Automatic syringes and related methods of use

Abstract

In one example, the Specified Auto-Syringe includes a housing; a container located within the housing configured to store a drug; a canister located within the housing configured to release a pressurized medium to discharge a drug from the container; a shroud coupled to the housing configured to move between a first position and a second position relative to the housing to allow the pressurized medium to be released by the canister; and a mandrel assembly located within the housing configured to push the shroud outward relative to the housing toward the first position after the pressurized medium has been released by the canister.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 509,214, filed on June 20, 2023, and U.S. Provisional Patent Application No. 63 / 587,389, filed on October 2, 2023, the entireties of which are incorporated herein by reference.

[0002] Aspects of the present disclosure relate to devices and methods for delivering fluid from a needle into a user using a mechanism that automatically controls the injection of a needle and fluid, such as a pressurizing medium. More specifically, embodiments of the present disclosure relate to an auto - injector and a method of delivering a dose of a drug to a user by exposing the injection needle outside the auto - injector while the drug is being released through the injection needle and automatically hiding the injection needle inside the auto - injector after the drug has been released through the injection needle.

Background Art

[0003] In various available auto - injectors, upon activation by the user, the needle is deployed and fluid is delivered from the needle into the user. After completion of the fluid delivery, the needle can be withdrawn for user comfort, needle safety, and positive product perception. However, many auto - injectors require separate user actions to insert and remove the needle. Additionally, many auto - injectors must be held in place by the user for an extended period of time, which can be inconvenient for the user.

Summary of the Invention

[0004] The accompanying drawings incorporated into and constituting portions thereof illustrate various exemplary embodiments and, together with their descriptions, serve to illustrate the principles of the disclosed embodiments. The drawings illustrate different aspects of the disclosure, and where appropriate, reference numbers indicating similar structures, components, materials, and / or elements in different drawings are similarly labeled. It is understood that various combinations of structures, components, and / or elements in various embodiments other than those specifically shown are contemplated and fall within the scope of the disclosure.

[0005] Numerous embodiments are described and illustrated in this specification. The devices and methods described are not limited to any single aspect and embodiment thereof, nor to any combination and / or permutation of such aspects and / or embodiments. Furthermore, each aspect and / or embodiment of the invention described may be used alone or in combination with one or more other aspects and / or embodiments of the invention described. For brevity, specific permutations and combinations are not discussed separately and / or illustrated in this specification. [Brief explanation of the drawing]

[0006] [Figure 1] This is a perspective view of an automatic syringe, as an example of the disclosure. [Figure 2] This is a perspective view of the chassis and container of the automatic syringe shown in Figure 1, as an example of this disclosure. [Figure 3] This is a perspective view of the chassis and container of the automatic syringe shown in Figure 1, as an example of this disclosure. [Figure 4] This is a partial perspective view of the cap and shroud of the automatic syringe shown in Figure 1, as an example of the present disclosure. [Figure 5] This is a partial perspective view of the cap and shroud of the automatic syringe shown in Figure 1, as an example of the present disclosure. [Figure 6] This is a partial perspective view of the cap and shroud of the automatic syringe shown in Figure 1, as an example of the present disclosure. [Figure 7]This is a partial perspective view of the cap and shroud of the automatic syringe shown in Figure 1, as an example of the present disclosure. [Figure 8] Figure 1 is a perspective view of the shroud of an automatic syringe, as an example of this disclosure. [Figure 9] Figure 1 is a perspective view of the shroud of an automatic syringe, as an example of this disclosure. [Figure 10] This is a perspective view of the actuator and canister of the automatic syringe shown in Figure 1, according to an example of this disclosure. [Figure 11] This is a cross-sectional view of the actuator and canister of the automatic syringe shown in Figure 1, according to an example of this disclosure. [Figure 12] Figures A and B are cross-sectional views of the actuator and canister of the automatic syringe shown in Figure 1, moving from a pre-operation state to an operating state, according to an example of the present disclosure. [Figure 13] A and B are cross-sectional views of the canister of the automatic syringe shown in Figure 1, moving from a pre-operation state to an operating state, according to an example of the present disclosure. [Figure 14] This is a cross-sectional view of the shroud and chassis of the automatic syringe shown in Figure 1, according to an example of this disclosure. [Figure 15] This is a cross-sectional view of the canister and carrier of the automatic syringe shown in Figure 1, according to an example of this disclosure. [Figure 16] A and B are perspective views of the indicator of the automatic syringe shown in Figure 1, moving from a pre-operation state to an operating state, as an example of the present disclosure. [Figure 17] A and B are perspective views of the indicator of the automatic syringe shown in Figure 1, moving from a pre-operation state to an operating state, as an example of the present disclosure. [Figure 18] A to C are cross-sectional views of a sliding piston of an automatic syringe of Figure 1, moving between multiple states, according to an example of the present disclosure. [Figure 19] A to C are cross-sectional views of the mandrel assembly and collar of the automatic syringe of Figure 1, moving between multiple states, according to an example of the present disclosure. [Figure 20] A and B are cross-sectional views of the carrier of the automatic syringe shown in Figure 1, moving from a pre-operation state to an operating state, according to an example of the present disclosure. [Figure 21] A - C are perspective views of the chassis and mandrel assembly of the auto - injector of FIG. 1 moving between multiple states according to an example of the present disclosure. [Figure 22] A - C are cross - sectional views of the shroud and slidable piston of the auto - injector of FIG. 1 moving between multiple states according to an example of the present disclosure. [Figure 23] A - B are perspective views of the chassis and actuator of the auto - injector of FIG. 1 moving from the pre - operation state to the early lock - out state according to an example of the present disclosure. [Figure 24] A - B are cross - sectional views of the mandrel assembly of the auto - injector of FIG. 1 moving from the pre - operation state to the early lock - out state according to an example of the present disclosure. [Figure 25] A - B are cross - sectional views of the shroud and valve assembly of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 26] A perspective view of the actuator and carrier of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 27] A perspective view of the actuator and shroud of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 28] A cross - sectional view of the indicator of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 29] A perspective view of the slidable piston of the auto - injector of FIG. 1 moving from the pre - operation state to the operation state according to an example of the present disclosure. [Figure 30] A perspective view of the slidable piston of the auto - injector of FIG. 1 moving from the pre - operation state to the operation state according to an example of the present disclosure. [Figure 31] A cross - sectional side view of the actuator and carrier of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 32] A cross - sectional view of the cannister of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 33] A cross - sectional view of the shroud and carrier of the auto - injector of FIG. 1 according to an example of the present disclosure. [Figure 34]Perspective view of the valve assembly of the auto-injector of FIG. 1 having a horizontal configuration, according to an example of the present disclosure. [Figure 35] Perspective view of the valve assembly of the auto-injector of FIG. 1 having a vertical configuration, according to an example of the present disclosure. [Figure 36] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 37] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 38] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 39] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 40] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 41] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 42] Partial view of the components of the valve assembly of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 43] Schematic view of the pressure sensing system of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 44] Schematic view of the drive system of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 45] Schematic view of the drive system of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 46] Schematic view of the drive system of the auto-injector of FIG. 1, according to an example of the present disclosure. [Figure 47] Perspective view of the auto-injector of FIG. 1 including a secondary indicator, according to an example of the present disclosure. [Figure 48] Perspective view of the auto-injector of FIG. 1 including a secondary indicator, according to an example of the present disclosure. [Figure 49]Figure 1 is a perspective view of an automatic syringe including a secondary indicator, as an example of the present disclosure. [Figure 50] Figure 1 is a perspective view of an automatic syringe including a secondary indicator, as an example of the present disclosure. [Figure 51] Figures 47-50 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 52] Figures 47-50 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 53] Figures A to C are side views of an autoinjector having a secondary indicator showing the dose status, as shown in Figures 47 to 50, according to an example of the present disclosure. [Figure 54] These are partial views of the auto-injector shown in Figures 47-50, which is positioned at the injection site, as an example of the present disclosure. [Figure 55] These are partial views of the auto-injector shown in Figures 47-50, which is positioned at the injection site, as an example of the present disclosure. [Figure 56] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 57] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 58] Figures 56-57 are schematic diagrams of an automatic syringe including a secondary indicator, as an example of this disclosure. [Figure 59] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 60] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 61] Figures 59-60 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 62] Figures 59-60 are schematic diagrams of an automatic syringe, as shown in one example of this disclosure. [Figure 63] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 64] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 65] Figures 63-64 are schematic diagrams of an automatic syringe, as shown in one example of this disclosure. [Figure 66] Figures 63-64 are schematic diagrams of an automatic syringe, as shown in one example of this disclosure. [Figure 67] This is a side view of another exemplary automatic syringe, as described in this disclosure. [Figure 68] This is a side view of another exemplary automatic syringe, as described in this disclosure. [Figure 69] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 70] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 71] Figures 69-70 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 72] Figures 69-70 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 73] Figures 69-70 are side views of an automatic syringe, as shown in one example of this disclosure. [Figure 74] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 75] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 76] Figures 74-75 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 77] Figures 74-75 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 78] Figures 74-75 are side views of an automatic syringe, as shown in this disclosure. [Figure 79] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 80] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 81] Figures 79-80 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 82] Figures 79-80 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 83] Figures 79-80 are side views of an automatic syringe, as shown in this disclosure. [Figure 84] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 85] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 86] Figures 84-85 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 87] Figures 84-85 are schematic diagrams of an automatic syringe, as shown in this disclosure. [Figure 88] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 89] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 90] Figures 88-89 are side views of an automatic syringe including a secondary indicator, as an example of this disclosure. [Figure 91] This is a side view of another exemplary automatic syringe, as described in this disclosure. [Figure 92] Figure 91 is a schematic diagram of an automatic syringe, as shown in this disclosure. [Figure 93] Figure 91 is a schematic diagram of an automatic syringe, as shown in this disclosure. [Figure 94] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 95] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 96] This is a perspective view of another exemplary automatic syringe, as shown in the present disclosure. [Figure 97] These are partial views of the automatic syringe shown in Figures 63-64, which are an example of the present disclosure. [Figure 98] These are partial views of the automatic syringe shown in Figures 79-80, which are an example of the present disclosure. [Figure 99] These are partial diagrams of the automatic syringe shown in Figures 84-85, which are examples of the present disclosure. [Figure 100] This is a partial view of the automatic syringe shown in Figure 91, as an example of the present disclosure. [Figure 101] This is a perspective view of an exemplary automatic syringe according to an example of the present disclosure. [Figure 102A] Figure 101 is a schematic diagram of the drive system of an automatic syringe, as an example of the present disclosure. [Figure 102B] Figure 101 is a schematic diagram of the drive system of an automatic syringe, as an example of the present disclosure. [Figure 102C] Figure 101 is a schematic diagram of the drive system of an automatic syringe, as an example of the present disclosure. [Figure 103] Figure 101 is an exploded perspective view of an automatic syringe, as shown in this disclosure. [Figure 104] Figure 101 is a cross-sectional perspective view of a portion of the automatic syringe, as an example of this disclosure. [Figure 105A] This is a partial perspective view of an automatic syringe shown in Figure 101, which is an example of the disclosure. [Figure 105B] This is a partial perspective view of an automatic syringe shown in Figure 101, which is an example of the disclosure. [Figure 106] Figure 101 is a partial perspective view of an activator of an automatic syringe, as an example of this disclosure. [Figure 107] This is a partial side view of the activator in Figure 107, as an example of the present disclosure. [Figure 108A] This is a partial view of the keyed structure of the activator in Figure 107, as an example of the present disclosure. [Figure 108B] This is a partial view of the keyed structure of the activator in Figure 107, as an example of the present disclosure. [Figure 108C] This is a partial view of the keyed structure of the activator in Figure 107, as an example of the present disclosure. [Figure 108D] This is a partial view of the keyed structure of the activator in Figure 107, as an example of the present disclosure. [Figure 109] This is a cross-sectional view of the activator in Figure 107 moving between multiple positions, according to an example of the present disclosure. [Figure 110] This is a cross-sectional view of the activator in Figure 107, which moves between multiple locations, according to an example of the present disclosure. [Figure 111] Figures A to C are schematic diagrams of parts of the needle mechanism of the automatic syringe shown in Figure 101, according to an example of this disclosure. [Figure 112]Figure 101 is a perspective view of the release tab of an automatic syringe, as shown in one example of this disclosure. [Figure 113] Figure 101 is a perspective view of the release tab of an automatic syringe, as shown in one example of this disclosure. [Figure 114] These are cross-sectional views of the release tabs shown in Figures 112-113, coupled to the automatic syringe shown in Figure 101, according to an example of this disclosure. [Figure 115] These are cross-sectional views of the release tabs shown in Figures 112-113, coupled to the automatic syringe shown in Figure 101, according to an example of this disclosure. [Figure 116] This is a partial perspective view of the release tabs shown in Figures 112-113, coupled to the automatic syringe shown in Figure 101, according to an example of the present disclosure. [Figure 117] This is a partial perspective view of the release tabs shown in Figures 112-113, coupled to the automatic syringe shown in Figure 101, according to an example of the present disclosure. [Figure 118] These are cross-sectional views of the release tabs shown in Figures 112-113, coupled to the automatic syringe shown in Figure 101, according to an example of this disclosure. [Figure 119A] Figure 101 is a perspective view of the carrier of an automatic syringe, as an example of this disclosure. [Figure 119B] Figure 101 is a perspective view of the carrier of an automatic syringe, as an example of this disclosure. [Figure 120] A and B are perspective views of another exemplary carrier of the auto-injector shown in Figure 101, according to an example of the present disclosure. [Figure 121] Figures 119A and 119B show perspective views of a carrier, as an example of this disclosure. [Figure 122] Figure 101 is a perspective view of the activator of an automatic syringe, as an example of this disclosure. [Figure 123] Figure 101 is a perspective view of the gear of an automatic syringe, as an example of this disclosure. [Figure 124] Figure 101 is a perspective view of the driver of an automatic syringe, as an example of this disclosure. [Figure 125] This is a side view of the driver shown in Figure 126, which is an example of the present disclosure. [Figure 126] This is a side view of the driver shown in Figure 126, which is an example of the present disclosure. [Figure 127] Figure 101 is a perspective view of the button of an automatic syringe, as an example of this disclosure. [Figure 128] This is a perspective view of the button of the automatic syringe shown in Figure 101, as an example of this disclosure. [Figure 129] Figure 101 is a perspective view of the button of an automatic syringe, as an example of this disclosure. [Figure 130] Figure 101 is a perspective view of the shuttle actuator and indicator slide of an automatic syringe, as shown in this disclosure. [Figure 131] Figure 101 is a perspective view of the shuttle actuator and indicator slide of an automatic syringe, as shown in this disclosure. [Figure 132] Figure 101 is a perspective view of the shuttle actuator and indicator slide of an automatic syringe, as shown in this disclosure. [Figure 133] Figure 101 is a perspective view of the fluid conduit of an automatic syringe, as shown in this disclosure. [Figure 134] Figure 101 shows a perspective view of the fluid conduit in Figure 133 and the driver in Figures 124-126, assembled to the sterile connector of the automatic syringe, as an example of the present disclosure. [Figure 135] This is a perspective view of the carrier of the automatic syringe shown in Figure 101, coupled to the gear shown in Figure 123, the drivers shown in Figures 124-126, the fluid conduit in Figure 133, and the shuttle actuators shown in Figures 130-132, according to an example of the present disclosure. [Figure 136] Figure 101 is an exploded perspective view of the valve assembly of an automatic syringe, as shown in this disclosure. [Figure 137] This is a perspective view of the valve assembly shown in Figure 136, according to an example of this disclosure. [Figure 138] Figure 136 is a perspective view of a valve assembly, as shown in this disclosure. [Figure 139] This is a perspective view of the valve assembly shown in Figure 136, according to an example of this disclosure. [Figure 140] This is a perspective view of the valve assembly shown in Figure 136, according to an example of this disclosure. [Figure 141]This is a perspective view of the valve assembly shown in Figure 136, according to an example of this disclosure. [Figure 142] Figure 136 is a perspective view of the diaphragm of a valve assembly, as shown in an example of this disclosure. [Figure 143] This is a cross-sectional side view of the diaphragm shown in Figure 142, which is an example of the disclosure. [Figure 144] This is a cross-sectional side view of the diaphragm shown in Figure 142, which is located within the valve assembly shown in Figure 136, according to an example of the present disclosure. [Figure 145] A and B are schematic side views of the ventilation system of the valve assembly shown in Figure 136, according to an example of the present disclosure. [Figure 146A] This is a cross-sectional view of a mandrel assembly according to an example of the present disclosure. [Figure 146B] This is a cross-sectional view of a mandrel assembly according to an example of the present disclosure. [Figure 146C] This is a cross-sectional view of a mandrel assembly according to an example of the present disclosure. [Figure 146D] This is a cross-sectional view of a mandrel assembly according to an example of the present disclosure. [Figure 147] A and B are a perspective view and a cross-sectional view of a lockout window according to an example of the present disclosure, respectively. [Figure 148] Figures A to C are cross-sectional views of a mandrel assembly according to an example of the present disclosure. [Figure 149A] This is a schematic diagram of a drive system according to an example of the disclosure. [Figure 149B] This is a schematic diagram of a drive system according to an example of the disclosure. [Figure 149C] This is a schematic diagram of a drive system according to an example of the disclosure. [Figure 150] This is a perspective view of a valve assembly, as an example of the present disclosure. [Figure 151] A and B are cross-sectional views of an actuator and an activator according to an example of the present disclosure. [Figure 152] This is a perspective view of an automatic syringe, as an example of the disclosure. [Figure 153]A and B are side views of an actuator and a pivot joint according to an example of the present disclosure, respectively. [Figure 154] This is a perspective view of an activator and valve assembly, as an example of the present disclosure. [Figure 155] This is a perspective view of the shroud and chassis, as an example of this disclosure. [Figure 156] A and B are perspective and cross-sectional views, respectively, of a shroud and chassis, according to an example of the present disclosure. [Figure 157] A and B are perspective and cross-sectional views, respectively, of a shroud and chassis, according to an example of the present disclosure. [Figure 158] This is a cross-sectional view of an automatic syringe, as an example of the disclosure. [Figure 159] Figures A through C are side views of an automatic syringe according to an example of the present disclosure. [Figure 160] A and B are cross-sectional views of a shroud and a cap, respectively, according to an example of the present disclosure. [Modes for carrying out the invention]

[0007] This specification describes and illustrates many embodiments. This disclosure is not limited to any single aspect or embodiment thereof, nor to any combination and / or permutation of such aspects and / or embodiments. Each aspect and / or embodiment of this disclosure may be used alone or in combination with one or more of the other aspects and / or embodiments thereof of this disclosure. For the sake of brevity, many of these combinations and permutations are not discussed separately in this specification.

[0008] In particular, for the sake of simplification and clarity of the illustration, specific aspects of the figures illustrate the overall structure and / or construction methods of various embodiments. Descriptions and details of well-known features and techniques may be omitted so as not to unnecessarily obscure other features. Elements in the figures are not necessarily drawn to a fixed scale. Dimensions of some features may be exaggerated relative to others to improve the understanding of the exemplary embodiments. For example, a person skilled in the art will recognize that section views are not drawn to scale and should not be considered to represent proportional relationships between different components. Section views are provided to illustrate the various components of the illustrated assembly and to show their relative positions to one another.

[0009] Examples of the present disclosure are described in detail here, and are shown in the accompanying drawings. Where possible, the same reference numerals are used throughout the drawings to refer to identical or similar parts. Embodiments of the present disclosure may be used with any type of fluid, such as liquid drug substances, liquid placebos, or other liquids that can be dispensed in dose form. In the following discussion, terms such as “about,” “approximately,” and “substantially” used to describe numerical values ​​indicate a variation of + / - 10% of that value, unless otherwise specified.

[0010] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof are intended to mean non-exclusive inclusion. Therefore, a process, method, product, or apparatus containing a list of elements may not contain only those elements, but may also contain other elements not expressly enumerated, or other elements specific to such process, method, product, or apparatus. The term “exemplary” is used to mean “example,” not “ideal.” In particular, any embodiment or configuration described herein as “example” or “exemplary” should not be construed as, for example, preferable or advantageous to other embodiments or configurations, but rather is intended to reflect or indicate that the embodiment(s) are “exemplary” and not “ideal.” As used herein, the terms “top,” “bottom,” “upward,” “downward,” “sideways,” and “radial” refer to a location (or part of a device) relative to the arrangement of a device shown in the drawings. The terms “vertical,” “perpendicular,” “horizontal,” “horizontal,” “upward,” “downward,” “lateral,” and “radially” refer to the direction or orientation of the arrangement of the devices shown in the drawings. Furthermore, terms such as “first,” “second,” etc., as used herein do not imply any order, quantity, or importance, but are used to distinguish elements, structures, steps, or processes from one another. Furthermore, the terms “a” and “an” as used herein do not imply a limitation of quantity, but rather mean the presence of one or more of the items mentioned.

[0011] Some conventional auto-injectors may require multiple user interactions for self-administration of drugs, including, for example, separate user interactions to extend the needle and then retract it after drug delivery. These additional steps increase the complexity of self-administration of drugs, can lead to user error, and may cause discomfort to the user. Therefore, this disclosure covers various embodiments of injection devices (e.g., auto-injectors) that facilitate self-administration of drugs or other therapeutic agents by a user. Specifically, according to certain embodiments, an auto-injector may not require any additional user interaction to withdraw the needle once it has been subcutaneously inserted into the user. Thus, the auto-injectors of this disclosure are simplified to help prevent misuse or user error. Furthermore, some conventional auto-injectors require multiple components and user operation, including various spring or motor mechanisms, to administer drugs. These additional components increase the complexity of manufacturing and can lead to mechanical failure or user error. Accordingly, this disclosure covers various embodiments of injection devices (e.g., auto-injectors) for simplifying and improving the administration of drugs or other therapeutic agents. The auto-injectors of this disclosure may include one or more components that are substantially similar to those described in PCT International Application No. PCT / US2020 / 040729, published as WO2021 / 003409, and PCT International Application No. PCT / US2021 / 065567, published as WO2022 / 147166.

[0012] In at least some embodiments, a handheld auto-injector may require the user to hold the auto-injector against the user's skin for the entire duration of the injection procedure. In some embodiments, a handheld auto-injector according to this disclosure may be configured to deliver drug volumes of less than 3.5 mL (or drug volumes 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). Drug volumes may be referred to herein as “doses”. Furthermore, a handheld auto-injector according to this disclosure may be configured to complete the injection procedure in 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, measured from 1) the time the user places the auto-injector on the skin to 2) the time the user removes the auto-injector from the skin after the injection is complete. As described herein, an early rise event may occur when the user removes the auto-injector from the skin before the injection is complete. The auto-injectors of this disclosure may be configured and operable to initiate a lockout in response to the occurrence of an early rise event or completion of dose delivery. This prevents further use and / or reactivation of the auto-injector to protect the user's safety.

[0013] Referring here to Figure 1, an exemplary automatic syringe 100 is shown in accordance with the examples of this disclosure. The automatic syringe 100 may include a housing 102 having a longitudinal length defined between an upper end 104 and a bottom end 106, and a cap 111 coupled to the bottom end 106. The cap 111 may be detachably coupled to the bottom end 106, and the bottom end 106 may define a user engagement surface along its external interface, through which a needle (see Figures 2-3) can be deployed from the housing 102 and retracted into the housing 102. The upper end 104 may define a user interface surface through which the user can control the automatic syringe 100, such as by manually gripping the housing 102 while the automatic syringe 100 is in use. In Figure 1, the housing 102 is shown partially transparent for illustrative purposes to show the internal components of the automatic syringe 100.

[0014] The automatic syringe 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 the upper end 104 and the bottom end 106 of the housing 102. The housing 102 may include one or more windows to facilitate visual inspection of the internal components of the automatic syringe 100 during use, such as visually observing the current operating state of the automatic syringe 100. In an example, the housing 102 may include a first window 108 formed along the outer surface of the housing 102 and extending vertically between the upper end 104 and the bottom end 106 along a portion of the housing 102 that is aligned with the container 112. Thus, the container 112 and the piston 114 located therein may be visually observed from outside the housing 102 through the first window 108, specifically, the contents of the container 112 and the relative position of the piston 114 may be visually inspected through the first window 108. The automatic syringe 100 may include a shield 118 positioned around the container 112, which is located within the housing 102 and obstructs the visibility of the rest of the internal components of the automatic syringe from the first window 108.

[0015] Referring further to Figure 1, container 112 may be sized and shaped to store the nominal value of the drug. The “nominal volume” of the container (also called “specified volume” or “specified capacity”) refers to the maximum capacity of the container as specified by the container manufacturer or safety standards body. The manufacturer or safety standards body may specify the nominal volume of the container to indicate that the container can be filled (aseptically or non-aseptically) with that volume of fluid and used while maintaining the integrity of the container’s closure and the safety, sterility, and / or sterility of the fluid contained within. When determining the nominal volume of the container, the manufacturer or safety standards body may also take into account variability that occurs during normal filling, closing, sealing, packaging, transportation, and administration procedures. For example, a pre-filled syringe may be filled with fluid up to its nominal volume, either manually or mechanically, and then sealed with either a vent or a vacuum plug, without the filling and sealing machinery and tools coming into contact with and potentially contaminating the contents of the syringe. Alternatively, the stopping machinery and tools may be sterile or aseptic and can come into contact with the contents of the syringe and / or the syringe itself without causing contamination.

[0016] Container 112 may have a nominal volume of approximately 5.0 mL in some examples, but any other suitable nominal volume (e.g., approximately 0.5 mL to approximately 50.0 mL, or approximately 2.0 mL to approximately 10.0 mL, or approximately 3.0 mL to approximately 6.0 mL, or approximately 1.0 mL to approximately 3.0 mL, or approximately 2.0 mL to approximately 5.0 mL, or another suitable range) may also be used depending on the drug to be delivered. In other examples, container 112 may have a nominal volume of approximately 0.5 mL or more, or approximately 2.0 mL or more, or approximately 3.0 mL or more, or approximately 4.0 mL or more, or approximately 5.0 mL or more. Container 112 may contain and store the drug for injection to the user, which may help maintain the sterility of the drug. In one embodiment, the container 112 may be configured to deliver a delivery amount of drug (for example, 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, more than about 1.0 mL, more than about 2.0 mL, more than about 3.0 mL, more than about 4.0 mL, more than about 5.0 mL, more than about 10.0 mL, more than about 20.0 mL, or another delivery amount).

[0017] The amount delivered may be less than the nominal volume of container 112. Furthermore, in order to deliver the delivered amount of drug to the user, container 112 itself may be filled with a different amount of drug (i.e., a filling amount). The filling amount may be a larger amount of drug than the delivered amount, taking into account, for example, the amount of drug that cannot be transferred from container 112 to the user due to dead space within container 112. Therefore, although container 112 may have a nominal volume of 5 mL, the filling amount of drug and the delivered amount may be less than 5 mL.

[0018] In one embodiment, when container 112 is used in a handheld auto-injector, the amount of drug delivered from container 112 may be 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 amount of drug delivered may depend on the viscosity of the drug and the handheld nature of the auto-injector 100. That is, in at least some embodiments, at a certain viscosity, a larger amount of drug may hinder the auto-injector 100's ability to complete the injection procedure in less than an acceptable time, for example, less than about 30 seconds. Therefore, the amount of drug delivered from the auto-injector 100 may be set such that the injection procedure, measured from 1) when the auto-injector 100 is placed on the user's skin to 2) when the auto-injector 100 is removed from the skin, is less than approximately 30 seconds or less than another approximate period (e.g., less than approximately 25 seconds, less than approximately 20 seconds, less than approximately 15 seconds, or less than approximately 10 seconds).

[0019] If the delivery volume and / or viscosity of the drug is too high, the time required to complete the injection procedure may be longer than commercially or clinically acceptable for a handheld device, and therefore the auto-injector 100 may not be able to function as a handheld auto-injector. In this case as well, as described above, in embodiments in which the container 112 is used in a handheld auto-injector, the delivery volume of the drug from the container 112 may be set so that the injection procedure as defined above is completed within a relatively short period of time (to avoid the need for additional features to attach the auto-injector 100 to the user so that the auto-injector 100 is a wearable auto-injector).

[0020] However, various embodiments of this disclosure are intended to relate to wearable auto-injectors that deliver relatively large amounts of medication (e.g., more than about 3.5 mL) and / or have a relatively long injection procedure time (e.g., more than about 30 seconds, more than about 1 minute, more than about 2 minutes, more than about 5 minutes, or more than about 1 hour) to complete the injection procedure, measured from 1) the time the auto-injector is placed on the user's skin to 2) the time the auto-injector is removed from the skin.

[0021] The container 112 may have a neck with a diameter of approximately 13 mm, a length of approximately 45 mm, and an inner diameter of approximately 19.05 mm. In another embodiment, the container 112 may be a standard 3 mL container having an 8 mm crimped top, an inner diameter of 9.7 mm, and a length of 64 mm. In a further embodiment, the container 112 may have a length of approximately 64 mm to 74 mm (excluding the length of the neck of the container 112 at the second end 374), for example, approximately 69.3 mm ± 0.15 mm. In embodiments including a neck, the container 112 may have a length in the range of approximately 65 mm to 75 mm, for example, approximately 70.8 mm ± 0.4 mm. These values ​​are merely examples, and other suitable dimensions may be used as needed. In some examples, the container 112 may be formed using conventional materials and may be shorter than existing devices, which may help maintain cost-effectiveness and miniaturization of the auto-injector 100. In some embodiments, the container 112 may be a shortened ISO 10 mL cartridge. The auto-injectors of this disclosure may be configured to deliver highly viscous liquids to a patient. For example, the auto-injector 100 of this disclosure may be configured to deliver liquids having 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.

[0022] Referring further to Figure 1, the container 112 may include a piston 114 movably disposed within the cavity of the container 112. The piston 114 may be moved by a pressurized fluid discharged from a fluid source, such as a canister 150. As further described herein, the pressurized fluid (e.g., gas) discharged from the canister 150 may cause the piston 114 to translate perpendicularly to the container 112 toward the bottom end 112B along the longitudinal axis of the container 112. The movement of the piston 114 toward the bottom end 112B of the container 112 allows the piston to act on the contents of the container 112 (e.g., drugs, pharmaceuticals, medicines, etc.). In some embodiments, the automatic syringe of this disclosure may be oriented such that the canister 150 and the piston in the container 112 are offset or otherwise not longitudinally aligned with each other.

[0023] As best shown in Figure 2, the shield 118 may be coaxially coupled to the vessel 112. The shield 118 may include an upper flange 117 positioned around the upper flange 115 of the vessel 112 and interface with the upper flange 115 of the vessel 112. The shield 118 may generally have a semicircular configuration extending around the outer surface of the vessel 112 and along the portion of the vessel 112 located inside the housing 102, opposite to the opposing portion of the vessel 112 adjacent to the first window 108 (see Figure 1). The vessel 112 may be coupled to the chassis 130 and may include an upper end 112A adjacent to the upper flange 115, and a bottom end 112B opposite to the upper end 112A, extending through the bottom end 132 of the chassis 130. The container 112 may include a needle 116 coupled to its bottom end 112B, the needle 116 may be in fluid communication with a fluid (e.g., a drug) stored in the container 112. As shown in Figure 3, the shield 118 may include a projection 119 (e.g., a tab, finger, etc.) that is received into a slot 131 on the chassis 130, thereby coupling the shield 118 to the chassis 130. In this case, the shield 118 may be fixed to both the container 112 and the chassis 130. The projection 119 is received into the slot 131 and the upper flange 117 is coupled to the upper flange 115, so that the auto-injector 100 may be configured to prevent unintended movement (e.g., translation, rotation, etc.) of the shield 118 relative to the container 112 and the chassis 130. The shield 118 may be sized, shaped, and / or otherwise configured to partially cover the container 112, thereby restricting visual access to the interior of the housing 102 through the first window 108. In other words, the shield 118 may define an opening that is sized, shaped, and / or otherwise configured to reveal the container 112 through the first window 108, while suppressing the visual exposure of other components within the housing 102. In some embodiments, the shield 118 may be formed from an opaque material having a predefined color (e.g., dark blue-green) to prevent visual access to the inside of the housing 102 through the first window 108.In other embodiments, the shield 118 may be completely omitted.

[0024] Returning to Figure 1, the housing 102 may further include a second window 110 formed along the outer surface of the housing 102 and extending along the portion of the housing 102 aligned with a portion of the indicator assembly 170. Thus, the indicator assembly 170 can be visually observed from outside the housing 102 through the second window 110. As described herein, the indicator assembly 170 may be configured to move from a first position to a second position relative to the second window 110 in response to the operation of the auto-injector 100, thereby visually indicating the operating state of the auto-injector 100, in particular changes in the dose state of the auto-injector 100, through the second window 110 (see Figures 16A to 17B).

[0025] Referring here to Figure 4, the automatic syringe 100 may include a shroud 120 at the bottom end 106 of the housing 102. The shroud 120 may be positioned inside the cap 111 when the cap 111 is coupled to the bottom end 106 of the housing 102. The automatic syringe 100 may further include an actuator 125 (e.g., a movable lever) and a mandrel assembly 180, each positioned within the shroud 120, particularly in contact with the inner surface 121 of the shroud 120. The shroud 120 may include a receptacle 181 along the inner surface 121, which is sized, shaped, and / or otherwise configured to receive and / or securely hold the end of the mandrel assembly 180. Therefore, the receptacle 181 may be operable to ensure that the mandrel assembly 180 is securely coupled to the shroud 120 so that the mandrel assembly 180 may be movable within the housing 102 in response to the simultaneous movement of the shroud 120 relative to the housing 102. The actuator 125 and the mandrel assembly 180 may be coupled to the respective parts of the chassis 130 as described herein. Each of the actuator 125 and the mandrel assembly 180 may be configured to move in response to the movement of the shroud 120 relative to the housing 102, thereby transitioning the autosyringer 100 from a pre-operational state to an operational state by initiating the release of pressurized medium throughout the autosyringer 100.

[0026] The mandrel assembly 180 may include a biasing mechanism 182 positioned around the outside of the mandrel assembly 180. The biasing mechanism 182 may be configured to push the mandrel assembly 180 in a predefined direction, bias the mandrel assembly 180 toward a predefined configuration, generate tactile feedback during the movement of the shroud 120, generate resistance against the shroud 120 retracting upward into the housing 102, and so on. In an example, the biasing mechanism 182 may be configured to bias the shroud 120 and the mandrel assembly 180 toward an extended (downward) position relative to the housing 102 when the biasing mechanism 182 is in an expansion configuration. As described herein, the biasing mechanism 182 may also be configured to generate controlled feedback toward the shroud 120 when the shroud 120 is actuated and pressed relatively upward into the housing 102, thereby transitioning the biasing mechanism 182 from an expansion configuration to a compression configuration. The biasing mechanism 182 may include, but is not limited to, a spring, a variety of suitable devices. In some embodiments, the biasing mechanism 182 may be omitted entirely.

[0027] The cap 111 may include one or more ribs 113A extending vertically upward from its inner lower surface toward the chassis 130. 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 against the bottom end 132, the cap 111 may be configured to restrain unintended movement of the chassis 130 relative to the housing 102 in order to prevent accidental activation of the auto-syringe 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 unintended release of the pressurized medium stored therein.

[0028] Referring further to Figure 4, the automatic syringe 100 includes a needle cover 116A that is removably coupled to the bottom end 112B of the container 112, and the needle 116 may be positioned inside the needle cover 116A. Thus, the needle cover 116A may be configured to surround the needle 116 when coupled to the needle cover 116A. The needle cover 116A may be sized, shaped, and / or otherwise configured such that it extends outward from the shroud 120, in particular through the bottom surface 122 of the shroud 120, so that the needle cover 116A may be positioned at least partially inside the cap 111. The cap 111 may include one or more clips 113B (e.g., tabs, fingers, stoppers, etc.) extending vertically upward from the inner bottom surface of the cap 111 toward the bottom surface 122 of the shroud 120. One or more clips 113B may be configured to engage with portions of the needle cover 116A that extend outward (for example, downward) from the shroud 120 and enter the cap 111.

[0029] Additionally, one or more clips 113B may be configured to securely attach the needle cover 116A to the cap 111 so that the needle cover 116A may be removable from the bottom end 112B of the container 112 when the cap 111 is separated from the bottom end 106 of the housing 102, thereby exposing the needle within the shroud 120. As best shown in Figure 5, the cap 111 may include a plurality of clips 113B configured to engage with the needle cover 116B. The needle cover 116B should be understood to be omitted in Figure 5 for illustrative purposes only. In the example, the needle cover 116B may include a constricted portion and / or distal neck defining one or more outer surfaces which are made to be of a size, shape, and / or other configuration such that they interface with the clips 113B in order to securely connect the needle cover 116B to the clips 113B. In other words, the needle cover 116B may include an interface along the outer end of the needle cover 116B that can be engaged by the clip 113B.

[0030] Figure 6 shows a cap 111 having one or more ribs 113A extending through a corresponding opening 121A formed in the inner surface 121 of the shroud 120, and a plurality of clips 113B aligned with an opening 121B on the inner surface 121. When the cap 111 is separated from the bottom end 106 of the housing 102 and the needle cover 116A is separated from the needle 116, it should be understood that the needle 116 may extend through the opening 121B as the shroud 120 moves vertically upward toward the housing 102 along a vertical path. Figure 7 shows the cap 111 separated from the shroud 120. It should be understood that the cap 111 is only partially shown in Figures 4 to 6 so that the cap 111 may include additional ribs 113A and / or clips 113B than those shown and described herein. In some cases, as shown in Figures 160A and 160B, the cap 4411 includes one or more retaining elements 4412 configured to engage with the shroud 4420 to help secure or partially secure the cap 4411 on the shroud 4420. The retaining elements 4412 may include protrusions, bumps, ridges, or any other suitable features.

[0031] Referring here to Figures 8 and 9, the housing 102 is shown with the cap 111 omitted so that the shroud 120 is exposed at the bottom end 106. The shroud 120 may be movably coupled to the chassis 130 between one or more positions to actuate the automatic syringe 100. Specifically referring to Figure 8, the shroud 120 may include one or more guide ribs 123A extending radially inward from the inner surface 121 of the shroud 120 (see Figure 6), and the chassis 130 may include one or more guide channels 133 formed along the outer surface of the chassis 130. The chassis 130 may include several guide channels 133 corresponding to several guide ribs 123A on the shroud 120, and vice versa. The guide channels 133 may be sized, shaped, and / or otherwise configured to accommodate one or more guide ribs 123A. The guide channel 133 may be further configured to restrict the direction of motion of the shroud 120 relative to the chassis 130, particularly during the stroke of the shroud 120 for discharging fluid from the container 112 while the automatic syringe 100 is in use. For example, the guide channel 133 may be configured to restrict the movement of the shroud 120 relative to the housing 102 and / or chassis 130 in the vertical direction, thereby suppressing the lateral movement of the shroud 120 relative to the housing 102 and / or chassis 130. In the example shown in Figure 8, the guide rib 123A may be coplanar with the top surface of the shroud 120. In the example shown in Figure 9, the guide rib 123B may extend vertically upward from the top surface of the shroud 120, resulting in improved stability of the shroud 120 at the start of the stroke relative to the guide rib 123A in Figure 8.

[0032] Referring here to Figures 10-11, 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 carrier 140. The actuator 125 may include a pin 129 at the second end 128, which is received in 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 enabling the 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 of the actuator 125, thereby configuring the actuator 125 to move (e.g., pivot) within the housing 102 around 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 second end 128 may be sized, shaped, 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 against the bottom end 142 when the actuator 125 pivots around the pin 129. In some embodiments, the carrier 140 may be completely omitted so that the actuator 125 can be configured to push the canister 150 directly.

[0033] Figures 10-11 show the shroud 120 in a first position and the auto-syringe 100 in a pre-operation state, and it should be understood that only the first end 127 of the actuator 125 is in contact with the inner surface 121 of the shroud 120. As described herein, the actuator 125 may be sized, shaped, and / or otherwise configured such that an additional portion of the body 126 contacts the inner surface 121 as the shroud 120 moves toward a second position and the auto-syringe 100 moves toward an operational state. In an example, the second end 128 may have a curved configuration corresponding to the curved configuration of the carrier 140 at the bottom end 142, so that the movement of the actuator 125 relative to the chassis 130 can cause the curved surface of the second end 128 to be pressed 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 a variety of other suitable shapes, sizes, and / or configurations beyond those shown and described herein without departing from the scope of the disclosure.

[0034] The carrier 140 may be sized, shaped, and / or otherwise configured to receive the canister 150. In this example, the canister 150 is fixed to the carrier 140, thereby configured to move within the housing 102 in response to the corresponding movement (e.g., translation) of the carrier 140 relative to the housing 102, for example, in response to the actuator 125 being pressed against the bottom end 142. The carrier 140 may include a pair of retaining mechanisms 146 extending outward (e.g., vertically upward) from the upper end 144 of the carrier 140 opposite the bottom end 142. Each of the pair of retaining mechanisms 146 may include, but are not limited to, clips, hands, fingers, tabs, projections, stoppers, etc. The carrier 140 may be positioned relatively below the valve assembly 160 within the housing 102, and the valve assembly 160 may include a pair of retaining mechanisms 162 positioned adjacent to the upper end 144. The retaining mechanism 162 may be configured to engage with the retaining mechanism 146 in response to the carrier 140 moving upward relative to the housing 102 toward the valve assembly 160 when the automatic syringe 100 moves from a pre-operational state to an operational state (see Figures 13A-13B). Each of the pair of retaining mechanisms 162 may include, but are not limited to, a corresponding clip, hand, finger, tab, projection, or retainer configured to mate with the retaining mechanism 146. In the example, the retaining mechanisms 146, 162 may each include inclined and / or angled surfaces configured to interact with each other when the carrier 140 moves longitudinally upward toward the valve assembly 160, as will be described in more detail herein.

[0035] Referring further to Figures 10-11, the canister 150 may have a neck 152 extending outward (e.g., upward) from the upper end 144 and be located inside the carrier 140. In the pre-operation state of the auto-injector 100, the neck 152 may be positioned relatively low and aligned with the puncture mechanism 164 of the valve assembly 160. The puncture mechanism 164 may include a needle, an activator pin, and various other suitable devices configured to puncture the seal and / or valve of the canister 150 with 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 with the neck 152. It should be understood that when the automatic syringe 100 is in a pre-operation state and before the carrier 140 moves the canister 150 upward toward the puncture mechanism 164, the canister 150 is not in fluid communication with the valve assembly 160. The valve assembly 160 may include a discharge outlet 169 located downstream and in fluid communication with the puncture mechanism 164, so that at least a portion of the pressurized medium received into the valve assembly 160 from the canister 150 may be discharged from the valve assembly 160 through the discharge outlet 169.

[0036] As best shown in Figure 11, the automatic syringe 100 may include an outlet channel 168 that is in fluid communication with a discharge outlet 169, and a sliding piston 190 that is movably positioned within the discharge outlet 169. The sliding piston 190 may include an operable dump valve that is configured as part of the ventilation system of the automatic syringe 100, as described and shown in more detail in Figures 44-46 (see ventilation system 2030). As described herein, at least a portion of the pressurized medium received from the canister 150 enters the discharge outlet 169 through the outlet channel 168, causing the sliding piston 190 to move relative to the discharge outlet 169 (for example, downward). The sliding piston 190 may have a body 192 having a longitudinal length extending between an upper end 194 and a lower end defined by a pair of snap arms 196. The body 192 may include one or more recesses 195 formed along the upper end 194, the recesses 195 being sized, shaped, and / or otherwise configured to receive a seal (e.g., an O-ring) within the recess to prevent the pressurized medium received from the outlet channel 168 from flowing along the outer surface of the sliding piston 190. Thus, the pressurized medium received in the discharge outlet 169 may be operable to be pressed against the body 192 at the upper end 194, thereby causing the sliding piston 190 to translate within the discharge outlet 169, for example downward, from a first (upper) position to a second (lower) position (see Figures 18A-18C). Each of the pair of snap arms 196 may include a retaining mechanism 198 at the end (lower end) of the snap arm 196. The retaining mechanism 198 may include, but is not limited to, a clip, hand, finger, tab, projection, etc. The holding mechanism 198 may be located within a first (upper) chamber 136 of the chassis 130, which is located relatively below and is in fluid communication with the outlet 169.

[0037] The chassis 130 may further include a second (lower) chamber 138 located relatively below 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 internal diameters. The chassis 130 may further include an inner lip 137 located between the first chamber 136 and the second chamber 138. The inner lip 137 may extend radially inward with respect to the inner surfaces of the first chamber 136 and the second chamber 138 so that the inner lip 137 can define a portion between the first chamber 136 and the second chamber 138 having relatively small cross-sectional dimensions and / or internal diameters. As described herein, a pair of retaining mechanisms 198 may be configured to engage with an inner lip 137 in response to pressurized gas received at the outlet 169 pushing the sliding piston 190 relatively downward into the first chamber 136 with at least a portion of the snap arm 196 extending into the second chamber 136. With the retaining mechanisms 198 engaged with the inner lip 137, the chassis 130 may be configured to prevent the sliding piston 190 from returning to its initial position in the outlet 169.

[0038] In this case, the pressurized medium received at the outlet 169 can be guided around the body 192 of the slidable piston 190 and discharged into the first chamber 136 and the second chamber 138. In some embodiments, the inner surface of the outlet 169, such as along the bottom adjacent to the first chamber 136, may include notches, channels, recesses, and / or cavities pressed radially outward with respect to the central longitudinal axis of the outlet 169, so that the outlet 169 may have an inner diameter that is larger along the bottom than at the top of the outlet 169. Thus, the pressurized medium received at the outlet 169 can be guided around the body 192 of the slidable piston 190 via the inner surface along the bottom, including the notches, before being discharged 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, which is maintained at atmospheric pressure, so that the pressurized medium received in the second chamber 138 is effectively discharged to eliminate the pressure rise inside the housing 102. In some embodiments, the housing 102 may include one or more vents 101 (see Figure 1) to maintain the internal cavity of the housing 102 at atmospheric pressure and to facilitate depressurization of the automatic syringe 100.

[0039] Referring here to Figures 12A and 12B, one or more components of the automatic syringe 100 are shown as it transitions from a pre-operation state (Figure 12A) to an operating state (Figure 12B). For illustrative purposes only, one or more other components of the automatic syringe 100 are omitted from Figures 12A and 12B. Referring first to Figure 12A, the shroud 120 is in a first position in which the inner surface 121 of the shroud 120 is axially offset from the bottom end 132 of the chassis 130, maintaining the shroud 120 in an extended position relative to the chassis 130. In this case, the actuator 125 may be at least partially located within the internal cavity 124 of the shroud 120 and the internal cavity 134 of the chassis 130, with only the first end 127 of the body 126 in contact with the inner surface 121. The carrier 140 and canister 150 can be in their respective first positions, with the retaining mechanism 146 disengaged from the retaining mechanism 162 and the puncture mechanism 164 separated from the neck 152 (see Figure 13A).

[0040] In the example, the chassis 130 may include a channel 135 positioned around the carrier 140, and the carrier 140 may include a pair of arms 148 extending laterally (radially) outward from the carrier 140. The channel 135 may be sized, shaped, and / or otherwise configured to receive the arms 148. In the example, the channel 135 may define a cylindrical cavity within which to receive the carrier 140. The channel 135 may be configured to guide the carrier 140 upward toward the valve assembly 160 in response to the movement of the actuator 125 relative to the bottom end 142, thereby preventing unintended lateral movement of the carrier 140 within the chassis 130. In other embodiments, the channel 135 and / or arms 148 may be omitted entirely from the automatic syringe 100. In further embodiments, the carrier 140 may be omitted so that the canister 150 is directly coupled to the chassis 130 and the valve assembly 160, respectively.

[0041] Referring to Figure 12B, the shroud 120 may be moved along a vertical path from a first position to a second position, in which case the shroud 120 is pressed upward to a retracted position relative to the chassis 130, with its inner surface 121 in contact with the bottom end 132, for example, in response to the bottom surface 122 of the shroud 120 interface with an object (e.g., the user of the auto-syringe 100). In this case, the actuator 125 may be moved (e.g., swiveled) around a pivot joint defined by the pin 129 and recess 139 to bring the auto-syringe 100 into operation. As the actuator 125 moves toward the second position, the shroud 120 is pressed against the first end 127 of the body 126 and its second end 128 in contact with the bottom end 142 of the carrier 140. The second end 128 may define a lever support surface for an actuator 125 configured to redirect the force generated by the movement of the shroud 120 toward the carrier 140 and canister 150. The carrier 140 may also be moved upward relative to the chassis 130 in response to the second end 128 being pressed against the bottom end 142, thereby translating the canister 150 toward the valve assembly 160 until the puncture mechanism 164 punctures the seal of the neck 152. Thus, the pressurized medium stored in the canister 150 can be released into the valve assembly 160 via the puncture mechanism 164.

[0042] It should be understood that the shroud 120, actuator 125, chassis 130, carrier 140, and / or mandrel assembly 180 may be configured and operable to require only low holding force to operate the auto-injector 100, so as to minimize the force required for the auto-injector 100 to begin dose delivery. In other words, one or more components of the auto-injector 100 may be sized, shaped, and / or otherwise configured to minimize the force required to press the shroud 120 against the subject's skin during use of the auto-injector 100 when delivering a dose to the subject.

[0043] Additionally, a pair of retaining mechanisms 146 may be moved upward toward the valve assembly 160 when the carrier 140 and canister 150 move simultaneously within the housing 102, thereby engaging the retaining mechanism 146 with the corresponding retaining mechanism 162 (see Figure 13B). In this case, the valve assembly 160 may be configured to securely fix the canister 150 to the valve assembly 160 in response to the valve assembly 160 coupling with the carrier 140. In some embodiments, at least a portion of the pressurized medium discharged from the canister 150 may generate a blowback force on the canister 150, causing the canister 150 to move downward toward the valve assembly 160. The engagement between the retaining mechanisms 146 and 162 may suppress and / or at least partially minimize the downward retraction of the canister 150 toward the valve assembly 160, thereby maintaining fluid communication between the canister 150 and the valve assembly 160.

[0044] In some embodiments, the auto-injector 100 may be configured to lock one or more components, such as the shroud 120, by preventing movement of those components if premature rise of the shroud 120 occurs during use of the auto-injector 100. In the event of a premature rise of the shroud 120, the auto-injector 100 may be configured to prevent reactivation and / or further use of the auto-injector 100 to protect user safety. A premature rise event may generally be defined as the occurrence of a premature, premature, and / or premature release of the shroud 120 by the user when the auto-injector 100 transitions from a pre-operation state to an operating state, or during injection of medication from the auto-injector 100 while it is operating in the operating state. In this case, the auto-injector 100 may be configured to lock one or more components (e.g., the shroud 120) so that they do not move further relative to the housing 102, even if they remain operational, thereby preventing further use and / or reactivation of the auto-injector 100. For example, the automatic syringe 100 may lock the relative position of the shroud 120 in either an extended (downward) configuration or a retracted (upward) configuration relative to the housing 102, thereby suppressing further movement and / or motion of the shroud 120. Locking the shroud 120 in a retracted configuration relative to the housing 102 may be to such an extent that the needle 116 remains located inside the shroud 120, thereby suppressing exposure of the needle 116 from outside the automatic syringe 100.

[0045] In one example, the auto-injector 100 may include a timer mechanism that can be operated to determine when an early rise event occurs. The timer mechanism may provide a buffer period that allows the user of the auto-injector 100 to perform an early rise quickly before the auto-injector 100 is locked out. For example, the timer mechanism may be programmed to allow such adjustment without locking the auto-injector 100 when the rapid adjustment of the auto-injector 100 does not exceed a predetermined threshold (e.g., 1 second). Such adjustment may include the physical removal of the auto-injector 100 from the user's skin after the initial operation, for reasons such as discomfort or accidental removal. When an early rise event occurs, i.e., the removal of the shroud 120 from the user's skin for a period exceeding a predetermined threshold determined by the timer mechanism, the auto-injector 100 may be configured to lock one or more components, thereby preventing further movement of the shroud 120 relative to the housing 102.

[0046] Once the delivery of the dose from the auto-injector 100 is complete, one or more components of the auto-injector 100, such as the sliding piston 190, the mandrel assembly 180, and / or the biasing mechanism 182, may be configured to interact with the shroud 120 to lock out the auto-injector 100 from reactivation. For example, as described in more detail herein, the sliding piston 190 may be configured to push the mandrel assembly 180 downward as it exits the discharge outlet 169 and enters the first chamber 136 and second chamber 138 into which the mandrel assembly 180 is received. In this case, the mandrel assembly 180 may be configured to push the shroud 120 downward and outward relative to the housing 102. Additionally and / or alternatively, the biasing mechanism 182 may be configured to push the mandrel assembly 180 downward, thereby further pushing the shroud 120 from the housing 102 in response to the biasing mechanism 182 automatically moving from a compression configuration to an expansion configuration, thereby automatically moving the shroud 120 from a second position to a first position. The biasing mechanism 182 should be understood to be configured to move automatically after a threshold amount of energy has been released from a canister 150 or the like. In this case, with the bottom surface 122 of the shroud 120 positioned on the outer surface of the subject's (e.g., patient's) skin, the shroud 120 may be configured to press against the outer surface, thereby lifting the housing 102 upward from the subject's skin. Thus, the autoinjector 100 may be able to operate to signal completion of dose delivery via visual feedback of the housing 102 being automatically lifted from the skin by the extension of the shroud 120, pushing itself away from the subject's skin.

[0047] Referring here to Figure 14, another exemplary shroud 220 and chassis 230 are shown. It should be understood that the shroud 220 and chassis 230 can be incorporated into the auto-syringe 100 in substantially the same manner as the shroud 120 and chassis 130 shown and described above, except for differences explicitly stated herein. For example, the shroud 220 may include a pair of flexible ribs 222 extending vertically upward through an internal cavity 124, with pins 224 located at the respective ends (upper ends) of the pair of flexible ribs 222. The chassis 230 may include a pair of arms 232 and a pair of pin guides 234 positioned relatively above the bottom end 132 within the internal cavity 134. The pin guides 234 may be formed along the rear surface of the arms 232 and may be sized, shaped, and / or otherwise configured to receive the pins 224 thereon to securely connect the shroud 220 to the chassis 230. The pin guide 234 may define an angled and / or inclined surface of an arm 232 that guides the pin 224 within the channel 236, which is configured to secure the pin 224 to the channel 236.

[0048] In the pre-operation state of the automatic syringe 100, as shown in Figure 14, a pair of flexible ribs 222 are in contact with a pair of arms 232, and each pin 224 is located relatively below the corresponding pin guide 234. In response to the upward movement of the shroud 220 relative to the chassis 230, the flexible ribs 222 may translate along the arms 232 until each pin 224 aligns with the pin guide 234. It should be understood that the flexible ribs 222 may be configured to move laterally (radially) and / or bend when the shroud 220 presses the flexible ribs 222 against the arms 232. For example, the flexible ribs 222 may be pushed radially outward when the shroud 220 moves upward relative to the chassis 230, and then bend radially inward when the pins 224 align with the pin guides 234. In this case, the shroud 220 may be in a second position, and the pin guide 234 may be configured to receive the pin 224 along the rear surface of the arm 232. As the shroud 220 moves partially downward relative to the chassis 230, the pin guide 234 can push the pin 224 into each channel 236 which is at least partially defined by the side (inner surface) of the arm 232. In other words, the pin guide 234 can guide the pin 224 into the channel 236, which is located radially inward of the arm 232. The channel 236 may have a cross-sectional dimension smaller than the cross-sectional dimension of the pin 224. Thus, the pin 224 can be securely fixed inside the channel 236, thereby locking the shroud 220 to the chassis 230 and preventing further downward movement of the shroud 220 relative to the chassis 230.

[0049] Referring here to Figure 15, another exemplary chassis 330, carrier 340, and valve assembly 360 are shown. It should be understood that the chassis 330, carrier 340, and valve assembly 360 can be incorporated into the automatic syringe 100 in substantially the same manner as the chassis 130, carrier 140, and valve assembly 160 shown and described above, except for differences explicitly stated herein. For example, the carrier 340 may be at least partially located within the valve assembly 360, and the neck 152 of the canister 150 may be received within the carrier 340. As described herein, the carrier 340 may be configured to move relative to the canister 150 and / or valve assembly 360 in response to the actuator 125 pushing the carrier 340 into the valve assembly 360 and upward toward the canister 150.

[0050] The valve assembly 360 may include a chamber 362 that defines a lumen, which is sized, shaped, and / or otherwise configured to receive the canister 150 and the carrier 340. The chamber 362 may include an upper end 364 and an open bottom end 366, with the canister 150 positioned adjacent to the upper end 364 relative to the carrier 340, and the carrier 340 positioned adjacent to the bottom end 366 relative to the canister 150. At least a portion of the carrier 340 may extend outward from the chamber 362 through the opening in the bottom end 366 and contact the actuator 125. In this example, the cross-sectional dimensions of the lumen of the chamber 362 may be larger than the cross-sectional dimensions of the canister 150 that is received therein, thereby forming a gap 368 between the inner surface of the chamber 362 and the outer surface of the canister 150. As described herein, the pressurized medium released from the canister 150 can be received into the chamber 362 and guided through the gap 368 toward the outlet 369 of the chamber 362 at the upper end 364.

[0051] Referring further to Figure 15, the carrier 340 may have a longitudinal length defined between an upper end 342 and a lower end 344, the upper end 342 may include an opening 341 for receiving the neck 152, and the lower end 344 may be closed and in contact with the second end 128 of the actuator 125. The opening 341 in the upper end 342 may be sized and / or shaped such that the upper end 342 defines an opening having a cross-sectional dimension larger than that of the neck 152, thereby forming a gap between the inner surface of the upper end 342 and the outer surface of the neck 152 that is received therein. In some embodiments, the edge 343 of the upper end 342 defining the opening 341 may be angled and / or tapered radially outward with respect to the central axis of the carrier 340, thereby defining an even larger gap between the upper end 342 and the neck 152 along the edge 343. As described herein, the carrier 340 may be configured to receive a pressurized medium stored in the canister 150 and release the pressurized medium into the valve assembly 360 through the opening 341.

[0052] The carrier 340 may include recesses and / or cavities along its longitudinal length between its upper end 342 and lower end 344. The recesses and / or cavities may be sized, shaped, 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 to prevent pressurized medium released from the canister 150 into the carrier 340 from escaping from the valve assembly 360. The carrier 340 may further include a puncture mechanism 348 (e.g., a needle, an activator pin, etc.) extending upward from the lower end 344. The puncture mechanism 348 may be positioned relatively below the neck 152 when the canister 150 is coupled to the carrier 340, and may be configured to move upward to puncture the seal of the neck 152 in response to the second end 128 being pressed against the bottom end 344 when the actuator 125 pivots around a pivot joint defined between the pin 129 and the recess 139.

[0053] In this case, the carrier 340 may be biased upward relative to the canister 150 and valve assembly 360 so that the puncture mechanism 348 punctures the seal of the neck 152, thereby releasing the pressurized medium stored in the canister 150 into the carrier 340. The carrier 340 may be configured to release the pressurized medium into the lumen of the chamber 362 through an opening 341 at the upper end 342. The fastener 346 may be configured to restrict the release of the pressurized medium from the chamber 362 through an opening at the bottom end 366 so that the pressurized medium is guided towards the upper end 364 through a gap 368 until it is received at the outlet 369. In some embodiments, the lumen of the chamber 362 may include one or more grooves along the gap 368, thereby increasing the spatial void for the pressurized medium to move from the carrier 340 along the outlet 369.

[0054] Referring to Figures 16A and 16B, the indicator assembly 170 may be located within the housing 102 adjacent to the upper 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 so 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, when the pressurized medium becomes equal between the two internal chambers of the valve assembly 160, at least a portion of the pressurized medium received within the valve assembly 160 may be configured to propel the piston 172 against the valve assembly 160 and / or the housing 102. For example, the piston 172 may be configured to move from a first position (Figure 16A) before the valve assembly 160 accepts the pressurized medium to a second position (Figure 16B) after the valve assembly 160 accepts the pressurized medium. It should be understood that the movement of the piston 172 may result in corresponding movement of the remaining components of the indicator assembly 170, including the first indicator surface 174, the second indicator surface 176, the first arm 177, and the second arm 178. The piston 172 may be formed integrally with the first indicator surface 174, the second indicator surface 176, the first arm 177, and the second arm 178. For example, the piston 172 may form a body integrated with the first indicator surface 174 via an intermediate arm 173 that connects the piston 172 to the first indicator surface 174, such that the first indicator surface 174, the second indicator surface 176, the first arm 177, and the second arm 178 move simultaneously when the piston 172 moves.

[0055] The indicator assembly 170 may be positioned within the housing 102 such that it at least partially overlaps the second window 110. In the first position, the piston 172 may be substantially positioned within the valve assembly 160, and the first indicator surface 174 may be aligned with the second window 110 when the auto-syringe 100 is in the pre-operation state (Figure 16A). In the second position, the piston 172 may be moved toward the upper end 104 relative to the housing 102, and the second indicator surface 176 may be aligned with the second window 110 when the auto-syringe 100 is in the operation state (Figure 16B). As a result of the piston 172 moving relative to the housing 102 in response to the pressurized medium in the valve assembly 160 pushing the piston 172, the first indicator surface 174 and the second indicator surface 176 may move relative to the second window 110. Accordingly, the indicator assembly 170 may be configured to generate visual feedback of the current operating state of the auto-injector 100 based on the relative positions of the first indicator surface 174 and the second indicator surface 176 with respect to the second window 110. Each of the first indicator surface 174 and the second indicator surface 176 may define a graphical interface including one or more stickers, markings, colorings, and / or markers that are distinguishable from each other. For example, the first indicator surface 174 may include a first color (e.g., white), and the second indicator surface 176 may include a second color (e.g., green) that is different from the first color. The distinct colorings of the first indicator surface 174 and the second indicator surface 176 may be visible through the second window 110 when aligned with it, indicating the current operating state of the auto-injector 100 to the user.

[0056] Referring further to Figures 16A and 16B, the 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. The relative positions, sizes, and / or shapes of the first arm 177 and / or the second arm 178 should be understood to be modified from those shown and described herein without departing from the scope of this disclosure. Thus, the first arm 177 and / or the second arm 178 may be located in a variety of other suitable positions along the indicator assembly 170 and / or within the housing 102. In this example, the first arm 177 may be sized, shaped, and / or otherwise configured to move (e.g., translate) within a track 179 formed within the housing 102, and the second arm 178 may be sized, shaped, and / or otherwise configured to move (e.g., translate) along a ramp 103 formed within the housing 102.

[0057] Track 179 may define a channel having a vertical configuration and may be configured to restrict the direction of motion of the indicator assembly 170 relative to the housing 102 during use of the auto-syringe 100, such as between the pre-operation state of the auto-syringe 100 (see Figure 16A) and the operating state of the auto-syringe 100 (see Figure 16B). For example, track 179 may be configured to restrict the movement of the indicator assembly 170 relative to the housing 102 in a vertical direction, thereby restricting the movement of the first arm 177 received therein and thereby suppressing the lateral movement of the indicator assembly 170 relative to the housing 102. Ramp 103 may include a slope and / or angled surface 103A that can be configured to at least partially deflect the second arm 178 radially outward during use of the auto-syringe 100, such as between the pre-operation state of the auto-syringe 100 (see Figure 16A) and the operating state of the auto-syringe 100 (see Figure 16B). For example, the second arm 178 may be at least partially flexible, and the ramp 103 may be configured to bend and / or flex the second arm 178 laterally outward so as it translates along the angled surface 103A, away from other internal components of the automatic syringe 100. The ramp 103 may flex the second arm 178 as it translates perpendicularly along the angled surface 103A, until the second arm 178 moves beyond the end (upper) portion 103B of the angled surface 103A.

[0058] Referring further to Figures 16A and 16B, the second arm 178 may be configured to bend and / or flex laterally inward relative to the housing 102 as it moves beyond the terminal portion 103B, thereby returning to its original unbent state. The indicator assembly 170 may be configured to generate audible feedback (e.g., a click) when the second arm 178, after translating over the terminal portion 103B, contacts a portion of the ramp 103 located beyond the angled surface 103A (e.g., relatively above the angled surface 103A). In other words, as the second arm 178 moves beyond the angled surface 103A, it bounces back to its original position, 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 when the automatic injector 100 completes dose delivery, the indicator assembly 170 may be configured to generate audible and visual feedback, with the second indicator surface 176 aligning with the second window 110 and the second arm 178 positioned relative to the ramp 103 to generate audible feedback. The terminal portion 103B may be configured to restrict further movement of the indicator assembly 170 by contact with the second arm 178. For example, as best shown in Figure 16B, the terminal portion 103B may form an obstruction that contacts the second arm 178 when the second arm 178 is positioned above the terminal portion 103B, thereby restricting downward translation of the second arm 178 toward the angled surface 103A.

[0059] In other embodiments, as shown in Figures 17A-17B, the first indicator surface 174 and the second indicator surface 176 may include similar markings, colors, and / or markers. Therefore, even if either the first indicator surface 174 or the second indicator surface 176 is aligned with the second window 110, no visual feedback to the user of the current operating state of the auto-syringe 100 is generated. In this embodiment, the indicator assembly 170 may be configured to generate only audible feedback indicating the current operating state of the auto-syringe 100, resulting from the interaction between the second arm 178 and the lamp 103. In this embodiment, the second window 110 may be omitted entirely from the housing 102.

[0060] Referring here to Figures 18A–18C, another exemplary housing 402, shroud 420, and chassis 430 are shown. It should be understood that the housing 402, shroud 420, and chassis 430 can be incorporated into the autosynergy 100 in substantially the same manner as the housing 102, shroud 120, and chassis 130 shown and described above, except for differences explicitly stated herein. For example, the housing 402 may include one or more clips 404 (e.g., tabs, fingers, etc.) formed along the bottom end 106, and the shroud 420 may include one or more corresponding clips 424 (e.g., tabs, fingers, etc.) formed along the upper edge 422 of the shroud 420 for mating with the clips 404. The one or more clips 404 may be configured to engage with the one or more clips 424 when the shroud 420 extends downward relative to the housing 402, preventing the shroud 420 from separating from the housing 402. As described herein, clips 404 and 424 may be configured to lock out the shroud 420 against the housing 402 once dose delivery from the auto-injector 100 is complete, in order to prevent reactivation.

[0061] In this example, the mandrel assembly 180 may be integrally mounted to the shroud 420 together with a biasing mechanism 182 positioned around the mandrel assembly 180. The biasing mechanism 182 may extend between opposing ends that contact the chassis 430 and the shroud 420, thereby biasing the shroud 420 to an extended position away from the chassis 430. The biasing mechanism 182 may be configured to add resistance to the upward movement of the shroud 420, particularly toward the chassis 430. As described herein, the biasing mechanism 182 may be further configured to extend the shroud 420 outward from within the housing 402 when the shroud 420 is pressed into the housing 402 and activated.

[0062] The chassis 430 may include one or more flexible spacers 432 positioned within the first chamber 136. The one or more flexible spacers 432 may be positioned around the inner surface of the first chamber 136 and may define cross-sectional dimensions relatively smaller than the lumen of the first chamber 136. The flexible spacers 432 may be configured to abut against a retaining mechanism 198 for the sliding piston 190, thereby maintaining the sliding piston 190 within the discharge outlet 169 and preventing the sliding piston 190 from moving outward from the valve assembly 160. In this example, the flexible spacers 432 may have angled, tapered, and / or inclined interface surfaces, and the retaining mechanism 198 may have corresponding interface surfaces configured to engage with the interface surfaces of the flexible spacers 432. In other words, the flexible spacers 432 and the retaining mechanism 198 may have generally inclined engagements with respect to each other. As described herein, the flexible spacer 432 may be configured to deform radially outward and / or compress in response to the sliding piston 190 translating into the first chamber 136 as pressurized medium from the valve assembly 160 enters the discharge outlet 169 through the outlet channel 168 (see Figures 18B-18C). As described herein, the chassis 430 may also be configured to lock the sliding piston 190 inside the first chamber 136 and the second chamber 138 in response to the inner lip 137 engaging with the retaining mechanism 198, thereby preventing the mandrel assembly 180 from moving into the first chamber 136 and the second chamber 138. In this case, the shroud 420 may be locked out and prevented from retracting into the housing 402 and toward the chassis 430.

[0063] In the pre-operation state shown in Figure 18A, the shroud 420 may be in a first position where the mandrel assembly 180 is located below the chassis 430, specifically below the first chamber 136 and the second chamber 138, respectively. The biasing mechanism 182 may also be in an expansion configuration, thereby pushing the shroud 420 downward away from the chassis 430. When the shroud 420 is pressed upward toward the chassis 430 to move the automatic syringe 100 into the operational state, the mandrel assembly 180 may move relatively upward, extending through the first chamber 136 and the second chamber 138, as shown in Figure 18B. In this case, the biasing mechanism 182 may be switched to a compression configuration between the shroud 420 and the chassis 430. In some embodiments, when the shroud 420 is fully pressed in the second position, the mandrel assembly 180 may be positioned adjacent to and / or in contact with the sliding piston 190. When pressurized medium is received into the valve assembly 160, at least a portion of the pressurized medium may be guided to the outlet channel 168. The pressurized medium received through the outlet channel 168 may encounter the upper end 194 of the sliding piston 190, thereby pushing the sliding piston 190 downward toward the discharge outlet 169.

[0064] Referring to Figure 18C, after dose delivery from the auto-injector 100 is complete, the force applied to the shroud 420 may be released, thereby allowing the biasing mechanism 182 to expand and the shroud 420 to return to the first position. Additionally and / or alternatively, as the pressurized medium received from the outlet channel 168 pushes the sliding piston 190 out of the discharge outlet 169, the shroud 420 may return to the first position in response to the sliding piston 190 pushing the mandrel assembly 180 downward. Clips 404 and 424 may collectively be configured to lock out the shroud 420 against the housing 402 after dose delivery from the auto-injector 100 is complete in order to prevent reactivation. In response to the biasing mechanism 182 returning to the expansion configuration and the shroud 420 moving downward relative to the chassis 430, the mandrel assembly 180 may 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 and the pressurized medium encounters the upper end 194, the sliding piston 190 may be propelled downward into the first chamber 136 and the second chamber 138. It should be understood that the force exerted on the sliding piston 190 by the pressurized medium from the outlet channel 168 may be relatively greater than the resistance strength and / or resistance force of the flexible spacer 432 against the retaining mechanism 198 for maintaining the sliding piston 190 in the discharge outlet 169. Thus, the sliding piston 190 may be configured to move (e.g., translate) relative to the discharge outlet 169 and extend through the first chamber 136 and the second chamber 138. In this case, the flexible spacer 432 may be deformed and / or compressed to move radially outward in order to allow the sliding piston 190 to be received through the first chamber 136.

[0065] The sliding piston 190 may be pushed out through the first chamber 136, and at least a portion of the snap arm 196 may extend into the second chamber 138. In some embodiments, the snap arm 196 may be biased radially inward toward each other when the sliding piston 190 extends into the first chamber 136 through the flexible spacer 432. When the snap arm 196 extends into the second chamber 138 through the inner lip 137, the snap arm 196 may be further biased radially inward. It should be understood that when the snap arm 196 enters the second chamber 138, it may move radially outward toward each other to return to a neutral position. A retaining mechanism 198 may be located in the second chamber 138 and engaged with the inner lip 137 to restrain the sliding piston 190 from moving relative to the chassis 430. In other words, the inner lip 137 may be configured to engage with the retaining mechanism 198 in the second chamber 138, thereby coupling the sliding piston 190 to the chassis 430, so that the sliding piston 190 locks to the chassis 430 at the end of dose delivery from the auto-injector 100. The pressurized medium received at the outlet 169 may flow along the outside of the sliding piston 190 and exit from the outlet 169 into the first chamber 136. With the first chamber 136 open to the internal cavity of the housing 402, which is maintained at atmospheric pressure, the auto-injector 100 may be configured to discharge the pressurized medium.

[0066] Referring further to Figure 18C, the sliding piston 190 may be fixed to the chassis 430, and the shroud 420 may be prevented from moving any further (upward) relative to the chassis 430, thereby preventing further operation of the automatic syringe 100. Specifically, because the snap arm 196 is positioned within the first chamber 136 and the second chamber 138 when the retaining mechanism 198 engages with the inner lip 137, the mandrel assembly 180 is prevented from moving upward relative to the chassis 430 and entering the first chamber 136 or the second chamber 138, for example, in response to the corresponding movement of the shroud 420. Thus, the sliding piston 190 may be configured to prevent further operation of the automatic syringe 100 by preventing the movement of the mandrel assembly 180 and the shroud 420. It should be understood that the sliding piston 190 may be configured to extend the mandrel assembly 180 and the shroud 420 coupled to the mandrel assembly 180 to a sufficient extent so that the needle 116 (see Figures 5 and 10) is positioned within the shroud 420 and effectively covered.

[0067] Referring here to Figures 19A–19C, other exemplary shrouds 520, chassis 530, and mandrel assembly 580 are shown. It should be understood that the shrouds 520, chassis 530, and mandrel assembly 580 can be incorporated into the auto-syringe 100 in substantially the same manner as the shrouds 120, chassis 130, and mandrel assembly 180 shown and described above, except for differences expressly stated herein. For example, the chassis 530 may include a pair of retaining mechanisms 532 arranged around the mandrel assembly 580. The retaining mechanisms 532 may include, but are not limited to, clips, hands, fingers, tabs, projections, stoppers, etc. The chassis 530 may further include a collar 510 coupled at the bottom end 132 of the chassis 530. The collar 510 extends relatively downward from the bottom end 132, and the mandrel assembly 580 can be positioned at least partially through the collar 510 and the chassis 530, respectively.

[0068] In particular, 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 relative to the inner surface 121 of the shroud 520, and the upper end 514 may be coupled to the bottom end 132. The collar 510 may include a pair of first openings 516 and a pair of second openings 518 located between the lower end 512 and the upper end 514, the second openings 518 being positioned adjacent to the upper end 514 relative to the first openings 516. The second openings 518 may be sized, shaped, 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 may be configured to move radially inward and / or bend relative to the central axis of the chassis 530 in response to the mandrel assembly 580 moving (e.g., translating) the collar 510 relative to the chassis 530 within the housing 102, in order to selectively couple and / or separate the chassis 530 from the collar 510. As described herein, the collar 510 may be configured to move relative to the chassis 530 in response to the corresponding movements of the shroud 520 and the mandrel assembly 580.

[0069] Referring further to Figures 19A to 19C, the mandrel assembly 580 may include a pair of retaining mechanisms 584 positioned relatively adjacent to the lower end 582 of the mandrel assembly 580. The retaining mechanisms 584 may include, but are not limited to, clips, hands, fingers, tabs, projections, retainers, etc. The first opening 516 may be sized, shaped, and / or otherwise configured to receive the retaining mechanisms 584 for securely coupling the collar 510 to the mandrel assembly 580. The retaining mechanisms 584 may be partially flexible and may be configured to move radially inward and / or bend relative to the central axis of the mandrel assembly 580 in response to the movement (e.g., translation) of the mandrel assembly 580 relative to the collar 510 within the housing 102, in order to selectively couple and / or separate the mandrel assembly 580 from the collar 510. As described herein, the mandrel assembly 580 may be configured to move relative to the collar 510 in response to the corresponding movement of the shroud 520.

[0070] Specifically referring to Figure 19A, with the automatic syringe 100 in a pre-operation state, the shroud 520 may be in a first position relative to the housing 102, with the retaining mechanism 584 inside the first opening 516, thereby removably coupling the mandrel assembly 580 to the collar 510. In this case, the retaining mechanism 532 may be located above (and separated from) the second opening 518 relative to it. The mandrel assembly 580 is coupled to the shroud 520, and the shroud 520 may be configured to move the mandrel assembly 580 upward relative to the housing 102 when the shroud 520 is pushed upward into the housing 102. Thus, the collar 510 can move simultaneously upward with the mandrel assembly 580 and the shroud 520 due to the engagement between the retaining mechanism 584 and the first opening 516. In other words, the mandrel assembly 580 may be configured to pull the collar 510 vertically upward with a retaining mechanism 584 received within the first opening 516. The biasing mechanism 182 may transition from an expansion configuration (Figure 19A) to a compression configuration (Figure 19B) when the shroud 520 pushes the mandrel assembly 580 upward against the housing 102.

[0071] Referring here to Figure 19B, with the automatic syringe 100 in operation, the shroud 520 may be in a second position relative to the housing 102, where the mandrel assembly 580 repositions the collar 510 relative to the chassis 530 such that the second opening 518 aligns with the retaining mechanism 532. In this case, the retaining mechanism 532 may be received 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 is flexed and / or flexibly bent radially inward. The upper end 514 may flex the retaining mechanism 532 radially inward until the retaining mechanism 532 is in a position aligned with the second opening 518. In this case, the retaining mechanism 532 may bend radially outward into the second opening 518, thereby returning the retaining mechanism 532 to a neutral state.

[0072] Referring here to Figure 19C, the auto-injector 100 may transition to a lockout state in which the shroud 520 can be returned toward a first position relative to the housing 102. For example, after dose delivery from the auto-injector 100 is complete, the force applied to the shroud 520 may be released, thereby allowing the biasing mechanism 182 to expand and the shroud 520 to return toward the first position. Specifically, the biasing mechanism 182 may be configured to push the mandrel assembly 580 downward relative to the housing 102, and the mandrel assembly 580 may be configured to push the shroud 520 in response to the mandrel assembly 580 contacting the inner surface (bottom surface) of the shroud 520. The chassis 530 may be coupled to the collar 510 by the engagement of the retaining mechanism 532 with the second opening 518, thereby restricting the movement of the collar 510 when the mandrel assembly 580 and shroud 520 are pushed downward against the housing 102. In other words, the collar 510 can be securely fixed to the chassis 530 by the engagement between the second opening 518 and the retaining mechanism 532.

[0073] Therefore, the retaining mechanism 584 may be configured to move radially inward toward each other and / or bend as the mandrel assembly 580 moves downward relative to the housing 102 and the collar 510 (e.g., translates). In this case, the retaining mechanism 584 may be configured to exit through the first opening 516, thereby separating the mandrel assembly 580 from the collar 510. The biasing mechanism 182 should be understood to expand to such an extent that the mandrel assembly 580 is pushed through the collar 510 until the retaining mechanism 584 is positioned below the lower end 512. The retaining mechanism 584 may also bend radially outward as it exits the collar 510 at the lower end 512, thereby returning the retaining mechanism 584 to a neutral position. In this case, the retaining mechanism 584 may be configured to bend outward and abut against the lower end 512, thereby preventing the retaining mechanism 584 from re-entering the collar 510. Therefore, the axial position of the mandrel assembly 580 relative to the collar 510 can be fixed. Once the mandrel assembly 580 is positioned against the inner surface of the shroud 520, upward movement of the shroud 520 may be suppressed, thereby locking the shroud 520 and preventing subsequent operation of the auto-injector 100.

[0074] Referring here to Figures 20A and 20B, other exemplary chassis 630 and carrier 640 are shown. It should be understood that the chassis 630 and carrier 640, respectively, can be incorporated into the auto-syringe 100 in substantially the same manner as the chassis 130 and carrier 140 shown and described above, except for differences explicitly stated herein. For example, the chassis 630 may include a lower flange 632 located adjacent to the bottom end 132 of the chassis 630, the lower flange 632 may be at least partially open to receive a portion of the carrier 640 through it. The carrier 640 may include a pair of retaining mechanisms 642 sized, shaped, and / or otherwise configured to extend into the lower flange 632. Specifically, the retaining mechanisms 642 may engage with the lower flange 632, thereby removably coupling the carrier 640 to the chassis 630. In the example, the retaining mechanisms 642 may include, but are not limited to, clips, hands, fingers, tabs, projections, retainers, etc.

[0075] The carrier 640 may further include an upper flange 644 and a biasing mechanism 646 (e.g., a spring) positioned between the lower flange 632 and the upper flange 644. The biasing mechanism 646 may be maintained in a compressed configuration when the retaining mechanism 642 is engaged with the lower flange 632. As described herein, the biasing mechanism 646 may be configured to push the carrier 640 upward relative to the lower flange 632 when transitioning from a compressed configuration (Figures 20A-20B) to an expanded configuration (not shown) in response to the retaining mechanism 642 disengaging from the lower flange 632.

[0076] The canister 150 may be positioned in the carrier 640 relatively above the upper flange 644 so that the canister 150 can be biased upward within the housing 102 by the biasing mechanism 646. The carrier 640 may include a plug 648 positioned between a pair of retaining mechanisms 642, the plug 648 may include a stem 650 extending outward from between the retaining mechanisms 642 toward the inner surface 121 of the shroud 120. It should be understood that the stem 650 may have a longitudinal length relatively longer than the corresponding longitudinal length of the retaining mechanisms 642 so that the stem 650 can be positioned closer to the inner surface 121 relative to the retaining mechanisms 642. The plug 648 may be fixed relative to the retaining mechanisms 642 so that the plug 648 cannot move relative to the retaining mechanisms 642. As described herein, the carrier 640 may be configured to move relative to the chassis 630 within the housing 102 in response to the corresponding movement of the plug 648.

[0077] Specifically, referring to Figure 20A, with the automatic syringe 100 in its pre-operation state, the shroud 120 can be in a first position where the inner surface 121 of the shroud 120 is offset from the stem 650. The biasing mechanism 182 can be in an expansion configuration, while the biasing mechanism 646 can be in a compression configuration. In this case, the carrier 640 can be coupled to the chassis 630 by an 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) can be fixed with respect to the chassis 630.

[0078] Referring here to Figure 20B, the automatic syringe 100 transitions to an operating state in response to the shroud 120 moving toward a second position in which its inner surface 121 can contact the stem 650. In this case, the shroud 120 may be configured to push the plug 648, thereby moving the carrier 640 upward relative to the chassis 630. In particular, the force applied to the plug 648 by the upward movement of the shroud 120 may cause the retaining mechanism 642 to bend and / or flex radially inward toward each other, thereby separating the retaining mechanism 642 from the lower flange 632. In this case, the carrier 640 may be able to move upward relative to the chassis 630 in response to the biasing mechanism 646 transitioning toward an expansion configuration and pushing the upper flange 644 upward. By pushing the carrier 640 upward relative to the housing 102, the canister 150 may also be moved to fluid communication with a valve assembly (not shown) located relatively above the canister 150, as described in detail above, thereby activating the release of pressurized medium from the canister 150.

[0079] Referring here to Figures 21A–21C, another exemplary chassis 730 and mandrel assembly 780 are shown. It should be understood that the chassis 730 and mandrel assembly 780 can be incorporated into the auto-syringe 100 in substantially the same manner as the chassis 130 and mandrel assembly 180 shown and described above, except for differences expressly stated herein. For example, the chassis 730 may include a cam path 732 which is sized, shaped, and / or otherwise configured to receive the peg 782 of the mandrel assembly 780. The cam path 732 may define a travel path for the peg 782 so that the chassis 730 can be configured to control the movement of the mandrel assembly 780 during use of the auto-syringe 100. As described herein, the mandrel assembly 780 may be configured to translate and rotate relative to the chassis 730 as the peg 782 moves along the travel path defined by the cam path 732. In some embodiments, the cam path 732 may include an opening channel formed in the wall and / or body of the chassis 730. The cam path 732 may include a longitudinal length extending between opposing ends that defines the movement path of the peg 782. With the mandrel assembly 780 coupled to and / or in contact with the inner surface 121 of the shroud 120, the chassis 730 may be configured to control the movement and / or position of the shroud 120 via the mandrel assembly 780.

[0080] As described herein, the chassis 730 may be configured to lock the shroud 120 by restraining the movement of the mandrel assembly 780 if an early rise of the shroud 120 occurs during use of the auto-injector 100. An early rise event may generally be defined as an early, premature, and / or premature release of the shroud 120 by the user when the auto-injector 100 transitions from a pre-operational state to an operational state. Alternatively, an early rise event may be defined as an early, premature, and / or premature release of the shroud 120 by the user as the auto-injector 100 after the start of the operational state but before the completion of full injection delivery of the drug from the auto-injector 100. In this case, the chassis 730 may be configured to lock the shroud 120 so that it does not move further relative to the housing 102, thereby restraining further use of the auto-injector 100.

[0081] Referring further to Figures 21A to 21C, the cam path 732 may include one or more paths and / or portions for guiding the movement of the peg 782 relative to the chassis 730 during various operating stages of the automatic syringe 100, thereby controlling the position of the shroud 120 relative to the housing 102. As described above, the cam path 732 may define an opening 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 that can operate to control the relative position of the peg 782. The first path 734 may have a longitudinal length defining a straight portion of the opening channel of the cam path 732 extending upward along the chassis 730, and the second path 736 may have a longitudinal length defining a curved portion of the opening channel of the cam path 732 extending laterally from the first path 734. The second path 736 may have an end portion 738 opposite to the first path 734, the end portion 738 may define an angled (e.g., about 90 degrees) portion of the cam path 732. The third path 740 may have a longitudinal length that defines a straight portion of the opening channel of the cam path 732 extending downward from the end portion 738.

[0082] It should be understood that the cam path 732 may include additional paths and / or fewer paths, or paths of various other suitable shapes and / or configurations, without departing from the scope of the present disclosure. For example, a first path 734 may be configured to receive the peg 782 in the cam path 732 in the pre-operation state of the auto-syringe 100 and maintain the mandrel assembly 780 in a first position relative to the chassis 730. A second path 736 may be configured to receive the peg 782 from the first path 734 and maintain the mandrel assembly 780 in a second position relative to the chassis 730 in the operation state of the auto-syringe 100, for example, in response to rotating the peg 782 and / or the mandrel assembly 780 in a first direction relative to the chassis 730 and the cam path 732. The second path 736 may be configured to receive the peg 782 from the first path 734, for example, in response to rotating the peg 782 and / or mandrel assembly 780 in a first direction relative to the chassis 730 and cam path 732. The third path 740 may be configured to receive the peg 782 from the second path 736, for example, in response to rotating the peg 782 and / or mandrel assembly 780 in a second direction relative to the chassis 730 and cam path 732, which is different from the first direction. In this case, the third path 740 may be configured to lock the mandrel assembly 780 in a third position relative to the chassis 730 when the automatic syringe delivery is complete.

[0083] Specifically referring to Figure 21A, with the automatic syringe 100 in its pre-operation state, the shroud 120 may be in a first position where the shroud 120 fully extends from the housing 102 and the peg 782 is positioned within the cam path 732 along a portion of the first path 734. In this case, the biasing mechanism 182 of the mandrel assembly 780 may also be in an expansion configuration such that the biasing mechanism 182 pushes the mandrel assembly 780 downward relative to the chassis 730, thereby pushing the shroud 120 toward the first position. The first path 734 can be understood to be sized, shaped, and / or otherwise configured to define a channel having cross-sectional dimensions substantially similar to those of the peg 782. In other words, the first path 734 does not include any excessive clearance and / or gaps to accommodate the premature exit of the peg 782 from the first path 734. Therefore, the movement of the peg 782 along the first path 734 may be constrained to move along the entire range of the first path 734 before entering the second path 736. Depending on the size, shape, and / or configuration of the first path 734, the chassis 730 may be configured to rotate the mandrel assembly 780 in the first direction within the housing 102 in response to the shroud 120 moving upward toward a second position and the peg 782 moving through the first path 734 to the second path 736.

[0084] Referring here to Figure 21B, with the auto-injector 100 in the pre-operation state, the shroud 120 may be in a second position where the shroud 120 retracts into the housing 102 and the peg 782 is positioned in the cam path 732 along a portion of the second path 736. In this case, the biasing mechanism 182 may move to a compression configuration in response to the upward movement of the shroud 120 and the vertical translation of the mandrel assembly 780 into the housing 102. In this example, it should be understood that the mandrel assembly 780 may be configured to translate vertically and rotate simultaneously when the shroud 120 moves relative to the chassis 730. The peg 782 may be located at the end 738 of the second path 736 when the dose from the auto-injector 100 has been completely dispensed. Thus, the second path 736 can restrain further movement of the peg 782 when the peg 782 is located at the end 738, thereby indicating completion of dose delivery. As described herein, the second path 736 may be sized, shaped, and / or otherwise configured such that when the peg 782 is located at the end portion 738, it pushes the peg 782 toward the third path 740.

[0085] It should be understood that the second path 736 may be sized, shaped, and / or otherwise configured to define a channel having a cross-sectional dimension substantially larger than the cross-sectional dimension of the peg 782. In other words, the second path 736 includes an excess clearance and / or gap 737 to accommodate the premature exit (release) of the peg 782 from the second path 736, such as in response to the occurrence of premature rise of the shroud 120 during use of the auto-syringe 100. Thus, the movement (e.g., rotation) of the peg 782 along the second path 736 does not have to be constrained to move along the entire range of the second path 734, such as to the terminal 738, before entering the third path 740. Instead, the cam path 732 may be sized and / or shaped along the second path 736 to guide the peg 782 toward the third path 740 when the shroud 120 rises prematurely, if the auto-syringe 100 does not fully transition to the working state through the gap 737. The gap 737 can define an alternative path for the peg 782 between the second path 736 and the third path 740. As will be described later, the peg 782 can be securely fixed within the cam path 732 once it reaches the third path 740, regardless of whether the peg 782 translates to the end portion 738.

[0086] Referring here to Figure 21C, with the automatic syringe 100 in the delivery complete state, the shroud 120 may automatically return toward a first position in which the shroud 120 extends from the housing 102 and the peg 782 is positioned in the cam path 732 along a portion of the third path 740. In this case, the biasing mechanism 182 may also automatically return (e.g., move) toward an expansion configuration so that the biasing mechanism 182 may be configured to push the mandrel assembly 780 downward relative to the chassis 730, thereby pushing the shroud 120 toward the first position. In this case, the mandrel assembly 780 and / or the peg 782 may be configured to rotate in a second direction different from the first direction. In the example, the third path 740 may define the closed end of the cam path 732 so that subsequent operation of the automatic syringe 100 is suppressed in response to the third path 740 locking the peg 782 at the closed end of the cam path 732. In other words, once the peg 782 is accepted into the third path 740, it is prevented from moving any further, and the mandrel assembly 780 may be locked to the chassis 730, thereby preventing the shroud 120 from moving 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.

[0087] Referring here to Figures 22A–22C, another exemplary shroud 820, chassis 830, valve assembly 860, and sliding piston 890 are shown. It should be understood that the shroud 820, chassis 830, valve assembly 860, and sliding piston 890 can be incorporated into the auto-syringe 100 in substantially the same manner as the shroud 120, chassis 130, valve assembly 160, and sliding piston 190 shown and described above, except for differences explicitly stated herein. For example, the shroud 820 may include a pair of retaining mechanisms 822 extending outward from the inner surface 121 of the shroud 820 toward the chassis 830. The pair of retaining mechanisms 822 may be spaced apart from each other by a cavity 824 formed between them. In some embodiments, the retaining mechanisms 822 may include, but are not limited to, clips, hands, fingers, tabs, projections, retainers, and the like. As described herein, the cavity 824 may be sized, shaped, and / or otherwise configured such that it receives at least a portion of the sliding piston 890 in response to the shroud 820 engaging with the sliding piston 890.

[0088] The chassis 830 may include a pair of retaining mechanisms 832 that are movably coupled to the shroud 820 via a biasing mechanism 834. The biasing mechanism 834 may be coupled to the shroud 820 along its inner surface 121. As described herein, the biasing mechanism 834 may be configured to push the shroud 820 away from the chassis 830, particularly downward relative to the chassis 830, when in the expansion configuration. The biasing mechanism 834 may be configured to transition from the expansion configuration to the compression configuration (Figure 22B) in response to the shroud 820 moving upward toward the chassis 830. 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 the low-pressure line of the auto-syringe 100, the second port 866 may be in fluid communication with the vent line and / or opening of the auto-syringe 100, and the lower opening 868 may be sized, shaped, and / or otherwise configured to receive at least a portion of the slidable piston 890 into the body 862 through the lower opening 868.

[0089] As described herein, the sliding piston 890 may be slidably received within the valve assembly 860, specifically, the upper end 892 of the sliding piston 890 may be movably positioned within the body 862. The sliding piston 890 may include a first seal 891 and a second seal 893 located along the upper end 892. When the sliding piston 890 is in a first position relative to the valve assembly 860 (see Figure 22A), the first seal 891 may be positioned between a first port 864 and a second port 866, and the second seal 893 may be positioned between a second port 866 and a lower opening 868. In this case, the first port 864 may be defluxed from the second port 866 by the position of the first seal 891 in the body 862 between them, and the second port may be defluxed from the lower opening 868 by the position of the second seal 893 in the body 862 between them. As described herein, the sliding piston 890 may be configured to selectively establish fluid communication between the first port 864 and the second port 866 in response to moving relative to the body 862 and repositioning the first seal 891 and / or the second seal 893.

[0090] Referring further to Figures 22A to 22C, the sliding piston 890 may include a lower end 894 located opposite the upper end 892. The lower end 894 may include a plurality of retaining mechanisms, each being sized, shaped, and / or otherwise configured to mount the sliding piston 890 to one or more other components of the automatic syringe 100, such as the shroud 820 and the chassis 830. In an example, the sliding piston 890 may include a central retaining mechanism 896 extending outward from the lower end 894, and a pair of lateral retaining mechanisms 898 positioned radially outward from the central retaining mechanism 896. In some embodiments, the central retaining mechanism 896 may include, but is not limited to, clips, hands, fingers, tabs, projections, hooks, etc. The pair of lateral retaining mechanisms 896 may include, but is not limited to, clips, hands, fingers, tabs, projections, stoppers, etc. When the sliding piston 890 is in its first position, with its upper end 892 positioned within the valve assembly 860, its lower end 894 may extend downward from the body 862 through the lower opening 868 of the valve assembly 860. Thus, the retaining mechanisms 896, 898 are positioned outside the body 862 when the sliding piston 890 is in its first position relative to the valve assembly 860.

[0091] Specifically referring to Figure 22A, with the automatic syringe 100 in a pre-operation state, the shroud 820 may be in a first position where the biasing mechanism 834 is in an expanded state, such that the shroud 820 is separated from the slidable piston 890. Furthermore, with the slidable piston 890 in its respective first position relative to the valve assembly 860, the chassis 830 is separated from the slidable piston 890. In response to upward movement of the shroud 820 toward the chassis 830, such as in response to applying a force against the bottom surface 122 to push the shroud 820 upward, the shroud 820 may be configured to compress the biasing mechanism 834. In this case, the retaining mechanism 822 may move toward the slidable piston 890 and engage with the central retaining mechanism 896, thereby coupling the shroud 820 to the slidable piston 890.

[0092] Referring here to Figure 22B, the automatic syringe 100 may be in an operating state in which the shroud 820 is translated toward a second position in which the sliding piston 890 is securely coupled to the shroud 820. Thus, the sliding piston 890 may be configured to move together with the shroud 820. It should be understood that the chassis 830 may remain fixed relative to the shroud 820 as the shroud 820 moves toward the chassis 830 and the second position. When the force applied to the shroud 820 against the bottom surface 122 is released, the biasing mechanism 834 may be configured to return toward an expansion configuration, thereby pushing the shroud 820 downward toward the chassis 830. In other words, the shroud 820 may be automatically returned toward the first position. In this case, the sliding piston 890 is coupled to the shroud 820, and the biasing mechanism 834 may be further configured to pull the sliding piston 890 at least partially out of the body 862 through the lower opening 868.

[0093] In some embodiments, the shroud 820 may be configured such that the retaining mechanism 822 engages with the central retaining mechanism 896 before and / or during the transition of the automatic syringe 100 from a pre-operational state (Figure 22A) to an operational state (Figure 22B). In this case, the shroud 820 may be coupled to a sliding piston 890 to accommodate premature retraction (release) of the shroud 820, such as in response to premature rise of the shroud 820 occurring during use of the automatic syringe 100. As described herein, with the shroud 820 coupled to the sliding piston 890, the biasing mechanism 834 may be configured to lock the shroud 820 to the chassis 830 when the operational state is completed, or when the shroud 820 rises prematurely while the automatic syringe 100 has not fully transitioned to the operational state.

[0094] Referring to Figure 22C, the automatic syringe 100 may transition toward a delivery completion state, causing the shroud 820 to automatically move toward or toward a first position, and the sliding piston 890 to move from each first position toward a second position. The shroud 820 may be configured to pull the sliding piston 890 downward so that the lateral retaining mechanism 898 can extend to interface with the retaining mechanism 832, thereby securely coupling the sliding piston 890 to the chassis 830. In this case, the sliding piston 890 may be held in the second position by its attachment to the shroud 820 and the chassis 830, thereby locking the shroud 820 and the sliding piston 890 in their respective positions. It should be understood that the shroud 820 and the sliding piston 890 may be positioned in the respective positions shown in Figure 22C if premature upward movement of the shroud 820 occurs, so as to prevent further operation of the automatic syringe 100.

[0095] Additionally, as the sliding piston 890 extends outside the body 862 through the lower opening 868, the upper end 892 moves relative to the first port 864 and the second port 866 so that the first seal 891 is positioned relative to the second port 866 and the second seal 893 is positioned relative to the lower opening 868. In other words, the second seal 893 may be positioned outside the body 862. In this case, the sliding piston 890 can be configured to fluidly couple the first port 864 to the second port 866 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. Thus, a low-pressure line fluidly communicating with the second port 866 can guide the pressurized gas received therein to the vent opening and / or line of the first port 864. Additionally, the sliding piston 890 may be configured to discharge the pressurized medium received from the low-pressure line between the first seal 891 and the second seal 893 (through the second port 866 from when the sliding piston 890 was in the first position) out of the valve assembly 860 through the lower opening due to the position of the second seal 893 relative to the lower opening 868.

[0096] Referring here to Figures 23A and 23B, another exemplary actuator 925 and chassis 930 are shown. It should be understood that the actuator 925 and chassis 930 can be incorporated into the auto-injector 100 in substantially the same manner as the actuator 125 and chassis 130 shown and described above, except for differences explicitly stated herein. For example, the actuator 925 may include a lever 922 movably coupled to the body 126. The 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 the closed end of the cam path 932. In other words, the first path 934 may have a longitudinal length defining a curved portion of the opening channel of the cam path 932 extending laterally along the chassis 930. In some examples, the first path 934 may be substantially U-shaped. The second path 936 may be located at the end of the first path 734. The cam path 932 may be sized, shaped, and / or otherwise configured to slidably receive at least a portion of the lever 922 within it. In other words, the lever 922 may be coupled to and movable relative to the body 126 and the cam path 932, respectively. The actuator 920 may further include a biasing mechanism 924 (e.g., a torsion spring) coupled to the body 126 and located adjacent to the lever 922. The biasing mechanism 924 may be configured to push the lever 922 so that it moves along the cam path 932 from the first path 934 toward the second path 936.

[0097] Referring to Figure 23A, with the automatic syringe 100 in a pre-operation state, the shroud 120 may be in a first position with a lever 922 and an expansion biasing mechanism 182 located along a first path 934. In response to moving the shroud 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 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-21C), the first path 934 may include a terminal portion defining the full stroke of the shroud 120 for delivering a full dose, and the second path 936 may include an excess clearance and / or gap defining an alternative path for the lever 922 in the event of an early rise event. In this case, the early rise of the shroud 120 may cause the lever 922 to move along the alternative path of the second path 936. In either case, the chassis 930 may be configured to lock the shroud 120 in response to the lever 922 being received at the closed end of the cam path 932 along the second path 936, as shown in Figure 23B. It should be understood that the biasing mechanism 182 may be configured to automatically return the shroud 120 toward the first position by pushing the shroud 120 downward relative to the chassis 930.

[0098] Referring here to Figures 24A and 24B, another exemplary mandrel assembly 1080 is shown. It should be understood that the mandrel assembly 1080 can be incorporated into the autosynergizer 100 in substantially the same manner as the mandrel assembly 180 shown and described above, except for differences explicitly stated herein. For example, as shown in Figure 24A, the mandrel assembly 1080 may include a pair of retaining mechanisms 1082 that can be positioned within the first chamber 136 when the shroud 120 is in a first position and the autosynergizer 100 is in a pre-operation state. The pair of retaining mechanisms 1082 may include, but are not limited to, clips, hands, fingers, tabs, projections, stoppers, etc. In this case, the mandrel assembly 1080 may be offset from the inner surface 121 of the shroud 120 and received on a relatively positioned ledge 1084 on the inner surface 121. The mandrel assembly 1080 may be configured to rotate in response to the shroud 120 moving toward a second position and the automatic syringe 100 transitioning to an operating state (not shown).

[0099] As shown in Figure 24B, in response to the rotation of the mandrel assembly 1080, the mandrel assembly 1080 may be translated downward so that it can be received along the inner surface 121. The retaining mechanism 1082 may be configured to move from the first chamber 136 to the second chamber 138 in response to the retaining mechanism 1082 flexing radially inward relative to each other in response to contact with the inner lip 137. Upon entering the second chamber 138, the retaining mechanism 1082 may be configured to flex radially outward and / or bend flexibly, thereby locking the mandrel assembly 1080 against the chassis 130. Once the mandrel assembly 1080 is received on the inner surface 121, the mandrel assembly 1080 may be configured to restrict further movement of the shroud 120 relative to the chassis 130. It should be understood that the mandrel assembly 1080 may be configured to exit the ledge 1084 and abut against the inner surface 121 in the event of complete dose delivery or premature rise. Therefore, if the shroud 120 rises prematurely, the mandrel assembly 1080 may move downward relative to the inner surface 121. In either case, the chassis 130 may be configured to lock the shroud 120 in response to the mandrel assembly 1080 being accepted against the inner surface 121 and the retaining mechanism 1082 being locked in the second chamber 138.

[0100] Referring here to Figures 25A and 25B, another exemplary shroud 1120, valve assembly 1160, and sliding piston 1190 are shown. It should be understood that the shroud 1120, valve assembly 1160, and sliding piston 1190 can be incorporated into the auto-syringe 100 in substantially the same manner as the shroud 120, valve assembly 160, and sliding piston 190 shown and described above, except for differences explicitly stated herein. For example, the shroud 1120 may include a stem 1122 sized, shaped, and / or otherwise configured to abut against the sliding piston 1190. In particular, the shroud 1120 may be configured to push the stem 1122 against the sliding piston 1190, thereby sealing the port 1162 of the valve assembly 1160 with the sliding piston 1190. In some embodiments, the sliding piston 1190 may include a fitting seal 1192 at the upper end of the sliding piston 1190, which may be configured to seal the port 1162 when the shroud 1120 presses the stem 1122 against the sliding piston 1190 with sufficient sealing force, as shown in Figure 25B. In some embodiments, the sliding piston 1190 may include a spring and / or other biasing mechanism so that the sliding piston 1190 can transition from an expansion configuration (Figure 25A) to a compression configuration (Figure 25B).

[0101] In the example, port 1162 may be in fluid communication with the low-pressure line of the auto-syringe 100. Since port 1162 is generally small in size, for example having a diameter of about 1 millimeter, the required sealing force is minimized by creating a surface seal over port 1162. If premature rise of the shroud 1120 occurs, the fitting seal 1192 may lose contact with port 1162, thereby allowing the pressurized medium from the low-pressure line fluid-coupled thereto to push the shroud 1120 downward, thereby locking the shroud 1120. It should be understood that the fitting seal 1192 does not seal ports that are in fluid communication with the vent line and / or opening of the valve assembly 1160. In some embodiments, the auto-syringe 100 may include a secondary indicator configured to generate a notification for properly lifting the shroud 1120 to transition to the operating state while avoiding the occurrence of premature rise.

[0102] Referring here to Figure 26, another exemplary actuator 1125 and chassis 1230 are shown. It should be understood that the actuator 1125 and chassis 1230 can be incorporated into the auto-syringe 100 in substantially the same manner as the actuator 125 and chassis 130 shown and described above, except for differences explicitly stated herein. For example, the actuator 1125 may include one or more retaining mechanisms 1226, and the chassis 1230 may include one or more corresponding retaining mechanisms 1232. When the shroud 120 is moved and the auto-syringe 100 is moved into operation, the retaining mechanism 1226 may be configured to engage with the retaining mechanism 1232. In this case, it should be understood that the retaining mechanism 584 of the mandrel assembly 580 may be positioned above the retaining mechanism 1226. The retaining mechanism 584 may be laterally movable and / or flexible in response to engaging with one or more other components of the auto-syringe 100. In some embodiments, the retaining mechanism 584 may be biased radially outward relative to the lower end 582 of the mandrel assembly 580. Each of the retaining mechanisms 584, 1226, and 1232 may include, but are not limited to, obstacles, tabs, protrusions, fingers, clips, retainers, and / or various other mechanisms.

[0103] If premature rise of the shroud 120 occurs, the mandrel assembly 580 may be configured to move relative to the actuator 1225 so that the retaining mechanism 584 can translate downward until it is positioned below the retaining mechanism 1226. It should be understood that the retaining mechanism 584 may be configured to flex radially inward toward the mandrel assembly 580 and / or bend when it moves downward by the retaining mechanism 1226 before extending below the retaining mechanism 1226 and bending radially outward to reach a neutral position. Once the retaining mechanism 584 is positioned downward and in contact with the retaining mechanism 1226, the mandrel assembly 580 may be configured to lock the shroud 120 from moving further relative to the chassis 1230.

[0104] Referring here to Figure 27, another exemplary shroud 1320 is shown. It should be understood that the shroud 1320 can be incorporated into the auto-injector 100 in substantially the same manner as the shroud 120 shown and described above, except for differences expressly stated herein. For example, the shroud 1320 may include a pocket 1322 formed along the inner surface 121. The pocket 1322 may include an enlarged end 1324 and a constricted end 1326 located adjacent to each other along the inner surface 121. The pocket 1322 may be positioned along the inner surface 121 of the shroud 1320 in alignment with the actuator 125. The pocket 1322 may be sized, shaped, and / or otherwise configured to receive the first end 127 of the actuator 125.

[0105] In response to the shroud 1320 moving upward toward the chassis 130, the actuator 125 may be configured to translate along the inner surface 121 and over the pocket 1322 until the first end 127 is received within the enlarged end 1324 as the auto-syringe 100 transitions from a pre-operated state to an operated state. The pocket 1322 may be sized, shaped, and / or otherwise configured such that it prevents the first end 127 from being received directly into the constricted end 1326, for example, from a position directly above the constricted end 1326. In other words, because the upper opening of the constricted end 1326 along the inner surface 121 is relatively smaller than the cross-sectional dimensions of the first end 127, the actuator 125 slides across the inner surface 121 without entering the constricted end 1326, so the first end 127 can translate directly over the constricted end 1326. Therefore, the first end 127 may not be received by the constricted end 1326, even though the constricted end 1326 is open directly below the first end 127, but may instead translate directly over the constricted end 1326.

[0106] As described herein, the lateral opening of the constricted end 1326 along the side of the constricted end 1326 adjacent to the enlarged end 1324 may be sized and / or shaped such that it has sufficient cross-sectional dimensions to receive the first end 127 through it. If premature rise of the shroud 1320 occurs, the inner surface 121 may move relative to the actuator 125 so that the first end 127 fits into the constricted end 1326 from the enlarged end 1324, thereby locking the actuator 125 against the shroud 1320. It should be understood that the pocket 1322, once received into it from the enlarged end 1324, may be configured to prevent the first end 127 from disengaging from the constricted end 1326. In this case, the shroud 1320 may be prevented from moving relative to the chassis 130 by a fixed engagement between the actuator 125 and the pocket 1322, particularly by ensuring that the first end 127 is securely engaged inside the constricted end 1326.

[0107] Referring here to Figure 28, another exemplary housing 1402, valve assembly 1460, and indicator assembly 1470 are shown. It should be understood that the housing 1402, valve assembly 1460, and indicator assembly 1470 can be incorporated into the auto-syringe 100 in substantially the same manner as the housing 102, valve assembly 160, and indicator assembly 170 shown and described above, except for differences explicitly stated herein. For example, the housing 1402 may include a window 1404 along the upper end 104, the window 1404 may define an opaque wall of the housing 1402 at the upper end 104. The indicator assembly 1470 may be positioned within the housing 1402 and offset from the window 1404 so that the indicator assembly 1470 is not visible through the window 1404 when the auto-syringe 100 is in a pre-operation state.

[0108] The indicator assembly 1470 can be fluid-coupled to the valve assembly 1460 such that, in response to the valve assembly 1460 receiving pressurized medium, the indicator assembly 1470 can be configured to translate upward within the housing 1402, particularly toward the upper end 104. Thus, when dose delivery from the auto-injector 100 is complete, the pressurized medium may push the indicator assembly 1470 toward the window 1404 so that the indicator assembly 1470 can be seen from outside the housing 1402, thereby generating visual feedback of dose delivery. In some embodiments, the indicator assembly 1470 may be configured to abut against the inner surface of the window 1404, thereby generating tactile feedback of dose delivery.

[0109] Referring here to Figures 29-30, another exemplary sliding piston 1590 is shown. Each sliding piston 1590 should be understood to be incorporated into the auto-injector 100 in substantially the same manner as the sliding piston 190 shown and described above, except for differences explicitly stated herein. For example, a sliding piston 1590 may include one or more first indicator surfaces 1592 and one or more second indicator surfaces 1594 arranged along the outside of the sliding piston 1590. Each of the first indicator surfaces 1592 and the second indicator surfaces 1594 may include one or more markings, colors, and / or markers that distinguish them from each other. For example, the first indicator surface 1592 may include a first color (e.g., green), and the second indicator surface 1594 may include a second color (e.g., white) different from the first color. The sliding piston 1590 and / or housing 102 may include one or more obstruction features 1596.

[0110] Specifically referring to Figure 29, in the pre-operation state of the automatic syringe 100, the sliding piston 1590 may be positioned such that the first indicator surface 1592 aligns with the obstruction feature 1596 and the second indicator surface 1594 is offset from the obstruction feature 1596, thereby offsetting the first indicator surface 1592 from the space and / or gap between adjacent obstruction features 1596 and not visible from the corresponding viewpoint V, while the second indicator surface 1594 is visible from viewpoint V. In this case, the second indicator surface 1594 may be operable to indicate the pre-operation state of the automatic syringe 100 when offset from the obstruction feature 1596 and visible through viewpoint V. In some embodiments, the obstruction feature 1596 may be the surface and / or wall of the automatic syringe 100.

[0111] Referring here to Figure 30, when the auto-injector 100 completes dose delivery and discharges, the sliding piston 1590 may be configured to move relative to the housing 102 such that a first indicator surface 1592 is visible from viewpoint V and a second indicator surface 1594 is no longer visible from viewpoint V. In this case, the first indicator surface 1592 may be operable to indicate the complete delivery state of the auto-injector 100 when it is offset from the obstruction feature 1596 and visible. Viewpoint V should be understood to be from the viewpoint and / or line of sight of the user of the auto-injector 100 while using the auto-injector 100, such as from outside the auto-injector 100.

[0112] Referring here to Figure 31, another exemplary actuator 1625 and carrier 1640 are shown. It should be understood that the actuator 1625 and carrier 1640 can be incorporated into the automatic syringe 100 in substantially the same manner as the actuator 125 and carrier 140 shown and described above, except for differences explicitly stated herein. For example, the actuator 1625 may include a projection 1628 along the second end 128, and the carrier 1640 may include a corresponding projection 1642 along the bottom end 142. Each of the projections 1628 and 1642 may include steps, tabs, contacts, and / or various other suitable extensions along the respective ends of the actuator 1625 and carrier 1640. In the first position, the projection 1642 may be located to the left of the projection 1628 before the movement of the actuator 1625 relative to the carrier 1640. In the second position, projection 1642 may be located to the right of projection 1628 after the movement of actuator 1625 relative to carrier 1640.

[0113] The projection 1628 may be configured to engage with projection 1642 in response to the actuator 1625 moving relative to the chassis 130 and contacting the carrier 1640. In this case, the actuator 1625 may be prevented from returning to its initial position relative to the chassis 130 when projection 1642 contacts projection 1628, thereby securely fixing the actuator 1625 and locking the shroud 120 from moving relative to the housing 102. In this case, the shroud 120 may be locked in a retracted position relative to the housing 102. In other embodiments, projections 1628 and 1642 may collectively be configured to reduce the reaction force on the shroud 120 generated in the canister 150 in response to the pressurized medium being released into the valve assembly 160.

[0114] Referring here to Figure 32, another exemplary canister 1750 and valve assembly 1760 are shown. It should be understood that the canister 1750 and valve assembly 1760 can be incorporated into the auto-syringe 100 in substantially the same manner as the canister 150 and valve assembly 1760 shown and described above, except for differences explicitly stated herein. For example, the 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) positioned around the neck 152. The valve assembly 1760 may include an interface surface 1762 positioned around a puncture mechanism 164. The retainer cap 1752 and seal 1756 can each be configured to fluidly couple the canister 1750 to the valve assembly 160. For example, the sealing surface 1754 may be configured to contact the outside of the interface surface 1762, and the seal 1756 may be configured to contact the inside of the interface surface 1762. Thus, the retainer cap 1752 and the seal 1756 can define a sealing system comprising two parts for the canister 1750. In some embodiments, the sealing surface 1754 may be configured to clip onto the interface surface 1762, and the retainer cap 1752 may provide sufficient resistance to retain against the pressure applied to the seal 1756 from the pressurized medium released from the canister 1750.

[0115] Referring here to Figure 33, another exemplary shroud 1820 and carrier 1840 are shown. It should be understood that the shroud 1820 and carrier 1840 can be incorporated into the auto-syringe 100 in substantially the same manner as the shroud 120 and carrier 140 shown and described above, except for differences expressly stated herein. For example, the shroud 1820 may include a pair of retaining mechanisms 1822 (e.g., clips, hooks, arms, tabs, etc.), and the 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) positioned between the movable body 1842 and the fixed body 1846. The locking pin 1848 may be positioned between the pair of arms 1844, and the pair of arms 1844 may be positioned within an opening through the fixed body 1846. A pair of arms 1844 may be at least partially flexible, and a locking pin 1848 may be configured to fix the pair of arms 1844 to the fixed body 1846 when positioned between the arms 1844. In other words, the locking pin 1848 may be positioned between the arms 1844 and configured to bend the arms 1844 radially outward relative to each other. The arms 1844 may be received through openings in the fixed body 1846 and the locking pin 1848 may be configured to press the pair of arms 1844 against the fixed body 1846, thereby securely coupling the movable body 1842 to the fixed body 1846.

[0116] The shroud 1820 may be positioned relatively below the carrier 1840, and the retaining mechanism 1822 may be configured to engage the locking pin 1848 when the shroud 1820 moves upward toward the carrier 1840. When the retaining mechanism 1822 engages with the locking pin 1848, the occurrence of an early rise event may cause the shroud 820 to move downward toward the carrier 1840. With the retaining mechanism 1822 engaged with the locking pin 1848, the shroud 1820 may be configured to pull the locking pin 1848 downward toward the fixed body 1846, thereby separating the locking pin 1848 from between the pair of arms 1844. In this case, the absence of the locking pin 1848 between the pair of arms 1844 creates a clearance gap between the pair of arms 1844, which may allow the arms 1844 to move laterally toward each other and enter the clearance gap. A pair of arms 1844 may be configured to bend radially inward from one another due to a clearance gap formed between them by the removal of a locking pin 1848. Thus, when a force is applied to the movable body 1842 by the biasing mechanism 1850, the arms 1844 may bend toward each other, thereby minimizing the cross-sectional shape of the arms 1844 and allowing them to extend through the opening in the fixed body 1846. When the biasing mechanism 1850 expands, the pair of arms 1844 may be configured to move vertically upward through the opening in the fixed body 1846 together with the movable body 1842 as the biasing mechanism 1850 expands (e.g., translate). The biasing mechanism 1850 can be fixed in the expanded configuration, thereby locking out the automatic syringe 100 from subsequent use.

[0117] Referring to Figure 34, an exemplary valve assembly 2040 of the automatic syringe 100 is shown. It should be understood that the valve assembly 2040 may be incorporated into the automatic syringe 100 in substantially the same manner as the valve assembly 160 shown and described above, except for differences explicitly stated herein. For example, the valve assembly 2040 may include a valve body 2042 having a first (upper) portion 2044 and a second (bottom) portion 2046, which are arranged within the housing 102 in a compact configuration, thereby resulting in a reduction in the cross-sectional shape of the housing 102 compared to the valve assembly 160.

[0118] In the example, the first (upper) portion 2044 may be configured to receive at least a portion of the canister 150, such as a neck 152, to facilitate fluid communication with the puncture mechanism 164. The valve assembly 2040 may include an outlet 169 having a slidable piston 190 movably disposed therein. The second (bottom) portion 2046 may be positioned vertically above the first (upper) portion 2044 so that the arrangement of the valve body 2042 may be configured to form a reduced cross-sectional profile within the housing 102 with respect to the valve assembly 160 shown and described above. In this case, the diaphragm 2012 of the valve assembly 2040 (not shown) may be oriented within the valve body 2042 in a horizontal configuration so that the diaphragm 2012 moves vertically along its axis of action. In other words, the body of the diaphragm 2012 may be positioned along a horizontal plane that is lateral to the longitudinal axis of the housing 102.

[0119] Referring further to Figure 34, the automatic syringe 100 may omit the carrier 140 entirely so that the canister 150 can move by an actuator 125 (not shown) to directly fluidize the valve assembly 2040. By positioning the canister 150 and the sliding piston 190 within the first (upper) portion 2044 of the valve body 2042, the valve assembly 2040 may be operable to provide a smaller sealing area and higher strength compared to the valve assembly 160. The second (bottom) portion 2046 may be configured to interface with the container 112, thereby reducing the height of the housing 102. The second (bottom) portion 2046 may fluidize the container 112 via a conduit 2048.

[0120] Referring to Figure 35, another exemplary valve assembly 2050 of the automatic syringe 100 is shown. It should be understood that the valve assembly 2050 may be incorporated into the automatic syringe 100 in substantially the same manner as the valve assembly 160 shown and described above, except for differences explicitly stated herein. For example, the valve assembly 2050 may include a valve body 2052 having a first (upper) portion 2054 and a second (bottom) portion 2056, which are arranged within the housing 102 in a compact configuration, thereby resulting in a reduction in the cross-sectional shape of the housing 102 compared to the valve assembly 160.

[0121] In the example, the first (upper) portion 2054 may be configured to receive at least a portion of the canister 150, such as a neck 152, to facilitate fluid communication with the puncture mechanism 164. The valve assembly 2050 may include an outlet 169 having a movably disposed sliding piston 190 (not shown) therein. The second (bottom) portion 2056 may be positioned horizontally and / or radially relative to the first (upper) portion 2054, such that the arrangement of the valve body 2052 may be configured to form a reduced cross-sectional shape within the housing 102 with respect to the valve assembly 160 shown and described above. In this case, the diaphragm 2012 of the valve assembly 2050 (not shown) may be oriented within the valve body 2052 in a vertical configuration, such that the diaphragm 2012 is positioned to move horizontally along its axis of action. In other words, the body of the diaphragm 2012 may be positioned along a vertical plane parallel to the longitudinal axis of the housing 102.

[0122] Referring further to Figure 35, the automatic syringe 100 may omit the carrier 140 entirely so that the canister 150 can be moved by the actuator 125 to directly fluidize the valve assembly 2050. By positioning the canister 150 and the sliding piston 190 within the first (upper) portion 2054 of the valve body 2052, the valve assembly 2050 may be operable to provide a smaller sealing area and higher strength compared to the valve assembly 160. The second (bottom) portion 2056 may be configured to interface with the container 112, thereby reducing the height of the housing 102.

[0123] Referring here to Figure 36, a valve assembly 160 of the automatic syringe 100 is shown. 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 located between a low-pressure body portion 2014 and a high-pressure body portion 2016 (see Figures 44-46). In some embodiments, the low-pressure body portion 2014 may be attached to the high-pressure body portion 2016 along one or more positions between them to ensure that the diaphragm 2012 is securely coupled thereto via various suitable means. 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 fix any one of the diaphragm 2012, the low-pressure body portion 2014, and the high-pressure body portion 2016 together. Each of the one or more weld paths may extend along a predefined portion within the valve assembly 160. In some embodiments, one or more weld paths may be continuous without intermediate interruptions, and in other embodiments, one or more weld paths may include one or more interruptions that form stress relief gaps within the valve assembly 160.

[0124] In the example, the valve assembly 160 may include a first (outer) weld path 1908 positioned around the outer circumference of the valve assembly 160, particularly along the boundary edge between the low-pressure body portion 2014 and the high-pressure body portion 2016. By extending continuously around the outer circumference, the first weld path 1908 may be configured and operable to seal the low-pressure body portion 2014 to the high-pressure body portion 2016. As shown and described herein, the first weld path 1908 may be further configured to ensure a diaphragm 2012 is coupled between the low-pressure body portion 2014 and the high-pressure body portion 2016 (see Figure 41).

[0125] Referring further to Figure 36, the valve assembly 160 may include one or more second (internal) weld paths 1910 arranged along portions of the valve assembly 160 located radially inward from the 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 together within the valve assembly 160. In this example, the valve assembly 160 may include a pair of second weld paths 1910 arranged around the diaphragm 2012. Each of the pair of second weld paths 1910 may be sized, shaped, 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 for the valve assembly 160, such that the stress relief gap 1912 may be configured to release a portion of the pressurized gas received into the valve assembly 160 when the pressure generated within the valve assembly 160 reaches a predetermined threshold during the operation of the automatic syringe 100. In this case, the stress relief gap 1912 may be operable to prevent excessive pressure buildup within the valve assembly 160, particularly between the high-pressure (first) cavity 2018 and the low-pressure (second) cavity 2020 of the valve assembly 160, as will be described in more detail below (see Figures 44-46).

[0126] Without departing from the scope of this disclosure, additional and / or fewer first weld paths 1908 and / or second weld paths 1910 may be included in the valve assembly 160. Additionally and / or alternatively, the first weld paths 1908 and / or second weld paths 1910 may be located along various other parts of the valve assembly 160 and may have various other suitable shapes and / or configurations other than those shown and described herein.

[0127] As best shown in Figure 42, 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 (outer) weld path 1908 in which the diaphragm 2012 is positioned. In some embodiments, the diaphragm 2012 may include a central body 2011A and an outer rim 2011B extending outward from the central body 2011A around the periphery of the diaphragm 2012, particularly along the bottom surface of the diaphragm 2012. In an example, the low-pressure body portion 2014 may include a corresponding cavity 2013, sized, shaped, and / or otherwise configured to receive the outer rim 2011B, thereby coupling the diaphragm 2012 to the low-pressure body portion 2014. The diaphragm 2012 may include a raised portion located at the radial center of the central body 2011A, the raised portion having a thickness that protrudes outward from the central body 2011A by a distance greater than the extension of the outer rim 2011B.

[0128] As will be described in detail below, the valve assembly 160 may include a valve seat 2028 formed along the low-pressure body portion 2014 (see Figures 44–46). The valve seat 2028 may be integral 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, as shown in Figure 42, the valve seat may include a vent insert 2028A coupled to the low-pressure body portion 2014. In this case, the vent 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 which is sized, shaped, and / or otherwise configured to receive the vent insert 2028A.

[0129] Referring further to Figure 42, the vent insert 2028A may include a cavity 2029 extending around the periphery of the vent insert 2028A, particularly along the bottom surface of the vent insert 2028A. In this example, the low-pressure body portion 2014 may include a corresponding inner ledge 2017, sized, shaped, and / or otherwise configured to extend into the cavity 2029, thereby joining the vent insert 2028A to the low-pressure body portion 2014. The vent insert 2028A may be joined to the low-pressure body portion 2014 via a third weld path 1914 positioned between the inner ledge 2017 and the cavity 2029. The vent insert 2028A may further include a conduit 2026. The conduit 2026 may be formed within the vent insert 2028A and extend within the interior of the valve assembly 160, particularly into the low-pressure cavity 2020. The vent insert 2028A may be sized and / or shaped such that the conduit 2026 includes a reduced diameter compared to the conduit 2026 of the valve seat 2028, as further described herein (see Figures 44–46). By providing a conduit 2026 with a reduced diameter, the vent insert 2028A may have a smaller cross-sectional shape with respect to the valve seat 2028, thereby facilitating a diaphragm 2012 having a correspondingly reduced diameter between the low-pressure body portion 2014 and the high-pressure body portion 2016.

[0130] Referring here to Figure 37, the valve assembly 160 may include an orifice assembly 161 (e.g., a pressure limiter) positioned between the low-pressure body portion 2014 and the high-pressure body portion 2016. The orifice assembly 161 may be configured to limit the flow rate of pressurized fluid received by the valve assembly 160 and subsequently discharged from the valve assembly 160 to a container 112 or the like. The high-pressure body portion 2016 may include a plurality of retaining teeth 163 that abut the upper surface of the orifice assembly 161, thereby ensuring secure coupling of 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 restrict 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 automatic syringe 100, particularly during the discharge of pressurized fluid from the canister 150 through the orifice assembly 161. The low-pressure body portion 2014 may include a channel 2019 that is in fluid communication with the orifice assembly 161 through the opening 166, so that pressurized fluid from the low-pressure body portion 2014 can move into the orifice assembly 161 through the channel 2019 and the opening 166. The valve assembly 160 may further include a gasket 165 (e.g., an O-ring) positioned below the orifice assembly 161 and in contact with the orifice assembly 161, thereby preventing the pressurized fluid entering the orifice assembly 161 at the opening 166 from being redirected around the outside of the orifice assembly 161 and flowing towards the channel 2019.

[0131] Referring here to Figures 38-40, exemplary retaining mechanisms for the valve assembly 160 are shown. Specifically, the exemplary retaining mechanism for the valve assembly 160 defines the interface around the puncture mechanism 164, which is configured and operable to establish fluid communication with the canister 150 during use of the auto-injector 100 as described above. The exemplary retaining mechanism may be configured and operable to hold, stabilize, and / or seal the puncture mechanism 164 during use of the auto-injector 100. It should be understood that any one of the exemplary retaining mechanisms shown and described herein may be incorporated into the auto-injector 100 without departing from the scope of this disclosure.

[0132] Specifically referring to Figure 38, the valve assembly 160 may include a first retaining mechanism 2060 for holding the puncture mechanism 164. In this example, the first retaining mechanism 2060 may include a gasket 2062 (e.g., an O-ring) positioned around the outside of the puncture mechanism 164, and the high-pressure body portion 2016 may include a plurality of retaining teeth 2064 that abut the upper surface of the gasket, thereby securely coupling the gasket 2062 around the puncture mechanism 164. The gasket 2062 may be further configured to redirect pressurized fluid released from the canister 150 into the valve assembly 160 via the puncture mechanism 164 around the outside of the puncture mechanism 164, preventing it from flowing out of the valve assembly 160. Multiple retaining teeth 2064 may be configured to restrict the movement of the gasket 2062, and the gasket 2062 may be configured to restrict the radial movement of the puncture mechanism 164 relative to the low-pressure body portion 2014 and the high-pressure body portion 2016 during use of the automatic syringe 100, particularly during connection with the canister 150 and / or during the discharge of pressurized fluid from the canister 150 into the orifice assembly 160.

[0133] In another example, as shown in Figure 39, the valve assembly 160 may include a second retaining mechanism 2070 for holding the puncture mechanism 164. In this example, the second retaining mechanism 2070 may include a body 2072 positioned around the outside of the puncture mechanism 164. In this example, the body 2072 may be integral with the low-pressure body portion 2014 so that the body 2072 and the low-pressure body portion 2014 may form a single unit. In other embodiments, the body 2072 of the second retaining mechanism 2070 may be separate from the low-pressure body portion 2014 and may be selectively coupled to the low-pressure body portion 2014. The body 2072 may include a channel and / or a lumen 2074 extending through it, the lumen 2074 may be sized, shaped, and / or otherwise configured to receive the puncture mechanism 164 through it. In the example, the diameter of the lumen 2074 may correspond to the diameter of the puncture mechanism 164, thereby securely connecting the puncture mechanism 164 to the body 2072. The second retaining mechanism 2070 may further include a notch 2076 formed along the upper surface of the body 2072. The notch 2076 may extend into the body 2072 toward the lumen 2074. The notch 2076 may include one or more grooves 2077 having an angled and / or tapered configuration or surface that extend radially inward toward the lumen 2074. In the example, the notch 2076 may be sized, shaped, and / or otherwise configured to receive and guide the puncture mechanism 214 into the lumen 2074. In some embodiments, the angled and / or tapered contour of the groove 2077 may be configured to restrict the movement of the puncture mechanism 164 relative to the body 2072, particularly its movement from the lumen 2074 during acceptance within the lumen 2074.

[0134] 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 used to form the retaining mechanism 2070. The second channel 2119 may define an undercut region below the body 2072 within the high-pressure body portion 2016 to form a weld path between the second retaining mechanism 2070 and the high-pressure body portion 2016. As shown in Figure 40, the valve assembly 160 may also include one or more canister retaining mechanisms 2088 (e.g., retaining bosses) for holding the canister 150.

[0135] Referring to Figure 41, the valve assembly 160 may be in fluid communication with the ventilation system 2030, as will be described in more detail below. In some embodiments, the ventilation system 2030 may be located within the valve assembly 160, while in other embodiments, the ventilation system 2030 may be separate from the valve assembly 160 and fluidly coupled to it. In this example, the ventilation system 2030 may be located within the valve assembly 160 between the low-pressure body portion 2014 and the high-pressure body portion 2016. The ventilation system 2030 may be fluidly coupled to one or more of the high-pressure (first) cavity 2018 and / or the low-pressure (second) cavity 2020.

[0136] The venting system 2030 may be configured to release (e.g., vent) the pressure generated within the valve assembly 160 once the delivery of the drug from the auto-injector 100 is complete. For example, the venting system 2030 may be configured to move (e.g., translate) between one or more positions in a first direction A and / or a second direction B relative to the low-pressure body portion 2014 and the high-pressure body portion 2016. The venting system 2030 may be operable to selectively define one or more fluid paths 10 for the pressurized fluid to move through the valve assembly 160 and for release into the internal cavity of the auto-injector 100 and / or the surrounding atmosphere as it moves between one or more positions. In this example, the venting system 2030 may include a body 2032 and a pair of gaskets 2033 positioned around the outside of the body 2032. The body 2032 may include a first opening 2034 and a second opening 2036 located along the end of the body 2032 opposite to the first opening 2034.

[0137] Referring further to Figure 41, the first opening 2034 and the second opening 2036 may be fluid-communicated with and aligned with each other along the longitudinal axis of the body 2032. The first opening 2034 may define an operating line of the vent system 2030 for receiving pressurized fluid through the body 2032 along the flow path 10. The body 2032 may have a third opening 2038 that is fluid-communicated with the first opening 2034 and is laterally aligned with the first opening 2034 and the second opening 2036. Each of the openings of the vent 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 shown in Figure 41, the body 2032 may be positioned relative to the valve assembly 160 such that the third opening 2038 aligns with the vent slot 2037 of the high-pressure body portion 2016. In this case, the pressurized fluid received into the body 2032 along the flow path 10 can exit the third opening 2038 and enter the vent slot 2037 to vent the valve assembly 160. The vent system 2030 may include an obstruction 2039 (e.g., a retaining arm) extending from the low-pressure body portion 2014 to restrict the movement (e.g., translation) of the body 2032 in the first direction A, such as when the vent system 2030 is in the position shown in Figure 41 where the third opening 2038 is aligned with the vent slot 2037. It should be understood that the body 2032 may be configured to move (e.g., translate) in response to the valve assembly 160 receiving pressurized medium from the canister 150.

[0138] Referring here to Figure 43, an exemplary pressure sensing system 2090 of the automatic syringe 100 is schematically shown. The pressure sensing system 2090 may include a housing 2091 having a container 112, a canister 150, a first accumulator 2094, a second accumulator 2096, a pressure limiter 2098, a piston 2097, and a biasing mechanism 2099 (e.g., a spring) disposed therein. In this example, the canister 150 may be in fluid communication with the first accumulator 2094 via a first conduit 2092A, and the first accumulator 2094 may be in fluid communication with the pressure limiter 2098 and the piston 2097, respectively, via a second conduit 2092B. Thus, pressurized fluid released from the canister 150 can be delivered to the first accumulator 2094 via the first conduit 2092A. The first accumulator 2094 and the second accumulator 2096 may each be capable of operating as energy storage devices, such as pressure storage reservoirs, in which a pressurized medium (e.g., gas) received therein can be held under sufficient pressure applied by an external power source. For example, the first accumulator 2094 may be configured to receive, store, and release pressurized fluid from the canister 150 to the second conduit 2092B. In some embodiments, the first accumulator 2094 may be configured to deliver the pressurized fluid to the second conduit 2092B at a pressurized level relatively higher than the original pressurized level received from the canister 150.

[0139] At least a first portion of the pressurized fluid may be discharged from the first accumulator 2094 through the second conduit 2092B toward the piston 2097, thereby moving (e.g., translating) the piston 2097. In this example, the piston 2097 may be pushed toward a first position by a biasing mechanism 2099, as shown in Figure 43. In response to receiving pressurized fluid from the first accumulator 2094, the piston 2097 may be configured to compress the biasing mechanism 2099 and move toward a second position. At least a second portion of the pressurized fluid may be discharged from the first accumulator 2094 through the second conduit 2092B toward the pressure limiter 2098. The pressure limiter 2098 may be configured to limit the flow rate of pressurized fluid received from the first accumulator 2094 through 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 path region in the second conduit 2092B and a low-pressure flow path region in the third conduit 2092C. In some embodiments, the pressure limiter 2098 may include a porous material, a meandering channel, and / or an orifice assembly.

[0140] Referring further to Figure 43, at least a first portion of the pressurized fluid received into the third conduit 2092C by the pressure limiter 2098 may be received and stored by the second accumulator 2096, and at least a second portion of the pressurized fluid received into the third conduit 2092C by the pressure limiter 2098 may be received in the container 112. In particular, the pressurized fluid received in the container 112 may be operable to move (e.g., push) a piston 114 within the container 112, thereby delivering the drug stored therein from the container 112. In this example, the biasing mechanism 2099 may be sized and / or configured to set a predetermined termination pressure such that the biasing mechanism 2099 returns to an expansion configuration when the pressurization in the pressure sensing system 2090 falls below a predetermined threshold (e.g., 150 psi). In other words, the biasing mechanism 2099 may be configured to expand and move (e.g., push) the piston 2097 in the opposite direction as the flow rate of pressurized fluid through the pressure sensing system 2090 decreases. It should be understood that the pressurization within the pressure sensing system 2090 may gradually decrease as the drug stored in the container 112 is discharged in response to the movement of the piston 114 within it.

[0141] In an example, the housing 2091 may include a window 2093 positioned such that, as the piston 2097 translates, the window 2093 can operate to provide visual feedback of the state of the auto-syringer 100 from the visualization of the relative position of the piston 2097 within the auto-syringer 100. In some examples, the piston 2097 may include one or more markings and / or other markers along the outer surface of the piston 2097 that can be seen through the window 2093, the one or more markings indicating various operating states of the auto-syringer 100 to the user. In a further example, the pressure sensing system 2090 may be configured to generate audible feedback indicating the state of the auto-syringer 100, in particular, when the piston 2097 moves (e.g., translates) to a position corresponding to the compression configuration of the biasing mechanism 2099 after completing the delivery of the drug from the container 112.

[0142] Referring here to Figures 44-46, an exemplary drive system 2000 for the auto-injector 100 is schematically shown. The drive system 2000 may be configured to provide a driving force for delivering the drug 20 from the container 112 to the patient. The drive system 2000 may include a canister 150 (i.e., a fluid source) fluid-coupled to one or more components of the auto-injector 100, such as the needle 116 and the valve assembly 160. The drive system 2000 may further 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. The canister 150 may be operably coupled to the container 112 via the first high-pressure line 2002 and the drive line 2008. Furthermore, the canister 150 may be fluidly coupled to the 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 embodiments, the drive system 2000 may include a pressure reduction mechanism (e.g., an orifice) along the first high-pressure line 2002.

[0143] The valve assembly 160 may include a diaphragm 2012 located between a low-pressure body portion 2014 and a high-pressure body portion 2016. Within the valve assembly 160, the diaphragm 2012 defines a high-pressure (first) cavity 2018 and a low-pressure (second) cavity 2020. The valve assembly 160 may further include a high-pressure (first) inlet 2022, a low-pressure (second) inlet 2024, and a conduit 2026. The conduit 2026 is formed within the valve seat 2028, which extends particularly into the low-pressure cavity 2020. The high-pressure cavity 2018 may be in fluid communication with the first high-pressure line 2002 via a second high-pressure line 2004 and inlet 2022. The low-pressure cavity 2020 may be in fluid communication with the low-pressure line 2006 via the low-pressure inlet 2024. The low-pressure cavity 2020 may be in fluid communication with the third line 2010 via the conduit 2026. The drive system 2000 may include a ventilation system 2030 that is fluidly connected by several fluid lines or conduits. For example, the ventilation system 2030 may be in fluid communication with the valve assembly 160 via the third line 2010. The ventilation system 2030 may be configured to ventilate the drive system 2000 by releasing pressurized fluid into the internal cavity of the auto syringe 100 and / or into the atmosphere. As described above, the ventilation system 2030 may include the sliding piston 190 of the auto syringe 100.

[0144] Referring further to Figures 44 to 46, the container 112 may include an upper end 112A and a bottom end 112B. The container 112 may include a cavity 112C having an opening at the upper end 112A and extending toward the bottom end 112B. The bottom end 112B may include a stopper 112D configured to assist in closing and / or sealing the bottom end 112B and to allow the needle 116 to be fluidly coupled to the container 112 at the bottom end 112B. The stopper 112D may include a line seal, a projection positioned at the neck of the container 112 (e.g., to reduce dead volume), and / or a septum formed from uncoated bromobutyl material or another suitable material. The cavity 112C may be closed at the upper end 112A by a piston 114. The piston 114 may include bromobutyl material coated with a fluoropolymer and, in some embodiments, may include a conical nose that helps reduce dead volume within the container 112. The piston 114 may include one or more rubber materials, among other materials, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile. As described in detail above, the container 112 may store the agent 20 (e.g., drugs, fluids, etc.) in the cavity 112C.

[0145] The canister 150 may include a non-latching can or a latching can. The canister 150 may be configured to distribute a liquid propellant to boil outside the canister 150 in order to provide pressurized gas (vapor pressure) that acts on the piston 114 in the container 112. In some embodiments, the canister 150 may contain pressurized gas that is released from the canister 150 and acts on the piston 114 in the container 112. In some embodiments, a latching can may remain latched open so that once opened, the entire contents of the propellant are distributed from there. Alternatively, in some embodiments, the canister 150 may be selectively controlled, including selectively operating and deactivating. For example, in an alternative embodiment, the flow of pressurized gas from the canister 150 may be stopped after the flow has started.

[0146] The fluid from the canister 150 can be any suitable propellant to provide vapor pressure and drive the piston 114 against the vessel 112. In some embodiments, the canister 150 may be a high-pressure canister configured to hold compressed gas. In certain embodiments, the propellant may be or may contain hydrofluoroalkanes ("HFA"), e.g., HFA134a, HFA227, HFA422D, HFA507, or HFA410A. In certain 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), nitrogen oxide (N2O), etc.).

[0147] Figure 44 shows the pre-operation state of the automatic syringe 100. To move the automatic syringe 100 from the pre-operation state in Figure 44, the canister 150 may be actuated to move the piston 114 toward the needle 116 along the longitudinal axis of the container 112. The canister 150 may be actuated to move to an open configuration in which the propellant can exit the canister 150 as pressurized gas. As described above, the canister 150 may be actuated in response to one or more components of the valve assembly 160 (e.g., the puncture mechanism 164) coming into contact with the canister 150. In some embodiments, the actuation is irreversible, so that the flow of pressurized gas from the canister 150 cannot be stopped once the pressurized gas is released from the canister 150.

[0148] When canister 150 is activated, pressurized gas may flow through the first high-pressure line 2002 and drive line 2008, and then into container 112. A portion of the pressurized gas from the first high-pressure line 2002 may be redirected to the high-pressure cavity 2018 via the second high-pressure line 2004 and high-pressure inlet 2022. As shown in Figure 45, the change in pressurization may cause the diaphragm 2012 to move into the low-pressure cavity 2020 and toward the conduit 2026 (for example, in the first direction), thereby sealing the valve seat 2028. Reduced-pressure gas may be redirected to the low-pressure cavity 2020 via the low-pressure line 2006 and low-pressure inlet 2024. The pressure difference between the high-pressure cavity 2018 and the low-pressure cavity 2020 may provide the force necessary for the diaphragm 2012 to seal the conduit 2026. The gas flowing through the drive line 2008 may initiate the movement of the piston 114 within the container 112 toward the needle 116. In particular, with the needle 116 in fluid communication with the drug 20 within the container 112, the operation of the canister 150 may apply pressure to the piston 114 contained in the cavity 112C, and this pressure may then be applied to the drug 20 itself by driving the piston 114 toward the bottom end 112B. In this case, as shown in Figure 45, the needle 116 is in fluid communication with the contents of the container 112 (e.g., the drug 20). As the gas from the drive line 2008 pushes the piston 114 toward the bottom end 112B, the drug 20 is discharged from the container 112 until the piston 114 reaches the bottom end 112B (and touches the bottom). As described above and below, the pressurized gas from the canister 150 may also drive the movement of one or more other components of the automatic syringe 100 (e.g., the indicator assembly 170, the sliding piston 190, etc.).

[0149] Referring here to Figure 46, when the piston 114 settles at the bottom end 112B, the pressure across the high-pressure cavity 2018 and the low-pressure cavity 2020 can be equalized, thereby causing the diaphragm 2012 to rise from the valve seat 2028 and open the conduit 2026. In this case, the diaphragm 2012 can move in a second direction opposite to the first direction. This allows the gas from the low-pressure line 2006 to move through the conduit 2026 and the third line 2010 to the ventilation system 2030, where the gas can be discharged from the ventilation system 2030 (see Figure 41). It should be understood that the canister 150 may be configured to contain sufficient pressurized fluid so that the release of pressurized gas can actuate the movement of both the cavity 112C and one or more other components of the auto-injector 100 (e.g., indicator assembly 170, sliding piston 190, etc.). In some cases, the canister 150 may contain excess pressurized gas, i.e., more fluid than is necessary 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 allows the movement of one or more components of the autosyringer 100 (e.g., the shroud 120, actuator 125, mandrel assembly 180, etc.) to initiate the retraction of the aforementioned components relative to the housing 102 of the autosyringer 100.

[0150] Referring here to Figures 47–52, an auto-syringe 100 is shown according to an example of this disclosure. It should be understood that the size, shape, and / or layout of the auto-syringe 100, in particular the vertical upright design of the housing 102, can enhance various aspects of the auto-syringe 100 in use. For example, aspects such as the position and visibility of the first window 108, the size and position of the secondary indicator (e.g., piston flag 114A) in the container 112, the shape and size of the shroud 120, and the controlled handling of the housing 102 by the user can be improved by the vertical upright design of the auto-syringe 100. In some embodiments, the housing 102 may be sized, shaped, and / or otherwise designed to provide an outer surface 102A between the upper end 104 and the bottom end 106 for displaying labels and / or other markings on the auto-syringe 100 (see Figures 49–52). For example, a label on the outer surface 102A may provide information indicating the contents of the auto-syringe 100, the direction of use of the auto-syringe 100, etc. It should be understood that the outer surface 102A may define the front, rear, and / or both of the housing 102. In further embodiments, the housing 102 may be sized, shaped, and / or otherwise designed to minimize the perceived and / or actual shape of the auto-injector 100, improve visual dose indication (e.g., primary indicator, secondary indicator, etc.), and facilitate an intuitive configuration that is generally less intrusive to the user.

[0151] In the example, particularly with reference to Figure 47, the size, shape, and / or bulk design of the shroud 120 can be relatively minimized. Additionally, the draft angle of the housing 102, and in particular the angles of the opposing pair of side walls 104A, 106A of the housing 102 between the upper end 104 and the lower end 106, can be minimized so that the side walls 104A, 106A are substantially parallel to each other. In some embodiments, the upper end 104 may have a domed and / or rounded configuration (see Figures 47-62 and 74-83), and in other embodiments, the upper end 104 may have a flat and / or planar configuration (see Figures 63-66 and 69-73).

[0152] In further embodiments, the housing may generally have an irregular shape, such as a trefoil contour, which can emphasize the cylindrical shape of the container 112 placed within the housing (see Figures 91-93). In some embodiments, the housing 102 may be formed from a clear mold having one or more frosted elements, while in other embodiments, the housing 102 may be formed from a clear mold having a painted finish on the back. As described herein, one or more components of the auto-syringe 100 may include corresponding or distinguishing colors to facilitate intuitive use and / or to minimize perceived threats when using the auto-syringe 100. As will be described in more detail below, the auto-syringe 100 may include one or more recesses, cavities, edges, ridges, and / or grip elements along the exterior of the housing 102, which may be configured to enhance the control and friction texture of the housing 102.

[0153] The auto-injector 100 may be configured to improve visual volume indication by having a piston 114 with a bright color scheme (e.g., red, yellow, orange) visible through the container 112 via a first window 108. The first window 108 may be positioned inside along the housing 102 instead of outside the housing 102 to further improve visual volume indication (see Figures 67-68 and 79-83). Furthermore, the auto-injector 100 may omit the outer window lens that is positioned entirely above the first window 108 (see Figures 56-57, 63-66, and 79-93). In some embodiments, secondary indicators may be provided within and / or along the exterior of the housing 102 (see Figures 47-48, 53A-53C, 56 and 91-93). In additional embodiments, the pressurized fluid (e.g., gas) released into the container 112 may be colored and easily visible through the first window 108. The auto-injector 100 may be configured to facilitate a generally less jarring and more intuitive configuration by incorporating a softer, more matte color displayed along the exterior of the housing 102, or one or more markings (e.g., directional graphics) displayed along the exterior of the housing, to indicate the direction or location of needle use (see Figures 50-53C, 69-71, 79-83) and / or a bright color displayed along the exterior of the housing 102.

[0154] Referring further to Figure 47, the auto-injector 100 may include one or more secondary indicators. In an example, the secondary indicator may include a piston flag 114A (e.g., a peg) configured to be attached to the piston 114 and operable (see Figures 53A-53C). The piston flag 114A may be sized, shaped, and / or otherwise configured to provide visual feedback of dose indication during use of the auto-injector 100. In other words, the piston flag 114A may be coupled to the piston 114 and operable to visually indicate the current position of the piston 114 relative to the container 112, thereby indicating the dose delivery status of the auto-injector 100. In some embodiments, the piston 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 flag 114A within the container 112 through the first window 108.

[0155] As shown in Figure 48, the piston flag 114A may include a plurality of threads 114B which can be configured to engage with the lumen of the piston 114, thereby screwing the piston flag 114A therein. The piston flag 114A may further include an upper end 114C which can be sized, shaped, and / or otherwise configured such that it extends outward from the piston 114 when the piston flag 114A is coupled therein. In other words, the upper end 114C may be located outside the piston 114 so that the piston flag 114A is easily visible from the first window 108 when coupled to the piston 114. In this example, the upper end 114C may have a cylindrical configuration, but in other embodiments, the upper end 114C may have a variety of other suitable sizes, shapes, and / or configurations.

[0156] Referring to Figures 49–52, the auto-injector 100 may include a rounded and / or domed configuration at the upper end 104, a window lens positioned on the first window 108 for sealing the container 112 within the housing 102, and the shroud 120 may include one or more operational markings 120B configured to facilitate the use of the auto-injector 100. In an example, the markings 120B may include directional graphics (e.g., arrows) indicating the direction of movement of the housing 102 relative to the shroud 120 for dose delivery. Additionally and / or alternatively, the markings 120B may be positioned along the outer portion of the shroud 120 to indicate the relative position of a needle (e.g., needle 116) positioned within the shroud 120, facilitating the positioning of the shroud 120 on the user's skin surface (see Figures 54–55). In this case, the marking 120B may be configured to indicate the precise alignment of the needle 116 at the intended injection site while the needle 116 remains positioned inside the shroud 120.

[0157] The shroud 120 may include a body 120A that is sized, shaped, and / or otherwise designed such that it has cross-sectional dimensions substantially corresponding to the contour of the housing 102 at the bottom end 106. In other words, the body 120A of the shroud 120 may match the cross-sectional shape of the housing 102, particularly the bottom end 106. In other embodiments, as shown and described herein, the shroud may have a cross-sectional shape that varies with respect to the housing in order to facilitate control of the shroud and / or to provide indication of the position of a needle placed therein (see Figures 59–68 and 84–93).

[0158] The automatic syringe 100 may further include one or more soft colors along the exterior of the housing 102, and side labels positioned along the outer surface 102A. In some embodiments, the draft angle of the housing 102 may be about 1 degree between the upper end 104 and the lower end 106. In other words, pairs of opposing side walls 104A, 106A of the housing 102 may be substantially parallel to each other and / or angled minimally. In an example, the outer surface 102A may be coplanar with adjacent outer surfaces of the housing 102. In other examples, as shown and described herein, the outer surface 102A may be concave and / or raised relative to adjacent outer surfaces of the housing 102 to facilitate the acceptance of the labels and / or reinforced grip of the automatic syringe 100. In some embodiments, the housing 102 may have a soft pebble shape, surface, and / or texture along the upper end 104 to enhance the user's grip interface of the automatic syringe 100.

[0159] The cap 111 may be removably coupled to the housing 102 at its bottom end 106, within which the shroud 120 is located. The cap 111 may include a bottom end 111A that is tapered radially outward and / or flared relative to the rest of the cap 111. The bottom end 111A may be configured to facilitate gripping the cap 111, for example, when removing the cap 111 from the housing 102 to expose the shroud 120 before dose delivery. In some embodiments, the bottom end 111A may include a geometric flare extending radially outward from the cap 111, and in other embodiments, the bottom end 111A may include an extended edge or ridge.

[0160] In exemplary use, as shown in Figures 53A–53C, the piston flag 114A may be configured to translate (vertically) through the container 112 as the piston 114 translates toward the container 112 to deliver volume in response to the shroud 120 moving toward the housing 102. Before volume delivery, with the shroud 120 in an extended position toward the housing 102, as shown in Figure 53A, the piston flag 114A may not be visible from the first window 108 when the piston 114 is maintained in a first position adjacent to the upper end 104. In this case, the position of the piston flag 114A may indicate that the auto-injector 100 is a new device that has not been operated before. As shown in Figure 53B, during volume delivery when the shroud 120 is retracted into the housing 102, the piston flag 114A may be visible from the first window 108 as the piston 114 translates downward (vertically) through the container 112. In this case, the position of the piston flag 114A may indicate the auto-injector 100 being used to deliver a portion of the dose stored in the container 112. Once the dose has been delivered and the shroud 120 has returned to its extended position relative to the housing 102, the piston flag 114A may be repositioned adjacent to the bottom end 106, as shown in Figure 53C, thereby indicating the auto-injector 100 as a used device.

[0161] Figures 54-55 show the auto-injector 100 positioned relative to the injection site, more specifically, the skin surface S of the user (e.g., patient). In some cases, the injection site may be located along a region of the user's body where the skin surface S may be curved (Figure 54), and in other cases, the injection site may be located along a region where the skin surface S may be substantially flat and / or planar (Figure 55). The shroud 120 may be sized, shaped, and / or otherwise configured such that when the shroud 120 retracts into the housing 102, the cross-sectional shape of the shroud 120 is minimized, the distance the needle 116 may extend outward from the shroud 120 is maximized, and thereby the depth to which the needle 116 extends through the skin surface S is maximized. In other words, the shroud 120 may be sized to have a length, width, and depth that collectively define the minimum cross-sectional dimensions of the shroud 120, thereby allowing the needle 116 to extend outward from the shroud 120 to its maximum extent. Thus, the auto-injector 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 shroud 120 may have various other suitable configurations for identifying the insertion point of the needle 116, enabling the user to precisely position the shroud 120 along the skin surface S to maximize the insertion depth of the needle 116.

[0162] Referring to Figures 56–58, another exemplary auto-syringe 2100 is shown in accordance with the examples of this disclosure. It should be understood that the auto-syringe 2100 may be substantially similar in configuration and operation to the auto-syringe 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-syringe 100 are used herein to identify similar components of the auto-syringe 2100. In the example, the auto-syringe 2100 may include a housing 2102 having a longitudinal length defined between an upper end 104 and a bottom end 106, with a shroud 120 movably coupled to the bottom end 106 (Figure 57). As best shown in Figure 56, the auto-syringe 2100 may include a cap 111 detachably coupled to the bottom end 106, thereby housing the shroud 120, and a cover 2106 detachably positioned over a window 2108 of the housing 2102 (see Figure 58). The cap 111 may be configured to prevent unintended movement of the shroud 120 before using the auto-syringe 2100 when the cap 111 is coupled to the bottom end 106. The cover 2106 may be configured to prevent unintended damage to and / or contact with the container 112 before using the auto-syringe 2100 when the cover 2106 is coupled to the housing 2102. As described later, the auto-syringe 2100 may be configured such that the window 2108 is not covered by the outer window lens, and the container 112 is exposed when the cover 2106 is removed.

[0163] As best shown in Figure 57, the window 2108 may be located along at least one of the opposing side walls 106A of the housing 2102. In other words, the window 2108 may be formed along the outer edge of the housing 2102. The window 2108 may define a cutout area within the housing 2102 to receive the container 112, so that the auto-syringe 2100 does not have to include an outer window lens and / or a barrier positioned over the window 2108. In other embodiments, as shown in Figure 58, the window 2108 may include a container 112 that hides the outer window lens within the housing 2102. Additionally, the auto-syringe 2100 may include a secondary indicator in the form of a flag 2114 located within the window 2108. The flag 2114 may be substantially similar in size, shape, and / or other configuration to the piston flag 114A shown and described above. Therefore, the flag 2114 may be configured to translate relative to the container 112 when the auto-injector 2100 is in use in order to provide the user with a dosage indication. In the example, the upper end 104 of the housing 102 may have a rounded and / or curved shape, and the housing 2102 may include a matte label and / or a textured label placed on the outer surface 102A to enhance the user's controlled grip of the auto-injector 2100. In some embodiments, the housing 2102 may have a configuration in which the draft angle is reduced along its longitudinal length between the upper end 104 and the bottom end 106 to enhance the ergonomic profile of the auto-injector 2100. In other words, pairs of opposing side walls 104A, 106A of the housing 2102 may be angled minimally relative to each other.

[0164] Referring to Figures 59–62, another exemplary automatic syringe 2150 is shown in accordance with the examples of this disclosure. It should be understood that the automatic syringe 2150 may be substantially similar in configuration and operation to the automatic syringe 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the automatic syringe 100 are used herein to identify similar components of the automatic syringe 2150. In the example, the automatic syringe 2150 may include a housing 2152 having a longitudinal length defined between an upper end 104 and a bottom end 106, a first window 108 extending along at least one side wall 106A, and an outer surface 102A as described in detail above. In the example, the upper end 104 may include a sculpted pebble shape, surface, and / or texture to enhance the user grip interface of the housing 2152. The housing 2152 may have a side draft of about 1 degree between the upper end 104 and the bottom end 106, particularly along the opposing pair of side walls 104A and 106A of the housing 2152. The housing 2152 may have a front draft of about 0 degrees between the upper end 104 and the bottom end 106, particularly along the outer surface 102A of the housing 2152.

[0165] In the example, the outer surface 102A may be concave with respect to adjacent outer surfaces of the housing 2152. Therefore, any labels and / or markings located on the outer surface 102A may be positioned along a plane concave with respect to the rest of the housing 2152. In some embodiments, a grip rim 2154 may be formed around the outer surface 102A. The grip rim 2154 may be configured and operable to enhance the grip interface of the housing 2152 during use. In other words, the grip rim 2154 may form a ridge for the user's fingers to grasp when manually controlling the auto-syringe 2150. The auto-syringe 2150 may include a shroud 2120 movably coupled to the housing 2152 at a bottom end 106. The shroud 2120 may have a keyhole profile defined by a bottom surface 2122, a rounded end 2126, and a constricted end 2128. The rounded end 2126 may have a substantially circular and / or cylindrical shape and may be aligned with the needle of the automatic syringe 2150 (e.g., needle 116) and positioned relative to the housing 2152. Thus, the rounded end 2126 may be configured to indicate the position of the needle located within the housing 2152. In other words, the rounded end 2126 may be positioned relative to the housing 2152 along the shroud 2120, parallel to and / or coinciding with the needle, to facilitate the positioning of the shroud 2120 at the injection site during use without extending the needle from the shroud 2120 through the opening 2124 in the bottom surface 2122.

[0166] Referring further to Figures 59 to 62, the auto-syringe 2150 may include a cap 2111 that is removably coupled to the housing 2152 at its bottom end 106. The cap 2111 includes a bottom end 2112 that is tapered radially outward and / or flared relative to the rest of the cap 2111, which may facilitate gripping of the cap 2111, such as when the cap 2111 is removed from the housing 2152 to expose the shroud 2120. The auto-syringe 2150 may further include one or more soft colors along the exterior of the outer surface 102A and the shroud 2120, respectively, compared to the color along the exterior of the rest of the housing 2152, which may help the user easily distinguish the components of the auto-syringe 2150 from one another during use.

[0167] Referring here to Figures 63–66, another exemplary auto-syringe 2200 is shown in accordance with the examples of this disclosure. It should be understood that the auto-syringe 2200 may be substantially similar in configuration and operation to the auto-syringes 100 and 2150 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-syringes 100 and 2150 are used herein to identify similar components of the auto-syringe 2200. For example, as best shown in Figure 97, the automatic syringe 2200 may include one or more internal components similar to those of the automatic syringe 100 (e.g., a container 112, a needle 116, an actuator 125, a chassis 130, a canister 150, a valve assembly 160, a mandrel assembly 180, a sliding piston 190, etc.), but these components may be positioned and / or oriented in alternative configurations within the housing 2202 of the automatic syringe 2200, based on the size and / or shape of the automatic syringe 2200, as described in detail herein.

[0168] In the example, the automatic syringe 2200 may include a housing 2202 having a longitudinal length defined between an upper end 104 and a bottom end 106, to which a shroud 2120 is movably coupled to the bottom end 106. The housing 2202 may generally have a rounded cross-sectional profile, thereby providing a curved configuration to the automatic syringe 2200. The housing 2202 may be defined by a pair of opposing side walls 104A, 106A, and may include a plane 2204 at the upper end 104. In some embodiments, recesses, cavities and / or indentations may be formed along the plane 2204 to facilitate the reception of the user's fingers during use of the automatic syringe 2200. In this case, the recesses along the plane 2204 may be configured to enhance the grip interface of the housing 2202 during use of the automatic syringe 2200.

[0169] The auto-injector 2200 may include a window 2208 located along at least one of the side walls 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 notch within the housing 2202 to receive the container 112, so that the auto-injector 2200 does not have to include an outer window lens and / or a barrier positioned above the window 2208 (see Figure 64). The shroud 2120 may include a keyhole profile defined by a bottom surface 2122, a rounded end 2126, and a constricted end 2128 (see Figure 66), as described in more detail above. The shroud 2120, in particular the rounded end 2126, may be configured to indicate the position of a needle positioned within the housing 2202 in order to improve the alignment of the auto-injector 2200 at the injection site during use.

[0170] Referring to Figures 67-68, another exemplary auto-syringe 2300 is shown in accordance with the examples of this disclosure. It should be understood that the auto-syringe 2300 may be substantially similar in configuration and operation to the auto-syringes 100, 2150 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-syringes 100, 2150 are used herein to identify similar components of the auto-syringe 2300. In the example, the auto-syringe 2300 may include a housing 2302 having a longitudinal length defined between an upper end 104 and a bottom end 106, to which a shroud 2120 is movably coupled to the bottom end 106. In the example, the upper 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 the pairs of opposing side walls 104A, 106A are substantially parallel to each other.

[0171] The automatic syringe 2300 may include a window 2308 positioned along the housing 2302 between the upper end 104 and the bottom end 106. In particular, the window 2308 may be located on the inside of the housing 2302. In other words, the window 2308 may be formed between a pair of opposing side walls 104A, 106A of the housing 2302. Positioning the window 2308 radially offset from the pair of opposing side walls 104A, 106A can improve the visibility of the container 112 and piston 114 contained within it during use, such as when the user's hand is positioned along the opposing side walls 104A, 106A to grasp the housing 2302. Having the window 2308 on the inside of the housing 2302 minimizes obstruction of the window 2308 by the user's hand. The window 2308 may define a notch within the housing 2302 to receive the container 112, so that the automatic syringe 2300 does not have to include an outer window lens and / or a barrier positioned above the window 2308.

[0172] Referring to Figures 69–73, another exemplary auto-syringe 2400 is shown in accordance with the examples of this disclosure. It should be understood that the auto-syringe 2400 may be substantially similar in configuration and operation to the auto-syringe 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-syringe 100 are used herein to identify similar components of the auto-syringe 2400. In the example, the auto-syringe 2400 may include a housing 2402 having a longitudinal length defined between an upper end 104 and a bottom end 106, a cap 111 removably coupled to the housing 2402 at the bottom end 106, and a shroud 120 movably coupled to the bottom end 106. As best shown in Figure 69, the cap 111 may be configured to conceal the shroud 120 when coupled to the bottom end 106. The shroud 120 may be exposed when the cap 111 is removed from the housing 2402, as shown in Figure 70.

[0173] The automatic syringe 2400 may have a flat configuration along the upper end 104, particularly a plane 2404. The upper end 104 may define elemental shapes, and a pair of opposing side walls 104A, 106A may be aligned substantially parallel to each other. In the example, the housing 2402 may include a transparent outer body 2408 along the portion of the housing 2402 that coincides with the position of the container 112 placed inside the housing 2402. The transparent outer body 2408 may be configured and operable to facilitate visual inspection of the container 112, particularly the position of the piston 114 relative to the container 112 during use of the automatic syringe 2400. In some embodiments, the transparent outer body 2408 may include a window. In the example, the automatic syringe 2400 may include a marking 2406 on the housing 2402, such as adjacent to the bottom end 106. The markings 2406 may include directional graphics (e.g., arrows) indicating the direction of movement of the housing 2402 relative to the shroud 120 during use, and / or the markings 2406 may be positioned along the outer portion of the housing 2402 to indicate the relative position of the needle (e.g., needle 116) within the housing 2402, thereby facilitating the positioning of the auto-injector 2400 on the user's skin surface for precise alignment of the needle at the intended injection site. In some embodiments, the auto-injector 2400 may be configured such that a label (not shown) can be wrapped around the outer periphery of the housing 2402. In further embodiments, the auto-injector 2400 may include a similar coloring scheme along the exteriors of the housing 2402 and the shroud 2120, respectively.

[0174] Referring to Figures 74–78, another exemplary auto-syringe 2500 is shown in accordance with the examples of this disclosure. It should be understood that the auto-syringe 2500 may be substantially similar in configuration and operation to the auto-syringe 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-syringe 100 are used herein to identify similar components of the auto-syringe 2500. In the example, the auto-syringe 2500 may include a housing 2502 having a longitudinal length defined between an upper end 104 and a bottom end 106, a cap 2511 removably coupled to the housing 2502 at the bottom end 106, and a shroud 2520 movably coupled to the bottom end 106. As shown in Figure 74, the cap 2511 may be configured to conceal the shroud 2520 when coupled to the bottom end 106. The shroud 2520 can be exposed by removing the cap 2511 from the housing 2502, as shown in Figure 75.

[0175] The cap 2511 may include a body having a rounded and / or curved cross-sectional shape, and the shroud 2520 may include a body 2522 having a corresponding rounded and / or curved cross-sectional shape. The auto-syringe 2500 may include a rounded configuration along the longitudinal length of the housing 2502, particularly between the upper end 104 and the bottom end 106. The rounded configuration of the auto-syringe 2500 may enhance the rounded tactile feel of the housing 2502 during use. The auto-syringe 2500 may include a window lens positioned on the window 2508 of the housing 2502, and a pair of opposing side walls 104A, 106A may be substantially parallel to each other. The shroud 2520 may include one or more operable markings 2524 configured to facilitate the use of the auto-syringe 2500. In the example, the marking 2524 may include a directional graphic (e.g., an arrow) indicating the direction of movement relative to the shroud 2520. Additionally and / or alternatively, the marking 2524 may be positioned along the outer portion of the shroud 2520 to indicate the relative position of the needle (e.g., needle 116) within the shroud 2520, facilitating the positioning of the shroud 2520 on the user's skin surface for precise alignment of the needle at the intended injection site. In some embodiments, the upper end 104 may be relatively flat to define the tactile form of the housing 2502. The auto-injector 2500 may include labels positioned along one or more outer surfaces of the housing 2502, such as the front and rear surfaces between pairs of opposing side walls 104A, 104B.

[0176] Referring to Figures 79–83, another exemplary auto-injector 2600 is shown in accordance with the examples of this disclosure. It should be understood that auto-injector 2600 may be substantially similar in configuration and operation to auto-injectors 100, 2500 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for auto-injectors 100, 2500 are used herein to identify similar components of auto-injector 2600. For example, as best shown in Figure 98, the automatic syringe 2600 may include one or more internal components similar to those of the automatic syringe 100 (e.g., a container 112, a needle 116, an actuator 125, a chassis 130, a carrier 140, a canister 150, a valve assembly 160, an indicator assembly 170, a mandrel assembly 180, a sliding piston 190, etc.), but these components may be positioned and / or oriented in alternative configurations within the housing 2602 of the automatic syringe 2600, based on the size and / or shape of the automatic syringe 2600, as described in detail herein.

[0177] In the example, the automatic syringe 2600 may include a housing 2602 having a longitudinal length defined between an upper end 104 and a lower end 106, to which a shroud 2520 is movably coupled to the lower end 106. The housing 2602 may have a generally rounded and / or narrowed cross-sectional profile, thereby providing the automatic syringe 2600 with a thinned configuration. The housing 2602 may be sized, shaped, and / or otherwise configured such that a pair of opposing side walls 104A, 106A are substantially parallel to each other. The upper end 104 and the lower end 106 may each be generally rounded and / or curved. The automatic syringe 2600 may include a window 2608 located inside the housing 2602. In other words, the window 2608 may be formed between the opposing side walls 104A, 106A of the housing 2602. The window 2608 may define a cutout area within the housing 2602 to receive the container 112, so that the automatic syringe 2600 does not have to include an outer window lens and / or a barrier positioned above the window 2608.

[0178] The shroud 2520 may include a body 2522, as described in more detail above. The shroud 2520 may include one or more operable markings 2622 along the body 2522, configured to facilitate the use of the auto-injector 2600. In an example, the markings 2622 may include directional graphics (e.g., arrows) indicating the direction of movement of the shroud 2520. Additionally and / or alternatively, the markings 2622 may be positioned along the outer portion of the body 2522 to indicate the relative position of the needle (e.g., needle 116) within the shroud 2520, facilitating the positioning of the shroud 2520 on the user's skin surface for precise alignment of the needle at the intended injection site.

[0179] In other embodiments, as best shown in Figure 83, the upper end 104 may be substantially flat and the lower end 106 may be rounded. In this case, the automatic syringe 2600 may have a flat configuration along the upper end 104. The upper end 104 may include a recess 2604 that is sized, shaped, and / or otherwise configured to enhance the grip interface of the housing 2602 during use of the automatic syringe 2600. For example, the recess 2604 may be sized and / or shaped to accommodate the user's fingers when gripping the upper end 104, thereby improving the controllability of the housing 2602.

[0180] Referring here to Figures 84–87, another exemplary automatic syringe 2700 is shown in accordance with the examples of this disclosure. It should be understood that the automatic syringe 2700 may be substantially similar in configuration and operation to the automatic syringe 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the automatic syringe 100 are used herein to identify similar components of the automatic syringe 2700. For example, as best shown in Figure 99, the automatic syringe 2700 may include one or more internal components similar to those of the automatic syringe 100 (e.g., a container 112, a needle 116, an actuator 125, a chassis 130, a canister 150, a valve assembly 160, a mandrel assembly 180, a sliding piston 190, etc.), but these components may be positioned and / or oriented in alternative configurations within the housing 2702 of the automatic syringe 2700, based on the size and / or shape of the automatic syringe 2700, as described in detail herein.

[0181] In an example, the auto-injector 2700 may include a housing 2702 having a longitudinal length defined between a top end 104 and a bottom end 106, and a shroud 2720 is movably coupled to the bottom end 106. The shroud 2720 may include a bottom surface 2722 (e.g., a user engagement interface) and a body 2724 that defines a cross-sectional shape of the shroud 2720 that is relatively smaller than the shroud 120 described above. The cross-sectional shape of the shroud 2720 may correspond to the position of a needle (e.g., needle 116) disposed within the housing 2702. Thus, the position of the shroud 2720 may indicate the injection position of the needle during use of the auto-injector 2700. The housing 2702 may include a plane 2701 at the top end 104 such that the housing 2702 may have a flat configuration along the top end 104.

[0182] In an example, the auto-injector 2700 may include an extended housing 2705 that is 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 270第六, where the top end 2704 is disposed relatively below the top end 104 and the bottom end 2706 is disposed along a plane generally parallel to the bottom end 106. The extended housing 2705 may extend radially outward from at least one of the opposing side walls 104A of the housing 2702, thereby disassembling the form of the auto-injector 2700 into a pair of housings 2702, 2705. The top end 2704 may define a user interface by which a user may control the auto-injector 2700 during use, such as manually gripping the extended housing 2705. It should be understood that one or more internal components of the auto-injector 27o0 may be disposed within the interiors of the housing 2702 and the extended housing 2705, respectively. In other words, the extended housing 2705 may provide a shrink-wrap housing for containing one or more components of the auto-injector 2700, as shown in FIG. 99.

[0183] The auto-injector 2700 may include a window 2708 disposed 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 edge of the housing 2702. The window 2708 may define a notch region within the housing 2702 for receiving the container 112 such that the auto-injector 2700 may not include an outer window lens and / or a barrier disposed over the window 2708 (see FIG. 85).

[0184] Referring to FIGS. 88 - 90, another exemplary auto-injector 2800 is shown in accordance with an example of the present disclosure. It should be understood that the auto-injector 2800 may be constructed and operable substantially similar to the auto-injector 100 shown and described above, except for the differences explicitly stated herein. Accordingly, like reference numerals of the auto-injector 100 are used herein to identify like components of the auto-injector 2800. In the example, the auto-injector 28️0 may include a housing 2802 having a longitudinal length defined between an upper end 104 and a bottom end 106, and a shroud 2820 is movably coupled to the bottom end 106. The shroud 2820 may include a bottom surface 2822 (e.g., a user engagement interface) and a body 2824 defining a narrowed cylindrical profile of the shroud 2820. In other words, the body 2824 may be sized, shaped, and / or otherwise designed as a single barrel configuration. The narrowed cylindrical profile of the body 2824 may correspond to the position of a needle (e.g., needle 116) disposed within the housing 2802. Accordingly, the position of the shroud 2820 may indicate the injection position of the needle during use of the auto-injector 2800.

[0185] In the example, the upper end 104 of the housing 2802 may have a rounded and / or curved shape, and the auto-syringe 2100 may include a window 2808 located along at least one of the opposing side walls 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 within the housing 2802 to receive the container 112, so that the auto-syringe 2800 does not have to include an outer window lens and / or a barrier positioned above the window 2808. In the example, the housing 2802 may include an outer surface 2804 that is concave with respect to adjacent outer surfaces of the housing 2802. Therefore, any labels and / or markings located on the outer surface 2804 may be concave with respect to adjacent exteriors of the housing 2802. In some embodiments, the outer surface 2804 may define a grip area of ​​the housing 2802 for manually controlling the auto-syringe 2800 during use. The auto-syringe 2800 may include a raised edge 2806 formed along the outside of the housing 2802 between the outer surface 2804 and the window 2808. The raised edge 2806 may be sized, shaped, and / or otherwise configured to improve the user's grip interface of the housing 2802 for the auto-syringe 2800.

[0186] Referring specifically to Figure 90, the auto-injector 2800 may include a secondary indicator 2810 located along the housing 2802, particularly on the outer surface 2804. The secondary indicator 2810 may be configured and operable to facilitate the use of the auto-injector 2800, such as by providing the user with a dosage indicator. In some embodiments, the secondary indicator 2810 may be configured to display one or more colors and / or other visual elements indicating the operating state of the auto-injector 2800. For example, the secondary indicator 2810 may coincide with an indicator assembly (e.g., indicator assembly 170) located inside the housing 2802, such that the indicator assembly can be seen from outside the housing 2802 through the secondary indicator 2810. In this case, the secondary indicator 2810 may include a window or notch opening inside the housing 2802. In the example, the auto-injector 2800 may include a cap 2811 that is removably coupled to the housing 2802 at the bottom end 106. The cap 2811 may be sized and / or shaped such that it has cross-sectional dimensions corresponding to the cross-sectional dimensions of the housing 2802, so that the cap 2811 may have an outer diameter larger than the narrowed cylindrical outer diameter of the shroud 2820.

[0187] Referring to Figures 91–93, another exemplary auto-injector 2900 is shown in accordance with the examples of this disclosure. It should be understood that the auto-injector 2900 may be substantially similar in configuration and operation to the auto-injector 100 shown and described above, except for differences expressly stated herein. Accordingly, similar reference numbers for the auto-injector 100 are used herein to identify similar components of the auto-injector 2900. For example, as best shown in Figure 100, the automatic syringe 2900 may include one or more internal components similar to those of the automatic syringe 100 (e.g., a container 112, a needle 116, an actuator 125, a chassis 130, a carrier 140, a canister 150, a valve assembly 160, an indicator assembly 170, a mandrel assembly 180, a sliding piston 190, etc.), but these components may be positioned and / or oriented in alternative configurations within the housing 2902 of the automatic syringe 2900, based on the size and / or shape of the automatic syringe 2900, as described in detail herein.

[0188] In the example, the automatic syringe 2900 may include a housing 2902 having a longitudinal length defined between an upper end 104 and a bottom end 106, with a shroud 2920 movably coupled to the bottom end 106 (see Figure 92). The automatic syringe 2900 may also include a cap 2911 detachably coupled to the bottom end 106, thereby positioning the shroud 2920 within the cap 2911 when the cap 2911 is coupled onto the housing 2902. The housing 2902 may include a plane 2904 at the upper end 104 so that the housing 2902 may have a flat configuration along the upper end 104. The housing 2902 may be sized, shaped, and / or otherwise designed to have a generally trefoil-like contour, with pairs of opposing side walls 104A, 106A converging at a central angle 2906. In other words, the housing 2902 may form a rounded triangular configuration (e.g., a Reuleaux triangle). It should be understood that the auto-injector 2900 may include alternative configurations and / or orientations of internal components than those of the auto-injector 100 shown and described above, taking into account the trefoil contour of the housing 2902.

[0189] The housing 2902 may include a window 2908 positioned along the central angle 2906 such that the window 2908 is located between a pair of opposing side walls 104A, 106A. The window 2908 may define a cutout area within the housing 2902 to receive a container 112 such that the automatic syringe 2900 does not have to include an outer window lens and / or a barrier positioned above the window 2908. The shroud 2920 may include a bottom surface 2922 (e.g., a user engagement interface) and a body 2724 that defines the cross-sectional dimensions of the shroud 2920 corresponding to the three-lobed contour of the housing 2902 described above.

[0190] The embodiments shown and described herein should be understood to generally have relatively reduced cross-sectional dimensions (e.g., height, width, and depth) to minimize user perception of a bulky appearance in an automatic syringe. The reduced profile of the automatic syringes of this disclosure may facilitate easier control and generally less intimidating, intuitive configuration for the user. The cross-sectional shapes of the embodiments shown and described herein may further facilitate grasping the automatic syringe with a variety of appropriate hand positions and grips. By incorporating a reduced profile, the need for the user to stabilize the automatic syringe of this disclosure with multiple hands can be minimized.

[0191] In the embodiments shown and described herein, the container 112 may include a 3-milliliter pre-filled syringe. In other embodiments, the auto-injector may be configured and operable to deliver a smaller volume of liquid from the container 112. In this case, one or more components of the auto-injector may be designed to correspond to the relative position of the piston 114 in the container 112 for delivering the intended dose. For example, as shown in Figure 94, the exemplary auto-injector 3000 may include a housing 3002 having a window 3008 with a relatively short longitudinal length to accommodate a smaller volume of liquid from the container 112. In other words, the window 3008 may be formed on the housing 3002 with a length matching the volume of liquid in the container 112, such that the length of the window 3008 is substantially shorter than the length of the container 112 positioned inside the housing 3002. In this case, the initial position of the piston 114 in the container 112 may be visible through the window 3008.

[0192] As a further example, as shown in Figure 95, the exemplary auto-injector 3100 may include a secondary label 3102 positioned on at least a portion of the first window 108, thereby covering the portion of the first window 108 corresponding to the unfilled volume of the container 112. In this case, the secondary label 3102 can cover and / or conceal the portion of the container 112 that does not contain the drug, so that the initial position of the piston 114 in the container 112 can be seen from the first window 108. The secondary label 3102 may be separate from one or more labels positioned along the outer surface 102A of the housing 102, and it should be understood that the secondary label 3102 may be directly coupled to the outer window lens of the first window 108 or otherwise attached. As another example, as shown in Figure 96, the exemplary auto-injector 3200 may include a label 3202 integrated with a label positioned on the outer surface 102A of the housing 102. In this case, the label 3202 may be positioned over at least a portion of the first window 108, thereby covering the portion of the first window 108 that corresponds to the unfilled volume of the container 112. In this case, the label 3202 can cover and / or conceal the portion of the container 112 that does not contain the drug, so that the initial position of the piston 114 inside the container 112 can be seen from the first window 108.

[0193] Referring here to Figure 101, another exemplary automatic syringe 4100 is shown in accordance with the examples of the present disclosure. The automatic syringe 4100 may include a housing having a bottom cover 4110 and a top cover (not shown). The bottom cover 4110 may be defined by a first end 4120 and a second end 4130. The bottom cover 4110 may define a tissue engagement surface along the external interface of the bottom cover 4110, through which a fluid conduit (e.g., a needle) can be deployed and retracted (see Figure 133). The top cover may define a user interface surface through which a user can control the automatic syringe 4100, such as through a window that provides visibility of one or more internal components of the automatic syringe 4100. The automatic syringe 4100 may include a needle mechanism 4200 and a valve assembly 4300 housed between the bottom cover 4110 and the top cover of the housing. The needle mechanism 4200 may include a carrier 4210 (Figures 119A-119B and 121), an activator 4230 (Figure 122), an actuator or button 4250 (Figures 127-129), a shuttle actuator 4260 (Figures 130-132), an indicator slide 4270 (Figures 130-132), a fluid conduit 4280 (Figure 133), and a needle retainer or sterile connector 4290 (Figure 134).

[0194] The valve assembly 4300 may be configured and operable substantially similarly to the valve assembly 160 shown and described above, except for differences explicitly stated herein. For example, the valve assembly 4300 may include a low-pressure body portion 4310, a high-pressure body portion 4330, and a fluid source 4350. The fluid source 4350 should be understood to be configured and operable similarly to the canister 150 shown and described above. The valve assembly 4300 may be operably coupled to the fluid conduit 4280 via a vessel 4370 having a stopper 4380. In other words, the fluid conduit 4280 may establish fluid communication with the vessel 4370, and the vessel 4370 may be operably coupled to the valve assembly 4300, thereby fluidly coupling the valve assembly 4300 to the fluid conduit 4280 through the vessel 4370. The container 4370 includes a piston 4378 that restricts the reception of fluid (e.g., pressurized gas) from the valve assembly 4300 to the container 4370 and / or the fluid conduit 4280. As described in detail herein, the needle mechanism 4200 and the valve assembly 4300 may be coupled to each other and collectively configured to deploy the fluid conduit through the bottom cover 4110 (Figure 133), deliver a drug dose from the container 4370 (Figures 102A-102C), and retract the needle into the housing of the auto-injector 4100 in response to a single action of the auto-injector 4100 by the user.

[0195] The automatic syringe 4100 may have any suitable dimensions that allow for portability and self-assembly by the user. The automatic syringe 4100 may have, for example, a length of about 0.5 inches to about 5.0 inches, a width of about 0.5 inches to about 3.0 inches, and a height of 0.5 inches to about 2.0 inches. The automatic syringe 4100 may also include a grip or friction coating so that the outer surface of the automatic syringe 4100 is a non-slip surface. The automatic syringe 4100 may be oriented about a longitudinal axis 10 (e.g., the X-axis), a left-right axis 12 (e.g., the Y-axis) substantially perpendicular to the longitudinal axis 10, and a transverse axis 14 (e.g., the Z-axis) substantially perpendicular to both the longitudinal axis 10 and the transverse axis 12. In some embodiments, the transverse automatic syringe of the present disclosure may have a dimension along the longitudinal axis 10 that is longer than the dimension along the left-right axis 12 and / or the transverse axis 14. It should be understood that the automatic syringe 4100 may be sized, shaped, and / or otherwise configured as a lateral device and / or a non-lateral device without departing from the scope of this disclosure.

[0196] In certain embodiments of the automatic syringe 4100, such as when the automatic syringe 4100 is a wearable automatic syringe, the automatic syringe 4100 may include one or more features for securing it to the user, such as an adhesive patch or a strap. For example, a wearable automatic syringe may include an adhesive patch positioned along the outside of the bottom cover 4110. The adhesive patch may be bonded to the outside of the bottom cover 4110 (e.g., a tissue engagement surface) to help secure the automatic syringe 4100 to the user's body (e.g., skin). The adhesive patch may be formed from cloth or any other suitable material and may include an adhesive. The adhesive may be a water-based or solvent-based adhesive, or, for example, a hot-melt adhesive. Suitable adhesives also include acrylic, dextrin-based, and urethane-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 may be joined to the bottom cover 4110, for example, by 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) that is larger than the width of the auto-injector 4100 (e.g., a dimension parallel to the left-right axis 12). In other embodiments of the present disclosure, the auto-injector 4100 does not include an adhesive patch. For example, the auto-injector 4100 may be a handheld auto-injector, as opposed to a wearable auto-injector. In at least some embodiments, the handheld auto-injector may require the user to hold the auto-injector 4100 against the user's skin for the entire duration of the injection procedure, while the wearable auto-injector may include features for securing the auto-injector 4100 against the skin.

[0197] Referring further to Figure 101, container 4370 may be sized and shaped to store the nominal value of the drug. The “nominal volume” of a container (also called “specified volume” or “specified capacity”) refers to the maximum capacity of the container as specified by the container manufacturer or safety standards body. The manufacturer or safety standards body may specify the nominal volume of a container to indicate that the container can be filled (aseptically or non-aseptically) with that volume of fluid and used while maintaining the closure, sealing, sterilization, packaging, transport, and / or the closure integrity of the container, and while maintaining the safety, sterility, and / or sterility of the fluid contained inside. When determining the nominal volume of a container, the manufacturer or safety standards body may also take into account variability that occurs during normal filling, sealing, sealing, packaging, transport, and administration procedures. For example, a pre-filled syringe may be filled with fluid up to its nominal volume, either manually or mechanically, and then sealed with either a vent or a vacuum plug, without the filling and sealing machinery and tools coming into contact with and potentially contaminating the contents of the syringe. Alternatively, the stopping machinery and tools may be sterile or aseptic and can come into contact with the contents of the syringe and / or the syringe itself without causing contamination.

[0198] Container 4370 may have a nominal volume of approximately 5.0 mL in some examples, but any other suitable nominal volume (e.g., approximately 0.5 mL to approximately 50.0 mL, or approximately 2.0 mL to approximately 10.0 mL, or approximately 3.0 mL to approximately 6.0 mL, or approximately 1.0 mL to approximately 3.0 mL, or approximately 2.0 mL to approximately 5.0 mL, or another suitable range) may also be used depending on the drug to be delivered. In other examples, container 4370 may have a nominal volume of approximately 0.5 mL or more, or approximately 2.0 mL or more, or approximately 3.0 mL or more, or approximately 4.0 mL or more, or approximately 5.0 mL or more. Container 4370 may contain and store drugs for injection to a user, and may help maintain the sterility of the drugs. In one embodiment, the container 4370 may be configured to deliver a delivery amount of drug (for example, 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, more than about 1.0 mL, more than about 2.0 mL, more than about 3.0 mL, more than about 4.0 mL, more than about 5.0 mL, more than about 10.0 mL, more than about 20.0 mL, or another delivery amount).

[0199] The amount delivered may be less than the nominal volume of container 4370. Furthermore, in order to deliver the delivered amount of drug to the user, container 4370 itself may be filled with a different amount of drug (i.e., a filling amount). The filling amount may be a larger amount of drug than the delivered amount, taking into account, for example, dead space in container 4370 or fluid conduit 4280 that prevents some drug from being transferred from container 4370 to the user. Therefore, although container 4370 may have a nominal volume of 5 mL, the filling amount and delivered amount of drug may be less than 5 mL.

[0200] In one embodiment, when container 4370 is used in a handheld auto-injector, the amount of drug delivered from container 4370 may be 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 amount of drug delivered may depend on the viscosity of the drug and the handheld nature of the auto-injector 4100. That is, in at least some embodiments, at a certain viscosity, a larger amount of drug may hinder the auto-injector 4100's ability to complete the injection procedure in less than an acceptable time, for example, less than about 30 seconds. Therefore, the amount of drug delivered from the auto-injector 4100 may be set such that the injection procedure, measured from 1) when the auto-injector 4100 is placed on the user's skin to 2) when the auto-injector 4100 is removed from the skin, is less than approximately 30 seconds or less than another approximate period (e.g., less than approximately 25 seconds, less than approximately 20 seconds, less than approximately 15 seconds, or less than approximately 10 seconds).

[0201] If the delivery volume and / or viscosity of the drug is too high, the time required to complete the injection procedure may be longer than commercially or clinically acceptable for a handheld device, and therefore the auto-injector 4100 may not be able to function as a handheld auto-injector. In this case as well, as described above, in embodiments in which the container 4370 is used in a handheld auto-injector, the delivery volume of the drug from the container 4370 may be set so that the injection procedure defined above is completed within a relatively short period of time (to avoid the need for additional features for attaching the auto-injector 4100 to the user so that the auto-injector 4100 is a wearable auto-injector). However, various embodiments of this disclosure are intended to relate to wearable auto-injectors that deliver relatively large amounts of medication (e.g., more than about 3.5 mL) and / or have a relatively long injection procedure time (e.g., more than about 30 seconds, more than about 1 minute, more than about 2 minutes, more than about 5 minutes, or more than about 1 hour) to complete the injection procedure, measured from 1) the time the auto-injector is placed on the user's skin to 2) the time the auto-injector is removed from the skin.

[0202] The container 4370 may have a neck with a diameter of approximately 13 mm, a length of approximately 45 mm, and an inner diameter of approximately 19.05 mm. In another embodiment, the container 4370 may be a standard 3 mL container having an 8 mm crimped top, an inner diameter of 9.7 mm, and a length of 64 mm. In a further embodiment, the container 4370 may have a length of approximately 64 mm to 74 mm (excluding the length of the neck of the container 4370 at the second end 4374 of the container 4370, as shown in Figures 102A to 102C), for example, approximately 69.3 mm ± 0.15 mm. In embodiments including a neck, the container 4370 may have a length in the range of approximately 65 mm to 75 mm, for example, approximately 70.8 mm ± 0.4 mm. These values ​​are merely examples, and other suitable dimensions may be used as needed. In some examples, the container 4370 may be formed using conventional materials and may be shorter than existing devices, thereby allowing the auto-injector 4100 to remain cost-effective and compact. In some embodiments, the container 4370 may be a shortened ISO 10 mL cartridge. The auto-injectors of the present disclosure may be configured to deliver highly viscous liquids to a patient. For example, the auto-injector 4100 of the present disclosure may be configured to deliver liquids having 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.

[0203] Referring further to Figure 101, the container 4370 may include a piston 4378 movably disposed within the cavity of the container 4370. The piston 4378 may be movable by a pressurized fluid discharged from a fluid source, such as a fluid source 4350 (Figures 102A-102C). As further described herein, the pressurized fluid (e.g., gas) discharged from the fluid source 4350 may translate the piston 4378 within the container 4370, causing the container 4370 to translate horizontally along the longitudinal axis 10 toward the second end 4130. As the piston 4378 moves toward the second end 4130, the piston 4378 acts on the contents within the container 4370 (e.g., drugs, pharmaceuticals, medicines, etc.), thereby ultimately transmitting a force to the container 4370, which in turn causes the container 4370 to move along the longitudinal axis 10. In some embodiments, the transverse automatic syringe may be oriented such that the fluid source 4350 and the piston 4378 are offset, or otherwise oriented so as not to be longitudinally aligned with each other.

[0204] Referring to Figures 102A to 102C, the drive system 4150 of the auto-injector 4100 is schematically shown. It should be understood that the drive system 4150 may be substantially similar to the drive system 2000 shown and described above, except for differences explicitly stated herein. The drive system 4150 may be configured to provide a driving force for delivering the drug 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 auto-injector 4100, e.g., the needle mechanism 4200 and the valve assembly 4300. The drive system 4150 may further 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 operably coupled to the container 4370 via the first high-pressure line 4152 and the drive line 4155. Furthermore, the fluid source 4350 can be fluidly coupled to the 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.

[0205] Referring further to FIGS. 102A - 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. The diaphragm 4320 may be configured and operable substantially similar to the diaphragm 2012 shown and described above, except for the differences explicitly stated herein. 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 further 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 that extends within the interior of the valve assembly 4300, particularly within 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 an inlet 4160. The low - pressure cavity 4163 may be in fluid communication with the low - pressure line 4154 via a low - pressure inlet 4162. The low - pressure cavity 4163 may be in fluid communication with a third line 4156 via the conduit 4164.

[0206] The drive system 4150 may include a venting system 4172 fluidly connected by several fluid lines or conduits. For example, the venting system 4172 may be in fluid communication with a fluid source 4350 via the high - pressure line 4152 and with the valve assembly 4300 via the third line 4156. The venting system 4172 may be configured to vent the drive system 4150 by discharging pressurized fluid into the interior cavity of the auto - injector 4100 (e.g., defined between the cover 4110 and the upper cover) and / or into the atmosphere. In some embodiments, the venting system 4172 may be configured and operable similar to the venting system 2030 shown and described above.

[0207] Referring further to 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 stopper 4380 configured to assist in closing and / or sealing the second end 4374 and to allow the insertion of a needle 4288 (e.g., a stake needle) of a fluid conduit 4280 (Figure 133) into the container 4370. As shown in Figure 101, the stopper 4380 may include a line seal, a projection located at the neck of the container 4370 (e.g., for reducing dead volume), and / or a partition wall 4382. The partition wall 4382 may be formed from 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 fluoropolymer-coated bromobutyl material and, in some embodiments, may include a conical nose that helps reduce dead volume in the container 4370. The piston 4378 may include one or more rubber materials, among other materials, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile. As described in detail above, the container 4370 may store the agent 20 (e.g., drugs, fluids, etc.) in the cavity 4376.

[0208] The fluid source 4350 may include a non-latching can or a latching can. The fluid source 4350 may be configured to distribute a liquid propellant to boil outside the fluid source 4350 in order to provide pressurized gas (vapor pressure) acting on the piston 4378 in the vessel 4370. In some embodiments, the fluid source 4350 may include pressurized gas released from the fluid source 4350 and acting on the piston 4378 in the vessel 4370. In some embodiments, the latching can may remain latched open so that once opened, the entire contents of the propellant are distributed from there. Alternatively, in some embodiments, the fluid source 4350 may be selectively controlled, including selectively operating and deactivating. For example, in an alternative embodiment, the flow of pressurized gas from the fluid source 4350 may be stopped after the flow has started.

[0209] The fluid from the fluid source 4350 may be any suitable propellant to provide vapor pressure to drive the piston 4378 against the vessel 4370 and to drive the vessel 4370 against the housing of the automatic syringe 4100. In some embodiments, the fluid source 4350 may be a high-pressure canister configured to hold compressed gas, similar to the canister 150 shown and described above. In certain embodiments, the propellant may be or may include a hydrofluoroalkane ("HFA"), such as HFA134a, HFA227, HFA422D, HFA507, or HFA410A. In certain embodiments, the propellant may be a hydrofluoroolefin ("HFO") such as HFO1234yf or HFO1234ze, an organic gas (e.g., carbon dioxide (CO2)), a cryogenic gas (e.g., argon (Ar), helium (He)), a hydrocarbon gas (e.g., propane, butane, propylene, ethane, methane), or an inorganic gas (e.g., ammonia, nitrogen dioxide (NO2), nitrogen oxide (N2O)), or may contain any of these.

[0210] In the pre-operation state of the auto-syringe 4100 shown in Figure 102A, the needle 4288 may be in contact with the second end 4374 of the container 4370. In some embodiments, the needle 4288 may be separated from the second end 4374 of the container 4370 in the pre-operation state of the auto-syringe 4100. To move the auto-syringe 4100 from the pre-operation state of Figure 102A, the fluid source 4350 may be actuated to move the container 4370 along the longitudinal axis 10 toward the needle 4288. The fluid source 4350 may be actuated to move to an open configuration in which the propellant can exit the fluid source 4350 as pressurized gas. As will be described in more detail below, the fluid source 4350 may be actuated in response to one or more components of the needle mechanism 4200 coming into contact with the fluid source 4350. In some embodiments, the actuation is irreversible and thereby the flow of pressurized gas from the fluid source 4350 cannot be stopped.

[0211] When the fluid source 4350 is activated, pressurized gas may flow through the high-pressure line 4152 and the drive line 4155, and then into the vessel 4370. A portion of the pressurized gas from the high-pressure line 4152 may be converted to the high-pressure cavity 4161 via the second high-pressure line 4153 and the high-pressure inlet 4160. As shown in Figure 102B, this may cause the diaphragm 4320 to move toward the conduit 4164 into the low-pressure cavity 4163, thereby sealing the valve seat 4166. Reduced-pressure gas may be converted 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 may provide the force necessary for the diaphragm 4320 to seal the conduit 4164. The gas flowing through the drive line 4155 may initiate the movement of the vessel 4370 toward the needle 4288.

[0212] When the needle 4288 is not yet in fluid communication with the drug 20 in the container 4370, the operation of the fluid source 4350 may apply pressure to the drug 20 contained in the cavity 4376, which may be applied to the container 4370 itself. This pressure may cause the container 4370 to move toward the needle 4288, thereby pushing the needle 4288 through the partition 4382 of the stopper 4380. In this case, as shown in Figure 102B, the needle 4288 is in fluid communication with the contents of the container 4370 (e.g., the drug 20). Gas from the drive line 4155 then pushes the piston 4378 toward the second end 4374, allowing the drug 20 to be discharged through the container 4370 until the piston 4378 reaches the second end 4374 (and touches the bottom). In other words, when the needle 4288 is in fluid communication with the drug 20 in the container 4370, the piston 4378 moves further toward the second end 4374, and the drug 20 can be pushed out through the needle 4288. As further described herein, pressurized gas from the fluid source 4350 may also drive the movement of one or more components of the needle mechanism 4200 (e.g., the activator 4230, the shuttle actuator 4260, the indicator slide 4270, etc.) to drive the injection of the needle 4286 of the fluid conduit 4280 into the user (Figure 133).

[0213] Referring here to Figure 102C, when the piston 4378 settles to the bottom at the second end 4374, the pressure across the high-pressure cavity 4161 and the low-pressure cavity 4163 can be equalized, thereby causing the diaphragm 4320 to rise from the valve seat 4166 and open the conduit 4164. This allows the gas from the low-pressure line 4154 to move through the conduit 4164 and the third line 4156 to the ventilation system 4172, where the gas can be discharged from the ventilation system 4150. It should be understood that the fluid source 4350 may be configured to contain sufficient pressurized fluid so that the release of pressurized gas can actuate both the movement of the container 4370 into the housing of the autosynergia 4100 and the movement of the piston 4378 into the cavity 4376. In some cases, the fluid source 4350 may contain excess pressurized gas, i.e., more fluid than is necessary to complete the delivery of the drug 20 from the container 4370. The release of pressurized gas from within the drive system 4150 may allow one or more components of the needle mechanism 4200 (e.g., activator 4230, shuttle actuator 4260, indicator slide 4270, etc.) to move, causing the needle 4286 to begin retracting into the automatic syringe 4100 (Figure 133).

[0214] Referring here to Figure 103, as shown in more detail in Figures 119A to 119B, the carrier 4210 may include a first flange 4211 having a ledge 4214 extending laterally outward from a 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 a second flange 4216 at a second end of the carrier 4210 in the opposite direction from the first end of the carrier 4210. The first flange 4211 may extend parallel to the transverse axis 14, and the ledge 4214 may extend parallel to the longitudinal axis 10, thereby the first flange 4211 and the ledge 4214 may be lateral to each other. In the embodiment, the first flange 4211 and the ledge 4214 may form a joint at a 90-degree angle to each other. The first flange 4211 may include a first slot opening 4213 that is sized, shaped, and / or otherwise configured to receive at least a portion of the fluid conduit 4280, and a second slot opening 4215 that is sized, shaped, and / or otherwise configured to receive at least a portion of the sterile connector 4290. The slot openings 4213 and 4215 may allow the carrier 4210 to receive the fluid conduit 4280 and the sterile connector 4290 in a state prior to the assembly of the auto-syringe 4100.

[0215] 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 activator 4230 through the first opening 4217, and the second flange 4216 may be configured to receive at least another portion of the activator 4230 through the second opening 4218, thereby coupling the activator 4230 to the carrier 4210 when the needle mechanism 4200 is assembled, as shown in Figure 105A. As described herein, the activator 4230 may be configured to move relative to the carrier 4210 when the automatic syringe 4100 is activated, for example, in response to the movement of a button 4250 to engage with the activator 4230.

[0216] As best shown in Figures 119A and 119B, the carrier 210 may further include a pair of legs 4212A, 4212B extending parallel to the longitudinal axis 10. The first leg 4212A may be sized, shaped, and / or otherwise configured to receive an elastic member 4269 (e.g., a spring), for example, around the outside of the first leg 4212A (see Figure 105B). In this example, the first leg 4212A may be sized, shaped, and / or otherwise configured as a mandrel assembly extending through and supporting the elastic member 4269. As further described herein, the first leg 4212A may also be configured to extend to at least a portion of the shuttle actuator 4260, such as between a pair of guide flanges 4224 of the shuttle actuator 4260, with the elastic member 4269 positioned around the first leg 4212A. The elastic member 4269 may be configured to move the shuttle actuator 4260 by pressing the pair of guide flanges 4224 when expanded. The second leg 4212B may be sized, shaped, and / or otherwise configured to at least partially define the movement path of the shuttle actuator 4260, which may be configured to move (e.g., translate) within the housing of the automatic syringe 4100 along that movement path. The second leg 4212B may be configured to align the shuttle actuator 4260 with the carrier 4210, thereby coupling the shuttle actuator 4260 with the carrier 4210 when the needle mechanism 4200 is in an assembled state.

[0217] The carrier 4210 may include one or more features (e.g., walls, slots, cavities, platforms, etc.) located between the first flange 4211 and the second flange 4216 to engage with one or more components of the needle mechanism 4200, such as the driver 4240 (Figures 124-126) and the button 4250 (Figures 127-129). For example, the carrier 4210 may include a rail 4222 which is sized, shaped, and / or otherwise configured to mate with a slot in the driver 4240. The rail 4222 may be configured to guide, stabilize, and control the movement of the driver 4240 relative to the carrier 4210. It should be noted that the carrier 4210 and driver 4240 of this disclosure are not limited to any particular combination of features, for example, the rail which may be configured so that the driver 4240 is received in a corresponding slot in the carrier 4210. The carrier 4210 may include an obstruction defined by a pair of projections 4220, between which an intermediate gap is formed. The projections 4220 may be positioned along the inner surface of the first flange 4211 and may be configured to securely connect the carrier 4210 to the button 4250 by engaging with the fastening mechanism 4254 of the button 4250 (Figure 127).

[0218] For example, the fastening mechanism 4254 may include a tab and / or hook that is received between a pair of projections 4220 (e.g., within the gap defined by the projections 4220) when the button 4250 is in a first (non-operating) position (see Figure 109). In other words, the fastening mechanism 4254 may be locked between a pair of projections 4220 when the button 4250 is in a first (non-operating) position and / or extended relative to the carrier 4210. The fastening mechanism 4254 may be configured to exit the gap between the pair of projections 4220 when the button 4250 is moved toward a second (operating) position (see Figure 110). In this case, the fastening mechanism 4254 may remain engaged by at least the lowest projection 4220 of the pair of projections 4220, thereby maintaining the button 4250 in the second (operating) position. In this case, the fastening mechanism 4254 and the lower projection 4220 may collectively be configured to prevent further movement of the button 4250, such as locking out and returning to a first (non-operating) position, thereby maintaining the button 4250 pressed against the carrier 4210. In some embodiments, the fastening mechanism 4254 may be configured to balance the button 4250 against the carrier 4210.

[0219] As best shown in Figure 119B, the carrier 4210 may include a pair of ledges 4223A, 4223B along the sidewall of the carrier 4210, offset from each other by a certain distance. The pair of ledges 4223A, 4223B may be positioned along the sidewall of the carrier 4210, including the obstacle 4225. The pair of ledges 4223A, 4223B may be configured to guide the translation of the activator 4230 in response to the expansion or compression of the elastic member 4239, as described later.

[0220] Referring to Figures 103 and 121, the carrier 210 may include a strut 4219 positioned between the first flange 4211 and the second flange 4216. In this example, the strut 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 strut 4219 may be sized, shaped, and / or otherwise configured to accommodate the gear 4229 of the needle mechanism 4200 (see Figure 135). The gear 4229 may be configured to rotate relative to the strut 4219 in response to the movement of one or more features of the needle mechanism 4200 (e.g., driver 4240, button 4250, shuttle actuator 4260, etc.). As will be described in more detail herein, the gear 4229 may result in the selective deployment and retraction of the fluid conduit 4280 (Figure 133) from the housing of the automatic syringe 4100.

[0221] As shown in Figure 123, the gear 4229 may include a double spur gear having a first gear portion 4229A and a second gear portion 4229B, each of which includes a plurality of teeth arranged around the outer circumference of the respective gear portion. It should be understood that the pitch ratios of the plurality of teeth in the first gear portion 4229A and the second gear portion 4229B may be different from each other. In embodiments, the first gear portion 4229A and the second gear portion 4229B may have a substantially circular shape, and the first gear portion 4229A may have 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 example, the first gear portion 4229A may have a first gear ratio that is different (e.g., smaller) than the second gear ratio of the second gear portion 4229B.

[0222] The first gear portion 4229A may be in contact with the second gear portion 4229B, and the two gear portions 4229A and 4229B may rotate around the same axis. It should be understood that the gear 4229 may be configured to mesh with and interact with multiple components of the needle mechanism 4200. For example, the first gear portion 4229A may be configured to interact with and be operable with the driver 4240 of the needle mechanism 4200 (see Figures 124-126), and the second gear portion 4229B may be configured to interact with and be operable with the shuttle actuator 4260 (see Figures 130-132). In this example, the shuttle actuator 4260 and the driver 4240 may be configured to move different distances relative to each other during the same rotation of the gear 4229, due to the difference in size and / or pitch ratio of the two gear portions 4229A and 4229B. The gear 4229 may further include openings 4229C extending through gear sections 4229A and 4229B, respectively, for receiving the support column 4219 of the carrier 4210 through it.

[0223] Referring to Figures 103 and 122, the activator 4230 may include a central body 4232 positioned between a first end 4231 and a second end 4233 located opposite the first end 4231. In this example, the second end 4233 may have a relatively larger cross-sectional shape than the central body 4232 and the first end 4231, and the central body 4232 may have a relatively larger cross-sectional shape than the first end 4231. In this example, each of the central body 4232, the first end 4231, and the second end 4233 may generally have a cylindrical and / or elongated shape. The activator 4230 may have a longitudinal length defined between the opposing end portions 4234, 4238 of the first end 4231 and the second end 4233. The activator 4230 may include a flange 4235 extending radially outward from a second end 4233 and one or more splines 4236 extending radially outward from a first end 4231. In an example, the activator 4230 may include a plurality of splines 4236 arranged around the outer surface of the first end 4231. As described herein, the activator 4230 may include a locking arrangement having a carrier 4210, which is configured and operable to control the longitudinal movement of one or more components of the automatic syringe 4100. The locking arrangement between the activator 4230 and the carrier 4210 may be at least partially defined by a plurality of splines 4236.

[0224] In some embodiments, the splines 4236 may include, but are not limited to, tabs, projections, grooves, protrusions, raised surfaces, and / or various other suitable features arranged along the outer surface of the first end 4231 to define a locking configuration of the activator 4230 that interfaces with the carrier 4210. Multiple splines 4236 may be configured to bond with one or more features on the first flange 4211 to securely bond the activator 4230 to the carrier 4210. For example, multiple splines 4236 may be sized, shaped, and / or otherwise configured to mate with multiple corresponding retaining elements 4217A arranged around the first opening 4217. If the splines 4236 can align with the retaining elements 4217A, the activator 4230 may be fixed and / or locked relative to the carrier 4210. The splines 4236 may be sized, shaped, and / or otherwise configured to extend through a plurality of corresponding slots 4217B formed on the first opening 4217 (see Figures 108B-108C) in order to separate the activator 4230 from the first flange 4211. In other words, the first opening 4217 may be at least partially defined by the plurality of slots 4217B, which, when aligned with them, receive the corresponding splines 4236 of the plurality of splines 4236. If the splines 4236 are not aligned with the retaining elements 4217A but can be aligned with the slots 4217B, the activator 4230 may be movable and / or unlocked relative to the carrier 4210. In conjunction with the multiple splines 4236, the locked arrangement between the activator 4230 and the carrier 4210 can be defined at least partially by the multiple stoppers 4217A and the multiple slots 4217B.

[0225] As shown in Figures 108C to 108D, at least one of the multiple stoppers 4217A may be positioned between a pair of adjacent slots 4217B of the multiple slots 4217B. Each of the stoppers 4217A may be configured to receive a corresponding spline 4236 therein to securely couple the central body 4232 of the activator 4230 to the first flange 4211 in a fixed configuration (e.g., oriented), as shown in Figure 108C. In this case, the first end 4231 may extend through the first opening 4217, and the carrier 4210 may be configured to maintain the activator 4230 in a fixed configuration when no force is applied thereto by a button 4250 or the like. In other words, the multiple stoppers 4217A, when received therein, may be configured to restrict the movement (e.g., rotation, translation, etc.) of the multiple splines 4236. As described herein, the button 4250 may be configured to move (e.g., rotate) the central body 4232 so that the spline 4236 does not align with the retaining arm 4217A but aligns with the slot 4217B, as shown in Figure 108D, thereby allowing the first opening 4217 to receive the spline 4236 and the end portion 4238 through it to separate the activator 4230 from the first flange 4211. In other words, aligning the spline 4236 with the slot 4217B prevents the activator 4230 from being held in a fixed configuration by the carrier 4210 and / or from moving relative to the carrier 4210. The activator 4230 may be configured to move away from the first flange 4211, thereby moving the first end 4231, the spline 4236, and the terminal portion 4238 out of the first opening 4217.

[0226] Referring to Figures 105A and 106-107, the activator 4230 may include an elastic member 4239 (e.g., a spring) which is sized, shaped, and / or otherwise configured to extend around the outside of the central body 4232. For example, the elastic member 4239 may be positioned on the central body 4232, with one end of the elastic member 4239 against the second end 4233 and the opposite end of the elastic member 4239 against the inner surface of the first flange 4211. The elastic member 4239 may be configured to transition between a compression configuration and an expansion configuration in response to the rotation of the activator 4230 caused by the actuation of the button 4250, in particular to the rotation of a plurality of splines 4236 relative to the first opening 4217. In the example, the elastic member 4239 can be compressed longitudinally between the second end 4233 and the first flange 4211 parallel to the longitudinal axis 10 (see Figure 103) when in an energy storage state, as shown in Figure 109. With the elastic member 4239 in an energy storage state (e.g., compressed configuration), the central body 4232 may be positioned in a first position where the first end 4231 is received through the first opening 4217, the spline 4236 engages with the retainer 4217A, and is not aligned with the slot 4217B.

[0227] The elastic member 4239 may be movable in an energy-releasing state (e.g., an expanded configuration), in which case the central body 4232 moves toward a second position different from the first position when the activator 4230 moves (e.g., rotates), particularly when the activator 4230 moves (e.g., rotates) toward the first opening 4217 of the plurality of splines 4236 (see Figure 110). In this case, the plurality of splines 4236 can disengage the plurality of retainers 4217A so that the plurality of splines 4236 can be received through the slots 4217B as described for the elastic member 4239, and can align with the plurality of slots 4217B. Since the movement of the splines 4236 and their ends 4238 relative to the first flange 4211 is no longer restrained by the engagement between the splines 4236 and the retaining elements 4217A, the elastic member 4239 may be configured to apply force to the central body 4232 relative to the first flange 4211, thereby causing the activator 4230 to move away from the first flange 4211 and relative to the carrier 4210. As the elastic member 4239 pushes the central body 4232 away from the first flange 4211, the splines 4236 may extend through the slots 4217B and the ends 4238 may extend through the first opening 4217 until the splines 4236 and their ends 4238 are positioned on the opposite (inside) side of the first flange 4211, as shown in Figure 110.

[0228] As shown in Figures 109 to 110, the activator 4230 may be in contact with the fluid source 4350, and in particular, the second end 4233 may be in contact with the fluid source 4350 along the terminal 4234. Thus, the activator 4230 may be configured to move the fluid source 4350 in response to the elastic member 4239 moving from an energy storage state (e.g., compression configuration) to an energy release state (e.g., expansion configuration). In other words, the terminal 4234 may push the fluid source 4350, thereby moving the fluid source 4350 toward the valve assembly 4300, relatively away from the second flange 4216 of the carrier 4210, in response to the button 4250 moving from a first (non-operated) position to a second (operated) position, releasing the elastic member 4239 from expansion configuration to expansion configuration. The fluid source 4350 may be activated, 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 activator 4230 may be held in the first position by the carrier 4210 due to the interaction between a plurality of splines 4236 on the first end 4231 and a plurality of corresponding retainers 4217A on the first flange 4211. Thus, the carrier 4210 may be configured to prevent the activator 4230 from moving horizontally from the first position to the second position before the button 4250 activates the auto-injector 4100.

[0229] Referring to Figures 103 and 127-129, the button 4250 may be a pressable actuator having a body 4251, a stop tab 4252 (e.g., an obstruction), 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 operating 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 the stop tab 4252. The stop tab 4252 may include one or more ridges and / or projections extending outward from there. One or more ridges on the stop tab 4252 may contact at least a portion of the shuttle actuator 4260 to prevent the shuttle actuator 4260 from moving relative to the carrier 4210 before the button 4250 is activated. One or more protrusions on the stop tab 4252 may block or obstruct the movement of the indicator slide 4270.

[0230] For example, as best shown in Figure 107, the stop tab 4252 may include at least one projection 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 projections along various other sides of the stop tab 4252 without departing from the scope of the present disclosure. In some embodiments, as shown in Figure 104, as will be described in more detail herein, the projection 4252A may be omitted from the stop tab 4252, and the upper cover 4118 may include a stop tab 4119. The fastening mechanism 4254 may include a flexible hook or fastener for engaging a pair of projections 4220 of the carrier 4210. As described in detail herein, the fastening mechanism 4254 may be configured to position the button 4250 in a first (non-acting) position relative to the carrier 4210 before actuation, and to maintain the button 4250 in a second (acting) position after actuation in response to interaction with one or more of the pair of projections 4220.

[0231] As best shown in Figures 128-129, the button 4250 may include a projection 4255 along the bottom surface of the body 4251. The projection 4255 may be configured to engage with an elastic member 4249 (see Figure 103) located within the carrier 4210. The elastic member 4249 may include a spring configured to apply resistance to the button 4250 when the user activates the button 4250, thereby generating tactile feedback to the body 4251. In other embodiments, the elastic member 4249 may be omitted entirely so that the button 4250 can avoid the projection 4255. The first leg 4256 and the second leg 2458 may extend outward (e.g., downward) from the body 4251, and the first leg 4256 may have a longer longitudinal length than the second leg 4258. The first leg 4256 may include a ramp 4259 positioned along the outer surface of the first leg 4256, the ramp 4259 may be configured to engage with 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 the side of the button 4250 adjacent to the fastening mechanism 4254. The second leg 4258 may be configured to engage with 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 the second leg 4258. The boss 4253 may be sized, shaped, and / or otherwise configured to interact with the activator 4230 when the button 4250 is actuated, such as causing movement (e.g., rotation) of the activator 4230.

[0232] As shown in Figure 108A, the boss 4253 may be positioned adjacent to and / or relative to the flange 4235 of the activator 4230 when the button 4250 is in a first (non-operated) position. In this case, as the button 4250 moves toward a second (operated) position, the boss 4253 abuts against the flange 4235, thereby causing a corresponding movement of the activator 4230. For example, referring here to Figure 108B, the button 4250 may be configured to move the activator 4230 in response to pressing the boss 4253 against the flange 4235, thereby rotating the second end 4233 relative to the carrier 4210. The second end 4233 forms a body integral with the central body 4232 and the first end 4231, and the rotation of the second end 4233 causes the central body 4232 and the first end 4231 to rotate simultaneously with respect to the carrier 4210. As described above, the movement (e.g., rotation) of the first end 4231 relative to the first flange 4211 may cause the splines 4236 to move away from alignment with the retaining elements 4217A and to move into alignment with the slots 4217B. In this case, when the splines 4236 are no longer engaged with the retaining elements 4217A, the end portion 4238 may no longer be constrained to a fixed position relative to the first flange 4211. In response to the spline 4236 disengaging the retaining arm 4217A, the force applied to the central body 4232 by the elastic member 4239 in a direction away from the first flange 4211 can move the spline 4236 and the end portion 4238 of the first end portion 4231 through the first opening 4217, as shown in Figure 110. Thus, the activator 4230 may be configured to move toward the second flange 4216 and, through the second opening 4218, press the end portion 4234 against the fluid source 4350 to initiate the delivery of the pressurized fluid stored in the fluid source 4350 to the valve assembly 4300.

[0233] Referring again to Figure 103, the container 4370 may be prevented from establishing a fluid connection with the fluid conduit 4280 by a stop tab 4252 extending from a button 4250, which may be configured to engage with a shuttle actuator 4260 coupled to the container 4370. For example, a ridge 4252B may be positioned in the movement path of the shuttle actuator 4260 when the button 4250 is in a first (non-operated) position, thereby preventing horizontal movement of the shuttle actuator 4260 and the container 4370 coupled to the shuttle actuator 4260 toward the sterilization connector 4290 and the fluid conduit 4280. A projection 4252A may be configured to engage with the indicator slide 4270 to obstruct the movement of the indicator slide 4270 in the same direction.

[0234] In other embodiments, as shown in Figure 104, the stop tab 4252 may be completely omitted, and the upper (outer) cover 4118 of the auto-injector 4100 may include a stop tab 4119 (e.g., an obstruction) to prevent the movement of the indicator slide 4270 toward the sterile connector 4290. The stop tab 4119 may extend radially inward from the inner surface of the upper cover 4118 in a direction parallel to the transverse axis 14, and may be positioned along the upper cover 4118 in a position aligned with the first end of the indicator slide 4270. In other words, the stop tab 4119 may extend vertically within the auto-injector 4100. Thus, the stop tab 4119 may be configured to engage with and / or abut against the indicator slide 4270 to prevent the movement of the indicator slide 4270 toward the longitudinal axis 10 (e.g., toward the sterile connector 4290). The stop tab 4119 may be sized and / or shaped to abut against the body 4274 when the button 4250 is in the first (non-operated) position and the second (operated) position. The stop tab 4119 may be configured to hold the indicator slide 4270 in a fixed position so that the indicator slide 4270 can be mated with and / or coupled to the shuttle actuator 4260 after the fluid released from the fluid source 4350 has driven the container 4370 (and shuttle actuator 4260) horizontally toward the sterilization connector 4290. In further embodiments, it should be understood that the auto-injector 4100 may include a projection 4252A on the stop tab 4252 and a stop tab 4119 on the upper cover 4118.

[0235] In this state, before the automatic syringe 4100 is activated, the indicator slide 4270 may be in a first position relative to the shuttle actuator 4260. In embodiments in which the housing of the automatic syringe 4100 includes a window for visualizing the needle mechanism 4200, the user may determine the relative state of the automatic syringe 4100 through the window based on visualizing the first position of the indicator slide 4270. As described in detail herein, in some embodiments, the indicator slide 4270 may include a graphical interface on the body 4274 of the indicator slide 4270 which can be configured to show the relative position of the indicator slide 4270 and / or the state of the automatic syringe 4100. Furthermore, the first position of the indicator slide 4270 may be visually indicated to the user based on a graphic display and / or interface (e.g., stickers, colors, etc.) located on the shuttle actuator 4260, which may be visible from the outside of the automatic syringe 4100 through both a window on the outer surface of the automatic syringe 4100 and a window 4278 on the indicator slide 4270.

[0236] Before the automatic syringe 4100 is activated, the legs 4272 of the indicator slide 4270 may be positioned adjacent to the fastening mechanism 4263 of the shuttle actuator 4260, as shown in Figure 105A, but may be disengaged from the fastening mechanism 4263 of the shuttle actuator 4260. As described herein, the shuttle actuator 4260 may be initially disengaged from the indicator slide 4270, and may be coupled to the indicator slide 4270 so that the shuttle actuator 4260 and the indicator slide 4270 move together within the housing of the automatic syringe 4100 when connected to each other. The automatic syringe 4100 may include a release tab 4140, which is removably coupled to a bottom cover 4110 (see Figure 101) to expose one or more openings along the (bottom) tissue engagement surface of the bottom cover 4110, allowing a button 4250 to be pressed. Button 4250 may also be actuated by applying a downward force to the body 4251, thereby moving button 4250 from a first (non-actuated) position to a second (actuated) position. Before the automatic syringe 4100 is actuated, the movement of the shuttle actuator 4260 relative to the carrier 4210 may be suppressed by the stop tab 4252 contacting a portion of the shuttle actuator 4260. Thus, by moving button 4250 toward the second position, the stop tab 4252 may be disengaged from the shuttle actuator 4260, thereby allowing the shuttle actuator 4260 to move relative to the carrier 4210 (for example, horizontally). In an embodiment (see Figure 104) in which the upper cover 4118 includes a stop tab 4119 that engages with the indicator slide 4270, the movement of the indicator slide 4270 toward the sterilization connector 4290 may be initially suppressed when the shuttle actuator 4260 moves away from the carrier 4210 during the initial actuation of button 4250.

[0237] Referring to Figures 109 to 110, when the button 4250 is moved toward a second position and the activator 4230 is rotated, the elastic member 4239 may be configured to automatically move from a first energy storage state (Figure 109) toward a first energy release state (Figure 110) in which the elastic member 4239 expands. In this case, the elastic member 4239 may be configured to push the activator 4230 toward the fluid source 4350 from the first flange 4211. The carrier 4210 may include a guide surface 4221 which is sized, shaped, and / or otherwise configured to receive the fluid source 4350 at least partially. The guide surface 4221 may be further configured to guide and / or direct the movement of the fluid source 4350 toward the valve assembly 4300 in response to the elastic member 4239 pushing the activator 4230 toward the fluid source 4350. In other words, the release of energy from the elastic member 4239 can be configured to move the activator 4230, particularly its second end 4233, horizontally from a first lateral position (Figure 109) to a second lateral position (Figure 110), causing the fluid source 4350 to move within the automatic syringe 4100 and establish fluid communication with the valve assembly 4300.

[0238] Additionally, the activator 4230 may be configured to actuate the fluid source 4350, for example, by bringing a portion of the fluid source 4350 into direct contact with the terminal 4234 to release pressurized fluid stored in the fluid source 4350. For example, the activator 4230 can contact, abut, and / or move the valve stem of the fluid source 4350 into an open configuration to allow the flow of fluid (e.g., gas) from the fluid source 4350. In other examples, the valve stem of the fluid source 4350 may be located within or adjacent to the valve assembly 4300 and stationary, so that the activator 4230 can move the fluid source 4350 into an open configuration by pushing the valve stem. In some embodiments, feedback (e.g., tactile, audible, etc.) may be generated by the needle mechanism 4200 in response to the activator 4230 contacting the fluid source 4350 to indicate the start of the dose delivery sequence of the auto-injector 4100 to the user.

[0239] Referring to Figures 105A and 105B, the elastic member 4269 of the needle mechanism 4200 is positioned around the first leg 4212A of the carrier 4210 and can be compressed between the second flange 4216 and the shuttle actuator 4260, particularly against the pair of guide flanges 4224. The elastic member 4269 may be configured to expand in response to the release of pressurized fluid from the fluid source 4350, thereby moving the shuttle actuator 4260 horizontally from a first position to a second position. As shown in Figure 111A, the shuttle actuator 4260 may be configured to translate horizontally as the elastic member 4269 expands due to contact between the elastic member 4269 and the guide flange 4224. The shuttle actuator 4260 may also be configured to move from a second position to a third position, as the elastic member 4269 is compressed in response to the release of pressurized fluid from the fluid source 4350. Therefore, when the shuttle actuator 4260 moves horizontally from the first state to the second state, the shuttle actuator 4260 may be configured to compress the elastic member 4269 in the same horizontal direction, as shown in Figure 111B. In other words, when the pressurized fluid is released from the fluid source 4350, the energy released from the pressurized fluid may be able to act on the container 4370 (see Figure 101) in the horizontal direction opposite to that of the elastic member 4269 during its initial expansion into the energy-releasing state.

[0240] The released energy may be configured to push the container 4370 and the shuttle actuator 4260 coupled to the container 4370 in opposite horizontal directions, thereby compressing the elastic member 4269. It should be understood that this movement of the components of the needle mechanism 4200 in opposite horizontal directions may be operable to establish fluid communication between the container 4370 and the fluid conduit 4280. For example, fluid communication is established when the container 4370 moves over the stationary second end (needle) 4288 (see Figure 102B) of the fluid conduit 4280, thereby allowing the needle 4288 to penetrate the stopper 4380 of the container 4370. Furthermore, this same movement of the components of the needle mechanism 4200 in opposite horizontal directions may be configured to drive an injection into the patient from the auto-injector 4100 at the first end (needle) 4286 (see Figure 133) of the fluid conduit 4280.

[0241] Referring to Figure 111B, the second horizontal movement of the shuttle actuator 4260 causes the rack 4265 of the shuttle actuator 4260 to rotate the gear 4229 in a first rotational direction (e.g., clockwise), thereby pushing the driver 4240 vertically downward (like a needle injection) through contact between the gear 4229 and the rack 4246 of the driver 4240. As described above, the gear 4229 may include two gear sections 4229A and 4229B of various sizes, so that each body section may have a different pitch ratio (see Figure 123). For example, gear 4229 may have a pitch ratio difference of 4:3 between two gear sections 4229A and 4229B, and gear sections 4229A and 4229B may have different diameters relative to each other so that gear 4229 can move shuttle actuator 4260 along a first distance (e.g., in the range of approximately 1 mm to 6 mm) while simultaneously moving driver 4240 along a second distance (e.g., in the range of approximately 6 mm to 10 mm) that is different from (e.g., greater than) the first distance. For example, a 6 mm movement of shuttle actuator 4260 may correspond to an 8 mm movement of driver 4240.

[0242] It should be further noted that one or more gears and / or gear parts of this disclosure are not limited to a particular pitch, diameter, length, and / or combination thereof. The gears and gear parts are adjustable and can be modified to accommodate any patient needle insertion depth. As described above, the vessel 4370 is in fluid communication with the fluid conduit 4280, and once the first end 4282 of the fluid conduit 4280 is deployed into the patient (Figure 111B), further release of energy (e.g., pressurized fluid) from the fluid source 4350 may be operable to move the piston 4378 through the vessel 4370, thereby discharging the drug 20 into the patient (see Figure 102C).

[0243] In some embodiments...

Claims

1. It is an automatic syringe, Housing and A container disposed within the housing, configured to store a drug, A canister disposed within the housing, the canister being configured to release a pressurized medium in order to discharge the drug from the container, A shroud coupled to the housing, configured to move between a first position and a second position relative to the housing so that the pressurized medium is discharged by the canister, A mandrel assembly disposed within the housing, configured to push the shroud outward relative to the housing toward a first position after the pressurized medium has been released by the canister, The automatic syringe comprising the above-mentioned features.

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

3. The container and the canister are further comprising a valve assembly fluidly coupled to the canister, The mandrel assembly includes a sliding piston located within the discharge outlet of the valve assembly and configured to be moved by the pressurized medium discharged by the canister, The automatic syringe according to claim 1, wherein the valve assembly is configured to guide the pressurized medium from the canister to the outlet so that the mandrel assembly pushes the shroud outwards.

4. The container and the canister are further comprising a valve assembly fluidly coupled to the canister, The canister is at least partially located within the valve assembly. The mandrel assembly includes a sliding piston located within the discharge outlet of the valve assembly and configured to be moved by the pressurized medium discharged by the canister, The automatic syringe according to claim 1, wherein the valve assembly is configured to guide the pressurized medium from the canister to the outlet so that the mandrel assembly pushes the shroud outwards.

5. The system further comprises a drive system including the canister, the container and a valve assembly fluid-coupled to the canister, a first flow path, a second flow path and a third flow path, The mandrel assembly includes a sliding piston located within the discharge outlet of the valve assembly and configured to be moved by the pressurized medium discharged by the canister, The drive system is configured to guide the pressurized medium from the canister through the first and second flow paths to the container via the valve assembly so that the drug can be discharged from the container. The automatic syringe according to claim 1, wherein the drive system is configured to guide the pressurized medium from the canister to the discharge outlet through the valve assembly so that the mandrel assembly pushes the shroud outwards.

6. The drive system further includes the canister, the container and a valve assembly fluid-coupled to the canister, a first flow path, a second flow path, a third flow path, and a flow limiter configured to restrict the flow of the pressurized medium between the first flow path and the second flow path. The mandrel assembly includes a sliding piston located within the discharge outlet of the valve assembly and configured to be moved by the pressurized medium discharged by the canister, The drive system is configured to guide the pressurized medium from the canister through the first and second flow paths to the container via the valve assembly so that the drug can be discharged from the container. The automatic syringe according to claim 1, wherein the drive system is configured to guide the pressurized medium from the canister to the discharge outlet through the valve assembly so that the mandrel assembly pushes the shroud outwards.

7. The housing further comprises a chassis located within the housing, The automatic syringe according to claim 1, wherein the chassis includes a lockout window configured to engage with a retaining mechanism of the mandrel assembly after the mandrel assembly has pushed the shroud toward the first position, thereby preventing the shroud from moving toward the second position.

8. The housing further comprises a chassis located within the housing, The chassis includes a lockout window configured to engage with a retaining mechanism of the mandrel assembly after the mandrel assembly has pushed the shroud toward the first position, thereby preventing the shroud from moving toward the second position. The automatic syringe according to claim 1, wherein the chassis further includes an audible feedback element configured to engage with the holding mechanism of the mandrel assembly in order to produce an audible sound.

9. The housing further comprises a chassis located within the housing, The chassis includes a lockout window configured to engage with a retaining mechanism of the mandrel assembly after the mandrel assembly has pushed the shroud toward the first position, thereby preventing the shroud from moving toward the second position. The automatic syringe according to claim 1, further comprising an audible feedback element configured to engage with the retaining mechanism of the mandrel assembly to produce a first audible sound indicating that injection from the automatic syringe has finished and a second audible sound indicating that the shroud has been locked out.

10. The housing further comprises a chassis located within the housing, The chassis includes a plurality of ribs, The automatic syringe according to claim 1, wherein the shroud is configured to receive the plurality of ribs and includes a plurality of openings configured to allow the plurality of ribs to contact the inner surface of the housing and to prevent the housing from being pressed inward.

11. It is an automatic syringe, Housing and A container disposed within the housing, configured to store a drug, A canister disposed within the housing, the canister being configured to release a pressurized medium in order to discharge the drug from the container, A shroud coupled to the housing, configured to move between a first position and a second position relative to the housing so that the pressurized medium is discharged by the canister, An actuator located between the canister and the shroud, configured such that when the shroud moves from a first position to a second position, the pressurized medium is released by the canister; A mandrel assembly disposed within the housing, configured to push the shroud outward relative to the housing toward a first position after the pressurized medium has been released by the canister, The automatic syringe comprising the above-mentioned features.

12. The activator further comprises a puncture mechanism and is configured to engage with the actuator, The actuator is configured to move in response to the shroud moving toward the second position, The automatic syringe according to claim 11, wherein the movement of the actuator causes the activator to move toward the canister, and the puncture mechanism punctures the canister, thereby releasing the pressurized medium into the canister.

13. The automatic syringe according to claim 11, wherein the shroud moves toward the second position so that the needle fluid-coupled to the container is exposed to the outside of the housing through an opening in the shroud.

14. As the shroud moves toward the second position, the needle fluidly coupled to the container is exposed to the outside of the housing through the opening of the shroud. The actuator is further provided with a biasing member configured to exert an outward force, The automatic syringe according to claim 11, wherein the actuator transmits the outward force onto the shroud, thereby providing resistance to the shroud moving toward the second position.

15. The automatic syringe according to claim 11, wherein the actuator includes a bifurcated end configured to contact the shroud at two points simultaneously.

16. It is an automatic syringe, Housing and A container disposed within the housing, configured to store a drug, A canister disposed within the housing, the canister being configured to release a pressurized medium in order to discharge the drug from the container, A shroud coupled to the housing, configured to move between a first position and a second position relative to the housing so that the pressurized medium is discharged by the canister, A mandrel assembly disposed within the housing, configured to push the shroud outward relative to the housing toward a first position after the pressurized medium has been released by the canister, A valve assembly fluidly coupled to the canister, the container, and the mandrel assembly, wherein the valve assembly is configured to guide the pressurized medium from the canister to the container so that the drug can be discharged from the container, and to guide the pressurized medium from the canister to the mandrel assembly so that the mandrel assembly pushes the shroud outward, The automatic syringe comprising the above-mentioned features.

17. The automatic syringe according to claim 16, wherein the mandrel assembly includes a slidable piston positioned within the discharge outlet of the valve assembly and configured to be moved by the pressurized medium discharged by the canister.

18. The housing further comprises a chassis located within the housing, The automatic syringe according to claim 16, wherein the chassis includes a lockout window configured to engage with a retaining mechanism of the mandrel assembly after the mandrel assembly has pushed the shroud toward the first position, thereby preventing the shroud from moving toward the second position.

19. The automatic syringe according to claim 16, further comprising an actuator located between the canister and the shroud, configured such that when the shroud moves from a first position to a second position, the pressurized medium is released by the canister.

20. An actuator is located between the canister and the shroud, and is configured such that when the shroud moves from a first position to a second position, the pressurized medium is released by the canister. The actuator further comprises a biasing member configured to exert an outward force on the actuator, The automatic syringe according to claim 16, wherein the actuator transmits the outward force onto the shroud, thereby providing resistance to the shroud moving toward the second position.

21. It is an automatic syringe, Housing and A container disposed within the housing, configured to store a drug, A needle coupled to the container, configured to release the drug to the outside of the housing when the automatic syringe is activated, A shroud coupled to the housing, wherein the shroud is configured to move between a first position where the shroud covers the needle and a second position where the shroud exposes the needle to the outside of the housing, A first mechanism configured to push the shroud toward the first position before the automatic syringe is activated, A second mechanism is configured to prevent the shroud from moving toward the second position after the agent has been released outside the housing, The automatic syringe comprising the above-mentioned features.

22. The automatic syringe according to claim 21, wherein the first mechanism includes a biasing member configured to exert downward pressure on the shroud.

23. The housing further comprises an actuator, which is located within the housing and is configured to activate the automatic syringe when the shroud moves from a first position to a second position. The biasing member is further configured to exert a downward force on the actuator, The automatic syringe according to claim 22, wherein the actuator is further configured to transmit the downward force onto the shroud, thereby providing resistance to the shroud moving toward the second position.

24. The auto-syringe according to claim 21, wherein the second mechanism includes a mandrel assembly disposed within the housing, the mandrel assembly being configured to separate from the shroud before the auto-syringe is operated and to engage with the shroud after the auto-syringe is operated.

25. The automatic syringe according to claim 24, wherein the second mechanism further includes a lockout window configured to engage with a retaining mechanism of the mandrel assembly after the mandrel assembly has engaged with the shroud.

26. The automatic syringe according to claim 25, wherein the lockout window is included in the chassis located within the housing.

27. The canister is located within the housing and is configured to release a pressurized medium to discharge the drug from the container via the needle when the automatic syringe is activated, The automatic syringe according to claim 24, wherein the mandrel assembly includes a slidable piston configured to be moved by the pressurized medium.

28. The automatic syringe according to claim 27, wherein the sliding piston is configured to move the drug by the pressurized medium after the drug has been discharged from the container through the needle.

29. The canister is located within the housing and is configured to release a pressurized medium to discharge the drug from the container via the needle when the automatic syringe is activated, The automatic syringe according to claim 21, wherein the second mechanism is configured to be operated by the pressurized medium released from the canister.

30. The automatic syringe according to claim 29, wherein the second mechanism is configured to be operated by the pressurized medium released from the canister after the drug has been discharged from the container via the needle.

Images