Drug delivery device assemblies and accessories for drug delivery devices

Abstract

The present invention provides a drug delivery device assembly including an injector housing, needle assembly, drive assembly, and alignment accessories. [Solution] The injector housing 112 includes a body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The needle assembly includes a syringe barrel for containing the drug, and a needle or cannula, which are at least partially located within the body. The drive assembly is at least partially located within the body and is operably connected to the needle assembly to bias the drug through the needle or cannula during the injection procedure, and the needle or cannula is configured to puncture the patient's skin at the injection site. The alignment accessory 50 includes an accessory body 60 which is selectively connected to the injector housing 112, and an alignment aid 70 configured to assist in aligning the accessory body 60 with the patient's skin at the injection site.

Description

Technical Field

[0001] Cross - reference to Related Applications Priority is claimed to U.S. Provisional Patent Application No. 63 / 109,618, filed November 4, 2020, and U.S. Provisional Patent Application No. 63 / 217,679, filed July 1, 2021, the entire contents of each of these applications being incorporated herein by reference.

[0002] The present disclosure generally relates to drug delivery device assemblies and accessories for drug delivery devices. More particularly, the present disclosure generally relates to an assembly and / or an alignment accessory comprising an accessory body configured to be selectively coupled to an injector housing and an alignment aid configured to maintain a desired alignment of the accessory body with respect to the patient's skin at the injection site.

Background Art

[0003] Drugs are administered to treat various conditions and diseases. Auto - injectors (e.g., pen - type auto - injectors) and on - body injectors provide several advantages in the delivery of agents such as drugs and / or therapies. One advantage can be, for example, the ease of use when compared to previous delivery methods using conventional syringes. Auto - injectors may be used to deliver many different agents having varying viscosities and / or desired amounts.

[0004] It may be desirable for the user of an auto - injector to maintain a particular force level and / or orientation during injection. The IFU of an auto - injector may instruct, encourage, or recommend such an inspection act. For example, a user may be desired or instructed to maintain a constant force or a baseline force during the injection procedure and / or to maintain the auto - injector in a direction perpendicular to the injection site. These steps may increase the likelihood of completion and success of the injection and / or reduce pain or discomfort.

[0005] Furthermore, it may be desirable for the user of the autoinjector to inspect and / or observe certain characteristics of the autoinjector before and / or during use. The autoinjector's Instructions for Use ("IFU") may direct, encourage, or recommend such inspection. For example, the user may wish to or be instructed to inspect the drug through the autoinjector's viewing window, such as by checking for particulate matter, discoloration, or contaminants, before using the autoinjector. The user may wish to or be instructed to observe the viewing window during the injection process, or at least before removing the autoinjector from contact with the patient's skin. More specifically, during the injection procedure, the user may determine when the injection is complete by observing the decrease in drug volume and the biasing of the drug from the drug delivery device by the plunger stopper. These steps may reduce the possibility of premature removal of the device from the delivery site, which could result in insufficient dose delivery due to spraying of the drug onto the skin surface.

[0006] However, some users of auto-injectors may find it difficult, uncomfortable, or otherwise inconvenient to apply the desired force in the desired direction while observing through the viewing window.

[0007] As will be further detailed below, this disclosure describes drug delivery device assemblies and accessories for drug delivery devices, such as autoinjectors, which embody advantageous alternatives to existing systems and methods, and which can address one or more of the challenges or needs described herein while also providing other benefits and advantages. [Overview of the project] [Means for solving the problem]

[0008] A drug delivery device assembly is provided, comprising an injector housing, a needle assembly, a drive assembly, and a positioning accessory. The injector housing may include a body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The needle assembly may include a syringe barrel containing a drug, at least partially disposed within the body, and a needle or cannula. The drive assembly is at least partially disposed within the body and operably coupled to the needle assembly to bias the drug through the needle or cannula during the injection procedure. The needle or cannula is configured to puncture the patient's skin at the injection site. The positioning accessory includes an accessory body configured to be selectively coupled to the injector housing, and a positioning aid configured to assist in aligning the accessory body with the patient's skin at the injection site.

[0009] The alignment aid may be configured to assist in the alignment of the accessory body relative to the patient's skin at the injection site by transmitting information to the user regarding the position of the accessory body relative to the patient's skin at the injection site. Additionally or alternatively, the alignment aid may be configured to assist in the alignment of the accessory body relative to the patient's skin at the injection site by maintaining the position of the accessory body relative to the patient's skin at the injection site.

[0010] The alignment aid may include a first sensor, which may be a contact sensor, configured to detect the position of the accessory body relative to the patient's skin at the injection site. The alignment aid may also include a second, third, and fourth sensor, each of which may be a contact sensor. The four sensors may be arranged at approximately equal intervals in a circular path along the accessory body. The alignment accessory may also include four indicator lights, each operably connected to the four sensors.

[0011] The positioning aid may include a contour portion configured to substantially conform to the contour of the patient's injection site. The positioning aid may also include a fixation portion configured to selectively secure the positioning accessory to the patient. The fixation portion may be an adjustable strap.

[0012] The alignment aid may include a fixing portion, which may contain an adhesive, configured to selectively fix the alignment accessory to the patient. The accessory body may be a ring portion configured to receive a portion of the injector housing.

[0013] Furthermore, a positioning accessory for a drug delivery device is provided, which includes an accessory body configured to be selectively connected to an injector, and a positioning aid configured to assist in positioning the accessory body relative to the patient's skin at the injection site.

[0014] The following description, in conjunction with the attached drawings, should provide a deeper understanding of this disclosure. Some of the drawings have been simplified by omitting selected elements for the purpose of more clearly illustrating other elements. Such omissions of elements in some drawings do not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless explicitly stated in the corresponding written description. [Brief explanation of the drawing]

[0015] [Figure 1] This is a front view of an exemplary drug delivery device that may be used in aspects of this disclosure. [Figure 2A] This is a front view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, including an injector and an accessory having an alignment aid. [Figure 2B] Figure 2A is a top-side perspective view of the alignment aid shown in Figure 2A. [Figure 2C] Figure 2A is a perspective view of the bottom side of the alignment aid. [Figure 2D] Figure 2A is an exploded view of the alignment aid shown. [Figure 2E] It is a cross-sectional view of the alignment aid shown in FIG. 2A. [Figure 2F] It is an upper side perspective view of the assembly in FIG. 2A where three of the four alignment aid indicators are lit. [Figure 3A] It is a perspective view of an accessory having an alignment aid for a drug delivery device according to an aspect of the present disclosure. [Figure 3B] It is a cross-sectional view of a part of a patient's body connected to the alignment aid shown in FIG. 3A. [Figure 3C] It shows an injector before being connected to the accessory shown in FIG. 3B. [Figure 3D] It shows the assembly of FIG. 3B when the injector is fully inserted but not locked. [Figure 3E] It shows the assembly of FIG. 3B when the injector is locked (by rotation) to the accessory. [Figure 4A] It shows an injector according to an aspect of the present disclosure. [Figure 4B] It shows the injector of FIG. 4A where the needle shield is pushed down but not rotated. [Figure 4C] It shows the injector of FIG. 4A where the needle shield is pushed down and rotated. [Figure 4D] It shows an injector before being connected to the alignment aid according to an aspect of the present disclosure. [Figure 4E] It shows the assembly of FIG. 4D when the injector is fully inserted but not locked. [Figure 4F] It shows the assembly of FIG. 4D when the injector is locked (by rotation) to the accessory. [Figure 5A] It is a front view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, including an injector and an accessory having an alignment aid. [Figure 5B] It is a perspective view of the alignment aid shown in FIG. 5A. [Figure 5C]Figure 5A is a perspective view of the alignment aid and injector. [Figure 6] This is a perspective view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, including an injector and an accessory having an alignment aid, with the accessory and alignment aid in a disconnected state. [Figure 7A] This is a perspective view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, which includes an injector, accessories, and an alignment aid in a connected, pre-injection state, and an accessory having an alignment aid, the alignment aid being partially transparent for illustrative purposes. [Figure 7B] Figure 7A is a perspective view of the injector and alignment aid shown, with the accessories and alignment aid connected and in the injection state, and the alignment aid partially transparent for illustrative purposes. [Figure 7C] Figure 7A is a perspective view of the injector and alignment aid shown in the post-injection state with the accessories and alignment aid connected, and the alignment aid is partially transparent for illustrative purposes. [Figure 8A] This is a perspective view of an exemplary drug delivery device assembly according to an aspect of the present disclosure, including an injector and an accessory having an alignment aid to which accessories and alignment aids are connected. [Figure 8B] Figure 8A is a perspective view of the alignment aid shown, with a portion of the alignment aid cut out along line BB for illustrative purposes. [Figure 8C] Figure 8A shows a cross-sectional view of the distal end of the injector and its accessories, in a pre-injection state with the accessories and alignment aid accessories connected. [Modes for carrying out the invention]

[0016] Generally speaking, according to these various embodiments, drug delivery devices (e.g., auto-injectors or other injectors) are connected to or used in conjunction with accessories for alignment assistance. For example, an accessory may be connected to an injector and configured to assist in aligning the accessory body with the patient's skin at the injection site.

[0017] As used herein, the term “approximately” means ±10% of the minimum significant figures. The term “patient’s skin” may refer to the user’s uncovered skin, bare skin, or bare skin, and / or the user’s skin covered by clothing, bandages, or other coverings.

[0018] As shown in Figure 1, an exemplary injector 10 generally includes an injector housing 11 defining a housing 12 which includes a distal end 14, a proximal end 16, and a longitudinal axis "L" extending between the distal end 14 and the proximal end 16. The distal end 14 of the injector 10 includes a substantially cylindrical needle shield 18 that assists in the operation of the injector 10, and a needle cap 19 that covers the needle shield 18 prior to the use of the injector. The needle assembly 20 includes a syringe barrel 22 that contains a drug 24 and is at least partially located within the housing 12 at or near the distal end 14, a plunger stopper 21 located within the syringe barrel 22, and a needle or cannula 26 used to inject the drug 24 into the desired injection site of the patient. In the illustrated example, the needle or cannula 26 may first be positioned within the housing 12 before operation and may protrude through the opening at the distal end 14 during drug delivery.

[0019] The drive assembly 30 is also located at least partially within the housing 12 and is operably connected to the needle assembly 20. The drive assembly 30 may include an actuator button 32 located at or near the proximal end 16 of the housing 12 to initiate the operation of the drive assembly 30. During operation, the user removes the needle cap 19 and places the needle shield 18 at the injection site (e.g., in the user's leg or stomach) to activate the actuator button 32. This activation causes the drive mechanism of the drive assembly 30 (in the form of a spring, motor, hydraulic or pressurizing mechanism) to exert a driving force on a part of the needle assembly 20, such as a plunger stopper 21, which drives the needle or cannula 26 through the opening of the housing 12 and into the patient, and further biases the drug 24 from the syringe barrel 22 toward the patient outside the needle or cannula 26. In some variations, the patient may manually insert the needle or cannula 26, and the operation of the drive mechanism 30 includes only biasing the plunger stopper 21 distally, thereby biasing the drug 24 from the syringe barrel 22 toward the patient out of the needle or cannula 26. The injector 10 does not have to include an actuator button and may be operated solely by the movement of the needle shield 18, rather than adding the movement of the needle shield to the actuator button.

[0020] The injector 10 may include any number of additional features and components that may assist and / or enhance the function of the device. In the illustrated example, a viewing window 36 located in or near the syringe barrel 22 provides a visual indication of the remaining amount of drug being administered. The needle cap 19 shields the needle 26 and prevents unintended activation of the injector 10 and deployment of the needle or cannula 26. The needle shield 18 works to unlock the injection or initiate the injection when the needle shield 18 is pressed against the patient's skin. To actuate the drive assembly 30, a specific force must be applied to the needle shield 18 of the injector 10, and this force is transmitted to the user's skin. In other examples, the injector 10 may additionally include one or more electronic modules that are coupled to the housing 12, the needle assembly 20, the drive assembly 30, and / or any other components of the injector 10. Furthermore, the injector 10 may also include any number of safety mechanisms, such as a retraction mechanism and a damping mechanism.

[0021] This example of the drug delivery device 10 takes the form of an auto-injector or a pen-type injector and can therefore be held in the user's hand throughout the drug delivery period. The drug delivery device 10 may be suitable for self-administration by the patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a physician or nurse). However, various realizations and configurations of the drug delivery device 10 are possible. In other examples, the drug delivery device 10 may be configured as a reusable injector for multiple uses.

[0022] Figure 2A shows a drug delivery device assembly 100, including an injector 110 and an accessory 50, according to an aspect of the present disclosure. The accessory 50 includes an accessory body 60 configured to be selectively coupled to an injector housing 112, and a positioning aid 70 configured to assist in positioning the accessory body 60 relative to the patient's skin at the injection site.

[0023] The accessory body 60 may include two opposing support flanges 62, each of which has an inner surface that substantially conforms to and can receive a portion of the injector housing 112. The flanges 62 may extend substantially in a direction parallel to the longitudinal axis L of the injector and / or substantially perpendicular to the bottom surface of the accessory 50, as will be described in more detail below. The accessory body 60 may also include two opposing locking arms 64 for selectively locking the accessory 50 against the injector 110. For example, the locking arms 64 may lock, connect, or otherwise hold the accessory 50 and the injector 110 together. As a more specific example, the locking arm 64 may have a protrusion 64a that can be received within and / or abut against the surface of the accessory body 60, and the locking arm 64 may be able to bend radially outward while the injector 110 is slid into the accessory body 60, and then move radially inward when the injector 110 is in its fully inserted position. In other words, the locking arm 64 bends outward and then bounces inward. As described above, the protrusion may abut against the surface of the accessory body 60 to selectively lock the accessory body 60 and the injector. For example, when in the locked position (as shown in Figure 2A), the protrusion 64a may abut against the lower (e.g., distal) surface of the window 36 to prevent the injector 110 from moving proximal to the accessory 50 while the locking arm 64 is in the locked position. The locking arm 64 may be released in various ways, such as by the user manually bending (e.g., bending) the locking arm 64 radially outward. Alternatively, the locking arm 64 may be released by the user rotating the injector 110 relative to the accessory 50 so that the protrusion 64a rotates away from the window 36. In such a configuration, the protrusion 64a may have an inclined surface or a rounded edge 64b (Figure 2B) to facilitate the release of the locking arm 64 from the injector 110.In other words, the edge 64b of the locking arm 64 may act as some kind of cam mechanism such that when the injector 110 is rotated relative to the accessory 50 (or vice versa), the locking arm 64 moves simultaneously in the rotational direction and radially outward, thereby causing the locking arm 64 to no longer seat in the window 36 and no longer lock the accessory 50 relative to the injector 110.

[0024] As shown in Figure 2C, the accessory body 60 further includes a cylindrical opening 66 located distal to the support flange 62 and the locking arm 64. The cylindrical opening 66 may receive a distal portion of the injector housing 112, such as a part of the injector 110 adjacent to the needle shield 18. The cylindrical opening 66 may have a diameter and shape that forms a friction fit with the injector 110. In such embodiments, the locking arm 64 may not be necessary, and the injector 110 may be disengaged from the accessory 50 by pulling and / or rotating the injector 110 relative to the accessory 50.

[0025] As described above, the accessory 50 includes an alignment aid 70 configured to assist in aligning the accessory body 60 with the patient's skin at the injection site. For example, the alignment aid 70 shown in Figures 2A to 2F includes at least two main features for assisting in aligning the accessory body 60 with the patient's skin at the injection site: a relatively wide contact surface 76 for engaging the injection site with the alignment sensor 74, and an alignment indicator 72 for informing the user when the assembly 100 is properly aligned with the injection site. Both of these main features are described in more detail below.

[0026] The relatively wide contact surface 76 provides the user with a wider surface to contact their skin (i.e., wider than the distal end of the injector 100) so that the contact force acting on the user's skin can be better distributed, the likelihood of the user's skin buckling or bending during contact can be reduced, and / or it can be easier for the user to hold the drug delivery device in the desired orientation (perpendicular to the injection site). As a more specific example, the diameter of the contact surface 76 is about 4 to 5 times larger than the diameter of the injector 110. Alternatively, the diameter of the contact surface may be any appropriate size, such as 1.5 to 2 times larger than the diameter of the injector, 2 to 3 times larger than the diameter of the injector, 3 to 4 times larger than the diameter of the injector, 4 to 5 times larger than the diameter of the injector, 5 to 6 times larger than the diameter of the injector, or any other appropriate size. The size of the contact surface 76 may also serve other functions, such as helping the user properly position the injector so that the needle is nearly perpendicular to the patient's skin at the injection site. As a more specific example, some users may find it easier to position a larger contact surface (e.g., contact surface 76) with the injection site because it is easier to see and / or feel when the contact surface 76 is parallel to the skin and / or pressed flat against the skin. As another example, the contact surface 76 may also flatten the user's skin at the injection site, thereby resulting in a more predictable and / or reproducible injection experience.

[0027] As described above, a second key feature that aids in alignment is at least one alignment sensor 74 and at least one alignment indicator 72. More specifically, the accessory shown in Figures 2A to 2F includes four alignment sensors 74a, 74b, 74c, and 74d, and four corresponding alignment indicators 72a, 72b, 72c, and 72d. The alignment sensors 74a, 74b, 74c, and 74d may be mechanical sensors having movable components that are pressed down or otherwise moved when the accessory 50 comes into contact with the user's skin. As a more specific example, as best shown in Figures 2D and 2E, the accessory 50 includes an upper housing 80 defining the accessory body 60, a lower housing 82 defining a contact surface 76 and connected to the upper housing 80 by a fastener 84, a plurality of springs 86 positioned between the upper housing 80 and the lower housing 82 to bias the respective components 80, 82 away from each other and create a “floating relationship” between the upper housing 80 and the lower housing 82, a circuit board 88 and a battery 89 operably connected to the switch 74 and indicator 72, four mechanical switches 74a, 74b, 74c, 74d, and four corresponding alignment indicators 72a, 72b, 72c, 72d. The upper housing 80 and the lower housing 82 are connected such that the lower housing 82 “floats” relative to the upper housing 80. In other words, the lower housing 82 can move inward (proximal) within the upper housing 80 at various angles. As a more specific example, the four springs 86 bias the lower housing 82 outward, away from the upper housing 80, but external forces, such as the user pressing the accessory 50 down and against the user's skin, can also push the lower housing 82 inward into the upper housing 80. Furthermore, the "floating" design of the two-part housing means that the lower housing 82 can move so as not to be parallel to the upper housing 80. In other words, if the force applied by the user is not perpendicular to the skin surface at the injection site, the lower housing 82 can be tilted relative to the upper housing 80 or angled relative to the upper housing 80.As a more specific example, the opening in the lower housing 82 that receives the fastener 84 is large enough so that the lower housing 82 can be tilted relative to the fastener 84 and to the upper housing 80.

[0028] The lower housing 82 also includes four projections 83a, 83b, 83c, and 83d, each of which is aligned with one of the four mechanical switches 74a, 74b, 74c, and 74d. When the lower housing 82 is fully extended (for example, in its stationary state), the four projections 83a, 83b, 83c, and 83d do not engage with the four mechanical switches 74a, 74b, 74c, and 74d. When the lower housing 82 is fully depressed (for example, when the user presses the injector and / or accessories down with sufficient force and presses them flat against the user's skin), each of the four projections 83a, 83b, 83c, and 83d contacts the corresponding mechanical switches 74a, 74b, 74c, and 74d. If the lower housing is partially pressed down (for example, if the user presses down the injector at a non-vertical angle or without applying sufficient force), only some of the protrusions will contact the switch, or none of the protrusions will contact it at all.

[0029] When one of the protrusions 83a, 83b, 83c, or 83d makes contact with its mechanical switch 74a, 74b, 74c, or 74d, the corresponding alignment indicators 72a, 72b, 72c, or 72d illuminate. As a result, the user observes the alignment indicators 72a, 72b, 72c, or 72d to determine which part of the bottom housing 82 is sufficiently pressed down. In other words, the user may adjust the force and direction of the injector 110 until all four alignment indicators 72a, 72b, 72c, or 72d are illuminated. Once all four alignment indicators 72a, 72b, 72c, or 72d are illuminated, the user can begin injection.

[0030] The indicator shown in the figure may be a light-emitting diode (LED) light, an organic light-emitting diode (OLED) light, an incandescent lamp, a neon lamp, or any other suitable type of light.

[0031] Figure 2F shows the system in use. For example, indicator lights 72a, 72c, and 72d are illuminated, thereby indicating to the user that these three parts of the lower housing 82 have been pressed down sufficiently to press down the mechanical switches 74a, 74c, and 74d. However, the user may also determine that the injector is not fully aligned based on the fact that indicator light 72b is not illuminated. As a result, the user will notice that they need to angle the injector slightly toward indicator light 72d until all four indicator lights are illuminated.

[0032] In alternative configurations, the sensors may be of a different type other than mechanical switches. As a more specific example, each alignment sensor detects contact, light, and / or other measurable or detectable conditions to determine whether a distinct portion of the contact surface 76 near each alignment sensor is properly engaged and / or aligned with the user's skin. For example, the alignment sensors in such embodiments may be optical sensors capable of detecting and / or measuring the amount of light falling on each sensor position. When a portion of the contact surface is pressed against and / or adjacent to the user's skin, sensors adjacent to that portion of the contact surface are likely to be covered by the user's skin, and little or no light may reach the sensors. When most or all of the contact surface is in contact with the user's skin (i.e., properly aligned), all four sensors are covered. Each alignment sensor is operably coupled to one of four alignment indicators so that the alignment indicators can communicate to the user when a sensor is covered. Therefore, if all four alignment indicators are lit, the user will notice that all four sensors are covered and the injector is properly aligned.

[0033] The alignment indicators 72a, 72b, 72c, and 72d may also have other configurations, such as lights that turn off (instead of turning on) when the contact surfaces are aligned. Alternatively, the indicators do not have to be light-based and may instead be tactile, auditory, or of other types.

[0034] Figures 3A to 3E show a drug delivery device assembly 200, including an injector 210 and an accessory 250, according to an aspect of the present disclosure. The accessory 250 includes an accessory body 260 configured to be selectively coupled to an injector housing 212, and an alignment aid 270 configured to assist in aligning the accessory body 260 with the patient's skin at the injection site.

[0035] The accessory body 260 may include a substantially cylindrical sleeve 262 defining a substantially cylindrical opening 264 configured to receive a portion of the injector housing 212. The sleeve may also have a receiving slot 263 for receiving a locking knob 234 on the auto-injector 210. The sleeve 260 may further include a locking slot 265 perpendicular to the receiving slot 263, which allows the user to rotate the injector 200 to move the locking knob 234 along the locking slot 265, and then the locking knob 234 to prevent longitudinal movement of the injector housing 212 relative to the accessory 250. The locking knob 234 of the injector may also prevent the injector from rolling when disconnected from the accessory.

[0036] As described above, the accessory 250 includes an alignment aid 270 configured to assist in aligning the accessory body 260 with the patient's skin at the injection site. For example, the accessory 250 shown in Figures 3A to 3E includes at least two main feature parts for assisting in aligning the accessory body 260 with the patient's skin at the injection site, namely, a contour part 272 configured to substantially conform to the contour of the patient's skin at the injection site, and a fixing part 274 configured to selectively fix the accessory 250 to the patient.

[0037] The contour portion 272 has a substantially arcuate shape that matches a portion of the curved part of the patient's body, such as the patient's thigh. The contour portion 272 may be flexible to match different shapes of different patients and different body parts, or the contour portion 272 may be relatively rigid and available in different shapes and sizes. The contour portion may have a relatively wide contact surface 276 that contacts the user's skin adjacent to the intended injection site. The relatively wide contact surface 276 may provide the user with a wider surface for contact with the user's skin (i.e., wider than the distal portion of the injector 200) so that the contact force acting on the user's skin can be better distributed, the user's skin 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 in the desired orientation (perpendicular to the injection site). In a more specific example, the length and width of the contact surface 276 are each about 3 to 5 times greater than the diameter of the injector 210. Alternatively, the length and width of the contact surface 276 may be approximately 2 to 6 times larger than the diameter of the injector, approximately 2 to 8 times larger than the diameter of the injector, approximately 2 to 10 times larger than the diameter of the injector, or any other appropriate size. The size of the contact surface 276 may also serve other functions, such as helping the user properly position the injector so that the needle is nearly perpendicular to the patient's skin at the injection site. As a more specific example, some users may find it easier to position a larger contact surface (e.g., contact surface 276) with the injection site because it is easier to see and / or feel when the contact surface 276 is parallel to the skin and / or pressed flat against the skin. As another example, the contact surface 276 may also give the skin a more uniform contour shape in the area of ​​the injection site, thereby resulting in a more predictable and / or reproducible injection experience.

[0038] The fixing portion 274 is connected to both ends of the contour portion 272 and is configured to selectively fix the accessory 250 to the patient. In a more specific example, the fixing portion 274 is a strap configured to selectively fix the contour portion 272 to the patient's body 280 by wrapping it around a portion of the patient's skin 282, such as the patient's thigh. The fixing portion may be an adjustable strap having a variable (adjustable) length, a flexible strap, and / or any other suitable configuration. The strap 274 shown in Figures 3A to 3E has one end 275 that forms a closed loop around one end of the contour portion, and a second end 277 that is a straight portion (not a closed loop) that passes through a portion of the contour portion 272, then folds back and can be fixed to itself by a hook-and-loop fastener or the like.

[0039] Figures 3C to 3E show the injector 210 in the stage of being connected to the accessory 250. Figure 3C shows the accessory 250 connected to the patient so that the collar is aligned with the desired injection site, but before the injector 210 is inserted into the main body 260. Figure 3D shows the assembly 200 when the injector 210 is fully inserted but not locked. Longitudinal movement of the injector 210 may push down the needle shield 218, which may trigger the injection procedure. Figure 3E shows the assembly 200 when the injector 210 is locked (by rotation) to the accessory 250 so that the user can release / let go of the injector without necessarily affecting the effectiveness and / or reproducibility of the injection.

[0040] Figures 4A–4C show another embodiment of the injector 310, which includes a needle shield 318 that can be longitudinally locked against the injector housing 312 (Figure 4C) when the injector 310 is locked against the accessory 350 by rotation. Rotation of the needle shield 318 relative to the injector housing 312 may also trigger the injection procedure. Figures 4D–4G show the injector 310 in the stage of being coupled to the accessory 350. Figure 4D shows the accessory 350 coupled to the patient so that the collar portion is aligned with the desired injection site, but before the injector 310 is inserted into the body 360. Figure 4E shows the assembly 300 when the injector 310 is fully inserted but not locked. Longitudinal movement of the injector 310 may push down the needle shield 318. Figure 4F shows the assembly 300 when the needle shield 318 rotates relative to the injector housing 312, thereby locking the injector 310 against the accessory 350 (by rotation) to trigger the injection procedure. At this point, the user may also be able to release / discard the injector without necessarily affecting the effectiveness and / or reproducibility of the injection.

[0041] Figures 5A to 5C show a drug delivery device assembly 400, including an injector 410 and an accessory 450, according to an aspect of the present disclosure. The accessory 450 includes an accessory body 460 configured to be selectively coupled to an injector housing 412, and an alignment aid 470 configured to assist in aligning the accessory body 460 with the patient's skin at the injection site.

[0042] The accessory body 460 may include a substantially cylindrical ring 460 configured to receive a portion of the injector housing 412. The cylindrical ring 460 may generally be highly rigid and may have a diameter large enough to receive another component of the injector 410, such as the needle shield 418 or the distal portion of the injector housing 412, thereby aligning the injector 410 with the desired injection site. The accessory 450 also includes an alignment aid 470 configured to assist in aligning the accessory body 460 with the patient's skin at the injection site. For example, the accessory 450 shown in Figures 5A-5C includes an adhesive patch configured to selectively adhere to the skin. The alignment aid 470 may have a relatively wide diameter that contacts the user's skin adjacent to the intended injection site so that the contact force acting on the user's skin can be more distributed, so that the user's skin is less likely to buckle or bend during contact, and / or so that the user can more easily hold the drug delivery device in the desired orientation (perpendicular to the injection site). As a more specific example, the diameter of the alignment aid 470 may be 1 to 1.5 times larger than the diameter of the injector 410. Alternatively, the diameter of the alignment aid 470 may be 1.5 to 2 times larger than the diameter of the injector 410, 1.5 to 3 times larger than the diameter of the injector 410, 1.5 to 4 times larger than the diameter of the injector 410, or any other appropriate size. The size of the alignment aid 470 may also serve other functions, such as helping the user properly position the injector so that the needle is nearly perpendicular to the patient's skin at the injection site.

[0043] Figure 6 shows a drug delivery device assembly 500, including an injector 510 and an accessory 550, according to an aspect of the present disclosure. The accessory 550 includes an accessory body 560 configured to be selectively coupled to an injector housing 512, and an alignment aid 570 configured to assist in aligning the accessory body 560 with the patient's skin at the injection site. The accessory 550 may also assist the user in operating the injector 510 by providing a wider, more stable surface that can push down and / or retract the needle shield 518 of the injector into the injector housing 512.

[0044] The accessory body 560 may include a substantially cylindrical sleeve 562 defining a substantially cylindrical opening 564 configured to receive a portion of the injector housing 512. The accessory 550 may also include at least one connecting feature for detachably or selectively connecting the accessory 550 to the injector 510. For example, the accessory body 560 shown in Figure 6 includes at least one connecting feature, such as a pair of connecting arms 566a, 566b, which form a friction-based mating and / or press-fit between the accessory 550 and the injector 510. In a more specific example, the connecting arms 566a, 566b may be spring-loaded arms that apply a radially inward force to the outer surface of the injector housing 512 when the injector is inserted into the accessory body 560, thereby selectively connecting the accessory 550 and the injector 510. As a more specific example, the arms 566a and 566b may have a size and shape (such as a specific thickness) such that when the injector is inserted into the accessory body 560, the arms 566a and 566b bend radially outward, thereby generating a radially inward force.

[0045] As described above, the accessory 550 includes an alignment aid 570 configured to assist in aligning the accessory body 560 with the patient's skin at the injection site. For example, the alignment aid 570 shown in Figure 6 has a relatively wide contact surface 576 that contacts the user's skin adjacent to the intended injection site. The relatively wide contact surface 576 may provide the user with a wider surface to contact their skin (i.e., wider than the distal end of the injector 510) so that the contact force acting on the user's skin can be better distributed, the user's skin may be less likely to buckle or bend during contact, and / or it may be easier for the user to hold the drug delivery device in the desired orientation (perpendicular to the injection site). In a more specific example, the length and width of the contact surface 576 are each about 3 to 5 times greater than the diameter of the injector 510. Alternatively, the length and width of the contact surface 576 may be approximately 2 to 6 times larger than the diameter of the injector, approximately 2 to 8 times larger than the diameter of the injector, approximately 2 to 10 times larger than the diameter of the injector, or any other appropriate size. The size of the contact surface 576 may also serve other functions, such as helping the user properly position the injector so that the needle is nearly perpendicular to the patient's skin at the injection site. As a more specific example, some users may find it easier to position a larger contact surface (e.g., contact surface 576) with the injection site because it is easier to see and / or feel when the contact surface 576 is parallel to the skin and / or pressed flat against the skin. As another example, the contact surface 576 may also give the skin a more uniform contour shape in the area of ​​the injection site, thereby resulting in a more predictable and / or reproducible injection experience.

[0046] After injection is complete, the needle shield 518 of the injector may extend distally (downward in Figure 6) along the longitudinal axis of the injector 510. This movement may encourage or facilitate relative motion between the injector 510 and the accessory 550, thereby facilitating the disconnection between the respective components 510 and 550. For example, the distal movement of the needle shield 518 may bias the accessory away from the housing 512 (or vice versa), thereby potentially overcoming the frictional forces provided by the arms 566a and 566b. In other words, the force biasing the needle shield 518 distally (likely due to spring forces from internal components inside the injector) may be sufficient to partially or completely overcome the radially inward forces from the arms 566a and 566b against the housing 512, thereby facilitating the disconnection between the respective components 510 and 550.

[0047] Figures 7A to 7C show a drug delivery device assembly 600, including an injector 610 and an accessory 650, according to an aspect of the present disclosure. Figure 7A shows the assembly in a connected, pre-injection state, with the injector and accessory connected, and the alignment aid partially transparent for illustrative purposes. Figure 7B shows the connected assembly with the injector and accessory connected during injection (e.g., injection state), with the assembly 600 in contact with / engaged with the patient's skin 682 at the desired injection site. During injection, the needle shield 618 contacts the bottom surface of the accessory 650, thereby facilitating relative movement between the needle shield and the injector housing 612, such as retracting the needle shield 618 into the housing 612 and simultaneously allowing a drug delivery member, such as a needle, to extend through the bottom opening 672 of the accessory. Figure 7C shows the assembly in a connected, post-injection state. The accessory 650 includes an accessory body 660 configured to be selectively coupled to the injector housing 612, and an alignment aid 670 configured to assist in aligning the accessory body 660 with the patient's skin at the injection site. The accessory 650 may also assist the user in operating the injector 610 by providing a wider, more stable surface that can push the needle shield 618 of the injector down and / or retract into the injector housing 612.

[0048] The accessory 650 includes a coupling feature, such as a single coupling arm 666 that operates similarly to the pair of coupling arms 566 shown in Figure 6.

[0049] Figures 8A–8C show a drug delivery device assembly 700, including an injector 710 and an accessory 750, according to an aspect of the present disclosure. The accessory 750 includes an accessory body 760 configured to be selectively coupled to an injector housing 712, and an alignment aid 770 configured to assist in aligning the accessory body 760 with the patient's skin at the injection site. The accessory 750 may also assist the user in operating the injector 710 by providing a wider, more stable surface that can push the needle shield of the injector down and / or retract into the injector housing 712.

[0050] The accessory 750 may also include at least one connecting feature for detachably or selectively connecting the accessory 750 to the injector 710. For example, the accessory body 760 shown in Figures 8A to 8C includes at least one connecting feature, such as a connecting flange 766 that forms a friction-based mating and / or press-fit between the accessory 750 and the injector 710. In a more specific example, the accessory 750 may include four connecting flanges 766a, 766b, 766c, and 766d, each configured to abut and / or engage with the needle shield 718. In a more specific example, the connecting flanges 766a, 766b, 766c, and 766d may be spring-loaded arms that apply a radially outward force to the inner surface of the needle shield 718 when the injector is inserted into the accessory body 760, thereby selectively connecting the accessory 750 to the injector 710. As a more specific example, the connecting flanges 766a, 766b, 766c, and 766d may have a size and shape that allows the flange to bend radially inward when the injector is inserted into the accessory body 760, and that allows the raised portion on the flange to pass through the inner surface of the needle shield.

[0051] 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 distance between the rear end and the outlet to which the needle is attached (but does not include the needle, if present).

[0052] The syringe barrel may have an inner diameter of 4 to 6.5 mm. If the syringe has a nominal maximum filling 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 filling volume of 0.5 ml, the inner diameter of the syringe barrel may be 4 to 5 mm.

[0053] The walls of the syringe barrel may have a thickness of at least 1 mm, approximately 1–3 mm, approximately 1.5–3 mm, or approximately 2.4–2.8 mm. The wall thickness limits or prevents sterile gas from entering the inside of the syringe, thereby minimizing or preventing contact with the liquid formulation contained in the pre-filled syringe.

[0054] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, the drugs specified below, and their generic and biosimilar equivalents, but not limited to those drugs. As used herein, the term "drug" is interchangeable with other similar terms and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, dietary supplements, supplements, biologics, biological agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or restrictive.

[0055] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container, which is either filled with the drug for treatment or pre-filled with the drug. The primary container may be a vial, cartridge, or pre-filled syringe.

[0056] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. Examples of such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastrim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0057] In other embodiments, the drug delivery device may contain, or be used with, an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the 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, for example, by binding to the receptor and causing dimerization of the receptor. Examples of 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. Examples of 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). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0058] Certain exemplary proteins, including their fusions, fragments, analogues, variants, or derivatives, are described below: fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies (also referred to as RANKL-specific antibodies, peptide bodies, etc.), OPGL-specific antibodies, peptide bodies, and related proteins; myostatin-specific peptide bodies, myostatin-binding proteins, peptide bodies, and related proteins; and in particular, IL-4 and / or IL-13 receptor binding. Antibodies, peptide bodies, and related proteins that inhibit the activity mediated by the synthesis of interleukin-1 receptor 1 ("IL1-R1"); antibodies, peptide bodies, and related proteins that inhibit the activity mediated by interleukin-1 receptor 1 ("IL1-R1"); For example, human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as epratuzumab (CAS registry number 501423-23-0), human CD22-specific fully humanized antibodies, humanized and fully human monoclonal antibodies, humanized and fully human antibodies, etc.; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins, including but not limited to anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 This includes, but is not limited to, antibodies, including, but not limited to, fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; and antibodies that inhibit the interaction between B7RP-1 and its native receptor ICOS on activated T cells, such as B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1" as well as B7H2, ICOSL, B7h, and CD275); and includes, but is not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7, particularly humanized monoclonal antibodies, such as IL-15-specific antibodies, peptide bodies, and related proteins;IFN-gamma specific antibodies, peptide bodies, and related proteins, including but not limited to human IFN-gamma specific antibodies, and fully human anti-IFN-gamma antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as ronal antibodies; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-beta-specific antibodies, peptide bodies, and related proteins; amyloid-beta protein-specific antibodies, peptide bodies, and related proteins; and proteins that bind to c-Kit and / or other stem cell factor receptors. c-Kit-specific antibodies, peptide bodies, and related proteins, etc., not limited to those; OX40L-specific antibodies, peptide bodies, and 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, novel hematopoietic stimulating proteins NESP; Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (aremtuzumab, 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, biosimilar of Herceptin®, or other products containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (Registered Trademark) (Panitumumab), Xgeva (Registered Trademark) (Denosumab), Prolia (Registered Trademark) (Denosumab), Immunoglobulin G2 Human Monoclonal Antibody against RANK Ligand, Enbrel (Registered Trademark) (Etanercept, TNF Receptor / Fc Fusion Protein, TNF Blocker), Nplate (Registered Trademark) (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution; Infergen (Registered Trademark) (Interferon Alphacon-1); Natrecor (Registered Trademark) (Nesiritide; Recombinant Human Type B Natriuretic Peptide (hBNP)); Kineret (Registered Trademark) (Anakinra); Leukine (Registered Trademark) (Sargamostim, rhuGM-CSF); LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex(registered trademark) (17-1A, edrecolomab); Trabio(registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem(registered trademark) (IDM-1); OvaRex(registered trademark) (B43.13); Nuvion(registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon(registered trademark) (epoetin beta); Neumega(registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (epoetin alfa); Remicade(registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (absiximab, anti-GP) Ib / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanorimumab); Mvasi® (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark)-(interferon alpha-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); 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 (saltumumab); M200 (boroxiximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1)); anti-BR3 mAb; Anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388); Anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); Anti-CD25 mAb (HuMax-TAC); Anti-CD3 mAb (NI-0401); Adekatumumab; 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).

[0059] In some embodiments, the drug delivery device may contain, or be used in conjunction with, sclerostin antibodies such as romosozumab, brosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), and other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, as well as, in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain, or be used in conjunction with, rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042, or the device may be used with them. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors (TIMPs) of metalloproteinases, such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (Erenumab-aooe), anti-human CGRP-R (calcitonin gene-associated peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to erenumab and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery device of this disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain, or be used with, an APJ macromolecule agonist, such as, but not limited to, apelin or its analogues. In some embodiments, a therapeutically effective amount of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or a TSLP receptor antibody may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain, or be used 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-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain, or be used in conjunction with, Parsabiv® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used in conjunction with, a VEGF antagonist such as a non-antibody VEGF antagonist, and / or a VEGF trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain, or be used in conjunction with, rozibafusp alfa (formerly known as 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, omecamutib mecarbir, small molecule selective cardiac myosin activator, or myotrope, or another product containing small molecule selective cardiac myosin activator that directly targets the cardiac contractile mechanism. In some embodiments, the drug delivery device may contain sotrasib (formerly known as AMG 510), KRAS. G12C Small molecule inhibitors, or KRAS G12CAnother product containing a small molecule inhibitor may be contained or used in conjunction with it. In some embodiments, the drug delivery device may contain or use in conjunction with it tezeperumab, a human monoclonal antibody, or another product containing a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (TSLP). In some embodiments, the drug delivery device may contain or use in conjunction with it AMG 714 that binds to interleukin-15 (IL-15), a human monoclonal antibody, or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or use in conjunction with it AMG 890 that reduces lipoprotein (a), also known as Lp(a), a small interfering RNA (siRNA), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing human IgG1 kappa antibody and / or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing Amjevita® or Amgevita® (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or 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 the half-life extension (HLE) anti-prostate-specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 171, or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 199, or another product containing a half-life extension (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 anti-PD-1 × IL-21 mutaine and / or an 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 the anti-CD33 × 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 with, AMG 427, or another product containing the extended half-life (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used with, AMG 430, or another product containing the anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used with, AMG 506, or another product containing the multispecific FAP × 4-1 BB-targeted DARPin® biologic being studied as a treatment for solid tumors. 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 designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain, or be used with, AMG 56. 2. The drug delivery device may contain, or be used in conjunction with, another product containing the half-life extension (HLE) CD19×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 efavavaluquin alfa (formerly AMG 592) or IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 596 or another product containing the CD3×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 the half-life extension (HLE) anti-CD33×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 the HLE (Hyperlife-Extended Epithelial) anti-B cell maturation antigen (BCMA) × 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 the HLE (Hyperlife-Extended Epithelial Tissue-Like Ligand 3 (DLL3) × 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 the HLE (Hyperlife-Extended Epithelial Tight Junction Constituent Protein Claudin 18.2 × CD3 BiTE® (bispecific T cell engager) construct.

[0060] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The embodiments for carrying out the invention should be interpreted merely as examples and do not describe all possible embodiments of the disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments are still included within the scope of the claims defining the invention as disclosed herein.

[0061] Those skilled in the art will understand that a wide variety of modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations will be interpreted as falling within the scope of the concept of the present invention.

Claims

1. An injector housing having a body with a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, A needle assembly, at least partially disposed within the main body, comprising a syringe barrel for containing a drug, and a needle or cannula, A drive assembly, at least partially located within the main body and operably connected to the needle assembly to bias the drug through the needle or cannula during an injection procedure, wherein the needle or cannula is configured to puncture the patient's skin at the injection site, It is an alignment accessory, An accessory body configured to be selectively connected to the injector housing, A positioning aid configured to assist in positioning the accessory body relative to the patient's skin at the injection site, Alignment accessories and A drug delivery device assembly, including a drug delivery device assembly.

2. The drug delivery device assembly according to claim 1, wherein the alignment assist device is configured to assist in the alignment of the accessory body with respect to the patient's skin at the injection site by transmitting to the user information regarding the position of the accessory body with respect to the patient's skin at the injection site.

3. The drug delivery device assembly according to claim 1 or 2, wherein the alignment assist device is configured to assist in the alignment of the accessory body with respect to the patient's skin at the injection site by maintaining the position of the accessory body with respect to the patient's skin at the injection site.

4. The drug delivery device assembly according to any one of claims 1 to 3, wherein the alignment aid includes a first sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

5. The drug delivery device assembly according to claim 4, wherein the first sensor is a contact sensor.

6. The drug delivery device assembly according to claim 4, further comprising a second sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

7. The drug delivery device assembly according to claim 6, further comprising a third sensor and a fourth sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

8. The drug delivery device assembly according to claim 7, wherein the first sensor, the second sensor, the third sensor, and the fourth sensor are arranged at substantially equal intervals in a circular path along the accessory body.

9. The drug delivery device assembly according to claim 8, wherein the first sensor, the second sensor, the third sensor, and the fourth sensor are contact sensors.

10. The drug delivery device assembly according to claim 9, wherein the alignment accessory further includes four indicator lights, each operably connected to the four sensors.

11. The drug delivery device assembly according to any one of claims 1 to 3, wherein the alignment aid includes a contour portion configured to substantially conform to the contour of the patient's injection site.

12. The drug delivery device assembly according to claim 11, wherein the alignment aid includes a fixing portion configured to selectively fix the alignment accessory to the patient.

13. The drug delivery device assembly according to claim 12, wherein the fixing portion is an adjustable strap.

14. The drug delivery device assembly according to claim 1, wherein the alignment aid includes a fixing portion configured to selectively fix the alignment accessory to the patient.

15. The drug delivery device assembly according to claim 12, wherein the fixing portion includes an adhesive.

16. The drug delivery device assembly according to claim 15, wherein the accessory body is a ring portion configured to receive a part of the injector housing.

17. The drug delivery device assembly according to any one of claims 1 to 3, wherein the alignment aid includes a connecting portion configured to selectively connect the drug delivery device and the alignment accessory.

18. The drug delivery device assembly according to claim 17, wherein the connecting portion is configured to selectively engage the injector body and the alignment accessory.

19. The drug delivery device assembly according to claim 17, wherein the connecting portion is configured to selectively engage the needle shield of the injector with the alignment accessory.

20. An accessory body configured to be selectively connected to an injector, A positioning aid configured to assist in positioning the accessory body relative to the patient's skin at the injection site, and Alignment accessories for drug delivery devices, including those mentioned above.

21. The alignment accessory according to claim 20, wherein the alignment aid is configured to assist in aligning the accessory body with respect to the patient's skin at the injection site by transmitting to the user information regarding the position of the accessory body with respect to the patient's skin at the injection site.

22. The alignment accessory according to claim 20 or 21, wherein the alignment aid is configured to assist in the alignment of the accessory body with respect to the patient's skin at the injection site by maintaining the position of the accessory body with respect to the patient's skin at the injection site.

23. The alignment accessory according to any one of claims 20 to 22, wherein the alignment aid includes a first sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

24. The alignment accessory according to claim 23, wherein the first sensor is a contact sensor.

25. The alignment accessory according to claim 23 or 24, further comprising a second sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

26. The alignment accessory according to any one of claims 23 to 25, further comprising a third sensor and a fourth sensor configured to detect the position of the accessory body relative to the patient's skin at the injection site.

27. The alignment accessory according to claim 26, wherein the first sensor, the second sensor, the third sensor, and the fourth sensor are arranged at substantially equal intervals in a circular path along the accessory body.

28. The alignment accessory according to claim 27, wherein the first sensor, the second sensor, the third sensor, and the fourth sensor are contact sensors.

29. The alignment accessory according to claim 28, further comprising four indicator lights operably connected to each of the four sensors.

30. The alignment aid according to any one of claims 20 to 22, wherein the alignment aid includes a contour portion configured to substantially conform to the contour of the patient's injection site.

31. The alignment aid according to claim 30, wherein the alignment aid includes a fixing portion configured to selectively fix the alignment accessory to the patient.

32. The fixing part is an adjustable strap, as described in claim 31.

33. The alignment aid according to claim 20, wherein the alignment aid includes a fixing portion configured to selectively fix the alignment accessory to the patient.

34. The fixing part includes an adhesive, as described in claim 33.

35. The alignment accessory according to claim 34, wherein the accessory body is a ring portion configured to receive a part of the injector housing.

36. The alignment accessory according to any one of claims 20 to 22, wherein the alignment aid includes a connecting portion configured to selectively connect the drug delivery device and the alignment accessory.

37. The alignment accessory according to claim 36, wherein the connecting portion is configured to selectively engage the injector body and the alignment accessory.

38. The alignment accessory according to claim 37, wherein the connecting portion is configured to selectively engage the needle shield of the injector with the alignment accessory.

Images