Auto-injector

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 of U.S. Provisional Patent Application No. 62 / 502,278, filed May 5, 2017, under 35 U.S.C. § 119(e), the entire disclosure of which is hereby incorporated by reference herein.

[0002] The present disclosure is directed to an auto - injector and related methods of use.

Background Art

[0003] In various available auto - injectors, upon activation by a user, the needle is deployed and fluid is delivered from the needle into the user. After completion of fluid delivery, the needle may be retracted for user comfort, needle safety, and positive perception of the product. However, many auto - injectors use separate springs or motors for the injection step and the needle removal step. Further, such injection assemblies generally require separate user operations for both insertion and removal of the needle.

Summary of the Invention

[0004] In one aspect, the present disclosure is directed to an injection device. The injection device includes a carrier, a needle, a driver coupled to the needle and 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 stopper configured to move from a first configuration to a second configuration. The stopper is configured to maintain the driver in the deployed configuration, and the movement of the stopper from the first configuration to the second configuration enables the shuttle to move the driver from the deployed configuration to the retracted configuration.

[0005] The shuttle is movable from a first position to a second position and from the second position to a third position. When the shuttle is at the first position, the driver is in a retracted configuration. When the shuttle is at the second position, the driver is in a deployed configuration. When the shuttle is at the third position, the driver is in a retracted configuration. The first position and the third position are different. The shuttle moves in one direction along an axis to move from the first position to the second position and from the second position to the third position. The shuttle is configured to move in only one direction. Further, the injection device also includes a deployment gear coupled to the carrier and a retraction gear coupled to the carrier. The driver is coupled to the deployment gear and the retraction gear. The shuttle includes a rack gear configured to engage with the deployment gear and the retraction gear. The direct engagement of the rack gear with the deployment gear moves the driver from the retracted configuration to the deployed configuration, and the direct engagement of the rack gear with the retraction gear moves the driver from the deployed configuration to the retracted configuration. The rack gear is in direct contact with only one of the deployment gear and the retraction gear at any given time. The rack gear is configured to drive the rotation of the deployment gear in a first direction to move the driver from the retracted configuration to the deployed configuration and to drive the rotation of the retraction gear in the first direction to move the driver from the deployed configuration to the retracted configuration. The driver includes a first rack and a second rack. The first rack is configured to engage with the deployment gear, and the second rack is configured to engage with the retraction gear. The first rack and the second rack are located on both sides of the driver. The shuttle is configured to move along a first axis, the driver is configured to move along a second axis, and the first axis and the second axis are perpendicular to each other. Before activation, the driver is in contact with an obstacle and is prevented from exiting the retracted configuration by the obstacle. Further, the injection device also includes a housing that encloses the carrier, and the obstacle is integral with the housing. The movement of the carrier relative to the housing moves the driver so as not to be in contact with the obstacle, enabling the driver to move from the retracted configuration to the deployed configuration. Also, the injection device includes an elastic member coupled to the shuttle. After the driver has moved so as not to be in contact with the obstacle, the elastic member extends from a first compressed state to a second compressed state to move the shuttle from the first position to the second position.After the stopper moves from the first configuration to the second configuration, the elastic member is configured to extend 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, the stopper having a first end fixed to the remainder of the carrier, a free second end, a first gear coupled to the carrier, a needle, and a driver coupled to the carrier, the first gear, and the needle, the driver being slidable relative to the carrier between a retracted configuration and a deployed configuration, and a shuttle including a rack gear configured to drive rotation of the first gear, rotation of the first gear moving the driver from the retracted configuration to the deployed configuration, and the free second end of the stopper being configured to at least temporarily impede 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, and while the free second end is in contact with the shuttle, bending of the stopper about its fixed first end slides the shuttle relative to the stopper, drives rotation of the second gear, and rotation of the second gear moves the driver from the deployed configuration to the retracted configuration.

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

[0009] The injection device further includes a vial, a piston, a motor, a controller, and a housing that encloses the needle when the needle is in the stored configuration, and the needle is withdrawn from the housing in the deployed configuration. The injection device may include a cover or shield that includes the distalmost portion of the needle in the stored configuration. The injection device may include an audio module, a visual module, and a tactile module, each of the modules being coupled to the controller and configured to provide feedback to a user of the injection device. The injection device may include an upper portion that seals an opening of the vial, the upper portion including a portion that includes a rubber material through which a sterilant passes, the needle including a proximalmost portion configured to couple with the vial, and the proximalmost portion of the needle being disposed within a 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 by the needle, the cantilever forming an open circuit portion that signals the controller that the needle is in the stored configuration when the needle is in the stored configuration, and the cantilever forming a closed circuit portion that signals the controller that the needle is in the deployed configuration when 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 connection with the embodiments shown in the accompanying drawings. These drawings show different aspects of the present disclosure, and where appropriate, reference numerals that indicate similar structures, components, materials, and / or elements in different figures are similarly named. It is understood that various combinations of structures, components, and / or elements other than those explicitly shown are intended to be within the scope of the present disclosure and are within the scope of the present disclosure.

[0011] Furthermore, there are many embodiments described and illustrated herein. The present disclosure is not limited to any single aspect, embodiment, or any combination and / or permutation of such aspects and / or embodiments. Moreover, each aspect and / or embodiment 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 the sake of simplicity, certain permutations and combinations are not separately described and / or illustrated herein. In particular, embodiments or aspects described as "exemplary" herein should not be construed as being preferred or advantageous over, for example, other embodiments or aspects. Rather, it is intended to reflect or indicate that the embodiment(s) is / are "exemplary" embodiments.

Brief Description of the Drawings

[0012]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 4A

Figure 4B

Figure 4C

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 14A

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

DETAILED DESCRIPTION OF THE INVENTION

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

[0014] In particular, for the sake of brevity and clarity of explanation, certain aspects of the figures illustrate the general structure and / or method of construction of the various embodiments. Descriptions and details of well-known features and techniques may be omitted in order to avoid obscuring other features needlessly. The elements in the figures are not necessarily drawn to scale, and the dimensions of some features may be exaggerated relative to other elements for purposes of enhancing the understanding of the exemplary embodiments. For example, one of ordinary skill in the art will understand that cross-sectional views are not drawn to actual size and should not be viewed as representing the proportional relationships between different components. Cross-sectional views serve to illustrate the various components of the assemblies shown and are provided to show their relative placement with respect to each other.

[0015] Now, reference is made in detail to the examples of the present disclosure shown in the accompanying drawings. Whenever possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts. In the following description, relative terms such as "about", "substantially", "approximately", and the like are used to indicate a possible variation of ±10% of the numerical values described.

[0016] As described above, existing self-injectors often require the intervention of multiple users to self-administer a drug, including, for example, separate user interventions to deploy the needle and then to store the needle after drug delivery. These additional steps can increase the complexity of self-administering the drug, cause user error, and cause user discomfort. Accordingly, the present disclosure is directed to various embodiments of an infusion device (e.g., a self-injector) that simplifies the self-administration of a drug or other therapeutic agent by a user. Specifically, according to certain embodiments, the self-injector may not require additional user intervention to withdraw the needle once the needle has been inserted subcutaneously into the user. Thus, the self-injector of the present disclosure is simplified to help prevent misuse or user error. Overall system An example of such an autoinjector 2 is shown in FIGS. 1-4. The autoinjector 2 may include a housing 3 having a tissue engaging (bottom) surface 4, and the needle may be deployed through the tissue engaging surface and stored via an opening 6 (FIG. 2). An activation switch 1409 (FIG. 2) may be disposed on the tissue engaging surface 4 and may be configured to activate the autoinjector 2 or otherwise put the autoinjector 2 into a “ready” mode. Also, a touch sensor 1410 (FIG. 2) may be disposed on the tissue engaging surface 4, and the controller of the autoinjector 2 may determine whether the autoinjector 2 is placed on the user's skin (indicating that the autoinjector should fire the needle or otherwise deploy) or whether the activation switch 1409 has been properly triggered (indicating that the operation of the autoinjector 2 should be stopped). The activation switch 1409 and the touch sensor 1410 are described in further detail below with respect to FIG. 4A. Also, a connection port 13 may 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 plurality 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 to enable portability and self-attachment by the 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 from about 0.5 inches to about 5.0 inches, a width from about 0.5 inches to about 3.0 inches, and a height from 0.5 inches to about 2.0 inches.

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

[0018] The adhesive patch 12 may be coupled to the tissue engagement surface 4 to help secure the self-injector 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 an aqueous or solvent-based adhesive or, for example, a hot melt adhesive. Also, suitable adhesives include not only natural and synthetic elastomers but also acrylic, dextrin-based, 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 another example, the patch 12 may include a non-woven polyester substrate and an acrylic or silicone adhesive. The patch 12 may be joined to the housing 3, for example, by 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 self-injector 2.

[0019] Needle mechanism Referring to FIGS. 5-11, the needle mechanism 20 includes a carrier 202 that is movable (e.g., slidable) within the housing 3 between a first position (FIG. 6) and a second position (FIG. 7). Also, the needle mechanism 20 may include a fluid tube 300 that is attached to the carrier 202 and may be deployed into the user and stored by a driver 320. A shuttle 340 (e.g., a shuttle actuator) may be configured to move the driver 320 via a deployment gear 360 and a retraction gear 362. The shuttle 340 may be coupled to an elastic member (e.g., a spring 370). A cover 380 (FIG. 5) may be coupled to the carrier 202 to enclose the various components of the needle mechanism 20.

[0020] Referring to FIG. 5, the fluid tube 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 inserted by a user. The needle 306 may include a sharp and / or angled tip and may generally extend 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 disposed within the autoinjector 2 to access the drug to be injected into the user through the vial 1302 (shown in FIG. 13 and described in further detail below). The fluid tube 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 intermediate portion 310 may be joined by a coil 312 that facilitates bending of the fluid tube 300 and movement of the needle 306 along the axis 44 during deployment into and storage from the user. Although the coil 312 is shown, other suitable shapes are contemplated, such as a serpentine shape, a curved shape, or other shapes that allow for bending of the fluid tube 300. The coil 312, or a similar structure, may function as a cantilever when the needle 306 is deployed and / or stored. Also, the coil 312 may bias the fluid tube 300 into the deployed configuration shown in FIG. 5. When 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 intermediate portion 310, and the needle 306 (which pierces through the user's skin), and into the user. In some examples, the fluid tube 300 may include only metal or a metal alloy. In other examples, the fluid tube 300 may include any other suitable material, such as a polymer, for example. The needle 308 and the intermediate portion 310 may define a thin-walled needle of 22 or 23 gauge. On the other hand, the needle 306 may be a 27-gauge needle. Also, other needle sizes, for example ranging from 6 gauge to 34 gauge, may be utilized as needed. The fluid tube 300 may reduce the amount of material in contact with the drug, reduce joint and assembly steps, and may require less sterilization than conventional devices.

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

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

[0023] Driver 320 includes two racks 322 and 324 (shown in FIG. 8) that are parallel to each other and disposed on both sides of driver 320. Racks 322 and 324 may include teeth and may be configured to engage and drive the rotation of deployment gear 360 and retraction gear 362, respectively. Driver 320 may include a lumen 326 (i.e., a track, recess, or other suitable structure) (FIG. 5) configured to receive needle 306 of fluid tube 300. Further, driver 320 may include a protrusion 330 (FIGS. 6 and 7) configured to slide within driver path 218 of carrier 202. Protrusion 330 may include a hook-like configuration that can "catch" obstacle 600, as will be described in further detail below.

[0024] Continuing to refer to FIG. 5, shuttle 340 may include a rack 342 configured to engage gears 360 and 362. Further, 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 and may extend along all or substantially all 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 of 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 retraction gear 362. At certain times, the rack 342 engages at most one of the deployment gear 360 and the retraction gear 362 at any given time. In some instances, such as when the rack 342 is longitudinally disposed between the deployment gear 360 and the retraction gear 362, the rack 342 may not be engaged with either the deployment gear 360 or the retraction gear 362. The shuttle 340 may be configured to move only along one axis (e.g., axis 40) and only in one direction along that axis. The force required to move the shuttle 340 along the track 220 may be provided by the extension of the spring 370. The spring 370 may be compressed from a rest state, and the extension 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 the movement of the shuttle 340.

[0026] The first position of the shuttle 340 shown in FIG. 8 may correspond to an unused state, an undeployed state, and / or a new state of the auto-injector 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 within the path (FIG. 6) of the driver 320. The obstacle 600, which may be a shelf of the housing 3 or another suitable blocking device, may prevent 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 the driver 320 also prevents the movement of the shuttle 340. The shuttle 340 may move 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 the obstacle 600 (FIG. 7), the spring 370 may extend and move 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 pierces the user's skin with the needle 306. 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 the extension of the spring 370 until its end face 344 abuts against the free end of the stopper 240 so that the shuttle 340 is maintained in the second position shown in FIGS. 9 and 10. In this regard, 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 tube 300 may be deployed among the users, and the fluid from the vial 1302 may be injected into the users through the needle 306. Further, 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 move from the second position to the third position by the bending of the stopper 240 around its fixed end 241. This bending will be described in further detail below with respect to FIGS. 12-14. The bending of the stopper 240 may allow the spring 370 to continue to extend and drive the shuttle 340 further along the track 220. In some examples, the stopper 240 may be received by and / or within the recess 346 of the shuttle 340, and the ramp 243 may slide within the slot 348 as the shuttle 340 moves from the second position to the third position.

[0029] The movement of the shuttle 340 from the second position to the third position may correspond to the retraction of the needle 306 into the housing 3 from the user. In particular, the rack 342 may engage the retraction gear 362 and rotate the retraction gear 362 in the same direction (e.g., clockwise or counterclockwise) as the deployment gear 360 is rotated. The rotation of the retraction gear 362 may drive the driver 320 back to the retracted position via the rack 324. The shuttle 340 may reach the third position where the driver 320 is fully retracted when its end face 344 engages the wall of the carrier 202, when the free end 242 of the stopper 240 reaches the end of the recess 346, and / or when the spring 370 reaches the 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 exiting 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 completion of a single injection). In other embodiments, the autoinjector 2 may be reset and reused. Further, the deployment gear 360 and the retraction gear 362 may, in some instances, be nothing more than rotating gears disposed within the autoinjector 2. Piercing system and sterilizing connector Figures 13 and 14 illustrate features of the piercing system 1300 of the autoinjector 2. Additional details of an exemplary piercing system may be described in U.S. Patent Application Publication No. 2016 / 0262984 A1 to Arnott et al., published September 15, 2016, which is hereby 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 assist in closing the second end 1306 and to allow a needle 308 (e.g., a staked needle) to be inserted into the vial 1302. The cavity 1308 may be closed at the first end 1304 by a piston 1316.

[0031] 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, but in some examples, vial 1302 may have a volume of 5 mL. In other examples, vial 1302 may have a volume 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. Vial 1302 may contain and store the drug for injection to the user and may help maintain the sterility of the drug. Vial 1302 may have a neck 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, 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. Vial 1302 may be a shortened ISO 10 mL cartridge.

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

[0033] In addition, the piercing system 1300 may include an upper portion 1354 disposed at the second end 1306. The upper portion 1354 may include a base 1355 disposed over the partition 1314 and the opening of the vial 1302. The upper portion 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 upper portion 1354 may be integrated with the partition 1314 (e.g., a one-piece or continuous structure). In alternative embodiments (not shown), the upper portion 1354 may be provided over or initially assembled on the fluid tube 300 and may not be installed on / and / or integrated directly with the vial 1302 or the partition 1314.

[0034] For example, a portion of the fluid tube 300, such as the needle 308, the tube, etc., may extend through the opening 1358 of 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 of the chamber 1356 may form a sterile sliding seal around the needle 308 so as to prevent pathogens or other contaminants from migrating into the cavity 1357. The needle 308 can move relative to the upper portion 1354 without interrupting 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 alternative embodiments, rather than the upper portion 1354, a helical flexible (e.g., rubber) bellows or bladder member may form the cavity 1357 and allow translation of the vial 1302 (or vice versa) relative to the needle 308. Also, the flexible member may seal or form the cavity 1354 around the needle 308 after sterilization.

[0035] In the alternative embodiment shown in FIG. 14A, the upper portion 1354a may be used with the piercing system 1300 instead of the upper portion 1354. The upper portion 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 within the stopper 1356a. The stopper 1356a may be formed from a solid stopper that is written with any holes, cavities, or openings and may be formed from a first rubber material. The first rubber material may be permeable to a sterilizing gas such as, for example, ethylene oxide or evaporated hydrogen peroxide. The first rubber material may include, among other things, one or more of isoprene, ethylene propylene diene monomer (M-class) rubber (EPDM), and styrene butadiene. The permeability of the first rubber material to the sterilizing gas may allow the needle 308 disposed within the stopper 1356a to be sterilized prior to use. The stopper 1356a may be formed around the needle 308 such that the needle 308 is stabbed into the stopper 1356a. The impermeability of the base 1355a to the sterilizing gas may prevent contamination and / or alteration of the drug contained within the vial 1302. The base 1355a may include, among other things, an impermeable rubber such as, for example, halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile.

[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 on the contents (e.g., drug, agent) within the vial 1302, which ultimately transmits a force to the second end 1306 of the vial 1302 and moves the vial 1302 along the longitudinal axis 40. The translation mechanism 1366 may include a 12 mm motor having a 5-stage gear reduction (360:1). The translation mechanism 1366 may have spring contacts that effect an electrical connection with an associated printed circuit board (e.g., the first electronic board 1402). The motor may be configured to produce a torque of about 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 main screw mechanism coupled to a piston 1316 that extends along the axis during relative rotation about the longitudinal axis 40. This telescopic main screw may have a 7° / 45° buttress thread shape with a 100N output, a 20mm stroke, and a pitch of 0.75mm. The material for the main screw mechanism may include acetal and polybutylene terephthalate. The main screw mechanism may extend within the piston 1316 to reduce the dead space behind the piston 1316. The piston 1316 is shown in FIGS. 13 and 14 with longitudinally spaced threads, but in some examples, such threads may not be present. In another exemplary embodiment (not shown), the translation mechanism 1366 may include a manually engagable surface or member that is manually operated by the user to move the piston 1316. For example, the punching 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 drive member or a hydraulic drive member that is actuated or initiated by the 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 required to move the piston 1316.

[0038] The piercing system 1300 also includes a collar 1390 coupled or fixed to the second end 1306. The collar 1390 may include fingers 1392 spaced circumferentially about and engaging 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 at least partially extends around the neck 1310, the opening of 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 outwardly from the neck 1310 and extend longitudinally past the neck 1310, the cap 1312, and the septum 1314.

[0039] In the pre-activated state of the piercing system 1300 shown in FIG. 13, the edge 1393 of the collar 1390 may engage a cam, latch, or actuating portion 1394 that extends radially or laterally inwardly of the corresponding driver retainer member 1395. The retainer member 1395 may be slidable relative to the collar 1390. The collar 1390 and the retainer member 1395 are in a pre-activated state or the arrangement shown in FIG. 13 such that at least a portion of the actuating portion 1394 of the cam or retainer member 1395 is disposed immediately behind the retaining portion 1399 of the driver 1398 that is slidable within the retainer member 1395. The wall 1391 of the driver 1398 may extend into and through the end cap portion 1396 of the retainer member 1395 and into the interior of the retainer member 1395, and the retaining portion 1399 of the driver 1398 may extend radially outwardly 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 the end of the wall 1391.

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

[0041] The needle 308 of the fluid tube 300 may be fixed or coupled to the driver 1398 such that the fluid tube 300 moves with the driver 1398. In the pre-activated state of the piercing system 1300, the needle 308 may be disposed within the sterilization cavity 1357 and / or within the cavity 1308 of the vial 1302, rather than through the base 1355 of the upper portion 1354 and the partition wall 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. Since 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 press against the actuating portion 1394 and deflect the actuating portion 1394 radially outward. Without the actuating portion 1394 blocking its path, the holding portion 1399 and the 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, and thus this movement of the driver 1398 towards the vial 1302 may also move the carrier 202 in the same direction. This movement corresponds to the movement of the carrier 202 relative to the housing 3 in FIGS. 6 and 7, which allows the protrusion 330 to remove the obstacle 600 and inject the needle 306.

[0043] Also, the movement of the needle 308 towards the second end 1306 of the vial 1302 also pierces the needle 308 through the base 1355 of the upper portion 1354, the partition wall 1314, and the cavity 1308 to establish 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 towards the second end 1306 drives the fluid through the needle 308 and the rest of the fluid tube 300. In some embodiments, the piercing system 1300 may be configured such that, after activation, more of the needle 308 extends into the cavity 1308 than into the portion already disposed within the sterilization cavity 1357. This may help prevent contamination of the contents of the vial 1302 with the non-sterile portion of the needle 308.

[0044] The bias member 1397 may be configured to extend such that the fluid tube 300 pierces the upper part 1354 and / or the partition wall 1314 at a high speed, for example, at a speed of at least about 10 mm / second or at least about 40 mm / second. The relatively rapid piercing of the upper part 1354 and / or the partition wall 1314 through the bias member 1397 may help prevent leakage of the contents of the cavity 1308, which may be pressurized via the piston 1316.

[0045] After the drug has been delivered to the user via the needle 306, the needle 306 may be automatically withdrawn from the user. Referring to FIGS. 12-14, the translation mechanism 1366 may be operated in reverse mode such that the rotation of the main screw is in the opposite direction compared to the insertion step. This counter rotation may cause the piston 316 to return towards the first end 1304 and move the vial 1302 in the opposite direction along the shaft 40 (compared to during fluid delivery and insertion of the needle 306). The movement of the vial 1302 in the opposite direction may cause it to push against the ramp 243 of the stopper 240 on the ramp 1500 of FIG. 12 (which is attached to the wall 1391). This may deflect the stopper 240 about its fixed end 241 in the direction of arrow 240a and cause the shuttle 340 to move from its second position to its third position, allowing the needle 306 to be retracted as described above. In this way, both the withdrawal of the needle and its insertion into the patient can be achieved with a single spring within the device.

[0046] It is further contemplated that the fluid tube 300 may be the only fluid tube of the autoinjector 2 configured to provide fluid communication with the vial 1302. Thus, the drug from the vial 1302 may be deployed only through the fluid tube 300 and into the user during normal operation of the autoinjector 2. Further, the needle 306 may be the only needle of the autoinjector 2 configured to be deployed into the patient. In this way, a single piece of metal or plastic can be used to carry fluid from the vial 1302 to the patient. Sterile needle shield Referring to FIGS. 24 and 25, the self-injector 2 may include a needle cover or needle shield 2400 configured to assist in maintaining the 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 from the flange 2406 toward 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 that communicates with the remainder of the lumen 2412. The seal 2414 may include a constriction portion 2414a, an intermediate portion 2414b, and an inner sealing portion 2414c. The intermediate portion 2414b may be disposed between the constriction portion 2414a and the inner sealing portion 2414c, and of the three components, the constriction portion 2414a may be disposed closest to the second end 2404. The intermediate portion 2414b may have an inner diameter larger than that of the constriction portion 2414a, and the constriction portion 2414a may have an inner diameter larger than that of the inner sealing zone 2414c. Also, the needle shield 2400 may include a membrane 2418 that covers the opening 2410 within the flange 2406. The membrane 2418 may be formed from a gas-permeable material that does not pass liquid, 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, such that the seal 2414 does not contaminate the needle 306 when the needle shield 2400 is separated from the housing 3.

[0047] The flange 2406 and the extension 2408 may be formed from plastic or other suitable materials. On the other hand, the seal 2414 is formed from a rubber material. In another embodiment, the flange 2406 and the extension 2408 may also be formed from rubber. The rubber material may be substantially similar to the material forming the stopper 1356a described above. For example, the rubber materials forming the flange 2406, the extension 2408, and the seal 2414 may be passed through a sterilant or a sterilizing gas such as ethylene oxide or evaporated hydrogen peroxide. The rubber material may include, among other things, one or more of isoprene, ethylene propylene diene monomer (M-class) rubber (EPDM), styrene butadiene, and thermoplastic elastomer (TPE). In one embodiment, when the flange 2406 is formed from a rubber material that permeates the sterilant, the flange 2406 may not include the opening 2410 and may instead be a solid plug of material.

[0048] The needle shield 2400 may be coupled to the self-injector 2 to maintain the sterility of the needle 306, for example, during shipment of the self-injector 2, prior to use. During this coupling, the needle 306 may pierce the inner sealing portion 2414c of the seal 2414, whereby the seal 2414 forms a seal around the needle 306. That is, the inner sealing portion 2414c may initially be a closed and pierceable membrane. Alternatively, the inner sealing portion 2414c may be a constricted portion having an inner diameter smaller than that of the constricted portion 2414a, and the needle 306 may slide through this smaller constricted portion. The pierced portion (inner sealing portion 2414c) of the seal 2414 may be relatively thin, whereby the pierced portion does not significantly blunt the needle 306. The constricted portion 2414a may engage a portion of the intermediate portion 310 of the conduit 300 and form a seal around a portion of the intermediate portion 310. The intermediate portion 310 may have an outer diameter larger than the outer diameter of the needle 306. Further, 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 self-injector 2 may be sterilized via exposure to a sterilizing gas (e.g., ethylene oxide) after the needle shield 2400 is coupled to the self-injector 2. Both the lumen 2412 and the gap 2414d, the surfaces defining the lumen 2412 and the gap 2414d, and the components contained therein (such as the exposed portion of the needle 306 that pierces the patient / user's tissue, etc.) 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 self-injector 2, such that when the self-injector 2 is removed from the packaging material, the needle shield 2400 is removed from the self-injector 2. For example, the flange 2406 may be fixed to the packaging material (not shown) by an adhesive. Then, when the user pulls the self-injector 2 out of the packaging material, the needle shield 2400 detaches from the housing 3, whereby the needle 306 can be freely deployed during normal operation of the self-injector 2. In some cases, the exposed portion of the seal 2414 (and / or the constriction 2414a itself) closer to the second end 2404 than the constriction 2414a may be contaminated after sterilization. Therefore, it may be important that these contaminated surfaces do not contact the needle 306 during withdrawal of the shield 2400 from the self-injector 2. The narrower inner diameter of the inner seal portion 2414c serves to ensure that these potentially contaminated portions, particularly those portions of the needle 306 that are inserted into the patient / user's tissue, do not contact the needle 306 by keeping the extension 2408 of the shield 2400 centered during 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 portion of the extension 2408 and will remain within the self-injector 2 when the needle shield 2400 is removed. Electronic devices Figure 4A shows the control system 1400 of the auto-injector 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 supply 1406. The first electronic board 1402 may include a controller 1408, a start 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 visual 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 supply 1406. Further, the controller 1408 may be operably coupled to the translation mechanism 1366 and may be configured to control the operation of the translation mechanism 1366 to initiate and control the insertion and retraction of the needle, 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 self-injector 2 may occur, for example, on an assembly line in 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 need not be the same size as shown in FIG. 4B. For example, when 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 self-injector 2. For example, the two halves (portions 1490 and 1492) of the device may be assembled together with the filled drug vial 1302 therein. In one example, the portion 1490 and the translation mechanism 1366 may be snap-fitted in place behind the vial 1302. The portion 1490 may be a portion of the 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, such as the needle mechanism, the sterilization connector, and the piercing mechanism described herein. In this example, the electrical connection of the motor of the translation mechanism 1366 must be made behind the vial 1302 while the translation mechanism 1366 is snap-fitted in place (i.e., during the assembly step in which the portions 1490 and 1492, as well as the vial 1302, are joined to form a complete and functional self-injector 2). To accommodate such an electrical connection, the drive train of the translation mechanism 1366 may include one or more spring contacts 1494 (see FIG. 4C), and the one or more spring contacts 1494 contact pads 1495 on the first electronic board 1402 (also see FIG. 4C) during assembly. Thus, the connection to the first electronic board 1402 of the translation mechanism 1366 (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 a more complex final assembly process for a simpler device (e.g., a self-injector). As a result, the intended assembly process described herein may lead to a reduction in labor costs.

[0053] The controller 1408 may be configured to receive information from the system 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 receive information from the system and system components, process the information according to various algorithms, and generate an information signal for notifying the user of the system status, component status, procedure status, or any other useful information monitored by the system, which may be directed to the audio module 1418, the visual module 1420, the tactile module 1422, or other indicators such as, for example, the second electronic board 1404. The processor may be a digital IC processor, an analog processor, or any other suitable logic or control system that implements 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 engagement 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 the electrical circuit and indicating to the controller 1408 that the autoinjector 2 should be activated. To conserve power, the components of the autoinjector 2 may be in a standby mode or a 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 cut 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.

[0055] The touch sensor 1410 may be configured to assist the controller 1408 in determining whether the self-injector 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 distinguish contact with the skin from contact with other materials such as wood, plastic, metal, or another material. When the skin is in the vicinity of the capacitive sensing electrode, a signal indicating such contact may be sent to the controller 1408. Thus, the touch sensor 1410 may help verify that the self-injector 2 is properly positioned on the user's skin even when the switch 1409 is pressed. The touch sensor 1410 may include capacitive sensing electrodes coupled to the first electronic board 1402 and also inside the housing 3. The housing 3 and the adhesive patch 12 may function as an overlay (insulator) that serves as a dielectric between the user's skin and the capacitive sensing electrodes. The contact points of the housing 3 and / or the portion 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 the placement of the self-injector 2 on the skin surface.

[0056] The needle insertion switch 1412 may be configured to send a signal to the controller 1408 indicating that the needle 306 is deployed in the user. For example, referring 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 arranged for 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 shaft 44 and deflect the curved cantilever 1510 and the first contact 1512 towards the second contact 1514. When the first contact 1512 and the second contact 1514 connect to each other, a signal indicating that the needle 306 has been successfully deployed in the user may be sent to the controller 1408. The separation of the first contact 1512 and the second contact 1514 may indicate that the needle 306 is being retracted from the user.

[0057] Emitter 1414 and detector 1416 may operate as an optical interruption sensor, i.e., a photointerrupter, so that controller 1408 can determine the state of autoinjector 2. Emitter 1414 may be a light emitting diode (LED) or other suitable light emitter, and detector 1416 may be a phototransistor configured to receive light emitted by emitter 1414, for example. In one example, although other suitable wavelengths of light may also be used, emitter 1414 may emit infrared light. Use of infrared light may help reduce interference from external light. Emitter 1414 and detector 1416 may be disposed throughout the housing 3 relative to each other such that a beam of light 1430 can pass from emitter 1414 through vial 1302 to detector 1416. Vial 1302, and any fluid contained therein, may be at least partially transparent to beam 1430 such that beam 1430 can pass through vial 1302 and its contents. As piston 1316 is moved toward the second end 1306 during drug delivery (see FIGS. 13 and 14), piston 1316, and in particular the shoulder of piston 1316, may block beam 1430. When detector 1416 cannot detect beam 1430, a signal may be sent to controller 1408, and controller 1408 may interpret the signal as indicating the end of injection (e.g., that all of the drug contained in vial 1302 has been dispensed). In some examples, the routing of beam 1430 may be considered when positioning emitter 1414 and detector 1416 relative to each other. For example, beam 1430 may be refracted as it passes through vial 1302 and any fluid contained therein, and emitter 1414 and detector 1416 may be offset from each other correspondingly. Additionally, emitter 1414 and detector 1416 may be offset from the center of housing 3 such that the shoulder of piston 1316 can block beam 1430. In at least some examples, an optical interruption sensor or similar mechanism may help avoid false positives in the event of a drive train failure. That is, the optical switch may help controller 1408 determine that an injection was not completed with a higher degree of certainty than by other mechanisms.

[0058] The audio module 1418 may include a speaker or the like to provide audio feedback to the user. The opening in the housing 3 may facilitate the movement of sound from the audio module 1418 to the user. The audio module 1418 may generate a tone or other sound at the start and end of the injection, and / or to indicate any other benchmark during the injection. 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 indicate LEDs of different colors to provide various messages to the user. For example, a plurality of green LEDs arranged within the ring could be used to indicate the progress of the injection over time. On the other hand, red LEDs 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, 16 LEDs may be arranged within a circle having a diameter of about 26.5 mm or a diameter ranging from about 10.0 mm to about 40.0 mm. The LEDs may be activated continuously around the circle to indicate the progress of the injection (e.g., within a progress ring arranged in a manner similar to a clock - see, for example, LED 52 in FIG. 4C). Also, the controller 1408 may be configured to receive feedback from various sensors and change the scale of the speed at which various LEDs are activated based on the feedback from the sensors. For example, the LEDs within the progress ring may be activated in three or more operating phases, including, for example, an injection sequence startup phase, an injection phase, and a storage phase. Those skilled in the art will recognize that the self - injector 2 may have more or fewer than the three operating phases described above. There may also be an expected time to complete each phase, but there may be some variability in the actual time experienced during any of the above - described operating phases of the self - injector 2. The algorithm may be utilized, for example, to avoid premature activation of the LEDs when a particular phase ends earlier than expected, or to stop the progression along the ring when a particular phase takes longer than expected.At any point in time, the algorithm may divide the number of unactivated LEDs in the progress ring by the remaining time estimated for the completion of drug delivery to determine the rate at which the remaining LEDs in the progress ring should be activated.

[0059] For example, prior to the start of the infusion sequence, the LEDs may be activated at a rate equal to the estimated time of the overall drug delivery process (e.g., the time estimated to complete all of the start of infusion sequence, infusion 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 the number that is the total number of LEDs in the progress ring minus any already activated LEDs. Thus, for example, if one LED is already activated, the estimated time of the entire drug delivery process may be divided by a number less than the total number of LEDs in the progress ring.

[0060] After completion of the start of infusion sequence, the LEDs may be activated at a rate equal to the sum of the estimated times to complete the remaining phases (e.g., infusion phase and storage phase) divided by the number of unlit LEDs in the progress ring. After completion of the infusion 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] Also, the visual module 1420 may include a display screen, a touch screen, or other suitable device to provide one-way or two-way communication with the user. The visual module 1420 may be viewable by the user from outside the housing 3 through a window in the housing 3. The tactile module 1422 may include a tactile motor configured to generate vibrations that, for example, the user can feel. The vibrations may signal the start and end of the infusion 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, such as, inter alia, Bluetooth (registered trademark), Bluetooth Low Energy (BLE), infrared, cellular network, and wireless network, etc. 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 self-injector 2, information regarding the completion of the injection, and / or information regarding the error state of the self-injector 2 to the user's device or to the cloud. Signals indicating needle insertion and / or early device removal will also be transmitted via the wireless communication module. Also, the controller 1408 may receive activation commands and / or delay commands via the wireless communication module.

[0063] FIG. 16 shows an exemplary method 2000 according to the present disclosure. The method 2000 may start at step 2002 where a user may place the self-injector 2 on their body such that the tissue engagement surface 4 contacts the skin surface. The self-injector 2 may be attached at any suitable location, such as, for example, the thigh, abdomen, shoulder, forearm, upper arm, leg, buttocks, or another suitable location. The self-injector 2 may be fixed to the skin by the adhesive patch 12. Fixing the self-injector 2 in step 2002 may cause the activation switch 1409 extending outwardly from the tissue engagement surface 4 to be pressed, completing the circuit. Completion of the circuit may cause a signal to be transmitted to the controller 1408 to transition from the power-saving sleep mode to the active mode. Alternatively, any other suitable mechanism may power on or otherwise activate the self-injector 2 before or after step 2002.

[0064] When the self-injector 2 is activated at step 2002, method 2000 may proceed to step 2004 where the controller 1408 determines whether the tissue engagement surface 4 is disposed on the skin surface. At step 2004, the controller 1408 may receive a measurement from the touch sensor 1410 indicating whether the self-injector 2 is disposed on the skin or another surface. For example, when the capacitance value received from the touch sensor 1410 is within a predetermined range, and the controller 1408 determines that the touch sensor 1410 is in contact with the skin, method 2000 may proceed to step 2008. For example, when the capacitance measurement received from the touch sensor 1410 indicates that the self-injector 2 is in contact with a non-skin surface such as wood or metal, and the controller 1408 determines that the touch sensor is not in contact with the skin, method 2000 may proceed to step 2006. At step 2006, the self-injector 2 may be placed in an error state. In the error state, 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 the display screen. In some examples, the self-injector 2 may need to be manually reset before the injection is completed. In other examples, the self-injector 2 may loop back to step 2004 where the controller 1408 attempts to continuously determine whether the touch sensor 1410 is in contact with the skin. Also, method 2000 may require that the touch sensor 1410 be in contact with the skin throughout the entire injection. Thus, at any point during the injection, if 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 stopping additional movement of the translation mechanism 1366), generate an error signal or message, and retract the needle 306 if the needle 306 is not already 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 towards the second end 1306 of the vial 1302 (see FIGS. 13 and 14), moving the vial 1302 itself in the same direction. This may move the needle 308 in the opposite direction in order to access the vial 1302 as described above. The movement of the driver 1398 and the needle 308 moves the carrier 202 in the same direction, which accounts for a series of events that ultimately deploy the needle 306 into the user by the mechanism described in FIGS. 5-11. The translation mechanism 1366 continues to move towards the second end 1306 until the desired amount of drug contained in the vial 1302 has been metered out to the user.

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

[0067] In some examples, the timing of the injection procedure measured from the initial activation of the activation switch 1409 to the storage 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, from about 30 seconds to about 45 seconds, or 120 seconds or less, or 90 seconds or less, or 60 seconds or less, or 45 seconds or less, or 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 to the user, whether power source 1406 has enough energy to complete the injection, whether the needle 306 is deployed and / or stored prematurely, whether the current of the motor of the translation mechanism 1366 is within an appropriate range, and whether the injection procedure has extended beyond the maximum allowable procedure time. When controller 1408 detects any of the above errors, controller 1408 may communicate such an error to the user and may, for example, pause or reverse translation mechanism 1366 and end the ongoing injection by storing the needle 306 from the user. Alternative embodiments Another embodiment of the needle mechanism is shown in FIGS. 17-19. The needle mechanism 2400 may include a base 2402 and a shuttle 2420. The base 2402 may have an extension member 2404 that extends away from the upper surface of the base 2402. Further, the base 2402 may include a channel 2406 that extends along the longitudinal axis of the base 2402 (parallel to axis 40) and is located deep within the upper surface of the base 2402. The channel 2406 may extend through the first wall 2407 and the second wall 2408 of the base 2402 and may extend through the extension member 2404. The extension member 2404 may include, for example, a slot 2410 that extends from an upper portion of the extension member 2404 through a portion of the base 2402 and toward the bottom surface of the base 2402. The slot 2410 is generally disposed perpendicular to the channel 2406 and may extend parallel to 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 each other. The first and second walls 2426, 2428 may be spaced apart by a distance equal to the width of the base 2402 to allow the base 2402 to translate with respect to the shuttle 2420. The opening 2424 may extend through the end member 2422 and 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 a first undeployed configuration. The first slot 2430 may be disposed adjacent to and longitudinally spaced 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 the bottom to the 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 described 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 that of the removal ramp. The shallower injection ramp may provide a mechanical advantage point. On the other hand, the portion rests and helps overcome static friction. The first curved portion allows insertion of a needle (e.g., the needle 306 described above) into the user for drug administration and the second curved portion allows removal of the needle 306 from the user. Also, the second wall 2428 may include two slots and an opening similar to the slots 2430 and 2432 and the opening 2434. The slots and opening of the second wall 2428 may be arranged in a similar or identical manner to the slots and opening disposed in the wall 2426.

[0071] In addition, the needle mechanism 2400 may include an elastic member or spring (not shown) coupled to the shaft 2456. The shaft 2456 may be disposed in the opening 2424 of the shuttle 2420. The shaft 2456 may be coupled to the protrusion 2454. The protrusion 2454 may slide through the elongated hole 2410 of the extension 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 extend to longitudinally slide the shuttle 2420 relative to the shaft 2456 along the longitudinal axis 40. Due to the curvature of the elongated holes 2430 and 2432, the longitudinal force applied to the shuttle 2420 also pushes the shuttle 2420 downward. Also, this downward movement moves the protrusion 2454 downward through the elongated hole 2410 and deploys the needle 306. When the needle mechanism 2400 is in the deployed configuration, the pins 2412 and 2414 are disposed at the connection between the peak or the injection and removal ramps of the elongated holes 2430 and 2432. Further, the protrusion 2454 is disposed at or near the center of the opening 2434. Also, the protrusion 2454 is disposed near the center of the elongated hole 2410 between the upper surface of the extension member 2404 and the bottom of the elongated hole 2410. The shaft 2456 may extend from within the opening 2424 beyond the end of the shuttle 2420.

[0073] When the drug is administered, the injection needle 470 may be removed by allowing the spring to further extend. The additional extension of the spring longitudinally slides the shuttle 2420 further relative to the shaft 2456 along the longitudinal axis 40. Due to the curvature of the elongated holes 2430 and 2432, the additional longitudinal force applied to the shuttle 2420 pushes the shuttle 2420 upward. Also, this upward movement moves the protrusion 2454 upward through the elongated hole 2410 and retracts the needle 306. The protrusion 2454 may be disposed in the drive member opening 2434 at the end closest to the end face 2422. Further, the protrusion 2454 is disposed near the upper portion of the elongated hole 2410. The shaft 2456 may extend even further from within the opening 2424 beyond the end of the shuttle 2420.

[0074] Another embodiment of the 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 tube (such as the fluid tube 300 described above), and may be configured to drive a needle at the end of the fluid tube 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, may be substantially parallel to each other, 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 the direction 3380 along the longitudinal axis 40, the second rack 3344 may rotate the gear 3360 in a first direction (e.g., counterclockwise). On the other hand, the first rack 3342 may move the gear 3360 in a second direction opposite to 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 via the rack 3222 and drive 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 the user. Extension of the spring 3370, which may be coupled to both the carrier 3302 and the inner surface of the shuttle 3340, may move the shuttle 3340 in the direction 3380 to initiate deployment and subsequent retraction of the needle. Further, it is contemplated that a stop similar to the stop 240 may be used to prevent 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 the needle assembly is shown in FIG. 21. The needle assembly 4000 includes a carrier 4202 and a driver (not shown except via protrusion 330). Also, although not shown, the needle assembly 4000 may include the following components, which may be substantially similar to the components described above by the same names, such as a shuttle, deployment gears and retraction gears, and a spring. The driver of the needle assembly 4000 may be coupled to a fluid tube (such as fluid tube 300), and may be configured to move the needle at the end of the fluid tube into the user. In the undeployed configuration (shown in FIG. 21), the protrusion 330 of the driver may be blocked by an obstacle 4600. The carrier 4202 may be driven in direction 4002 to allow the protrusion 330 to slide downwardly past the lamp 4602 and move the driver and associated needle from the retracted configuration to the deployed configuration. The carrier 4202 may be driven in direction 4002 by, for example, a translation mechanism 1366 and a vial 1302 in a manner substantially similar to that described above with respect to carrier 202.

[0076] The needle assembly 4000 may include a stopper 4240 that is separate from the carrier 4202. The stopper 4240 may be driven in direction 4004 by a spring 4241. The end of the stopper 4240 may include an overhang 4242 that may serve to maintain the driver in the deployed configuration by blocking the retraction path of the protrusion 330. Thus, when the driver is deployed, the protrusion 330 may be positioned directly beneath the overhang 4242 of the stopper 4240, preventing retraction of the driver until the stopper 4240 is moved. Retraction of the driver and needle may be accomplished by applying a force to the stopper 4240 in direction 4002 via one or more mechanical couplings (not shown) to compress the spring 4241, for example, by reversing the motor of the translation mechanism 1366. Movement of the stopper 4240 in direction 4002 may provide a gap for the protrusion 330 to move back to the retracted configuration.

[0077] Yet another embodiment of the needle assembly is shown in FIGS. 22 and 23. The needle assembly 5300 includes a carrier 5302. In this embodiment, the stopper 5240 may be configured to directly interfere with the rotation of the deployment gear and / or the retraction gear 5360, rather than directly interfering with 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 the deployment and / or retraction of the 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 stopper 5240 may include an aperture 5380 through which the toggle 5362 may be disposed. The aperture 5380 may include a circular portion 5382 and a limiting portion 5384. The circular portion 5382 may have a diameter larger than the length of the toggle 5362 to allow for unimpeded rotation of the toggle 5362 (and the gear 5360). On the other hand, the toggle 5362 is disposed within the circular portion 5382. The stopper 5240 may be slidable relative to the carrier 5302 by any suitable mechanism. When the stopper 5240 and the carrier 5302 are slid relative to each other, 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 to "one embodiment" or "an embodiment" in this specification mean that a particular feature, structure, or characteristic described in connection with the embodiment may be included in, utilized in, and / or incorporated into one, some, or all of the embodiments of the present disclosure. The use or occurrence of the phrase "in one embodiment" or "in another embodiment" in the specification does not refer to the same embodiment, but rather separate or alternative embodiments do not necessarily exclude one another and are not limited to a single exclusive embodiment. The same applies to the terms "embodiments" and "examples". The present disclosure is not limited to any single aspect or its embodiments, nor to any combination and / or permutation of such aspects and / or embodiments. Furthermore, each aspect of the present disclosure and / or its embodiments may be used alone or in combination with one or more of the other aspects of the present disclosure and / or its embodiments. For the sake of simplicity, certain permutations and combinations are not separately described and / or illustrated in this specification.

[0080] Furthermore, as indicated above, embodiments or implementations described herein as "exemplary" should not be construed as preferred or advantageous over, for example, other embodiments or implementations. Rather, it is intended to convey or indicate that one or more embodiments are exemplary embodiments.

Claims

1. A syringe, comprising: a housing; a drug container disposed within the housing; a fluid tube having a movable puncture end and a container end; wherein in a first configuration, the fluid tube is completely housed within the housing; in a second configuration, the movable puncture end of the fluid tube extends outside the housing; and in a third configuration, the fluid tube is completely housed within the housing; a seal coupled to the drug container and impermeable to gaseous sterilant; a stopper adjacent to the seal and permeable to the gaseous sterilant; in a first position, the container end of the fluid tube is disposed within the stopper and is not in fluid communication with the drug container; a syringe.

2. The syringe according to claim 1, wherein the container end of the fluid tube is movable through the stopper and the seal to a second position; in the second position, the container end is in fluid communication with the drug container; a syringe.

3. The syringe according to claim 1, further comprising a shield covering an opening of the housing, wherein the shield comprises a material that is permeable to the gaseous sterilant and impermeable to liquid; a syringe.

4. The syringe according to claim 1, wherein the seal is disposed to close an opening at one end of the drug container; a syringe.

5. The syringe according to claim 1, wherein after being exposed to the gaseous sterilant in the first position, the container end of the fluid tube disposed within the stopper is configured to maintain a sterile state within the housing; a syringe.

6. The syringe according to claim 1, wherein the stopper comprises one or more of isoprene, ethylene propylene diene monomer (M-class) rubber (EPDM), or styrene butadiene; a syringe.

7. The syringe according to claim 1, wherein the stopper is permeable to one or both of ethylene oxide and evaporated hydrogen peroxide; a syringe.

8. The syringe according to claim 1, wherein the syringe is configured to allow the gaseous sterilant to enter the housing through an opening of the housing or a shield covering the opening when the gaseous sterilant is disposed outside the housing; a syringe.

9. The syringe according to claim 1, wherein the stopper comprises rubber; Syringe.

10. The syringe according to claim 1, wherein the syringe, (i) the movable puncturing end is in the first configuration and the fluid tube is completely housed within the housing, (ii) the drug container is disposed within the housing, (iii) the internal space of the fluid tube is sealed from the liquid disposed outside the housing, and is configured to enable sterilization of the fluid tube by the gaseous sterilant disposed outside the housing in this state. Syringe.

11. The syringe according to claim 1, wherein a predetermined portion inside the housing is not configured to maintain a sterilized state after the syringe has been exposed to the gaseous sterilant. Syringe.

12. The syringe according to claim 1, wherein the syringe further includes a needle shield and is disposed within a package, and removal of the syringe from the package causes the needle shield to be removed from the syringe. Syringe.

13. A method for sterilizing a non-sterile syringe, comprising exposing the non-sterile syringe to a sterilant outside the housing of the non-sterile syringe while a drug container is completely housed within the housing of the non-sterile syringe, and sterilizing at least a portion of a fluid tube completely housed within the housing of the non-sterile syringe, wherein the fluid tube includes a movable puncturing end, and in a first configuration, the fluid tube is completely housed within the housing, in a second configuration, the movable puncturing end extends outside the housing, and other portions of the fluid tube are housed within the housing, and in a third configuration, the fluid tube is completely housed within the housing. Method.

14. The method according to claim 13, wherein while the non-sterile syringe is being exposed to the sterilant, the non-sterile syringe is in an assembled configuration, and in the assembled configuration, the non-sterile syringe is configured to extend the movable puncturing end of the fluid tube outside the housing through the housing and be actuated to deliver a drug through the fluid tube. Method.

15. The method according to claim 13, wherein while the non-sterile syringe is being exposed to the sterilant, the container end of the fluid tube is disposed within a stopper. Method.

16. The method according to claim 13, wherein while the non-sterile syringe is being exposed to the sterilant, the container end of the fluid tube is disposed within a stopper. The stopper is permeable to one or both of ethylene oxide and evaporated hydrogen peroxide. Method. **Claim 17** The method according to claim 13, while the non-sterile syringe is exposed to the sterilant, the container end of the fluid tube is disposed within the stopper, the stopper includes one or more of isoprene, ethylene propylene diene monomer (M-class) rubber (EPDM), or styrene butadiene. Method. **Claim 18** The method according to claim 13, while the non-sterile syringe is exposed to the sterilant, the container end of the fluid tube is disposed within the stopper, the stopper contains rubber. Method. **Claim 19** The method according to claim 13, the sterilant is configured to enter the housing through the opening of the housing or a shield covering the opening. Method. **Claim 20** The method according to claim 13, after the non-sterile syringe has been exposed to the sterilant, a predetermined portion inside the housing is not configured to maintain a sterile state. Method.

Images