Self-injection

Abstract

To provide an injection device.SOLUTION: 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, where 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.SELECTED DRAWING: Figure 4A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit, pursuant to 35 U.S.C. §119(e), of U.S. Provisional Patent Application No. 62 / 502,278, filed May 5, 2017, the entirety of which is incorporated by reference herein.

[0002] The present disclosure is directed to auto-injectors and related methods of use. [Background technology]

[0003] In a variety of available autoinjectors, upon activation by a user, a needle is deployed and fluid is delivered from the needle into the user. After fluid delivery is completed, the needle may be retracted for user comfort, needle safety, and positive product perception. However, many autoinjectors use separate springs or motors for the injection and needle removal steps. Furthermore, such injection assemblies generally require separate user actions for both needle insertion and removal. Summary of the Invention

[0004] In one aspect, the present disclosure is directed to an injection device including a carrier, a needle, a driver coupled to the needle, the driver being slidable relative to the carrier between a stored configuration and a deployed configuration, a shuttle configured to move the driver between the stored configuration and the deployed configuration, and a stop configured to move from a first configuration to a second configuration, the stop configured to maintain the driver in the deployed configuration, and movement of the stop from the first configuration to the second configuration enables the shuttle to move the driver from the deployed configuration to the stored configuration.

[0005] The shuttle is movable from a first position to a second position and from the second position to a third position, and when the shuttle is in the first position, the driver is in a stored configuration, when the shuttle is in the second position, the driver is in a deployed configuration, and when the shuttle is in the third position, the driver is in a stored 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 in only one direction. The injection device also includes a deployment gear coupled to the carrier and a storage gear coupled to the carrier, the driver is coupled to the deployment gear and the storage gear, and the shuttle includes a rack gear configured to engage the deployment gear and the storage gear, and direct engagement of the rack gear with the deployment gear moves the driver from the deployed configuration to the stored configuration, and direct engagement of the rack gear with the storage gear moves the driver from the deployed configuration to the stored configuration. The rack gear is in direct contact with only one of the deployment gear and the storage gear at any one time. The rack gear is configured to drive rotation of the deployment gear in a first direction to move the driver from the stored configuration to the deployed configuration and to drive rotation of the storage gear in a first direction to move the driver from the deployed configuration to the stored configuration. The driver includes a first rack and a second rack, the first rack configured to engage the deployment gear and the second rack configured to engage the storage gear. The first rack and the second rack are located on opposite sides of the driver. The shuttle is configured to move along a first axis and the driver is configured to move along a second axis, the first axis and the second axis being perpendicular to each other. The driver is in contact with the obstacle prior to activation and is prevented from exiting the storage configuration by the obstacle. The injection device also includes a housing enclosing the carrier, the obstacle being integral with the housing. Movement of the carrier relative to the housing moves the driver out of contact with the obstacle and allows the driver to move from the stored configuration to the deployed configuration. The injection device also includes a resilient member coupled to the shuttle, the resilient member configured to expand from the first compressed state to the second compressed state after the driver is moved out of contact with the obstacle 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 the rest state to move the shuttle from the second position to the third position.

[0006] In another aspect, the present disclosure is directed to an injection device including a carrier including a stopper having 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 stored configuration and a deployed configuration, and a shuttle including a rack gear configured to drive rotation of the first gear, wherein rotation of the first gear moves the driver from the stored configuration to the deployed configuration, and the free second end of the stopper is configured to at least temporarily prevent movement of the shuttle while the driver is in the deployed configuration.

[0007] The injection device further includes a second gear coupled to the carrier, such that bending of the stop around the fixed first end thereof while the free second end is in contact with the shuttle causes the shuttle to slide relative to the stop and drives rotation of the second gear, which moves the driver from the deployed configuration to the stored configuration.

[0008] In another aspect, the present disclosure is directed to an injection device including a needle movable between a stored 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 placed in contact with a user, and after receiving the indication, to send a signal to the motor to drive the piston in a first direction to place the needle and the vial in fluid communication and move the needle from the stored configuration to the deployed configuration, without requiring any intervention by a user after receiving the indication, and after sending the signal to drive the motor in the first direction, to automatically send a signal to the motor to drive the piston in a second direction to move the needle from the deployed configuration to the stored configuration.

[0009] The injection device further includes a housing enclosing the vial, piston, motor, controller, and needle when the needle is in the retracted configuration, and the needle is withdrawn from within the housing in the deployed configuration. The injection device may include a cover or shield including a distalmost portion of the needle in the retracted configuration. The injection device may include an audio module, a visual module, and a tactile module, each of the modules coupled to the controller and configured to provide feedback to a user of the injection device. The injection device may include a top portion sealing an opening of the vial, the top portion including a portion including a rubber material permeable to a sterilant, and the needle including a proxialmost portion configured to couple with the vial, and the proxialmost portion of the needle is disposed within the portion formed from the rubber material before the needle and the vial are in fluid communication with each other. The injection device may include a cantilever coupled to the controller and movable with the needle, where when the needle is in the retracted configuration the cantilever forms part of an open circuit that signals 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 the controller that the needle is in the deployed configuration.

[0010] 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. Aspects of the present disclosure may be implemented in conjunction with the embodiments illustrated in the accompanying drawings, which illustrate different aspects of the disclosure, and where appropriate, reference numerals designating similar structures, components, materials, and / or elements in different figures are similarly named, and it is understood that various combinations of structures, components, and / or elements other than those explicitly shown are contemplated and within the scope of the present disclosure.

[0011] Moreover, there are many embodiments described and illustrated herein. The present disclosure is not limited to any single aspect or embodiment thereof, or to any combination and / or permutation of such aspects and / or embodiments. Moreover, each of the aspects and / or embodiments of the present disclosure may be utilized alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For simplicity, certain permutations and combinations are not separately described and / or illustrated herein. In particular, an embodiment or implementation described herein as "exemplary" should not be construed as preferred or advantageous over, for example, other embodiments or implementations. Rather, it is intended to reflect or show that the embodiment(s) are "example" embodiment(s). [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a perspective view of an autoinjector according to an example of the present disclosure. [Diagram 2] FIG. 2 is a bottom view of the autoinjector of FIG. 1. [Diagram 3] 2 is a side view of the autoinjector of FIG. 1 showing the activation switch pulled away from the tissue-facing surface. [Figure 4] FIG. 2 is an exploded view of the autoinjector of FIG. 1. [Figure 4A] FIG. 2 is a schematic diagram of a control system for the autoinjector of FIG. 1. [Figure 4B] FIG. 1 is an exploded view of an autoinjector according to the present disclosure. [Figure 4C] FIG. 2 is a perspective view of a portion of a housing and an electronic board according to an aspect of the present disclosure. [Diagram 5] FIG. 13 is an exploded view of the needle mechanism. [Figure 6] FIG. 6 is a perspective view of the needle mechanism of FIG. 5 in a first position. [Figure 7] FIG. 6 is a side view of the needle mechanism of FIG. [Figure 8] FIG. 6 is a side view of the needle mechanism of FIG. [Figure 9] FIG. 6 is a side view of the needle mechanism of FIG. [Figure 10]FIG. 6 is a side view of the needle mechanism of FIG. [Figure 11] FIG. 6 is a side view of the needle mechanism of FIG. [Figure 12] FIG. 2 is a side cross-sectional view of a portion of the autoinjector of FIG. 1. [Figure 13] FIG. 2 is a side cross-sectional view of the drilling mechanism. [Figure 14] FIG. 2 is a side cross-sectional view of the drilling mechanism. [Figure 14A] FIG. 13 is a cross-sectional view of a cap used in an alternative piercing mechanism. [Figure 15] FIG. 13 is a side view of the needle insertion switch. [Figure 16] 1 is a flow chart of an exemplary method according to the present disclosure. [Figure 17] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 18] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 19] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 20] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 21] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 22] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 23] 13 illustrates a needle mechanism according to another example of the present disclosure. [Figure 24] FIG. 2 is a cross-sectional view of the autoinjector and needle shield of FIG. [Diagram 25] FIG. 25 is an enlarged view of a portion of FIG. 24. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Again, there are many embodiments described and illustrated herein. The present disclosure is not limited to any single aspect or embodiment thereof, or to any combination and / or permutation of such aspects and / or embodiments. Each of the aspects of the present disclosure, and / or its embodiments, may be utilized alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For simplicity, many of these combinations and permutations are not separately described herein.

[0014] In particular, for simplicity and clarity of explanation, certain aspects of the figures show the general structure and / or method 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, and dimensions of some features may be exaggerated relative to other elements to enhance understanding of example embodiments. For example, those skilled in the art will appreciate that cross-sectional views are not drawn to scale and should not be viewed as depicting proportional relationships between different components. Cross-sectional views are provided to help illustrate various components of the depicted assemblies and to show their relative placement with respect to one another.

[0015] 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 following description, relative terms such as "about," "substantially," "approximately," etc. are used to indicate a possible variation of ±10% from the numerical values ​​set forth.

[0016] As discussed above, existing autoinjectors often require multiple user interventions to self-administer a drug, including, for example, separate user interventions to deploy the needle and then retract the needle after drug delivery. These additional steps increase the complexity of self-administration of the drug, may introduce user error, and may cause user discomfort. Accordingly, the present disclosure is directed to various embodiments of an injection device (e.g., an autoinjector) that simplifies a user's self-administration of a drug or other therapeutic agent. Specifically, according to certain embodiments, an autoinjector may not require additional user intervention to withdraw the needle once it has been subcutaneously inserted into the user. Thus, the autoinjector of the present disclosure is simplified to help prevent misuse or user error. Overall System Examples of such autoinjectors 2 are shown in Figures 1-4. The autoinjector 2 may include a housing 3 having a tissue-engaging (bottom) surface 4 through which the needle may be deployed and retracted via an opening 6 (Figure 2). An activation switch 1409 (Figure 2) may be disposed on the tissue-engaging surface 4 and may be configured to activate the autoinjector 2 or otherwise place the autoinjector 2 in a "ready" mode. A touch sensor 1410 (Figure 2) may also be disposed on the tissue-engaging surface 4 and may be configured to help a controller of the autoinjector 2 determine whether the autoinjector 2 is placed on the user's skin (indicating that the autoinjector should fire or otherwise deploy the needle) or whether the activation switch 1409 has been properly triggered (indicating that operation of the autoinjector 2 should be stopped). The activation switch 1409 and the touch sensor 1410 are described in more detail below with respect to Figure 4A. A connection port 13 may also be disposed on the tissue-engaging surface 4 to facilitate programming of the autoinjector 2. The housing 3 may include a transparent window 50 to allow a viewer to visualize one or more displays or LEDs 52 (see FIG. 4B) disposed within the housing 3, and may include a number of openings 51 configured to facilitate the movement of sound generated within the housing 3 (e.g., by a speaker). The LEDs 52 may be arranged in an annular configuration or other suitable configuration. The autoinjector 2 may have any suitable dimensions suitable for allowing portability and self-attachment by a user. In one example, the autoinjector 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 ​​may also be utilized, including, for example, a length of about 0.5 inches to about 5.0 inches, a width of about 0.5 inches to about 3.0 inches, and a height of 0.5 inches to about 2.0 inches.

[0017] The autoinjector 2 may be oriented about a longitudinal axis 40 (e.g., X-axis), a lateral axis 42 (e.g., Y-axis) that is substantially perpendicular to the longitudinal axis 40, and a vertical axis 44 (e.g., Z-axis) that is substantially perpendicular to both the longitudinal axis 40 and the lateral axis 42.

[0018] An adhesive patch 12 may be coupled to the tissue-engaging surface 4 to help secure the autoinjector 2 to the user's body (e.g., skin). The adhesive patch 12 may be formed from a fabric or other suitable material and may include an adhesive. The adhesive may be a water-based or solvent-based adhesive, or may be, for example, a hot melt adhesive. Suitable adhesives also include natural and synthetic elastomers, as well as acrylic, dextrin, and urethane-based adhesives. In some examples, the adhesive provided on the patch 12 may be activated upon contact with the user's skin. In yet another example, the patch 12 may include a non-woven polyester substrate and an acrylic or silicone adhesive. The patch 12 may be bonded to the housing 3 by, for example, a double-sided adhesive or by other mechanisms such as ultrasonic welding. The patch 12 may have a length dimension that is greater than the width of the autoinjector 2.

[0019] needle mechanism 5-11, 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 may also include a fluid conduit 300 that is attached to carrier 202 and deployed into a user and retracted by driver 320. Shuttle 340 (e.g., shuttle actuator) may be configured to move driver 320 via deployment gear 360 and retraction gear 362. Shuttle 340 may be coupled to a resilient member (e.g., spring 370). A cover 380 (FIG. 5) may be coupled to carrier 202 to enclose various components of needle mechanism 20.

[0020] 5, the fluid conduit 300 may extend from a first end 302 to a second end 304. The first end 302 may include a needle 306 configured to be injected into a user. The needle 306 may include a sharp and / or angled tip and may extend generally along or parallel to the axis 44. The second end 304 may include a needle 308 substantially similar to the needle 306, but may be positioned within the autoinjector 2 to penetrate a vial 1302 (shown in FIG. 13 and described in more detail below) and access a medication to be injected into the user. The fluid conduit 300 may include an intermediate portion 310 including a first portion extending along or parallel to the axis 40 and a second portion along or parallel to the axis 40. The first and second portions of the middle section 310 may be joined with a coil 312 that facilitates bending of the fluid conduit 300 and movement along the axis 44 of the needle 306 during deployment and retraction into and out of the user. Although the coil 312 is shown, other suitable shapes that allow bending of the fluid conduit 300 are contemplated, such as, for example, serpentine, curvilinear, or other shapes. The coil 312, or a similar structure, may act as a cantilever when the needle 306 is deployed and / or retracted. The coil 312 may also bias the fluid conduit 300 into the deployed configuration shown in FIG. 5. Once the needle 308 penetrates the vial 1302 and establishes fluid communication with the vial 1302 (see, e.g., FIG. 14), the drug may move from the vial 1302, through the needle 308, the middle section 310, and the needle 306 (which is pierced through the user's skin) and into the user. In some examples, the fluid conduit 300 may comprise only metal or a metal alloy. In other examples, the fluid conduit 300 may comprise any other suitable material, such as, for example, a polymer. The needle 308 and intermediate section 310 may define a thin-walled needle, such as a 22 gauge or 23 gauge, while the needle 306 may be a 27 gauge needle. Other needle sizes, ranging from, for example, 6 gauge to 34 gauge, may also be utilized as desired. The fluid conduit 300 reduces the amount of material that comes into contact with the drug, reduces joints and assembly steps, and may require less sterilization than conventional devices.

[0021] The carrier 202 may be formed from plastic (e.g., injection molded plastic), metal, metal alloy, etc., and may include a flange 204 having an opening 206 and posts 210 and 212. The carrier 202 may also include an opening 216 through which a needle or other fluid conduit may be deployed. The opening 216 may be a slot recessed from an end face of the carrier 202, or in an alternative embodiment, the entire periphery of the opening 216 may be defined by the material of the carrier 202. The carrier 202 also includes a driver passage 218. The driver passage 218 may be a slot in the carrier 202 that extends along or parallel to the axis 44. The driver passage 218 may be configured to receive a protrusion of a driver 320, such as, for example, a protrusion 330, described in more detail below. The carrier 202 may also include a shuttle passage 220 along which a shuttle 340 may travel, as described in more detail below.

[0022] The carrier 202 may include a stop 240 configured to engage the shuttle 340. The stop 240 may be a cantilever having a fixed end 241 (FIG. 8) and a free end 242 (FIG. 8). The stop 240 may include an angled ramp 243 (FIGS. 9 and 12) that, when engaged or pushed by a ramp 1500 (described with reference to FIG. 12), causes the stop 240 to deflect about the fixed end 241. In a first position, the free end 242 may block or otherwise impede movement of the shuttle 340, and in a second configuration, may allow movement of the shuttle 340. The relationship of the stop 240 to the shuttle 340 is described in more detail below in this application.

[0023] The driver 320 includes two (shown in FIG. 8 ) racks 322 and 324 parallel to one another and disposed on opposite sides of the driver 320. The racks 322 and 324 may include teeth and may be configured to engage and drive the rotation of the deployment gear 360 and the storage gear 362, respectively. The driver 320 may include a lumen 326 (i.e., a track, recess, or other suitable structure) ( FIG. 5 ) configured to receive the needle 306 of the fluid conduit 300. The driver 320 may also include a protrusion 330 ( FIGS. 6 and 7 ) configured to slide within the driver channel 218 of the carrier 202. The protrusion 330 may include a hook-like configuration that can “catch” an obstruction 600, as described in more detail below.

[0024] 5, shuttle 340 may include a rack 342 configured to engage gears 360 and 362. Shuttle 340 may also include an end face 344 and a recess 346 extending along the 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 center of recess 346 or may extend along the entirety or substantially the entirety of recess 346.

[0025] The shuttle 340 may move along the 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 the shuttle 340 moves along the track 220, the rack 342 may first engage the deployment gear 360 and then engage the storage gear 362. At a particular time, the rack 342 engages at most one of the deployment gear 360 and the storage gear 362 at any one time. In some instances, such as when the rack 342 is longitudinally disposed between the deployment gear 360 and the storage gear 362, the rack 342 is not engaged with either the deployment gear 360 or the storage gear 362. The shuttle 340 may be configured to move only along one axis (e.g., axis 40) and in only one direction along the one axis. The force required to move the shuttle 340 along the track 220 may be provided by the expansion of the spring 370. The spring 370 may be compressed from a rest state, and the expansion of the spring 370 may move the shuttle 340 along the track 220 through the series of positions / configurations described above. At various positions of the shuttle 340, different features of the autoinjector 2 may directly or indirectly block movement of the shuttle 340.

[0026] The first position of the shuttle 340 shown in FIG. 8 may correspond to an unused, undeployed, and / or new state of the autoinjector 2. In this first position, the driver 320 may be in an undeployed state. The shuttle 340 is maintained in the first position by the placement of an obstacle 600 in the path of the driver 320 (FIG. 6). The obstacle 600, which may be a shelf of the housing 3 or another suitable blocking device, may impede the movement of the driver 320 by engaging and / or holding the protrusion 330. Thus, since the driver 320, the deployment gear 360, and the rack 342 are coupled to each other, blocking of the driver 320 also impedes the movement of the shuttle 340. The shuttle 340 may be moved from the first position to the second position by moving the obstacle 600 relative to the carrier 202 (or vice versa). In one example, the carrier 202 is moved (e.g., to the left in FIG. 6) while the obstacle 600 remains stationary.

[0027] When the path of the driver 320 does not include an obstacle 600 (FIG. 7), the spring 370 may expand, moving the shuttle 340 along the track 220. This linear movement of the shuttle 340 may rotate the deployment gear 360 counterclockwise (or clockwise in other examples) via the rack 342, and the rotation of the deployment gear 360 may move the driver 320 downward along the axis 44 via the rack 322 of the driver 320. This downward movement of the driver 320 causes the needle 306 to pierce the user's skin. In some examples, the driver 320 may be configured to move relative to the carrier 202 only along the axis 44.

[0028] The shuttle 340 may be moved by extension of the spring 370 until its end face 344 abuts the free end of the stop 240 such that the shuttle 340 is maintained in the second position shown in FIGS. 9 and 10. At this point, the free end 242 may prevent further extension of the spring 370 and further movement of the shuttle 340 along the track 220. In this second position, the fluid conduit 300 may be deployed in the user and fluid from the vial 1302 may be injected into the user through the needle 306. Additionally, while the shuttle 340 is in the second position, the rack 342 may be engaged with the deployment gear 360 to maintain the needle 306 in the deployed configuration. The shuttle 340 may be moved from the second position to the third position by bending of the stop 240 about its fixed end 241. This bending is described in further detail below with respect to FIGS. 12-14. The bending of stop 240 may allow spring 370 to continue to extend, 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.

[0029] Movement of the shuttle 340 from the second position to the third position may correspond to retraction of the needle 306 from the user into the housing 3. In particular, the rack 342 may engage the storage gear 362 and rotate the storage gear 362 in the same direction (e.g., counterclockwise or clockwise) as the deployment gear 360 is rotated. Rotation of the storage gear 362 may urge the driver 320 back to the retracted position via the rack 324. The shuttle 340 may reach the third position, in which the driver 320 is fully retracted, when its end face 344 engages a wall of the carrier 202, when the free end 242 of the stop 240 reaches the end of the recess 346, and / or when the spring 370 reaches a rest state.

[0030] In some embodiments, when the driver 320 retracts from the deployed state to the stored state, the driver 320 may be prevented from emerging from the stored state. As a result, the needle 306 is prevented from redeploying into the user. In this configuration, the autoinjector 2 may be a disposable device (e.g., discarded after one completed injection). In other embodiments, the autoinjector 2 may be reset and reused. Additionally, the deployment gear 360 and storage gear 362 may be simply rotating gears disposed within the autoinjector 2 in some examples. Piercing system and sterile connector 13 and 14 illustrate features of a piercing system 1300 of the autoinjector 2. Additional details of an exemplary piercing system may be found in U.S. Patent Application Publication No. 2016 / 0262984 A1 to Arnott et al., published Sep. 15, 2016, which is incorporated by reference in its entirety. The piercing system 1300 includes a primary container, chamber, syringe, cartridge, or vial 1302 having a first end 1304 and a second end 1306. The vial 1302 may also include a cavity 1308 that is open at the first end 1304 and extends toward the second end 1306. The second end 1306 may include a neck 1310 having a cap 1312 that engages the neck 1310 to close the second end 1306. A septum 1314 may be disposed between the vial 1302 and the cap 1312 to help close the second end 1306 and allow a needle 308 (e.g., a stapled needle) to be inserted into the vial 1302. The cavity 1308 may be closed at the first end 1304 by a piston 1316.

[0031] The vial 1302 may have a capacity of 5 mL in some examples, although any other suitable volume (e.g., 1 mL to 50 mL, or 2 mL to 10 mL, or 3 mL to 6 mL, or 2 mL to 5 mL, or another suitable range) may also be utilized depending on the drug to be delivered. In other examples, the vial 1302 may have a capacity of 1 mL or more, or 2 mL or more, or 3 mL or more, or 4 mL or more, or 5 mL or more. The vial 1302 may contain and store the drug for injection into the user and may help maintain the sterility of the drug. The vial 1302 may have a neck with a diameter of 13 mm, a length of 45 mm, and an inner diameter of 19.05 mm. These values ​​are merely exemplary and other suitable dimensions may be utilized as needed. In some examples, the vial 1302 may be formed using conventional materials and may be shorter than existing devices, which may help the autoinjector 2 remain cost-effective and compact. The vial 1302 may be a shortened ISO 10 mL cartridge.

[0032] Septum 1314 may comprise an uncoated bromobutyl material, or another suitable material. Piston 1316 may comprise a fluoropolymer coated bromobutyl material and may include a conical tip 1316a to help reduce dead volume in vial 1302. Piston 1316 may comprise one or more rubber materials, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile, among other materials.

[0033] The piercing system 1300 may also include a top 1354 disposed at the second end 1306. The top 1354 may include a base 1355 disposed over the septum 1314 and the opening of the vial 1302. The top 1354 may include a chamber 1356 extending from the base 1355 in a direction away from the piston 1316. The chamber 1356 defines a cavity 1357 and includes an opening 1358 in communication with the cavity 1357. In some embodiments, the top 1354 may be integral with the septum 1314 (e.g., one-piece or one-piece structure). In alternative embodiments (not shown), the top 1354 may be provided on the fluid conduit 300 or may be initially assembled on the fluid conduit 300 and placed directly on / with the vial 1302 and / or may not be integral with the septum 1314.

[0034] A portion of the fluid conduit 300, such as needle 308, tubing, etc., may extend through an opening 1358 in the chamber 1356 and into the cavity 1357, rather than through the base 1355 in a pre-activated state. The opening 1358 may be pre-formed or may be formed by the penetration of the needle 308 through the chamber 1356. The opening 1358 in the chamber 1356 may form a sterile sliding seal around the needle 308 such that pathogens or other contaminants are prevented from migrating into the cavity 1357. The needle 308 can move relative to the top 1354 without breaking the sterile seal therebetween. The cavity 1357 may be sterile or aseptic such that the inner surface of the cavity 1357 and the needle 308 are sterile. In another embodiment, the cavity 1357 may be sterilized after the needle 308 is inserted through the opening 1358 and into the cavity 1357. In an alternative embodiment, rather than top 1354, a convoluted flexible (e.g., rubber) bellows or bladder member may form cavity 1357 to allow translation of vial 1302 relative to needle 308 (or vice versa). The flexible member may also seal or form cavity 1354 around needle 308 after sterilization.

[0035] In an alternative embodiment shown in FIG. 14A, a top 1354a may be used with the piercing system 1300 in place of the top 1354. The top 1354a may include a stopper 1356a and a base 1355a disposed over the opening of the vial 1302. The stopper 1356a may extend from the base 1355a in a direction away from the piston 1316. In a pre-activated state, the needle 308 may be disposed in the stopper 1356a. The stopper 1356a may be formed of a solid stopper that may be formed from a first rubber material, voiding any holes, cavities, or openings. The first rubber material may be permeable to sterilizing gases, such as ethylene oxide or vaporized hydrogen peroxide. The first rubber material may include one or more of isoprene, ethylene propylene diene monomer (M class) rubber (EPDM), and styrene butadiene, among others. The permeability of the first rubber material to sterilizing gas may allow the needle 308, which is disposed in the stopper 1356a, to be sterilized prior to use. The stopper 1356a may be molded around the needle 308, such that the needle 308 is inserted into the stopper 1356a. The impermeability of the base 1355a to sterilizing gas may prevent contamination and / or alteration of the drug contained in the vial 1302. The base 1355a may include an impermeable rubber, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile, among others.

[0036] The piston 1316 may be coupled to a translation mechanism 1366 configured to translate the piston 1316 and the vial 1302 in a direction toward the second end 1306. Movement of the piston 1316 toward the second end 1306 causes the piston 1316 to act against the contents (e.g., drug, medication) in the vial 1302, which ultimately transmits a force to the second end 1306 of the vial 1302, moving the vial 1302 along the longitudinal axis 40. The translation mechanism 1366 may include a 12 mm motor with a 5-stage gear reduction (360:1). The translation mechanism 1366 may have spring contacts that create an electrical connection with an associated printed circuit board (e.g., the first electronic board 1402). The motor may be configured to create a torque of approximately 136 mN*m at 36 rpm. These design parameters of the motor are merely exemplary and any other suitable motor may be utilized.

[0037] The translation mechanism 1366 may include a lead screw mechanism coupled to the piston 1316 that extends along the axis upon relative rotation about the longitudinal axis 40. The telescopic lead screw may have a 7° / 45° buttress thread profile with 100 N power, 20 mm stroke, and 0.75 mm pitch. Materials for the lead screw mechanism may include acetal and polybutylene terephthalate. The lead screw mechanism may extend into the piston 1316 to reduce dead space behind the piston 1316. Although the 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), the translation mechanism 1366 may include a manually engageable surface or member that is manually operated by a user to move the piston 1316. For example, the drilling system 1300 may include a cartridge or plunger coupled to the back of the piston 1316. In another exemplary embodiment (not shown), the translation mechanism 1366 may include a pneumatic or hydraulic drive member that is actuated or initiated by a user to move the piston 1316. The drive member may take the form of, for example, an expanding bellows, an expanding bladder, an expanding diaphragm, or a sliding seal or piston. Direct pneumatic or hydraulic pressure may provide the force needed to move the piston 1316.

[0038] The drilling system 1300 also includes a collar 1390 coupled or secured to the second end 1306. The collar 1390 may include a plurality of circumferentially spaced fingers 1392 that engage and circumscribe the neck 1310. The collar 1390 may be fixed or otherwise coupled to the second end 1306. The collar 1390 may include a wall 1390a that extends at least partially around the neck 1310, the opening in the second end 1306, the cap 1312, the septum 1314, and / or the top 1354. The wall 1390a of the collar 1390 may be disposed radially or laterally outward from the neck 1310 and extend longitudinally past the neck 1310, the cap 1312, and the septum 1314.

[0039] 13, an edge 1393 of the collar 1390 may engage a corresponding radially or laterally inwardly extending cam, latch, or actuating portion 1394 of a driver retainer member 1395. The retainer member 1395 may be slidable relative to the collar 1390. The collar 1390 and retainer member 1395 are in the pre-actuated state or arrangement shown in FIG. 13 such that at least a portion of the cam or actuating portion 1394 of the retainer member 1395 is positioned immediately rearward of a retaining portion 1399 of a driver 1398 that is slidable within the retainer member 1395. A wall 1391 of the driver 1398 may extend into and through an end cap portion 1396 of the retainer member 1395 as well as into the interior of the retainer member 1395, and a retaining portion 1399 of the driver 1398 may extend radially outward from the wall 1391. In some embodiments, the wall 1391 of the driver 1398 may be substantially cylindrical and the retaining portion 1399 of the driver 1398 may be a flange extending around an end of the wall 1391.

[0040] In a pre-activated state of the piercing system 1300, an elastically deformed biasing member or resilient member 1397 may be disposed between a cap portion 1396 of the retainer member 1395 and a retaining portion 1399 of the driver 1398. The biasing member 1397 may exert a force on the driver 1398 in the pre-activated state of the piercing system 1300 acting in a direction toward the vial 1302. The biasing member 1397 may be any member effective in applying a force in the pre-activated state and then releasing said force upon activation, as described below with respect to FIG. 14. In some embodiments, the biasing member 1397 may be a conical or flat spring.

[0041] The needle 308 of the fluid conduit 300 may be fixed or coupled to the driver 1398 such that the fluid conduit 300 moves with the driver 1398. In a pre-activated state of the piercing system 1300, the needle 308 may be positioned in the base 1355 of the top 1354, in the sterile cavity 1357, and / or in the cavity 1308 of the vial 1302, but not through the septum 1314.

[0042] To move the piercing system 1300 from the pre-activated state of FIG. 13, the translation mechanism 1366 may be activated to move the piston 1316 towards the second end 1306 and translate the vial 1302 along the longitudinal axis 40 towards the driver 1398. Because the needle 308 is not yet in fluid communication with the vial 1302, activation of the translation mechanism 1366 applies pressure to the fluid contained in the vial 1302 which is then applied to the vial 1302 itself. This pressure also causes the edge 1393 to push against the actuation portion 1394, deflecting the actuation portion 1394 radially outward. Without the actuation portion 1394 blocking its path, the retention portion 1399 and needle 308 are moved towards the vial 1302 by the extension of the biasing member 1397. The driver 1398 may be coupled to the flange 204 of the carrier 202, such that this movement of the driver 1398 towards the vial 1302 may also move the carrier 202 in the same direction, which corresponds to the movement of the carrier 202 relative to the housing 3 in Figures 6 and 7, which allows the protrusion 330 to clear the obstruction 600 and inject the needle 306.

[0043] Movement of the needle 308 toward the second end 1306 of the vial 1302 also causes the needle 308 to pierce through the base 1355 of the top 1354, the septum 1314, and the cavity 1308, placing it in fluid communication with the contents of the vial 1302. Once the needle 308 is in fluid communication with the vial 1302, additional movement of the piston 1316 toward the second end 1306 drives fluid through the needle 308 and the remainder of the fluid conduit 300. In some embodiments, the piercing system 1300 may be configured such that, after activation, less of the needle 308 extends into the cavity 1308 than the portion already disposed in the sterile cavity 1357. This may help to prevent contamination of the contents of the vial 1302 with non-sterile portions of the needle 308.

[0044] The biasing member 1397 may be configured to extend such that the fluid conduit 300 pierces the top 1354 and / or septum 1314 at a high rate, such as at a rate of at least about 10 mm / sec, or at least about 40 mm / sec. The relatively rapid piercing of the top 1354 and / or septum 1314 via the biasing member 1397 may help to prevent leakage of the contents of the cavity 1308, which may be pressurized via the piston 1316.

[0045] After the drug is delivered to the user through the needle 306, the needle 306 may be automatically withdrawn from the user. With reference to FIGS. 12-14, the translation mechanism 1366 may be operated in a reverse mode such that the rotation of the lead screw is in the opposite direction compared to the insertion step. This counter rotation may cause the piston 316 to move back towards the first end 1304 and move the vial 1302 in the opposite direction along the axis 40 (compared to during fluid delivery and insertion of the needle 306). The movement of the vial 1302 in the opposite direction may cause the ramp 1500 of FIG. 12 (attached to the wall 1391) to push against the ramp 243 of the stop 240. This may cause the stop 240 to deflect around its fixed end 241 in the direction of the arrow 240a and the shuttle 340 to move from its second position to its third position to retract the needle 306 as described above. In this manner, needle withdrawal and insertion into the patient can both be accomplished with a single spring within the device.

[0046] It is further contemplated that the fluid conduit 300 may be the only fluid conduit of the autoinjector 2 configured to be in fluid communication with the vial 1302. Thus, medication from the vial 1302 may be deployed only through the fluid conduit 300 and into a user during normal operation of the autoinjector 2. Furthermore, the needle 306 may be the only needle of the autoinjector 2 configured to be deployed into a patient. In this manner, a single piece of metal or plastic may be used to transport fluid from the vial 1302 to the patient. Sterile Needle Shield 24 and 25, the autoinjector 2 may include a needle cover or needle shield 2400 configured to help maintain sterility of the needle 306. The needle shield 2400 may extend from a first end 2402 to a second end 2404. A flange 2406 may be disposed at the first end 2402 and a tubular extension 2408 may extend the flange 2406 towards the second end 2404. The needle shield 2400 may include an opening 2410 through the flange 2406 that may communicate with a lumen 2412 extending through the extension 2408. A seal 2414 may be disposed at the second end 2404 within the lumen 2412. The seal 2414 may define an opening 2416 in communication with the remainder of the lumen 2412. The seal 2414 may include a narrowed portion 2414a, a middle portion 2414b, and an inner sealing portion 2414c. The middle portion 2414b may be disposed between the narrowed portion 2414a and the inner sealing portion 2414c, and of the three components, the narrowed portion 2414a may be disposed closest to the second end 2404. The middle portion 2414b may have a larger inner diameter than the narrowed portion 2414a, which may have a larger inner diameter than the inner sealing zone 2414c. The needle shield 2400 may also include a membrane 2418 covering the opening 2410 in the flange 2406. The membrane 2418 may be formed from a liquid-tight, gas-permeable material, such as, for example, a high density polyethylene fiber membrane. In one example, the membrane 2418 may be a Tyvek® brand material. The membrane 2418 may help keep the seal 2414 sterile so that it does not contaminate the needle 306 when the needle shield 2400 is separated from the housing 3 .

[0047] The flange 2406 and extension 2408 may be formed from a plastic or other suitable material, while the seal 2414 is formed from a rubber material. Also, in another embodiment, the flange 2406 and extension 2408 may be formed from rubber. The rubber material may be substantially similar to the material forming the plug 1356a described above. For example, the rubber material forming the flange 2406, extension 2408, and seal 2414 may be permeable to a sterilant or germicidal gas, such as, for example, 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 elastomer (TPE), among others. In one embodiment, when the flange 2406 is formed from a rubber material that is permeable to a sterilant, the flange 2406 may not include an opening 2410, and may instead be a solid plug of material.

[0048] The needle shield 2400 may be coupled to the autoinjector 2 prior to use, for example during shipping of the autoinjector 2, to maintain sterility of the needle 306. During this coupling, the needle 306 may pierce the inner sealing portion 2414c of the seal 2414, which causes the seal 2414 to form a seal around the needle 306. That is, the inner sealing portion 2414c may be an initially closed, pierceable membrane. Alternatively, the inner sealing portion 2414c may be a constricted portion having a smaller inner diameter than the constricted portion 2414a, and the needle 306 may slide through this smaller constricted portion. The perforated portion of the seal 2414 (the inner sealing portion 2414c) may be relatively thin, such that the perforated portion does not significantly dull the needle 306. The constricted portion 2414a may engage a portion of the middle portion 310 of the conduit 300 and form a seal around the portion of the middle portion 310. The intermediate portion 310 may have an outer diameter that is greater than the outer diameter of the needle 306. Additionally, a volume or gap 2414d may be formed between the inner diameter of the intermediate portion 2414b and the outer diameter of the intermediate portion 310.

[0049] The autoinjector 2 may be sterilized via exposure to a sterilizing gas (e.g., ethylene oxide) after the needle shield 2400 is coupled to the autoinjector 2. Both the lumen 2412 and the gap 2414d, the surfaces defining the lumen 2412 and the gap 2414d, and the components contained therein (e.g., the exposed portion of the needle 306 that pierces the patient / user's tissue) may be sterilized after exposure to the sterilizing gas. The user may be instructed to manually remove the needle shield 2400, for example, by pulling the needle shield 2400 away from the housing 3. In another embodiment, the needle shield 2400 may be integrated with the packaging material of the autoinjector 2, such that the needle shield 2400 is removed from the autoinjector 2 when the autoinjector 2 is removed from the packaging material. For example, the flange 2406 may be secured to the packaging material (not shown) by an adhesive. When the user then withdraws the autoinjector 2 from the packaging material, the needle shield 2400 detaches from the housing 3, which allows the needle 306 to freely deploy during normal operation of the autoinjector 2. In some cases, the exposed portions of the seal 2414 closer to the second end 2404 than the constricted portion 2414a (and / or the constricted portion 2414a itself) may become contaminated after sterilization. It may therefore be important that these contaminated surfaces do not come into contact with the needle 306 during withdrawal of the shield 2400 from the autoinjector 2. The narrower inner diameter of the inner seal portion 2414c helps ensure that these potentially contaminated portions do not come into contact with the needle 306, particularly those portions of the needle 306 that are inserted into the patient / user's tissue, by keeping the extension 2408 of the shield 2400 centered upon removal.

[0050] In an alternative embodiment, the seal 2414 may be directly coupled to the driver 320. In this embodiment, the seal 2414 may seal against the plastic or other portions of the extension 2408 and will remain within the autoinjector 2 when the needle shield 2400 is removed. electronic equipment 4A illustrates a control system 1400 of the autoinjector 2. The control system 1400 may include components disposed on a first electronic board 1402 and a second electronic board 1404, and may include a power source 1406. The first electronic board 1402 may include a controller 1408, an activation switch 1409, a touch sensor 1410, a needle insertion switch 1412, and an emitter 1414. The second electronic board 1404 may include a detector 1416, an audio module 1418, a vision module 1420, and a tactile module 1422. One or more of the components of the first electronic board 1402 and the second electronic board 1404 may be operably coupled to the controller 1408 and may be powered by the power source 1406. The controller 1408 may also be operatively coupled to the translation mechanism 1366 and configured to control operation of the translation mechanism 1366 to initiate and control needle insertion and retraction, as described above. The translation mechanism 1366 may be coupled to the first electronic board 1404 via one or more spring contacts during the final assembly step in which the vial 1302 is inserted into the housing 3.

[0051] Most of the assembly of the autoinjector 2 may occur, for example, on an assembly line at a manufacturing facility. The two halves (or portions) of the device may then be shipped to a drug filling facility or a final assembly facility. In fact, the two separate portions 1490 and 1492 do not have to be the same size as shown in FIG. 4B. For example, once a drug vial, such as vial 1302, is filled with a drug or other agent, the vial 1302 may be assembled with the rest of the autoinjector 2. For example, the two halves of the device (portions 1490 and 1492) may be assembled with the filled drug vial 1302 therein. In one example, portion 1490 and translation mechanism 1366 may be snapped into place behind the vial 1302. Portion 1490 may be part of a housing 3 that includes a base or module configured to include the translation mechanism 1366 and its associated electronics. The portion 1492 may be a portion of the housing 3 that includes substantially all of the other components described herein, including, for example, the needle mechanism, sterile connector, and piercing mechanism described herein. In this example, the electrical connection of the motor of the translation mechanism 1366 must be made while the translation mechanism 1366 is snapped onto the back of the vial 1302 (i.e., during the assembly step where the portions 1490 and 1492 and the vial 1302 are combined to form a complete and functional autoinjector 2). To accommodate such electrical connection, the drive train of the translation mechanism 1366 may include one or more spring contacts 1494 (see FIG. 4C ), which upon assembly contact pads 1495 (also see FIG. 4C ) on the first electronic board 1402. Thus, the connection of the translation mechanism 1366 to the first electronic board 1402 (including the controller 1408) may be made without any loose wires or other similar structures.

[0052] Such an assembly process may be relatively simpler than simpler devices (e.g., autoinjectors) with relatively more complicated final assembly processes. As a result, the contemplated assembly processes described herein may result in reduced labor costs.

[0053] The controller 1408 may be configured to accept information from the systems and system components described above and process the information according to various algorithms to generate control signals for controlling the translation mechanism 1366. The processor may accept information from the systems and system components, process the information according to various algorithms, and generate information signals that may be directed to an audio module 1418, a visual module 1420, a tactile module 1422, or other indicators, for example, on the second electronic board 1404, to inform a user of system status, component status, procedure status, or any other useful information being monitored by the system. The processor may be a digital IC processor, an analog processor, or any other suitable logic or control system implementing the control algorithms.

[0054] As described above with respect to FIGS. 2 and 3, the activation switch 1409 may be a mechanical plunger type switch that extends away from the tissue engaging surface 4 of the autoinjector 2. The activation switch 1409 may include an electrical circuit that is broken unless the activation switch 1409 is pressed. For example, when the autoinjector 2 is attached to the user's skin, the switch 1409 may be pressed, completing an electrical circuit and indicating to the controller 1408 that the autoinjector 2 should be activated. To conserve power, components of the autoinjector 2 may be in a dormant or sleep mode until the switch 1409 is activated. In yet another example, the autoinjector 2 may not be powered at all until the switch 1409 is activated, and deactivation of the switch 1409 may completely shut off power to the autoinjector 2. While a mechanical plunger type switch is disclosed, any other suitable mechanism for activating the autoinjector 2 may be utilized, including, for example, a button pressed by the user, an audio signal, a wireless signal from another electronic device, among others.

[0055] The touch sensor 1410 may be configured to help the controller 1408 determine whether the autoinjector 2 is properly deployed on the user's skin. In one example, the touch sensor 1410 may be a capacitive sensing electrode or any other device configured to differentiate contact with the skin against other materials, such as, for example, wood, plastic, metal, or another material. When the skin is in the vicinity of the capacitive sensing electrode, a signal indicative of such contact may be sent to the controller 1408. Thus, the touch sensor 1410 may help to verify that the autoinjector 2 is properly placed on the user's skin when the switch 1409 is pressed. The touch sensor 1410 may include a capacitive sensing electrode coupled to the first electronic board 1402 and also to the interior of the housing 3. The housing 3 and the adhesive patch 12 may act as an overlay (insulator) that acts as a dielectric between the user's skin and the capacitive sensing electrode. Contact with the housing 3 and / or portions of the adhesive patch 12 near the capacitive sensing electrodes may increase the capacitance of the electrodes, for example by about 1 to about 10 pF, indicating placement of the autoinjector 2 on the skin surface.

[0056] The needle insertion switch 1412 may be configured to send a signal to the controller 1408 that the needle 306 has been deployed in the user. For example, with reference to FIG. 15 , the needle insertion switch 1412 may include a curved cantilever 1510 that includes a first contact 1512. The needle insertion switch 1412 may also include a second contact 1514. The first contact 1512 may be placed in electrical contact with the second contact 1514 when the needle 306 is deployed in the user. During deployment of the needle 306, the driver 320 may move downward along the axis 44, deflecting the curved cantilever 1510 and the first contact 1512 toward the second contact 1514. When the first contact 1512 and the second contact 1514 connect with each other, a signal may be sent to the controller 1408 indicating that the needle 306 has been successfully deployed in the user. Separation of the first contact 1512 and the second contact 1514 may indicate that the needle 306 is retracted from the user.

[0057] The emitter 1414 and detector 1416 may operate as optical interrupt sensors, i.e., photointerrupters, to allow the controller 1408 to determine the status of the autoinjector 2. The emitter 1414 may be a light emitting diode (LED) or other suitable light emitter, and the detector 1416 may be, for example, a phototransistor configured to receive light emitted by the emitter 1414. In one example, the emitter 1414 may emit infrared light, although other suitable wavelengths of light may also be used. The use of infrared light may help reduce interference from external light. The emitter 1414 and detector 1416 may be positioned across from one another within the housing 3 to allow a beam of light 1430 to pass from the emitter 1414 through the vial 1302 to the detector 1416. The vial 1302, and any fluid contained therein, may be at least partially transparent to the beam 1430 such that the beam 1430 may pass through the vial 1302 and its contents. When the piston 1316 is moved toward the second end 1306 during drug delivery (see FIGS. 13 and 14), the piston 1316, and in particular the shoulder of the piston 1316, may block the beam 1430. When the detector 1416 fails to detect the beam 1430, a signal may be sent to the controller 1408, which may interpret the signal as indicating the end of the injection (e.g., that all of the drug contained in the vial 1302 has been released). In some examples, the retraction path of the beam 1430 may be considered when positioning the emitter 1414 and the detector 1416 relative to one another. For example, the beam 1430 may be refracted as it passes through the vial 1302 and any fluid contained therein, and the emitter 1414 and detector 1416 may be offset from one another accordingly. Additionally, the emitter 1414 and detector 1416 may be offset from the center of the housing 3 such that a shoulder of the piston 1316 may block the beam 1430. In at least some examples, an optical block sensor or similar mechanism may help to avoid false positives in the event of a drive train failure. That is, an optical switch may help the controller 1408 determine that the injection was not completed with greater certainty than other mechanisms.

[0058] The audio module 1418 may include a speaker or the like to provide audio feedback to the user. An opening in the housing 3 may facilitate the transfer of sound from the audio module 1418 to the user. The audio module 1418 may generate a tone or other sound to indicate the beginning and end of the infusion and / or any other benchmarks during the infusion. The visual module 1420 may include one or more LEDs or similar devices to provide visual feedback to the user. The visual module 1420 may exhibit different colored LEDs to provide various messages to the user. For example, multiple green LEDs arranged in a ring could be used to indicate the progress of the infusion over time, while a red LED could be used to indicate 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 configuration, the 16 LEDs may be arranged in a circle having a diameter of about 26.5 mm or a diameter of about 10.0 mm to about 40.0 mm. The LEDs may be activated sequentially around a circle to indicate the progress of the injection (e.g., in a progress ring arranged in a manner similar to a clock - see, for example, LED 52 in FIG. 4C). The controller 1408 may also be configured to receive feedback from various sensors and scale the rate at which the various LEDs are activated based on the feedback from the sensors. For example, the LEDs in the progress ring may be activated in three or more operational stages including, for example, an injection sequence activation stage, an injection stage, and a storage stage. Those skilled in the art will recognize that the autoinjector 2 may have more or less operational stages than the three described above. There may also be an expected time to complete each stage, but there may also be some variability in the actual time experienced during any of the above-mentioned operational stages of the autoinjector 2. Algorithms may be utilized, for example, to help avoid premature activation of the LEDs when a particular stage is completed sooner than expected, or to stop progression along the ring when a particular stage takes longer than expected.At any point in time, the algorithm may divide the estimated remaining time for completion of drug delivery by the number of unactivated LEDs in the progress ring to determine the rate at which the remaining LEDs in the progress ring should be activated.

[0059] For example, prior to 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 the injection sequence activation phase, injection phase, and storage phase) divided by the total number of unactivated LEDs in the progress ring. In other words, 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 minus any already activated LEDs. Thus, for example, if one LED has already been activated, the estimated time of the entire drug delivery process may be divided by a number that is less than the total number of LEDs in the progress ring.

[0060] After completion of the injection sequence activation phase, the LEDs may be activated at a rate equal to the sum of the estimated time to complete the remaining phases (e.g., injection phase and storage 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 storage phase divided by the number of unlit LEDs.

[0061] The vision module 1420 may also include a display screen, touch screen, or other suitable device to provide one-way or two-way communication with a user. The vision module 1420 may be viewable by a user from outside the housing 3 via a window in the housing 3. The haptic module 1422 may include a haptic motor configured to generate vibrations that can be felt by the user, for example. The vibrations may signal the start and end of an injection and / or may help provide additional information to the user.

[0062] The controller 1408 may be coupled to a wireless communication module and an antenna. The wireless communication module may be configured to transmit data from the controller 1408 to, for example, a mobile device, a computer, a mobile phone, etc. The wireless communication module may be configured to transmit information in one or more wireless modalities, for example, 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, the controller 1408 may be configured to transmit diagnostic information of the user and / or the autoinjector 2, information regarding the completion of an injection, and / or information regarding an error condition of the autoinjector 2 to a user's device or to the cloud. Signals indicative of needle insertion and / or premature device removal may also be transmitted via the wireless communication module. The controller 1408 may also receive activation and / or delay commands via the wireless communication module.

[0063] FIG. 16 illustrates an exemplary method 2000 according to the present disclosure. The method 2000 may begin at step 2002, where a user may place the autoinjector 2 on their body such that the tissue engaging surface 4 is in contact with a skin surface. The autoinjector 2 may be attached to any suitable location, such as, for example, the thigh, abdomen, shoulder, forearm, upper arm, leg, buttocks, or another suitable location. The autoinjector 2 may be secured to the skin by an adhesive patch 12. Securement of the autoinjector 2 at step 2002 may cause an activation switch 1409 extending outwardly from the tissue engaging surface 4 to be depressed, completing a circuit. Completion of the circuit may cause a signal to be sent to the 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 the autoinjector 2 before or after step 2002.

[0064] Once the autoinjector 2 is activated at step 2002, the method 2000 may proceed to step 2004 where the controller 1408 may determine whether the tissue engaging surface 4 is placed on a skin surface. At step 2004, the controller 1408 may receive a measurement from the touch sensor 1410 indicating whether the autoinjector 2 is placed on the skin or another surface. For example, if the controller 1408 determines that the touch sensor 1410 is in contact with skin when the capacitance value received from the touch sensor 1410 is within a predetermined range, the method 2000 may proceed to step 2008. If the controller 1408 determines that the touch sensor is not in contact with skin, for example, if the capacitance measurement received from the touch sensor 1410 indicates that the autoinjector 2 is in contact with a non-skin surface such as wood or metal, the method 2000 may proceed to step 2006. At step 2006, the autoinjector 2 may be placed in an error state. In an 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, the autoinjector 2 may need to be manually reset before the injection is completed. In other examples, the autoinjector 2 may loop back to step 2004 where the controller 1408 continuously attempts to determine if the touch sensor 1410 is in contact with the skin. The method 2000 may also require that the touch sensor 1410 be in contact with the skin during the entire injection. Thus, if at any point during the injection the controller 1408 determines that the touch sensor 1410 is no longer in contact with the skin, the controller 1408 may stop the injection (e.g., by ceasing further movement of the translation mechanism 1366), may generate an error signal or message, and may retract the needle 306 if it was not extended.

[0065] In step 2008, the controller 1408 may send a signal to activate the translation mechanism 1366. Once activated, the translation mechanism 1366 may move toward the second end 1306 of the vial 1302 (see FIGS. 13 and 14), causing the vial 1302 itself to move in the same direction. This may cause the needle 308 to move in the opposite direction to access the vial 1302 as described above. The movement of the driver 1398 and the needle 308 causes the carrier 202 to move in the same direction, which describes the sequence of events that ultimately deploys the needle 306 into the user by the mechanism described in FIGS. 5-11. The translation mechanism 1366 continues to move toward the second end 1306 until the desired amount of the drug contained within the vial 1302 has been dispensed to the user.

[0066] The method 2000 may proceed to step 2010 where the controller 1408 may determine whether the injection is complete. This determination may be based on the interruption of the beam 1430 by the piston 1316 (as described with respect to FIGS. 4A, 13, and 14). That is, when the beam 1430 is broken (not received by the detector 1416), the controller 1408 may determine that the injection is complete. Once the controller 1408 determines that the injection is complete, the controller 1408 may send a signal to the translation mechanism 1366 to reverse the direction of rotation of the lead screw, which may cause the lamp 1500 to push the lamp 243 of the stop 240, allowing retraction of the needle 306, as described above with respect to FIG. 11. In one example, the controller 1408 may provide a delay after receiving an indication that the beam 1430 has been interrupted. The delay may be, for example, 0.1 to 60 seconds. Additional end detection mechanisms may be used in place of or in combination with the interruption type sensors described above. For example, the current of the motor of the translation mechanism 1366 may be utilized to determine whether the injection is complete. That is, when the piston 1316 reaches the second end 1306 of the vial 1302, the current to the motor increases (e.g., as a result of the piston 1316 engaging the end of the vial 1302), signaling the ejection of all or substantially all of the contents of the vial 1302. One exemplary combination would include the use of a beam 1430 where interruption of the beam 1430 indicates, for example, that 90-98 percent of the injection is completed. The current of the motor of the translation mechanism 1366 would then be analyzed to determine whether the remaining 2-10 percent of the injection is completed. In another example, instead of using an optical switch, a delay from the start of the translation mechanism 1366 may be used by the controller 1408 to determine when to reverse the translation mechanism 1366. In one example, the delay may be, for example, from about 1 second to 120 seconds, although other suitable times are contemplated. In any event, the delay from the start may be long enough to allow for the contents of vial 1302 to be expelled.

[0067] In some examples, the timing of the injection procedure, measured from the initial activation of the activation switch 1409 to the retraction of the 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, or from about 30 seconds to about 45 seconds, or about 120 seconds or less, or about 90 seconds or less, or about 60 seconds or less, or about 45 seconds or less, or about 30 seconds or less.

[0068] Method 2000 may include additional steps. For example, method 2000 may include determining whether the drug in vial 1302 is too cold for delivery into the user, whether power source 1406 has sufficient energy to complete the injection, whether needle 306 is prematurely deployed and / or retracted, whether the current of the motor of translation mechanism 1366 is within an appropriate range, and whether the injection procedure has extended beyond a maximum allowable procedure time. When controller 1408 detects any of the above errors, controller 1408 may communicate such error to the user and may terminate the ongoing injection, for example, by pausing or reversing translation mechanism 1366 and retracting needle 306 from the user. Alternative Embodiments Another embodiment of a needle mechanism is shown in Figures 17-19. The needle mechanism 2400 may include a base 2402 and a shuttle 2420. The base 2402 may have an elongated member 2404 extending away from a top surface of the base 2402. The base 2402 may also include a channel 2406 extending along a longitudinal axis of the base 2402 (parallel to axis 40) and recessed into the top surface of the base 2402. The channel 2406 may extend through a first wall 2407 and a second wall 2408 of the base 2402 and may extend through the elongated member 2404. The elongated member 2404 may include a slot 2410, for example, that extends from a top of the elongated member 2404, through a portion of the base 2402, and toward a bottom surface of the base 2402. The slot 2410 may be disposed generally perpendicular to the channel 2406 and extend parallel to the axis 44. The base 2402 may further include a pin 2412 and a second pin 2414.

[0069] The 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. The first wall 2426 and the second wall 2428 may be substantially parallel to one another. The first and second walls 2426, 2428 may be spaced apart a distance the width of the base 2402 to allow the base 2402 to translate relative to the shuttle 2420. An opening 2424 may extend through the end member 2422, which may be configured to receive a first end of the shaft 2456.

[0070] The wall 2426 may include a first slot 2430, a second slot 2432, and a driver member opening 2434 having an engagement portion 2434a (where the protrusion 2454 may rest in the first, undeployed configuration). The first slot 2430 may be disposed adjacent to and spaced longitudinally from the second slot 2432. The first slot 2430 engages the pin 2412 and the second slot 2432 engages the pin 2414. The slots 2430, 2432 may include a first curved portion or injection ramp extending from a bottom to a top of the shuttle 2420, a peak disposed near the opening 2434, and a second curved portion or removal ramp extending from the peak to a location near the bottom of the shuttle 2420. When viewed from the needle mechanism 2400 above, the first curved portion may have, for example, a convex shape, and the second curved portion may have, for example, a concave shape. The injection ramp may have, for example, an angle and curvature less than the angle and curvature of the removal ramp. A shallower injection ramp may provide a mechanical advantage. The other portion rests and helps to overcome stiction. The first curved portion allows for the insertion of a needle (e.g., needle 306 described above) into the user for administration of the drug, and the second curved portion allows for the removal of the needle 306 from the user. The second wall 2428 may also include two slots and openings similar to the slots 2430 and 2432, and the opening 2434. The slots and openings of the second wall 2428 may be arranged in a similar or identical manner to the slots and openings arranged in the wall 2426.

[0071] The needle mechanism 2400 may also include a resilient member or spring (not shown) coupled to a shaft 2456. The shaft 2456 may be disposed in the opening 2424 of the shuttle 2420. The shaft 2456 may be coupled to a protrusion 2454. The protrusion 2454 may slide through the slot 2410 of the elongated member 2404 and may be coupled to the needle 306.

[0072] To move from the undeployed configuration shown in FIG. 17 to the deployed configuration shown in FIG. 18, the spring may expand to allow the shuttle 2420 to slide longitudinally along the longitudinal axis 40 relative to the shaft 2456. Due to the curvature of the slots 2430 and 2432, the longitudinal force applied to the shuttle 2420 also pushes the shuttle 2420 downward. This downward movement also moves the protrusions 2454 downward through the slots 2410, deploying the needles 306. When the needle mechanism 2400 is in the deployed configuration, the pins 2412 and 2414 are located at the connections between the injection and removal slopes of the peaks or slots 2430 and 2432. Additionally, the protrusions 2454 are located at or near the center of the openings 2434. Additionally, the protrusions 2454 are located near the center of the slots 2410 between the top surface of the extension member 2404 and the bottom of the slots 2410. The shaft 2456 may extend beyond the end of the shuttle 2420 and through the opening 2424 .

[0073] Once the medication has been administered, the infusion needle 470 may be removed by allowing the spring to expand further. The additional expansion of the spring causes the shuttle 2420 to slide longitudinally further along the longitudinal axis 40 relative to the shaft 2456. Due to the curvature of the slots 2430 and 2432, the additional longitudinal force applied to the shuttle 2420 pushes the shuttle 2420 upward. This upward movement also causes the projection 2454 to move upward through the slot 2410, retracting the needle 306. The projection 2454 may be disposed in the drive member opening 2434 at the end closest to the end face 2422. Additionally, the projection 2454 is disposed near the top of the slot 2410. The shaft 2456 may extend even further out of the opening 2424 beyond the end of the shuttle 2420.

[0074] Another embodiment of a needle assembly is shown in FIG. 20. The needle assembly 3300 includes a carrier 3302, a driver 3320, a shuttle 3340, a gear 3360, and a spring (elastic member) 3370. The driver 3320 may be coupled to a fluid conduit (such as the fluid conduit 300 described above) and may be configured to drive a needle at the end of the fluid conduit into a user. The driver 3320 may be similar to the driver 320, except that it may include only one rack gear 3222 configured to be driven by the gear 3360. The shuttle 3340 may be similar to the shuttle 340, except that it may include a first rack 3342 and a second rack 3344. The first rack 3342 and the second rack 3344 may be longitudinally spaced apart, but may be substantially parallel to one another, and may engage the gear 3360 at different times. In some examples, the first rack 3342 and the second rack 3344 may be configured to engage the gear 3360 only at different times. When the shuttle 3340 moves in a direction 3380 along the longitudinal axis 40, the second rack 3344 may rotate the gear 3360 in a first direction (e.g., counterclockwise). Meanwhile, the first rack 3342 may move the gear 3360 in a second direction opposite the first direction (e.g., clockwise) when the shuttle 3340 moves in the direction 3380. Rotation of the gear 3360 in the first direction may move the driver 3320 downward through the rack 3222 to propel the needle into the user, and rotation of the gear 3360 in the second direction may move the driver 3320 upward to retract the needle from within the user. The expansion of a spring 3370, which may be coupled to both the carrier 3302 and an inner surface of the shuttle 3340, may move the shuttle 3340 in the direction 3380 to initiate deployment and subsequent retraction of the needle. It is further contemplated that a stop similar to the stop 240 may be used to impede longitudinal movement of the shuttle 3340 when the driver 3320 (and associated needle) is in the deployed configuration. The stop will then move out of the path of the shuttle 3340 to allow retraction of the driver 3320 and its associated needle.

[0075] Yet another embodiment of a needle assembly is shown in FIG. 21. The needle assembly 4000 includes a carrier 4202 and a driver (shown only via protrusion 330). The needle assembly 4000 may also include the following components, which are not shown but may be substantially similar to the components described above with the same names, such as a shuttle, deployment and storage gears, and a spring. The driver of the needle assembly 4000 may be coupled to a fluid conduit (such as fluid conduit 300) and may be configured to move a needle at the end of the fluid conduit into the user. In the undeployed configuration (shown in FIG. 21), the protrusion 330 of the driver may be blocked by an obstruction 4600. The carrier 4202 may be urged in a direction 4002 to allow the protrusion 330 to slide down a ramp 4602 and move the driver and associated needle from the stored configuration to the deployed configuration. Carrier 4202 may be urged in direction 4002, for example, by translation mechanism 1366 and vial 1302, in a manner substantially similar to that described above with respect to carrier 202.

[0076] The needle assembly 4000 may include a stop 4240 that is separate from the carrier 4202. The stop 4240 may be urged in a direction 4004 by a spring 4241. An end of the stop 4240 may include an overhang 4242 that may help maintain the driver in the deployed configuration by blocking the retraction path of the projection 330. Thus, when the driver is deployed, the projection 330 may be located directly under the overhang 4242 of the stop 4240, preventing retraction of the driver until the stop 4240 is moved. Retraction of the driver and needle may be achieved by, for example, reversing the motor of the translation mechanism 1366, which may apply a force against the stop 4240 in a direction 4002 to compress the spring 4241 via one or more mechanical linkages (not shown). Movement of the stop 4240 in the direction 4002 may provide clearance for the projection 330 to move back to the retracted configuration.

[0077] Yet another embodiment of a needle assembly is shown in Figures 22 and 23. The needle assembly 5300 includes a carrier 5302. In this embodiment, the stop 5240 may be configured to directly impede rotation of the deployment gear and / or retraction gear 5360 instead of directly impeding either the shuttle or the driver of the needle assembly. In this embodiment, the gear 5360 may be coupled to a toggle 5362 via a shaft 5361. The gear 5360 may rotate about an axis 5364 to facilitate deployment and / or retraction of an associated driver and / or needle. The toggle 5362 may have a length extending substantially perpendicular to the axis 5364 and may rotate about the axis 5364.

[0078] The stop 5240 may include an opening 5380 through which the toggle 5362 may be disposed. The opening 5380 may include a circular portion 5382 and a limiting portion 5384. The circular portion 5382 may have a diameter greater than a length of the toggle 5362 to allow unhindered rotation of the toggle 5362 (and the gear 5360). Meanwhile, the toggle 5362 is disposed within the circular portion 5382. The stop 5240 may be slidable relative to the carrier 5302 by any suitable mechanism. When the stop 5240 and the carrier 5302 are slid relative to one another, the toggle 5362 may slide within the limiting portion 5384, which may be sized to limit the rotation of the toggle 5362 (and the gear 5360). For example, when the toggle 5362 is generally rectangular as shown, the limiting portion 5384 may be rectangular.

[0079] In particular, references herein to "one embodiment" or "embodiments" mean that a particular feature, structure, or characteristic described in connection with an embodiment may be included in, utilized in, and / or incorporated into one, some, or all of the embodiments of the present disclosure. Use or appearance of the phrases "in one embodiment" or "in another embodiment" within the specification are not necessarily referring to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of one or more other embodiments, nor are they limited to a single exclusive embodiment. The same also applies to the terms "embodiment" and "example." The present disclosure is not limited to any single aspect or embodiment thereof, nor to any combination and / or permutation of such aspects and / or embodiments. Furthermore, each of the aspects of the present disclosure and / or its embodiments may be utilized alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For simplicity, certain permutations and combinations are not separately described and / or illustrated herein.

[0080] Moreover, as noted above, any embodiment or implementation described herein as "exemplary" is not to be construed as preferred or advantageous over other embodiments or implementations, for example, but rather is intended to convey or illustrate that one or more embodiments are example embodiment(s).

Claims

1. 1. An injection device comprising: a needle movable from a stored configuration to a deployed configuration; a piston configured to move within the vial; a motor configured to drive the piston; a controller coupled to the motor, determining that the injection device is placed in contact with a user; After said determining, sending a signal to said motor to drive said piston in a first direction to move said needle from said stored configuration to said deployed configuration; automatically sending a signal to the motor to drive the piston in a second direction to retract the needle after sending the signal to drive the motor in the first direction without requiring any intervention by the user after the determining. The controller configured as follows: An injection device comprising:

2. 10. The injection device of claim 1, further comprising a housing that encloses the vial, the piston, the motor, the controller, and the needle when the needle is in the stored configuration, and wherein the needle is withdrawn from within the housing in the deployed configuration.

3. 3. The injection device of claim 1 or 2, further comprising a cover or shield that includes a distal-most portion of the needle in the retracted configuration.

4. 4. The injection device of claim 1, further comprising an audio module, a visual module and a tactile module, each of said modules coupled to the controller and configured to provide feedback to the user.

5. 5. The injection device of claim 1, further comprising a top portion sealing an opening of the vial, the top portion including a portion comprising a rubber material permeable to a sterilant, the needle including a proximal end configured to couple with the vial, the proximal end of the needle being disposed within the portion formed from the rubber material before the needle and the vial are in fluid communication with each other.

6. 6. The injection device of claim 1, further comprising a cantilever coupled to the controller and movable by the needle, wherein when the needle is in the stored configuration, the cantilever forms part of an open circuit that signals the controller that the needle is in the stored configuration, and when the needle is in the deployed configuration, the cantilever forms part of a closed circuit that signals the controller that the needle is in the deployed configuration.

7. An injection device according to any preceding claim, further comprising one or more spring contacts configured to form an electrical connection between the motor and the controller.

8. Further comprising an activation switch switchable between an extended state and a depressed state; An injection device according to any preceding claim, wherein the determination is based at least in part on the activation switch being in the pressed state.

9. a touch sensor configured to detect contact with the skin; An injection device according to any preceding claim, wherein the determination is based at least in part on the touch sensor detecting contact with skin.

10. 10. The injection device of claim 9, wherein the touch sensor comprises a capacitive sensing electrode and is configured to detect contact with the skin based on a change in capacitance of the capacitive sensing electrode.

11. an emitter configured to emit light through the vial; 11. The injection device of claim 1, further comprising: a detector configured to receive the light and configured to detect when the piston blocks the light.

12. 12. The injection device of claim 11, wherein the controller is further configured to send the signal to the motor to drive the piston in the second direction in response to the piston obstructing the light.

13. 12. The injection device of claim 11, wherein the controller is further configured to, in response to the piston blocking the light, send the signal to the motor to drive the piston in the second direction after a predetermined delay.

14. 14. The injection device of claim 1, further comprising a wireless communication module configured to transmit to a remote device one or more of the following: diagnostic information for the injection device; information indicative of an error condition of the injection device; and information indicative of completion of injection.

15. The injection device of any one of claims 1 to 13, further comprising a wireless communication module configured to receive an activation command from a remote device, said determination being based at least in part on said activation command.

16. A method of operating the injection device of claim 1, comprising: exposing the injection device to a sterilizing gas; removing the injection device from packaging material thereby removing a needle shield from the needle; The method includes:

17. A method for treating a patient comprising: administering to the patient a drug in a vial, the vial being configured to be in fluid communication with the needle; and An audio providing device; a housing enclosing the needle, the vial, and the sound providing device; a plurality of lights coupled to the housing and configured to illuminate upon activation of the injection device; 10. The injection apparatus of claim 1, wherein the audio providing device is configured to provide an audio signal indicating completion of an injection sequence.

18. the vial is configured to be in fluid communication with the needle; An injection device according to any one of the preceding claims.

19. in response to the motor driving the piston in the first direction, the needle is placed in fluid communication with the vial. An injection device according to any one of the preceding claims.

20. 1. A controller for an injection device, comprising: one or more memories storing instructions; one or more processors operably coupled to the one or more memories, the one or more processors executing the instructions to determining that the injection device is placed in contact with a user; after said determining, moving the needle from a retracted configuration to a deployed configuration by driving a piston in a first direction within the vial by sending a signal to a motor; automatically sending a signal to the motor to drive the piston in a second direction to retract the needle after sending the signal to drive the motor in the first direction without requiring any intervention by the user after the determining. The controller is configured as follows:

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