CROSS-REFERENCE TO RELATED APPLICATIONS

[001 ] This patent application claims the benefit under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62/502,278, filed on May 5, 2017, the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

[002] This disclosure is directed to an auto-injector and related methods of use.

INTRODUCTION

[003] In various available auto-injectors, upon activation by a user, a needle is deployed, and fluid is delivered from the needle into the user. After completion of fluid delivery, the needle may be retracted for user comfort, needle safety, and positive perception of the product. However, many auto-injectors use separate springs or motors for the injection and needle removal steps. In addition, such injection assemblies generally require separate user actions for both inserting and removing the needle.

SUMMARY OF THE DISCLOSURE

[004] In one aspect, the present disclosure is directed to an injection device. The injection device includes a carrier, a needle, a driver coupled to the needle, the driver being slidable relative to the carrier between a retracted configuration and a deployed configuration, a shuttle configured to move the driver between the retracted configuration and the deployed configuration, and a stop configured to move from a first configuration to a second configuration, wherein the stop is configured to maintain the driver in the deployed configuration, and movement of the stop from the first configuration to the second configuration allows the shuttle to move the driver from the deployed configuration to the retracted configuration.

[005] The shuttle is movable from a first position to a second position, and from the second position to a third position, wherein when the shuttle is in the first position, the driver is in the retracted configuration, when the shuttle is in the second position, the driver is in the deployed configuration, when the shuttle is in the third position, the driver is in the retracted configuration. The first position and the third position are different. The shuttle moves in one direction along an axis to move from the first position to the second position, and from the second position to the third position. The shuttle is configured to move only in the one direction. The injection device also includes a deployment gear coupled to the carrier, and a retraction gear coupled to the carrier, wherein the driver is coupled to the deployment gear and the retraction gear, the shuttle includes a rack gear configured to engage the deployment gear and the retraction gear, wherein direct engagement of the rack gear with the deployment gear moves the driver from the retracted configuration to the deployed configuration, and direct engagement of the rack gear with the retraction gear moves the driver from the deployed configuration to the retracted configuration. The rack gear directly contacts only one of the deployment gear and the retraction gear at any time. The rack gear is configured to drive rotation of the deployment gear in a first direction to move the driver from the retracted

configuration to the deployed configuration, and drive rotation of the retraction gear in the first direction to move the driver from the deployed configuration to the retracted configuration. The driver includes a first rack and a second rack, wherein the first rack is configured to engage the deployment gear, and the second rack is configured to engage the retraction gear. The first rack and the second rack are located on opposing sides of the driver. The shuttle is configured to move along a first axis, the driver is configured to move along a second axis, and the first axis and the second axis are perpendicular to one another. The driver, before activation, is in contact with an impediment, and is prevented from moving out of the retracted configuration by the impediment. The injection device also includes a housing enclosing the carrier, wherein the impediment is integral with the housing. The movement of the carrier relative to the housing moves the driver out of contact with the impediment, allowing the driver to move from the retracted configuration to the deployed configuration. The injection device also includes a resilient member coupled to the shuttle, wherein, after the driver is moved out of contact with the impediment, the resilient member is configured to expand from a first compressed state to a second compressed state to move the shuttle from the first position to the second position. After the stop is moved from the first configuration to the second configuration, the resilient member is configured to expand from the second compressed state to a resting state to move the shuttle from the second position to the third position.

[006] In another aspect, the present disclosure is directed to an injection device that includes a carrier including a stop, wherein the stop has a first end fixed to a remainder of the carrier, and a free second end, a first gear coupled to the carrier, a needle, a driver coupled to the carrier, the first gear, and the needle, the driver being slidable relative to the carrier between a retracted configuration and a deployed configuration, a shuttle including a rack gear configured to drive rotation of the first gear, wherein the rotation of the first gear moves the driver from the retracted configuration to the deployed configuration, wherein the free second end of the stop is configured to at least temporarily prevent movement of the shuttle while the driver is in the deployed configuration.

[007] The injection device further includes a second gear coupled to the carrier, wherein flexion of the stop about the fixed first end, while the free second end is in contact with the shuttle, causes the shuttle to slide relative to the stop and drive rotation of the second gear, wherein the rotation of the second gear moves the driver from the deployed configuration to the retracted configuration.

[008] In another aspect, the present disclosure is directed to an injection device that includes a needle movable between a retracted configuration and a deployed configuration, a vial configured to be in fluid communication with the needle, a piston configured to move within the vial, a motor configured to drive the piston, and a controller coupled to the motor, wherein the controller is configured to receive an indication that the injection device is positioned in contact a user, after receiving the indication, sending a signal to the motor to drive the piston in a first direction to put the needle and the vial in fluid communication and move the needle from the retracted configuration to the deployed configuration, and without requiring any intervention by a user after receiving the indication, and after sending the signal to drive the motor in the first direction, automatically sending a signal to the motor to drive the piston in a second direction to move the needle from the deployed configuration to the retracted configuration.

[009] The injection device further includes a housing enclosing the vial, the piston, the motor, the controller, and the needle when the needle is in the retracted configuration, wherein the needle extends out of the housing in the deployed configuration. The injection device may include a cover or a shield that contains the distalmost portion of the needle in the retracted configuration. The injection device may include an audio module, a visual module, and a haptic module, each of the modules being coupled to the controller and configured to provide feedback to a user of the injection device. The injection device may include a top that seals an opening of the vial, the top including a portion including a rubber material that is permeable to a sterilant, wherein the needle includes a proximalmost portion configured to be coupled with the vial, and, before the needle and vial are in fluid communication with one another, the proximalmost portion of the needle is disposed within the portion formed of the rubber material. The injection device may include a cantilever coupled to the controller, and movable by the needle, wherein, when the needle is in the retracted configuration, the cantilever forms part of an open circuit that signals to the controller that the needle is in the retracted configuration, and when the needle is in the deployed configuration, the cantilever forms part of a closed circuit that signals to the controller that the needle is in the deployed configuration.

BRIEF DESCRIPTION OF THE FIGURES

[010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various examples and together with the description, serve to explain the principles of the disclosed examples and

embodiments.

[011] Aspects of the disclosure may be implemented in connection with embodiments illustrated in the attached drawings. These drawings show different aspects of the present disclosure and, where appropriate, reference numerals illustrating like structures, components, materials and/or elements in different figures are labeled similarly. It is understood that various combinations of the structures, components, and/or elements, other than those specifically shown, are contemplated and are within the scope of the present disclosure. [012] Moreover, there are many embodiments described and illustrated herein. The present disclosure is neither limited to any single aspect nor embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Moreover, each of the aspects of the present disclosure, and/or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and/or embodiments thereof. For the sake of brevity, certain permutations and combinations are not discussed and/or illustrated separately herein. Notably, an embodiment or implementation described herein as "exemplary" is not to be construed as preferred or advantageous, for example, over other embodiments or implementations; rather, it is intended reflect or indicate the embodiment(s) is/are "example" embodiment(s).

[013] FIG. 1 is a perspective view of an auto-injector, according to an example of the disclosure.

[014] FIG. 2 is a bottom view of the auto-injector of FIG. 1.

[015] FIG. 3 is a side view of the auto-injector of FIG. 1 , showing an activating switch extending away from a tissue-facing surface.

[016] FIG. 4 is an exploded view of the auto-injector of FIG. 1.

[017] FIG. 4A is a schematic illustration of a control system of the auto- injector of FIG. 1.

[018] FIG. 4B is an exploded view of an auto-injector according to the disclosure.

[019] FIG. 4C is a perspective view of a portion of a housing and an electronics board, according to an aspect of the disclosure.

[020] FIG. 5 is an exploded view of a needle mechanism. [021] FIG. 6 is a perspective view of the needle mechanism of FIG. 5 in a first position.

[022] FIGS. 7-11 are side views of the needle mechanism of FIG. 5.

[023] FIG. 12 is a side cross-sectional view of a portion of the auto-injector of

FIG. 1.

[024] FIGS. 13 and 14 are side cross-sectional views of a piercing mechanism.

[025] FIG. 14A is a cross-sectional view of a cap used in an alternative piercing mechanism.

[026] FIG. 15 is a side view of a needle insert switch.

[027] FIG. 16 is a flowchart of an exemplary method according to the disclosure.

[028] FIGS. 17-23 illustrate needle mechanisms according to other examples of the present disclosure.

[029] FIG. 24 is a cross-sectional view of the auto-injector of FIG. 1 and a needle shield.

[030] FIG. 25 is an enlargement of a portion of FIG. 24.

[031] Again, there are many embodiments described and illustrated herein. The present disclosure is neither limited to any single aspect nor embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Each of the aspects of the present disclosure, and/or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and/or embodiments thereof. For the sake of brevity, many of those combinations and permutations are not discussed separately herein. [032] Notably, for simplicity and clarity of illustration, certain aspects of the figures depict the general structure and/or manner of construction of the various embodiments. Descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring other features. Elements in the figures are not necessarily drawn to scale; the dimensions of some features may be exaggerated relative to other elements to improve understanding of the example embodiments. For example, one of ordinary skill in the art appreciates that the cross- sectional views are not drawn to scale and should not be viewed as representing proportional relationships between different components. The cross-sectional views are provided to help illustrate the various components of the depicted assembly, and to show their relative positioning to one another.

DETAILED DESCRIPTION

[033] Reference will now be made in detail to examples of the present disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. In the discussion that follows, relative terms such as "about," "substantially," "approximately," etc. are used to indicate a possible variation of ±10% in a stated numeric value.

[034] As described above, existing auto-injectors often require multiple user interactions to self-administer a drug, including, e.g., separate user interactions for deploying a needle and subsequently retracting the needle after drug delivery. These additional steps can increase complexity of self-administration of drugs, introduce user errors, and cause user discomfort. Accordingly, the present disclosure is directed to various embodiments of an injection device (e.g., auto-injector) that simplifies self-administration of drugs, or other therapeutic agents, by a user. Specifically, according to certain embodiments, the auto-injector may not require any additional user interaction to withdraw a needle once the needle is subcutaneously inserted into the user. Thus, auto-injectors of the present disclosure are simplified to help prevent misuse or user error.

[035] OVERALL SYSTEM

[036] An example of such an auto-injector 2 is shown in FIGS. 1 -4. Auto- injector 2 may include a housing 3 having a tissue-engaging (e.g., bottom) surface 4 through which a needle may be deployed and retracted via an opening 6 (FIG. 2). An activating switch 1409 (FIG. 2) may be disposed on tissue-engaging surface 4, and may be configured to activate auto-injector 2, or otherwise place auto-injector 2 in a "ready" mode. A touch sensor 1410 (FIG. 2) also may be disposed on tissue- engaging surface 4. and may be configured to help a controller of auto-injector 2 determine whether auto-injector 2 is disposed on the skin of a user (indicating that the auto-injector should fire or otherwise deploy a needle), or whether activating switch 1409 was improperly triggered (indicating that operation of auto-injector 2 should be stopped). Activating switch 1409 and touch sensor 1410 will be discussed in further detail below with respect to FIG. 4A. A connecting port 13 also may be disposed on tissue-engaging surface 4 to facilitate programming of auto-injector 2. Housing 3 may include a transparent window 50 to enable a viewer to visualize one or more displays or LEDs 52 (referring to FIG. 4B) disposed within housing 3, and also may include a plurality of openings 51 configured to facilitate the travel of sound generated within housing 3 (by, e.g., a speaker). The LEDs 52 may be arranged in a ring-like formation, or any other suitable formation. Auto-injector 2 may have any suitable dimensions suitable to enable portability and self-attachment by a user. In one example, auto-injector 2 may have a length of about 2.98 inches, a width of about 2.07 inches, and a height of about 1.07 inches. However, other suitable values also may be utilized, including, e.g., a length from about 0.5 inches to about 5.0 inches, a width of about 0.5 inches to about 3.0 inches, and a height from 0.5 inches to about 2.0 inches.

[037] Auto-injector 2 may be oriented about a longitudinal axis 40 (e.g., an X axis), a lateral axis 42 (e.g., a Y axis) that is substantially perpendicular to longitudinal axis 40, and a vertical axis 44 (e.g., a Z axis) that is substantially perpendicular to both longitudinal axis 40 and lateral axis 42.

[038] An adhesive patch 12 may be coupled to tissue-engaging surface 4 to help secure auto-injector 2 to a user's body (e.g., skin). Adhesive patch 12 may be formed from fabric or any other suitable material, and may include an adhesive. The adhesive may be an aqueous or solvent-based adhesive, or may be a hot melt adhesive, for example. Suitable adhesives also include acrylic based, dextrin based, and urethane based adhesives as well as natural and synthetic elastomers. In some examples, the adhesive provided on patch 12 may be activated upon contact with a user's skin. In yet another example, patch 12 may include a non-woven polyester substrate and an acrylic or silicone adhesive. Patch 12 may be joined to housing 3 by, e.g., a double-sided adhesive, or by other mechanisms like ultrasonic welding. Patch 12 may have a length dimension greater than a width of auto-injector 2.

[039] NEEDLE MECHANISM

[040] Referring to FIGS. 5-11 , a needle mechanism 20 includes a carrier 202 that is movable (e.g., slidable) within housing 3 between a first position (FIG. 6) and a second position (FIG. 7). Needle mechanism 20 also may include a fluid conduit 300 that is mounted to carrier 202, and which may be deployed into a user, and retracted by a driver 320. A shuttle 340 (e.g., a shuttle actuator) may be configured to move driver 320 via a deployment gear 360, and a retraction gear 362. Shuttle 340 may be coupled to a resilient member (e.g., a spring 370). A cover 380 (FIG. 5) may be coupled to carrier 202 to enclose various components of needle mechanism 20.

[041] Referring to FIG. 5, fluid conduit 300 may extend from a first end 302 to a second end 304. First end 302 may include a needle 306 that is configured to be injected into a user. Needle 306 may include a sharp and/or beveled tip, and may extend generally along or parallel to axis 44. Second end 304 may include a needle 308 that is substantially similar to needle 306, but may be positioned within auto- injector 2 to penetrate a vial 1302 (shown in FIG. 13 and described in further detail below) to access drugs to be injected into the user. Fluid conduit 300 may include an intermediate section 310 including one portion extending along or parallel to axis 40. and a second portion extending along or parallel to axis 40. The first and second portions of intermediate section 310 may be joined in a coil 312 that facilitates flexion of fluid conduit 300 and movement of needle 306 along axis 44 during deployment into the user, and during retraction out of the user. While a coil 312 is shown, any other suitable shape, e.g., a serpentine, curved, or other shape that enables flexion of fluid conduit 300 is also contemplated. Coil 312, or similar structure, may act as a cantilever when needle 306 is deployed and/or retracted. Coil 312 also may bias fluid conduit 300 into the deployed configuration shown in FIG. 5. Once needle 308 penetrates and establishes fluid communication with vial 1302 (see, e.g., FIG. 14), drugs may travel from vial 1302, through needle 308, intermediate section 310, and needle 306 (pierced through the user's skin), and into the user. In some examples, fluid conduit 300 may include only metal or a metal alloy. In other examples, fluid conduit 300 may be include any other suitable material, such as, e.g., polymers or the like. Needle 308 and intermediate portion 310 may define a 22 or 23 Gauge, thin- walled needle, while needle 306 may be a 27 Gauge needle. Other needle sizes ranging from, e.g., 6 Gauge to 34 Gauge, also may be utilized as appropriate. Fluid conduit 300 may reduce the amount of material that contacts the drugs, reduce joints and assembly steps, and require less sterilization than conventional devices.

[042] Carrier 202 may be formed of plastic (e.g., injection-molded plastic), a metal, metal alloy, or the like, and may include a flange 204 with an opening 206, and posts 210 and 212. Carrier 202 also may include an opening 216 through which a needle or other fluid conduit may be deployed. Opening 216 may be a slot that is recessed from an end surface of carrier 202, or, in an alternative embodiment, an entirety of the perimeter of opening 216 may be defined by material of carrier 202. Carrier 202 also includes a driver path 218. Driver path 218 may be a slot in carrier 202 that extends along or parallel to axis 44. Driver path 218 may be configured to receive a protrusion of driver 320, such as, e.g., protrusion 330 discussed in further detail below. Carrier 202 also may include a shuttle path 220, along which shuttle 340 may move, as described in further detail below.

[043] Carrier 202 also may include a stop 240 that is configured to engage shuttle 340. Stop 240 may be a cantilever having a fixed end 241 (FIG. 8) and a free end 242 (FIG. 8). Stop 240 may include an inclined ramp 243 (FIGS. 9 and 12) that, when engaged or pushed by a ramp 1500 (described with reference to FIG. 12), causes stop 240 to deflect about fixed end 241. In a first position, free end 242 may block or otherwise impede movement of shuttle 340, and in a second configuration, may permit movement of shuttle 340. The relationship between stop 240 and shuttle 340 will be discussed in further detail later in the application. [044] Driver 320 includes two racks 322 and 324 (shown in FIG. 8) parallel to one another and disposed on opposing sides of driver 320. Racks 322 and 324 may include teeth and may be configured to engage with and drive rotation of deployment gear 360 and retraction gear 362, respectively. Driver 320 may include a lumen 326 (or a track, recess, or other suitable structure) (FIG. 5) that is configured to receive needle 306 of fluid conduit 300. Driver 320 also may include protrusion 330 (FIGS. 6 and 7) that is configured to slide within driver path 218 of carrier 202. Protrusion 330 may include a hook-like configuration that can "catch" on impediment 600, as described in further detail below.

[045] With continuing reference to FIG. 5, shuttle 340 may include a rack 342 configured to engage with gears 360 and 362. Shuttle 340 also may include an end surface 344. and a recess 346 that extends along a length of shuttle 340 in the same direction as rack 342. A slot 348 (FIG. 9) may extend along the length of recess 346. Slot 348 may extend through the middle of recess 346 and may extend along an entirety or substantial entirety of recess 346.

[046] Shuttle 340 may move along track 220 from a first, starting position (FIG. 8), to a second, intermediate position (FIGS. 9 and 10), and from the second position to a third, final position (shown between the second and third configurations in FIG. 11 ). As shuttle 340 moves along track 220, rack 342 may first engage deployment gear 360, and then retraction gear 362. At certain times, rack 342 engages at most one of deployment gear 360 and retraction gear 362 at any given time. In some examples, such as when rack 342 is disposed longitudinally between deployment gear 360 and retraction gear 362, rack 342 is not engaged with either of deployment gear 360 and retraction gear 362. Shuttle 340 may be configured to move only along one axis (e.g., axis 40) and only in one direction along the one axis. The force required to move shuttle 340 along track 220 may be provided by expansion of spring 370. Spring 370 may be compressed from a resting state, and the expansion of spring 370 may move shuttle 340 along track 220 through the series of positions/configurations set forth above. At various positions of shuttle 340, different features of auto-injector 2 may directly or indirectly block movement of shuttle 340.

[047] The first position of shuttle 340, shown in FIG. 8, may correspond to an unused, undeployed, and/or new state of auto-injector 2. In this first position, driver 320 may be in an undeployed state. Shuttle 340 is maintained in the first position by the positioning of an impediment 600 in the path of driver 320 (FIG. 6). Impediment 600, which may be a shelf of housing 3, or another suitable blocking device, may prevent movement of driver 320 by engaging and/or retaining protrusion 330.

Therefore, because driver 320, deployment gear 360, and rack 342 are coupled to one another, the blockage of driver 320 also prevents movement of shuttle 340. Shuttle 340 may move from the first position to the second position by moving impediment 600 relative to carrier 202 (or vice versa). In one example, carrier 202 is moved (e.g., to the left in FIG. 6) while impediment 600 remains stationary.

[048] When the path of driver 320 is free from impediment 600 (FIG. 7), spring 370 may expand and move shuttle 340 along track 220. This linear movement of shuttle 340 may rotate deployment gear 360 counter-clockwise (or clockwise in other examples) via rack 342, and the rotation of deployment gear 360 may move driver 320 downward along axis 44, via rack 322 of driver 320. This downward movement of driver 320 may cause needle 306 to pierce through the skin of a user. In some examples, driver 320 may be configured to move, relative to carrier 202, along only axis 44. [049] Shuttle 340 may be moved by the expansion of spring 370 until its end surface 344 abuts free end 242 of stop 240 such that shuttle 340 is maintained in the second position shown in FIGS. 9 and 10. At this point, free end 242 may prevent further expansion of spring 370 and further movement of shuttle 340 along track 220. In this second position, fluid conduit 300 may be deployed within a user, and fluid from vial 1302 may be injected into the user via needle 306. Additionally, while shuttle 340 is in the second position, rack 342 may be engaged with deployment gear 360 to maintain needle 306 in the deployed configuration. Shuttle 340 may move from the second position to the third position by the flexion of stop 240 about its fixed end 241. Further details of this flexion are set forth below with respect to FIGS. 12-14. The flexion of stop 240 may allow spring 370 to continue expanding, urging shuttle 340 further along track 220. In some examples, stop 240 may be received by and/or within recess 346 of shuttle 340. and ramp 243 may slide within slot 348. as shuttle 340 moves from the second position to the third position.

[050] The movement of shuttle 340 from the second position to the third position may correspond to the retraction of needle 306 from the user into housing 3. In particular, rack 342 may engage with and rotate retraction gear 362 in the same direction (e.g., counter-clockwise or clockwise) as deployment gear 360 was rotated. The rotation of retraction gear 362 may urge driver 320 back to a retracted position via rack 324. Shuttle 340 may reach the third position, where driver 320 is fully- retracted, when its end surface 344 engages a wall of carrier 202, when free end 242 of stop 240 reaches an end of recess 346, and/or when spring 370 reaches a resting state.

[051] In some embodiments, once driver 320 moves from the deployed state back to the retracted state, it may be prevented from moving out of the retracted state. As a result, needle 306 will be prevented from re-deployment into the user. In this configuration, auto-injector 2 may be a single-use device (e.g., discarded after completing one injection). In other embodiments, auto-injector 2 may be reset and reused. Furthermore, deployment gear 360 and retraction gear 362 may be the only rotating gears disposed within auto-injector 2, in some examples.

[052] PIERCING SYSTEM AND STERILE CONNECTOR

[053] FIGS. 13 and 14 show features of a piercing system 1300 of auto- injector 2. Additional details of exemplary piercing systems can be found in U.S. Patent Application Publication No. 2016/0262984 A1 to Arnott et al., published on September 15, 2016, the entirety of which is incorporated by reference herein. Piercing system 1300 includes a primary container, chamber, syringe, cartridge, or vial 1302 with a first end 1304 and a second end 306. Vial 1302 also may include a cavity 1308 opened at first end 1304 and extending toward second end 1306.

Second end 1306 may include a neck 1310 with a cap 1312 that engages neck 1310 to close second end 1306. A septum 1314 may be positioned between vial 1302 and cap 1312 to assist with closing second end 1306, and allow for needle 308 (e.g., a staked needle) to be inserted into vial 1302. Cavity 308 may be closed at first end 304 by a piston 1316.

[054] Vial 1302 may have a 5 ml_ capacity in some examples, although any other suitable volume (e.g., from 1 mL to 50 ml_, or from 2 mL to 10 ml_, or from 3 mL to 6 mL, or from 2 mL to 5mL, or another suitable range) also may be utilized depending on the drug to be delivered. In other examples, vial 1302 may have a capacity greater than or equal to 1 mL, or greater than or equal to 2 mL, or greater than or equal to 3 mL, or greater than or equal to 4 mL, or greater than or equal to 5 mL. Vial 1302 may contain and preserve a drug for injection into a user, and may help maintain sterility of the drug. Vial 1302 may have a 13 mm diameter neck, a 45 mm length, and an internal diameter of 19.05 mm. These values are merely exemplary, and other suitable dimensions may be utilized as appropriate. In some examples, vial 1302 may be formed using conventional materials, and may be shorter than existing devices, which can help auto-injector 2 remain cost-effective and small. Vial 1302 may be a shortened ISO 10 mL cartridge.

[055] Septum 1314 may include an uncoated bromobutyl material, or another suitable material. Piston 1316 may include a fluoropolymer coated bromobutyl material, and also may include a conical nose 1316a to help reduce dead volume within vial 1302. Piston 1316 may include one or more rubber materials such as, e.g., halobutyls (e.g., bromobutyl, chlorobutyl. florobutyl) and/or nitriles, among other materials.

[056] Piercing system 1300 also may include a top 1354 positioned at second end 1306. Top 1354 may include a base 1355 positioned over septum 1314 and the opening of vial 1302. Top 1354 may include a chamber 1356 extending from base 1355 in a direction away from piston 1316. Chamber 1356 defines a cavity 1357 and includes an opening 1358 in communication with cavity 1357. In some embodiments, top 1354 may be integrated with septum 1314 (e.g., integral or of one- piece construction). In alternative embodiments (not shown), top 1354 may be provided or initially assembled on fluid conduit 300 and not installed directly on/with vial 1302 and/or integrated with septum 1314.

[057] A portion of fluid conduit 300, such as needle 308, a tube or the like, may extend through opening 1358 of chamber 1356 and into cavity 1357, but not through base 1355 in the pre-activated state. Opening 1358 may be pre-formed, or may be formed by the penetration of needle 308 through chamber 1356. Opening 1358 of chamber 1356 may form a sterile sliding seal about needle 308 such that pathogens or other contaminants are prevented from passing into cavity 1357.

Needle 308 can move relative to top 1354 without disrupting the sterile seal therebetween. Cavity 1357 may be sterile or aseptic such that the inner surfaces of cavity 1357 and needle 308 are sterile. In another embodiment, cavity 1357 may be sterilized after needle 308 is inserted through opening 1358 and into cavity 1357. In alternative embodiments, rather than top 1354, a convoluted flexible (e.g., rubber) bellows or bladder member may form cavity 1357 and allow translation of vial 1302 relative to needle 308 (or vice versa). The flexible member also may seal or form cavity 1354 about needle 308 after sterilization.

[058] In an alternative embodiment shown in FIG. 14A, a top 1354a may be used with piercing system 1300 in lieu of top 1354. Top 1354a may include a plug 1356a and a base 1355a positioned over the opening of vial 1302. Plug 1356a may extend from base 1355a in a direction away from piston 1316. In the pre-activated state, needle 308 may be disposed within plug 1356a. Plug 1356a may be a solid plug which is devoid of any holes, cavities, or openings, and which may be formed of a first rubber material. The first rubber material may be permeable to a sterilizing gas, such as, e.g., ethylene oxide or vaporized hydrogen peroxide. The first rubber material may include one or more of isoprene, ethylene propylene diene monomer ( -class) rubber (EPDM), and styrene-butadiene, among others. The permeability of the first rubber material to a sterilizing gas may allow needle 308, which is disposed within the plug 1356a, to be sterilized before use. Plug 1356a may be molded about needle 308, so that needle 308 is impaled into plug 1356a. The impermeability of base 1355a to the sterilizing gas may prevent contamination and/or alteration of a drug contained within vial 1302. Base 1355a may include impermeable rubbers such as, e.g., halobutyls (e.g., bromobutyl, chlorobutyl, florobutyl) and/or nitriles, among other materials.

[059] Piston 1316 may be coupled to a translation mechanism 1366 that is configured to translate piston 1316 and vial 1302 in a direction toward second end 1306. The movement of piston 1316 toward second end 1306 causes piston 1316 to act against the contents within vial 1302 (e.g., drugs, medications), which ultimately transfers force against second end 1306 of vial 1302, causing vial 1302 to move along longitudinal axis 40. Translation mechanism 1366 may include a 12 mm motor with a five-stage gear reduction (360:1 ). Translation mechanism 1366 may have spring contacts that create an electrical connection with an associated printed circuit board (e.g., first electronic board 1402). The motor may be configured to generate a torque of about 136 mN*m at 36 rpm. These design parameters of the motor are merely exemplary, and any other suitable motor also may be utilized.

[060] Translation mechanism 1366 may include a leadscrew mechanism coupled to piston 1316 that extends axially upon relative rotation about longitudinal axis 40. This telescoping leadscrew may have a 100 N output a 20 mm stroke, and a 7°/45° buttress thread shape with a 0.75 mm pitch. The materials for the leadscrew mechanism may include acetal and polybutylene terephthalate. The leadscrew mechanism may extend within piston 1316 to reduce dead space behind piston 1316. While piston 1316 is shown in FIGS. 13 and 14 with longitudinally spaced threads, in some examples, such threads may not be present. In another exemplary embodiment (not shown), translation mechanism 1366 may include a manually engageable surface or member that is manually manipulated by a user to move piston 1316. For example, piercing system 1300 may include a cartridge or a plunger coupled to the back side of piston 1316. In another exemplary embodiment (not shown), translation mechanism 1366 may include a pneumatic or hydraulic drive member that is actuated or initiated by a user to move piston 316. The drive member may be in the form of expanding bellows, an expanding bladder, an expanding diaphragm, or a sliding seal or piston, for example. The direct pneumatic or hydraulic pressure may provide the force required to move piston 1316.

[061] Piercing system 1300 also includes a collar 1390 coupled or fixed to second end 1306. Collar 1390 may include a plurality of circumferentially spaced apart fingers 1392 that engage and surround neck 1310. Collar 1390 may be fixed, or otherwise coupled to second end 1306. Collar 1390 may include a wall 1390a that extends at least partially about neck 1310, the opening of second end 1306, cap 1312. septum 1314, and/or top 1354. Wall 1390a of collar 1390 may be positioned radially or laterally outward of neck 1310 and extend longitudinally past neck 1310, cap 1312, and septum 1314.

[062] In the pre-activated state of piercing system 1300 shown in FIG. 13, an edge 1393 of collar 1390 may engage a corresponding radially or laterally inwardly extending cam, latch or actuation portion 1394 of a driver retainer member 1395. Retainer member 1395 may be slidable relative to collar 1390. Collar 1390 and retainer member 1395 may be configured such that in the pre-activated state or arrangement shown in FIG. 13, at least a portion of the cam or actuation portion 1394 of retainer member 1395 is positioned directly behind a retaining portion 1399 of a driver 1398 slidable within retainer member 1395. A wall 1391 of driver 1398 may extend into and through an end cap portion 1396 of retainer member 1395 and into an interior portion of retainer member 1395, and retaining portion 1399 of driver 1398 may extend radially outward from wall 391. In some embodiments, wall 1391 of driver 1398 may be substantially cylindrical and retaining portion 1399 of driver 1398 may be a flange extending about an end of the wall 1391.

[063] In the pre-activated state of piercing system 1300, an elastically deformed biasing or resilient member 1397 may be positioned between cap portion 1396 of retainer member 1395 and retaining portion 1399 of driver 1398. Biasing member 1397 may exert a force against driver 1398 in the pre-activated state of piercing system 1300 acting in the direction towards vial 1302. Biasing member 1397 may be any member effective in applying the force in the pre-activated state, and then releasing such force upon activation, as discussed below with reference to FIG. 14. In some embodiments, biasing member 1397 may be a conical or flat spring.

[064] Needle 308 of fluid conduit 300 may be fixed or coupled to driver 1398 such that fluid conduit 300 moves with driver 1398. In the pre-activated state of piercing system 1300, needle 308 may be positioned within the sterile cavity 1357, but not through base 1355 of top 1354, septum 1314, and/or into cavity 1308 of vial 1302.

[065] To move piercing system 1300 from the pre-activated state of FIG. 13, translation mechanism 1366 may be activated to move piston 1316 towards second end 1306 and translate vial 1302 along longitudinal axis 40 toward driver 1398. Because the needle 308 is not yet in fluid communication with vial 1302, activation of translation mechanism 1366 applies a pressure against the fluid contained in vial 1302, which is then applied to vial 1302 itself. This pressure also causes edge 1393 to push against and deflect actuation portion 1394 radially outward. Without actuation portion 1394 blocking its path, retaining portion 1399 and needle 308 are moved toward vial 1302 by the expansion of biasing member 1397. Driver 1398 may be coupled to flange 204 of carrier 202, and thus, this movement of driver 1398 toward vial 1302 also may move carrier 202 in the same direction. This movement corresponds to the movement of carrier 202 relative to housing 3 in FIGS. 6 and 7, which enables protrusion 330 to clear impediment 600 to inject needle 306.

[066] The movement of needle 308 toward second end 1306 of vial 1302 also causes needle 308 to pierce through base 1355 of top 1354, septum 1314, and cavity 1308, into fluid communication with the contents of vial 1302. Once needle 308 is in fluid communication with vial 1302, further movement of piston 1316 toward second end 1306 urges fluid through needle 308 and a remainder of fluid conduit 300. In some embodiments, piercing system 1300 may be configured such that, after activation, no more of needle 308 than the portion that was already positioned within sterile cavity 1357 extends into cavity 1308. This may help prevent contamination of the contents of vial 1302 with non-sterile portions of needle 308.

[067] Biasing member 1397 may be configured to expand such that fluid conduit 300 pierces top 1354 and/or septum 1314 at a high speed, such as at a speed of at least about 10 mm/sec, or at least about 40 mm/sec. The relatively quick piercing of top 1354 and/or septum 1314 via biasing member 1 97 may help prevent leakage of the contents of cavity 1308 which may be under pressure via piston 13 6.

[068] After drugs have been delivered to the user via needle 306, needle 306 may be automatically withdrawn from the user. Referring to FIGS. 12-14, translation mechanism 1366 may be operated in a reverse mode such that the rotation of the lead screw is in an opposite direction compared to the insertion step. This counter- rotation may cause piston 316 to move back toward first end 1304, and also cause vial 1302 to move in an opposite direction along axis 40 (as compared to during fluid delivery and insertion of needle 306). The movement of vial 1302 in the opposing direction may cause ramp 1500 in FIG. 12 (which is attached to wall 1391) to push against ramp 243 of stop 240. This may cause stop 240 to deflect about its fixed end 241 in the direction of arrow 240a, and allow shuttle 340 to move from its second position to its third position to retract needle 306 as set forth above, in this way, withdrawal and insertion of the needle into a patient can both be accomplished with a single spring within the device.

[069] It is further contemplated that fluid conduit 300 may be the only fluid conduit of auto-injector 2 configured to be in fluid communication with vial 1302. Thus, drugs from vial 1302 may be deployed only through fluid conduit 300 and into the user during normal operation of auto-injector 2. Additionally, needle 306 may be the only needle of auto-injector 2 configured to be deployed into a patient. In this way. a single piece of metal or plastic can be used to carry the fluid from vial 1302 to a patient.

[070] STERILE NEEDLE SHIELD

[071] Referring to FIGS. 24 and 25, auto-injector 2 may include a needle cover or a needle shield 2400 that is configured to help maintain sterility of needle 306. Needle shield 2400 may extend from a first end 2402 toward a second end 2404. A flange 2406 may be disposed at first end 2402, and a tubular extension 2408 may extend from flange 2406 toward second end 2404. Needle shield 2400 may include an opening 2410 through flange 2406, which may be in communication with a lumen 2412 extending through extension 2408. A seal 2414 may be disposed at second end 2404 within lumen 2412. Seal 2414 may define an opening 2416 that is in communication with a remainder of lumen 2412. Seal 2414 may include a constricted portion 2414a, an intermediate portion 2414b, and an inner sealing portion 2414c. Intermediate portion 2414b may be disposed between constricted portion 2414a and inner sealing portion 2414c, and of the three components, constricted portion 2414a may be disposed closest to second end 2404.

Intermediate portion 2414b may have a larger inner diameter than constricted portion 2414a, and constricted portion 2414a may have a larger inner diameter than inner sealing zone 2414c. Needle shield 2400 also may include a membrane 2418 that covers opening 2410 in flange 2406. Membrane 2418 may be formed from a gas- permeable material that is not permeable to liquids, such as, e.g., a high-density polyethylene fiber membrane. In one example, membrane 2418 may be Tyvek® brand material. Membrane 2418 may help keep seal 2414 sterile, so that seal 2414 does not contaminate needle 306 when needle shield 2400 is disengaged from housing 3.

[072] Flange 2406 and extension 2408 may be formed from a plastic or other suitable material, while seal 2414 is formed from a rubber material. In another embodiment, flange 2406 and extension 2408 also may be formed from rubber. The rubber material may be substantially similar to the material forming plug 1356a set forth above. For example, the rubber material forming flange 2406, extension 2408, and seal 2414 may be permeable to a sterilant or a sterilizing gas, such as, e.g., ethylene oxide or vaporized hydrogen peroxide. The rubber material may include one or more of isoprene, ethylene propylene diene monomer (M-class) rubber (EPDM), styrene-butadiene, and thermoplastic elastomers (TPE), among others. In one embodiment, when flange 2406 is formed from a sterilant-permeable rubber material, flange 2406 may not include an opening 2410, and instead may be a solid plug of material.

[073] Needle shield 2400 may be coupled with auto-injector 2 in order to maintain sterility of needle 306 during, e.g., shipping of auto-injector 2 before use. During this coupling, needle 306 may pierce through inner sealing portion 2414c of seal 2414, so that seal 2414 forms a seal around needle 306. That is, inner sealing portion 2414c initially may be a closed and pierceable membrane. Alternatively, inner sealing portion 2414c may be a constricted portion having a smaller inner diameter than constricted portion 2414a, and needle 306 may slide through this smaller constricted portion. The pierced portion {inner sealing portion 2414c) of seal 2414 may be relatively thin, so that it does not significantly dull needle 306. Constricted portion 2414a may engage with and form a seal around a portion of intermediate section 310 of conduit 300. Intermediate section 310 may have a larger outer diameter than an outer diameter of needle 306. Additionally, a volume or gap 2414d may be formed between an inner diameter of intermediate portion 2414b and the outer diameter of intermediate section 310.

[074] Auto-injector 2 may be sterilized via exposure to a sterilizing gas (e.g.. ethylene oxide) after needle shield 2400 is coupled to auto-injector 2. Both lumen 2412 and gap 2414d, surfaces defining lumen 2412 and gap 2414d, and

components contained therein (such as, e.g., exposed portions of needle 306 that pierce through tissue of a patient/user) may be sterilized after exposure to the sterilizing gas. A user may be instructed to manually remove needle shield 2400, for example, by pulling needle shield 2400 away from housing 3. In another

embodiment, needle shield 2400 may be integrated with a packaging of auto-injector 2, such that, when auto-injector 2 is removed from the packaging, needle shield 2400 is removed from auto-injector 2. For example, flange 2406 may be secured to the packaging (not shown) by an adhesive. Then, when the user withdraws auto- injector 2 from the packaging, needle shield 2400 will disengage from housing 3, so that needle 306 can be freely deployed in the normal operation of auto-injector 2. In some cases, exposed portions of seal 2414 closer to second end 2404 than constricted portion 2414a (and/or constricted portion 2414a itself) may become contaminated after sterilization. Thus, it may be important that these contaminated surfaces do not contact needle 306 during withdrawal of shield 2400 from auto- injector 2. The narrower inner diameter of inner seal portion 2414c helps ensure that these potentially contaminated portions do not contact needle 306, particularly those portions of needle 306 that are inserted into tissues of a patient/user, by keeping extension 2408 of shield 2400 centered upon removal.

[075] In an alternative embodiment, seal 2414 may be directly coupled to driver 320. In this embodiment, seal 2414 may seal against a plastic or other portion of extension 2408, and would remain within auto-injector 2 when needle shield 2400 is removed.

[076] ELECTRONICS

[077] FIG. 4A shows a control system 1400 of auto-injector 2. Control system 1400 may include components positioned on a first electronics board 1402 and a second electronics board 1404, and also may include a power source 1406. First electronics board 1402 may include a controller 1408, an activating switch 1409, a touch sensor 1410, a needle insert switch 1412, and an emitter 1414. Second electronics board 1404 may include a detector 1416, an audio module 1418, a visual module 1420, and a haptic module 1422. One or more of the components of first electronics board 1402 and second electronics board 1404 may be operatively coupled to controller 1408, and powered by power source 1406. Controller 1408 also may be operatively coupled to translation mechanism 1366, and may be configured to control operation of translation mechanism 1366 to initiate and control needle insertion and retraction as set forth above. Translation mechanism 1366 may be coupled to first electronics board 1404 via one or more spring contacts during a final assembly step where vial 1302 is inserted into housing 3.

[078] The majority of the assembly of auto-injector 2 may occur, e.g., on an assembly line at a manufacturing facility. Then, two device halves (or portions) may be shipped to a drug filling or final assembly facility. Indeed, the two separate portions 1490 and 1492 need not be the same size, as illustrated in FIG. 4B. Once a drug vial, e.g., vial 1302, is filled with a drug or other medicament, vial 1302 may be assembled with a remainder of auto-injector 2. For example, the two device halves (portions 1490 and 1492) may be assembled together with the filled drug vial 1302 therein. In one example, portion 1490 and translation mechanism 1366 may be snapped in place behind vial 1302. Portion 1490 may be part of housing 3 including a base or module configured to contain translation mechanism 1366 and its associated electronics. Portion 1492 may be a part of housing 3 containing substantially all of the other components described herein, including, e.g.. the needle mechanism, sterile connector, and piercing mechanisms described herein. In this example, an electrical connection of the motor of translation mechanism 1366 must be made during the snapping of translation mechanism 1366 behind vial 1302 (i.e.. during the assembly step where portions 1490 and 1492. and vial 1302 are combined to form a complete and functional auto-injector 2). To accommodate such an electrical connection, the drivetrain of translation mechanism 1366 may include one or more spring contacts 1494 (referring to FIG. 4C) that will contact pads 1495 (also referring to FIG. 4C) on the first electronics board 1402 upon assembly. Thus, the connection of translation mechanism 1366 to first electronics board 1402 (including controller 1408) may be made without any loose wires or other similar structures. [079] Such an assembly process may be relatively simpler than simpler devices (e.g., auto-injectors) with relatively more complex final assembly processes. As a result, the contemplated assembly process described herein may lead to a reduction of labor costs.

[080] Controller 1408 may be configured to accept information from the system and system components described above, and process the information according to various algorithms to produce control signals for controlling translation mechanism 1366. The processor may accept information from the system and system components, process the information according to various algorithms, and produce information signals that may be directed to audio module 1418, visual module 1420, haptic module 1422, or other indicators of, e.g., second electronics board 1404, in order to inform a user of the system status, component status, procedure status or any other useful information that is being monitored by the system. The processor may be a digital IC processor, analog processor or any other suitable logic or control system that carries out the control algorithms.

[081] As discussed above with respect to FIGS. 2 and 3, activating switch 1409 may be a mechanical plunger-type switch that extends away from tissue- engaging surface 4 of auto-injector 2. Activating switch 1409 may include an electrical circuit that is broken unless activating switch 1409 is depressed. For example, when auto-injector 2 is attached to a user's skin, switch 1409 may be depressed, completing the electrical circuit, and indicating to controller 1408 that auto-injector 2 should be activated. In order to conserve power, the components of auto-injector 2 may be in an idle or sleep mode until switch 1409 is activated. In yet another example, auto-injector 2 may not be powered at all until switch 1409 is activated, and deactivation of switch 1409 may cut off power to auto-injector 2 entirely. While a mechanical plunger-type switch is disclosed, any other suitable mechanism for activating auto-injector 2 may be utilized, including, e.g., a button depressed by the user, voice signals, a wireless signal from another electronic device, among others.

[082] Touch sensor 1410 may be configured to help controller 1408 determine whether auto-injector 2 is properly deployed on the skin of a user. In one example, touch sensor 1410 may be a capacitive sensing electrode or any other device configured to differentiate contact with skin versus other materials, such as, e.g., wood, plastic, metal, or another material. When skin is in the proximity of the capacitive sensing electrode, a signal indicative of such contact may be sent to controller 1408. Thus, touch sensor 1410 may serve to verify that auto-injector 2 is properly placed on a user's skin, even if switch 1409 is depressed. Touch sensor 1410 may include a capacitive sensing electrode coupled to first electronics board 1402 and also to an interior of housing 3. Housing 3 and adhesive patch 12 may act as an overlay (insulator) that acts as a dielectric between the skin of the user and the capacitive sensing electrode. Contact of portions of housing 3 and/or adhesive patch 12 near the capacitive sensing electrode may cause the capacitance of the electrode to increase, for example, by about 1 to about 10 pF, indicating placement of auto- injector 2 on a skin surface.

[083] Needle insert switch 1412 may be configured to send a signal to controller 1408 that needle 306 is deployed within a user. For example, referring to FIG. 15, needle insert switch 1412 may include a curved cantilever 1510 including a first contact 1512. Needle insert switch 1412 also may include a second contact 1514. First contact 1512 may be placed into electrical contact with second contact 1514 when needle 306 is deployed into the user. During deployment of needle 306, driver 320 may move downward along axis 44 and deflect curved cantilever 1510 and first contact 1512 toward second contact 514. When first contact 1512 and second contact 1514 connect to one another, a signal may be sent to controller 1408 indicating that needle 306 has been successfully deployed into the user. The separation of first contact 1512 and second contact 1514 may indicate that needle 306 has been retracted from the user.

[084] Emitter 1414 and detector 1416 may operate as an optical interruption sensor, or photo-interrupter in order to allow controller 1408 to determine a state of auto-injector 2. Emitter 1414 may be a light emitting diode (LED) or other suitable light emitter, and detector 1416 may be, e.g., a phototransistor configured to receive light emitted by emitter 1414. In one example, emitter 1414 may emit infrared light, although other suitable wavelengths of light also may be used. The use of infrared light may help reduce interference from external light. Emitter 1414 and detector 1416 may be arranged across from one another within housing 3 to enable a beam of light 1430 to pass from emitter 1414, through vial 1302, to detector 1416. Vial 1302, and any fluid contained therein may be at least partially transparent to beam 1430 so that beam 1430 may pass through vial 1302 and its contents. As piston 1316 is moved toward second end 1306 during drug delivery (referring to FIGS. 13 and 14), piston 1316, and in particular a shoulder of piston 1316, may interrupt beam 1430. When detector 1416 fails to sense beam 1430, a signal may be sent to controller 1408, which may interpret the signal to indicate an end of an injection (e.g., that all of the drug contained within vial 1302 has been expelled). In some examples, the refraction path of beam 1430 may be considered when positioning emitter 1414 and detector 1416 relative to one another. For example, beam 1430 may be refracted as it passes through vial 1302 and any liquid contained therein, and emitter 1414 and detector 1416 may be offset from one another accordingly. Additionally, emitter 1414 and detector 1416 may be offset from a center of housing 3 so that the shoulder of piston 1316 may block beam 1430. In at least some examples, an optical interruption sensor or similar mechanism may help avoid false positives in the event of a drive train failure. That is, the optical switch may help controller 1408 determine that an injection was not completed with greater accuracy than other mechanisms.

[085] Audio module 1418 may include a speaker or the like to provide audio feedback to the user. Openings in housing 3 may facilitate the travel of sound from audio module 1418 to the user. Audio module 1418 may generate a tone or other sound at the start and at the end of injection, and/or to indicate any other benchmark during the injection. Visual module 1420 may include one or more LEDs or similar devices to provide visual feedback to the user. Visual module 1420 may include different colored LEDs to provide various messages to the user. For example, a plurality of green LEDs arranged in a ring could be used to display progress of the injection over time, while a red LED could be used to display an error to the user. Any other suitable colors, combinations, and/or numbers of LEDs may be used in various examples. For example, a combination of red, blue, and purple LEDs may be utilized. In one arrangement, sixteen LEDs may be arranged in a circle having a diameter of about 26.5 mm, or a diameter from about 10.0 mm to about 40.0 mm. The LEDs may be activated sequentially around the circle to indicate progress of an injection (e.g., in a progress ring arranged in a similar manner as a clock - see, for example, LEDs 52 on FIG. 4C). Controller 1408 also may be configured to receive feedback from various sensors, and rescale a speed that various LEDs are activated based on feedback from the sensors. For example, the LEDs in the progress ring may be activated in three or more operation phases including, e.g., an injection sequence activation phase, an injection phase, and a retraction phase. Those of ordinary skill in the art will recognize that auto-injector 2 may have more or less than the above-described three operation phases. There may be an expected time for completing each phase, but there also may be some variability in the actual times experienced during any of the aforementioned operation phases of auto-injector 2. An algorithm may be utilized to help avoid the premature activation of LEDs, for example, when a certain phase finishes earlier than expected, or to have progress along the ring stopped when a certain phase takes longer than expected. At any given point, the algorithm may divide the remaining estimated time for completion of drug delivery by the number of unactivated LEDs in the progress ring, to determine a rate at which the remaining LEDs in the progress ring should be activated.

[086] For example, before the injection sequence activation phase, the LEDs may be activated at a rate equal to the estimated time of the entire drug delivery process (e.g., the estimated time to complete all of injection sequence activation phase, the injection phase, and the retraction phase) divided by the total number of unactivated LEDs in the progress ring. Stated differently, the estimated time of the entire drug delivery process may be divided by a number that is the total number of LEDs in the progress ring less any already-activated LEDs. Thus, if, for example, one LED is already activated, the estimated time of the entire drug delivery process may be divided by one less than the total number of LEDs in the progress ring.

[087] After completion of the injection sequence activation phase, the LEDs may be activated at a rate equal to the sum of estimated times for completing the remaining phases (e.g., the injection phase and the retraction phase) divided by the number of unlit LEDs in the progress ring. After completion of the injection phase. the LEDs may be activated at a rate equal to the estimated time to complete the retraction phase, divided by the number of unlit LEDs.

[088] Visual module 1420 also may include a display screen, touch screen, or other suitable device to provide one-way or two-way communication with the user. Visual module 1420 may be visible by the user from outside of housing 3 via a window in housing 3. Haptic module 1422 may include, e.g., a haptic motor configured to generate vibrations that can be felt by the user. Vibrations may signal the start and the end of an injection, and/or may help provide additional information to a user.

[089] Controller 1408 may be coupled to a wireless communication module and an antenna. The wireless communication module may be configured to transmit data from controller 1408 to. e.g., a mobile device, computer, cell phone, or the like. The wireless communication module may be configured to transmit information over one or more wireless modalities, such as, e.g., Bluetooth, Bluetooth low energy (BLE), infrared, cellular networks, and wireless networks, among others. The antenna may be any suitable device configured to assist the wireless communication module in data transmission and/or amplification. Thus, controller 1408 may be configured to transmit diagnostic information of the user and/or auto-injector 2, information pertaining to completion of an injection, and/or information pertaining to an error state of auto-injector 2 to a device of the user, or to the cloud. Signals indicative of needle insertion and/or early device removal also could be transmitted via the wireless communication module. Controller 1408 also may receive activation and/or delay commands via the wireless communication module.

[090] FIG. 16 shows an exemplary method 2000 according to the disclosure. Method 2000 may start at step 2002, where a user may position auto-injector 2 on her body so that tissue-engaging surface 4 contacts a skin surface. Auto-injector 2 may be mounted in any suitable location, such as, e.g., the thigh, abdomen, shoulder, forearm, upper arm, leg, buttocks, or another suitable location. Auto- injector 2 may be secured to the skin by adhesive patch 12. The securement of auto- injector 2 at step 2002 may cause activating switch 1409, which extends outward from tissue-engaging surface 4 to be depressed and complete a circuit. The completion of the circuit may cause a signal to be sent to controller 1408 to transition from a power-saving, sleep mode, to an active mode. Alternatively, any other suitable mechanism may power on or otherwise activate auto-injector 2 before or after step 2002.

[091] Once auto-injector 2 is activated at step 2002, method 2000 may proceed to step 2004, where controller 1408 may determine whether tissue- engaging surface 4 is positioned on a skin surface. At step 2004, controller 1408 may receive a measurement from touch sensor 1410 indicating whether auto-injector 2 is positioned on skin or another surface. If controller 1408 determines that touch sensor 1410 is in contact with skin, for example, when a capacitance value received from touch sensor 1410 is within a predetermined range, method 2000 may proceed to step 2008. If controller 1408 determines that touch sensor is not in contact with skin, for example, if the capacitance measurement received from touch sensor 1410 indicates that auto-injector 2 is in contact with a non-skin surface like wood or metal, method 2000 may proceed to step 2006. At step 2006, auto-injector 2 may be placed into an error condition. In the error condition, an LED may be activated (e.g., a red LED) to indicate to the user that an error has occurred, or a message may be displayed on a display screen. In some examples, auto-injector 2 may need to be manually reset before an injection can be completed. In other examples, auto- injector 2 may loop back to step 2004, wherein controller 1408 continuously attempts to determine whether touch sensor 1410 is in contact with skin. Method 2000 also may require that touch sensor 14 0 be in contact with skin during the entire injection. Thus, if at any point during the injection, controller 1408 determines that touch sensor 1410 is no longer in contact with skin, controller 1408 may stop the injection (e.g., by stopping further movement of translation mechanism 1366), may generate an error signal or message, and may retract needle 306 if it had been extended.

[092] At step 2008, controller 1408 may send a signal to activate translation mechanism 1366. Once activated, translation mechanism 1366 may move toward second end 1306 of vial 1302 (referring to FIGS. 13 and 14). causing vial 1302 itself to move in the same direction. This may cause needle 308 to move in the opposing direction to access vial 1302 as set forth above. The movement of driver 1398 and needle 308 causes carrier 202 to move in the same direction, which sets forth the chain of events that ultimately deploys needle 306 into the user by the mechanisms set forth in FIGS. 5-11. Translation mechanism 1366 will continue to move toward second end 1306 until a desired amount of the drug contained within vial 1302 is dispensed into the user.

[093] Method 2000 may proceed to step 2010. where controller 1408 may determine whether the injection is complete. This determination may be based on interruption of beam 1430 by piston 1316 (as described with reference to FIGS. 4A, 13, and 14). That is, when beam 1430 is broken (not received by detector 1416), controller 1408 may determine that injection is complete. Once controller 1408 determines that the injection is complete, controller 1408 may send a signal to translation mechanism 1366 to reverse the direction of rotation of the lead screw, which may cause ramp 1500 to push against ramp 243 of stop 240, enabling retraction of needle 306 as discussed above with reference to FIG. 11. In one example, controller 1408 may institute a delay after receiving an indication that beam 1430 has been interrupted. The delay may be from, e.g., 0.1 to 60 seconds. An additional end detection mechanism may be used instead of or in combination with the interruption-type sensor described above. For example, a current of the motor of translation mechanism 1366 may be utilized to determine whether an injection has been completed. That is, when piston 1316 reaches second end 1306 of vial 1302, the current on the motor will increase (e.g., as a result of piston 1316 engaging the end of vial 1302), signaling the expulsion of all or substantially all of the contents of vial 1302. One exemplary combination could include the use of beam 1430, where interruption of beam 1430 indicates that, e.g., 90 to 98 percent of the injection has been completed. Then, the current of the motor of translation mechanism 1366 could be analyzed to determine whether the remaining 2 to 10 percent of the injection has been completed. In another example, instead of using an optical switch, a delay from the initiation of the translation mechanism 1366 may be used by controller 1408 to determine when to reverse translation mechanism 1366. In one example, this delay may be from, e.g., about 1 to about 120 seconds, although other suitable times are also contemplated. In any event, the delay from initiation may be long enough to permit emptying of vial 1302.

[094] In some examples, a timing of an injection procedure, measured from the initial activation of activating switch 1409 to retraction of needle 306 from the user after drug delivery, may be from about 20 seconds to about 90 seconds, or from about 25 seconds to about 60 seconds, from about 30 seconds to about 45 seconds, or less than or equal to about 120 seconds, or less than or equal to about 90 seconds, or less than or equal to about 60 seconds, or less than or equal to about 45 seconds, or less than or equal to about 30 seconds.

[095] Method 2000 also may include additional steps. For example, method 2000 may include determining whether a drug within vial 1302 is too cold for delivery into the user, whether power source 1406 has enough energy to complete an injection, whether needle 306 has been prematurely deployed and/or retracted, whether the current of the motor of translation mechanism 1366 is in an appropriate range, and whether an injection procedure has extended beyond a maximum acceptable procedure time. When controller 1408 senses any of the above errors, it may communicate such errors to the user, and may end an ongoing injection by, e.g., halting or reversing translation mechanism 1366 and retracting needle 306 from the user.

[096] ALTERNATE EMBODIMENTS

[097] Another embodiment of a needle mechanism is shown in FIGS. 17-19. Needle mechanism 2400 may include a base 2402 and a shuttle 2420. Base 2402 may have an extension member 2404 extending away from a top surface of base 2402. Base 2402 also may include a channel 2406 extending along a longitudinal axis of base 2402 (parallel to axis 40) and recessed into a top surface of base 2402. Channel 2406 may extend through a first wall 2407 and a second wall 2408 of base 2402, and also extend through the extension member 2404. The extension member 2404 may include, for example, a slot 2410 extending from a top of the extension member 2404 through a portion of base 2402 towards the bottom surface of base 2402. The slot 2410 may be positioned generally perpendicular to channel 2406 and extend parallel to axis 44. Base 2402 may further include a pin 2412 and a second pin 2414. [098] Shuttle 2420 may include an end member 2422 coupled to a first wall 2426 on a first side, and a second wall 2428 on a second side. First wall 2426 and second wall 2428 may be substantially parallel to one another. The first and second walls 2426, 2428 may be spaced apart by the distance of the width of base 2402 to allow for base 2402 to translate with respect to shuttle 2420. An opening 2424 may extend through the end member 2422, which may be configured to receive a first end of a shaft 2456.

[099] Wall 2426 may include a first slot 2430, a second slot 2432, and a driver member opening 2434 with an enlarged portion 2434a (where a projection 2454 may rest in a first, undeployed configuration). First slot 2430 may be positioned adjacent to and longitudinally spaced apart from second slot 2432. First slot 2430 engages the pin 2412 and second slot 2432 engages pin 2414. Slots 2430, 2432 may include a first curved portion or injection slope extending from a bottom toward a top of shuttle 2420, a peak positioned near opening 2434, and a second curved portion or removal slope extending from the peak to a position near the bottom of shuttle 2420. The first curved portion may have, for example, a convex shape and the second curved portion may have, for example, a concave shape when viewed from above needle mechanism 2400. The injection slope may have, for example, an angle and curvature less than the angle and curvature of the removal slope. The shallower injection slope may provide a mechanical advantage while the parts are at rest to help overcome static friction. The first curved portion allows for the insertion of a needle (e.g., needle 306 described above) into a user for administration of a medication and the second curved portion allows for removal of the needle 306 from the user. Second wall 2428 also may include two slots and an opening similar to slots 2430 and 2432, and openings 2434. The slots and openings of second wall 2428 may be arranged in a similar or identical manner as those positioned on wall 2426.

[0100] Needle mechanism 2400 also may include an elastic member or spring (not shown) that is coupled to shaft 2456. Shaft 2456 may be positioned in opening 2424 of shuttle 2420. Shaft 2456 may be coupled to a projection 2454. Projection 2454 may slide through slot 2410 of extension member 2404, and may be coupled to needle 306.

[0101] To move from an undeployed configuration shown in FIG. 17 to a deployed configuration shown in FIG. 18, the spring may be allowed to expand, causing shuttle 2420 to slide longitudinally relative to shaft 2456 along longitudinal axis 40. Due to the curvature of slots 2430 and 2432. the longitudinal force applied to shuttle 2420 also pushes shuttle 2420 downward. This downward motion also causes projection 2454 to move downward through slot 2410, deploying needle 306. When needle mechanism 2400 is in the deployed configuration, pins 2412 and 2414 are positioned at the peak or connection between the injection slope and removal slope of slots 2430 and 2432. In addition, the projection 2454 is positioned near the middle or center of opening 2434. Projection 2454 also is positioned near a middle of the slot 2410 between a top surface of the extension member 2404 and a bottom of the slot 2410. Shaft 2456 may extend out of opening 2424 beyond the end of shuttle 2420.

[0102] Once the medication has been administered, the injection needle 470 may be removed by allowing the spring to expand further. Further expansion of the spring causes shuttle 2420 to slide further longitudinally relative to shaft 2456 along the longitudinal axis 40. Due to the curvature of slots 2430 and 2432, the additional longitudinal force applied to shuttle 2420 also pushes shuttle 2420 upward. This upward motion also causes projection 2454 to move upward through slot 2410, retracting needle 306. Projection 2454 may be positioned in the drive member opening 2434 at an end closest to end surface 2422. In addition, projection 2454 is positioned near a top of slot 2410. Shaft 2456 may extend even further out of opening 2424 beyond the end of shuttle 2420.

[0103] Another embodiment of an needle assembly is shown in FIG. 20.

Needle assembly 3300 includes a carrier 3302, a driver 3320, a shuttle 3340, a gear 3360, and a spring (resilient member) 3370. Driver 3320 may be coupled to a fluid conduit (such as fluid conduit 300 described above) and may be configured to drive a needle at the end of that fluid conduit into the user. Driver 3320 may be similar to driver 320, except that driver 320 may include only one rack gear 3222 that is configured to be driven by gear 3360. Shuttle 3340 may be similar to shuttle 340. except that it may include a first rack 3342 and a second rack 3344. First rack 3342 and second rack 3344 may be longitudinally spaced apart but substantially parallel to one another, and may engage gear 3360 at different times. In some examples, first rack 3342 and second rack 3344 may be configured to engage gear 3360 only at different times. Second rack 3344 may cause gear 3360 to rotate in a first direction (e.g., counter-clockwise) when shuttle 3340 moves in direction 3380 along longitudinal axis 40, while first rack 3342 may cause gear 3360 to move in a second direction opposing the first direction (e.g., clockwise) when shuttle 3340 moves in direction 3380. The rotation of gear 3360 in the first direction may move driver 3320 downward via rack 3222 and urge a needle into the user, and the rotation of gear 3360 in the second direction may move driver 3320 upward to retract the needle out of the user. Expansion of spring 3370, which may be coupled to both carrier 3302 and an inner surface of shuttle 3340 may move shuttle 3340 in direction 3380 to initiate deployment and subsequent retraction of a needle. Additionally, it is contemplated that a stop, similar to stop 240, may be used to impede longitudinal movement of shuttle 3340 when driver 3320 (and an associated needle) are in a deployed configuration. The stop could then be moved out of the path of shuttle 3340 to enable retraction of driver 3320 and its associated needle.

[0104] Yet another embodiment of a needle assembly is shown in FIG. 21. Needle assembly 4000 includes a carrier 4202 and a driver (shown only via protrusion 330). Needle assembly 4000 also may include the following components which are not shown, but which may be substantially similar to components described above by the same name, such as, e.g., a shuttle, deployment and retraction gears, and a spring. The driver of needle assembly 4000 may be coupled to a fluid conduit (such as fluid conduit 300) and may be configured to drive a needle at the end of that fluid conduit into the user. In an undeployed configuration (shown in FIG. 21), protrusion 330 of the driver may be blocked by an impediment 4600. Carrier 4202 may be urged in direction 4002 to enable protrusion 330 to slide down ramp 4602, moving the driver and associated needle from the retracted configuration to a deployed configuration. Carrier 4202 may be urged in direction 4002 by, e.g., translation mechanism 1366 and vial 1302, in a substantially similar manner as set forth above with respect to carrier 202.

[0105] Needle assembly 4000 may include a stop 4240 that is separate from carrier 4202. Stop 4240 may be urged in direction 4004 by a spring 4241. An end of stop 4240 may include an overhang 4242, which may help maintain the driver in the deployed configuration by blocking a retraction path of protrusion 330. Thus, when the driver is deployed, protrusion 330 may be positioned underneath overhang 4242 of stop 4240, preventing retraction of the driver until stop 4240 is moved. Retraction of the driver and needle may be accomplished by, e.g., reversing the motor of translation mechanism 1366, which may, via one or more mechanical linkages (not shown), apply a force against stop 4240 in the direction 4002 to compress spring 4241. The movement of stop 4240 in the direction 4002 may provide clearance for protrusion 330 to move back to the retracted configuration.

[0106] Yet another embodiment of a needle assembly is shown in FIGS. 22 and 23. Needle assembly 5300 includes a carrier 5302. In this embodiment, a stop 5240 may be configured to directly impede rotation of a deployment and/or retraction gear 5360 instead of directly impeding either a shuttle or driver of the needle assembly. In this embodiment, gear 5360 may be coupled to a toggle 5362 via a shaft 5361. Gear 5360 may rotate about axis 5364 to facilitate deployment and/or retraction of an associated driver and/or needle. Toggle 5362 may have a length that extends substantially perpendicular to axis 5364, and also may rotate about axis 5364.

[0107] Stop 5240 may include an opening 5380, through which toggle 5362 may be disposed. Opening 5380 may include a circular portion 5382, and a restricting portion 5384. Circular portion 5382 may have a diameter that is greater than a length of toggle 5362 to enable unimpeded rotation of toggle 5362 (and gear 5360) while toggle 5362 is disposed within circular portion 5382. Stop 5240 may be slidable relative to carrier 5302 by any suitable mechanism. When stop 5240 and carrier 5302 are slid relative to one another, toggle 5362 may slide within restricting portion 5384, which may be sized to restrict rotation of toggle 5362 (and gear 5360). For example, when toggle 5362 is generally rectangular as shown, restricting portion 5384 also may be rectangular. [0108] Notably, reference herein to "one embodiment," or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included, employed and/or incorporated in one, some or all of the embodiments of the present disclosure. The usages or appearances of the phrase "in one embodiment" or "in another embodiment" in the specification are not referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of one or more other embodiments, nor limited to a single exclusive embodiment. The same applies to the terms "implementation," and "example." The present disclosure are neither limited to any single aspect nor embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Moreover, each of the aspects of the present disclosure, and/or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and/or embodiments thereof. For the sake of brevity, certain permutations and combinations are not discussed and/or illustrated separately herein.

[0109] Further, as indicated above, an embodiment or implementation described herein as "exemplary" is not to be construed as preferred or

advantageous, for example, over other embodiments or implementations; rather, it is intended convey or indicate the embodiment or embodiments are example embodiment(s).