RIGID NEEDLE SHIELD REMOVER WITH DROP-PROOF FEATURE FOR AUTOINJECTOR.

Abstract

This document provides a subassembly for a drug delivery device, comprising a housing, a retractable needle cover with a distal end having a flange, the needle cover being received within the housing and configured to have a pre-use position in which the needle cover extends from the housing and a use position in which the needle cover is at least partially retracted into the housing. Retraction of the needle cover into the housing activates the drug delivery device. The subassembly also includes a cap assembly, which is configured to prevent movement of the needle cover into the use position.

Description

Rigid needle shield extractor with drop-proof feature for autoinjector BACKGROUND OF THE INVENTION Field of invention This disclosure relates generally to auto-injectors and methods of assembling them and, more specifically, to devices for removing needle guards from auto-injectors, devices for preventing unintentional activation of auto-injectors, and methods for assembling auto-injectors that include such devices. Description of the related technique Automated drug delivery devices, such as autoinjectors, are designed with removable needle shields to maintain needle sterility and prevent accidental contact between the needle and the user. Many of these needle shields are elastomeric, and ensuring accurate placement and a firm grip between the needle shield and the caps or other removal devices can be challenging. This can result in excessive force being required to remove the shield, or in slippage and an inability to remove it at all. Therefore, there is a need in the art for a needle shield extractor that can be reliably positioned for quick and easy needle shield removal when using the autoinjector. Furthermore, automated drug delivery devices can be prone to accidental activation when force is applied. Specifically, devices with intermittent contact activation may be susceptible to accidental activation if dropped. Therefore, there is a need in the art for a device that can prevent the unintentional activation of an autoinjector. BRIEF DESCRIPTION OF THE INVENTION This document provides a subassembly for a drug delivery device, which has a housing; a displaceable needle cover with a distal end having a flange, the needle cover received within the housing and configured to have a pre-use position in which the needle cover extends from the housing and a use position in which the needle cover is displaced at least partially into the housing, wherein displacement of the needle cover into the housing activates the drug delivery device by interaction with a drive mechanism;and a cap assembly, including a cap extractor configured to be grasped by a user and a retainer received within the cap extractor and configured to engage the tab of the needle cover of the drug delivery device, wherein the arrangement of the retainer with respect to the tab is configured to prevent movement of the needle cover into the use position. Also provided herein is a drug delivery device comprising a housing; a syringe having a needle and received at least partially within the housing; a needle cover having a tab at a distal end thereof and having a pre-use position in which the needle is positioned within the needle cover and a use position in which the needle is positioned at least partially outside the needle cover, wherein, in the use position, the needle cover is configured to activate the drug delivery device to administer a drug; and a cap assembly comprising a cap extractor and a retainer received within the cap extractor, the retainer being configured to prevent movement of the needle cover from the pre-use position to the use position. The following are additional achievements and aspects: A subassembly for a drug delivery device comprising: a housing; a displaceable needle cover comprising a distal end comprising a flange, the needle cover received within the housing and configured to have a pre-use position in which the needle cover extends from the housing and a use position in which the needle cover is at least partially displaced into the housing, wherein displacement of the needle cover into the housing activates the drug delivery device by interaction with a drive mechanism; and a cap assembly, comprising: a cap extractor configured to be gripped by a user;and a retainer received within the cap extractor and configured to engage the tab of the needle cover of the drug delivery device, wherein the arrangement of the retainer with respect to the tab is configured to prevent movement of the needle cover into the use position. The subassembly described above, wherein the retainer comprises at least one projection configured to engage with the tab of the needle cover. The subassembly described above, where the coupling of at least one retainer projection and needle cover tab prevents movement of the needle cover to the use position. The subassembly described above, wherein the tab is disposed on an outer surface of the needle cover and the projection is an inwardly oriented projection arranged radially outward from the tab. The subset described above, where the protrusion meets the tab at a proximal end thereof. / un uzuu The subassembly described above, wherein the retainer comprises at least one radially extending projection and the lid extractor comprises at least one opening in a side wall thereof. The subassembly described above, wherein the at least one radially extending projection is configured to deflect radially outwards when the at least one radially extending projection is aligned with the at least one opening in the lid extractor. The subassembly described above, wherein the retainer is displaceable with respect to the cap extractor from a first position in which the at least one radially extending projection is not aligned with the at least one opening in the cap extractor and cannot be deflected radially outwards to a second position in which the at least one radially extending projection is aligned with the at least one opening in the cap extractor, so that the at least one radially extending projection is able to be deflected radially outwards. A drug delivery device comprising: a housing; a syringe comprising a needle and received at least partially within the housing; a needle cover comprising a tab at a distal end thereof and having a pre-use position in which the needle is positioned within the needle cover and a use position in which the needle is positioned at least partially outside the needle cover, wherein, in the use position, the needle cover is configured to activate the drug delivery device to administer a drug; and a cap assembly comprising a cap extractor and a retainer received within the cap extractor, the retainer being configured to prevent movement of the needle cover from the pre-use position to the use position. The drug delivery device described above, wherein the retainer comprises at least one projection configured to engage with the needle cover tab. The drug delivery device described above, where the coupling of at least one retainer projection and needle cover tab prevents movement of the needle cover into the use position. The drug delivery device described above, wherein the retainer comprises at least one radially extending projection and the cap extractor comprises at least one opening in a side wall thereof. The drug delivery device described above, wherein the at least one radially extending projection is configured to deflect radially outwards when the at least one radially extending projection is aligned with the at least one opening in the cap extractor. The drug delivery device described above, wherein the retainer is displaceable with respect to the cap extractor from a first position in which the at least one radially extending projection is not aligned with the at least one opening in the cap extractor and cannot be deflected radially outwards to a second position in which the at least one radially extending projection is aligned with the at least one opening in the cap extractor, so that the at least one radially extending projection is able to be deflected radially outwards. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1A is a side view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 1B is a bottom view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 2A is an exploded view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 2B is a perspective view of the lid assembly shown in Figure 2A; Figure 3 is a cross-sectional view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 4A is a perspective view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 4B is a perspective view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 5A is an exploded perspective view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 5B is a perspective view of a lid extractor from a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 5C is a perspective view of a retainer for a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 6 is a cross-sectional perspective view of a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 7 is a cross-sectional view of an autoinjector including a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 8 is a cross-sectional view of an autoinjector including a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 9 is a cross-sectional view of an autoinjector including a lid assembly according to a non-limiting embodiment or aspect described herein; Figure 10 is a cross-sectional view of a subassembly including a lid assembly according to a non-limiting embodiment or aspect described herein; Figures 11A, 11B, 11C, 11D, 11E, 11F, 11G, 11H, 111, 11J show assembly stages of a subassembly according to a non-limiting embodiment or aspect described herein; and Figure 12 shows a side view of an autoinjector according to a non-limiting embodiment or aspect described herein. DESCRIPTION OF THE INVENTION The following description is provided to enable those skilled in the art to perform and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Each and every one of these modifications, variations, equivalents, and alternatives is intended to fall within the spirit and scope of the present invention. For the purposes of the following description in this document, the terms upper, lower, right, left, vertical, horizontal, superior, inferior, lateral, longitudinal, and their derivatives shall refer to the invention as they are oriented in the figures in the drawings. However, it should be understood that the invention may adopt various alternative variations, unless expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely illustrative embodiments of the invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting. This document provides a cap assembly for a drug delivery device that includes a needle. In non-limiting embodiments or aspects, the drug delivery device is an autoinjector or other similar device for the automatic or manual administration of a substance to a user. Referring to Figures 1A-6, a cap assembly (100) is shown, which in non-limiting embodiments or aspects is a shield removal assembly that includes a retainer (110) and a cap extractor (150). The retainer (110) is nested within the cap extractor (150). In non-limiting embodiments or aspects, the cap extractor (150) is flared at its distal end to form an ergonomic gripping surface that allows a user to firmly grasp the cap extractor.The retainer (110) and the cap extractor (150) can be made of any rigid material, for example, and without limitation, plastics and the like. Figures 2A, 2B, and 5A-5C show exploded views of a non-limiting embodiment or aspect of the cap assembly described herein. The cap extractor (150) includes a proximal end (155), which is configured to be closer to the housing, and a distal end (160). In non-limiting embodiments or aspects, the proximal end (155) of the cap extractor (150) includes two or more arms that engage with a housing (not shown) of an autoinjector. In such embodiments or aspects, the arms of the cap extractor (150) include at least one projection or protrusion to allow secure and releasable engagement with the autoinjector housing. The distal end (160) of the cap extractor (150) includes at least one opening (162) through it. In non-limiting embodiments or aspects, the cap extractor (150) includes at least one opening (170) in one of its side walls.In non-limiting embodiments or aspects, the lid extractor (150) includes two openings (170). In non-limiting embodiments or aspects, the lid extractor (150) includes two openings (170) located on opposite sides of the lid extractor (150). Continuing with reference to Figures 1A, 1B, 2A, 2B, 4A, 4B, 5A, and 5B, the retainer (110) includes proximal (115, closest to the housing) and distal (120) ends. In non-limiting embodiments or aspects, the proximal end (115) of the retainer (110) includes two or more arms that engage with the needle shield (not shown) of an autoinjector. In such embodiments or aspects, the arms of the retainer (110) include at least one projection to allow secure engagement with the needle shield. The distal end (120) of the retainer (110) includes at least one opening (122) through it. In non-limiting embodiments, the distal end (120) of the retainer (110) is configured to engage with the distal end (160) of the cap extractor (150).In non-limiting embodiments or aspects, the opening (162) at the distal end (160) of the lid extractor (150) has a larger diameter than the opening (122) at the distal end (120) of the retainer (110). In non-limiting embodiments or aspects, this difference in diameter allows the retainer (110) to be inserted into the lid extractor (150) through the opening (162) at the distal end (160) of the lid extractor (150). As described above, the proximal end (115) of the retainer (110) may include at least one gripping feature, such as a projection, to allow secure attachment to a needle shield. Turning to Figures 3 and 6, a cap assembly according to a non-limiting embodiment or aspect is shown, wherein the retainer (110) includes at least one gripping feature (125) at a proximal end (115) thereof. The at least one gripping feature may be at least one projection (125), and may be configured to be capable of gripping a needle shield by a tab thereof. In non-limiting embodiments or aspects, the retainer (110) and cap extractor (150) of the cap assembly (100) are configured or arranged so that the needle shield and / or syringe of an autoinjector (not shown) can be displaced relative to the retainer by inserting a device, such as a tool, through openings (122, 162) at the distal ends (120, 160) of the retainer (110) and cap extractor (150), respectively. Inserting a tool through the openings of the cap extractor and retainer allows the needle shield and syringe to be displaced proximally and thus permits adjustment of the position of the projections (125) relative to the needle shield to ensure a secure grip between the retainer (110) and the needle shield. Continuing with reference to Figures 3 and 6, as previously described in non-limiting embodiments or aspects, the lid extractor (150) includes at least one opening (170) in a side wall thereof. The at least one opening (170) is configured to allow at least one radially extending projection (135) on the retainer (110) to extend through it. In the embodiment or non-limiting aspect shown in Figures 3 and 6, at least one radially extending projection (135) extends from an arm extending proximally from the distal end (120) of the retainer (110). In other embodiments or non-limiting aspects (not shown), the at least one radially extending projection (135) is positioned on a main body of the retainer (110). Referring to Figures 2A and 2B, a delay arrangement is provided between the lid extractor (150) and the retainer (110) during the removal of the lid assembly (100). The retainer (110) is received within the lid extractor (150) such that at least one projection (112) is disposed proximally to at least one protrusion (152) of the lid extractor (150). In non-limiting embodiments or aspects, the at least one projection (112) prevents the retainer (110) from displacing distally from the lid extractor (150) by engaging with a proximal surface of the at least one protrusion (152). In non-limiting embodiments or aspects, the retainer (110) further includes at least one tab (114), disposed distally to the at least one protrusion (152) of the lid extractor (150).In this way, the retainer (110) is prevented from moving proximally away from the cap extractor (150) by engaging a proximal surface of at least one tab (114) with a distal surface of at least one protrusion (152). The longitudinal space between the at least one protrusion (112) and the at least one tab (114) on the retainer (110) creates a predetermined amount of clearance between these components. Consequently, in non-limiting embodiments or aspects, when the cap extractor (150) is pulled distally to remove the cap assembly (100) from a drug delivery device to which it is attached, the cap extractor (150) is pulled a certain distance before the at least one protrusion (152) engages with the at least one protrusion (112) of the retainer (110). This creates a delay between the start of the cap extractor's (150) movement and the start of the retainer's (110) movement.When the cap extractor (150) is moved sufficiently so that at least one protrusion (152) engages with at least one projection (112), the retainer (110) begins to move away from the drug delivery device and, due to the placement of at least one projection (125) with respect to the needle guard, the needle guard begins to move away from the syringe and needle. This document also provides an autoinjector comprising a housing, a syringe having a barrel, a needle, a needle shield, and a cap assembly. Turning to Figures 7-9, an autoinjector is shown comprising a housing, a syringe (200) having a barrel (210) and a needle (220) attached thereto, a removable needle shield (230) configured to at least partially surround the needle (220), and a cap assembly (100). The autoinjector housing (a lower housing (310) is shown, although it should be understood that the autoinjector may include an upper housing, as described below) comprises a proximal end and a distal end, the distal end being open to allow the needle (220) to pass through it for the administration of a substance to a user. The removable needle shield (230) may include proximal (232) and distal (234) ends. In non-limiting embodiments, the removable needle shield (230) is a two-piece needle shield, comprising an elastomeric inner portion and a rigid outer portion. In non-limiting embodiments, the rigid outer portion at least partially surrounds the elastomeric inner portion of the needle shield (230). In non-limiting embodiments, the needle shield (230) includes at least one tab or protrusion (235). In non-limiting embodiments, the at least one tab or protrusion (235) is located on the elastomeric inner portion to engage with the rigid outer portion. In non-limiting embodiments, the needle shield (230) includes at least one additional gripping feature (233) on its proximal end (232).In non-limiting embodiments or aspects, the at least one complementary gripping feature (233) is configured to be complementary to and attachable to the at least one gripping feature (125) of the retainer. In non-limiting embodiments or aspects, the at least one complementary gripping feature (233) is the proximal edge of the needle protector (230). In non-limiting embodiments or aspects, the elastomeric part of the needle protector (230) is formed from one or more natural or synthetic rubbers and / or thermoplastic elastomer, or combinations thereof. In non-limiting embodiments or aspects, the rigid outer part of the needle protector (230) is formed from a rigid plastic. In non-limiting embodiments or aspects, the rigid outer part is formed from polypropylene. The cap assembly (100) includes, as described above, the cap extractor (150) and the retainer (110). In non-limiting embodiments or aspects, the cap extractor (150) and / or the retainer (110) include one or more of the features described above. In non-limiting embodiments or aspects, the cap extractor (150) at least partially surrounds the open distal end of the housing. In non-limiting embodiments or aspects, the cap extractor (150) is not rotatable with respect to the housing. The autoinjector housing and / or the cap extractor (150) may include features suitable for preventing rotation of the cap extractor (150), and consequently the retainer (110) and the needle guard (230), with respect to the housing and the needle (220), during removal of the needle guard (230).In non-limiting embodiments or aspects, suitable anti-rotation features include one or more projections, guide channels and / or protrusions on the lid extractor (150) and / or housing. This document also provides a method for assembling an autoinjector, including a cap assembly, comprising the steps of providing a lower housing assembly for an autoinjector, inserting a syringe into the lower assembly, and placing an upper assembly onto the lower assembly. In a first step, a lower housing assembly (300) is provided, including the cap assembly (100) attached thereto. The lower housing assembly (300) includes a lower housing (310). In non-limiting embodiments or aspects, the lower assembly (300) includes a ring (320) at a proximal end thereof. The lower housing assembly (300) includes a proximal end and a distal end, the distal end being open to allow a syringe needle to pass through it, and the proximal end of the lower housing (310) being open to allow a syringe to be inserted into the housing.The housing may be made of any suitable material, including, for example and without limitation, rigid plastic. The lower assembly (300) also includes a lid assembly (100). The lid assembly (100) includes, as described above, the lid extractor (150) and the retainer (110), each of which has distal ends (160, 120) with an opening (162, 122) passing through them. In non-limiting embodiments or aspects, the lid extractor (150) and / or the retainer (110) include one or more of the features described above. In an initial configuration (for example, when the lid assembly (100) is placed on the lower housing (310)), the distal end (120) of the retainer (110) is separated from the distal end (160) of the lid extractor (150). Referring to Figure 7, in non-limiting embodiments or aspects, in a second step of the method, a syringe (200) is inserted into the lower housing (310). The syringe (200) may include a barrel (210) for containing a drug or other substance, a needle (220) disposed at a distal end of the barrel (210), and a removable needle guard (230). The syringe (200), barrel (210), needle (220), and needle guard (230) may include one or more of the features described above. The syringe barrel (210) may be of any useful size and may be made of any useful material, such as glass or plastic. In non-limiting embodiments or aspects, the syringe (200) is a single-unit syringe, and the needle (220) is formed from the syringe barrel (210).In non-limiting embodiments or aspects, the syringe barrel (210) is not formed with the needle (220) inside; instead, a needle shaft (not shown) contains the needle (220). The syringe needle (220) can be made of any suitable material and can have any suitable gauge. The needle shield (230) can be a one-piece needle shield made of an elastomeric material, or a two-piece needle shield with an inner part made of an elastomeric material and an outer part made of a rigid material. The needle shield (230) at least partially surrounds the needle (220). In non-limiting embodiments or aspects, the syringe (200) includes a flange (240) at its proximal end. At the end of the second step, the distal end (120) of the retainer (110) remains longitudinally separated from the distal end (160) of the cap extractor (150). In non-limiting embodiments or aspects, the step of inserting the syringe (200) includes moving the syringe (200) toward the distal end of the housing (310), preferably so that the at least one gripping feature (125) is longitudinally separated from the proximal end of the needle guard. In other words, the at least one gripping feature (125) is more proximal than in its final position (shown in Figure 9). In this position, the distal end (234) of the syringe flange encounters the ring (320). In this position, the proximal end (115) of the retainer (110) contacts the syringe barrel (210). As described above, at the end of this step, the distal end (120) of the retainer (110) is held proximally to the distal end (160) of the lid extractor (150), such that the distal end (120) of the retainer (110) is longitudinally separated from the distal end (160) of the lid extractor (150). In non-limiting embodiments or aspects, a tool (not shown) is inserted into the opening (162) of the lid extractor (150). This tool can be used to push the retainer (110) proximally, so that the distal end (120) of the retainer (110) is longitudinally separated from the distal end (160) of the lid extractor (150). In non-limiting embodiments or aspects, the proximal end (115) of the retainer (110) includes at least one gripping feature, such as projections (125), and the projections (125) contact the syringe barrel (210) proximal to the distal end of the syringe barrel (210). In this way, the retainer (110) is in an overloaded position, where the at least one gripping feature (125) is too far proximally from the needle guard (230) (Figure 7). In non-limiting embodiments or aspects, the needle guard (230) includes at least one tab or protrusion (235), and the proximal end (115) of the retainer (110) includes at least one gripping feature (125), and the at least one gripping feature (125) contacts the syringe barrel (210) proximal to the at least one tab or protrusion (235). Referring to Figure 8, in non-limiting embodiments or aspects, a third step of the syringe assembly method includes, after inserting the syringe (200) into the lower housing (310), moving the syringe (200) proximally. In non-limiting embodiments or aspects, pushing the syringe (200) proximally into the lower housing (310) is achieved by inserting a device through the at least one opening (162, 122) at the distal ends (160, 120) of the cap extractor (150) and the retainer (110), and applying pressure to push the syringe (200) proximally. In non-limiting embodiments or aspects, and as shown in Figure 8, when the syringe (200) is pushed proximally, the at least one gripping feature (125) of the retainer (110) engages with the needle shield at a more proximal end thereof.In non-limiting embodiments or aspects, the at least one gripping feature (125) engages with a corresponding complementary at least one gripping feature (233) on the needle guard (230). In non-limiting embodiments or aspects, after pushing the syringe (200) proximally, the syringe tab (240) separates longitudinally from the ring (320) of the lower assembly (300). At the end of this step, the at least one gripping feature (125) engages with the complementary at least one gripping feature (233) of the needle guard (230), the distal end (120) of the retainer (110) is separated longitudinally from the distal end (160) of the cap extractor (150), and the syringe tab (240) is separated longitudinally from the ring (320). In non-limiting embodiments or aspects, the method includes a fourth step of placing an upper assembly (not shown), which includes an upper housing, onto the lower assembly. As with the lower assembly and lower housing, the upper assembly and upper housing can be formed of any suitable material, including, for example and without limitation, a rigid plastic. In non-limiting embodiments or aspects, the step of placing the upper assembly onto the lower assembly causes the syringe to move distally so that the syringe flange (240) engages the ring (320). Referring to Figure 9, after assembly, the distal end (120) of the retainer (110) falls or is otherwise displaced towards the distal end (160) of the cap extractor (150), so that the distal end (120) of the retainer (110) meets the distal end (160) of the cap extractor (150). IVIA / a / ZUZ I / un uzuu Once an end user wants to remove the needle shield, they pull the cap extractor. As described above, the gap between the at least one protrusion (112) of the retainer (110) and the at least one protrusion (152) of the cap extractor (150) creates a delay between the start of the longitudinal movement of the cap extractor (150) away from the lower housing assembly (300) and the start of the longitudinal movement of the retainer (110) away from the lower housing assembly (300). Referring back to Figure 10, in non-limiting embodiments or aspects, the cap assembly (100) functions to prevent the activation of a drug delivery device, such as an autoinjector, to which the cap assembly (100) is attached. Referring to Figure 12, a non-limiting embodiment or aspect of an autoinjector with which this assembly can be used is shown. The autoinjector (500) includes the lower housing assembly (300) as described above, an upper housing subassembly (400), a cap extractor (150), and a retainer (110). The lower housing subassembly includes a housing (310) and a needle cover (330). In the embodiments or non-limiting aspects shown in Figures 10-12, the needle cover (330) is configured to protect the needle (220) of a user's syringe (200) when, for example, the removable needle guard (230) has been removed.The needle cover (330) can be moved from an extended (pre-use) position to a retracted (use) position, where it moves proximally into the lower housing assembly (300), and then to a second extended (post-use) position. In both extended positions (pre- and post-use), the needle cover (330) at least partially protects the needle (220). In the use position, the needle cover (330) does not protect the needle, which can be inserted into a user's skin. In the embodiments or non-limiting aspects shown in Figures 10-12, in order to use the autoinjector (500), a user removes the cap assembly (100) as described above (and below) and applies the distal end of the autoinjector (500) to the skin at the intended injection site. The needle cover (330) is positioned on the distal end of the autoinjector and thus contacts the user's skin. Applying force to the autoinjector (500) against the skin causes the needle cover (330) to move proximally into the housing (310) of the lower housing subassembly. In embodiments or non-limiting aspects, the movement of the needle cover (330) allows for proximal administration of the drug, for example, by interaction of the needle cover (330) with a container holder (not shown).Specifically, in non-limiting embodiments or aspects, proximal movement of the needle cover (330) causes the needle cover (330), at its proximal end (335), to contact a container holder provided in the upper housing subassembly (400), which then causes the container holder to move proximally. The container holder may have at least one window (not shown) that allows pushed-in locking elements (not shown), which hold the plunger (not shown) of the autoinjector (500) in a pre-use position against the pushing force of an injection spring (not shown), to move radially to an unpushed position. The radial movement of the locking elements releases the plunger, which is displaced out of the container holder by the injection spring, which moves a piston (not shown) in the syringe barrel (210) to cause injection of drug through the needle (220).As can be seen from the embodiment or aspect described above, proximal movement of the needle cover (330) can cause unintentional activation of the autoinjector (500). Therefore, as shown in Figures 10 and 11A-11J, in non-limiting embodiments or aspects, a subassembly for a drug delivery device, such as an autoinjector, is provided. The subassembly includes a housing (310), a needle cover (330), and a cap assembly (100) comprising a retainer (110) and a cap extractor (150). In non-limiting embodiments or aspects, the retainer (110) prevents unintentional proximal movement of the needle cover (330) and, consequently, unintentional activation of a drug delivery device of which the subassembly is a component. In non-limiting embodiments or aspects, the retainer (110) includes at least one projection, such as an inwardly oriented projection (136).In non-limiting embodiments or aspects, the at least one inwardly oriented projection (136) is disposed on the same proximally extending arm on which at least one radially extending projection (135) is placed. Continuing with reference to Figures 10 and 11A-11J, in non-limiting embodiments or aspects, the needle cover (330) includes at its distal end an outwardly projecting flange or lip (340). In non-limiting embodiments or aspects, the inwardly facing projection (136) on the retainer (110) is located proximally to the flange or lip (340) of the needle cover (330), preventing the needle cover (330) from moving proximally a sufficient distance to allow activation of the autoinjector (500). In non-limiting embodiments or aspects, the inwardly facing projection (136) engages with the flange or lip (340) of the needle cover (330), substantially or completely preventing proximal movement of the needle cover (330). Figure 10 shows a non-limiting embodiment or aspect in which the flange or tab (340) is disposed on an outer surface of the needle cover (330), and the projection (136) is an inwardly facing projection configured to engage the flange or tab (340). In non-limiting embodiments or aspects (not shown), the projection is an outwardly facing projection and is disposed on an arm extending proximally from the distal end of the retainer (110) through an inner space defined by the needle cover (330), and is configured to engage a flange or tab disposed on an inner surface of the needle cover. Returning to Figures 11A-11J, the assembly process mentioned above is shown, with special attention to the interaction between the at least one inwardly facing projection (136) and the flange or tab (340) of the needle cover (330), and the at least one radially extending projection (135) and the at least one opening (170). Figures 11A and 11B show the needle cover (330) (graphically isolated from the rest of the lower housing assembly (300)), with a flange or tab (340) and a cap assembly including a cap extractor and retainer, before the needle cover is placed in the cap assembly. Figures 11C and 11D show an initial assembly stage, when the cap assembly is first placed onto the needle cover. The at least one projection (135) extending radially from the retainer is able to deflect outward due to its longitudinal positioning relative to the at least one opening (170). The flange or tab (340) of the needle cover is engaged with a proximal orientation surface of the at least one inwardly oriented projection (136). Figures 11E and 11F show a further stage in the assembly process. The flange or tab (340) has begun to move distally past the at least one inwardly facing projection (136). In non-limiting embodiments or aspects, where the at least one inwardly facing projection (136) is positioned over at least one arm of the retainer, the arm or arms may flex outward as the flange or tab (340) passes over the at least one projection (136), allowing the needle cover to move distally past the projection or projections (136). Continuing with reference to Figures 11A-11J, Figures 11G and 11H show a further stage in the assembly process, where the flange (340) has passed distally through the at least one inwardly facing projection (136). In non-limiting embodiments or aspects where the at least one inwardly facing projection (136) can be flexed outward to allow the flange (340) to pass distally, the arm or arms have returned to an unpushed state. As described above, after the lower housing (310) is assembled onto the needle cover and cap assembly, the retainer moves distally (Figures 111 and 11J). The arrangement of the lower housing assembly (310) prevents the protrusions (135) from aligning with the openings (170). Consequently, the arms, including the protrusions (135), are prevented from flexing outward whenever the cap assembly (100) is assembled onto the lower housing assembly (300). The inward-facing protrusions (136) are then engaged with the tab (340) of the needle cover (330). This engagement prevents proximal translation of the needle cover (330), which, as described above, prevents activation of the autoinjector. In this way, unintentional activation of the device can be avoided. To use the autoinjector, the user must first remove the cap assembly (100). To do this, they pull the cap extractor (150) away from the lower housing (310). Due to axial clearance between the retainer (110) and the cap extractor (150), the cap extractor (150) will move relative to the retainer (110), so that at least one projection (135) realigns with at least one opening (170). This allows the retainer arm (110) to deflect outwards and disengage between the inwardly facing projection (136) and the tab (340) of the needle cover (330). This disengages the retainer (110) from the needle cover (330). The needle cover (330) is then free to move proximally to actuate an injection. Although the invention has been described in detail for illustrative purposes based on what are currently considered the most practical and preferred embodiments, it is understood that such detail is for such purposes only and that the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is understood that the present invention contemplates the possibility of combining, to the extent possible, one or more features of any embodiment with one or more features of any other embodiment.

Claims

1. A subassembly for a drug delivery device comprising: a housing (310); a displaceable needle cover (330) comprising a distal end comprising a flange (340), the needle cover (330) received within the housing (310) and configured to have a pre-use position in which the needle cover (330) extends from the housing (310) and a use position in which the needle cover (330) is at least partially displaced into the housing (310), wherein the displacement of the needle cover (330) into the housing (310) activates the drug delivery device by interaction with a drive mechanism; and a cap assembly (100), comprising: a cap extractor (150) configured to be gripped by a user;and a retainer (110) received within the cap extractor (150) and configured to engage with the tab (340) of the needle cover (330) of the drug delivery device, wherein the arrangement of the retainer (110) with respect to the tab (340) is configured to prevent movement of the needle cover (330) to the use position, and wherein the retainer comprises at least one radially extending projection (135) and the cap extractor (150) comprises at least one opening (170) in a side wall thereof.

2. The subassembly of claim 1, wherein the retainer (110) comprises at least one projection (136) configured to engage with the tab (340) of the needle cover (330).

3. The subassembly of claim 2, wherein the coupling of at least one projection (136) of the retainer (110) and the tab (340) of the needle cover (330) prevents movement of the needle cover (330) to the use position.

4. The subassembly of claim 2 or claim 3, wherein the tab (340) is disposed on an outer surface of the needle cover (330) and the projection (136) is an inwardly oriented projection arranged radially outward from the tab (340).

5. The subassembly of any of claims 2-4, wherein the projection (136) meets the flange (340) at a proximal end thereof.

6. The subassembly of claim 5, wherein the at least one radially extending projection (135) is configured to deflect radially outwards when the at least one radially extending projection (135) is aligned with the at least one opening (170) in the lid extractor (150).

7. The subassembly of claim 6, wherein the retainer (110) is displaceable with respect to the cap extractor (150) from a first position in which at least one radially extending projection (135) is not aligned with the at least one opening (170) in the cap extractor (150) and cannot be radially deflected outwards to a second position in which at least one radially extending projection (135) is aligned with the at least one opening (170) in the cap extractor (150), so that the at least one radially extending projection is capable of being radially deflected outwards.

8. A drug delivery device (500) comprising the subassembly for a drug delivery device of claim 1, further comprising a syringe (200) comprising a needle (220) and received at least partially within the housing (310), wherein in a position of use the needle (220) is positioned at least partially outside the needle cover (330), wherein, in the position of use, the needle cover (330) is configured to activate the drug delivery device to deliver a drug.

9. The drug delivery device of claim 8, wherein the retainer (110) comprises at least one projection (136) configured to engage with the flange (340) of the needle cover (330).

10. The drug delivery device of claim 9, wherein the coupling of at least one projection (136) of the retainer (110) and the tab (340) of the needle cover (330) prevents movement of the needle cover (330) to the use position.

11. The drug delivery device of any of claims 8-10, wherein the retainer comprises at least one radially extending projection (135) and the cap extractor (150) comprises at least one opening (170) in a side wall thereof.

12. The drug delivery device of claim 11, wherein the at least one radially extending projection (135) is configured to deflect radially outwards when the at least one radially extending projection (135) is aligned with the at least one opening (170) in the cap extractor (150).

13. The drug delivery device of claim 11 or claim 12, wherein the retainer (110) is displaceable with respect to the cap extractor (150) from a first position in which at least one radially extending projection (135) is not aligned with the at least one opening (170) in the cap extractor (150) and cannot be radially deflected outwards to a second position in which at least one radially extending projection (135) is aligned with the at least one opening (170) in the cap extractor (150), such that the at least one radially extending projection is capable of being radially deflected outwards.

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