Lockable needle shield remover assembly for wearable injector

Abstract

A needle shield remover assembly for a wearable injector includes a needle shield and a needle shield remover. The needle shield remover includes a first portion comprising a handle and pair of extension members, with each of the pair of extension members including a first connector member and a cam arm. The needle shield remover also includes a second portion comprising a receptacle, second connector members mateable with the first connector members, and a pair of cam locking tabs. The first portion is rotatable relative to the second portion to transition the needle shield remover from a prone position to an activated position, with the first portion oriented orthogonal to the second portion when in the activated position. With the first portion in the activated position, the cam locking tabs lock the cam arms in place, to prevent transitioning of the needle shield remover back to the prone position.

Description

Attorney Docket No. 04684-2504929 (P-29993.WO01)LOCKABLE NEEDLE SHIELD REMOVER ASSEMBLY FOR WEARABLE INJECTORCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 690,373 entitled “Lockable Needle Shield Remover Assembly for Wearable Injector” filed September 4, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to a needle shield remover assembly for a wearable injector and, more particularly, to a cammed needle shield remover that may be locked in an activated position, so as to prevent reattachment of the needle shield remover assembly.Description of Related Art

[0003] Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as 1 mL, an auto-injector is typically used, which typically has an injection time of about 10 to 15 seconds. When the volume of fluid or drug to be administered is above 1 mL, the injection time generally becomes longer resulting in difficulties for the patient to maintain contact between the device and the target area of the patient’s skin. Further, as the volume of drug to be administered becomes larger, increasing the time period for injection becomes desirable. The traditional method for a drug to be injected slowly into a patient is to initiate an IV and inject the drug into the patient’ s body slowly. Such a procedure is typically performed in a hospital or outpatient setting.

[0004] Certain devices allow for self-injection in a home setting and are capable of gradually injecting a liquid therapeutic preparation into the skin of a patient. In some cases, these devices are small enough (both in height and in overall size) to allow them to be “worn” by a patient while the liquid therapeutic preparation is being infused into the patient. These devices66Z3923.DOCX Page 1 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation to flow out of a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to cause the liquid therapeutic preparation to begin to flow at the proper time and a triggering mechanism to initiate the injection.

[0005] Referring to FIG. 16, in order to maintain sterility and to prevent accidental needle sticks, the needle of a drug delivery device is covered by a needle shield 2 prior to use. Prior to use of the device, a user may remove the needle shield 2 by grasping the needle shield 2 or by grasping a needle shield remover 4 that removes the needle shield 2 when the needle shield remover 4 is separated from the device.

[0006] With regard to wearable injectors that include a needle shield and needle shield remover as described above, it is recognized that removal of the needle shield via the needle shield remover removes a sterility barrier provided by the needle shield and exposes the needle to the ambient environment. With this sterility barrier removed, it is undesirable for a user of the injector to replace the needle shield and re-use the injector at a later time, as such actions increase the risk of microbial contamination to the user. Existing needle shield remover designs are not configured to prevent such reattachment of the needle shield (and needle shield remover) after removal, and thus reattachment of the needle shield (and needle shield remover) to the wearable injector remains a risk in existing wearable injectors.

[0007] Accordingly, a need exists for a wearable injector that includes a needle shield remover that is configured to prevent reattachment of the needle shield remover and needle shield to the wearable injector after initial removal thereof. Such a needle shield remover would thus prevent re-use of the wearable injector and reduce the risk of microbial contamination to the user.SUMMARY OF THE INVENTION

[0008] Provided herein is a needle shield remover assembly for a wearable injector. The needle shield remover assembly includes a needle shield comprising a body defining an opening at a first end thereof, the opening configured to receive a needle of the wearable injector. The needle shield remover assembly also includes a needle shield remover configured to engage the needle shield. The needle shield remover includes a first portion comprising a handle and pair of extension members extending out from the handle, with each of the pair of extension members including a first connector member and a cam arm, each cam arm formed at an end of the respective extension member and extending out past the first connector member. The needle shield remover also includes a second portion comprising a receptacle66Z3923.DOCX Page 2 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) configured to receive and engage a portion of the needle shield, second connector members configured to mate with the first connector members to secure the first portion to the second portion, and a pair of cam locking tabs positioned adjacent the second connector members. The first portion of the needle shield remover is rotatable relative to the second portion of the needle shield remover to transition the needle shield remover from a prone position to an activated position, with the first portion oriented orthogonal to the second portion when in the activated position. With the first portion rotated to be oriented orthogonal to the second portion, the pair of cam locking tabs lock the cam arms in place, to prevent transitioning of the needle shield remover from the activated position back to the prone position.

[0009] In some embodiments, the first portion and the second portion of the needle shield remover define an engagement surface configured to engage the needle shield and the wearable injector, the receptacle provided on the engagement surface.

[0010] In some embodiments, the second portion of the needle shield remover comprises a plurality of needle shield engagement members extending upwardly from the engagement surface and that collectively define the receptacle.

[0011] In some embodiments, the body of the needle shield comprises an extension portion comprising a disc-shaped member, the disc-shaped member formed at a second end of the body, and a protrusion having a tapered surface and a planar surface, the tapered surface positioned closer to the second end of the body than the planar surface, wherein the plurality of needle shield engagement members are configured to be biased radially outward when engaged with the tapered surface and are configured to engage the planar surface of the needle shield after the needle shield remover is connected to the needle shield

[0012] In some embodiments, the second portion of the needle shield remover comprises device connectors extending upwardly from the engagement surface and configured to secure the second portion of the needle shield remover to the wearable injector.

[0013] In some embodiments, each of the pair of extension members comprises a flexion point formed therein at a location adjacent a respective first connector member, wherein the first portion of the needle shield remover bends and rotates relative to the second portion of the needle shield remover at the flexion points.

[0014] In some embodiments, the flexion points comprise grooves or channels formed in the extension members, with a thickness of the extension members reduced at the grooves or channels.

[0015] In some embodiments, the cam lock tabs extend upwardly from the engagement surface and are positioned such that an outer edge thereof hangs out over the cam arms when66Z3923.DOCX Page 3 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) the first portion of the needle shield remover is in the prone position, with the cam lock tabs thus positioned in a travel path of the cam arms as they move with the first portion from the prone position to the activated position.

[0016] In some embodiments, each of the pair of cam locking tabs comprises an outwardly facing sloped engagement surface, and wherein the cam arms are brought into contact with the sloped engagement surface as the first portion is rotated toward the activated position.

[0017] In some embodiments, when the first portion of the needle shield remover is fully rotated to the activated position, the cam arms disengage the engagement surface of the cam lock tabs and are pushed past the cam lock tabs, such that the cam arms are positioned behind a flat rearward-facing surface of the cam lock tabs and locked in place, with the locked cam arms preventing reattaching of the needle shield remover assembly to the wearable injector.

[0018] In some embodiments, wherein the first connector portion and the second connector portion comprise a connector member and a connector recess, respectively.

[0019] In some embodiments, the connector recess and the connector member form a snap fit connection.

[0020] Also provided herein is a wearable injector. The wearable injector includes a housing having a top surface and a bottom surface and a container received within the housing and configured to receive a medicament, with the container comprising a stopper configured to move within the container. The wearable injector also includes a drive assembly configured to move the stopper, a needle having a retracted position where the needle is positioned within the housing and an extended position where a portion of the needle protrudes from the housing, and a needle shield remover assembly. The needle shield remover assembly includes a needle shield comprising a body defining an opening at a first end thereof, the opening configured to receive the needle, and a needle shield remover comprising a first portion and a second portion, wherein the first portion of the needle shield remover is rotatable relative to the second portion of the needle shield remover to transition the needle shield remover from a prone position to an activated position, with the first portion oriented orthogonal to the second portion when in the activated position. The needle shield remover also includes a locking arrangement that prevents the needle shield remover from returning to the prone position after it has been fully actuated to the activated position.

[0021] In some embodiments, the locking arrangement comprises a pair of cam arms provided on the first portion of the needle shield remover and a pair of cam locking tabs provided on the second portion of the needle shield remover.66Z3923.DOCX Page 4 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)

[0022] In some embodiments, the first portion comprises a handle and pair of extension members extending out from the handle, with each of the pair of extension members including a first connector member and a respective cam arm of the pair or cam arms, with each cam arm formed at an end of the respective extension member and extending out past the first connector member, and the second portion comprises a plurality of needle shield engagement members that define a receptacle and are configured to engage a portion of the needle shield and second connector members configured to mate with the first connector members to secure the first portion to the second portion, wherein the pair of cam locking tabs are positioned adjacent the second connector members, and wherein with the first portion rotated to be oriented orthogonal to the second portion, the pair of cam locking tabs lock the pair of cam arms in place, to prevent transitioning of the needle shield remover from the activated position back to the prone position.

[0023] In some embodiments, each of the pair of extension members comprises a groove or channel formed therein at a location adjacent a respective first connector member, wherein the first portion of the needle shield remover bends and rotates relative to the second portion of the needle shield remover at the grooves or channels.

[0024] In some embodiments, the cam lock tabs extend upwardly from an engagement surface defined by the first and second portions of the needle shield remover and are positioned such that an outer edge thereof hangs out over the cam arms when the first portion of the needle shield remover is in the prone position, with the cam lock tabs thus positioned in a travel path of the cam arms as they move with the first portion from the prone position to the activated position.

[0025] In some embodiments, each of the pair of cam locking tabs comprises an outwardly facing sloped engagement surface, and wherein the cam arms are brought into contact with the sloped engagement surface as the first portion is rotated toward the activated position.

[0026] In some embodiments, when the first portion of the needle shield remover is fully rotated to the activated position, the cam arms disengage the engagement surface of the cam lock tabs and are pushed past the cam lock tabs, such that the cam arms are positioned behind a flat rearward-facing surface of the cam lock tabs and locked in place.

[0027] In some embodiments, the second portion of the needle shield remover comprises device connectors extending upwardly from the engagement surface and configured to secure the second portion of the needle shield remover to the bottom surface of the housing of the wearable injector.66Z3923.DOCX Page 5 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0029] FIG. 1 is a perspective view of a wearable injector, according to one aspect of the present invention;

[0030] FIG. 2 is a perspective, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention;

[0031] FIG. 3 is a front, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention;

[0032] FIG. 4 is a top view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing a top portion of the housing removed and the wearable injector in a pre-use position;

[0033] FIG. 5 is a top, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a pre-use position;

[0034] FIG. 6 is a front, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a pre-use position;

[0035] FIG. 7 is a top view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing a top portion of the housing removed and the wearable injector in an initial actuation position;

[0036] FIG. 8 is a top, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in an initial actuation position;

[0037] FIG. 9 is a front, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in an initial actuation position;

[0038] FIG. 10 is a top view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing a top portion of the housing removed and the wearable injector in a use position;

[0039] FIG. 11 is a top, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a use position;

[0040] FIG. 12 is a front, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a use position;66Z3923.DOCX Page 6 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)

[0041] FIG. 13 is a top view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing a top portion of the housing removed and the wearable injector in a post-use position;

[0042] FIG. 14 is a top, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a post-use position;

[0043] FIG. 15 is a front, cross-sectional view of the wearable injector of FIG. 1, according to one aspect of the present invention, showing the wearable injector in a post-use position;

[0044] FIG. 16 is a partial cross-sectional view of a prior art needle shield remover assembly;

[0045] FIG. 17 is a partial cross-sectional view of a needle shield remover assembly, according to one aspect or embodiment of the present application, showing the needle shield remover assembly connected to the wearable injector;

[0046] FIG. 18 is a perspective view of a needle shield, according to one aspect or embodiment of the present application;

[0047] FIG. 19 is a perspective view of the needle shield remover of FIG. 17, showing the needle shield remover in a prone position;

[0048] FIG. 20 is a perspective view of the needle shield remover assembly of FIG. 17, showing the needle shield remover in an activated position;

[0049] FIGS. 21 A and 2 IB are exploded views of the needle shield remover of FIGS. 19 and 20;

[0050] FIGS. 22A and 22B are perspective views of a second portion of the needle shield remover of FIGS. 19 and 20;

[0051] FIGS. 23 A and 23B are perspective views of a first portion of the needle shield remover of FIGS. 19 and 20;

[0052] FIG. 24 is a detailed view of Section A of FIG. 20; and

[0053] FIG. 25 is a partial cross-sectional view of the needle shield remover assembly of FIG. 17.DETAILED DESCRIPTION

[0054] The following description is provided to enable those skilled in the art to make 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. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.66Z3923.DOCX Page 7 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)

[0055] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0056] Referring to FIGS. 1-15, a wearable injector 10 according to one aspect of the present disclosure includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, the container 14, the valve assembly 16, and the needle actuator assembly 18 are at least partially positioned within a cavity defined by a housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, although other suitable arrangements for the housing 20 may be utilized. In one aspect, the wearable injector 10 is an injector device configured to be worn or secured to a user and to deliver a predetermined dose of a medicament provided within the container 14 via injection into the user. The device 10 may be utilized to deliver a “bolus injection” where a medicament is delivered within a set time period. The medicament may be delivered over a time period of up to 45 minutes, although other suitable injection amounts and durations may be utilized. A bolus administration or delivery can be carried out with rate controlling or have no specific rate controlling. The device 10 may deliver the medicament at a fixed pressure to the user with the rate being variable. The general operation of the device 10 is described below in reference to FIGS. 1-15.

[0057] Referring again to FIGS. 1-15, the device 10 is configured to operate through the engagement of an actuation button 26 by a user, which results in a needle 28 of the needle actuator assembly 18 piercing the skin of a user, the actuation of the drive assembly 12 to place the needle 28 in fluid communication with the container 14 and to expel fluid or medicament from the container 14, and the withdrawal of the needle 28 after injection of the medicament is complete. The general operation of a wearable injector is shown and described in International Publication Nos. 2013 / 155153 and 2014 / 179774, which are hereby incorporated by reference in their entirety. The housing 20 of the device 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide an indication to a user on the status of the device 10 and a container window 31 for viewing the container 14. The indicator window 30 may be a magnifying lens for providing a clear view of the indicator arrangement 32. The66Z3923.DOCX Page 8 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) indicator arrangement 32 moves along with the needle actuator assembly 18 during use of the device 10 to indicate a pre-use status, use status, and post-use status of the device 10. The indicator arrangement 32 provides visual indicia regarding the status, although other suitable indicia, such as auditory or tactile, may be provided as an alternative or additional indicia.

[0058] Referring to FIGS. 4-6, during a pre-use position of the device 10, the container 14 is spaced from the drive assembly 12 and the valve assembly 16 and the needle 28 is in a retracted position. During the initial actuation of the device 10, as shown in FIGS. 7-9, the drive assembly 12 engages the container 14 to move the container 14 toward the valve assembly 16, which is configured to pierce a closure 36 of the container 14 and place the medicament within the container 14 in fluid communication with the needle 28 via a tube (not shown) or other suitable arrangement. The drive assembly 12 is configured to engage a stopper 34 of the container 14, which will initially move the entire container 14 into engagement with the valve assembly 16 due to the incompressibility of the fluid or medicament within the container 14. The initial actuation of the device 10 is caused by engagement of the actuation button 26 by a user, which releases the needle actuator assembly 18 and the drive assembly 12 as discussed below in more detail. During the initial actuation, the needle 28 is still in the retracted position and about to move to the extended position to inject the user of the device 10.

[0059] During the use position of the device 10, as shown in FIGS. 10-12, the needle 28 is in the extended position at least partially outside of the housing 20 with the drive assembly 12 moving the stopper 34 within the container 14 to deliver the medicament from the container 14, through the needle 28, and to the user. In the use position, the valve assembly 16 has already pierced a closure 36 of the container 14 to place the container 14 in fluid communication with the needle 28, which also allows the drive assembly 12 to move the stopper 34 relative to the container 14 since fluid is able to be dispensed from the container 14. At the post-use position of the device 10, shown in FIGS. 13-15, the needle 28 is in the retracted position and engaged with a pad 38 to seal the needle 28 and prevent any residual flow of fluid or medicament from the container 14. The container 14 and valve assembly 16 may be the container 14 and valve assembly 16 shown and described in International Publication No. WO 2015 / 081337, which is hereby incorporated by reference in its entirety.

[0060] Referring to FIGS. 17-25, according to aspects of the disclosure, the wearable injector 10 of FIGS. 1-15 further includes a needle shield remover assembly 40 having a needle shield 42 and a needle shield remover 44. The needle shield 42 is configured to enclose at least a portion of the needle 28 of the wearable injector 10 to prevent accidental needle sticks and to66Z3923.DOCX Page 9 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) maintain the sterility of the needle 28. As discussed in more detail below, separating the needle shield remover 44 from the wearable injector 10 also removes the needle shield 42 from the wearable injector 10. The needle shield remover assembly 40 may also include one or more features to prevent the actuation of the wearable injector 10 while the needle shield remover assembly 40 is connected to the wearable injector 10.

[0061] The needle shield 42 includes a body 54 defining an opening 56 configured to receive the needle 28 of the wearable injector 10. The body 54 of the needle shield 42 includes an extension portion 58 having a top surface 60 and bottom surface 62 positioned opposite the top surface 60.

[0062] The needle shield remover 44 includes a first portion 64 and a second portion 66. The first portion 64 and the second portion 66 comprise separate components that may be assembled together such that the first portion 64 is connected to the second portion 66, with the first portion 64 being rotatable relative to the second portion 66, as explained in further detail below. When assembled, the first portion 64 and the second portion 66 of the needle shield remover 44 provide an engagement surface 68 that includes features configured to engage the housing 20 of the wearable injector and the needle shield 42, as explained in further detail below.

[0063] Referring to FIG. 18, the body 54 of the needle shield 42 has first end 70 and a second end 72 positioned opposite the first end 70. The opening 56 of the body 54 is positioned at the first end 70 and the extension portion 58 is positioned at the second end 72. The extension portion 58 includes a disc-shaped member 74, although other suitable shapes and arrangements may be utilized. The extension portion 58 also includes a cylindrical member 76, with the discshaped member 74 defining the second end 72 of the body 54 of the needle shield 42. The body 54 of the needle shield 42 includes a protrusion 78 having a tapered surface 80 and a planar surface 82, with the tapered surface 80 positioned closer to the second end 72 of the body 54 than the planar surface 82. As discussed below, the tapered surface 80 and the planar surface 82 interact with the needle shield remover 44 to allow the needle shield remover 44 to be connected to the needle shield 42 while still enabling the needle shield 42 to be removed by the needle shield remover 44 during use.

[0064] Referring again to FIGS. 17-25, the second portion 66 of needle shield remover 44 includes a plurality of needle shield engagement members 84 that generally define a receptacle 85, with the receptacle 85 receiving a portion of the needle shield 42 and the engagement members 84 configured to collectively engage a portion of the needle shield 42. The plurality of needle shield engagement members 84 are configured to be biased radially66Z3923.DOCX Page 10 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) outward when engaged with the tapered surface 80 of the body 54 of the needle shield 42 and are further configured to engage the planar surface 82 of the of needle shield 42 after the needle shield remover 44 is connected to the needle shield 42, as best shown in FIGS. 17 and 25. With the needle shield 42 positioned over the needle 28 of the wearable injector 10, the plurality of needle shield engagement members 84 can be inserted into the wearable injector 10, with the needle shield remover 44 in the unassembled position, such that the needle shield engagement members 84 engage the tapered surface 80 of the protrusion 78 of the needle 28 to bias the needle shield engagement members 84 radially outward as the needle shield engagement members 84 are inserted into the housing 20 of the wearable injector 10. As an end of the needle shield engagement members 84 passes by the tapered surface 80 of the protrusion 78 of the needle shield 42, the needle shield engagement members 84 return to their original position. The needle shield remover 44 is then moved to the assembled position with the needle shield remover 44 connected to the housing 20 of the wearable injector 10. When the needle shield remover 44 is in the assembled positioned and connected to the wearable injector 10, subsequently removing the needle shield remover 44 from the housing 20 of the wearable injector 10, such as by pulling the needle shield 42 in a direction parallel to a longitudinal axis of the needle 28, will cause the needle shield engagement members 84 and receptable 85 to engage the top surface 60 of the extension portion 58 of the needle shield 42 and / or cause the needle shield engagement members 84 to engage the planar surface 82 of the needle shield 42 to remove the needle shield 42 from the wearable injector 10.

[0065] The first portion 64 of the needle shield remover 44 is connected to the second portion 66 of the needle shield remover 44 via a connector 86. The connector 86 may generally include a “first connector member” and a “second connector member” that may mate together to secure the first portion 64 and the second portion 66. In some embodiments, the first connector member and second connector member of the connector 86 may comprise a connector recess 88 positioned on one of the first portion 64 and the second portion 66 and a connector member 90 positioned on the other of the first portion 64 and the second portion 66. As shown in FIGS. 19-21, in one aspect or embodiment, the connector recess 88 is provided on the second portion 66 and the connector member 90 is provided on the first portion 64. The connector recess 88 and the connector member 90 form a snap fit connection, although other suitable arrangements may be utilized.

[0066] The second portion 66 of the needle shield remover 44 also includes additional connectors and stabilizers for securing and orienting the needle shield remover 44 to / with the wearable injector 10. The needle shield remover 44 includes device connectors 92 configured66Z3923.DOCX Page 11 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) to secure the second portion 66 of the needle shield remover 44 to the wearable injector 10, with the device connectors 92 insertable into openings formed in the housing 20 of the wearable injector 10. The needle shield remover 44 includes a stabilizing and alignment member 94 that may an engage an outer surface of the housing 20 of the wearable injector 10, to aid in positioning of the needle shield remover 44 relative to the housing 20.

[0067] The second portion 66 of the needle shield remover 44 includes a first half 96 moveable relative to a second half 98, with the second half 98 rotatable under the first half 96. The second half 98 includes a cover 100 configured to cover the needle shield 42 after the needle shield remover 44 is connected to the needle shield 42, with the cover 100 positioned under the engagement members 84 when the second half 98 is rotated under the first half 96. The first half 96 of the second portion 66 of the needle shield remover 44 is connected to the second half 98 of the second portion 66 of the needle shield remover 44 via a hinge 102, although other suitable arrangements may be utilized.

[0068] With regard to the first portion 64 of the needle shield remover 44, the first portion 64 may comprise a generally U-shaped member that includes a handle 104 and extension members 106. The handle 104 may be grasped by a healthcare technician or patient to remove the needle shield remover 44 from the housing 20 of the wearable injector 10. In some embodiments, the handle 104 is circular, although other suitable shapes and arrangements may be utilized. The extension members 106 extend out from handle and include a portion of the connector 86 thereon. In the illustrated embodiment, each of the extension members 106 includes a connector member 90 thereon that engages a respective connector recess 88 formed in the second portion 66.

[0069] As shown best in FIGS. 19 and 20, the needle shield remover 44 is actuatable between a prone position (FIG. 19) and an activated position (FIG. 20) via rotation of the first portion 64 relative to the first portion 66. To actuate the needle shield remover 44, a user may grasp the handle 104 and apply a force thereto that causes the first portion 64 to rotate / actuate from its initial / prone position where it is parallel to the second portion 66 to an activated position where it is generally orthogonal to the second portion 66. As a force is applied to the handle 104, the first portion 64 may bend and rotate about flexion points 108 provided on the extension members 106 of first portion 64. In one embodiment, the flexion points 108 may comprise grooves formed on the opposing sides extension members 106 that are positioned adjacent the connector member 90, with the grooves having a reduced thickness that allows for bending of the extension members 106 at these locations and for the first portion 64 to be rotated relative to the second portion 66.66Z3923.DOCX Page 12 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)

[0070] With the needle shield remover 44 in the activated position and the first portion 64 rotated to be generally orthogonal to the second portion 66, a user may then apply a pulling force to the handle 104 that causes the needle shield remover 44 and needle shield 42 to separate from the wearable injector 10.

[0071] According to aspects of the disclosure, a locking arrangement 110 is provided on the needle shield remover 44 that prevents the needle shield remover 44 from returning to the prone position after it has been fully actuated to the activated position. The locking arrangement 110 may comprise a pair of cam lock tabs 112 and a pair of cam arms 114 and that may be selectively brought into engagement with each other as the needle shield remover 44 is actuated from the prone position to the activated position.

[0072] The cam arms 114 are formed at the ends of extension members 106, with the cam arms 114 extending out past the connector members 90 formed on the extension members 106. With the needle shield remover 44 in the prone position, the cam arms 114 may be seated / positioned within indents 116 formed in the second portion 66, with cam arms 114 (and extension members 106) aligned with the second portion 66 so as to present a continuous outer edge for the needle shield remover 44. In some embodiments, an end portion or surface of the cam arms 114 may comprise a rounded or angled surface. The cam arms 114 are connected to handle 104 via extension members 106 and are configured to rotate along with the handle 104 and extension members 106 when the first portion 64 bends and rotates about flexion points 108, such that the cam arms 114 are oriented generally orthogonal to the second portion 66 when the handle 104 (and cam arms 114) are in the activated position.

[0073] The cam lock tabs 112 are formed on each of opposing sides of the second portion 66 and adjacent the connector 86 (i.e., adjacent recesses 88) and the cam arms 114. The cam lock tabs 112 are provided as protrusions that extend upwardly from the engagement surface 68 of the second portion 66 - with the cam lock tabs 112 thus positioned above the cam arms 114 when the first portion 64 (and cam arms 114 thereof) is in the prone position. The cam lock tabs 112 each include an outwardly facing engagement surface 118 that comes into contact with the cam arms 114 as the first portion 64 is rotated from the prone position to the activated position. The engagement surfaces 118 of the cam lock tabs 112 may comprise an angled or sloped surface along which the cam arms 114 may slide as they move with first portion 64 from the prone position to the activated position. The cam lock tabs 112 are positioned on second portion 66 such that an outer edge thereof hangs out over the cam arms 114 - with the cam lock tabs 112 thus positioned within a travel path of the cam arms 114 as they move with the first portion 64 from the prone position to the activated position.66Z3923.DOCX Page 13 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)

[0074] In use of the needle shield remover 44, when a user actuates the handle 104 to cause the first portion 64 (including handle 104, extension members 106, and cam arms 114) to rotate from the prone position to the activated position, the cam arms 114 engage and interact with the cam lock tabs 112. As the first portion 64 rotates toward the activated position, the cam arms 114 are brought into contact with the cam lock tabs 112 and are caused to slide along the engagement surfaces 118 of the cam lock tabs 112. As the cam arms 114 slide along the engagement surfaces 118 of the cam lock tabs 112, the cam arms 114 are caused to deflect outwardly and, upon the first portion 64 being rotated to a fully orthogonal position (relative to second portion 66), the cam arms 114 are pushed past the cam lock tabs 112 and disengage the engagement surfaces 118 thereof. Upon disengagement of the cam arms 114 from the cam lock tabs 112, the cam arms 114 are able to snap / deflect back inwardly, with the cam arms 114 thus positioned behind a flat rearward-facing surface 120 of the cam lock tabs 112.

[0075] Upon positioning of the cam arms 114 positioned behind the cam lock tabs 112, interference between the cam lock tabs 112 and the cam arms 114 prevents the first portion 64 of the needle shield remover 44 from returning to its prone position. With the first portion 64 of the needle shield remover 44 in the activated position and prevented from returning to its prone position, re-insertion of the needle shield remover 44 (and needle shield 42) into the housing 20 of the wearable injector 10 is prevented. That is, with the needle shield remover 44 in the activated position, the cam arms 114 are positioned so as to protrude upwardly (above engagement surface 68) by a length / height that is greater than a height of the engagement members 84 and the device connectors 92, so as to prevent reattachment of the needle shield 42 and the needle shield remover 44 with the wearable injector 10.

[0076] Beneficially, embodiments of the disclosure thus provide a needle shield remover assembly for a wearable injector that includes a cammed needle shield remover configured to be locked in an activated position, so as to prevent reattachment of the needle shield remover and needle shield to the wearable injector after initial removal thereof. The needle shield remover thus prevents re-use of the wearable injector, so as to reduce the risk of microbial contamination to the user.

[0077] While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.66Z3923.DOCX Page 14 of 20

Claims

Attorney Docket No. 04684-2504929 (P-29993.WO01)WHAT IS CLAIMED IS:

1. A needle shield remover assembly for a wearable injector comprising: a needle shield comprising a body defining an opening at a first end thereof, the opening configured to receive a needle of the wearable injector; and a needle shield remover configured to engage the needle shield, the needle shield remover comprising: a first portion comprising a handle and pair of extension members extending out from the handle, with each of the pair of extension members including a first connector member and a cam arm, each cam arm formed at an end of the respective extension member and extending out past the first connector member; and a second portion comprising: a receptacle configured to receive and engage a portion of the needle shield; second connector members configured to mate with the first connector members to secure the first portion to the second portion; and a pair of cam locking tabs positioned adjacent the second connector members; wherein the first portion of the needle shield remover is rotatable relative to the second portion of the needle shield remover to transition the needle shield remover from a prone position to an activated position, with the first portion oriented orthogonal to the second portion when in the activated position; and wherein with the first portion rotated to be oriented orthogonal to the second portion, the pair of cam locking tabs lock the cam arms in place, to prevent transitioning of the needle shield remover from the activated position back to the prone position.

2. The needle shield remover assembly of claim 1 , wherein the first portion and the second portion of the needle shield remover define an engagement surface configured to engage the needle shield and the wearable injector, the receptacle provided on the engagement surface.

3. The needle shield remover assembly of claim 2, wherein the second portion of the needle shield remover comprises a plurality of needle shield engagement66Z3923.DOCX Page 15 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) members extending upwardly from the engagement surface and that collectively define the receptacle.

4. The needle shield remover assembly of claim 3, wherein the body of the needle shield comprises: an extension portion comprising a disc-shaped member, the disc-shaped member formed at a second end of the body; and a protrusion having a tapered surface and a planar surface, the tapered surface positioned closer to the second end of the body than the planar surface; wherein the plurality of needle shield engagement members are configured to be biased radially outward when engaged with the tapered surface and are configured to engage the planar surface of the needle shield after the needle shield remover is connected to the needle shield.

5. The needle shield remover assembly of claim 2, wherein the second portion of the needle shield remover comprises device connectors extending upwardly from the engagement surface and configured to secure the second portion of the needle shield remover to the wearable injector.

6. The needle shield remover assembly of claim 2, wherein each of the pair of extension members comprises a flexion point formed therein at a location adjacent a respective first connector member, wherein the first portion of the needle shield remover bends and rotates relative to the second portion of the needle shield remover at the flexion points.

7. The needle shield remover assembly of claim 6, wherein the flexion points comprise grooves or channels formed in the extension members, with a thickness of the extension members reduced at the grooves or channels.

8. The needle shield remover assembly of claim 1, wherein the cam lock tabs extend upwardly from the engagement surface and are positioned such that an outer edge thereof hangs out over the cam arms when the first portion of the needle shield remover is in the prone position, with the cam lock tabs thus positioned in a travel path of the cam arms as they move with the first portion from the prone position to the activated position.66Z3923.DOCX Page 16 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01)9. The needle shield remover assembly of claim 8, wherein each of the pair of cam locking tabs comprises an outwardly facing sloped engagement surface, and wherein the cam arms are brought into contact with the sloped engagement surface as the first portion is rotated toward the activated position.

10. The needle shield remover assembly of claim 9, wherein when the first portion of the needle shield remover is fully rotated to the activated position, the cam arms disengage the engagement surface of the cam lock tabs and are pushed past the cam lock tabs, such that the cam arms are positioned behind a flat rearward-facing surface of the cam lock tabs and locked in place, with the locked cam arms preventing reattaching of the needle shield remover assembly to the wearable injector.

11. The needle shield remover assembly of claim 1, wherein the first connector portion and the second connector portion comprise a connector member and a connector recess, respectively.

12. The needle shield remover assembly of claim 8, wherein the connector recess and the connector member form a snap fit connection.

13. A wearable injector comprising: a housing having a top surface and a bottom surface; a container received within the housing, the container configured to receive a medicament, the container comprising a stopper configured to move within the container; a drive assembly configured to move the stopper; a needle having a retracted position where the needle is positioned within the housing and an extended position where a portion of the needle protrudes from the housing; and a needle shield remover assembly comprising: a needle shield comprising a body defining an opening at a first end thereof, the opening configured to receive the needle; and a needle shield remover comprising a first portion and a second portion, wherein the first portion of the needle shield remover is rotatable relative to the second portion of the needle shield remover to transition the needle shield remover from a prone position to66Z3923.DOCX Page 17 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) an activated position, with the first portion oriented orthogonal to the second portion when in the activated position; wherein the needle shield remover includes a locking arrangement that prevents the needle shield remover from returning to the prone position after it has been fully actuated to the activated position.

14. The wearable injector of claim 13, wherein the locking arrangement comprises a pair of cam arms provided on the first portion of the needle shield remover and a pair of cam locking tabs provided on the second portion of the needle shield remover.

15. The wearable injector of claim 14, wherein the first portion comprises a handle and pair of extension members extending out from the handle, with each of the pair of extension members including a first connector member and a respective cam arm of the pair or cam arms, with each cam arm formed at an end of the respective extension member and extending out past the first connector member; and wherein the second portion comprises: a plurality of needle shield engagement members that define a receptacle and are configured to engage a portion of the needle shield; and second connector members configured to mate with the first connector members to secure the first portion to the second portion; and wherein the pair of cam locking tabs are positioned adjacent the second connector members; and wherein with the first portion rotated to be oriented orthogonal to the second portion, the pair of cam locking tabs lock the pair of cam arms in place, to prevent transitioning of the needle shield remover from the activated position back to the prone position.

16. The wearable injector of claim 15, wherein each of the pair of extension members comprises a groove or channel formed therein at a location adjacent a respective first connector member, wherein the first portion of the needle shield remover bends and rotates relative to the second portion of the needle shield remover at the grooves or channels.

17. The wearable injector of claim 16, wherein the cam lock tabs extend upwardly from an engagement surface defined by the first and second portions of the needle shield remover and are positioned such that an outer edge thereof hangs out over the cam arms66Z3923.DOCX Page 18 of 20Attorney Docket No. 04684-2504929 (P-29993.WO01) when the first portion of the needle shield remover is in the prone position, with the cam lock tabs thus positioned in a travel path of the cam arms as they move with the first portion from the prone position to the activated position.

18. The wearable injector of claim 17, wherein each of the pair of cam locking tabs comprises an outwardly facing sloped engagement surface, and wherein the cam arms are brought into contact with the sloped engagement surface as the first portion is rotated toward the activated position.

19. The wearable injector of claim 18, wherein when the first portion of the needle shield remover is fully rotated to the activated position, the cam arms disengage the engagement surface of the cam lock tabs and are pushed past the cam lock tabs, such that the cam arms are positioned behind a flat rearward-facing surface of the cam lock tabs and locked in place.

20. The wearable injector of claim 16, wherein the second portion of the needle shield remover comprises device connectors extending upwardly from the engagement surface and configured to secure the second portion of the needle shield remover to the bottom surface of the housing of the wearable injector.66Z3923.DOCX Page 19 of 20

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