Drug delivery devices

Abstract

The drug delivery device may include: a housing defining a longitudinal axis and having an opening; and a drug storage container, the drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The device may also include a plunger that is movable toward a distal end of the drug storage container to expel the drug from the drug storage container through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber, and an outer wall cooperating with the inner wall to define a body thickness. The device may further include a plunger biasing member at least partially disposed within the axial chamber, the plunger biasing member being configured to advance the plunger toward the distal end of the drug storage container.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 908,504, filed on September 30, 2019, entitled “Drug Delivery Device,” and U.S. Provisional Application No. 62 / 961,031, filed on January 14, 2020, entitled “Drug Delivery Device,” each of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to drug delivery devices, and more particularly to devices for automatically infusing a drug into a patient. Background Art

[0004] The general aversion to exposed needles, as well as health and safety concerns, has led to the development of drug delivery devices that conceal the needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer a variety of benefits over traditional forms of drug delivery, including, for example, delivery via conventional syringes.

[0005] Many injector systems use spiral spring structures and other spring structures to provide actuation energy to realize functions such as needle insertion and / or fluid delivery. Using springs can provide simple and low-cost benefits, but there may be certain limitations. For example, in spring actuators, there is a linear relationship between force and displacement. In order to provide enough energy for drug delivery at the end of the plunger stroke, excessive energy can be input to the system at the beginning of drug delivery. As another example, when delivering a drug of higher viscosity via an automatic injector, the required spring force may increase. A spring with a higher spring constant can transfer greater force to medicine and main container. The various physical properties of the spring may affect the spring stiffness, and therefore affect the spring force, such as the wire diameter of the spring, the average diameter of the spring, the number of spring coils and the spring material. Therefore, it may be desirable and / or advantageous to include a device component that can obtain spring design flexibility and / or be convenient to have a spring with different physical properties and the rest of the device components for use together.

[0006] The present disclosure sets forth drug delivery devices that represent advantageous alternatives to existing drug delivery devices and that may address one or more of the challenges or needs noted herein. Summary of the invention

[0007] One aspect of the present disclosure provides a drug delivery device, the drug delivery device including a housing defining a longitudinal axis and having an opening and a drug storage container, the drug storage container including a delivery member having an insertion end, the insertion end being configured to extend at least partially through the opening during a delivery state. The device may further include a plunger, the plunger being movable toward the distal end of the drug storage container to discharge the drug from the drug storage container through the delivery member, the plunger including a body portion having an inner wall defining an axial chamber, and an outer wall cooperating with the inner wall to define a body thickness. The device may also include a plunger biasing member at least partially arranged in the axial chamber, the plunger biasing member being configured to advance the plunger toward the distal end of the drug storage container.

[0008] The plunger body portion may have a hollow tubular shape. The plunger body portion may be made of metal or non-metal.

[0009] The plunger may be configured to selectively rotate from an initial rotational position to a second rotational position under a biasing force applied by the plunger biasing member, and after rotating from the initial rotational position to the second rotational position, linearly translate toward a distal end of the drug storage container under the biasing force applied by the plunger biasing member.

[0010] The device may further include a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide.One of the plunger and the plunger guide may include a cam, and the other of the plunger and the plunger guide may include a cam follower.

[0011] The plunger may include a cam follower and the plunger guide includes a cam, and the cam follower may be formed by at least one flange extending radially outwardly from the plunger.

[0012] The thickness of the plunger body may be less than 0.6 mm, less than 0.4 mm, less than 0.3 mm, less than 0.2 mm, less than 0.1 mm, or less than 0.05 mm.

[0013] Another aspect of the present disclosure provides a drug delivery device, the drug delivery device including a housing defining a longitudinal axis and having an opening and a drug storage container, the drug storage container including a delivery member having an insertion end, the insertion end being configured to extend at least partially through the opening during a delivery state. The device may further include a plunger, the plunger being movable toward the distal end of the drug storage container to discharge the drug from the drug storage container through the delivery member, the plunger including a plunger body having an inner wall defining an axial chamber, and an outer wall cooperating with the inner wall to define a body thickness of less than 0.6 mm. The device may also include a plunger biasing member, the plunger biasing member being coupled to the plunger and configured to advance the plunger toward the distal end of the drug storage container. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] It is believed that the present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings. Some drawings may be simplified by omitting selected elements in order to more clearly show other elements. The omission of these elements in certain drawings does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it may be clearly indicated in the corresponding written description. Moreover, all drawings are not necessarily drawn to scale.

[0015] Figure 1A is a perspective view of an exemplary drug delivery device according to various embodiments;

[0016] Figure 1B yes Figure 1A A perspective view of a drug delivery device in which a cover is removed from the drug delivery device;

[0017] Figure 1C yes Figure 1A A perspective view of the drug delivery device in a pre-injection configuration;

[0018] Figure 1D yes Figure 1A A three-dimensional view of the drug delivery device in an injection configuration;

[0019] Figure 2 is a cross-sectional view of the drug delivery device of FIG1 ;

[0020] Figure 3A yes Figure 2 an exploded assembly view of a portion (i.e., a drive mechanism) of a drug delivery device;

[0021] Figure 3B yes Figure 2 An exploded assembly view of a drug delivery device;

[0022] Figure 4A is a perspective view of an exemplary drug storage container for a drug delivery device according to various embodiments;

[0023] Figure 4B is a perspective view of an exemplary container holder for a drug delivery device according to various embodiments, wherein the container holder is in an open position;

[0024] Figure 4C yes Figure 4B The container holder in Figure 4A A perspective view of a drug storage container coupled to the container holder in FIG. 1 , wherein the container holder is in a closed position;

[0025] Figure 4D is a perspective view of an exemplary container holder for a drug delivery device according to various embodiments, wherein the container holder is in a closed position;

[0026] Figure 4E is a perspective view of an exemplary housing for a drug delivery device according to various embodiments;

[0027] Figure 4F It is around Figure 4C A partial cross-sectional view of the container holder and the drug storage container taken along line 4F-4F in FIG.

[0028] Figure 5A It is around Figure 4C A partial cross-sectional view of a container holder, a medicinal storage container, and a partial cross-sectional view of a distal portion of an exemplary plunger guide coupled to the container holder and the medicinal storage container, taken along line 5A-5A of FIG.

[0029] Figure 5B is a perspective view of an exemplary plunger guide according to various embodiments;

[0030] Figure 5C yes Figure 5B A perspective partial cross-sectional view of a plunger guide;

[0031] Fig. 6A is a perspective view of an exemplary guard member according to various embodiments;

[0032] Figure 6B is a perspective view of an exemplary guard extension according to various embodiments;

[0033] Figure 6C is a perspective, partial cross-sectional view of a guard extension, a release member, and a plunger guide, wherein these components are in a pre-injection position;

[0034] Fig. 7A is a perspective view of an exemplary release member according to various embodiments;

[0035] Figure 7B yes Fig. 7AAnother perspective view of the release member in FIG.

[0036] Figure 8 yes Figure 5B Plunger guide, Fig. 7A The release member, and Figure 2 A perspective view of the plunger 26 is shown, wherein the guide member is shown in transparent form for the purpose of illustration;

[0037] Fig. 9A is a perspective view of an exemplary plunger guide, an exemplary release member, and an exemplary plunger, wherein a portion of the guide member is shown in cutaway form for purposes of illustration, and wherein the drug delivery device is in a pre-injection position;

[0038] Fig. 9B yes Fig. 9A A perspective view of the components of , wherein the plunger is in a released position prior to axial travel of the plunger;

[0039] Fig. 9C yes Fig. 9A A perspective view of the components of , wherein the plunger is in a released position after the plunger begins axial travel;

[0040] Fig. 10A yes Fig. 9A A top view of the components in which the drug delivery device is in a pre-injection position;

[0041] Fig. 10B yes Fig. 9B A top view of the components in which the plunger is in a released position prior to axial travel of the plunger;

[0042] Fig. 10C yes Fig. 9C A top view of the components in which the plunger is in a released position after the plunger begins axial travel;

[0043] Fig.11A yes Fig. 9A and additional components (such as an exemplary guard extension), and wherein the drug delivery device is in a pre-injection position;

[0044] Fig. 11B yes Fig.11A a perspective view of the components in which the guard extension has been moved proximally but the plunger has not yet been released;

[0045] Fig. 11C yes Fig.11A a perspective view of the components in which the guard extension has been moved further proximally and the plunger has been released but has not yet advanced axially;

[0046] Fig. 12A yes Fig. 9Aa perspective view of the components and an exemplary guard biasing member in which the plunger is in a released position after the plunger begins axial travel, wherein some of these components are shown in cutaway form for purposes of illustration;

[0047] Fig. 12B yes Fig. 12A a perspective view of the components and a more detailed view of the device, wherein the plunger is at or near the end-of-dose release position, but the release member is not yet in the end-of-dose position, and wherein the guard extension member and the guard biasing member are removed for illustration purposes;

[0048] Fig. 12C yes Fig. 12A A perspective view of the components of , wherein the release member is in an end-of-dose position;

[0049] Fig.13 is a perspective view of an exemplary locking ring according to various embodiments;

[0050] Fig.14 is a perspective view of a distal portion of an exemplary device according to various embodiments when the guard member is in a pre-deflected state prior to injection, and wherein a portion of the housing is shown in cutaway form for purposes of illustration;

[0051] Fig.15A yes Fig.14 a perspective view of a distal portion of the device shown with the guard member in an initial deflection stage;

[0052] Fig. 15B is with Fig.15A The same device and phases as Fig.15A The stereograms shown are views that differ by approximately 90 degrees;

[0053] Fig.16A yes Fig.14 A perspective view of the distal portion of the device shown, wherein the guard member is further extended from Fig.15A The stage shown is deflected distally;

[0054] Fig. 16B is with Fig.16A The same device and phases as Fig.16A The stereograms shown are views that differ by approximately 90 degrees;

[0055] Fig.17 yes Fig.14 a perspective view of a distal portion of the device shown with the guard member in a fully deflected or nearly fully deflected position relative to the housing, such as during an injection phase;

[0056] Fig.18A yes Fig.14a perspective view of a distal portion of the device shown with the guard member in a fully retracted, locked position relative to the housing and the device in a post-injection stage;

[0057] Fig.18B yes Fig.14 a perspective view of a distal portion of the device shown with the guard member in an almost fully retracted locked position relative to the housing and the device in a post-injection stage;

[0058] Fig.19A is a graph showing an exemplary force profile during an injection process of an exemplary drug delivery device, wherein the relative displacement between the device housing and the guard member (in millimeters) is plotted along the x-axis and the resistance force (in Newtons) is plotted along the y-axis;

[0059] Fig.19B Similar to Fig.19A , is another exemplary force profile during an injection process of an exemplary drug delivery device;

[0060] FIG. 20A to FIG. 20G Another exemplary drug delivery device according to various embodiments is shown;

[0061] FIG. 21A to FIG. 21F Yet another exemplary drug delivery device according to various embodiments is shown;

[0062] Fig. 22 Shows FIG. 20A to FIG. 20G and FIG. 21A to FIG. 21F The protective member shown;

[0063] Fig.23 Shows FIG. 20A to FIG. 20G The lock ring shown;

[0064] Fig.24 Shows Fig.19A and Fig.19B The two force distribution curves and the force distribution curves of each device are shown respectively, namely FIG. 20A to FIG. 20G The device 400 shown causes a force distribution curve (shown as a dashed line) to be drawn by FIG. 21A to FIG. 21F Another force distribution curve caused by the device 500 shown (as shown by the dot-dash line);

[0065] Fig.25 shows a perspective view of an exemplary housing according to various embodiments; and

[0066] FIG. 26A to FIG. 26D Another exemplary drug delivery device according to various embodiments is depicted, wherein Fig.26A and Fig.26B Different perspective views showing the locking ring of a drug delivery device, Fig.26CA perspective view of a protective member of a drug delivery device is shown, and Fig.26D A cut-away view of a portion of a drug delivery device is shown. DETAILED DESCRIPTION

[0067] The present disclosure generally relates to a drug delivery device that can be operated by a user to deliver drugs, or delivers drugs by itself when the patient is a user. Various features for streamlining, simplifying, automating and / or promoting certain aspects of drug delivery are disclosed, such as those used in automatic injectors, on-body injectors or other automatic or partially automatic drug delivery devices (collectively referred to as automatic injectors or automatic injectors). For example, these features can include automatically covering the needle in the state before and / or after delivery, automatically inserting the needle and / or cannula into the user's body, automatically enabling the drive mechanism, automatically indicating to the user that drug delivery has been completed and other features. Although known drug delivery devices combine separate or independently operable mechanisms to realize each of their automated features, the present disclosure includes eliminating and / or combining at least some of these features, and / or providing device components that can obtain device design flexibility. For example, the device can include components that can obtain spring design flexibility and / or facilitate the use of springs with different physical properties with the remaining device components. As another example, the device can include components that reduce the number of parts, the complexity of parts, the gross weight of the device and / or the total complexity of the device. For example, the present disclosure may include a plunger that is movable toward a distal end of a drug storage container to expel a drug from the drug storage container through a delivery member, wherein the plunger includes a body portion having an inner wall defining an axial chamber, and an outer wall that cooperates with the inner wall to define a body thickness. The present disclosure may also include a plunger biasing member at least partially disposed within the axial chamber, wherein the plunger biasing member is configured to advance the plunger toward the distal end of the drug storage container.

[0068] Figures 1 to 3 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a medicament or drug. The drug may be, but is not limited to, various biological agents, such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, but the disclosure is not limited to a particular state.

[0069] Various embodiments and configurations of the drug delivery device 10 are possible. The current embodiment of the drug delivery device 10 is configured as a disposable injector for single use. In other embodiments, the drug delivery device 10 can be configured as a reusable injector for multiple uses. The drug delivery device 10 is operable to be self-administered by the patient or administered by a caregiver or a formally trained healthcare provider (e.g., a doctor or nurse). The exemplary drug delivery device shown in the drawings can take the form of an automatic injector or a pen-type injector, and can therefore be held in the user's hand for the duration of drug delivery, and can also or alternatively be adapted to other drug delivery devices and / or configurations.

[0070] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. For example, each state may have several sub-states or stages. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after being assembled and before being activated by the user. In some embodiments, the pre-delivery state may exist between the time when the drug delivery device 10 leaves the manufacturing facility and the time when the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the time after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 at the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 when drug delivery (also referred to herein as administration) is ongoing. The post-delivery state may correspond to the configuration of the drug delivery device 10 after the drug delivery is completed and / or when the stopper is arranged in the end position of administration in the drug storage container.

[0071] like Figure 1A and Figure 1B As shown, the drug delivery device 10 includes a housing or shell 12. In some embodiments, the size and dimensions of the shell 12 can be determined so that a person can hold the injector 10 in one hand. The shell 12 can have a generally elongated shape, such as a cylindrical shape, and extend along a longitudinal axis A between a proximal end and a distal end. The opening 14 ( Figure 3B ) may be formed in the distal end to permit delivery member 16 ( Figure 2 ) extends out of the housing 12. The transparent or translucent inspection window 17 ( Figure 1A to Figure 1B) can be positioned in the wall of housing 12 to permit a user to view the components (including drug storage container 20) inside drug delivery device 10. Viewing drug storage container 20 through window 17 can allow a user to confirm that drug delivery is ongoing and / or has been completed. Removable cover 19 can cover opening 14 prior to use of drug delivery device 10, and in some embodiments, can include grip 13 ( Figure 2 ), which is configured to assist in removing the sterile barrier 21 (e.g., a rigid needle cover (RNS) or a non-rigid needle cover (nRNS), etc.) mounted on the insertion end 28 of the delivery member 16. The grip 13 may include one or more inwardly projecting barbs or arms that mechanically engage the sterile barrier 21, frictionally or otherwise, when the user separates the removable cap 19 from the housing 12, thereby pulling the sterile barrier 21 together with the removable cap 19. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0072] like Figure 2 As shown, the drive mechanism 30 can be partially or completely arranged within the housing 12. Generally, the drive mechanism 30 can be configured to store energy and, when the user activates the drive mechanism 30 or in response to the user activating the drive mechanism, release or output the energy to drive the plunger 26, thereby expelling the drug 22 from the drug storage container 20, through the delivery member 16, and into the patient's body. In the current embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 can be configured differently, for example, wherein the drive mechanism 30 stores electrical potential energy or chemical potential energy. Generally, when the drive mechanism 30 is activated, the drive mechanism 30 can convert the potential energy into kinetic energy to move the plunger 26. As shown in FIG. Figure 3A As best shown in FIG. 4 , in one embodiment, the drive mechanism 30 includes a plunger biasing member 50, a hollow rod 46 for supporting the plunger biasing member 50, a plunger biasing member base 38, a release member 52, a plunger guide 60, an extension biasing member 35, and a guard extension 37. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) that is initially maintained in an energized state. In the energized state, the plunger biasing member 50 may be compressed so that its axial length is shorter than its length in its natural or unenergized state. When released, the plunger biasing member 50 may attempt to expand to its natural axial length and thereby apply a biasing force to push the plunger 26 in a distal direction.

[0073] like Figure 2 and Figure 3BAs best shown, in one embodiment, the device 10 includes a housing 12, which may include two separate and interconnected structures: a rear end cap 23 (e.g., a rear closure) at the proximal end of the drug delivery device 10; and a tubular housing 25 that extends substantially completely along the length of the drug delivery device 10 and defines the opening 14. In addition or alternatively, the housing 12 may include fewer or more components, such as a two-piece tubular housing having a front portion and a rear portion. The tubular housing 25 can have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 can have a generally hemispherical shape or a hollow cylindrical shape having an open end and a closed end. In some embodiments, the rear end cap 23, as well as the tubular housing 25 and any components to be positioned therein, can be assembled together to define different subassemblies, such as a drive mechanism 30 ( Figure 3A ). In some embodiments, the different subassemblies are assembled independently of each other and subsequently combined with each other and with the drug storage container 20 to form a fully assembled drug delivery device 10. In certain such embodiments, some or all of the above-mentioned assembly stages can be performed in different manufacturing facilities or environments. In alternative embodiments, the housing 12 can be constructed in one piece, so that the housing 12 is defined by a single integral structure that integrates the rear cover and the tubular housing into a single component.

[0074] The drug storage container 20 is arranged in the internal space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 can be pre-filled and transported by the manufacturer to a place where the drug storage container 20 is combined with the rest of the drug delivery device 10. For example, the drug 22 can be distributed and / or provided to the patient in more than one use scenario, such as as a pre-filled syringe or as an automatic injector including a pre-filled syringe. By using the same or similar syringe components in each scenario, some of the above steps can be streamlined or simplified for at least two different use scenarios, such as filling, labeling, packaging, transportation and distribution. As another example, in the case where some or all of these same syringe components are used in multiple use scenarios, some regulatory approaches to marketing and / or distributing drugs can be streamlined and / or simplified for at least one use scenario in these multiple use scenarios.

[0075] The housing 12 may be preloaded with a drug storage container 20, for example, by a manufacturer, or alternatively by a user before using the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal hole or reservoir. The wall may be made of glass or plastic. The stopper 24 may be movably arranged in the drug storage container 20 so that it can move in a distal direction between the proximal end and the distal end of the drug storage container 20 along the longitudinal axis A. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the inner surface 15 of the wall of the drug storage container 20 so that when the stopper 24 moves, the drug 22 will be prevented or inhibited from leaking through the stopper 24. The distal movement of the stopper 24 discharges the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 in a distal direction. In the present embodiment, the plunger 26 and the stopper 24 are initially spaced apart from each other by a gap 18 ( Figure 2 ). When the drive mechanism 30 is enabled, the plunger 26 moves in the distal direction to reduce the gap and contact the stopper 24. The subsequent distal movement of the plunger 26 drives the stopper 24 in the distal direction to discharge the drug 22 from the drug storage container 20. In alternative embodiments, the stopper 24 and the plunger 26 may initially contact each other or be coupled to each other, for example, via a threaded connection, so that they can move together starting with the movement of the plunger 26. Once the stopper 24 moves, it can continue to move in the distal direction until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may be referred to as an end-of-dose or end-of-delivery position, and may correspond to a completion or substantial completion of delivering the drug 22 to the patient.

[0076] In some embodiments, the volume of drug 22 contained in the reservoir of drug storage container 20 can be equal to 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 (e.g., ± 10%) 3 mL, or less than or equal to approximately (e.g., ± 10%) 1 mL, or less than or equal to approximately (e.g., ± 10%) 2 mL, or less than or equal to approximately (e.g., ± 10%) 3 mL, or less than or equal to approximately In some embodiments, the present invention relates to a method for producing a liquid having a concentration of at least about (e.g., ±10%) 4 mL, or less than about (e.g., ±10%) 5 mL, or less than or equal to about (e.g., ±10%) 10 mL, or in a range between about (e.g., ±10%) 1-10 mL, or in a range between about (e.g., ±10%) 1-5 mL, or in a range between about (e.g., ±10%) 1-4 mL, or in a range between about (e.g., ±10%) 1-3 mL, or in a range between about (e.g., ±10%) 1-2.5 mL.

[0077] The delivery member 16 is or is operable to be connected in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery member 16 can define an insertion end 28 of the delivery member 16. The insertion end 28 can include a sharp tip having other sharp geometric shapes to allow the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 can be hollow and have an internal passageway. One or more openings can be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 into the patient's body.

[0078] In one embodiment, the drug storage container 20 can be a pre-filled syringe and has a hollow metal stake needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and can be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle can be connected to the drug storage container 20 by a Luer lock or other suitable connection. In other embodiments, the drug storage container 20 can be a needle-free cartridge and, as such, may not initially be in fluid communication with the delivery member 16. In such embodiments, during operation of the drug delivery device 10, the drug storage container 20 can move toward the proximal end of the delivery member 16, or vice versa, so that the proximal end of the delivery member 16 penetrates the septum covering the opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0079] The drug storage container 20 may include a body portion 20g having a distal end 20e and a proximal end 20f. The drug storage container 20 may be fixed relative to the housing 12 such that the drug storage container 20 cannot move relative to the housing 12 after being installed in the housing 12. Thus, in the pre-delivery state, the delivery state, and the post-delivery state, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 in the housing 12. For example, Figure 2 As shown, the delivery member 16 extends beyond the distal end of the housing 12 defining the opening 14. However, in some configurations, such as Figure 2 In the storage configuration shown, the delivery member 16 is covered / protected by the sterile barrier 21 and a guard member 32 that surrounds the delivery member 16 and protects or reduces the possibility of an accidental or premature needle stick.

[0080] The container holder 31 may have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A, and the drug storage container 20 may be partially or completely arranged in the container holder 31. The distal end of the container holder 31 may include an inwardly protruding flange 33 that abuts against the shoulder portion 20a of the drug storage container 20, thereby preventing the drug storage container 20 from moving distally during actuation of the plunger 26.

[0081] In one embodiment, the container holder 31 stabilizes and / or fixes the position of the medicinal storage container 20 within the housing 12. For example, the container holder 31 can be configured to support the medicinal storage container 20 relative to the housing 12, near at least a portion of the distal end of the body portion of the medicinal storage container 20 (including, for example, near the entire distal end of the body portion of the medicinal storage container 20), so that the resultant force of the plunger biasing member 50 acting on the medicinal storage container 20 is at least substantially completely borne by the distal end of the body portion of the medicinal storage container 20.

[0082] As used herein, the term "body portion" of the medicinal storage container 20 is a generally cylindrical portion of the medicinal storage container 20. For example, Figure 4A The body portion 20g of the illustrated drug storage container 20 extends from the distal side of the flange 20c to the proximal side of the shoulder portion 20a. As a more specific example, Figure 4A The body portion 20g of the illustrated medicinal storage container 20 has a relatively constant inner diameter and / or a relatively constant outer diameter along its length. Figure 4A and Figure 2As shown, the drug storage container 20 defines a shoulder portion 20a near the distal end 20e of the body portion 20g. The delivery member 16 extends distally from the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the drug storage container 20 further includes a neck portion 20g, which is positioned distal to the shoulder portion 20a and is configured to support the delivery member 16, such as a stake needle.

[0083] The term "resultant force" refers to the force that pushes the drug storage container 20 along the axis A when and due to the actuation of the plunger biasing member 50 during and after the injection state. For example, when the plunger 26 is actuated and driven in the distal direction along the axis A, the plunger pushes the stopper 24 in the distal direction. Due to this set of direct contact between the plunger 26 and the stopper 24, as well as the friction between the stopper 24 and the drug storage container 20, and the force required to push the drug 22 through the relatively small diameter delivery member 16, the drug storage container 20 is still pushed in the distal direction even though the plunger 26 may not directly contact, abut or engage the body portion of the drug storage container 20. Thus, the drug storage container 20 may be subjected to a relatively high resultant force during the injection process, more specifically during the actuation of the plunger 26.

[0084] The concentrated force of the resultant force acting on the drug storage container 20 during plunger actuation is highest in the portion of the drug storage container 20 that resists distal movement. For example, in the device shown in the drawings, the concentrated force is highest near at least a portion of the distal end 20e of the body portion 20g of the drug storage container 20. As a more specific example, the concentrated force is highest at the shoulder portion 20a where the container holder 31 supports the drug storage container 20. As an even more specific example, the concentrated force is at least substantially completely borne by the shoulder portion 20a of the drug storage container 20. The term "substantially completely" may mean greater than 50%, may mean greater than 70%, may mean greater than 75%, may mean greater than 80%, may mean greater than 80%, may mean greater than 85%, may mean greater than 90%, may mean greater than 95%, may mean greater than 98%, or any other suitable value.

[0085] The concentrated force of the resultant force acting on the drug storage container 20 during plunger actuation is preferably not significantly borne by the outwardly protruding flange 20d of the drug storage container 20. For example, since the force is substantially entirely borne by the distal portion 20e of the body portion 20g of the drug storage container 20, the concentrated force in and near the outwardly protruding flange 20d is relatively low. As a more specific example, the percentage of the resultant force acting on the entire drug storage container 20 borne by the outwardly protruding flange 20d may be less than 20%, or may be less than 15%, or may be less than 10%, or may be less than 5%, or may be less than 3%, or may be less than 2%, or may be less than 1%, or may be about 0%.

[0086] like Figure 2 and Figure 4B As shown, the container holder 31 includes a plurality of flanges 33, each flange including an arcuate inclined surface 33a that substantially matches 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 into the container holder 31, the flanges 33 cooperate to support the shoulder portion 20a and limit the travel of the drug storage container 20 in the distal direction. The flanges 33 are spaced apart from each other by gaps 33b (FIG. 3b) to allow the flanges 33 to flex, as discussed in more detail below. FIG. 4A to FIG. 4C The container holder 31 shown includes four flanges 33, but any suitable number of flanges may be utilized, as described below with respect to Figure 4D Another exemplary design is shown for discussion.

[0087] The container holder 31 may have an open position 29a ( Figure 4B ) and closed position 29b ( Figure 4C ), in the open position, the container holder is capable of receiving the drug storage container 20 during assembly, and in the closed position, the container holder is capable of supporting or at least partially supporting the drug storage container 20. As a more specific example, the container holder 31 includes a pair of arms 31a, 31b, which extend axially from the annular ring 31c so that the arms 31a, 31b can be flexed away from or toward each other to move between the open position 29a and the closed position 29b. The annular ring 31c in the accompanying drawings is positioned near the distal end of the container holder 31 so that when the container holder 31 is in the open position 29a, the proximal portions of the arms 31a, 31b can extend away from each other. The container holder 31 further includes mating connectors 31d, 31e adjacent to the top (proximal) portion of the container holder 31, which are configured to snap fit with each other when the container holder is in the closed position 29b. As a more specific example, when the mating connectors 31d, 31e are engaged with one another, the friction fit between the respective components holds the container holder 31 in the closed position 29b.

[0088] The container holder 31 shown in the drawings also includes a pair of inwardly protruding flanges 31f, 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 protruding flanges 31f, 31g are spaced apart from each other so that the radially outwardly protruding flange 20b on the drug storage container 20 can be placed into the container holder 31 (via insertion in the distal direction). In other words, when the container holder 31 is in the open position 29a, the radially outwardly protruding flange 20b on the drug storage container 20 can pass through the gap between the inwardly protruding flanges 31f, 31g. Once the medicinal storage container 20 is fully inserted into the container holder 31 (e.g., such that the shoulder portion 20a of the medicinal storage container 20 contacts the inwardly protruding flange 33), the container holder arms 31a, 31b are able to move to the closed position 29b, in which the inwardly protruding flanges 31f, 31g prevent the medicinal storage container 20 from leaving the container holder 31 in the proximal direction. In other words, once the medicinal storage container 20 is inserted into the container holder 31 and the medicinal storage container 20 is in the closed position 29b, the medicinal storage container 20 is held in the container holder 31 by the inwardly protruding flange 33 near the distal end of the container holder 31 and the inwardly protruding flanges 31f, 31g near the proximal end of the container holder 31.

[0089] like Figure 4B and Figure 4C As shown, the container holder 31 includes relative surfaces 31i, 31h defining an opening 31j, which is used to receive the flange 20b of the drug storage container 20. For example, the container holder 31 shown in the drawings includes two distal-facing surfaces 31i and two proximal-facing surfaces 31h, which cooperate to define two openings 31j, each of which receives the opposite portion of the flange 20b. The relative surfaces 31i, 31h define a lower boundary and an upper boundary to position the flange 20b when the drug storage container 20 is positioned in the container holder 31 and in the closed position 29b. This range from the lower boundary to the upper boundary can provide flexibility for drug storage containers 20 of different lengths and / or for the length tolerance range of the drug storage container 20. However, as discussed in more detail below, additional components of the device 10 can further stabilize the drug storage container 20 adjacent to the flange 20b when the drug storage container 20 / container holder 31 is assembled inside the housing 12. The opening 31j can also prevent and / or limit rotational movement of the drug storage container 20. For example, the opposite rounded sections 20c of the flange 20b can each extend at least partially through the opening 31j, and the opposite linear sections 20d of the flange 20b can each abut the sidewall defining the opening 31j to prevent and / or limit rotational movement between the respective components 20, 31.

[0090] like Figure 4BAs shown, the container holder 31 may include additional mating connectors 31k, 31m, which are positioned distally of the mating connectors 31d, 31e. The corresponding mating mating connectors 31d, 31e; 31k, 31m can work together to create a snap fit between the corresponding arms 31a, 31b of the container holder 31 to secure it in the closed position 29b.

[0091] It may be desirable that the annular ring 31c is positioned substantially opposite (along axis A) to the mating connectors 31d, 31e to facilitate the opening and closing of the container holder arms 31a, 31b. For example, the distance between the annular ring 31c and the inwardly protruding flanges 31f, 31g may be proportional to the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 is in the open position 29a. Therefore, in order to maximize the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 is in the open position 29a, the distance between the annular ring 31c and the inwardly protruding flanges 31f, 31g (e.g., the effective length of the arms 31a, 31b) may be maximized. In addition, the thickness, height, and material properties of the annular ring 31c may each affect the deflection of the arms 31a, 31b and / or the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 is in the open position 29a. As discussed above, the gap 33b between these flanges can also promote and / or limit the amount of flexure of the arms 31a, 31b and / or the gap between the inwardly protruding flanges 31f, 31g when the container holder 31 moves to the open position 29a. For example, when the arms 31a, 31b flex outwardly, the flange 33 can move inwardly.

[0092] The container holder 31 shown in the drawings may include an alignment ridge 31n that abuts the inner 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 corresponding components 12, 31. As an example, the housing 12 may include a slot 12a formed on the inner surface of the housing to receive the alignment ridge 31n. The housing 12 may include a plurality of slots, and the container holder 31 may include a plurality of alignment ridges to radially align the corresponding components 12, 31. For example, the container holder 31 shown in the drawings includes two alignment ridges 31n, and the housing 12 includes two slots 12a. These slots 12a are spaced apart from each other and are sized to receive the corresponding alignment ridges 31n when the container holder 31 is inserted into the housing 12. The slot 12a shown in the drawings is defined by a generally annular collar 12d portion that is integrated with the housing 12 (but the collar portion may alternatively be one or more components coupled or fastened to the housing). The annular collar 12d may not extend around the entire inner surface of the housing 12, and instead have a cutout or void to permit a portion of the guard member 32 to extend between respective portions of the annular collar 12d. Alternatively, the annular collar 12d may be radially inwardly spaced from the inner surface of the housing 12 at least at one or more locations to facilitate extension of a portion of the guard member beyond the collar 12d.

[0093] The annular collar 12 d may further define inclined surfaces 12 e on opposite sides of each locking slot 12 c to further assist in alignment between the container holder 31 and the housing 12 .

[0094] Figure 4A , Figure 4B ,and Figure 4C The illustrated feature includes an alignment ridge 31n positioned distal to the support ridge 31o. For example, the height of the support ridge 31o (measured perpendicular to the outer surface of the container holder 31) is less than the height of the alignment ridge 31n, so that only the alignment ridge 31n is received within the alignment slot 12a, rather than the support ridge 31o. Alternatively, the alignment ridge may extend substantially or entirely along the axial length of the container holder 31, as described below with respect to Figure 4D Another exemplary design is shown for discussion.

[0095] The drug storage container 20 may be further or more securely coupled to the container holder 31 (and thus to the housing 12) to prevent the drug storage container 20 and the container holder 31 from moving relative to the housing 12 during operation of the drug delivery device 10. For example, Figure 4B and Figure 4C As shown, the container holder 31 may include a plurality of locking ridges 33c on the flange 33 that form a friction fit with the portion(s) of the housing 12. As a more specific example and as shown in Figure 2 and Figure 3B As shown, housing 12 includes a plurality of locking slots 12c, each of which receives a corresponding locking ridge 33c of a container holder 31 to prevent and / or limit relative motion between corresponding components 12, 31. As a more specific example, these locking ridges 33c each extend radially from the outer surface of flange 33. Container holder 31 can include any suitable number of locking ridges 33c, such as one, two, three, four or more. The locking slots 12c shown in the drawings are limited by annular collars 12d, but they can alternatively be limited by another component. These locking slots 12c are spaced apart from each other and their size is determined to receive corresponding locking ridges 33c when a medicine storage container is positioned in container holder 31. As a more specific example, these locking ridges 33c and locking slots 12c snaps form friction fit, so that container holder 31 and therefore medicine container 20 are firmly secured in housing 12. As an even more specific example, when the locking ridge 33 c snaps into the locking slot 12 c , the flange 33 may be slightly compressed inwardly to form a more secure fit between the container holder 31 and the drug container 20 .

[0096] The inner surface of the container holder 31 may include a compressible member, such as an elastomeric member positioned between the inner surface of the container holder 31 and the drug container 20. As a more specific example, the elastomeric member may be a rubber ring. Alternatively or additionally, the natural deflection of the flange 33 may be used as the compressible member.

[0097] When the locking ridge 33c snaps into the corresponding locking slot 12c, the locking ridge can provide audible and / or tactile feedback to the user or assembler, thereby indicating to the assembler(s) that the corresponding components 12, 31 have been positioned as desired. In addition, the size and position of the corresponding components can be determined so that feedback only occurs when the drug container 20 is also positioned as desired. For example, if the drug container 20 is positioned too far in the distal direction relative to the container holder 31, so that the body of the drug container 20 is aligned with the flange 33 instead of the shoulder portion 20a being aligned with the flange 33, the locking ridge 33c may not be radially compressed enough to fit the locking ridge 33c within the locking slot 12c. Conversely, if the drug container 20 is not inserted far enough in the distal direction relative to the container holder 31, so that the sterile barrier 21 is aligned with the flange 33 instead of the shoulder portion 20a being aligned with the flange 33, the locking ridge 33c can be compressed radially inward to a certain extent so that the locking ridge 33c can slide radially inside the locking slot 12c, or the locking ridge 33c enters the locking slot 12c but may not generate enough radially outward force to generate audible and / or tactile feedback. Although audible and / or tactile feedback may be advantageous during manual assembly of the container holder 31, the assembly of the container holder 31 does not need to be performed manually and can be performed partially or completely by manufacturing equipment in some embodiments.

[0098] The housing 12, the container holder 31, and their respective components as described above provide many advantages. For example, by firmly coupling the medicine container 20 to the housing 12 via the shoulder portion 20a (opposite to the flange portion), the device 10 can reduce the incidence of glass breakage or other damage. As a more specific example, medicine containers (such as syringes) typically have a shoulder portion that is stronger and / or able to withstand higher forces than the flange portion. In other words, it may be advantageous that, since the shoulder may be stronger and more resistant to breakage than the flange, the concentrated force on the medicine container is higher at the shoulder than at the flange.

[0099] As another potential advantage of this configuration, by securely coupling the drug container 20 to the housing 12 via the distal portion (e.g., the shoulder portion 20a), the device 10 can have a more predictable, repeatable, and / or consistent injection depth than designs that secure the drug container 20 via a flange (e.g., a "hanging" design). For example, because the barrel length of the drug container 20 can vary more widely than the shoulder barrel length, the distance between the shoulder portion 20a and the delivery member 16 of the syringe is typically more predictable and / or has a smaller manufacturing tolerance than the distance between the flange 20b and the delivery member 16. Additionally or alternatively, the distance between the flange 20b and the delivery member 16 includes any tolerance / variation of the distance between the shoulder portion 20a and the delivery member 16, so any tolerance / variation is "stacked up."

[0100] like Figure 4C As shown, when the drug storage container 20 is inserted into the container holder 31 and the drug storage container 20 is in the closed position 29b, a portion of the drug storage container 20 extends beyond the distal end of the container holder 31. For example, the sterile barrier 21 is significantly or completely positioned outside the container holder 31 to facilitate removal of the sterile barrier 21 during use of the device 10, such as Figure 4C and Figure 4F As shown and discussed in more detail below. In addition, the delivery member 16 extends beyond the distal end of the container holder 31 (as discussed above).

[0101] Figure 4D Another exemplary container holder 131 is shown, which has some features that are functionally similar to those included in the container holder 31, each of which is assigned the same reference numerals, but increased by 100. For example, the container holder 131 includes a pair of arms 131a, 131b; an annular ring 131c connecting these arms 131a, 131b; corresponding sets of mating connectors 131d, 131e, 131k, 131m for selectively fixing these arms in a closed position 129b; a pair of inwardly protruding flanges 131f, 131g; a pair of opposing surfaces 131h, 131i to define the lower and upper limits of the travel of the flange of the drug storage container; and an opening 131j for receiving the flange of the drug storage container. The container holder 131 also includes a plurality of flanges 133, which are located at the distal end of the container holder 131 and are configured to support the drug storage container. For example, the container holder 131 includes two flanges 133, each flange including an arcuate inclined surface 133a that substantially matches the arcuate shape of the shoulder portion of the drug storage container. FIG. 4A to FIG. 4C Compared to the four flanges 33 shown in the container holder 31 shown, Figure 4D The container holder 131 shown has two flanges 133; therefore, each of these flanges 133 preferably has a larger circumference than the flange 33. The container holder 131 also includes an alignment ridge 131n, which is received in an alignment slot 12a formed in the inner surface of the housing 12 to properly align the container holder 131 in the housing 12 during assembly and prevent and / or limit rotational movement between the respective components 12, 131. Compared with the alignment ridge 31n, Figure 4D The illustrated alignment ridge 131 n extends substantially completely along the axial length of the container holder 131 .

[0102] and FIG. 4B to FIG. 4CLike the container holder 31 shown, the container holder 131 may include a plurality of locking ridges 133c on the flange 133 that form a friction fit with the portion(s) of the housing 12. As a more specific example and as shown in FIG. Figure 4D and Figure 4E As shown, the housing 12 includes a plurality of locking slots 12c, each of which receives a corresponding flange 133c of the container holder 131 to prevent and / or limit relative movement between the corresponding components 12, 131. When the locking ridges 133c snap into the corresponding locking slots 12c, the locking ridges can also provide audible and / or tactile feedback to the user or assembler, thereby indicating to the assembler (multiple) that the corresponding components 12, 131 have been positioned as desired. In addition, the container holder 131 can provide the same or similar advantages described above with respect to the container holder 31.

[0103] In yet another exemplary design, the container holder may have a fixed state, rather than having arms that open and close. As a more specific example, the container holder may have a proximal opening that is sized to be sufficient to permit receipt of a syringe. The container holder may still have a distally positioned flange for receiving and securing a shoulder portion of the syringe, particularly when the container holder is coupled to the injector housing.

[0104] Figure 4F and Figure 5A The distal side of the drug container 20 is shown ( Figure 4F ) part and proximal ( Figure 5A ) part) and its interaction with various other components of the device 10. For example, Figure 4F A partial cross-sectional view of a distal portion of a drug container 20 positioned within a container holder 31 is shown, wherein the shoulder portion 20a is supported by the flange 33. As another example, Figure 5A A cross-sectional view of a proximal portion of a drug container 20 is shown positioned within the container holder 31 such that the drug container flange 20b is positioned between the opposing surfaces 31h, 31i and within the opening 31j. Figure 5A The illustrated drug container 20 is further supported by a plunger guide 60, such as a flexible arm 60a of the plunger guide 60. As a more specific example, the flexible arm 60a extends generally distally and slightly radially inwardly from a distal portion of the plunger guide 60b. As an even more specific example, Figure 5A The illustrated plunger guide 60 includes a distal surface 60b that abuts the inwardly projecting flanges 31f, 31g of the container holder 31; a flexible arm 60a extends from the distal surface 60b between the inwardly projecting flanges 31f, 31g.

[0105] The flexible arm 60a can have a size, shape, and material type that promotes and / or permits the flexible arm 60a to flex. As a more specific example, the flexible arm 60a is preferably flexible in a radial direction so that when the drug container 20 and the plunger guide 60 are inserted into the housing, the flexible arm 60a is aligned with the flange 20b and applies at least a mild radial force (radially inward) to the drug container 20. In this configuration, the drug container 20 is primarily supported by the container holder 31 at its distal portion (e.g., the shoulder portion 20a), and is also at least secondarily supported by the plunger guide 60 at its proximal portion (e.g., the flange portion 20b). As a more specific example, the flexible arm 60a can provide radial support for the flange portion 20b and prevent and / or resist lateral movement of the drug container 20 relative to the housing 12. Such a configuration can reduce or eliminate rattles of the device 10, and / or can facilitate proper alignment of the drug container 20 during assembly. As another more specific example, flexible arms 60a can provide axial support (e.g., in a distal direction) to prevent undesired axial movement of drug container 20 relative to housing 12. Device 10 can have any suitable number of flexible arms 60a, such as one, two, three, four, or more.

[0106] The container holder 31 may also include at least one support flange 31r having a size, shape and material type that promotes and / or permits its flexure. As a more specific example, the support flange 31r is preferably flexible in the radial direction so that when the medicine container 20 and the container holder 31 are inserted into the housing, the support flange 31r is aligned with the body portion 20g of the medicine container and applies at least a mild radial force (radially inward) to the medicine container 20. In this configuration, the medicine container 20 is mainly supported by the container holder 31 at its distal portion (e.g., the shoulder portion 20a), and is also supported by the container holder 31 at least secondarily in the center or proximal region of the body portion 20g. As a more specific example, the support flange 31r can provide radial support to the medicine container 20 and prevent and / or resist lateral movement of the medicine container 20 relative to the housing 12. Such a configuration can reduce or eliminate the rattle of the device 10 and / or can contribute to the proper alignment of the medicine container 20 during assembly. As another more specific example, the support flange 31r can, but need not necessarily, provide axial support (e.g., in the distal direction) to prevent undesired axial movement of the drug container 20 relative to the housing 12. The device 10 can have any suitable number of support flanges 31r, such as one, two, three, four or more. The container holder 31 shown in the drawings includes four support flanges 31r, which are equally spaced around the circumference of the container holder.

[0107] Although the flexible arms 60a and / or the support flanges 31r are shown in the figures as providing at least some support to the medicinal storage container 20, the container holder substantially completely supports the medicinal storage container 20 relative to the housing 12 through the distal end of the body portion 20g of the medicinal storage container 20, as discussed above. As a more specific example, the flexible arms 60a and / or the support flanges 31r may provide little or no support along the longitudinal axis A, and only provide support in a direction transverse to the axis A. As an even more specific example, the container holder 31 substantially completely supports the medicinal storage container 20 relative to the housing 12 through the distal end of the body portion 20g of the medicinal storage container 20 to resist forces along the axis A, such as those experienced during the injection process.

[0108] As mentioned above, Figure 5A The plunger guide 60 shown includes a distal surface 60b that abuts the inwardly protruding flanges 31f, 31g of the container holder 31. This configuration can help reduce or prevent radial movement of the container holder 31 within the housing 12. For example, Figure 5A As shown, the container holder includes an annular wall 31p that cooperates with the inwardly projecting flanges 31f, 31g to define an annular seat for the distal surface 60b of the plunger guide 60. The annular wall 31p can center the plunger guide 60 relative to the container holder 31 and the drug container 20 so that the plunger 26 is also aligned with these components 31, 20. The annular wall 31p can also reduce or prevent radial movement of the plunger guide 60 relative to the housing 12. This configuration can also help reduce or prevent axial movement of the container holder 31 within the housing 12. For example, as Figure 2 As shown, the plunger guide 60 extends from the rear end cover 23 to the midpoint of the device 10, at which point the plunger guide abuts the container holder 31. Therefore, the container holder 31 is restricted by the plunger guide 60 to move toward Figure 2 In addition, if the distal surface 60b does not abut the inwardly protruding flanges 31f, 31g, for example, the rear end cap 23 may not be installed unless the plunger guide 60 is properly aligned axially and radially with the container holder 31.

[0109] like Figure 5B and Figure 5CAs shown, the plunger guide 60 can have a hollow and generally cylindrical or tubular shape and can be centered on the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger guide 60 can be greater than the outer diameter or other outer dimension of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 can be positioned radially between the plunger 26 and the release member 52. In this way, the plunger 26 can be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 can be at least partially disposed within the release member 52, as shown in FIG. Figure 2 Additional features and functions of the plunger guide 60 are discussed below.

[0110] like Figure 2 As shown, the plunger guide 60 can be fixedly coupled to the housing such that the plunger guide 60 is substantially and / or generally immovable relative to the housing 12. For example, Figure 1C and Figure 5B As shown, the plunger guide includes a locking tab 60f that is sized and shaped to be received and aligned within a locking keyway 12f formed in the housing 12. As a more specific example, the plunger guide 60 and the housing 12 each include a pair of corresponding components 60f, 12f that cooperate to prevent relative rotation between the plunger guide 60 and the housing 12. Additionally or alternatively, an annular ridge 60g formed on the outer surface of the plunger guide 60 can form a friction fit with the inner surface of the housing to resist or prevent rotation between the corresponding components 12, 60.

[0111] Plunger 26 (such as Figure 2 , Figure 3AThe plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an interior space sized to receive the plunger biasing member 50 therein. It is generally desirable to minimize the thickness of the annular wall 39 to the extent possible and without compromising the integrity of the plunger 26 to maximize the inner diameter of the plunger 26. This allows a larger diameter plunger biasing member 50 to fit within the interior space of the plunger 26, which in turn allows a more powerful plunger biasing member 50 to be achieved. As a more specific example, the thickness of the annular wall 39 may be less than 2 mm. As another more specific example, the thickness of the annular wall may be less than 1 mm. As another more specific example, the thickness of the annular wall may be less than 0.6 mm. As another more specific example, the thickness of the annular wall may be less than 0.3 mm. As another more specific example, the thickness of the annular wall may be less than 0.2 mm. As another more specific example, the thickness of the annular wall may be less than 0.1 mm. As another more specific example, the thickness of the annular wall can be less than 0.05 mm. The annular wall 39 can be made of any suitable material, such as metal or plastic. It may be advantageous for the annular wall 39 to be made of metal, such as steel or aluminum, to minimize the thickness of the annular wall 39. For example, if the thickness of the annular wall 39 is greater than 0.05 mm, the metal annular wall 39 may have sufficient axial strength and / or resistance to buckling to be used in the device. Conversely, if the thickness of the annular wall 39 is greater than 1 mm, the plastic annular wall 39 may have sufficient axial strength and / or resistance to buckling to be used in the device.

[0112] In addition or alternatively, the hollow rod 46 can promote and / or provide more flexibility in spring design. For example, it may be desirable or advantageous to use the device with different springs according to the characteristics of the drug and / or the desired drug delivery curve. For example, a drug with a higher viscosity may require a spring with a higher spring stiffness and / or spring force, and therefore it may be desirable or advantageous to have flexibility in the physical properties of the spring. As a more specific example, the following various physical properties of the spring may affect the spring stiffness and therefore affect the spring force, such as the wire diameter of the spring (typically increasing the wire diameter will increase the spring stiffness), the average diameter of the spring (typically increasing the average diameter will reduce the spring stiffness), the number of spring coils (typically increasing the number of coils will increase the spring stiffness) and the spring material. These physical properties can be adjusted to provide different spring stiffnesses, and the thickness of the hollow rod 46 may also be adjusted to maintain the outer diameter of the entire plunger 26 constant or relatively constant, so that the rest of the device (such as the plunger guide 60 and the stopper 24) remains constant. Additionally or alternatively, the hollow stem 46 may promote and / or provide more longitudinal stability of the plunger biasing member 50 , such as by preventing or reducing buckling or other lateral movement.

[0113] The plunger biasing member 50 shown in the drawings may include the following dimensions: 0.65 mm wire diameter, 5.40 mm spring outer diameter, and 80 to 86 turns (depending on the pitch), but other suitable spring characteristics may be utilized. The plunger biasing member 50 shown in the drawings may be formed of stainless steel with a strength of 2300 n / mm, but other suitable materials may be utilized. The hollow rod 46 shown in the drawings may include the following dimensions and materials: 63 mm length, 6 mm outer diameter, 0.20 mm wall thickness; and stainless steel with a strength of 600 to 750 n / mm, but other suitable dimensions and materials may be utilized.

[0114] As described in greater detail below, the plunger 26 may be configured to selectively rotate relative to the housing 12 and linearly translate relative to the housing 12 during operation of the drug delivery device 10 .

[0115] The plunger 26 may be constructed of multiple interconnected pieces, or alternatively have a one-piece construction. In the current embodiment, the plunger 26 is constructed of three separate and interconnected structures: a top ring 45 that defines the proximal end of the plunger 26; a base 47 that defines the distal end of the plunger 26; and a hollow rod 46 that is located between the top ring 45 and the base 47 and rigidly connects the two. The positions of the top ring 45, the hollow rod 46, and the base 47 can be fixed relative to each other so that these components can be immovable relative to each other. The top ring 45, the hollow rod 46, and the base 47 each have an annular configuration and can be centered on the longitudinal axis A. The top ring 45 and the hollow rod 46 can each have a corresponding central opening extending from one end of the component to the other end to define an axial chamber; while the base 47 can have a central opening that extends through the proximal end of the base 47, but is closed at the distal end of the base 47. The closed end of the base 47 can define a seat or abutment surface for the plunger biasing member 50. In an alternative embodiment, the central opening can extend from one end to the other through the base 47. In such an alternative embodiment, the inner diameter of the central opening of the base 47 can be smaller than the outer diameter of the plunger biasing member 50, so that the base 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is actuated, the base 47 can be the portion of the plunger 46 that contacts the stopper 24 to push the stopper 24 in the distal direction.

[0116] The top ring 45 may include one or more flanges or protrusions 48 extending radially outward from a central portion of the top ring 45. Each of these protrusions 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 mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distally facing cam surface 49 may be arranged at an angle to, or non-parallel to, an imaginary plane perpendicular to the longitudinal axis A.

[0117] In some embodiments, the top ring 45 and / or the base 47 may be constructed of a material different from the hollow rod 46. In some embodiments, the top ring 45 and / or the base 47 are constructed of plastic, while the hollow rod 46 may be constructed of metal. This configuration allows the plastic material used for the top ring 45 to facilitate the camming action described below by providing a relatively low coefficient of friction, and the plastic material used for the base 47 can help absorb or attenuate any shock or vibration associated with the base 47 hitting the plug 24. The metal material used for the hollow rod 46 can provide sufficient rigidity to avoid buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, the hollow rod 46, and / or the base 47 can be made of the same material (including, for example, metal or plastic). In some such embodiments, the top ring 45, the hollow rod 46, and the base 47 can be integrally formed in one piece to define a single, integral structure.

[0118] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used to implement an injection. The guard mechanism may include a guard member 32 that is movably arranged at or near the distal end of the housing 12, adjacent to the opening 14. The guard member 32 may have a hollow and generally tubular or cylindrical portion 32a centered on the longitudinal axis A, and may have a pair of arms 32b extending proximally from the cylindrical portion 32a. The guard member 32 further includes a distal end 32c and a proximal end 32d, the distal end generally including the cylindrical portion 32a, and the proximal end may be defined by the arms 32b. These arms 32b may be significantly or completely received in the housing 12, so that no portion thereof extends from the housing 12. The cylindrical portion 32a may be at least partially and / or selectively received in the housing 12. For example, the guard member 32 can be configured to move relative to the housing 12 such that a portion of the guard member 32 is received within the housing 12 in some stages / states and extends from the housing 12 in other stages / states, as discussed in more detail below.

[0119] As Figure 2 , Figure 4E6, the arms 32b of the guide member 32 are radially spaced apart from each other along the circumference 32g of the guard 32, so that the arms 32b can slide between the protruding sections of the annular collar 12d formed on the inner surface of the housing 12. For example, the arc length between the corresponding edges of the arms 32b is at least slightly greater than the arc length of the protruding section of the annular collar 12d, so that the arms can slide axially between the protruding sections of the annular collar 12d without contacting the collar.

[0120] As described above, the guard member 32 can be configured to move between an extended position and a retracted position relative to the housing 12, in which at least a portion of the cylindrical portion 32a of the guard member 32 extends through the opening 14 in the housing 12, and in the retracted position, a shorter length of the cylindrical portion 32a extends through the opening 14 in the housing 12 or no portion of the cylindrical portion 32a extends through the opening in the housing. 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, where the value of X is greater than Y. The length X can be any suitable value, such as 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, 1 mm, or another value. The length Y can be any suitable value less than X, such as 3 mm, 2 mm, 1 mm, 0.5 mm, 0 mm, or another value. Figure 1C and Figure 1D Shown: Exemplary pre-injection configuration ( Figure 1C ), wherein the protective member 32 is in the extended position 32e, and the length of the exposed portion X of the protective member 32 can be approximately 5mm to 11mm; and the injection configuration ( Figure 1D ), wherein the protective member 32 is in the retracted position 32f, and the length of the exposed portion Y of the protective member 32 is approximately 0 mm to 2 mm (so that the distal end 32c of the protective member 32 is flush with the opening 14 of the housing 12). In one embodiment, the distance Y is greater than 0 (e.g., 1 mm) to help ensure that the device 10 can be activated before the protective member is flush with the housing 12.

[0121] The guard member 32 can also be configured to move in the opposite direction, i.e., from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 can translate linearly in the proximal direction; and when moving from the retracted position to the extended position, the guard member 32 can translate linearly in the distal direction. At least in the extended position, the guard member 32 can extend beyond the insertion end 28 of the delivery member 16 and surround the insertion end. As another example, Figure 1C and Figure 2 Shown in the extended position (and Figure 2As discussed above, moving the guard member 32 from the extended position to the retracted position (e.g., by pressing the distal end of the guard member 32 against the injection site of the patient's skin) can allow the insertion end 28 of the delivery member 16 to be inserted into the patient's skin.

[0122] During the injection process, the guard member 32 can remain stationary relative to the user's skin 5, while the housing 12 and several components disposed therein move relative to the guard member 32 and the skin 5. However, the present disclosure is directed to moving, retracting, translating, and depressing the guard member 32. These references and descriptions can be considered to refer to the relative movement between the guard member 32 and the housing 12, regardless of which component (the guard member 32 or the housing 12) moves relative to the user's skin 5.

[0123] The delivery device 10 can utilize an inertial drive design rather than a spring drive design to insert the needle into the patient's subcutaneous tissue. As a more specific example, when the patient presses the distal end of the protective member 32 against the injection site of the patient's skin, the housing 12 of the delivery device 10 can be advanced toward the injection site. When the patient presses down a predetermined distance or presses down with a predetermined force, the delivery device 10 achieves a quick release to utilize the energy stored in the patient's muscles while compressing the needle guard and its spring to a defined release point. The release mechanism is designed so that the needle insertion speed obtained exceeds the patient's reaction speed, and the combination of this speed and the mass of the device allows the needle to quickly and completely penetrate the skin to a subcutaneous depth. Compared to known injectors in which the entire main container moves forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing and therefore can provide a simplified, more robust design.

[0124] In alternative embodiments, the drug storage container 20 may be movably coupled to the housing 12 such that the drug storage container 20 can move relative to the housing 12 during operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may be retracted into the opening 14 in the housing 12 in the pre-delivery state. Subsequently, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be deployed through the opening 14 in the housing 12 for insertion into the patient. In some embodiments, this movement may be the result of the drug storage container 20 having been driven in a distal direction relative to the housing 12.

[0125] In some embodiments, the guard member 32 may be rotationally fixed or rotationally limited relative to the housing 12. Thus, while the guard member 32 may be able to translate linearly relative to the housing 12, the guard member 32 may be significantly or completely prevented from rotating relative to the housing 12. As a more specific example, the cylindrical portion 32a of the guard member 32 may include a protrusion extending therefrom, such as a ridge 32h, which aligns with a corresponding feature on the inner surface of the housing 12. For example, the inner surface of the housing adjacent to the distal end of the housing 12 may include a slot, a pair of adjacent ridges, or another component or set of components that cooperate with the ridge 32h to significantly or completely prevent rotation of the guard member 32. This arrangement may also help align the respective components 32, 12 with each other during assembly.

[0126] The device 10 may further include an extension biasing member 35 and a shield extension 37. The shield extension 37 may be positioned proximal to the shield member 32; and the extension biasing member 35 shown in the drawings is positioned proximal to the shield extension 37. The shield extension 37 may have a hollow and generally cylindrical or tubular shape centered on the longitudinal axis A. As a more specific example, the shield extension 37 may include a generally cylindrical body 37a. The shield extension 37 may also include an arm 37b for receiving, supporting, and / or retaining a distal portion of the extension biasing member 35. In addition, the shield extension 37 may be movable relative to the housing 12 in a linear direction along the longitudinal axis A. In the current embodiment, the shield extension 37 is a structure separate from the shield member 32. However, in an alternative embodiment, the shield extension 37 and the shield member 32 may be integrally formed in one piece to define a single integral structure. In such an alternative embodiment, the proximal end of the shield member 32 may correspond to the shield extension 37.

[0127] Similar to the guard member 32, the guard extension 37 can be rotationally fixed relative to the housing 12. Thus, while the guard extension 37 may be able to translate linearly relative to the housing 12, the guard extension 37 may be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, the guard extension 37 can cooperate with the plunger guide 60 to limit or prevent rotation between the respective components 37, 60. Therefore, and because the plunger guide 60 is fixedly connected to the housing 12, the guard extension 37 can be rotationally fixed relative to the housing 12 by the plunger guide 60. For example, the plunger guide 60 can include a longitudinal ridge 60c near the distal portion of the plunger guide 60. The ridge can be received within a longitudinal channel on the inner surface of the guard extension 37, and / or within a pair or corresponding features that cooperate to receive the ridge 60c. In an alternative embodiment, the ridge and slot arrangement can be reversed so that the guard extension 37 has one or more radially inwardly extending ridges and the plunger guide has one or more slots or other recesses to matingly or snugly receive the one or more ridges. As yet another alternative, the guard extension 37 can include an anti-rotation feature that mates with a corresponding feature on the inner surface of the housing 12.

[0128] The guard extension 37 and / or the release member 52 may have an axial travel limit to limit the distance they can travel in the distal direction. Figure 6C As shown, the plunger guide 60 may include an axial ridge 60c formed on an outer surface of the plunger guide 60 and positioned adjacent to the distal portion. The distal-facing surface 52j of the release member 52 may abut the proximal-facing surface 60d defined by the axial ridge 60c, thereby defining the farthest travel point of the release member 52. The release member 52 may also include a locking flange 52a, which in turn limits the distal travel of the guard extension 37. For example, the locking ridge 52a may abut the annular collar 37d of the guard extension 37 to define the farthest travel point of the guard extension 37. The axial ridge 60c and the locking ridge 52a shown in the figures do not necessarily limit the travel of the release member 52 and the guard extension 37 in the proximal direction, but only limit the travel in the distal direction.

[0129] like Figure 2 As best shown, the extension biasing member 35 is positioned between and in contact with the guard extension 37 and the release member 52. The extension biasing member 35 can be configured to bias or urge the guard extension 37 in a distal direction and / or bias or urge the release member 52 in a proximal direction. Figure 2 In the device 10 shown in the pre-delivery or storage state, the extension biasing member 35 is initially in an energized state (e.g., compressed). In other words, when the device 10 is in the pre-delivery state, Figure 2 As shown, the extension biasing member 35 applies a distally directed (downward) biasing force to the guard extension 37 and a proximally directed (upward) biasing force to the release member 52 .

[0130] During operation of the device, the user can translate the guard member 32 (relative to the housing 12) in a proximal direction by pressing the guard member 32 against the injection site. In doing so, the guard member 32 moves toward the guard extension 37 and reduces the gap 37g therebetween ( Figure 2 ). Once the gap 37g is eliminated, the guard member 32 and the guard extension 37 move together in the proximal direction until, for example, the guard member 32 reaches the retracted position 32f. When the injection is completed and the drug delivery device 10 is lifted away from the injection site, the extension biasing member 35 can advance the guard extension 37 so that the guard extension 37 and the guard member 32 move together in the distal direction. This movement (and / or the biasing force from the locking ring biasing member 51) returns the guard member 32 to the extended position 32e, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the extension biasing member 35 may include a compression spring (e.g., a helical compression spring). In addition, in embodiments where the plunger biasing member 50 also includes a compression spring, the extension biasing member 35 can be arranged around the plunger biasing member 50 and / or have a larger diameter than the plunger biasing member.

[0131] However, in some alternative embodiments, when the device is in the pre-delivery state, the extension biasing member 35 can be in a non-energized (natural) state. In these embodiments, the biasing member 35 can be compressed or energized when the guard member 32 is deflected in the proximal direction.

[0132] After drug delivery is complete and the guard member 32 has been redeployed to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent a user from subsequently accessing the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. In accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 that is configured to selectively rotate depending on the axial position of the guard member 32 to lock the guard member 32 in the extended position once the guard member 32 has moved from the retracted position to the extended position, as discussed in more detail below.

[0133] As discussed above, the plunger biasing member 50 can be at least partially disposed within the plunger 26 and can have a distal end that abuts the proximally facing inner surface of the plunger 26 and / or can be fixedly attached to the inner surface of the plunger 26. Such that the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 can be equal to or less than the inner diameter of the top ring 45 and / or equal to or less than the inner diameter of the hollow shaft 46. In some embodiments, the distal end of the plunger biasing member 50 can abut the proximally facing inner surface of the base 47 of the plunger 26. In addition, as Figure 2 and Figure 3A As best shown, the proximal end 50a of the plunger biasing member 50 can abut the distally facing surface 38a of the plunger biasing member base 38. The plunger biasing member base 38 can be fixedly attached to the rear housing 27 such that the plunger biasing member base 38 provides a stationary surface for pushing the plunger biasing member 50 away. Figure 3A and Figure 5B As shown, the plunger base 38 may include flanges 38b that are received within openings 60h formed in the proximal portion of the plunger guide, thereby fixedly coupling the plunger base to the plunger guide 60. This configuration allows the plunger biasing member 50 to expand in length when released from an energized state by the distal end of the plunger biasing member 50 moving in a distal direction away from the stationary proximal end of the plunger biasing member 50. This movement can push the plunger 26 in a distal direction, which in turn can push the stopper 24 in a distal direction to expel the drug 22 from the drug storage container 20 to the delivery member 16 and then into the patient's body. However, in the embodiment shown in the drawings, the release of the plunger biasing member 50 or any other biasing member cannot drive the delivery member 16 downward relative to the housing 12. Instead, the drug container 20, and therefore the delivery member 16, is substantially or completely fixedly coupled relative to the housing 12. And, the delivery member 16 is driven into the patient's skin 5 by the inertial force created by the downward force of the patient (or medical care provider or other person administering the dose).

[0134] refer to Fig. 7A and Figure 7B , the release member 52 may have a hollow and generally cylindrical or tubular shape and may be centered on the longitudinal axis A. Figure 2 As shown, the release member 52 can be positioned radially between the plunger guide 60 and the guard extension 37. Figure 2As shown, the release member 52 is also radially positioned between the guard extension 37 and the plunger guide 60. In addition, the extension biasing member 35 can be axially positioned between the release member 52 and the guard extension 37 and can be radially arranged around the release member 52. Generally, the release member 52 is configured to: (1) operably couple the guard member 32 and the plunger 26 in an activation sequence; (2) generate an audible signal indicating the end of drug delivery. Such configuration allows the release member 52 to be used to perform these two separate functions and thereby reduce the number of moving parts required for the drug delivery device 10.

[0135] The channel surfaces 52b are each configured to receive the protrusions 48 of the top ring 45 and permit axial movement of the plunger 26 relative to the release member 52, but resist or prevent rotational movement between the plunger 26 and the release member 52. As shown in the drawings, although the channel surfaces 52 extend adjacent to the inner surface of the release member 52, the channel surfaces 52 do not have an arcuate shape but have a generally square shape (e.g., Figure 7B and Fig. 10A Best in Show).

[0136] The release member 52 includes a channel surface 52b that extends proximally through the most proximal (e.g., top) surface of the tubular body of the release member 52. For example, the release member 52 includes a proximally facing contact surface 52d for end-of-dose notification, as described in more detail below, and each of these channel surfaces 52b extends through the contact surface 52 to provide a continuous path for the top ring 45 while also permitting sufficient clearance to be achieved between the proximally facing contact surface 52d and a corresponding surface related to the end-of-dose notification.

[0137] Depending on the stage of operation of the drug delivery device 10, the release member 52 can be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12. The initial rotation of the release member 52 associated with activation can be powered by the plunger biasing member 50 and / or the extension biasing member 35; while the subsequent rotation of the release member 52 associated with the generation of the end-of-dose signal can be powered only by the extension biasing member 35. Any linear translation of the release member 52 without rotation can be powered only by the extension biasing member 35. In some embodiments, the release member 52 can only translate linearly in the proximal direction; however, alternative embodiments can permit the release member 52 to translate linearly in both the proximal and distal directions.

[0138] Having described the general configuration of the drug delivery device 10, reference will now be made to 9A to 12C1 to describe a method of injecting using the drug delivery device 10. As a preliminary step, the user can remove the drug delivery device 10 from any secondary packaging (such as a plastic bag and / or a cardboard box). Moreover, as a preliminary step, the user can prepare the injection site, for example, by wiping the patient's skin with alcohol. Next, the user can pull down and remove the removable cover 19 from the front housing 25. As a result of this movement, the grip 13 can pull and remove the sterile barrier 21 from the drug storage container 20. This can expose the insertion end 28 of the delivery member 16. However, at this stage, the insertion end 28 of the delivery member 16 will remain surrounded by the protective member 32 because the protective member 32 is arranged in the extended position. Next, the user can position the drug delivery device 10 on the injection site and then push the distal end of the protective member 32 against the injection site. The force applied by the user will overcome the biasing force of the extension biasing member 35 and the biasing force of the locking ring biasing member 51, thereby causing the protective member 32 to retract into the opening 14 and move from the extended position to the retracted position in the proximal direction. During the retraction movement of the guard member 32 , the delivery member 16 remains stationary relative to the housing 12 .

[0139] Several device components include various features, surfaces, and openings that interact with the plunger 26 and control its release movement (e.g., injection sequence). Generally, the injection sequence is from the guard member 32 in the proximal direction ( Figure 2 The retraction / axial movement of the plunger 26 (in the distal direction) begins, which causes the guard extension 37 to move axially to unlock the release member 52. Once the release member 52 is unlocked (e.g., the first travel stage), the plunger 26 and the plunger biasing member 50 advance the release member 52 to rotate clockwise and permit the plunger 26 (in the distal direction, Figure 2 The plunger then pushes the stopper 24 in the distal direction, thereby pushing the drug 22 from the drug container 20 and out of the delivery member 16. Once the plunger reaches a certain point along the axial length of the device, the movement of the release member 52 is further unlocked (e.g., a second travel stage) and the release member moves in the proximal direction ( Figure 2 The injection sequence will now be described in more detail.

[0140] Figure 2 , Fig. 9A , Figure 10, and Fig.11AThe pre-injection state is shown. The movement of the guard member 32 from the extended position to the retracted position may cause several actions to occur. Because the delivery member 16 remains stationary relative to the housing 12 during the retraction of the guard member 32, the insertion end 28 of the delivery member 16 is extended through the opening in the distal end of the guard member 32, thereby piercing the patient's skin and penetrating the patient's subcutaneous tissue at the injection site. In addition, the retraction of the guard member 32 can also activate the drive mechanism 30 to discharge the drug 22 from the drug storage container 20, as described in more detail below.

[0141] In the pre-delivery state before the needle guard 32 is retracted, the plunger 26 and the release member 52 may each be arranged in a respective initial rotational position, such as Fig. 9A , Figure 10 and Fig.11A As shown. The plunger biasing member 50 can be in an energized state. Therefore, the plunger biasing member 50 can apply a biasing force directed toward the distal side to the plunger 26 to advance the distally facing cam surface 49 onto the proximally facing cam surface 60j. The resulting camming action can propel the plunger 26 to rotate in a clockwise direction. Despite these (multiple) biasing forces, neither the release member 52 nor the plunger 26 can rotate in the pre-delivery state. This is because the release member 52 and the plunger are fixed in a rotational sense in the pre-injection state. Accordingly, the release member 52, the plunger guide 60, the shield extension 37, and the housing 12 work in conjunction with each other to keep the plunger biasing member 50 in the energized state before retracting the shield member 32, as now described in more detail.

[0142] like Figure 2 As best shown, when the guard member 32 moves in the proximal direction ( Figure 2 When the shield member 32 is facing upward (in the figure), the proximal end 32d of the shield member 32 contacts the distally facing surface of the shield extension 37 and pushes the shield extension in the proximal direction. Figure 6B and Fig. 7A As shown, the inner surface of the annular wall of the guard extension 37 includes a locking flange 37c, and the annular outer surface of the release member 52 includes a corresponding locking flange 52a. Figure 2 , Fig. 9A , Fig. 10A and Fig.11A As shown, the locking flange 37c of the guard extension 37 engages the locking flange 52a of the release member 52, thereby locking the release member 52 in a rotational sense (eg, Fig.11A At this point in the sequence, the distally facing cam surface 49 of the top ring 45 of the plunger 26 abuts the proximally facing cam surface 60j of the plunger guide 60, such that the plunger 26 is restricted from axial travel (eg, Fig. 9A and Fig. 10AThe distally facing cam surface 49 and / or the proximally facing cam surface 60j may include a ramp surface to facilitate movement of the top ring 45 of the plunger 26 along the Fig. 9A and Fig. 10A For example, the distally facing cam surface 49 has a slope of about 10 degrees, but may also have any suitable slope 60m (such as Fig. 9B and Fig. 9C 2, 6, 14, 5, 15, 4, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 110, 111, 114, 115, 116, 117, 118, 119, 110, 111, 112, 113, 114, 1 Therefore, as long as the guard extension 37 locks the release member 52 in a rotational sense (such as Figure 2 , Fig. 9A , Fig. 10A and Fig.11A ), the top ring 45 will remain rotationally locked by the channel surface 52b and axially locked by the proximally facing cam surface 60j.

[0143] Fig. 11B 52 and 54. The unlocking stage is shown in which the guard extension 37 is translated in the proximal direction until the locking flange 37c of the guard extension 37 no longer engages the locking flange 52a of the release member 52 and the release is no longer rotationally locked. At this stage in the injection sequence, two things happen simultaneously or nearly simultaneously: (1) the guard extension 37 is unlocked due to the camming surface (generally aligned with the camming surface) on one or both of the inner surface of the release member 52 and the outer surface of the plunger guide 60. Fig. 9C and Figure 7B 52c, but on the inner surface of the release member 52 rather than the outer surface indicated as 52c) (such as rib 60n Figure 5B ), the protection biasing member 35 releases the member 52 in a clockwise direction ( Fig. 9B50) and pushes upward to convert the axial force of the guard biasing member 35 into a lateral (clockwise) force and cause the release member 52 to rotate clockwise and move upward (proximally); and (2) due to the camming action between the surface 49 of the plunger 26 and the surface 60j of the plunger guide 60, the plunger biasing member 50 pushes the top ring 45 in a clockwise direction and downward (distal), thereby causing the plunger 26 to move clockwise and slightly downward along the ramp surface 60j. In other words, both the release member 52 and the top ring 45 of the plunger 26 rotate clockwise simultaneously or substantially simultaneously due to the forces from the respective biasing members 35, 50. These sliding motions between the surface 49 of the plunger 26 and the surface 60j of the plunger guide 60 produce rotation as well as linear translation (as opposed to a helical path). Accordingly, the plunger guide 60 can act as a cam, and the plunger rod 26 acts as a cam follower.

[0144] Fig. 9B , Fig. 10B and Fig. 11C The unlocking stage is shown. In this stage, the distally facing cam surface 49 of the top ring 45 clears the proximally facing cam surface 60j of the plunger guide 60, so that the top ring 45 (and therefore the plunger 26) is no longer axially restrained by the plunger guide 60. As a result, the plunger biasing member 50 axially advances the plunger 26 in the distal direction.

[0145] Fig. 9C , Fig. 10C ,and Fig. 12A The downward stroke phase is shown. Fig. 9C , Fig. 10C ,and Fig. 12ADuring the downward stroke phase of the plunger 26, the top ring 45 is still visible near the proximal portion of the plunger guide 60, but it quickly travels along the longitudinal slot 86 and the channel surface 52b formed in the plunger guide 60. During this phase, the top ring 45 of the plunger 26 travels along both the channel surface 52b of the release member 52 and the longitudinal slot 86 of the plunger guide 60, thereby preventing any rotation between the three components (26, 52, 60). As a more specific example, since the plunger guide 60 is fixed in a rotational sense relative to the housing 12, the release member 52 cannot rotate when the top ring 45 is positioned within both the channel surface 52b and the longitudinal slot 86. And during this phase, as the plunger 26 travels distally, the gap 18 between the base 47 of the plunger 26 and the stopper 24 is reduced, and the base 47 contacts the stopper 24. The device 10 is designed so that the plunger 26 travels with a force sufficient to drive the stopper 24 in a distal direction and advance the drug 22 from the delivery member 16. At the same time, the device 10 is also designed to reduce or eliminate the possibility of glass breakage, undesirable forces acting on the patient, and / or undesirable shock, vibration, or sound due to the interaction between the base 47 and the stopper 24. For example, the design parameters of the plunger biasing member 50 can be designed to meet these two sets of design goals. As another example, a damping component can be positioned between the base 47 and the stopper 24, or at another location in the device 10, to damp the force between the base 47 and the stopper 24. For example, the base 47 can include an elastic component, a section, or other damping features. In addition or alternatively, the stopper 24 can be formed of an elastic material including inherent damping properties. In addition or alternatively, the stopper 24 can include additional elastic components, sections, or other damping features.

[0146] In some embodiments, the camming action between the distally facing cam surface 49 on the protrusion 48 and the proximally facing cam surface 60j of the plunger guide 60 can provide a damping effect. More specifically, the sliding friction between these two surfaces can be selected to slow the initial expansion of the plunger biasing member 50. Thus, the speed of the plunger 26 can be reduced during the initial expansion of the plunger biasing member 50 compared to an uninhibited expansion of the plunger biasing member 50. The reduced speed of the plunger 26 can cause the plunger 26 to strike the stopper 24 with less force, which reduces the chance of structural damage to the drug storage container 20 and / or contributes to a more comfortable injection for the user.

[0147] Fig. 12B and Fig. 12C As discussed above, during the downward stroke phase, when the top ring 45 is positioned within the channel surface 52b and the longitudinal slot 86, the release member 52 cannot rotate relative to the plunger guide 60. However, in some embodiments, during the downward stroke phase, the release member 52 cannot rotate relative to the plunger guide 60. Fig. 12BAt the end of the dosing start phase shown, the top ring 45 may leave the distal end of the release member 52 and no longer restrict or prevent the rotation of the release member 52. As a more specific example, Fig. 12B As shown in the bottom portion of , when the top ring 45 leaves the channel surface 52b and / or the distal surface 52d of the release member, the release member 52 is no longer rotationally restrained by the top ring 45 and the release member 52 is urged upward by the guard biasing member 35. Due to the upward force of the guard biasing member 35 and the cam surface, the release member 52 rotates clockwise as it moves upward in a spiral path, and the proximal-facing surface 52d of the release member 52 contacts the distal-facing surface 60p of the plunger guide 60, thereby producing an audible click. As a more specific example, Fig. 12B A gap 90 is shown between the respective surfaces 52d, 60p, but this gap 90 is subsequently eliminated as the release member 52 advances proximally, as shown in FIG. Fig. 12C The length of the channel surface 52b and the plunger 26 can be designed so that when the stopper 24 reaches a desired travel point within the drug storage container 20 (such as the end of the stopper's travel near the distal end of the drug storage container 20), the top ring 45 leaves the channel surface 52b.

[0148] As a more specific example of the cam surface arrangement between the release member 52 and the plunger guide 60 and as discussed above, the rib 60n of the plunger guide 60 is aligned with the inner surface ( Fig. 7A and Figure 7B The rib 60n is aligned with the guide member 52 (indicated as 52c in the figure) (but on the inner surface rather than the outer surface indicated as 52c). The rib 60n has a ramp surface to help promote and / or facilitate relative rotation between the components 52, 60. More specifically, the propulsion force of the guard biasing member 35 combined with the ramp surface of the rib 60n generates a rotational force (e.g., torque) and rotates the release member 52 relative to the plunger guide 60. During the first stage of rotation of the release member 52 (e.g., Fig. 11B The unlocking stage shown in FIG. 1 ) is formed when the rib 60n is released along a first section of the inner cam surface 52c of the release member 52, such as Figure 7B During the second phase of the rotation of the release member 52 (eg, Fig. 12B and Fig. 12C The end of the dosing stage shown), the rib 60n is arranged along the second section of the inner cam surface 52c of the release member 52, such as Figure 7B The second section 52g shown is traveled. Figure 7BIt can be seen that the second section 52g includes a recess 52h that can receive the rib 60n and permit the release member 52 to quickly move proximally toward the plunger guide 60 and produce an audible click sound of the end of the dose. In summary, during the end of the dose phase, the top ring 45 leaves the channel surface 52b of the release member 52, and the guard biasing member 35 and the rib 60n cause the release member 52 to rotate and move upward, ending with the release member 52 quickly moving upward (proximally) to contact the plunger guide 60 when the rib 60n moves into the recess 52h.

[0149] Once the patient and / or medical care provider hears the audible sound, he / she / they can be informed that the drug administration is complete. In some embodiments, the user can be informed of the importance of the audible signal through instructions provided by the drug delivery device 10. In some embodiments, these instructions can take the form of an instruction for use (IFU) booklet packaged with the drug delivery device 10. In some embodiments, the user can obtain additional confirmation that the drug delivery is complete by observing the stopper 24 and / or the plunger 26 moving through the window 17. In some embodiments, the audible signal can be accompanied by a vibration or other tactile feedback generated by the release member 52 hitting the plunger guide 60. The audible notification can be in the form of a click or a clapping sound, or any other suitable audible signal that the user can perceive. The audible signal can be generated simultaneously or substantially simultaneously with the stopper 24 reaching the end position of the drug administration.

[0150] As described above, in addition to its retention function, the release member 52 can also be used to generate an audible signal indicating to the user that the drug delivery or administration is complete. This dual function can reduce the number of parts and / or design complexity. Alternatively, the release member 52 does not need to have this indicator function. In an alternative embodiment, the indicator can be defined by a structure that is separate from the release member 52 but rigidly attached thereto.

[0151] Although the above description can use the extension biasing member 35 to provide the actuation energy required to generate the end-of-dose signal, alternative embodiments can utilize a biasing member separate from the extension biasing member 35 to achieve this purpose. In some such embodiments, this additional biasing member can have a distal end fixed relative to the housing 12, and a proximal end against the distal surface of the release member 52. In this way, the biasing member can be pushed away from the housing 12 to apply a biasing force to the release member 52 in the proximal direction. In addition, this biasing member can operate independently of the plunger biasing member 50 and the extension biasing member 35.

[0152] In any case, once the user receives some confirmation that drug delivery is complete, the user can lift the drug delivery device 10 away from the injection site. In the absence of any resistance, the extension biasing member 35 can push the guard member 32 from the retracted position to the extended position to cover the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 can rotate the locking ring 40 to a position that will prevent the guard member 32 from being subsequently retracted.

[0153] For example, as discussed above, in some embodiments, the drug delivery device 10 can include a locking ring 40 configured to lock the guard member 32 in the extended position after the guard member 32 has moved from the retracted position to the extended position. In the current embodiment, the locking ring 40 is centered on the longitudinal axis A and rotates about it. Figure 2 As shown, the proximal end of the locking ring 40 can be in contact with a portion of the housing 12, and the distal end of the locking ring 40 can be at least partially disposed within the guard member 32. The locking ring biasing member 51 can be positioned in the axial direction between the distally facing surface of the locking ring 40 and the proximally facing surface of the guard member 32. The locking ring biasing member 51 can initially be in a compressed or energized state, thereby biasing the locking ring 40 and the guard member 32 away from each other. In this way, the locking ring biasing member 51 can apply a biasing force to push the guard member 32 toward the extended position, and apply a biasing force to push the proximal end of the locking ring 40 against a portion of the housing 12, such as the annular collar 12d. In some embodiments, the locking ring biasing member 51 can include a compression spring (e.g., a helical compression spring).

[0154] The locking ring 40 can also be used to provide initial resistance to the movement of the guard member 32. As discussed above, the device 10 can be inserted into the patient by adopting, utilizing, or otherwise taking advantage of inertial forces. The locking ring 40 and / or other components can provide initial resistance to the movement of the guard member 32 to establish the force of the user input, as discussed in more detail below.

[0155] Fig.13 A perspective view of the locking ring 40 is shown. Fig.13 In the example shown, the locking ring 40 includes a cam surface 40a that is non-parallel to the axis A and is configured to convert the translational movement of the sheath guard 32 into the rotational movement of the locking ring 40. As a more specific example, Fig.13Cam surface 40a is shown at an angle 40d of approximately -30 degrees with axis A. Any suitable angle may be utilized, such as -10 to -80 degrees, -20 to -70 degrees, -20 to -60 degrees, -20 to -50 degrees, -20 to -40 degrees, -25 to -35 degrees, or any other suitable angle. Angle 40d may also be positive (so that the angled surface flips about axis A), but such a configuration causes locking ring 40 to rotate in the opposite direction. In such a case, any suitable angle may be utilized, such as 10 to 80 degrees, 20 to 70 degrees, 20 to 60 degrees, 20 to 50 degrees, 20 to 40 degrees, 25 to 35 degrees, or any other suitable angle.

[0156] exist Fig.13 In the example shown, the locking ring 40 includes a locking arm 40b, which may be a generally cantilevered arm extending from a body portion of the locking ring 40 (along the circumference of the locking ring 40). The locking arm 40b may include a ridge 40c extending transversely to the body portion of the locking ring 40 (i.e., outwardly and non-parallel to the axis A).

[0157] Fig.14 The locking ring 40 and other various components of the device are shown in a pre-deflection stage (e.g., before the guard member 32 is axially deflected in the proximal direction). Fig.14 Shown are: a distal portion of the housing 12, in a partial cross-sectional view for illustration purposes; a guard member 32, which is in a translucent form and partially cut away for illustration purposes; a locking ring 40, and a portion of the housing inner collar 12d. The guard member 32 includes a plurality of ribs formed on its annular inner surface. Fig.14 The ribs are shown, but portions of the annular surface itself are cut away for illustration purposes. Similarly, although portions of the housing 12 are cut away for illustration purposes, Fig.14 1 and 12. An annular collar 12d is formed on the inner surface of the housing 12. When the device 10 is in the pre-deflection stage (e.g. Fig.14 32k, the ridge 40c is adjacent to the inertia rib 32k formed on the annular inner surface of the guard member 32. As a more specific example, when the device 10 is in the pre-deflection stage, the ridge 40c is arranged to the left of the inertia rib 32k, so that the locking ring 40 generally resists rotation (and thereby resists axial deflection of the guard member 32) until the ridge 40c is able to move beyond the inertia rib 32k (i.e., over the inertia rib 32k). This arrangement is discussed in more detail below.

[0158] Fig.15A and Fig. 15B1 and 2. Views taken from different angles (spaced approximately 90 degrees apart from one another) are shown when the device is in an initial deflection phase, just after the guard member 32 has been released from engagement with the locking arm 40b. As a more specific example, the locking ring 40 has been rotated so that the ridge 40c has just passed the locking rib 32k, thereby allowing the guard member 32 to deflect more freely (in the proximal direction). At this point in the sequence, the injection sequence may not have been enabled. For example, the plunger biasing member 50 may not have been released because the housing 12 has not yet advanced distally enough to allow the delivery member 16 to penetrate the user's tissue.

[0159] In order to make the components of the device Fig.14 The stage shown moves to Fig.15A and Fig. 15B At the stage shown, two main events generally occur simultaneously: initial rotation of the locking ring 40 and release from the locking arm 40b. Fig. 15B In the initial rotation shown, the locking ring cam surface 40a is generally aligned with the cam rib 32j to convert the translational movement of the sheath guard 32 into the rotational movement of the locking ring 40. As a more specific example, when the sheath guard is retracted, the proximally facing top surface of the cam rib 32j exerts an axial upward force on the cam surface 40a. As a more specific example, the angle formed by the cam surface 40a and the axis A causes the upward force from the cam rib 32j to have an axial component (along the axis A) and a rotational component (transverse to the axis A), thereby rotating the locking ring 40. In other words, during the rotation of the locking ring 40, the locking ring 40 is rotated. Fig.14 The stages shown and Fig.15A and Fig. 15B In both stages shown, the deflection (retraction) of the guard member 32 causes the lock ring 40 to rotate. The cam rib 32j pushes the lock ring 40 to rotate to the right (i.e., from Fig. 15B The locking arm 40b can generally resist such movement. For example, when the guard member 32 is pressed, the guard member moves from Fig.14 Move the position shown to Fig.15A and Fig. 15B As a more specific example, when the device 10 is in Fig.14 In the position shown, the ridge 40c is arranged to the left of the inertia rib 32k, so that the locking ring 40 cannot rotate beyond a certain point until the ridge 40c is able to pass over the inertia rib 32k. The ridge 40c may be able to pass over the inertia rib 32k via the radially inward deflection of the locking arm 40b, as shown in FIG. Fig.15AAs shown. In such a design, the deflection of the locking arm 40b at least partially determines the force required to cause the ridge 40c to pass over the inertia rib 32k. In other words, the deflection of the locking arm 40b at least partially determines the force required to deflect the protective member 32 sufficiently to enable the injection process. The angle formed by the ridge 40c and the circumference of the locking ring 40 can also partially determine the force required to deflect the protective member 32 sufficiently to enable the injection process. In addition, the rotation angle that the locking ring 40 must undergo in order to cause the ridge 40c to pass over the inertia rib 32k at least partially determines: the distance that the protective member 32 translates (axially) before the locking arm 40b "releases" the protective member 32.

[0160] During operation, when the patient presses the distal end of the protective member 32 against the injection site of the patient's skin, the housing 12 of the delivery device 10 can be advanced toward the injection site by a relatively small distance (e.g., 2-4 mm). The patient can then feel the resistance between the inertia rib 32k and the ridge 40c. When the patient presses down with more force, the ridge 40c passes over the inertia rib 32k, and the delivery device 10 achieves a quick release to utilize the energy stored in the patient's muscles while compressing the needle guard and its spring to a defined release point. The release mechanism, such as the deflection of the locking arm 40b described above, the rotation angle required to pass over the inertia rib 32, and other parameters can be designed so that when the ridge 40c passes over the inertia rib 32k, the needle insertion speed obtained exceeds the patient's reaction speed, and this speed combined with the mass of the device causes the needle to quickly and completely penetrate the skin to a subcutaneous depth. In other words, once the protective member 32 reaches Fig.15A and Fig. 15B 32 is inserted into the distal portion of the device, the resistance to deflection of the protective member 32 is significantly reduced, so that the needle is inserted until 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 protective member 32 caused by the components in the distal portion of the device comes from the locking ring biasing member 51, but this resistance is significantly lower than the resistance provided by the locking arm 40b. And, it is worth noting that the user can still feel the resistance to deflection of the protective member 32 due to other sub-components in the device (e.g., the activation of the drive mechanism 30). Even though the insertion process starts very quickly from this point, the subsequent stages will be examined in detail in the accompanying drawings and the following text.

[0161] Fig.16A and Fig. 16B It shows that when the device is in the stage of continuing to move downward (in the ratio Fig.15A and Fig. 15B At a later point in time, where the housing has moved further in the distal direction and the guard member 32 has been further retracted), views are taken from different angles (spaced approximately 90 degrees apart from each other). Fig.16A and Fig. 16BAt this point in the sequence shown, the injection sequence may or may not have begun, depending on the desired release parameters, such as needle length, desired insertion depth, distance between guard member 32 and needle tip.

[0162] like Fig.16A As shown, at this point in the sequence, the cam rib 32j of the guard member 32 passes over or is about to pass over the cam surface 40a, allowing the guard member 32 to deflect without rotating the lock ring 40. In addition or alternatively, the ramp surface 40e of the lock ring 40 can engage the ramp surface 12g of the housing 12 (which can be defined by the annular collar 12d, with the housing 12 being provided with a plurality of cam surfaces 40e and 40e of the lock ring 40). Fig.25 The corresponding surfaces 40e, 12g of the bevel surface are similar or identical); this interaction between the locking ring 40 can also cause the locking ring 40 to rotate until it reaches Fig.16A and Fig. 16B Additionally or alternatively, at this stage of insertion, stop ridge 40f of locking ring 40 engages stop ridge 32n and limits rotation of locking ring 40. However, as discussed above, at this stage, guard member 32 is able to deflect without requiring or causing further rotation of locking ring 40. More specifically, as Fig. 16B and Fig.17 As shown, adjacent ribs (stop rib 32 n and cam rib 32 j ) extend between adjacent components of the locking ring 40 (stop ridge 40 f and cam surface 40 a ) such that the guard member 32 can deflect relative to the housing 12 .

[0163] Fig.17 A view is shown when the device is in the final stage of insertion, with the guard member fully or nearly fully retracted. At this point in the sequence, the injection sequence may have been initiated. For example, the plunger biasing member 50 may have been released and the delivery member 16 has been inserted into the user's tissue. In addition, at this point in the sequence, the guard member 32 is at or nearly in its fully retracted position relative to the housing 12, and the device 10 remains against the patient's skin. The user preferably maintains the device 10 in this position at least until the drug delivery process is complete (i.e., a full dose of the drug 22 has been delivered to the patient) and the end-of-dose notification indicates that the drug is complete. Of note, for purposes of illustration, Fig.17 The guard member 32 is shown with portions cut away, and Fig.17 Not shown is the housing 12 (including the annular collar) or the medicinal storage container 20 .

[0164] Fig.18A and Fig.18B The device 10 is shown in a locked configuration with the guard member 32 in a fully extended position ( Fig.18A ) or almost fully extended position ( Fig.18BAs a more specific example, the stop rib 32n and the cam rib 32j of the guard member 32 are aligned with the stop ridge 40f to limit and / or prevent the guard member 32 from deflecting in the proximal direction. As another more specific example, the guard member 32 can only move in the proximal direction. Fig.18A The distance shown by the gap 91 in the shield member 32 prevents the shield member 32 from moving axially in the proximal direction a distance sufficient to expose the delivery member 16. In other words, the shield member 32 is locked in the shielding position to annularly surround the needle and minimize or prevent unintentional needle sticks.

[0165] In some embodiments, the grip 13 can be configured to prevent the locking arm 40b from deflecting before the removable cap 19 is removed. As an example, the outer surface of the grip 13 can be configured to abut against the inner surface of the locking arm 40b to prevent the locking arm 40b from deflecting radially inward before the removable cap 19 is removed. This configuration can reduce the possibility of accidental locking due to vibration or sudden movement during transportation or storage of the drug delivery device 10 before use. When the removable cap 19 with the grip 13 is removed, the locking arm 40b can be allowed to deflect in the manner described above.

[0166] The locking ring 40 and the housing 12 have corresponding stop surfaces that abut against each other and prevent rotation therebetween. For example, the locking ring 40 may have stop surfaces 40g and 40h ( Fig.18A , Fig.13 ), which abut against the stop surfaces 12j, 12k of the annular collar 12d ( Fig.18A ). The corresponding stop surfaces 40g, 40h of the locking ring 40 and the corresponding stop surfaces 12j, 12k of the annular collar 12d may be stepped surfaces to prevent or resist rotation between the locking ring 40 and the housing 12. The locking ring biasing member 51 may push the locking ring 40 in the proximal direction and / or push the guard member 32 in the distal direction to retain the locking ring 40 in a position such as Fig.18A and Fig.18B The position shown is that of abutting the annular collar 12d.

[0167] The circular cross section of the housing 12 can make it easy to roll on the surface when it is placed on its side. In order to suppress or prevent such rolling, a part or all of the removable cover 19 can have a non-circular cross section. In the embodiment shown in the accompanying drawings, the removable cover 19 has a distal end with a non-circular cross section and a proximal end with a circular cross section. In this way, when moving from the proximal end of the removable cover 19 to the distal end of the removable cover 19, the cross section of the removable cover 19 gradually changes from a circular cross section to a non-circular cross section. In the embodiment shown, the non-circular cross section of the distal end of the removable cover 19 generally takes the form of a square. In other embodiments, the non-circular cross section can be a rectangle, a triangle, or any other polygonal or partially polygonal shape, as long as one or more sides of the removable cover 19 are flat or substantially flat to suppress or prevent rolling. In addition, the size of the non-circular cross section of the distal end of the removable cover 19 can gradually increase as it moves toward the distal direction, so that the distalmost part of the distal end of the removable cover 19 has a larger cross-sectional area than the most proximal part of the distal end of the removable cover 19. This configuration provides the distal end of the removable cover 19 with a flared shape, which in turn may help a user grasp the removable cover 19 and pull it away from the housing 12 .

[0168] In some embodiments, the housing 12 and the removable cover 19 can each include a corresponding anti-rotation feature. When the removable cover 19 is in the storage position, these anti-rotation features can engage with each other to prevent or inhibit the removable cover 19 from rotating relative to the housing 12. In some embodiments, when the removable cover 19 is in the storage position, the anti-rotation feature of the housing 12 can be adjacent to and substantially aligned with the anti-rotation feature of the removable cover 19. For example, Figure 1A The radial protrusion 9 is shown positioned adjacent to the distal end of the housing 112. Figure 1B As shown, the removable cover 19 includes an opening 8, the size of which can be determined to accommodate the radial protrusion 9 when the removable cover 19 is in the storage position. Due to this mating engagement, the removable cover 19 may not be able to rotate relative to the housing 12. This can be advantageous if the user attempts to twist the removable cover 19 when pulling the removable cover 19 away from the housing 12. In some cases, the rotation of the removable cover 19 may rotate the sterile barrier, such as RNS or FNS, which in turn may cause the needle tip to pierce the sealing member in the RNS or FNS. Therefore, at least during the initial moment of cover removal, arranging the radial protrusion 9 in the opening 8 can prevent the piercing of the needle. In an alternative embodiment, the opening 8 can be formed in the wall of the housing 12, and the radial protrusion 9 can extend from the proximal end of the removable cover 19 toward the proximal direction.

[0169] In other embodiments, the removable cover can be permitted and / or intended to rotate relative to the housing. For example, the removable cover includes (multiple) features that convert the rotational movement of the removable cover into an axial auxiliary force to help advance the cover away from the housing. As a more specific example, the removable cover and / or the housing can have a cam surface, such as a wavy surface, which converts the rotational movement of the removable cover relative to the housing into a distal axial movement of the removable cover relative to the housing. The axial auxiliary force provided by such an arrangement can benefit various types of users, including users with limited flexibility and / or strength due to, for example, disease.

[0170] FIG. 19A to FIG. 19B Each shows an exemplary force distribution curve during the injection process of an exemplary drug delivery device, wherein the relative displacement (in millimeters) between the device housing and the protective member is plotted along the x-axis, and the resistance (in Newtons) is plotted along the y-axis. For example, the displacement (along the x-axis) shows the relative axial displacement between the protective member 32 and the housing 12 along the axis A. As discussed above, this relative axial displacement can be understood to refer to the translational movement of the housing 12 relative to the protective member 32 (such as when the user pushes the housing in the distal direction toward the user's injection site while the user's tissue prevents the protective member 32 from moving in the same direction), or it can be understood to refer to the translational movement of the protective member 32 relative to the housing (such as when the housing 12 remains in place and the user pushes the protective member 32 in the proximal direction). In any event, the x-axis (horizontal) of the graph of Figure 19 shows the relative displacement between the protective member 32 and the housing 12. The y-axis (vertical) of the graph of Figure 19 shows the resistance during various points of the relative displacement between the protective member 32 and the housing 12. For example, for Fig.19A As shown in the force distribution curve, at the point when the guard member 32 and the housing 12 experience a relative displacement of approximately 2 mm, the resistance experienced by the user is approximately 7.75 N. As an even more specific example, the resistance may refer to the force experienced by the user due to the mechanical interaction between the components of the device. Fig.14 When housing 12 is first advanced toward an injection site during the pre-injection state shown, the resistance is generally equal to the force required to compress spring 51 and the force required to advance inertia rib 32k beyond ridge 40c. FIG. 19A to FIG. 19B The force profiles in show several exemplary possible desired force and displacement values, and it should therefore be understood that these values ​​may vary depending on the design of the previously mentioned interactions.

[0171] However, if Fig.19AAs shown in the exemplary force profile in FIG. 2 , for the first approximately 1 mm of travel between the guard member 32 and the housing, the resistance is relatively low, and after point 202, the resistance increases rapidly (primarily due to the force required to push the inertial rib 32k over the ridge 40c) to a peak resistance at point 204. Once the ridge 40c passes over the inertial rib 32k ( Fig.15A ), the resistance is quickly reduced to point 206, where the resistance is mainly due to the compression spring 51 ( Fig.14 ) The force required, compression spring 35 ( Fig. 11B ) and the friction between the various moving parts in the device. At point 208, the needle is inserted into the user's tissue, and at point 210, the injection phase begins and the drug 22 is injected into the user's tissue. Once the user overcomes the peak resistance at point 204, the user's inertia can drive the housing and the drug storage container toward the injection site, thereby urging the needle to be inserted. Due to the user's inertia, this injection phase (between points 204 and 208) can be performed over a relatively short period of time to increase the likelihood of the needle being fully inserted rather than partially inserted and to reduce the likelihood that the user will stop the movement of the device before or during the partial needle insertion. In other words, once the user exceeds the peak resistance at point 204, the user can "commit" to the needle insertion and / or injection process.

[0172] Fig.19B Another exemplary force profile is shown, where the peak force (point 304) is below Fig.19A 304, so the user needs a lower initial force to commit to insertion. This force profile can make it less likely that the user will stop the process during the initial compression (point 302), such as by prematurely removing the device from the tissue. However, it may be desirable that the peak force 304 be high enough to reduce the likelihood that the user will stop the injection between the peak force 304 and the needle insertion 308. In other words, the vertical distance (along the y-axis) between points 304 and 308 should be large enough to allow this injection phase to occur over a relatively short period of time.

[0173] FIG. 20A to FIG. 20G 4 shows a distal portion of an alternative design of the device 400, mainly showing the housing 412, the guard member 432, the locking ring 440, and the locking ring biasing member 451. Fig. 20A and Fig. 22As shown, the guard member 432 includes an annular base portion 432a, a pair of longitudinally extending arms 432b, a ridge 432h, a plurality of internal ribs (discussed in more detail below), and at least one opening 432x (also referred to as a hole in the annotations to some of the figures) through at least one of the ribs and the wall of the guard member. The opening 432x does not have to be an opening formed through the entire wall of the guard member 432. For example, the opening may simply be a break in a long rib or a protrusion section having a shorter height rather than a cutout of a portion of the wall and ribs of the guard member 432. The internal ribs of the guard member 432 include a first rib (preferably longer than the other ribs) (also referred to as a long rib 432r) and a pair of shorter ribs 432s, 432t. The opening 432x is formed through the long rib 432r and is aligned with a component of the locking ring 440 and is sized to selectively receive the component, as discussed further below. As Fig. 20A and Fig.23 As shown, the locking ring 440 includes a plurality of stop surfaces 440g, 440h, a U-shaped protrusion 440w (configured to be received within the opening 432x), and a plurality of proximally facing cam surfaces 440x, 440y. Fig. 20A and Fig.23 The locking ring 440 is shown without Fig.13 The surface 40a in the design shown corresponds to the distally facing cam surface. Fig. 20A As shown, during the unbiased state before injection of the device 400, each of the two U-shaped protrusions 440w is not initially received in the opening 432x. Instead, at this time, the proximal portion of the long rib 432r (i.e., the portion of the long rib near the opening 432x) is received in the U-shaped protrusion 440w to prevent the locking ring from moving upward (proximally) relative to the guard member. When the housing 412 moves downward (distal) and / or the guard member 432 moves upward (proximally), as shown in FIG. Fig. 20B As shown, the locking ring 440 is able to move upward (proximally) from the spring 451, thereby causing the cam surfaces on the housing 412 to contact the locking ring cam surfaces 440x, 440y and rotationally advance the locking ring. Fig. 20B In the stage shown, the locking ring 440 cannot rotate because the proximal portion of the long rib 432r is aligned with / received within the U-shaped protrusion 440w. Fig. 20B As shown, the housing cam surface 412x engages the locking ring cam surface 440y. However, as the relative movement between the guard member and the housing progresses to Fig. 20CIn the state shown, the engagement between the housing cam surface 412x and the lock ring cam surface 440y and the further relative movement between the guard member and the housing result in the following: (1) the engagement between the housing cam surface 412x and the lock ring cam surface 440y stops the upward movement of the lock ring, allowing the proximal portion of the long rib 432r to move out of alignment / engagement with the U-shaped protrusion 440, so that the U-shaped protrusion 440w is now aligned with the opening 432x, and (2) the corresponding cam surfaces 412x, 440y engage to rotate the lock ring 440. Fig.20D As shown, the locking ring rotates to a certain point (two-thirds of its total rotation) at which point the locking ring is rotationally restricted by the short ribs 432s, 432t in the guard member (more specifically, Fig.23 The stop surface 440v is shown engaging the short ribs 432s, 432t). Fig.20E In the stage shown, the guard member arm 432b is sufficiently moved relative to the housing 412 to enable the injection sequence to be initiated. Fig.20F As shown, once the user releases the pressure on the housing and permits relative proximal movement of the housing and / or distal movement of the guard member, the locking ring is restricted in rotation until the stop surface 440v passes over the short ribs 432s, 432t and the locking ring rotates to Figure 20G Locked configuration shown.

[0174] FIG. 26A to FIG. 26D Another alternative design of the device 600 is shown, mainly showing the housing 612, the protective member 632, the locking ring 640, and the locking ring biasing member 651. As shown in 26C, the protective member 632 includes an annular base portion 632a, a pair of longitudinally extending arms 632b, a ridge 632h, a plurality of internal ribs (discussed in more detail below), and at least one opening 632x (also referred to herein as a hole) through at least one of the ribs and the wall of the protective member. Each rib of the protective member 632 can be configured as a protrusion extending radially inward. The opening 632x does not have to be an opening formed through the entire wall of the protective member 632. For example, the opening 632x can be simply a break in a long rib or a protrusion section with a shorter height rather than a cutout of a portion of the wall and ribs of the protective member 632. The opening 632x is formed through the rib 632r and is aligned with a component of the locking ring 640 and is sized to selectively receive the component, as further discussed below. As Fig.26A , Fig.26B and Fig.26D As shown, the locking ring 640 includes a plurality of stop surfaces 640h, 640g, at least one tab-shaped protrusion 640w (configured to be received within the opening 632x), and a plurality of proximally facing cam surfaces 640y. Fig.26AAs shown, each tab-shaped protrusion 640w can be configured as a protrusion extending radially outward and can include a proximal-facing flange surface 640z. Fig.26D As shown, during the unbiased state of the device 600 prior to injection, each of the two tab-shaped protrusions 640w is not initially received within the opening 632x. Instead, at this time, the proximally facing cam surface 612x of the housing 612 engages the distally facing cam surface 640y of the locking ring 640 to prevent or resist upward (proximal) movement of the locking ring 640 relative to the guard member 632. At the same time, the tab-shaped protrusions 640w each respectively engage with a pair of ramp surfaces 632y (also referred to herein as the proximally facing cam surfaces 632y). At this stage of injection, the guard member 632 has been partially deflected (e.g., Fig. 20B ), but the locking ring 640 has not yet rotated, and the guard member 632 has not yet moved upward a sufficient distance to initiate the injection sequence. At this point, due to the corresponding engagements described above (i.e., the proximally facing cam surface 612x of the housing 612 engages with the distally facing cam surface 640y of the locking ring 640, and the proximally facing cam surface 640z of the tab-shaped protrusion 640w of the locking ring 640 engages with the ramp surface 632y of the guard member), the user feels resistance to further movement of the injector housing 612. This resistance may or may prompt the user to press down on the injector with a force sufficient to overcome the resistance (i.e., the peak resistance of the injector). The peak resistance is generated by the above-mentioned interaction (the interaction between the distally facing cam surface 612x of the housing 612 and the proximally facing cam surface 640y of the locking ring 640, and the interaction between the distally facing cam surface 640z of the tab-shaped protrusion 640w of the locking ring 640 and the ramp surface 632y of the guard member), and when the user's force is sufficient to cause the tab-shaped protrusion 640w of the locking ring 640 to slide along the ramp surface 632y of the guard member and the proximally facing cam surface 640y of the locking ring 640 to slide along the distally facing cam surface 612x of the housing 612 (to Fig.26D In other words, the locking ring 640 rotates in the direction of arrow 601 and moves slightly downward (toward the distal side), as shown in FIG. Fig.26D Once the locking ring 640 is rotated enough to allow the locking ring's tab-shaped projection 640w to clear the guard member's ramped surface 632y, the guard member 632 is able to move axially upward (proximally). At this point, two things happen: (1) the guard member 632 translates in the proximal direction a sufficient distance to initiate the injection sequence; (2) the locking ring's tab-shaped projection 640w aligns with the guard member opening 632x ( Fig.26C ) are axially aligned, and thereby, due to the interaction between the proximally facing cam surface 640y of the locking ring 640 and the distally facing cam surface 612x of the housing 612, the locking ring 640 is allowed to move in the direction of arrow 602 ( Fig.26D ) is rotated and slightly upward (proximal direction). After the injection is turned on, the locking ring 640 is in a position to lock the sheath, similar to the other embodiments described. The injector 600 can be designed so that events (1) and (2) occur simultaneously, so that once the protective member translates a distance sufficient to turn on the injection, the locking ring rotates an angle sufficient to turn on the locking sequence. It can be expected that this will significantly or completely prevent the user from attempting multiple injections. It can also be expected that this will significantly or completely prevent the locking sequence from being turned on when the injection sequence is not turned on. In other words, the above configuration can reduce the possibility that the user has a locked injector that has not delivered a dose.

[0175] To facilitate rotation of the locking ring 640 relative to the housing 612 and / or the protective member 632, any two or combinations of the following may be parallel to each other: the (multiple) distal-facing cam surfaces 612x of the housing 612, the (multiple) proximally-facing cam surfaces 632y of the protective member 632, the (multiple) distal-facing cam surfaces 640z of the locking ring 640, and the (multiple) proximally-facing cam surfaces 640y of the locking ring 640.

[0176] FIG. 21A to FIG. 21F The distal portion of another alternative design of device 500 is shown, primarily showing housing 512, guard member 532, locking ring 540, and locking ring biasing member 551. The components of device 500 are similar to those of device 400, except that, in addition to U-shaped protrusions 440w, locking ring 540 has only a pair of parallel protrusions 540w that have no horizontal protrusion connecting them. In other words, protrusion 540w has a "side portion" of the U-shape, but not a "bottom portion" of the U-shape. Fig.21A In the state shown, the protrusion 540w is received in the long rib of the protective member 532 to prevent the rotational movement of the lock ring. Fig.21B As shown, protrusion 540w is aligned with the opening in the guard member, thereby allowing rotational movement of the locking ring relative to the guard member (and being urged by the cam surface on the housing). Fig. 21C As shown in the state of FIG. 4 , the locking ring is rotated until the stop surface 440v engages the short rib in the guard member. Fig.21D The distal components of the device are shown during infusion activation. Fig.21E The state of the distal component is shown after the user releases pressure and the guard member is able to move (extend distally) relative to the housing. Fig.21F The locked configuration is shown.

[0177] Fig.24 Provides the Fig.19A and Fig.19B The force distribution curve shown is similar to that of FIG. 20A to FIG. 20GThe drug delivery device 400 and FIG. 21A to FIG. 21F A graph for comparing the force profile caused by the drug delivery device 500 is shown. Fig.19A and Fig.19B , Fig.24 The resistance experienced by the user is plotted against the displacement of the sheath (e.g., sheath guard 32). Fig.24 Determine where in each force profile the locking point associated with the locking ring is designed to occur. Fig.24 Shows Fig.19A and Fig.19B The locking point of the force profile in occurs at the same sheath displacement as when the user experiences peak resistance. In contrast, the locking point of the force profile associated with drug delivery devices 400 and 500 does not coincide with the sheath displacement corresponding to the peak resistance experienced by the user.

[0178] continue Fig.24 , the force profile associated with drug delivery device 400 is similar to Fig.19A and Fig.19B The force profile in Figure 1 shows the force profile in Figure 2, where the user experiences a sudden surge in resistance caused by the sheath being displaced prior to needle insertion. Fig.19A and Fig.19B Unlike the force profile of FIG. 4A , the resistance experienced by a user of drug delivery device 400 may continue to increase after this surge (until the activation point). Fig.24 It is shown that a user of drug delivery device 500 may not experience a sudden surge in resistance during sheath displacement, but may instead experience a gradual increase in resistance until the activation point. Manufacturers may choose to use a device that provides a plurality of resistances based on, for example, the desired user experience, the physical and / or mental abilities of the target user or patient population, mechanical safety considerations, and / or additional considerations. Fig.24 Displayed force distribution curve or different force distribution curves.

[0179] From the above, it can be seen that the present disclosure advantageously provides a streamlined design for a drug delivery device having an automated feature. The various mechanisms and components of the drug delivery device can interact with each other in a synergistic manner to limit the number of moving parts required for the drug delivery device, thereby improving the reliability of the drug delivery device and saving costs, as well as providing other benefits and advantages.

[0180] It will be appreciated that the apparatus and method according to the present disclosure may have one or more advantages over conventional techniques, any one or more of which may be present in a specific embodiment that conforms to the features of the present disclosure included in the embodiment. Other advantages not specifically listed herein may also be appreciated.

[0181] The above description describes various devices, assemblies, parts, subsystems and methods used in relation to drug delivery devices. Devices, assemblies, parts, subsystems, methods or drug delivery devices may further include or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also included. The drug can be in liquid form, in lyophilized form or in a form that can be reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0182] The drug will be contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug to be used for treatment. The primary container can be a vial, a cartridge, or a pre-filled syringe.

[0183] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor (such as granulocyte colony stimulating factor (G-CSF)), or the device can be used with a colony stimulating factor. Such G-CSF agents include, but are not limited to (Pegfilgrastim, Pegylated filgrastim, Pegylated G-CSF, Pegylated hu-Met-G-CSF) and (filgrastim, G-CSF, hu-MetG-CSF), (Pegfilgrastim-cbqv), (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0184] 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, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include but are not limited to (Epoetin α), (darbepoetin alfa), (Epoetine δ), (methoxy polyethylene glycol-epoetin beta), MRK-2578, INS-22, (Epoetin ζ), (Epoetin β), (Epoetin ζ), (Epoetin α), Epoetin α Hexal, (Epoetin α), (Epoetine θ), (Epoetine θ), (Epoetin theta), Epoetin alpha, Epoetin beta, Epoetin iota, Epoetin omega, Epoetin delta, Epoetin zeta, Epoetin theta and Epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0185] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that inhibit activity mediated by binding of IL-4 and / or IL-13 to the receptor; interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly human CD22-specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD 22-specific IgG antibodies, such as a disulfide-linked dimer of a human-mouse monoclonal hLL2γ-chain and a human-mouse monoclonal hLL2κ chain, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS Registry No. 501423-23-0; IGF-1 receptor-specific antibodies, peptibodies and related proteins, etc., including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, etc. ("B7RP-1", also known as B7H2, ICOSL, B7h and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for example, 145c7; IFNγ-specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ 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 targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of OX40 receptors; (alteplase, tPA); (Darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); (epoetin alfa, or erythropoietin); GLP-1, (interferon beta-1a); (tositumomab, anti-CD22 monoclonal antibody); (interferon-β); (alemtuzumab, anti-CD52 monoclonal antibody); (Epoetin delta); (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); (etanercept, TNF receptor / Fc fusion protein, TNF blocker); (Epoetin alpha); (cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Somatropin, human growth hormone); (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti for the treatment of breast or gastric cancer TM (Trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of trastuzumab or another product containing trastuzumab; (Somatropin, human growth hormone); (adalimumab); (panitumumab), (Dinosutumab), (Dinosutumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; (interferon alfacon-1); (Nesiritide; recombinant human B-type natriuretic peptide (hBNP)); (Anakinra); (sargramostim, rhuGM-CSF); (epatuzumab, anti-CD22 mAb); Benlysta TM (lymphostat B, belimumab, anti-BlyS mAb); (tenecteplase, a t-PA analog); (methoxypolyethylene glycol-epoetin beta); (gemtuzumab ozogamicin); (efalizumab); (certolizumab pegol, CDP 870); Soliris TM (eculizumab); pexelizumab (anti-C5 complement); (MEDI-524); (ranibizumab); (17-1A, edrecolomab); (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); (IDM-1); (B43.13); (viciluzumab); cantuzumab mertansine (huC242-DM1); (Epoetin beta); (Opreleukin, human interleukin-11); Orthoclone (Muromonab-CD3, anti-CD3 monoclonal antibody); (Epoetin alpha); (infliximab, anti-TNFα monoclonal antibody); (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); (anti-IL6 receptor mAb); (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi TM (bevacizumab-awwb); (rituximab, anti-CD20 mAb); (erlotinib); (interferon alfa-2a); (basiliximab); (lumiracoxib); (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); (natalizumab, anti-α4 integrin mAb); (MDX-1303, anti-anthrax protective antigen mAb); ABthrax TM ; (omalizumab); ETI211 (anti-MRSA mAb); IL-1trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); (daclizumab); (daclizumab, anti-IL-2Rα mAb); (ibritumomab tiuxetan); (ezetimibe); (atacicept, TACI-Ig); anti-CD80 mAb (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001);Anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3). ;

[0186] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody for treating osteoporosis and / or fracture healing in postmenopausal women, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity TM (Lomosozumab-aqqg), another product comprising lomosozumab, and in other embodiments, comprising a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to (evolocumab) and (alirocumab). In other embodiments, the drug delivery device may contain or be used with rituximab, bixalomer, trebananib, ganitazumab, canatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with a drug for treating melanoma or other cancers. (talimogene laherparepvec) or another oncolytic HSV, or the device can be used with it, the other oncolytic HSV includes but is not limited to OncoVEXGALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device can include or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device can include a (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab or used together with it. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptor (such as but not limited to erenumab) and bispecific antibody molecules targeting CGRP receptor and other headache targets can also be delivered using the drug delivery device of the present disclosure. In addition, bispecific T cell engagers Antibodies (such as but not limited to (blinatumomab)) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with an APJ macromolecular agonist, such as but not limited to apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), anti-TNFα monoclonal antibody, In some embodiments, the drug delivery device may include a biosimilar of infliximab (Janssen Biotech, Inc.) or another product containing infliximab or used together with it. (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutyramido)-4-methylpentanamide, or another product comprising or for use with carfilzomib. In some embodiments, the drug delivery device may comprise a drug for treating various inflammatory diseases. (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast or used together with it. In some embodiments, the drug delivery device can contain Parsabiv for treating secondary hyperparathyroidism (sHPT) in chronic kidney disease (KD) dialysis patients. TM (Vicositriptyline HCl, KAI-4169) or another product comprising Vicositriptyline HCl or used together with it. In some embodiments, the drug delivery device may comprise ABP 798 (rituximab), / MabThera TM In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate of, or another product comprising an anti-CD20 monoclonal antibody. 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-Trap (such as aflibercept (Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)). In some embodiments, the drug delivery device may contain ABP 959 (eculizumab), In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate, or another product comprising a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecadimecarb (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile mechanism, or another product comprising a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotolacib (formerly AMG 510), KRAS G12C Small molecule inhibitors, or KRAS G12C In some embodiments, the drug delivery device may contain or be used with another product that is a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product that contains a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product that contains a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein (a) (also known as Lp(a)), or another product that contains a small interfering RNA (siRNA) that lowers lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1κ antibody), In some embodiments, the drug delivery device may contain Amjevita TM or Amgevita TM (formerly ABP 501) (mab anti-TNF human IgG1), In some embodiments, the drug delivery device may contain AMG 160, or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 (bispecific T cell engager) construct or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 133 or another product containing gastric inhibitory peptide receptor (GIPR) antagonists and GLP-1R agonists or use it together. In some embodiments, the drug delivery device may include AMG 171 or another product containing growth differentiation factor 15 (GDF15) analogs or use it together. In some embodiments, the drug delivery device may include AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) or use it together. In some embodiments, the drug delivery device may comprise AMG 199 or a bispecific T cell engager construct comprising a half-life extended (HLE) In some embodiments, the drug delivery device may contain or be used with another product of the invention. In some embodiments, the drug delivery device may contain or be used with AMG256 or another product (comprising anti-PD-1 x IL21 mutant protein and / or IL-21 receptor agonist) designed to selectively turn on the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain AMG330 or a product comprising anti-CD33 x anti-CD3 In some embodiments, the drug delivery device may contain or be used with another product of a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product (comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody) being studied for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 In some embodiments, the drug delivery device may contain or be used with another product comprising a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product (comprising a multispecific FAP x 4-1BB-targeting In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager, and the use 2+1 technology design. In some embodiments, the drug delivery device may contain AMG 562 or contain half-life extended (HLE) CD19 x CD3 In some embodiments, the drug delivery device may contain or be used with another product comprising a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product comprising Efavaleukin alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product comprising a CD3x epidermal growth factor receptor vIII (EGFRvIII) In some embodiments, the drug delivery device may comprise AMG 673 or comprise half-life extended (HLE) anti-CD33 x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 701 or comprise half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 757 or comprise half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 (bispecific T cell engager) construct or for use with it. In some embodiments, the drug delivery device may contain AMG 910 or contain a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2x CD3 Another product of the (bispecific T cell engager) construct is used together with it.

[0187] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, which still fall within the scope of the claims defining the invention disclosed herein.

[0188] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes and combinations are deemed to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: a housing defining a longitudinal axis and having an opening; a medicinal storage container comprising a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; a plunger movable toward a distal end of the drug storage container to expel drug from the drug storage container through the delivery member, the plunger comprising a body portion having an inner wall defining an axial chamber, and an outer wall cooperating with the inner wall to define a body thickness of less than 0.6 mm; as well as A plunger biasing member is coupled to the plunger and configured to urge the plunger toward the distal end of the medicinal storage container.

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

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

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

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

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

7. The drug delivery device of claim 1, wherein: The drug storage container is filled or pre-filled with a drug, and wherein the drug includes one of the following: a drug comprising a human IgG1κ antibody, a drug comprising a small interfering RNA (siRNA) that reduces lipoprotein (a), a drug comprising Erenuzumab, Etanercept, Tezelumab, Efavaleukinα, Eloumab, and a drug comprising a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist.

8. A drug delivery device comprising: a housing defining a longitudinal axis and having an opening; a guard movably disposed adjacent to the opening; a medicinal storage container comprising a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; a plunger movable toward a distal end of the drug storage container to expel drug from the drug storage container through the delivery member, the plunger comprising a body portion having an inner wall defining an axial chamber, and an outer wall cooperating with the inner wall to define a body thickness; a plunger biasing member disposed at least partially within the axial chamber, the plunger biasing member configured to urge the plunger toward a distal end of the medicinal storage container; as well as a release member configured to rotate relative to the housing and operably couple the guard and the plunger at least during activation, Wherein, the plunger is configured as: selectively rotate from an initial rotational position to a second rotational position under a biasing force applied by the plunger biasing member; and After rotating from the initial rotational position to the second rotational position, the plunger linearly translates toward the distal end of the medicinal storage container under the biasing force applied by the plunger biasing member.

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

10. The drug delivery device according to any one of claims 8 or 9, wherein: The body portion is made of metal.

11. The drug delivery device according to any one of claims 8 or 9, wherein: The body portion is made of non-metal.

12. The drug delivery device of any one of claims 8 to 9, further comprising a plunger guide fixed relative to the housing, the plunger being at least partially disposed within the plunger guide.

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

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

15. The drug delivery device according to any one of claims 8 to 9, wherein: The thickness of the body is less than 0.6 mm.

16. The drug delivery device according to any one of claims 8 to 9, wherein: The thickness of the body is less than 0.4 mm.

17. The drug delivery device according to any one of claims 8 to 9, wherein: The thickness of the body is less than 0.3 mm.

18. The drug delivery device according to any one of claims 8 to 9, wherein: The thickness of the body is less than 0.2 mm.

19. The drug delivery device according to any one of claims 8 to 9, wherein: The thickness of the body is less than 0.1 mm.

20. The drug delivery device of any one of claims 8 to 9, wherein: The thickness of the body is less than 0.05 mm.

21. The drug delivery device of any one of claims 8 to 9, wherein: The drug storage container is filled or pre-filled with a drug, and wherein the drug includes one of the following: a drug comprising a human IgG1κ antibody, a drug comprising a small interfering RNA (siRNA) that reduces lipoprotein (a), a drug comprising Erenuzumab, Etanercept, Tezelumab, Efavaleukinα, Eloumab, and a drug comprising a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist.

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