Accessories for drug injection devices

Abstract

Provided herein are accessories for drug injection devices and methods of injecting a drug using the drug injection devices and the attached accessory. The accessory may comprise a first engagement surface that can engage the needle guard of the drug injection device and a second engagement surface that can engage a lower housing of the drug injection device. The needle guard of the drug injection device may be configured to transition between an extended position in which the needle guard shields a needle of the drug injection device and a retracted position in which the needle guard retracts relative to the lower housing to reveal the needle. When engaged with the corresponding portions of the drug injection device, the accessories described herein can prevent the needle guard of the drug injection device from transitioning from the retracted position to the extended position prior to completing the injection.

Description

ACCESSORIES FOR DRUG INJECTION DEVICESFIELD

[0001] This disclosure relates generally to accessories for drug injection devices, and more specifically to accessories that prevent needle guard lock out prior to completing injection with the drug injection device.BACKGROUND

[0002] Several advancements have been made over the years to help facilitate administration of active pharmaceutical ingredients (APIs) beyond conventional syringe and needle use. Notably, advancements include incorporating safety mechanisms in syringes and other injection devices that shield the needle before and after injection, thereby minimizing concerns related to safety and disposal due to contaminated needles and accidental punctures with needles. For example, manual and automatic injection devices (i.e., injectors) shield the needle by retracting the needle or placing a needle guard around the needle. The needle guard can be spring-loaded to transition between shielding the needle before / after injection and exposing the needle for injection. When the injector is placed on the injection site, the needle guard transitions from an extended position toward a retracted position. When the injector is removed from the injection site, the needle guard transitions to an extended, locked position.

[0003] Automatic injection devices typically require the user to hold the injection device against the injection site for several seconds while the device automatically injects the API. Manual injectors require the user to hold the injection device against the injection site and also require the user to apply a force to an actuator or a plunger of the device to manually inject the API. For instance, U.S. patent number 9,233,213 (“the ’213 patent”), issued on January 12, 2016, the teachings of which are hereby incorporated by reference as if set forth in their entirety herein, discloses examples of manual injection devices. For each device of the ’213 patent, the user applies a force to an actuator that includes a movable upper housing of the injection device to translate the upper housing relative to a lower housing of the device to cause inj ection of the API at the inj ection site. The movement of the upper housing is partially independent of that of the needle guard. When the needle guard is initially extended prior to injection, the upper housing cannot be moved. Once the needle guard is retracted, the user can apply force to the upper housing to cause injection ofthe API atthe injection site. Once the injection is complete (e.g., the upper housing has been moved to a dispensed position), the upper housing is locked with respect to movement relative to the lower housing.

[0004] In administering an API using either auto- or manual injectors, many users, and the elderly in particular, may experience fatigue in their arm or hand from holding the device during the injection, leading them to remove the device prematurely from the injection site, or, in the case of manual injection devices, release the force applied to the device for injecting the API part- way through injection, for example, to change hands or take a break from injection. Releasing the device prior to completion of the injection can cause the above-described spring-loaded needle guard of the drug injection device to extend from the retracted position relative to the lower housing of the injection device and transition to its final extended position. As explained above, in this final extended position, the needle guard is configured to lock out to shield the needle so that the needle cannot be reinserted into the patient, resulting in an incomplete injection. Moreover, if the needle guard is locked out prior to completion of the injection, the upper housing is not locked out, and the user can continue to move the upper housing to dispense the API extracorporeally, resulting in wasted API.SUMMARY

[0005] Needle guards of drug injection devices can prematurely transition from a retracted position that facilitates injection with a needle to a locked, extended position in which the needle is shielded prior to completion of the injection. For example, if the user removes the device from the injection site, swaps the hand holding the device to the injection site, or otherwise releases the force applying the device to the injection site during injection, the spring-loaded needle guard can transition from the retracted position to the locked extended position. The accessories described herein can prevent movement of the needle guard of the drug injection device from the retracted position to the extended position until the injection is complete. The accessories may removably engage the needle guard of the drug injection device and the lower housing of the drug injection device to prevent movement of the needle guard prior to completion of the injection. An upper housing of the drug injection device may engage the accessory when the injection is complete to disengage the accessory from the lower housing and allow the needle guard to transition to the final extended and locked position in which the needle is shielded.

[0006] The accessories described herein may be usable with automatic and / or manual injection devices that include a needle guard moveable between an extended position, in which the needle guard shields a needle, and one or more retracted positions, in which the needle guard is retracted relative to a lower housing of the drug injection device. Without the accessories described herein, if during use of the drug injection device the needle guard prematurely locks out in the extended position, the user may notbe able to complete the injection. For example, the force from the spring- loaded needle guard may cause at least a portion of the needle to retract from the injection site, and in turn, the user may not be able to insert the needle to the intended injection depth or may not be able to reinsert the needle into the injection site at all. The user may not recognize that the needle is not properly inserted and may attempt to complete the injection anyways, at least because the upper housing of the drug injection device that controls injection can still be advanced relative to the lower housing of the device. This erroneous attempt at injection can lead to wasted medication, inaccurate dosing, and spillage of the drug outside of the injection site. In any instance, the needle guard locking out prior to completion of injection can compromise the efficacy of the prescribed drug regimen. Thus, using the accessories described herein in combination with drug injection devices that include needle guards can allow users to release the drug injection device to take a break from injecting, modify their grip on the device, alternate hands applying force to the device, etc. during injection with the drug injection device, and still properly complete the injection.

[0007] In some examples, an accessory for a drug injection device is provided, the accessory comprising: a first engagement surface configured to engage a needle guard of the drug injection device that transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle; and a second engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0008] In some examples, a system is provided, comprising: a drug injection device, comprising: a lower housing containing a barrel fluidly connected to a needle; an upper housing supported relative to the lower housing; and a needle guard configured to transition from an extended position, in which the needle guard extends from the lower housing over the needle, to a retractedposition, in which the needle guard retracts relative to the lower housing to expose the needle; and an accessory attached to the needle guard and comprising an engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0009] In some examples, a method of assembling a drug injection device with an accessory is provided, comprising: attaching the accessory to the drug injection device such that a first engagement surface of the accessory engages a needle guard of the drug injection device, the needle guard configured to transition from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle, and such that a second engagement surface of the accessory engages a lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0010] In some examples, a method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device, comprising: positioning a needle guard of the drug injection device on an injection site, wherein the needle guard transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing to expose the needle; and moving an upper housing of the drug injection device relative to the lower housing of the drug injection device to inject the API at the injection site, wherein an accessory attached to the needle guard comprises an engagement surface that engages the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until the injection is complete.BRIEF DESCRIPTION OF THE FIGURES

[0011] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative examples and the accompanying drawings.

[0012] FIG. 1A illustrates a first perspective view of a first exemplary accessory for a drug injection device, in accordance with some examples.

[0013] FIG. IB illustrates a second perspective view of the first exemplary accessory for a drug injection device, in accordance with some examples.

[0014] FIG. 1C illustrates a side view of the first exemplary accessory for a drug injection device, in accordance with some examples.

[0015] FIG. ID illustrates a front view of the first accessory for a drug injection device, in accordance with some examples.

[0016] FIG. IE illustrates a top view of the first exemplary accessory for a drug injection device, in accordance with some examples.

[0017] FIG. 2A illustrates a cross-sectional view of the first exemplary accessory attached to a drug injection device, in accordance with some examples.

[0018] FIG. 2B illustrates a perspective view of the first exemplary accessory attached to the drug injection device, in accordance with some examples.

[0019] FIG. 3A illustrates a perspective view of a second exemplary accessory attached to a drug injection device, in accordance with some examples.

[0020] FIG. 3B illustrates a front view of the second exemplary accessory attached to the drug injection device, in accordance with some examples.

[0021] FIG. 3C illustrates a side view of the second exemplary accessory attached to the drug injection device, in accordance with some examples.

[0022] FIG. 3D illustrates a cross-sectional view of the second exemplary accessory attached to the drug injection device, in accordance with some examples.

[0023] FIG. 4A illustrates a third exemplary accessory in a first position, in accordance with some examples.

[0024] FIG. 4B illustrates the third exemplary accessory in a second position, in accordance with some examples.

[0025] FIG. 5 A illustrates a first step of a method for assembling a drug injection device with an accessory, in accordance with some examples.

[0026] FIG. 5B illustrates a second step of the method for assembling the drug injection device with the accessory, in accordance with some examples.

[0027] FIG. 5C illustrates a first step of the method for injecting an API using the drug injection device with an accessory, in accordance with some examples.

[0028] FIG. 5D illustrates a second step of the method for injecting an API using the drug injection device with the accessory, in accordance with some examples.

[0029] FIG. 5E illustrates a third step of the method for injecting an API using the drug injection device with the accessory, in accordance with some examples.

[0030] FIG. 6A illustrates an exemplary drug injection device, in accordance with some examples.

[0031] FIG. 6B illustrates a cross-sectional view of the exemplary drug injection device, in accordance with some examples.DETAILED DESCRIPTION

[0032] Accessories for drug injection devices including needle guards and methods of using the drug injection devices with the accessories for injection are described herein. The accessories may engage the needle guard of the drug injection device and a lower housing of the drug injection device to prevent premature movement of the needle guard to a final locked position prior to completion of the injection. Upon completion of the injection, the accessory may be engaged by an upper housing of the drug injection device that is movable relative to the lower housing to inject the API to release the accessory and in turn cause the needle guard to transition to the final extended position to shield the needle.

[0033] The needle guard of the drug injection device (i.e., injector) may be spring-loaded to transition between an extended position, in which the needle guard extends from the lower housing to shield a needle of the drug injection device, and a retracted position, in which the needle guard is retracted relative to the lower housing to expose the needle for injection. The needle guard of the drug injection device is important in preventing accidental needle punctures, crosscontamination, and other safety and disposal concerns associated with exposed needles. However, the needle guard may have drawbacks during injection in that it may transition to the final locked position prior to completing the injection, for example, in the instance the user removes the drug injection device from the injection site, alternates hands applying force to the device, or otherwise releases their grip from the device during injection. In this final locked position, the needle is shielded by the needle guard and the user may be unable to complete the injection. When transitioning to the extended position, the spring-loaded needle guard may cause the needle to retract from the injection site, which the user may be unaware of and may still attempt to complete the injection. This scenario could occur because the upper housing of the drug injection device,which the user moves relative to the lower housing to inject the API at the injection site, may (in some injection devices) still be moved despite the needle guard being locked out. In this instance, the medication may be injected to the incorrect injection depth or may spill outside of the injection site. In any scenario, the needle guard prematurely locking out prior to completion of the injection results in wasted medication and an incomplete treatment regimen.

[0034] Therefore, with the drug injector accessories described herein, the benefits of manual and automatic drug injection devices that include a needle guard can be preserved in that the needle guard can still be utilized following completion of the injection to shield the needle. However, using the drug injection devices with the accessories can improve the treatment regimen by preventing the needle guard from locking the device prior to completion of the injection.

[0035] The following description describes exemplary drug injector accessories with reference to several examples, the features of which are understood to be used in any combination unless stated otherwise. Moreover, as will be explained in greater detail below, it is to be understood that the accessory features described herein may be embodied in a standalone accessory configured to be attached to a drug injection device, or in some examples may be incorporated into the drug injection device itself. Methods of assembling the drug injection device with the accessory and methods of injecting with the aforementioned system are also described herein.Accessories for Drug Injection Devices

[0036] FIGS. 1A-1E illustrate an accessory 100 according to a first example for a drug injection device. FIGS. 2A-2B illustrate a drug injection system 150 comprising the accessory 100 attached to the drug injection device 130. The accessory 100 may removably attach to the drug injection device 130. The accessory 100 may comprise a first engagement surface 102 and a second engagement surface 104. The first engagement surface 102 may be configured to engage a needle guard of a drug injection device (e.g., needle guard 134 of drug injection device 130), and the second engagement surface 104 may be configured to engage a lower housing of a drug injection device (e.g., lower housing 132 of drug injection device 130).

[0037] The needle guard 134 may be configured to transition between one or more extended positions to one or more retracted positions. In an extended position, the needle guard 134 may extend from the lower housing 132 over a needle of the drug injection device 130. In a retracted position, the needle guard 134 may retract relative to the lower housing 132 to expose the needle. In some examples, the needle guard 134 may thread inwards relative to the lower housing 134 orcollapse relative to itself to expose the needle. Thus, by engaging the second engagement surface 104 with the lower housing 132 of the drug injection device, movement of the needle guard 134 from a retracted position to a final extended position can be prevented until an injection of an API is complete.

[0038] When the accessory 100 is attached to the drug injection device 130, movement of the accessory 100 in a proximal direction may cause corresponding movement of the needle guard 134 in the proximal direction to transition the needle guard 134 to a retracted position. For example, when the second engagement surface 104 is engaged with the lower housing 132 of the drug injection device 130, the needle guard 134 may transition from an initial extended position to an at least partially retracted position.

[0039] In some examples, the accessory 100 may be configured to move in the proximal direction as well as in a distal direction toward the distal end of the drug injection device 130 while attached to the drug injection device 130. For example, the second engagement surface 104 may be moveable along the lower housing 132 within a predetermined range of movement limited by one or more features of the lower housing 132. For example, second engagement surface 104 may be an inner surface of accessory 100 comprising one or more protrusions. The one or more protrusions of the second engagement surface 104 may be configured to be received within one or more openings 136 (e.g., windows and / or recesses) of the drug injection device 130. In some examples, the one or more protrusions may attach to the one or more openings 136 in one or more predetermined positions corresponding to the amount of retraction of the needle guard 134. For example, the one or more protrusions may be moveable within the one or more openings 136 in a plurality of predetermined positions that correspond to at least one or more partially retracted positions of the needle guard 134 and a fully retracted position of the needle guard 134.

[0040] As explained in greater detail below with respect to the drug injection device 130 and methods of injecting using the drug injection device 130 with the attached accessory 100, injecting an API may include advancing an upper housing 138 of the drug injection device 130 from a preuse position to a dispensed position. When the drug injection device 130 transitions to the dispensed position, the upper housing 138 may be configured to engage with the second engagement surface 104 of the accessory 100. In this position, at least a portion of the second engagement surface 104 may disengage from the lower housing 132, which in turn can cause theneedle guard 134 to move from the at least partially retracted position to the extended position to shield the needle.

[0041] The first engagement surface 102 may comprise one or more inner surfaces of the accessory 100. For example, the first engagement surface 102 may comprise an inner surface of the accessory 100 that can engage a distal surface of the needle guard 134 of the drug injection device 130, as shown at least in FIG. 2A. In this manner, the first engagement surface 102 may define an opening configured to allow passage of the needle of the drug injection device 130 through the distal end of accessory 100. The opening may in some examples comprise a circular or other cross-sectional shape with a through-hole fit for a needle. In some examples, the first engagement surface 102 may comprise one or more inner side walls of the accessory 100 in addition to or instead of an inner distal end of the accessory 100. In some examples, the first engagement surface 102 may be configured to attach to the needle guard 134 of the drug injection device 130 via a press-fit, snap- fit, slip-fit, threaded connection, adhesive, etc. In some examples, the first engagement surface 102 may comprise one or more resiliently biased tabs and / or moveable pins configured to engage with a corresponding portion (e g., an opening) of the needle guard 134. In some examples, the first engagement surface 102 may not attach to the needle guard 134, and instead may merely contact or mate with the needle guard 134.

[0042] As explained above, in some examples, the second engagement surface 104 may be an inner surface of the accessory 100 comprising one or more protrusions. The one or more protrusions may be configured to be received by one or more openings 136 on the lower housing 132 of the drug injection device 130, as shown at least in FIGS. 2A-2B. In some examples, the opposite scenario may occur in which the second engagement surface 104 comprises one or more openings (e.g., recesses and / or windows) configured to receive one or more corresponding portions (e.g., protrusions) of the drug injection device 130. Combinations of the aforementioned examples may be understood to be encompassed in the scope of this disclosure. For example, the second engagement surface 104 of the accessory may comprise one or more protrusions as well as one or more openings configured to receive one or more protrusions of the drug injection device 130.

[0043] In some examples, a portion of the accessory 100 comprising the second engagement surface 104 (e.g., the one or more protrusions described above) may be resiliently moveable to engage and / or disengage from the lower housing 132 of the drug injection device 130. In attaching the accessory, the engagement surface 104 may be moved away from the engaged position andthen resiliently returned to the engaged position for engagement with the lower housing 132. In detaching the accessory, the engagement surface 104 may be moved away from the engaged position to facilitate removing the accessory 100. In some examples, the aforementioned one or more protrusions may comprise one or more projections, tabs, ball lock pins, or other flexible members configured to removably engage a corresponding portion of the drug injection device 130. In some examples, the accessory 100 may comprise one or more arms 106 extending from a distal portion of the accessory 100. The one or more arms 106 may comprise an inner surface comprising the second engagement surface 104, thereby comprising the one or more protrusions. The one or more arms 106 may be resiliently biased towards an engaged position. For example, as shown in FIGS. 4A-4B, the one or more arms 306 of accessory 300 may be moveable between a natural state (FIG. 4A) and an expanded state (FIG. 4B), for example in attaching the accessory 300 to the drug injection device 130.

[0044] In some examples, as shown in at least FIGS. 1 A-1D, at least a portion of the one or more arms 106 may protrude outward toward a receptacle 116 of the accessory 100. The protrusions of the one or more arms 106 may be received by one or more corresponding openings 136 (e.g., recesses and / or windows) of the drug injection device 130. The protrusion of the one or more arms 106 (or more generally, of a portion of accessory 100 comprising second engagement surface 104) may comprise an actuation surface at a proximal end of the arm 106 that can be at least partially received by the one or more openings 136 of the drug injection device. The actuation surface of the one or more arms 106 may be provided at an angle relative to a central axis of the drug injection device 130 when attached to accessory 100. When the accessory 100 is attached to the drug injection device 130, the actuation surface may extend at an angle from a proximal portion of the arm 106 toward a distal portion of the arm 106 and into the drug injection device 130. The actuation surface may terminate at the second engagement surface 104. In some examples, the second engagement surface 104 may be configured to removably clip to the corresponding portion of the lower housing 132 of drug injection device 130 (e.g., openings 136 on the lower housing 132). The actuation surface of the arm 106 may be configured to engage with a corresponding actuation surface of the upper housing 138 of the drug injection device 130 to disengage the accessory 100 (e.g., the second engagement surface 104 of accessory 100) from the corresponding portion of the lower housing 132 of drug injection device 130 (e.g., openings 136 on the lower housing 132). For example, when the upper housing 138 engages the actuation surface of the one or more arms 106,the second engagement surface 104 of the one or more arms 106 may detach (or unclip) from the one or more openings 136 to disengage the second engagement surface 104 from the lower housing 132. In some examples, the actuation surface of the upper housing 138 may instead or additionally comprise an angled portion for engaging with the second engagement surface 104.

[0045] In an alternative example in which the accessory 100 comprises one or more arms 106 extending from a distal portion of the accessory 100, the one or more arms 106 may comprise one or more openings 108 configured to receive one or more protrusions of the lower housing 132 of the drug injection device 130. In some examples, the openings 108 may not receive a corresponding portion of the drug injection device 130. Rather, the openings 108 may serve at least to visualize contents of a syringe barrel contained within the drug injection device 130. A combination of the aforementioned examples may also be envisaged. For example, in the instance the accessory 100 comprises one or more arms 106, each arm 106 may comprise one or more protrusions as well as one or more openings 108 (e.g., recesses and / or windows) to receive protrusions of the lower housing 132. In another example, one or more arms 106 may comprise one or more openings 108 to receive protrusions of the lower housing 132, whereas a different one or more arms 106 may comprise one or more protrusions.

[0046] In some examples, the accessory 100 may comprise one or more alignment portions configured to guide alignment of the second engagement surface 104 with the lower housing 132 of the drug injection device 130. For example, the accessory 100 may comprise one or more central alignment members 112a and one or more peripheral alignment members 112b on a side of the central alignment member 112a. In some examples, the accessory 100 may comprise a set of alignment portions on one or more sides of the accessory 100. For example, as shown at least in FIGS. 1A-1D, the accessory 100 may comprise one or more arms 106 comprising the second engagement surface 104 and extending from a distal portion of the accessory 100, and one or more alignment portions comprising alignment members 112a, 112b extending from the distal portion of the accessory 100 between each of the one or more arms 106. The alignment portions may comprise one or more openings 114 configured to receive one or more protrusions 133 on the lower housing 132 of the drug injection device 130. For example, the one or more openings 114 of the alignment portions may separate the central alignment members 112a and the one or more peripheral alignment members 112b. In some examples, a given alignment portion of the accessorymay comprise at least two alignment members separated by at least one opening 114 that can receive a protrusion 133 of the drug injection device 130.

[0047] In some examples, the alternative scenario may be envisaged, in which one or more alignment portions of the accessory 100 comprises one or more protrusions configured to be received by one or more openings of the drug injection device 130 to guide alignment of the second engagement surface 104 with the lower housing 132 of the drug injection device 130.

[0048] The accessory 100 may comprise a receptacle 116 configured to receive at least a portion of the drug injection device 130. For example, the receptacle 116 may be configured to receive the needle guard 134 of the drug injection device 130. The shape of the receptacle 116 may be configured to correspond with that of the drug injection device 130. For example, in the instance at least a portion of the drug injection device 130 (e.g., the lower housing 132 and / or needle guard 134) comprises a cylindrical shape, at least the receptacle 116 of accessory 100 may comprise a cylindrical shape. As shown in at least in FIG. IB, the first engagement surface 102 may be at a distal end of the receptacle 116. Moreover, the second engagement surface 104 may surround at least a portion of the receptacle 116. For example, the second engagement surface 104 may surround about 25%, 50%, 75%, 90%, 95%, or 100% of the receptacle 116. In some examples, a first portion of the receptacle 116 may be surrounded by the second engagement surface 104 (e.g., one or more arms 106 comprising the second engagement surface 104), and a second portion of the receptacle 116 may be surrounded by the one or more alignment portions.

[0049] In some examples, the accessory 100 may comprise a skin-engaging surface 110. The skinengaging surface 110 may be at a distal end of the accessory 100 to engage the skin during injection when the accessory 100 is attached to the drug injection device 130. The first engagement surface 102 may be opposite from the skin-engaging surface 110. For example, the skin-engaging surface 110 may comprise an outer surface of the distal end of the accessory 100, whereas the first engagement surface 102 may comprise an inner surface of the distal end of the accessory 100. The surface area of the skin-engaging surface 110 may be variable, for example, to accommodate for comfort of the user during injection. Likewise, the surface area of the first engagement surface 102 configured to engage the needle guard 134 may be variable to distribute the force applied by the user to the drug injection device 130 during injection. The surface area of the skin-engaging surface 110 may be substantially the same as that of first engagement surface 102, or in some embodiments may be greater than that of first engagement surface 102.

[0050] In some examples, the accessory 100 may comprise a transparent material, a semitransparent material, and / or an opaque material comprising one or more cut-outs (e g., openings 108) to allow visualization of the API contained in the drug injection device 130. In some examples, the accessory 100 may comprise one or more of polycarbonate, polypropylene, polyethylene, polyether ether ketone (PEEK), polyphenyl sulfone (PPSU), Polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), Acrylonitrile butadiene styrene (ABS), Acrylonitrile styrene acrylate (ASA), or a mixture of polymers. In some examples, the accessory 100 may comprise medical-grade stainless steel in addition to or instead of one or more of the aforementioned polymers.

[0051] FIGS. 3A-3D illustrate a drug injection system 250 comprising a drug injection device 130 and an injector accessory 200 according to a second example. The accessory 200 may comprise any one or more features of accessory 100 described herein with respect to FIGS. 1A-1E and 2A- 2B. In some examples, accessory 200 may differ from accessory 100 in that the accessory 200 may not comprise one or more alignment portions. In other words, the one or more alignment portions, including one or more alignments members 1 12a, 1 12b and one or more openings 114 may be optional.

[0052] The accessory 200 may additionally or alternatively differ from accessory 100 in the shape of the portion of the accessory that comprises the second engagement surface. For example, in a similar manner as described with respect to accessory 100, the second engagement surface 204 of accessory 200 may comprise an inner surface of the accessory 200. Moreover, the accessory 200 may comprise one or more arms 206 comprising the second engagement surface 204. However, the shape of the one or more arms 206 may be different from that of arms 106. For example, a height of a given arm 206 may be less than that of arm 106 such that the one or more arms 206 does not substantially cover the one or more openings 136 of drug injection device 130, as shown at least in FIG. 3D. In this manner, the one or arms 206 may not comprise one or more openings (e.g., windows) to visualize contents of the barrel contained within the drug injection device 130.

[0053] FIGS. 4A-4B illustrate an accessory 300 for a drug injection device. The accessory 300 may comprise any one or more features of accessories 100, 200 described herein with respect to FIGS. 1A-1E, 2A-2B, and 3A-3D. For example, as shown and described above, the accessory 300 may comprise one or more arms 306 extending from a distal portion of the accessory 300. The one or more arms 306 may comprise the second engagement surface 304. In a similar manner asdescribed herein with respect to accessory 200 illustrated in FIGS. 3A-3D, accessory 300 may not comprise alignment portions (e.g., alignment members 112a, 112b, and openings 114).Drug Injection Devices

[0054] The drug injection devices can include manual and / or automatic drug injection devices used to deliver a variety of active pharmaceutical ingredients (APIs). FIGS. 6A-6B illustrates an exemplary drug injection device 130 comprising a lower housing 132, a needle guard 134, and an upper housing 138 supported relative to the lower housing 132. The lower housing may house, or contain, a container such as a barrel 140 of a syringe or drug cartridge. The barrel 140 may be fluidly connected to a needle 142 for injecting the API at the injection site. As described herein, the needle guard 134 may transition from an extended position in which the needle guard 134 extends from the lower housing 132 over the needle 142, to a retracted position, in which the needle guard 134 retracts relative to the lower housing 132 to expose the needle 142. Alternatively, the needle guard 134 may thread inwards relative to the lower housing 132 or collapse relative to itself to expose the needle 142.

[0055] The lower housing 132 may comprise one or more openings 136 for viewing contents of the syringe barrel 140 within the drug injection device 130. In some examples, the drug injection device 130 may comprise a first opening 136 on first side of lower housing 132 and a second opening 136 on a second side of lower housing 132 opposite the first side. The first opening and / or second opening may extend through the lower housing 132, thereby defining a first window and / or a second window. Alternatively, the first opening and / or the second opening may extend partially into, but not through, the lower housing 132, thereby defining a first recess and / or a second recess. In any instance, the one or more openings 136 may be configured to receive one or more engagement surfaces of the accessories (e.g., second engagement surface 104 of accessory 100). For example, the one or more engagement surfaces 104 may be an inner surface of the accessory 100 comprising one or protrusions that can be inserted to the one or more openings 136.

[0056] The lower housing 132 may comprise one or more protrusions 133. The one or more protrusions 133 may be optionally utilized to properly align the accessory with the drug injection device 130 when assembling the system. For example, as described above, the accessory (e.g., accessory 100) may comprise one or more alignment members 112a, 112b separated by openings 114. The openings 114 may receive the one or more protrusions 133 of the lower housing 132 toguide alignment of the second engagement surface 104 of the accessory 100 with the corresponding one or more openings 136 of lower housing 132.

[0057] The upper housing 138 may be an actuator configured to move relative to the lower housing 132 in a first direction. For example, upper housing 138 may translate distally toward the needle guard 134 when a user applies a force to the upper housing 138. The upper housing 138 may move in the first direction when transitioning from a pre-use position to a dispensed position. In the preuse position, the injection has yet to begin. In the dispensed position, the injection is complete. The upper housing 138 may be coupled to a plunger rod 144 such that moving the upper housing 138 causes the plunger rod 144 to be advanced through the syringe barrel 140, thereby injecting the API contained in the barrel 140 at the injection site via the needle 142 fluidly connected to the syringe barrel 140. As the user moves the upper housing 138, the upper housing 138 may progressively cover the lower housing 132 to indicate a progress of the injection.

[0058] The needle guard 134 may be configured to move relative to the lower housing 132 in a second direction opposite the first direction. For example, the needle guard 134 may translate proximally toward the upper housing 138 when the drug injection device 130 is applied to an injection site and a force directed toward the injection site is applied to the device 130. The needle guard 134 may move in the second direction when transitioning from the extended position to the retracted position. The needle guard 134 may be configured to move in the first direction (i.e., distally) from the retracted position and to a final extended position when the injection is complete. The needle guard 134 may be spring-loaded (i.e., resiliently biased). In this manner, to retract the needle guard 134 into the lower housing 132, the force applied to the device may be greater than the spring force to cause compression of the spring. Decreasing the applied force to a force less than the spring force may cause re-expansion of the spring, thereby causing the needle guard 134 to transition from the lower housing 132 toward the extended position. In some examples, when the applied force is insufficient to overcome the spring force, at least a portion of the needle 142 may withdraw from the injection site. When the drug injection device 130 is properly engaged with the accessories (e.g., accessory 100) described herein, the user need not apply any force to the needle guard 134 to maintain the needle guard 134 in the retracted position. Instead, the accessory maintains the needle guard 134 in the retracted position, thereby applying a counterforce that opposes the spring force of the needle guard 134 to prevent the needle guard 134 from extending. Thus, the only force required by the user may be that necessary to inject the drug (e.g.,in depressing the upper housing 138 towards the lower housing 132), which the user can pause and release at any time during injection without the needle guard 134 prematurely returning to the extended position.

[0059] Example drug injection devices are described in greater detail in U.S. Patent No. 9,233,213, granted January 12, 2016, the entire contents of which is incorporated herein by reference.

[0060] In some examples, the drug injection devices described herein (e.g., drug injection device 130) may comprise one or more features described with respect to the injector accessories (e.g., accessory 100, 200, or 300). For example, lower housing 132 may comprise the accessory. In this example, lower housing 132 may comprise one or more arms (e.g., arms 106) or another body comprising a first engagement surface 102 configured to engage with the needle guard 134 to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0061] In another example, needle guard 134 of the drug injection device may comprise the accessory. For example, a distal end of needle guard 134 may comprise first engagement surface 102, and the one or more arms 106 or another body comprising a second engagement surface 104 may extend from needle guard 134 to engage with lower housing 132 and prevent movement of the needle guard 134 from the retracted position to the extended position prior to completion of the injection.

[0062] In either instance, in a drug injection device comprising one or more features of the accessories described herein, the needle guard 134 may comprise a skin-engaging surface 135 at a distal end of the device that can engage the skin during injection. Moreover, combinations of the aforementioned examples are understood to be reasonably encompassed by the description provided herein. For example, each of the lower housing 132 and the needle guard 134 may comprise one or more features of the accessories described herein to prevent movement of the needle guard to the locked, extended position prior to completion of the injection.Methods of Assembling

[0063] In some examples, a method for assembling a drug injection device with an accessory may be provided. FIGS. 5A-5B may illustrate exemplary steps of assembling a drug injection device with an accessory for preventing movement of a needle guard of the injection device to a locked extended position.

[0064] The method may comprise attaching the accessory (e.g., accessory 100) to the drug injection device (e.g., drug injection device 130) such that a first engagement surface 102 of the accessory 100 engages a needle guard 134 of the drug injection device 130 and a second engagement surface 104 of the accessory 100 engages a lower housing 132 of the drug injection device 130.

[0065] As shown in FIG. 5A, prior to attaching the accessory (e.g., accessory 100, 200, or 300) to the drug injection device 130, the method may comprise positioning the accessory (e.g., a skinengaging surface of the accessory) on or near the injection site. Attaching the accessory and the drug injection device may comprise aligning the drug injection device with the accessory. For example, the drug injection device (e g , needle guard 134 of drug injection device 130) may be inserted into a corresponding receptacle of the accessory such that an engagement surface (e.g., first engagement surface 102) of the accessory is aligned with a corresponding surface of the drug injection device (e.g., a surface of needle guard 134). Once aligned, the accessory may be attached to the needle guard 134, for example, via a press-fit, snap-fit, slip-fit, threaded connection, adhesive, etc.

[0066] Attaching the accessory and the drug injection device may comprise aligning a second engagement surface (e.g., second engagement surface 104 of accessory 100) with a corresponding portion of the drug injection device. For example, the engagement surface 104 may be an inner surface of the accessory comprising one or more protrusions. The one or more protrusions may be configured to be received by one or more openings 136 (e.g., windows and / or recesses) on the lower housing 132 of the drug injection device. Thus, as shown in FIG. 5B, attaching the accessory to the drug injection device may comprise aligning the one or more protrusions with the one or more openings 136 and inserting the protrusions into the openings 136. As described herein, the one or more protrusions may be disposed on one or more arms 106 of the accessory 100. The arms 106 may comprise flexible members that are resiliently biased to removably engage a corresponding portion of the drug injection device 130. For example, as the accessory 100 is attached to the drug injection device 130, the one or more arms 106 may flex outwardly to allow an actuation surface of the one or more projections to engage a corresponding actuation surface of the drug injection device 130. For example, the one or more arms 106 may engage the lower housing 132, and such engagement may cause the arms 106 to flex outwardly. When the actuation surfaces of the accessory 100 and the drug injection device 130 are properly aligned, a biasingforce may cause the one or more arms 106 comprising the one or more protrusions to flex inwardly to an engaged position.

[0067] In some examples, when the drug injection device (e.g., needle guard 134) is inserted to the receptacle of the accessory and a force is applied to the drug injection device against the injection site, the spring force associated with needle guard 134 may be overcome to cause the needle guard 134 to transition from an initial extended position to an at least partially retracted position to allow the one or more engagement surfaces 104 to engage with the one or more openings 136 on lower housing 132. In this manner, movement of the accessory in a proximal direction (e.g., to engage the one or more engagement surfaces 104 with the one or more openings 136) may cause corresponding movement of the needle guard 134 in the proximal direction, thereby transitioning the needle guard 134 to the at least partially retracted position.

[0068] In some examples, aligning the one or more engagement surfaces 104 with the corresponding portion(s) of the lower housing 132 may comprise using one or more alignment portions (e.g., alignment portions 112a, 112b of accessory 100) to guide alignment between the engagement surface 104 and the lower housing 132 of the drug injection device 130. For example, the one or more alignment portions may comprise one or more openings 114 that can receive one or more corresponding protrusions on the lower housing 132 and guide the accessory 100 onto the drug injection device.Methods of Injecting an API

[0069] In some examples, a method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device may be provided. FIGS. 5C-5E illustrate exemplary steps of an API injection method using a drug injection device and accessory. The methods of injecting the API provided herein may encompass any one or more steps provided above with respect to assembling a drug injection device with an accessory. It is to be understood that one or more steps of the method for injecting the API may occur subsequent to the one or more steps described herein for assembling the drug injection device with the accessory.

[0070] In some examples, whether prior to, during, or after attaching the accessory to the drug injection device, the method may include positioning the needle guard 134 on the injection site. As shown in FIG. 5C, when the one or more engagement surfaces 104 are removably engaged with the openings 136 on lower housing 132, needle guard 134 may be positioned in an at least partially retracted state relative to the lower housing 132.

[0071] When the needle guard 134 is retracted and positioned on the injection site, the needle 142 may be injected to the injection site and the user may begin dosing. Injecting the API at the injection site may include moving the upper housing 138 of the drug injection device 130 relative to the lower housing 132, for example, by applying a force to the upper housing 138 to cause the upper housing 138 to translate toward a distal end of the drug injection device 130. As explained herein, the upper housing 138 may be coupled to a plunger rod 144 configured to be advanced through a syringe barrel 140 contained in the drug injection device to cause injection of the API contained in the barrel 140 at the injection site via a needle 142 fluidly connected to the barrel 140 and inserted to the injection site.

[0072] As shown in FIG. 5D, at any time during injection, the user may have the flexibility to change their grip on the device, swap hands applying force to the device, take a break from applying force, remove and reinsert the needle 142 (if desired), etc. without the needle guard 134 re-extending from the lower housing 132 prior to completing the injection.

[0073] In some examples, when dosing is complete, the upper housing 138 may engage with the engagement surface 104 of the accessory 100, thereby causing the engagement surface 104 to disengage from the corresponding portion(s) (e.g., openings 136) of the lower housing 132. FIG. 5E illustrates the engagement surface 104 of the accessory disengaged from the opening 136 of the drug injection device when the injection is complete. In some examples, detaching the engagement surface 104 from the lower housing 132 may cause the accessory to fully detach from the drug injection device 130. In some examples, the engagement surface 104 may detach from the corresponding portion of the lower housing 132 (e.g., one or more openings 136), whereas a first engagement surface 102 may remain attached. In any instance, when the engagement surface 104 disengages from the corresponding portion of lower housing 132, the needle guard 134 may be configured to transition from the at least partially retracted position to a final extended position. The final extended position may be substantially the same as the initial extended position. In some examples, the final extended position may be greater than or less than the initial extended position. In the final extended position, the needle guard 134 may be configured to lock out to shield the needle 142 and prevent accidental needle sticks, cross-contamination, etc.

[0074] It is to be understood that the method of injecting an API as described herein may be reasonably adapted for use with a drug injection device that comprises one or more features of the injector accessories provided herein. For example, the method may not require one or more stepsrelated to attaching the accessory to the drug injection device, as will be understood by one of ordinary skill in the art. Rather, injecting an API using a drug injection device that comprises one or more features of the injector accessories described herein may comprise engaging one or more engagement surfaces with corresponding portions of the drug injection device to prepare the drug injection device for injection. For example, in the instance the needle guard 134 comprises one or more features of the accessories described herein (e.g., one or more arms 106 extending from the needle guard 134), the engagement surface 104 of the one or more arms 106 may be engaged with one or more openings 136 on the lower housing 102 to at least partially retract the needle guard 134. In an alternate example, in the instance the lower housing 132 of the drug injection device 130 comprises one or more features of the accessories described herein (e g , one or more arms 106 extending from lower housing 132), the one or more arms 106 comprising the engagement surface 104 may be engaged with the needle guard 134 to retain the needle guard 134 from fully shielding the needle prior to completion of the injection.

[0075] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0076] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and / or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes, “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0077] The numerical ranges disclosed inherently support any range or value within the disclosed numerical ranges, including the endpoints, even though a precise range limitation is not stated verbatim in the specification because this disclosure can be practiced throughout the disclosed numerical ranges.

[0078] The foregoing description, for the purpose of explanation, has been described with reference to specific examples. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The examples were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various examples with various modifications as are suited to the particular use contemplated.

[0079] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.EMBODIMENTS

[0080] Embodiment 1. An accessory for a drug injection device, the accessory comprising: a first engagement surface configured to engage a needle guard of the drug injection device that transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle; and a second engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0081] Embodiment 2. The accessory of embodiment 1, wherein the accessory is configured to engage the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

[0082] Embodiment 3. The accessory of embodiment 1 or 2, wherein, when the second engagement surface engages with the lower housing of the drug injection device, the needle guard is configured to transition from an initial extended position to an at least partially retracted position.

[0083] Embodiment 4. The accessory of embodiment 3, wherein the second engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with an upper housing of the drug injection device.

[0084] Embodiment 5. The accessory of embodiment 3 or 4, wherein, when the second engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

[0085] Embodiment 6. The accessory of any one of embodiments 1-5, comprising a skin-engaging surface at a distal end of the accessory that is configured to engage the skin during the injection.

[0086] Embodiment 7. The accessory of embodiment 6, wherein the first engagement surface is opposite the skin-engaging surface.

[0087] Embodiment 8. The accessory of any one of embodiments 1-7, wherein the first engagement surface is an inner surface that engages a distal surface of the needle guard of the drug injection device.

[0088] Embodiment 9. The accessory of any one of embodiments 1-8, wherein the second engagement surface is an inner surface comprising one or more protrusions configured to be received by one or more openings on the lower housing of the drug injection device.

[0089] Embodiment 10. The accessory of any one of embodiments 1-9, comprising a receptacle configured to receive at least a portion of the needle guard of the drug injection device therein.

[0090] Embodiment 11. The accessory of embodiment 10, wherein the first engagement surface is at a distal end of the receptacle.

[0091] Embodiment 12. The accessory of embodiment 10 or 11, wherein the second engagement surface surrounds at least a portion of the receptacle.

[0092] Embodiment 13. The accessory of any one of embodiments 1-9, wherein the accessory comprises one or more alignment portions configured to guide alignment of the second engagement surface with the lower housing of the drug injection device.

[0093] Embodiment 14. The accessory of embodiment 13, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0094] Embodiment 15. The accessory of any one of embodiments 1-14, wherein a portion of the accessory comprising the second engagement surface is resiliently moveable to engage and / or disengage from the lower housing of the drug injection device.

[0095] Embodiment 16. The accessory of any one of embodiments 1-15, wherein a portion of the accessory comprising the first engagement surface is configured to engage the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

[0096] Embodiment 17. The accessory of any one of embodiments 1-16, wherein the first engagement surface defines an opening configured to allow passage of the needle of the drug injection device through the accessory.

[0097] Embodiment 18. The accessory of any one of embodiments 1-17, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of an active pharmaceutical ingredient contained in the drug injection device.

[0098] Embodiment 19. The accessory of any one of embodiments 1-18, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, polyether ether ketone (PEEK), polyphenyl sulfone (PPSU), Polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), Acrylonitrile butadiene styrene (ABS), Acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

[0099] Embodiment 20. An assembly for drug injection, comprising: the accessory of any one of embodiments 1-19; and the drug injection device.

[0100] Embodiment 21. The assembly of embodiment 20, wherein the drug injection device comprises an upper housing supported relative to the lower housing.

[0101] Embodiment 22. The assembly of embodiment 21, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

[0102] Embodiment 23. The assembly of any one of embodiments 20-22, wherein the drug injection device is an automatic injection device or a manual injection device.

[0103] Embodiment 24. A system, comprising: a drug injection device, comprising: a lower housing containing a barrel fluidly connected to a needle; an upper housing supported relative to the lower housing, and a needle guard configured to transition from an extended position, in which the needle guard extends from the lower housing over the needle, to a retracted position, in which the needle guard retracts relative to the lower housing to expose the needle; and an accessory attached to the needle guard and comprising an engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0104] Embodiment 25. The system of embodiment 24, wherein the lower housing of the drug injection device comprises the accessory.

[0105] Embodiment 26. The system of embodiment 24, wherein the accessory is removably attached to the needle guard.

[0106] Embodiment 27. The system of embodiment 26, wherein the accessory comprises an inner distal surface that engages a distal surface of the needle guard.

[0107] Embodiment 28. The system of embodiment 26 or 27, wherein the accessory is configured to attach to the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

[0108] Embodiment 29. The system of any one of embodiments 26-28, wherein the accessory comprises one or more alignment portions configured to guide alignment of the engagement surface with the lower housing of the drug injection device.

[0109] Embodiment 30. The system of embodiment 29, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0110] Embodiment 31. The system of any one of embodiments 24-30, wherein the accessory is attached to the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

[0111] Embodiment 32. The system of any one of embodiments 24-31, wherein, when the engagement surface engages with the lower housing of the drug injection device, the needle guard is configured to transition from an initial extended position to an at least partially retracted position.

[0112] Embodiment 33. The system of embodiment 32, wherein the engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with the upper housing of the drug injection device.

[0113] Embodiment 34. The system of embodiment 32 or 33, wherein, when the engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

[0114] Embodiment 35. The system of any one of embodiments 24-34, wherein the accessory comprises a skin-engaging surface at a distal end of the accessory that is configured to engage the skin during the injection.

[0115] Embodiment 36. The system of any one of embodiments 24-35, wherein the engagement surface of the accessory is an inner surface comprising one or more protrusions configured to be received by one or more openings on the lower housing of the drug injection device.

[0116] Embodiment 37. The system of any one of embodiments 24-36, wherein the accessory comprises a receptacle that receives at least a portion of the needle guard.

[0117] Embodiment 38. The system of embodiment 37, wherein the engagement surface of the accessory surrounds at least a portion of the receptacle.

[0118] Embodiment 39. The system of any one of embodiments 24-38, wherein a portion of the accessory comprising the engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

[0119] Embodiment 40. The system of any one of embodiments 24-39, wherein the accessory defines an opening configured to allow passage of the needle of the drug injection device through the accessory.

[0120] Embodiment 41. The system of any one of embodiments 24-40, wherein the upper housing transitions from a pre-use position, in which the injection has yet to begin, to a dispensed position, in which the injection is complete, the upper housing configured to engage with the engagement surface of the accessory in the dispensed position.

[0121] Embodiment 42. The system of any one of embodiments 24-41, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

[0122] Embodiment 43. The system of any one of embodiments 24-42, wherein the drug injection device is an automatic injection device or a manual injection device.

[0123] Embodiment 44. The system of any one of embodiments 24-43, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of an active pharmaceutical ingredient contained in the barrel of the drug injection device.

[0124] Embodiment 45. The system of any one of embodiments 24-44, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, polyether ether ketone (PEEK), polyphenyl sulfone (PPSU), Polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), Acrylonitrile butadiene styrene (ABS), Acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

[0125] Embodiment 46. A method of assembling a drug injection device with an accessory, comprising: attaching the accessory to the drug injection device such that a first engagement surface of the accessory engages a needle guard of the drug injection device, the needle guard configured to transition from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle, and such that a second engagement surface of the accessory engages a lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

[0126] Embodiment 47. The method of embodiment 46, wherein, when the first engagement surface engages the needle guard of the drug injection device, movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

[0127] Embodiment 48. The method of embodiment 46 or 47, wherein, when the second engagement surface engages with the lower housing of the drug injection device, the needle guard transitions from an initial extended position to an at least partially retracted position.

[0128] Embodiment 49. The method of embodiment 48, wherein the second engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with an upper housing of the drug injection device.

[0129] Embodiment 50. The method of embodiment 48 or 49, wherein, when the second engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

[0130] Embodiment 51. The method of any one of embodiments 46-50, wherein the first engagement surface is an inner surface of the accessory, such that attaching the accessory to the drug injection device comprises engaging the inner surface of the accessory with a distal surface of the needle guard of the drug injection device.

[0131] Embodiment 52. The method of any one of embodiments 46-51, wherein the second engagement surface is an inner surface comprising one or more protrusions and the lower housing of the drug injection device comprises one or more corresponding openings, such that attaching the accessory to the drug injection device comprises inserting the one or more protrusions to the one or more openings.

[0132] Embodiment 53. The method of any one of embodiments 46-52, wherein attaching the accessory to the drug injection device comprises inserting at least a portion of the needle guard into a receptacle of the accessory.

[0133] Embodiment 54. The method of embodiment 53, wherein the first engagement surface is at a distal end of the receptacle.

[0134] Embodiment 55. The method of embodiment 53 or 54, wherein the second engagement surface surrounds at least a portion of the receptacle.

[0135] Embodiment 56. The method of any one of embodiments 46-55, wherein attaching the accessory to the drug injection device comprises using one or more alignment portions of the accessory to guide alignment of the second engagement surface with the lower housing of the drug injection device.

[0136] Embodiment 57. The method of embodiment 56, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0137] Embodiment 58. The method of any one of embodiments 46-57, wherein a portion of the accessory comprising the second engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

[0138] Embodiment 59. The method of any one of embodiments 46-48, wherein a portion of the accessory comprising the first engagement surface engages the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

[0139] Embodiment 60. A method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device, comprising: positioning a needle guard of the drug injection device on an injection site, wherein the needle guard transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing to expose the needle; and moving an upper housing of the drug injection device relative to the lower housing of the drug injection device to inject the API at the injection site, wherein an accessory attached to the needle guard comprises an engagement surface that engages the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until the injection is complete.

[0140] Embodiment 61. The method of embodiment 60, wherein the lower housing of the drug injection device comprises the accessory.

[0141] Embodiment 62. The method of embodiment 60, wherein the accessory is removably attached to the drug injection device.

[0142] Embodiment 63. The method of embodiment 62, wherein the accessory comprises an inner distal surface that engages a distal surface of the needle guard.

[0143] Embodiment 64. The method of embodiment 63, wherein the accessory comprises a skinengaging surface that engages skin at the injection site, the skin-engaging surface opposite the inner distal surface of the accessory.

[0144] Embodiment 65. The method of any one of embodiments 62-64, comprising, prior to positioning the needle guard on the injection site, attaching the accessory to the needle guard of the drug injection device.

[0145] Embodiment 66. The method of any one of embodiments 62-65, wherein the accessory is attached to the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

[0146] Embodiment 67. The method of embodiment 65 or 66, wherein the engagement surface is an inner surface comprising one or more protrusions and the lower housing of the drug injection device comprises one or more corresponding openings, such that attaching the accessory to the drug injection device comprises inserting the one or more protrusions to the one or more openings.

[0147] Embodiment 68. The method of any one of embodiments 65-67, wherein attaching the accessory to the drug injection device comprises inserting at least a portion of the needle guard into a receptacle of the accessory.

[0148] Embodiment 69. The method of any one of embodiments 65-68, wherein attaching the accessory to the needle guard of the drug injection device comprises using one or more alignment portions of the accessory to guide alignment of the engagement surface with the lower housing of the drug injection device.

[0149] Embodiment 70. The method of embodiment 69, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0150] Embodiment 71. The method of any one of embodiments 60-70, wherein the accessory is attached to the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

[0151] Embodiment 72. The method of any one of embodiments 60-71, wherein, when the engagement surface engages with the lower housing of the drug injection device, the needle guard transitions from an initial extended position to an at least partially retracted position.

[0152] Embodiment 73. The method of any one of embodiments 60-72, wherein the engagement surface disengages from the lower housing of the drug injection device when engaged with the upper housing of the drug injection device.

[0153] Embodiment 74. The method of embodiment 72 or 73, wherein, when the engagement surface disengages from the lower housing of the drug injection device, the needle guard transitions from the at least partially retracted position to the extended position.

[0154] Embodiment 75. The method of any one of embodiments 60-74, wherein a portion of the accessory comprising the engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

[0155] Embodiment 76. The method of any one of embodiments 60-75, wherein the accessory defines an opening that allows passage of the needle of the drug injection device through the accessory.

[0156] Embodiment 77. The method of any one of embodiments 60-76, wherein the upper housing transitions from a pre-use position, in which the injection has yet to begin, to a dispensed position, in which the injection is complete, and the upper housing engages with the engagement surface of the accessory in the dispensed position.

[0157] Embodiment 78. The method of any one of embodiments 60-77, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

[0158] Embodiment 79. The method of any one of embodiments 60-78, wherein the drug injection device is an automatic injection device or a manual injection device.

[0159] Embodiment 80. The method of any one of embodiments 60-79, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of the API contained in the drug injection device.

Claims

CLAIMSWhat is claimed is:

1. An accessory for a drug injection device, the accessory comprising: a first engagement surface configured to engage a needle guard of the drug injection device that transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle; and a second engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

2. The accessory of claim 1, wherein the accessory is configured to engage the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

3. The accessory of claim 1 or 2, wherein, when the second engagement surface engages with the lower housing of the drug injection device, the needle guard is configured to transition from an initial extended position to an at least partially retracted position.

4. The accessory of claim 3, wherein the second engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with an upper housing of the drug injection device.

5. The accessory of claim 3 or 4, wherein, when the second engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

6. The accessory of any one of claims 1-5, comprising a skin-engaging surface at a distal end of the accessory that is configured to engage the skin during the injection.

7. The accessory of claim 6, wherein the first engagement surface is opposite the skinengaging surface.

8. The accessory of any one of claims 1-7, wherein the first engagement surface is an inner surface that engages a distal surface of the needle guard of the drug injection device.

9. The accessory of any one of claims 1-8, wherein the second engagement surface is an inner surface comprising one or more protrusions configured to be received by one or more openings on the lower housing of the drug injection device.

10. The accessory of any one of claims 1-9, comprising a receptacle configured to receive at least a portion of the needle guard of the drug injection device therein.

11. The accessory of claim 10, wherein the first engagement surface is at a distal end of the receptacle.

12. The accessory of claim 10 or 11, wherein the second engagement surface surrounds at least a portion of the receptacle.

13. The accessory of any one of claims 1-9, wherein the accessory comprises one or more alignment portions configured to guide alignment of the second engagement surface with the lower housing of the drug injection device.

14. The accessory of claim 13, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

15. The accessory of any one of claims 1-14, wherein a portion of the accessory comprising the second engagement surface is resiliently moveable to engage and / or disengage from the lower housing of the drug injection device.

16. The accessory of any one of claims 1-15, wherein a portion of the accessory comprising the first engagement surface is configured to engage the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

17. The accessory of any one of claims 1-16, wherein the first engagement surface defines an opening configured to allow passage of the needle of the drug injection device through the accessory.

18. The accessory of any one of claims 1-17, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of an active pharmaceutical ingredient contained in the drug injection device.

19. The accessory of any one of claims 1-18, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, poly ether ether ketone (PEEK), polyphenyl sulfone (PPSU), Polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), Acrylonitrile butadiene styrene (ABS), Acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

20. An assembly for drug injection, comprising: the accessory of any one of claims 1-19; and the drug injection device.

21. The assembly of claim 20, wherein the drug injection device comprises an upper housing supported relative to the lower housing.

22. The assembly of claim 21, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

23. The assembly of any one of claims 20-22, wherein the drug injection device is an automatic injection device or a manual injection device.

24. A system, comprising: a drug injection device, comprising: a lower housing containing a barrel fluidly connected to a needle; an upper housing supported relative to the lower housing; and a needle guard configured to transition from an extended position, in which the needle guard extends from the lower housing over the needle, to a retracted position, in which the needle guard retracts relative to the lower housing to expose the needle; and an accessory attached to the needle guard and comprising an engagement surface configured to engage the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

25. The system of claim 24, wherein the lower housing of the drug injection device comprises the accessory.

26. The system of claim 24, wherein the accessory is removably attached to the needle guard.

27. The system of claim 26, wherein the accessory comprises an inner distal surface that engages a distal surface of the needle guard.

28. The system of claim 26 or 27, wherein the accessory is configured to attach to the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

29. The system of any one of claims 26-28, wherein the accessory comprises one or more alignment portions configured to guide alignment of the engagement surface with the lower housing of the drug injection device.

30. The system of claim 29, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

31. The system of any one of claims 24-30, wherein the accessory is attached to the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

32. The system of any one of claims 24-31, wherein, when the engagement surface engages with the lower housing of the drug injection device, the needle guard is configured to transition from an initial extended position to an at least partially retracted position.

33. The system of claim 32, wherein the engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with the upper housing of the drug injection device.

34. The system of claim 32 or 33, wherein, when the engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

35. The system of any one of claims 24-34, wherein the accessory comprises a skin-engaging surface at a distal end of the accessory that is configured to engage the skin during the injection.

36. The system of any one of claims 24-35, wherein the engagement surface of the accessory is an inner surface comprising one or more protrusions configured to be received by one or more openings on the lower housing of the drug injection device.

37. The system of any one of claims 24-36, wherein the accessory comprises a receptacle that receives at least a portion of the needle guard.

38. The system of claim 37, wherein the engagement surface of the accessory surrounds at least a portion of the receptacle.

39. The system of any one of claims 24-38, wherein a portion of the accessory comprising the engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

40. The system of any one of claims 24-39, wherein the accessory defines an opening configured to allow passage of the needle of the drug injection device through the accessory.

41. The system of any one of claims 24-40, wherein the upper housing transitions from a preuse position, in which the injection has yet to begin, to a dispensed position, in which the injection is complete, the upper housing configured to engage with the engagement surface of the accessory in the dispensed position.

42. The system of any one of claims 24-41, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

43. The system of any one of claims 24-42, wherein the drug injection device is an automatic injection device or a manual injection device.

44. The system of any one of claims 24-43, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of an active pharmaceutical ingredient contained in the barrel of the drug injection device.

45. The system of any one of claims 24-44, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, poly ether ether ketone (PEEK), polyphenyl sulfone (PPSU), Polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), Acrylonitrile butadiene styrene (ABS), Acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

46. A method of assembling a drug injection device with an accessory, comprising:attaching the accessory to the drug injection device such that a first engagement surface of the accessory engages a needle guard of the drug injection device, the needle guard configured to transition from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing of the drug injection device to expose the needle, and such that a second engagement surface of the accessory engages a lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until an injection is complete.

47. The method of claim 46, wherein, when the first engagement surface engages the needle guard of the drug injection device, movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

48. The method of claim 46 or 47, wherein, when the second engagement surface engages with the lower housing of the drug injection device, the needle guard transitions from an initial extended position to an at least partially retracted position.

49. The method of claim 48, wherein the second engagement surface is configured to disengage from the lower housing of the drug injection device when engaged with an upper housing of the drug injection device.

50. The method of claim 48 or 49, wherein, when the second engagement surface disengages from the lower housing of the drug injection device, the needle guard is configured to transition from the at least partially retracted position to the extended position.

51. The method of any one of claims 46-50, wherein the first engagement surface is an inner surface of the accessory, such that attaching the accessory to the drug injection device comprises engaging the inner surface of the accessory with a distal surface of the needle guard of the drug injection device.

52. The method of any one of claims 46-51, wherein the second engagement surface is an inner surface comprising one or more protrusions and the lower housing of the drug injection device comprises one or more corresponding openings, such that attaching the accessory to the drug injection device comprises inserting the one or more protrusions to the one or more openings.

53. The method of any one of claims 46-52, wherein attaching the accessory to the drug injection device comprises inserting at least a portion of the needle guard into a receptacle of the accessory.

54. The method of claim 53, wherein the first engagement surface is at a distal end of the receptacle.

55. The method of claim 53 or 54, wherein the second engagement surface surrounds at least a portion of the receptacle.

56. The method of any one of claims 46-55, wherein attaching the accessory to the drug injection device comprises using one or more alignment portions of the accessory to guide alignment of the second engagement surface with the lower housing of the drug injection device.

57. The method of claim 56, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

58. The method of any one of claims 46-57, wherein a portion of the accessory comprising the second engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

59. The method of any one of claims 46-48, wherein a portion of the accessory comprising the first engagement surface engages the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

60. A method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device, comprising: positioning a needle guard of the drug injection device on an injection site, wherein the needle guard transitions from an extended position, in which the needle guard extends from a lower housing of the drug injection device over a needle of the drug injection device, to a retracted position, in which the needle guard retracts relative to the lower housing to expose the needle; and moving an upper housing of the drug injection device relative to the lower housing of the drug injection device to inject the API at the injection site, wherein an accessory attached to the needle guard comprises an engagement surface that engages the lower housing of the drug injection device to prevent movement of the needle guard from the retracted position to the extended position until the injection is complete.

61. The method of claim 60, wherein the lower housing of the drug injection device comprises the accessory.

62. The method of claim 60, wherein the accessory is removably attached to the drug injection device.

63. The method of claim 62, wherein the accessory comprises an inner distal surface that engages a distal surface of the needle guard.

64. The method of claim 63, wherein the accessory comprises a skin-engaging surface that engages skin at the injection site, the skin-engaging surface opposite the inner distal surface of the accessory.

65. The method of any one of claims 62-64, comprising, prior to positioning the needle guard on the injection site, attaching the accessory to the needle guard of the drug injection device.

66. The method of any one of claims 62-65, wherein the accessory is attached to the needle guard of the drug injection device via a press-fit, snap-fit, slip-fit, or threaded connection.

67. The method of claim 65 or 66, wherein the engagement surface is an inner surface comprising one or more protrusions and the lower housing of the drug injection device comprises one or more corresponding openings, such that attaching the accessory to the drug injection device comprises inserting the one or more protrusions to the one or more openings.

68. The method of any one of claims 65-67, wherein attaching the accessory to the drug injection device comprises inserting at least a portion of the needle guard into a receptacle of the accessory.

69. The method of any one of claims 65-68, wherein attaching the accessory to the needle guard of the drug injection device comprises using one or more alignment portions of the accessory to guide alignment of the engagement surface with the lower housing of the drug injection device.

70. The method of claim 69, wherein the one or more alignment portions comprises one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

71. The method of any one of claims 60-70, wherein the accessory is attached to the needle guard such that movement of the accessory in a proximal direction causes corresponding movement of the needle guard in the proximal direction to transition the needle guard to the retracted position.

72. The method of any one of claims 60-71, wherein, when the engagement surface engages with the lower housing of the drug injection device, the needle guard transitions from an initial extended position to an at least partially retracted position.

73. The method of any one of claims 60-72, wherein the engagement surface disengages from the lower housing of the drug injection device when engaged with the upper housing of the drug injection device.

74. The method of claim 72 or 73, wherein, when the engagement surface disengages from the lower housing of the drug injection device, the needle guard transitions from the at least partially retracted position to the extended position.

75. The method of any one of claims 60-74, wherein a portion of the accessory comprising the engagement surface is spring-loaded to engage and / or disengage from the lower housing of the drug injection device.

76. The method of any one of claims 60-75, wherein the accessory defines an opening that allows passage of the needle of the drug injection device through the accessory.

77. The method of any one of claims 60-76, wherein the upper housing transitions from a pre-use position, in which the injection has yet to begin, to a dispensed position, in which the injection is complete, and the upper housing engages with the engagement surface of the accessory in the dispensed position.

78. The method of any one of claims 60-77, wherein the upper housing is configured to move relative to lower housing in a first direction and the needle guard is configured to move relative to the lower housing in the first direction and in a second direction opposite the first direction.

79. The method of any one of claims 60-78, wherein the drug injection device is an automatic injection device or a manual injection device.

80. The method of any one of claims 60-79, wherein the accessory comprises a transparent material, a semi-transparent material, or an opaque material comprising one or more cut-outs that allow visibility of the API contained in the drug injection device.

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