Hard needle shield remover with a drop test function for an auto-injector

Abstract

To provide a needle shield remover that can be disposed in a reliable manner to quickly and easily remove a needle shield when an automatic injector is used, and provide a device capable of preventing unintended actuation of the automatic injector.SOLUTION: A sub-assembly of a drug delivery device includes a housing and a displaceable needle cover having a distal end including a flange. The needle cover is configured so as to have a before-use position in which the needle cover is received inside the housing and extends from the housing, and a use position in which the needle cover is displaced inside the housing at least partially. When the needle cover is displaced inside the housing, the drug delivery device is actuated. The sub-assembly further includes a cap assembly configured to prevent the needle cover from moving to the use position.SELECTED DRAWING: Figure 10

Description

Technical Field

[0001] The present disclosure generally relates to an autoinjector and a method of assembling the same, and more specifically, to an apparatus for removing a needle shield from an autoinjector, an apparatus for preventing inadvertent actuation of the autoinjector, and a method of assembling an autoinjector including such an apparatus.

Background Art

[0002] Auto drug delivery devices such as autoinjectors are designed with removable shields to maintain the sterility of the needle and prevent inadvertent contact between the needle and the user. Many of these needle shields are elastic, and it can be difficult to ensure an exact placement and a firm grip between the needle shield and a cap or other removal device, such that excessive force is required to remove the shield or slippage occurs and the shield cannot be removed at all.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Accordingly, there is a need in the art for a needle shield remover that can be reliably positioned to quickly and easily remove a needle shield when an autoinjector is used.

[0004] Furthermore, auto drug delivery devices can suffer from a tendency to inadvertently activate when force is applied to the device. In particular, "push-on" actuation devices can inadvertently activate when the device is dropped. Accordingly, there is a need in the art for an apparatus that can prevent inadvertent actuation of an autoinjector.

Means for Solving the Problems

[0005] The sub-assemblies of the drug delivery device provided herein include a housing and a displaceable needle cover having a distal end that includes 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 displaced at least partially within the housing, the displacement of the needle cover into the housing actuating the drug delivery device via interaction with a drive mechanism, a needle cover, and a cap assembly including a cap remover configured to be gripped by a user and a retainer received within the cap remover and configured to engage a flange of the needle cover of the drug delivery device, the arrangement of the retainer relative to the flange being configured to prevent movement of the needle cover to its use position.

[0006] Also provided herein is a drug delivery device including a housing, a syringe having a needle and receiving the housing at least partially therein, a needle cover having a flange at its distal end and having a pre-use position in which the needle is disposed within the needle cover and a use position in which the needle is disposed at least partially outside of the needle cover, the needle cover in the use position being configured to actuate the drug delivery device to deliver a drug, a cap remover, and a cap assembly including a retainer received within the cap remover, the retainer being configured to prevent the needle cover from moving from its pre-use position to its use position.

[0007] Further embodiments and aspects are described below.

[0008] The sub-assembly of the drug delivery device provided herein includes a housing and a displaceable needle cover having a distal end including a flange, which is received within the housing and configured to have a pre-use position where the needle cover extends from the housing and a use position where the needle cover is at least partially displaced within the housing. The displacement of the needle cover into the housing actuates the drug delivery device via interaction with a drive mechanism. The sub-assembly further includes a cap assembly comprising a cap remover configured to be gripped by a user and a retainer received within the cap remover and configured to engage the flange of the needle cover of the drug delivery device. The arrangement of the retainer relative to the flange is configured to prevent movement of the needle cover to its use position.

[0009] In the above-described sub-assembly, the retainer includes at least one protrusion configured to engage the flange of the needle cover.

[0010] In the above-described sub-assembly, the engagement of at least one protrusion of the retainer with the flange of the needle cover prevents movement of the needle cover to its use position.

[0011] In the above-described sub-assembly, the flange is disposed on the outer surface of the needle cover, and the protrusion is an inward protrusion disposed radially outward of the flange.

[0012] In the above-described sub-assembly, the protrusion is adjacent to the flange at its proximal end.

[0013] In the above-described sub-assembly, the retainer includes at least one radially extending protrusion, and the cap remover includes at least one opening in its side wall.

[0014] In the above-described sub-assembly, when at least one radially extending protrusion is aligned with at least one opening of the cap remover, the at least one radially extending protrusion is configured to deflect radially outward.

[0015] In the above sub-assembly, the retainer is such that at least one radially extending protrusion is not aligned with at least one opening of the cap remover and cannot deflect radially outwards. From a first position where it cannot deflect radially outwards, the retainer is shiftable relative to the cap remover to a second position where at least one radially extending protrusion is aligned with at least one opening of the cap remover, such that as a result at least one radially extending protrusion can deflect radially outwards.

[0016] Also provided herein is a drug delivery device comprising a housing, a syringe having a needle and at least partially receiving the housing, a needle cover having a flange at its distal end, a pre-use position where the needle is disposed within the needle cover, and a use position where the needle is disposed at least partially outside the needle cover, and wherein the needle cover is configured to actuate the drug delivery device to deliver a drug in the use position, a cap remover, and a cap assembly including a retainer received within the cap remover, the retainer being configured to prevent the needle cover from moving from the pre-use position to the use position.

[0017] In the above sub-assembly, the retainer comprises at least one protrusion configured to engage a flange of the needle cover.

[0018] In the above drug delivery device, the engagement between at least one protrusion of the retainer and the flange of the needle cover prevents the needle cover from moving to the use position.

[0019] In the above drug delivery device, the retainer includes at least one radially extending protrusion and the cap remover includes at least one opening in its side wall.

[0020] In the above sub-assembly, when at least one radially extending protrusion is aligned with at least one opening of the cap remover, the at least one radially extending protrusion is configured to deflect radially outwards.

[0021] In the drug delivery device described above, the retainer is shiftable relative to the cap remover from a first position in which at least one radially extending protrusion is not aligned with at least one opening of the cap remover and cannot deflect radially outward, to a second position in which at least one radially extending protrusion is aligned with at least one opening of the cap remover, such that as a result, at least one radially extending protrusion can deflect radially outward.

Brief Description of the Drawings

[0022]

Figure 1A

Figure 1B

Figure 2A

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Figure 4B

Figure 5A

Figure 5B

Figure 5C

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11A

Figure 11B

Figure 11C

Figure 11D

Figure 11E

Figure 11F

Figure 11G

Figure 11H

Figure 11I

Figure 11J

Figure 12

Best Mode for Carrying Out the Invention

[0023] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0024] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "uppermost", "lowermost", "lateral", "longitudinal", and their derivatives shall relate to the invention as oriented in the drawings. However, it will be understood that the invention may assume various alternative variations unless explicitly specified to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0025] Provided herein is a shield removal assembly for a drug delivery device including a needle. In non-limiting embodiments or aspects, the drug delivery device is an auto-injector or other similar device for automatic or manual delivery of a substance to a user. Referring to FIGS. 2 and 3, there is a cap assembly 100 which, in non-limiting embodiments or aspects, is a shield removal assembly including a retainer 110 and a cap remover 150. The retainer 110 is nested within the cap remover 150. In non-limiting embodiments or aspects, the cap remover 150 flares at its distal end to form an ergonomic gripping surface to enable the user to firmly grip the cap remover. The retainer 110 and the cap remover 150 can be formed of any rigid material, such as, but not limited to, plastic.

[0026] FIGS. 2A, 2B, and 5A - 5C show exploded views of non-limiting embodiments or aspects of the shield removal assembly described herein. The cap remover 150 includes a proximal end 155 configured to be closest to the housing and a distal end 160. In non-limiting embodiments or aspects, the proximal end 155 of the cap remover 150 includes two or more arms that engage with a housing (not shown) of the auto-injector. In such non-limiting embodiments or aspects, the arms of the cap remover 150 include at least one protrusion or shoulder to enable a secure and releasable engagement with the housing of the auto-injector. The distal end 160 of the cap remover 150 includes at least one opening 162 therethrough. In non-limiting embodiments or aspects, the cap remover 150 includes at least one opening 170 in its sidewall. In non-limiting embodiments or aspects, the cap remover 150 includes two openings 170. In non-limiting embodiments or aspects, the cap remover 150 includes two openings 170 disposed on opposite sides of the cap remover 150.

[0027] Continuing to refer to FIGS. 1, 2A, 2B, 4, 5A, and 5B, retainer 110 includes a proximal end (115, closest to the housing) and a distal end 120. In non-limiting embodiments or aspects, the proximal end 115 of retainer 110 includes two or more arms that engage with a needle shield (not shown) of the auto-injector. In such non-limiting embodiments or aspects, the arms of retainer 110 include at least one protrusion to enable secure engagement with the needle shield. The distal end 120 of retainer 110 includes at least one opening 122 therethrough. In non-limiting embodiments, the distal end 120 of retainer 110 is configured to be adjacent to the distal end 160 of cap remover 150. In non-limiting embodiments or aspects, the opening 162 of the distal end 160 of cap remover 150 has a larger diameter than the opening 122 of the distal end 120 of retainer 110. Due to this difference in diameter, in non-limiting embodiments or aspects, retainer 110 can be introduced into cap remover 150 through the opening 162 of the distal end 160 of cap remover 150.

[0028] As described above, the proximal end 115 of retainer 110 can include at least one gripping formation, such as a protrusion, to enable secure engagement with the needle shield. Looking at FIGS. 3 and 6, a shield removal assembly according to a non-limiting embodiment or aspect is shown in which retainer 110 includes at least one gripping formation 125 at its proximal end 115. The at least one gripping formation is at least one protrusion 125 and is configured such that it can grip the needle shield by its flange.

[0029] In non-limiting embodiments or aspects, the retainer 110 and the cap remover 150 of the shield removal assembly 100 are configured or arranged to be movable relative to the retainer by introducing a device such as a tool through the openings 122, 162 at the distal ends 120, 160 of the retainer 110 and the cap remover 150, respectively, for the needle shield and / or syringe of an auto-injector (not shown). Placing a tool through the openings of the cap remover and the retainer enables displacement of the needle shield and the syringe in the proximal direction, so that the position of the protrusion 125 relative to the needle shield can be adjusted to secure a grip between the retainer 110 and the needle shield.

[0030] Continuing to refer to FIGS. 3 and 6, in non-limiting embodiments or aspects as described above, the cap remover 150 includes at least one opening 170 in its sidewall. The at least one opening 170 is configured to allow at least one radially extending protrusion 135 on the retainer 110 to pass therethrough and extend. In the non-limiting embodiment or aspect shown in FIGS. 3 and 6, the at least one radially extending protrusion 135 extends from an arm that extends proximally from the distal end 120 of the retainer 110. In other non-limiting embodiments or aspects (not shown), the at least one radially extending protrusion 135 is disposed on the body of the retainer 110.

[0031] Referring to FIGS. 2A and 2B, during removal of the shield removal assembly 100, a delay arrangement is provided between the cap remover 150 and the retainer 110. The retainer 110 is received within the cap remover 150 such that at least one protrusion 112 is disposed proximal to at least one shoulder 152 of the cap remover 150. In non-limiting embodiments or aspects, at least one protrusion 112 prevents the retainer 110 from being displaced distally from the cap remover 150 by engagement with the proximal surface of at least one shoulder 152. In non-limiting embodiments or aspects, the retainer 110 further includes at least one flange 114 disposed distal to at least one shoulder 152 of the cap remover 150. In this way, the retainer 110 prevents displacement proximally from the cap remover 150 by engagement of the proximal surface of at least one flange 114 with the distal surface of at least one shoulder 152. The longitudinal space between at least one protrusion 112 and at least one flange 114 on the retainer 110 provides a predetermined amount of "play" between these components. Thus, in non-limiting embodiments or aspects, when the cap remover 150 is pulled distally to remove the shield removal assembly 100 from the drug delivery device to which it is attached, the cap remover 150 is pulled a specific distance before at least one shoulder 152 engages at least one protrusion 112 of the retainer 110. This provides a delay between the start of movement of the cap remover 150 and the start of movement of the retainer 110. When the cap remover 150 has moved sufficiently such that at least one shoulder 152 engages at least one protrusion 112, the retainer 110 begins to be pulled away from the drug delivery device and, due to the arrangement of at least one protrusion 125 relative to the needle shield, the needle shield begins to be pulled away from the syringe and needle.

[0032] Also provided herein is an autoinjector including a housing, a barrel, a needle, a syringe having a needle shield, and a cap assembly. Referring to FIGS. 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, and a shield removal assembly 100. The autoinjector housing (although a lower housing 310 is shown, it should be understood that the autoinjector can include an upper housing as described below.) includes a proximal end and a distal end, the distal end being open to allow the needle 220 to pass therethrough and to allow a substance to be delivered to a user.

[0033] The removable needle shield 230 can include a proximal end 232 and a distal end 234. In non-limiting embodiments or aspects, the removable needle shield 230 is a two-piece needle shield including an inner elastomeric portion and a rigid outer portion. In non-limiting embodiments or aspects, the rigid outer portion at least partially surrounds the inner elastomeric portion of the needle shield 230. In non-limiting embodiments or aspects, the needle shield 230 includes at least one flange or shoulder 235. In non-limiting embodiments or aspects, the at least one flange or shoulder 235 is disposed on the inner elastomeric portion for engagement with the rigid outer portion. In non-limiting embodiments or aspects, the needle shield 230 includes at least one complementary gripping feature 233 on its proximal end 232. In non-limiting embodiments or aspects, the at least one complementary gripping feature 233 is complementary to and configured to engage with at least one gripping feature 125 of a retainer. In non-limiting embodiments or aspects, the at least one complementary gripping feature 233 is at the proximal end of the needle shield 230.

[0034] In non-limiting embodiments or aspects, the elastomeric portion of the needle shield 230 is formed of one or more natural or synthetic rubbers and / or thermoplastic elastomers, or combinations thereof. In non-limiting embodiments or aspects, the rigid outer portion of the needle shield 230 is formed of a rigid plastic. In non-limiting embodiments or aspects, the rigid outer portion is formed of polypropylene.

[0035] The cap assembly 100 includes, as described above, a cap remover 150 and a retainer 110. In non-limiting embodiments or aspects, the cap remover 150 and / or the retainer 110 includes one or more of the features described above. In non-limiting embodiments or aspects, the cap remover 150 at least partially surrounds the open distal end of the housing. In non-limiting embodiments or aspects, the cap remover 150 is not rotatable relative to the housing. The auto-injector housing, and / or the cap remover 150, can include suitable features for preventing rotation of the cap remover 150, and thus the retainer 110 and the needle shield 230, relative to the housing and the needle 220 during removal of the needle shield 230. In non-limiting embodiments or aspects, suitable anti-rotation features include one or more protrusions, guide channels, and / or shoulders on the cap remover 150 and / or the housing.

[0036] Also provided herein is a method of assembling an auto-injector including a shield removal assembly, the method including the steps of providing a lower housing assembly of the auto-injector, inserting a syringe into the lower assembly, and disposing an upper assembly on the lower assembly. In a first step, a lower housing assembly 300 including a shield removal assembly 100 engaged therewith is provided. 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 its proximal end. The lower housing assembly 300 includes a proximal end and a distal end, the distal end being open such that the needle of the syringe can pass therethrough, and the proximal end of the lower housing 310 being open such that the syringe can pass therethrough and being inserted into the housing. The housing can be formed of any suitable material, including, for example, but not limited to, rigid plastic. The lower assembly 300 also includes a cap assembly 100. The cap assembly 100 includes a cap remover 150 and a retainer 110 as described above, each having a distal end 160, 120 having an opening 162, 122 therethrough. In non-limiting embodiments or aspects, the cap remover 150 and / or the retainer 110 includes one or more of the features described above. In an initial configuration (e.g., when the shield removal assembly 100 is disposed on the lower housing 300), the distal end 120 of the retainer 110 is spaced from the distal end 160 of the cap remover 150.

[0037] Referring to FIG. 7, in a non-limiting embodiment or aspect, in the second step of the method, syringe 200 is inserted into lower housing 310. Syringe 200 can include a barrel 210 for holding a drug or other substance therein, a needle 220 disposed at the distal end of barrel 210, and a removable needle shield 230. Syringe 200, barrel 210, needle 220, and needle shield 230 can include one or more of the features described above. Syringe barrel 210 can be of any useful size and can be formed of any useful material such as glass or plastic. In a non-limiting embodiment or aspect, syringe 200 is a unitary syringe, and needle 220 is formed with syringe barrel 210. In a non-limiting embodiment or aspect, syringe barrel 210 is not formed with needle 220 therein, and instead, a needle hub (not shown) holds needle 220. Syringe needle 220 can be formed of any useful material and can be of any suitable gauge. Needle shield 230 can be a one-piece needle shield formed of an elastomeric material or a two-piece needle shield having an inner portion formed of an elastomeric material and an outer portion formed of a rigid material. Needle shield 230 at least partially surrounds needle 220. In a non-limiting embodiment or aspect, syringe 200 includes a flange 240 at its proximal end. At the end of the second step, distal end 120 of retainer 110 remains longitudinally spaced from distal end 160 of cap remover 150.

[0038] In a non-limiting embodiment or aspect, the step of inserting syringe 200 preferably includes moving syringe 200 toward the distal end of housing 310 such that at least one gripping formation 125 is longitudinally spaced from the proximal end of the needle shield. In other words, at least one gripping formation 125 is proximal to its final position (shown in FIG. 9). At this position, the distal end 234 of the syringe flange is adjacent to ring 320. At this position, the proximal end 115 of retainer 110 contacts syringe barrel 210.

[0039] As described above, at the end of this step, the distal end 120 of the retainer 110 is maintained proximal to the distal end 160 of the cap remover 150, such that the distal end 120 of the retainer 110 is longitudinally spaced from the distal end 160 of the cap remover 150. In non-limiting embodiments or aspects, a tool (not shown) is inserted into the opening 162 of the cap remover 150. This tool can be used to push the retainer 110 in the proximal direction, such that the distal end 120 of the retainer 110 is longitudinally spaced from the distal end 160 of the cap remover 150.

[0040] In non-limiting embodiments or aspects, the proximal end 115 of the retainer 110 includes at least one gripping formation, such as a protrusion 125, which contacts the syringe barrel 210 proximal to the distal end of the syringe barrel 210. In this way, the retainer 110 is in an "overstroke" position, with at least one gripping formation 125 positioned very proximal to the needle shield 230 (FIG. 7). In non-limiting embodiments or aspects, the needle shield 230 includes at least one flange or shoulder 235, the proximal end 115 of the retainer 110 includes at least one gripping formation 125, and at least one gripping formation 125 contacts the syringe barrel 210 proximal to at least one flange or shoulder 235.

[0041] Referring to FIG. 8, in a non-limiting embodiment or aspect, a third step of the method of assembling the syringe includes moving the syringe 200 proximally after inserting the syringe 200 into the lower housing 310. In a non-limiting embodiment or aspect, the step of moving the syringe 200 proximally within the lower housing 310 is accomplished by inserting the device through at least one opening 162, 122 of the cap remover 150 and the distal ends 160, 120 of the retainer 110, and applying pressure to push the syringe 200 proximally. In a non-limiting embodiment or aspect, as shown in FIG. 8, when the syringe 200 is pushed proximally, at least one gripping formation 125 of the retainer 110 engages the needle shield at its most proximal end. In a non-limiting embodiment or aspect, at least one gripping formation 125 engages at least one corresponding complementary gripping formation 233 on the needle shield 230. In a non-limiting embodiment or aspect, after the syringe 200 has been pushed proximally, the syringe flange 240 is longitudinally spaced from the ring 320 of the lower assembly 300. At the end of this step, at least one gripping formation 125 engages at least one complementary gripping formation 233 of the needle shield 230, the distal end 120 of the retainer 110 is longitudinally spaced from the distal end 160 of the cap remover 150, and the syringe flange 240 is longitudinally spaced from the ring 320.

[0042] In a non-limiting embodiment or aspect, the method includes a fourth step of placing an upper assembly (not shown) including an upper housing on top of the lower assembly. Similar to the lower assembly and the lower housing, the upper assembly and the upper housing can be formed of any suitable material, including, for example, but not limited to, rigid plastic. In a non-limiting embodiment or aspect, placing the upper assembly on the lower assembly causes the syringe to move distally such that the syringe flange 240 is adjacent to the ring 320.

[0043] Referring to FIG. 9, after assembly, the distal end 120 of the retainer 110 either drops or, if not, displaces toward the distal end 160 of the cap remover 150, such that the distal end 120 of the retainer 110 abuts the distal end 160 of the cap remover 150.

[0044] If the end user desires to remove the needle shield, the cap remover is pulled. As described above, the gap between at least one protrusion 112 of the retainer 110 and at least one shoulder 152 of the cap remover 150 causes a delay between the start of the longitudinal movement of the cap remover 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.

[0045] Referring to FIG. 10, in a non-limiting embodiment or aspect, the cap assembly 100 functions to prevent actuation of a drug delivery device, such as an auto-injector, to which the cap assembly 100 is attached. Referring to FIG. 12, one non-limiting embodiment or aspect of an auto-injector in which the present assembly can be utilized is shown. The auto-injector 500 includes a lower housing assembly, or sub-assembly 300, an upper housing sub-assembly 400, a cap remover 150, and a retainer 110 as described above. The lower sub-assembly includes a housing 310 and a needle cover 330. In the non-limiting embodiments or aspects shown in FIGS. 10-12, the needle cover 330 is configured to protect the needle 220 of the syringe 200 from the user, for example, when a removable needle shield 230 is removed. The needle cover 330 is movable from an extended position (prior to use) to a retracted position (during use), and the needle cover 330 moves proximally to the lower housing assembly 300 to a second extended position (after use). In both extended positions (prior to use and after use), the needle cover 330 at least partially shields the needle 220. In the use position, the needle cover 330 does not shield the needle and the needle is inserted into the user's skin.

[0046] In non-limiting embodiments or aspects, as shown in FIGS. 10-12, to use the auto-injector 500, the user removes the cap assembly 100 as described above (and below) and applies the distal end of the auto-injector 500 to the skin of the intended injection site. The needle cover 330 is disposed at the distal end of the auto-injector and thus contacts the user's skin. When a force is applied to the auto-injector 500 towards the skin, the needle cover 330 moves proximally into the housing 310 of the lower housing sub-assembly. In non-limiting embodiments or aspects, the proximal movement of the needle cover 330 enables drug delivery, for example, via the interaction of the needle cover 330 with a container holder (not shown). Specifically, in non-limiting embodiments or aspects, due to the proximal movement of the needle cover 330, the needle cover 330 contacts, at its proximal end 335, the container holder provided in the upper housing sub-assembly 400, thereby displacing the container holder proximally. The container holder can have at least one window (not shown) that enables a biased blocking element (not shown), which holds the plunger (not shown) of the auto-injector 500 in a pre-use position against the biasing force of an injection spring (not shown) and moves to a radially unbiased position. The radial movement of the blocking element releases the plunger, and the plunger is pushed out of the container holder by the injection spring, moving a piston (not shown) within the syringe barrel 210 to inject the drug through the needle 220.

[0047] As can be understood from the above embodiments or aspects, the proximal movement of the needle cover 330 can cause an unintended actuation of the auto-injector 500. Thus, as shown in FIGS. 10 and 11, provided in a non-limiting embodiment or aspect is a sub-assembly for a drug delivery device such as an auto-injector. The sub-assembly includes a housing 310, a needle cover 330, and a cap assembly 100 including a retainer 110 and a cap remover 150. In a non-limiting embodiment or aspect, the retainer 110 prevents an unintended proximal movement of the needle cover 330 and thus prevents an unintended actuation of the drug delivery device of which the sub-assembly is a component. In a non-limiting embodiment or aspect, the retainer 110 includes at least one protrusion such as an inward protrusion 136. In a non-limiting embodiment or aspect, the at least one inward protrusion 136 is disposed on an arm extending proximally at the same proximal location where at least one radially extending protrusion 135 is disposed.

[0048] Continuing to refer to FIGS. 10 and 11, in a non-limiting embodiment or aspect, the needle cover 330 includes an outwardly projecting lip or flange 340 at its distal end. In a non-limiting embodiment or aspect, the inward protrusion 136 on the retainer 110 is disposed proximal to the lip or flange 340 of the needle cover 330 and prevents the needle cover 330 from moving proximally by a distance sufficient to enable actuation of the auto-injector 500. In a non-limiting embodiment or aspect, the inward protrusion 136 engages or abuts the lip or flange 340 of the needle cover 330 and substantially or completely prevents proximal movement of the needle cover 330.

[0049] FIG. 10 shows a non-limiting embodiment or aspect in which a lip or flange 340 is disposed on the outer surface of the needle cover 330, and the protrusion 136 is an inward protrusion configured to engage with the lip or flange 340. In a non-limiting embodiment or aspect (not shown), the protrusion is an outward protrusion and is disposed on an arm extending proximally through the internal space defined by the needle cover 330 from the distal end of the retainer 110 and configured to engage with a lip or flange disposed on the inner surface of the needle cover.

[0050] Referring to FIG. 11, the above-described assembly process focused on the interaction between at least one inward protrusion 136 and the lip or flange 340 of the needle cover 330, and between at least one radially extending protrusion 135 and at least one opening 170 is shown.

[0051] FIGS. 11A and 11B show the needle cover 330 having a lip or flange 340 (separated from the remainder of the lower housing assembly 300 in the drawing) before the needle cover is disposed in the cap assembly, and the cap assembly including a cap rim remover and a retainer.

[0052] FIGS. 11C and 11D show the first step of the assembly when the cap assembly is first disposed on the needle cover. At least one radially extending protrusion 135 of the retainer can be deflected outward for its longitudinal positioning relative to at least one opening 170. The lip or flange 340 of the needle cover is engaged with the proximal-facing surface of at least one inward protrusion 136.

[0053] Figures 11E and 11F show further steps in the assembly process. The lip or flange 340 has begun to move distally beyond at least one inwardly projecting portion 136. In a non-limiting embodiment or aspect where at least one inwardly projecting portion 136 is disposed on at least one arm of the retainer, the lip or flange 340 is enabled to move distally beyond at least one projecting portion 136 and the needle cover moves distally beyond the projecting portion 136.

[0054] Continuing to refer to FIG. 11, FIGS. 11G and 11H show further steps in the assembly process where the lip or flange 340 has passed distally by at least one inwardly projecting portion 136. In a non-limiting embodiment or aspect, at least one inwardly projecting portion 136 bends outwardly to enable the lip or flange 340 to pass distally and the arm has returned to a non-biased state.

[0055] As described above, after the lower housing 310 is assembled to the needle cover and cap assembly, the retainer moves distally (FIGS. 11I and 11J). Due to the arrangement of the assembly of the lower housing 310, the projecting portions 135 are prevented from moving such that they are aligned with the openings 170. As a result, the arms including the projecting portions 135 are prevented from bending outward as long as the cap assembly 100 is assembled to the lower housing assembly 300. As a result, the inwardly projecting portions 136 are maintained in engagement with the flange 340 of the needle cover 330. This engagement prevents proximal translation of the needle cover 330, which, as described above, would interfere with the operation of the auto-injector. In this way, unintentional operation of the device can be avoided.

[0056] To enable the use of the auto-injector, the user must first remove the cap assembly 100. To do so, the cap remover 150 is pulled away from the lower housing 310. Due to the axial "play" between the retainer 110 and the cap remover 150, the cap remover 150 moves relative to the retainer 110, such that at least one protrusion 135 is again aligned with at least one opening 170, thereby deflecting the arms of the retainer 110 outwardly and enabling the engagement between the inwardly directed protrusion 136 and the flange 340 of the needle cover 330 to be released. This enables the engagement between the retainer 110 and the needle cover 33 to be released. The needle cover 330 can then move freely proximally to cause an injection.

[0057] The invention has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiments or aspects thereof, but such details are for that purpose only, and it is to be understood that the invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the invention contemplates, to the extent possible, that one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A housing, A displaceable needle cover having a distal end including a flange, which is received within the housing and is configured to have a pre-use position where the needle cover extends from the housing and a use position where the needle cover is displaced at least partially within the housing, wherein displacement of the needle cover into the housing actuates the drug delivery device via interaction with a drive mechanism, the needle cover; A cap assembly, A cap remover configured to be gripped by a user, and The cap assembly including a retainer received within the cap remover and configured to engage the flange of the needle cover of the drug delivery device; A sub-assembly of a drug delivery device comprising: The arrangement of the retainer relative to the flange is configured to prevent movement of the needle cover to its use position; The retainer comprises at least one protrusion configured to engage the flange of the needle cover; Engagement between the at least one protrusion of the retainer and the flange of the needle cover prevents movement of the needle cover to its use position; The flange is disposed on the outer surface of the needle cover, and the protrusion is an inward protrusion disposed radially outward of the flange; The retainer comprises at least one radially extending protrusion, and the cap remover includes at least one opening in its side wall; The at least one radially extending protrusion deflects radially outward when the at least one radially extending protrusion is aligned with the at least one opening of the cap remover, thereby releasing the engagement between the inward protrusion of the retainer and the flange of the needle cover, the sub-assembly.

2. The sub-assembly according to claim 1, wherein the protrusion is proximal and adjacent to the flange.

3. The cap remover is shiftable relative to the retainer from a first position in which at least one radially extending protrusion is not aligned with at least one opening of the cap remover and cannot deflect radially outward, to a second position in which the at least one radially extending protrusion is aligned with at least one opening of the cap remover, such that the at least one radially extending protrusion can deflect radially outward. The subassembly according to claim 1.

4. A subassembly of a drug delivery device according to claim 1, comprising a syringe that includes a needle and is at least partially received within a housing, wherein in the use position, the needle is disposed at least partially outside the needle cover, and in the use position, the needle cover is configured to operate the drug delivery device to deliver a drug. The drug delivery device.

5. The drug delivery device according to claim 4, wherein the retainer includes at least one protrusion configured to engage the flange of the needle cover.

6. The drug delivery device according to claim 5, wherein the engagement between the at least one protrusion of the retainer and the flange of the needle cover prevents movement of the needle cover to the use position.

7. The drug delivery device according to claim 4, wherein the retainer includes at least one radially extending protrusion, and the cap remover includes at least one opening in its side wall.

8. The drug delivery device according to claim 7, wherein the at least one radially extending protrusion is configured to deflect radially outward when the at least one radially extending protrusion is aligned with at least one opening of the cap remover.

9. The drug delivery device according to claim 7, wherein the cap remover is shiftable relative to the retainer from a first position in which at least one radially extending protrusion is not aligned with at least one opening of the cap remover and cannot deflect radially outward, to a second position in which the at least one radially extending protrusion is aligned with at least one opening of the cap remover, such that the at least one radially extending protrusion can deflect radially outward.

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