Drug delivery devices

Abstract

This concerns a device for automatically injecting drugs into patients. [Solution] The drug delivery device may include a drug storage container 20 having a housing with an opening, a body portion having a proximal end and a distal end, and a delivery member extending from the distal end of the body portion. The device may also include a plunger movable toward the distal end of the drug storage container for discharging a drug from the drug storage container through the delivery member, and a plunger biasing member configured to push the plunger toward the distal end of the drug storage container. The device may further include a container holder 31 configured to support the drug storage container relative to the housing such that the resultant force acting on the drug storage container from the plunger biasing member is at least substantially completely supported by the distal end of the body portion of the drug storage container.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 908,504, filed on September 30, 2019, entitled "Drug Delivery Device"; U.S. Provisional Patent Application No. 62 / 961,006, filed on January 14, 2020, entitled "Drug Delivery Device"; and U.S. Provisional Patent Application No. 62 / 961,014, filed on January 14, 2020, entitled "Drug Delivery Device", which are hereby incorporated by reference in their entirety.

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

Background Art

[0003] General aversion to exposed needles and health and safety concerns have led to the development of drug delivery devices that hide the needle or other insertion member before use and automate various aspects of the injection process. Such devices offer various advantages compared to conventional forms of drug delivery, including, for example, delivery by a conventional syringe.

[0004] Many injector systems use a coil spring structure to supply operating energy for functions such as needle insertion and / or fluid delivery. While the use of springs can offer advantages such as simplicity and low cost, it may have certain limitations. For example, there is a linear relationship between force and the displacement of the spring actuator. When initiating drug delivery, an excess amount of energy may be input to the system to supply sufficient energy for drug delivery at the end of the plunger stroke. As another example, when delivering more viscous drugs by an autoinjector, the required spring force will likely increase. The higher the spring constant, the greater the force that can be transmitted to the drug product and the primary container. Since kinetic energy is proportional to the square of the velocity, even a small increase in the spring constant can lead to a large change in the net kinetic energy applied to the drug and the primary container. The force generated by the excess energy can cause catastrophic consequences, such as damage or destruction of the primary container and the drug product. Therefore, it may be desirable or advantageous to provide a drug delivery device that can maintain the intended spring force load while mitigating such undesirable effects.

[0005] While autoinjectors may offer differences in operation compared to conventional non-automated drug delivery devices such as syringes, they may still use the same or similar primary containers as syringes. For example, an autoinjector may include a syringe, a syringe barrel, and / or other syringe components that serve as drug storage container components. Therefore, it may be desirable or advantageous for the remaining components of the autoinjector to correspond to syringe components, both during device assembly and operation.

[0006] This disclosure describes a drug delivery device that embodies a favorable alternative to existing drug delivery devices and can address one or more of the challenges or needs described herein. [Overview of the project] [Means for solving the problem]

[0007] One aspect of the present disclosure provides a drug delivery device comprising a drug storage container having a housing defining a longitudinal axis and having an opening, a main body portion having a proximal end and a distal end, and a delivery member extending from the distal end of the main body portion. The device may further include a plunger movable toward the distal end of the drug storage container for discharging a drug from the drug storage container through the delivery member, and a plunger biasing member configured to push the plunger toward the distal end of the drug storage container. The device may also include a container holder configured to support the drug storage container relative to the housing.

[0008] The container holder may support the drug storage container against the housing such that the resultant force acting on the drug storage container from the plunger biasing member is at least substantially completely supported by the distal end of the body portion of the drug storage container. For example, the container holder may support the drug storage container against the housing near (e.g., proximal) at least a portion of the distal end of the body portion of the drug storage container such that the resultant force acting on the drug storage container from the plunger biasing member is at least substantially completely supported by the distal end of the body portion of the drug storage container.

[0009] The container holder may include at least two inwardly projecting flanges configured to receive the distal end of the drug storage container body. The flanges may be separated from each other by at least two gaps.

[0010] The container holder may include an elastic portion configured to absorb at least a portion of the resultant force. The elastic portion may include an elastomer component. Additionally or alternatively, the elastic portion may include at least two inwardly projecting flanges configured to receive the distal end of the drug storage container body portion.

[0011] The container holder may be positioned within the housing and coupled to the housing in such a manner that it substantially prevents relative movement between the container holder and the housing. The housing may include an inner surface defining at least two slots, and the container holder may be coupled to the housing by the slots. The container holder may include at least two or four locking protrusions configured to be received within the slots, and the inner surface of the housing may define at least two or four slots for receiving the locking protrusions.

[0012] The container holder may be defined by the features of the housing and may be configured to substantially prevent relative movement between the drug storage container and the housing.

[0013] The drug storage container may include at least one outwardly projecting flange at the proximal end of the main body portion, and the drug storage container may be coupled to a container holder such that the resultant force acting on the drug storage container is not largely supported by the at least one outwardly projecting flange. The container holder may define at least one opening configured to receive at least one outwardly projecting flange.

[0014] The device may include a flexible arm configured to support the proximal end of the drug storage container body. For example, the device may include a plunger guide configured to receive at least a portion of a plunger biasing member, the plunger guide including a proximal end coupled to the housing and a distal end configured to contact the container holder. The plunger guide may define a flexible arm.

[0015] The container holder may include an open position for receiving a drug storage container and a closed position for securing the drug storage container. The container holder may include at least two arms configured to be selectively secured to each other.

[0016] The container holder may include at least one arm that is movable between an open position and a closed position.

[0017] The container holder may include at least two arms that are movable relative to each other between an open position and a closed position. The arms may extend generally along the longitudinal axis. The container holder may further include an annular ring that supports at least two of the arms. The annular ring may be adjacent to the distal part of the container holder, and at least two of the arms may extend proximal along the longitudinal axis.

[0018] The container holder may include at least one or at least two locking components configured to secure the container holder in a closed position. Each of the at least two locking components may include a pair of mating connectors configured to secure the container holder in a closed position. The container holder may include at least two inwardly projecting flanges configured to receive the distal end of a drug storage container. The container holder may also include at least two proximal inwardly projecting flanges configured to define a proximal opening for receiving a drug storage container when the container holder is in an open position.

[0019] Another aspect of the present disclosure provides a drug delivery device comprising a drug storage container having a housing defining a longitudinal axis and having an opening, a body portion having a proximal end and a distal end, and a delivery member extending from the distal end of the body portion. The device may further include a plunger movable toward the distal end of the drug storage container for discharging a drug from the drug storage container through the delivery member, and a plunger biasing member configured to push the plunger toward the distal end of the drug storage container. The device may also include a container holder configured to substantially fully support the drug storage container relative to the housing by the distal end of the body portion of the drug storage container.

[0020] This disclosure is considered to be more fully understood when interpreted 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 a particular element in any of the exemplary embodiments, except where explicitly described in the corresponding written specification. Furthermore, none of the drawings are necessarily drawn to an exact scale.

Brief Description of the Drawings

[0021] [Figure 1A] A perspective view of an exemplary drug delivery device according to various embodiments. [Figure 1B] A perspective view of the drug delivery device of FIG. 1A with the cap removed. [Figure 1C] A perspective view of the drug delivery device of FIG. 1A in the pre-injection configuration. [Figure 1D] A perspective view of the drug delivery device of FIG. 1A in the injection configuration. [Figure 2] A cross-sectional view of the drug delivery device of FIG. 1. [Figure 3A] An exploded view of a portion of the drug delivery device of FIG. 2, namely the drive mechanism. [Figure 3B] An exploded view of the drug delivery device of FIG. 2. [Figure 4A] A perspective view of an exemplary drug storage container for use with a drug delivery device according to various embodiments. [Figure 4B] A perspective view of an exemplary container holder for use with a drug delivery device according to various embodiments, with the container holder in the open position. [Figure 4C] A perspective view of the container holder of FIG. 4B coupled to the drug storage container of FIG. 4A, with the container holder in the closed position. [Figure 4D] A perspective view of an exemplary container holder for use with a drug delivery device according to various embodiments, with the container holder in the closed position. [Figure 4E]This is a perspective view of an exemplary housing for use with drug delivery devices according to various embodiments. [Figure 4F] This is a partial cross-sectional view of the container holder and drug storage container taken along line 4F-4F in Figure 4C. [Figure 5A] Figure 4C shows a partial cross-sectional view of the container holder and drug storage container, as well as a partial cross-sectional view of the distal portion of an exemplary plunger guide connected to the container holder and drug storage container, taken along line 5A-5A. [Figure 5B] This is a perspective view of exemplary plunger guides in various embodiments. [Figure 5C] Figure 5B is a perspective cross-sectional view of the plunger guide. [Figure 6A] This is a perspective view of exemplary guard members according to various embodiments. [Figure 6B] This is a perspective view of an exemplary guard extension according to various embodiments. [Figure 6C] This is a perspective cross-sectional view of the guard extension, releaser, and plunger guide, with the components in their pre-injection positions. [Figure 7A] This is a perspective view of exemplary release members according to various embodiments. [Figure 7B] This is another perspective view of the release member shown in Figure 7A. [Figure 8] Figure 5B shows the plunger guide, Figure 7A shows the release member, and Figure 2 shows the plunger 26, with the guide member shown in a semi-transparent form for illustrative purposes. [Figure 9A] This is a perspective view of an exemplary plunger guide, an exemplary release member, and an exemplary plunger, with a portion of the guide member shown in a cutout for illustrative purposes, and the drug delivery device in the pre-injection position. [Figure 9B] This is a perspective view of the components of Figure 9A, where the plunger is in the released position before axial movement by the plunger. [Figure 9C] This is a perspective view of the components of Figure 9A, showing the plunger in the released position after the axial movement by the plunger has begun. [Figure 10A]This is a top view of the components of Figure 9A, with the drug delivery device in the pre-injection position. [Figure 10B] This is a top view of the component shown in Figure 9B, where the plunger is in the released position before axial movement by the plunger. [Figure 10C] This is a top view of the component in Figure 9C, where the plunger is in the released position after the axial movement by the plunger has begun. [Figure 11A] This is a perspective view of the components of Figure 9A and additional components such as an exemplary guard extension, with the drug delivery device in the pre-injection position. [Figure 11B] Figure 11A is a perspective view of the components, showing that the guard extension has moved proximal, but the plunger is not released. [Figure 11C] Figure 11A is a perspective view of the components, where the guard extension has moved further proximal, and the plunger is released but has not yet moved axially. [Figure 12A] Figure 9A is a perspective view of the components and an exemplary guard biasing member, with the plunger in the released position after the start of axial movement by the plunger, and some of the components shown in notched form for illustrative purposes. [Figure 12B] Figure 12A shows a perspective view of the components and a more distal view of the device, with the guard expansion member and guard biasing member removed for illustrative purposes, the plunger at or near the end of administration position, but the release member not yet at the end of administration position. [Figure 12C] This is a perspective view of the components of Figure 12A, with the release agent in the end-of-administration position. [Figure 13] This is a perspective view of exemplary lock rings in various embodiments. [Figure 14] This is a perspective view of the distal portion of an exemplary device according to various embodiments, with the guard member in its pre-injection and pre-deflection state, and a portion of the housing shown as a notch for illustrative purposes. [Figure 15A] Figure 14 is a perspective view of the distal portion of the device shown, where the guard member is in the initial deflection stage. [Figure 15B]This is a perspective view of the same device and stage as shown in Figure 15A, viewed at approximately 90 degrees from Figure 15A. [Figure 16A] This is a perspective view of the distal portion of the device shown in Figure 14, where the guard member has been deflected further distally from the stage shown in Figure 15A. [Figure 16B] This is a perspective view of the same device and stage as shown in Figure 16A, viewed at approximately 90 degrees from Figure 16A. [Figure 17] Figure 14 is a perspective view of the distal portion of the device shown, where the guard member is in a position that is completely or almost completely deflected relative to the housing, such as during the injection phase. [Figure 18A] Figure 14 is a perspective view of the distal portion of the device shown, with the guard member fully retracted and locked in the housing, and the device in the post-injection stage. [Figure 18B] Figure 14 is a perspective view of the distal portion of the device, where the guard member is almost completely retracted into the housing and in a locked position, and the device is in the post-injection stage. [Figure 19A] This graph shows an exemplary force profile during the 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] This is another exemplary force profile during the injection process of an exemplary drug delivery device, similar to that shown in Figure 19A. [Figure 20A] This shows another exemplary drug delivery device in various embodiments. [Figure 20B] This shows another exemplary drug delivery device in various embodiments. [Figure 20C] This shows another exemplary drug delivery device in various embodiments. [Figure 20D] This shows another exemplary drug delivery device in various embodiments. [Figure 20E] This shows another exemplary drug delivery device in various embodiments. [Figure 20F] This shows another exemplary drug delivery device in various embodiments. [Figure 20G] This shows another exemplary drug delivery device in various embodiments. [Figure 21A] This shows yet another exemplary drug delivery device in various embodiments. [Figure 21B] This shows yet another exemplary drug delivery device in various embodiments. [Figure 21C] This shows yet another exemplary drug delivery device in various embodiments. [Figure 21D] This shows yet another exemplary drug delivery device in various embodiments. [Figure 21E] This shows yet another exemplary drug delivery device in various embodiments. [Figure 21F] This shows yet another exemplary drug delivery device in various embodiments. [Figure 22] Figures 20A to 20G and 21A to 21F show the guard members. [Figure 23] Figures 20A to 20G show the lock rings. [Figure 24] Two of the force profiles are shown in Figures 19A and 19B, respectively. One force profile (shown as a dashed line) is attributed to device 400 shown in Figures 20A to 20G, and the other force profile (shown as a dotted line) is attributed to device 500 shown in Figures 21A to 21F, illustrating the force profiles of various devices. [Figure 25] Exemplary perspective views of housings in various embodiments are shown. [Figure 26A] Figures 26A and 26B show different perspective views of the locking ring of the drug delivery device, Figure 26C shows a perspective view of the guard member of the drug delivery device, and Figure 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device in various embodiments. [Figure 26B]Figures 26A and 26B show different perspective views of the locking ring of the drug delivery device, Figure 26C shows a perspective view of the guard member of the drug delivery device, and Figure 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device in various embodiments. [Figure 26C] Figures 26A and 26B show different perspective views of the locking ring of the drug delivery device, Figure 26C shows a perspective view of the guard member of the drug delivery device, and Figure 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device in various embodiments. [Figure 26D] Figures 26A and 26B show different perspective views of the locking ring of the drug delivery device, Figure 26C shows a perspective view of the guard member of the drug delivery device, and Figure 26D shows a cross-sectional view of a portion of the drug delivery device, illustrating another exemplary drug delivery device in various embodiments. [Modes for carrying out the invention]

[0022] This disclosure generally relates to drug delivery devices that can be operated for a user to administer a drug, or, if the user is a patient, for self-administration of a drug. Various features are disclosed for simplifying, streamlining, automating and / or facilitating certain aspects of drug delivery, such as those used in autoinjectors, on-body injectors, or other automatic or partially automatic drug delivery devices (collectively, autoinjectors or auto-injectors). For example, these features include, among other things, automatically covering the needle in a pre-delivery and / or post-delivery state, automatically inserting the needle and / or cannula into the user, automatically activating a drive mechanism, and automatically indicating to the user that drug delivery is complete. Autoinjectors may offer these operational differences compared to conventional non-automated drug delivery devices such as syringes, although autoinjectors may still use the same or similar primary container as syringes. For example, an autoinjector may include a syringe, a syringe barrel, and / or other syringe components that serve as components of a drug storage container. Therefore, it may be desirable, advantageous, and / or necessary for the remaining components of the autoinjector to correspond to syringe components. For example, an autoinjector may include components for holding and / or supporting a drug storage container (i.e., a container holder). More specifically, the container holder may hold and / or support the drug storage container in a manner corresponding to relatively high-energy components such as coils or other springs used in the autoinjector. Even more specifically, the container holder may hold and / or support the drug storage container in a manner that reduces, minimizes, and / or prevents damage or destruction of the drug storage container by forces generated by external forces such as the autoinjector's springs and / or drops.As a more specific example, the container holder of this disclosure may be configured to support the drug storage container against the housing proximal to at least a portion of the distal end of the drug storage container body, such that the resultant force acting on the drug storage container from the plunger biasing member is at least substantially completely supported by the distal end of the drug storage container. Additionally or alternatively, the container holder of this disclosure may be configured to support the drug storage container substantially completely against the housing by the distal end of the drug storage container body. Additionally or alternatively, the container holder of this disclosure may hold and / or support the drug storage container in a manner that simplifies and / or facilitates the assembly process. As a more specific example, the container holder may have an open position for receiving the drug storage container and a closed position for securing the drug storage container. Additionally or alternatively, the container holder of this disclosure may include at least one arm movable between the open position and the closed position.

[0023] Figures 1 to 3 show some diagrams of embodiments of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological formulations such as peptides, peptide bodies, or antibodies. The drug may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0024] Various embodiments and configurations of the drug delivery device 10 are possible. In this embodiment of the drug delivery device 10, it is configured as a single-use, disposable injector. In other embodiments, the drug delivery device 10 may be configured as a multi-use, reusable injector. The drug delivery device 10 is operable for self-administration by the patient or for administration by a caregiver or formally trained healthcare provider (e.g., a physician or nurse). The exemplary drug delivery device shown in the figure may take the form of an auto-injector or a pen-type injector and can therefore be held in the user's hand for the duration of drug delivery, or alternatively, may be suitable for other drug delivery devices and / or configurations.

[0025] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery state, i.e., storage state, a delivery state, i.e., administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state may have several sub-states or stages. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before activation by the user. In some embodiments, the pre-delivery state may exist in 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 package and the moment before positioning the drug delivery device 10 relative to the 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 complete and / or when the stopper is placed at the end-of-dosing position in the drug storage container.

[0026] As shown in Figures 1A and 1B, the drug delivery device 10 includes an external casing or housing 12. In some embodiments, the housing 12 may be sized and sized to allow a person to grasp the injector 10 with one hand. The housing 12 may have a substantially 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 (Figure 3B) may be formed at the distal end to allow the insertion end 28 of the delivery member 16 (Figure 2) to extend to the outside of the housing 12. A transparent or translucent inspection window 17 (Figures 1A-1B) may be placed in the wall of the housing 12 to allow the user to see the internal components of the drug delivery device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window 17, the user can confirm that drug delivery is in progress and / or completed. A removable cap 19 may cover the opening 14 before use of the drug delivery device 10, and in some embodiments, a gripper 13 (Figure 2) may be included, configured to assist in the removal of a sterile barrier 21 (e.g., a rigid needle shield (RNS), a non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage with the sterile barrier 21, pulling the sterile barrier 21 together with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0027] As shown in Figure 2, the drive mechanism 30 may be located partially or entirely within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and release or output that energy when the drive mechanism 30 is activated by the user or in response to the activation of the drive mechanism 30 by the user, driving the plunger 26 to dispense the drug 22 from the drug storage container 20 to the patient through the delivery member 16. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, but alternative embodiments of the drive mechanism 30 may be configured differently, for example, the drive mechanism 30 stores electrical or chemical potential energy. Generally, when the drive mechanism 30 is activated, the drive mechanism 30 can convert the potential energy into kinetic energy to move the plunger 26. As best shown in Figure 3A, in one embodiment, the drive mechanism 30 includes a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member seat 38, a release member 52, a plunger guide 60, an extender biasing member 35, and a guard extension 37. The plunger biasing member 50 may include a compression spring (e.g., a compression coil spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 can be compressed such that its axial length is shorter than when it is in its natural or de-bent state. When released, the plunger biasing member 50 attempts to expand to its natural axial length, thereby acting a biasing force and pushing the plunger 26 distally.

[0028] As best shown in Figures 2 and 3B, in one embodiment, the device 10 includes a housing 12, which may include two separate, interconnected structures: a rear end cap 23 (e.g., a rear cover) at the proximal end of the drug delivery device 10, and a tubular housing 25 extending substantially along the length of the drug delivery device 10 and defining an opening 14. Additionally or alternatively, the housing 12 may include fewer or more components, for example, a two-part tubular housing having a front portion and a rear portion. The tubular housing 25 may be hollow and substantially cylindrical or tubular in shape, and the rear end cap 23 may have a substantially hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25 and any components located therein may be combined to define different subassemblies, such as a drive mechanism 30 (Figure 3A). In some embodiments, different subassemblies are assembled independently of each other and then combined with each other and with the drug storage container 20 to form a fully assembled drug delivery device 10. In such particular embodiments, some or all of the aforementioned assembly steps may be carried out in different manufacturing facilities or environments. In another embodiment, the housing 12 may be assembled in one part such that the housing 12 is defined by a single monolithic structure that integrates the rear cap and the tubular housing into a single component.

[0029] The drug storage container 20 is positioned within the internal space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 may be pre-filled and transported, for example, by the manufacturer to a location where the drug storage container 20 will be combined with the rest of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to the patient in more than one use case, such as in a pre-filled syringe or an auto-injector containing a pre-filled syringe. By using the same or similar syringe components in either case, at least some of the above processes, such as filling, labeling, packaging, shipping, and delivery, can be streamlined or simplified with respect to two different use cases. As another example, if some or all of the same syringe components are used in multiple use cases, some regulatory routes for selling and / or delivering the drug can be streamlined and / or simplified with respect to at least one of the multiple use cases.

[0030] The housing 12 may be pre-loaded with a drug storage container 20, for example, by the manufacturer, or the drug storage container 20 may be loaded by the user before use of the drug delivery device 10. The drug storage container 20 may include rigid walls defining an internal bore or reservoir. The walls may be made of glass or plastic. A stopper 24 may be movably positioned within the drug storage container 20 so as to be able to 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 be in slidable and airtight contact with the inner surface 15 of the wall of the drug storage container 20 so as to prevent or stop the drug 22 from leaking over the stopper 24 when the stopper 24 is moving. The distal movement of the stopper 24 causes the drug 22 to be discharged from the reservoir of the drug storage container 20 to the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially separated from each other by a gap 18 (Figure 2). When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap and come into contact with the stopper 24. The subsequent distal movement of the plunger 26 drives the stopper 24 distally, discharging the drug 22 from the drug storage container 20. In another embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or coupled to each other, for example, via a screw coupling, so that they move together from the start of the plunger 26's movement. Once the stopper 24 has moved, it may continue to move distally until it contacts the proximal opposing portion of the inner surface 15 of the wall of the drug storage container 20. This position on the stopper 24 may also be called the end of administration or end of delivery position, and may correspond to when the delivery of drug 22 to the patient is complete or substantially complete.

[0031] In some embodiments, the volume of drug 22 contained in the reservoir of the drug storage container 20 may be equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.5 mL, or approximately (e.g., ±10%) equal to 2.5 mL, or equal to 3 mL, or approximately (e.g., ±10%) equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 1 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) less than or equal to 3 mL. It is fine, or it may be less than or about (e.g., ±10%) 4 mL, or less than or about (e.g., ±10%) 5 mL, or less than or about (e.g., ±10%) 10 mL, or it may be within the range of 1 to 10 mL, or it may be within the range of 1 to 5 mL, or it may be within the range of 1 to 4 mL, or it may be within the range of 1 to 3 mL, or it may be within the range of 1 to 2.5 mL, or about (e.g., ±10%).

[0032] The delivery member 16 is connected to or operable to be connected in fluid communication with the reservoir of the drug storage container 20. The 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 any other pointed geometric shape, allowing the insertion end 28 to penetrate the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and have an internal passage. One or more openings may be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 to the patient.

[0033] In one embodiment, the drug storage container 20 may be a pre-filled syringe having 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 permanently in fluid communication with the reservoir of the drug storage container 20. In another embodiment, the needle may be coupled to the drug storage container 20 via a Luer lock or other suitable connection. In yet another embodiment, the drug storage container 20 may be a needleless cartridge and therefore may not initially be in fluid communication with the delivery member 16. In such an embodiment, during the operation of the drug delivery device 10, the drug storage container 20 may move toward or toward the proximal end of the delivery member 16 so that the proximal end of the delivery member 16 penetrates the septum covering the opening of the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0034] The drug storage container 20 may include a main body portion 20g having a distal end 20e and a proximal end 20f. The drug storage container 20 may be mounted to the housing 12 such that, once the drug storage container 20 is placed inside the housing 12, it does not move relative to the housing 12. Thus, in the pre-delivery, delivered, and post-delivery states, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 of the housing 12. For example, as shown in Figure 2, the delivery member 16 extends beyond the distal end of the housing 12 defining the opening 14. However, in some configurations, such as the storage configuration shown in Figure 2, the delivery member 16 is covered / protected by a sterile barrier 21 and guard member 32 surrounding the delivery member 16 to prevent or reduce the likelihood of unintentional or premature needle stick injuries.

[0035] The container holder 31 may have a hollow and substantially cylindrical or tubular shape centered on a longitudinal axis A, and the drug storage container 20 may be partially or entirely placed inside the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33, which abuts against the shoulder portion 20a of the drug storage container 20, thereby preventing distal movement of the drug storage container 20 during the operation of the plunger 26.

[0036] In one embodiment, the container holder 31 fixes and / or secures 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 at least proximal to a portion of the distal end of the body portion of the drug storage container 20 (e.g., proximal to the entire distal end of the body portion of the drug storage container 20) such that the resultant force acting on the drug storage container 20 from the plunger biasing member 50 is at least substantially completely supported by the distal end of the body portion of the drug storage container 20.

[0037] As used herein, the term “body portion” of the drug storage container 20 refers to the substantially cylindrical portion of the drug storage container 20. For example, the body portion 20g of the drug storage container 20 shown in Figure 4A extends from the distal side of the flange 20c to the proximal side of the shoulder portion 20a. In a more specific example, the body portion 20g of the drug storage container 20 shown in Figure 4A has a relatively constant inner diameter and / or a relatively constant outer diameter along its length. As shown in Figures 4A and 2, the drug storage container 20 defines the shoulder portion 20a proximal to the 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. In a more specific example, the drug storage container 20 further includes a neck portion 20g located distal to the shoulder portion 20a and configured to support the delivery member 16, such as a fixed needle.

[0038] The term "resultant force" refers to the force that pushes the drug storage container 20 along axis A during and after the injection process, when the plunger biasing member 50 is activated and as a result of the activation of the plunger biasing member 50. For example, when the plunger 26 is activated and driven distally along 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 force 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 if the plunger 26 cannot directly contact, abut, or engage with the main body of the drug storage container 20. Consequently, the drug storage container 20 may experience a relatively high resultant force during the injection process, more specifically, while the plunger 26 is activated.

[0039] The concentration of the resultant force acting on the drug storage container 20 during plunger operation is greatest at the portion of the drug storage container 20 that prevents distal movement. For example, in the device shown in the figure, the force concentration is greatest proximal to at least a portion of the distal end 20e of the main body portion 20g of the drug storage container 20. In a more specific example, the force concentration is greatest at the shoulder portion 20a where the drug storage container 20 is supported by the container holder 31. In an even more specific example, the force concentration is at least substantially completely supported by the shoulder portion 20a of the drug storage container 20. The term “substantially completely” may 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 appropriate number.

[0040] The concentration of the resultant force acting on the drug storage container 20 during plunger operation is preferably not well supported by the outwardly projecting flange 20d of the drug storage container 20. For example, since the force is substantially entirely supported by the distal portion 20e of the main body portion 20g of the drug storage container 20, the concentration of force at and near the outwardly projecting flange 20d is relatively small. As a more specific example, the proportion of the resultant force acting on the entire drug storage container 20 supported by the outwardly projecting 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%.

[0041] As shown in Figures 2 and 4B, the container holder 31 includes a plurality of flanges 33, each containing an arc-shaped inclined surface 33a that substantially conforms to the arc-shaped shoulder 20a of the drug storage container 20. In 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 restrict distal movement of the drug storage container 20. To allow the flanges 33 to bend, as will be described in more detail below, the flanges 33 are separated from each other by gaps 33b (Figure 3b). The container holder 31 shown in Figures 4A to 4C includes four flanges 33, but any suitable number of flanges may be used, as will be described below with respect to another exemplary design shown in Figure 4D.

[0042] The container holder 31 may have an open position 29a (Figure 4B) in which the container holder 31 can receive the drug storage container 20 during assembly, and a closed position 29b (Figure 4C) in which the container holder 31 can support or at least partially support the drug storage container 20. In a more specific example, the container holder 31 includes a pair of arms 31a, 31b extending axially from an annular ring 31c, 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 located 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. The container holder 31 further includes mating connectors 31d and 31e adjacent to the top (proximal) portion of the container holder 31, which are configured to snap together when the container holder is in the closed position 29b. In a more specific example, when the mating connectors 31d and 31e are engaged with each other, the frictional mating between the components holds the container holder 31 in the closed position 29b.

[0043] The container holder 31 shown in the figure also includes a pair of inwardly projecting flanges 31f, 31g positioned adjacent to the proximal end of the container holder 31. When the container holder 31 is in the open position 29a, the inwardly projecting flanges 31f, 31g are spaced apart from each other so that a radially outward projecting flange 20b on the drug storage container 20 can be positioned inside the container holder 31 (by distal insertion). In other words, when the container holder 31 is in the open position 29a, the outwardly projecting flange 20b on the drug storage container 20 can eliminate the gap between the inwardly projecting flanges 31f, 31g. When the drug storage container 20 is fully inserted into the container holder 31 (for example, so that the shoulder portion 20a of the drug storage container 20 contacts the inwardly projecting flange 33), the container holder arms 31a, 31b can move to the closed position 29b, in which the inwardly projecting flanges 31f, 31g prevent the drug storage container 20 from exiting the container holder 31 proximally. In other words, once the drug storage container 20 is inserted into the container holder 31 and is in the closed position 29b, the drug storage container 20 is held in place within the container holder 31 by the inwardly projecting flange 33 near the distal end of the container holder 31 and by the inwardly projecting flanges 31f, 31g near the proximal end of the container holder 31.

[0044] As shown in Figures 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 figure includes two distal opposing surfaces 31i and two proximal opposing surfaces 31h, which work together to define two openings 31j for receiving opposite portions of the flange 20b, respectively. The opposing surfaces 31h, 31i define a lower boundary and an upper boundary for arranging the flange 20b when the drug storage container 20 is placed inside the container holder 31 in the closed position 29b. This range from the lower boundary and upper boundary may provide flexibility for drug storage containers 20 of various lengths and / or a range of tolerances for the length of the drug storage container 20. However, as will be described in more detail below, when the drug storage container 20 / container holder 31 assembly is inside the housing 12, additional components of the device 10 may further secure the drug storage container 20 near the flange 20b. The opening 31j can also prevent and / or limit the rotational movement of the drug storage container 20. For example, each of the opposite rounded sections 20c of the flange 20b may extend at least partially through the opening 31j, and each of the opposite straight sections 20d of the flange 20b may abut against the side wall defining the opening 31j, thereby preventing and / or limiting the rotational movement between each of the components 20, 31.

[0045] As shown in Figure 4B, the container holder 31 may include additional mating connectors 31k, 31m positioned distal to the mating connectors 31d, 31e. Each pair of mating connectors 31d, 31e; 31k, 31m work together to provide a snap fit between them and the arms 31a, 31b of the container holder 31, allowing the container holder 31 to be fixed in the closed position 29b.

[0046] The annular ring 31c may be preferably positioned on approximately the opposite side (along axis A) of the mating connectors 31d, 31e to facilitate the opening and closing of the container holder arms 31a, 31b. For example, when the container holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly projecting flanges 31f, 31g may be proportional to the clearance gap between the inwardly projecting flanges 31f, 31g. Therefore, when the container holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly projecting flanges 31f, 31g (e.g., the effective length of arms 31a, 31b) may be maximized to maximize the gap between the inwardly projecting flanges 31f, 31g. Furthermore, when the container holder 31 is in the open position 29a, the thickness, height, and material properties of the annular ring 31c may affect the bending of the arms 31a, 31b and / or the gap between the inwardly projecting flanges 31f, 31g, respectively. As described above, the gap 33b between the flanges may also facilitate and / or define the amount of bending of the arms 31a, 31b and / or the gap between the inwardly projecting flanges 31f, 31g when the container holder 31 moves to the open position 29a. For example, as the arms 31a, 31b bend outward, the flange 33 may move inward.

[0047] The container holder 31 shown in the drawing may include alignment ridges 31n that abut against the inner surface of the housing 12 in order 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 a plurality of slots, and the container holder 31 may include a plurality of alignment ridges for radially aligning the components 12, 31. For example, the container holder 31 shown in the figure includes two alignment ridges 31n, and the housing 12 includes two slots 12a. The slots 12a are spaced apart from each other and are 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 figure is defined by a substantially annular collar 12d portion that is integrated with the housing 12 (alternatively, the collar portion may be one or more components that are coupled to or attached to the housing). The annular collar 12d does not have to extend across the entire inner surface of the housing 12, but instead has notches or gaps to allow a portion of the guard member 32 to extend between the portions of the annular collar 12d. Alternatively, the annular collar 12d may be spaced radially inward from the inner surface of the housing 12 at at least one location to facilitate a portion of the guard member extending beyond the collar 12d.

[0048] The annular collar 12d may further define inclined surfaces 12e on both sides of each lock slot 12c to further assist in the alignment between the container holder 31 and the housing 12.

[0049] The components shown in Figures 4A, 4B, and 4C include an alignment ridge 31n located at the distal end of the support ridge 31o. For example, the support ridge 31o has a lower height (measured perpendicular to the outer surface of the container holder 31) than the alignment ridge 31n, so that only the alignment ridge 31n is received in the alignment slot 12a, rather than the support ridge 31o. Alternatively, as will be described below with respect to another exemplary design shown in Figure 4D, the alignment ridge may extend substantially or entirely along the axial length of the container holder 31.

[0050] The drug storage container 20 may be coupled to the container holder 31 (and consequently to the housing 12) more or more securely so as to prevent the drug storage container 20 and the container holder 31 from moving relative to the housing 12 during the operation of the drug delivery device 10. For example, as shown in Figures 4B and 4C, the container holder 31 may include a plurality of locking protrusions 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 Figures 2 and 3B, the housing 12 includes a plurality of locking slots 12c that each receive a locking protrusion 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 locking protrusion 33c extends radially from the outer surface of the flange 33. The container holder 31 may include, for example, one, two, three, four, or any suitable number of locking protrusions 33c. The lock slots 12c shown in the figure are defined by annular collars 12d, but alternatively, they may be defined by other components. The lock slots 12c are spaced apart from each other and are sized to accommodate, for example, each lock protrusion 33c when a drug storage container is placed in the container holder 31. In a more specific example, for example, to secure the container holder 31 and, consequently, the drug product container 20 within the housing 12, the lock protrusions 33c are snapped into the lock slots 12c by friction fitting. In an even more specific example, when the lock protrusions 33c are snapped into the lock slots 12c, the flange 33 may be pushed slightly inward to form a more secure fit between the container holder 31 and the drug product container 20.

[0051] The inner surface of the container holder 31 may include compressible components, such as elastomer components, that are positioned between the inner surface of the container holder 31 and the drug product container 20. More specifically, the elastomer component may be a rubber ring. Alternatively or additionally, the natural curvature of the flange 33 may function as a compressible component.

[0052] The locking protrusion 33c can provide the user or assembler with audible and / or tactile feedback when snapping it into the corresponding locking slot 12c, thereby indicating to the assembler that each component 12, 31 is positioned as desired. Furthermore, each component may be made and positioned such that feedback is only produced when the drug product container 20 is also positioned as desired. For example, if the drug product container 20 is positioned far distal to the container holder 31 such that the body of the drug product container 20 is aligned with the flange 33 rather than the shoulder portion 20a being aligned with the flange 33, the locking protrusion 33c may not be pushed radially far enough to engage with the locking slot 12c. Conversely, if the drug product container 20 is not inserted distally far enough from the container holder 31 so that the sterile barrier 21 aligns with the flange 33 rather than the shoulder portion 20a aligning with the flange 33, the locking protrusion 33c may be pushed radially inward to such an extent that the locking protrusion 33c can slide radially inward within the locking slot 12c, or to such an extent that the locking protrusion 33c enters the locking slot 12c but does not generate enough radially outward force to produce audible and / or tactile feedback. While audible and / or tactile feedback may be advantageous during manual assembly of the container holder 31, the assembly of the container holder 31 does not need to be performed manually and, in some embodiments, may be performed partially or entirely by manufacturing equipment.

[0053] The housing 12, container holder 31, and their respective components offer numerous advantages. For example, by securely connecting the drug product container 20 to the housing 12 via the shoulder portion 20a (rather than the flange portion), the device 10 may have a reduced incidence of glass breakage or other damage. As a more specific example, drug product containers such as syringes often have a shoulder portion that is more robust and / or can withstand stronger forces than the flange portion. In other words, because the shoulder is more robust and more resistant to breakage than the flange, it can be advantageous for the force concentration on the drug product container to be higher at the shoulder than at the flange.

[0054] Another potential advantage of this configuration is that by securely coupling the drug product container 20 to the housing 12 via the distal portion (e.g., the shoulder portion 20a), the device 10 may have a more predictable, repeatable, and / or constant injection depth compared to designs that fix the drug product container 20 via a flange (e.g., a “hanging” design). For example, since the barrel length of the drug product container 20 can vary more significantly than the shoulder length of the barrel, the distance between the shoulder portion 20a and the delivery member 16 of the syringe is typically more predictable and / or subject to smaller manufacturing tolerances than the distance between the flange 20b and the delivery member 16. Additionally or alternatively, since the distance between the flange 20b and the delivery member 16 includes any tolerance / variation of the distance between the shoulder portion 20a and the delivery member 16, any tolerance / variation is “stacked.”

[0055] 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 as will be described in more detail below, for example, the sterile barrier 21 is positioned substantially or completely outside the container holder 31 to facilitate the removal of the sterile barrier 21 when the device 10 is in use. Furthermore, the delivery member 16 extends beyond the distal end of the container holder 31 (as described above).

[0056] Figure 4D shows another exemplary container holder 131 having several features functionally similar to those included in container holder 31, each of which is assigned the same reference number except that 100 has been added. For example, container holder 131 includes a pair of arms 131a, 131b; an annular ring 131c connecting the arms 131a, 131b; sets of mating connectors 131d, 131e, 131k, 131m for selectively fixing the arms in a closed position 129b; a pair of inwardly projecting flanges 131f, 131g; a pair of opposing surfaces 131h, 131i defining the lower and upper limits of movement of the flanges of the drug storage container; and an opening 131j for receiving the flanges of the drug storage container. Container holder 131 also includes a plurality of flanges 133, which are located at the distal end of container holder 131 and configured to support drug storage containers. For example, the container holder 131 includes two flanges 133, each of which includes an arc-shaped inclined surface 133a that substantially matches the arc-shaped shoulder of the drug storage container. The container holder 131 shown in Figure 4D has two flanges 133, compared to the four flanges 33 shown in the container holder 31 shown in Figures 4A-4C. Therefore, it is preferable that each flange 133 has a circumference larger than that of the flanges 33. The container holder 131 also includes an alignment ridge 131n that is received in an alignment slot 12a formed on the inner surface of the housing 12 in order 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 Figure 4D extends substantially entirely along the axial length of the container holder 131, in contrast to the alignment ridge 31n.

[0057] Similar to the container holder 31 shown in Figures 4B-4C, the container holder 131 may include a plurality of locking protrusions 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 Figures 4D and 4E, the housing 12 includes a plurality of locking slots 12c, each receiving a locking protrusion 133c of the container holder 131 to prevent and / or limit relative movement between the components 12, 131. The locking protrusions 133c can also provide audible and / or tactile feedback to the user or assembler when snapping them into the corresponding locking slots 12c, thereby indicating to the assembler that the components 12, 131 are positioned as desired. Furthermore, the container holder 131 may offer the same or similar advantages as those described above with respect to the container holder 31.

[0058] In yet another exemplary design, the container holder may be fixed rather than having an opening and closing arm. In a more specific example, the container holder may have a proximal opening made large enough to allow the syringe to be received. The container holder may further have a distally located flange for receiving and securing the shoulder of the syringe, particularly when the container holder is coupled to the injector housing.

[0059] Figures 4F and 5A illustrate the distal (Figure 4F) and proximal (Figure 5A) portions of the drug product container 20, as well as their interactions with various other components of the device 10. For example, Figure 4F shows a partial cross-sectional view of the distal portion of the drug product container 20, which is positioned within a container holder 31, with its shoulder portion 20a supported by a flange 33. As another example, Figure 5A shows a cross-sectional view of the proximal portion of the drug product container 20, which is positioned within the container holder 31, such that the drug product container flange 20b is positioned between opposing surfaces 31h, 31i and within the opening 31j. The drug product container 20 shown in Figure 5A is further supported by a plunger guide 60, such as a flexible arm 60a of the plunger guide 60. As a more specific example, the flexible arm 60a extends approximately distally and slightly radially inward from the distal portion of the plunger guide 60b. As a more specific example, the plunger guide 60 shown in Figure 5A includes a distal surface 60b that abuts against the inwardly projecting flanges 31f, 31g of the container holder 31, and a flexible arm 60a extends from the distal surface 60b between the inwardly projecting flanges 31f, 31g.

[0060] The flexible arm 60a may have a size, shape, and type of material that promotes and / or enables the deflection of the flexible arm 60a. In a more specific example, it is preferable that the flexible arm 60a is radially flexible so 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 firstly supported by the container holder 31 at its distal portion (e.g., shoulder portion 20a) and at least secondly supported by the plunger guide 60 at its proximal portion (e.g., flange portion 20b). In a more specific example, the flexible arm 60a can provide radial support to the flange portion 20b and prevent and / or block transverse movement of the drug product container 20 relative to the housing 12. Such a configuration can reduce or eliminate rattling noise from the device 10 and / or facilitate proper alignment of the drug product container 20 during assembly. In another, more specific example, the flexible arm 60a may provide axial support (e.g., distal) to prevent undesirable axial movement of the drug product container 20 relative to the housing 12. The device 10 may have, for example, one, two, three, four, or any suitable number of flexible arms 60a.

[0061] 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 allows its deflection. In 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 firstly supported by the container holder 31 at its distal portion (e.g., shoulder portion 20a), and at least secondly supported by the container holder 31 in the central or proximal region of the body portion 20g. In a more specific example, the support flange 31r can provide radial support to the drug product container 20 and prevent and / or block transverse movement of the drug product container 20 relative to the housing 12. Such a configuration can reduce or eliminate rattling noise from the device 10 and / or facilitate proper alignment of the drug product container 20 during assembly. In another, more specific example, the support flanges 31r can provide axial support (e.g., distal) to prevent undesirable axial movement of the drug product container 20 relative to the housing 12, but this is not required. The device 10 may have, for example, one, two, three, four, or any suitable number of support flanges 31r. The container holder 31 shown in the figure includes four support flanges 31r arranged at equal intervals around it.

[0062] The flexible arm 60a and / or support flange 31r shown in the figure provide at least some support to the drug storage container 20, but as described above, the container holder substantially fully supports the drug storage container 20 against the housing 12 by the distal end of the main body portion 20g of the drug storage container 20. In a more specific example, the flexible arm 60a and / or support flange 31r may provide little or no support along the longitudinal axis A, and support only transversely to axis A. In an even more specific example, the container holder 31 substantially fully supports the drug storage container 20 against the housing 12 with respect to forces along axis A, for example, forces received during the injection process, by the distal end of the main body portion 20g of the drug storage container 20.

[0063] As shown above, the plunger guide 60 shown in Figure 5A includes a distal surface 60b that abuts against the inwardly projecting flanges 31f, 31g of the container holder 31. This configuration can help reduce or prevent the radial movement of the container holder 31 within the housing 12. For example, as shown in Figure 5A, the container holder includes an annular wall 31p, which, in cooperation with the inwardly projecting flanges 31f, 31g, defines an annular sheet for the distal surface 60b of the plunger guide 60. The annular wall 31p can align the plunger guide 60 with respect to the container holder 31 and the drug product container 20. Thus, the plunger 26 is also aligned with these components 31, 20. The annular wall 31p can also reduce or prevent the radial movement of the plunger guide 60 relative to the housing 12. This configuration can also help reduce or prevent the axial movement of the container holder 31 within the housing 12. For example, as shown in Figure 2, the plunger guide 60 extends from the rear end cap 23 to the midpoint of the device 10 (where the plunger guide 60 contacts the container holder 31). As a result, in Figure 2, the container holder 31 is restricted from moving upward in the axial direction (i.e., proximal) by the plunger guide 60. Furthermore, for example, if the distal surface 60b does not contact the inwardly projecting flanges 31f, 31g, the rear end cap 23 may not be able to be attached unless the plunger guide 60 is properly aligned with the container holder 31 in the axial and radial directions.

[0064] As shown in Figures 5B and 5C, the plunger guide 60 may be hollow and have a substantially cylindrical or tubular shape, and may be centered on the longitudinal axis A. The outer diameter or other external dimensions of the proximal end of the plunger guide 60 may be larger than the outer diameter or other external dimensions of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 may be radially positioned between the plunger 26 and the release member 52. Therefore, as shown in Figure 2, the plunger 26 may be at least partially positioned within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 may be at least partially positioned within the release member 52. Further features and functions of the plunger guide 60 will be described below.

[0065] As shown in Figure 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, as shown in Figures 1C and 5B, the plunger guide includes a locking tab 60f, which is made to be sized, shaped, and positioned to be received within a locking key 12f formed within the housing 12. In a more specific example, the plunger guide 60 and the housing 12 each include a pair of components 60f, 12f, which cooperate to prevent relative rotation between the plunger guide 60 and the housing 12. Additionally or alternatively, an annular ridge 60g 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 stop rotation between the components 12, 60.

[0066] The plunger 26 (best shown in Figures 2 and 3A) may be hollow and have a substantially cylindrical or tubular shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space made sized to receive the plunger biasing member 50. Generally, in order to maximize the inner diameter of the plunger 26, it is desirable to minimize the thickness of the annular wall 39 as much as possible without compromising the integrity of the plunger 26. This makes it possible to accommodate a plunger biasing member 50 of a larger diameter within the internal space of the plunger 26, thereby enabling 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 yet another more specific example, the thickness of the annular wall may be less than 0.6 mm. As yet another more specific example, the thickness of the annular wall may be less than 0.3 mm. As yet 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 yet another, more specific example, the thickness of the annular wall may be less than 0.05 mm. The annular wall 39 can 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 out of 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 its thickness 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 its thickness is greater than 1 mm.

[0067] Additionally or alternatively, the hollow rod 46 may facilitate and / or provide greater flexibility in spring design. For example, depending on the properties of the drug and / or the desired drug delivery profile, it may be desirable or advantageous to use a device with different springs. For example, higher viscosity drugs may require springs with higher spring constants and / or spring forces, and therefore, flexibility in the physical properties of the spring may be desirable or advantageous. As a more specific example, various physical properties of the spring, such as the wire diameter of the spring (generally, increasing the wire diameter increases the spring constant), the center diameter of the spring (generally, increasing the center diameter decreases the spring constant), the number of turns of the spring (generally, increasing the number of turns increases the spring constant), and the material of the spring, can affect the spring constant, and therefore the spring force. These physical properties can be adjusted to provide different spring constants, and in some cases the thickness of the hollow rod 46 can also be adjusted to maintain a constant or relatively constant outer diameter of the overall plunger 26, and to keep the remaining components of the device, such as the plunger guide 60 and stopper 24, constant. Additionally or alternatively, the hollow rod 46 can promote and / or provide greater longitudinal stability of the plunger biasing member 50, for example, by preventing or reducing buckling or other transverse motion.

[0068] The plunger biasing member 50 shown in the figure may have the following dimensions, namely a wire diameter of 0.65 mm, a spring outer diameter of 5.40 mm, and 80 to 86 turns (depending on the pitch), but other suitable spring characteristics may be used. The plunger biasing member 50 shown in the figure may be made of stainless steel with a strength of 2300 N / mm, but other suitable materials may be used. The hollow rod 46 shown in the figure may have the following dimensions and material, namely a length of 63 mm, an outer diameter of 6 mm, a wall thickness of 0.20 mm, and stainless steel with a strength of 600 to 750 N / mm, but other suitable dimensions and materials may be used.

[0069] As will be described in more detail below, during the operation of the drug delivery device 10, the plunger 26 may be configured to selectively rotate relative to the housing 12 and to translate linearly relative to the housing 12.

[0070] The plunger 26 may be made of multiple interconnected parts, or alternatively, it may have a single, integrated structure. In this embodiment, the plunger 26 is made of three separate, interconnected structures: a top ring 45 defining the proximal end of the plunger 26, a base portion 47 defining the distal end of the plunger 26, and a hollow rod 46 positioned between the top ring 45 and the base portion 47, firmly connecting them. The positions of the top ring 45, the hollow rod 46, and the base portion 47 may be fixed relative to each other so that these components cannot move relative to each other. The top ring 45, the hollow rod 46, and the base portion 47 may each have an annular structure and may be centered about a longitudinal axis A. The top ring 45 and the hollow rod 46 may each have their own central opening, each central opening extending from end to end of its component and defining an axial chamber, while the base portion 47 may have a central opening that is through the proximal end of the base portion 47 but closed at the distal end of the base portion 47. The closed end of the base portion 47 may define a seat or contact 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 so that the base portion 47 holds the distal end of the plunger biasing member 50 in the plunger 26. When the drive mechanism 30 is activated, the base portion 47 may become part of the plunger 46 that contacts the stopper 24 and pushes the stopper 24 distally.

[0071] The top ring 45 may include one or more flanges or projections 48 extending radially outward from the center of the top ring 45. Each projection 48 may include a distal opposing cam surface 49. As will be described in more detail below, the distal opposing cam surface 49 may interact with a mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distal opposing cam surface 49 may be positioned at an angle to an imaginary plane perpendicular to the longitudinal axis A, or otherwise non-parallel to it.

[0072] In some embodiments, the top ring 45 and / or base portion 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or base portion 47 may be made of plastic, while the hollow rod 46 may be made of metal. With this configuration, the plastic material used for the top ring 45 can facilitate the cam operation described below by providing a relatively low coefficient of friction. The plastic material used for the base portion 47 may help absorb or dampen any shocks or vibrations associated with the base portion 47 colliding with the stopper 24. The metal material used for the hollow rod 46 may provide sufficient rigidity to avoid buckling under the biasing force acted by the plunger biasing member 50. In another embodiment, 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 such particular embodiments, the top ring 45, hollow rod 46, and base portion 47 may be integrally formed into a single part to define a single monolithic structure.

[0073] The drug delivery device 10 may further include a guard mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used for administration of infusion. The guard mechanism may include a guard member 32 movably positioned adjacent to the opening 14 at or near the distal end of the housing 12. The guard member 32 may have a hollow and substantially tubular or cylindrical portion 32a centered about a longitudinal axis A, and a pair of arms 32b extending proximal from the cylindrical portion 32a. The guard member 32 further includes a distal end 32c which may substantially include the cylindrical portion 32a, and a proximal end 32d which may be defined by the arms 32b. The arms 32b may be substantially or completely receptive within the housing 12 such that no portion thereof extends from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively receptive within the housing 12. As will be described in more detail below, for example, the guard member 32 may be configured to move relative to the housing 12 so that in one stage / state, a portion of the guard member 32 is received within the housing 12, and in other stages / states, it extends from the housing 12.

[0074] In one exemplary configuration shown in Figures 2, 4E, and 6, the arms 32b of the guide member 32 are radially spaced apart from each other along the circumference 32g of the guard 32, so that the arms 32b can slide between the projections 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 projection of the annular collar 12d. Thus, the arms can slide axially between the projections of the annular collar 12d without contacting the collar.

[0075] As shown 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 cylindrical portion 32a extends through the opening 14 of the housing 12 or no portion of the cylindrical portion 32a extends through the opening 14 of the housing 12. In other words, in the extended position, a cylindrical portion 32a of length X extends through the opening 14 of the housing 12, and in the retracted position, a cylindrical portion 32a of length Y extends through the opening 14 of the housing 12, where X is greater than Y. Length X may be any suitable number, e.g., 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. Length Y may be any suitable number smaller than X, e.g., 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. Figures 1C and 1D show an exemplary pre-injection configuration (Figure 1C) in which the guard member 32 is in the extended position 32e and the length X of the exposed portion of the guard member 32 may be approximately 5 mm to 11 mm, and an injected configuration (Figure 1D) in which the guard member 32 is in the retracted position 32f and the length Y of the exposed portion of the guard member 32 is approximately 0 mm to 2 mm (the distal end 32c of the guard member 32 is flush with the opening 14 of the housing 12). In one embodiment, the distance Y is greater than 0 (e.g., 1 mm) to help ensure that the device 10 can be activated before the guard member becomes flush with the housing 12.

[0076] 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 can translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 can translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond the insertion end 28 of the delivery member 16 and surround the insertion end 28 of the delivery member 16. For further explanation, Figures 1C and 2 show the guard member 32 in the extended position (covered by a removable cap 19 in Figure 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.

[0077] During the injection process, the guard member 32 may remain stationary relative to the user's skin 5, while the housing 12 and several components located within it move relative to the guard member 32 and the skin 5. Nevertheless, this disclosure refers to the movement, retraction, translation, and indentation of the guard member 32. These references and descriptions may be considered to refer to the 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.

[0078] The delivery device 10 may employ an inertia-driven design rather than a spring-driven design to insert the needle into the patient's subcutaneous tissue. In 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. As the patient pushes down by a predetermined distance or force, the delivery device 10 compresses the needle cover and its spring to a predetermined release point while performing a rapid release to utilize the energy stored in the patient's muscle. 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, causes the needle to penetrate the skin quickly and completely to subcutaneous depth. This embodiment prevents relative movement between the drug storage container 20 and the housing compared to known injectors in which the entire primary container moves forward relative to the housing, and therefore may provide a simplified, more robust design.

[0079] In another embodiment, the drug storage container 20 may be movably coupled to the housing 12 so that the drug storage container 20 can move relative to the housing 12 during the operation of the drug delivery device 10. In such a particular alternative embodiment, the insertion end 28 of the delivery member 16 may be retracted into the opening 14 of the housing 12 in the pre-delivery state. Then, during the operation of the infusion device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 of the housing 12 for insertion into the patient. In some embodiments, this movement may result from the drug storage container 20 being driven distally relative to the housing 12.

[0080] In some embodiments, the guard member 32 may be fixed or restricted to rotate relative to the housing 12. Thus, even if the guard member 32 may be able to translate linearly relative to the housing 12, rotation of the guard member 32 relative to the housing 12 may be substantially or completely prevented. In a more specific example, the cylindrical portion 32a of the guard member 32 may include projections extending therefrom, such as raised portions 32h that align with corresponding features on the inner surface of the housing 12. For example, the inner surface of the housing adjacent to the distal end of the housing 12 may include slots, a pair of adjacent raised portions, or another component or set of components that cooperate with the raised portion 32h to substantially or completely prevent rotation of the guard member 32. This configuration may also be useful for aligning each component 32, 12 with respect to each other during assembly.

[0081] The device 10 may further include an extender biasing member 35 and a guard extension 37. The guard extension 37 may be located proximal to the guard member 32, and the extender biasing member 35 shown in the figure is located proximal to the guard extension 37. The guard extension 37 may have a hollow and substantially cylindrical or tubular shape, centered about the longitudinal axis A. In a more specific example, the guard extension 37 may include a substantially cylindrical body 37a. The guard extension 37 may also include an arm 37b for receiving, supporting, and / or holding the distal portion of the extender biasing member 35. Furthermore, the guard extension 37 may be linearly movable along the longitudinal axis A relative to the housing 12. In this embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in another embodiment, the guard extension 37 and the guard member 32 may be integrally formed into a single part to define a single monolithic structure. In another such embodiment, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0082] Similar to the guard member 32, the guard extension 37 can be rotatably fixed to the housing 12. Therefore, although the guard extension 37 may be able to translate linearly relative to the housing 12, it can be prevented from rotating relative to the housing 12. In some embodiments, to achieve this effect, the guard extension 37 can cooperate with the plunger guide 60 to restrict or prevent rotation between the components 37, 60. As a result, and because the plunger guide 60 is fixedly connected to the housing 12, the guard extension 37 can be rotatably fixed to the housing 12 via the plunger guide 60. For example, the plunger guide 60 may include a longitudinal ridge 60c near the distal portion of the plunger guide 60. The ridge can be received within a longitudinal channel and / or a pair or corresponding feature on the inner surface of the guard extension 37 that cooperate to receive the ridge 60c. In another embodiment, the arrangement of the protrusions and slots may be reversed such that the guard extension 37 has one or more radially inwardly extending protrusions, and the plunger guide has one or more slots or other recesses for mating or tightly receiving one or more protrusions. In yet another alternative embodiment, the guard extension 37 may include an anti-rotation feature that mates with a corresponding feature on the inner surface of the housing 12.

[0083] The guard extension 37 and / or release member 52 may have axial movement limits that restrict the distance they can move distally. For example, as shown in Figure 6C, the plunger guide 60 may include an axial ridge 60c, which is formed on the outer surface and positioned adjacent to the distal portion of the plunger guide 60. The distal opposing surface 52j of the release member 52 abuts against the proximal opposing surface 60d defined by the axial ridge 60c, thereby defining the most distal point of movement of the release member 52. The release member 52 may also include a lock flange 52a that further restricts the distal movement of the guard extension 37. For example, the lock flange 52a abuts against the annular collar 37d of the guard extension 37, thereby defining the most distal point of movement of the guard extension 37. The axially raised portion 60c and the locking raised portion 52a shown in the figure do not necessarily restrict the proximal movement of the release member 52 and the guard extension portion 37, but only restrict their distal movement.

[0084] As best shown in Figure 2, the extender biasing member 35 is positioned between the guard extension 37 and the release member 52, and is in contact with both the guard extension 37 and the release member 52. The extender biasing member 35 may be configured to bias or push the guard extension 37 distally and / or bias or push the release member 52 proximal. In the device 10 shown in Figure 2, which is pre-delivery, i.e., in storage, the extender biasing member 35 is initially in a biased state (e.g., compressed). In other words, as shown in Figure 2, when the device 10 is in the pre-delivery state, the extender biasing member 35 applies a distal (downward) biasing force to the guard extension 37 and a proximal (upward) biasing force to the release member 52.

[0085] While the device is in operation, the user can move the guard member 32 proximal (relative to the housing 12) by pressing it against the injection site. In doing so, the guard member 32 moves toward the guard extension 37, closing the gap 37g (Figure 2) between them. Once the gap 37g is removed, the guard member 32 and the guard extension 37 move together proximal, for example, until the guard member 32 reaches a retracted position 32f. When the injection is complete and the drug delivery device 10 is removed from the injection site, the extender biasing member 35 can push the guard extension 37 so that the guard extension 37 and the guard member 32 move together distally. This movement (and / or biasing by the lock ring biasing member 51) causes the guard member 32 to return to its extended position 32e. This has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the extender biasing member 35 may include a compression spring (e.g., a compression coil spring). Furthermore, in embodiments in which the plunger biasing member 50 also includes a compression spring, the extender biasing member 35 may be positioned around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0086] However, in some alternative embodiments, the extender biasing member 35 may be in an unbiased (natural) state when the device is in a pre-delivery state. In these embodiments, the biasing member 35 may be compressed or biased when the guard member 32 is deflected in the proximal direction.

[0087] After drug delivery is complete and the guard member 32 has been redeployed to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent the next user from contacting the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. As will be described in more detail below, in order to lock the guard member 32 in the extended position once it has moved from the retracted position to the extended position, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to rotate selectively depending on the axial position of the guard member 32.

[0088] As described above, the plunger biasing member 50 may be at least partially located within the plunger 26 and may have a distal end that abuts against the proximal opposing inner surface of the plunger 26 and / or may be firmly attached to the inner surface of the plunger 26. Since the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 may be less than or equal to 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 against the proximal opposing inner surface of the base portion 47 of the plunger 26. Furthermore, as best shown in Figures 2 and 3A, the proximal end 50a of the plunger biasing member 50 may abut against the distal opposing surface 38a of the plunger biasing member seat 38. The plunger biasing member seat 38 may be firmly attached to the rear housing 27 such that the plunger biasing member seat 38 provides a stationary surface for pushing the plunger biasing member 50 away. For example, as shown in Figures 3A and 5B, the plunger seat 38 may include a flange 38b, which is received within an opening 60h formed in the proximal part of the plunger guide, thereby securely connecting the plunger seat to the plunger guide 60. With this configuration, when the plunger biasing member 50 is released from its biased state, its length can be expanded by the distal end of the plunger biasing member 50 moving distally away from the stationary proximal end of the plunger biasing member 50. This movement can push the plunger 26 distally, which in turn pushes the stopper 24 distally, allowing the drug 22 to be dispensed from the drug storage container 20 into the delivery member 16 and then to the patient. However, in the embodiment shown in the figures, neither the release of the plunger biasing member 50 nor any other biasing member drives the delivery member 16 downward relative to the housing 12. Rather, the drug product container 20, and consequently the delivery member 16, are substantially or completely fixedly coupled to the housing 12. Rather, the delivery member 16 is driven toward the patient's skin 5 by an inertial force generated by a downward force applied by the patient (or healthcare provider or other person administering the dose).

[0089] Referring to Figures 7A and 7B, the release member 52 may be hollow and have a substantially cylindrical or tubular shape, and may be centered on the longitudinal axis A. As shown in Figure 2, the release member 52 may be radially positioned between the plunger guide 60 and the guard extension 37. Also as shown in Figure 2, the release member 52 is also radially positioned between the guard extension 37 and the plunger guide 60. Furthermore, the extender biasing member 35 may be axially positioned between the release member 52 and the guard extension 37, and may also be radially positioned around the release member 52. In general, the release member 52 is configured to (1) operatively couple the guard member 32 and the plunger 26 in the operating sequence, and (2) generate an audible signal indicating the end of drug delivery. With this configuration, the release member 52 is used to perform two separate functions, and therefore the number of moving parts required for the drug delivery device 10 is reduced.

[0090] Each channel surface 52b is configured to receive the projection 48 of the top ring 45, allowing axial movement of the plunger 26 relative to the release member 52, but blocking or preventing rotational movement between the plunger 26 and the release member 52. As shown in the figure, the channel surfaces 52 extend adjacent to the inner surface of the release member 52, but the channel surfaces 52 do not have an arc shape, but instead have a shape divided into substantially rectangular sections (as best shown in Figures 7B and 10A).

[0091] The release member 52 includes a channel surface 52b that extends proximal to the nearest (e.g., apex) surface of the tubular body of the release member 52. For example, the release member 52 includes a proximal opposing contact surface 52d for end-of-dosing notification (which will be described in more detail below) and a channel surface 52b, each of which extends beyond the contact surface 52 to provide a continuous path to the top ring 45 while also allowing sufficient clearance between the proximal opposing contact surface 52d and the corresponding surface involved in end-of-dosing notification.

[0092] The release member 52 may be configured to rotate relative to the housing 12 and / or translate linearly relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the release member 52 associated with activation may be driven by the plunger biasing member 50 and / or the extender biasing member 35, while subsequent rotations of the release member 52 associated with generating the end-of-dosing signal may be driven solely by the extender biasing member 35. Any linear translation of the release member 52 without rotation may be driven solely by the extender biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction. However, in other embodiments, linear translation of the release member 52 may be possible in both the proximal and distal directions.

[0093] Having described the general configuration of the drug delivery device 10, we will now describe how to use the drug delivery device 10 to perform an injection, referring to Figures 9A to 12C. As a preliminary step, the user can remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or cardboard box. Also as a preliminary step, the user can prepare the injection site, for example, by wiping the patient's skin with an alcohol wipe. The user can then pull off the removable cap 19 from the front housing 25. As a result of this movement, the gripper 13 can pull off the sterile barrier 21 from the drug storage container 20. This exposes the insertion end 28 of the delivery member 16. Nevertheless, since the guard member 32 is positioned in an extended position, at this stage the insertion end 28 of the delivery member 16 remains surrounded by the guard member 32. The user can 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 lock ring biasing member 51, thereby pulling the guard member 32 into the opening 14 and moving it proximally from the extended position to the retracted position. While the guard member 32 is retracting, the delivery member 16 remains stationary relative to the housing 12.

[0094] Some of the device components include various features, surfaces, and openings for interaction with the plunger 26 and for controlling the release movement of the plunger 26 (e.g., the injection sequence). Generally, the injection sequence is initiated by the retraction / axial movement of the guard member 32 in the proximal direction (upward in Figure 2), which results in the axial movement of the guard extension 37 and unlocks the release member 52. Once the release member 52 is unlocked (e.g., the first stage of movement), the plunger 26 and the plunger biasing member 50 push the release member 52 so that it rotates clockwise, allowing the plunger 26 to move axially (distally, downward in Figure 2). The plunger then pushes the stopper 24 distally, thereby dispensing the drug 22 from the drug product container 20 and the delivery member 16. When the plunger reaches a specific point along the axial length of the device, the movement of the release member 52 is further unlocked (e.g., a second stage of movement), and the release moves proximal (upward in Figure 2) to contact the plunger guide 60, thereby generating an indication of the end of administration (e.g., an audible click). The injection sequence is now described in more detail.

[0095] Figures 2, 9A, 10, and 11A show the pre-injection stage. The movement of the guard member 32 from the extended position to the retracted position can produce several actions. While the guard member 32 is retracted, the delivery member 16 remains stationary relative to the housing 12, so that the insertion end 28 of the delivery member 16 extends through the opening at the distal end of the guard member 32, thereby puncturing the patient's skin at the injection site and penetrating into the patient's subcutaneous tissue. Furthermore, as will be described in more detail below, the retraction of the guard member 32 can also activate the drive mechanism 30 and discharge the drug 22 from the drug storage container 20.

[0096] As shown in Figures 9A, 10, and 11A, in the pre-delivery state before the needle guard 32 retracts, the plunger 26 and the release member 52 can each be positioned in their respective initial rotational positions. The plunger biasing member 50 can be in a biased state. Consequently, the plunger biasing member 50 can act on the plunger 26 with a distally oriented biasing force that pushes the distal opposing cam surface 49 against the proximal opposing cam surface 60j. The resulting cam action can rotate the plunger 26 clockwise. Despite these biasing forces, neither the release member 52 nor the plunger 26 rotates in the pre-delivery state. This is because, in the pre-injection state, the release member 52 and the plunger are rotatably fixed. Therefore, as will be described in more detail here, before the guard member 32 retracts, the release member 52, the plunger guide 60, the guard extension 37, and the housing 12 work in conjunction with each other to keep the plunger biasing member 50 in a biased state.

[0097] As best illustrated in Figure 2, when the guard member 32 moves proximal (upward in Figure 2), the proximal end 32d of the guard member 32 contacts the distal opposing surface of the guard extension 37, pushing the guard extension proximal. As shown in Figures 6B and 7A, the inner surface of the annular wall of the guard extension 37 includes a lock flange 37c, and the outer annular surface of the release member 52 includes a corresponding lock flange 52a. As shown in Figures 2, 9A, 10A, and 11A, when the device is in the pre-injection stage, the lock flange 37c of the guard extension 37 engages with the lock flange 52a of the release member 52, thereby rotatably locking the release member 52 (as best illustrated in Figure 11A). At this point in the sequence, the distal opposing cam surface 49 of the top ring 45 of the plunger 26 contacts the proximal opposing cam surface 60j of the plunger guide 60, and this interaction prevents the plunger 26 from moving axially (best shown in Figures 9A and 10A). The distal opposing cam surface 49 and / or the proximal opposing cam surface 60j include inclined surfaces to facilitate the relative motion of the top ring 45 of the plunger 26 in the direction of arrow 60k (clockwise) in Figures 9A and 10A. For example, the distal opposing cam surface 49 has a slope 60m of about 10 degrees (best shown in Figures 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, the distal opposing cam surface 49 of the top ring 45 may have a slope 49a of about 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. One or more slopes of each surface 60j, 49 generate a transverse force in the axial force by the plunger biasing member 50, thereby pushing the top ring 45 of the plunger 26 in a clockwise direction 60k. However, as described above, while the top ring 45 is positioned within and / or in contact with the channel surface 52b, the release member 52 prevents or inhibits rotational movement between the release member 52 and the plunger.As a result, as long as the guard extension 37 rotatably locks the release member 52 (as shown in Figures 2, 9A, 10A, and 11A), the top ring 45 remains rotatably locked by the channel surface 52b and axially locked by the proximal opposing cam surface 60j.

[0098] The unlocking stage is shown in Figure 11B. In this stage, the lock flange 37c of the guard extension 37 disengages from the lock flange 52a of the release member 52, and the guard extension 37 translates proximally until the release is no longer rotatably locked. In this stage of the injection sequence, the following two things happen simultaneously or almost simultaneously: (1) The inner surface of the release member 52 (approximately aligned with reference numeral 52c shown in Figures 9C and 7B, but rather the inner surface rather than the outer surface shown by reference numeral 52c of the release member 52), or the axial force from the guard biasing member 35 is converted into a lateral (clockwise) force, causing the release member 52 to rotate clockwise and move upward (proximal) by a cam surface on one or both of the outer surfaces (rib 60n (Figure 5B) etc.) of the plunger guide 60, thereby causing the release member 52 to be pushed clockwise (as shown in Figure 9B) and upward, and (2) the cam action between the surfaces 49, 60j of the plunger 26 and the plunger guide 60 causes the plunger biasing member 50 to push the top ring 45 clockwise and downward (distal), thereby moving the plunger 26 clockwise and slightly downward along the inclined surface 60j. In other words, both the release member 52 and the top ring 45 of the plunger 26 rotate clockwise simultaneously or substantially simultaneously due to the forces from the respective biasing members 35 and 50. This sliding motion between the surfaces 49 and 60j of the plunger 26 and the plunger guide 60 produces rotation and linear translation (the same as a helical path). Thus, the plunger guide 60 can function as a cam, and the plunger rod 26 can function as a cam follower.

[0099] The unlocking stage is shown in Figures 9B, 10B, and 11C. In this stage, the distal opposing cam surface 49 of the top ring 45 releases the proximal opposing cam surface 60j of the plunger guide 60 so 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 pushes the plunger 26 distally in the axial direction.

[0100] The downward stroke phase 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 moves rapidly along the longitudinal slot 86 formed within the plunger guide 60 and the channel surface 52b. During this phase, the top ring 45 of the plunger 26 moves along both the channel surface 52b of the release member 52 and the longitudinal slot 86 of the plunger guide 60, thereby preventing rotation between any of the three components (26, 52, and 60). As a more specific example, the plunger guide 60 is rotatably mounted to the housing 12, while the top ring 45 is located both within the channel surface 52b and within the longitudinal slot 86, so the release member 52 cannot rotate. Furthermore, during this stage, as the plunger 26 moves distally, the gap 18 between the base 47 of the plunger 26 and the stopper 24 decreases, and the base 47 comes into contact with the stopper 24. The device 10 is designed so that the plunger 26 moves with sufficient force to drive the stopper 24 distally and push 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 shock vibrations or sounds due to the interaction between the base 47 and the stopper 24. For example, the design parameters of the plunger biasing member 50 may be designed to satisfy these two sets of design objectives. As another example, damping components may be placed between the base 47 and the stopper 24 or elsewhere in the device 10 to dampen the force between the base 47 and the stopper 24. For example, the base 47 may include an elastomer component, part, or other damping feature. Additionally or alternatively, the stopper 24 may be formed of an elastomer material having inherent damping properties. Additionally or alternatively, the stopper 24 may include additional elastomer components, parts, or other damping features.

[0101] In some embodiments, the cam action between the distal opposing cam surface 49 on the projection 48 and the proximal opposing cam surface 60j of the plunger guide 60 can provide a damping effect. More specifically, the sliding friction between these two surfaces can be selected to delay the initial expansion of the plunger biasing member 50. Consequently, during the initial expansion of the plunger biasing member 50, the speed of the plunger 26 may be reduced compared to the free, unhindered expansion of the plunger biasing member 50. This reduction in the speed of the plunger 26 allows the plunger 26 to collide with the stopper 24 with less force, thereby reducing the possibility of structural damage to the drug storage container 20 and / or facilitating a more comfortable dispensing for the user.

[0102] The end-of-administration stage is shown in Figures 12B and 12C. As described above, during the downward stroke stage, the release member 52 cannot rotate relative to the plunger guide 60 while the top ring 45 is positioned within the channel surface 52b and the longitudinal slot 86. However, in the end-of-administration stage shown in Figure 12B, the top ring 45 can, in some embodiments, release the distal end of the release member 52 and no longer restrict or prevent the rotation of the release member 52. In a more specific example, as shown in the lower part of Figure 12B, the top ring 45 exits the channel surface 52b and / or distal surface 52d of the releaser, so that the release member 52 is no longer rotatably constrained by the top ring 45 and is pushed upward by the guard biasing member 35. The upward force from the guard biasing member 35 and the cam surface causes the release member 52 to rotate clockwise while moving upward along a helical path, causing the proximal opposing surface 52d of the release member 52 to contact the distal opposing surface 60p of the plunger guide 60, thereby producing an audible click. In a more specific example, Figure 12B shows a gap 90 between each surface 52d, 60p, which is then removed when the release member 52 moves proximal as shown in Figure 12C. The length of the channel surface 52b and the plunger 26 may be designed so that the top ring 45 exits the channel surface 52b when the stopper 24 reaches a desired moving point within the drug storage container 20, such as its moving end near the distal end of the drug storage container 20.

[0103] As a more specific example of the cam surface configuration between the release 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 (but rather the inner surface, rather than the outer surface, indicated by reference numeral 52c) of the release member 52, as shown by reference numeral 52c in Figures 7A and 7B. The rib 60n has an inclined 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, when combined with the inclined surface of the rib 60n, generates a rotational force (e.g., torque) that rotates the release member 52 relative to the plunger guide 60. During the first stage of rotation of the release member 52 (e.g., the unlocking stage shown in Figure 11B), the rib 60n moves along a first section of the internal cam surface 52c of the release member 52, for example, the first section 52f shown in Figure 7B. During the second stage of rotation of the release member 52 (for example, the end-of-dose stage shown in Figures 12B and 12C), the rib 60n moves along a second section of the internal cam surface 52c of the release member 52, for example, the second section 52g shown in Figure 7B. As seen in Figure 7B, the second section 52g includes a pocket 52h that can receive the rib 60n and allows the release member 52 to move quickly proximal toward the plunger guide 60, generating an audible click signaling the end of the dosing. In summary, during the end-of-dose stage, the top ring 45 releases the channel surface 52b of the release member 52, the guard biasing member 35 and the rib 60n rotate the release member 52 upward, and the rapid upward (proximal) movement of the release member 52 as the rib 60n moves into the pocket 52h ends in contact with the plunger guide 60.

[0104] When a patient and / or healthcare provider hears an audible sound, they may be notified that administration is complete. In some embodiments, the user may be informed of the importance of the audible signal by instructions provided with the drug delivery device 10. In some embodiments, these instructions may be in the form of an Instructions for Use (IFU) brochure packaged with the drug delivery device 10. In some embodiments, the user may obtain additional confirmation that drug delivery is complete by observing the movement of the stopper 24 and / or plunger 26 through the window 17. In some embodiments, the audible signal may be accompanied by vibration or other tactile feedback generated as a result of the release member 52 colliding with the plunger guide 60. The audible notification may be in the form of a click or slap or any other appropriate audible signal that the user can recognize. The audible signal may be generated simultaneously with or substantially simultaneously with the stopper 24 reaching the end-of-administration position.

[0105] As described above, in addition to its holding function, the release member 52 may also be used to generate an audible signal to indicate to the user that drug delivery, i.e., administration, is complete. The roles of these two functions can reduce the number of parts and / or the complexity of the design. Alternatively, the release member 52 does not need to have this indicator function. In another embodiment, the indicator may be defined by a structure that is separate from the release member 52 but securely attached to it.

[0106] In the above description, the extender biasing member 35 can be used to provide the operating energy necessary to generate the end-of-dose signal, but in another embodiment, a biasing member separate from the extender biasing member 35 may be used for this purpose. In such a particular embodiment, this additional biasing member may have a distal end fixed to the housing 12 and a proximal end that abuts the distally opposing surface of the release member 52. Thus, the biasing member can push the housing 12 aside and apply a biasing force to the release member 52 in the proximal direction. Furthermore, this biasing member may operate independently of the plunger biasing member 50 and the extender biasing member 35.

[0107] In any case, once the user receives some confirmation that drug delivery is complete, the user can then lift the drug delivery device 10 from the injection site. With nothing obstructing the extender biasing member 35, the extender biasing 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 cause the lock ring 40 to rotate to a position that prevents further retraction of the guard member 32.

[0108] 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 a retracted position to an extended position. In this embodiment, the locking ring 40 is centered about a longitudinal axis A and rotates about the longitudinal axis A. As shown in Figure 2, the proximal end of the locking ring 40 may be in contact with a portion of the housing 12, and the distal end of the locking ring 40 may be at least partially located within the guard member 32. A locking ring biasing member 51 may be axially positioned between the distal opposing surface of the locking ring 40 and the proximal opposing 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. Therefore, the lock ring biasing member 51 can not only act as a biasing force to push the guard member 32 toward the extended position, but can also act as a biasing force to push the proximal end of the lock ring 40 toward a portion of the housing 12, such as the annular collar 12d. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a compression coil spring).

[0109] The locking ring 40 may also function to provide initial resistance to the movement of the guard member 32. As described above, the device 10 may be inserted into the patient using, leveraging, or otherwise utilizing inertial force. As will be described in more detail below, the locking ring 40 and / or other components may provide initial resistance to the movement of the guard member 32 in order to accumulate the force applied by the user.

[0110] Figure 13 shows a perspective view of the lock ring 40. In the example shown in Figure 13, the lock ring 40 includes a cam surface 40a, which is not parallel to axis A and is configured to convert the translational motion of the shield guard 32 into rotational motion of the lock ring 40. In a more specific example, the cam surface 40a shown in Figure 13 has an angle 40d of approximately -30 degrees with respect to axis A. 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 also be a positive number (so that the angled surface is inverted about axis A), but such a configuration will rotate the lock ring 40 in the opposite direction. In such cases, any suitable angle such as 10-80 degrees, 20-70 degrees, 20-60 degrees, 20-50 degrees, 20-40 degrees, 25-35 degrees, or any other suitable angle may be used.

[0111] In the example shown in Figure 13, the locking ring 40 includes a locking arm 40b which may be a substantially cantilevered arm extending from the main body of the locking ring 40 (along the circumference of the locking ring 40). The locking arm 40b may include a protrusion 40c extending transversely (i.e., outward and non-parallel to axis A) with respect to the main body of the locking ring 40.

[0112] Figure 14 shows the lock ring 40 in the pre-deflection stage (for example, before the guard member 32 is axially deflected in the proximal direction) along with various other components of the device. For example, Figure 14 shows the distal portion of the housing 12 (partial cross-section for illustrative purposes), the guard member 32 (translucent and partially cutaway for illustrative purposes), the lock ring 40, and a portion of the internal collar 12d of the housing. The guard member 32 includes several ribs formed on its annular inner surface. These ribs are shown in Figure 14, although a portion of the annular surface itself has been cut out for illustrative purposes. Similarly, a portion of the housing 12 has been cut out for illustrative purposes, but the annular collar 12d formed on the inner surface of the housing 12 can be seen in Figure 14. When the device 10 is in the pre-deflection stage (as shown in Figure 14), the raised portion 40c is adjacent to the inertial rib 32k formed on the internal annular surface of the guard member 32. As a more specific example, when the device 10 is in the pre-deflection stage, the raised portion 40c is positioned to the left of the inertia rib 32k such that the lock ring 40 largely prevents rotation (and thereby prevents axial deflection of the guard member 32) until the raised portion 40c can move beyond the inertia rib 32k (i.e., can pass through the inertia rib 32k). This configuration will be described in more detail below.

[0113] Figures 15A and 15B show views from different angles (approximately 90 degrees apart from each other) of the device in the initial deflection phase, immediately after the guard member 32 has been released from engagement with the locking arm 40b. As a more specific example, the locking ring 40 has rotated so that the raised portion 40c has just passed the locking rib 32k, thereby allowing the guard member 32 to deflect more freely (proximal). At this point in the sequence, the injection sequence does not appear to have been initiated. For example, the plunger biasing member 50 does not appear to have been released yet, as the housing 12 has not yet moved distally enough for the delivery member 16 to puncture the user's tissue.

[0114] For the device components to transition from the stage shown in Figure 14 to the stages shown in Figures 15A and 15B, two main events occur almost simultaneously: the initial rotation of the locking ring 40 and its release from the locking arm 40b. Regarding the initial rotation, as shown in Figure 15B, the locking ring cam surface 40a is roughly aligned with the cam rib 32j to convert the translational motion of the shield guard 32 into rotational motion of the locking ring 40. More specifically, as the shield guard is retracted, the proximal opposing top surface of the cam rib 32j applies an axially upward force to the cam surface 40a. More specifically, depending on the angle of the cam surface 40a with respect to axis A, the upward force from the cam rib 32j has an axial component (along axis A) and a rotational component (crossing axis A), thereby causing the locking ring 40 to rotate. In other words, in both the stage shown in Figure 14 and the stages shown in Figures 15A and 15B, the deflection (retraction) of the guard member 32 causes rotation of the lock ring 40. The cam rib 32j biases the lock ring 40 to rotate to the right (i.e., counterclockwise when viewed from above in Figure 15B), while the locking arm 40b can substantially prevent such movement. For example, when the guard member 32 is pushed, the guard member 32 moves from the position shown in Figure 14 to the positions shown in Figures 15A and 15B. As a more specific example, when the device 10 is in the position shown in Figure 14, the raised portion 40c is positioned to the left of the inertia rib 32k so that the lock ring 40 cannot rotate beyond a certain point until the raised portion 40c can pass the inertia rib 32k. As shown in Figure 15A, the raised portion 40c can pass the inertia rib 32k due to the radially inward deflection of the locking arm 40b. In such a design, the bending of the locking arm 40b at least partially determines the force required for the raised portion 40c to pass the inertia rib 32k. In other words, the bending of the locking arm 40b at least partially determines the force required to sufficiently deflect the guard member 32 and initiate the injection process. The angle of the raised portion 40c with respect to the periphery of the lock ring 40 can also partially determine the force required to sufficiently deflect the guard member 32 and initiate the injection process.Furthermore, the degree of rotation that the lock ring 40 must perform for the raised portion 40c to pass the inertia rib 32k at least partially determines the distance that the guard member 32 translates (axially) before the locking arm 40b “releases” the guard member 32.

[0115] 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 raised portion 40c. When the patient pushes down with further force, the raised portion 40c passes the inertia rib 32k, and the delivery device 10 compresses the needle cover and its spring to a predetermined release point while rapidly releasing to utilize the energy stored in the patient's muscles. The release mechanism, such as the flexion of the locking arm 40b described above, the degree of rotation required to pass the inertia rib 32k, and other parameters may be designed so that when the raised portion 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, quickly and completely penetrates the skin to a subcutaneous depth. In other words, once the guard member 32 reaches the position shown in Figures 15A and 15B, the resistance to pressing 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 of the insertion process, the primary resistance to the deflection of the guard member 32 due to the distal components of the device is provided by the locking ring biasing member 51, but this resistance is significantly less than the resistance provided by the locking arm 40b. It should also be noted that the user may still feel resistance to the deflection of the guard member 32, which is due to other sub-components of the device, such as the activation of the drive mechanism 30. From this point onward, the insertion process proceeds very quickly, and the subsequent stages will be discussed in detail in the figures and the following chapters.

[0116] Figures 16A and 16B show views from different angles (shifted approximately 90 degrees from each other) when the device is in a continuous downward movement phase (later than in Figures 15A and 15B, where the housing has moved further distally and the guard member 32 has retracted further). At the point in the sequence shown in Figures 16A and 16B, the injection sequence may or may not have started, depending on desired release parameters such as the needle length, desired insertion depth, and the distance between the guard member 32 and the tip of the needle.

[0117] As shown in Figure 16A, at this point in the sequence, the cam rib 32j of the guard member 32 is passing over or about to pass over the cam surface 40a so that the guard member 32 can be deflected without rotating the lock ring 40. Additionally or alternatively, the inclined surface 40e of the lock ring 40 may engage with the inclined surface 12g of the housing 12 (which may be defined by the annular collar 12d and is similar to or the same as the inclined surface 412g in Figure 25). This interaction between each surface 40e, 12g may also facilitate the rotation of the lock ring 40 until it reaches the point shown in Figures 16A and 16B. Additionally or alternatively, at this insertion stage, the stop ridge 40f of the lock ring 40 engages with the stop rib 32n, restricting the rotation of the lock ring 40. However, as described above, at this stage, the guard member 32 can be deflected without requiring or causing further rotation of the lock ring 40. More specifically, as shown in Figures 16B and 17, the guard member 32 is deflected relative to the housing 12 because the adjacent ribs (stop rib 32n and cam rib 32j) extend between the adjacent components of the lock ring 40 (stop protrusion 40f and cam surface 40a).

[0118] Figure 17 shows the device in the final insertion stage when the guard member is fully or nearly fully retracted. At this point in the sequence, the injection sequence appears to be initiated. 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 in or near 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 total dose of drug 22 is delivered to the patient) and until the completion of administration notification indicates that administration is complete. Note that for illustrative purposes, the guard member 32 shown in Figure 17 has a cut-out portion, and Figure 17 does not show the housing 12 (including the annular collar) or the drug storage container 20.

[0119] Figures 18A and 18B show the device 10 in a lockout configuration when the guard member 32 is in the fully extended position (Figure 18A) or nearly fully extended position (Figure 18B). As a more specific example, the stop rib 32n and cam rib 32j of the guard member 32 are aligned with the stop protrusion 40f to limit and / or prevent the deflection of the guard member 32 in the proximal direction. As another more specific example, the guard member 32 can only move proximal to a distance indicated by the gap 91 in Figure 18A, so the guard member 32 cannot move axially proximal enough to expose the delivery member 16. In other words, the guard member 32 is locked in a guard position that annularly surrounds the needle, minimizing or preventing accidental needle sticks.

[0120] In some embodiments, the gripper 13 may be configured to prevent deflection of the locking arm 40b before the removable cap 19 is removed. For example, the outer surface of the gripper 13 may be configured to abut against the inner surface of the locking arm 40b to prevent radial inward deflection of the locking arm 40b before the removable cap 19 is removed. This configuration reduces the possibility of unintended lockout due to vibration or sudden movements during transport or storage of the drug delivery device 10 before use. Once the removable cap 19 is removed together with the gripper 13, the locking arm 40b can be deflected as described above.

[0121] The lock ring 40 and the housing 12 each have a stop surface, which abuts against each other to prevent rotation between the lock ring 40 and the housing 12. For example, the lock ring 40 may have stop surfaces 40g and 40h (Figures 18A, 13) that abut against the stop surfaces 12j and 12k (Figure 18A) of the annular collar 12d. Each stop surface 40g, 40h of the lock ring 40 and each stop surface 12j and 12k of the annular collar 12d may be a stepped surface to prevent or prevent rotation between the lock ring 40 and the housing 12. The lock ring biasing member 51 can push the lock ring 40 proximal and / or the guard member 32 distally to hold the lock ring 40 in a predetermined position, i.e., in contact with the annular collar 12d, as shown in Figures 18A and 18B.

[0122] The circular cross-section of the housing 12 may cause it to roll easily on a surface when the housing 12 is laid on its side. To prevent or stop such rolling, part 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 it moves from the proximal end 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 is substantially square in shape. In other embodiments, the non-circular cross-section may be rectangular, triangular, or any other polygon or partial polygon, as long as one or more faces of the removable cap 19 are flat or substantially flat to prevent or stop rolling. Furthermore, the non-circular cross-section of the distal end of the removable cap 19 may gradually increase in size as it moves distally, such that the most distal part of the distal end of the removable cap 19 has a larger cross-sectional area than the most proximal part of the distal end of the removable cap 19. This configuration provides a flared shape to the distal end of the removable cap 19, which may further assist the user in grasping and removing the removable cap 19 from the housing 12.

[0123] In some embodiments, the housing 12 and the removable cap 19 may each include their own anti-rotation features. These anti-rotation features may engage with each other to prevent or deter the removable cap 19 from rotating relative to the housing 12 when the removable cap 19 is in a storage position. In some embodiments, when the removable cap 19 is in a storage position, the anti-rotation features of the housing 12 may be adjacent to and substantially in line with the anti-rotation features of the removable cap 19. For example, the radial projection 9 shown in Figure 1A is located adjacent to the distal end of the housing 112. As shown in Figure 1B, the removable cap 19 includes an opening 8 which may be made to be sized to mate-receive the radial projection 9 when the removable cap 19 is in a storage position. As a result of this mating engagement, the removable cap 19 may not be able to rotate relative to the housing 12. This may be beneficial if the user attempts to twist the removable cap 19 when removing it from the housing 12. In some cases, the rotation of the removable cap 19 may cause the sterile barrier, such as the RNS or FNS, to rotate, which may further cause the tip of the needle to enter the RNS or FNS of the sealing member. Therefore, by positioning the radial projection 9 within the opening 8 at least at the initial moment of cap removal, the coring of the needle can be prevented. In another embodiment, the opening 8 may be formed in the wall of the housing 12, and the radial projection 9 may extend proximal from the proximal end of the removable cap 19.

[0124] In other embodiments, the removable cap may be made rotatable and / or intended to rotate relative to the housing. For example, the removable cap may include a feature that converts the rotational motion of the removable cap into an axial assisting force that helps to separate the cap from the housing. In a more specific example, the removable cap and / or housing may have a cam surface, such as a corrugated surface, that converts the rotational motion of the removable cap relative to the housing into an axial distal motion of the removable cap relative to the housing. The axial assisting force provided by such a configuration may be beneficial to a variety of users, including, for example, users with limited dexterity and / or muscle strength due to illness.

[0125] Figures 19A and 19B show exemplary force profiles during the 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), respectively. For example, the displacement (along the x-axis) represents the relative axial displacement between the guard member 32 and the housing 12 along axis A. As described above, this relative axial displacement can be understood as referring to the translational motion of the housing 12 relative to the guard member 32 (e.g., when the user pushes the housing distally toward the user's injection site, while the user's tissue prevents the guard member 32 from moving in the same direction), or it can be understood as referring to the translational motion 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 proximal). In any case, the x-axis (horizontal) of the graph in Figure 19 represents the relative displacement between the guard member 32 and the housing 12. The y-axis (vertical) of the graph in Figure 19 shows the resistance force at various points in time regarding the 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 have a relative displacement of approximately 2 mm is approximately 7.75 N in the force profile shown in Figure 19A. In a more specific example, resistance force may refer to the force experienced by the user due to the mechanical interaction between the components of the device. For example, when the housing 12 is first pushed toward the injection site in the pre-injection state shown in Figure 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 beyond the raised portion 40c. The force profiles in Figures 19A and 19B show several exemplary, potentially desired force and displacement values, and it should be understood that these values ​​may vary depending on the design of the aforementioned interaction.

[0126] Nevertheless, as shown in the exemplary force profile in Figure 19A, the initial resistance force is relatively small during the first approximately 1 mm of movement between the guard member 32 and the housing, then the resistance force increases rapidly at point 202 (mainly due to the force required to push the inertia rib 32k beyond the raised portion 40c), reaching a peak resistance force at point 204. As the inertia rib 32k passes the raised portion 40c (Figure 15A), the resistance force decreases rapidly to point 206. At this point, the resistance force is mainly due to the force required to compress the spring 51 (Figure 14), the force required to compress the spring 35 (Figure 11B), and the 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, and the drug 22 is injected into the user's tissue. If the user overcomes the peak resistance force at point 204, the user's inertia can drive the housing and drug storage container 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 of full needle insertion rather than partial insertion, and reducing the likelihood of the user stopping the device's movement before or during partial needle insertion. In other words, once the user clears the peak resistance at point 204, the user can "concentrate" on the needle insertion and / or injection process.

[0127] Figure 19B shows another exemplary force profile in which the peak force (point 304) is smaller than that of the corresponding point (204) in Figure 19A, requiring a smaller initial force for the user to concentrate on insertion. This force profile may reduce the likelihood of the user interrupting the process, such as prematurely removing the device from the tissue during the initial push-in (point 302). However, it may be desirable to have a peak force 304 high enough to reduce the likelihood of the user interrupting the injection between peak force 304 and needle insertion 308. In other words, the vertical distance (along the y-axis) between point 304 and point 308 should be large enough to allow this injection stage to be performed in a relatively short time.

[0128] Figures 20A to 20G show the distal portion of another design of device 400, primarily showing the housing 412, guard member 432, lock ring 440, and lock ring biasing member 451. As shown in Figures 20A and 22, the guard member 432 includes an annular base portion 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 called a hole in some annotations in the figures) formed in at least one of the ribs and walls of the guard member. The opening 432x does not have to be an opening formed in the entire wall of the guard member 432. For example, the opening may be a discontinuity in a long rib or projection section having a lower height, rather than a notch in part of the wall and rib of the guard member 432. The internal ribs of the guard member 432 preferably include a first rib that is longer than the other ribs (also known as the long rib 432r) and a pair of shorter ribs 432s, 432t. The opening 432x is formed within the long rib 432r and is sized to align with the components of the lock ring 440 and to selectively receive, for example, the components of the lock ring 440, as will be further described below. As shown in Figures 20A and 23, the lock ring 440 includes a plurality of stop surfaces 440g, 440h, a U-shaped projection 440w (configured to be received within the opening 432x), and a plurality of proximal opposing cam surfaces 440x, 440y. However, the lock ring 440 shown in Figures 20A and 23 does not have a distal opposing cam surface corresponding to the surface 40a in the design shown in Figure 13. As shown in Figure 20A, before the injection of device 400, while in the non-deflection state, each of the two U-shaped projections 440w is not initially received within the opening 432x. Rather, at this point, for example, the proximal portion of the long rib 432r (i.e., the portion of the long rib proximal to the opening 432x) is received within the U-shaped projection 440w to prevent the lock ring from moving upward (proximal) relative to the guard member.As shown in Figure 20B, as the housing 412 moves downward (distal) and / or the guard member 432 moves upward (proximal), the lock ring 440 can move upward (proximal) away from the spring 451, thereby bringing the cam surface of the housing 412 into contact with the lock ring cam surfaces 440x, 440y and pushing the lock ring rotatably. In the stage shown in Figure 20B, the lock ring 440 cannot rotate because the proximal portion of the long rib 432r is aligned with / received within the U-shaped projection 440w. Also, as shown in Figure 20B, the housing cam surface 412x engages with the lock ring cam surface 440y. However, as the relative motion between the guard member and the housing progresses to the state shown in Figure 20C, the engagement between the housing cam surface 412x and the lock ring cam surface 440y, combined with further relative motion between the guard member and the housing, results in the following: (1) the engagement between the housing cam surface 412x and the lock ring cam surface 440y stops the upward movement of the lock ring, allowing the proximal portion of the long rib 432r to disengage from alignment / engagement with the U-shaped projection 440w, where the U-shaped projection 440w aligns with the opening 432x; and (2) the engagement of the respective cam surfaces 412x and 440y rotates the lock ring 440. As shown in Figure 20D, the lock ring rotates to a point (approximately two-thirds of its full rotation) where it is rotatably constrained by the short ribs 432s, 432t of the guard member (more specifically, the stop surface 440v shown in Figure 23 engages with the short ribs 432s, 432t). In the state shown in Figure 20E, the guard member arm 432b moves sufficiently relative to the housing 412 for the injection sequence to begin. As shown in Figure 20F, when the user releases pressure against the housing, allowing relative proximal movement of the housing and / or distal movement of the guard member, the lock ring is rotatably constrained until the stop surface 440v passes the short ribs 432s, 432t and the lock ring rotates to the lockout configuration shown in Figure 20G.

[0129] Figures 26A to 26D show another alternative design of device 600, primarily showing the housing 612, the guard member 632, the lock ring 640, and the lock ring biasing member 651. As shown in Figure 26B, the 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 the guard member 632 may be configured as a projection extending radially inward. The opening 632x does not have to be an opening formed across the entire wall of the guard member 632. For example, the opening 632x may be a discontinuity in a long rib or projection section having a lower height, rather than a notch in part of the wall and rib of the guard member 632. The opening 632x is formed within the rib 632r and is sized to align with and selectively receive, for example, the components of the lock ring 640, as will be further described below. As shown in Figures 26A, 26B, and 26D, the lock ring 640 includes a plurality of stop surfaces 640g, 640h, at least one tab-shaped projection 640w (configured to be received within the opening 632x), and a plurality of proximal opposing cam surfaces 640y. As shown in Figure 26A, each tab-shaped projection 640w may be configured as a projection extending radially outward and may include a proximal opposing cam surface 640z. As shown in Figure 26D, before injection of the device 600, during the partial deflection state, each of the two tab-shaped projections 640w is not initially received within the opening 632x. Rather, at this point, the proximal opposing cam surface 612x of the housing 612 engages with the distal opposing cam surface 640y of the lock ring 640, preventing or blocking the lock ring 640 from moving upward (proximal) relative to the guard member 632. At the same time, each of the tab-shaped projections 640w engages with a pair of ramp surfaces 632y (also referred to herein as the proximal opposing cam surface 632y).At this injection stage, the guard member 632 is partially deflected (e.g., Figure 20B), but the lock ring 640 has not yet rotated, and the guard member 632 has not yet moved upward far enough to initiate the injection sequence. At this point, the user feels resistance to further movement of the injector housing 612 due to each of the aforementioned engagements, namely the engagement between the proximal opposing cam surface 612x of the housing 612 and the distal opposing cam surface 640y of the lock ring 640, and the engagement between the proximal opposing cam surface 640z of the tab-shaped projection 640w of the lock ring 640 and the ramp surface 632y of the guard member. This resistance may or could prompt the user to push down the injector with enough force to overcome the resistance (i.e., the peak resistance of the injector). The peak resistance is generated by the aforementioned interaction (the distal opposing cam surface 612x of the housing 612 and the proximal opposing cam surface 640y of the lock ring 640, and the distal opposing cam surface 640z of the tab-shaped projection 640w of the lock ring 640 and the ramp surface 632y of the guard member). The peak resistance is overcome (i.e., released) when the user's force is sufficient to cause the tab-shaped projection 640w of the lock ring 640 to slide along the inclined surface 632y of the guard member, and the proximal opposing cam surface 640y of the lock ring 640 to slide along the distal opposing cam surface 612x of the housing 612 (to the left in Figure 26D). In other words, the lock ring 640 rotates in the direction of arrow 601 and moves slightly downward (distal) (as shown in Figure 26D). When the locking ring 640 has rotated sufficiently so that the tab-shaped projection 640w of the locking ring passes the inclined surface 632y of the guard member, the guard member 632 can move axially upward (proximal). At this point, two things happen: (1) the guard member 632 has translated proximally by a sufficient distance, for example, to initiate the injection sequence, and (2) the tab-shaped projection 640w of the locking ring is axially aligned with the opening 632x of the guard member (Figure 26C), thereby allowing the locking ring 640 to rotate in the direction of arrow 602 (Figure 26D) and slightly upward (proximal) due to the interaction between the proximal opposing cam surface 640y of the locking ring 640 and the distal opposing cam surface 612x of the housing 612.Similar to the other embodiments described above, after injection has started, the lock ring 640 is in a position where it 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 has translated a distance sufficient to start injection, the lock ring rotates by a sufficient angle to start the lockout sequence. This may be desirable to substantially or completely prevent the user from attempting to perform multiple injections. This may also be desirable to substantially or completely prevent the lockout sequence from starting without the injection sequence having started. In other words, the above configuration can reduce the likelihood that the user will have a locked-out injector with an undelivered dose.

[0130] To facilitate the rotation of the lock ring 640 relative to the housing 612 and / or guard member 632, any two or any combination of the distal opposing cam surfaces 612x of the housing 612, the proximal opposing cam surface 632y of the guard member 632, the distal opposing cam surface 640z of the lock ring 640, and the proximal opposing cam surfaces 640y of the lock ring 640 may be parallel to each other.

[0131] Figures 21A to 21F show the distal portion of another alternative design of device 500, primarily showing the 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 the lock ring 540 has only a pair of parallel protrusions 540w instead of a U-shaped protrusion 440w, and does not have a horizontal protrusion connecting them. In other words, the protrusion 540w has a U-shaped "side" but not a U-shaped "bottom". In the state shown in Figure 21A, the protrusion 540w is received within the long rib of the guard member 532 to prevent rotational movement of the lock ring. Because relative movement occurs between the guard member and the housing, the protrusion 540w aligns with the opening in the guard member, as shown in Figure 21B, 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 Figure 21C, the lock ring then rotates until the stop surface 440v engages with 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 in a state where the user releases pressure and the guard member can move relative to the housing (extend distally). Figure 21F shows the lockout configuration.

[0132] Figure 24 provides a graph for comparing the force profiles shown in Figures 19A and 19B with the force profiles of drug delivery devices 400 (shown in Figures 20A-20G) and 500 (shown in Figures 21A-21F). Similar to Figures 19A and 19B, Figure 24 plots the resistance force experienced by the user against the displacement of the shield (e.g., shield guard 32). Furthermore, Figure 24 reveals where the lock point associated with the lock ring is designed to occur within each force profile. Figure 24 shows that the lock point in the force profiles in Figures 19A and 19B occurs at the same amount of shield displacement as when the user experiences peak resistance. In contrast, the lock points in the force profiles associated with drug delivery devices 400 and 500 do not coincide with the amount of shield displacement corresponding to the peak resistance experienced by the user.

[0133] Continuing to refer to Figure 24, the force profile associated with the drug delivery device 400 is similar to the force profiles in Figures 19A and 19B in that, prior to needle insertion, the user experiences a sharp increase in resistance due to shield displacement. Unlike the force profiles in Figures 19A and 19B, the resistance experienced by the user of the drug delivery device 400 may continue to increase after this increase (up to the activation point). Figure 24 shows that the user of the drug delivery device 500 may not experience a sharp increase in resistance during shield displacement, but rather a gradually increasing resistance up to the activation point. Manufacturers may select one or a different force profile from those shown in Figure 24 depending, for example, the desired user experience, the physical and / or mental capabilities of the target user or patient population, mechanical safety considerations, and / or additional considerations.

[0134] From the above, it can be seen that this disclosure advantageously provides an efficient design for drug delivery devices having automated features. Various mechanisms and components of drug delivery devices can interact synergistically with each other to limit the number of moving parts required of the drug delivery device, thereby improving the reliability of the drug delivery device, saving costs, and providing other benefits and advantages.

[0135] Naturally, the devices and methods described herein may have one or more advantages over the prior art, and any one or more of these may exist in particular embodiments according to the features of the disclosure included in those embodiments. Other advantages not specifically mentioned herein may be understood in the same way.

[0136] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used with, drugs specified below, including, but not limited to, their generic and biosimilar equivalents. As used herein, the term "drug" may be interchangeable with other similar terms and may refer to any type of drug or therapeutic material, including traditional and non-traditional medicines, dietary supplements, supplements, biological preparations, biological activators 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 restrictive.

[0137] The drug is contained within a reservoir. In some cases, the reservoir is a primary container that is either filled with the drug for treatment or pre-filled with the drug. The primary container may be a vial, cartridge, or pre-filled syringe.

[0138] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. 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-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006, pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0139] In other embodiments, the drug delivery device may contain, or be used with, an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythrocyte production. In some embodiments, the ESA is an erythrocyte-stimulating protein. As used in the present invention, “erythrocyte-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Examples of erythrocyte-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Examples of erythrocyte production-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). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0140] Certain exemplary proteins, including their fusions, fragments, analogues, variants, or derivatives, are described below: fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies, including OPGL-specific antibodies, peptide bodies, and related proteins (also referred to as RANKL-specific antibodies, peptide bodies, etc.); myostatin-binding proteins, peptide bodies, and related proteins, including myostatin-specific peptide bodies; and in particular, IL-4 receptor-specific antibodies, peptide bodies, and related proteins that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors. ;Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptide bodies, related proteins, etc.;Ang2 specific antibodies, peptide bodies, related proteins, etc.;NGF specific antibodies, peptide bodies, related proteins, etc.;CD22 specific antibodies, peptide bodies, related proteins, etc., in particular, dimers of human-mouse monoclonal hLL2γ chain disulfide bound to human-mouse monoclonal hLL2κ chain, for example, human epratuzumab (CAS registry number 501423-23-0) Human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as CD22-specific fully humanized antibodies; including but not limited to humanized and fully human monoclonal antibodies; including but not limited to anti-IGF-1R antibodies; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins; including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies; including but not limited to fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; including but not limited to antibodies that suppress the interaction between B7RP-1 and ICOS, the innate receptor of B7RP-1 on activated T cells; B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1", B7H2, ICOSL, B7h, and CD275); for example, HuMax such as 145c7; IL-15 antibodies and related proteins, including but not limited to them, particularly humanized monoclonal antibodies, IL-15 specific antibodies, peptide bodies, related proteins, etc.; human IFNIFN γ-specific antibodies, peptide bodies, and related proteins, including but not limited to γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; and HGF / SF:cMet targeting antibodies such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). Includes, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors, such as c-Kit-specific antibodies, peptide bodies, and related proteins; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; Activin A-specific antibodies, peptide bodies, and proteins; TGF-β-specific antibodies, peptide bodies, and related proteins; Amyloid-β protein-specific antibodies, peptide bodies, and related proteins; c-Kit-specific antibodies, peptide bodies, and related proteins, including but not limited to those that bind to c-Kit and / or other stem cell factor receptors; O OX40L-specific antibodies, peptide bodies, 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 erythrocyte-stimulating protein (NESP), Epogen (Registered Trademark) (Epoetin Alpha, or Erythropoietin), GLP-1, Avonex (Registered Trademark) (Interferon β-1a), Bexxar (Registered Trademark) (Tositumomab, anti-CD22 monoclonal antibody), Betaseron (Registered Trademark) (Interferon-β), Campath (Registered Trademark) (Alemtuzumab, anti-CD52 monoclonal antibody), Dynepo (Registered Trademark) (Epoetin Delta), Velcade (Registered Trademark) (Bortezomib), MLN0002 (Anti-α4β7)mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Kanjinti® (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin®, or other products containing trastuzumab for the treatment of breast or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimuma Vectibix(registered trademark) (panitumumab), Xgeva(registered trademark) (denosumab), Prolia(registered trademark) (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel(registered trademark) (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate(registered trademark) (romiplostim), rilotumumab, ganitumumab, conatumumab, brodalumab, insulin in solution, Infergen(registered trademark) (interferon alphacon-1), Natrecor(registered trademark) (nesiritide, recombinant human type B natriuretic peptide (hBNP)), Kineret(registered trademark) (anakinra), Leukine(registered trademark) (sargamostim, rhuGM-CSF), LymphoCide(registered trademark) (epratuzumab, anti-CD22 mAb), Benlysta (trademark) (Linfostat 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), Paxerizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (reldelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem (registered trademark) (IDM-1), OvaRex (registered trademark) (B43.13), Nuvion (registered trademark) (vizilizumab), cantuzumab meltansine (huC242-DM1), NeoRecormon (registered trademark) (epoetin beta), Neumega (registered trademark) (oprelbequin, human interleukin-11), Orthoclone OKT3 (registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit (registered trademark) (epoetin alfa), Remicade (registered trademark) (infliximab, anti-TNFα monoclonal antibody), Reopro (registered trademark) (absiximab, anti-GP) IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanorimumab), Mvasi® (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon α-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507), Tysabri® (natalizumab, anti-α4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax®, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor co-protein)), VEGF trap (VEGFR1 Ig domain fused with IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (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 (saltumumab), M200 (boroxiximab, 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).

[0141] In some embodiments, the drug delivery device may contain, or be used with, a sclerostin antibody, such as BPS804 (Novartis), Evenity® (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing. In other embodiments, it may contain, or be used with, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain, or be used with, rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042, or the device may be used with them. In some embodiments, the drug delivery device may contain or be used with an endogenous metalloproteinase tissue inhibitor (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (Erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as erenumab and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery device of this disclosure.In addition, bispecific T cell induction (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of the Disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to Apelin or its analogues. In some embodiments, therapeutically effective doses of anti-thymoid stromal lymphocyte generating factor (TSLP) or TSLP receptor antibodies may be used in or with the drug delivery device of the Disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola® (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used 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-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used with Parsabiv® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used with another product containing ABP798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF inhibitor such as a non-antibody VEGF inhibitor and / or a VEGF trap such as aflibercept (fused to the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2, and the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rozibafusp alfa (formerly 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 with another product containing omecamutib mecarbir (a small molecule selective cardiac myosin activator) or myotrope (which directly targets the cardiac contractile mechanism) or a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotrasib (formerly known as AMG510), KRAS. G12C Small molecule inhibitors, or KRAS G12CAnother product containing a small molecule inhibitor may be contained or used in conjunction with it. In some embodiments, the drug delivery device may contain or use in conjunction with it tezeperumab, a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or use in conjunction with it AMG714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or use in conjunction with it AMG890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing and / or conjugating to the p40 subunit of the human cytokine interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita® or Amgevita® (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing the human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG160, or another product containing the extended half-life (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain or be used with AMG119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG171, or another product containing a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG199, or another product containing an extended half-life (HLE) bispecific T cell derivative construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG256, or another product containing an anti-PD-1xIL21 mutaine 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 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 with AMG404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being studied as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG427, or another product containing an extended half-life (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 with AMG430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG506, or another product containing a multispecific FAPx4-1BB-targeted DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used 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 with AMG562, or another product containing an extended half-life (HLE) CD19xCD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used with efavaloikin alfa (formerly AMG592), or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device... The drug delivery device may contain or be used with AMG596, or another product containing the 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 with AMG673, or another product containing the extended half-life (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used with AMG701, or another product containing the extended half-life (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 with AMG757, or another product containing the extended half-life (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 long-lived (HLE) epithelial cell tightly bound protein claudink 18.2xCD3 BiTE® (bispecific T cell derivative) construct.

[0142] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited to exemplary embodiments. The embodiments for carrying out the invention should be interpreted merely as examples and do not describe all possible embodiments of the disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments are still included within the scope of the claims defining the invention as disclosed herein.

[0143] Those skilled in the art will understand that a wide variety of modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations will be interpreted as falling within the scope of the concept of the present invention.

Claims

1. A housing having an opening and defining a longitudinal axis, A drug storage container having a main body portion having a proximal end and a distal end, and a delivery member extending from the distal end of the main body portion, A plunger movable toward the distal end of the drug storage container is provided for discharging the drug from the drug storage container through the delivery member, A plunger biasing member configured to push the plunger toward the distal end of the drug storage container, A container holder configured to support the drug storage container relative to the housing such that the resultant force acting on the drug storage container from the plunger biasing member is at least substantially completely supported by the distal end of the main body portion of the drug storage container, Drug delivery devices, including those mentioned above.

2. The drug delivery device according to claim 1, wherein the distal end of the main body portion of the drug storage container includes an end face, the delivery member extends from the end face, and the container holder is configured to support the drug storage container with respect to the housing near the end face.

3. The drug delivery device according to claim 1 or 2, wherein the container holder includes at least two inwardly projecting flanges configured to receive the distal end of the drug storage container body portion.

4. The drug delivery device according to claim 3, wherein the two inwardly protruding flanges are separated from each other by at least two gaps.

5. The drug delivery device according to any one of claims 2 to 4, wherein the container holder includes an elastic portion configured to absorb at least a portion of the resultant force.

6. The drug delivery device according to claim 5, wherein the elastic portion includes an elastomer component.

7. The drug delivery device according to claim 6, wherein the elastic portion includes at least two inwardly projecting flanges configured to receive the distal end of the drug storage container body portion.

8. The drug delivery device according to claim 1 or 2, wherein the container holder is positioned within the housing and coupled to the housing so as to substantially prevent relative movement between the container holder and the housing.

9. The drug delivery device according to claim 8, wherein the housing includes an inner surface defining at least two slots, and the container holder is coupled to the housing by the slots.

10. The drug delivery device according to claim 9, wherein the container holder includes at least two locking protrusions configured to be received in the slot.

11. The drug delivery device according to claim 8, wherein the housing includes an inner surface defining at least four slots, and the container holder is coupled to the housing by the slots.

12. The drug delivery device according to claim 11, wherein the container holder includes at least four locking protrusions configured to be received in the slot.

13. The drug delivery device according to claim 1 or 2, wherein the container holder is defined by the features of the housing and is configured to substantially prevent relative movement between the drug storage container and the housing.

14. The drug delivery device according to claim 13, wherein the housing includes an inner surface defining at least two inwardly projecting flanges configured to receive the distal end of the drug storage container body portion.

15. A drug delivery device according to any one of claims 1 to 14, wherein the drug storage container includes at least one outwardly projecting flange at the proximal end of the main body portion, and the drug storage container is coupled to the container holder such that the resultant force acting on the drug storage container is not adequately supported by the at least one outwardly projecting flange.

16. The drug delivery device according to claim 15, wherein the container holder defines at least one opening configured to receive the at least one outwardly projecting flange.

17. The drug delivery device according to any one of claims 1 to 16, wherein the container holder includes a flexible arm configured to support the proximal end of the drug storage container body.

18. A drug delivery device according to any one of claims 1 to 16, further comprising a plunger guide configured to receive at least a portion of the plunger biasing member, wherein the plunger guide includes a proximal end coupled to the housing and a distal end configured to contact the container holder.

19. The drug delivery device according to claim 18, wherein the plunger guide includes a flexible arm configured to support the proximal end of the drug storage container body.

20. The drug delivery device according to any one of claims 1 to 19, wherein the container holder includes at least two arms configured to be selectively fixed to each other.

21. The drug delivery device according to any one of claims 1 to 20, wherein the container holder includes an open position for receiving the drug storage container and a closed position for securing the drug storage container.

22. The drug delivery device according to any one of claims 1 to 20, wherein the container holder includes at least one arm that is movable between an open position and a closed position.

23. The drug delivery device according to claim 21 or 22, wherein the container holder includes at least two arms that are movable relative to each other between the open position and the closed position.

24. The drug delivery device according to claim 23, wherein the at least two arms extend substantially along the longitudinal axis.

25. The drug delivery device according to claim 24, wherein the container holder further includes an annular ring supporting the at least two arms.

26. The drug delivery device according to claim 25, wherein the annular ring is adjacent to the distal portion of the container holder, and the at least two arms extend proximal along the longitudinal axis.

27. The drug delivery device according to any one of claims 21 to 26, wherein the container holder includes at least one locking component configured to fix the container holder in the closed position.

28. The drug delivery device according to claim 27, wherein the container holder includes at least two locking components configured to fix the container holder in the closed position.

29. The drug delivery device according to claim 28, wherein each of the at least two locking components includes a pair of mating connectors configured to fix the container holder in the closed position.

30. The drug delivery device according to any one of claims 21 to 29, wherein the container holder includes at least two inwardly projecting flanges configured to receive the distal end of the drug storage container.

31. The drug delivery device according to any one of claims 21 to 30, wherein the container holder includes at least two proximal, inwardly projecting flanges configured to define a proximal opening for receiving the drug storage container when the container holder is in the open position.

32. A housing having an opening and defining a longitudinal axis, A drug storage container having a main body portion having a proximal end and a distal end, and a delivery member extending from the distal end of the main body portion, A plunger movable toward the distal end of the drug storage container is provided for discharging the drug from the drug storage container through the delivery member, A plunger biasing member configured to push the plunger toward the distal end of the drug storage container, A container holder configured to substantially completely support the drug storage container with respect to the housing by the distal end of the main body portion of the drug storage container, Drug delivery devices, including those mentioned above.

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