EA045416B1 - DRUG DELIVERY DEVICE AND METHOD OF DRUG DELIVERY - Google Patents

Description

Cross references to related applications

This application claims priority to U.S. Provisional Application No. 62/908504, filed September 30, 2019, entitled Drug Delivery Device, U.S. Provisional Application No. 62/960996, filed January 14, 2020, entitled Drug Delivery Device and Methods of Delivering a Drug and U.S. Provisional Patent Application No. 62/962042, filed January 16, 2020, entitled Drug Delivery Device and Methods of Delivering a Drug, each of which is incorporated by reference.

Field of technology to which the invention relates

The present invention relates to drug delivery devices and methods of drug delivery, in particular to devices and methods for automatically injecting a drug into a patient.

Prerequisites for creating the invention

The general antipathy to exposed needles, as well as health and safety concerns, have led to the development of drug delivery devices that conceal the needle or other injectable element before use and that automate various aspects of the injection process. Such devices offer various advantages over traditional forms of drug delivery, such as delivery via a traditional syringe.

The drug delivery device may contain various mechanisms to implement various automated functions. Such features may include automatic closure of the needle in a pre-delivery and/or post-delivery state, automatic insertion of the needle and/or cannula into the user, automatic activation of the drive mechanism, automatic indication to the user that drug delivery has been completed, among other features. Typically, a drug delivery device contains a separate or independently operating mechanism for each of its automated functions. As a consequence, with each added feature, the mechanical complexity of the device tends to increase. This in turn can increase the size of the device, making it awkward for the user to handle, as well as increasing the cost and time required for production. As demand for drug delivery devices with improved usability and safety increases, finding a way to implement more automated functionality without unduly increasing the complexity of the drug delivery device poses challenging design and manufacturing challenges.

The present invention provides drug delivery devices that embody advantageous alternatives to existing drug delivery devices and are capable of meeting one or more of the objectives or requirements mentioned herein.

The essence of the invention

One aspect of the present invention provides a drug delivery device comprising a housing that defines a longitudinal axis and has an opening and a drug storage container comprising a delivery element having an insertion end configured to pass at least partially through the opening, the storage container the drug is connected to the body so as to substantially prevent relative movement between them. The device may further include a piston configured to move distally with respect to the drug storage container to push the drug from the drug storage container through the delivery element, and a piston biasing element configured to push the piston in a distal direction. The device may also include a fuse located adjacent the housing opening that is operatively coupled to the piston bias element such that relative movement between the fuse and the housing along the longitudinal axis allows release of the piston bias element. The device may further comprise a latch component configured to resist relative movement between the fuse and the housing until the latch component is released by force of the user. Resistance from the locking component may induce (eg, stimulate) the user to increase the user's force, and when the locking component is released, the user's force may cause the body and drug storage container to move toward the injection site. In at least some embodiments, release of the locking component may allow inertial forces from the user's effort to be applied to drive the housing and drug storage container toward the injection site.

The latch component may include an annular latch that is rotatable relative to the housing about a longitudinal axis. The ring retainer may have a first position in which the ring retainer resists relative motion between the fuse and the housing, and a second position in which the ring retainer does not resist relative motion between the fuse and the housing. The ring lock may further or alternatively comprise a locking arm having a base and a deflectable end, wherein the deflection

- 1 045416 deflectable end allows the ring retainer to rotate between the first position and the second position. The locking arm may also include a locking projection.

The fuse may include an inertial rib configured to engage with the ring retainer and resist rotational movement of the ring retainer relative to the housing. The fuse may further comprise an inertial rib configured to engage the deflectable end of the locking arm and resist movement of the ring lock from the first position to the second position. The fuse may include a cam rib configured to engage a cam surface of the ring retainer and push the ring retainer to a second position.

The ring retainer may include a cam surface configured to engage the guard and push the ring retainer to a third position. The ring retainer may also include a locking projection configured to selectively engage the guard and limit or resist relative movement between the guard and the ring retainer along the longitudinal axis when the ring retainer is in a third position.

The guard may include a proximally facing cam surface and the body may include a distally facing cam surface. The ring retainer may comprise a distally facing cam surface and a proximally facing cam surface configured to engage the proximally facing cam surface of the guard and the distal cam surface of the housing, respectively, when the ring retainer is in a first position, to resist proximal movement of the guard. One or more of the proximally facing cam surface of the guard and the distal cam surface of the housing may push the ring lock to rotate from a first position to a second position as the guard moves proximally. The distally facing cam surface of the ring retainer may be configured to disengage from the proximally facing cam surface of the guard when the ring retainer is rotated to a second position.

The ring retainer may include a radially outwardly extending projection, and the radially outwardly extending projection may include a distally facing cam surface. The guard may include a radially inwardly extending projection, and the radially inwardly extending projection may include a first proximally facing cam surface.

Any two of the following elements, or any combination thereof, are parallel to each other: a proximally facing cam surface of the guard, a distal facing cam surface of the housing, a distal facing cam surface of the ring retainer, and a proximally facing cam surface of the ring retainer.

Another aspect of the present invention provides a drug delivery device comprising a housing defining a longitudinal axis and having an opening and a drug storage container containing a delivery element having an insertion end configured to pass at least partially through the opening, the drug storage container the means is connected to the housing so as to substantially prevent relative movement between them. The device may further include a piston configured to move distally with respect to the drug storage container to push the drug from the drug storage container through the delivery element, and a piston biasing element configured to push the piston in a distal direction. The device may also include a fuse positioned adjacent the opening such that the housing has a first position relative to the fuse in which the piston bias element is locked, and a second position relative to the fuse in which the piston bias element is unlocked. The device may further comprise a latch component configured to hold the housing in the first position until the latch component is released by force of the user. Resistance from the locking component may induce (eg, stimulate) the user to increase the user's force, and when the locking component is released, the user's force may cause the body and drug storage container to move toward the injection site. In at least some embodiments, release of the locking component may allow inertial forces from the user's effort to be applied to drive the housing and drug storage container toward the injection site.

Another aspect of the present invention provides a method of delivering a drug to a user, comprising providing a drug delivery device comprising

- 2 045416 housing, a drug storage container having a delivery element and connected to the housing so as to substantially prevent relative motion therebetween, a piston configured to move relative to the drug storage container to push the drug out of the storage container drug through a delivery element, a piston displacement element configured to push the piston in a distal direction, a guard coupled to the housing, and a locking component configured to resist relative motion between the guard and the housing. Another step may include placing the drug delivery device in contact with the user such that the guard surrounds the user's injection site. Another step may include applying a force by the user to the housing toward the injection site sufficient to overcome the resistance of the locking component and to provide relative motion between the housing and the lock, thereby causing the housing and drug storage container to move toward the injection site. In at least some embodiments, overcoming the resistance of the locking component may allow inertial forces from the user's effort to be applied to drive the body and drug storage container in motion toward the injection site.

Brief description of graphic materials

It is believed that the present invention will become more apparent from the following description taken in conjunction with the accompanying drawings. Some of the graphics may have been simplified by eliminating selected elements in order to present other elements more clearly. Such exclusions of elements in certain graphics do not necessarily imply the presence or absence of specific elements in any of the exemplary embodiments, unless expressly stated in the relevant description. In addition, none of the figures in the graphic materials are depicted to scale.

In fig. 1A is a perspective view of an example drug delivery device in accordance with various embodiments.

In fig. 1B is a perspective view of the drug delivery device of FIG. 1A with its cap removed.

In fig. 1C is a perspective view of the drug delivery device of FIG. 1A in pre-injection configuration.

In fig. 1D is a perspective view of the drug delivery device of FIG. 1A in injection configuration.

In fig. 2 is a cross-sectional view of the drug delivery device of FIG. 1.

In fig. 3A is an exploded perspective view of a part, namely, a driving mechanism, of the drug delivery device of FIG. 2.

In fig. 3B is an exploded perspective view of the drug delivery device of FIG. 2.

In fig. 4A is a perspective view of an example of a drug storage container for use with a drug delivery device in accordance with various embodiments.

In fig. 4B is a perspective view of an example of a container holder for use with a drug delivery device in accordance with various embodiments, wherein the container holder is in an open position.

In fig. 4C is a perspective view of the container holder of FIG. 4B connected to the drug storage container of FIG. 4A, where the container holder is in the closed position.

In fig. 4D is a perspective view of an example of a container holder for use with a drug delivery device in accordance with various embodiments, wherein the container holder is in a closed position.

In fig. 4E is a perspective view of an example housing for use with a drug delivery device in accordance with various embodiments.

In fig. 4F is a partial cross-sectional view of a container holder and a medicine storage container taken along line 4F-4F in FIG. 4C.

In fig. 5A is a partial cross-sectional view of a container holder, a drug storage container, taken along line 5A-5A in FIG. 4C, as well as a partial cross-sectional view of the distal portion of an example piston guide connected to the container holder and the drug storage container.

In fig. 5B is a perspective view of an example of a piston guide in accordance with various embodiments.

In fig. 5C is a partial cross-sectional perspective view of the piston guide

- 3 045416 according to Fig. 5V.

In fig. 6A is a perspective view of an example of a safety member in accordance with various embodiments.

In fig. 6B is a perspective view of an example of a safety extension portion according to various embodiments.

In fig. 6C is a partial cross-sectional perspective view of a safety extension portion, a trigger member, and a piston guide on which the components are in a pre-injection position.

In fig. 7A is a perspective view of an example of a trigger element in accordance with various embodiments.

In fig. 7B is another perspective view of the trigger element of FIG. 7A.

In fig. 8 is a perspective view of the piston guide of FIG. 5B, the trigger element of FIG. 7A and the piston 26 shown in FIG. 2, in which the guide element is shown in a translucent form for illustrative purposes.

In fig. 9A is a perspective view of an example of a piston guide, an example of a trigger member, and an example of a piston in which a portion of the guide member is shown in cross-section for illustrative purposes and in which the drug delivery device is in a pre-injection position.

In fig. 9B is a perspective view of the components of FIG. 9A, in which the piston is in the released position before the axial movement performed by the piston.

In fig. 9C is a perspective view of the components of FIG. 9A, in which the piston is in the released position after the axial movement of the piston has begun.

In fig. 10A is a top view of the components of FIG. 9A, in which the drug delivery device is in a pre-injection position.

In fig. 10B is a top view of the components of FIG. 9B, in which the piston is in the released position before the axial movement performed by the piston.

In fig. 10C is a top view of the components of FIG. 9C, in which the piston is in the released position after the axial movement of the piston has begun.

In fig. 11A is a perspective view of the components of FIG. 9A plus additional components, such as an example of a safety extension portion, and in which the drug delivery device is in a pre-injection position.

In fig. 11B is a perspective view of the components of FIG. 11A, in which the safety extension was pushed proximally but the piston was not released.

In fig. 11C is a perspective view of the components of FIG. 11A, in which the safety extension has been moved further proximally and the piston has been released but has not yet moved axially.

In fig. 12A is a perspective view of the components of FIG. 9A plus an example of a fuse bias element where the piston is in the released position after the axial movement of the piston has begun, with some of the components shown in cross-section for illustrative purposes.

In fig. 12B is a perspective view of the components of FIG. 12A plus a more distal view of the device, where the piston is in the release position at or near the end of dosing, but the trigger element is not yet in the end of dosing position, and where the safety extension element and the safety bias element are removed for illustrative purposes.

In fig. 12C is a perspective view of the components of FIG. 12A, where the trigger element is at the end of the dose administration position.

In fig. 13 is a perspective view of an example of a ring retainer in accordance with various embodiments.

In fig. 14 is a perspective view of the distal portion of an example device in accordance with various embodiments, with the safety element in a pre-injection, pre-deflected state, and in which portions of the housing are shown in cross-section for illustrative purposes.

In fig. 15A is a perspective view of the distal portion of the device shown in FIG. 14, where the safety element is at the initial stage of deflection.

In fig. 15B is a perspective view of the same device and the same step as in FIG. 15A, from a viewpoint approximately 90° relative to that shown in FIG. 15A.

In fig. 16A is a perspective view of the distal portion of the device shown in FIG. 14, where the safety element is further deflected in a distal direction from the step shown in FIG. 15A.

In fig. 16B is a perspective view of the same device and the same step as in FIG. 16A, from a viewpoint approximately 90° relative to that shown in FIG. 16A.

- 4 045416

In fig. 17 is a perspective view of the distal portion of the device shown in FIG. 14, where the safety element is in a completely deflected or almost completely deflected position with respect to the housing, such as during the injection phase.

In fig. 18A is a perspective view of the distal portion of the device shown in FIG. 14, where the safety element is in a fully deflected locked position relative to the housing and the device is in the post-injection stage.

In fig. 18B is a perspective view of the distal portion of the device shown in FIG. 14, where the safety element is in an almost fully retracted locked position relative to the housing and the device is in the post-injection stage.

In fig. 19A is a graph showing an example force profile during the injection process of an example drug delivery device, where the relative displacement between the device body and the guard member is noted along the x-axis (in millimeters) and the resistance is noted along the y-axis (in Newtons).

In fig. 19B shows another example of a force profile during the injection process of an example drug delivery device similar to the profile of FIG. 19A.

In fig. 20A-20G show another example of a drug delivery device in accordance with various embodiments.

In fig. 21A-21F show another example of a drug delivery device in accordance with various embodiments.

In fig. 22 shows the safety element shown in FIG. 20A-20G and 21A-21F.

In fig. 23 shows the ring retainer shown in FIG. 20A-20G.

In fig. 24 shows force profiles of various devices, with two force profiles shown in FIG. 19A and 19B, respectively, one force profile (shown as a dashed line) relates to the device 400 shown in FIG. 20A-20G, and the other force profile (depicted by the dotted line) relates to the device 500 shown in FIG. 21A-21F.

In fig. 25 is a perspective view of an example housing in accordance with various embodiments.

In fig. 26A-26D depict another example of a drug delivery device in accordance with various embodiments, wherein FIG. 26A and 26B are various perspective views of a ring retainer of a drug delivery device; FIG. 26C is a perspective view of a safety member of a drug delivery device, and FIG. 26D is a cross-sectional view of a portion of a drug delivery device.

Detailed description

The present invention generally relates to drug delivery devices used by a user to administer a drug or, in the case where the patient is a user, to self-administer a drug. Various features are disclosed, such as automatically closing the needle in a pre-delivery and/or post-delivery state, automatically inserting a needle and/or cannula into a user, automatically activating a drive mechanism, automatically indicating to a user that drug delivery has been completed, among other features. Although known drug delivery devices contain a separate or independently operating mechanism for implementing each of its automated features, the present invention includes eliminating and/or combining at least some of these features. For example, the present invention includes a fixed or substantially fixed relationship between the housing and the drug storage container, and a locking component configured to resist relative movement between the guard and the housing until the locking component is released by force of the user, thereby thereby, for example, applying inertial forces from the user's efforts to drive the body and container for storing the drug in motion towards the injection site. As a consequence, the delivery device does not require or contain an independent component for automatically inserting a needle and/or cannula into the user, thereby reducing the mechanical complexity, durability and/or cost of the device. These and other advantages will be apparent to one skilled in the art when considering the present invention.

In fig. 1-3 depict several views of an embodiment 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, without limitation, various biological preparations such as peptides, peptibodies or antibodies. The drug may be in the form of a fluid or liquid, although the present invention is not limited to a particular condition.

Various implementations and configurations of the drug delivery device 10 are possible. The present embodiment of the drug delivery device 10 is designed as a disposable injector intended for single use. In other embodiments, the drug delivery device 10 can be made in the form of a reusable

- 5 045416 injector intended for repeated use. The drug delivery device 10 is configured to be used for self-administration by a patient or for administration by a caregiver or formally trained healthcare professional (eg, a doctor or nurse). Examples of drug delivery devices shown in the figures may take the form of an auto-injector or pen-type injector and, as such, may be held in the user's hand for the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and /or configurations.

The configuration of various components that are 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 or a storage state, a delivery or dosing state, and a post-delivery state, although fewer or more states are also possible. For example, each state may have several substates 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, a pre-delivery state may exist during the time period between the release of the drug delivery device 10 from the manufacturing facility and the activation of the drive mechanism 30 of the drug delivery device 10 by the patient or user. This includes times after the user has removed the drug delivery device 10 from any secondary packaging and before placing the drug delivery device 10 adjacent to the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 during a drug delivery process, also referred to herein as dosing. The post-delivery state may correspond to the configuration of the drug delivery device 10 after completion of drug delivery and/or when the plug is at the end of dosing position in the drug storage container.

As shown in FIG. 1A and 1B, the drug delivery device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and sized to allow a person to hold the injector 10 with one hand. The body 12 may have a generally oblong shape, such as a cylindrical shape, and extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (FIG. 3B) may be formed at the distal end to allow the insertion end 28 of delivery element 16 (FIG. 2) to pass outside the housing 12. A clear or translucent viewing window 17 (FIGS. 1A, 1B) may be located in the wall housing 12 to allow the user to inspect the component(s) inside the drug delivery device 10, including the drug storage container 20. Inspection of the drug storage container 20 through the window 17 may allow the user to verify that drug delivery is ongoing and/or completed. The removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10 and, in some embodiments, may include a gripping device 13 (FIG. 2) configured to facilitate removal of the sterile barrier 21 (e.g., a rigid needle cap (RNS), a non-rigid cap needle (nRNS), etc.) mounted on the insertion end 28 of the delivery element 16. The gripping device 13 may include one or more inwardly projecting tenons or legs that mechanically engage by friction or otherwise with the sterile barrier 21 to pull the sterile barrier 21 along with the release cap 19 when the user removes the release cap 19 from the housing 12. Thus removal of the removable cap 19 removes the sterile barrier 21 from the delivery element 16.

As shown in FIG. 2, the drive mechanism 30 may be located partially or completely within the housing 12. Typically, the drive mechanism 30 may be configured to store energy and, upon activation or in response to activation of the drive mechanism 30 by a user, release or output that energy to drive the piston 26 into motion to expel the drug 22 from the drug storage container 20 through the delivery element 16 into the patient. In the present embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may have a different configuration, such as in which the drive mechanism 30 stores electrical or chemical potential energy. Typically, when the drive mechanism 30 is activated, the drive mechanism 30 may convert potential energy into kinetic energy to move the piston 26. As best illustrated in FIG. 3A, in one embodiment, the drive mechanism 30 includes a piston bias element 50, a hollow rod 46 to support the piston bias element 50, a piston bias element seat 38, a trigger element 52, a piston guide 60, an extension bias element 35, and a safety extension portion 37. The piston bias 50 may include a compression spring (eg, a coil compression spring) that is initially held in tension. When under stress, the piston bias element 50 may be compressed such that its axial length is shorter than it would be naturally.

- 6 045416 or in a relaxed state. When released, the piston bias element 50 may attempt to expand to its natural axial length and, as a result, apply a bias force that pushes the piston 26 in a distal direction.

As best shown in FIG. 2 and 3B, in one embodiment, the device 10 includes a housing 12, which may include two separate and interconnected structures: a rear end cap 23 (eg, a back cover) at the proximal end of the drug delivery device 10; and a tubular body 25 extending substantially the entire length of the drug delivery device 10 and defining an opening 14. Additionally or alternatively, the body 12 may include fewer or more components, such as a two-piece tubular body having a front and a rear portion. The tubular body 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical shape or a hollow cylinder shape with an open end and a closed end. In some embodiments, the rear end cap 23 and tubular housing 25, as well as any components housed therein, may be assembled together to form various subassemblies, such as the drive mechanism 30 (FIG. 3A). In some embodiments, the various sub-assemblies are assembled independently of each other and later combined with each other as well as with the drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the assembly phases described above may occur at different manufacturing sites or under different manufacturing conditions. In alternative embodiments, the body 12 may be formed as a single piece such that the body 12 is formed by a single monolithic structure that integrates the back cap and the tubular body into a single component.

The drug storage container 20 is located in the interior space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 can be pre-filled and delivered, for example by the manufacturer, to the place where the drug storage container 20 is combined with the rest of the drug delivery device 10. For example, drug 22 may be dispensed and/or provided to patients in more than one use case, such as as a prefilled syringe or as an auto-injector containing a prefilled syringe. By using the same or similar syringe components in either case, at least some of the above steps of filling, labeling, packaging, delivery and distribution can be improved or simplified for two different uses. As another example, if multiple uses utilize some or all of the same syringe components, certain regulatory marketing and/or distribution pathways for the drug may be improved and/or simplified for at least one of the multiple uses.

The drug storage container 20 may be preloaded into the housing 12, for example by the manufacturer, or alternatively, the drug storage container 20 may be loaded by the user prior to use of the drug delivery device 10. The drug storage container 20 may comprise a rigid wall defining an internal channel or reservoir. The wall can be made of glass or plastic. The stopper 24 may be movably positioned in the drug storage container 20 so that it can move distally along the longitudinal axis A between the proximal end and the distal end of the drug storage container 20. Stopper 24 may be made of rubber or any other suitable material. The stopper 24 is slidably and sealably in contact with an interior surface 15 of the wall of the drug storage container 20 so as to prevent or contain the leakage of the drug 22 past the stopper 24 when the stopper 24 is in motion. The distal movement of the plug 24 forces the drug 22 from the reservoir of the drug storage container 20 into the delivery element 16. The proximal end of the drug storage container 20 may be open to allow the piston 26 to pass into the drug storage container 20 and push the plug 24 in a distal direction. In the present embodiment, the piston 26 and plug 24 are initially separated from each other by a gap 18 (FIG. 2). When the actuator 30 is activated, the piston 26 moves distally, eliminating the gap, and comes into contact with the plug 24. Subsequent movement of the piston 26 in the distal direction causes the plug 24 to move in the distal direction to push the drug 22 out of the drug storage container 20. In alternative embodiments, plug 24 and piston 26 may initially be in contact with each other or may be connected to each other, such as by a threaded connection, such that they move together when piston 26 begins to move. Once plug 24 is in motion, it may continue to move. in the distal direction until it comes into contact with the proximally facing portion of the inner surface 15 of the wall of the drug storage container 20. This position of plug 24 may be referred to as the end of dosing position or the end of delivery position and may correspond to a state where delivery of the drug 22 to the patient is completed or substantially completed.

In some embodiments, the volume of drug 22 contained in the reservoir of drug storage container 20 may be 1 ml, or equal to approximately (e.g., ±10%) 1 ml, or equal to 2.5 ml, or equal to approximately (e.g., ±10%) 2.5 ml, or equal to 3 ml, or equal to approximately (eg ±10%) 3 ml, or may be less than or equal to approximately (eg ±10%) 1 ml, or may be less than or equal to approximately (e.g., ±10%) 2 mL, or may be less than or equal to approximately (e.g., ±10%) 3 mL, or may be less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g. , ±10%) 5 ml, or may be less than or equal to approximately (e.g., ±10%) 10 ml, or may be in the range of approximately (e.g., ±10%) 1-10 ml, or in the range of approximately (e.g., ±10%) 1-10 ml, or in the range of approximately (e.g., ±10%) ±10%) 1-5 ml, or in the range of approximately (e.g. ±10%) 1-4 ml, or in the range of approximately (e.g. ±10%) 1-3 ml, or in the range of approximately (e.g. ±10 %) 1-2.5 ml.

The delivery element 16 is connected or operably connected in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery element 16 may form the insertion end 28 of the delivery element 16. The insertion end 28 may include a pointed tip with another pointed geometric shape allowing the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery element 16. The delivery element 16 may be hollow and include an internal channel. One or more holes may be formed in the administration end 28 to allow the drug to flow from the delivery element 16 into the patient's body.

In one embodiment, the drug storage container 20 may be a pre-filled syringe and includes a permanently hollow metal needle for the delivery element 16. Here, the needle is stationary relative to the wall of the drug storage container 20 and can be in constant fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be connected to the drug storage container 20 via a luer lock or other suitable connection. In still other embodiments, the drug storage container 20 may be a cartridge without a needle and as such may not be in fluid communication with the delivery element 16 initially. In such embodiments, the drug storage container 20 may move toward the proximal end of the delivery element 16 or in the opposite direction during operation of the drug delivery device 10 such that the proximal end of the delivery element 16 penetrates the partition covering the opening in the drug storage vessel 20 means, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery element 16.

The drug storage container 20 may comprise a main body 20g with a distal end 20e and a proximal end 20f. The drug storage container 20 may be stationary relative to the housing 12 such that the drug storage container 20 does not move relative to the housing 12 once installed in the housing 12. Thus, the insertion end 28 of the delivery element 16 continuously passes through the opening 14 in the housing 12 at pre-delivery condition, delivery condition and post-delivery condition. For example, as shown in FIG. 2, delivery member 16 extends beyond the distal end of housing 12, which defines opening 14. However, in some configurations, such as the storage configuration shown in FIG. 2, the delivery element 16 is covered/protected by a sterile barrier 21 and a safety element 32 that surrounds the delivery element 16 and protects against or reduces the likelihood of unintentional or premature needlestick.

The container holder 31 may be hollow and generally cylindrical or tubular in shape, centered about the longitudinal axis A, and the drug storage container 20 may be located partially or completely within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33 adjacent to the shoulder portion 20a of the drug storage container 20, thereby preventing distal movement of the drug storage container 20 during activation of the piston 26.

In one embodiment, the container holder 31 secures and/or fixes the position of the medication storage container 20 within the housing 12. For example, the container holder 31 may be configured to support the medication storage container 20 relative to the housing 12 adjacent to at least part of the distal end of the main portion of the drug storage container 20 (including, for example, adjacent to the entire distal end of the main portion of the drug storage container 20) such that the net force acting on the drug storage container 20 from the piston biasing element 50 is at least substantially completely transferred by the distal end of the main portion of the drug storage container 20.

The term body of the drug storage container 20 as used herein generally refers to the cylindrical portion of the drug storage container 20. For example, the main part 20g of the medicine storage container 20 shown in FIG. 4A extends from the distal side of the flange 20c to the proximal side of the shoulder portion 20a. As a more specific example, the main part 20g of the medicine storage container 20 shown in FIG. 4A has a relatively constant inner diameter and/or a relatively constant outer diameter along its length. As shown in FIG. 4A and 2, near the distal end 20e of the body 20g, the medicine storage container 20 forms a shoulder portion 20a. The delivery element 16 extends in a distal direction from the distal end 20e of the main portion 20g of the drug storage container 20. As 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 a delivery element 16, such as a permanent needle.

The term resultant force refers to the force propelling the drug storage container 20 along axis A upon and due to activation of the piston biasing member 50 during and after the injection state. For example, when piston 26 is activated and driven distally along axis A, it pushes plug 24 distally. As a result of this direct contact between the piston 26 and the plug 24, as well as the frictional forces between the plug 24 and the drug storage container 20 and the forces required to push the drug 22 through the relatively small diameter delivery element 16, the drug storage container 20 is pushed distally even though the piston 26 may not directly contact, abut or engage the main portion of the drug storage container 20. As a result, the drug storage container 20 may be subject to a relatively high net force during the injection process, more specifically during activation of the piston 26.

The force concentration of the resultant force acting on the drug storage container 20 during activation of the piston is highest in that portion of the drug storage container 20 that resists movement in the distal direction. For example, in the device shown in the figures, the concentration of force is greatest near at least a portion of the distal end 20e of the main portion 20g of the drug storage container 20. As a more specific example, the concentration of force is greatest at the shoulder portion 20a, where the drug storage container 20 is supported by the container holder 31. As an even more specific example, the force concentration is at least substantially completely transferred by the shoulder portion 20a of the drug storage container 20. The term substantially entirely can mean more than 50%, it can mean more than 70%, it can mean more than 75%, it can mean more than 80%, it can mean more than 80%, it can mean more than 85% it can mean more than 90%, it can mean more than 95%, it can mean more than 98%, or any other suitable amount.

The force concentration of the resultant force acting on the drug storage container 20 during activation of the piston is preferably slightly transferred by the outwardly projecting flange 20d of the drug storage container 20. For example, since the force is substantially completely transferred by the distal portion 20e of the main portion 20g of the drug storage container 20, the force concentration in and adjacent to the outwardly projecting flange 20d is relatively low. As a more specific example, the percentage of the net force acting on the entire drug storage container 20 that is carried by the outwardly projecting flange 20d may be less than 20%, or it may be less than 15%, or it may be less than 10 %, or it may be less than 5%, or it may be less than 3%, or it may be less than 2%, or it may be less than 1%, or it may be approximately 0%.

As shown in FIG. 2 and 4B, the container holder 31 includes a plurality of flanges 33, each of which includes an arcuate inclined surface 33a that substantially corresponds to the arcuate shape of the shoulder portion 20a of the drug storage container 20. As a more specific example, when the drug storage container 20 is inserted within the container holder 31, the flanges 33 cooperate to support the shoulder portion 20a and limit the distal movement of the drug storage container 20. The flanges 33 are separated from each other by a gap 33b (Fig. 3b) to allow the flanges 33 to bend, as will be described in more detail below. The container holder 31 shown in FIG. 4A-4C comprises four flanges 33, but any suitable number of flanges may be used, as will be described below with respect to another example design shown in FIG. 4D.

- 9 045416

The container holder 31 may have an open position 29a (FIG. 4B), in which it is capable of receiving the container 20 to store the drug during assembly, and a closed position 29b (FIG. 4C), in which it is capable of supporting or at least partially supporting container 20 for storing medicine. As a more specific example, the container holder 31 includes a pair of legs 31a, 31b extending axially from the ring-shaped hoop 31c such that the legs 31a, 31b can flex away from or toward each other to move between an open position 29a and a closed position 29b. The annular hoop 31c in the figures is located adjacent the distal end of the container holder 31 so that the proximal portions of the legs 31a, 31b are capable of diverging when the container holder 31 is in the open position 29a. The container holder 31 further includes mating connectors 31d, 31e adjacent to the upper (proximal) portion of the container holder 31, which are configured to snap together when the container holder is in the closed position 29b. As a more specific example, when the mating connectors 31d, 31e are in engagement with each other, the frictional fit between the respective components holds the container holder 31 in the closed position 29b.

The container holder 31 shown in the figures also includes a pair of inwardly projecting flanges 31 f, 31g located 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 the radially outwardly projecting flange 20b on the drug storage container 20 is able to be accommodated in the container holder 31 (by insertion in the distal direction) . In other words, when the container holder 31 is in the open position 29a, the outwardly projecting flange 20b on the medicine storage container 20 is capable of clearing the gap between the inwardly projecting flanges 31f, 31g. Once 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 flanges 33), the container holder legs 31a, 31b are allowed to move to the closed position 29b. wherein the inwardly projecting flanges 31f, 31g prevent the drug storage container 20 from leaving the container holder 31 in a proximal direction. In other words, once the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, the drug storage container 20 will be held within the container holder 31 by the inwardly projecting flanges 33 near the distal end of the holder. 31 of the container and by means of inwardly projecting flanges 31f, 31g near the proximal end of the container holder 31.

As shown in FIG. 4B and 4C, the container holder 31 includes opposing surfaces 31i, 31h defining an opening 31j for receiving a flange 20b of the medicine storage container 20. For example, the container holder 31 shown in the figures includes two distal facing surfaces 31i and two proximally facing surfaces 31h, which respectively cooperate to form two openings 31j, each of which receives opposing portions of the flange 20b. The opposing surfaces 31h, 31i form lower and upper frames for positioning the flange 20b when the medicine storage container 20 is located inside the container holder 31 in the closed position 29b. This range from lower to upper frames may provide flexibility for different lengths of drug storage containers 20 and/or a range of tolerances for the length of drug storage container 20. However, as described in more detail below, additional components of the device 10 may further secure the drug storage container 20 adjacent to the flange 20b when the drug storage container 20/receptacle holder 31 assembly is located within the housing 12. The openings 31j may also prevent and /or limit the rotational movement of the drug storage container 20. For example, each of the opposing rounded sections 20c of the flange 20b may extend at least partially through the openings 31j, and each of the opposing linear sections 20d of the flange 20b may abut side walls defining the openings 31j to prevent and/or limit rotational movement between the respective components 20, 31.

As shown in FIG. 4B, container holder 31 may include additional mating connectors 31k, 31m that are located distal to mating connectors 31d, 31e. Corresponding pairs of mating connectors 31d, 31e; 31k, 31m may operate together to create a snap connection between the respective legs 31a, 31b of the container holder 31 to secure it in the closed position 29b.

It may be desirable for the ring-shaped hoop 31c to be positioned substantially opposite (along axis A) to the mating connectors 31d, 31e to facilitate opening and closing of the container holder legs 31a, 31b. For example, the distance between the ring-shaped hoop 31c and the inwardly projecting flanges 31f, 31g may be proportional to the gap between the inwardly projecting flanges 31f, 31g when the container holder 31 is in the open position 29a. Therefore, in order

- 10 045416 to maximize the gap between the inwardly projecting flanges 31f, 31g, when the container holder 31 is in the open position 29a, the distance between the annular hoop 31c and the inwardly projecting flanges 31f, 31g (for example, the effective length of the legs 31a, 31b) can be maximized. Additionally, the thickness, height and material properties of the ring-shaped hoop 31c may affect the bending of the legs 31a, 31b and/or the gap between the inwardly projecting flanges 31f, 31g when the container holder 31 is in the open position 29a. As discussed above, the flange gap 33b may also improve and/or determine the amount of flex of the legs 31a, 31b and/or the gap between the inwardly projecting flanges 31f, 31g when the container holder 31 is moved to the open position 29a. For example, when the legs 31a, 31b bend outward, the flanges 33 can move inward.

The container holder 31 shown in the drawings may include an alignment lip 31n that abuts the interior surface of the housing 12 to radially align the container holder 31 within the housing 12 during assembly and prevent and/or limit radial movement between the respective components 12, 31. As an example, the housing 12 may include a groove 12a formed on the inner surface of the housing to receive the alignment projection 31n. The body 12 may include a plurality of slots and the container holder 31 may include a plurality of alignment tabs for radially aligning the respective components 12, 31. For example, the container holder 31 shown in the figures includes two alignment tabs 31n and the housing 12 includes two slots 12a. The slots 12a are spaced apart from each other and are sized to receive the respective alignment projections 31n when the container holder 31 is inserted into the housing 12. The slots 12a shown in the figures are formed by part of a generally annular sleeve 12d that is integral with the housing 12 (although the bushing-type portion may alternatively be one or more components coupled to or attached to the housing). The annular sleeve 12d may not extend around the entire internal surface of the housing 12, but instead has cutouts or gaps to allow portions of the safety member 32 to pass between corresponding portions of the annular sleeve 12d. Alternatively, the annular sleeve 12d may be spaced radially inwardly from the inner surface of the housing 12 in at least one or more positions to facilitate passage of parts of the safety element past the sleeve 12d.

The annular sleeve 12d may further define inclined surfaces 12e on opposite sides of each of the locking slots 12c to further facilitate alignment between the container holder 31 and the body 12.

The components shown in FIG. 4A, 4B, and 4C include an alignment projection 31n that is located at the distal end of the support projection 31o. For example, the support protrusion 31o has a smaller height (measured perpendicular to the outer surface of the container holder 31) than that of the leveling protrusion 31n, so that only the leveling protrusion 31n is located inside the alignment groove 12a and not the support protrusion 31o. Alternatively, the alignment lip may extend substantially or entirely along the axial length of the container holder 31, as will be described below with respect to another example of the design of FIG. 4D.

The drug storage container 20 may be additionally or more securely coupled to the container holder 31 (and thereby the housing 12) so as to prevent movement of the drug storage container 20 and the container holder 31 relative to the housing 12 during operation of the drug delivery device 10 facilities. For example, as shown in FIG. 4B and 4C, the container holder 31 may include a plurality of locking projections 33c on flanges 33 that form a friction fit with the housing portion(s) 12. As a more specific example and as shown in FIG. 2 and 3B, the housing 12 includes a plurality of locking slots 12c, each of which receives corresponding locking projections 33c of the container holder 31 to prevent and/or limit relative movement between the respective components 12, 31. As a more specific example, each of the locking projections 33c extends in a radial direction from the outer surfaces of the flanges 33. The container holder 31 may include any suitable number of locking projections 33c, such as one, two, three, four or more. The locking grooves 12c shown in the figures are formed by the annular sleeve 12d, but alternatively they may be formed by another component. The locking grooves 12c are spaced apart from each other and are sized to receive the corresponding locking projections 33c when the drug storage container is positioned inside the container holder 31. As a more specific example, the locking projections 33c engage in a frictional fit with the locking grooves 12c so as to secure the container holder 31, and thereby the drug container 20, within the housing 12. As an even more specific example, when the locking projections 33c snap into the locking slots 12c, the flanges 33 may be slightly compressed inward to form a more secure fit between the container holder 31 and the drug container 20.

The inner surface of the container holder 31 may include a compressible component, such as an elastomeric component, that is positioned between the inner surface of the container holder 31 and the drug container 20. As a more specific example, the elastomeric component may be a rubber ring. Alternatively or additionally, the function of the compressible component can be performed by the natural bending of the flanges 33.

The locking tabs 33c may provide audible and/or tactile feedback to the user or assembler when snapped into the corresponding locking slots 12c, thereby indicating to the assembler(s) that the corresponding components 12, 31 are located in the correct location. Additionally, the dimensions and arrangement of the respective components can be such that feedback only occurs when the drug container 20 is also positioned as desired. For example, if the medication container 20 is positioned too far distal to the container holder 31 such that the body of the medication container 20 is aligned with the flanges 33 instead of the shoulder portion 20a being aligned with the flanges 33, then the locking the projections 33c may not be able to compress radially enough to allow the locking projections 33c to fit inside the locking slots 12c. Conversely, if the drug container 20 is not inserted far enough distal to the container holder 31 so that the sterile barrier 21 is aligned with the flanges 33 instead of the shoulder portion 20a being aligned with the flanges 33, then the locking projections 33c will be able to compress radially inwardly to such an extent that the locking protrusions 33c will be able to slide radially into the locking slots 12c, or the locking protrusions 33c will engage the locking slots 12c but may not produce sufficient radially outward force to generating audio and/or tactile feedback. Although audible and/or tactile feedback may be advantageous during manual assembly of the container holder 31, assembly of the container holder 31 does not necessarily have to be performed manually and, in some embodiments, may be performed partially or entirely by manufacturing equipment.

The housing 12, container holder 31 and their respective components, as described above, offer many advantages. For example, by securely connecting the medication container 20 to the housing 12 via a shoulder portion 20a (as opposed to a flange portion), the device 10 may have a reduced incidence of glass breakage or other damage. As a more specific example, drug containers such as syringes often have a shoulder portion that is stronger and/or capable of withstanding higher forces than a flange portion. In other words, it may be advantageous for the concentration of force on the drug container to be higher on the arm than on the flange, since the arm may be stronger and more resistant to fracture than the flange.

Another potential advantage of this configuration is that by securely connecting the drug container 20 to the body 12 via a distal portion (e.g., shoulder portion 20a), the device 10 may have a more predictable, reproducible, and/or consistent injection depth than in structures that attach the drug container 20 via a flange (eg, a hanging structure). For example, the distance between the shoulder 20a and the delivery element 16 for a syringe is typically more predictable and/or has a lower manufacturing tolerance than the distance between the flange 20b and the delivery element 16, since the length of the barrel of the drug container 20 can vary more widely than length of the cylinder support shoulder. Additionally or alternatively, the distance between the flange 20b and the delivery element 16 includes any tolerances/variations in the distance between the shoulder portion 20a and the delivery element 16, so that any tolerances/variations are superimposed.

As shown in FIG. 4C, when the medicine storage container 20 is inserted into the container holder 31 and the medicine storage container 20 is in the closed position 29b, a portion of the medicine storage container 20 extends beyond the distal end of the container holder 31. For example, the sterile barrier 21 is located substantially or entirely outside the container holder 31 to facilitate removal of the sterile barrier 21 during use of the device 10, as shown in FIG. 4C and 4F and as will be described in more detail below. Additionally, the delivery element 16 extends beyond the distal end of the container holder 31 (as described above).

In fig. 4D shows another example of a container holder 131 that has some features functionally similar to those included in the container holder 31, each of which is assigned the same reference number but increased by 100. For example, the container holder 131 includes a pair of legs 131a, 131b; an annular hoop 131c connecting the legs 131a, 131b; corresponding sets of mating connectors 131d, 131e, 131k, 131m for selectively securing the legs in the closed position 129b; a pair of flanges 131f, 131g protruding inwards; a pair of opposing surfaces 131h, 131i for forming lower and upper limits of movement for the flange of the medicine storage container; and a hole 131j for receiving a flange of a medicine storage container. The container holder 131 also includes a plurality of flanges 133 located at the distal end of the container holder 131 and configured to support the container for storing the drug. For example, the container holder 131 includes two flanges 133, each of which includes an arcuate inclined surface 133a that substantially corresponds to the arcuate shape of the shoulder portion of the drug storage container. The container holder 131 shown in FIG. 4D has two flanges 133, as opposed to the four flanges 33 shown in the container holder 31 shown in FIG. 4A-4C; therefore, each of the flanges 133 preferably has a larger circumference than the flanges 33. The container holder 131 also includes an alignment lip 131n that is positioned within an alignment groove 12a formed in the inner surface of the housing 12 to properly align the container holder 131 within the housing 12 during assembly. and to prevent and/or limit rotational movement between the respective components 12, 131. The alignment lip 131n shown in FIG. 4D extends substantially the entire axial length of the container holder 131, as opposed to the alignment lip 31n.

As with the container holder 31 shown in FIG. 4B, 4C, the container holder 131 may include a plurality of locking projections 133c on the flanges 133 that form a friction fit with the housing portion(s) 12. As a more specific example and as shown in FIG. 4D and 4E, the housing 12 includes a plurality of locking slots 12c, each of which receives corresponding locking projections 133c of the container holder 131 to prevent and/or limit relative movement between the respective components 12, 131. The locking projections 133c may also provide audible and/or tactile feedback. feedback to the user or assembler when snapped into the respective locking slots 12c, thereby indicating to the assembler(s) that the corresponding components 12, 131 are located in the correct location. Additionally, the container holder 131 may provide the same or similar advantages as those described above with respect to the container holder 31.

In yet another example of a design, the container holder may have a fixed state rather than having opening and closing legs. As a more specific example, the container holder may have a proximal opening sized to accept a syringe. The container holder may still have distally located flanges to accommodate and secure the shoulder portion of the syringe, particularly when the container holder is connected to the injector body.

In fig. 4F and 5A show the distal (FIG. 4F) and proximal (FIG. 5A) portions of the drug container 20 and their interaction with various other components of the device 10. For example, in FIG. 4F is a partial cross-sectional view of a distal portion of a drug container 20 located within a container holder 31 with the shoulder portion 20a supported by flanges 33. As another example, FIG. 5A is a cross-sectional view of the proximal portion of the medicine container 20 disposed inside the container holder 31 so that the medicine container flange 20b is positioned between the opposing surfaces 31h, 3li and inside the hole 31j. The medicine container 20 shown in FIG. 5A is further supported by the piston guide 60, such as the flexible leg 60a of the piston guide 60. As a more specific example, the flexible leg 60a extends generally distally and slightly radially inward from the distal portion of the piston guide 60b. As an even more specific example, the piston guide 60 shown in FIG. 5A includes a distal surface 60b that abuts the inwardly projecting flanges 31f, 31g of the container holder 31; a flexible leg 60a extends from the distal surface 60b into the space between the inwardly projecting flanges 31f, 31g.

Flexible leg 60a may have a size, shape, and type of material that enhances and/or allows bending of flexible leg 60a. As a more specific example, the flexible leg 60a is preferably radially flexible such that when the drug container 20 and the plunger guide 60 are inserted into the housing, the flexible leg 60a is aligned with the flange 20b and exerts at least a slight radial force (at direction radially inward) onto the container 20 for the medicinal product. In this configuration, the drug container 20 is primarily supported at its distal portion (e.g., the shoulder portion 20a) by the container holder 31, and is also at least secondarily supported at its proximal portion (e.g., the flange portion 20b) through the piston guide 60. As a more specific example, the flexible leg 60a may provide radial support to the flange portion 20b and prevent and/or resist lateral movement of the medication container 20 relative to the housing 12. Such a configuration may reduce or eliminate rattling sounds from the device 10 and/or may assist in proper alignment of the medication container 20 during assembly. As yet another more specific example, the flexible leg 60a may provide axial support (eg, in a distal direction) to prevent unwanted axial movement of the medication container 20 relative to the body 12. The device 10 may have any suitable number of flexible legs 60a, for example one, two, three, four or more.

The container holder 31 may also include at least one support flange 31r which is of a size, shape and type of material that facilitates and/or allows it to bend. As a more specific example, the support flange 31r is preferably flexible in the radial direction,

- 13 045416 so that when the drug container 20 and the container holder 31 are inserted into the housing, the support flange 31r is aligned with the main body of the drug container 20g and applies at least a slight radial force (in a radially inward direction) on the drug container 20 medicine. In this configuration, the drug container 20 is primarily supported on its distal portion (eg, the shoulder portion 20a) by the container holder 31, and is also at least secondarily supported on the central or proximal region of the body 20g by the holder 31 containers. As a more specific example, the support flange 31r may provide radial support to the medication container 20 and prevent and/or resist lateral movement of the medication container 20 relative to the housing 12. Such a configuration may reduce or eliminate rattling sounds from the device 10 and /or may assist in proper alignment of the medication container 20 during assembly. As yet another more specific example, the support flange 31r may, but not necessarily, provide axial support (e.g., in a distal direction) to prevent unwanted axial movement of the drug container 20 relative to the body 12. The device 10 may have any suitable number support flanges 31r, for example one, two, three, four or more. The container holder 31 shown in the figures includes four support flanges 31r which are spaced equally apart around its circumference.

Although the flexible leg 60a and/or support flanges 31r shown in the figures provide at least some support for the drug storage container 20, the container holder substantially fully supports the drug storage container 20 with respect to the body 12 by the distal end of the main portion 20g of the drug storage container 20, as discussed above. As a more specific example, the flexible leg 60a and/or support flanges 31r may provide little or no support along the longitudinal axis A and provide support only in a direction transverse to the axis A. As an even more specific example, the container holder 31 at essentially fully supports the drug storage container 20 with respect to the body 12 by the distal end of the main portion 20g of the drug storage container 20 for forces along the A-axis, such as those experienced during the injection process.

As stated above, the piston guide 60 shown in FIG. 5A includes a distal surface 60b that abuts the inwardly projecting flanges 31f, 31g of the container holder 31. This configuration may help reduce or prevent radial movement of the container holder 31 within the housing 12. For example, as shown in FIG. 5A, the container holder includes a cylindrical wall 31p that cooperates with the inwardly projecting flanges 31f, 31g to form an annular seat for the distal surface 60b of the piston guide 60. The cylindrical wall 31p may center the piston guide 60 relative to the container holder 31 and the drug container 20 so that the piston 26 is also aligned with these components 31, 20. The cylindrical wall 31p may also reduce or prevent radial movement of the piston guide 60 with respect to to the housing 12. This configuration may also help reduce or prevent axial movement of the container holder 31 within the housing 12. For example, as shown in FIG. 2, the piston guide 60 extends from the rear end cap 23 to the midpoint of the device 10, where it abuts the container holder 31. As a result, the container holder 31 is restricted from moving in the axial upward direction in FIG. 2 (for example, in the proximal direction) by means of the piston guide 60. In addition, the rear end cap 23 may not be able to be installed if the piston guide 60 is not properly aligned axially and radially with the container holder 31, for example if the distal surface 60b does not abut the inwardly projecting flanges 31f, 31g.

As shown in FIG. 5B and 5C, the piston guide 60 may be hollow and generally cylindrical or tubular in shape and may be centered about the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the piston guide 60 may be greater than the outer diameter or other outer dimension of the distal end of the guide 60 piston At least a portion of the distal end of the piston guide 60 may be positioned radially between the piston 26 and the trigger member 52. Thus, the piston 26 may be located at least partially within the distal end of the piston guide 60, and the distal end of the piston guide 60 may be positioned along at least partially within the trigger element 52, as shown in FIG. 2. Other features and functions of the piston guide 60 are discussed below.

As shown in FIG. 2, the piston guide 60 may be fixedly coupled to the housing such that the piston guide 60 is substantially and/or generally stationary relative to the housing 12. For example, as shown in FIG. 1C and 5B, the piston guide includes a locking tab 60f that is sized, shaped, and aligned to fit within a wedge lock 12f formed within the housing 12. As a more specific example, each of the piston guide 60 and housing 12 includes a pair of corresponding components 60f, 12f that cooperate to prevent relative rotation between the piston guide 60 and the housing 12. Additionally or alternatively, annular projections 60g formed on the outer surface of the piston guide 60 may form a frictional fit with the inner surface of the housing to resist rotation between the respective components. 12, 60 or its prevention.

The piston 26 (as best illustrated in FIGS. 2, 3A) may be hollow and generally cylindrical or tubular in shape. The piston 26 may include a cylindrical wall 39 with an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space sized to accommodate a piston bias element 50. In general, it is desirable to minimize the thickness of the cylindrical wall 39 as much as possible without compromising the integrity properties of the piston 26 in order to minimize the internal diameter of the piston 26. This allows a large diameter piston bias element 50 to be located in the internal space of the piston 26, which in turn the turn provides greater power to the piston displacement element 50. As a more specific example, the thickness of the cylindrical wall 39 may be less than 2 mm. As another more specific example, the thickness of the cylindrical wall may be less than 1 mm. As another more specific example, the thickness of the cylindrical wall may be less than 0.6 mm. As another more specific example, the thickness of the cylindrical wall may be less than 0.3 mm. As another more specific example, the thickness of the cylindrical wall may be less than 0.2 mm. As another more specific example, the thickness of the cylindrical wall may be less than 0.1 mm. As another more specific example, the thickness of the cylindrical wall may be less than 0.05 mm. The cylindrical wall 39 may be made of any suitable material, such as metal or plastic. It may be advantageous to construct the cylindrical wall 39 from a metal, such as steel or aluminum, in order to minimize the thickness of the cylindrical wall 39. For example, the metal cylindrical wall 39 may have sufficient axial strength and/or resistance to bending for use in the device if the thickness of the cylindrical wall 39 is more than 0.05 mm. In contrast, the plastic cylindrical wall 39 may have sufficient axial strength and/or bending resistance for use in the device if the thickness of the cylindrical wall 39 is more than 1 mm.

The hollow rod 46 may additionally or alternatively promote and/or provide greater flexibility in the spring design. For example, it would be desirable or advantageous to use a device with different springs depending on the characteristics of the drug and/or the desired drug delivery profile. For example, a higher viscosity drug may require a spring with a higher spring stiffness and/or spring compression force, and therefore it may be desirable or advantageous to have the physical characteristics of the spring adaptable. As a more specific example, the spring stiffness, and therefore the compression force of the spring, can be influenced by various physical characteristics of the spring, such as the diameter of the spring wire (usually increasing the wire diameter increases the spring stiffness), the average diameter of the spring (usually increasing the average diameter decreases the spring stiffness) , the number of coils of the spring (usually increasing the number of coils increases the stiffness of the spring) and the material of the spring. These physical characteristics can be adjusted to provide different spring rates while also potentially adjusting the thickness of the hollow rod 46 to maintain a constant or relatively constant outer diameter of the entire piston 26 so as to keep the remaining parts of the device, such as the piston guide 60 and plug 24, constant. The hollow rod 46 may additionally or alternatively promote and/or provide greater longitudinal stability to the piston bias element 50, such as by preventing or reducing flexing or other lateral movement.

The piston bias element 50 shown in the figures may have the following dimensions: wire diameter 0.65 mm, spring outer diameter 5.40 mm, and a number of turns from 80 to 86 (depending on pitch), but other suitable characteristics may be used. springs. The piston bias element 50 shown in the figures may be formed from 2300 N/mm stainless steel, but other suitable materials may be used. The hollow rod 46 shown in the figures may have the following dimensions and materials: length 63 mm, outer diameter 6 mm, wall thickness 0.20 mm and stainless steel material with a strength of 600 to 750 N/mm, but other suitable ones can be used sizes and materials.

As described in more detail below, the piston 26 may be configured to be selectively rotatable relative to the housing 12 and to be linearly movable relative to the housing 12 during operation of the drug delivery device 10.

The piston 26 may consist of several parts connected together, or alternatively may be of one piece construction. In the present embodiment, the piston 26 consists of three separate structures connected to each other: an upper ring 45 forming the proximal end of the piston 26; a base 47 forming the distal end of the piston 26; and a hollow rod 46 located between the upper ring 45 and the base 47 and rigidly connecting them. Upper position

- 15 045416 rings 45, hollow rod 46 and base 47 can be fixed relative to each other so that these components are stationary relative to each other. Each of the top ring 45, the hollow rod 46 and the base 47 may have an annular structure and be centered about the longitudinal axis A. Both the top ring 45 and the hollow rod 46 may have a corresponding central hole extending from end to end of the component so as to define axial chamber; wherein the base 47 may have a central opening that extends through the proximal end of the base 47, but which is closed at the distal end of the base 47. The closed end of the base 47 may form a seat or abutment surface for the piston bias element 50. In alternative embodiments, the central hole may extend through the base 47 from end to end. In such alternative embodiments, the inner diameter of the central hole of the base 47 may be smaller than the outer diameter of the piston bias element 50 such that the base 47 retains the distal end of the piston bias element 50 within the piston 26. When the actuator 30 is activated, the base 47 may be part of the piston 46 which contacts the plug 24 to push the plug 24 in a distal direction.

The upper ring 45 may include one or more flanges or projections 48 extending radially outward from a central portion of the upper ring 45. Each of the projections 48 may include a distally facing cam surface 49. As described in more detail below, the distally facing cam surface 49 may interact with a corresponding cam surface on the piston guide 60 to release the piston bias element 50. In some embodiments, the distally facing cam surface 49 may be positioned at an angle or otherwise non-parallel to an imaginary plane perpendicular to the longitudinal axis A.

In some embodiments, the top ring 45 and/or base 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and/or base 47 may be made of plastic, while the hollow rod 46 may be made of metal. In such a configuration, the plastic material used for the top ring 45 may assist in the camming action described below by providing a relatively low coefficient of friction, and the plastic material used for the base 47 may assist in absorbing or dampening any shock or vibration associated with runout. base 47 over plug 24. The metal material used for the hollow rod 46 may provide sufficient rigidity to prevent bending under the bias force applied by the piston bias member 50. In alternative embodiments, the top ring 45, hollow rod 46, and/or base 47 may be made of the same material, including, for example, metal or plastic. In some such embodiments, the top ring 45, hollow rod 46, and base 47 may be formed as one integral piece so as to form a single monolithic structure.

The drug delivery device 10 may further include a safety mechanism to prevent contact with the insertion end 28 of the delivery element 16 when the drug delivery device 10 is not in use for injection. The safety mechanism may include a safety element 32 movably located at or adjacent to a distal end of the housing 12 adjacent to the opening 14. The safety member 32 may have a hollow and generally tubular or cylindrical portion 32a centered about the longitudinal axis A, and may have a pair of legs 32b extending proximally from the cylindrical portion 32a. The safety member 32 further includes a distal end 32c, which may generally comprise a cylindrical portion 32a, and a proximal end 32d, which may be formed by legs 32b. The legs 32b may be located substantially or entirely within the housing 12 such that no part thereof protrudes from the housing 12. The cylindrical portion 32a may be at least partially and/or selectively located within the housing 12. For example, the safety element 32 may be adapted to move relative to the housing 12 such that parts of the safety element 32 are located within the housing 12 in/in some stages/states and extend from the housing 12 in/in other stages/states, as discussed in more detail below.

As one example of the configuration shown in FIG. 2, 4E and 6, the legs 32b of the guide member 32 are spaced radially from each other around the circumference 32g of the fuse 32 so that the legs 32b are able to slide between the projecting sections of the annular sleeve 12d formed on the inner surface of the housing 12. For example, so that the arc length between the respective edges of the legs 32b is at least slightly greater than the arc length of the projecting section of the annular sleeve 12d, so that the legs are able to slide axially between the projecting sections of the annular sleeve 12d without contacting the sleeve.

As discussed above, the safety member 32 may be adapted to move relative to the housing 12 between an extended position, in which at least a portion of the cylindrical portion 32a of the safety member 32 extends through an opening 14 in the housing 12, and a retracted position.

- 16 045416 by a position in which a shorter length of the cylindrical portion 32a passes through the hole 14 in the housing 12 or no part of the cylindrical portion 32a passes through it. In other words, in the extended position, the length X of the cylindrical portion 32a extends through the opening 14 in the housing 12, and in the retracted position, the length Y of the cylindrical portion 32a extends through the opening 14 in the housing 12, wherein X is a value greater than Y. The length X may be any suitable value such as 10, 8, 6, 4, 2, 1 mm or other value. The length Y may be any suitable value that is less than X, such as 3, 2, 1, 0.5, 0 mm or other value. In fig. 1C and 1D show an example of a pre-injection configuration (FIG. 1C), in which the safety element 32 is in the extended position 32e, and the length of the exposed portion X of the safety element 32 can be approximately 5 to 11 mm, and an injection configuration (FIG. 1D), in which the safety element 32 is in the retracted position 32f, and the length of the exposed portion Y of the safety element 32 is approximately 0 mm to 2 mm (so that the distal end 32c of the safety element 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 safety element is flush with the housing 12.

The safety element 32 may also be adapted to move in the opposite direction, namely from a retracted position to an extended position. When moving from the extended position to the retracted position, the safety element 32 can be translated linearly in a proximal direction; and when moving from the retracted position to the extended position, the safety element 32 can be linearly moved in a distal direction. At least in the extended position, the safety element 32 can extend beyond the insertion end 28 of the delivery element 16 and surround it. As a further illustration, FIG. 1C and 2 show the safety element 32 in the extended position (and covered by the removable cap 19 in FIG. 2). As discussed 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, can result in insertion of the insertion end 28 of the delivery element 16 into the patient's skin.

During the injection process, the guard 32 may remain stationary relative to the user's skin 5 while the housing 12 and several components located therein move with respect to the guard 32 and the skin 5. However, the present invention relates to movement , retraction, translation, and descent of the guard 32. These references and descriptions may be considered to refer to the relative motion between the guard 32 and the housing 12 regardless of which component (guard 32 or housing 12) moves relative to the user's skin 5 .

The delivery device 10 may employ an inertial drive design instead of a spring drive design to introduce a needle into the subcutaneous tissue of a patient. As a more specific example, when the patient presses the distal end of the guard 32 against the patient's skin at the injection site, the body 12 of the delivery device 10 may be advanced toward the injection site. When the patient applies pressure to a predetermined distance or with a predetermined force, the delivery device 10 performs a rapid release using the energy stored in the patient's muscles, thereby compressing the needle cap and its spring to a certain release point. The release mechanism is designed so that the resulting speed of needle insertion exceeds the patient's response rate, and the combination of this speed and the mass of the device causes the needle to quickly and completely penetrate the skin to the depth of the subcutaneous tissue. Compared to prior art injectors in which the entire main container is moved forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing and can therefore provide a simplified, more robust design.

In alternative embodiments, the drug storage container 20 may be movably attached to the housing 12 such that the drug storage container 20 is movable relative to the housing 12 during operation of the drug delivery device 10. In some such alternative embodiments, the insertion end 28 of the delivery element 16 may be drawn inside the opening 14 in the housing 12 in a pre-delivery state. Subsequently, during operation of the injection device 10, the insertion end 28 of the delivery element 16 may be extended through the opening 14 in the housing 12 for insertion into the patient's body. This movement, in some embodiments, may result from driving the drug storage container 20 in a distal direction relative to the housing 12.

In some embodiments, the safety element 32 may be rotationally stationary or rotationally limited relative to the housing 12. Therefore, although the safety element 32 may be able to translate linearly with respect to the housing 12, the rotation of the safety element 32 with respect to the housing 12 may be substantially

- 17 045416 wu or completely prevented. As a more specific example, the cylindrical portion 32a of the safety member 32 may include a projection extending therefrom, such as a projection 32h, that aligns with a corresponding feature on the interior surface of the housing 12. For example, the interior surface of the housing adjacent the distal end of the housing 12 may include a groove, a pair of adjacent projections, or another component or set of components that cooperate with the projection 32h to substantially or completely prevent rotation of the safety element 32. This arrangement may also help align the respective components 32, 12 with each other during assembly.

The device 10 may further include an extension biasing member 35 and a safety extension portion 37. The safety extension portion 37 may be positioned adjacent the safety member 32; and the extension bias member 35 shown in the figures is located adjacent the safety extension portion 37. The safety extension portion 37 may be hollow and generally cylindrical or tubular in shape, centered about the longitudinal axis A. As a more specific example, the safety extension portion 37 may comprise a generally cylindrical main body 37a. The safety extension portion 37 may also include legs 37b for housing, supporting, and/or holding the distal portion of the extension bias member 35. In addition, the safety extension portion 37 may be configured to move in a linear direction along the longitudinal axis A relative to the body 12. In the present embodiment, the safety extension portion 37 is a structure separate from the safety member 32. However, in alternative embodiments, the safety extension portion 37 37 and the safety element 32 can be made in the form of one single piece to form a single monolithic structure. In such alternative embodiments, the proximal end of the safety member 32 may correspond to the safety extension portion 37.

Like the safety member 32, the safety extension 37 may be rotationally stationary relative to the housing 12. Therefore, although the safety extension 37 may be able to translate linearly relative to the housing 12, rotation of the safety extension 37 relative to the housing 12 may be prevented. To achieve this effect, in some embodiments, the safety extension portion 37 may cooperate with the piston guide 60 to limit or prevent rotation between the respective components 37, 60. As a result, and since the piston guide 60 is fixedly connected to the housing 12, the safety extension portion 37 may be rotationally secured to the housing 12 by a piston guide 60. For example, the piston guide 60 may include a longitudinal projection 60c adjacent a distal portion of the piston guide 60. The protrusion may be located within the longitudinal channel on the inner surface of the safety extension portion 37 and/or a pair of corresponding elements that cooperate to accommodate the protrusion 60c. In alternative embodiments, the tongue and groove arrangement may be reversed such that the safety extension 37 has one or more radially inwardly extending projections and the piston guide has one or more slots or other recesses to accommodate the one or more projections by mating or close fitting. As yet another alternative, the safety extension 37 may include a rotation preventing member that mates with a corresponding member on the inner surface of the housing 12.

The safety extension 37 and/or the trigger 52 may have axial movement restrictions that limit the distance they can move distally. For example, as shown in FIG. 6C, the piston guide 60 may include an axial projection 60c formed on an outer surface and located adjacent to a distal portion of the piston guide 60. The distal facing surface 52j of the firing member 52 may be adjacent to the proximally facing surface 60d formed by the axial projection 60c, thereby defining the distalmost point of movement for the firing member 52. The firing member 52 may also include a locking flange 52a, which, in turn, turn, restricts the distal movement of the safety extension portion 37. For example, the locking projection 52a may be adjacent to the annular sleeve 37d of the safety extension portion 37 to form the most distal movement point for the safety extension portion 37. The axial projection 60c and the locking projection 52a shown in the figures are do not necessarily restrict the movement of the trigger member 52 and the safety extension portion 37 in the proximal direction, but only in the distal direction.

As best depicted in FIG. 2, the extension bias element 35 is located between and in contact with the safety extension portion 37 and the trigger member 52. The extension biasing member 35 may be configured to bias or push the safety extension portion 37 in a distal direction and/or bias or push the trigger member 52 proximally. In the device 10 shown in FIG. 2, which is in the pre-delivery or storage state, the extension bias element 35 is initially in a stressed state (eg, compressed). In other words, when the device 10 is in a pre-delivery state, as shown in FIG. 2, the extension bias element 35 applies a distal (downward) bias force to the safety extension portion 37 and a proximal (up) bias force to the trigger member 52.

During operation of the device, the user may cause the guard 32 to move (relative to the body 12) in a proximal direction, pressing the guard 32 against the injection site. When this is done, the safety element 32 will move towards the safety extension 37 and close the gap 37g between them (Fig. 2). Once the gap 37g is eliminated, the safety member 32 and the safety extension portion 37 move together in a proximal direction until, for example, the safety member 32 reaches the retracted position 32f. When the injection is completed and the drug delivery device 10 is lifted from the injection site, the extension bias member 35 can push the safety extension portion 37 so that the safety extension portion 37 and the safety member 32 move together in the distal direction. This movement (and/or the biasing force from the ring retainer bias element 51) returns the safety element 32 to the extended position 32e, which has the effect of closing the insertion end 28 of the delivery element 16. In some embodiments, the extension bias element 35 may include a compression spring (eg, a coil compression spring). Additionally, in embodiments in which the piston bias element 50 also includes a compression spring, the extension bias element 35 may be located around and/or have a larger diameter than the piston bias element 50.

However, in some alternative embodiments, the extension bias element 35 may be in a relaxed (natural) state when the device is in its pre-delivery condition. In these embodiments, the displacement element 35 may become compressed or stressed when the safety element 32 is deflected in a proximal direction.

When drug delivery has completed and the guard 32 has returned to the extended position, it may be desirable to lock the safety member 32 in the extended position to prevent subsequent user contact with the insertion end 28 of the delivery element 16 and/or to prevent reuse of the drug delivery device 10 . To this end, some embodiments of the drug delivery device 10 may include a ring lock 40 that is selectively rotatable depending on the axial position of the safety element 32 in order to lock the safety element 32 in the extended position after the safety element 32 has moved from the retracted position to the extended position, as will be discussed in more detail below.

As discussed above, the piston bias element 50 may be located at least partially within the piston 26 and may include a distal end abutting the proximally facing inner surface of the piston 26 and/or may be fixedly attached to the inner surface of the piston 26. in order for the piston bias element 50 to be positioned within the piston 26, the outer diameter or other dimension of the piston bias element 50 may be equal to or less than the inside diameter of the upper ring 45 and/or equal to or less than the inside diameter of the hollow rod 46. In some embodiments, the distal end of the element The piston offset 50 may abut the proximally facing inner surface of the base 47 of the piston 26. Additionally, as best illustrated in FIG. 2 and 3A, the proximal end 50a of the piston bias element 50 may be adjacent to the distal facing surface 38a of the piston bias element seat 38. The piston bias element seat 38 may be fixedly attached to the rear housing 27 such that the piston bias element seat 38 provides a stationary surface from which the piston bias element 50 pushes. For example, as shown in FIG. 3A and 5B, the piston seat 38 may include flanges 38b that are positioned within holes 60h formed in the proximal portion of the piston guide, thereby statically connecting the piston seat to the piston guide 60. In such a configuration, the piston biasing member 50, when released from the stressed state, may expand in length, with the distal end of the piston biasing member 50 moving in a distal direction from the stationary proximal end of the piston biasing member 50. This movement may push the piston 26 in a distal direction, which in turn may push the plug 24 in a distal direction to push the drug 22 from the drug storage container 20 into the delivery element 16 and then into the patient's body. However, in the embodiment shown in the figures, neither the release of the piston bias element 50 nor any other bias elements cause the delivery element 16 to move downward relative to the housing 12. In contrast, the drug container 20, and as a result the element 16 are substantially or completely fixedly connected to the body 12. Instead, the delivery element 16 is inserted into the patient's skin 5 under the influence of an inertial force generated by a downward force applied by the patient (or health care professional, or other person administering the dose).

As shown in FIG. 7A and 7B, the trigger member 52 may be hollow and generally cylindrical or tubular in shape and may be centered about the longitudinal axis A. As shown in FIG. 2, the trigger member 52 may be positioned radially between the piston guide 60 and the safety extension 37. As also shown in FIG. 2, the trigger 52 is also located radially between the safety extension 37 and the piston guide 60. In addition, the extension bias element 35 may be located axially between the trigger member 52 and the safety extension portion 37 and may be located radially around the trigger member 52. In general, the trigger member 52 is configured to (1) operatively connect the safety member 32 and piston 26 in activation sequence; and (2) generating an audible signal indicating completion of drug delivery. In such a configuration, the trigger element 52 is used to perform two separate functions and thus reduces the number of moving parts required by the drug delivery device 10.

Each of the channel surfaces 52b is configured to receive projections 48 of the upper ring 45 and allow axial movement of the piston 26 relative to the trigger member 52, but resist or prevent rotational movement between the piston 26 and the trigger member 52. As shown in the figures, although the channel surface 52 extends adjacent to the inner surface of the trigger member 52, the channel surface 52 is not arcuate, but instead has a generally rectangular shape (as best depicted in FIGS. 7B and 10A).

Trigger 52 includes a channel surface 52b that extends proximally beyond the most proximal (e.g., top) surface of the tubular body of trigger 52. For example, trigger 52 includes a proximally facing contact surface 52d for notifying the end of dosage administration, such that will be described in more detail below, and each of the channel surfaces 52b extends beyond the contact surface 52 to provide a continuous path with respect to the upper ring 45, while providing sufficient clearance between the proximally facing contact surface 52d and the corresponding surface participating in notification of the end of the dose administration.

The trigger element 52 may be rotatable relative to the housing 12 and/or linearly movable relative to the housing 12, depending on the stage of operation of the drug delivery device 10. The initial rotation of the trigger element 52 associated with activation may be driven by the piston bias element 50 and/or the extension bias element 35; whereas the subsequent rotation of the trigger element 52 associated with the generation of the dose end signal can only be driven by the extension bias element 35. Any linear translational movement of the trigger element 52 without rotation can only be actuated by the extension bias element 35. In some embodiments, the trigger 52 may be linearly movable only in the proximal direction; however, alternative embodiments may allow linear translational movement of the trigger element 52 in both proximal and distal directions.

After describing the general configuration of the drug delivery device 10, a method of using the drug delivery device 10 to perform injection will be described next with reference to FIGS. 9A-12C. As a preliminary step, the user may remove the drug delivery device 10 from any accessory packaging, such as a plastic bag and/or a 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 and detach the removable cap 19 from the front housing 25. As a result of this movement, the gripping device 13 can pull and detach the sterile barrier 21 from the drug storage container 20. This may open the insertion end 28 of the delivery element 16. However, the insertion end 28 of the delivery element 16 will remain surrounded by the safety element 32 at this stage, since the safety element 32 is located in the extended position. Next, the user can place the drug delivery device 10 over the injection site and then press the distal end of the safety member 32 against the injection site. The force applied by the user will overcome the biasing force of the extension bias member 35 and the biasing force of the ring retainer biasing member 51, thereby causing the safety member 32 to retract into the opening 14, moving from an extended position to a retracted position in the proximal direction. The delivery element 16 remains stationary relative to the housing 12 while the safety element 32 is retracted.

Some of the components of the device include various features, surfaces and openings for interacting with the piston 26 and controlling its release movement (eg, injection sequence). In general, the injection sequence begins with a retracting/axial movement of the safety member 32 in a proximal direction (upward in FIG. 2), which causes an axial movement of the safety extension 37, which unlocks

- 20 045416 does not have a trigger 52. Once the trigger 52 is released (eg, the first stage of movement), the piston 26 and the piston bias element 50 push the trigger 52 to rotate clockwise and provide axial movement of the piston 26 (in the distal direction, down in Fig. 2). The piston then pushes the plug 24 in a distal direction, thereby expelling the drug 22 from the drug container 20 and from the delivery element 16. Once the piston reaches a certain point along the axial length of the device, movement of the trigger member 52 is then blocked (eg, the second stage of movement) and the trigger mechanism moves proximally (upward in FIG. 2) and contacts the piston guide 60, thereby providing an indication of the end of the dose (such as an audible click). The injection sequence will be described in more detail below.

The pre-injection stage is shown in FIG. 2, 9A, 10 and 11A. Moving the safety member 32 from the extended position to the retracted position may result in several actions. Because the delivery element 16 remains stationary relative to the body 12 while the guard 32 is retracted, the insertion end 28 of the delivery element 16 is forced to extend through the opening in the distal end of the guard 32, thereby piercing the patient's skin at the injection site and penetrating the patient's subcutaneous tissue. Additionally, retraction of the safety member 32 may also activate the drive mechanism 30 to expel the drug 22 from the drug storage container 20, as described in more detail below.

In the pre-delivery state, before the needle guard 32 is retracted, both the piston 26 and the trigger member 52 may be in an appropriate initial rotational position, as shown in FIG. 9A, 10 and 11A. The piston bias element 50 may be in a stressed state. As a consequence, the piston bias element 50 can apply a distally directed bias force to the piston 26, which pushes the distally facing cam surface 49 towards the proximally facing cam surface 60j. The resulting cam action may cause the piston 26 to rotate clockwise. Despite these biasing forces(y), neither the trigger 52 nor the piston 26 rotates in the pre-delivery state. This is due to the fact that the trigger element 52 and the piston are rotationally stationary in the pre-injection state. Accordingly, the trigger member 52, the piston guide 60, the safety extension 37, and the housing 12 operate in conjunction with each other to hold the piston bias member 50 in tension before retracting the safety member 32, as described in more detail below.

As best shown in FIG. 2, when the safety member 32 is moved in the proximal direction (upward in FIG. 2), the proximal end 32d of the safety member 32 contacts the distal facing surface of the safety extension portion 37 and pushes the safety extension portion in the proximal direction. As shown in FIG. 6B and 7A, the inner surface of the cylindrical wall of the safety extension portion 37 includes a locking flange 37c and an outer cylindrical surface of the trigger member 52 corresponding to the locking flange 52a. When the device is in the pre-injection stage, as shown in FIG. 2, 9A, 10A and 11A, the locking flange 37c of the safety extension portion 37 engages the locking flange 52a of the trigger member 52, thereby locking the trigger member 52 against rotation (as best illustrated in FIG. 11A). At this point in the sequence, the distally facing cam surface 49 of the upper ring 45 of the piston 26 abuts the proximally facing cam surface 60j of the piston guide 60 such that the piston 26 is kept from moving axially by this interaction (best illustrated in FIG. 9A and 10A). The distal facing cam surface 49 and/or the proximally facing cam surface 60j has an inclined surface to facilitate relative movement of the upper ring 45 of the piston 26 in the direction of arrow 60k in FIG. 9A and 10A (clockwise). For example, the distally facing cam surface 49 has a slope 60m of approximately 10° (best illustrated in FIGS. 9B and 9C), but may have any suitable slope, such as 9 to 11°, 8 to 12°, 7 to 13°, 6 to 14°, 5 to 15°, 4 to 16° or any other suitable inclination. Additionally or alternatively, the distally facing cam surface 49 of the upper ring 45 may have an inclination 49a of approximately 10°, but may have any suitable inclination, such as 9 to 11°, 8 to 12°, 7 to 13°, 6 to 14°, 5 to 15°, 4 to 16° or any other suitable inclination. The inclination(s) of one or more respective surfaces 60j, 49 cause the axial force from the piston bias element 50 to produce a force in the transverse direction, thereby pushing the top ring 45 of the piston 26 in a 60k clockwise direction. However, as discussed above, the trigger 52 resists or prevents rotational movement between the trigger 52 and the piston while the top ring 45 is located within and/or in contact with the bore surface 52b. As a result, while the safety extension 37 locks against rotation of the trigger element 52 (as shown in FIGS. 2, 9A, 10A and 11A), the upper ring 45 will remain locked against rotation by the channel surface 52b and locked in the axially facing direction. in the proximal direction by the cam surface 60j.

The unlocking step is shown in FIG. 11B, wherein the safety extension portion 37 is progressively moved in a proximal direction until the locking flange 37 of the safety extension portion 37c disengages from the locking flange 52a of the trigger member 52 and the trigger mechanism is no longer locked against rotation. At this point in the injection sequence, two events occur simultaneously or nearly simultaneously: (1) the fuse bias element 35 pushes the trigger element 52 in a clockwise direction (shown in FIG. 9B) and upward due to a cam surface on one or both of the inner surfaces. trigger element 52 (typically aligned with position 52c indicated in FIGS. 9C and 7B, but on the inner surface of trigger element 52 rather than the outer surface indicated by 52c) or the outer surface of piston guide 60 (e.g., rib 60n, FIG. 5B ) which converts the axial force from the fuse bias element 35 into a lateral (clockwise) force and causes the trigger element 52 to rotate clockwise and move upward (proximally); and (2) the piston bias element 50 pushes the upper ring 45 in a clockwise and downward direction (distal direction) due to the camming action between the surfaces 49, 60j of the piston 26 and the piston guide 60, thereby causing the piston 26 to move clockwise and slightly down an inclined surface 60j. In other words, the trigger member 52 and the top ring 45 of the piston 26 both rotate clockwise simultaneously or substantially simultaneously under the influence of forces from the respective bias elements 35, 50. This sliding movement between the surfaces 49, 60j of the piston 26 and the piston guide 60 results in rotation , as well as to linear translational movement (resembling a spiral trajectory). Accordingly, the piston guide 60 may function as a cam and the piston rod 26 may function as a cam follower.

The unlocked stage is shown in FIG. 9B, 10B and 11C. At this point, the distally facing cam surface 49 of the top ring 45 has released the proximally facing cam surface 60j of the piston guide 60 so that the top ring 45 (and thus the piston 26) is no longer held axially by the piston guide 60. As a result, the piston bias element 50 pushes the piston 26 along its axis in the distal direction.

The downward stroke stage of the piston is shown in FIG. 9C, 10C and 12A. At this point in FIG. 9C, 10C and 12A, the top ring 45 is still visible near the proximal portion of the piston guide 60, but will quickly move along the longitudinal groove 86 formed in the piston guide 60 and the bore surface 52b. At this stage, the upper ring 45 of the piston 26 moves along both the surface 52b of the firing channel 52 and the longitudinal groove 86 of the piston guide 60, thereby preventing rotation between any of the three components (26, 52, 60). As a more specific example, since the piston guide 60 is rotationally stationary relative to the housing 12, as long as the top ring 45 is located within both the bore surface 52b and the longitudinal groove 86, the trigger member 52 cannot rotate. Also at this stage, as the piston 26 moves distally, the gap 18 between the base 47 of the piston 26 and the plug 24 decreases and the base 47 comes into contact with the plug 24. The device 10 is designed such that the piston 26 moves with a force sufficient to cause the plug 24 to move in the distal direction and ejecting the drug 22 from the delivery element 16. At the same time, the device 10 is also designed to reduce or eliminate the likelihood of glass breaking, unwanted forces acting on the patient, and/or unwanted shock vibration or sound resulting from the interaction between the base 47 and the plug 24. For example, the design parameters of the bias element 50 pistons can be designed to meet these two sets of design goals. As another example, a damping component may be located between the base 47 and the plug 24 or elsewhere in the device 10 to attenuate the forces between the base 47 and the plug 24. For example, the base 47 may include an elastomeric component, portion, or other damping element. Additionally or alternatively, plug 24 may be made of an elastomeric material that has damping properties. Additionally or alternatively, plug 24 may include an additional elastomeric component, portion, or other damping element.

In some embodiments, the cam action between the distally facing cam surface 49 on the protrusion 48 and the proximally facing cam surface 60j of the piston guide 60 may provide a damping effect. In particular, sliding friction between these two surfaces can be selected to slow down the initial expansion of the piston bias element 50. As a consequence, the speed of the piston 26 may be reduced during the initial expansion of the piston biasing element 50, compared to the free, unrelaxed expansion of the piston biasing element 50. The reduced speed of the piston 26 may cause the piston 26 to strike the plug 24 with less force, which reduces the likelihood of structural damage.

- 22 045416 damages the container 20 for storing the medicinal product and/or contributes to a more comfortable injection for the user.

The end of dose administration step is shown in FIG. 12V and 12C. As discussed above, during the downstroke phase of the piston, when the upper ring 45 is located within the bore surface 52b and the longitudinal groove 86, the trigger member 52 cannot rotate relative to the piston guide 60. However, at the initial end of dosing phase shown in FIG. 12B, the top ring 45 may, in some embodiments, release the distal end of the trigger member 52 and no longer restrict or prevent rotation of the trigger member 52. As a more specific example, as shown in the lower portion of FIG. 12B, when the upper ring 45 leaves the channel surface 52b and/or the distal firing mechanism surface 52d, the firing member 52 is no longer rotationally constrained by the upper ring 45, and the firing member 52 is pushed upward by the fuse bias element 35. As a result of the upward force of the fuse displacement element 35 and the cam surfaces, the firing element 52 rotates clockwise during its upward movement in a helical path, and the proximally facing surface 52d of the firing element 52 is in contact with the distal facing surface 60p of the piston guide 60, producing an audible clicking sound. As a more specific example, FIG. 12B shows a gap 90 between the respective surfaces 52d, 60p, but this gap 90 is subsequently eliminated when the trigger 52 is moved proximally, as shown in FIG. 12C. The length of the channel surface 52b and piston 26 can be designed such that the top ring 45 leaves the channel surface 52b when the plug 24 reaches a desired point of movement within the drug storage container 20, such as its end of movement near the distal end of the drug storage container 20 .

As a more specific example of the arrangement of the cam surface between the trigger member 52 and the piston guide 60, and as discussed above, a rib 60n of the piston guide 60 is aligned with the inner surface of the trigger member 52, as indicated by 52c in FIG. 7A and FIG. 7B (but on the inner surface rather than the outer surface as indicated by 52c). The rib 60n has an inclined surface to help improve and/or promote relative rotation between the components 52, 60. More specifically, the buoyant force of the fuse bias element 35 in combination with the inclined surface of the rib 60p creates a rotational force (e.g., torque) and forces the firing element 52 rotate relative to the piston guide 60. During the first rotation step of the trigger 52 (eg, the unlocking step shown in FIG. 11B), the rib 60n moves along the first portion of the inner cam surface 52c of the trigger 52, such as the first portion 52f shown in FIG. 7B. During the second rotation phase of the trigger 52 (eg, the end-of-dose phase shown in FIGS. 12B and 12C), the rib 60n moves along a second portion of the inner cam surface 52c of the trigger 52, such as the second portion 52g shown in FIGS. 7B. As can be seen in FIG. 7B, the second portion 52g includes a pocket 52h that may receive a rib 60n and allow the trigger 52 to rapidly move proximally toward the plunger guide 60 and cause an audible click when the dose is completed. In general, at the end of dose administration, the upper ring 45 releases the channel surface 52b of the trigger element 52, and the fuse bias element 35 and rib 60n cause the trigger element 52 to rotate and move upward, which ends with a rapid upward (in the proximal direction) movement of the trigger element 52 until contact with guide 60 of the piston when moving the rib 60p into pocket 52h.

When the patient and/or healthcare provider hears the beep, he/she/they can be notified that the dose has been administered. In some embodiments, the user may be informed of the meaning of the beep through instructions provided with the drug delivery device 10. In some embodiments, these instructions may take the form of an instructions for use (IFU) brochure included in the packaging with the drug delivery device 10. In some embodiments, the user may receive additional confirmation that drug delivery is complete by observing the movement of plug 24 and/or piston 26 through window 17. In some embodiments, the audible signal may be accompanied by vibration or other tactile feedback generated by the impact the starting element 52 on the piston guide 60. The audible notification may be in the form of a click or knock or any other suitable audible signal perceived by the user. The audible signal may be generated simultaneously or substantially simultaneously with the stopper 24 reaching the end of dosage position.

As described above, in addition to its retention function, the trigger 52 may also be used to generate an audible signal indicating to the user that the delivery or dosage of the drug has been completed. This dual functionality can reduce the number of parts and/or design complexity. Alternatively, the trigger element 52 need not have this indicating function. In alternative embodiments, the annunciator may be configured in a separate structure from the trigger element 52,

- 23 045416 but rigidly attached to it.

Although the foregoing descriptions may use extension bias element 35 to provide the activation energy necessary to generate the end of dose signal, in alternative embodiments a bias element separate from extension bias element 35 may be used for this purpose. In some such embodiments, this additional bias element may have a distal end stationary relative to the housing 12 and a proximal end abutting the distal facing surface of the trigger element 52. Thus, the bias element may be pushed away from the housing 12 to apply bias force in a proximal direction to the trigger element 52. In addition, this bias element can operate independently of the piston bias element 50 and the extension bias element 35.

In any case, once the user has some evidence of completion of drug delivery, the user can then lift the drug delivery device 10 from the injection site. Without experiencing resistance, the extension bias element 35 can push the safety element 32 from a retracted position to an extended position to cover the insertion end 28 of the delivery element 16. In some embodiments, this movement of the safety element 32 may cause the ring retainer 40 to rotate to a position in which it prevents the subsequent retraction of the safety element 32.

For example, as discussed above, in some embodiments, the drug delivery device 10 may include a ring lock 40 configured to lock the safety member 32 in the extended position after the safety member 32 has moved from the retracted position to the extended position. In this embodiment, the ring retainer 40 is centered and rotates about the longitudinal axis A. As shown in FIG. 2, the proximal end of the ring retainer 40 may be in contact with a portion of the housing 12, and the distal end of the ring retainer 40 may be located at least partially within the safety element 32. The ring retainer bias element 51 may be located axially between the distal facing surface of the annular retainer 40 and the proximally facing surface of the safety element 32. The ring retainer bias element 51 may initially be in a compressed or stressed state such that it displaces the ring retainer 40 and the safety element 32 in opposite directions from each other. Thus, the ring retainer biasing member 51 can apply a bias force by pushing the safety member 32 toward the extended position, and also apply a bias force by pushing the proximal end of the ring retainer 40 toward a portion of the body 12, such as the ring sleeve 12d. In some embodiments, the ring retainer bias element 51 may include a compression spring (eg, a coil compression spring).

The ring retainer 40 may also serve to provide initial resistance to movement of the guard 32. As discussed above, the device 10 may be inserted into the patient's body using a tourniquet or otherwise employing inertial forces. The ring retainer 40 and/or other components may provide initial resistance to the movement of the safety element 32 to increase the force applied by the user, as described in more detail below.

In fig. 13 is a perspective view of the ring retainer 40. In the example shown in FIG. 13, the ring retainer 40 has a cam surface 40a that is not parallel to axis A and is configured to convert the translational movement of the safety guard 32 into a rotational movement of the ring retainer 40. As a more specific example, the cam surface 40a shown in FIG. 13 is at an angle of 40d to axis A, equal to approximately -30°. Any suitable angle may be used, for example -10 to -80°, -20 to -70°, -20 to -60°, -20 to -50°, -20 to -40°, - 25 to -35° or any other suitable angle. Angle 40d may also be a positive number (causing the inclined surface to flip about axis A), but such a configuration will cause the ring retainer 40 to rotate in the opposite direction. In such a case, any suitable angle may be used, for example 10 to 80°, 20 to 70°, 20 to 60°, 20 to 50°, 20 to 40°, 25 to 35° or any other suitable corner.

In the example shown in FIG. 13, the ring retainer 40 includes a locking arm 40b, which may be typically a cantilever arm extending (around the circumference of the ring retainer 40) from the main portion of the ring retainer 40. The locking arm 40b may include a ridge 40c extending transversely to the main portion of the ring retainer. 40 (i.e. outward and not parallel to axis A).

In fig. 14 shows the annular retainer 40 along with various other components of the device at a pre-deflection stage (eg, before the safety element 32 is axially deflected in the proximal direction). For example, in FIG. 14 shows the distal portion of the housing 12, which is shown in partial cross-section for illustrative purposes, the safety

- 24 045416 element 32 in translucent and partially cropped form for illustrative purposes, ring retainer 40 and part of inner housing sleeve 12d. The safety element 32 includes a plurality of ribs formed on its annular inner surface. These ribs are shown in Fig. 14, but portions of the annular surface itself are trimmed for illustrative purposes. Likewise, although portions of housing 12 have been trimmed for illustrative purposes, FIG. 14, an annular sleeve 12d formed on the inner surface of the housing 12 is visible. When the device 10 is in the pre-deflection stage (as shown in FIG. 14), the ridge 40c is adjacent to the inertial rib 32k formed on the inner annular surface of the safety member 32. As a further In a particular example, when the device 10 is in the pre-deflection stage, the ridge 40c is located to the left of the inertial rib 32k, such that the ring retainer 40 generally resists rotation (and thereby resists the axial deflection of the safety element 32) until the ridge 40c will not be able to pass by the inertial edge 32k (ie, release the inertial edge 32k). This arrangement is discussed in more detail below.

In fig. 15A and 15B are views from different angles (differing by approximately 90° from each other) when the device is in the initial stage of deflection immediately after the safety member 32 has disengaged from the locking arm 40b. As a more specific example, the ring lock 40 is rotated such that the ridge 40c releases the locking rib 32k, thereby allowing the safety member 32 to deflect more freely (proximally). At this point in the sequence, the injection sequence was probably not activated. For example, the piston displacement element 50 has likely not yet been released because the housing 12 has not yet moved distally enough for the delivery element 16 to pierce the user's tissue.

In order for the device components to move from the step shown in FIG. 14, to the step shown in FIG. 15A and 15B, two events occur generally simultaneously with each other: the initial rotation of the ring lock 40 and the release from the lock arm 40b. Regarding the initial rotation, as shown in FIG. 15B, the cam surface 40a of the ring retainer is generally aligned with the cam rib 32j to convert the translational motion of the safety guard 32 into the rotational movement of the ring retainer 40. As a more specific example, when retracting the safety guard, the proximally facing top surface of the cam rib 32j employs an axial, directional upward force to the cam surface 40a. As a more specific example, the angle of the cam surface 40a relative to the axis A causes the upward force from the cam rib 32j to have an axial component (along the A axis) as well as a rotational component (perpendicular to the A axis), thereby rotating the ring retainer 40. In other words, as in the step shown in FIG. 14 and at the stage shown in FIG. 15A and 15B, deflection (retraction) of the safety member 32 causes the ring lock 40 to rotate. While the cam rib 32j causes the ring lock 40 to rotate to the right (i.e., counterclockwise when viewed from above in FIG. 15B), the locking arm 40b may generally resist such movement. For example, when the safety member 32 is compressed, it moves from the position shown in FIG. 14 to the position shown in FIG. 15A and 15B. As a more specific example, when device 10 is in the position shown in FIG. 14, the ridge 40c is located to the left of the inertial rib 32k such that the ring lock 40 cannot rotate beyond a certain point until the ridge 40c can clear the inertial rib 32k. The ridge 40c can release the inertial rib 32k due to the radially inward deflection of the locking arm 40b, as shown in FIG. 15A. With this design, the deflection of the locking arm 40b at least partially determines the force required for the ridge 40c to release the inertial rib 32k. In other words, the deflection of the locking arm 40b at least partially determines the force required to deflect the safety member 32 sufficiently to activate the injection process. The angle of the ridge 40c relative to the circumference of the ring retainer 40 may also partially determine the force required to deflect the safety member 32 sufficiently to activate the injection process. Additionally, the degree of rotation that the ring latch 40 must undergo in order for the protrusion 40c to release the inertial rib 32k at least partially determines the distance that the safety element 32 will be translated (axially) before the latch arm 40b releases the safety element. element 32.

During surgery, as the patient presses the distal end of the guard 32 against the patient's skin at the injection site, the body 12 of the delivery device 10 may be advanced toward the injection site a relatively short distance (eg, 2-4 mm). In this case, the patient may feel resistance between the 32k inertial rib and the 40c ridge. When the patient presses with great force, the ridge 40c releases the inertial rib 32k and the delivery device 10 provides a rapid release to utilize the energy stored in the patient's muscles while compressing the needle cap and its spring to a certain release point. Release mechanism such as the above-described bending of the locking arm 40b, degree of rotation angle, required

- 25 045416 used to release the inertial rib 32, and other parameters, can be designed such that when the protrusion 40c releases the inertial rib 32k, the resulting speed of needle insertion exceeds the patient's reaction rate, and the combination of this speed and the mass of the device causes rapid and complete penetration of the needle into the skin to a subcutaneous depth. In other words, once the safety element 32 reaches the position shown in FIG. 15A and 15B, the pressure resistance of the safety member is significantly reduced so that the needle is inserted before the patient can stop the insertion process. As a more specific example, at this stage of the insertion process, the main resistance to deflection of the safety element 32, which relates to the components in the distal part of the device, comes from the displacement element 51 of the ring lock, but this resistance is significantly lower than that of the lock arm 40b. In addition, it should be noted that the user may still experience resistance to deflection of the safety element 32, which relates to other subcomponents of the device, for example when activating the drive mechanism 30. Although the insertion process occurs very quickly from this point, subsequent steps will be discussed in detail. discussed in the figures and in the text below.

In fig. 16A and 16B show views from different angles (differing by approximately 90° from each other) when the device is in the stage of continuing downward movement (a later point in time than in FIGS. 15A and 15B, where the body has moved further distally, and safety element 32 is retracted even further). In the sequence step shown in FIG. 16A and 16B, the injection sequence may or may not begin depending on desired release parameters such as needle length, desired insertion depth, distance between guard 32 and needle tip.

As shown in FIG. 16A, at this point in the sequence, the cam rib 32j of the safety element 32 releases or nearly releases the cam surface 40a so that the safety element 32 can be deflected without rotation of the ring retainer 40. Additionally or alternatively, the inclined surface 40e of the ring retainer 40 can be engaged with the inclined surface 12g a housing 12 (which may be formed by an annular sleeve 12d similar to or the same as the inclined surface 412g in FIG. 25); this interaction between the respective surfaces 40e, 12g may also cause the ring retainer 40 to rotate until it reaches the point shown in FIG. 16A and 16B. Additionally or alternatively, at this insertion stage, the locking protrusion 40f of the ring lock 40 engages the locking rib 32n and restricts rotation of the ring lock 40. However, as discussed above, at this stage, the safety element 32 is able to deflect without requiring or causing further rotation of the ring lock 40. latch 40. More specifically, as shown in FIG. 16B and 17, adjacent ribs (locking ridge 32n and cam ridge 32j) extend between adjacent components of the ring retainer 40 (locking lip 40f and cam surface 40a) so that the locking member 32 is deflectable relative to the housing 12.

In fig. 17 shows a view when the device is in the final stage of insertion, when the safety element is fully or almost completely retracted. At this point in the sequence, the injection sequence was likely activated. For example, the piston displacement element 50 has likely been released and the delivery element 16 has been introduced into the user's tissue. Additionally, at this point in the sequence, the safety member 32 is in a nearly or fully retracted position relative to the body 12 and the device 10 is still held against the patient's skin. The user will preferably hold the device 10 in this position at least until the drug delivery process is complete (i.e., until the full dose of drug 22 has been delivered to the patient) and the end of dose notification indicates that administration dose completed. It should be noted that for illustrative purposes, the safety element 32 shown in FIG. 17 has trimmed parts, and FIG. 17 does not show the housing 12 (including the annular sleeve) or the drug container 20.

In fig. 18A and 18B show device 10 in a locked configuration when safety element 32 is in the fully extended position (FIG. 18A) or in the nearly fully extended position (FIG. 18B). As a more specific example, the locking rib 32n and the cam rib 32j of the safety element 32 are aligned with the locking projection 40f to limit and/or prevent deflection of the safety element 32 in the proximal direction. As another more specific example, the safety element 32 is capable of moving proximally only the distance shown by the gap 91 in FIG. 18A such that the safety element 32 is not capable of moving axially in the proximal direction a distance sufficient to deploy the delivery element 16. In other words, the safety element 32 is locked in a protected position, ringing around the needle and minimizing or preventing unintentional needle sticks.

In some embodiments, before removing the removable cap 19, the gripping device 13 may be configured to prevent deflection of the locking arm 40b. For example, the outer surface of the gripping device 13 may be configured to

- 26 045416 resting on the inner surface of the locking arm 40b to prevent radially inward deflection of the locking arm 40b before removing the removable cap 19. This configuration can reduce the likelihood of inadvertent locking caused by vibrations or sudden movements during transport or storage of the drug delivery device 10 before use . When the removable cap 19 with the gripping device 13 is removed, the locking arm 40b can be deflected in the manner described above.

The ring retainer 40 and the housing 12 have corresponding stop surfaces that abut each other and prevent rotation between them. For example, the ring retainer 40 may have abutment surfaces 40g and 40h (FIGS. 18A, 13) that abut the abutment surfaces 12j, 12k (FIG. 18A) of the annular sleeve 12d. The corresponding thrust surfaces 40g, 40h of the ring retainer 40 and the corresponding thrust surfaces 12j, 12k of the ring sleeve 12d may be stepped surfaces to prevent or resist rotation between the ring retainer 40 and the body 12. The ring retainer biasing member 51 may push the ring retainer 40 in a proximal direction and /or a safety member 32 in the distal direction to hold the ring retainer 40 in place, as shown in FIG. 18A and 18B, namely abutting against the annular sleeve 12d.

The circular cross-section of the housing 12 may make it prone to rolling on a surface when placed on its side. In order to inhibit or prevent such rolling, part or all of the removable cap 19 may have a non-circular cross-section. In the embodiment shown in the figures, 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 of the removable cap 19 to the distal end of the removable cap 19. In the illustrated embodiment, the non-circular cross-section of the distal end of the removable cap 19 is generally shaped like a square. In other embodiments, the non-circular cross-section may have a rectangular, triangular or any other polygonal or partially polygonal shape as long as one or more sides of the removable cap 19 are flat or substantially flat to inhibit or prevent rolling. In addition, the non-circular cross-section of the distal end of the removable cap 19 may gradually increase in size in the distal direction, whereby the distal end portion of the distal end of the removable cap 19 has a larger cross-sectional area than the proximally extreme portion of the distal end of the removable cap 19. This configuration gives the distal end of the removable cap 19 a flared shape, which in turn can help the user to hold the removable cap 19 with his hand and pull it off the body 12.

In some embodiments, both the housing 12 and the removable cap 19 may include a suitable anti-rotation element. These anti-rotation members may engage with each other to prevent or inhibit rotation of the detachable cap 19 relative to the housing 12 when the detachable cap 19 is in a storage position. In some embodiments, the rotation-preventing member of the body 12 may be adjacent and generally in line with the rotation-preventing member of the removable cap 19 when the removable cap 19 is in a storage position. For example, the radial projection 9 shown in FIG. 1A is located adjacent the distal end of the housing 112. As shown in FIG. 1B, the removable cap 19 has an opening 8 that is sized to conjugately receive the radial projection 9 when the removable cap 19 is in a storage position. As a consequence of this associated engagement, the release cap 19 cannot rotate relative to the body 12. This may be useful if the user attempts to rotate the release cap 19 as he pulls the release cap 19 off the body 12. In some cases, rotating the release cap 19 may result in rotation sterile barrier such as the RNS or FNS, which in turn may cause the needle tip to become embedded in the sealing member within the RNS or FNS. Thus, the presence of a radial protrusion 9 located inside the hole 8 at least during the initial moments of removing the cap can prevent the needle from entering inside. In alternative embodiments, an opening 8 may be formed in the wall of the housing 12 and a radial projection 9 may extend proximally from the proximal end of the removable cap 19.

In other embodiments, the removable cap may be capable of and/or configured to rotate relative to the housing. For example, the removable cap may have feature(s) that convert the rotational motion of the removable cap into an axial assist force to assist in pushing the removable cap away from the housing. As a more specific example, the removable cap and/or body may have a cam surface, such as a wave-shaped surface, that converts the rotational motion of the removable cap relative to the body into distal axial movement of the removable cap relative to the body. The axial assist force provided by such an arrangement may be beneficial to a variety of users, including those with limited mobility and/or physical strength, such as due to illness.

In fig. 19A-19B show an example force profile during the injection process of an example device.

- 27 045416 drug delivery, where the relative displacement between the device body and the safety element is noted along the x-axis (in millimeters), and the resistance is noted along the y-axis (in Newtons). For example, the displacement (x-axis) indicates the relative axial displacement along the A-axis between the safety element 32 and the housing 12. As discussed above, this relative axial displacement can be understood as relating to the translational movement of the housing 12 relative to the safety element 32 (for example, in the case when the user pushes the housing in a distal direction towards the user's injection site while the user's tissue prevents the movement of the guard 32 in the same direction), or it can be understood to refer to the translational movement of the guard 32 relative to the housing (for example, when the housing 12 is held in place and the user pushes the safety element 32 in a proximal direction). In any case, the x-axis (horizontal) graph in FIG. 19 shows the relative displacement between the safety element 32 and the housing 12. The y-axis (vertical) of the graph in FIG. 19 shows the resistance force at various points of relative displacement between the safety member 32 and the housing 12. For example, at the point where the safety element 32 and the housing 12 have undergone a relative displacement of approximately 2 mm, the resistance force experienced by the user is approximately 7.75 N for force profile shown in FIG. 19A. As an even 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 initially pushing the body 12 toward the injection site in the pre-injection state shown in FIG. 14, the resistance force is generally equal to the force required to compress the spring 51 as well as the force required to push the inertial rib 32k past the ridge 40c. Force profile in Fig. 19A, 19B provide several examples of potentially desirable force and displacement values, and thus it should be understood that these values may vary depending on the design features of the interactions previously noted.

However, as shown in the example force profile in FIG. 19A, the initial resistance force is relatively small during the first approximately 1 mm between the safety element 32 and the housing, after which at point 202 the resistance force increases rapidly (mainly due to the force required to push the inertial rib 32k past the ridge 40c), and the maximum the drag force is achieved at point 204. Once the inertial rib 32k releases the ridge 40c (FIG. 15A), the drag force quickly decreases until point 206, where the drag force is primarily due to the forces required to compress the spring 51 (FIG. 14), the forces required to compress the spring 35 (FIG. 11B) and the frictional forces between the various moving components within the device. At point 208, the needle enters the user's tissue, and at point 210, the injection phase begins and the drug 22 is introduced into the user's tissue. Once the user overcomes the peak resistance force at point 204, the user's inertia may cause the body and drug storage container to move toward the injection site, accelerating needle insertion. This injection step (between points 204 and 208) can occur over a relatively short period of time due to the user's inertia to increase the likelihood that the needle will be fully inserted rather than partially and reduce the likelihood that the user will stop moving the device before or during partial needle insertion. In other words, once the user passes the peak value of the resistance force at point 204, the user can thereby confirm the insertion of the needle and/or the injection process.

In fig. 19B shows another example of a force profile where the peak force (point 304) is lower than the corresponding point (204) in FIG. 19A such that the user requires less initial force to confirm insertion. This force profile may reduce the likelihood that the user will stop the process during the initial indentation (point 302), such as by prematurely removing the device from the tissue. However, it may be desirable for the peak force 304 to be high enough to reduce the likelihood that the user will stop the injection between peak force 304 and needle insertion 308. In other words, the vertical distance (y-axis) between points 304 and 308 must be large enough to facilitate completion of this injection step in a relatively short period of time.

In fig. 20A-20G show a distal portion of an alternative design of the device 400, primarily representing a housing 412, a safety element 432, a ring retainer 440, and a ring retainer bias element 451. As shown in FIG. 20A and 22, the safety member 432 includes an annular base portion 432a, a pair of longitudinally extending legs 432b, a ridge 432h, several internal ribs (discussed in more detail below), and at least one hole 432x (also referred to as a recess in the annotations to some figures) formed in at least one of the ribs and the wall of the safety element. The hole 432x does not have to be an opening through the entire wall of the safety element 432. For example, the hole may simply be a depression in a long rib or a raised portion with a lower height, rather than a cutout in the wall of the security element 432 and part of the rib. The internal ribs of the safety element 432 include a first rib, which is preferably

- 28 045416 longer than the other ribs (also known as long ribs 432r), and a pair of shorter ribs 432s, 432t. An opening 432x is formed in the long rib 432r and is aligned and sized to selectively receive a component of the ring retainer 440, which will be further described below. As shown in FIG. 20A and 23, the ring retainer 440 has a plurality of abutment surfaces 440g, 440h, a U-shaped projection 440w (configured to be positioned within an opening 432x), and a plurality of proximally facing cam surfaces 440x, 440y. However, the ring retainer 440 shown in FIG. 20A and 23 do not have distally facing cam surfaces corresponding to surface 40a in the structure shown in FIG. 13. As shown in FIG. 20A, in the pre-injection state without deflection of the device 400, each of the two U-shaped protrusions 440w is not initially positioned in the holes 432x. Instead, at this point, the proximal portion of the long rib 432r (i.e., the portion of the long rib proximal to the opening 432x) engages the U-shaped protrusion 440w to prevent upward (proximal) movement of the retainer ring relative to the safety member. . As housing 412 moves downward (distally) and/or guard member 432 moves upward (proximally), as shown in FIG. 20B, the ring retainer 440 is capable of moving upward (proximally) away from the spring 451, thereby causing the cam surfaces on the housing 412 to contact the cam surfaces 440x, 440y of the ring retainer and rotationally push the ring retainer. At the stage shown in FIG. 20B, the ring retainer 440 is unable to rotate due to the proximal portion of the long rib 432r being aligned with or positioned within the U-shaped protrusion 440w. Also, as shown in FIG. 20B, the housing cam surface 412x engages the ring retainer cam surface 440y. However, as the relative movement between the safety member and the housing occurs to the state shown in FIG. 20C, the engagement between the housing cam surface 412x and the ring retainer cam surface 440y, in combination with further relative movement between the safety member and the housing, causes the following: (1) the engagement between the housing cam surface 412x and the ring retainer cam surface 440y stops the upward movement of the retainer ring to the proximal portion of the long rib 432r is capable of disengaging with the U-shaped protrusion such that the U-shaped protrusion 440w is then aligned with the hole 432x; and (2) engagement of the corresponding cam surface 412x, 440y causes the ring retainer 440 to rotate. As shown in FIG. 20D, the ring retainer is rotated to a point (approximately two-thirds of its full rotation) at which it is now limited in rotation by short ribs 432s, 432t in the safety member (specifically, the thrust surface 440v shown in FIG. 23 engages short ribs 432s, 432t). In the state shown in FIG. 20E, the guard legs 432b move sufficiently relative to the body 412 so that the injection sequence is started. As shown in FIG. 20F, once the user releases pressure on the housing and allows relative proximal movement of the housing and/or distal movement of the guard, the ring lock is limited in rotation until the stop surface 440v releases the short ribs 432s, 432t, and the ring lock will not rotate to the unlocked position shown in FIG. 20G.

In fig. 26A-26D show another alternative design of the device 600, primarily representing a housing 612, a safety element 632, a ring retainer 640, and a ring retainer bias element 651. As shown at 26C, the safety member 632 includes an annular base portion 632a, a pair of longitudinally extending legs 632b, a ridge 632h, several internal ribs (discussed in more detail below), and at least one hole 632x (also referred to as a recess herein). document) formed in at least one of the ribs and the wall of the safety element. Each rib of the safety element 632 may be configured as a protrusion extending radially inward. The hole 632x need not be an opening through the entire wall of the safety element 632. For example, the hole 632x may simply be a depression in a long rib or a raised portion with a lower height, rather than a cutout in the wall of the security element 632 and part of the rib. An opening 632x is formed in the rib 632r and is aligned and sized to selectively receive a component of the ring retainer 640, which will be further described below. As shown in FIG. 26A, 26B, and 26D, the ring retainer 640 has a plurality of abutment surfaces 640g, 640h, at least one insert projection 640w (configured to be positioned within the opening 632x), and a plurality of proximally facing cam surfaces 640y. As shown in FIG. 26A, each insert protrusion 640w may be configured as a radially outward extending protrusion and may include a proximally facing cam surface 640z. As shown in FIG. 26D, in the pre-injection state with the device 600 partially deflected, each of the two insert-like projections 640w is not initially positioned in the holes 632x. Instead, at this stage, facing proximally to

- 29 045416 control cam surface 612x of body 612 engages distally facing cam surface 640y of ring retainer 640 to prevent or resist upward (proximal) movement of ring retainer 640 relative to safety member 632. At the same time, projections 640w in the form of an insert, respectively engaged with a pair of inclined surfaces 632y (also referred to herein as proximally facing cam surfaces 632y). At this stage of injection, guard 632 is partially deflected (eg, in FIG. 20B), but ring lock 640 has not yet rotated and guard 632 has not yet moved upward enough to begin the injection sequence. At this point, the user will feel resistance to further movement of the injector body 612 due to the respective engagements described above, namely, the proximally facing cam surface 612x of the body 612 with the distal facing cam surface 640y of the ring retainer 640 and the proximally facing cam surface 640z of the protrusion 640w in the form of an insert of the ring retainer 640 with the inclined surface 632y of the safety element. This resistance may or is likely to induce the user to press the injector with a force sufficient to overcome the resistance (ie, the peak resistance of the injector). The peak resistance is caused by the aforementioned interactions (converted in the distal direction of the fist surface 612x of the case 612 with a fist surface of 640U of the annular fixer 640 and a fist surface 640Z 640z in the form of an insert of the chain fixor 640 with a slope of the surface 63 2U safety element), and it is overcome (i.e., released) when the user's force is sufficient to cause the insert-shaped protrusion 640w of the ring retainer 640 to slide along the inclined surface 632y of the safety member and for the proximally facing cam surface 640y of the ring retainer 640 to slide along the distal direction of the cam surface 612x of the housing 612 (left in Fig. 26D). In other words, the ring retainer 640 will rotate in the direction of arrow 601 and move slightly downward (distal) as shown in FIG. 26D. Once the ring retainer 640 has rotated sufficiently so that the ring retainer insert protrusion 640w releases the inclined surface 632y of the safety element, the safety element 632 will be able to move axially upward (proximally). At this point, two events occur: (1) the safety element 632 will move proximally sufficiently so that the injection sequence will begin; and (2) the ring retainer insert protrusion 640w will become axially aligned with the safety member opening 632x (FIG. 26C), thereby allowing the ring retainer 640 to rotate in the direction of arrow 602 (FIG. 26D) and slightly upward (proximally). ) due to the interaction between the proximally facing cam surface 640y of the ring retainer 640 and the distal facing cam surface 612x of the housing 612. Once the injection is initiated, the ring retainer 640 will be in a position in which it can lock the guard, similar to other embodiments described higher. The injector 600 may be designed such that events (1) and (2) occur simultaneously such that, once the safety element is translated a distance sufficient to initiate injection, the locking ring is rotated through an angle sufficient to initiate the locking sequence. This may be advisable to substantially or completely prevent the user from attempting multiple injections. It may also be advisable to substantially or completely prevent the blocking sequence from starting without simultaneously starting the injection sequence. In other words, the above configuration can reduce the likelihood that a user has a blocked injector with an undelivered dose.

To facilitate rotation of the ring retainer 640 relative to the housing 612 and/or the safety element 632, any two or combinations thereof of the following elements may be parallel to each other: the distally facing cam surface(s) 612x of the housing 612 facing ( s) proximally facing cam surface(s) 63 2y of the safety element 632, distally facing cam surface(s) 640z of the ring retainer 640 and proximally facing cam(s) surface(s) 640 of ring retainer 640.

In fig. 2^-2^ shows a distal portion of another alternative design of device 500, generally showing housing 512, safety member 532, ring retainer 540, and ring retainer bias element 551. The components of the device 500 are similar to those of the device 400, except that instead of a U-shaped protrusion 440w, the ring retainer 540 has only a pair of parallel protrusions 540w that do not have a horizontal protrusion connecting them. In other words, the 540w lugs have U-shaped sides but no U-shaped bottom. In the state shown in FIG. 21A, projections 540w are located within the long rib of the safety element 532 to prevent rotational movement of the stakes.

- 30 045416 cylinder lock. When relative motion occurs between the safety element and the housing, as shown in FIG. 21B, the projections 540w are aligned with the hole in the safety element, thereby allowing rotational movement of the ring retainer relative to the safety element (and are pushed by the cam surface on the body). As shown in the state of FIG. 21C, the ring retainer is subsequently rotated until the thrust surface 440v engages the short ribs in the safety member. In Fig. 21D shows the distal components of the device during injection activation. In fig. 21E shows the state of the distal components after the user has released pressure and the safety element is allowed to move (extend distally) relative to the housing. In fig. 21F shows the locking configuration.

In fig. 24 is a graph comparing the force profiles shown in FIG. 19A and 19B with force profiles related to the drug delivery device 400 shown in FIG. 20A-20G and the drug delivery device 500 shown in FIG. 21A-21F. Similar to Fig. 19A and 19B, in FIG. 24 shows the resistance force experienced by the user as a function of the offset of the protection (eg, the safety fuse 32). In addition, in FIG. Figure 24 shows where in each force profile the locking point associated with the ring lock should appear. In fig. 24 shows that the fixation point for the force profiles in FIG. 19A and 19B occurs at the same protection offset as the peak resistance experienced by the user. In contrast, the fixation point for the force profiles associated with the drug delivery devices 400 and 500 does not coincide with the guard offset corresponding to the peak resistance experienced by the user. The device 600 shown in FIG. 26A-26D may be designed such that the fixation point appears simultaneously with or immediately after the user tests the peak resistance. Although the force profile of device 600 is not shown in FIG. 24, the force profile may be similar to that in FIG. 19A and 19B, namely with a relatively sharp peak and decline. However, the force profile of device 600 may be shifted to the right such that the peak occurs closer to the point of needle insertion (between 5 and 6 mm of offset in FIG. 24).

If we go to Fig. 24, the force profile associated with the drug delivery device 400 is similar to the force profiles in FIG. 19A and 19B in the sense that before insertion of the needle the user experiences a sudden jump in resistance caused by the displacement of the guard. In contrast to the force profiles in Fig. 19A and 19B, the resistance experienced by the user of the drug delivery device 400 may continue to increase after this jump (up to the activation point). In fig. 24 illustrates that the user of the drug delivery device 500 may not experience a sudden jump in resistance during guard bias, but instead may experience a gradual increase in resistance until the activation point. The manufacturer can select one of the force profiles shown in FIG. 24, or other force profile depending, for example, on the desired user experience, physical and/or mental abilities of the target users or patients, mechanical safety considerations, and/or other considerations.

From the above, it is clear that the present invention advantageously provides an improved design of a drug delivery device having automated features. The various mechanisms and components of a drug delivery device may interact with each other in a synergistic manner to limit the number of moving parts required by the drug delivery device, thereby increasing the reliability of the drug delivery device and reducing costs, as well as providing other advantages and benefits.

As will be appreciated, the devices and methods of the present invention may have one or more advantages over conventional technology, and any one or more of these advantages may be present in a particular embodiment in accordance with the features of the present invention included in that embodiment. Other benefits not specifically listed herein may also be appreciated.

The description above describes various devices, assemblies, components, subsystems and methods of use related to a drug delivery device. The drug delivery devices, assemblies, components, subsystems, methods or devices may further contain a drug or be used with a drug, including, without limitation, the drugs listed below, as well as generic and biosimilar analogs thereof. The term drug as used herein may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including conventional and non-conventional pharmaceuticals, nutraceuticals, supplements, biologicals, bioactives and formulations, macromolecules, biosimilars , bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generic analogues. Also included are non-therapeutic materials for administration by injection. The drug may be in liquid form, lyophilized form, or reconstituted from lyophilized form. Further illustrative list of medicinal products

- 31 045416 means should not be regarded as comprehensive or limiting.

The medicine is contained in a reservoir. In some cases, the reservoir is a main container that is filled or pre-filled for drug treatment. The main container may be a tube, cartridge, or pre-filled syringe.

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

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. ESA is any molecule that stimulates erythropoiesis. In some embodiments, ESA is an erythropoiesis-stimulating protein. As used herein, the expression erythropoiesis-stimulating protein means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing its dimerization. Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs or derivatives, which bind to and activate the erythropoietin receptor; antibodies that bind to the erythropoietin receptor and activate the receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include, but are not limited to, 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), Binocrit® (epoetin-alpha), Epoetin-alpha Hexal, Abseamed® (epoetin-alpha), Ratioepo® (epoetin-alpha) -theta), Eporatio® (epoetin-theta), Biopoin® (epoetin-theta), epoetin-alpha, epoetin-beta, epoetinyota, epoetin-omega, epoetin-delta, epoetin-zeta, epoetin-theta and epoetin-delta, pegylated erythropoietin, carbamylated erythropoietin, as well as molecules or variants or analogs thereof.

Specific exemplary proteins include the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies and related proteins, and the like. (also called RANKL-specific antibodies, peptibodies, etc.), including fully humanized and human OPGL-specific antibodies, in particular fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies and related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by IL-4 and/or IL-13 binding to the receptor; interleukin-1 receptor-1 (IL1-R1)-specific antibodies, peptibodies, related proteins, and the like; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, and the like, in particular, human CD22-specific antibodies, such as, but not limited to, humanized and fully human antibodies, including without limitation, humanized and fully human monoclonal antibodies, in particular including, but not limited to, human CD22-specific IgG antibodies, such as, for example, a dimer of the gamma chain of the humanized mouse monoclonal antibody hLL2 linked via a disulfide bond to the kappa chain of the humanized mouse monoclonal antibody hLL2, including without limitation, for example, the human CD22-specific fully humanized antibody epratuzumab, having CAS registration number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies and related proteins and the like, including but not limited to anti-IGF-1R antibodies; B-7 related protein-1 specific antibodies, peptibodies, related proteins, etc. (B7RP-1, also referred to as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human IgG2 monoclonal antibodies, in particular a fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1 , including without limitation those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to the anti-IL-15 antibodies HuMax and related proteins, such as, for example, 145c7; IFN-gamma-specific antibodies, peptibodies, related proteins, and the like, including, without limitation, human IFN-gamma-specific antibodies, and including, without limitation, fully human anti-IFN-gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., and other TALL specific binding proteins; parathyroid hormone (PTH)-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor (TPO-R)-specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor (HGF)-specific antibodies, peptibodies, related proteins, etc., including those that target the HGF/SF:c-Met signaling pathway axis (HGF/SF:c-Met), such as completely human monoclonal antibodies that neutralize hepatocyte growth factor/scatter factor (HGF/SF); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; Activin A-specific antibodies, peptibodies, proteins, etc.; TGF-beta specific antibodies, peptibodies, related proteins, etc.; amyloid beta protein specific antibodies, peptibodies, related proteins, etc.; c-Kit-specific antibodies, peptibodies, related proteins, and the like, including, without limitation, proteins that bind c-Kit and/or other stem cell factor receptors; OX40L-specific antibodies, peptibodies, related proteins, and the like, including, without limitation, proteins that bind OX40L and/or other OX40 receptor ligands; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (mAb to α4β7); MLN1202 (mAb to chemokine receptor CCR2); Enbrel® (etanercept, TNF receptor/Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR/HER1/c-ErbB-1 antibody); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, mAb to the HER2/neu receptor (erbB2)); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or other product containing trastuzumab for the treatment of breast cancer or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2-based human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor/Fc fusion protein, TNF blocker), Nplate® (romiplostim ), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargramostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat-B, belimumab, mAb to BlyS); Metalyse® (tenecteplase, t-PA analogue); Mircera® (methoxypolyethylene glycol epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris ™ (eculizumab); pexelizumab (anti-complement C5 antibody); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab) ; Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DMl); NeoRecormon® (epoetin beta); Neumega® (oprelvekin , human interleukin-11); Orthoclone OKT3® (muromonab-CD3, a monoclonal antibody to CD3); Procrit® (epoetin-alpha); Remicade® (infliximab, a monoclonal antibody to TNFa); Reopro® (abciximab, a monoclonal antibody to the GP receptor lIb/Ilia); Actemra® (IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see US Pat. No. 7153507); Tysabri® (natalizumab, mAb to integrin a4); Valortim® (MDX-1303, mAb to the protective antigen of B. anthracis); ABthrax™; Xolair® (omalizumab); ETI211 (mAb to MRSA); IL-1 decoy (the Fc portion of human IgG1 and the extracellular domains of both components of the IL-1 receptor (type I receptor and receptor accessory protein)); VEGF decoy (VEGFR1 Ig domains fused to IgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritutomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); monoclonal antibody to CD80 (galiximab); mAb to CD23 (lumiliximab); BR2-Fc (huBR3/huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; mAb to human TRAIL receptor 1); HuMax-CD20 (ocrelizumab, mAb to human CD20); HuMax-EGFR (zalutumumab); M200 (volociximab, mAb to α5β1 integrin); MDX-010 (ipilimumab, mAb to CTLA-4 and VEGFR-1 (IMC-18F1); mAb to BR3; mAb to toxin A and toxin B of C. difficile C, MDX-066 (CDA-1) and MDX-1388) ; dsFv conjugates to CD22PE38 (CAT-3888 and CAT-8015); mAb to CD25 (HuMax-TAC); mAb to CD3 (NI-0401); adecatumumab; mAb to CD30 (MDX-060); MDX-1333 (anti-IFNAR antibody); mAb to CD38 (HuMax CD38); mAb to CD40L; mAb to Cripto; an anti-CTGF antibody for idiopathic pulmonary fibrosis in a phase I study (FG-3019) from Fibrogen; mAb to CTLA4; mAb to eotaxin-1 (CAT-213); mAb to FGF8; mAb to ganglgioside GD2; mAb to ganglgioside GM2; mAb to human GDF-8 (MYO-029); mAb to the GM-CSF receptor (CAM3001); mAb to HepC (HuMax HepC); mAb to IFNa (MEDI-545); mAb to IGF1R; mAb to IGF-1R (HuMax- 33 045416

Inflam); mAb to IL12 (AVT-874); mAb to IL12/IL23 (CNTO 1275); mAb to IL13 (CAT-354); mAb to IL2Ra (HuMax-TAC); IL5 receptor mAb; mAb to integrin receptors (MDX-018, CNTO 95); IP10 mAb for ulcerative colitis (MDX-1100); BMS-66513; mAb to mannose receptor/hCGP (MDX-1307); dsFv conjugate to mesothelin-PE38 (CAT-5001); mAb to PD1 (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); mAb to TGFe (GC-1008); mAb to human TRAIL receptor-2 (HGS-ETR2); mAb to TWEAK; mAb to VEGFR/Flt-1; mAb KZP3 (HuMax-ZP3)

In some embodiments, the drug delivery device may contain or be used with an anti-sclerostin antibody, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and/ or fracture healing; and in other embodiments, a monoclonal antibody (IgG) that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprunt, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or other oncolytic HSV for the treatment of melanoma or other types of cancer, including but not limited to OncoVEXGALV/CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042, or the device can be used with them. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain or may be used with Aimovig® (erenumab), an anti-human CGRP-R (calcitonin gene-related peptide receptor type 1) antibody, or other erenumab-containing product for the treatment of migraines. Antibodies that antagonize the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab and bispecific antibody molecules that target the CGRP receptor and other targets associated with headache, can also be delivered by a drug delivery device. means according to the present invention. Additionally, bispecific T cell recruiting activator (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), can be used in or with the drug delivery device of the present invention. In some embodiments, the drug delivery device may contain or be used with a high molecular weight APJ agonist, such as, but not limited to, apelin or analogs thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with a drug delivery device of the present invention. In some embodiments, the drug delivery device may contain or may be used with Avsola™ (infliximab-axxq), an anti-TNFa monoclonal antibody, Remicade® (infliximab) biosimilar (Janssen Biotech, Inc.), or other infliximab-containing product for the treatment of autoimmune diseases . In some embodiments, the drug delivery device may contain or may be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2 -methyloxirane-2-y1)-1-oxopentan-2ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetαamido)-4-phenylbutanamido)-4-methylpentanamide or other product containing carfilzomib for treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or may be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]- 2,3dihydro-1,3-dioxy-1H-isoindol-4-yl]acetamide or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or may 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) on hemodialysis. In some embodiments, the drug delivery device may contain or may be used with ABP 798 (rituximab), a suitable Rituxan®/MabThera™ biosimilar, or other anti-CD20 monoclonal antibody product. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist, such as a non-antibody VEGF antagonist, and/or a VEGF decoy, such as aflibercept (VEGFR1 Ig domain 2 and VEGFR2 Ig domain 3 fused with the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or may be used with ABP 959 (eculizumab), a suitable Soliris® biosimilar, or other product containing a monoclonal antibody that specifically binds to the C5 protein of the complement system. In some embodiments, the drug delivery device may

- 34 045416 hold or can be used with rosibafusp alfa (formerly known as AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activity of ICOSL and BAFF. In some embodiments, the drug delivery device may contain or may be used with the agent omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or a myotrope that directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or may be used with sotorasib (formerly known as AMG 510), a small molecule KRAS ^G12C inhibitor, or other product containing a small molecule KRAS ^G12C inhibitor. In some embodiments, the drug delivery device may contain or may be used with the agent tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (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 may be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL) -15). In some embodiments, the drug delivery device may contain or may be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or other small interfering RNA (siRNA) product. , which reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or may be used with ABP 654 (human kappa chain IgG1 antibody), a suitable Stelara® biosimilar, or other product containing a human kappa chain IgG1 antibody and/or binds to the p40 subunit human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or may be used with Amjevita™ or Amgevita™ (formerly known as ABP 501) (human TNF IgG1 mAb), a suitable Humira® biosimilar, or other product containing human TNF IgG1 mAb. In some embodiments, the drug delivery device may comprise, or may be used with, AMG 160, or another product comprising a prostate-specific membrane antigen (PSMA) extended half-life (HLE) construct and a BiTE® (bispecific T cell recruitment activator) antibody to CD3. In some embodiments, the drug delivery device may comprise or may be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may comprise or may be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or may be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or may be used with AMG 171 or another product containing a differential growth factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may contain or may be used with AMG 176 or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise, or may be used with, AMG 199 or another product comprising a bispecific T cell engagement activator (BiTE®) half-life extended (HLE) construct. In some embodiments, the drug delivery device may contain or may be used with AMG 256 or another product containing an anti-PD-1 antibody and an IL21 mutein and/or an IL-21 receptor agonist designed to selectively engage the interleukin 21 (IL) pathway -21) in programmed cell death protein 1 (PD-1) positive cells. In some embodiments, the drug delivery device may comprise or may be used with AMG 330 or another product comprising an anti-CD33 antibody construct and an anti-CD3 BiTE® (Bispecific T-cell Engagement Activator) antibody construct. In some embodiments, the drug delivery device may contain or may be used with AMG 404 or another product containing an anti-programmed cell death protein 1 (PD-1) monoclonal antibody that is being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may comprise, or may be used with, AMG 427 or another product comprising an anti-FMS-like tyrosine kinase 3 (FLT3) antibody construct and an anti-CD3 BiTE® (bispecific T cell recruitment activator) antibody construct, having an increased

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Claims (29)

half-life (HLE). In some embodiments, the drug delivery device may contain or may be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or may be used with AMG 506 or another product containing a multi-specific DARPin® biologic targeting FAP and 4-1BB that is being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or may be used with AMG 509 or another product containing a bivalent T cell recruitment activator and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may comprise or may be used with AMG 562 or another product comprising a CD19 x CD3 BiTE® (bispecific T cell engagement activator) extended half-life (HLE) construct. In some embodiments, the drug delivery device may contain or may be used with Efavaleukin alfa (formerly known as AMG 592) or another product containing an IL-2 Fc mutein fusion protein. In some embodiments, the drug delivery device may contain or may be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell recruitment activator) molecule. In some embodiments, the drug delivery device may comprise, or may be used with, AMG 673 or another product comprising an anti-CD33 antibody construct and an anti-CD3 BiTE® (Bispecific T Cell Engagement Activator) antibody having an extended half-life (FILE) construct. In some embodiments, the drug delivery device may comprise, or may be used with, AMG 701 or another product comprising a B-cell maturation antigen (BCMA) construct and a BiTE® (bispecific T-cell recruitment activator) CD3 antigen having increased half-life (FILE). In some embodiments, the drug delivery device may comprise, or may be used with, AMG 757 or another product comprising an anti-delta-like ligand 3 (DLL3) antibody construct and an anti-CD3 BiTE® (bispecific T-cell recruitment activator) antibody construct, having an extended half-life (HLE). In some embodiments, the drug delivery device may comprise, or may be used with, AMG 910 or other product comprising a construct based on the epithelial cell tight junction protein claudin 18.2 and a BiTE® (bispecific T cell recruitment activator) anti-CD3 antibody having extended half-life (HLE). Although drug delivery devices, assemblies, components, subsystems and methods have been described by way of exemplary embodiments, they are not limited to them. The detailed description should be interpreted as being given by way of example only, and does not describe every possible embodiment of the present invention. Numerous alternative embodiments may be implemented using either current technology or technology developed after the filing date of this patent, which nevertheless fall within the scope of the invention(s) described herein. Those skilled in the art will appreciate that numerous modifications, changes and combinations may be made in connection with the embodiments described above without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, changes and combinations should be considered to fall within the scope of the idea(s) of the present invention. CLAIM 1. Device (10, 400, 500, 600) for drug delivery, containing a housing (12, 412, 512, 612) forming a longitudinal axis (A) and having an opening (14); a drug storage container (20) comprising a delivery element (16) having an insertion end (28) configured to pass at least partially through the opening in the delivery state, the drug storage container being connected to the body so that to essentially prevent relative movement between them; a piston (26) movable in a distal direction relative to the drug storage container to push the drug (22) out of the drug storage container through the delivery element; a piston displacement element (50) configured to push the piston in a distal direction; a fuse (32, 432, 532, 632) disposed adjacent the opening, the fuse being operatively coupled to the piston bias member such that relative movement between the fuse and the housing along the longitudinal axis releases the piston bias member; And - 36 045416 a latch component (40, 440, 540, 640) configured to resist relative movement between the fuse and the housing until the latch component is released by force of the user, wherein the resistance from the latch component causes the user to increase the force of the user, and, when the locking component is released, the force of the user causes the housing and the drug storage container to move towards the injection site; and wherein at least a portion of the latch component is rotatable relative to the housing about a longitudinal axis, wherein at least a portion of the latch component has a first position in which at least a portion of the latch component resists relative movement between the fuse and the housing, and a second a position in which at least a portion of the lock component offers no or less resistance to relative movement between the fuse and the housing. 2. The drug delivery device according to claim 1, characterized in that at least part of the retainer component (40, 440, 540, 640) contains a ring retainer (40, 440, 540, 640). 3. The drug delivery device according to claim 2, characterized in that the ring retainer includes a locking arm (40b) having a base and a deflectable end, wherein deflection of the deflectable end allows the ring retainer to rotate between a first position and a second position. 4. The drug delivery device according to claim 3, characterized in that the deflectable end includes a locking protrusion (40c). 5. The drug delivery device according to any one of claims 2 to 4, characterized in that the fuse contains an inertial rib (32k) configured to engage with the ring retainer and provide resistance to the rotational movement of the ring retainer relative to the housing. 6. The drug delivery device according to claim 5, characterized in that the inertial rib is configured to engage with the deflectable end of the locking arm and provide resistance to the movement of the ring lock from the first position to the second position. 7. The drug delivery device according to claim 6, characterized in that the fuse further comprises a cam rib (32j) configured to engage the first cam surface (40a) of the ring retainer and push the ring retainer to the second position. 8. The drug delivery device according to claim 7, characterized in that the ring retainer further comprises a second cam surface (40e) configured to engage the fuse and push the ring retainer to a third position; and a locking projection (40f) configured to selectively engage the guard and limit or resist relative movement between the guard and the ring retainer along the longitudinal axis when the ring retainer is in the third position. 9. The drug delivery device according to claim 2, characterized in that the fuse comprises a first proximally facing cam surface (632u); the housing includes a first distally facing cam surface (612x); and the ring retainer includes a second distally facing cam surface (640z) and a second proximally facing cam surface configured to engage, respectively, the first proximally facing cam surface of the guard and the first distal cam surface of the housing when the ring retainer is in the first position to resist movement of the guard in the proximal direction. 10. The drug delivery device of claim 9, wherein one or more of the first proximally facing cam surface of the guard and the first distal cam surface of the housing pushes the ring lock to rotate from the first position to the second position during movement of the fuse in the proximal direction. 11. The drug delivery device of claim 10, wherein the second distally facing cam surface of the ring retainer is configured to disengage from the first proximally facing cam surface of the retainer when the ring retainer is rotated to the second position. 12. The drug delivery device according to any one of claims 9 to 11, characterized in that any two of or a combination of the following elements are parallel to each other: the first proximally facing cam surface of the fuse, the first distal cam surface of the housing, the second facing distally - 37 045416 the cam surface of the ring retainer and the second cam surface of the ring retainer facing proximally. 13. The drug delivery device according to any one of claims 9 to 12, characterized in that the ring retainer includes a radially outwardly extending projection (640w) and the radially outwardly extending projection includes a second distally facing cam surface. 14. The drug delivery device according to any one of claims 9 to 13, characterized in that the guard comprises a radially inwardly extending protrusion (632r) and the radially inwardly extending protrusion comprises a first proximally facing cam surface. 15. Device (10, 400, 500, 600) for drug delivery, comprising a housing (12, 412, 512, 612) forming a longitudinal axis and having an opening; a drug storage container (20) comprising a delivery element (16) having an insertion end (28) configured to pass at least partially through the opening in the delivery state, the drug storage container being connected to the body so that to essentially prevent relative movement between them; a piston (26) movable in a distal direction relative to the drug storage container to push the drug (22) out of the drug storage container through the delivery element; a piston displacement element (50) configured to push the piston in a distal direction; a fuse (32, 432, 532, 632) located adjacent to the hole such that the housing has a first position relative to the fuse in which the piston bias element is locked, and a second position relative to the fuse in which the piston bias element is unlocked; and a latch component (40, 440, 540, 640) configured to hold the housing in the first position until the latch component is released by force of the user, wherein resistance from the latch components causes the user to increase the force of the user, and when the latch component released, the user's force causes the housing and the drug storage container to move towards the injection site; and wherein at least a portion of the latch component is rotatable relative to the housing about a longitudinal axis, wherein at least a portion of the latch component has a first position in which at least a portion of the latch component resists relative movement between the fuse and the housing, and a second a position in which at least a portion of the lock component offers no or less resistance to relative movement between the fuse and the housing. 16. The drug delivery device according to claim 15, characterized in that at least a portion of the retainer component (40, 440, 540, 640) contains a ring retainer (40, 440, 540, 640). 17. The drug delivery device according to claim 16, characterized in that the ring lock (40b) includes a locking arm having a base and a deflectable end, wherein deflection of the deflectable end allows the ring lock to rotate between a first position and a second position. 18. The drug delivery device according to claim 17, characterized in that the deflectable end includes a locking projection (40c). 19. The drug delivery device according to any one of claims 16 to 18, characterized in that the fuse includes an inertial rib (32k) configured to engage with the ring retainer and resist the rotational movement of the ring retainer relative to the housing. 20. The drug delivery device according to claim 19, characterized in that the inertial rib is configured to engage with the deflectable end of the locking arm and provide resistance to the movement of the ring lock from the first position to the second position. 21. The drug delivery device according to claim 20, characterized in that the fuse further comprises a cam rib (32j) configured to engage the first cam surface of the ring retainer and push the ring retainer to the second position. 22. The drug delivery device according to claim 21, characterized in that the ring retainer further comprises a second cam surface (40e) configured to engage the fuse and push the ring retainer to a third position; and a locking projection (40f) configured to selectively engage the guard and limit or resist relative movement between the guard and the ring retainer along the longitudinal axis when the ring retainer is in the third position. - 38 045416 23. The drug delivery device according to claim 16, characterized in that the fuse comprises a first proximally facing cam surface (632u); the housing includes a first distally facing cam surface (612x); and the ring retainer includes a second distally facing cam surface (640z) and a second proximally facing cam surface configured to engage, respectively, the first proximally facing cam surface of the guard and the first distal cam surface of the housing when the ring retainer is in the first position to resist movement of the guard in the proximal direction. 24. The drug delivery device of claim 23, wherein one or more of the first proximally facing cam surface of the guard and the first distal cam surface of the housing pushes the ring lock to rotate from the first position to the second position during movement of the fuse in the proximal direction. 25. The drug delivery device of claim 24, wherein the second distally facing cam surface of the ring retainer is configured to disengage from the first proximally facing cam surface of the retainer when the ring retainer is rotated to the second position. 26. The drug delivery device according to any one of claims 23 to 25, characterized in that any two or a combination of the following elements are parallel to each other: the first proximally facing cam surface of the fuse, the first distal cam surface of the body, the second a distally facing cam surface of the ring retainer and a second proximally facing cam surface of the ring retainer. 27. The drug delivery device according to any one of claims 23 to 26, characterized in that the ring retainer includes a radially outwardly extending protrusion and the radially outwardly extending protrusion (640w) comprises a second distally facing cam surface. 28. The drug delivery device according to any one of claims 23 to 27, characterized in that the guard comprises a radially inwardly extending protrusion (632r) and the radially inwardly extending protrusion comprises a first proximally facing cam surface. 29. A method for delivering a medicinal product to a user, including providing a device (10, 400, 500, 600) for delivering a medicinal product containing a housing, a container (20) for storing the medicinal product, having a delivery element (16) and connected to the housing so that to essentially prevent relative movement between them, the piston (26) configured to move relative to the drug storage container to push the drug (22) out of the drug storage container through the delivery element, the piston displacement element (50) configured to pushing the piston in a distal direction, a guard (32, 432, 532, 632) coupled to the housing, and a locking component (40, 440, 540, 640) configured to resist relative movement between the guard and the housing; positioning the drug delivery device in contact with the user so that the guard surrounds the user's injection site; and applying a force by the user to the housing toward the injection site sufficient to overcome the resistance of the locking component and to cause relative motion between the housing and the lock, thereby causing the housing and the drug storage container to move toward the injection site; wherein at least a portion of the latch component is rotatable relative to the housing about a longitudinal axis, wherein at least a portion of the latch component has a first position in which at least a portion of the latch component resists relative movement between the fuse and the housing, and a second position wherein at least a portion of the retainer component provides no or less resistance to relative motion between the fuse and the housing. -