage container 20 relative to the housing 12 proximal to at least a portion of the distal end of the body portion of the drug storage container 20 (e.g., including proximal to the entire distal end of the body portion of the drug storage container 20) such that the resultant force acting from the plunger biasing member 50 on the drug storage container 20 is at least substantially fully supported by the distal end of the body portion of the drug storage container 20.

[0030] As used herein, the term "body portion" of the drug storage container 20 refers to a generally cylindrical portion of the drug storage container 20. For example, the body portion 20g of the drug storage container 20 shown in FIG. 4A extends from a distal side of the flange 20c to a proximal side of the shoulder 20a. As a more specific example, the body portion 20g of the drug storage container 20 shown in FIG. 4A has a relatively constant inner diameter and / or a relatively constant outer diameter along its length. As shown in FIGS. 4A and 2, the drug storage container 20 defines a shoulder 20a proximal to a distal end 20e of the body portion 20g. The delivery member 16 extends distally from the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the drug storage container 20 further includes a neck 20g disposed distal to the shoulder 20a and configured to support a delivery member 16, such as a fixture needle.

[0031] The term "resultant force" refers to the force exerted on the drug-storage container 20 along the axis A upon and by actuation of the plunger biasing member 50 during and after an injection condition. For example, when the plunger 26 is actuated and driven distally along the axis A, the plunger 26 pushes the stopper 24 distally. As a result of this direct contact between the plunger 26 and the stopper 24, as well as the frictional forces between the stopper 24 and the drug-storage container 20 and the force required to push the drug 22 through the relatively small diameter delivery member 16, the drug-storage container 20 is pushed distally even though the plunger 26 cannot directly contact, abut, or engage a body portion of the drug-storage container 20. As a result, the drug-storage container 20 may be subjected to a relatively high resultant force during the injection process, and more specifically, during actuation of the plunger 26.

[0032] The force concentration of the resultant force acting on the drug storage container 20 during plunger actuation is greatest at the portion of the drug storage container 20 that resists distal movement. For example, in the device shown in the figures, the force concentration is greatest proximal to at least a portion of the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the force concentration is greatest at the shoulder 20a where the drug storage container 20 is supported by the container holder 31. As an even more specific example, the force concentration is greatest at least substantially completely supported by the shoulder 20a of the drug storage container 20. The term "substantially completely" can mean more than 50%, more than 70%, more than 75%, more than 80%, more than 80%, more than 85%, more than 90%, more than 95%, more than 98%, or any other suitable number.

[0033] The force concentration of the resultant force acting on the drug reservoir 20 during plunger actuation is preferably not significantly supported by the outwardly protruding flange 20d of the drug reservoir 20. For example, the force is substantially completely supported by the distal portion 20e of the body portion 20g of the drug reservoir 20, so that the force concentration at and near the outwardly protruding flange 20d is relatively small. As a more specific example, the percentage of the resultant force acting on the entire drug reservoir 20 that is supported by the outwardly protruding flange 20d may be less than 20%, or less than 15%, or less than 10%, or less than 5%, or less than 3%, or less than 2%, or less than 1%, or about 0%.

[0034] As shown in FIGS. 2 and 4B, the container holder 31 includes a plurality of flanges 33, each including an arcuately inclined surface 33a that substantially matches the arcuate shape of the shoulder 20a of the drug storage container 20. As a more specific example, when the drug storage container 20 is inserted into the container holder 31, the flanges 33 cooperate to support the shoulder 20a and limit distal movement of the drug storage container 20. As described in more detail below, the flanges 33 are separated from one another by gaps 33b (FIG. 3b) to allow for flexing of the flanges 33. The container holder 31 shown in FIGS. 4A-4C includes four flanges 33, although any suitable number of flanges may be used, as described below with respect to another exemplary design shown in FIG. 4D.

[0035] The container holder 31 may have an open position 29a (FIG. 4B) in which the container holder 31 can receive the drug storage container 20 during assembly, and a closed position 29b (FIG. 4C) in which the container holder 31 can support or at least partially support the drug storage container 20. As a more specific example, the container holder 31 includes a pair of arms 31a, 31b extending axially from an annular ring 31c, and the arms 31a, 31b can bend away from or toward each other to transition between the open position 29a and the closed position 29b. The annular ring 31c in the figure is disposed near the distal end of the container holder 31, so that when the container holder 31 is in the open position 29a, the proximal portions of the arms 31a, 31b can extend away from each other. Container holder 31 further includes mating connectors 31d, 31e adjacent the top (proximal) portion of container holder 31 that are configured to snap fit together when container holder 31 is in closed position 29b. As a more specific example, when mating connectors 31d, 31e are engaged with each other, a friction fit between the components holds container holder 31 in closed position 29b.

[0036] The illustrated container holder 31 also includes a pair of inwardly protruding flanges 31f, 31g disposed adjacent the proximal end of the container holder 31. When the container holder 31 is in the open position 29a, the inwardly protruding flanges 31f, 31g are spaced apart from one another so that the radially outwardly protruding flange 20b on the medication storage container 20 can be disposed (by distal insertion) within the container holder 31. In other words, when the container holder 31 is in the open position 29a, the outwardly protruding flange 20b on the medication storage container 20 can eliminate a gap between the inwardly protruding flanges 31f, 31g. When the drug storage container 20 is fully inserted into the container holder 31 (e.g., so that the shoulder 20a of the drug storage container 20 contacts the inwardly protruding flange 33), the container holder arms 31a, 31b can transition to the closed position 29b, where the inwardly protruding flanges 31f, 31g prevent the drug storage container 20 from proximally exiting the container holder 31. In other words, when the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, the drug storage container 20 is retained within the container holder 31 by the inwardly protruding flange 33 near the distal end of the container holder 31 and by the inwardly protruding flanges 31f, 31g near the proximal end of the container holder 31.

[0037] 4B and 4C, the container holder 31 includes opposing surfaces 31i, 31h that define an opening 31j for receiving the flange 20b of the drug storage container 20. For example, the container holder 31 shown in the figures includes two distal opposing surfaces 31i and two proximal opposing surfaces 31h, which cooperate to define two openings 31j that respectively receive opposite portions of the flange 20b. The opposing surfaces 31h, 31i define lower and upper boundaries for positioning the flange 20b when the drug storage container 20 is placed within the container holder 31 in the closed position 29b. This range from the lower and upper boundaries may provide flexibility for drug storage containers 20 of various lengths and / or a range of tolerance for the length of the drug storage container 20. However, as described in more detail below, additional components of device 10 may further secure drug storage container 20 near flange 20b when the drug storage container 20 / container holder 31 assembly is inside housing 12. Opening 31j may also prevent and / or limit rotational movement of drug storage container 20. For example, opposing rounded sections 20c of flange 20b may each extend at least partially through opening 31j, and opposing straight sections 20d of flange 20b may each abut a sidewall defining opening 31j, preventing and / or limiting rotational movement between components 20, 31.

[0038] 4B, the container holder 31 may include additional mating connectors 31k, 31m located distally of the mating connectors 31d, 31e. Each pair of mating connectors 31d, 31e; 31k, 31m may function together to provide a snap fit between the respective arms 31a, 31b of the container holder 31 to secure the container holder 31 in the closed position 29b.

[0039] It may be desirable to position the annular ring 31c substantially opposite (along axis A) the mating connectors 31d, 31e to facilitate opening and closing of the vessel holder arms 31a, 31b. For example, when the vessel holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly protruding flanges 31f, 31g may be proportional to the clearance gap between the inwardly protruding flanges 31f, 31g. Thus, when the vessel holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly protruding flanges 31f, 31g (e.g., the effective length of the arms 31a, 31b) may be maximized to maximize the gap between the inwardly protruding flanges 31f, 31g. Additionally, the thickness, height, and material properties of the annular ring 31c can each affect the amount of flexing of the arms 31a, 31b and / or the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 is in the open position 29a. As discussed above, the gap 33b between the flanges can also facilitate and / or define the amount of flexing of the arms 31a, 31b and / or the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 transitions to the open position 29a. For example, as the arms 31a, 31b flex outward, the flanges 33b can move inward.

[0040] The container holder 31 shown in the figures may include alignment ridges 31n that abut the inner surface of the housing 12 to radially align the container holder 31 within the housing 12 during assembly and to prevent and / or limit radial movement between the components 12, 31. As an example, the housing 12 may include slots 12a formed on the inner surface of the housing to receive the alignment ridges 31n. The housing 12 may include multiple slots, and the container holder 31 may include multiple alignment ridges to radially align the components 12, 31. For example, the container holder 31 shown in the figures includes two alignment ridges 31n, and the housing 12 includes two slots 12a. The slots 12a are spaced apart and sized to receive, for example, each alignment ridge 31n when the container holder 31 is inserted into the housing 12. The slot 12 shown in the figures is defined by a generally annular collar 12d portion that is integral with the housing 12 (although, alternatively, the collar portion may be one or more components that are coupled or attached to the housing). The annular collar 12d may not extend the entire inner surface of the housing 12, but instead may have cutouts or gaps to allow portions of the guard member 32 to extend between portions of the annular collar 12d. Alternatively, the annular collar 12d may be spaced radially inward from the inner surface of the housing 12 in at least one or more locations to facilitate portions of the guard member extending beyond the collar 12d.

[0041] The annular collar 12d may further define angled surfaces 12e on either side of each locking slot 12c to further assist in alignment between the container holder 31 and the housing 12.

[0042] 4A, 4B, and 4C include alignment ridges 31n disposed at the distal ends of support ridges 31o. For example, support ridges 31o have a height (measured perpendicular to the outer surface of vessel holder 31) that is less than alignment ridges 31n such that only alignment ridges 31n, rather than support ridges 31o, are received within alignment slots 12a. Alternatively, the alignment ridges may extend substantially or completely along the axial length of vessel holder 31, as described below with respect to another exemplary design shown in FIG. 4D.

[0043] The drug storage container 20 may be further or more securely coupled to the container holder 31 (and therefore to the housing 12) such that the drug storage container 20 and the container holder 31 are prevented from moving relative to the housing 12 during operation of the drug delivery device 10. For example, as shown in FIGS. 4B and 4C , the container holder 31 may include a plurality of locking ridges 33c on the flange 33 that form a friction fit with a portion of the housing 12. As a more specific example and as shown in FIGS. 2 and 3B , the housing 12 includes a plurality of locking slots 12c that respectively receive each of the locking ridges 33c of the container holder 31 to prevent and / or limit relative movement between the respective components 12, 31. As a more specific example, each of the locking ridges 33c extends radially from the outer surface of the flange 33. The container holder 31 may include any suitable number of locking ridges 33c, for example, one, two, three, four, or more. The locking slots 12c shown in the figures are defined by annular collars 12d, but alternatively, they may be defined by separate components. The locking slots 12c are spaced apart and sized to receive, for example, respective locking ridges 33c when the medication storage container is placed within the container holder 31. As a more specific example, the locking ridges 33c may snap into the locking slots 12c via a friction fit to secure the container holder 31, and therefore the medication product container 20, within the housing 12. As an even more specific example, when the locking ridges 33c snap into the locking slots 12c, the flanges 33 may be pushed slightly inward, creating a more secure fit between the container holder 31 and the medication product container 20.

[0044] The inner surface of the container holder 31 may include a compressible component, such as an elastomeric component, disposed between the inner surface of the container holder 31 and the drug product container 20. As a more specific example, the elastomeric component may be a rubber ring. Alternatively, or additionally, the natural flex of the flange 33 may function as the compressible component.

[0045] Locking ridges 33c can provide audible and / or tactile feedback to the user or assembler as they snap into corresponding locking slots 12c, thereby indicating to the assembler that each component 12, 31 is positioned as desired. Additionally, each component can be sized and positioned such that feedback occurs only when drug product container 20 is also positioned as desired. For example, if drug product container 20 is positioned too distally relative to container holder 31, such that the body of drug product container 20 is aligned with flange 33 rather than shoulder 20a being aligned with flange 33, locking ridges 33c may not be compressed radially enough for locking ridges 33c to fit within locking slots 12c. Conversely, if the drug product container 20 is not inserted distally far enough into the container holder 31 so that the sterility barrier 21 is aligned with the flange 33 rather than the shoulder 20a being aligned with the flange 33, the locking ridges 33c may be forced radially inward to the extent that they can slide radially inward through the locking slots 12c, or to the extent that they enter the locking slots 12c but are unable to exert sufficient radially outward force to generate audible and / or tactile feedback. While audible and / or tactile feedback may be advantageous during manual assembly of the container holder 31, assembly of the container holder 31 need not be performed manually and, in some embodiments, may be performed in part or entirely by a manufacturing facility.

[0046] The above-described housing 12, container holder 31, and their respective components provide many advantages. For example, by securely coupling drug product container 20 to housing 12 via shoulder 20a (rather than flange), device 10 may experience a reduced incidence of glass breakage or other damage. As a more specific example, drug product containers, such as syringes, often have shoulders that are stronger and / or can handle greater forces than flanges. In other words, because the shoulder is stronger and more resistant to breakage than the flange, it may be advantageous for the force concentration on the drug product container to be higher at the shoulder than at the flange.

[0047] Another potential advantage of this configuration is that by securely coupling drug product container 20 to housing 12 via a distal portion (e.g., shoulder 20a), device 10 may have a more predictable, repeatable, and / or consistent injection depth compared to designs that secure drug product container 20 via a flange (e.g., a "hanging" design). For example, because the barrel length of drug product container 20 may vary more than the barrel shoulder length, the distance between shoulder 20a and syringe delivery member 16 is typically more predictable and / or has smaller manufacturing tolerances than the distance between flange 20b and delivery member 16. Additionally or alternatively, the distance between flange 20b and delivery member 16 includes any tolerances / variations in the distance between shoulder 20a and delivery member 16, so that any tolerances / variations are "stacked up."

[0048] As shown in Figure 4C, when the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, a portion of the drug storage container 20 extends beyond the distal end of the container holder 31. As shown in Figures 4C and 4F and described in more detail below, for example, the sterility barrier 21 is disposed substantially or completely outside the container holder 31 to facilitate removal of the sterility barrier 21 during use of the device 10. Additionally, the delivery member 16 extends beyond the distal end of the container holder 31 (as described above).

[0049] 4D shows another exemplary container holder 131 having several features similar in function to those included in container holder 31, each of which is assigned the same reference numeral, except for the increment of 100. For example, container holder 131 includes a pair of arms 131a, 131b; an annular ring 131c connecting arms 131a, 131b; sets of mating connectors 131d, 131e, 131k, 131m for selectively securing the arms in closed position 129b; a pair of inwardly protruding flanges 131f, 131g; a pair of opposing surfaces 131h, 131i defining lower and upper limits of travel for the flange of a medication storage container; and an opening 131j for receiving the flange of a medication storage container. Container holder 131 also includes a plurality of flanges 133 disposed at a distal end of container holder 131 and configured to support medication storage containers. For example, the container holder 131 includes two flanges 133, each of which includes an arcuately inclined surface 133a that substantially matches the arcuate shape of the shoulder of the medication storage container. The container holder 131 shown in FIG. 4D has two flanges 133, as opposed to the four flanges 33 shown on the container holder 31 shown in FIGS. 4A-4C. Accordingly, each of the flanges 133 preferably has a larger circumference than the flanges 33. The container holder 131 also includes an alignment ridge 131n that is received within an alignment slot 12a formed on the inner surface of the housing 12 to properly align the container holder 131 within the housing 12 during assembly and to prevent and / or limit rotational movement between the components 12, 131. The alignment ridge 131n shown in FIG. 4D, in contrast to the alignment ridge 31n, extends substantially completely along the axial length of the container holder 131.

[0050] Similar to the container holder 31 shown in FIGS. 4B-4C, the container holder 131 may include a plurality of locking ridges 133c on the flange 133 that form a friction fit with a portion of the housing 12. As a more specific example and as shown in FIGS. 4D and 4E, the housing 12 includes a plurality of locking slots 12c that respectively receive the locking ridges 133c of the container holder 131 to prevent and / or limit relative movement between the components 12, 131. The locking ridges 133c may also provide audible and / or tactile feedback to the user or assembler as they snap into the corresponding locking slots 12c, thereby indicating to the assembler that the components 12, 131 are positioned as desired. Additionally, the container holder 131 may provide the same or similar advantages as those described above with respect to the container holder 31.

[0051] In yet another exemplary design, the vessel holder may have a fixed position rather than having arms that open and close. As a more specific example, the vessel holder may have a proximal opening sized sufficiently to allow receipt of a syringe. The vessel holder may further have a distally located flange for receiving and securing a shoulder of a syringe, particularly when the vessel holder is mated with the injector housing.

[0052] 4F and 5A illustrate the distal ( FIG. 4F ) and proximal ( FIG. 5A ) portions of drug product container 20 and its interaction with various other components of device 10. For example, FIG. 4F illustrates a partial cross-sectional view of the distal portion of drug product container 20 positioned within container holder 31, with shoulder 20a supported by flange 33. As another example, FIG. 5A illustrates a cross-sectional view of the proximal portion of drug product container 20 positioned within container holder 31, such that drug product container flange 20b is positioned between opposing surfaces 31h, 31i and within opening 31j. The drug product container 20 illustrated in FIG. 5A is further supported by plunger guide 60, such as flexible arm 60a of plunger guide 60. As a more specific example, flexible arm 60a extends generally distally and slightly radially inward from the distal portion of plunger guide 60. As an even more specific example, the plunger guide 60 shown in FIG. 5A includes a distal surface 60b that abuts the inwardly protruding flanges 31f, 31g of the container holder 31, and a flexible arm 60a extends from the distal surface 60b between the inwardly protruding flanges 31f, 31g.

[0053] The flexible arm 60a can have a size, shape, and material type that promotes and / or allows deflection of the flexible arm 60a. As a more specific example, the flexible arm 60a is preferably radially flexible such that when the drug product container 20 and plunger guide 60 are inserted into the housing, the flexible arm 60a aligns with the flange 20b and applies at least a gentle radial force (radially inward) to the drug product container 20. In this configuration, the drug product container 20 is supported primarily at its distal portion (e.g., shoulder portion 20a) by the container holder 31 and at least secondarily at its proximal portion (e.g., flange portion 20b) by the plunger guide 60. As a more specific example, the flexible arm 60a provides radial support for the flange portion 20b, which can prevent and / or inhibit lateral movement of the drug product container 20 relative to the housing 12. Such a configuration may reduce or eliminate rattle noise from device 10 and / or facilitate proper alignment of drug product container 20 during assembly. As another more specific example, flexible arm 60a may provide axial support (e.g., distally) to prevent undesired axial movement of drug product container 20 relative to housing 12. Device 10 may have any suitable number of flexible arms 60a, for example, one, two, three, four, or more.

[0054] The container holder 31 may also include at least one support flange 31r having a size, shape, and type of material that facilitates and / or enables its deflection. As a more specific example, the support flange 31r is preferably radially flexible so that, when the drug product container 20 and the container holder 31 are inserted into the housing, the support flange 31r aligns with the body portion 20g of the drug product container and applies at least a gentle radial force (radially inward) to the drug product container 20. In this configuration, the drug product container 20 is supported primarily by the container holder 31 at its distal portion (e.g., shoulder 20a) and at least secondarily by the container holder 31 at a central or proximal region of the body portion 20g. As a more specific example, the support flange 31r provides radial support for the drug product container 20 and can prevent and / or inhibit lateral movement of the drug product container 20 relative to the housing 12. Such a configuration can reduce or eliminate rattle noise from device 10 and / or facilitate proper alignment of drug product container 20 during assembly. As another more specific example, support flange 31r can, but need not, provide axial support (e.g., in the distal direction) to prevent undesired axial movement of drug product container 20 relative to housing 12. Device 10 may have any suitable number of support flanges 31r, for example, one, two, three, four, or more. The depicted container holder 31 includes four support flanges 31r evenly spaced about its circumference.

[0055] While the flexible arms 60a and / or support flanges 31r shown in the figures provide at least some support for the drug storage container 20, as described above, the container holder substantially entirely supports the drug storage container 20 relative to the housing 12 by the distal end of the body portion 20g of the drug storage container 20. As a more specific example, the flexible arms 60a and / or support flanges 31r may provide little or no support along the longitudinal axis A, and may provide support only transverse to the axis A. As an even more specific example, the container holder 31 substantially entirely supports the drug storage container 20 relative to the housing 12 by the distal end of the body portion 20g of the drug storage container 20 with respect to forces along the axis A, such as forces experienced during an injection process.

[0056] As noted above, the plunger guide 60 shown in FIG. 5A includes a distal surface 60b that abuts the inwardly projecting flanges 31f, 31g of the container holder 31. This configuration can help reduce or prevent radial movement of the container holder 31 within the housing 12. For example, as shown in FIG. 5A, the container holder includes an annular wall 31p that cooperates with the inwardly projecting flanges 31f, 31g to define an annular seat for the distal surface 60b of the plunger guide 60. The annular wall 31p can center the plunger guide 60 relative to the container holder 31 and the drug product container 20, so that the plunger 26 is similarly aligned with these components 31, 20. The annular wall 31p can also reduce or prevent radial movement of the plunger guide 60 relative to the housing 12. This configuration can also help reduce or prevent axial movement of the container holder 31 within the housing 12. For example, as shown in Figure 2, plunger guide 60 extends from rear end cap 23 to the midpoint of device 10, where plunger guide 60 abuts vessel holder 31. As a result, vessel holder 31 is restricted from moving axially upward (i.e., proximally) in Figure 2 by plunger guide 60. Furthermore, rear end cap 23 may not be able to be installed unless plunger guide 60 is properly axially and radially aligned with vessel holder 31, for example, if distal surface 60b does not abut inwardly protruding flanges 31f, 31g.

[0057] As shown in FIGS. 5B and 5C , plunger guide 60 may have a hollow, generally cylindrical or tubular shape and may be centered about longitudinal axis A. The outer diameter or other outer dimension of the proximal end of plunger guide 60 may be larger than the outer diameter or other outer dimension of the distal end of plunger guide 60. At least a portion of the distal end of plunger guide 60 may be radially disposed between plunger 26 and releaser member 52. Thus, as shown in FIG. 2 , plunger 26 may be at least partially disposed within the distal end of plunger guide 60, and the distal end of plunger guide 60 may be at least partially disposed within releaser member 52. Further features and functions of plunger guide 60 are described below.

[0058] As shown in FIG. 2 , the plunger guide 60 may be fixedly coupled to the housing 12 such that the plunger guide 60 is substantially and / or nearly immovable relative to the housing 12. For example, and as shown in FIGS. 1C and 5B , the plunger guide includes a locking tab 60 f sized, shaped, and aligned to be received within a locking key 12 f formed in the housing 12. As a more specific example, the plunger guide 60 and the housing 12 each include a pair of components 60 f, 12 f that cooperate to prevent relative rotation between the plunger guide 60 and the housing 12. Additionally or alternatively, an annular ridge 60 g formed on the outer surface of the plunger guide 60 may form a friction fit with the inner surface of the housing to prevent or prevent rotation between the components 12, 60.

[0059] The plunger 26 (best shown in FIGS. 2 and 3A ) may have a hollow, generally cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an interior space sized to receive the plunger biasing member 50. Generally, to maximize the inner diameter of the plunger 26, it is desirable to minimize the thickness of the annular wall 39 to the extent possible without compromising the integrity of the plunger 26. This allows a larger diameter plunger biasing member 50 to fit within the interior space of the plunger 26, which in turn allows for a more robust plunger biasing member 50. As a more specific example, the thickness of the annular wall 39 may be less than 2 mm. As another more specific example, the thickness of the annular wall may be less than 1 mm. As another more specific example, the thickness of the annular wall may be less than 0.6 mm. As another more specific example, the thickness of the annular wall may be less than 0.3 mm. As another more specific example, the thickness of the annular wall may be less than 0.2 mm. As another more specific example, the thickness of the annular wall may be less than 0.1 mm. As another more specific example, the thickness of the annular wall may be less than 0.05 mm. The annular wall 39 may be made of any suitable material, such as metal or plastic. To minimize the thickness of the annular wall 39, it may be advantageous to make the annular wall 39 from a metal, such as steel or aluminum. For example, a metal annular wall 39 may have sufficient axial strength and / or buckling resistance for use in a device if the thickness of the annular wall 39 is greater than 0.05 mm. In contrast, a plastic annular wall 39 may have sufficient axial strength and / or buckling resistance for use in a device if the thickness of the annular wall 39 is greater than 1 mm.

[0060] Additionally or alternatively, the hollow rod 46 may facilitate and / or provide greater flexibility in spring design. For example, it may be desirable or advantageous to use a device with different springs depending on the characteristics of the drug and / or the desired drug delivery profile. For example, a more viscous drug may require a spring with a higher spring constant and / or spring force, and therefore, flexibility in the physical characteristics of the spring may be desirable or advantageous. As a more specific example, various physical characteristics of the spring, such as the wire diameter of the spring (generally, an increase in wire diameter increases the spring constant), the center diameter of the spring (generally, an increase in center diameter decreases the spring constant), the number of turns of the spring (generally, an increase in the number of turns increases the spring constant), and the spring material, can affect the spring constant and therefore the spring force. These physical properties may be adjusted to provide different spring rates, while also, in some cases, adjusting the thickness of hollow rod 46 to maintain a constant or relatively constant outer diameter of the overall plunger 26 and to maintain constant the remaining components of the device, such as plunger guide 60 and stopper 24. Additionally or alternatively, hollow rod 46 may promote and / or provide greater longitudinal stability of plunger biasing member 50, such as by preventing or reducing buckling or other transverse movement.

[0061] The plunger biasing member 50 shown in the figures may have the following dimensions: wire diameter 0.65 mm, spring outer diameter 5.40 mm, and 80-86 turns (depending on pitch), although other suitable spring characteristics may be used. The plunger biasing member 50 shown in the figures may be formed from stainless steel with a strength of 2300 n / mm, although other suitable materials may be used. The hollow rod 46 shown in the figures may have the following dimensions and material: length 63 mm, outer diameter 6 mm, wall thickness 0.20 mm, and stainless steel material with a strength of 600-750 n / mm, although other suitable dimensions and materials may be used.

[0062] As will be described in more detail below, during operation of the drug delivery device 10, the plunger 26 may be configured to selectively rotate relative to the housing 12 and translate linearly relative to the housing 12.

[0063] The plunger 26 may be made of multiple interconnected parts, or alternatively, may have a unitary structure. In this embodiment, the plunger 26 is made of three separate, interconnected structures: a top ring 45, which defines the proximal end of the plunger 26; a base portion 47, which defines the distal end of the plunger 26; and a hollow rod 46, which is disposed between and rigidly connects the top ring 45 and the base portion 47. The positions of the top ring 45, hollow rod 46, and base portion 47 may be fixed relative to one another so that these components cannot move relative to one another. The top ring 45, hollow rod 46, and base portion 47 may each have an annular structure and may be centered about the longitudinal axis A. The top ring 45 and hollow rod 46 may each have a respective central opening that extends from end to end of the component to define an axial chamber, while the base portion 47 may have a central opening that extends through the proximal end of the base portion 47 but is closed at the distal end of the base portion 47. The closed end of the base portion 47 may define a seat or abutment surface for the plunger biasing member 50. In another embodiment, the central opening may extend through the base portion 47 from end to end. In such an alternative embodiment, the inner diameter of the central opening of the base portion 47 may be smaller than the outer diameter of the plunger biasing member 50 such that the base portion 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is activated, the base portion 47 may be the portion of the plunger 26 that abuts the stopper 24 and urges the stopper 24 distally.

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

[0065] In some embodiments, the top ring 45 and / or the base portion 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or the base portion 47 may be made of plastic, while the hollow rod 46 may be made of metal. In this configuration, the plastic material used for the top ring 45 may facilitate the camming action described below by providing a relatively low coefficient of friction. The plastic material used for the base portion 47 may help absorb or dampen any shock or vibration associated with the base portion 47 striking the stopper 24. The metal material used for the hollow rod 46 may provide sufficient rigidity to avoid buckling under the biasing force exerted by the plunger biasing member 50. In other embodiments, the top ring 45, hollow rod 46, and / or base portion 47 may be made of the same material, including, for example, metal or plastic. In certain such embodiments, the top ring 45, hollow rod 46, and base portion 47 may be integrally formed into one piece to define a single monolithic structure.

[0066] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a guard member 32 movably positioned at or near the distal end of the housing 12 adjacent the opening 14. The guard member 32 may have a hollow, generally tubular or cylindrical portion 32a centered about the longitudinal axis A and may have a pair of arms 32b extending proximally from the cylindrical portion 32a. The guard member 32 further includes a distal end 32c that may generally include the cylindrical portion 32a and a proximal end 32d that may be defined by the arms 32b. The arms 32b may be substantially or completely received within the housing 12 such that a portion of the arms 32b does not extend from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively received within the housing 12. As described in more detail below, for example, guard member 32 may be configured to move relative to housing 12 such that in some states / conditions, a portion of guard member 32 is received within housing 12 and in other states, extends from housing 12.

[0067] 2, 4E, and 6, the arms 32b of the guide member 32 are radially spaced apart along the periphery 32g of the guard 32 so that the arms 32b can slide between the protrusions of the annular collar 12d formed on the inner surface of the housing 12. For example, the arc length between each edge of the arms 32b is at least slightly longer than the arc length of the protrusions of the annular collar 12d. Thus, the arms can slide axially between the protrusions of the annular collar 12d without contacting the collar.

[0068] As indicated above, the guard member 32 may be configured to move relative to the housing 12 between an extended position in which at least a portion of the cylindrical portion 32a of the guard member 32 extends through the opening 14 of the housing 12, and a retracted position in which a shorter length of the cylindrical portion 32a or none of the cylindrical portion 32a extends through the opening 14 of the housing 12. In other words, in the extended position, the cylindrical portion 32a has a length X that extends through the opening 14 of the housing 12, and in the retracted position, the cylindrical portion 32a has a length Y that extends through the opening 14 of the housing 12, where X is greater than Y. The length X may be any suitable number, e.g., 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y may be any suitable number less than X, e.g., 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. 1C and 1D illustrate an exemplary pre-injection configuration (FIG. 1C) in which guard member 32 is in extended position 32e and the length X of the exposed portion of guard member 32 can be approximately 5 mm to 11 mm, and an injection configuration (FIG. 1D) in which guard member 32 is in retracted position 32f and the length Y of the exposed portion of guard member 32 is approximately 0 mm to 2 mm (distal end 32c of guard member 32 is flush with opening 14 of housing 12). In one embodiment, distance Y is greater than 0 (e.g., 1 mm) to help ensure that device 10 can be activated before the guard member is flush with housing 12.

[0069] The guard member 32 may also be configured to move in the opposite direction, i.e., from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 may translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 may translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond and surround the insertion end 28 of the delivery member 16. For further explanation, FIGS. 1C and 2 show the guard member 32 in the extended position (covered by the removable cap 19 in FIG. 2). As described above, moving the guard member 32 from the extended position to the retracted position, for example, by pressing the distal end of the guard member 32 against the patient's skin at the injection site, may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin.

[0070] During the injection process, the guard member 32 may remain stationary relative to the user's skin 5, while the housing 12 and some components disposed therein are moving relative to the guard member 32 and the skin 5. Nevertheless, this disclosure refers to the guard member 32 moving, retracting, translating, and pushing. These references and descriptions may be considered to refer to relative motion between the guard member 32 and the housing 12, regardless of which component (guard member 32 or housing 12) is moving relative to the user's skin 5.

[0071] The delivery device 10 may use an inertia-driven design rather than a spring-driven design to insert the needle into the patient's subcutaneous tissue. As a more specific example, when the patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 may advance toward the injection site. When the patient presses down a predetermined distance or with a predetermined force, the delivery device 10 compresses the needle cover and its spring to a predetermined release point while implementing a rapid release to utilize stored energy in the patient's muscles. The release mechanism is designed so that the resulting needle insertion speed exceeds the patient's reaction speed, and this speed, combined with the mass of the device, allows the needle to quickly and completely penetrate the skin to a subcutaneous depth. Compared to known injectors in which the entire primary container moves forward relative to the housing, this embodiment prevents relative motion between the drug reservoir 20 and the housing, thus providing a simplified, more robust design.

[0072] In another embodiment, the drug reservoir 20 may be movably coupled to the housing 12 such that the drug reservoir 20 can move relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may be retracted into the opening 14 of the housing 12 in a pre-delivery state. Thereafter, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be deployed through the opening 14 of the housing 12 for insertion into a patient. In some embodiments, this movement may be the result of the drug reservoir 20 being driven distally relative to the housing 12.

[0073] In some embodiments, the guard member 32 may be rotationally fixed or rotationally limited relative to the housing 12. Thus, while the guard member 32 may be able to translate linearly relative to the housing 12, the guard member 32 may be substantially or completely prevented from rotating relative to the housing 12. As a more specific example, the cylindrical portion 32a of the guard member 32 may include a protrusion extending therefrom, such as a ridge 32h, that aligns with a corresponding feature on the inner surface of the housing 12. For example, the inner surface of the housing adjacent the distal end of the housing 12 may include a slot, a pair of adjacent ridges, or another component or set of components that cooperates with the ridge 32h to substantially or completely prevent rotation of the guard member 32. This configuration may also aid in aligning the components 32, 12 relative to one another during assembly.

[0074] Device 10 may further include an extender bias member 35 and a guard extension 37. Guard extension 37 may be disposed proximal to guard member 32, with extender bias member 35 shown disposed proximal to guard extension 37. Guard extension 37 may have a hollow, generally cylindrical or tubular shape centered about longitudinal axis A. As a more specific example, guard extension 37 may include a generally cylindrical body 37a. Guard extension 37 may also include arms 37b for receiving, supporting, and / or retaining a distal portion of extender bias member 35. Furthermore, guard extension 37 may be linearly movable along longitudinal axis A relative to housing 12. In this embodiment, guard extension 37 is a separate structure from guard member 32. However, in another embodiment, guard extension 37 and guard member 32 may be integrally formed in one piece to define a single monolithic structure. In such an alternative embodiment, the proximal end of the guard member 32 may correspond to a guard extension 37 .

[0075] Similar to guard member 32, guard extension 37 may be rotatably fixed relative to housing 12. Thus, while guard extension 37 may be able to translate linearly relative to housing 12, guard extension 37 may be prevented from rotating relative to housing 12. In some embodiments, to achieve this effect, guard extension 37 may cooperate with plunger guide 60 to limit or prevent rotation between components 37, 60. As a result, and because plunger guide 60 is fixedly connected to housing 12, guard extension 37 may be rotatably fixed to housing 12 via plunger guide 60. For example, plunger guide 60 may include a longitudinal ridge 60c near a distal portion of plunger guide 60. The ridge may be received within a longitudinal channel on the interior surface of guard extension 37 and / or a pair or corresponding feature that cooperates to receive ridge 60c. In another embodiment, the ridge and slot arrangement may be reversed, such that the guard extension 37 has one or more radially inwardly extending ridges and the plunger guide has one or more slots or other recesses for matingly or snugly receiving the one or more ridges. As yet another alternative, the guard extension 37 may include anti-rotation features that mate with corresponding features on the interior surface of the housing 12.

[0076] The guard extension 37 and / or the releaser member 52 may have axial movement limits that limit the distance they can move distally. For example, as shown in FIG. 6C , the plunger guide 60 may include an axial ridge 60c formed on its outer surface and disposed adjacent to a distal portion of the plunger guide 60. The distal-facing surface 52j of the releaser member 52 may abut a proximal-facing surface 60d defined by the axial ridge 60c, thereby defining a distal-most point of travel for the releaser member 52. The releaser member 52 may also include a locking flange 52a that further limits the distal movement of the guard extension 37. For example, the locking flange 52a may abut an annular collar 37d of the guard extension 37, defining a distal-most point of travel for the guard extension 37. The axial ridge 60c and locking ridge 52a shown in the figures do not necessarily limit the movement of the releaser member 52 and guard extension 37 in the proximal direction, only in the distal direction.

[0077] As best shown in FIG. 2 , the extender bias member 35 is disposed between and contacts the guard extension 37 and the releaser member 52. The extender bias member 35 may be configured to bias or urge the guard extension 37 in a distal direction and / or to bias or urge the releaser member 52 in a proximal direction. With the device 10 shown in FIG. 2 in a pre-delivery or storage state, the extender bias member 35 is initially in a biased state (e.g., compressed). In other words, when the device 10 is in the pre-delivery state as shown in FIG. 2 , the extender bias member 35 exerts a distal (downward) biasing force on the guard extension 37 and a proximal (upward) biasing force on the releaser member 52.

[0078] During operation of the device, a user can translate the guard member 32 proximally (relative to the housing 12) by pressing the guard member 32 against the injection site. In doing so, the guard member 32 moves toward the guard extension 37, closing the gap 37g ( FIG. 2 ) between them. When the gap 37g is removed, the guard member 32 and the guard extension 37 move together proximally until, for example, the guard member 32 reaches the retracted position 32f. Once the injection is complete and the drug delivery device 10 is moved away from the injection site, the extender bias member 35 can urge the guard extension 37 such that the guard extension 37 and the guard member 32 move together distally. This movement (and / or the biasing force of the locking ring bias member 51) returns the guard member 32 to the extended position 32e, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the extender bias member 35 can include a compression spring (e.g., a compression coil spring). Additionally, in embodiments in which plunger biasing member 50 also includes a compression spring, extender biasing member 35 may be disposed around plunger biasing member 50 and / or may have a larger diameter than plunger biasing member 50 .

[0079] However, in some alternative embodiments, the extender biasing member 35 may be in an unbiased (natural) state when the device is in the pre-delivery state. In these embodiments, the biasing member 35 may be compressed or biased when the guard member 32 is deflected proximally.

[0080] After drug delivery is completed and the guard member 32 is redeployed to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent a subsequent user from contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. As described in more detail below, in accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the guard member 32 to lock the guard member 32 in the extended position once the guard member 32 is moved from the retracted position to the extended position.

[0081] As described above, the plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end abutting the proximally facing inner surface of the plunger 26 and / or may be securely attached to the inner surface of the plunger 26. Because the plunger biasing member 50 may be received within the plunger 26, the outer diameter or other dimension of the plunger biasing member 50 may be equal to or smaller than the inner diameter of the top ring 45 and / or the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut the proximally facing inner surface of the base portion 47 of the plunger 26. Furthermore, as best shown in FIGS. 2 and 3A , the proximal end 50 a of the plunger biasing member 50 may abut the distal facing surface 38 a of the plunger biasing member seat 38. The plunger biasing member seat 38 may be securely attached to the rear housing 27 such that the plunger biasing member seat 38 provides a resting surface for the plunger biasing member 50 to push against. 3A and 5B, the plunger seat 38 may include a flange 38b that is received within an opening 60h formed in the proximal portion of the plunger guide 60, thereby securely coupling the plunger seat to the plunger guide 60. Thus configured, when released from a biased state, the plunger biasing member 50 may expand in length by moving the distal end of the plunger biasing member 50 distally away from the stationary proximal end of the plunger biasing member 50. This movement may push the plunger 26 distally, which may further push the stopper 24 distally, expelling the drug 22 from the drug storage container 20 into the delivery member 16 and subsequently to the patient. However, in the illustrated embodiment, release of the plunger biasing member 50, or any other biasing member, does not drive the delivery member 16 downwardly relative to the housing 12. Instead, the drug product container 20, and consequently the delivery member 16, is substantially or completely fixedly coupled to the housing 12. Rather, the delivery member 16 is driven towards the patient's skin 5 by inertial forces generated by a downward force by the patient (or healthcare provider or other person administering the dose).

[0082] 7A and 7B, the releaser member 52 may have a hollow, generally cylindrical or tubular shape and may be centered about the longitudinal axis A. As shown in FIG. 2, the releaser member 52 may be radially disposed between the plunger guide 60 and the guard extension 37. Also shown in FIG. 2, the releaser member 52 is also radially disposed between the guard extension 37 and the plunger guide 60. Furthermore, the extender bias member 35 may be axially disposed between the releaser member 52 and the guard extension 37 and radially disposed around the releaser member 52. Generally, the releaser member 52 is configured to (1) operatively couple the guard member 32 and the plunger 26 in an actuation sequence and (2) generate an audible signal indicating the end of drug delivery. Configured in this manner, the releaser member 52 is used to perform two separate functions, thus reducing the number of moving parts required for the drug delivery device 10.

[0083] Each channel surface 52b is configured to receive a projection 48 of the top ring 45 and permit axial movement of the plunger 26 relative to the releaser member 52, but inhibit or prevent rotational movement between the plunger 26 and the releaser member 52. As shown, the channel surfaces 52b extend adjacent the inner surface of the releaser member 52, but the channel surfaces 52b do not have an arcuate shape, but instead have a generally rectangularly bounded shape (as best seen in FIGS. 7B and 10A).

[0084] The releaser member 52 includes a channel surface 52b that extends proximally beyond the proximal-most (e.g., top) surface of the tubular body of the releaser member 52. For example, the releaser member 52 includes a proximal-facing contact surface 52d for end-of-dose indication (described in further detail below) and a channel surface 52b, each of which extends beyond the contact surface 52d to provide a continuous path for the top ring 45 while also allowing sufficient clearance between the proximal-facing contact surface 52d and the corresponding surface involved in end-of-dose indication.

[0085] The releaser member 52 may be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the releaser member 52 associated with activation may be driven by the plunger biasing member 50 and / or the extender biasing member 35, while subsequent rotation of the releaser member 52 associated with generating an end-of-dose signal may be driven solely by the extender biasing member 35. Any linear translation of the releaser member 52 without rotation may be driven solely by the extender biasing member 35. In some embodiments, the releaser member 52 may translate linearly only in the proximal direction. However, other embodiments may allow linear translation of the releaser member 52 in both the proximal and distal directions.

[0086] Having described the general configuration of the drug delivery device 10, a method of using the drug delivery device 10 to perform an injection will now be described with reference to FIGS. 9A-12C. As a preliminary step, a user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or a cardboard box. Also as a preliminary step, the user may prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. The user may then pull the removable cap 19 off the front housing 25. As a result of this movement, the gripper 13 may pull and remove the sterility barrier 21 from the drug reservoir 20, thereby exposing the insertion end 28 of the delivery member 16. Nevertheless, because the guard member 32 is in the extended position, the insertion end 28 of the delivery member 16 remains enclosed by the guard member 32 at this stage. The user may then place the drug delivery device 10 over the injection site and then press the distal end of the guard member 32 against the injection site. The force applied by the user overcomes the biasing force of the extender biasing member 35 and the biasing force of the locking ring biasing member 51, thereby retracting the guard member 32 into the opening 14 and moving it proximally from the extended position to the retracted position. During the retraction movement of the guard member 32, the delivery member 16 remains stationary relative to the housing 12.

[0087] Some of the device components include various features, surfaces, and openings for interaction with and controlling the release movement of the plunger 26 (e.g., the injection sequence). Generally, the injection sequence is initiated by retraction / axial movement of the guard member 32 in a proximal direction (upward in FIG. 2 ), which causes axial movement of the guard extension 37 and unlocks the releaser member 52. Once the releaser member 52 is unlocked (e.g., the first stage of movement), the plunger 26 and plunger biasing member 50 urge the releaser member 52 to rotate clockwise, allowing axial movement (distal, downward in FIG. 2 ) of the plunger 26. The plunger then urges the stopper 24 distally, thereby expelling the drug 22 from the drug product container 20 and from the delivery member 16. When the plunger reaches a particular point along the axial length of the device, further movement of the releaser member 52 is unlocked (e.g., second stage of movement) and the releaser moves proximally (upward in FIG. 2 ) until it contacts the plunger guide 60, thereby generating an end-of-dose indication (such as an audible click). The injection sequence will now be described in more detail.

[0088] The pre-injection stage is shown in Figures 2, 9A, 10, and 11A. Movement of guard member 32 from the extended position to the retracted position can result in several actions. During retraction of guard member 32, delivery member 16 remains stationary relative to housing 12, so that insertion end 28 of delivery member 16 extends through the opening at the distal end of guard member 32, thereby piercing the patient's skin at the injection site and penetrating the patient's subcutaneous tissue. Additionally, as described in more detail below, retraction of guard member 32 can also activate drive mechanism 30, expelling drug 22 from drug reservoir 20.

[0089] As shown in FIGS. 9A, 10, and 11A, in the pre-delivery state before retraction of the needle guard 32, the plunger 26 and the releaser member 52 may each be disposed in their initial rotational positions. The plunger biasing member 50 may be in a biased state. Consequently, the plunger biasing member 50 may exert a distally directed biasing force on the plunger 26, urging the distally facing cam surface 49 against the proximal facing cam surface 60j. The resulting camming action may cause the plunger 26 to rotate in a clockwise direction. Despite these biasing forces, neither the releaser member 52 nor the plunger 26 rotates in the pre-delivery state because the releaser member 52 and the plunger are rotatably fixed in the pre-injection state. Thus, as described in more detail herein, the releaser member 52, plunger guide 60, guard extension 37, and housing 12 operate in conjunction with one another to maintain the plunger biasing member 50 in the biased state before retraction of the guard member 32.

[0090] As best shown in Figure 2, when guard member 32 moves proximally (upward in Figure 2), proximal end 32d of guard member 32 contacts the distally facing surface of guard extension 37, urging the guard extension proximally. As shown in Figures 6B and 7A, the inner surface of the annular wall of guard extension 37 includes locking flange 37c, and the outer annular surface of releaser member 52 includes a corresponding locking flange 52a. As shown in Figures 2, 9A, 10A, and 11A, when the device is in the pre-injection stage, locking flange 37c of guard extension 37 engages locking flange 52a of releaser member 52, thereby rotationally locking releaser member 52 (as best shown in Figure 11A). At this point in the sequence, the distally facing cam surface 49 of the top ring 45 of the plunger 26 abuts the proximally facing cam surface 60j of the plunger guide 60, and this interaction restrains the plunger 26 from axial movement (best shown in FIGS. 9A and 10A). The distally facing cam surface 49 and / or the proximal facing cam surface 60j include a sloped surface to facilitate relative movement of the top ring 45 of the plunger 26 in the direction of arrow 60k (clockwise) in FIGS. 9A and 10A. For example, the distally facing cam surface 49 has a slope 60m of approximately 10 degrees (best shown in FIGS. 9B and 9C), but may have any suitable slope such as 9-11 degrees, 8-12 degrees, 7-13 degrees, 6-14 degrees, 5-15 degrees, 4-16 degrees, or any other suitable slope. Additionally or alternatively, distally facing cam surface 49 of top ring 45 may have a slope 49a of approximately 10 degrees, but may have any suitable slope, such as 9-11 degrees, 8-12 degrees, 7-13 degrees, 6-14 degrees, 5-15 degrees, 4-16 degrees, or any other suitable slope. The slope of one or more of each surface 60j, 49 creates a transverse force to the axial force by plunger biasing member 50, thereby urging top ring 45 of plunger 26 in a clockwise direction 60k. However, as discussed above, while top ring 45 is disposed within and / or in contact with channel surface 52b, releaser member 52 inhibits or prevents rotational movement between releaser member 52 and plunger.As a result, as long as guard extension 37 rotationally locks releaser member 52 (as shown in FIGS. 2, 9A, 10A, and 11A), top ring 45 remains rotationally locked by channel surface 52b and axially locked by proximal opposing cam surface 60j.

[0091] The unlocking stage is shown in Figure 1 IB. During this stage, guard extension 37 translates proximally until locking flange 37c of guard extension 37 disengages locking flange 52a of releaser member 52, and the releaser is no longer rotationally locked. During this stage of the injection sequence, two things occur simultaneously or nearly simultaneously: (1) the guard bias member 35 urges the releaser member 52 in a clockwise direction (as shown in FIG. 9B ) and upward due to camming surfaces on one or both of the inner surface of the releaser member 52 (which is generally aligned with reference numeral 52c shown in FIGS. 9C and 7B , but is the inner surface rather than the outer surface of the releaser member 52 designated by reference numeral 52c) or the outer surface of the plunger guide 60 (such as rib 60n ( FIG. 5B )), which converts the axial force by the guard bias member 35 into a lateral (clockwise) force, causing the releaser member 52 to rotate clockwise and move upward (proximally); and (2) the plunger bias member 50 urges the top ring 45 in a clockwise and downward (distally) direction due to the camming action between surfaces 49, 60j of the plunger 26 and the plunger guide 60, thereby moving the plunger 26 clockwise and slightly downward along the sloped surface 60j. In other words, both the releaser member 52 and the top ring 45 of the plunger 26 are rotated clockwise simultaneously or substantially simultaneously by the forces from their respective biasing members 35, 50. This sliding motion between the surfaces 49, 60j of the plunger 26 and the plunger guide 60 results in rotation and linear translation (equivalent to a helical path). Thus, the plunger guide 60 may function as a cam and the plunger rod 26 may function as a cam follower.

[0092] The unlocking stage is shown in Figures 9B, 10B, and 11C. In this stage, the distally facing cam surface 49 of the top ring 45 releases the proximally facing cam surface 60j of the plunger guide 60 such that the top ring 45 (and therefore the plunger 26) is no longer axially constrained by the plunger guide 60. As a result, the plunger biasing member 50 urges the plunger 26 axially distally.

[0093] The downward stroke stage is shown in Figures 9C, 10C, and 12A. At this point in Figures 9C, 10C, and 12A, the top ring 45 is still visible near the proximal portion of the plunger guide 60, but it moves quickly along the longitudinal slot 86 and channel surface 52b formed in the plunger guide 60. During this stage, the top ring 45 of the plunger 26 moves along both the channel surface 52b of the releaser member 52 and the longitudinal slot 86 of the plunger guide 60, thereby preventing rotation between any of the three components (26, 52, 60). As a more specific example, the plunger guide 60 is rotatably mounted relative to the housing 12, while the releaser member 52 cannot rotate because the top ring 45 is disposed within both the channel surface 52b and the longitudinal slot 86. Also, during this phase, as the plunger 26 moves distally, the gap 18 between the base portion 47 of the plunger 26 and the stopper 24 decreases, and the base portion 47 contacts the stopper 24. The device 10 is designed so that the plunger 26 moves with sufficient force to drive the stopper 24 distally and force the drug 22 out of the delivery member 16. At the same time, the device 10 is also designed to reduce or eliminate the possibility of, for example, glass breakage, undesirable forces acting on the patient, and / or undesirable impact vibrations or sounds due to interaction between the base portion 47 and the stopper 24. For example, the design parameters of the plunger biasing member 50 can be designed to meet these two sets of design goals. As another example, a damping component can be positioned between the base portion 47 and the stopper 24 or elsewhere within the device 10 to dampen the force between the base portion 47 and the stopper 24. For example, the base portion 47 can include an elastomeric component, portion, or other damping feature. Additionally or alternatively, stopper 24 may be formed of an elastomeric material that includes inherent damping properties. Additionally or alternatively, stopper 24 may include additional elastomeric components, portions, or other damping features.

[0094] In some embodiments, the camming action between the distally facing camming surface 49 on the projection 48 and the proximal facing camming surface 60j of the plunger guide 60 may provide a damping effect. More specifically, the sliding friction between these two surfaces may be selected to slow the initial expansion of the plunger biasing member 50. Consequently, during the initial expansion of the plunger biasing member 50, the velocity of the plunger 26 may be reduced compared to free, unhindered expansion of the plunger biasing member 50. The reduced velocity of the plunger 26 may allow the plunger 26 to impact the stopper 24 with less force, thereby reducing the potential for structural damage to the medication reservoir 20 and / or facilitating a more comfortable injection for the user.

[0095] The end-of-dose phase is illustrated in Figures 12B and 12C. As described above, during the downward stroke phase, the releaser member 52 cannot rotate relative to the plunger guide 60 while the top ring 45 is disposed within the channel surface 52b and longitudinal slot 86. However, during the initiation end-of-dose phase illustrated in Figure 12B, the top ring 45, in some embodiments, can release the distal end of the releaser member 52 and no longer restrict or prevent rotation of the releaser member 52. As a more specific example, as shown in the lower portion of Figure 12B, as the top ring 45 exits the releaser channel surface 52b and / or distal surface 52d, the releaser member 52 is no longer rotationally constrained by the top ring 45 and is urged upward by the guard bias member 35. The upward force of the guard bias member 35 and cam surface causes the releaser member 52 to rotate clockwise while moving upward in a helical path, causing the proximal-facing surface 52d of the releaser member 52 to contact the distal-facing surface 60p of the plunger guide 60, thereby producing an audible click. As a more specific example, FIG. 12B shows a gap 90 between the surfaces 52d, 60p, which is subsequently removed as the releaser member 52 moves proximally, as shown in FIG. 12C. The channel surface 52b and the length of the plunger 26 can be designed so that the top ring 45 exits the channel surface 52b when the stopper 24 reaches a desired point of travel within the drug reservoir 20, such as the end of its travel near the distal end of the drug reservoir 20.

[0096] As a more specific example of a cam surface configuration between the releaser member 52 and the plunger guide 60, and as described above, the rib 60n of the plunger guide 60 is aligned with the inner surface of the releaser member 52, indicated by reference numeral 52c in FIGS. 7A and 7B (but the inner surface rather than the outer surface indicated by reference numeral 52c). The rib 60n has an angled surface to help facilitate and / or promote relative rotation between the components 52, 60. More specifically, the biasing force of the guard biasing member 35, in combination with the angled surface of the rib 60n, generates a rotational force (e.g., torque) to rotate the releaser member 52 relative to the plunger guide 60. During a first stage of rotation of the releaser member 52 (e.g., the unlocking stage shown in FIG. 11B), the rib 60n moves along a first section of the inner cam surface 52c of the releaser member 52, e.g., first section 52f shown in FIG. 7B. During a second phase of rotation of the releaser member 52 (e.g., the end-of-dose phase shown in FIGS. 12B and 12C), the rib 60 moves along a second section of the internal cam surface 52c of the releaser member 52, such as the second section 52g shown in FIG. 7B. As seen in FIG. 7B, the second section 52g includes a pocket 52h that can receive the rib 60 and allow the releaser member 52 to move proximally toward the plunger guide 60, generating an audible end-of-dose click. In summary, during the end-of-dose phase, the top ring 45 releases the channel surface 52b of the releaser member 52, and the guard biasing member 35 and the rib 60 cause the releaser member 52 to rotate and move upward, terminating in contact with the plunger guide 60 due to the rapid upward (proximal) movement of the releaser member 52 as the rib 60 moves into the pocket 52h.

[0097] The patient and / or healthcare provider may be notified that dosing is complete when they hear an audible sound. In some embodiments, the user may be informed of the significance of the audible signal by instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an Instructions for Use (IFU) pamphlet packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by observing the movement of the stopper 24 and / or plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by vibration or other tactile feedback generated as a result of the releaser member 52 impacting the plunger guide 60. The audible notification may be in the form of a click or slap sound or any other suitable audible signal perceptible to the user. The audible signal may be generated simultaneously or substantially simultaneously with the stopper 24 reaching the end-of-dose position.

[0098] As mentioned above, in addition to its retention function, the releaser member 52 can also be used to generate an audible signal that indicates to the user that drug delivery or administration is complete. This dual-function role can reduce part count and / or design complexity. Alternatively, the releaser member 52 need not have this indicator function. In another embodiment, the indicator can be defined by a structure that is separate from but securely attached to the releaser member 52.

[0099] While the foregoing description refers to the extender biasing member 35 being used to provide the actuation energy necessary to generate the end-of-dose signal, in alternative embodiments, a biasing member separate from the extender biasing member 35 may be used for this purpose. In certain such embodiments, this additional biasing member may have a distal end fixed relative to the housing 12 and a proximal end that abuts the distally facing surface of the releaser member 52. The biasing member may thus displace the housing 12 and exert a biasing force on the releaser member 52 in a proximal direction. Furthermore, this biasing member may operate independently of the plunger biasing member 50 and the extender biasing member 35.

[0100] In either case, once the user receives some confirmation that drug delivery is complete, the user can then lift the drug delivery device 10 from the injection site. With nothing obstructing the extender bias member 35, the extender bias member 35 can push the guard member 32 from the retracted position to the extended position, covering the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 can rotate the locking ring 40 into a position that prevents subsequent retraction of the guard member 32.

[0101] For example, as described above, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to lock the guard member 32 in the extended position when the guard member 32 moves from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered about and rotates about the longitudinal axis A. As shown in FIG. 2 , a proximal end of the locking ring 40 may contact a portion of the housing 12, and a distal end of the locking ring 40 may be at least partially disposed within the guard member 32. A locking ring biasing member 51 may be axially disposed between a distally facing surface of the locking ring 40 and a proximally facing surface of the guard member 32. The locking ring biasing member 51 may initially be in a compressed or biased state to bias the locking ring 40 and the guard member 32 away from each other. Thus, lock ring biasing member 51 can exert a biasing force that urges guard member 32 toward the extended position, as well as a biasing force that urges the proximal end of lock ring 40 against a portion of housing 12, such as annular collar 12d. In some embodiments, lock ring biasing member 51 can include a compression spring (e.g., a compression coil spring).

[0102] The locking ring 40 may also function to provide initial resistance to movement of the guard member 32. As described above, the device 10 may be inserted into a patient using, leveraging, or otherwise utilizing inertial forces. As described in more detail below, the locking ring 40 and / or other components may provide initial resistance to movement of the guard member 32 to accumulate user-input forces.

[0103] FIG. 13 shows a perspective view of the lock ring 40. In the example shown in FIG. 13, the lock ring 40 includes a cam surface 40a that is not parallel to the axis A and is configured to convert translational motion of the shield guard 32 into rotational motion of the lock ring 40. As a more specific example, the cam surface 40a shown in FIG. 13 is at an angle 40d relative to the axis A of approximately −30 degrees. Any suitable angle, such as −10 to −80 degrees, −20 to −70 degrees, −20 to −60 degrees, −20 to −50 degrees, −20 to −40 degrees, −25 to −35 degrees, or any other suitable angle, may be used. The angle 40d may be a positive number (such that the angled surface is flipped about the axis A), however, such a configuration causes the lock ring 40 to rotate in the opposite direction. In such cases, any suitable angle may be used, such as 10 to 80 degrees, 20 to 70 degrees, 20 to 60 degrees, 20 to 50 degrees, 20 to 40 degrees, 25 to 35 degrees, or any other suitable angle.

[0104] 13, locking ring 40 includes locking arms 40b, which may be generally cantilevered arms extending from (along the periphery of) a body portion of locking ring 40. Locking arms 40b may include ridges 40c that extend transversely (i.e., outwardly and non-parallel to axis A) relative to the body portion of locking ring 40.

[0105] FIG. 14 illustrates the locking ring 40 along with various other components of the device in a pre-deflection stage (e.g., before the guard member 32 is axially deflected proximally). For example, FIG. 14 illustrates the distal portion of the housing 12 (partially cross-sectional for illustrative purposes), the guard member 32 (translucent and partially cut away for illustrative purposes), the locking ring 40, and a portion of the housing's inner collar 12d. The guard member 32 includes a plurality of ribs formed on its inner annular surface. These ribs are visible in FIG. 14, although portions of the annular surface itself have been cut away for illustrative purposes. Similarly, portions of the housing 12 have been cut away for illustrative purposes, although the annular collar 12d formed on the inner surface of the housing 12 is visible in FIG. 14. When the device 10 is in a pre-deflection stage (as shown in FIG. 14), the raised portion 40c is adjacent to the inertia rib 32k formed on the inner annular surface of the guard member 32. As a more specific example, when device 10 is in a pre-deflection stage, ridge 40c is positioned to the left of inertia rib 32k such that locking ring 40 generally prevents rotation (thereby preventing axial deflection of guard member 32) until ridge 40c can move past (i.e., pass through) inertia rib 32k. This configuration is described in more detail below.

[0106] 15A and 15B show views from different angles (approximately 90 degrees apart) of the device in the initial deflection stage, just after guard member 32 has released from engagement with locking arm 40b. As a more specific example, locking ring 40 has rotated such that ridge 40c has just cleared locking rib 32k, thereby allowing guard member 32 to deflect more freely (proximally). At this point in the sequence, the injection sequence does not appear to have been initiated. For example, plunger biasing member 50 does not appear to have been released yet because housing 12 has not yet moved distally enough for delivery member 16 to pierce the user's tissue.

[0107] For the device components to transition from the stage shown in FIG. 14 to the stage shown in FIGS. 15A and 15B, two main events occur substantially simultaneously: the initial rotation of lock ring 40 and its release from locking arms 40b. With respect to the initial rotation, as shown in FIG. 15B, lock ring cam surface 40a is generally aligned with cam rib 32j to convert translational motion of shield guard 32 into rotational motion of lock ring 40. As a more specific example, as the shield guard is retracted, the proximally facing top surface of cam rib 32j applies an axially upward force to cam surface 40a. As a more specific example, due to the angle of cam surface 40a relative to axis A, the upward force from cam rib 32j has an axial component (along axis A) and a rotational component (transverse to axis A), causing lock ring 40 to rotate. In other words, in both the stage shown in FIG. 14 and the stages shown in FIGS. 15A and 15B, deflection (retraction) of guard member 32 causes rotation of lock ring 40. While cam rib 32j biases lock ring 40 to rotate to the right (i.e., counterclockwise when viewed from above in FIG. 15B), locking arm 40b may substantially block such movement. For example, when guard member 32 is pushed, guard member 32 moves from the position shown in FIG. 14 to the position shown in FIGS. 15A and 15B. As a more specific example, when device 10 is in the position shown in FIG. 14, ridge 40c is positioned to the left of inertia rib 32k so that lock ring 40 cannot rotate beyond a certain point until ridge 40c can pass inertia rib 32k. As shown in FIG. 15A, radially inward deflection of locking arm 40b may allow ridge 40c to pass inertia rib 32k. In such a design, the flexion of the locking arms 40b at least partially determines the force required for the ridges 40c to clear the inertia ribs 32k. In other words, the flexion of the locking arms 40b at least partially determines the force required to sufficiently deflect the guard member 32 to initiate the injection process. The angle of the ridges 40c relative to the circumference of the locking ring 40 may also partially determine the force required to sufficiently deflect the guard member 32 to initiate the injection process.Furthermore, the degree of rotation that locking ring 40 must undergo in order for ridge 40c to clear inertia rib 32k will at least partially determine the distance guard member 32 will translate (axially) before locking arm 40b will "release" guard member 32.

[0108] During operation, when the patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 may advance a relatively small distance (e.g., 2-4 mm) toward the injection site. The patient may then feel resistance between the inertia rib 32k and the protuberance 40c. As the patient presses down with more force, the protuberance 40c passes the inertia rib 32k, and the delivery device 10 compresses the needle cover and its spring to a predetermined release point while implementing a rapid release to utilize stored energy in the patient's muscles. The release mechanism, such as the bending of the locking arm 40b described above, the degree of rotation required to clear the inertia rib 32k, and other parameters may be designed so that when the protuberance 40c passes the inertia rib 32k, the resulting needle insertion speed exceeds the patient's reaction speed, and this speed, combined with the mass of the device, allows the needle to quickly and completely penetrate the skin to a subcutaneous depth. In other words, once the guard member 32 reaches the position shown in Figures 15A and 15B, resistance to pushing on the guard member is significantly reduced, allowing the needle to be inserted before the patient can stop the insertion process. As a more specific example, at this stage in the insertion process, the primary resistance to deflection of the guard member 32 from the distal components of the device comes from the locking ring bias member 51, which is significantly less than the resistance provided by the locking arm 40b. Note also that the user may still feel resistance to deflection of the guard member 32 due to other sub-components of the device, such as the activation of the drive mechanism 30. From this point on, the insertion process occurs very quickly, but subsequent stages are discussed in more detail in the figures and in the following sections.

[0109] 16A and 16B show views from different angles (approximately 90 degrees apart) when the device is in its continued downward movement phase (later than in FIGS. 15A and 15B, with the housing moving further distally and the guard member 32 further retracted). At the point in the sequence shown in FIGS. 16A and 16B, the injection sequence may or may not have begun, depending on the desired release parameters, such as needle length, desired insertion depth, and distance between the guard member 32 and the needle tip.

[0110] As shown in FIG. 16A, at this point in the sequence, cam rib 32j of guard member 32 has passed or is about to pass cam surface 40a, allowing guard member 32 to deflect without rotating lock ring 40. Additionally or alternatively, angled surface 40e of lock ring 40 may engage angled surface 12g of housing 12 (which may be defined by annular collar 12d and be similar to or the same as angled surface 412g of FIG. 25). This interaction between surfaces 40e, 12g may also facilitate rotation of lock ring 40 until lock ring 40 reaches the point shown in FIGS. 16A and 16B. Additionally or alternatively, stop ridge 40f of lock ring 40 engages stop rib 32n, limiting rotation of lock ring 40 at this stage of insertion. However, as noted above, at this stage, guard member 32 can deflect without requiring or causing further rotation of lock ring 40. More specifically, as shown in Figures 16B and 17, adjacent ribs (stop rib 32n and cam rib 32j) extend between adjacent components of lock ring 40 (stop ridge 40f and cam surface 40a), causing guard member 32 to bias against housing 12.

[0111] FIG. 17 shows the device in its final insertion stage, with the guard member fully or nearly fully retracted. At this point in the sequence, the injection sequence appears to be activated. For example, the plunger biasing member 50 appears to be released, and the delivery member 16 is inserted into the user's tissue. Furthermore, at this point in the sequence, the guard member 32 is at or approaching its fully retracted position relative to the housing 12, and the device 10 is still pressed against the patient's skin. The user preferably holds the device 10 in this position at least until the drug delivery process is complete (i.e., when the full dose of the drug 22 has been delivered to the patient) and the end-of-dose notification indicates that administration is complete. Note that for purposes of illustration, portions of the guard member 32 shown in FIG. 17 have been cut away, and FIG. 17 does not show the housing 12 (including the annular collar) or the drug reservoir 20.

[0112] 18A and 18B show device 10 in a locked configuration when guard member 32 is in a fully extended position (FIG. 18A) or a nearly fully extended position (FIG. 18B). As a more specific example, stop ribs 32n and camming ribs 32j of guard member 32 are aligned with stop ridges 40f to limit and / or prevent deflection of guard member 32 in the proximal direction. As another more specific example, guard member 32 can only move proximally the distance indicated by gap 91 in FIG. 18A, so guard member 32 cannot move axially proximally a sufficient distance to expose delivery member 16. In other words, guard member 32 is locked in a guard position that annularly surrounds the needle and minimizes or prevents inadvertent needle sticks.

[0113] In some embodiments, the gripper 13 can be configured to prevent deflection of the locking arms 40b prior to removal of the removable cap 19. By way of example, the outer surface of the gripper 13 can be configured to abut the inner surface of the locking arms 40b to prevent radially inward deflection of the locking arms 40b prior to removal of the removable cap 19. This configuration can reduce the possibility of unintentional lockout due to vibration or sudden movement during transportation or storage of the drug delivery device 10 prior to use. Once the removable cap 19 is removed along with the gripper 13, the locking arms 40b can be deflected as described above.

[0114] Lock ring 40 and housing 12 have respective stop surfaces that abut against each other to prevent rotation between lock ring 40 and housing 12. For example, lock ring 40 may have stop surfaces 40g and 40h (FIGS. 18A, 13) that abut against stop surfaces 12j and 12k (FIG. 18A) on annular collar 12d. Each stop surface 40g, 40h on lock ring 40 and each stop surface 12j, 12k on annular collar 12d may be a stepped surface to prevent or inhibit rotation between lock ring 40 and housing 12. Lock ring biasing member 51 may urge lock ring 40 proximally and / or guard member 32 distally to hold lock ring 40 in a predetermined position, as shown in FIGS. 18A and 18B, i.e., abutting annular collar 12d.

[0115] The circular cross-section of the housing 12 may cause the housing 12 to tend to roll across a surface when the housing 12 is laid on its side. To inhibit or prevent such rolling, a portion or all of the removable cap 19 may have a non-circular cross-section. In the illustrated embodiment, the removable cap 19 has a distal end with a non-circular cross-section and a proximal end with a circular cross-section. Thus, the cross-section of the removable cap 19 gradually transitions from a circular cross-section to a non-circular cross-section as one moves from the proximal end of the removable cap 19 to the distal end of the removable cap 19. In the illustrated embodiment, the non-circular cross-section of the distal end of the removable cap 19 takes the form of a substantial square. In other embodiments, the non-circular cross-section may be rectangular, triangular, or any other polygonal or partial polygonal shape, so long as one or more faces of the removable cap 19 are flat or substantially flat to inhibit or prevent rolling. Additionally, the non-circular cross-section of the distal end of removable cap 19 may gradually increase in size moving distally, such that the most distal portion of the distal end of removable cap 19 has a larger cross-sectional area than the most proximal portion of the distal end of removable cap 19. This configuration imparts a flared shape to the distal end of removable cap 19, which may further aid a user in grasping and removing removable cap 19 from housing 12.

[0116] In some embodiments, the housing 12 and the removable cap 19 may each include respective anti-rotation features. These anti-rotation features may engage with one another to prevent or inhibit the removable cap 19 from rotating relative to the housing 12 when the removable cap 19 is in the storage position. In some embodiments, the anti-rotation feature of the housing 12 may be adjacent to and substantially aligned with the anti-rotation feature of the removable cap 19 when the removable cap 19 is in the storage position. For example, the radial protrusion 9 shown in FIG. 1A is disposed adjacent the distal end of the housing 112. As shown in FIG. 1B, the removable cap 19 includes an opening 8 that may be sized to matingly receive the radial protrusion 9 when the removable cap 19 is in the storage position. As a result of this mating engagement, the removable cap 19 may be unable to rotate relative to the housing 12. This may be beneficial if a user attempts to twist the removable cap 19 to remove it from the housing 12. In some cases, rotation of removable cap 19 can cause a sterility barrier, such as an RNS or FNS, to rotate, which in turn can cause the needle tip to become embedded in the RNS or FNS of the seal member. Therefore, positioning radial projection 9 within opening 8 can prevent needle coring, at least during the initial moments of cap removal. In another embodiment, opening 8 can be formed in the wall of housing 12, and radial projection 9 can extend proximally from the proximal end of removable cap 19.

[0117] In other embodiments, the removable cap may be capable of and / or intended to rotate relative to the housing. For example, the removable cap may include a feature that translates rotational movement of the removable cap into an axial assist force that assists in separating the cap from the housing. As a more specific example, the removable cap and / or housing may have a cam surface, such as a wavy surface, that translates rotational movement of the removable cap relative to the housing into axial distal movement of the removable cap relative to the housing. The axial assist force provided by such a configuration may be beneficial to a variety of users, including those with limited dexterity and / or strength due to, for example, an illness.

[0118] 19A-19B each illustrate an exemplary force profile during an injection process of an exemplary drug delivery device, with the relative displacement between the device housing and guard member plotted along the x-axis (millimeters) and the resistance plotted along the y-axis (Newtons). For example, displacement (along the x-axis) indicates the relative axial displacement between the guard member 32 and the housing 12 along axis A. As discussed above, this relative axial displacement can be understood to refer to the translational movement of the housing 12 relative to the guard member 32 (e.g., when a user pushes the housing distally toward the user's injection site, while the user's tissues prevent the guard member 32 from moving in the same direction), or to the translational movement of the guard member 32 relative to the housing (e.g., when the housing 12 is held in place and the user pushes the guard member 32 proximally). In either case, the x-axis (horizontal) of the graph in FIG. 19 indicates the relative displacement between the guard member 32 and the housing 12. The y-axis (vertical) of the graph in FIG. 19 represents the resistance force at various points in time for relative displacement between the guard member 32 and the housing 12. For example, the resistance force experienced by the user when the guard member 32 and the housing 12 undergo a relative displacement of approximately 2 mm is approximately 7.75 N in the force profile shown in FIG. 19A. As a more specific example, resistance may refer to the force experienced by the user due to mechanical interactions between device components. For example, when initially pushing the housing 12 toward the injection site in the pre-injection state shown in FIG. 14, the resistance force is approximately equal to the force required to compress the spring 51 and the force required to push the inertia rib 32k past the protuberance 40c. The force profiles in FIGS. 19A-19B represent some example, potentially desired force and displacement values; therefore, it is understood that these values ​​may vary depending on the design of the aforementioned interactions.

[0119] Nevertheless, as shown in the exemplary force profile of FIG. 19A, the initial resistance is relatively small for the first approximately 1 mm of movement between the guard member 32 and the housing, after which the resistance rapidly increases at point 202 (primarily due to the force required to push the inertia rib 32k over the ridge 40c) and reaches a peak resistance at point 204. Once the inertia rib 32k passes the ridge 40c (FIG. 15A), the resistance rapidly decreases to point 206. At this point, the resistance is primarily due to the force required to compress the spring 51 (FIG. 14), the force required to compress the spring 35 (FIG. 11B), and frictional forces between the various moving components within the device. At point 208, the needle is inserted into the user's tissue, and at point 210, the injection phase begins, with the drug 22 being injected into the user's tissue. Once the user overcomes the peak resistance at point 204, the user's inertia can drive the housing and drug reservoir toward the injection site, facilitating needle insertion. This injection phase (between points 204 and 208) can occur relatively quickly due to user inertia, increasing the likelihood that the needle will be fully inserted rather than partially inserted, and decreasing the likelihood that the user will stop the device before or during partial needle insertion. In other words, once the user clears the peak resistance force at point 204, the user can "commit" to the needle insertion and / or injection process.

[0120] 19B shows another example force profile in which the peak force (point 304) is lower than the corresponding point (204) in FIG. 19A, such that a smaller initial force is required for the user to commit to insertion. This force profile may reduce the likelihood that the user will stop the process, such as by prematurely removing the device from the tissue, during the initial push (point 302). However, it may be desirable to have the peak force 304 high enough to reduce the likelihood that the user will stop the injection between peak force 304 and needle insertion 308. In other words, the vertical distance (along the y-axis) between points 304 and 308 should be large enough to allow this injection stage to occur in a relatively short time.

[0121] 20A-20G show the distal portion of another design of device 400, primarily showing housing 412, guard member 432, locking ring 440, and locking ring biasing member 451. As shown in FIGS. 20A and 22, guard member 432 includes an annular base 432a, a pair of longitudinally extending arms 432b, a raised portion 432h, a plurality of internal ribs (described in more detail below), and at least one opening 432x (also referred to as a hole in some of the figure annotations) formed in at least one of the ribs and walls of the guard member. The opening 432x need not be an opening formed in the entire wall of guard member 432. For example, the opening could simply be a discontinuity in a long rib or protruding section having a lower height, rather than a cutout in a portion of the wall and rib of guard member 432. The internal ribs of guard member 432 include a first rib that is preferably longer than the other ribs (also known as long rib 432r) and a pair of shorter ribs 432s, 432t. An opening 432x is formed in long rib 432r and is sized to align with and selectively receive components of lock ring 440, for example, as described further below. As shown in FIGS. 20A and 23, lock ring 440 includes a plurality of stop surfaces 440g, 440h, a U-shaped protrusion 440w (configured to be received in opening 432x), and a plurality of proximally facing cam surfaces 440x, 440y. However, lock ring 440 shown in FIGS. 20A and 23 does not have a distally facing cam surface corresponding to surface 40a in the design shown in FIG. 13. 20A, during the pre-implant, undeflected state of device 400, each of the two U-shaped protrusions 440w is not initially received within opening 432x. Rather, at this point, the proximal portion of long rib 432r (i.e., the portion of long rib proximal to opening 432x) is received within U-shaped protrusion 440w, for example, to prevent upward (proximal) movement of the locking ring relative to the guard member.As shown in FIG. 20B, as housing 412 moves downward (distal) and / or guard member 432 moves upward (proximal), lock ring 440 can move upward (proximally) from spring 451, causing the cam surfaces of housing 412 to contact lock ring cam surfaces 440x, 440y and rotatably urging the lock ring. At the stage shown in FIG. 20B, lock ring 440 cannot rotate because the proximal portion of long rib 432r is aligned with / received within U-shaped protrusion 440w. Also shown in FIG. 20B, housing cam surface 412x engages lock ring cam surface 440y. However, as the relative motion between the guard member and housing progresses to the condition shown in FIG. 20C, the engagement between housing cam surface 412x and lock ring cam surface 440y, combined with further relative motion between the guard member and housing, causes the following: (1) the engagement between housing cam surface 412x and lock ring cam surface 440y stops the upward movement of the lock ring and allows the proximal portion of long rib 432r to move out of alignment / engagement with U-shaped protrusion 440w, which is now aligned with opening 432x, and (2) the engagement of the respective cam surfaces 412x, 440y causes lock ring 440 to rotate. As shown in Figure 20D, the locking ring rotates to a point (approximately two-thirds of its full rotation) where it is now rotationally restrained by short ribs 432s, 432t on the guard member (more specifically, stop surfaces 440v shown in Figure 23 engage short ribs 432s, 432t). In the state shown in Figure 20E, the guard member arms 432b have moved sufficiently relative to the housing 412 to begin the injection sequence. As shown in Figure 20F, when the user releases pressure on the housing, allowing relative proximal movement of the housing and / or distal movement of the guard member, the locking ring is rotationally restrained until stop surfaces 440v pass short ribs 432s, 432t and the locking ring rotates to the locked out configuration shown in Figure 20G.

[0122] 26A-26D illustrate another alternative design of device 600, primarily showing housing 612, guard member 632, locking ring 640, and locking ring biasing member 651. As shown in FIG. 26B, guard member 632 includes an annular base portion 632a, a pair of longitudinally extending arms 632b, a raised portion 632h, a plurality of internal ribs (described in more detail below), and at least one opening 632x (also referred to herein as a hole) formed in at least one of the ribs and walls of the guard member. Each rib of guard member 632 may be configured as a protrusion extending radially inward. Opening 632x need not be an opening formed in the entire wall of guard member 632. For example, opening 632x may simply be a discontinuity in a long rib or protrusion section having a reduced height, rather than a cutout in a portion of the wall and rib of guard member 632. Openings 632x are formed in ribs 632r and are aligned with and sized to selectively receive components of lock ring 640, for example, as described further below. As shown in FIGS. 26A, 26B, and 26D, lock ring 640 includes a plurality of stop surfaces 640g, 640h, at least one tab-shaped protrusion 640w (configured to be received within opening 632x), and a plurality of proximally facing cam surfaces 640y. As shown in FIG. 26A, each tab-shaped protrusion 640w may be configured as a radially outward extending protrusion and may include a proximally facing cam surface 640z. As shown in FIG. 26D, prior to implantation of device 600, during the partially deflected state, each of two tab-shaped protrusions 640w is initially not received within opening 632x. Rather, at this point, proximally facing cam surfaces 612x of housing 612 engage distally facing cam surfaces 640y of locking ring 640, preventing or inhibiting upward (proximally) movement of locking ring 640 relative to guard member 632. At the same time, tab-shaped protrusions 640w each engage a pair of ramp surfaces 632y (also referred to herein as proximally facing cam surfaces 632y).At this stage of the injection, the guard member 632 is partially deflected (e.g., as shown in FIG. 20B), but the locking ring 640 has not yet rotated, and the guard member 632 has not yet moved upwardly far enough to initiate the injection sequence. At this point, the user will experience resistance to further movement of the injector housing 612 due to the engagements described above, i.e., between the proximal-facing cam surface 612x of the housing 612 and the distal-facing cam surface 640y of the locking ring 640, and between the proximal-facing cam surface 640z of the tab-shaped protrusion 640w of the locking ring 640 and the guard member ramp surface 632y. This resistance can or may prompt the user to depress the injector with enough force to overcome the resistance (i.e., the peak resistance of the injector). The peak resistance is created by the aforementioned interactions (distal-facing cam surface 612x of housing 612 and proximal-facing cam surface 640y of lock ring 640, and distal-facing cam surface 640z of tab-shaped protrusion 640w of lock ring 640 and guard member ramp surface 632y), and is overcome (i.e., released) when the user's force is sufficient to cause tab-shaped protrusion 640w of lock ring 640 to slide along guard member ramped surface 632y and proximal-facing cam surface 640y of lock ring 640 to slide along distal-facing cam surface 612x of housing 612 (to the left in FIG. 26D ). In other words, lock ring 640 rotates in the direction of arrow 601 and moves slightly downward (distal) (as shown in FIG. 26D ). Once locking ring 640 has rotated sufficiently so that locking ring tab-shaped protrusion 640w clears guard member angled surface 632y, guard member 632 can move axially upward (proximally). At this point, two things happen: (1) guard member 632 translates proximally a sufficient distance to, for example, initiate an injection sequence, and (2) locking ring tab-shaped protrusion 640w axially aligns with guard member opening 632x (FIG. 26C), thereby allowing locking ring 640 to rotate in the direction of arrow 602 (FIG. 26D) and slightly upward (proximally) due to interaction between proximally facing cam surface 640y of locking ring 640 and distally facing cam surface 612x of housing 612.As with the other embodiments described above, after an injection has been initiated, the locking ring 640 is in a position that can lock out the shield. The injector 600 may be designed so that events (1) and (2) occur simultaneously, such that when the guard member translates a sufficient distance to initiate an injection, the locking ring rotates a sufficient angle to initiate the lockout sequence. This may be desirable to substantially or completely prevent a user from attempting to perform multiple injections. This may also be desirable to substantially or completely prevent a lockout sequence from being initiated without also initiating an injection sequence. In other words, the above configuration can reduce the likelihood of a user having a locked-out injector with an undelivered dose.

[0123] To facilitate rotation of lock ring 640 relative to housing 612 and / or guard member 632, any two or combination of the following may be parallel to one another: distally facing cam surface 612x of housing 612, proximally facing cam surface 632y of guard member 632, distally facing cam surface 640z of lock ring 640, and proximally facing cam surface 640y of lock ring 640.

[0124] 21A-21F show the distal portion of another alternative design of device 500, primarily showing housing 512, guard member 532, lock ring 540, and lock ring biasing member 551. The components of device 500 are similar to those of device 400, except that lock ring 540 has only a pair of parallel protrusions 540w instead of U-shaped protrusion 440w, and no horizontal protrusion connecting them. In other words, protrusion 540w has a U-shaped "side" but no U-shaped "bottom." In the state shown in FIG. 21A, protrusion 540w is received within a long rib of guard member 532 to prevent rotational movement of the lock ring. As relative movement occurs between the guard member and the housing, protrusion 540w aligns with an opening in the guard member, thereby allowing rotational movement of the lock ring relative to the guard member (and being pushed by the cam surface of the housing), as shown in FIG. 21B. As shown in Figure 21C, the locking ring is then rotated until stop surface 440v engages the short rib of the guard member. Figure 21D shows the distal components of the device during injection activation. Figure 21E shows the distal components after the user releases pressure, allowing the guard member to move (extend distally) relative to the housing. Figure 21F shows the lockout configuration.

[0125] FIG. 24 provides a graph comparing the force profiles shown in FIGS. 19A and 19B with those of the drug delivery device 400 shown in FIGS. 20A-20G and the drug delivery device 500 shown in FIGS. 21A-21F. Similar to FIGS. 19A and 19B, FIG. 24 plots the resistance force experienced by the user versus the displacement of the shield (e.g., shield guard 32). Additionally, FIG. 24 reveals where the locking point associated with the locking ring is designed to occur within each force profile. FIG. 24 shows that the locking points of the force profiles in FIGS. 19A and 19B occur at the same shield displacement as when the user experiences peak resistance. In contrast, the locking points of the force profiles associated with the drug delivery device 400 and the drug delivery device 500 do not coincide with the shield displacement corresponding to the peak resistance experienced by the user.

[0126] 24 , the force profile associated with drug delivery device 400 is similar to the force profiles of FIGS. 19A and 19B in that, prior to needle insertion, the user experiences a sudden increase in resistance due to shield displacement. Unlike the force profiles of FIGS. 19A and 19B , the resistance experienced by a user of drug delivery device 400 may continue to increase after this increase (until an activation point). FIG. 24 illustrates that a user of drug delivery device 500 may not experience a sudden increase in resistance during shield displacement, but rather may experience a gradually increasing resistance until an activation point. A manufacturer may select one of the force profiles shown in FIG. 24 or a different force profile depending, for example, on the desired user experience, the physical and / or mental capabilities of the intended user or patient population, mechanical safety considerations, and / or additional considerations.

[0127] From the above, it can be seen that the present disclosure advantageously provides a streamlined design of a drug delivery device having automated features, wherein the various mechanisms and components of the drug delivery device can interact with each other synergistically to limit the number of moving parts required by the drug delivery device, thereby improving the reliability of the drug delivery device, saving costs, as well as providing other benefits and advantages.

[0128] It will be understood that devices and methods according to the present disclosure may have one or more advantages over the prior art, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment, and other advantages not specifically recited herein may be understood as well.

[0129] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0130] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0131] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006, pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0132] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates red blood cell production. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0133] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, and related proteins, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to their receptors. Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., the human form of epratuzumab (CAS Registry Number 501423-23-0). Human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, particularly including but not limited to, human CD22-specific IgG antibodies, such as CD22-specific fully humanized antibodies; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, and related proteins (also referred to as "B7RP-1," B7H2, ICOSL, B7h, and CD275), including but not limited to, those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells, including but not limited to, a B7RP-specific fully human monoclonal IgG2 antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1; HuMax, e.g., 145c7 IL-15 specific antibodies, peptibodies, related proteins, etc., including, but not limited to, IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies; human IFNIFN-γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to, IFN-γ-specific antibodies, and fully human anti-IFN-γ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; and those targeting the hepatocyte growth factor / scatter factor (HGF / SF:c-Met) axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize HGF / SF. including, hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc.; TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-β-specific antibodies, peptibodies, related proteins, etc.; amyloid β protein-specific antibodies, peptibodies, related proteins, etc.; c-Kit-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to X40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP), Epogen (R) (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast cancer or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), (panitumumab), Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP)), Kineret® (anakinra), Leukine® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat B, belimumab, anti-BlySmAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Mvasi™ (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon alpha-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-alpha4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (VEGFR1 Ig domain fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatumumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (zalutumumab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-Clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMaxCD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF idiopathic pulmonary fibrosis stage 1 febrile disease (FG-3019), anti-CTLA4 mAb, anti-Eotakisin 1 mAb (CAT-213), anti-FGF8 mAb, anti-Gangri-Octop GD2 mAb, anti-Gangri-Octop GM2 mAb, anti-GDF-8 Hite 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 (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-Integrin receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), BMS-66513, anti-Mannos receptor / hCGβ mAb (MDX-1307), anti-Methotrein 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 mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, and anti-ZP3 mAb (HuMax-ZP3).

[0134] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, BPS804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing; in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)—N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF inhibitor, such as a non-antibody VEGF inhibitor, and / or a VEGF trap, such as aflibercept (fused to Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2, Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP959 (eculizumab), a biosimilar candidate for Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used in conjunction with rozivacsp alfa (formerly AMG570), a novel bispecific antibody-peptide conjugate that simultaneously inhibits the activity of ICOSL and BAFF. In some embodiments, the drug delivery device may contain or be used in conjunction with omecamtiv mecarbil (a small molecule selective cardiac myosin activator) or a myotrope (which directly targets the cardiac contractile machinery) or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG510), a KRAS inhibitor. G12C Small molecule inhibitors, or KRAS G12CThe drug delivery device may contain or be used in conjunction with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG714, a human monoclonal antibody that binds interleukin-15 (IL-15), or a human monoclonal antibody that binds interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used in conjunction with Amjevita™ or Amgevita™ (formerly ABP501) (a monoclonal antibody anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product including a human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG160, or another product including a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA)xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG119 or a 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 in conjunction with another product containing AMG119, or a 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 in conjunction with another product containing AMG133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG199, or a half-life extended (HLE) bispecific T cell derivative construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG256, or another product containing an anti-PD-1xIL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1)-positive cells. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG330, or another product containing an anti-CD33xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3)xanti-CD3 BiTE® (bispecific T cell derivative) construct.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG506, or another product containing a multispecific FAPx4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG509, or another product containing a bivalent T cell derivative and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG562, or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with efabaleukin alfa (formerly AMG592), or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG509, or another product containing a bivalent T cell derivative and designed using XmAb® 2+1 technology. The device may contain or be used in conjunction with AMG596, or another product containing a CD3x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell derivative) molecule. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG673, or another product containing a half-life extended (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG701, or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG757, or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG910 or another product containing the half-life extended (HLE) epithelial cell tight junction protein Claudin 18.2xCD3 BiTE® (bispecific T cell derivative) construct.

[0135] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to the exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0136] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. a housing defining a longitudinal axis and having an opening; a drug reservoir including a delivery member having an insertion end configured to extend at least partially through the opening in a delivery state; a plunger movable toward a distal end of the drug reservoir to expel the drug from the drug reservoir through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness of less than 0.6 millimeters; a plunger biasing member coupled to the plunger and configured to urge the plunger toward the distal end of the medication reservoir; 10. A drug delivery device comprising:

2. The drug delivery device of claim 1 , wherein the body thickness is less than 0.4 millimeters.

3. The drug delivery device of claim 1 , wherein the body thickness is less than 0.3 millimeters.

4. The drug delivery device of claim 1 , wherein the body thickness is less than 0.2 millimeters.

5. The drug delivery device of claim 1 , wherein the body thickness is less than 0.1 millimeters.

6. The drug delivery device of claim 1 , wherein the body thickness is less than 0.05 millimeters.

7. a housing defining a longitudinal axis and having an opening; a drug reservoir including a delivery member having an insertion end configured to extend at least partially through the opening in a delivery state; a plunger movable toward a distal end of the drug reservoir to expel the drug from the drug reservoir through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber and an outer wall cooperating with the inner wall to define a body thickness; a plunger biasing member disposed at least partially within the axial chamber, the plunger biasing member configured to urge the plunger toward the distal end of the medication reservoir; 10. A drug delivery device comprising:

8. The drug delivery device of claim 7 , wherein the body portion has a hollow tubular shape.

9. 9. The drug delivery device of claim 7 or 8, wherein the body portion is made of metal.

10. 9. The drug delivery device of claim 7 or 8, wherein the body portion is non-metallic.

11. The plunger selectively rotate from an initial rotation position to a second rotation position under a biasing force exerted by the plunger biasing member; and after rotating from the initial rotational position to the second rotational position, translating linearly toward the distal end of the medication reservoir under the biasing force exerted by the plunger biasing member. The drug delivery device according to any one of claims 7 to 10, wherein the drug delivery device is configured as follows:

12. A drug delivery device according to any one of claims 7 to 11, further comprising a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide.

13. 13. The drug delivery device of claim 12, wherein one of the plunger and the plunger guide includes a cam and the other of the plunger and the plunger guide includes a cam follower.

14. 14. The drug delivery device of claim 13, wherein the plunger includes the cam follower, the plunger guide includes the cam, and the cam follower is formed by at least one flange extending radially outward from the plunger.

15. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.6 millimeters.

16. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.4 millimeters.

17. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.3 millimeters.

18. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.2 millimeters.

19. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.1 millimeters.

20. The drug delivery device of any one of claims 7 to 14, wherein the body thickness is less than 0.05 millimeters.

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