Autoinjector and related methods of use

Abstract

In one example, there is disclosed herein an autoinjector, the autoinjector comprising: a housing; a container disposed within the housing, the container being configured to store a medicament; a canister disposed within the housing, the canister configured to release a pressurized medium to expel the medicament from the container; a shroud coupled to the housing, the shroud configured to move relative to the housing between a first position and a second position to cause the pressurized medium to be released by the canister; and a mandrel assembly disposed within the housing, the mandrel assembly configured to push the shroud outwardly relative to the housing toward the first position after the pressurized medium is released by the canister.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 509,214, filed June 20, 2023, and U.S. Provisional Application No. 63 / 587,389, filed October 2, 2023, the entire application of which is incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure relate to apparatus and methods for delivering fluid from a needle into a user's body using a mechanism (e.g., a pressurized medium) that automatically controls the injection of the needle and fluid. More specifically, embodiments of this disclosure relate to an autoinjector and method for delivering a drug to a user by exposing the injection needle to the outside of the autoinjector when a dose of the drug is released via the injection needle and automatically retracting the injection needle into the autoinjector after the drug has been released via the injection needle.

[0003] Foreword In various available autoinjectors, a needle is deployed upon user activation, and fluid is delivered from the needle into the user's body. Once fluid delivery is complete, the needle can be withdrawn to ensure user comfort, needle safety, and a positive experience with the product. However, many autoinjectors require individual user action to insert and remove the needle. Additionally, many autoinjectors must remain attached to the user for extended periods, which can be inconvenient. Attached Figure Description

[0004] The accompanying drawings, incorporated in and constituting a part of this patent specification, illustrate various exemplary embodiments and, together with the specification, serve to explain the principles of the disclosed embodiments. The drawings illustrate different aspects of this disclosure, and where appropriate, reference numerals showing similar structures, components, materials, and / or elements in different drawings are similarly labeled. It should be understood that, apart from those specifically shown, various combinations of structures, components, and / or elements in the various embodiments are contemplated and are within the scope of this disclosure.

[0005] This document describes and illustrates numerous embodiments. The described apparatus and methods are neither limited to any single aspect or embodiment thereof, nor to any combination and / or arrangement of such aspects and / or embodiments. Furthermore, aspects of the described invention and / or its embodiments may be used alone or in combination with one or more other aspects of the described invention and / or its embodiments. For the sake of brevity, certain arrangements and combinations are not discussed and / or described separately herein.

[0006] Based on the examples in this disclosure, Figure 1 This is a perspective view of an autoinjector.

[0007] Based on the examples in this disclosure, Figures 2 to 3 for Figure 1 A perspective view of the chassis and container of an auto-injector.

[0008] Based on the examples in this disclosure, Figures 4 to 7 for Figure 1 A partial perspective view of the cap and shield of an autoinjector.

[0009] Based on the examples in this disclosure, Figures 8 to 9 for Figure 1 A perspective view of the shield of an autoinjector.

[0010] Based on the examples in this disclosure, Figure 10 for Figure 1 A perspective view of the actuator and canister of an auto-injector.

[0011] Based on the examples in this disclosure, Figure 11 for Figure 1 Cross-sectional view of the actuator and canister of an auto-injector.

[0012] Based on the examples in this disclosure, Figures 12A to 12B To move from the pre-startup state to the startup state Figure 1 Cross-sectional view of the actuator and canister of an auto-injector.

[0013] Based on the examples in this disclosure, Figures 13A to 13B To move from the pre-startup state to the startup state Figure 1 A cross-sectional view of the canister of an auto-injector.

[0014] Based on the examples in this disclosure, Figure 14 for Figure 1 Cross-sectional view of the shield and chassis of the automatic injector.

[0015] Based on the examples in this disclosure, Figure 15 for Figure 1 Cross-sectional view of the canister and carrier of an auto-injector.

[0016] Based on the examples in this disclosure, Figures 16A to 16B To move from the pre-startup state to the startup state Figure 1 A perspective view of the indicator of an auto-injector.

[0017] Based on the examples in this disclosure, Figures 17A to 17B To move from the pre-startup state to the startup state Figure 1 A perspective view of the indicator of an auto-injector.

[0018] Based on the examples in this disclosure, Figures 18A to 18C For moving between multiple states Figure 1 A cross-sectional view of the sliding piston of an autoinjector.

[0019] Based on the examples in this disclosure, Figures 19A to 19C For moving between multiple states Figure 1 Cross-sectional view of the spindle assembly and collar of an autoinjector.

[0020] Based on the examples in this disclosure, Figures 20A to 20B To move from the pre-startup state to the startup state Figure 1 A cross-sectional view of the carrier of an auto-injector.

[0021] Based on the examples in this disclosure, Figures 21A to 21C For moving between multiple states Figure 1 A perspective view of the chassis and spindle assembly of an autoinjector.

[0022] Based on the examples in this disclosure, Figures 22A to 22C For moving between multiple states Figure 1 A cross-sectional view of the shield and sliding piston of an autoinjector.

[0023] Based on the examples in this disclosure, Figures 23A to 23B To move from the pre-start state to the pre-lock state Figure 1 A perspective view of the chassis and actuator of an auto-injector.

[0024] Based on the examples in this disclosure, Figures 24A to 24B To move from the pre-start state to the pre-lock state Figure 1 Cross-sectional view of the spindle assembly of an autoinjector.

[0025] Based on the examples in this disclosure, Figures 25A to 25B for Figure 1 A cross-sectional view of the guard and valve assembly of an autoinjector.

[0026] Based on the examples in this disclosure, Figure 26 for Figure 1 A perspective view of the actuator and carrier of an auto-injector.

[0027] Based on the examples in this disclosure, Figure 27 for Figure 1 A perspective view of the actuator and shield of an auto-injector.

[0028] Based on the examples in this disclosure, Figure 28 for Figure 1 A cross-sectional view of the indicator of an auto-injector.

[0029] Based on the examples in this disclosure, Figures 29 to 30 To move from the pre-startup state to the startup state Figure 1 A perspective view of the sliding piston of an autoinjector.

[0030] Based on the examples in this disclosure, Figure 31for Figure 1 A cross-sectional side view of the actuator and carrier of an autoinjector.

[0031] Based on the examples in this disclosure, Figure 32 for Figure 1 A cross-sectional view of the canister of an auto-injector.

[0032] Based on the examples in this disclosure, Figure 33 for Figure 1 Cross-sectional view of the shield and carrier of the auto-injector.

[0033] Based on the examples in this disclosure, Figure 34 For horizontal configuration Figure 1 A perspective view of the valve assembly of an autoinjector.

[0034] Based on the examples in this disclosure, Figure 35 For those with vertical configuration Figure 1 A perspective view of the valve assembly of an autoinjector.

[0035] Based on the examples in this disclosure, Figures 36 to 42 for Figure 1 A partial view of the components of the valve assembly of an autoinjector.

[0036] Based on the examples in this disclosure, Figure 43 for Figure 1 A schematic diagram of the pressure sensing system of an automatic injector.

[0037] Based on the examples in this disclosure, Figures 44 to 46 for Figure 1 A schematic diagram of the drive system for an automatic injector.

[0038] Based on the examples in this disclosure, Figures 47 to 50 For including secondary indicators Figure 1 A perspective view of an autoinjector.

[0039] Based on the examples in this disclosure, Figures 51 to 52 for Figures 47 to 50 A schematic diagram of an auto-injector.

[0040] Based on the examples in this disclosure, Figures 53A to 53C For a secondary indicator with indicated dose status Figures 47 to 50 A side view of an autoinjector.

[0041] Based on the examples in this disclosure, Figures 54 to 55 For positioning against the injection site Figures 47 to 50 A partial view of an autoinjector.

[0042] Based on the examples in this disclosure, Figures 56 to 57 A perspective view of another exemplary autoinjector.

[0043] Based on the examples in this disclosure, Figure 58 For including secondary indicators Figures 56 to 57 A schematic diagram of an auto-injector.

[0044] Based on the examples in this disclosure, Figures 59 to 60 A perspective view of another exemplary autoinjector.

[0045] Based on the examples in this disclosure, Figures 61 to 62 for Figures 59 to 60 A schematic diagram of an auto-injector.

[0046] Based on the examples in this disclosure, Figures 63 to 64 A perspective view of another exemplary autoinjector.

[0047] Based on the examples in this disclosure, Figures 65 to 66 for Figures 63 to 64 A schematic diagram of an auto-injector.

[0048] Based on the examples in this disclosure, Figures 67 to 68 This is a side view of another exemplary autoinjector.

[0049] Based on the examples in this disclosure, Figures 69 to 70 A perspective view of another exemplary autoinjector.

[0050] Based on the examples in this disclosure, Figures 71 to 72 for Figures 69 to 70 A schematic diagram of an auto-injector.

[0051] Based on the examples in this disclosure, Figure 73 for Figures 69 to 70 A side view of an autoinjector.

[0052] Based on the examples in this disclosure, Figures 74 to 75 A perspective view of another exemplary autoinjector.

[0053] Based on the examples in this disclosure, Figures 76 to 77 for Figures 74 to 75 A schematic diagram of an auto-injector.

[0054] Based on the examples in this disclosure, Figure 78 for Figures 74 to 75 A side view of an autoinjector.

[0055] Based on the examples in this disclosure, Figures 79 to 80 A perspective view of another exemplary autoinjector.

[0056] Based on the examples in this disclosure, Figures 81 to 82 for Figures 79 to 80 A schematic diagram of an auto-injector.

[0057] Based on the examples in this disclosure, Figure 83 for Figures 79 to 80 A side view of an autoinjector.

[0058] Based on the examples in this disclosure, Figures 84 to 85 A perspective view of another exemplary autoinjector.

[0059] Based on the examples in this disclosure, Figures 86 to 87 for Figures 84 to 85 A schematic diagram of an auto-injector.

[0060] Based on the examples in this disclosure, Figures 88 to 89 A perspective view of another exemplary autoinjector.

[0061] Based on the examples in this disclosure, Figure 90 For including secondary indicators Figures 88 to 89 A side view of an autoinjector.

[0062] Based on the examples in this disclosure, Figure 91 This is a side view of another exemplary autoinjector.

[0063] Based on the examples in this disclosure, Figures 92 to 93 for Figure 91 A schematic diagram of an auto-injector.

[0064] Based on the examples in this disclosure, Figure 94 A perspective view of another exemplary autoinjector.

[0065] Based on the examples in this disclosure, Figure 95 A perspective view of another exemplary autoinjector.

[0066] Based on the examples in this disclosure, Figure 96 A perspective view of another exemplary autoinjector.

[0067] Based on the examples in this disclosure, Figure 97 for Figures 63 to 64 A partial view of an autoinjector.

[0068] Based on the examples in this disclosure, Figure 98 for Figures 79 to 80 A partial view of an autoinjector.

[0069] Based on the examples in this disclosure, Figure 99 for Figures 84 to 85 A partial view of an autoinjector.

[0070] Based on the examples in this disclosure, Figure 100 for Figure 91 A partial view of an autoinjector.

[0071] Based on the examples in this disclosure, Figure 101This is a perspective view of an exemplary autoinjector.

[0072] Based on the examples in this disclosure, Figures 102A to 102C for Figure 101 A schematic diagram of the drive system for an automatic injector.

[0073] Based on the examples in this disclosure, Figure 103 for Figure 101 An exploded perspective view of an autoinjector.

[0074] Based on the examples in this disclosure, Figure 104 for Figure 101 A cross-sectional perspective view of a portion of an autoinjector.

[0075] Based on the examples in this disclosure, Figures 105A to 105B for Figure 101 A partial perspective view of an autoinjector.

[0076] Based on the examples in this disclosure, Figure 106 for Figure 101 A partial perspective view of the initiator of an autoinjector.

[0077] Based on the examples in this disclosure, Figure 107 for Figure 106 A partial side view of the launcher.

[0078] Based on the examples in this disclosure, Figures 108A to 108D for Figure 107 A partial view of the keyed arrangement of the launcher.

[0079] Based on the examples in this disclosure, Figures 109 to 110 For moving between multiple locations Figure 107 A cross-sectional view of the starter.

[0080] Based on the examples in this disclosure, Figures 111A to 111C for Figure 101 A schematic diagram of the needle mechanism of an automatic injector.

[0081] Based on the examples in this disclosure, Figures 112 to 113 for Figure 101 A perspective view of the peeling strip of an auto-injector.

[0082] Based on the examples in this disclosure, Figures 114 to 115 For coupling to Figure 101 auto-injector Figures 112 to 113 Cross-sectional view of the peeling strip.

[0083] Based on the examples in this disclosure, Figures 116 to 117 For coupling to Figure 101 auto-injector Figures 112 to 113A partial perspective view of the peeled-off sheet.

[0084] Based on the examples in this disclosure, Figure 118 For coupling to Figure 101 auto-injector Figures 112 to 113 Cross-sectional view of the peeling strip.

[0085] Based on the examples in this disclosure, Figures 119A to 119B for Figure 101 A perspective view of the carrier of an auto-injector.

[0086] Based on the examples in this disclosure, Figures 120A to 120B for Figure 101 A perspective view of another exemplary carrier of an autoinjector.

[0087] Based on the examples in this disclosure, Figure 121 for Figures 119A to 119B A perspective view of the carrier.

[0088] Based on the examples in this disclosure, Figure 122 for Figure 101 A perspective view of the initiator of an auto-injector.

[0089] Based on the examples in this disclosure, Figure 123 for Figure 101 A perspective view of the gears of an auto-injector.

[0090] Based on the examples in this disclosure, Figure 124 for Figure 101 A perspective view of the actuator of an auto-injector.

[0091] Based on the examples in this disclosure, Figures 125 to 126 for Figure 124 Side view of the driver.

[0092] Based on the examples in this disclosure, Figures 127 to 129 for Figure 101 A perspective view of the button on an auto-injector.

[0093] Based on the examples in this disclosure, Figures 130 to 132 for Figure 101 A perspective view of the shuttle actuator and indicator slider of an auto-injector.

[0094] Based on the examples in this disclosure, Figure 133 for Figure 101 A perspective view of the fluid conduit of an autoinjector.

[0095] Based on the examples in this disclosure, Figure 134 To assemble Figure 101 The sterile connector for the auto-injector Figure 133 fluid conduits and Figures 124 to 126 A perspective view of the driver.

[0096] Based on the examples in this disclosure, Figure 135 For coupling to Figure 123 gears, Figures 124 to 126 The driver, Figure 133 fluid conduits and Figures 130 to 132 shuttle actuator Figure 101 A perspective view of the carrier of an auto-injector.

[0097] Based on the examples in this disclosure, Figure 136 for Figure 101 Exploded perspective view of the valve assembly of an autoinjector.

[0098] Based on the examples in this disclosure, Figures 137 to 141 for Figure 136 A perspective view of the valve assembly.

[0099] Based on the examples in this disclosure, Figure 142 for Figure 136 A perspective view of the diaphragm of the valve assembly.

[0100] Based on the examples in this disclosure, Figure 143 for Figure 142 A cross-sectional side view of the diaphragm.

[0101] Based on the examples in this disclosure, Figure 144 To set Figure 136 Valve assembly Figure 142 A cross-sectional side view of the diaphragm.

[0102] Based on the examples in this disclosure, Figures 145A to 145B for Figure 136 A side view of the discharge system of the valve assembly.

[0103] Based on the examples in this disclosure, Figures 146A to 146D This is a cross-sectional view of the mandrel assembly.

[0104] Based on the examples in this disclosure, Figures 147A to 147B These are perspective and cross-sectional views of the locked window, respectively.

[0105] Based on the examples in this disclosure, Figures 148A to 148C This is a cross-sectional view of the mandrel assembly.

[0106] Based on the examples in this disclosure, Figures 149A to 149C This is a schematic diagram of the drive system.

[0107] Based on the examples in this disclosure, Figure 150 This is a perspective view of the valve assembly.

[0108] Based on the examples in this disclosure, Figure 151A and Figure 151B This is a cross-sectional view of the actuator and starter.

[0109] Based on the examples in this disclosure, Figure 152 This is a perspective view of an autoinjector.

[0110] Based on the examples in this disclosure, Figure 153A and Figure 153B These are side views of the actuator and the pivot joint, respectively.

[0111] Based on the examples in this disclosure, Figure 154 A perspective view of the starter and valve assembly.

[0112] Based on the examples in this disclosure, Figure 155 Perspective view of the shield and chassis.

[0113] Based on the examples in this disclosure, Figure 156A and Figure 156B These are perspective and cross-sectional views of the protective cover and chassis, respectively.

[0114] Based on the examples in this disclosure, Figure 157A and Figure 157B These are perspective and cross-sectional views of the protective cover and chassis, respectively.

[0115] Based on the examples in this disclosure, Figure 158 This is a cross-sectional view of an autoinjector.

[0116] Based on the examples in this disclosure, Figures 159A to 159C This is a side view of an autoinjector.

[0117] Based on the examples in this disclosure, Figure 160A and Figure 160B This is a cross-sectional view of the shield and cap.

[0118] This document describes and illustrates numerous embodiments. This disclosure is neither limited to any single aspect or embodiment thereof, nor to any combination and / or arrangement of such aspects and / or embodiments. Aspects of this disclosure and / or embodiments thereof may be employed individually or in combination with one or more other aspects of this disclosure and / or embodiments thereof. For the sake of brevity, many such combinations and arrangements are not discussed separately herein.

[0119] It is worth noting that, for the sake of simplicity and clarity, certain aspects of the drawings illustrate the general structure and / or construction of various embodiments. Descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring other features. Elements in the drawings are not necessarily drawn to scale; the dimensions of some features may be exaggerated relative to other elements to improve understanding of the exemplary embodiments. For example, those skilled in the art will understand that cross-sectional views are not drawn to scale and should not be considered as representations of proportional relationships between different components. Cross-sectional views are provided to help illustrate the various components of the illustrated elements and to show their relative positioning to each other. Detailed Implementation

[0120] Reference will now be made in detail to examples of this disclosure shown in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. Embodiments of this disclosure can be used with any type of product containing fluids, such as liquid pharmaceutical substances, liquid placebos, or other liquids that can be dispersed in dosage forms. Unless otherwise specified, in the discussion below, the terms “about,” “approximately,” “substantially,” etc., when used to describe numerical values, indicate a variation of that value by + / - 10%.

[0121] As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “exemplary” means “example,” not “ideal.” It is important to note that embodiments or implementations described herein as “examples” or “exemplary” should not be construed as being preferred or advantageous, for example, relative to other embodiments or implementations; rather, they are intended to reflect or indicate that an embodiment is an “example,” not an “ideal.” As used herein, the terms “top,” “bottom,” “upper,” “lower,” “lateral,” and “radial” refer to the position (or portion) of the arrangement of the apparatus illustrated in the figures. The terms “vertical,” “vertically,” “horizontally,” “horizontally,” “upward,” “downward,” “lateral,” and “radial” refer to the direction or orientation of the arrangement of the apparatus illustrated in the figures. Furthermore, the terms “first,” “second,” etc., used herein do not indicate any order, quantity, or importance, but are used to distinguish an element, structure, step, or process from another element, structure, step, or process. Furthermore, the terms “one” and “a” used in this article do not indicate a quantity limitation, but rather the presence of one or more of the cited items.

[0122] Some conventional autoinjectors may require multiple user interactions to administer medication, including separate user interactions for example, to deploy the needle and subsequently withdraw it after medication delivery. These additional steps increase the complexity of self-administration, introduce user error, and cause user discomfort. Therefore, this disclosure relates to various embodiments of injection devices (e.g., autoinjectors) that simplify user self-administration of medications or other therapeutic agents. Specifically, according to some embodiments, once the needle is subcutaneously inserted into the user's body, the autoinjector can withdraw the needle without any additional user interaction. Thus, the autoinjector of this disclosure is simplified to help prevent misuse or user error. Additionally, some conventional autoinjectors require multiple components and user operations to administer medication, including various spring or motor mechanisms. These additional components increase manufacturing complexity and introduce mechanical failure or user error. Therefore, this disclosure relates to various embodiments of injection devices (e.g., autoinjectors) that simplify and improve the administration of medications or other therapeutic agents. The autoinjector disclosed herein may include one or more components substantially similar to those described in International PCT Application PCT / US2020 / 040729 (published as WO 2021 / 003409) and International PCT Application PCT / US2021 / 065567 (published as WO 2022 / 147166), each of which is incorporated herein by reference.

[0123] In at least some embodiments, the handheld autoinjector may require the user to keep the autoinjector against the user's skin throughout the injection process. In some embodiments, the handheld autoinjector according to this disclosure may be configured to deliver a volume of less than 3.5 mL (or a volume of about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, or about 3.5 mL). The volume of the drug may be referred to herein as a "dose". Furthermore, the handheld autoinjector according to this disclosure may be configured to complete the injection process as measured from (1) the time when the user places the autoinjector on the skin to (2) the time when the user removes the autoinjector from the skin after the injection is completed, said process being less than about 30 seconds, less than about 25 seconds, less than about 20 seconds, less than about 15 seconds, or less than about 10 seconds. As described herein, an early-lift event may occur when the user removes the autoinjector from the skin before the injection is completed. The autoinjector disclosed herein can be configured and operated to initiate a latch-up in response to the occurrence of an early lift event or the completion of dose delivery, thereby inhibiting further use of the autoinjector and / or restarting to ensure user safety.

[0124] Now for reference Figure 1An exemplary autoinjector 100 is illustrated according to an example of this disclosure. The autoinjector 100 may include a housing 102 having a longitudinal length defined between a tip 104 and a bottom 106, and a cap 111 coupled to the bottom 106. The cap 111 may be detachably coupled to the bottom 106, and the bottom 106 may define a user engagement surface along an external interface of the bottom 106, the needle (see [link to documentation]). Figures 2 to 3 The autoinjector 100 can be deployed from and retracted into the housing 102 via the user engagement surface. The top 104 may define a user interface surface from which the user can control the autoinjector 100, such as by manually gripping the housing 102 during use of the autoinjector 100. It should be understood that, for illustrative purposes, the housing 102... Figure 1 The central portion is drawn transparently to show the internal components of the autoinjector 100.

[0125] The autoinjector 100 may include a container 112, a chassis 130, a carrier 140, a canister 150 (e.g., a fluid source), a valve assembly 160, and an indicator assembly 170 housed between a top end 104 and a bottom end 106 of a housing 102. The housing 102 may include one or more windows to facilitate visual inspection of the internal components of the autoinjector 100 during use, such as visually observing the current operational status of the autoinjector 100. In this example, the housing 102 may include a first window 108 formed along the outer surface of the housing 102 and extending vertically between the top end 104 and the bottom end 106 along the portion of the housing 102 aligned with the container 112. Therefore, the container 112 and the piston 114 disposed therein can be visually observed from the outside of the housing 102 via the first window 108, and specifically, the contents of the container 112 and the relative position of the piston 114 can be visually inspected through the first window 108. The autoinjector 100 may include a guard plate 118 disposed within the housing 102 and positioned around the container 112 to prevent the remaining internal components of the autoinjector from being seen from the first window 108.

[0126] Still referencing Figure 1The size and shape of container 112 may be designed to store a nominal value of pharmaceutical agent. The "nominal volume" (also known as "specified volume" or "specified capacity") of a container refers to the maximum capacity of the container as determined by the container manufacturer or safety standards organization. Manufacturers or safety standards organizations may specify a nominal volume of a container to indicate that the container can be filled with that volume of fluid (sterile or non-sterile) and can be sealed, stoppered, sterilized, packaged, transported, and / or used while maintaining the container's airtight integrity and simultaneously maintaining the safety, sterility, and / or sterility of the fluid contained within. In determining the nominal volume of a container, manufacturers or safety standards organizations may also consider variations that occur during normal filling, sealing, stoppering, packaging, transport, and administration processes. For example, a pre-filled syringe may be manually or mechanically filled with fluid to its nominal volume and then stoppered using a drain tube or vacuum, without the filling and stoppering machinery and tools coming into contact with and potentially contaminating the contents of the syringe. Alternatively, the insertion machinery and tools may be sterile or sterile and capable of contacting the contents of the syringe and / or the syringe itself without causing any contamination.

[0127] In some examples, container 112 may have a nominal volume of about 5.0 mL, but may also use any other suitable nominal volume (e.g., about 0.5 mL to about 50.0 mL, or about 2.0 mL to about 10.0 mL, or about 3.0 mL to about 6.0 mL, or about 1.0 mL to about 3.0 mL, or about 2.0 mL to about 5.0 mL, or another suitable range) depending on the medication to be delivered. In other examples, container 112 may have a nominal volume greater than or equal to about 0.5 mL, or greater than or equal to about 2.0 mL, or greater than or equal to about 3.0 mL, or greater than or equal to about 4.0 mL, or greater than or equal to about 5.0 mL. Container 112 can contain and store medications for injection into the user and can help maintain the sterility of the medication. In one embodiment, container 112 may be configured to deliver a delivery amount of the agent (e.g., about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, about 3.5 mL, greater than about 1.0 mL, greater than about 2.0 mL, greater than about 3.0 mL, greater than about 4.0 mL, greater than about 5.0 mL, greater than about 10.0 mL, greater than about 20.0 mL, or another delivery amount).

[0128] The delivery volume may be less than the nominal volume of container 112. Furthermore, in order to deliver the delivery volume of medication to the user, container 112 itself may be filled with a different dose of medication than the delivery volume (i.e., the fill volume). The fill volume may be greater than the delivery volume to account for medication that cannot be transferred from container 112 to the user due to, for example, dead space in container 112. Therefore, although container 112 may have a nominal volume of 5 mL, the fill volume and delivery volume of the medication may be less than 5 mL.

[0129] In one embodiment, when container 112 is used in a handheld autoinjector, the delivery volume of the agent from container 112 can be from about 0.5 mL to about 4.0 mL, from about 1.0 mL to about 3.5 mL, from about 3.0 mL, from about 3.1 mL, from about 3.2 mL, from about 3.3 mL, from about 3.4 mL, or from about 3.5 mL. The delivery volume of the agent may be related to the viscosity of the agent and the handheld nature of the autoinjector 100. That is, in at least some embodiments, at certain viscosities, a higher volume of agent may impede the ability of the autoinjector 100 to complete the injection process in less than an acceptable time, such as less than about 30 seconds. Therefore, the delivery amount of the drug from the autoinjector 100 can be set such that the injection process, measured from (1) the time when the autoinjector 100 is placed on the user's skin to (2) the time when the autoinjector 100 is removed from the skin, is less than about 30 seconds or less than about another time period (e.g., less than about 25 seconds, less than about 20 seconds, less than about 15 seconds, or less than about 10 seconds).

[0130] When the delivery volume and / or viscosity of the drug is too high, the autoinjector 100 may not be usable as a handheld autoinjector because the time required to complete the injection process may be longer than commercially or clinically acceptable for a handheld device. Again, as stated above, in embodiments where container 112 is used in a handheld autoinjector, the delivery volume of the drug from container 112 can be set, regardless of the nominal volume of container 112, such that the injection process as defined above is completed within a relatively short time period (to avoid the need for additional features to attach the autoinjector 100 to the user, making the autoinjector 100 a wearable autoinjector).

[0131] However, it is anticipated that various embodiments of this disclosure may relate to wearable autoinjectors that deliver a relatively large amount of medication (e.g., greater than about 3.5 mL) and / or have a relatively long injection process time (e.g., longer than about 30 seconds, longer than about 1 minute, longer than about 2 minutes, longer than about 5 minutes, or longer than about 1 hour) compared to handheld autoinjectors, to complete the injection process measuring from (1) the time point when the autoinjector is placed on the user's skin to (2) the time point when the autoinjector is removed from the skin.

[0132] Container 112 may have a neck with a diameter of about 13 mm, a length of about 45 mm, and an inner diameter of about 19.05 mm. In another embodiment, container 112 may be a standard 3 mL container with a rolled top of 8 mm, an inner diameter of 9.7 mm, and a length of 64 mm. In another embodiment, container 112 may have a length of about 64 mm to 74 mm, such as, for example, about 69.3 mm ± 0.15 mm (excluding the length of the neck at the second end 374 of container 112). In embodiments including the neck, container 112 may have a length ranging from about 65 mm to 75 mm, such as, for example, about 70.8 mm ± 0.4 mm. These values ​​are merely exemplary, and other suitable dimensions may be utilized as appropriate. In some examples, container 112 may be formed using conventional materials and may be shorter than existing devices, which can help keep the autoinjector 100 cost-effective and small. In some embodiments, container 112 may be a shortened ISO 10 mL cylinder. The autoinjector of this disclosure can be configured to deliver highly viscous liquids to a patient. For example, the autoinjector 100 of this disclosure can be configured to deliver liquids with a viscosity of about 0 cP to about 100 cP, about 5 cP to about 45 cP, about 10 cP to about 40 cP, about 15 cP to about 35 cP, about 20 cP to about 30 cP, or about 25 cP.

[0133] Still referencing Figure 1 Container 112 may include a piston 114 movably disposed within a cavity of container 112. Piston 114 may be moved by pressurized fluid discharged from a fluid source, such as, for example, canister 150. As further described herein, the pressurized fluid (e.g., gas) discharged from canister 150 may cause piston 114 to translate vertically relative to container 112 along the longitudinal axis of container 112 toward bottom end 112B. The movement of piston 114 toward bottom end 112B of container 112 may cause the piston to act on the contents (e.g., medicine, pharmaceutical, etc.) within container 112. In some embodiments, the autoinjector of this disclosure may be oriented such that the pistons within canister 150 and container 112 are offset, or otherwise non-longitudinally aligned with each other.

[0134] like Figure 2 As can be seen, the guard plate 118 can be coaxially coupled to the container 112. The guard plate 118 may include a top flange 117 disposed around and mating with the top flange 115 of the container 112. The guard plate 118 may generally have a semi-circular configuration that surrounds the outer surface of the container 112 and extends along a portion of the container 112 located inside the housing 102 and is opposite to the opposite portion of the container 112 positioned adjacent to the first window 108 (see [link]). Figure 1Container 112 may be coupled to chassis 130 and may include a top end 112A adjacent to a top flange 115 and a bottom end 112B opposite to top end 112A and extending through chassis 130. Container 112 may include a needle 116 coupled to bottom end 112B, and needle 116 may be in fluid communication with a fluid (e.g., a pharmaceutical agent) stored in container 112. Figure 3 As can be seen, the guard plate 118 may include protrusions 119 (e.g., pull tabs, fingers, etc.) received within a groove 131 on the chassis 130, thereby coupling the guard plate 118 to the chassis 130. In this configuration, the guard plate 118 can be secured to each of the container 112 and the chassis 130. With the protrusions 119 received within the groove 131 and the top flange 117 coupled to the top flange 115, the autoinjector 100 can be configured to prevent unintentional movement (e.g., translation, rotation, etc.) of the guard plate 118 relative to the container 112 and the chassis 130. The size and shape of the guard plate 118 may be designed and / or otherwise configured to partially cover the container 112, thereby preventing visual observation of the interior of the housing 102 via the first window 108. In other words, the guard plate 118 may define an opening whose size and shape may be designed and / or otherwise configured to expose the container 112 via the first window 108 while suppressing visual exposure of other components within the housing 102. In some embodiments, the protective panel 118 may be formed of an opaque material with a predefined color (e.g., turquoise) to prevent the housing 102 from being visually observed through the first window 108. In other embodiments, the protective panel 118 may be omitted entirely.

[0135] Return to reference Figure 1 The housing 102 may also include a second window 110, which is formed along the outer surface of the housing 102 and extends along a portion of the housing 102 aligned with a portion of the indicator assembly 170. Thus, the indicator assembly 170 can be visually observed from the outside of the housing 102 via the second window 110. As described herein, the indicator assembly 170 can be configured to move relative to the second window 110 from a first position to a second position in response to activation of the autoinjector 100, thereby visually indicating the operating state of the autoinjector 100, and in particular changes in the dosage state of the autoinjector 100, via the second window 110 (see [link to documentation]). Figures 16A to 17B ).

[0136] Now for reference Figure 4The autoinjector 100 may include a shield 120 at the bottom end 106 of the housing 102. The shield 120 may be disposed inside the cap 111 when the cap 111 is coupled to the bottom end 106 of the housing 102. The autoinjector 100 may also include an actuator 125 (e.g., a movable rod) and a spindle assembly 180, each disposed within the shield 120 and particularly against the inner surface 121 of the shield 120. The shield 120 may include a socket 181 along the inner surface 121, the size and shape of which may be designed and / or otherwise configured to receive and / or securely retain an end of the spindle assembly 180. Thus, the socket 181 may be operable to securely couple the spindle assembly 180 to the shield 120, such that the spindle assembly 180 is movable within the housing 102 in response to simultaneous movement of the shield 120 relative to the housing 102. Actuator 125 and spindle assembly 180 can be coupled to corresponding portions of chassis 130, as described herein. Actuator 125 and spindle assembly 180 can each be configured to move in response to movement of shroud 120 relative to housing 102 to transition autoinjector 100 from a pre-start state to an start state by initiating the release of pressurized medium throughout autoinjector 100.

[0137] The spindle assembly 180 may include a biasing mechanism 182 disposed externally around the spindle assembly 180. The biasing mechanism 182 may be configured to push the spindle assembly 180 toward a predefined direction, bias the spindle assembly 180 toward a predefined configuration, generate tactile feedback during movement of the housing 120, generate resistance against the housing 120 retracting upwards into the housing 102, etc. In this example, the biasing mechanism 182 may be configured to bias the housing 120 and the spindle assembly 180 relative to the housing 102 toward an extended (downward) position when the biasing mechanism 182 is in an expanded configuration. As described herein, the biasing mechanism 182 may be configured to generate controlled feedback to the housing 120 when the housing 120 is actuated and pressed into the housing 102 in a relatively upward direction, thereby causing the biasing mechanism 182 to change from an expanded configuration to a compressed configuration. The biasing mechanism 182 may include various suitable means, including but not limited to springs. In some embodiments, the biasing mechanism 182 may be omitted entirely.

[0138] The cap 111 may include one or more ribs 113A extending vertically upward from the lower inner surface of the cap 111 toward the chassis 130. The one or more ribs 113A may be configured to abut against the bottom end 132 of the chassis 130 when the cap 111 is coupled to the bottom end 106 of the housing 102. With the ribs 113A abutting the bottom end 132, the cap 111 may be configured to suppress unintentional movement of the chassis 130 relative to the housing 102 to prevent accidental activation of the autoinjector 100. In other words, the ribs 113A may be configured to push the chassis 130 upward when the cap 111 is coupled to the housing 102, thereby locking the chassis 130 in a fixed position relative to internal components of the housing 102 (such as the canister 150) to prevent accidental release of pressurized media stored therein.

[0139] Still referencing Figure 4 The autoinjector 100 may include a needle cap 116A detachably coupled to the bottom end 112B of the container 112, wherein a needle 116 is disposed within the needle cap 116A. Thus, the needle cap 116A may be configured to close the needle when the needle 116 is coupled thereto. The size and shape of the needle cap 116A may be designed and / or otherwise configured to extend outward from the shroud 120 and specifically through the bottom surface 122 of the shroud 120, such that the needle cap 116A may be at least partially disposed within the cap 111. The cap 111 may include one or more clamps 113B (e.g., pull tabs, fingers, levers, etc.) extending vertically upward from the lower inner surface of the cap 111 toward the bottom surface 122 of the shroud 120. The one or more clamps 113B may be configured to engage portions of the needle cap 116A extending outward (e.g., downward) from the shroud 120 and into the cap 111.

[0140] Additionally, one or more clamps 113B may be configured to securely attach the needle cap 116A to the cap 111, such that when the cap 111 is separated from the bottom end 106 of the housing 102, the needle cap 116A can be removed from the bottom end 112B of the container 112, thereby exposing the needle 116 within the shield 120. Figure 5 As can be seen, cap 111 may include a plurality of clamps 113B configured to engage pin cap 116B. It should be understood that this is for illustrative purposes only. Figure 5 The needle cap 116B is omitted in this example. In this example, the needle cap 116B may include a narrow portion defining one or more outer surfaces and / or a distal neck, the dimensions and shape of which may be designed and / or otherwise configured to mate with the clamp 113B for securely coupling the needle cap 116B to the clamp 113B. In other words, the needle cap 116B may include an interface along its outer end, which may be engaged by the clamp 113B.

[0141] Figure 6A cap 111 is illustrated, having one or more ribs 113A extending through a corresponding opening 121A formed on the inner surface 121 of the cover 120, and a plurality of clamps 113B aligned with the opening 121B on the inner surface 121. It should be understood that when the cap 111 is separated from the bottom end 106 of the housing 102 and the needle cap 116A is separated from the needle 116, the needle 116 can extend through the opening 121B as the cover 120 is moved vertically upward along a vertical path toward the housing 102. Figure 7 The illustration depicts a cap 111 isolated from the shield 120. It should be understood that cap 111 is... Figures 4 to 6 The image is partially drawn such that the cap 111 may include additional ribs 113A and / or clamps 113B in addition to the ribs and / or clamps shown and described herein. In some cases, such as Figure 160A and Figure 160B As illustrated, the cap 4411 includes one or more retaining elements 4412 configured to engage with the shield 4420 to assist in securing or partially securing the cap 4411 to the shield 4420. The retaining element 4412 may include protrusions, bumps, ridges, or any other suitable features.

[0142] Now for reference Figures 8 to 9 The diagram illustrates housing 102, with cap 111 omitted, leaving shield 120 exposed at bottom end 106. Shield 120 is movably coupled to chassis 130 between one or more locations for actuating autoinjector 100. See details. Figure 8 The shield 120 may include an inner surface 121 of the shield 120 (see...) Figure 6 One or more guide ribs 123A extending radially inward, and the chassis 130 may include one or more guide channels 133 formed along the outer surface of the chassis 130. It should be understood that the chassis 130 may include a plurality of guide channels 133 corresponding to the plurality of guide ribs 123A on the shroud 120, and vice versa. The size and shape of the guide channels 133 may be designed and / or otherwise configured to accommodate one or more guide ribs 123A. The guide channels 133 may also be configured to restrict the direction of movement of the shroud 120 relative to the chassis 130 during use of the autoinjector 100, particularly during the stroke of the shroud 120 for discharging fluid from the container 112. For example, the guide channels 133 may be configured to restrict movement of the shroud 120 relative to the housing 102 and / or the chassis 130 to the vertical direction, thereby suppressing lateral movement of the shroud 120 relative to the housing 102 and / or the chassis 130. Figure 8 In the example shown, guide rib 123A may be flush with the top surface of shield 120. Figure 9 In the example shown, guide rib 123B may extend vertically upward from the top surface of the cover 120 to, relative to Figure 8The guide rib 123A provides enhanced stability to the shield 120 at the start of the stroke.

[0143] Now for reference Figures 10 to 11 The actuator 125 may include a body 126 defined by a first end 127 movably coupled to the shroud 120 and a second end 128 movably coupled to the chassis 130 and the carrier 140. The actuator 125 may include a pin 129 at the second end 128, which is received within a recess 139 of the chassis 130. The pin 129 may be configured to move (e.g., pivot, rotate, etc.) within the recess 139, thereby allowing corresponding movement of the actuator 125 relative to the chassis 130. In other words, the connection between the pin 129 and the recess 139 may define a pivot joint for the actuator 125, such that the actuator 125 is configured to move (e.g., pivot) within the housing 102 about the pivot joint defined by the pin 129 and the recess 139. As described herein, the actuator 125 may be configured to move in response to the shroud 120 being pressed upward into the housing 102 along a vertical path. The size and shape of the second end 128 may be designed and / or otherwise configured to abut against the bottom end 142 of the carrier 140. As described herein, the actuator 125 may be configured to push the carrier 140 vertically upward relative to the housing 102 in response to the second end 128 pushing the bottom end 142 as the actuator 125 pivots about the pin 129. In some embodiments, the carrier 140 may be omitted entirely, such that the actuator 125 may be configured to directly push the canister 150.

[0144] It should be understood that Figures 10 to 11 The illustration depicts a shield 120 in a first position and an autoinjector 100 in a pre-activation state, wherein only the first end 127 of the actuator 125 contacts the inner surface 121 of the shield 120. As described herein, the actuator 125 may be sized and shaped and / or otherwise configured to contact the inner surface 121 at an additional portion of the body 126 when the shield 120 moves toward a second position and the autoinjector 100 transitions to the activation state. In this example, the second end 128 may have a curved configuration corresponding to the curved configuration of the carrier 140 at the bottom end 142, such that movement of the actuator 125 relative to the chassis 130 causes the curved surface of the second end 128 to push against the corresponding curved surface of the bottom end 142. In other examples, the second end 128 and / or the bottom end 142 may have various other suitable shapes, sizes, and / or configurations other than those shown and described herein without departing from the scope of this disclosure.

[0145] The size and shape of the carrier 140 may be designed and / or otherwise configured to accommodate the can 150. In this example, the can 150 is fixed relative to the carrier 140 such that the can 150 is configured to move within the housing 102 in response to a corresponding movement (e.g., translation) of the carrier 140 relative to the housing 102, such as in response to the actuator 125 pushing the bottom end 142. The carrier 140 may include a pair of retaining mechanisms 146 extending outward (e.g., vertically upward) from a top end 144 of the carrier 140 opposite the bottom end 142. Each of the pair of retaining mechanisms 146 may include, but is not limited to, a clamp, a hand, a finger, a pull tab, a protrusion, a lever, etc. The carrier 140 may be disposed within the housing 102 opposite to the valve assembly 160, and the valve assembly 160 may include a pair of retaining mechanisms 162 positioned adjacent to the top end 144. The retaining mechanism 162 can be configured to engage the retaining mechanism 146 in response to the carrier 140 moving upward relative to the housing 102 and toward the valve assembly 160 when the autoinjector 100 moves from the pre-activation state to the activation state (see [link]). Figures 13A to 13B Each of the retaining mechanisms 162 may include, but is not limited to, a corresponding clamp, hand, finger, pull tab, protrusion, or lever configured to mate with retaining mechanism 146. In this example, retaining mechanisms 146, 162 may each include inclined and / or angled surfaces configured to interact with each other as the carrier 140 moves toward valve assembly 160 in a longitudinally upward direction, as further described herein.

[0146] Still referencing Figures 10 to 11 The canister 150 may be disposed within the carrier 140, while the neck 152 extends outward (e.g., upward) from the tip 144. In the pre-activation state of the autoinjector 100, the neck 152 may be positioned opposite and aligned with the puncture mechanism 164 of the valve assembly 160. The puncture mechanism 164 may include a needle, an activation pin, and various other suitable devices configured to puncture the seal and / or valve of the canister 150 at the neck 152 to fluidly couple the valve assembly 160 to the canister 150. As described herein, the valve assembly 160 may be configured to receive a pressurized medium (e.g., gas) from the canister 150 in response to the puncture mechanism 164 puncturing the seal at the neck 152. It should be understood that the canister 150 is not in fluid communication with the valve assembly 160 when the autoinjector 100 is in the pre-activation state and before the carrier 140 moves the canister 150 upward toward the puncture mechanism 164. Valve assembly 160 may include a release outlet 169 located downstream and in fluid communication with puncture mechanism 164, such that at least a portion of the pressurized medium received from tank 150 in valve assembly 160 may be released from valve assembly 160 via release outlet 169.

[0147] like Figure 11Ideally, the autoinjector 100 may include an outlet channel 168 in fluid communication with a release outlet 169, and a slidable piston 190 movably disposed within the release outlet 169. The slidable piston 190 may include a drain valve configured and operable as a discharge system of the autoinjector 100, such as... Figures 44 to 46 The following is described and illustrated in more detail (see Discharge System 2030). As described herein, at least a portion of the pressurized medium received from tank 150 may enter release outlet 169 via outlet channel 168 and cause a sliding piston 190 to move relative to release outlet 169 (e.g., in a downward direction). The sliding piston 190 may have a body 192, the longitudinal length of which extends between an upper end 194 and a lower end defined by a pair of snap-fit ​​arms 196. The body 192 may include one or more recesses 195 formed along the upper end 194, the size and shape of which may be designed and / or otherwise configured to receive a seal (e.g., an O-ring) therein to inhibit the transmission of pressurized medium received from outlet channel 168 along the outer surface of the sliding piston 190. Therefore, the pressurized medium contained in the release outlet 169 is operable to push the body 192 at the upper end 194, thereby causing the slidable piston 190 to translate within the release outlet 169 (e.g., in the downward direction) from a first (upper) position toward a second (lower) position (see...). Figures 18A to 18C Each of the pair of latching arms 196 may include a retaining mechanism 198 located at the lower end of the latching arm 196. The retaining mechanism 198 may include, but is not limited to, a clamp, a hand-like member, a finger-like member, a pull tab, a protrusion, etc. The retaining mechanism 198 may be disposed within a first (upper) chamber 136 of the chassis 130, wherein the first chamber 136 is disposed relatively below and in fluid communication with the release outlet 169.

[0148] The chassis 130 may also include a second (lower) chamber 138 disposed opposite to the first (upper) chamber 136 and above the mandrel assembly 180. In this example, the first chamber 136 and the second chamber 138 may each have substantially similar cross-sectional dimensions and / or inner diameters. The chassis 130 may also include an inner lip 137 disposed between the first chamber 136 and the second chamber 138. The inner lip 137 may extend radially inward relative to the inner surfaces of the first chamber 136 and the second chamber 138, such that the inner lip 137 may define a portion between the first chamber 136 and the second chamber 138 having a relatively small cross-sectional dimension and / or inner diameter. As described herein, a pair of retaining mechanisms 198 may be configured to engage the inner lip 137 in response to pressurized gas contained in the release outlet 169 pushing the slidable piston 190 relatively downward into the first chamber 136 and at least a portion of the latching arm 196 extending into the second chamber 138. When the retaining mechanism 198 is engaged with the inner lip 137, the chassis 130 can be configured to prevent the sliding piston 190 from returning to its initial position within the release outlet 169.

[0149] In this configuration, the pressurized medium contained in the release outlet 169 can be guided around the body 192 of the slidable piston 190 and released into the first chamber 136 and the second chamber 138. In some embodiments, the inner surface of the release outlet 169, for example along the bottom portion adjacent to the first chamber 136, may include cuts, channels, recesses, and / or cavities that are recessed radially outward relative to the central longitudinal axis of the release outlet 169, such that the release outlet 169 may include an inner diameter along the bottom portion that is larger than that along the top portion of the release outlet 169. Thus, the pressurized medium contained in the release outlet 169 can be guided around the body 192 of the slidable piston 190 via the inner surface along the bottom portion including the cuts before being released into the first chamber 136 and the second chamber 138. The second chamber 138 may be in fluid communication with the internal cavity of the housing 102 maintained at atmospheric pressure, such that the pressurized medium contained in the second chamber 138 is effectively discharged to relieve pressure buildup within the housing 102. In some embodiments, housing 102 may include one or more discharge ports 101 (see...) Figure 1 This is used to maintain the internal cavity of the housing 102 at atmospheric pressure and to help depressurize the autoinjector 100.

[0150] Now for reference Figures 12A to 12B One or more components of the autoinjector 100 are shown in the autoinjector 100 in a pre-start state. Figure 12A ) to startup state ( Figure 12B The transition between ) should be understood as being for illustrative purposes only. Figures 12A to 12B One or more other components of the auto-injector 100 are omitted. (Original reference) Figure 12A The shield 120 is in a first position, in which the shield 120 is held in an extended position relative to the chassis 130 and the inner surface 121 of the shield 120 is axially offset from the bottom end 132 of the chassis 130. In this case, the actuator 125 may be at least partially positioned within the inner cavity 124 of the shield 120 and the inner cavity 134 of the chassis 130, and only the first end 127 of the body 126 contacts the inner surface 121. The carrier 140 and the canister 150 may be in their respective first positions, in which the holding mechanism 146 is disengaged from the holding mechanism 162 and the puncture mechanism 164 is separated from the neck 152 (see [link to relevant documentation]). Figure 13A ).

[0151] In this example, chassis 130 may include a channel 135 disposed around carrier 140, and carrier 140 may include a pair of arms 148 extending laterally (radially) outward from carrier 140. The channel 135 may be sized and shaped and / or otherwise configured to receive arms 148. In this example, channel 135 may define a cylindrical cavity for receiving carrier 140 therein. Channel 135 may be configured to guide carrier 140 upward toward valve assembly 160 in response to movement of actuator 125 against bottom end 142, thereby suppressing unintentional lateral movement of carrier 140 within chassis 130. In other embodiments, channel 135 and / or arms 148 may be completely omitted from autoinjector 100. In yet another embodiment, carrier 140 may be omitted, such that canister 150 is directly coupled to each of chassis 130 and valve assembly 160.

[0152] refer to Figure 12BThe shield 120 is movable along a vertical path from a first position to a second position, in which the shield 120 is pressed upward relative to the chassis 130 to a retracted position, such as in response to the bottom surface 122 of the shield 120 engaging with an object (e.g., a user of the autoinjector 100), and the inner surface 121 contacts the bottom end 132. In this case, the actuator 125 is movable (e.g., pivoted) about a pivot joint defined by a recess 139 of the pin 129 to transition the autoinjector 100 to an activated state. As the actuator 125 moves toward the second position, the shield 120 pushes a first end 127 of the body 126, thereby bringing a second end 128 abutting against the bottom end 142 of the carrier 140. The second end 128 may define a rod support surface of the actuator 125, which is configured to redirect the force generated by the movement of the shield 120 to the carrier 140 and the canister 150. The carrier 140 can move upward relative to the chassis 130 in response to the second end 128 pushing the bottom end 142, thereby causing the can 150 to translate toward the valve assembly 160 until the puncture mechanism 164 punctures the seal of the neck 152. Thus, the pressurized medium stored in the can 150 can be released into the valve assembly 160 via the puncture mechanism 164.

[0153] It should be understood that the shield 120, actuator 125, chassis 130, carrier 140, and / or spindle assembly 180 may be configured and operable to actuate the autoinjector 100 with only low holding force, thereby minimizing the force required for the autoinjector 100 to begin delivering a dose. In other words, the size and shape of one or more components of the autoinjector 100 may be designed and / or otherwise configured to minimize the force required to press the shield 120 against the subject's skin during dose delivery to the subject using the autoinjector 100.

[0154] Additionally, when the carrier 140 and the can 150 move simultaneously within the housing 102, a pair of retaining mechanisms 146 can move upward toward the valve assembly 160, thereby engaging the retaining mechanism 146 with the corresponding retaining mechanism 162 (see...). Figure 13B In this configuration, valve assembly 160 may be configured to securely fasten tank 150 to the valve assembly in response to coupling of valve assembly 160 with carrier 140. In some embodiments, at least a portion of the pressurized medium discharged from tank 150 may generate a blowback force on tank 150, thereby causing tank 150 to move downward and away from valve assembly 160. Engagement between retaining mechanism 146 and retaining mechanism 162 may suppress and / or at least partially minimize downward retraction of tank 150 relative to valve assembly 160, thereby maintaining fluid communication between tank 150 and valve assembly 160.

[0155] In some embodiments, the autoinjector 100 may be configured to lock one or more components (such as the shield 120) by inhibiting movement of one or more parts when premature lifting of the shield 120 occurs during use of the autoinjector. In the event of a premature lifting of the shield 120, the autoinjector 100 may be configured to inhibit restarting and / or further use of the autoinjector 100 to preserve user safety. A premature lifting event can generally be defined as the occurrence of a user prematurely, untimely, and / or prematurely releasing the shield 120 when the autoinjector 100 transitions from a pre-start state to a start state or during the injection of a drug from the autoinjector 100 while operating in the start state. In this case, the autoinjector 100 may be configured and operable to lock one or more components (e.g., the shield 120) to prevent further movement of the components relative to the housing 102, thereby inhibiting further use and / or restarting of the autoinjector 100. For example, the autoinjector 100 can lock the relative position of the shield 120 in an extended (downward) configuration or a retracted (upward) configuration relative to the housing 102, thereby inhibiting further actuation and / or movement of the shield 120. It should be understood that locking the shield 120 in the retracted configuration relative to the housing 102 can achieve the goal of keeping the needle 116 positioned inside the shield 120, thereby preventing the needle 116 from being exposed outside the autoinjector 100.

[0156] In one example, the autoinjector 100 may include a timer mechanism operable to determine the occurrence of an early lift event. The timer mechanism can provide a buffer period to allow the user of the autoinjector 100 to quickly perform an early lift before the autoinjector 100 is locked. For example, the timer mechanism may be programmed to allow rapid adjustments to the autoinjector 100 without locking the autoinjector 100 before such adjustments exceed a predefined threshold (e.g., one second). Such adjustments may include physically removing the autoinjector 100 relative to the user's skin after initial activation, for reasons such as discomfort or accidental removal. Once an early lift event occurs—that is, the duration of removal of the shield 120 from the user's skin exceeds a predetermined threshold determined by the timer mechanism—the autoinjector 100 may be configured to lock one or more components, thereby inhibiting further movement of the shield 120 relative to the housing 102.

[0157] When a dose is delivered from the autoinjector 100, one or more components of the autoinjector 100 (such as the sliding piston 190, the spindle assembly 180, and / or the biasing mechanism 182) may be configured to interact with the shield 120 to lock the autoinjector 100 to prevent restarting. For example, as described further herein, the sliding piston 190 may be configured to push the spindle assembly 180 downward as it exits the release outlet 169 and enters the first chamber 136 and the second chamber 138 in which the spindle assembly 180 is received. In this case, the spindle assembly 180 may be configured to push the shield 120 outward relative to the housing 102 in the downward direction. Additionally and / or alternatively, the biasing mechanism 182 may be configured to push the spindle assembly 180 downward, thereby further pushing the shield 120 out of the housing 102 in response to the automatic movement of the biasing mechanism 182 from a compression configuration to an expansion configuration, thereby automatically moving the shield 120 from a second position to a first position. It should be understood that the biasing mechanism 182 is configured to move automatically after a threshold amount of energy, such as that released from the canister 150. In this case, with the bottom surface 122 of the shield 120 positioned on the outer surface of the subject's (e.g., a patient's) skin, the shield 120 can be configured to push the outer surface, thereby causing the housing 102 to detach from the subject's skin in an upward direction. Thus, the autoinjector 100 can be operable to push it away from the subject's skin to signal the completion of dose delivery via visual feedback from the housing 102, which automatically elevates itself from the skin due to the extension of the shield 120.

[0158] Now for reference Figure 14 Another exemplary shield 220 and chassis 230 are illustrated. It should be understood that, apart from the differences explicitly stated herein, shield 220 and chassis 230 can be incorporated into the autoinjector 100 in a manner substantially similar to that of shield 120 and chassis 130 shown and described above. For example, shield 220 may include a pair of flexible ribs 222 extending vertically upward through an internal cavity 124, and pins 224 positioned at the respective ends (upper) of the pair of flexible ribs 222. Chassis 230 may include a pair of arms 232 disposed within an internal cavity 134 and above a bottom end 132, and a pair of pin guides 234. Pin guides 234 may be formed along the rear surface of arms 232, and their size, shape, and / or other configuration may be designed and / or otherwise configured to receive pins 224 thereon for securely coupling shield 220 to chassis 230. The pin guide 234 may define an angled and / or inclined surface of the arm 232, the surface guiding the pin 224 into a channel 236 configured to secure the pin 224 therein.

[0159] In the pre-start state of the autoinjector 100, such as Figure 14As can be seen, a pair of flexible ribs 222 contact a pair of arms 232, and each pin 224 is positioned relative to the corresponding pin guide 234 below. In response to upward movement of the shield 220 relative to the chassis 230, the flexible ribs 222 can translate along the arms 232 until each pin 224 is aligned with the pin guide 234. It should be understood that the flexible ribs 222 can be configured to move and / or flex in a lateral (radial) direction as the shield 220 pushes the flexible ribs 222 against the arms 232. For example, the flexible ribs 222 can be pushed radially outward as the shield 220 moves upward relative to the chassis 230, and subsequently allowed to flex radially inward as the pins 224 are aligned with the pin guides 234. In this case, the shield 220 can be in a second position and the pin guides 234 can be configured to receive the pins 224 along the rear surface of the arms 232. As the shield 220 moves partially downward relative to the chassis 230, the pin guide 234 wedges the pin 224 into a corresponding channel 236, which is at least partially defined by the lateral (inner) surface of the arm 232. In other words, the pin guide 234 guides the pin 224 into the channel 236, which is positioned radially inward of the arm 232. The cross-sectional dimension of the channel 236 may be smaller than that of the pin 224. Therefore, the pin 224 can be securely fixed within the channel 236, thereby locking the shield 220 to the chassis 230 and preventing further downward movement of the shield 220 relative to the chassis 230.

[0160] Now for reference Figure 15 Another exemplary chassis 330, carrier 340, and valve assembly 360 are illustrated. It should be understood that, except for the differences explicitly stated herein, chassis 330, carrier 340, and valve assembly 360 can be incorporated into the autoinjector 100 in a manner substantially similar to that of chassis 130, carrier 140, and valve assembly 160 shown and described above. For example, carrier 340 may be at least partially disposed within valve assembly 360, and the neck 152 of canister 150 may be accommodated within carrier 340. As described herein, carrier 340 may be configured to move relative to canister 150 and / or valve assembly 360 in response to actuator 125 pushing carrier 340 into valve assembly 360 in an upward direction and propelling it toward canister 150.

[0161] Valve assembly 360 may include a chamber 362 defining an internal lumen, the size and shape of which may be designed and / or otherwise configured to accommodate canister 150 and carrier 340. Chamber 362 may include a top end 364 and an open bottom end 366, with canister 150 positioned relative to carrier 340 adjacent to the top end 364, and carrier 340 positioned relative to canister 150 adjacent to the bottom end 366. At least a portion of carrier 340 may extend outward from chamber 362 via an opening at bottom end 366 and may contact actuator 125. In this example, the cross-sectional dimension of the internal lumen of chamber 362 may be larger than the cross-sectional dimension of canister 150 contained therein, thereby forming a gap 368 between the inner surface of chamber 362 and the outer surface of canister 150. As described herein, pressurized medium released from canister 150 may be contained within chamber 362 and guided via gap 368 toward outlet 369 of chamber 362 at top end 364.

[0162] Still referencing Figure 15 The carrier 340 may have a longitudinal length defined between a top end 342 and a bottom end 344, wherein the top end 342 may include an opening 341 to receive a neck 152, and the bottom end 344 may be closed and contact a second end 128 of the actuator 125. The size and / or shape of the opening 341 at the top end 342 may be designed such that the top end 342 defines a cross-sectional dimension larger than the opening of the neck 152, such that a gap is formed between the inner surface of the top end 342 and the outer surface of the neck 152 received therein. In some embodiments, the edge 343 of the top end 342 defining the opening 341 may be angled and / or narrowed in a radially outward direction relative to the central axis of the carrier 340, thereby defining a larger gap along the edge 343 between the top end 342 and the neck 152. As described herein, the carrier 340 may be configured to receive a pressurized medium stored in a tank 150 and to release the pressurized medium to a valve assembly 360 via the opening 341.

[0163] The carrier 340 may include a recess and / or cavity located between a top end 342 and a bottom end 344 along the longitudinal length of the carrier 340. The size and shape of the recess and / or cavity may be designed and / or otherwise configured to receive a fastener 346 (e.g., an O-ring). The fastener 346 may be configured to fluidly seal the carrier 340 to the valve assembly 360 and prevent pressurized medium released from the canister 150 into the carrier 340 from leaving the valve assembly 360. The carrier 340 may also include a puncture mechanism 348 (e.g., a needle, actuator pin, etc.) extending upward from the bottom end 344. The puncture mechanism 348 may be positioned opposite the neck 152 when the canister 150 is coupled to the carrier 340, and is configured to move upward in response to the second end 128 pushing the bottom end 344 to puncture the seal of the neck 152 when the actuator 125 pivots about a pivot joint defined between the pin 129 and the recess 139.

[0164] In this configuration, the carrier 340 may be biased upward relative to the tank 150 and valve assembly 360, such that the piercing mechanism 348 pierces the seal at the neck 152, thereby releasing the pressurized medium stored in the tank 150 into the carrier 340. The carrier 340 may be configured to release the pressurized medium into the internal lumen of the chamber 362 via an opening 341 at the top end 342. A fastener 346 may be configured to prevent the pressurized medium from being released from the chamber 362 through the opening at the bottom end 366, such that the pressurized medium is guided towards the top end 364 via a gap 368 until it is received at the outlet 369. In some embodiments, the internal lumen of the chamber 362 may include one or more grooves along the gap 368, thereby increasing the spatial clearance for the pressurized medium to travel from the carrier 340 to the outlet 369.

[0165] refer to Figures 16A to 16B The indicator assembly 170 may be disposed within the housing 102 adjacent to the top end 104. In this example, the indicator assembly 170 may include a piston 172, a first indicator surface 174, a second indicator surface 176, a first arm 177, and a second arm 178. The piston 172 may be at least partially received within a portion of the valve assembly 160 such that the piston 172 is in fluid communication with the valve assembly 160. In this example, the piston 172 may be configured to move (e.g., translate) in response to the valve assembly 160 receiving pressurized medium released from the canister 150. More specifically, at least a portion of the pressurized medium contained within the valve assembly 160 may be configured to push the piston 172 relative to the valve assembly 160 and / or the housing 102 when the pressurized medium is balanced between the two internal chambers of the valve assembly 160. For example, the piston 172 may be configured from a first position before the valve assembly 160 receives pressurized medium ( Figure 16A The second position after the valve assembly 160 receives the pressurized medium ( Figure 16BMovement. It should be understood that movement of piston 172 can cause corresponding movement of the remaining components of indicator assembly 170, including first indicator surface 174, second indicator surface 176, first arm 177, and second arm 178. Piston 172 may be integrally formed with first indicator surface 174, second indicator surface 176, first arm 177, and second arm 178. For example, piston 172 may be integral with first indicator surface 174 via intermediate arm 173 connecting piston 172 to first indicator surface 174, such that movement of piston 172 provides simultaneous movement of first indicator surface 174, second indicator surface 176, first arm 177, and second arm 178.

[0166] The indicator assembly 170 may be disposed within the housing 102 to at least partially overlap with the second window 110. In a first position, when the autoinjector 100 is in a pre-activation state, the piston 172 may be substantially disposed within the valve assembly 160 and the first indicator surface 174 may be aligned with the second window 110. Figure 16A In the second position, when the autoinjector 100 is in the activated state, the piston 172 is movable relative to the housing 102 toward the top 104 and the second indicator surface 176 is aligned with the second window 110. Figure 16B As piston 172 moves relative to housing 102 in response to pressurized medium within valve assembly 160, first indicator surface 174 and second indicator surface 176 can move relative to second window 110. Therefore, indicator assembly 170 can be configured to generate visual feedback on the current operational status of autoinjector 100 based on the relative positions of first indicator surface 174 and second indicator surface 176 relative to second window 110. First indicator surface 174 and second indicator surface 176 can each define a graphical interface including one or more stickers, symbols, colors, and / or markings that differ from each other. For example, first indicator surface 174 may include a first color (e.g., white), and second indicator surface 176 may include a second color (e.g., green) different from the first color. The different colors of first indicator surface 174 and second indicator surface 176, visible through second window 110 when aligned with it, can indicate the current operational status of autoinjector 100 to the user.

[0167] Still referencing Figures 16A to 16BThe indicator assembly 170 may further include a first arm 177 extending radially outward from a first indicator surface 174 and a second arm 178 extending downward from a second indicator surface 176. It should be understood that the relative positions, dimensions, and / or shapes of the first arm 177 and / or the second arm 178 may differ from those shown and described herein without departing from the scope of this disclosure. Therefore, the first arm 177 and / or the second arm 178 may be positioned along the indicator assembly 170 and / or within the housing 102 in a variety of other suitable locations. In this example, the dimensions and shape of the first arm 177 may be designed and / or otherwise configured to move (e.g., translate) within a track 179 formed within the housing 102, and the dimensions and shape of the second arm 178 may be designed and / or otherwise configured to move (e.g., translate) along a ramp 103 formed within the housing 102.

[0168] Track 179 may define a channel with a vertical configuration and may be configured to operate during use of the autoinjector 100, such as in the pre-start state of the autoinjector 100. Figure 16A ) and the start-up status of the auto-injector 100 (see Figure 16B Between the points, the direction of movement of the indicator assembly 170 relative to the housing 102 is restricted. For example, the track 179 may be configured to restrict the movement of the indicator assembly 170 relative to the housing 102 to the vertical direction, thereby suppressing lateral movement of the indicator assembly 170 relative to the housing 102 by restricting the movement of the first arm 177 housed therein. The ramp 103 may include an inclined and / or angled surface 103A, which may be configured to, during use of the autoinjector 100, such as in the pre-activation state of the autoinjector 100 ( Figure 16A ) and the start-up status of the auto-injector 100 (see Figure 16B Between the two sides, the second arm 178 is at least partially deflected in a radially outward direction. For example, the second arm 178 may be at least partially flexible, and the ramp 103 may be configured to laterally flex and / or bend the second arm 178 away from other internal components of the autoinjector 100 as the second arm 178 translates along the angled surface 103A. When the second arm 178 translates vertically along the angled surface 103A, the ramp 103 may deflect the second arm 178 until the second arm 178 moves beyond the terminal (upper) end 103B of the angled surface 103A.

[0169] Still referencing Figures 16A to 16BWhen the movement extends beyond terminal 103B, the second arm 178 can be configured to laterally flex and / or bend relative to housing 102, thereby returning to its original undeflected state. The indicator assembly 170 can be configured to generate audible feedback (e.g., a clicking sound) after the second arm 178 has translated above terminal 103B and contacts a portion of the ramp 103 positioned beyond (e.g., relatively above) the angled surface 103A. In other words, the second arm 178 can rapidly return to its original position when the movement extends beyond the angled surface 103A, thereby contacting a portion of the ramp 103 with sufficient force to generate an audible sound in response to the interaction. It should be understood that the second arm 178 can be positioned relative to ramp 103 to simultaneously generate audible feedback when the second indicator surface 176 is aligned with the second window 110, such that the indicator assembly 170 can be configured to generate both audible and visual feedback once the autoinjector 100 has completed dose delivery. Terminal 103B can be configured to suppress further movement of the indicator assembly 170 due to its proximity to the second arm 178. For example, as Figure 16B Ideally, when the second arm 178 is positioned above the terminal 103B, the terminal 103B can form an obstruction to contact the second arm 178, thereby inhibiting the second arm 178 from translating in the downward direction toward the angled surface 103A.

[0170] In other implementations, such as Figures 17A to 17B As can be seen, the first indicator surface 174 and the second indicator surface 176 may include similar markings, colors, and / or labels. Therefore, the alignment of the first indicator surface 174 or the second indicator surface 176 with the second window 110 does not provide visual feedback to the user of the autoinjector 100 regarding its current operating status. In this case, the indicator assembly 170 can be configured to generate only auditory feedback indicating the current operating status of the autoinjector 100, resulting from the interaction between the second arm 178 and the ramp 103. In this embodiment, the second window 110 may be completely omitted from the housing 102.

[0171] Now for reference Figures 18A to 18CAnother exemplary housing 402, shield 420, and chassis 430 are illustrated. It should be understood that, except for the differences explicitly stated herein, housing 402, shield 420, and chassis 430 can be incorporated into the autoinjector 100 in a manner substantially similar to that of housing 102, shield 120, and chassis 130 shown and described above. For example, housing 402 may include one or more clamps 404 (e.g., pull tabs, fingers, etc.) formed along bottom end 106, and shield 420 may include one or more corresponding clamps 424 (e.g., pull tabs, fingers, etc.) formed along top edge 422 of shield 420 for mating with clamps 404. One or more clamps 404 may be configured to engage one or more clamps 424 as shield 420 extends downward relative to housing 402 to prevent shield 420 from decoupling from housing 402. As described herein, clamps 404 and 424 may be configured together to lock the shield 420 relative to housing 402 to suppress restarting upon completion of dose delivery from autoinjector 100.

[0172] In this example, the spindle assembly 180 may be integrally attached to the housing 420, wherein a biasing mechanism 182 is disposed around the spindle assembly 180. The biasing mechanism 182 may extend between opposite ends that contact each of the chassis 430 and the housing 420, thereby biasing the housing 420 to an extended position away from the chassis 430. The biasing mechanism 182 may be configured to apply resistance to upward movement of the housing 420, particularly the housing 420, toward the chassis 430. As described herein, the biasing mechanism 182 may also be configured to extend the housing 420 outward from within the housing 402 when the housing 420 is pressed into the housing 402 to reach an activated state.

[0173] The chassis 430 may include one or more flexible spacers 432 disposed within the first chamber 136. The one or more flexible spacers 432 may be disposed around an inner surface of the first chamber 136 and may define a relatively small cross-sectional dimension compared to the internal lumen of the first chamber 136. The flexible spacers 432 may be configured to abut against a retaining mechanism 198 of a sliding piston 190, thereby retaining the sliding piston 190 within a release outlet 169 and inhibiting outward movement of the sliding piston 190 from the valve assembly 160. In this example, the flexible spacers 432 may have angled, tapered, and / or inclined interfaces, and the retaining mechanism 198 may have a corresponding interface configured to engage with the interface of the flexible spacers 432. In other words, the flexible spacers 432 and the retaining mechanism 198 may have a generally inclined engagement with each other. As described herein, the flexible spacer 432 can be configured to deform and / or compress radially outward in response to the sliding piston 190 translating into the first chamber 136 in response to the pressurized medium from the valve assembly 160 entering the release outlet 169 via the outlet passage 168 (see [link to document]). Figures 18B to 18CAs described herein, chassis 430 can be configured to lock the slidable piston 190 inside the first chamber 136 and the second chamber 138 in response to engagement of the inner lip 137 retaining mechanism 198, thereby preventing the spindle assembly 180 from moving into the first chamber 136 and the second chamber 138. In this configuration, shield 420 can be locked and prevented from retracting into housing 402 and toward chassis 430.

[0174] exist Figure 18A In the pre-start state shown, the shield 420 can be in a first position, with the central shaft assembly 180 positioned below the chassis 430, and specifically below each of the first chamber 136 and the second chamber 138. The biasing mechanism 182 can be in an expanded configuration, thereby pushing the shield 420 away from the chassis 430 in the downward direction. When the shield 420 is pressed upward toward the chassis 430 to switch the autoinjector 100 to the start state, as... Figure 18B As can be seen, the spindle assembly 180 is relatively upwardly movable and extends through the first chamber 136 and the second chamber 138. In this configuration, the biasing mechanism 182 can be switched to a compression configuration between the shroud 420 and the chassis 430. In some embodiments, when the shroud 420 is fully pressed into the second position, the spindle assembly 180 can be positioned adjacent to and / or in contact with the sliding piston 190. When pressurized medium is contained within the valve assembly 160, at least a portion of the pressurized medium can be directed to the outlet passage 168. The pressurized medium received through the outlet passage 168 encounters the upper end 194 of the sliding piston 190, thereby pushing the sliding piston 190 downward relative to the release outlet 169.

[0175] refer to Figure 18CAfter delivery of a dose from the autoinjector 100 is complete, the force applied to the shield 420 can be released, thereby allowing the biasing mechanism 182 to expand, thus returning the shield 420 to a first position. Alternatively and additionally, when pressurized medium received from the outlet channel 168 pushes the sliding piston 190 away from the release outlet 169, the shield 420 can return to the first position in response to the sliding piston 190 pushing the spindle assembly 180 downward. Clamps 404 and 424 can be collectively configured to lock the shield 420 relative to the housing 402 to suppress restarting upon completion of dose delivery from the autoinjector 100. In response to the biasing mechanism 182 returning to the expanded configuration and the shield 420 moving downward relative to the chassis 430, the spindle assembly 180 can be pushed out of the first chamber 136 and the second chamber 138. When the first chamber 136 and the second chamber 138 are emptied by the mandrel assembly 180, the pressurized medium encountering the upper end 194 can push the slidable piston 190 into the first chamber 136 and the second chamber 138 in a downward direction. It should be understood that the force applied to the slidable piston 190 by the pressurized medium from the outlet channel 168 can be relatively greater than the resistance strength and / or force of the flexible spacer 432 against the retaining mechanism 198 to hold the slidable piston 190 within the release outlet 169. Therefore, the slidable piston 190 can be configured to move (e.g., translate) relative to the release outlet 169 and extend through the first chamber 136 and the second chamber 138. In this case, the flexible spacer 432 can deform and / or compress radially outward to allow the slidable piston 190 to be received through the first chamber 136.

[0176] A sliding piston 190 can be pushed through a first chamber 136, and at least a portion of a latching arm 196 can extend into a second chamber 138. In some embodiments, as the sliding piston 190 extends into the first chamber 136 and through the flexible spacer 432, the latching arms 196 can be radially inwardly biased toward each other. As the latching arms 196 extend through the inner lip 137 and into the second chamber 138, the latching arms 196 can be further biased in the radially inward direction. It should be understood that the latching arms 196 can be radially outwardly moved relative to each other to return to a neutral position upon entering the second chamber 138. Movement of the sliding piston 190 relative to the chassis 430 can be suppressed by a retaining mechanism 198 disposed within the second chamber 138 and engaging the inner lip 137. In other words, the inner lip 137 can be configured to couple the slidable piston 190 to the chassis 430 in response to the retaining mechanism 198 engaged within the second chamber 138, thereby locking the slidable piston 190 to the chassis 430 at the end of dose delivery from the autoinjector 100. The pressurized medium contained in the release outlet 169 can travel along the outside of the slidable piston 190 and exit the release outlet 169 into the first chamber 136. The first chamber 136 is open to the internal cavity of the housing 402 maintained at atmospheric pressure, allowing the autoinjector 100 to discharge the pressurized medium.

[0177] Still referencing Figure 18C When the slidable piston 190 is fixed to the chassis 430, the shield 420 can be prevented from moving further (upward) relative to the chassis 430, thereby preventing additional activation of the autoinjector 100. Specifically, since the locking arm 196 is positioned within the first chamber 136 and the second chamber 138 when the retaining mechanism 198 engages the inner lip 137, the mandrel assembly 180 is prevented from moving upward relative to the chassis 430 and into the first chamber 136 or the second chamber 138, such as in response to a corresponding movement of the shield 420. Thus, the slidable piston 190 can be configured to prevent subsequent activation of the autoinjector 100 by impeding movement of the mandrel assembly 180 and the shield 420. It should be understood that the slidable piston 190 can be configured to extend the mandrel assembly 180 and the shield 420 coupled to the mandrel assembly 180 to a sufficient extent that the needle 116 (see Figure 5 and Figure 10 It is placed inside the protective cover 420 and effectively covered.

[0178] Now for reference Figures 19A to 19CAnother exemplary shield 520, chassis 530, and spindle assembly 580 are illustrated. It should be understood that, except for the differences explicitly stated herein, shield 520, chassis 530, and spindle assembly 580 can be incorporated into the autoinjector 100 in a manner substantially similar to that of shield 120, chassis 130, and spindle assembly 180 shown and described above. For example, chassis 530 may include a pair of retaining mechanisms 532 disposed around spindle assembly 580. Retaining mechanisms 532 may include, but are not limited to, clamps, hand-like elements, finger-like elements, pull tabs, protrusions, levers, etc. Chassis 530 may also include a collar 510 coupled at a bottom end 132 of chassis 530. Collar 510 may extend relatively downward from bottom end 132, with spindle assembly 580 passing at least partially through each of the collar 510 and chassis 530.

[0179] Specifically, the collar 510 may have a longitudinal length defined between a lower end 512 and an upper end 514. The lower end 512 may be coupled to and / or positioned abutting against the inner surface 121 of the shroud 520, and the upper end 514 may be coupled to the lower end 132. The collar 510 may include a pair of first openings 516 and a pair of second openings 518 positioned between the lower end 512 and the upper end 514, wherein the second openings 518 are positioned adjacent to the upper end 514 relative to the first openings 516. The size and shape of the second openings 518 may be designed and / or otherwise configured to receive a retaining mechanism 532 for securely coupling the collar 510 to the chassis 530. The retaining mechanism 532 may be partially flexible and configured to, for example, move radially inward and / or flex relative to the central axis of the chassis 530 in response to movement (e.g., translation) of the collar 510 within the housing 102 and relative to the chassis 530 of the spindle assembly 580, for selective coupling and / or decoupling of the chassis 530 to and / or from the collar 510. As described herein, the collar 510 may be configured to move relative to the chassis 530 in response to corresponding movement of the housing 520 and the spindle assembly 580.

[0180] Still referencing Figures 19A to 19CThe spindle assembly 580 may include a pair of retaining mechanisms 584 positioned relative to the lower end 582 of the spindle assembly 580. The retaining mechanisms 584 may include, but are not limited to, clamps, hands, fingers, pull tabs, protrusions, levers, etc. The size and shape of the first opening 516 may be designed and / or otherwise configured to receive the retaining mechanisms 584 for securely coupling the collar 510 to the spindle assembly 580. The retaining mechanisms 584 may be partially flexible and configured to, for example, move radially inward and / or flex relative to the central axis of the spindle assembly 580 in response to movement (e.g., translation) of the spindle assembly 580 within the housing 102 and relative to the collar 510, for selectively coupling and / or decoupling the spindle assembly 580 from the collar 510. As described herein, the spindle assembly 580 may be configured to move relative to the collar 510 in response to a corresponding movement of the housing 520.

[0181] For details, please refer to the following: Figure 19A When the autoinjector 100 is in a pre-activation state, the shield 520 may be in a first position relative to the housing 102, in which the retaining mechanism 584 is within the first opening 516, thereby detachably coupling the spindle assembly 580 to the collar 510. In this case, the retaining mechanism 532 may be positioned relative to (and decoupled from) the second opening 518. When the spindle assembly 580 is coupled to the shield 520, the shield 520 may be configured to move the spindle assembly 580 upward relative to the housing 102 as the shield 520 is pushed upward into the housing 102. Therefore, due to the engagement between the retaining mechanism 584 and the first opening 516, the collar 510 may move upward simultaneously with the spindle assembly 580 and the shield 520. In other words, the spindle assembly 580 may be configured to pull the collar 510 upward vertically with the retaining mechanism 584 received in the first opening 516. It should be understood that when the guard 520 pushes the spindle assembly 580 upward relative to the housing 102, the biasing mechanism 182 can be extended from the expanded configuration ( Figure 19A ) to compressed configuration ( Figure 19B ).

[0182] Now for reference Figure 19BWhen the autoinjector 100 is in the activated state, the shield 520 may be in a second position relative to the housing 102. In this second position, the spindle assembly 580 repositions the collar 510 relative to the chassis 530 such that the second opening 518 is aligned with the retaining mechanism 532. In this configuration, the retaining mechanism 532 may be accommodated within the second opening 518, thereby coupling the chassis 530 to the collar 510. It should be understood that the chassis 530 may be configured such that when the upper end 514 encounters the retaining mechanism 532 as the collar 510 moves upward into the chassis 530, the retaining mechanism 532 deflects radially inward and / or flexibly bends. The upper end 514 may cause the retaining mechanism 532 to deflect radially inward until the retaining mechanism 532 is positioned aligned with the second opening 518. In this configuration, the retaining mechanism 532 may bend radially outward into the second opening 518, thereby returning the retaining mechanism 532 to a neutral state.

[0183] Now for reference Figure 19C The autoinjector 100 can be switched to a locked state, in which the shield 520 can return to a first position relative to the housing 102. For example, after a dose has been delivered from the autoinjector 100, the force applied to the shield 520 can be released, thereby allowing the biasing mechanism 182 to expand, thus returning the shield 520 to the first position. Specifically, the biasing mechanism 182 can be configured to push the spindle assembly 580 downward relative to the housing 102, and the spindle assembly 580 can be configured to push the shield 520 in response to contact of the spindle assembly 580 with the inner (bottom) surface of the shield 520. When the chassis 530 is coupled to the collar 510 via engagement of the retaining mechanism 532 with the second opening 518, the chassis 530 can be configured to suppress movement of the collar 510 when the spindle assembly 580 and the shield 520 are pushed downward relative to the housing 102. In other words, the collar 510 can be securely fixed to the chassis 530 due to the engagement between the second opening 518 and the retaining mechanism 532.

[0184] Therefore, the retaining mechanism 584 can be configured to move and / or flex radially inward toward each other as the spindle assembly 580 moves (e.g., translates) relative to the housing 102 and collar 510 in a downward direction. In this case, the retaining mechanism 584 can be configured to exit the first opening 516, thereby disengaging the spindle assembly 580 from the collar 510. It should be understood that the biasing mechanism 182 can expand to such an extent that the spindle assembly 580 is pushed through the collar 510 until the retaining mechanism 584 is positioned relatively below the lower end 512. The retaining mechanism 584 can be bent radially outward as it exits the collar 510 at the lower end 512, thereby returning the retaining mechanism 584 to a neutral state. In this case, as the retaining mechanism 584 deflects outward and abuts the lower end 512, the collar 510 can be configured to prevent the retaining mechanism 584 from re-entering the collar 510. Therefore, the axial position of the spindle assembly 580 relative to the collar 510 can be fixed. When the spindle assembly 580 is positioned against the inner surface of the cover 520, movement of the cover 520 in the upward direction can be inhibited, thereby locking the cover 520 and preventing the autoinjector 100 from subsequently activating.

[0185] Now for reference Figures 20A to 20B Another exemplary chassis 630 and carrier 640 are illustrated. It should be understood that, apart from the differences explicitly stated herein, chassis 630 and carrier 640 can be incorporated into the autoinjector 100 in a manner substantially similar to that of chassis 130 and carrier 140 shown and described above. For example, chassis 630 may include a lower flange 632 positioned adjacent to the bottom end 132 of chassis 630, and the lower flange 632 may be at least partially open to accommodate a portion of carrier 640 passing therethrough. Carrier 640 may include a pair of retaining mechanisms 642, the size and shape of which may be designed and / or otherwise configured to extend into the lower flange 632. Specifically, retaining mechanisms 642 may engage with the lower flange 632, thereby detachably coupling carrier 640 to chassis 630. In this example, retaining mechanisms 642 may include, but are not limited to, clamps, hands, fingers, pull tabs, protrusions, levers, etc.

[0186] The carrier 640 may also include an upper flange 644 and a biasing mechanism 646 (e.g., a spring) disposed between the lower flange 632 and the upper flange 644. When the retaining mechanism 642 is engaged with the lower flange 632, the biasing mechanism 646 can be held in a compressed configuration. As described herein, the biasing mechanism 646 can be configured to shift from a compressed configuration (…). Figures 20A to 20B When the configuration is changed to an expanded configuration (not shown), the carrier 640 is pushed upward relative to the lower flange 632 in response to the disengagement of the retaining mechanism 642 from the lower flange 632.

[0187] The can 150 may be positioned within the carrier 640 at a location relatively higher than the upper flange 644, such that the can 150 may be upwardly biased within the housing 102 by a biasing mechanism 646. The carrier 640 may include a plug 648 disposed between a pair of retaining mechanisms 642, and the plug 648 may include a handle 650 extending outward in a downward direction toward the inner surface 121 of the shroud 120 from between the retaining mechanisms 642. It should be understood that the longitudinal length of the handle 650 may be relatively greater than the corresponding longitudinal length of the retaining mechanism 642, such that the handle 650 may be positioned closer to the inner surface 121 relative to the retaining mechanism 642. The plug 648 may be fixed relative to the retaining mechanism 642, such that the plug 648 is immovable relative to the retaining mechanism 642. As described herein, the carrier 640 may be configured to move within the housing 102 and relative to the chassis 630 in response to a corresponding movement of the plug 648.

[0188] For details, please refer to the following: Figure 20A When the autoinjector 100 is in the pre-start state, the shield 120 may be in a first position, in which the inner surface 121 of the shield 120 is offset from the handle 650. The biasing mechanism 182 may be in an expanded configuration, while the biasing mechanism 646 may be in a compressed configuration. In this case, the carrier 640 may be coupled to the chassis 630 by the engagement between the retaining mechanism 642 and the lower flange 632, such that the relative position of the canister 150 (located within the carrier 640) may be fixed relative to the chassis 630.

[0189] Now for reference Figure 20B When the autoinjector 100 transitions to the activated state in response to the movement of the shroud 120 toward the second position, in which the inner surface 121 may abut against the handle 650, the shroud 120 may be configured to push the plug 648, thereby moving the carrier 640 in the upward direction relative to the chassis 630. Specifically, the force applied to the plug 648 by the upward movement of the shroud 120 may cause the retaining mechanism 642 to deflect and / or bend radially inward toward each other, thereby discoupled from the lower flange 632. In this case, the carrier 640 may be movable in the upward direction relative to the chassis 630 in response to the biasing mechanism 646 transitioning to an expanded configuration and pushing the upper flange 644 upward. By pushing the carrier 640 in the upward direction relative to the housing 102, the canister 150 may simultaneously move into fluid communication with a valve assembly (not shown) disposed opposite above the canister 150, as described in detail above, thereby initiating the release of pressurized medium from the canister 150.

[0190] Now for reference Figures 21A to 21CAnother exemplary chassis 730 and mandrel assembly 780 are illustrated. It should be understood that, apart from the differences explicitly stated herein, chassis 730 and mandrel assembly 780 can be incorporated into autoinjector 100 in a manner substantially similar to that of chassis 130 and mandrel assembly 180 shown and described above. For example, chassis 730 may include a cam path 732, the size and shape of which may be designed and / or otherwise configured to receive the plug 782 of mandrel assembly 780. Cam path 732 may define a travel path for plug 782 such that chassis 730 may be configured to control movement of mandrel assembly 780 during use of autoinjector 100. As described herein, mandrel assembly 780 may be configured to translate and rotate relative to chassis 730 as plug 782 moves through the travel path defined by cam path 732. In some embodiments, cam path 732 may include an open channel formed within the wall and / or body of chassis 730. Cam path 732 may include a longitudinal length extending between opposite ends, defining the travel path of bolt 782. When spindle assembly 780 is coupled to and / or contacts the inner surface 121 of shroud 120, chassis 730 may be configured to control movement and / or position of shroud 120 via spindle assembly 780.

[0191] As described herein, the chassis 730 may be configured to lock the shield 120 by inhibiting movement of the spindle assembly 780 when premature lifting of the shield 120 occurs during use of the autoinjector 100. A premature lifting event can generally be defined as the user prematurely, untimely, and / or prematurely releasing the shield 120 when the autoinjector 100 transitions from a pre-start state to an start state. Alternatively, a premature lifting event can be defined as the user prematurely, untimely, and / or prematurely releasing the shield 120 after the autoinjector 100 has started in the start state but before the complete injection delivery of the agent from the autoinjector 100 is completed. In this case, the chassis 730 may be configured to lock the shield 120 to prevent further movement relative to the housing 102, thereby inhibiting further use of the autoinjector 100.

[0192] Still referencing Figures 21A to 21CThe cam path 732 may include one or more paths and / or portions for guiding the movement of the plug 782 relative to the chassis 730 during various operational phases of the autoinjector 100, thereby controlling the position of the shield 120 relative to the housing 102. As described above, the cam path 732 may define an open channel formed along the wall and / or body of the chassis 730. In this example, the cam path 732 may include a first path 734, a second path 736, and a third path 740, each having a shape and / or configuration operable to control the relative position of the plug 782. The first path 734 may have a longitudinal length of a straight portion extending upward along the chassis 730 defining the open channel of the cam path 732, and the second path 736 may have a longitudinal length of a curved portion defining the open channel of the cam path 732 extending laterally from the first path 734. The second path 736 may have a terminal 738 opposite to the first path 734, and the terminal 738 may define an angled (e.g., about ninety degrees) portion of the cam path 732. The third route 740 may have a longitudinal length of a straight section extending downward from the terminal 738 of the open channel defining the cam path 732.

[0193] It should be understood that the cam path 732 may include additional and / or fewer paths, or paths having various other suitable shapes and / or configurations, without departing from the scope of this disclosure. In this example, the first path 734 may be configured to receive the plug 782 within the cam path 732 and hold the mandrel assembly 780 in a first position relative to the chassis 730 in a pre-start state of the autoinjector 100. The second path 736 may be configured to receive the plug 782 from the first path 734 and hold the mandrel assembly 780 in a second position relative to the chassis 730, such as in response to rotation of the plug 782 and / or the mandrel assembly 780 relative to the chassis 730 and the cam path 732 in a first direction, in the start state of the autoinjector 100. The second path 736 may also be configured to receive the plug 782 from the first path 734, such as in response to rotation of the plug 782 and / or the mandrel assembly 780 relative to the chassis 730 and the cam path 732 in the first direction. The third route 740 may be configured to receive the plug 782 from the second route 736, such as in response to rotation of the plug 782 and / or the spindle assembly 780 relative to the chassis 730 and the cam path 732 in a second direction different from the first direction. In this case, the third route 740 may be configured to lock the spindle assembly 780 in a third position relative to the chassis 730 when the delivery of the autoinjector 100 is complete.

[0194] For details, please refer to the following: Figure 21AWhen the autoinjector 100 is in the pre-activation state, the shield 120 may be in a first position, in which the shield 120 extends fully from the housing 102 and the plug 782 is positioned within the cam path 732 along a portion of the first route 734. In this case, the biasing mechanism 182 of the spindle assembly 780 may be in an expanded configuration such that the biasing mechanism 182 can be configured to push the spindle assembly 780 in a downward direction relative to the chassis 730, thereby pushing the shield 120 toward the first position. It should be understood that the dimensions and shape of the first route 734 may be designed and / or otherwise configured to define a channel with cross-sectional dimensions substantially similar to those of the plug 782. In other words, the first route 734 does not include any unnecessary gaps and / or voids to allow the plug 782 to leave the first route 734 prematurely. Therefore, the movement of the plug 782 along the first route 734 may be limited to traveling along the entire range of the first route 734 before entering the second route 736. Due to the size, shape, and / or configuration of the first route 734, the chassis 730 can be configured to rotate the spindle assembly 780 within the housing 102 in a first direction in response to the shroud 120 moving toward a second position in an upward direction and the bolt 782 moving through the first route 734 to the second route 736.

[0195] Now for reference Figure 21B When the autoinjector 100 is in the activated state, the shield 120 may be in a second position, in which the shield 120 is retracted into the housing 102 and the plug 782 is positioned within the cam path 732 along a portion of the second route 736. In this case, the biasing mechanism 182 may move to a compression configuration in response to the upward movement of the shield 120 and the vertical translation of the spindle assembly 780 into the housing 102. In this example, it should be understood that the spindle assembly 780 may be configured to translate vertically and rotate simultaneously as the shield 120 moves relative to the chassis 730. When the dose from the autoinjector 100 has been completely dispensed, the plug 782 may be positioned at the terminal 738 of the second route 736. Therefore, when the plug 782 is positioned at the terminal 738, the second route 736 may inhibit further movement of the plug 782, thereby indicating that dose delivery is complete. As described herein, the size and shape of the second route 736 may be designed and / or otherwise configured to push the bolt 782 toward the third route 740 when the bolt 782 is positioned at the terminal 738.

[0196] It should be understood that the size and shape of the second route 736 may be designed and / or otherwise configured to define a channel with a cross-sectional dimension substantially larger than that of the plug 782. In other words, the second route 736 includes excess clearance and / or gap 737 to allow the plug 782 to prematurely disengage (release) from the second route 736, such as in response to premature lifting of the shield 120 during use of the autoinjector 100. Thus, the movement (e.g., rotation) of the plug 782 along the second route 736 before entering the third route 740 is not limited to traveling along the entire range of the second route 736, such as reaching the terminal 738. Instead, the cam path 732 may be sized and / or shaped along the second route 736 to guide the plug 782 toward the third route 740 if the shield 120 is prematurely lifted without the autoinjector 100 being fully transitioned to the activated state via the gap 737. The gap 737 may define an alternative path for the plug 782 between the second route 736 and the third route 740. As described below, bolt 782 can be securely fixed within cam path 732 when it reaches third route 740, regardless of whether bolt 782 is translated to terminal 738.

[0197] Now for reference Figure 21C When the autoinjector 100 is in a delivery-completed state, the shield 120 can automatically return to a first position, in which the shield 120 extends from the housing 102 and the plug 782 is positioned within the cam path 732 along a portion of the third route 740. In this case, the biasing mechanism 182 can automatically return to an expanded configuration (e.g., move) such that the biasing mechanism 182 can be configured to push the spindle assembly 780 in a downward direction relative to the chassis 730, thereby pushing the shield 120 toward the first position. In this case, the spindle assembly 780 and / or the plug 782 can be configured to rotate in a second direction different from the first direction. In this example, the third route 740 can define a closed end of the cam path 732 such that subsequent activation of the autoinjector 100 is inhibited in response to the third route 740 locking the plug 782 at the closed end of the cam path 732. In other words, when the plug 782 is prevented from moving further while contained within the third route 740, the spindle assembly 780 can be locked to the chassis 730, thereby preventing movement of the shield 120 relative to the housing 102. In this example, the first direction may include a clockwise direction, and the second direction may include a counterclockwise direction.

[0198] Now for reference Figures 22A to 22CThe illustration depicts another exemplary shield 820, chassis 830, valve assembly 860, and slidable piston 890. It should be understood that shield 820, chassis 830, valve assembly 860, and slidable piston 890 can be incorporated into the autoinjector 100 in a manner substantially similar to that of shield 120, chassis 130, valve assembly 160, and slidable piston 190 shown and described above. For example, shield 820 may include a pair of retaining mechanisms 822 extending outward in an upward direction toward chassis 830 from inner surface 121 of shield 820. The pair of retaining mechanisms 822 may be spaced apart from each other by a cavity 824 formed therebetween. In some embodiments, retaining mechanisms 822 may include, but are not limited to, clamps, hands, fingers, pull tabs, protrusions, levers, etc. As described herein, the size and shape of the cavity 824 may be designed and / or otherwise configured to accommodate at least a portion therein in response to engagement of the shroud 820 with the slidable piston 890.

[0199] The chassis 830 may include a pair of retaining mechanisms 832 movably coupled to the shroud 820 via a biasing mechanism 834. The biasing mechanism 834 may be coupled to the shroud 820 along an inner surface 121. As described herein, the biasing mechanism 834 may be configured to push the shroud 820 away from the chassis 830, particularly in the downward direction, when in an expanded configuration. The biasing mechanism 834 may be configured to change from an expanded configuration to a compressed configuration in response to upward movement of the shroud 820 toward the chassis 830. Figure 22B The valve assembly 860 may include a body 862 having a first port 864, a second port 866, and a lower opening 868. The first port 864 may be in fluid communication with a low-pressure line of the autoinjector 100, the second port 866 may be in fluid communication with a discharge line and / or opening of the autoinjector 100, and the lower opening 868 may be sized, shaped, and / or otherwise configured to accommodate at least a portion of a slidable piston 890 within the body 862 via the lower opening 868.

[0200] As described herein, a slidable piston 890 can be slidably housed within a valve assembly 860, and specifically, the upper end 892 of the slidable piston 890 can be movably disposed within the body 862. The slidable piston 890 may include a first seal 891 and a second seal 893 positioned along the upper end 892. When the slidable piston 890 is in a first position relative to the valve assembly 860 (see...), Figure 22AA first seal 891 may be disposed between a first port 864 and a second port 866, and a second seal 893 may be disposed between the second port 866 and a lower opening 868. In this configuration, since the first seal 891 is located within the body 862 between the first port 864 and the second port 866, the first port 864 may be fluidly decoupled from the second port 866, and since the second seal 893 is located within the body 862 between the second port 866 and the lower opening 868, the second port 866 may be fluidly decoupled from the lower opening 868. As described herein, a slidable piston 890 may be configured to selectively establish fluid communication between the first port 864 and the second port 866 in response to movement and repositioning of the first seal 891 and / or the second seal 893 relative to the body 862.

[0201] Still referencing Figures 22A to 22C The slidable piston 890 may include a lower end 894 positioned opposite the upper end 892. The lower end 894 may include a plurality of retaining mechanisms, each of which may be sized and shaped and / or otherwise configured to attach the slidable piston 890 to one or more other components of the autoinjector 100, such as a shield 820 and a chassis 830. In this example, the slidable piston 890 may include a central retaining mechanism 896 extending outward from the lower end 894, and a pair of lateral retaining mechanisms 898 disposed radially outward from the central retaining mechanism 896. In some embodiments, the central retaining mechanism 896 may include, but is not limited to, a clamp, a hand, a finger, a pull tab, a protrusion, a hook, etc. The pair of lateral retaining mechanisms 898 may include, but is not limited to, a clamp, a hand, a finger, a pull tab, a protrusion, a lever, etc. When the slidable piston 890 is in the first position, with the upper end 892 disposed within the valve assembly 860, the lower end 894 can extend downward from the main body 862 through the lower opening 868 of the valve assembly 860. Therefore, when the slidable piston 890 is in the first position relative to the valve assembly 860, the retaining mechanisms 896 and 898 are disposed outside the main body 862.

[0202] For details, please refer to the following: Figure 22AWhen the autoinjector 100 is in a pre-start state, the shield 820 may be in a first position, in which the biasing mechanism 834 is in an expanded state, causing the shield 820 to decouple from the sliding piston 890. Furthermore, when the sliding piston 890 is in a corresponding first position relative to the valve assembly 860, the chassis 830 is decoupled from the sliding piston 890. In response to moving the shield 820 toward the chassis 830 in an upward direction, such as in response to applying a force to the bottom surface 122 to push the shield 820 upward, the shield 820 may be configured to compress the biasing mechanism 834. In this case, the retaining mechanism 822 may move toward the sliding piston 890 and engage with the center retaining mechanism 896, thereby coupling the shield 820 to the sliding piston 890.

[0203] Now for reference Figure 22B The autoinjector 100 can be in an activated state, and the shield 820 can be translated toward a second position, in which the slidable piston 890 is firmly coupled to the shield 820. Therefore, the slidable piston 890 can be configured to move together with the shield 820. It should be understood that when the shield 820 moves toward the chassis 830 and the second position, the chassis 830 can remain fixed relative to the shield 820. When the force applied to the shield 820 against the bottom surface 122 is released, the biasing mechanism 834 can be configured to return to the expanded configuration, thereby pushing the shield 820 away from the chassis 830 in a downward direction. In other words, the shield 820 can automatically return toward the first position. In this case, when the slidable piston 890 is coupled to the shield 820, the biasing mechanism 834 can also be configured to at least partially pull the slidable piston 890 out of the body 862 through the lower opening 868.

[0204] In some implementations, the shield 820 may be configured such that the retaining mechanism 822 may be configured to hold the autoinjector 100 in its pre-start state. Figure 22A ) transition to startup state ( Figure 22B Before and / or during engagement of the center retention mechanism 896. In this case, such as in response to premature lifting of the shield 820 during use of the autoinjector 100, the shield 820 may be coupled to the slidable piston 890 to allow premature disengagement (release) of the shield 820. As described herein, when the shield 820 is coupled to the slidable piston 890, the biasing mechanism 834 may be configured to lock the shield 820 to the chassis 830 upon completion of the activation state or when the shield 820 is prematurely lifted before the autoinjector 100 has fully transitioned to the activation state.

[0205] refer to Figure 22CThe autoinjector 100 can transition to a delivery-completed state, wherein the shield 820 automatically moves toward or returns to a first position and the sliding piston 890 moves from the corresponding first position toward a second position. The shield 820 can be configured to pull the sliding piston 890 to a certain extent in a downward direction, such that a lateral holding mechanism 898 can engage with a holding mechanism 832, thereby firmly coupling the sliding piston 890 to the chassis 830. In this case, the sliding piston 890 can be held in the second position due to its attachment to each of the shield 820 and the chassis 830, thereby locking the shield 820 and the sliding piston 890 in their respective positions. It should be understood that when the shield 820 undergoes premature lifting, the shield 820 and the sliding piston 890 can be positioned in... Figure 22C The corresponding position shown prevents further activation of the autoinjector 100.

[0206] Additionally, when the slidable piston 890 extends out of the body 862 via the lower opening 868, the upper end 892 is movable relative to the first port 864 and the second port 866, wherein the first seal 891 is positioned opposite the second port 866 and the second seal 893 is positioned opposite the lower opening 868. In other words, the second seal 893 can be positioned outside the body 862. In this case, due to the position of the upper end 892 within the body 862 and, in particular, the position of the first seal 891 relative to the body 862, the slidable piston 890 can be configured to fluidly couple the first port 864 to the second port 866. Therefore, a low-pressure line in fluid communication with the second port 866 can guide pressurized gas received therein to the discharge opening and / or line at the first port 864. Additionally, since the second seal 893 is positioned relatively lower than the lower opening 868, the slidable piston 890 can be configured to discharge any pressurized medium received from the low-pressure line between the first seal 891 and the second seal 893 (via the second port 866 when the slidable piston 890 is in the first position) to the valve assembly 860 via the lower opening 868.

[0207] Now for reference Figures 23A to 23BAnother exemplary actuator 925 and chassis 930 are illustrated. It should be understood that, apart from the differences explicitly stated herein, actuator 925 and chassis 930 can be incorporated into autoinjector 100 in a manner substantially similar to that of actuator 125 and chassis 130 shown and described above. For example, actuator 925 may include a rod 922 movably coupled to body 126. Chassis 930 may include a cam path 932 defined by a first path 934 and a second path 936. In this example, the first path 934 may define an angled and / or inclined surface along the cam path 932, and the second path 936 may define a closed end of the cam path 932. In other words, the first path 934 may have a longitudinal length of a curved portion defining an open channel of the cam path 932 extending laterally along chassis 930. In some examples, the first path 934 may be generally U-shaped. The second path 936 may be positioned at the end of the first path 934. The dimensions and shape of the cam path 932 may be designed and / or otherwise configured to slidably accommodate at least a portion of the rod 922 therein. In other words, the rod 922 may be coupled to and movable relative to each of the body 126 and the cam path 932. The actuator 920 may also include a biasing mechanism 924 (e.g., a torsion spring) coupled to the body 126 and positioned adjacent to the rod 922. The biasing mechanism 924 may be configured to actuate the rod 922 to move along the cam path 932 from the first path 934 toward the second path 936.

[0208] refer to Figure 23A When the autoinjector 100 is in a pre-start state, the shield 120 may be in a first position, while the lever 922 is positioned along the first path 934 and the biasing mechanism 182 is in an expanded configuration. In response to moving the shield 120 upward toward the chassis 930, the actuator 920 may be configured to move, thereby pivoting the lever 922 relative to the body 126 and translating the lever 922 relative to the cam path 932. In this example, the control lever 922 may be configured to move (e.g., pivot, rotate, translate, etc.) through a curved portion of the first path 934. Similar to the cam path 732 shown and described above (… Figures 21A to 21C The first route 934 may include a terminal that defines the full stroke of the shield 120 for delivering the full dose, and the second route 936 may include excess clearance and / or gaps to define an alternative path for the lever 922 in the event of an early lift event. In this case, an early lift of the shield 120 may cause the control lever 922 to travel along the alternative path of the second route 936. In either case, the chassis 930 may be configured to lock the shield 120 in response to the lever 922 being received at the closed end of the cam path 932 along the second route 936, as... Figure 23BIt is evident that the biasing mechanism 182 can be configured to automatically return the shield 120 to the first position by pushing the shield 120 downward relative to the chassis 930.

[0209] Now for reference Figures 24A to 24B Another exemplary spindle assembly 1080 is illustrated. It should be understood that, apart from the differences explicitly stated herein, spindle assembly 1080 can be incorporated into autoinjector 100 in a manner substantially similar to that of spindle assembly 180 shown and described above. For example, as... Figure 24A As can be seen, the spindle assembly 1080 may include a pair of retaining mechanisms 1082, which may be disposed within the first chamber 136 when the shield 120 is in the first position and the autoinjector 100 is in the pre-activation state. The pair of retaining mechanisms 1082 may include, but are not limited to, clamps, hand-like members, finger-like members, pull tabs, protrusions, levers, etc. In this case, the spindle assembly 1080 may be offset from the inner surface 121 of the shield 120 and accommodated on a lug 1084 positioned opposite to the inner surface 121. The spindle assembly 1080 may be configured to rotate in response to the shield 120 moving toward a second position and the autoinjector 100 transitioning to the activation state (not shown).

[0210] like Figure 24B As can be seen, in response to rotation of the spindle assembly 1080, the spindle assembly 1080 can be translated in a downward direction, such that the spindle assembly 1080 can be received along the inner surface 121. The retaining mechanism 1082 can be configured to move from the first chamber 136 to the second chamber 138 in response to radially inward deflection towards each other abutting the inner lip 137. Upon entry into the second chamber 138, the retaining mechanism 1082 can be configured to deflect in a radially outward direction and / or flexibly bend, thereby locking the spindle assembly 1080 relative to the chassis 130. When the spindle assembly 1080 is received on the inner surface 121, the spindle assembly 1080 can be configured to inhibit further movement of the shield 120 relative to the chassis 130. It should be understood that the spindle assembly 1080 can be configured to disengage from the tab 1084 and abut against the inner surface 121 in the event of complete dose delivery or premature elevation. Therefore, the advance lifting of the shield 120 allows the spindle assembly 1080 to be lowered against the inner surface 121. In either case, the chassis 130 can be configured to lock the shield 120 in response to the spindle assembly 1080 being abutted against the inner surface 121 and the receiving and retaining mechanism 1082 being locked within the second chamber 138.

[0211] Now for reference Figures 25A to 25BAnother exemplary shield 1120, valve assembly 1160, and sliding piston 1190 are illustrated. It should be understood that, except for the differences explicitly stated herein, shield 1120, valve assembly 1160, and sliding piston 1190 can be incorporated into the autoinjector 100 in a manner substantially similar to that shown and described above. For example, shield 1120 may include a handle 1122, the size and shape of which may be designed and / or otherwise configured to abut against sliding piston 1190. Specifically, shield 1120 may be configured to push handle 1122 against sliding piston 1190, thereby using sliding piston 1190 to seal port 1162 of valve assembly 1160. In some embodiments, the slidable piston 1190 may include a compliant seal 1192 at its upper end, and the compliant seal 1192 may be configured to seal port 1162 when the shroud 1120 abuts against the push handle 1122 of the slidable piston 1190 with sufficient sealing force, such as... Figure 25B As can be seen, in some embodiments, the slidable piston 1190 may include a spring and / or other biasing mechanism, such that the slidable piston 1190 can be extended from an expanded configuration ( Figure 25A Towards compressed configuration ( Figure 25B )change.

[0212] In this example, port 1162 may be in fluid communication with the low-pressure line of the autoinjector 100. By forming a face seal on port 1162, the necessary sealing force is minimized because port 1162 is typically small, such as having a diameter of approximately 1 mm. When premature lifting of the shroud 1120 occurs, the compliant seal 1192 may lose contact with port 1162, thereby allowing pressurized medium from the low-pressure line fluidly coupled thereto to push the shroud 1120 in a downward direction, thereby locking the shroud 1120. It should be understood that the compliant seal 1192 does not seal ports in fluid communication with the discharge line and / or opening of the valve assembly 1160. In some embodiments, the autoinjector 100 may include a secondary indicator configured to generate notification for properly lifting the shroud 1120 to transition to the activating state while preventing premature lifting from occurring.

[0213] Now for reference Figure 26Another exemplary actuator 1125 and chassis 1230 are illustrated. It should be understood that, apart from the differences explicitly stated herein, actuator 1125 and chassis 1230 can be incorporated into the autoinjector 100 in a manner substantially similar to that of actuator 125 and chassis 130 shown and described above. For example, actuator 1125 may include one or more retaining mechanisms 1226, and chassis 1230 may include one or more corresponding retaining mechanisms 1232. Retaining mechanisms 1226 may be configured to engage retaining mechanisms 1232 when the shroud 120 is moved and the autoinjector 100 is switched to an activated state. In this case, it should be understood that retaining mechanism 584 of mandrel assembly 580 may be disposed opposite retaining mechanism 1226. Retaining mechanism 584 may be laterally movable and / or deflectable in response to engaging one or more other components of autoinjector 100. In some embodiments, retaining mechanism 584 may be radially outwardly biased relative to the lower end 582 of mandrel assembly 580. The retaining mechanisms 584, 1226, and 1232 may each include, but are not limited to, obstructions, pull tabs, protrusions, fingers, clamps, levers, and / or various other mechanisms.

[0214] In the event of premature lifting of the shield 120, the spindle assembly 580 can be configured to move relative to the actuator 1225, such that the retaining mechanism 584 can be translated in the downward direction until the retaining mechanism 584 is positioned relative to the retaining mechanism 1226. It should be understood that the retaining mechanism 584 can be configured to radially inwardly deflect and / or bend toward the spindle assembly 580 before radially outwardly deflecting to a neutral state as it moves downward via the retaining mechanism 1226 and extends below the retaining mechanism 1226. When the retaining mechanism 584 is positioned below and abutting the retaining mechanism 1226, the spindle assembly 580 can be configured to lock the shield 120 to prevent further movement relative to the chassis 1230.

[0215] Now for reference Figure 27 Another exemplary shield 1320 is illustrated. It should be understood that, apart from the differences explicitly stated herein, shield 1320 can be incorporated into autoinjector 100 in a manner substantially similar to that of shield 120 shown and described above. For example, shield 1320 may include a pouch 1322 formed along an inner surface 121. Pouch 1322 may include an enlarged end 1324 and a narrow end 1326 positioned adjacent to each other along the inner surface 121. Pouch 1322 may be positioned along the inner surface 121 of shield 1320 aligned with actuator 125. The size and shape of pouch 1322 may be designed and / or otherwise configured to receive a first end 127 of actuator 125.

[0216] In response to moving the shield 1320 upward toward the chassis 130, the actuator 125 can be configured to translate relative to the inner surface 121 and over the pouch 1322 until the autoinjector 100 transitions from a pre-activation state to an activation state, at which point the first end 127 is received within the enlarged end 1324. It should be understood that the size and shape of the pouch 1322 can be designed and / or otherwise configured to prevent the first end 127 from being received directly within the narrow end 1326, such as from a position directly above the narrow end 1326. In other words, because the top opening of the narrow end 1326 along the inner surface 121 is relatively smaller than the cross-sectional dimension of the first end 127, the first end 127 can translate directly over the narrow end 1326 without entering the narrow end 1326 as the actuator 125 slides across the inner surface 121. Therefore, the first end 127 can be translated directly above the narrow end 1326 without being contained within the narrow end 1326, even though the narrow end 1326 is developed directly below the first end 127.

[0217] As described herein, the size and / or shape of the lateral opening of the narrow end 1326 along one side adjacent to the enlarged end 1324 can be designed to have a cross-sectional dimension sufficient to accommodate the first end 127. When the shroud 1320 is prematurely raised, the inner surface 121 can move relative to the actuator 125 such that the first end 127 is snapped from the enlarged end 1324 into the narrow end 1326, thereby locking the actuator 125 relative to the shroud 1320. It should be understood that the bag 1322 can be configured to prevent the first end 127 from being released from the narrow end 1326 when it is received therein from the enlarged end 1324. In this case, movement of the shroud 1320 relative to the chassis 130 is suppressed due to the fixed engagement between the actuator 125 and the bag 1322, and particularly the secure engagement of the first end 127 within the narrow end 1326.

[0218] Now for reference Figure 28 Another exemplary housing 1402, valve assembly 1460, and indicator assembly 1470 are illustrated. It should be understood that, except for the differences explicitly stated herein, housing 1402, valve assembly 1460, and indicator assembly 1470 can be incorporated into the autoinjector 100 in a manner substantially similar to that of housing 102, valve assembly 160, and indicator assembly 170 shown and described above. For example, housing 1402 may include a window 1404 along a top apex 104, and window 1404 may define an opaque wall of housing 1402 at the top apex 104. Indicator assembly 1470 may be disposed within housing 1402 and offset from window 1404 such that indicator assembly 1470 is not visible through window 1404 when the autoinjector 100 is in a pre-activation state.

[0219] The indicator assembly 1470 is fluidly coupled to the valve assembly 1460, such that the indicator assembly 1470 can be configured to translate in an upward direction within the housing 1402, particularly toward the top 104, in response to the valve assembly 1460 receiving pressurized medium. Therefore, upon completion of dose delivery from the autoinjector 100, the pressurized medium can push the indicator assembly 1470 toward the window 1404, making it visible from the outside of the housing 1402, thereby providing visual feedback on dose delivery. In some embodiments, the indicator assembly 1470 can be configured abutting the inner surface of the window 1404, thereby providing tactile feedback on dose delivery.

[0220] Now for reference Figures 29 to 30 Another exemplary sliding piston 1590 is illustrated. It should be understood that, apart from the differences explicitly stated herein, the sliding piston 1590 can be incorporated into the autoinjector 100 in a manner substantially similar to that of the sliding piston 190 shown and described above. For example, the sliding piston 1590 may include one or more first indicator surfaces 1592 and one or more second indicator surfaces 1594 disposed along the exterior of the sliding piston 1590. The first indicator surfaces 1592 and the second indicator surfaces 1594 may each include one or more marks, colors, and / or markings that differ from each other. For example, the first indicator surface 1592 may include a first color (e.g., green), while the second indicator surface 1594 may include a second color (e.g., white) that differs from the first color. The sliding piston 1590 and / or housing 102 may include one or more barrier features 1596.

[0221] For details, please refer to the following: Figure 29 In the pre-activation state of the autoinjector 100, the slidable piston 1590 can be positioned such that the first indicator surface 1592 is aligned with the barrier feature 1596 and the second indicator surface 1594 is offset from the barrier feature 1596, such that the first indicator surface 1592 is not visible from a viewpoint V that is offset from and coincides with the space and / or gap between the adjacent barrier feature 1596, while the second indicator surface 1594 is visible from viewpoint V. In this configuration, the second indicator surface 1594 is operable to indicate the pre-activation state of the autoinjector 100 when it is offset from the barrier feature 1596 and is visible via viewpoint V. In some embodiments, the barrier feature 1596 may be a surface and / or wall of the autoinjector 100.

[0222] Now for reference Figure 30When the autoinjector 100 completes dose delivery and dispensing, the slidable piston 1590 can be configured to move relative to the housing 102 such that the first indicator surface 1592 is visible from viewpoint V and the second indicator surface 1594 is no longer visible from viewpoint V. In this case, the first indicator surface 1592 can be operable to indicate the complete delivery state of the autoinjector 100 when it is offset from and visible from the obstruction feature 1596. It should be understood that viewpoint V can be from the perspective and / or viewing angle of the user of the autoinjector 100 during use of the autoinjector 100, for example, from outside the autoinjector 100.

[0223] Now for reference Figure 31 Another exemplary actuator 1625 and carrier 1640 are illustrated. It should be understood that, apart from the differences explicitly stated herein, actuator 1625 and carrier 1640 can be incorporated into the autoinjector 100 in a manner substantially similar to that of actuator 125 and carrier 140 shown and described above. For example, actuator 1625 may include a protrusion 1628 along a second end 128, and carrier 1640 may include a corresponding protrusion 1642 along a bottom end 142. Protrusions 1628 and 1642 may each include a step, tab, support, and / or various other suitable extensions along the respective ends of actuator 1625 and carrier 1640. In a first position, protrusion 1642 may be positioned to the left of protrusion 1628 before the actuator 1625 is moved relative to carrier 1640. In the second position, after the actuator 1625 moves relative to the carrier 1640, the protrusion 1642 can be positioned to the right of the protrusion 1628.

[0224] The protrusion 1628 can be configured to engage the protrusion 1642 in response to movement of the actuator 1625 relative to the chassis 130 and abutment against the carrier 1640. In this case, when the protrusion 1642 abuts against the protrusion 1628, the actuator 1625 can be prevented from returning to its initial position relative to the chassis 130, thereby firmly securing the actuator 1625 and locking the shield 120 to prevent movement relative to the housing 102. In this case, the shield 120 can be locked in the retracted position relative to the housing 102. In other embodiments, the protrusions 1628 and 1642 can be jointly configured to reduce the backflush force generated at the tank 150 in response to the release of pressurized medium into the valve assembly 160 onto the shield 120.

[0225] Now for reference Figure 32Another exemplary canister 1750 and valve assembly 1760 are illustrated. It should be understood that, except for the differences explicitly stated herein, canister 1750 and valve assembly 1760 can be incorporated into the autoinjector 100 in a manner substantially similar to that of canister 150 and valve assembly 1760 shown and described above. For example, canister 1750 may include a retainer cap 1752 having a sealing surface 1754 coupled to a neck 152, and a seal 1756 (e.g., an O-ring) disposed around the neck 152. Valve assembly 1760 may include an interface surface 1762 disposed around a puncture mechanism 164. Retainer cap 1752 and seal 1756 may each be configured to fluidly couple canister 1750 to valve assembly 160. For example, sealing surface 1754 may be configured to contact the exterior of interface surface 1762, and seal 1756 may be configured to contact the interior of interface surface 1762. Therefore, retainer cap 1752 and seal 1756 may define a two-part sealing system for tank 1750. In some embodiments, sealing surface 1754 may be configured to clamp onto interface surface 1762, and retainer cap 1752 may provide sufficient resistance to retain pressure against the pressure exerted on seal 1756 by pressurized medium released from tank 1750.

[0226] Now for reference Figure 33 Another exemplary shield 1820 and carrier 1840 are illustrated. It should be understood that, apart from the differences explicitly stated herein, shield 1820 and carrier 1840 can be incorporated into the autoinjector 100 in a manner substantially similar to that of shield 120 and carrier 140 shown and described above. For example, shield 1820 may include a pair of retaining mechanisms 1822 (e.g., clamps, hooks, arms, pull tabs, etc.), and carrier 1840 may include a movable body 1842 having a pair of arms 1844, a fixed body 1846, a locking pin 1848, and a biasing mechanism 1850 (e.g., a spring) disposed between the movable body 1842 and the fixed body 1846. The locking pin 1848 may be disposed between the pair of arms 1844, and the pair of arms 1844 may be disposed within an opening through the fixed body 1846. The pair of arms 1844 may be at least partially flexible, and the locking pin 1848 may be configured to secure the pair of arms 1844 to the fixed body 1846 when positioned between the arms 1844. In other words, when the locking pin 1848 is positioned between the arms 1844, the locking pin 1848 may be configured to bend the arms 1844 radially outward relative to each other. When the arms 1844 are received through an opening in the fixed body 1846, the locking pin 1848 may be configured to push the pair of arms 1844 against the fixed body 1846, thereby securely coupling the movable body 1842 to the fixed body 1846.

[0227] A shield 1820 may be positioned opposite the carrier 1840, and a retaining mechanism 1822 may be configured to engage a locking pin 1848 when the shield 1820 moves upward toward the carrier 1840. When the retaining mechanism 1822 engages the locking pin 1848, a pre-lifting event may cause the shield 1820 to move downward relative to the carrier 1840. When the retaining mechanism 1822 engages the locking pin 1848, the shield 1820 may be configured to pull the locking pin 1848 downward relative to the fixed body 1846, thereby disengaging the locking pin 1848 from the pair of arms 1844. In this case, when the locking pin 1848 is no longer positioned between the pair of arms 1844, a gap may be formed between the pair of arms 1844 to allow the arms 1844 to move laterally toward each other and into the gap. Due to the gap formed therebetween caused by the removal of the locking pin 1848, the pair of arms 1844 may be configured to bend radially inward toward each other. Therefore, the force applied to the movable body 1842 by the biasing mechanism 1850 causes the arms 1844 to bend towards each other, thereby minimizing the cross-sectional profile of the arms 1844 to allow them to extend through the opening in the fixed body 1846. When the biasing mechanism 1850 expands, the pair of arms 1844 can be configured to move vertically (e.g., translate) in the upward direction together with the movable body 1842 through the opening in the fixed body 1846. The biasing mechanism 1850 can be fixed in the expanded configuration, thereby locking the autoinjector 100 to prevent subsequent use.

[0228] refer to Figure 34 An exemplary valve assembly 2040 of an autoinjector 100 is illustrated. It should be understood that, except for the differences explicitly pointed out herein, the valve assembly 2040 can be incorporated into the autoinjector 100 in a substantially similar manner to the valve assembly 160 shown and described above. For example, the valve assembly 2040 may include a valve body 2042 having a first (top) portion 2044 and a second (bottom) portion 2046 arranged in a compact configuration within a housing 102, thereby providing a reduced cross-sectional profile of the housing 102 relative to the valve assembly 160.

[0229] In this example, the first (top) portion 2044 may be configured to receive at least a portion of the canister 150, such as the neck 152, to facilitate fluid communication with the puncture mechanism 164. The valve assembly 2040 may include a release outlet 169 in which a slidable piston 190 is movably disposed. The second (bottom) portion 2046 may be vertically disposed above the first (top) portion 2044, such that the arrangement of the valve body 2042 may be configured to form a reduced cross-sectional profile within the housing 102 relative to the valve assembly 160 shown and described above. In this case, the diaphragm 2012 (not shown) of the valve assembly 2040 may be horizontally oriented within the valve body 2042, such that the diaphragm 2012 is arranged to move vertically along its axis of action. In other words, the body of the diaphragm 2012 may be arranged transversely along a horizontal plane relative to the longitudinal axis of the housing 102.

[0230] Still referencing Figure 34 The auto-injector 100 can completely omit the carrier 140, allowing the canister 150 to be moved via an actuator 125 (not shown) into direct fluid communication with the valve assembly 2040. By positioning the canister 150 and the sliding piston 190 within the first (top) portion 2044 of the valve body 2042, the valve assembly 2040 can be operated to provide a smaller sealing area and greater strength relative to the valve assembly 160. The second (bottom) portion 2046 can be configured to abut against the container 112, thereby reducing the height of the housing 102. The second (bottom) portion 2046 is in fluid communication with the container 112 via a conduit 2048.

[0231] refer to Figure 35 Another exemplary valve assembly 2050 of the autoinjector 100 is illustrated. It should be understood that, apart from the differences explicitly pointed out herein, the valve assembly 2050 can be incorporated into the autoinjector 100 in a substantially similar manner to the valve assembly 160 shown and described above. For example, the valve assembly 2050 may include a valve body 2052 having a first (top) portion 2054 and a second (bottom) portion 2056 compactly arranged within a housing 102, thereby providing a reduced cross-sectional profile of the housing 102 relative to the valve assembly 160.

[0232] In this example, the first (top) portion 2054 may be configured to receive at least a portion of the canister 150, such as the neck 152, to facilitate fluid communication with the puncture mechanism 164. The valve assembly 2050 may include a release outlet 169 in which a slidable piston 190 (not shown) is movably disposed. The second (bottom) portion 2056 may be arranged horizontally and / or radially relative to the first (top) portion 2054, such that the arrangement of the valve body 2052 may be configured to form a reduced cross-sectional profile within the housing 102 relative to the valve assembly 160 shown and described above. In this configuration, the diaphragm 2012 (not shown) of the valve assembly 2050 may be vertically oriented within the valve body 2052, such that the diaphragm 2012 is arranged to move horizontally along its axis of action. In other words, the body of the diaphragm 2012 may be arranged along a vertical plane parallel to the longitudinal axis of the housing 102.

[0233] Still referencing Figure 35 The autoinjector 100 completely omits the carrier 140, allowing the canister 150 to be moved via the actuator 125 into direct fluid communication with the valve assembly 2050. By positioning the canister 150 within the first (top) portion 2054 and positioning the sliding piston 190 within the valve body 2052, the valve assembly 2050 can be operated to provide a smaller sealing area and higher strength relative to the valve assembly 160. The second (bottom) portion 2056 can be configured to dock with the container 112, thereby reducing the height of the housing 102.

[0234] Now for reference Figure 36 The diagram illustrates a valve assembly 160 of an autoinjector 100. As described in detail herein, the valve assembly 160 may include a high-pressure (first) inlet 2022, a low-pressure (second) inlet 2024, and a diaphragm 2012 positioned between a low-pressure body portion 2014 and a high-pressure body portion 2016 (see [reference]). Figures 44 to 46 In some embodiments, the low-pressure body portion 2014 may be attached to the high-pressure body portion 2016 via various suitable means and at one or more locations therebetween to securely couple the diaphragm 2012 therein. For example, the low-pressure body portion 2014 may be attached to the high-pressure body portion 2016 via one or more weld paths to secure any one of the diaphragm 2012, the low-pressure body portion 2014, and the high-pressure body portion 2016 to each other. Each of the one or more weld paths may extend along a predefined portion within the valve assembly 160. In some embodiments, the one or more weld paths may be continuous without intermediate interruptions, while in other embodiments, the one or more weld paths may include one or more interruptions forming a stress-relief gap within the valve assembly 160.

[0235] In this example, valve assembly 160 may include a first (external) weld path 1908 disposed around the outer periphery of valve assembly 160 and particularly along the interface edge between low-pressure body portion 2014 and high-pressure body portion 2016. By extending continuously around the outer periphery, the first weld path 1908 may be configured and operable to seal low-pressure body portion 2014 to high-pressure body portion 2016. As shown and described herein, the first weld path 1908 may also be configured to securely couple diaphragm 2012 between low-pressure body portion 2014 and high-pressure body portion 2016 (see [link to documentation]). Figure 41 ).

[0236] Still referencing Figure 36 The valve assembly 160 may include one or more second (internal) weld paths 1910 disposed along a portion of the valve assembly 160 radially inwardly positioned from a first (external) weld path 1908. The second weld paths 1910 may be configured and operable to seal the diaphragm 2012, the low-pressure body portion 2014, and the high-pressure body portion 2016 to each other within the valve assembly 160. In this example, the valve assembly 160 may include a pair of second weld paths 1910 disposed around the diaphragm 2012. The respective dimensions and shapes of the pair of second weld paths 1910 may be designed and / or otherwise configured to form at least one stress relief gap 1912 around the diaphragm 2012. The stress relief gap 1912 may be configured and operable as a pressure relief mechanism of the valve assembly 160, such that during operation of the autoinjector 100, the stress relief gap 1912 may be configured to release a portion of the pressurized gas contained within the valve assembly 160, such as when the pressure generated within the valve assembly 160 reaches a predetermined threshold. In this configuration, the stress relief gap 1912 is operable to prevent excessive pressure buildup within the valve assembly 160, and particularly between the high-pressure (first) cavity 2018 and the low-pressure (second) cavity 2020 of the valve assembly 160, as described in more detail below (see [link to relevant documentation]). Figures 44 to 46 ).

[0237] It should be understood that additional and / or fewer first weld paths 1908 and / or second weld paths 1910 may be included in the valve assembly 160 without departing from the scope of this disclosure. Additionally and / or alternatively, the first weld paths 1908 and / or second weld paths 1910 may be positioned along various other portions of the valve assembly 160 and may have various other suitable shapes and / or configurations besides those shown and / or described herein.

[0238] like Figure 42As can be seen, the outer edges of the low-pressure body portion 2014 and the high-pressure body portion 2016 can be welded to each other via a first (external) welding path 1908, with the diaphragm 2012 disposed therebetween. In some embodiments, the diaphragm 2012 may include a central body 2011A having an outer edge 2011B extending outward from the central body 2011A and around the periphery of the diaphragm 2012, particularly along the bottom surface of the diaphragm 2012. In this example, the low-pressure body portion 2014 may include a corresponding cavity 2013, the size and shape of which may be designed and / or otherwise configured to accommodate the outer edge 2011B, thereby coupling the diaphragm 2012 to the low-pressure body portion 2014. The diaphragm 2012 may include a raised portion located at a radially central position of the central body 2011A, the thickness of which protrudes outward from the central body 2011A by a distance greater than the extension of the outer edge 2011B.

[0239] As described in detail below, valve assembly 160 may include valve seat 2028 formed along low-pressure body portion 2014 (see below). Figures 44 to 46 The valve seat 2028 may be integrally formed with the low-pressure body portion 2014, such that the valve seat 2028 and the low-pressure body portion 2014 form a single unit. In other embodiments, such as Figure 42 As can be seen, the valve seat may include a discharge insert 2028A coupled to the low-pressure body portion 2014. In this case, the discharge insert 2028A may extend into the interior of the valve assembly 160 between the diaphragm 2012 and the low-pressure body portion 2014, such as within the low-pressure (second) cavity 2020. In this example, the low-pressure body portion 2014 may include a central opening 2015, the size and shape of which may be designed and / or otherwise configured to accommodate the discharge insert 2028A.

[0240] Still referencing Figure 42The discharge insert 2028A may include a cavity 2029 extending around the periphery of the discharge insert 2028A and particularly along the bottom surface of the discharge insert 2028A. In this example, the low-pressure body portion 2014 may include a corresponding inner lug 2017, the size and shape of which may be designed and / or otherwise configured to extend into the cavity 2029, thereby coupling the discharge insert 2028A to the low-pressure body portion 2014. The discharge insert 2028A may be coupled to the low-pressure body portion 2014 via a third weld path 1914 disposed between the inner lug 2017 and the cavity 2029. The discharge insert 2028A may also include a conduit 2026. The conduit 2026 may be formed within the discharge insert 2028A and extends into the interior of the valve assembly 160 and particularly into the low-pressure cavity 2020. The size and / or shape of the discharge insert 2028A may be designed such that the conduit 2026 includes a reduced diameter relative to the valve seat 2028, as further described herein (see [link]). Figures 44 to 46 By providing a conduit 2026 with a reduced diameter, the discharge insert 2028A can have a smaller cross-sectional profile relative to the valve seat 2028, thereby helping the diaphragm 2012 to have a correspondingly reduced diameter between the low-pressure body portion 2014 and the high-pressure body portion 2016.

[0241] Now for reference Figure 37 The valve assembly 160 may include an orifice assembly 161 (e.g., a pressure limiter) disposed between the low-pressure body portion 2014 and the high-pressure body portion 2016. The orifice assembly 161 may be configured to restrict the flow of pressurized fluid contained within the valve assembly 160 and subsequently released outside the valve assembly 160 (e.g., to container 112). The high-pressure body portion 2016 may include a plurality of retaining teeth 163 abutting the top surface of the orifice assembly 161, thereby securely coupling the orifice assembly 161 between the low-pressure body portion 2014 and the high-pressure body portion 2016. The plurality of retaining teeth 163 may be configured to inhibit movement of the orifice assembly 161 relative to the low-pressure body portion 2014 and the high-pressure body portion 2016 during use of the autoinjector 100 and particularly during the release of pressurized fluid from the container 150 through the orifice assembly 161. The low-pressure body portion 2014 may include a channel 2019 in fluid communication with the orifice assembly 161 via an opening 166, allowing pressurized fluid from the low-pressure body portion 2014 to travel through the channel 2019 and through the opening 166 into the orifice assembly 161. The valve assembly 160 may also include a gasket 165 (e.g., an O-ring) disposed below and in contact with the orifice assembly 161, thereby preventing pressurized fluid entering the orifice assembly 161 at the opening 166 from being redirected to the outside of the orifice assembly 161 and toward the channel 2019.

[0242] Now for reference Figures 38 to 40 An exemplary retaining mechanism of valve assembly 160 is illustrated. Specifically, the exemplary retaining mechanism of valve assembly 160 defines a surrounding interface of puncture mechanism 164, which is configured and operable to establish fluid communication with canister 150 during use of the autoinjector 100 as described above. The exemplary retaining mechanism may be configured and operable to retain, stabilize, and / or seal puncture mechanism 164 during use of the autoinjector 100. It should be understood that any of the exemplary retaining mechanisms shown and described herein may be incorporated into the autoinjector 100 without departing from the scope of this disclosure.

[0243] For details, please refer to the following: Figure 38 The valve assembly 160 may include a first retaining mechanism 2060 for retaining the puncture mechanism 164. In this example, the first retaining mechanism 2060 may include a gasket 2062 (e.g., an O-ring) disposed around the exterior of the puncture mechanism 164, and the high-pressure body portion 2016 may include a plurality of retaining teeth 2064 abutting the top surface of the gasket 2062, thereby securely coupling the gasket 2062 around the puncture mechanism 164. The gasket 2062 may also be configured to prevent pressurized fluid released from the tank 150 and entering the valve assembly 160 via the puncture mechanism 164 from being redirected to the exterior of the puncture mechanism 164 and out of the valve assembly 160. Multiple retaining teeth 2064 may be configured to inhibit movement of gasket 2062, and gasket 2062 may be configured to inhibit radial movement of puncture mechanism 164 relative to low-pressure body portion 2014 and high-pressure body portion 2016 during use of autoinjector 100 and particularly during connection with canister 150 and / or release of pressurized fluid from canister 150 into valve assembly 160.

[0244] In another example, such as Figure 39As can be seen, the valve assembly 160 may include a second retaining mechanism 2070 for retaining the puncture mechanism 164. In this example, the second retaining mechanism 2070 may include a body 2072 disposed around the exterior of the puncture mechanism 164. In this example, the body 2072 may be integrally formed with the low-pressure body portion 2014, such that the body 2072 and the low-pressure body portion 2014 can form a single body. In other embodiments, the body 2072 of the second retaining mechanism 2070 may be separable from and selectively coupled to the low-pressure body portion 2014. The body 2072 may include a channel and / or lumen 2074 extending therethrough, and the size and shape of the lumen 2074 may be designed and / or otherwise configured to accommodate the puncture mechanism 164 passing through it. In this example, the diameter of the lumen 2074 may correspond to the diameter of the puncture mechanism 164, thereby securely coupling the puncture mechanism 164 to the body 2072. The second retaining mechanism 2070 may further include a cut 2076 formed along the top surface of the body 2072. The cut 2076 may extend into the body 2072 and toward the lumen 2074. The cut 2076 may include one or more grooves 2077 having an angled and / or tapered configuration or surface extending radially inward toward the lumen 2074. In this example, the size and shape of the cut 2076 may be designed and / or otherwise configured to receive and guide the puncture mechanism 214 into the lumen 2074. In some embodiments, the angled and / or tapered profile of the groove 2077 may be configured to inhibit movement of the puncture mechanism 164 relative to the body 2072 and, particularly, inhibit its exit from the lumen 2074 when received within it.

[0245] The retaining mechanism 2070 may further include a first channel 2078 formed at least partially along the body 2072 and a second channel 2119 formed at least partially along the low-pressure body portion 2014. The first channel 2078 may extend from the lumen 2074 and may define an undercut for forming the retaining mechanism 2070. The second channel 2119 may extend below the body 2072 and may define a undercut region within and below the high-pressure body portion 2072 for forming a welding path between the second retaining mechanism 2070 and the high-pressure body portion 2016. Figure 40 As shown, the valve assembly 160 may also include one or more tank holding mechanisms 2088 (e.g., holding bosses) for holding the tank 150.

[0246] refer to Figure 41As described in further detail below, valve assembly 160 may be in fluid communication with discharge system 2030. In some embodiments, discharge system 2030 may be located within valve assembly 160, while in other embodiments, discharge system 2030 may be separate from and fluidly coupled to valve assembly 160. In this example, discharge system 2030 may be located within valve assembly 160 between low-pressure body portion 2014 and high-pressure body portion 2016. Discharge system 2030 may be fluidly coupled to one or more of high-pressure (first) cavity 2018 and / or low-pressure (second) cavity 2020.

[0247] The discharge system 2030 may be configured to release (e.g., vent) pressure generated within the valve assembly 160 upon completion of drug delivery from the autoinjector 100. For example, the discharge system 2030 may be configured to move (e.g., translate) between one or more locations relative to the low-pressure body portion 2014 and the high-pressure body portion 2016 in a first direction A and / or a second direction B to release pressure in the valve assembly 160. The discharge system 2030 may be operable to selectively define one or more flow paths 10 for pressurized fluid to travel through the valve assembly 160 and to be released into the internal cavity of the autoinjector 100 and / or the surrounding atmosphere as it moves between one or more flow paths. In this example, the discharge system 2030 may include a body 2032 and a pair of gaskets 2033 disposed around the exterior of the body 2032. The body 2032 may include a first opening 2034 and a second opening 2036 positioned along an end of the body 2032 opposite to the first opening 2034.

[0248] Still referencing Figure 41 The first opening 2034 and the second opening 2036 are fluidly connected and aligned with each other along the longitudinal axis of the body 2032. The first opening 2034 may define an activation line for the discharge system 2030 to receive pressurized fluid passing through the body 2032 along the flow path 10. The body 2032 may have a third opening 2038, which is fluidly connected to the first opening 2034 and laterally aligned with respect to the first opening 2034 and the second opening 2036. Each opening of the discharge system 2030 may define a portion of the fluid path 10 based on the relative position of the body 2032 within the valve assembly 160. For example, as Figure 41As can be seen, the body 2032 can be positioned relative to the valve assembly 160 such that the third opening 2038 is aligned with the discharge channel 2037 of the high-pressure body portion 2016. In this configuration, pressurized fluid contained in the body 2032 along the flow path 10 can exit through the third opening 2038 and enter the discharge channel 2037 to allow the valve assembly 160 to discharge. The discharge system 2030 may include a barrier 2039 (e.g., a retaining arm) extending from the low-pressure body portion 2014 to restrict movement (e.g., translation) of the body 2032 in a first direction A, such as when the discharge system 2030 is in Figure 41 When the position shown is such that the third opening 2038 is aligned with the discharge channel 2037. It should be understood that the body 2032 can be configured to move (e.g., translate) in response to the valve assembly 160 receiving pressurized fluid from the tank 150.

[0249] Now for reference Figure 43 An exemplary pressure sensing system 2090 of an autoinjector 100 is schematically illustrated. The pressure sensing system 2090 may include a housing 2091 in which a container 112, a canister 150, a first reservoir 2094, a second reservoir 2096, a pressure limiter 2098, a piston 2097, and a biasing mechanism 2099 (e.g., a spring) are disposed. In this example, the canister 150 may be in fluid communication with the first reservoir 2094 via a first conduit 2092A, and the first reservoir 2094 may be in fluid communication with the pressure limiter 2098 and the piston 2097 respectively via a second conduit 2092B. Therefore, pressurized fluid released from the canister 150 may be delivered to the first reservoir 2094 via the first conduit 2092A. The first reservoir 2094 and the second reservoir 2096 may each function as an energy storage device (such as a pressure storage container) in which a pressurized medium (e.g., gas) contained therein may be maintained under sufficient pressure applied by an external source. For example, the first accumulator 2094 may be configured to contain, store, and release pressurized fluid from tank 150 to the second conduit 2092B. In some embodiments, the first accumulator 2094 may be configured to deliver pressurized fluid to the second conduit 2092B at a pressure relatively higher than the original pressurization received from tank 150.

[0250] At least a first portion of the pressurized fluid can be released from the first reservoir 2094 toward the piston 2097 via the second conduit 2092B, thereby causing the piston 2097 to move (e.g., translate). In this example, the piston 2097 can be pushed toward a first position by the biasing mechanism 2099, such as... Figure 43As shown. In response to receiving pressurized fluid from the first accumulator 2094, the piston 2097 may be configured to compress the bias mechanism 2099 and move toward a second position. At least a second portion of the pressurized fluid may be released from the first accumulator 2094 toward the pressure limiter 2098 via the second conduit 2092B. The pressure limiter 2098 may be configured to restrict the flow of pressurized fluid received from the first accumulator 2094 via the second conduit 2092B before the pressurized fluid enters the third conduit 2092C of the pressure sensing system 2090. Thus, the pressure limiter 2098 may define a high-pressure flow region at the second conduit 2092B and a low-pressure flow region at the third conduit 2092C. In some embodiments, the pressure limiter 2098 may include a porous material, a serpentine channel, and / or an orifice assembly.

[0251] Still referencing Figure 43 At least a first portion of the pressurized fluid contained in the third conduit 2092C via pressure limiter 2098 can be received and stored therein by the second reservoir 2096, and at least a second portion of the pressurized fluid contained in the third conduit 2092C via pressure limiter 2098 can be contained in container 112. Specifically, the pressurized fluid contained in container 112 can be operable to move (e.g., push) piston 114 within container 112, thereby delivering the stored medication out of container 112. In this example, the biasing mechanism 2099 can be sized and / or configured to set a predefined end pressure such that the biasing mechanism 2099 will return to an expanded configuration when the pressure within the pressure sensing system 2090 drops below a predetermined threshold (e.g., 150 psi). In other words, the biasing mechanism 2099 can be configured to expand piston 2097 and move (e.g., push) piston 2097 in the opposite direction when the flow rate of pressurized fluid through the pressure sensing system 2090 decreases. It should be understood that the pressure within the pressure sensing system 2090 may gradually decrease as the medicine stored in container 112 is discharged in response to the movement of piston 114 within container 112.

[0252] In this example, housing 2091 may include window 2093, which is positioned such that, when piston 2097 is translated, window 2093 is operable to provide visual feedback on the status of autoinjector 100 based on visualization of the relative position of piston 2097 within injector 100. In some examples, piston 2097 may include one or more signs and / or other markings visible through window 2093 along the outer surface of piston 2097, and said one or more markings indicate to the user various operational states of autoinjector 100. In another example, pressure sensing system 2090 may be configured to generate auditory feedback indicating the status of autoinjector 100, particularly upon completion of drug delivery from container 112, when piston 2097 moves (e.g., translates) to a position corresponding to the compression configuration of biasing mechanism 2099.

[0253] Now for reference Figures 44 to 46 An exemplary drive system 2000 for an autoinjector 100 is schematically illustrated. The drive system 2000 can be configured to provide driving force to deliver medication 20 from container 112 to a patient. The drive system 2000 may include a canister 150 (i.e., a fluid source) fluidly coupled to one or more components of the autoinjector 100, such as needle 116 and valve assembly 160. The drive system 2000 may also include a first high-pressure line 2002, a second high-pressure line 2004, a low-pressure line 2006, a drive line 2008, and a third line 2010. Canister 150 may be operatively coupled to container 112 via the first high-pressure line 2002 and drive line 2008. Furthermore, canister 150 may be fluidly coupled to valve assembly 160 via one or more of the first high-pressure line 2002, the second high-pressure line 2004, and the low-pressure line 2006. In some implementations, the drive system 2000 may include a pressure reducing mechanism (e.g., an orifice) along the first high-pressure line 2002.

[0254] Valve assembly 160 may include a diaphragm 2012 positioned between a low-pressure body portion 2014 and a high-pressure body portion 2016. Within valve assembly 160, diaphragm 2012 defines a high-pressure (first) cavity 2018 and a low-pressure (second) cavity 2020. Valve assembly 160 may also include a high-pressure (first) inlet 2022, a low-pressure (second) inlet 2024, and a conduit 2026. Conduit 2026 is formed within a valve seat 2028, which extends into valve assembly 160 and particularly into the interior of the low-pressure cavity 2020. High-pressure cavity 2018 may be in fluid communication with a first high-pressure line 2002 via a second high-pressure line 2004 and high-pressure inlet 2022. Low-pressure cavity 2020 may be in fluid communication with a low-pressure line 2006 via low-pressure inlet 2024. Low-pressure cavity 2020 may be in fluid communication with a third line 2010 via conduit 2026. The drive system 2000 may include a discharge system 2030 fluidly connected via several fluid lines or conduits. For example, the discharge system 2030 may be fluidly in communication with the valve assembly 160 via a third line 2010. The discharge system 2030 may be configured to discharge by releasing pressurized fluid into the cavity of the autoinjector 100 and / or into the atmosphere. As described above, the discharge system 2030 may include a slidable piston 190 of the autoinjector 100.

[0255] Still referencing Figures 44 to 46 Container 112 may include a top end 112A and a bottom end 112B. Container 112 may include a cavity 112C having an opening at the top end 112A and extending toward the bottom end 112B. The bottom end 112B may include a stopper 112D configured to help close and / or seal the bottom end 112B and allow the needle 116 to fluidly couple to the container 112 at the bottom end 112B. The stopper 112D may include a line seal, a protrusion disposed in the neck of the container 112 (e.g., to reduce dead volume), and / or a septum formed of uncoated bromobutyl material or another suitable material. The cavity 112C may be closed at the top end 112A by a piston 114. The piston 114 may include a bromobutyl material coated with a fluoropolymer, and in some embodiments, may include a tapered nose to help reduce dead volume within the container 112. Piston 114 may comprise one or more rubber materials, such as, for example, halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile, as well as other materials. As described in detail above, container 112 may store agent 20 (e.g., pharmaceutical, fluid substance, etc.) within cavity 112C.

[0256] Canister 150 may include a non-locking canister or a latching canister. Canister 150 may be configured to dispense liquid propellant for boiling outside canister 150 to provide pressurized gas (vapor pressure) acting on piston 114 in container 112. In some embodiments, canister 150 may include pressurized gas released from canister 150 and acting on piston 114 in container 112. In some embodiments, a latching canister may be latched open once opened, allowing the full contents of the propellant to be dispensed from the canister. Alternatively, in some embodiments, canister 150 may be selectively controlled, including selectively starting and stopping. For example, in an alternative embodiment, the flow of pressurized gas from canister 150 may be stopped after flow has begun.

[0257] The fluid from tank 150 may be any suitable propellant used to provide vapor pressure to drive piston 114 relative to container 112. In some embodiments, tank 150 may be a high-pressure tank configured to store compressed gas. In some embodiments, the propellant may be or may contain hydrofluoroalkane (“HFA”), such as HFA134a, HFA227, HFA422D, HFA507, or HFA410A. In some embodiments, the propellant may be or may contain hydrofluoroolefin (“HFO”), such as HFO1234yf or HFO1234ze, organic gases (e.g., carbon dioxide (CO2), etc.), cryogenic gases (e.g., argon (Ar), helium (He), etc.), hydrocarbon gases (e.g., propane, butane, propylene, ethane, methane, etc.), or inorganic gases (e.g., ammonia, nitrogen dioxide (NO2), nitrous oxide (N2O), etc.).

[0258] Figure 44 The image shows the autoinjector 100 in its pre-start state. To enable the autoinjector 100 to automatically... Figure 44 Before activation, the canister 150 can be activated to move the piston 114 along the longitudinal axis of the container 112 toward the needle 116. The canister 150 can be actuated to move to an open configuration, in which propellant can exit the canister 150 as pressurized gas. As described above, the canister 150 can be actuated in response to contact of one or more components of the valve assembly 160 (e.g., the puncture mechanism 164). In some embodiments, the actuation is irreversible, such that the flow of pressurized gas from the canister 150 cannot be stopped when pressurized gas is released from the canister 150.

[0259] When tank 150 is actuated, pressurized gas can flow through the first high-pressure line 2002 and drive line 2008, and then to container 112. Some pressurized gas from the first high-pressure line 2002 can be delivered to the high-pressure cavity 2018 via the second high-pressure line 2004 and high-pressure inlet 2022. Figure 45As can be seen, due to the pressure change, the diaphragm 2012 can move into the low-pressure cavity 2020 and toward the conduit 2026 (e.g., in the first direction), thereby sealing the valve seat 2028. Depressurized gas can be delivered to the low-pressure cavity 2020 via the low-pressure line 2006 and the low-pressure inlet 2024. The pressure difference between the high-pressure cavity 2018 and the low-pressure cavity 2020 provides the force required to seal the conduit 2026 through the diaphragm 2012. Gas flowing through the drive line 2008 can cause the piston 114 within the container 112 to move toward the needle 116. Specifically, when the needle 116 is in fluid communication with the drug 20 within the container 112, actuation of the canister 150 can apply pressure to the piston 114 housed in the cavity 112C, which can then be applied to the drug 20 itself via the piston 114 driven toward the bottom end 112B. In this case, as Figure 45 As can be seen, needle 116 is in fluid communication with the contents (e.g., agent 20) of container 112. When gas from drive line 2008 pushes piston 114 toward bottom end 112B, agent 20 is expelled from container 112 until piston 114 reaches bottom end 112B (and touches the bottom). As described above and below, pressurized gas from canister 150 can also drive the movement of one or more other components of autoinjector 100 (e.g., indicator assembly 170, sliding piston 190, etc.).

[0260] Now for reference Figure 46 When piston 114 touches the bottom at end 112B, the pressures at both ends of high-pressure cavity 2018 and low-pressure cavity 2020 can be balanced, thereby causing diaphragm 2012 to rise away from valve seat 2028 and open conduit 2026. In this case, diaphragm 2012 can move in a second direction opposite to the first direction. This allows gas from low-pressure line 2006 to travel via conduit 2026 and third line 2010 to exhaust system 2030, from which gas can be discharged (see...). Figure 41 It should be understood that the canister 150 may be configured to contain sufficient pressurized fluid such that the release of pressurized gas actuates the piston 114 relative to both the cavity 112C and one or more other components of the autoinjector 100 (e.g., indicator assembly 170, sliding piston 190, etc.). In some cases, the canister 150 may contain an excess of pressurized gas, i.e., more fluid than is required to complete the delivery of the drug 20 from the container 112. In this case, the release of pressurized fluid from within the drive system 2000 may allow movement of one or more components of the autoinjector 100 (e.g., shield 120, actuator 125, spindle assembly 180, etc.) to initiate the retraction of said components relative to the housing 102 of the autoinjector 100.

[0261] Now for reference Figures 47 to 52An autoinjector 100 is illustrated according to an example of this disclosure. It should be understood that the size, shape, and / or layout of the autoinjector 100, and particularly the vertically upright design of the housing 102, can enhance various aspects of the autoinjector 100 during use. For example, aspects such as the position and visibility of the first window 108; the size and position of secondary indicators (e.g., piston indicator flag 114A) in the container 112; the shape and size of the shield 120; and the vertically upright design of the autoinjector 100 can improve the user's controlled operation of the housing 102. In some embodiments, the size and shape of the housing 102 may be designed and / or otherwise designed to provide an outer surface 102A between the top end 104 and the bottom end 106 (see [link to relevant documentation]). Figures 49 to 52 Labels and / or other markings may be used to display labels on the autoinjector 100. For example, a label on the outer surface 102A may provide information indicating the contents of the autoinjector 100, instructions for using the autoinjector 100, etc. It should be understood that the outer surface 102A may define the front surface, rear surface, and / or both of the housing 102. In other embodiments, the size and shape of the housing 102 may be designed and / or otherwise designed to improve visual dosing indication (e.g., primary indicator, secondary indicator, etc.); minimize the perceived and / or actual outline of the autoinjector 100; and facilitate intuitive configuration that generally does not intimidate the user.

[0262] In this example, special reference Figure 47 The size, shape, and / or volume design of the shield 120 can be relatively minimized. Additionally, the draft angle of the housing 102, and particularly the angle between the top end 104 and the bottom end 106 of the pair of opposing sidewalls 104A, 106A of the housing 102, can be minimized, such that the sidewalls 104A, 106A are substantially parallel to each other. In some embodiments, the top end 104 may have a dome and / or circular configuration (see...). Figures 47 to 62 and Figures 74 to 83 In other embodiments, the top 104 may have a flat and / or planar configuration (see [reference]). Figures 63 to 66 and Figures 69 to 73 ).

[0263] In another embodiment, the shell may typically have an irregular shape, such as a trilobal profile, wherein the cylindrical form of the container 112 disposed within the shell may be emphasized (see [reference]). Figures 91 to 93In some embodiments, the housing 102 may be formed of a transparent molding having one or more frosted elements, while in other embodiments, the housing 102 may be formed of a transparent molding having a back-sprayed finish. As described herein, one or more components of the autoinjector 100 may include colors that correspond to or distinguish from each other to facilitate intuitive use and / or minimize perceived fear when using the autoinjector 100. As described in further detail below, the autoinjector 100 may include one or more recesses, cavities, edges, ridges, and / or gripping elements along the exterior of the housing 102, which may be configured to enhance the control and friction texture of the housing 102.

[0264] The autoinjector 100 can be configured to improve visual dosing indication using a piston 114, which has a vibrant color scheme (e.g., red, yellow, orange) visible through a first window 108 via a container 112. The first window 108 may be disposed on the inner side along the housing 102 (see [reference]). Figures 67 to 68 and Figures 79 to 83 Instead of the outer side of housing 102, the visual dose indication is further improved. Furthermore, the autoinjector 100 can completely omit the outer window lens positioned above the first window 108 (see...). Figures 56 to 57 , Figures 63 to 66 , Figures 79 to 93 In some embodiments, the secondary indicator may be disposed within the housing 102 and / or along the exterior of the housing 102 (see [reference]). Figures 47 to 48 , Figures 53A to 53C , Figure 56 as well as Figures 91 to 93 In an additional embodiment, the pressurized fluid (e.g., gas) released into container 112 may be colored and easily visible through the first window 108. The autoinjector 100 may be configured to facilitate visual configuration by incorporating a softer matte color displayed along the outer surface of housing 102, the direction of use of the indicator needle, or its position (see [link to documentation]). Figures 50 to 53C One or more signs (e.g., directional graphics) displayed along the exterior of housing 102 and / or bright colors displayed along the outer surface of housing 102 are generally less intimidating.

[0265] Still referencing Figure 47 The autoinjector 100 may include one or more secondary indicators. In this example, a secondary indicator may include a piston indicator flag 114A (e.g., a plug), which is configured and operable to attach to the piston 114 (see [link to documentation]). Figures 53A to 53CThe size and shape of the piston indicator flag 114A may be designed and / or otherwise configured to provide visual feedback on dosage indication during use of the autoinjector 100. In other words, when coupled to the piston 114, the piston indicator flag 114A may be operable to visually indicate the current position of the piston 114 relative to the container 112, thereby indicating the dosage delivery status of the autoinjector 100. In some embodiments, the piston indicator flag 114A may include one or more colors, symbols, and / or other visual elements that may be operable to enhance the visibility of the piston indicator flag 114A within the container 112 via the first window 108.

[0266] like Figure 48 As shown, the piston indicator flag 114A may include a plurality of threads 114B, which may be configured to engage the internal lumen of the piston 114, thereby threadedly coupling the piston indicator flag 114A to the piston 114. The piston indicator flag 114A may also include a tip 114C, the size and shape of which may be designed and / or otherwise configured to extend outward from the piston 114 when the piston indicator flag 114A is coupled to the piston 114. In other words, when the piston indicator flag 114A is coupled to the piston 114, the tip 114C may be located outside the piston 114, thereby making the tip 114C easily visible from the first window 108. In this example, the tip 114C may have a cylindrical configuration; however, in other embodiments, the tip 114C may have a variety of other suitable sizes, shapes, and / or configurations.

[0267] refer to Figures 49 to 52 The autoinjector 100 may include a circular and / or dome configuration at its top 104, a window lens positioned above a first window 108 to enclose a container 112 within the housing 102, and a shield 120 may include one or more markings 120B configured and operable to facilitate the use of the autoinjector 100. In this example, markings 120B may include directional graphics (e.g., arrows) indicating the direction of movement of the housing 102 relative to the shield 120 to deliver a dose. Additionally and / or alternatively, markings 120B may be positioned along an external portion of the shield 120 to indicate the relative position of a needle (e.g., needle 116) disposed within the shield 120 to facilitate placement of the shield 120 on the user's skin surface (see [link to documentation]). Figures 54 to 55 In this configuration, the mark 120B can be configured to indicate precise alignment of the needle 116 at the intended injection site while the needle 116 remains positioned inside the shield 120.

[0268] The shield 120 may include a body 120A whose size and shape may be designed and / or otherwise designed to have cross-sectional dimensions substantially corresponding to the profile of the housing 102 at the bottom end 106. In other words, the body 120A of the shield 120 may conform to the cross-sectional profile of the housing 102 and, in particular, the bottom end 106. In other embodiments, as shown and described herein, the shield may have a cross-sectional profile that varies relative to the housing to facilitate control of the shield and / or provide indication of the position of a needle disposed therein (see [link to documentation]). Figures 59 to 68 and Figures 84 to 93 ).

[0269] The autoinjector 100 may also include one or more soft colors along the exterior of the housing 102, and a side label disposed along the outer surface 102A. In some embodiments, the draft angle of the housing 102 may be approximately 1 degree between the top end 104 and the bottom end 106. In other words, a pair of opposing sidewalls 104A, 106A of the housing 102 may be substantially parallel and / or have minimal angles relative to each other. In this example, the outer surface 102A may be flush with the adjacent outer surface of the housing 102. In other examples, as shown and described herein, the outer surface 102A may be recessed and / or protruding relative to the adjacent outer surface of the housing 102 to facilitate label reception and / or enhance grip on the autoinjector 100. In some embodiments, the housing 102 may have a pebble shape, surface, and / or texture along the top end 104 to enhance the user's grip and engagement of the autoinjector 100.

[0270] The cap 111 may be detachably coupled to the housing 102 at its bottom end 106, in which the shield 120 is disposed. The cap 111 may include a bottom end 111A that tapers and / or expands radially outward relative to the rest of the cap 111. The bottom end 111A may be configured to facilitate easy gripping of the cap 111, such as during dose delivery when the cap 111 is removed from the housing 102 to expose the shield 120. In some embodiments, the bottom end 111A may include a geometrically flared opening extending radially outward from the cap 111, while in other embodiments, the bottom end 111A may include an extended edge or ridge.

[0271] In exemplary use, such as Figures 53A to 53C As can be seen, the piston indicator flag 114A can be configured to translate (vertically) through the container 112 when the piston 114 translates relative to the container 112 in response to the movement of the shroud 120 relative to the housing 102 to deliver a dose. Prior to dose delivery, when the shroud 120 is in the extended position relative to the housing 102, the piston indicator flag 114A may not be visible from the first window 108 because the piston 114 is held in a first position adjacent to the tip 104, as... Figure 53AAs can be seen. In this case, the position of the piston indicator flag 114A indicates that the autoinjector 100 is a new device that has not been previously activated. During dose delivery, when the shield 120 is retracted into the housing 102, as... Figure 53B As the piston 114 moves downward (vertically) through the container 112, the piston indicator flag 114A is visible through the first window 108. In this case, the position of the piston indicator flag 114A indicates that the autoinjector 100 is being used to deliver a portion of the dose stored in the container 112. When the dose is delivered and the shield 120 returns to its extended position relative to the housing 102, as... Figure 53C As can be seen, the piston indicator flag 114A can be repositioned near the bottom end 106, thereby indicating that the autoinjector 100 is a used device.

[0272] Figures 54 to 55 An autoinjector 100 is illustrated positioned against the injection site, more specifically, the skin surface S of the user (e.g., a patient). In some cases, the injection site may be located in an area where the skin surface S of the user's body may curve ( Figure 54 In other cases, the injection site may be located in an area along the skin surface S that is substantially flat and / or planar. Figure 55 The size and shape of the shield 120 may be designed and / or otherwise configured to minimize the cross-sectional profile of the shield 120 and maximize the distance the needle 116 can extend outward from the shield 120 when the shield 120 is retracted into the housing 102, thereby maximizing the depth to which the needle 116 extends through the skin surface S. In other words, the dimensions of the shield 120 may be designed to have a length, width, and depth that collectively define a minimum cross-sectional dimension of the shield 120, thereby allowing the needle 116 to extend outward from the shield 120 to a maximum extent. Thus, the autoinjector 100 may be operable for use at curved and / or flat injection sites while maintaining a sufficient insertion depth of the needle 116 through the skin surface S. In other embodiments, as shown and described herein, the shield 120 may have various other suitable configurations for identifying the insertion point of the needle 116 to allow the user to precisely position the shield 120 along the skin surface S to maximize the insertion depth of the needle 116.

[0273] refer to Figures 56 to 58Another exemplary autoinjector 2100 is illustrated according to examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, autoinjector 2100 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for autoinjector 100 are used herein to designate similar components of autoinjector 2100. In this example, autoinjector 2100 may include a housing 2102 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 120 movably coupled to the bottom end 106. Figure 57 ).like Figure 56 As can be seen, the autoinjector 2100 may include: a cap 111 detachably coupled to a bottom end 106, thereby housing a shield 120 therein; and a cover 2106 detachably disposed above a window 2108 of the housing 2102 (see [link to documentation]). Figure 58 The cap 111 can be configured to suppress unintentional movement of the shield 120 before use of the autoinjector 2100 when the cap 111 is coupled to the bottom end 106. The cover 2106 can be configured to suppress unintentional damage and / or contact with the container 112 before use of the autoinjector 2100 when the cover 2106 is coupled to the housing 2102. As described below, the autoinjector 2100 can be configured such that the window 2108 is not covered by the external window lens, thereby exposing the container 112 when the cover 2106 is removed.

[0274] like Figure 57 As can be seen, window 2108 can be positioned along at least one of the opposing sidewalls 106A of housing 2102. In other words, window 2108 can be formed along the outer edge of housing 2102. Window 2108 can define a cutout area in housing 2102 for receiving container 112, such that autoinjector 2100 may not include an external window lens and / or barrier disposed above window 2108. In other embodiments, such as Figure 58As can be seen, window 2108 may include an external window lens concealing container 112 within housing 2102. Additionally, autoinjector 2100 may include a secondary indicator in the form of a flag 2114 positioned within window 2108. The size and shape of flag 2114 may be designed and / or otherwise configured to be substantially similar to the piston flag 114A shown and described above. Thus, flag 2114 may be configured to translate relative to container 112 during use of autoinjector 2100 to provide dosage indication to the user. In this example, top 104 of housing 102 may have a rounded and / or curved form, and housing 2102 may include matte and / or textured labels disposed on outer surface 102A to enhance controlled grip of autoinjector 2100 by the user. In some embodiments, housing 2102 may have a reduced draft configuration along its longitudinal length between top 104 and bottom 106 to enhance the ergonomic profile of autoinjector 2100. In other words, the pair of opposing sidewalls 104A, 106A of the housing 2102 can have a minimum angle relative to each other.

[0275] refer to Figures 59 to 62 Another exemplary autoinjector 2150 is illustrated according to examples of this disclosure. It should be understood that, apart from the differences explicitly pointed out herein, the autoinjector 2150 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to identify similar components of the autoinjector 2150. In this example, the autoinjector 2150 may include a housing 2152 having a longitudinal length defined between a top end 104 and a bottom end 106, a first window 108 extending along at least one sidewall 106A, and an outer surface 102A, as described in detail above. In this example, the top end 104 may include an sculpted pebble shape, surface, and / or texture to enhance the user's grip and engagement of the housing 2152. The housing 2152 may have a side draft angle of approximately 1 degree between the top end 104 and the bottom end 106, and particularly along a pair of opposing sidewalls 104A, 106A of the housing 2152. The housing 2152 may have a front draft angle of approximately 0 degrees between the top end 104 and the bottom end 106 and particularly along the outer surface 102A of the housing 2152.

[0276] In this example, outer surface 102A may be recessed relative to the adjacent outer surface of housing 2152. Therefore, any labels and / or markings positioned on outer surface 102A may be positioned relative to the remaining outer surface of housing 2152 along the recessed plane. In some embodiments, a gripping edge 2154 may be formed around the periphery of outer surface 102A. The gripping edge 2154 may be configured and operable to enhance the gripping engagement of housing 2152 during use. In other words, the gripping edge 2154 may form a ridge for a user's fingers to grip when manually controlling the autoinjector 2150. The autoinjector 2150 may include a shield 2120 movably coupled to housing 2152 at a bottom end 106. Shield 2120 may have a keyhole profile defined by a bottom surface 2122, a rounded end 2126, and a narrow end 2128. The rounded end 2126 may have a generally circular and / or cylindrical shape and may be positioned relative to the housing 2152 to align with the needle (e.g., needle 116) of the autoinjector 2150. Thus, the rounded end 2126 may be configured to indicate the position of the needle disposed within the housing 2152. In other words, the rounded end 2126 may be positioned relative to the housing 2152 in a position parallel to and / or coincident with the needle along the shield 2120 to facilitate easy positioning of the shield 2120 at the injection site during use without extending the needle out of the shield 2120 via the opening 2124 on the bottom surface 2122.

[0277] Still referencing Figures 59 to 62 As shown, the autoinjector 2150 may include a cap 2111 detachably coupled to the housing 2152 at its bottom end 106. The cap 2111 may include a bottom end 2112 that is radially tapered and / or flared out relative to the rest of the cap 2111, to facilitate easy gripping of the cap 2111, for example, during removal of the cap 2111 from the housing 2152 to expose the shield 2120. The autoinjector 2150 may also include one or more soft colors along the respective exterior of the outer surface 102A and the shield 2120, relative to the color of the exterior along the rest of the housing 2152, to help the user easily distinguish the components of the autoinjector 2150 during use.

[0278] Now for reference Figures 63 to 66 Another exemplary autoinjector 2200 is illustrated based on examples of this disclosure. It should be understood that, apart from the differences explicitly pointed out herein, the autoinjector 2200 can be configured, operated, and is substantially similar to the autoinjectors 100, 2150 shown and described above. Therefore, similar reference numerals for autoinjectors 100, 2150 are used herein to designate similar components of the autoinjector 2200. For example, as... Figure 97Ideally, the autoinjector 2200 may include one or more internal components similar to those of the autoinjector 100 (e.g., container 112, needle 116, actuator 125, chassis 130, canister 150, valve assembly 160, spindle assembly 180, slidable piston 190, etc.), however, these components may be positioned and / or oriented within the housing 2202 of the autoinjector 2200 based on the size and / or shape of the autoinjector 2200 as described in detail herein.

[0279] In this example, the autoinjector 2200 may include a housing 2202 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2120 movably coupled to the bottom end 106. The housing 2202 may generally have a circular cross-sectional profile, thereby providing a curved configuration for the autoinjector 2200. The housing 2202 may be defined by a pair of opposing sidewalls 104A, 106A, and may include a planar surface 2204 at the top end 104. In some embodiments, recesses, cavities, and / or notches may be formed along the planar surface 2204 to facilitate accommodating a user's finger during use of the autoinjector 2200. In this case, the recess along the planar surface 2204 may be configured to enhance the gripping engagement of the housing 2202 during use of the autoinjector 2200.

[0280] The autoinjector 2200 may include at least one window 2208 positioned along at least one sidewall 106A of the housing 2202. In other words, the window 2208 may be formed along the outer edge of the housing 2202. The window 2208 may define a cutout in the housing 2202 for receiving the container 112, such that the autoinjector 2200 may not include an external window lens and / or barrier disposed above the window 2208 (see [link to documentation]). Figure 64 The shield 2120 may include a keyhole profile defined by a bottom surface 2122, a rounded end 2126, and a narrow end 2128 as described in more detail above (see [link to documentation]). Figure 66 The shield 2120, and in particular the rounded end 2126, can be configured to indicate the position of the needle disposed within the housing 2202, for improving the alignment of the autoinjector 2200 at the injection site during use.

[0281] refer to Figures 67 to 68Another exemplary autoinjector 2300 is illustrated according to examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, the autoinjector 2300 can be configured, operated, and is substantially similar to the autoinjectors 100, 2150 shown and described above. Therefore, similar reference numerals for autoinjectors 100, 2150 are used herein to designate similar components of the autoinjector 2300. In this example, the autoinjector 2300 may include a housing 2302 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2120 movably coupled to the bottom end 106. In this example, the top end 104 of the housing 2302 may have a rounded and / or curved form, and the draft angle of the housing 2302 may be relatively reduced such that a pair of opposing sidewalls 104A, 106A are substantially parallel to each other.

[0282] The autoinjector 2300 may include a window 2308 disposed along the housing 2302 between a top end 104 and a bottom end 106. Specifically, the window 2308 may be positioned internally within the housing 2302. In other words, the window 2308 may be formed between a pair of opposing sidewalls 104A, 106A of the housing 2302. Positioning the window 2308 radially offset from the pair of opposing sidewalls 104A, 106A enhances the visibility of the container 112 and the piston 114 disposed therein during use, such as when a user's hand is positioned along the pair of opposing sidewalls 104A, 106A to grasp the housing 2302. When the window 2308 is internally within the housing 2302, obstruction of the window 2308 by the user's hand is minimized. The window 2308 may define a cutout in the housing 2302 for receiving the container 112, such that the autoinjector 2300 may not include an external window lens and / or barrier positioned above the window 2308.

[0283] refer to Figures 69 to 73 Another exemplary autoinjector 2400 is illustrated based on examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, the autoinjector 2400 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to identify similar components of the autoinjector 2400. In this example, the autoinjector 2400 may include a housing 2402 having a longitudinal length defined between a top end 104 and a bottom end 106, a cap 111 detachably coupled to the housing 2402 at the bottom end 106, and a shield 120 movably coupled to the bottom end 106. Figure 69 As can be seen, the cap 111 can be configured to hide the shield 120 when coupled to the bottom 106. For example... Figure 70 As shown, the shield 120 can be exposed when the cap 111 is removed from the housing 2402.

[0284] The autoinjector 2400 may have a flat configuration along its top end 104 and, in particular, a planar surface 2404. The top end 104 may define a basic form, and a pair of opposing sidewalls 104A, 106A may be aligned substantially parallel to each other. In this example, the housing 2402 may include a transparent outer body 2408 along a portion of the housing 2402 that coincides with the position of the container 112 disposed within the housing 2402. The transparent outer body 2408 may be configured and operable to facilitate visual inspection of the position of the container 112, and in particular the piston 114, relative to the container 112 during use of the autoinjector 2400. In some embodiments, the transparent outer body 2408 may include a window. In this example, the autoinjector 2400 may include a mark 2406 on the housing 2402, such as adjacent to the bottom end 106. The mark 2406 may include a directional graphic (e.g., an arrow) indicating the direction of movement of the housing 2402 relative to the shield 120 during use, and / or the mark 2406 may be positioned along an external portion of the housing 2402 to indicate the relative position of the needle (e.g., needle 116) within the housing 2402 to facilitate placement of the autoinjector 2400 onto the user's skin surface for precise aiming of the needle at the intended injection site. In some embodiments, the autoinjector 2400 may be configured such that a label (not shown) may cover the outer periphery of the housing 2402. In other embodiments, the autoinjector 2400 may include a similar color scheme along the respective exteriors of the housing 2402 and the shield 2120.

[0285] refer to Figures 74 to 78 Another exemplary autoinjector 2500 is illustrated based on examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, the autoinjector 2500 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to identify similar components of the autoinjector 2500. In this example, the autoinjector 2500 may include a housing 2502 having a longitudinal length defined between a top end 104 and a bottom end 106, a cap 2511 detachably coupled to the housing 2502 at the bottom end 106, and a shield 2520 movably coupled to the bottom end 106. Figure 74 As can be seen, cap 2511 can be configured to hide shield 2520 when coupled to the bottom end 106. For example... Figure 75 As can be seen, when the cap 2511 is removed from the housing 2502, the shield 2520 can be exposed.

[0286] The cap 2511 may include a body having a circular and / or curved cross-sectional profile, and the shield 2520 may include a body 2522 having a corresponding circular and / or curved cross-sectional profile. The autoinjector 2500 may include a circular configuration along the longitudinal length of the housing 2502, particularly between the top end 104 and the bottom end 106. The circular configuration of the autoinjector 2500 enhances the circular tactile feel of the housing 2502 during use. The autoinjector 2500 may include a window lens disposed above a window 2508 on the housing 2502, and a pair of opposing sidewalls 104A, 106A may be substantially parallel to each other. The shield 2520 may include one or more markings 2524 configured and operable to facilitate the use of the autoinjector 2500. In this example, the markings 2524 may include directional graphics (e.g., arrows) indicating the direction of movement of the shield 2520. Additionally and / or alternatively, a mark 2524 may be positioned along an external portion of the shield 2520 to indicate the relative position of a needle (e.g., needle 116) within the shield 2520, facilitating placement of the shield 2520 on the user's skin surface for precise needle aiming at the intended injection site. In some embodiments, the tip 104 may be relatively flat to define the tactile form of the housing 2502. The autoinjector 2500 may include labels disposed along one or more outer surfaces of the housing 2502, such as the front and rear surfaces between a pair of opposing sidewalls 104A, 106A.

[0287] refer to Figures 79 to 83 Another exemplary autoinjector 2600 is illustrated based on examples of this disclosure. It should be understood that, apart from the differences explicitly pointed out herein, the autoinjector 2600 can be configured, operated, and is substantially similar to the autoinjectors 100, 2500 shown and described above. Therefore, similar reference numerals for autoinjectors 100, 2500 are used herein to designate similar components of the autoinjector 2600. For example, as... Figure 98 As shown, the autoinjector 2600 may include one or more internal components similar to those of the autoinjector 100 (e.g., container 112, needle 116, actuator 125, chassis 130, carrier 140, canister 150, valve assembly 160, indicator assembly 170, spindle assembly 180, slidable piston 190, etc.). However, these components may be positioned and / or oriented within the housing 2602 of the autoinjector 2600 based on the size and / or shape of the autoinjector 2600 as described in detail herein.

[0288] In this example, the autoinjector 2600 may include a housing 2602 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2520 movably coupled to the bottom end 106. The housing 2602 may generally have a reduced and / or narrow cross-sectional profile, thereby providing an elongated configuration for the autoinjector 2600. The size and shape of the housing 2602 may be designed and / or otherwise configured such that a pair of opposing sidewalls 104A, 106A are substantially parallel to each other. The top end 104 and the bottom end 106 may each be generally circular and / or curved. The autoinjector 2600 may include a window 2608 inside the housing 2602. In other words, the window 2608 may be formed between the opposing sidewalls 104A, 106A of the housing 2602. The window 2608 may define a cutout area in the housing 2602 for receiving a container 112, such that the autoinjector 2600 may not include an external window lens and / or barrier disposed above the window 2608.

[0289] The shield 2520 may include a body 2522 as described in more detail above. The shield 2520 may include one or more markings 2622 along the body 2522, which are configured and operable to facilitate the use of the autoinjector 2600. In this example, the markings 2622 may include directional graphics (e.g., arrows) indicating the direction of movement of the shield 2520. Additionally and / or alternatively, the markings 2622 may be positioned along an external portion of the body 2522 to indicate the relative position of a needle (e.g., needle 116) within the shield 2520 to facilitate placement of the shield 2520 on the user's skin surface for precise needle alignment with the intended injection site.

[0290] In other implementations, such as Figure 83 As can be seen, the tip 104 may be generally flat and the bottom 106 may be rounded. In this case, the autoinjector 2600 may have a flat configuration along the tip 104. The tip 104 may include a recess 2604 whose size and shape are designed and / or otherwise configured to enhance the gripping engagement of the housing 2602 during use of the autoinjector 2600. For example, the size and / or shape of the recess 2604 may be designed to accommodate a user's fingers when gripping the tip 104, thereby providing enhanced control over the housing 2602.

[0291] Now for reference Figures 84 to 87 Another exemplary autoinjector 2700 is illustrated based on examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, the autoinjector 2700 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to designate similar parts of the autoinjector 2700. For example, as... Figure 99As can be seen, the autoinjector 2700 may include one or more internal components similar to those of the autoinjector 100 (e.g., container 112, needle 116, actuator 125, chassis 130, canister 150, valve assembly 160, spindle assembly 180, slidable piston 190, etc.). However, these components may be positioned and / or oriented within the housing 2702 of the autoinjector 2700 based on the size and / or shape of the autoinjector 2700 as described in detail herein.

[0292] In this example, the autoinjector 2700 may include a housing 2702 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2720 movably coupled to the bottom end 106. The shield 2720 may include a bottom surface 2722 (e.g., a user engagement interface) and a body 2724 defining a cross-sectional profile of the shield 2720, which is relatively smaller than the shield 120 described above. The cross-sectional profile of the shield 2720 may correspond to the position of a needle (e.g., needle 116) disposed within the housing 2702. Therefore, the position of the shield 2720 may indicate the injection position of the needle during use of the autoinjector 2700. The housing 2702 may include a planar surface 2701 at the top end 104, such that the housing 2702 may have a flat configuration along the top end 104.

[0293] In this example, the autoinjector 2700 may include an extended housing 2705 radially offset from the housing 2702. The extended housing 2705 may have a longitudinal length defined between a top end 2704 and a bottom end 2706, wherein the top end 2704 is positioned relatively below the top end 104 and the bottom end 2706 is positioned along a plane substantially parallel to the bottom end 106. The extended housing 2705 may extend radially outward from at least one of the opposing sidewalls 104A of the housing 2702, thereby disassembling the autoinjector 2700 into a pair of housings 2702, 2705. The top end 2704 may define a user interface along which a user can control the autoinjector 2700 during use, such as by manually grasping the extended housing 2705. It should be understood that one or more internal components of the autoinjector 2700 may be disposed within the respective housing 2702 and the extended housing 2705. In other words, the extended housing 2705 may provide a shrink-fit shell for accommodating one or more components of the autoinjector 2700, such as... Figure 99 visible.

[0294] The autoinjector 2700 may include a window 2708 positioned along at least one of the opposing sidewalls 106A of the housing 2702. In other words, the window 2708 may be formed along the outer side of the housing 2702. The window 2708 may define a cutout area in the housing 2702 for receiving the container 112, such that the autoinjector 2700 may not include an external window lens and / or barrier disposed above the window 2708 (see [link to documentation]). Figure 85 ).

[0295] refer to Figures 88 to 90 Another exemplary autoinjector 2800 is illustrated based on examples of this disclosure. It should be understood that, except for the differences explicitly pointed out herein, the autoinjector 2800 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to identify similar components of the autoinjector 2800. In this example, the autoinjector 2800 may include a housing 2802 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2820 movably coupled to the bottom end 106. The shield 2820 may include a bottom surface 2822 (e.g., a user engagement interface) and a body 2824 defining a narrow cylindrical profile of the shield 2820. In other words, the size and shape of the body 2824 are designed and / or otherwise designed for a monotube configuration. The narrow cylindrical profile of the body 2824 may correspond to the location of a needle (e.g., needle 116) disposed within the housing 2802. Therefore, the position of the shield 2820 can indicate the injection position of the needle during the use of the autoinjector 2800.

[0296] In this example, the top end 104 of the housing 2802 may have a circular and / or curved form, and the autoinjector 2800 may include a window 2808 positioned along at least one of the opposing sidewalls 106A of the housing 2802. In other words, the window 2808 may be formed along the outer edge of the housing 2802. The window 2808 may define a cutout area in the housing 2802 for receiving the container 112, such that the autoinjector 2800 may not include an external window lens and / or barrier disposed above the window 2808. In this example, the housing 2802 may include an outer surface 2804 recessed relative to the adjacent outer surface of the housing 2802. Therefore, any labels and / or markings located on the outer surface 2804 may be recessed relative to the adjacent outer surface of the housing 2802. In some embodiments, the outer surface 2804 may define a gripping area of ​​the housing 2802 for manual control of the autoinjector 2800 during use. The autoinjector 2800 may include a raised edge 2806 formed along the exterior of the housing 2802 between the outer surface 2804 and the window 2808. The size and shape of the raised edge 2806 may be designed and / or otherwise configured to enhance the user's grip and engagement of the autoinjector 2800 with the housing 2802.

[0297] For details, please refer to the following: Figure 90The autoinjector 2800 may include a secondary indicator 2810 positioned along the housing 2802 and particularly on the outer surface 2804. The secondary indicator 2810 may be configured and operable to aid in the use of the autoinjector 2800, such as by providing a dose indication to a user. In some embodiments, the secondary indicator 2810 may be configured to display one or more colors and / or other visual elements indicating the operational status of the autoinjector 2800. For example, the secondary indicator 2810 may coincide with an indicator assembly (e.g., indicator assembly 170) disposed within the housing 2802, such that the indicator assembly is visible from the outside of the housing 2802 via the secondary indicator 2810. In this case, the secondary indicator 2810 may include a window or cutout opening in the housing 2802. In this example, the autoinjector 2800 may include a cap 2811 detachably coupled to the housing 2802 at its bottom end 106. The size and / or shape of the cap 2811 may be designed to have a cross-sectional dimension corresponding to the cross-sectional dimension of the housing 2802, such that the cap 2811 may have a larger profile than the narrow cylindrical profile of the shield 2820.

[0298] refer to Figures 91 to 93 Another exemplary autoinjector 2900 is illustrated based on examples of this disclosure. It should be understood that, apart from the differences explicitly pointed out herein, the autoinjector 2900 can be configured, operated, and is substantially similar to the autoinjector 100 shown and described above. Therefore, similar reference numerals for the autoinjector 100 are used herein to designate similar components of the autoinjector 2900. For example, as... Figure 100 As can be seen, the autoinjector 2900 may include one or more internal components similar to those of the autoinjector 100 (e.g., container 112, needle 116, actuator 125, chassis 130, carrier 140, canister 150, valve assembly 160, indicator assembly 170, spindle assembly 180, slidable piston 190, etc.). However, these components may be positioned and / or oriented within the housing 2902 of the autoinjector 2900 based on the size and / or shape of the autoinjector 2900 as described in detail herein.

[0299] In this example, the autoinjector 2900 may include a housing 2902 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shield 2920 movably coupled to the bottom end 106 (see [link]). Figure 92The autoinjector 2900 may include a cap 2911 detachably coupled to a bottom end 106, thereby housing a shield 2920 within the cap 2911 when coupled to a housing 2902. The housing 2902 may include a planar surface 2904 at a top end 104, such that the housing 2902 may have a flat configuration along the top end 104. The size and shape of the housing 2902 may be designed and / or otherwise designed to have a generally trilobed profile, wherein a pair of opposing sidewalls 104A, 106A converge at a central corner 2906. In other words, the housing 2902 may form a rounded triangular configuration (e.g., a Reuleaux triangle). It should be understood that, given the trilobed profile of the housing 2902, the autoinjector 2900 may include alternative configurations and / or orientations of internal components different from those of the autoinjector 100 shown and described above.

[0300] The housing 2902 may include a window 2908 positioned along a central corner 2906, such that the window 2908 is positioned between a pair of opposing sidewalls 104A, 106A. The window 2908 may define a cutout area in the housing 2902 for receiving the container 112, such that the autoinjector 2900 may not include an external window lens and / or barrier disposed above the window 2908. The shield 2920 may include a bottom surface 2922 (e.g., a user engagement interface) and a body 2724 defining the cross-sectional dimensions of the shield 2920, the cross-sectional dimensions corresponding to the trefoil profile of the housing 2902 described above.

[0301] It should be understood that the embodiments shown and described herein typically have relatively reduced cross-sectional dimensions (e.g., height, width, and depth) to minimize the user's perception of the autoinjector as having a bulky appearance. The reduced profile of the autoinjector of this disclosure facilitates intuitive configuration, making it easier to control and generally less intimidating to the user. The cross-sectional profile of the embodiments shown and described herein also facilitates the use of a variety of suitable hand postures and grips for holding the autoinjector. By combining the reduced profile, the need for the user to use multiple hands to stabilize the autoinjector of this disclosure is minimized.

[0302] In the embodiments shown and described herein, container 112 may include a 3 ml pre-filled syringe. In other embodiments, an autoinjector may be configured and operable to deliver a smaller filling volume from container 112. In this case, one or more components of the autoinjector may be designed to adapt to the relative position of piston 114 within container 112 for delivering the intended dose volume. For example, as Figure 94As can be seen, the exemplary autoinjector 3000 may include a housing 3002 having a window 3008, the longitudinal length of which is relatively short to accommodate the small filling volume of the container 112. In other words, the window 3008 may be formed on the housing 3002, the length of which coincides with the filling volume of the container 112, such that the length of the window 3008 is significantly shorter than the length of the container 112 disposed within the housing 3002. In this case, the initial position of the piston 114 in the container 112 is visible from the window 3008.

[0303] Provide other examples, such as Figure 95 As shown, an exemplary autoinjector 3100 may include a secondary label 3102 disposed above at least a portion of a first window 108, thereby covering the portion of the first window 108 that overlaps with the unfilled volume of the container 112. In this case, the secondary label 3102 may cover and / or conceal the portion of the container 112 without the drug, such that the initial position of the piston 114 in the container 112 is visible from the first window 108. It should be understood that the secondary label 3102 may be detachable from one or more labels disposed along the outer surface 102A of the housing 102, and the secondary label 3102 may be coupled or otherwise directly attached to the outer window lens of the first window 108. As another example, such as Figure 96 As can be seen, the exemplary autoinjector 3200 may include a label 3202 integral with a label disposed above the outer surface 102A of the housing 102. In this case, the label 3202 may be disposed above at least a portion of the first window 108, thereby covering the portion of the first window 108 that overlaps with the unfilled volume of the container 112. In this case, the label 3202 may cover and / or conceal the portion of the container 112 without the drug, such that the initial position of the piston 114 in the container 112 is visible from the first window 108.

[0304] Now for reference Figure 101 Another exemplary autoinjector 4100 is illustrated according to an example of this disclosure. The autoinjector 4100 may include a housing having a base cap 4110 and a top cap (not shown). The base cap 4110 may be defined by a first end 4120 and a second end 4130. The base cap 4110 may define a tissue engagement surface along an external interface of the base cap 4110 through which a fluid conduit (e.g., a needle) may be deployed and withdrawn (see [reference]). Figure 133 The top cover may define a user interface surface from which a user can control the autoinjector 4100, such as through a window providing visibility of one or more internal components of the autoinjector 4100. The autoinjector 4100 may include a needle mechanism 4200 and a valve assembly 4300 housed between a bottom cover 4110 and a top cover of the housing. The needle mechanism 4200 may include a carrier 4210 (…). Figures 119A to 119B and Figure 121), Starter 4230 ( Figure 122 ), actuator or button 4250 ( Figures 127 to 129 ), shuttle actuator 4260 ( Figures 130 to 132 ), indicator slider 4270 ( Figures 130 to 132 ), fluid conduit 4280 ( Figure 133 ), and needle retainer or sterile connector 4290 ( Figure 134 ).

[0305] Apart from the differences explicitly stated herein, valve assembly 4300 may be configured and operable substantially similarly to valve assembly 160 shown and described above. For example, valve assembly 4300 may include a low-pressure body portion 4310, a high-pressure body portion 4330, and a fluid source 4350. It should be understood that fluid source 4350 may be configured and operable similarly to tank 150 shown and described above. Valve assembly 4300 may be operatively coupled to fluid conduit 4280 via container 4370 having stopper 4380. In other words, fluid conduit 4280 may establish fluid communication with container 4370, and container 4370 may be operatively coupled to valve assembly 4300, thereby fluidly coupling valve assembly 4300 to fluid conduit 4280 through container 4370. Container 4370 includes a piston 4378 that inhibits the reception of fluid (e.g., pressurized gas) from valve assembly 4300 into container 4370 and / or fluid conduit 4280. As described in detail herein, needle mechanism 4200 and valve assembly 4300 may be coupled to each other and are collectively configured to deploy the fluid conduit via bottom cover 4110. Figure 133 ), delivered from container 4370 ( Figures 102A to 102C The device dispenses a specific dose of medication and retracts the needle back into the housing of the autoinjector 4100 in response to a single actuation of the autoinjector 4100 by the user.

[0306] The autoinjector 4100 may have any suitable size to allow for user carrying and self-attachment. The autoinjector 4100 may, for example, have 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 about 0.5 inches to about 2.0 inches. The autoinjector 4100 may also include a gripping or friction coating, making the outer surface of the autoinjector 4100 a non-slip surface. The autoinjector 4100 may be oriented about a longitudinal axis 10 (e.g., the X-axis), a transverse axis 12 substantially perpendicular to the longitudinal axis 10 (e.g., the Y-axis), and a transverse axis 14 substantially perpendicular to both the longitudinal axis 10 and the transverse axis 12 (e.g., the Z-axis). In some embodiments, the lateral autoinjector of this disclosure may have a dimension along the longitudinal axis 10 longer than along the transverse axis 12 and / or the transverse axis 14. It should be understood that the size and shape of the autoinjector 4100 may be designed and / or otherwise configured as a lateral and / or non-lateral device without departing from the scope of this disclosure.

[0307] In some embodiments of the autoinjector 4100, such as when the autoinjector 4100 is a wearable autoinjector, the autoinjector 4100 may include one or more features, such as an adhesive patch, a band, etc., for attachment to a user. For example, a wearable autoinjector may include an adhesive patch positioned along the exterior of a base cap 4110. The adhesive patch may be coupled to the exterior of the base cap 4110 (such as a tissue-engaging surface) to help secure the autoinjector 4100 to the user's body (e.g., skin). The adhesive patch may be formed of fabric or any other suitable material and may include an adhesive. For example, the adhesive may be an aqueous adhesive or a solvent-based adhesive, or it may be a hot-melt adhesive. Suitable adhesives also include acrylic-based, dextrin-based, and carbamate-based adhesives, as well as natural and synthetic elastomers. In some examples, the adhesive provided on the patch may be activated upon contact with the user's skin. In yet another example, the adhesive patch may include a nonwoven polyester substrate and an acrylic or silicone adhesive. The adhesive patch can be bonded to the base cap 4110 by, for example, double-sided adhesive or by other mechanisms such as ultrasonic welding. The adhesive patch may have a longitudinal dimension (e.g., a dimension parallel to the longitudinal axis 10) greater than the width (e.g., a dimension parallel to the transverse axis 12) of the autoinjector 4100. In other embodiments of this disclosure, the autoinjector 4100 does not include the adhesive patch. For example, in contrast to a wearable autoinjector, the autoinjector 4100 may be a handheld autoinjector. In at least some embodiments, a handheld autoinjector may require the user to hold the autoinjector 4100 against the user's skin throughout the injection process, while a wearable autoinjector may include features for securing the autoinjector 4100 to the skin.

[0308] Still referencing Figure 101The size and shape of container 4370 may be designed to store a nominal value of pharmaceutical agent. The "nominal volume" (also known as "specified volume" or "specified capacity") of a container refers to the maximum capacity of the container as determined by the container manufacturer or safety standards organization. Manufacturers or safety standards organizations may specify a container's nominal volume to indicate that the container can be filled with that volume of fluid (sterile or non-sterile) and can be sealed, stoppered, sterilized, packaged, transported, and / or used while maintaining the container's airtight integrity and simultaneously maintaining the safety, sterility, and / or sterility of the fluid contained within. In determining the nominal volume of a container, manufacturers or safety standards organizations may also consider variations that occur during normal filling, sealing, stoppering, packaging, transport, and management procedures. For example, a pre-filled syringe may be manually or mechanically filled with fluid to its nominal volume and then stoppered using a drain tube or vacuum, without the filling and stoppering machinery and tools coming into contact with and potentially contaminating the syringe contents. Alternatively, the insertion machinery and tools may be sterile or sterile and capable of contacting the contents of the syringe and / or the syringe itself without causing any contamination.

[0309] In some examples, container 4370 may have a nominal volume of about 5.0 mL, but may also use any other suitable nominal volume depending on the medication to be delivered (e.g., about 0.5 mL to about 50.0 mL, or about 2.0 mL to about 10.0 mL, or about 3.0 mL to about 6.0 mL, or about 1.0 mL to about 3.0 mL, or about 2.0 mL to about 5.0 mL, or another suitable range). In other examples, container 4370 may have a nominal volume greater than or equal to about 0.5 mL, or greater than or equal to about 2.0 mL, or greater than or equal to about 3.0 mL, or greater than or equal to about 4.0 mL, or greater than or equal to about 5.0 mL. Container 4370 can contain and preserve medications intended for injection into a user and can help maintain the sterility of the medication. In one embodiment, container 4370 may be configured to deliver a delivery amount of the agent (e.g., about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, about 3.5 mL, greater than about 1.0 mL, greater than about 2.0 mL, greater than about 3.0 mL, greater than about 4.0 mL, greater than about 5.0 mL, greater than about 10.0 mL, greater than about 20.0 mL, or another delivery amount).

[0310] The delivery volume may be less than the nominal volume of container 4370. Furthermore, in order to deliver the delivery volume of medication to the user, container 4370 itself may be filled with a different dose of medication than the delivery volume (i.e., the fill volume). The fill volume may be greater than the delivery volume to account for medication that cannot be transferred from container 4370 to the user due to dead space, for example, in container 4370 or fluid conduit 4280. Therefore, although container 4370 may have a nominal volume of 5 mL, the fill volume and delivery volume of the medication may be less than 5 mL.

[0311] In one embodiment, when container 4370 is used in a handheld autoinjector, the delivery volume of the agent from container 4370 can be from about 0.5 mL to about 4.0 mL, from about 1.0 mL to about 3.5 mL, from about 3.0 mL, from about 3.1 mL, from about 3.2 mL, from about 3.3 mL, from about 3.4 mL, or from about 3.5 mL. The delivery volume of the agent may be related to the viscosity of the agent and the handheld nature of the autoinjector 4100. That is, in at least some embodiments, at certain viscosities, a higher volume of agent may impede the ability of the autoinjector 4100 to complete the injection process in less than an acceptable time, such as less than about 30 seconds. Therefore, the delivery amount of the drug from the autoinjector 4100 can be set such that the injection process, measured from (1) the time when the autoinjector 4100 is placed on the user's skin to (2) the time when the autoinjector 4100 is removed from the skin, is less than about 30 seconds or less than about another time period (e.g., less than about 25 seconds, less than about 20 seconds, less than about 15 seconds, or less than about 10 seconds).

[0312] When the delivery volume and / or viscosity of the drug is too high, the autoinjector 4100 may not be usable as a handheld autoinjector because the time required to complete the injection process may be longer than that of a commercially or clinically acceptable handheld device. Again, as stated above, in embodiments where container 4370 is used in a handheld autoinjector, the delivery volume of the drug from container 4370 can be set, regardless of the nominal volume of container 4370, to complete the injection process as defined above within a relatively short time period (to avoid the need for additional features to attach the autoinjector 4100 to the user, making the autoinjector 4100 a wearable autoinjector). However, it is anticipated that various embodiments of this disclosure may relate to wearable autoinjectors that deliver relatively large amounts of medication (e.g., greater than about 3.5 mL) and / or have relatively long injection times (e.g., longer than about 30 seconds, longer than about 1 minute, longer than about 2 minutes, longer than about 5 minutes, or longer than about 1 hour) compared to handheld autoinjectors, to complete the injection process from (1) the time point when the autoinjector is placed on the user's skin to (2) the time point when the autoinjector is removed from the skin.

[0313] Container 4370 may have a neck with a diameter of about 13 mm, a length of about 45 mm, and an inner diameter of about 19.05 mm. In another embodiment, container 4370 may be a standard 3 mL container with a rolled top of 8 mm, an inner diameter of 9.7 mm, and a length of 64 mm. In yet another embodiment, container 4370 may have a length of about 64 mm to 74 mm, such as, for example, about 69.3 mm ± 0.15 mm (excluding the length of the neck of container 4370 at the second end 4374 of container 4370, e.g.) Figures 102A to 102C (See below). In embodiments including the neck, the container 4370 may have a length ranging from about 65 mm to 75 mm, such as, for example, about 70.8 mm ± 0.4 mm. These values ​​are merely exemplary and other suitable sizes may be used as appropriate. In some examples, the container 4370 may be formed using conventional materials and may be shorter than existing devices, which can help keep the autoinjector 4100 cost-effective and small. In some embodiments, the container 4370 may be a shortened ISO 10 mL cylinder. The autoinjector of this disclosure may be configured to deliver highly viscous liquids to a patient. For example, the autoinjector 4100 of this disclosure may be configured to deliver liquids with viscosities of about 0 cP to about 100 cP, about 5 cP to about 45 cP, about 10 cP to about 40 cP, about 15 cP to about 35 cP, about 20 cP to about 30 cP, or about 25 cP.

[0314] Still referencing Figure 101 The container 4370 may include a piston 4378 movably disposed within a cavity of the container 4370. The piston 4378 can be connected to a fluid source, such as fluid source 4350. Figures 102A to 102C The pressurized fluid discharged from fluid source 4350 causes piston 4378 to translate within container 4370 and to translate container 4370 horizontally along longitudinal axis 10 toward second end 4130. The movement of piston 4378 toward second end 4130 causes piston 4378 to act on the contents (e.g., medicine, pharmaceutical, etc.) within container 4370, ultimately transferring force to container 4370, thereby causing container 4370 to move along longitudinal axis 10. In some embodiments, the transverse autoinjector may be oriented such that fluid source 4350 is offset from piston 4378, or otherwise not longitudinally aligned with each other.

[0315] refer to Figures 102A to 102CThe diagram schematically illustrates the drive system 4150 of an autoinjector 4100. It should be understood that, except for the differences explicitly described herein, the drive system 4150 may be substantially similar to the drive system 2000 shown and described above. The drive system 4150 may be configured to provide driving force to deliver the medication 20 from the container 4370 to the patient. The drive system 4150 may include a fluid source 4350 fluidly coupled to one or more components of the autoinjector 4100, such as the needle mechanism 4200 and the valve assembly 4300. The drive system 4150 may also include a first high-pressure line 4152, a second high-pressure line 4153, a low-pressure line 4154, a drive line 4155, and a third line 4156. The fluid source 4350 may be operatively coupled to the container 4370 via the first high-pressure line 4152 and the drive line 4155. In addition, fluid source 4350 may be fluid-coupled to valve assembly 4300 via one or more of the first high-pressure line 4152, the second high-pressure line 4153 and the low-pressure line 4154.

[0316] Still referencing Figures 102A to 102C The valve assembly 4300 may include a diaphragm 4320 positioned between a low-pressure body portion 4310 and a high-pressure body portion 4330. It should be understood that, except for the differences explicitly described herein, the diaphragm 4320 may be configured and operable to be substantially similar to the diaphragm 2012 shown and described above. Within the valve assembly 4300, the diaphragm 4320 defines a high-pressure (first) cavity 4161 and a low-pressure (second) cavity 4163. The valve assembly 4300 may also include a high-pressure (first) inlet 4160, a low-pressure (second) inlet 4162, and a conduit 4164. The conduit 4164 is formed within a valve seat 4166, which extends into the interior of the valve assembly 4300 and, in particular, into the low-pressure cavity 4163. The high-pressure cavity 4161 may be in fluid communication with the high-pressure line 4152 via a second high-pressure line 4153 and inlet 4160. The low-pressure cavity 4163 can be in fluid communication with the low-pressure pipeline 4154 via the low-pressure inlet 4162. The low-pressure cavity 4163 can also be in fluid communication with the third pipeline 4156 via the conduit 4164.

[0317] The drive system 4150 may include a discharge system 4172 fluidly connected via multiple fluid lines or conduits. For example, the discharge system 4172 may be fluidly connected to a fluid source 4350 via a first high-pressure line 4152 and to a valve assembly 4300 via a third line 4156. The discharge system 4172 may be configured to discharge the drive system 4150 by releasing pressurized fluid into an internal cavity of the autoinjector 4100 (e.g., defined between the bottom cap 4110 and the top cap) and / or into the atmosphere. In some embodiments, the discharge system 4172 may be configured and operable similarly to the discharge system 2030 shown and described above.

[0318] Still referencing Figures 102A to 102C The container 4370 may include a first end 4372 and a second end 4374. The container 4370 may also include a cavity 4376 having an opening at the first end 4372 and extending toward the second end 4374. The second end 4374 may include a stop 4380 configured to assist in closing and / or sealing the second end 4374 and allow fluid conduit 4280 ( Figure 133 The needle 4288 (e.g., a stalled needle) is inserted into the container 4370. For example... Figure 101 As shown, the stopper 4380 may include a line seal, a protrusion (e.g., for reducing dead volume) disposed in the neck of the container 4370, and / or a septum 4382. The septum 4382 may be formed of an uncoated bromobutyl material or another suitable material. The cavity 4376 may be closed at the first end 4372 by a piston 4378. The piston 4378 may include a bromobutyl material coated with a fluoropolymer, and in some embodiments may include a tapered nose to help reduce dead volume within the container 4370. The piston 4378 may include one or more rubber materials, such as halogenated butyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile, as well as other materials. As described in detail above, the container 4370 may store agent 20 (e.g., pharmaceutical product, fluid substance, etc.) within the cavity 4376.

[0319] Fluid source 4350 may include a non-locking canister or a latching canister. Fluid source 4350 may be configured to dispense liquid propellant for boiling outside fluid source 4350 to provide pressurized gas (vapor pressure) acting on piston 4378 in container 4370. In some embodiments, fluid source 4350 may include pressurized gas released from fluid source 4350 and acting on piston 4378 in container 4370. In some embodiments, a latching canister can be latched open once opened, allowing the full contents of the propellant to be dispensed from the canister. Alternatively, in some embodiments, fluid source 4350 may be selectively controlled, including selectively starting and stopping. For example, in an alternative embodiment, the flow of pressurized gas from fluid source 4350 may be stopped after flow has begun.

[0320] The fluid from fluid source 4350 may be any suitable propellant used to provide vapor pressure to drive piston 4378 relative to container 4370 and container 4370 relative to the housing of autoinjector 4100. In some embodiments, fluid source 4350 may be a high-pressure vessel configured to store compressed gas, similar to container 150 shown and described above. In some embodiments, the propellant may be or may contain hydrofluorocarbons (“HFA”), such as HFA134a, HFA227, HFA422D, HFA507, or HFA410A. In some embodiments, the propellant may be or may contain hydrofluoroolefins (“HFO”), such as HFO1234yf or HFO1234ze, organic gases (e.g., carbon dioxide (CO2) etc.), cryogenic gases (e.g., argon (Ar), helium (He) etc.), hydrocarbon gases (e.g., propane, butane, propylene, ethane, methane etc.) or inorganic gases (e.g., ammonia, nitrogen dioxide (NO2), nitrous oxide (N2O) etc.).

[0321] exist Figure 102A In the pre-activation state of the autoinjector 4100, the needle 4288 may contact the second end 4374 of the container 4370. In some embodiments, in the pre-activation state of the autoinjector 4100, the needle 4288 may be spaced apart from the second end 4374 of the container 4370. To allow the autoinjector 4100 to... Figure 102A Before activation, fluid source 4350 can be actuated to move container 4370 along longitudinal axis 10 toward needle 4288. Fluid source 4350 can be actuated to move to an open configuration in which propellant can exit fluid source 4350 as pressurized gas. As described in further detail below, fluid source 4350 can be actuated in response to contact of one or more components of needle mechanism 4200 (e.g., actuator 4230). In some embodiments, actuation is irreversible, such that the flow of pressurized gas from fluid source 4350 cannot be stopped.

[0322] When fluid source 4350 is actuated, pressurized gas can flow through high-pressure line 4152 and drive line 4155, and then to container 4370. Some pressurized gas from high-pressure line 4152 can be transferred to high-pressure cavity 4161 via second high-pressure line 4153 and high-pressure inlet 4160. Figure 102BAs shown, this allows the diaphragm 4320 to move into the low-pressure cavity 4163 and toward the conduit 4164, thereby sealing the valve seat 4166. Depressurized gas can be transferred to the low-pressure cavity 4163 via the low-pressure line 4154 and the low-pressure inlet 4162. The pressure difference between the high-pressure cavity 4161 and the low-pressure cavity 4163 provides the force required to seal the conduit 4164 through the diaphragm 4320. Gas flowing through the drive line 4155 to drive the piston actuates the movement of the container 4370 toward the needle 4288.

[0323] When the needle 4288 is not yet in fluid communication with the medication 20 within the container 4370, activation of the fluid source 4350 can apply pressure to the medication 20 contained within the cavity 4376, which can then be applied to the container 4370 itself. This pressure can cause the container 4370 to move toward the needle 4288, thereby forcing the needle 4288 through the septum 4382 of the stopper 4380. In this case, as Figure 102B As can be seen, needle 4288 is in fluid communication with the contents (e.g., agent 20) of container 4370. Gas from drive line 4155 can then push piston 4378 toward second end 4374 to expel agent 20 through container 4370 until piston 4378 reaches second end 4374 (and touches the bottom). In other words, once needle 4288 is in fluid communication with agent 20 in container 4370, further movement of piston 4378 toward second end 4374 can push agent 20 through needle 4288. As further described herein, pressurized gas from fluid source 4350 can also drive movement of one or more components of needle mechanism 4200 (e.g., actuator 4230, shuttle actuator 4260, indicator slider 4270, etc.) to drive fluid conduit 4280 ( Figure 133 The needle 4286 was injected into the user's body.

[0324] Now for reference Figure 102CWhen piston 4378 bottoms out at second end 4374, the pressures at both ends of high-pressure cavity 4161 and low-pressure cavity 4163 are balanced, thereby causing diaphragm 4320 to rise away from valve seat 4166 and open conduit 4164. This allows gas from low-pressure line 4154 to travel via conduit 4164 and third line 4156 to discharge system 4172, where gas can be discharged from drive system 4150. It should be understood that fluid source 4350 may be configured to contain sufficient pressurized fluid such that the release of pressurized gas actuates both movement of container 4370 relative to the housing of autoinjector 4100 and movement of piston 4378 relative to cavity 4376. In some cases, fluid source 4350 may contain excess pressurized gas, i.e., more fluid than is required to complete the delivery of agent 20 from container 4370. The release of pressurized fluid from the drive system 4150 allows movement of one or more components of the needle mechanism 4200 (e.g., actuator 4230, shuttle actuator 4260, indicator slider 4270, etc.) to actuate the needle 4286. Figure 133 It is withdrawn back into the autoinjector 4100.

[0325] Now for reference Figure 103 And as Figures 119A to 119B As can be seen in more detail, the carrier 4210 may include a first flange 4211 having a lug 4214 extending laterally outward from the first flange 4211 at a first end of the carrier 4210. The carrier 4210 may include a second flange 4212 having a pair of legs 4212A, 4212B extending laterally outward from the second flange 4216 at a second end of the carrier 4210 in a direction opposite to the first end of the carrier 4210. The first flange 4211 may extend parallel to the longitudinal axis 14, and the lug 4214 may extend parallel to the longitudinal axis 10, such that the first flange 4211 and the lug 4214 may be transversely relative to each other. In this embodiment, the first flange 4211 and the lug 4214 may be connected at a 90-degree angle relative to each other. The first flange 4211 may include a first slot opening 4213 that is sized and shaped to accommodate at least a portion of a fluid conduit 4280 and a second slot opening 4215 that is sized and shaped to accommodate at least a portion of a sterile connector 4290. Slot openings 4213 and 4215 may allow the carrier 4210 to accommodate the fluid conduit 4280 and the sterile connector 4290 in a pre-assembled state of the autoinjector 4100.

[0326] The first flange 4211 may include a first opening 4217 positioned adjacent to the first slot opening 4213, and the second flange 4216 may include a second opening 4218 positioned longitudinally aligned with the first opening 4217 along the longitudinal axis 10. The first flange 4211 may be configured to receive at least a portion of the actuator 4230 through the first opening 4217, and the second flange 4216 may be configured to receive at least another portion of the actuator 4230 through the second opening 4218, thereby coupling the actuator 4230 to the carrier 4210 when the needle mechanism 4200 is in the assembled state, as... Figure 105A As shown. As described herein, the initiator 4230 can be configured to move relative to the carrier 4210 when the autoinjector 4100 is activated, such as in response to the movement of the button 4250 to engage the initiator 4230.

[0327] like Figures 119A to 119B As can be seen, the carrier 4210 may also include a pair of legs 4212A, 4212B extending parallel to the longitudinal axis 10. The size and shape of the first leg 4212A may be designed and / or otherwise configured to accommodate an elastic member 4269 (e.g., a spring), such as, for example, surrounding the exterior of the first leg 4212A (see...). Figure 105B In this example, the first leg 4212A may be sized and / or otherwise configured to extend through and support the spindle assembly of the resilient member 4269. As further described herein, the first leg 4212A may be configured to extend into at least a portion of the shuttle actuator 4260, such as between a pair of guide flanges 4224 of the shuttle actuator 4260, wherein the resilient member 4269 is disposed around the first leg 4212A. The resilient member 4269 may be configured to move the shuttle actuator 4260 by pressing against the pair of guide flanges 4224 during expansion. The second leg 4212B may be sized and / or otherwise configured to at least partially define the travel path of the shuttle actuator 4260, which may be configured to move (e.g., translate) within the housing of the autoinjector 4100 along said travel path. The second leg 4212B can be configured to align the shuttle actuator 4260 with the carrier 4210, thereby coupling the shuttle actuator 4260 to the carrier 4210 when the needle mechanism 4200 is in the assembled state.

[0328] The carrier 4210 may include one or more features (e.g., walls, grooves, cavities, platforms, etc.) positioned between the first flange 4211 and the second flange 4216 for engaging one or more components of the engagement needle mechanism 4200, such as the actuator 4240. Figures 124 to 126 ) and button 4250 ( Figures 127 to 129For example, the carrier 4210 may include a track 4222, the size and shape of which may be designed and / or otherwise configured to match a slot in the actuator 4240. The track 4222 may be configured to guide, stabilize, and control the movement of the actuator 4240 relative to the carrier 4210. It should be noted that the carrier 4210 and actuator 4240 of this disclosure are not limited to any particular combination of features, such that, for example, the actuator 4240 may include a track configured to be received within a corresponding slot in the carrier 4210. The carrier 4210 may include a barrier defined by a pair of protrusions 4220 with an intermediate gap formed between them. The protrusions 4220 may be positioned along the inner surface of the first flange 4211 and may be configured to engage the fastening mechanism 4254 of the button 4250. Figure 127 The carrier 4210 is securely coupled to the button 4250.

[0329] For example, the fastening mechanism 4254 may be included when the button 4250 is in the first (unacted) position (see [reference]). Figure 109 A pull tab and / or hook are accommodated between a pair of protrusions 4220 (e.g., within the gap defined by the protrusions 4220). In other words, when the button 4250 is in a first (unactuated) position and / or extended state relative to the carrier 4210, the fastening mechanism 4254 can be locked between the pair of protrusions 4220. The fastening mechanism 4254 can be configured to move the button 4250 toward a second (actuated) position (see...). Figure 110 The button 4250 is then separated from the gap between the pair of protrusions 4220. In this case, the fastening mechanism 4254 can maintain engagement through at least one of the bottommost protrusions 4220, thereby holding the button 4250 in the second (actuated) position. In this case, the fastening mechanism 4254 and the bottommost protrusion 4220 can be configured together to lock and inhibit further movement of the button 4250, such as returning to the first (unactuated) position, thereby holding the button 4250 in a pressed state relative to the carrier 4210. In some embodiments, the fastening mechanism 4254 can be configured to balance the button 4250 relative to the carrier 4210.

[0330] like Figure 119B As shown, the carrier 4210 may include a pair of lugs 4223A, 4223B offset from each other along the sidewall of the carrier 4210. The pair of lugs 4223A, 4223B may be positioned along the sidewall of the carrier 4210, which includes a barrier 4225. The pair of lugs 4223A, 4223B may be configured to guide the actuator 4230 to translate in response to the expansion or compression of the elastic member 4239, as described below.

[0331] refer to Figure 103 and Figure 121The carrier 210 may include a post 4219 positioned between the first flange 4211 and the second flange 4216. In this example, the post 4219 may extend in a direction parallel to each of the first flange 4211 and the second flange 4216, such as parallel to the transverse axis 12. The size and shape of the post 4219 may be designed and / or otherwise configured to receive the gear 4229 of the needle mechanism 4200 (see [link to documentation]). Figure 135 Gear 4229 may be configured to rotate relative to post 4219 in response to movement of one or more features of needle mechanism 4200 (e.g., actuator 4240, button 4250, shuttle actuator 4260, etc.). As described in further detail herein, gear 4229 may provide fluid conduit 4280 ( Figure 133 Selective deployment and withdrawal from the housing of the autoinjector 4100.

[0332] like Figure 123 As can be seen, gear 4229 may include a double-spur gear having a first gear portion 4229A and a second gear portion 4229B, each gear portion including a plurality of teeth disposed around the outer circumference of the respective gear portion. It should be understood that the pitch ratio of the plurality of teeth on each of the first gear portion 4229A and the second gear portion 4229B may vary relative to each other. In this embodiment, the first gear portion 4229A and the second gear portion 4229B may have a generally circular shape, wherein the first gear portion 4229A has a smaller outer diameter than the second gear portion 4229B, or alternatively, the first gear portion 4229A may have a larger outer diameter than the second gear portion 4229B. In this case, the first gear portion 4229A may have a first gear ratio that is different from (e.g., smaller) than the second gear ratio of the second gear portion 4229B.

[0333] The first gear portion 4229A may be adjacent to the second gear portion 4229B, and the two gear portions 4229A and 4229B may rotate about the same axis. It should be understood that gear 4229 may be configured to mesh and interact with multiple components of the needle mechanism 4200. For example, the first gear portion 4229A may be configured and operable to engage with the driver 4240 of the needle mechanism 4200 (see...). Figures 124 to 126 The second gear portion 4229B can be configured and operable to interact with the shuttle actuator 4260 (see...). Figures 130 to 132Interaction. In this example, due to the difference in size and / or pitch ratio of the two gear portions 4229A, 4229B, the shuttle actuator 4260 and the driver 4240 can be configured to move different distances relative to each other during the same rotation of gear 4229. Gear 4229 may also include a post 4219 extending through openings 4229C of each of gear portions 4229A, 4229B for receiving a carrier 4210 passing therethrough.

[0334] refer to Figure 103 and Figure 122 The starter 4230 may include a central body 4232 disposed between a first end 4231 and a second end 4233 positioned opposite the first end 4231. In this example, the second end 4233 may have a cross-sectional profile relatively larger than the central body 4232 and the first end 4231, and the central body 4232 may have a cross-sectional profile relatively larger than the first end 4231. In this example, the central body 4232, the first end 4231, and the second end 4233 may each generally have a cylindrical and / or elongated profile. The starter 4230 may have a longitudinal length defined between opposing terminals 4234, 4238 of the first end 4231 and the second end 4233. The starter 4230 may include a flange 4235 extending radially outward from the second end 4233 and one or more splines 4236 extending radially outward from the first end 4231. In this example, the starter 4230 may include a plurality of splines 4236 disposed around the outer surface of the first end 4231. As described herein, the initiator 4230 may include a keying arrangement having a carrier 4210, wherein the keying arrangement is configured and operable to control longitudinal movement of one or more components of the autoinjector 4100. The keying arrangement between the initiator 4230 and the carrier 4210 may be at least partially defined by a plurality of splines 4236.

[0335] In some embodiments, spline 4236 may include, but is not limited to, tabs, protrusions, grooves, projections, raised surfaces, and / or various other suitable features disposed along the outer surface of the first end 4231 to define a keyed configuration for mating the actuator 4230 with the carrier 4210. Multiple splines 4236 may be configured to couple with one or more features on the first flange 4211 to securely couple the actuator 4230 to the carrier 4210. For example, the dimensions and shapes of the multiple splines 4236 may be designed and / or otherwise configured to mate with multiple corresponding latches 4217A disposed around the first opening 4217. With the splines 4236 aligned with the latches 4217A, the actuator 4230 may be in a fixed and / or locked state relative to the carrier 4210. The dimensions and shapes of the multiple splines 4236 may also be designed and / or otherwise configured to extend through multiple corresponding slots 4217B formed in the first opening 4217 (see...). Figures 108B to 108C This is for disengaging the starter 4230 from the first flange 4211. In other words, the first opening 4217 may be at least partially defined by a plurality of slots 4217B configured to receive the plurality of splines when aligned with corresponding splines 4236 of the plurality of splines 4236. When the splines 4236 are misaligned with the latches 4217A and aligned with the slots 4217B, the starter 4230 may be in a movable and / or unlocked state relative to the carrier 4210. When engaged with the plurality of splines 4236, the keyed arrangement between the starter 4230 and the carrier 4210 may be at least partially defined by the plurality of latches 4217A and the plurality of slots 4217B.

[0336] like Figures 108C to 108D As can be seen, at least one of the plurality of levers 4217A may be disposed between an adjacent pair of slots 4217B in the plurality of slots 4217B. Each lever 4217A may be configured to receive a corresponding spline 4236 therein for securely coupling the central body 4232 of the starter 4230 to the first flange 4211 in a fixed configuration (e.g., orientation), such as Figure 108C As shown. In this configuration, the first end 4231 may extend through the first opening 4217, and the carrier 4210 may be configured to hold the actuator 4230 in a fixed configuration when no force is applied to the actuator, such as by the button 4250. In other words, the plurality of levers 4217A may be configured to suppress movement (e.g., rotation, translation, etc.) of the splines 4236 when they are received therein. As described herein, the button 4250 may be configured to move (e.g., rotate) the central body 4232, thereby causing the splines 4236 to move (e.g., rotate) out of alignment with the levers 4217A and become aligned with the slot 4217B, as Figure 108DAs can be seen, this allows the first opening 4217 to accommodate the spline 4236 and the terminal 4238 passing through it for disengaging the starter 4230 from the first flange 4211. In other words, when the spline 4236 is aligned with the groove 4217B, the starter 4230 is no longer held in a fixed configuration by the carrier 4210 and / or prevented from moving relative to the carrier 4210. The starter 4230 can be configured to move in a direction away from the first flange 4211, thereby causing the first end 4231, the spline 4236, and the terminal 4238 to move out of the first opening 4217.

[0337] refer to Figure 105A and Figures 106 to 107 The starter 4230 may include a resilient member 4239 (e.g., a spring) whose size and shape may be designed and / or otherwise configured to extend outward around the central body 4232. For example, the resilient member 4239 may be disposed above the central body 4232 and positioned such that one end of the resilient member 4239 abuts against a second end 4233 and the opposite end of the resilient member 4239 abuts against the inner surface of a first flange 4211. The resilient member 4239 may be configured to switch between a compressed and expanded configuration in response to rotation of the starter 4230, and particularly of the plurality of splines 4236, relative to the first opening 4217, as caused by actuation of the button 4250. In this example, the resilient member 4239, when in an energy storage state, may be parallel to the longitudinal axis 10 (see...). Figure 103 The longitudinal direction of the component is compressed between the second end 4233 and the first flange 4211, as shown in the figure. Figure 109 As can be seen, when the elastic member 4239 is in an energy storage state (e.g., in a compressed configuration), the central body 4232 can be positioned in a first position, in which the first end 4231 is received through the first opening 4217 and the spline 4236 engages with the stop 4217A and is misaligned with the groove 4217B.

[0338] The elastic member 4239 may be able to move to an energy-release state (e.g., an expanded configuration), in which, when the actuator 4230 and, in particular, the plurality of splines 4236, move (e.g., rotate) relative to the first opening 4217, the central body 4232 moves toward a second position different from the first position (see [link to relevant documentation]). Figure 110In this configuration, the multiple splines 4236 can disengage from the multiple latches 4217A and align with the multiple slots 4217B, such that the multiple splines 4236 can be accommodated through the slots 4217B when the resilient member 4239 expands. With the multiple splines 4236 and terminals 4238 no longer inhibited from moving relative to the first flange 4211 due to the engagement between the multiple splines 4236 and the multiple latches 4217A, the resilient member 4239 can be configured to apply force to the central body 4232 and abut against the first flange 4211, thereby causing the actuator 4230 to move relative to the carrier 4210 and away from the first flange 4211. When the elastic member 4239 pushes the central body 4232 away from the first flange 4211, multiple splines 4236 can extend through multiple slots 4217B and terminals 4238 can extend through the first opening 4217 until the multiple splines 4236 and terminals 4238 are positioned on opposite (inner) sides of the first flange 4211, as... Figure 110 visible.

[0339] like Figures 109 to 110 As can be seen, the actuator 4230 can contact the fluid source 4350, and specifically, the second end 4233 can be adjacent to the fluid source 4350 along the terminal 4234. Therefore, the actuator 4230 can be configured to move the fluid source 4350 in response to the resilient member 4239 moving from an energy storage state (e.g., compression configuration) to an energy release state (e.g., expansion configuration). In other words, in response to the button 4250 moving from a first (unactuated) position to a second (actuated) position to release the resilient member 4239 from the compression configuration to the expansion configuration, the terminal 4234 can push the fluid source 4350, thereby moving the fluid source 4350 relatively away from the second flange 4216 of the carrier 4210 and toward the valve assembly 4300. The fluid source 4350 can be actuated, punctured, and / or opened in response to interaction with the valve assembly 4300, thereby releasing the pressurized medium stored in the fluid source 4350 into the valve assembly 4300. It should be understood that before the button 4250 moves from the first position to the second position, the actuator 4230 can be held in the first position by the carrier 4210 due to the interaction between the plurality of splines 4236 on the first end 4231 and the corresponding plurality of splines on the first flange 4211. Therefore, the carrier 4210 can be configured to prevent the actuator 4230 from horizontal movement from the first position to the second position before the autoinjector 4100 is actuated by the button 4250.

[0340] refer to Figure 103 and Figures 127 to 129The button 4250 may be a pressable actuator having a body 4251, a stop tab 4252 (e.g., a stop), a boss 4253, a fastening mechanism 4254, a first leg 4256, and a second leg 4258. The body 4251 may include a top surface defining a contact interface for actuating the button 4250. The stop tab 4252 may extend outward from a first side of the body 4251, and the fastening mechanism 4254 may extend outward from a second side of the body 4251 opposite to the stop tab 4252. The stop tab 4252 may include one or more ridges and / or protrusions extending outward therefrom. One or more ridges of the stop tab 4252 may abut against at least a portion of the shuttle actuator 4260 to inhibit movement of the shuttle actuator 4260 relative to the carrier 4210 prior to actuation of the button 4250. One or more protrusions of the stop tab 4252 may block or otherwise prevent the movement of the indicator slider 4270.

[0341] For example, such as Figure 107 As can be seen, the stop tab 4252 may include at least one protrusion 4252A extending outward from the body 4251 and at least one ridge 4252B defining the end of the stop tab 4252 opposite to the body 4251. In other embodiments, the stop tab 4252 may include additional and / or fewer ridges and / or protrusions along various other sides of the stop tab 4252 without departing from the scope of this disclosure. In some embodiments, and as described in further detail herein, the protrusion 4252A may be omitted from the stop tab 4252, and the top cover 4118 may include a stop tab 4119, such as Figure 104 As can be seen, the fastening mechanism 4254 may include flexible hooks or clasps for engaging a pair of protrusions 4220 of the carrier 4210. As described in detail herein, the fastening mechanism 4254 may be configured to, in response to interaction with one or more of the pair of protrusions 4220, position the button 4250 relative to the carrier 4210 in a first (unactuated) position before actuation and hold the button 4250 in a second (actuated) position after actuation.

[0342] like Figures 128 to 129 As shown, button 4250 may include a protrusion 4255 along the bottom surface of body 4251. Protrusion 4255 may be configured to engage an elastic member 4249 disposed within carrier 4210 (see...). Figure 103The resilient member 4249 may include a spring configured to apply resistance to the button 4250 to provide tactile feedback to the body 4251 when the user actuates the button 4250. In other embodiments, the resilient member 4249 may be omitted entirely, allowing the button 4250 to exclude the protrusion 4255. A first leg 4256 and a second leg 2458 may extend outward (e.g., downward) from the body 4251, and the longitudinal length of the first leg 4256 may be greater than that of the second leg 4258. The first leg 4256 may include a ramp 4259 positioned along the outer surface of the first leg 4256, which may be configured to engage at least a portion of the carrier 4210 when the button 4250 is actuated. The second leg 4258 may extend outward (e.g., downward) from the body 4251 along one side of the button 4250 adjacent to the fastening mechanism 4254. The second leg 4258 may be configured to engage at least a portion of the carrier 4210 when the button 4250 is actuated. The boss 4253 of the button 4250 may extend outward (e.g. downward) from the body 4251 along the side of the button 4250 opposite to the second leg 4258. The size and shape of the boss 4253 may be designed and / or otherwise configured to interact with the actuator 4230 when the button 4250 is actuated, such as to cause movement (e.g., rotation) of the actuator 4230.

[0343] like Figure 108A As can be seen, when button 4250 is in the first (unacted) position, boss 4253 can be positioned adjacent to and / or against flange 4235 of actuator 4230. In this case, movement of button 4250 toward the second (acted) position allows boss 4253 to come into contact with flange 4235, thereby causing a corresponding movement of actuator 4230. For example, now referring to... Figure 108B The button 4250 can be configured to move the actuator 4230 in response to the boss 4253 pushing the flange 4235, thereby causing the second end 4233 to rotate relative to the carrier 4210. When the second end 4233 is integral with the central body 4232 and the first end 4231, the rotation of the second end 4233 causes the central body 4232 and the first end 4231 to rotate simultaneously relative to the carrier 4210. As described above, the movement (e.g., rotation) of the first end 4231 relative to the first flange 4211 can cause the plurality of splines 4236 to move without aligning with the plurality of latches 4217A and to align with the plurality of slots 4217B. In this case, when the splines 4236 are no longer engaged with the latches 4217A, the terminal 4238 is no longer restricted to a fixed position relative to the first flange 4211. In response to the disengagement of spline 4236 from latch 4217A, a force applied to the central body 4232 by the elastic member 4239 in a direction away from the first flange 4211 can move spline 4236 and the end 4238 of the first end 4231 through the first opening 4217, as... Figure 110Therefore, the starter 4230 can be configured to move toward the second flange 4216 and through the second opening 4218 to push the terminal 4234 against the fluid source 4350 to begin delivering pressurized fluid stored in the fluid source 4350 to the valve assembly 4300.

[0344] Return to reference Figure 103 A stop tab 4252 extending from button 4250 can prevent fluid connection between container 4370 and fluid conduit 4280. Stop tab 4252 can be configured to engage shuttle actuator 4260 coupled to container 4370. For example, when button 4250 is in a first (unactuated) position, ridge 4252B can be positioned in the path of motion of shuttle actuator 4260, thereby preventing shuttle actuator 4260 and container 4370 coupled to shuttle actuator 4260 from moving horizontally in the direction toward sterile connector 4290 and fluid conduit 4280. Protrusion 4252A can be configured to engage indicator slider 4270 to prevent indicator slider 4270 from moving in the same direction.

[0345] In other implementations, such as Figure 104 As can be seen, the stop tab 4252 can completely omit the protrusion 4252A, and the top (outer) cover 4118 of the autoinjector 4100 may include a stop tab 4119 (e.g., an obstruction) to prevent the indicator slider 4270 from moving toward the sterile connector 4290. The stop tab 4119 may extend radially inward from the inner surface of the top cover 4118 in a direction parallel to the longitudinal axis 14, and may be positioned along the top cover 4118 at a position aligned with a first end of the indicator slider 4270. In other words, the stop tab 4119 may extend vertically within the autoinjector 4100. Therefore, the stop tab 4119 may be configured to engage and / or abut the indicator slider 4270 to prevent the indicator slider 4270 from moving in a direction parallel to the longitudinal axis 10 (e.g., toward the sterile connector 4290). The size and / or shape of the stop tab 4119 may be designed to abut against the body 4274 when the button 4250 is in a first (unactuated) position and a second (actuated) position. The stop tab 4119 may be configured to hold the indicator slider 4270 in a fixed position such that the indicator slider 4270 may mate and / or couple with the shuttle actuator 4260 after fluid released from the fluid source 4350 drives the container 4370 (and the shuttle actuator 4260) in a horizontal direction toward the sterile connector 4290. It should be understood that, in another embodiment, the autoinjector 4100 may include each of the protrusion 4252A on the stop tab 4252 and the stop tab 4119 on the top cap 4118.

[0346] In this state, the indicator slider 4270 may be in a first position relative to the shuttle actuator 4260 before the autoinjector 4100 is actuated. In embodiments where the housing of the autoinjector 4100 includes a window to make the needle mechanism 4200 visible, the user can identify the relative state of the autoinjector 4100 through the window based on making the first position of the indicator slider 4270 visible. As described in detail herein, in some embodiments, the indicator slider 4270 may include a graphical interface on the body 4274 of the indicator slider 4270, which may be configured to indicate the relative position of the indicator slider 4270 and / or the state of the autoinjector 4100. Furthermore, a first position of the indicator slider 4270 can be visually indicated to the user based on a graphic display and / or interface (e.g., stickers, colors, etc.) positioned on the shuttle actuator 4260. The graphic display and / or interface can be seen from the outside of the autoinjector 4100 through a window on the outer surface of the autoinjector 4100 and a window 4278 of the indicator slider 4270.

[0347] Before actuating the autoinjector 4100, such as Figure 105A As can be seen, the leg 4272 of the indicator slider 4270 can be positioned adjacent to but decoupled from the fastening mechanism 4263 of the shuttle actuator 4260. As described herein, the shuttle actuator 4260 can initially be decoupled from the indicator slider 4270 and can be coupled to the indicator slider 4270 such that the shuttle actuator 4260 and the indicator slider 4270 can be configured to move together within the housing of the autoinjector 4100 when connected to each other. The autoinjector 4100 may include a release tab 4140, which is detachably coupled to the bottom cover 4110 (see...). Figure 101 One or more openings are exposed along the tissue engagement surface of the bottom cover 4110, allowing the button 4250 to be pressed. The button 4250 can be actuated by applying a downward force to the body 4251, thereby moving the button 4250 from a first (unactuated) position toward a second (actuated) position. Before the autoinjector 4100 is activated, movement of the shuttle actuator 4260 relative to the carrier 4210 is inhibited because the stop tab 4252 is abutted against a portion of the shuttle actuator 4260. Therefore, moving the button 4250 toward the second position disengages the stop tab 4252 from the shuttle actuator 4260, thereby allowing the shuttle actuator 4260 to move relative to (e.g., horizontally toward) the carrier 4210. In an embodiment where the top cover 4118 includes a stop tab 4119 engaging with an indicator slider 4270 (see [link to embodiment]). Figure 104 When the shuttle actuator 4260 moves away from the carrier 4210 during the initial actuation of the button 4250, the movement of the indicator slider 4270 toward the sterile connector 4290 can be suppressed from the outset.

[0348] refer to Figures 109 to 110 When button 4250 is moved toward the second position to rotate starter 4230, elastic member 4239 can be configured to automatically exit the first energy storage state. Figure 109 The first energy release state as it expands toward the elastic member 4239 ( Figure 110 The resilient member 4239 may be configured to push the actuator 4230 away from the first flange 4211 and toward the fluid source 4350. The carrier 4210 may include a guide surface 4221, the size and shape of which may be designed and / or otherwise configured to at least partially accommodate the fluid source 4350 therein. The guide surface 4221 may also be configured to point toward and / or guide the fluid source 4350 toward the valve assembly 4300 in response to the resilient member 4239 pushing the actuator 4230 toward the fluid source 4350. In other words, releasing energy from the resilient member 4239 may be configured to cause the actuator 4230, and particularly the second end 4233, from the first lateral position ( Figure 109 ) Horizontally toward the second lateral position ( Figure 110 The fluid source 4350 moves within the autoinjector 4100 and is in fluid communication with the valve assembly 4300.

[0349] Additionally, the actuator 4230 may be configured to activate the fluid source 4350 by, for example, bringing a portion of the fluid source 4350 into direct contact with the terminal 4234 to release pressurized fluid stored therein. For example, the actuator 4230 may contact, abut, and / or move the valve stem of the fluid source 4350 to an open configuration, allowing fluid (e.g., gas) to flow from the fluid source 4350. In other examples, the valve stem of the fluid source 4350 may be positioned within or adjacent to the valve assembly 4300 and in a stationary state, such that the actuator 4230 may be configured to actuate the valve stem to thereby move the fluid source 4350 to an open configuration. In some embodiments, in response to the actuator 4230 contacting the fluid source 4350, feedback (e.g., tactile, auditory, etc.) may be generated by the needle mechanism 4200 to instruct the user to initiate the dose delivery procedure of the autoinjector 4100.

[0350] refer to Figures 105A to 105B The elastic member 4269 of the needle mechanism 4200 may be disposed around the first leg 4212A of the carrier 4210 and compressed between the second flange 4216 and the shuttle actuator 4260, and particularly abuts against a pair of guide flanges 4224. The elastic member 4269 may be configured to move the shuttle actuator 4260 horizontally from a first position to a second position in response to expansion caused by the release of pressurized fluid from the fluid source 4350. Figure 111AAs can be seen, the shuttle actuator 4260 can be configured to translate horizontally when the elastic member 4269 expands due to contact between the elastic member 4269 and the guide flange 4224. The shuttle actuator 4260 can be configured to move from a second position to a third position in response to the release of pressurized fluid by the fluid source 4350, thereby compressing the elastic member 4269. Therefore, when the shuttle actuator 4260 moves horizontally from the first state to the second state, the shuttle actuator 4260 can be configured to... Figure 111B The elastic member 4269 is compressed in the same horizontal direction. In other words, once the pressurized fluid is released from the fluid source 4350, the energy released from the pressurized fluid can be operated to act on the container 4370 in the opposite horizontal direction to the elastic member 4269 during the initial expansion of the elastic member 4269 to the energy release state (see [link]). Figure 101 ).

[0351] The released energy can be configured to push container 4370 and shuttle actuator 4260 coupled to container 4370 in opposite horizontal directions, thereby compressing elastic member 4269. It should be understood that this movement of the components of needle mechanism 4200 in opposite horizontal directions can be operable to establish fluid communication between container 4370 and fluid conduit 4280. For example, when container 4370 moves onto the fixed second end (needle) 4288 of fluid conduit 4280 (see...) Figure 102B This establishes fluid communication, thereby forcing the needle 4288 through the stop 4380 of the container 4370. Furthermore, this same opposite horizontal movement of the components of the needle mechanism 4200 can be configured to drive the fluid conduit 4280 (see...). Figure 133 The first end (needle) 4286 leaves the autoinjector 4100 and enters the patient's body for injection.

[0352] refer to Figure 111B The movement of the shuttle actuator 4260 in the second horizontal direction causes the rack 4265 of the shuttle actuator 4260 to rotate the gear 4229 in a first rotational direction (e.g., clockwise). This, through the contact between the gear 4229 and the rack 4246 of the driver 4240, forces the driver 4240 into a downward vertical direction (needle injection). As described above, the gear 4229 may include two gear portions 4229A and 4229B of different sizes, such that each main body portion may have a different pitch ratio (see...). Figure 123For example, gear 4229 may have a pitch ratio difference of 4:3 between the two gear portions 4229A and 4229B, and gear portions 4229A and 4229B may have different diameters relative to each other, such that gear 4229 can move shuttle actuator 4260 along a first distance (e.g., ranging from about 1 mm to 6 mm) while moving driver 4240 along a second distance different from (e.g., greater than) the first distance (e.g., ranging from about 6 mm to 10 mm). For example, a 6 mm stroke of shuttle actuator 4260 may correspond to an 8 mm stroke of driver 4240.

[0353] It should also be noted that one or more gears and / or gear portions of this disclosure are not limited to specific pitch, diameter, length, and / or combinations thereof. The gears and gear portions may be adjustable and can be modified to accommodate the needle insertion depth of any patient. As described above, once the container 4370 is in fluid communication with the fluid conduit 4280, and the first end 4282 of the fluid conduit 4280 is deployed into the patient's body ( Figure 111B If further release of energy from fluid source 4350 (e.g., pressurized fluid) is possible, piston 4378 may move through container 4370, thereby discharging agent 20 into the patient's body (see [link to relevant documentation]). Figure 102C ).

[0354] In some embodiments, in response to the shuttle actuator 4260 contacting one or more components of the needle mechanism 4200 (e.g., gear 4229, elastic member 4269, etc.), feedback (e.g., tactile, auditory, etc.) may be generated by the needle mechanism 4200 to indicate to the user the delivery of a dose. When button 4250 has been moved to the second position ( Figure 110 When the button 4250 is in the first position, the stop pull tab 4252 can be moved to start the above-mentioned dose delivery procedure. Figure 109 The new plane is positioned relatively low. Therefore, when the shuttle actuator 4260 and / or the indicator slider 4270 move horizontally toward the button 4250, the stop tab 4252 can now engage one or more of the shuttle actuator and / or the indicator slider. In this state, the support leg 4272 can move toward and engage the fastening mechanism 4263 (see...). Figure 105AThis allows the shuttle actuator 4260 to be coupled to the indicator slider 4270. In this configuration, the shuttle actuator 4260 and the indicator slider 4270 can be configured to move together in response to their coupling. Specifically, when the shuttle actuator 4260 moves from its first state to its second state, the stop tab 4252 (and / or stop tab 4119) can maintain the horizontal position of the indicator slider 4270 (preventing the indicator slider 4270 from moving toward the sterile connector 4290), thereby allowing the shuttle actuator 4260 to interlock with the indicator slider 4270.

[0355] like Figure 103 As shown and as described above, the protrusion 4252A on the stop tab 4252 may abut against the indicator slider 4270, while the ridge 4252B of the stop tab 4252 contacts the shuttle actuator 4260. The protrusion 4252A may extend parallel to the through axis 14, and the ridge 4252B may extend parallel to the longitudinal axis 10, such that the protrusion 4252A is arranged perpendicular to the ridge 4252B. When the button 4250 is actuated, the protrusion 4252A may remain in contact with the indicator slider 4270, thereby preventing the indicator slider 4270 from moving horizontally toward the sterile connector 4290, even after the shuttle actuator 4260 has disengaged from the ridge 4252B. It should be understood that the protrusion 4252A may have a length sufficient to remain in contact with the indicator slider 4270 after the button 4250 has moved from the first (unactuated) position to the second (actuated) position. In other embodiments, such as Figure 104 As can be seen and as described above, instead of and / or in addition to the protrusion 4252A, the stop tab 4119 can remain in contact with the indicator slider 4270.

[0356] Therefore, when the autoinjector 4100 is actuated, the movement of the shuttle actuator 4260 from its first state to its second state makes the second indicator (located on the surface of the shuttle actuator 4260) visible through a window in the housing of the autoinjector 4100 and through window 4278. For example, the shuttle actuator 4260 may include a second platform 4266B on which the second indicator is included. In this case, the window may be aligned with a portion of the body 4274 and / or the window 4278 of the indicator slider 4270, thereby exposing a portion of the second platform 4266B (including the second indicator) disposed below the body 4274. As described herein, the second platform 4266B may include one or more graphical interfaces (e.g., colors, text, symbols, etc.) that indicate the state of the autoinjector 4100 when viewed by a user through window 4278. The first and second indicators on the second platform 4266B may have different characteristics and / or attributes, such as, but not limited to, patterned pieces of color and / or material, stickers, etchings, or other suitable mechanisms for providing different visual cues to the user.

[0357] When the piston 4378 completes the delivery of the agent 20 by touching the bottom at the second end 4374 of the container 4370, the pressure acting on the container 4370 can be reduced and / or eliminated. For example, the discharge system 4172 ( Figure 102C The pressure generated within the valve assembly 4300 can be released during the delivery of agent 20 via fluid conduit 4280. The disappearance of the fluid force acting on container 4370 allows elastic member 4269 to exit its second energy storage state and / or compression configuration. Figure 111B ) moves to its second energy release state and / or expansion state ( Figure 111C This expansion or movement of the elastic member 4269 can drive the shuttle actuator 4260 in a second horizontal direction. The horizontal movement of the shuttle actuator 4260 causes the rack 4265 to drive the gear 4229 in a second rotational direction opposite to the first rotational direction (e.g., counterclockwise). This opposite rotation, by forcing the actuator 4240 in an upward vertical direction, withdraws the needle 4286 from the patient's body and into the autoinjector 4100, as... Figure 111C As shown.

[0358] As the shuttle actuator 4260 moves horizontally via the expansion of the resilient member 4269, the indicator slider 4270 can similarly move with the shuttle actuator 4260. Thus, the indicator slider 4270 can move toward a third position visible through a window in the housing of the autoinjector 4100 to indicate the final state of the autoinjector 4100. In some embodiments, in response to the expansion of the resilient member 4269 and / or the vertical movement of the actuator 4240 to retract the fluid conduit 4280 into the housing of the autoinjector 4100, the needle mechanism 4200 can generate feedback (e.g., tactile, audible, etc.) to indicate to the user that dose delivery has been completed. In some embodiments, the actuator 4240 can contact a surface of the carrier 4210 or a top inner surface of the housing of the autoinjector 4100 (e.g., top cap 4118) to generate feedback (e.g., tactile, audible) indicating completion of delivery. In other embodiments, the actuator 4230 and / or shuttle actuator 4260 may contact one or more components and / or surfaces within the autoinjector 4100 to generate corresponding feedback when a dose is delivered to the user, for example, by force provided by a second or subsequent expansion of the elastic member 4269 after dose delivery. This movement of the indicator slider 4270 with the shuttle actuator 4260 can be configured to move the window 4278 away from alignment with a window on the exterior of the autoinjector 4100. Instead, the surface of the indicator slider 4270, which includes a third indicator different from the first and second indicators, is now visible through the exterior window of the autoinjector 4100.

[0359] Return to reference Figure 101 As described above, the autoinjector 4100 may include a pull tab 4140 coupled to the base cap 4110. The pull tab 4140 may include a first end 4142 at least partially positioned below one or more openings in the base cap 4110 and extending through one or more openings in the base cap 4110. The pull tab 4140 may include a second end 4144 extending outwardly from one end of the base cap 4110 in various suitable lengths, shapes, sizes, and / or configurations. The second end 4144 may be selectively grasped by a user to remove the pull tab 4140 from the base cap 4110. It should be understood that the pull tab 4140 may be configured to close one or more openings along the base cap 4110 when coupled to the base cap 4110. The pull tab 4140 may be configured to prevent the button 4250 from being pressed when coupled to the autoinjector 4100.

[0360] The first end 4142 may include a pair of pull tabs 4146 and a retaining ring 4148, the retaining ring extending through the bottom cover 4110 and into the interior of the autoinjector 4100 when the pull tabs 4140 are coupled to the bottom cover 4110. The pull tabs 4140 may be disposed on at least a portion of the outer (tissue-engaging) surface of the bottom cover 4110. Figure 112 As can be seen, a pair of pull tabs 4146 may ...

Claims

1. An automatic injector, comprising: case; A container disposed within the housing, the container being configured to store a pharmaceutical agent; A canister disposed within the housing, the canister being configured to release a pressurized medium to discharge the pharmaceutical agent from the container; A shield coupled to the housing, the shield being configured to move relative to the housing between a first position and a second position to allow the pressurized medium to be released from the tank; as well as A spindle assembly disposed within the housing is configured to push the shield outward relative to the housing toward the first position after the pressurized medium is released from the tank.

2. The autoinjector of claim 1, wherein the mandrel assembly includes a slidable piston configured to be moved by the pressurized medium released by the canister.

3. The autoinjector as described in claim 1: The autoinjector also includes a valve assembly that is fluidly coupled to the container and the canister. The spindle assembly includes a slidable piston disposed within the release outlet of the valve assembly and configured to be moved by the pressurized medium released from the tank. The valve assembly is configured to direct the pressurized medium from the tank to the release outlet so that the spindle assembly pushes the shield outward.

4. The autoinjector as described in claim 1: The autoinjector also includes a valve assembly that is fluidly coupled to the container and the canister. The tank is at least partially disposed within the valve assembly. The spindle assembly includes a slidable piston disposed within the release outlet of the valve assembly and configured to be moved by the pressurized medium released from the tank. The valve assembly is configured to direct the pressurized medium from the tank to the release outlet so that the spindle assembly pushes the shield outward.

5. The autoinjector as described in claim 1: The autoinjector further includes a drive system comprising the canister, a valve assembly fluidly coupled to the container and the canister, a first flow path, a second flow path, and a third flow path. The spindle assembly includes a slidable piston disposed within the release outlet of the valve assembly and configured to be moved by the pressurized medium released from the tank. The drive system is configured to guide the pressurized medium from the tank to the container via the valve assembly through the first flow path and the second flow path to discharge the agent from the container. The drive system is configured to guide the pressurized medium from the tank to the release outlet via the valve assembly, causing the spindle assembly to push the shield outward.

6. The autoinjector as described in claim 1: The autoinjector further includes a drive system comprising the canister, a valve assembly fluidly coupled to the container and the canister, a first flow path, a second flow path, a third flow path, and a flow restrictor configured to limit the flow of the pressurized medium between the first flow path and the second flow path. The spindle assembly includes a slidable piston disposed within the release outlet of the valve assembly and configured to be moved by the pressurized medium released from the tank. The drive system is configured to guide the pressurized medium from the tank to the container via the valve assembly through the first flow path and the second flow path to discharge the agent from the container. The drive system is configured to guide the pressurized medium from the tank to the release outlet via the valve assembly, causing the spindle assembly to push the shield outward.

7. The autoinjector as described in claim 1: The autoinjector also includes a chassis disposed within the housing. The chassis includes a locking window configured to engage with a retaining mechanism of the spindle assembly after the spindle assembly pushes the shield toward the first position, thereby inhibiting movement of the shield toward the second position.

8. The autoinjector as described in claim 1: The autoinjector also includes a chassis disposed within the housing. The chassis includes a locking window configured to engage with a retaining mechanism of the spindle assembly after the spindle assembly pushes the shield toward the first position, thereby preventing the shield from moving toward the second position. The chassis also includes an auditory feedback element configured to engage with the retaining mechanism of the spindle assembly to produce audible sound.

9. The autoinjector as described in claim 1: The autoinjector also includes a chassis disposed within the housing. The chassis includes a locking window configured to engage with a retaining mechanism of the spindle assembly after the spindle assembly pushes the shield toward the first position, thereby preventing the shield from moving toward the second position. The chassis also includes an auditory feedback element configured to engage with the retaining mechanism of the spindle assembly to generate a first audible sound indicating that an injection from the autoinjector has been completed and a second audible sound indicating that the shield has been locked.

10. The autoinjector as claimed in claim 1: The autoinjector also includes a chassis disposed within the housing. The chassis described therein includes multiple ribs, and The shield includes a plurality of openings configured to receive the plurality of ribs and allow the plurality of ribs to contact the inner surface of the housing and prevent the housing from being pressed inward.

11. An automatic injector comprising: case; A container disposed within the housing, the container being configured to store a pharmaceutical agent; A canister disposed within the housing, the canister being configured to release a pressurized medium to discharge the pharmaceutical agent from the container; A shield coupled to the housing, the shield being configured to move relative to the housing between a first position and a second position to allow the pressurized medium to be released from the tank; An actuator, positioned between the tank and the shield, is configured to release the pressurized medium from the tank when the shield moves from the first position to the second position. A spindle assembly disposed within the housing is configured to push the shield outward relative to the housing toward the first position after the pressurized medium is released from the tank.

12. The autoinjector as claimed in claim 11: The autoinjector also includes an actuator, which comprises a puncture mechanism and is configured to engage with the actuator. The actuator is configured to move in response to the shield moving toward the second position, and The movement of the actuator causes the initiator to move toward the can and the puncture mechanism to puncture the can, thereby causing the can to release the pressurized medium.

13. The autoinjector of claim 11, wherein the movement of the shield toward the second position exposes the needle, which is fluid coupled to the container, to the outside of the housing through an opening in the shield.

14. The autoinjector as claimed in claim 11: The movement of the shield toward the second position causes the needle, to be coupled to the container by fluid, to be exposed outside the housing through an opening in the shield; and The autoinjector also includes a biasing member configured to apply an outward force to the actuator. The actuator transfers the outward force to the shield, thereby providing resistance to the shield moving toward the second position.

15. The autoinjector of claim 11, wherein the actuator includes a bifurcated end configured to simultaneously contact the shield at two points.

16. An automatic injector comprising: case; A container disposed within the housing, the container being configured to store a pharmaceutical agent; A canister disposed within the housing, the canister being configured to release a pressurized medium to discharge the pharmaceutical agent from the container; A shield coupled to the housing, the shield being configured to move relative to the housing between a first position and a second position to allow the pressurized medium to be released from the tank; A spindle assembly disposed within the housing, the spindle assembly being configured to push the shield outward relative to the housing toward the first position after the pressurized medium is released from the tank; as well as A valve assembly fluidly coupled to the tank, the container, and the spindle assembly, the valve assembly being configured to direct the pressurized medium from the tank to the container to discharge the agent from the container, and to direct the pressurized medium from the tank to the spindle assembly to push the shield outward.

17. The autoinjector of claim 16, wherein the spindle assembly includes a slidable piston disposed within the release outlet of the valve assembly and configured to be moved by the pressurized medium released by the canister.

18. The autoinjector as claimed in claim 16: The autoinjector also includes a chassis disposed within the housing. The chassis includes a locking window configured to engage with a retaining mechanism of the spindle assembly after the spindle assembly pushes the shield toward the first position, thereby inhibiting movement of the shield toward the second position.

19. The autoinjector of claim 16, further comprising an actuator positioned between the canister and the shield and configured to release the pressurized medium from the canister when the shield moves from the first position to the second position.

20. The autoinjector of claim 16, further comprising: An actuator, positioned between the tank and the shield, and configured to release the pressurized medium from the tank when the shield moves from the first position to the second position; as well as A biasing member, configured to apply an outward force to the actuator. The actuator transfers the outward force to the shield, thereby providing resistance to the shield moving toward the second position.

21. An automatic injector comprising: case; A container disposed within the housing, the container being configured to store a pharmaceutical agent; A needle coupled to the container, the needle being configured to release the drug to the outside of the housing when the autoinjector is activated; A shield, coupled to the housing, is configured to move between a first position, in which the shield covers the needle, and in the second position, the shield exposes the needle to the outside of the housing. A first mechanism is configured to push the shield toward the first position before the autoinjector is activated; as well as A second mechanism is configured to inhibit the movement of the shield toward the second position after the agent has been released to the outside of the housing.

22. The autoinjector of claim 21, wherein the first mechanism includes a biasing member configured to apply downward pressure to the shield.

23. The autoinjector as claimed in claim 22: The autoinjector also includes an actuator disposed within the housing and configured to activate the autoinjector when the shield moves from the first position to the second position. The biasing member is further configured to apply a downward force to the actuator, and The actuator is also configured to transfer the downward force onto the shield, thereby providing resistance to movement of the shield toward the second position.

24. The autoinjector of claim 21, wherein the second mechanism includes a spindle assembly disposed within the housing, the spindle assembly being configured to disengage from the shield before the autoinjector is activated and to engage with the shield after the autoinjector is activated.

25. The autoinjector of claim 24, wherein the second mechanism further includes a locking window configured to engage with a retaining mechanism of the mandrel assembly after engagement with the shield.

26. The autoinjector of claim 25, wherein the locking window is included in a chassis disposed within the housing.

27. The autoinjector as claimed in claim 24: The autoinjector also includes a canister disposed within the housing, the canister being configured to release a pressurized medium when the autoinjector is activated to expel the medication from the container via the needle. The spindle assembly includes a slidable piston configured to move by the pressurized medium.

28. The autoinjector of claim 27, wherein the slidable piston is configured to be moved by the pressurized medium after the medication is expelled from the container via the needle.

29. The autoinjector as claimed in claim 21: The autoinjector also includes a canister disposed within the housing, the canister being configured to release a pressurized medium when the autoinjector is activated to expel the medication from the container via the needle. The second mechanism is configured to be actuated by the pressurized medium released from the tank.

30. The autoinjector of claim 29, wherein the second mechanism is configured to be actuated by the pressurized medium released from the can after the agent is discharged from the container via the needle.

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