Accessory for drug injection device

Abstract

Provided herein are attachments for drug injection devices and methods of injecting drugs using drug injection devices and attached attachments. The attachment may include a first engagement surface configured to engage a needle protector of the drug injection device and a second engagement surface configured to engage a lower housing of the drug injection device. A needle protector of the drug injection device may be configured to transition between an extended position, in which the needle protector shields a needle of the drug injection device, and a retracted position, in which the needle protector is retracted relative to the lower housing to expose the needle. When engaged with a corresponding portion of the drug injection device, the attachments described herein may prevent a needle protector of the drug injection device from transitioning from a retracted position to an extended position prior to completion of an injection.

Description

Technical Field

[0001] This disclosure relates in general to accessories for drug injection devices, and more specifically to accessories for preventing needle protectors from locking before an injection is completed using the drug injection device. Background Technology

[0002] Over the years, several advancements have been made beyond conventional syringes and needles to facilitate the administration of active pharmaceutical ingredients (APIs). Notably, these advancements include the incorporation of safety mechanisms into syringes and other injection devices that shield the needle before and after injection, thereby minimizing safety and disposal-related problems due to contaminated needles and accidental needle punctures. For example, manual and automated injection devices (i.e., syringes) shield the needle by retracting it or by placing a needle protector around it. The needle protector may be spring-loaded to switch between shielding and exposing the needle before / after injection. When the syringe is placed on the injection site, the needle protector shifts from an extended position to a retracted position. When the syringe is removed from the injection site, the needle protector shifts to an extended, locked position.

[0003] Automated injection devices typically require the user to hold the injection device against the injection site for several seconds while the device automatically injects API. Manual injectors require the user to hold the injection device against the injection site and also require the user to apply force to the actuator or plunger of the device to manually inject the API. For example, U.S. Patent No. 9,233,213 (“'213 Patent”), published January 12, 2016 (the teachings of which are incorporated herein by reference, as if set forth herein in their entirety), discloses an example of a manual injection device. For each device in the '213 Patent, the user applies force to an actuator comprising a movable upper housing of the injection device to translate the upper housing relative to a lower housing of the device, thereby injecting API at the injection site. The movement of the upper housing is partially independent of the movement of the needle protector. When the needle protector is initially extended before injection, the upper housing cannot move. Once the needle protector retracts, the user can apply force to the upper housing to inject API at the injection site. Once injection is complete (e.g., the upper housing has moved to the dispensing position), the movement of the upper housing relative to the lower housing is locked.

[0004] When administering APIs using automatic or manual syringes, many users, especially the elderly, may experience arm or hand fatigue from holding the device during injection, causing them to remove the device prematurely from the injection site, or, in the case of manual injection devices, to release the force applied to the device used to administer the API midway through the injection, for example, to switch hands or pause the injection. Releasing the device before the injection is complete allows the aforementioned spring-loaded needle protector of the drug injection device to extend from a retracted position relative to the lower housing of the injection device and change to its final extended position. As described above, in this final extended position, the needle protector is configured to lock to shield the needle, preventing the needle from being reinserted into the patient, thus resulting in incomplete injection. Furthermore, if the needle protector is locked before the injection is complete, the upper housing is not locked, and the user can continue to move the upper housing to dispense API externally, resulting in API waste. Summary of the Invention

[0005] The needle protector of a drug injection device can be prematurely switched from a retracted position, facilitating needle injection, to a locked extended position, in which the needle is shielded until injection is complete. For example, if the user removes the device from the injection site, exchanges the hand holding the device to the injection site, or otherwise releases the force applied to the injection site during injection, the spring-loaded needle protector can switch from the retracted position to the locked extended position. The accessory described herein prevents the needle protector of the drug injection device from moving from the retracted position to the extended position until injection is complete. The accessory removably engages the needle protector of the drug injection device with the lower housing of the drug injection device to prevent movement of the needle protector before injection is complete. When injection is complete, the upper housing of the drug injection device engages the accessory to disengage the accessory from the lower housing and allow the needle protector to switch to a final extended and locked position, in which the needle is shielded.

[0006] The accessory described herein is for use with automated and / or manual injection devices that include a needle protector movable between an extended position and one or more retracted positions, in which the needle protector shields the needle and in which the needle protector retracts relative to the lower housing of the drug injection device. Without the accessory described herein, if the needle protector locks prematurely in the extended position during use of the drug injection device, the user may be unable to complete the injection. For example, a force from a spring-loaded needle protector may cause at least a portion of the needle to retract from the injection site, and consequently, the user may be unable to insert the needle to the intended injection depth or may be unable to reinsert the needle into the injection site at all. The user may not realize that the needle is not properly inserted and may attempt to complete the injection in any way, at least because the upper housing of the drug injection device, which controls injection, can still advance relative to the lower housing of the device. Such erroneous injection attempts may result in medication waste, inaccurate administration, and medication spillage at the injection site. In any case, a needle protector that locks before the injection is completed may impair the effectiveness of the prescribed medication regimen. Therefore, using the accessories described herein in combination with a drug injection device including a needle protector allows the user to release the drug injection device during injection to pause the injection, change their grip on the device, alternate the hands applying force to the device, etc., 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 protector of the drug injection device, the needle protector transitioning from an extended position to a retracted position, in the extended position extending from a lower housing of the drug injection device over the needle of the drug injection device, and in the retracted position retracting 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 the needle protector from moving from the retracted position to the extended position until injection is completed.

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

[0009] In some examples, a method of assembling a drug injection device with an accessory is provided, the method comprising: attaching the accessory to the drug injection device such that a first engagement surface of the accessory engages a needle protector of the drug injection device, the needle protector being configured to transition from an extended position to a retracted position, in the extended position extending from a lower housing of the drug injection device over the needle of the drug injection device, and in the retracted position retracting 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 the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until injection is completed.

[0010] In some examples, a method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device includes: positioning a needle protector of the drug injection device at an injection site, wherein the needle protector is rotated from an extended position to a retracted position, in which the needle protector extends from a lower housing of the drug injection device over the needle of the drug injection device, and in the retracted position, the needle protector is retracted 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 attachment to the needle protector includes an engagement surface that engages the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until the injection is completed. Attached Figure Description

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

[0012] Figure 1A A first perspective view is shown, illustrating a first exemplary accessory for a drug injection device according to some examples.

[0013] Figure 1B A second perspective view is shown, illustrating a first exemplary accessory for a drug injection device according to some examples.

[0014] Figure 1C A side view of a first exemplary accessory for a drug injection device, according to some examples, is shown.

[0015] Figure 1D A front view of a first accessory for a drug injection device, according to some examples, is shown.

[0016] Figure 1E A top view of a first exemplary accessory for a drug injection device, according to some examples, is shown.

[0017] Figure 2A A cross-sectional view is shown, according to some examples, of a first exemplary attachment to a drug injection device.

[0018] Figure 2B A perspective view illustrating a first exemplary attachment to a drug injection device according to some examples is shown.

[0019] Figure 3A A perspective view illustrating a second exemplary attachment to a drug injection device, according to some examples.

[0020] Figure 3B A front view of a second exemplary attachment to a drug injection device, according to some examples, is shown.

[0021] Figure 3C A side view is shown of a second exemplary attachment to a drug injection device, according to some examples.

[0022] Figure 3D A cross-sectional view is shown, according to some examples, of a second exemplary attachment to a drug injection device.

[0023] Figure 4A A third exemplary attachment in the first position is illustrated according to some examples.

[0024] Figure 4B A third exemplary attachment in the second position is illustrated according to some examples.

[0025] Figure 5A The first step of a method for assembling a drug injection device with accessories, according to some examples, is illustrated.

[0026] Figure 5B The second step of a method for assembling a drug injection device with accessories, according to some examples, is illustrated.

[0027] Figure 5C The first step of a method for injecting an API using a drug injection device and accessories, according to some examples, is illustrated.

[0028] Figure 5D The second step of a method for injecting an API using a drug injection device and accessories, according to some examples, is illustrated.

[0029] Figure 5E The third step of a method for injecting an API using a drug injection device and accessories, according to some examples, is illustrated.

[0030] Figure 6A An exemplary drug injection device is illustrated according to some examples.

[0031] Figure 6B A cross-sectional view of an exemplary drug injection device is shown according to some examples. Detailed Implementation

[0032] This document describes an accessory for a drug injection device including a needle protector and a method of using a drug injection device with an accessory for injection. The accessory engages the needle protector of the drug injection device and the lower housing of the drug injection device to prevent the needle protector from prematurely moving to its final locked position before injection is completed. Upon completion of injection, the accessory is engaged by the upper housing of the drug injection device (which is movable relative to the lower housing to inject the API), thereby releasing the accessory and subsequently causing the needle protector to retract to its final extended position to shield the needle.

[0033] The needle protector of a drug injection device (i.e., a syringe) may be spring-loaded and switch between an extended position and a retracted position. In the extended position, the needle protector extends from the lower housing to cover the needle of the drug injection device. In the retracted position, the needle protector retracts relative to the lower housing to expose the needle for injection. The needle protector of a drug injection device is important in preventing accidental needle punctures, cross-contamination, and other safety and disposal issues associated with an exposed needle. However, the needle protector can have disadvantages during injection because it may switch to a final locked position before the injection is completed, for example, if the user removes the drug injection device from the injection site, alternates force on the device, or otherwise releases their grip on the device during injection. In the final locked position, the needle is covered by the needle protector, and the user may not be able to complete the injection. When switched to the extended position, the spring-loaded needle protector retracts the needle from the injection site, which the user may not be aware of and may still attempt to complete the injection. This scenario can occur because, even though the needle protector is locked, the upper housing of the drug injection device (in some devices) may still move relative to the lower housing to inject the API at the injection site. In this case, the medication may be injected at the incorrect depth or may spill over into the injection site. In any scenario, prematurely locking the needle protector before the injection is complete leads to medication waste and an incomplete treatment plan.

[0034] Therefore, by using the drug injector accessory described herein, the benefits of both manual and automated drug injection devices, including a needle protector, can be retained, as the needle protector can still be used to cover the needle after injection is complete. However, using a drug injection device with the accessory can improve the treatment protocol by preventing the needle protector from locking the device before injection is complete.

[0035] The following description illustrates exemplary drug injector accessories with reference to several examples, and unless otherwise stated, their features are to be understood as being used in any combination. Furthermore, as will be elaborated in more detail below, it should be understood that the accessory features described herein may be embodied in a separate accessory configured to attach to a drug injection device, or in some examples may be integrated into the drug injection device itself. This document also describes methods for assembling the drug injection device with the accessories and methods for injection using the aforementioned system.

[0036] Accessories for drug injection devices

[0037] Figures 1A to 1E Annex 100 is illustrated according to a first example of a drug injection device. Figures 2A to 2B An example of a drug injection system 150 is illustrated, including an accessory 100 attached to a drug injection device 130. The accessory 100 is removably attached to the drug injection device 130. The accessory 100 may include a first engagement surface 102 and a second engagement surface 104. The first engagement surface 102 may be configured to engage a needle protector of the drug injection device (e.g., a needle protector 134 of the drug injection device 130), and the second engagement surface 104 may be configured to engage a lower housing of the drug injection device (e.g., a lower housing 132 of the drug injection device 130).

[0038] The needle protector 134 can be configured to switch between one or more extended positions and one or more retracted positions. In the extended position, the needle protector 134 extends from the lower housing 132 over the needle of the drug injection device 130. In the retracted position, the needle protector 134 retracts relative to the lower housing 132 to expose the needle. In some examples, the needle protector 134 may be inserted inward relative to the lower housing 134 or folded 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, the needle protector 134 is prevented from moving from the retracted position to the final extended position until the API injection is completed.

[0039] When the accessory 100 is attached to the drug injection device 130, movement of the accessory 100 in the proximal direction can cause a corresponding movement of the needle protector 134 in the proximal direction to change the needle protector 134 to a retracted position. For example, when the second engagement surface 104 engages with the lower housing 132 of the drug injection device 130, the needle protector 134 can change from an initial extended position to at least a partially retracted position.

[0040] In some examples, the attachment 100 may be configured to move proximally and distally toward the distal end of the drug injection device 130 when attached to it. For example, the second engagement surface 104 may be movable along the lower housing 132 within a predetermined range of movement limited by one or more features of the lower housing 132. For example, the second engagement surface 104 may be an inner surface of the attachment 100 including one or more protrusions. 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, one or more protrusions may be attached to one or more openings 136 at one or more predetermined locations corresponding to one or more partial retraction positions and a fully retracted position of the needle protector 134. For example, one or more protrusions may be movable within one or more openings 136 at multiple predetermined locations corresponding to at least one or more partially retracted positions and a fully retracted position of the needle protector 134.

[0041] As described below in more detail with respect to the drug injection device 130 and the method of injection using the drug injection device 130 with the attached accessory 100, injecting the API may include advancing the upper housing 138 of the drug injection device 130 from a pre-use position to a dispensing position. When the drug injection device 130 is moved to the dispensing 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 allows the needle protector 134 to move from a at least partially retracted position to an extended position to shield the needle.

[0042] The first engagement surface 102 may include one or more inner surfaces of the attachment 100. For example, the first engagement surface 102 may include an inner surface of the attachment 100 that may engage the distal surface of the needle protector 134 of the drug injection device 130, such as at least in Figure 2AAs shown in the diagram. In this way, the first engagement surface 102 may define an opening configured to allow a needle of the drug injection device 130 to pass through the distal end of the attachment 100. In some examples, the opening may include a circular or other cross-sectional shape having a through-hole suitable for a needle. In some examples, in addition to or in place of the inner distal end of the attachment 100, the first engagement surface 102 may also include one or more inner sidewalls of the attachment 100. In some examples, the first engagement surface 102 may be configured to be attached to the needle protector 134 of the drug injection device 130 via press-fit, snap-fit, sliding fit, threaded connection, adhesive, etc. In some examples, the first engagement surface 102 may include one or more resiliently biased tabs and / or movable pins configured to engage with corresponding portions (e.g., openings) of the needle protector 134. In some examples, the first engagement surface 102 may not be attached to the needle protector 134, but may only contact or engage with the needle protector 134.

[0043] As described above, in some examples, the second engagement surface 104 may be the inner surface of the accessory 100, including 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, such as at least in Figures 2A to 2B As shown in the illustration. In some examples, the opposite scenario may occur, where the second engagement surface 104 includes 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 foregoing examples are to be understood to be included within the scope of this disclosure. For example, the second engagement surface 104 of an accessory may include one or more protrusions and one or more openings configured to receive one or more protrusions of the drug injection device 130.

[0044] In some examples, a portion of attachment 100 including the second engagement surface 104 (e.g., one or more of the aforementioned protrusions) is resiliently movable to engage and / or disengage with the lower housing 132 of the drug injection device 130. When attaching the attachment, the engagement surface 104 can move away from the engagement position and then resiliently return to the engagement position to engage with the lower housing 132. When disassembling the attachment, the engagement surface 104 can move away from the engagement position to facilitate removal of attachment 100. In some examples, the aforementioned one or more protrusions may include one or more projections, tabs, ball-and-socket pins, or other flexible members configured to removably engage a corresponding portion of the drug injection device 130. In some examples, attachment 100 may include one or more arms 106 extending from a distal portion of attachment 100. One or more arms 106 may include an inner surface including the second engagement surface 104, thereby including one or more protrusions. One or more arms 106 may be resiliently biased toward the engagement position. For example, as Figures 4A to 4B As shown, one or more arms 306 of Attachment 300 can be in their natural state ( Figure 4A ) and extended state ( Figure 4B The device can move between these devices, for example, when attaching the accessory 300 to the drug injection device 130.

[0045] In some examples, such as at least Figures 1A to 1DAs shown, at least a portion of one or more arms 106 may project outward toward the receiving seat 116 of the attachment 100. The protrusions of 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 protrusions of one or more arms 106 (or more generally, the protrusions of the attachment 100 including the portion of the second engagement surface 104) may include an actuating surface at the proximal end of the arm 106, which may be received at least partially by one or more openings 136 of the drug injection device. When attached to the attachment 100, the actuating surfaces of one or more arms 106 may be angled relative to the central axis of the drug injection device 130. When the attachment 100 is attached to the drug injection device 130, the actuating surfaces may extend at an angle from the proximal portion of the arm 106 toward the distal portion of the arm 106 and into the drug injection device 130. The actuating surfaces may terminate at the second engagement surface 104. In some examples, the second engagement surface 104 may be configured to removably clamp to a corresponding portion (e.g., opening 136 on the lower housing 132) of the drug injection device 130. The actuating surface of the arm 106 may be configured to engage with a corresponding actuating surface of the upper housing 138 of the drug injection device 130 to disengage the attachment 100 (e.g., the second engagement surface 104 of the attachment 100) from the corresponding portion (e.g., opening 136 on the lower housing 132) of the drug injection device 130. For example, when the upper housing 138 engages the actuating surfaces of one or more arms 106, the second engagement surfaces 104 of one or more arms 106 may separate (or release) from one or more openings 136 to disengage the second engagement surfaces 104 from the lower housing 132. In some examples, the actuating surface of the upper housing 138 may alternatively or additionally include an angled portion for engaging with the second engagement surface 104.

[0046] In an alternative example where attachment 100 includes one or more arms 106 extending from a distal portion of attachment 100, the one or more arms 106 may include 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 opening 108 may not receive a corresponding portion of the drug injection device 130. Instead, the opening 108 may be used at least to visualize the contents of a syringe barrel contained within the drug injection device 130. Combinations of the foregoing examples are also contemplated. For example, in the case where attachment 100 includes one or more arms 106, each arm 106 may include one or more protrusions and 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 include one or more openings 108 to receive protrusions of the lower housing 132, while different one or more arms 106 may include one or more protrusions.

[0047] In some examples, attachment 100 may include one or more alignment portions configured to guide the alignment of the second engagement surface 104 with the lower housing 132 of the drug injection device 130. For example, attachment 100 may include one or more central alignment members 112a and one or more peripheral alignment members 112b on one side of the central alignment member 112a. In some examples, attachment 100 may include a set of alignment portions on one or more sides of attachment 100. For example, as at least Figures 1A to 1D As shown, attachment 100 may include one or more arms 106, each arm including a second engagement surface 104 and extending from a distal portion of attachment 100; and one or more alignment portions, each or more alignment portions including alignment members 112a, 112b extending from the distal portion of attachment 100 between each of the one or more arms 106. The alignment portions may include 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, one or more openings 114 of the alignment portion may separate a central alignment member 112a from one or more peripheral alignment members 112b. In some examples, a given alignment portion of the attachment may include at least two alignment members separated by at least one opening 114, the at least one opening receiving a protrusion 133 of the drug injection device 130.

[0048] In some examples, alternative scenarios can be envisioned, in which one or more alignment portions of the attachment 100 include one or more protrusions configured to be received by one or more openings of the drug injection device 130 to guide the alignment of the second engagement surface 104 with the lower housing 132 of the drug injection device 130.

[0049] Attachment 100 may include a receiver 116 configured to receive at least a portion of the drug injection device 130. For example, receiver 116 may be configured to receive a needle protector 134 of the drug injection device 130. The shape of receiver 116 may be configured to correspond to the shape of the drug injection device 130. For example, if at least a portion of the drug injection device 130 (e.g., the lower housing 132 and / or the needle protector 134) comprises a cylindrical shape, at least the receiver 116 of attachment 100 may include a cylindrical shape. Figure 1B As shown, the first engagement surface 102 may be located at the distal end of the receiver 116. Furthermore, the second engagement surface 104 may surround at least a portion of the receiver 116. For example, the second engagement surface 104 may surround approximately 25%, 50%, 75%, 90%, 95%, or 100% of the receiver 116. In some examples, a first portion of the receiver 116 may be surrounded by the second engagement surface 104 (e.g., one or more arms 106 including the second engagement surface 104), and a second portion of the receiver 116 may be surrounded by one or more alignment portions.

[0050] In some examples, attachment 100 may include a skin-engaging surface 110. The skin-engaging surface 110 may be located at the distal end of attachment 100 to engage the skin during injection when attachment 100 is attached to drug injection device 130. A first engaging surface 102 may be opposite the skin-engaging surface 110. For example, skin-engaging surface 110 may include the outer surface of the distal end of attachment 100, while the first engaging surface 102 may include the inner surface of the distal end of attachment 100. The surface area of ​​skin-engaging surface 110 may be variable, for example, to accommodate user comfort during injection. Similarly, the surface area of ​​the first engaging surface 102, configured to engage needle protector 134, may be variable to distribute the force applied by the user to drug injection device 130 during injection. The surface area of ​​skin-engaging surface 110 may be substantially the same as the surface area of ​​the first engaging surface 102, or in some embodiments may be larger than the surface area of ​​the first engaging surface 102.

[0051] In some examples, Attachment 100 may include a transparent, translucent, and / or opaque material, comprising one or more cutouts (e.g., opening 108) to allow visualization of the API contained in the drug injection device 130. In some examples, Attachment 100 may include one or more of polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or mixtures of polymers. In some examples, in addition to or in place of one or more of the aforementioned polymers, Attachment 100 may also include medical-grade stainless steel.

[0052] Figures 3A to 3D An example of a drug injection system 250 according to a second example is shown, comprising a drug injection device 130 and a syringe accessory 200. Accessory 200 may include, as described herein, a drug injection system 250 comprising, a drug injection device 130 and a syringe accessory 200. Figures 1A to 1E and Figures 2A to 2B Any one or more features of Annex 100. In some examples, Annex 200 may differ from Annex 100 in that Annex 200 may not include one or more alignment portions. In other words, one or more alignment portions including one or more alignment members 112a, 112b and one or more openings 114 may be optional.

[0053] Attachment 200 may additionally or alternatively differ from attachment 100 in the shape of the portion of the attachment including the second engagement surface. For example, in a manner similar to that described with respect to attachment 100, the second engagement surface 204 of attachment 200 may include the inner surface of attachment 200. Furthermore, attachment 200 may include one or more arms 206 that include the second engagement surface 204. However, the shape of the one or more arms 206 may differ from the shape of arm 106. For example, the height of a given arm 206 may be less than the height of arm 106, such that the one or more arms 206 substantially do not cover one or more openings 136 of the drug injection device 130, as at least in Figure 3D As shown in the diagram. In this way, one or more arms 206 may not include one or more openings (e.g., windows) to visualize the contents of the tube contained within the drug injection device 130.

[0054] Figures 4A to 4B An accessory 300 for a drug injection device is illustrated. Accessory 300 may include items described herein with respect to... Figures 1A to 1E , Figures 2A to 2B and Figures 3A to 3DAny one or more features of attachments 100 and 200. For example, as shown and described above, attachment 300 may include one or more arms 306 extending from a distal portion of attachment 300. One or more arms 306 may include a second engagement surface 304. (This is in accordance with the provisions of this document regarding...) Figures 3A to 3D In a manner similar to that described in Annex 200, Annex 300 may not include alignment portions (e.g., alignment members 112a, 112b and opening 114).

[0055] Drug injection device

[0056] Drug injection devices may include manual and / or automated drug injection devices for delivering multiple active pharmaceutical ingredients (APIs). Figures 6A to 6B An exemplary drug injection device 130 is illustrated, comprising a lower housing 132, a needle protector 134, and an upper housing 138 supported relative to the lower housing 132. The lower housing may accommodate or contain a cartridge 140 of a container, such as a syringe or drug reservoir. The cartridge 140 may be fluidly connected to a needle 142 for injecting an API at an injection site. As described herein, the needle protector 134 is convertible from an extended position to a retracted position, in which the needle protector 134 extends from the lower housing 132 over the needle 142, and in a retracted position, the needle protector 134 retracts relative to the lower housing 132 to expose the needle 142. Alternatively, the needle protector 134 may be inserted inward relative to the lower housing 132 or folded relative to itself to expose the needle 142.

[0057] The lower housing 132 may include one or more openings 136 for viewing the contents of the syringe barrel 140 within the drug injection device 130. In some examples, the drug injection device 130 may include a first opening 136 on a first side of the lower housing 132 and a second opening 136 on a second side of the lower housing 132 opposite to the first side. The first and / or second openings may extend through the lower housing 132, thereby defining a first window and / or a second window. Alternatively, the first and / or second openings may extend partially into but not through the lower housing 132, thereby defining a first recess and / or a second recess. In any case, the one or more openings 136 may be configured to receive one or more engagement surfaces of an accessory (e.g., a second engagement surface 104 of the accessory 100). For example, the one or more engagement surfaces 104 may be an inner surface of the accessory 100, which includes one or more protrusions that can be inserted into the one or more openings 136.

[0058] The lower housing 132 may include one or more protrusions 133. When assembling the system, the one or more protrusions 133 may optionally be used to properly align the accessory with the drug injection device 130. For example, as described above, the accessory (e.g., accessory 100) may include one or more alignment members 112a, 112b separated by an opening 114. The opening 114 may receive one or more protrusions 133 of the lower housing 132 to guide the second engagement surface 104 of the accessory 100 to align with a corresponding one or more openings 136 of the lower housing 132.

[0059] The upper housing 138 may be an actuator configured to move relative to the lower housing 132 in a first direction. For example, when a user applies force to the upper housing 138, the upper housing 138 may translate distally toward the needle protector 134. The upper housing 138 may move in the first direction when changing from the pre-use position to the dispensing position. In the pre-use position, injection has not yet begun. In the dispensing position, injection is complete. The upper housing 138 may be coupled to a plunger rod 144 such that moving the upper housing 138 advances the plunger rod 144 through the syringe barrel 140, thereby injecting the API contained in the barrel 140 at the injection site via a needle 142 fluidly connected to the syringe barrel 140. As the user moves the upper housing 138, the upper housing 138 may gradually cover the lower housing 132 to indicate the progress of the injection.

[0060] The needle protector 134 may be configured to move relative to the lower housing 132 in a second direction opposite to the first direction. For example, when the drug injection device 130 is applied to the injection site and a force toward the injection site is applied to the device 130, the needle protector 134 may translate proximally toward the upper housing 138. When changing from an extended position to a retracted position, the needle protector 134 may move in the second direction. The needle protector 134 may be configured to move from the retracted position to a final extended position in the first direction (i.e., distally) upon completion of injection. The needle protector 134 may be spring-loaded (i.e., elastically biased). In this way, in order to retract the needle protector 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. Reducing the applied force to less than the spring force may cause the spring to re-expand, thereby causing the needle protector 134 to change from the lower housing 132 toward the extended position. In some examples, at least a portion of the needle 142 can be withdrawn from the injection site when the applied force is insufficient to overcome the spring force. When the drug injection device 130 is properly engaged with an accessory described herein (e.g., accessory 100), the user does not need to apply any force to the needle protector 134 to maintain it in the retracted position. Instead, the accessory holds the needle protector 134 in the retracted position, thereby applying a reaction force opposite to the spring force of the needle protector 134 to prevent it from extending. Thus, the only force required by the user may be the force required to inject the drug (e.g., when pressing the upper housing 138 toward the lower housing 132), which the user can pause and release at any time during injection without the needle protector 134 prematurely returning to the extended position.

[0061] An exemplary drug injection device is described in more detail in U.S. Patent No. 9,233,213, issued January 12, 2016, the entire contents of which are incorporated herein by reference.

[0062] In some examples, the drug injection device described herein (e.g., drug injection device 130) may include one or more features described with respect to syringe accessories (e.g., accessories 100, 200, or 300). For example, the lower housing 132 may include an accessory. In this example, the lower housing 132 may include one or more arms (e.g., arm 106) or another body including a first engagement surface 102 configured to engage with a needle protector 134 to prevent the needle protector from moving from a retracted position to an extended position until injection is complete.

[0063] In another example, the needle protector 134 of the drug injection device may include accessories. For example, the distal end of the needle protector 134 may include a first engagement surface 102, and one or more arms 106 or another body including a second engagement surface 104 may extend from the needle protector 134 to engage with the lower housing 132 and prevent the needle protector 134 from moving from the retracted position to the extended position before the injection is completed.

[0064] In any case, in a drug injection device including one or more features of the accessories described herein, the needle protector 134 may include a skin engagement surface 135 at a distal end of the device that engages the skin during injection. Furthermore, combinations of the foregoing examples are to be reasonably covered by the description provided herein. For example, each of the lower housing 132 and the needle protector 134 may include one or more features of the accessories described herein to prevent the needle protector from moving to a locked extended position before injection is completed.

[0065] Assembly method

[0066] In some examples, a method for assembling a drug injection device with accessories may be provided. Figures 5A to 5B Exemplary steps may be illustrated in assembling a drug injection device with an accessory for preventing the needle protector of the injection device from moving to a locked extension position.

[0067] The method may include attaching an accessory (e.g., accessory 100) to a drug injection device (e.g., drug injection device 130) such that a first engagement surface 102 of accessory 100 engages a needle protector 134 of drug injection device 130, and a second engagement surface 104 of accessory 100 engages a lower housing 132 of drug injection device 130.

[0068] like Figure 5A As shown, before attaching an accessory (e.g., accessory 100, 200, or 300) to the drug injection device 130, the method may include positioning the accessory (e.g., a skin-engaging surface of the accessory) at or near the injection site. Attaching the accessory and the drug injection device may include aligning the drug injection device with the accessory. For example, the drug injection device (e.g., the needle protector 134 of the drug injection device 130) may be inserted into a corresponding receiving seat of the accessory such that the engaging surface of the accessory (e.g., the first engaging surface 102) is aligned with a corresponding surface of the drug injection device (e.g., the surface of the needle protector 134). Once aligned, the accessory may be attached to the needle protector 134, for example, via press-fit, snap-fit, sliding fit, threaded connection, adhesive, etc.

[0069] The attachment and drug injection device may include aligning a second engagement surface (e.g., the second engagement surface 104 of attachment 100) with a corresponding portion of the drug injection device. For example, engagement surface 104 may be an inner surface of an attachment including 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... Figure 5B As shown, attaching an accessory to a drug injection device may include aligning one or more protrusions with one or more openings 136 and inserting the protrusions into the openings 136. As described herein, one or more protrusions may be provided on one or more arms 106 of the accessory 100. Arms 106 may include flexible members that are resiliently biased to removably engage corresponding portions of the drug injection device 130. For example, when the accessory 100 is attached to the drug injection device 130, one or more arms 106 may bend outward to allow the actuating surfaces of one or more protrusions to engage corresponding actuating surfaces of the drug injection device 130. For example, one or more arms 106 may engage a lower housing 132, and this engagement may allow the arms 106 to bend outward. When the actuating surfaces of the accessory 100 and the drug injection device 130 are properly aligned, a biasing force may cause one or more arms 106, including one or more protrusions, to bend inward to an engaged position.

[0070] In some examples, when the drug injection device (e.g., needle protector 134) is inserted into the receiver of the accessory and force is applied to the drug injection device against the injection site, the spring force associated with the needle protector 134 can be overcome to change the needle protector 134 from an initial extended position to at least a partially retracted position, thereby allowing one or more engagement surfaces 104 to engage with one or more openings 136 on the lower housing 132. In this way, movement of the accessory in the proximal direction (e.g., to engage one or more engagement surfaces 104 with one or more openings 136) can cause a corresponding movement of the needle protector 134 in the proximal direction, thereby changing the needle protector 134 to at least a partially retracted position.

[0071] In some examples, aligning one or more mating surfaces 104 with corresponding portions of the lower housing 132 may include using one or more alignment portions (e.g., alignment portions 112a, 112b of attachment 100) to guide the alignment between the mating surfaces 104 and the lower housing 132 of the drug injection device 130. For example, one or more alignment portions may include one or more openings 114 that can receive one or more corresponding protrusions on the lower housing 132 and guide attachment 100 onto the drug injection device.

[0072] Methods of injecting API

[0073] In some examples, a method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device may be provided. Figures 5C to 5E Exemplary steps of an API injection method using a drug injection device and accessories are illustrated. The API injection method provided herein may encompass any one or more steps provided above regarding the assembly of a drug injection device and accessories. It should be understood that one or more steps of the API injection method may occur after one or more steps described herein for assembling a drug injection device and accessories.

[0074] In some examples, the method may include positioning the needle protector 134 at the injection site, whether before, during, or after attaching the accessory to the drug injection device. Figure 5C As shown, when one or more engagement surfaces 104 are removably engaged with openings 136 on the lower housing 132, the needle protector 134 can be positioned relative to the lower housing 132 in a at least partially retracted state.

[0075] When the needle protector 134 is retracted and positioned at the injection site, the needle 142 can be inserted into the injection site, and the user can begin drug administration. Injecting the API at the injection site may include, for example, moving the upper housing 138 of the drug injection device 130 relative to the lower housing 132 by applying a force to the upper housing 138 to translate the upper housing 138 toward the distal end of the drug injection device 130. As described herein, the upper housing 138 may be coupled to a plunger rod 144 configured to advance through a syringe barrel 140 contained within the drug injection device to inject the API contained in the barrel 140 at the injection site via a needle 142 fluidly connected to the barrel 140 and inserted into the injection site.

[0076] like Figure 5D As shown, at any time during the injection, the user has the flexibility to change their grip on the device, switch hands applying force to the device, pause the application of force, remove and reinsert the needle 142 (if necessary), etc., and the needle protector 134 does not extend back from the lower housing 132 until the injection is complete.

[0077] In some examples, when administration is complete, the upper housing 138 may engage with the engagement surface 104 of the accessory 100, thereby disengaging the engagement surface 104 from the corresponding portion (e.g., opening 136) of the lower housing 132. Figure 5EAn example is illustrated of an engagement surface 104 of an accessory that disengages from the opening 136 of the drug injection device upon completion of injection. In some examples, separating the engagement surface 104 from the lower housing 132 allows the accessory to be completely separated from the drug injection device 130. In some examples, the engagement surface 104 may detach from a corresponding portion of the lower housing 132 (e.g., one or more openings 136), while the first engagement surface 102 remains attached. In any case, when the engagement surface 104 disengages from the corresponding portion of the lower housing 132, the needle protector 134 may be configured to transition from at least a 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 protector 134 may be configured to lock to shield the needle 142 and prevent accidental needlesticking, cross-contamination, etc.

[0078] It should be understood that the method of injecting an API as described herein is reasonably applicable to use with a drug injection device that includes one or more features of the syringe accessories provided herein. For example, as those skilled in the art will understand, the method may not require one or more steps associated with attaching the accessory to the drug injection device. Instead, injecting an API using a drug injection device that includes one or more features of the syringe accessories described herein may include 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 case where the needle protector 134 includes one or more features of the accessories described herein (e.g., one or more arms 106 extending from the needle protector 134), engagement surfaces 104 of one or more arms 106 may engage with one or more openings 136 on the lower housing 102 to at least partially retract the needle protector 134. In an alternative example, where the lower housing 132 of the drug injection device 130 includes one or more features of the accessories described herein (e.g., one or more arms 106 extending from the lower housing 132), one or more arms 106 including the engagement surface 104 may engage with the needle protector 134 to prevent the needle protector 134 from completely obscuring the needle until the injection is completed.

[0079] Unless otherwise specified, all specialized terms, symbols, and other technical and scientific terms or specialized expressions used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some instances, for clarity and / or ease of reference, terms with commonly understood meanings are defined herein, and these definitions should not necessarily be construed as indicating a significant difference from the meanings commonly understood in the art.

[0080] As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the / described” include plural references. It should also be understood that, as used herein, the term “and / or” refers to and covers any and all possible combinations of one or more of the associated listed items. It should also be understood that, when used herein, the terms “comprising” and / or “including” specify the presence of the stated feature, integer, step, operation, element, component, and / or unit, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0081] The disclosed numerical ranges inherently support any range or value within the disclosed numerical ranges, including endpoints, even if no precise range limitation is stated verbatim in the specification, because this disclosure can be practiced throughout the entire disclosed numerical range.

[0082] For illustrative purposes, the foregoing description has been described with reference to specific examples. However, the illustrative discussion above is not intended to be exhaustive or to limit the invention to the exact forms disclosed. Many modifications and changes can be made to this disclosure based on the foregoing teachings. The examples were chosen and described in order to best illustrate the principles of these techniques and their practical applications. Thus, it is intended to enable others skilled in the art to best utilize these techniques and various examples with various modifications suitable for the particular intended use.

[0083] Although this disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood to be included within the scope of this disclosure and examples as defined by the claims.

[0084] Implementation Plan

[0085] Implementation Scheme 1. An accessory for a drug injection device, the accessory comprising:

[0086] A first engagement surface, configured to engage a needle protector of the drug injection device, the needle protector transitioning from an extended position to a retracted position. In the extended position, the needle protector extends from the lower housing of the drug injection device over the needle of the drug injection device; in the retracted position, the needle protector retracts relative to the lower housing of the drug injection device to expose the needle.

[0087] A second engagement surface is configured to engage the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until injection is complete.

[0088] Implementation Scheme 2. The attachment according to Implementation Scheme 1, wherein the attachment is configured to engage the needle protector such that movement of the attachment in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector to the retracted position.

[0089] Implementation Scheme 3. According to the appendix of Implementation Scheme 1 or 2, wherein when the second engagement surface engages with the lower housing of the drug injection device, the needle protector is configured to change from an initial extended position to at least a partially retracted position.

[0090] Implementation Scheme 4. According to the appendix of Implementation Scheme 3, wherein the second 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.

[0091] Implementation Scheme 5. According to the appendix of Implementation Scheme 3 or 4, wherein when the second engagement surface disengages from the lower housing of the drug injection device, the needle protector is configured to transition from the at least partially retracted position to the extended position.

[0092] Implementation Scheme 6. An accessory according to any one of Implementation Schemes 1 to 5, comprising a skin-engaging surface at a distal end of the accessory, the skin-engaging surface being configured to engage the skin during the injection.

[0093] Implementation Scheme 7. The appendix according to Implementation Scheme 6, wherein the first engagement surface is opposite to the skin engagement surface.

[0094] Implementation Scheme 8. An appendix according to any one of Implementation Schemes 1 to 7, wherein the first engagement surface is the inner surface of the distal surface of the needle protector of the drug injection device.

[0095] Implementation Scheme 9. An appendix according to any one of Implementation Schemes 1 to 8, wherein the second engagement surface is an inner surface including one or more protrusions configured to receive by one or more openings on the lower housing of the drug injection device.

[0096] Implementation Scheme 10. An appendix according to any one of Implementation Schemes 1 to 9 includes a receiver configured to receive at least a portion of the needle protector of the drug injection device therein.

[0097] Implementation Scheme 11. The attachment according to Implementation Scheme 10, wherein the first engagement surface is located at the distal end of the receiving seat.

[0098] Implementation Scheme 12. The appendix according to Implementation Scheme 10 or 11, wherein the second engagement surface surrounds at least a portion of the receiving seat.

[0099] Implementation Scheme 13. An appendix according to any one of Implementation Schemes 1 to 9, wherein the appendix includes one or more alignment portions configured to guide the alignment of the second engagement surface with the lower housing of the drug injection device.

[0100] Implementation Scheme 14. According to the appendix of Implementation Scheme 13, wherein the one or more alignment portions include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0101] Implementation Scheme 15. An accessory according to any one of Implementation Schemes 1 to 14, wherein the portion of the accessory including the second engagement surface is resiliently movable to engage and / or disengage with the lower housing of the drug injection device.

[0102] Implementation Scheme 16. An accessory according to any one of Implementation Schemes 1 to 15, wherein the portion of the accessory including the first engagement surface is configured to engage the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

[0103] Implementation Scheme 17. An accessory according to any one of Implementation Schemes 1 to 16, wherein the first engagement surface defines an opening configured to allow the needle of the drug injection device to pass through the accessory.

[0104] Implementation Scheme 18. An appendix according to any one of Implementation Schemes 1 to 17, wherein the appendix comprises a transparent, translucent, or opaque material having one or more incisions, the one or more incisions allowing visualization of the active pharmaceutical ingredient contained in the drug injection device.

[0105] Implementation Scheme 19. An appendix according to any one of Implementation Schemes 1 to 18, wherein the appendix comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

[0106] Implementation Scheme 20. A component for drug injection, comprising:

[0107] Annexes according to any one of Implementation Schemes 1 to 19; and

[0108] The drug injection device.

[0109] Implementation Scheme 21. The component according to Implementation Scheme 20, wherein the drug injection device includes an upper housing supported relative to the lower housing.

[0110] Implementation Scheme 22. The component according to Implementation Scheme 21, wherein the upper housing is configured to move relative to the lower housing in a first direction, and the needle protector is configured to move relative to the lower housing in the first direction and in a second direction opposite to the first direction.

[0111] Implementation Scheme 23. The component according to any one of Implementation Schemes 20 to 22, wherein the drug injection device is an automatic injection device or a manual injection device.

[0112] Implementation Scheme 24. A system comprising:

[0113] Drug injection device, the drug injection device comprising:

[0114] A lower housing, the lower housing comprising a cylinder fluidly connected to the needle;

[0115] Upper housing, which is supported relative to the lower housing; and

[0116] A needle protector configured to transition from an extended position to a retracted position, wherein in the extended position the needle protector extends from the lower housing over the needle, and in the retracted position the needle protector retracts relative to the lower housing to expose the needle; and

[0117] An accessory is attached to the needle protector and includes an engagement surface configured to engage the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until injection is complete.

[0118] Implementation Scheme 25. The system according to Implementation Scheme 24, wherein the lower housing of the drug injection device includes the accessory.

[0119] Implementation Scheme 26. The system according to Implementation Scheme 24, wherein the accessory is removably attached to the needle protector.

[0120] Implementation Scheme 27. The system according to Implementation Scheme 26, wherein the accessory includes an inner distal surface that engages the distal surface of the needle protector.

[0121] Implementation Scheme 28. The system according to Implementation Scheme 26 or 27, wherein the accessory is configured to be attached to the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

[0122] Implementation Scheme 29. The system according to any one of Implementation Schemes 26 to 28, wherein the accessory includes one or more alignment portions configured to guide the alignment of the engagement surface with the lower housing of the drug injection device.

[0123] Implementation Scheme 30. The system according to Implementation Scheme 29, wherein the one or more alignment portions include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0124] Implementation Scheme 31. The system according to any one of Implementation Schemes 24 to 30, wherein the accessory is attached to the needle protector such that movement of the accessory in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector to the retracted position.

[0125] Implementation Scheme 32. The system according to any one of Implementation Schemes 24 to 31, wherein when the engagement surface engages with the lower housing of the drug injection device, the needle protector is configured to change from an initial extended position to at least a partially retracted position.

[0126] Implementation Scheme 33. The system according to Implementation Scheme 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.

[0127] Implementation Scheme 34. The system according to Implementation Scheme 32 or 33, wherein when the engagement surface disengages from the lower housing of the drug injection device, the needle protector is configured to transition from the at least partially retracted position to the extended position.

[0128] Implementation Scheme 35. The system according to any one of Implementation Schemes 24 to 34, wherein the accessory includes a skin-engaging surface at a distal end of the accessory, the skin-engaging surface being configured to engage the skin during the injection.

[0129] Implementation Scheme 36. The system according to any one of Implementation Schemes 24 to 35, wherein the engagement surface of the accessory is an inner surface including one or more protrusions configured to receive by one or more openings on the lower housing of the drug injection device.

[0130] Implementation Scheme 37. The system according to any one of Implementation Schemes 24 to 36, wherein the accessory includes a receiver for receiving at least a portion of the needle protector.

[0131] Implementation Scheme 38. The system according to Implementation Scheme 37, wherein the engagement surface of the accessory surrounds at least a portion of the receiver.

[0132] Implementation Scheme 39. The system according to any one of Implementation Schemes 24 to 38, wherein the portion of the accessory including the engagement surface is spring-loaded to engage and / or disengage with the lower housing of the drug injection device.

[0133] Implementation Scheme 40. The system according to any one of Implementation Schemes 24 to 39, wherein the accessory defines an opening configured to allow the needle of the drug injection device to pass through the accessory.

[0134] Implementation Scheme 41. The system according to any one of Implementation Schemes 24 to 40, wherein the upper housing is transitioned from a pre-use position to a dispensing position, in the pre-use position before the injection has begun, and in the dispensing position after the injection has been completed, the upper housing is configured to engage with the engagement surface of the accessory in the dispensing position.

[0135] Implementation Scheme 42. The system according to any one of Implementation Schemes 24 to 41, wherein the upper housing is configured to move relative to the lower housing in a first direction, and the needle protector is configured to move relative to the lower housing in the first direction and in a second direction opposite to the first direction.

[0136] Implementation Scheme 43. The system according to any one of Implementation Schemes 24 to 42, wherein the drug injection device is an automatic injection device or a manual injection device.

[0137] Implementation Scheme 44. The system according to any one of Implementation Schemes 24 to 43, wherein the accessory comprises a transparent, translucent, or opaque material having one or more slits, the one or more slits allowing visualization of the active pharmaceutical ingredient contained in the barrel of the drug injection device.

[0138] Implementation Scheme 45. The system according to any one of Implementation Schemes 24 to 44, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

[0139] Implementation Scheme 46. A method for assembling a drug injection device and accessories, comprising:

[0140] The accessory is attached to the drug injection device such that a first mating surface of the accessory engages a needle protector of the drug injection device, the needle protector being configured to transition from an extended position to a retracted position. In the extended position, the needle protector extends from the lower housing of the drug injection device over the needle of the drug injection device; in the retracted position, the needle protector retracts relative to the lower housing of the drug injection device to expose the needle.

[0141] The second engagement surface of the accessory engages with the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until the injection is complete.

[0142] Implementation Scheme 47. The method according to Implementation Scheme 46, wherein when the first engagement surface engages the needle protector of the drug injection device, movement of the attachment in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector to the retracted position.

[0143] Implementation Scheme 48. The method according to Implementation Scheme 46 or 47, wherein when the second engagement surface engages with the lower housing of the drug injection device, the needle protector changes from an initial extended position to at least a partially retracted position.

[0144] Implementation Scheme 49. The method according to Implementation Scheme 48, wherein the second 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.

[0145] Implementation Scheme 50. The method according to Implementation Scheme 48 or 49, wherein when the second engagement surface disengages from the lower housing of the drug injection device, the needle protector is configured to transition from the at least partially retracted position to the extended position.

[0146] Implementation Scheme 51. The method according to any one of Implementation Schemes 46 to 50, wherein the first engagement surface is the inner surface of the accessory, such that attaching the accessory to the drug injection device includes engaging the inner surface of the accessory with the distal surface of the needle protector of the drug injection device.

[0147] Implementation Scheme 52. The method according to any one of Implementation Schemes 46 to 51, wherein the second engagement surface is an inner surface including one or more protrusions, and the lower housing of the drug injection device includes one or more corresponding openings, such that attaching the accessory to the drug injection device includes inserting the one or more protrusions into the one or more openings.

[0148] Implementation Scheme 53. The method according to any one of Implementation Schemes 46 to 52, wherein attaching the accessory to the drug injection device comprises: inserting at least a portion of the needle protector into the receiving seat of the accessory.

[0149] Implementation Scheme 54. The method according to Implementation Scheme 53, wherein the first engagement surface is located at the distal end of the receiving seat.

[0150] Implementation Scheme 55. The method according to Implementation Scheme 53 or 54, wherein the second engagement surface surrounds at least a portion of the receiving seat.

[0151] Implementation Scheme 56. The method according to any one of Implementation Schemes 46 to 55, wherein attaching the accessory to the drug injection device comprises: using one or more alignment portions of the accessory to guide the alignment of the second engagement surface with the lower housing of the drug injection device.

[0152] Implementation Scheme 57. The method according to Implementation Scheme 56, wherein the one or more alignment portions include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0153] Implementation Scheme 58. The method according to any one of Implementation Schemes 46 to 57, wherein the portion of the accessory including the engagement surface is spring-loaded to engage and / or disengage with the lower housing of the drug injection device.

[0154] Implementation Scheme 59. The method according to any one of Implementation Schemes 46 to 48, wherein the portion of the accessory including the first engagement surface engages the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

[0155] Implementation Scheme 60. A method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device, comprising:

[0156] Positioning the needle protector of the drug injection device at the injection site, wherein the needle protector is changed from an extended position to a retracted position, in the extended position, the needle protector extends from the lower housing of the drug injection device above the needle of the drug injection device, and in the retracted position, the needle protector retracts relative to the lower housing to expose the needle; and

[0157] The upper housing of the drug injection device is moved 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 protector includes an engagement surface that engages the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until the injection is completed.

[0158] Implementation Scheme 61. The method according to Implementation Scheme 60, wherein the lower housing of the drug injection device includes the accessory.

[0159] Implementation Scheme 62. The method according to Implementation Scheme 60, wherein the accessory is removably attached to the drug injection device.

[0160] Implementation Scheme 63. The method according to Implementation Scheme 62, wherein the accessory includes an inner distal surface that engages the distal surface of the needle protector.

[0161] Implementation Scheme 64. The method according to Implementation Scheme 63, wherein the accessory includes a skin-engaging surface that engages with the skin at the injection site, the skin-engaging surface being opposite the medial distal surface of the accessory.

[0162] Implementation Scheme 65. The method according to any one of Implementation Schemes 62 to 64, comprising attaching the accessory to the needle protector of the drug injection device before positioning the needle protector on the injection site.

[0163] Implementation Scheme 66. The method according to any one of Implementation Schemes 62 to 65, wherein the accessory is attached to the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

[0164] Implementation Scheme 67. The method according to Implementation Scheme 65 or 66, wherein the mating surface is an inner surface including one or more protrusions, and the lower housing of the drug injection device includes one or more corresponding openings, such that attaching the accessory to the drug injection device includes inserting the one or more protrusions into the one or more openings.

[0165] Implementation Scheme 68. The method according to any one of Implementation Schemes 65 to 67, wherein attaching the accessory to the drug injection device comprises: inserting at least a portion of the needle protector into the receiving seat of the accessory.

[0166] Implementation Scheme 69. The method according to any one of Implementation Schemes 65 to 68, wherein attaching the accessory to the needle protector of the drug injection device comprises: using one or more alignment portions of the accessory to guide the alignment of the engagement surface with the lower housing of the drug injection device.

[0167] Implementation Scheme 70. The method according to Implementation Scheme 69, wherein the one or more alignment portions include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

[0168] Implementation Scheme 71. The method according to any one of Implementation Schemes 60 to 70, wherein the accessory is attached to the needle protector such that movement of the accessory in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector to the retracted position.

[0169] Implementation Scheme 72. The method according to any one of Implementation Schemes 60 to 71, wherein when the engagement surface engages with the lower housing of the drug injection device, the needle protector changes from an initial extended position to at least a partially retracted position.

[0170] Implementation Scheme 73. The method according to any one of Implementation Schemes 60 to 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.

[0171] Implementation Scheme 74. The method according to Implementation Scheme 72 or 73, wherein when the engagement surface disengages from the lower housing of the drug injection device, the needle protector changes from the at least partially retracted position to the extended position.

[0172] Implementation Scheme 75. The method according to any one of Implementation Schemes 60 to 74, wherein the portion of the accessory including the engagement surface is spring-loaded to engage and / or disengage with the lower housing of the drug injection device.

[0173] Implementation Scheme 76. The method according to any one of Implementation Schemes 60 to 75, wherein the attachment defines an opening that allows the needle of the drug injection device to pass through the attachment.

[0174] Implementation Scheme 77. The method according to any one of Implementation Schemes 60 to 76, wherein the upper housing is transitioned from a pre-use position to a dispensing position, in the pre-use position before the injection has begun, in the dispensing position after the injection has been completed, and the upper housing engages with the engagement surface of the accessory in the dispensing position.

[0175] Implementation Scheme 78. The method according to any one of Implementation Schemes 60 to 77, wherein the upper housing is configured to move relative to the lower housing in a first direction, and the needle protector is configured to move relative to the lower housing in the first direction and in a second direction opposite to the first direction.

[0176] Implementation Scheme 79. The method according to any one of Implementation Schemes 60 to 78, wherein the drug injection device is an automatic injection device or a manual injection device.

[0177] Implementation Scheme 80. The method according to any one of Implementation Schemes 60 to 79, wherein the accessory comprises a transparent, translucent, or opaque material having one or more incisions, the one or more incisions allowing visualization of the API contained in the drug injection device.

Claims

1. An accessory for a drug injection device, the accessory comprising: A first engagement surface is configured to engage a needle protector of the drug injection device, the needle protector transitioning from an extended position to a retracted position, in the extended position extending from the lower housing of the drug injection device over the needle of the drug injection device, and in the retracted position retracting relative to the lower housing of the drug injection device to expose the needle. and A second engagement surface is configured to engage the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until injection is complete.

2. The accessory of claim 1, wherein the accessory is configured to engage the needle protector such that movement of the accessory in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector 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 protector is configured to change from an initial extended position to at least a partially retracted position.

4. The appendix of claim 3, wherein the second 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.

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 protector is configured to transition from the at least partially retracted position to the extended position.

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

7. The attachment according to claim 6, wherein the first engagement surface is opposite to the skin engagement surface.

8. The appendix according to any one of claims 1 to 7, wherein the first engagement surface is the inner surface of the distal surface of the needle protector that engages the drug injection device.

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

10. The appendix according to any one of claims 1 to 9, comprising a receiver configured to receive at least a portion of the needle protector of the drug injection device therein.

11. The accessory according to claim 10, wherein the first engagement surface is located at the distal end of the receiver.

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

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

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

15. The accessory according to any one of claims 1 to 14, wherein the portion of the accessory including the second engagement surface is resiliently movable to engage with and / or disengage from the lower housing of the drug injection device.

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

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

18. The accessory according to any one of claims 1 to 17, wherein the accessory comprises a transparent, translucent, or opaque material having one or more incisions, the one or more incisions allowing visualization of the active pharmaceutical ingredient contained in the drug injection device.

19. The appendix according to any one of claims 1 to 18, wherein the appendix comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

20. A component for drug injection, comprising: Annexes according to any one of claims 1 to 19; as well as The drug injection device.

21. The component of claim 20, wherein the drug injection device includes 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 the lower housing in a first direction, and the needle protector is configured to move relative to the lower housing in the first direction and in a second direction opposite to the first direction.

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

24. A system comprising: Drug injection device, the drug injection device comprising: A lower housing, the lower housing comprising a cylinder fluidly connected to the needle; Upper housing, which is supported relative to the lower housing; and A needle protector configured to transition from an extended position to a retracted position, wherein in the extended position the needle protector extends from the lower housing over the needle, and in the retracted position the needle protector retracts relative to the lower housing to expose the needle; and An accessory is attached to the needle protector and includes an engagement surface configured to engage the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until injection is complete.

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

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

27. The system of claim 26, wherein the accessory includes an inner distal surface that engages the distal surface of the needle protector.

28. The system of claim 26 or 27, wherein the accessory is configured to be attached to the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

29. The system according to any one of claims 26 to 28, wherein the accessory includes one or more alignment portions configured to guide the 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 include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

31. The system according to any one of claims 24 to 30, wherein the accessory is attached to the needle protector such that movement of the accessory in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector 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 protector is configured to change from an initial extended position to at least a 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 protector is configured to transition from the at least partially retracted position to the extended position.

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

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

37. The system according to any one of claims 24 to 36, wherein the accessory includes a receiver for receiving at least a portion of the needle protector.

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

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

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

41. The system according to any one of claims 24 to 40, wherein the upper housing changes from a pre-use position to a dispensing position, in the pre-use position before the injection has begun, and in the dispensing position after the injection has been completed, the upper housing is configured to engage with the engagement surface of the accessory in the dispensing position.

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

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

44. The system according to any one of claims 24 to 43, wherein the accessory comprises a transparent, translucent, or opaque material having one or more slits, the one or more slits allowing visualization of the active pharmaceutical ingredient contained in the barrel of the drug injection device.

45. The system according to any one of claims 24 to 44, wherein the accessory comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.

46. ​​A method for assembling a drug injection device and accessories, comprising: The accessory is attached to the drug injection device such that a first mating surface of the accessory engages the needle protector of the drug injection device. The needle protector is configured to change from an extended position to a retracted position. In the extended position, the needle protector extends from the lower housing of the drug injection device over the needle of the drug injection device. In the retracted position, the needle protector retracts relative to the lower housing of the drug injection device to expose the needle. The second engagement surface of the accessory engages with the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until the injection is complete.

47. The method of claim 46, wherein, When the first engagement surface engages the needle protector of the drug injection device, movement of the attachment in the proximal direction causes a corresponding movement of the needle protector in the proximal direction to turn the needle protector 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 protector changes from an initial extended position to at least a 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 the 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 protector is configured to transition from the at least partially retracted position to the extended position.

51. The method according to any one of claims 46 to 50, wherein the first engagement surface is the inner surface of the attachment, such that attaching the attachment to the drug injection device includes engaging the inner surface of the attachment with the distal surface of the needle protector of the drug injection device.

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

53. The method according to any one of claims 46 to 52, wherein attaching the accessory to the drug injection device comprises inserting at least a portion of the needle protector into the receiving seat of the accessory.

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

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

56. The method of any one of claims 46 to 55, wherein attaching the accessory to the drug injection device includes using one or more alignment portions of the accessory to guide the 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 include one or more openings configured to receive one or more protrusions on the lower housing of the drug injection device.

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

59. The method according to any one of claims 46 to 48, wherein the portion of the accessory including the first engagement surface engages the needle protector of the drug injection device via a press fit, snap fit, sliding fit, or threaded connection.

60. A method for injecting an active pharmaceutical ingredient (API) contained in a drug injection device, comprising: The needle protector of the drug injection device is positioned at the injection site, wherein the needle protector is changed from an extended position to a retracted position, in the extended position the needle protector extends from the lower housing of the drug injection device above the needle of the drug injection device, and in the retracted position the needle protector retracts relative to the lower housing to expose the needle. as well as The upper housing of the drug injection device is moved 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 protector includes an engagement surface that engages the lower housing of the drug injection device to prevent the needle protector from moving from the retracted position to the extended position until the injection is completed.

61. The method of claim 60, wherein the lower housing of the drug injection device includes 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 includes an inner distal surface that engages the distal surface of the needle protector.

64. The method of claim 63, wherein the accessory includes a skin-engaging surface that engages with the skin at the injection site, the skin-engaging surface being opposite the medial distal surface of the accessory.

65. The method of any one of claims 62-64, comprising: The accessory is attached to the needle protector of the drug injection device before the needle protector is positioned on the injection site.

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

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

68. The method of any one of claims 65 to 67, wherein attaching the accessory to the drug injection device comprises: Insert at least a portion of the needle protector into the receiver of the accessory.

69. The method of any one of claims 65 to 68, wherein attaching the accessory to the needle protector of the drug injection device comprises: One or more alignment portions of the accessory are used to guide the alignment of the mating surface with the lower housing of the drug injection device.

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

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

72. The method according to any one of claims 60 to 71, wherein, When the engagement surface engages with the lower housing of the drug injection device, the needle protector changes from an initial extended position to at least a partially retracted position.

73. The method according to any one of claims 60 to 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 protector changes from the at least partially retracted position to the extended position.

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

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

77. The method according to any one of claims 60 to 76, wherein the upper housing changes from a pre-use position to a dispensing position, in the pre-use position before the injection has begun, in the dispensing position after the injection has been completed, and the upper housing engages with the engagement surface of the accessory in the dispensing position.

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

79. The method according to any one of claims 60 to 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 to 79, wherein the accessory comprises a transparent, translucent, or opaque material having one or more incisions, the one or more incisions allowing visualization of the API contained in the drug injection device.

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