Drug delivery device assembly and drug delivery device accessories

Abstract

A drug delivery device assembly is provided that includes an injector housing, a needle assembly, a drive assembly, and a reflective surface. The injector housing may include a body having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, and at least one window. The needle assembly may include a syringe barrel containing a medicament and a needle or cannula, at least a portion of the syringe barrel being positioned so as to be visible through the at least one window. The drive assembly is at least partially disposed within the body and operably coupled to the needle assembly to urge the medicament through the needle or cannula during an injection sequence. The reflective surface is positioned relative to the window to improve visibility of the syringe barrel.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 109,603, filed November 4, 2020, the entire contents of which are expressly incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery device assemblies and accessories for drug delivery devices. In particular, the present disclosure generally relates to assemblies and / or accessories that include a reflective surface positioned relative to a drug delivery device window, such as to enhance visibility of a syringe barrel of the drug delivery device. [Background technology]

[0003] Drugs are administered to treat a variety of conditions and diseases. Autoinjectors (e.g., pen autoinjectors) and on-body injectors offer several advantages in the delivery and / or treatment of pharmaceuticals, such as drugs. One benefit may include ease of use compared to previous delivery methods, such as using a traditional syringe. Autoinjectors may be used to deliver many different medications with varying viscosities and / or desired volumes.

[0004] It may be desirable for a user of an autoinjector to inspect and / or verify certain characteristics of the autoinjector before and / or during use. The autoinjector Instructions for Use ("IFU") may instruct, encourage, or recommend such inspection actions. For example, a user may wish or be instructed to inspect the medication through the autoinjector viewing window before using the autoinjector, such as to check for particulates, discoloration, or contaminants. A user may wish or be instructed to check the viewing window during the injection process, or at least before removing the autoinjector from contact with the patient's skin. More specifically, during an injection sequence, a user can observe the decreasing volume of medication and the advancement of the plunger stopper, which urges the medication from the drug delivery device, to identify when the injection is complete. These steps may reduce the likelihood of prematurely removing the device from the delivery site, which could result in an insufficient dose being delivered due to spraying of the medication onto the skin surface.

[0005] It may be desirable for an autoinjector user to maintain a particular force level and / or orientation during an injection. The autoinjector and accessory IFUs may instruct, facilitate, or recommend such behavior. For example, a user may desire or be instructed to maintain a constant or baseline force and / or maintain the autoinjector in a perpendicular orientation relative to the injection site during an injection sequence. These steps may increase the likelihood of a complete and successful injection and / or reduce pain or discomfort.

[0006] However, some autoinjector users find it awkward, uncomfortable, or otherwise inconvenient to apply the desired force in the desired orientation while viewing the viewing window. For example, some users may prefer to look in a direction generally parallel to and / or along the longitudinal axis of the autoinjector. Such an orientation may allow the user to generally ensure that the autoinjector remains perpendicular to the injection site. However, such an orientation may not be conducive to viewing the viewing window, which is typically located on the side of the autoinjector.

[0007] Another potential problem with existing autoinjector designs includes instability during injection, which can occur even when a user attempts to hold the device in a desired orientation, as discussed above. As another example, instability can result from interactions between the device and the patient's skin. Autoinjectors typically have a feature on the front of the device that acts to unlock or initiate an injection when pressed against the user's skin. The reliability of activation can depend on the condition of the skin or tissue into which the drug is being injected, with less stable tissue resulting in activation difficulties. Activation requires a certain force to be applied to the device, which is transmitted to the user's skin. This force is converted into pressure, and depending on the surface area of ​​the device in contact with the user's skin, this pressure may need to significantly displace the user's tissue until sufficient force is achieved to unlock or initiate the injection. This can result in the autoinjector needing to press harder against the injection site, which can cause significant discomfort and hesitation when administering medication to the patient.

[0008] As described in further detail below, the present disclosure describes drug delivery device assemblies and accessories for drug delivery devices, such as autoinjectors, that embody advantageous alternatives to existing systems and methods, and that may address one or more of the problems or needs described herein as well as provide other benefits and advantages. Summary of the Invention [Means for solving the problem]

[0009] A drug delivery device assembly is provided that includes an injector housing, a needle assembly, a drive assembly, and a reflective surface. The injector housing may include a body having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, and at least one window. The needle assembly may include a syringe barrel containing a medicament and a needle or cannula, at least a portion of the syringe barrel being positioned so as to be visible through the at least one window. The drive assembly is at least partially disposed within the body and operably coupled to the needle assembly to urge the medicament through the needle or cannula during an injection sequence. The reflective surface is positioned relative to the window to improve visibility of the syringe barrel.

[0010] The assembly may include a plunger stopper disposed within the syringe barrel and operatively coupled to the drive assembly to urge the medicament through the needle or cannula during an injection sequence. The reflective surface may be positioned relative to the window to enhance visibility of the plunger stopper during an injection sequence. More particularly, the reflective surface may be positioned relative to the window such that the plunger stopper is visible through the reflective surface from a position along the longitudinal axis proximal to the proximal end of the injector housing during an injection sequence.

[0011] The assembly may include an adapter coupling the reflective surface and the injector housing. The adapter may include a sleeve portion configured to receive at least a portion of the injector housing. The adapter may include a base portion defining a distal portion of the adapter, and the sleeve portion may extend from the base portion generally parallel to the longitudinal axis.

[0012] The reflective surface may generally define a reflector axis such that the reflector axis and the longitudinal axis define an angle between 15 and 75 degrees. The angle may be between 30 and 60 degrees, between 40 and 50 degrees, or about 45 degrees. The reflective surface may include a concave portion that curves about the reflector axis and may be generally aligned with a window. The reflective surface may be a mirror or glass.

[0013] An accessory for a drug delivery device is also provided, including a base portion configured to be operably coupled to a drug delivery device having a window, and a reflective surface extending from the base and positioned relative to the window to improve visibility of the syringe barrel.

[0014] The present disclosure will be better understood from the following description taken in conjunction with the accompanying drawings, in which elements may be selectively omitted or simplified in some drawings to more clearly show other elements. The omission of such elements in some drawings does not necessarily represent the presence or absence of the particular element in any of the illustrative embodiments, unless expressly described in the corresponding written description. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of an exemplary drug delivery device that may be utilized with aspects of the present disclosure. [Figure 2] FIG. 1 is a perspective view of an exemplary accessory for a drug delivery device according to an aspect of the present disclosure having a reflective surface positioned to enhance the visibility of certain components or portions of the drug delivery device. [Figure 3] FIG. 2 is a plan view of the exemplary accessory shown in FIG. [Figure 4] FIG. 1 is a side view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, including an injector having a window and an accessory having a reflective surface positioned relative to the injector to improve visibility of the injector window. [Figure 5]FIG. 10 is a perspective view of another exemplary drug delivery device assembly according to aspects of the present disclosure, in which the injector window and its internal components are visible in a reflective surface. [Figure 6] FIG. 5 is a perspective view of the exemplary drug delivery device assembly shown in FIG. 4 during a later stage of an injection sequence. [Figure 7] FIG. 10 is a perspective view of another exemplary drug delivery device assembly according to aspects of the present disclosure, in which the injector window and its internal components are visible in a reflective surface. [Figure 8] FIG. 8 is a side view of the drug delivery device assembly shown in FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0016] Generally speaking, in accordance with these various embodiments, a drug delivery device (e.g., an autoinjector or other syringe) is coupled to or used in conjunction with an accessory to enhance the visibility of certain components or portions of the drug delivery device. For example, the accessory may include a reflective surface positioned relative to a window of the drug delivery device to enhance the visibility of the syringe barrel.

[0017] As used herein, the term "about" means + / - 10% of the least significant figure. The term "patient's skin" may refer to the user's uncovered, naked, or bare skin and / or the user's skin when covered by clothing, bandages, or other coverings.

[0018] As shown in FIG. 1 , an exemplary injector 10 includes an injector housing 11 that generally defines a housing 12 including a distal end 14, a proximal end 16, and a longitudinal axis L extending between the distal and proximal ends 14, 16. The distal end 14 of the injector 10 includes a generally cylindrical needle shield 18 that aids in actuation of the injector 10 and a needle cap 19 that covers the needle shield 18 prior to use of the injector. A needle assembly 20 is disposed at least partially within the housing 12 at or near the distal end 14 and includes a syringe barrel 22 that contains a medicament 24, a plunger stopper 21 disposed within the syringe barrel 22, and a needle or cannula 26 that is used to inject the medicament 24 into a patient. In the illustrated example, the needle or cannula 26 may be initially positioned within the housing 12 prior to actuation and may protrude through an opening in the distal end 14 during drug delivery.

[0019] A drive assembly 30 is also disposed at least partially within the housing 12 and operatively coupled to the needle assembly 20. The drive assembly 30 may include an actuator button 32 positioned at or near the proximal end 16 of the body 12 that initiates actuation of the drive assembly 30. During operation, a user removes the needle cap 19, places the needle shield 18 against an injection location (e.g., on their leg or stomach), and actuates the actuator button 32. This actuation causes a drive mechanism (in the form of a spring, motor, hydraulic, or pressurized mechanism, etc.) of the drive assembly 30 to exert a driving force on the needle assembly 20, such as the plunger stopper 21, which inserts the needle or cannula 26 through an opening in the housing 12 and into the patient and / or further urges the medicament 24 from the syringe barrel 22, out of the needle or cannula 26 and toward the patient. In some variations, the patient can manually insert the needle or cannula 26, and actuation of the drive mechanism 30 simply involves urging the plunger stopper 21 distally, thereby forcing the medicament 24 from the syringe barrel 22 out the needle or cannula 26 and toward the patient. The injector 10 may not include an actuator button, and instead may be actuated by movement of the needle shield 18 alone, rather than by movement of the actuator button plus the needle shield. The injector 10 may not include an actuator button, and instead may be actuated by movement of the needle shield 18 alone, rather than by movement of the actuator button plus the needle shield.

[0020] The injector 10 may include any number of additional features and components that may aid and / or enhance the functionality of the device. In the illustrated example, one or more knobs 34 protrude from the exterior surface 35 of the housing 12 as an anti-roll mechanism. The one or more knobs 34 may be integrally formed with the housing 12 of the injector 10 or may be coupled to the exterior surface 35 by welding, adhesive, or another adhesive method. Additionally, a viewing window 36 positioned on or near the syringe barrel 22 provides a visual indication of the amount of drug remaining during administration. The needle shield cap protects the needle 26 and prevents unintentional actuation of the injector 10 and deployment of the needle or cannula 26. The needle shield 18 acts to unlock or initiate an injection when the needle shield 18 is pressed against the patient's skin. Activation of the drive assembly 30 requires a specific force to be applied to the needle shield 18 of the injector 10, which is transmitted to the user's skin. In other examples, injector 10 may additionally include one or more electronic modules coupled to housing 12, needle assembly 20, drive assembly 30, and / or any other components of injector 10. Additionally, injector 10 may also include any number of safety mechanisms, such as a retraction mechanism, a damping mechanism, etc.

[0021] This embodiment of the drug delivery device 10 takes the form of an auto-injector or pen injector and can therefore be held in the user's hand for the duration of drug delivery. The drug delivery device 10 may be suitable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). However, various implementations and configurations of the drug delivery device 10 are possible. In other embodiments, the drug delivery device 10 may be configured as a multi-use, reusable injector.

[0022] As shown in FIG. 2, an exemplary accessory 50 according to an embodiment of the present disclosure is illustrated. The accessory 50 may be utilized with an injector such as that shown in FIG. 1. The accessory 50 includes a reflective surface 70 positioned to enhance the visibility of certain components or portions of the drug delivery device. For example, the accessory 50 may enhance the visibility of the plunger stopper 21 during an injection sequence. It may be desirable for a user to check the viewing window 36 during the injection process, or at least before removing the injector 10 from contact with the patient's skin. More specifically, during the injection sequence, the user may observe the decreasing volume of the medicament 24 and / or the plunger stopper 21 urging the medicament 24 from the injector 10 to identify when the injection is complete. Doing so may reduce the likelihood of prematurely removing the device from the delivery site, which could result in an insufficient dose being delivered due to spraying of the medicament onto the skin surface.

[0023] The exemplary accessory 50 shown in FIG. 2 includes an adapter 52 configured to couple with an injector and a flange 54 that defines or supports a reflective surface 70. The adapter 52 includes a base portion 56 that defines a distal portion 58 of the adapter 52 and a sleeve portion 60 that extends from the base portion 56 in a direction generally parallel to the longitudinal axis L of the injector 10 when the injector 10 is coupled with the accessory 50. The base portion 56 provides a user with a larger surface for contacting the user's skin so that contact forces acting on the user's skin may be better distributed, the user's skin may be less likely to buckle or fold during contact, and / or the user may more easily hold the drug delivery device in a desired orientation (perpendicular to the injection site). The accessory 50 may further include a latching component 62 that facilitates selective coupling of the accessory 50 with the injector. For example, the latch component 62 shown in FIG. 2 is a flexible arm having a ridge 64 (FIG. 3) on its inner side that abuts against the distal wall of the viewing window 36 and is configured to prevent movement between the accessory 50 and the injector unless and until the latch component 62 is moved away from the injector.

[0024] Accessory 50 may be a single, integral component having at least one portion that is reflective, namely, reflective surface 70. Alternatively, reflective surface 70 may be a separate component, such as a mirror made from glass, polymer, or metal, that is coupled with the remainder of accessory 50. For example, reflective surface 70 may be overmolded with flange 54 or coupled to flange 54 via adhesive or fasteners.

[0025] The flange 54 and / or reflective surface 70 may generally define a reflector axis R (FIGS. 2 and 4), i.e., an axis that defines the center point of the flange 54. The reflector axis R and the longitudinal axis L define an angle 74, which may be between 15 and 75 degrees, between 30 and 60 degrees, between 40 and 50 degrees, or approximately 45 degrees. The angle 74 may be selected based on several factors, as discussed below. The angle 74 may also be adjustable, as discussed further below. The reflective surface 70 may be flat or contoured. The flange 54 and reflective surface 70 shown in the figures each have a contour, i.e., a concave portion 76 that curves about the reflector axis R. The contour may help to improve visibility of the field of view window by focusing it. The flange 54 may also have curvature in another direction, such as a convex portion 77. Convex portion 77 may have the contour shown in FIG. 2 and may help to improve visibility of the viewing window by focusing it.

[0026] The position of the flange 54 may be fixed relative to the adapter 52, or the flange 54 may be adjustable relative to the adapter 52 to allow a user to adjust the position and / or angle 74 of the reflective surface 70. For example, the flange may have a portion, such as a base portion, that is constructed from a flexible or deformable material. Additionally or alternatively, the flange may be coupled to the adapter via a ball joint, hinge joint, or another adjustable fixture.

[0027] During operation, the accessory 50 may improve the visibility of the plunger stopper 21 during an injection sequence in various ways, such as by increasing and / or modifying the area through which the user can view the plunger stopper 21. For example, with reference to FIG. 1 , a user with their eye in position 102 adjacent to the longitudinal axis L and proximal to the proximal end 16 of the injector 10 will likely be unable to see the viewing window 36 without further assistance. Conversely, a user with their eye in the same position 102 relative to the injector / accessory assembly 110 shown in FIG. 4 will likely be able to see the viewing window 36 through the reflective surface 70, as discussed in more detail below. The position 102 shown in FIGS. 1 and 4 may be a desirable location for designing the angle of the reflector axis R because a user may prefer to direct their gaze (e.g., have a line of sight) in a direction generally parallel to and / or along the longitudinal axis of the autoinjector. Such an orientation may also allow the user to maintain a viewing angle parallel to the direction of force applied to the autoinjector. However, as discussed above, different users may have different preferred lines of sight. To achieve this goal, as discussed above, it may be desirable for the flange to be movable relative to the adapter.

[0028] Another design consideration for the flange location and angle is the user's preferred hand position. For example, during an injection sequence, some users may choose to place their hand near the viewing window, as shown in Figures 5 and 6. The orientation of flange 54, as shown in Figures 5 and 6, allows the user to use this hand orientation while viewing the viewing window through reflective surface 70.

[0029] Figure 4 shows a drug delivery device assembly 100 including an injector 110 and the accessory 50 from Figures 2-3. As discussed above, the angle 74 of the reflective surface 70 may be fixed or adjustable.

[0030] 7 and 8 illustrate another exemplary drug delivery device assembly 200 according to an embodiment of the present disclosure, in which a drug delivery device 210 having an injector window 236 is coupled to an accessory 250 having a reflective surface 270 configured to enhance the visibility of certain components or portions of the drug delivery device 210. For example, the window 236 is visible on the reflective surface 270, as shown in FIG. 7. The accessory 250 shown in FIGS. 7 and 8 includes a disk-shaped adapter 252 defining a cylindrical inner surface 253 for receiving the drug delivery device 210 and a generally circular / donut-shaped reflective surface 270 on an upper (proximal) portion of the adapter 252. The adapter 254 and the drug delivery device 210 may have components for selectively coupling them, such as a press-fit connection, a latch connection, or another suitable selective coupling arrangement. In addition to coupling the reflective surface 270 and the drug delivery device 210, the adapter 252 may also function to provide a larger contact surface area with the injection site, as shown in FIG. 8. For example, because the adapter 252 has a larger diameter than the distal end of the drug delivery device 210, contact forces acting on the user's skin 280 may be more distributed, the user's skin 280 may be less likely to buckle or fold during contact, and / or it may be easier for the user to hold the drug delivery device 210 in a desired orientation. The reflective surface 270 shown in Figures 7 and 8 covers the entire top surface of the accessory 250, thereby giving the user a 360-degree reflective view of the injector, potentially making it easier to improve visibility of the window 236 from various angles.

[0031] The syringe barrel may have a length of 45-85 mm, 60-65 mm, or another suitable length. The length of the syringe barrel is the length between the rear end and the outlet where the needle is attached (but does not include the needle, if present).

[0032] The syringe barrel may have an inner diameter of 4 to 6.5 mm. If the syringe has a nominal maximum fill volume of 1 ml, the inner diameter of the syringe barrel may be 5.5 to 6.5 mm. If the syringe has a nominal maximum fill volume of 0.5 ml, the inner diameter of the syringe barrel may be 4 to 5 mm.

[0033] The wall of the syringe barrel may have a thickness of at least 1 mm, about 1 to 3 mm, about 1.5 to 3 mm, or about 2.4 to 2.8 mm. The wall thickness limits or prevents sterilizing gas from entering the interior of the syringe, thereby minimizing or preventing contact with the liquid formulation contained within the pre-filled syringe.

[0034] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also encompassed. Drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0035] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0036] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0037] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0038] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and antibodies that bind to receptors for IL-4 and / or IL-13, among others. IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which inhibit activity mediated by the binding of IL-4 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 a dimer of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain. human CD22-specific antibodies, including, but not limited to, humanized and fully human monoclonal antibodies, particularly including, but not limited to, human CD22-specific IgG antibodies, such as, for example, the human CD22-specific fully humanized antibody epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including, but not limited to, anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 B-7 related protein 1 specific antibodies, peptibodies, related proteins, etc. (also referred to as "B7RP-1" and B7H2, ICOSL, B7h, and CD275), including but not limited to, antibodies that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including but not limited to, fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1; IL-15 specific antibodies, peptibodies, related proteins, etc., particularly humanized monoclonal antibodies, including but not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7;IFN gamma-specific antibodies, peptibodies, related proteins, and the like, including but not limited to, human IFN gamma-specific antibodies, and fully human anti-IFN gamma antibodies; TALL-1-specific antibodies, peptibodies, related proteins, and the like, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, and the like; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, and the like; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) Hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as monoclonal antibodies; TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-beta-specific antibodies, peptibodies, related proteins, etc.; amyloid-beta protein-specific antibodies, peptibodies, related proteins, etc.; proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, those c-Kit-specific antibodies, peptibodies, related proteins, etc., including but not limited to; OX40L-specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, de novo hematopoietic stimulating protein Protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered trademark) (Panitumumab), Xgeva® (Denosumab), Prolia® (Denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (Etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (Romiplostim), Rilotumumab, Ganitumab, Conatumumab, Brodalumab, Insulin in solution; Infergen® (Interferon alfacon-1); Natrecor® (Nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (Anakinra); Leukine® (Sargamostim, rhuGM-CSF); LymphoCide® (Epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP IL6 / IL6 receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri® (natalizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG1 and the extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; 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 1 fibrogen (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).

[0039] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) molecules, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNF-α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)—N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1), such as aflibercept. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 959 (eculizumab), a biosimilar candidate for Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used in conjunction with rozivacsp alfa (formerly 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 in conjunction with omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the cardiac contractile machinery, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS inhibitor. G12C Small molecule inhibitors, or KRAS G12CThe drug delivery device may contain or be used in conjunction with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used in conjunction with Amjevita™ or Amgevita™ (formerly ABP 501) (a mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product containing a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 160, or another product containing a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or a half-life extended (HLE) bispecific T-cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or IL-21 receptor agonist designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1)-positive cells. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 506, or another product containing a multispecific FAP x 4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 509, or another product containing a bivalent T-cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 562, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing efavalukin alfa (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 596 or a CD3x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell engager) molecule. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 673 or another product containing a half-life extended (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0040] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary, but not limited to, embodiments. The detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0041] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. 1. A drug delivery device assembly comprising: an injector housing having a body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and at least one window; a needle assembly at least partially disposed within the body, the needle assembly including a syringe barrel containing a medicament and a needle or cannula, at least a portion of the syringe barrel positioned so as to be visible through the at least one window; a drive assembly at least partially disposed within the body and operably coupled to the needle assembly to urge the medicament through the needle or cannula during an injection sequence; a reflective surface positioned relative to the window to enhance visibility of the syringe barrel; an adapter that connects the reflective surface and the injector housing; Equipped with Drug delivery device assembly.

2. The drug delivery device assembly of claim 1 , further comprising a plunger stopper disposed within the syringe barrel and operably coupled to the drive assembly to force the medication through the needle or cannula during the injection sequence.

3. The drug delivery device assembly of claim 2 , wherein the reflective surface is positioned relative to the window to enhance visibility of the plunger stopper during the injection sequence.

4. The drug delivery device assembly of claim 3, wherein the reflective surface is positioned relative to the window so that during the injection sequence, the plunger stopper is visible through the reflective surface from a position along the longitudinal axis proximal to the proximal end of the injector housing.

5. The drug delivery device assembly of claim 1 , wherein the adapter includes a sleeve portion configured to receive at least a portion of the injector housing.

6. The drug delivery device assembly of claim 5 , wherein the adapter includes a base portion defining a distal portion of the adapter, and the sleeve portion extends from the base portion generally parallel to the longitudinal axis.

7. A drug delivery device assembly according to any one of claims 1, 5 to 6, wherein the position and / or angle of the reflective surface relative to the adapter is adjustable.

8. 8. The drug delivery device assembly of claim 1, wherein the reflective surface generally defines a reflector axis, the reflector axis and the longitudinal axis defining an angle between 15 and 75 degrees.

9. 9. The drug delivery device assembly of claim 8, wherein the angle is (a) between 30 and 60 degrees, (b) between 40 and 50 degrees, or (c) about 45 degrees.

10. The drug delivery device assembly of any one of claims 8 to 9, wherein the reflective surface includes a concave portion curved about the reflector axis, the concave portion being generally aligned with the window.

11. The drug delivery device assembly of any one of claims 1 to 10, wherein the reflective surface comprises a mirror comprising glass or metal.

12. 1. An accessory for a drug delivery device, comprising: a base portion configured to be operably coupled to the drug delivery device, the drug delivery device comprising: an injector housing having a body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and at least one window; a needle assembly at least partially disposed within the body, the needle assembly including a syringe barrel containing a medicament and a needle or cannula, at least a portion of the syringe barrel positioned so as to be visible through the at least one window; a drive assembly disposed at least partially within the body and operably coupled to the needle assembly to urge the medicament through the needle or cannula during an injection sequence; a reflective surface extending from the base portion and positioned relative to the window to enhance visibility of the syringe barrel; Accessories for drug delivery devices.

13. The accessory of claim 12 , further comprising a sleeve portion configured to receive at least a portion of the injector housing.

14. The accessory of claim 13 , wherein the base portion defines a distal portion accessory, and the sleeve portion extends from the base portion generally parallel to the longitudinal axis.

15. An accessory according to any one of claims 12 to 14, wherein the position and / or angle of the reflective surface relative to the longitudinal axis is adjustable.

16. An accessory according to any one of claims 12 to 15, wherein the reflective surface generally defines a reflector axis, the reflector axis and the longitudinal axis defining an angle between 15 and 75 degrees.

17. An accessory as described in any one of claims 15 to 16, wherein the angle between the reflective surface and the longitudinal axis is (a) between 30 and 60 degrees, (b) between 40 and 50 degrees, or (c) approximately 45 degrees.

18. An accessory according to any one of claims 16 to 17, wherein the reflective surface includes a concave portion curved about the reflector axis, the concave portion being generally aligned with the window.

19. An accessory according to any one of claims 12 to 18, wherein the reflective surface comprises a mirror comprising glass or metal.

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