Auto-injector and related methods of use

Abstract

To provide an auto-injector and related methods of use.SOLUTION: An auto-injector may include a housing having a longitudinal axis and a transverse axis, the housing having a shorter dimension along the transverse axis than along the longitudinal axis, where the transverse axis is perpendicular to the longitudinal axis; a flow path having a first end and a second end; and a container enclosing a first fluid, the container extending from the first end toward the second end along or parallel to the longitudinal axis and being movable from a first position to a second position along or parallel to the longitudinal axis, the container being isolated from the flow path in the first position and connected to the flow path in the second position.SELECTED DRAWING: Figure 3A

Description

[Technical field]

[0001] The present disclosure relates to auto-injectors and related methods of use. [Background technology]

[0002] Various existing auto-injectors deploy a needle when actuated by a user, deliver fluid to the user through the needle, and retract the needle after fluid delivery is complete for user comfort, needle safety, and improved product perception. Summary of the Invention [Problem to be solved by the invention]

[0003] However, many auto-injectors require the user to insert and remove the needle in separate actions. Additionally, many existing auto-injectors are tall. For example, existing pen-type injectors, in which the drug container is positioned along the injection axis, are tall relative to the patient's skin. Such auto-injectors can cause anxiety to patients because their height often gives the impression that the needle is long, when in fact the needle is relatively short. Additionally, many auto-injectors must be held in place by the user for long periods of time, which is inconvenient for the user. [Means for solving the problem]

[0004] In one aspect, the disclosure relates to an automatic injector comprising a housing having a longitudinal axis and a transverse axis, the housing having a dimension along the transverse axis that is shorter than the dimension along the longitudinal axis and perpendicular to the longitudinal axis, a flow path having a first end and a second end, and a container containing a first fluid, the container extending from the first end to the second end along or parallel to the longitudinal axis, movable from a first position to a second position along or parallel to the longitudinal axis, the container being out of communication with the flow path in the first position and in communication with the flow path in the second position. The container further comprises a plunger configured to move from the first end to the second end of the container to expel the first fluid from the container into the flow path. The first end of the flow path is insertable into the container, and the second end of the flow path is extendable from the housing through an opening in the housing in a direction along or parallel to the transverse axis.

[0005] The automatic injector further comprises a fluid source configured to release a pressurized second fluid, the container being movable from a first position to a second position upon release of the pressurized second fluid from the fluid source, the plunger being urged from the first end of the container toward the second end thereof such that the first fluid is expelled from the container into the flow path. The container has a seal at the second end of the container, and in the first position, a gap is provided between the seal and the first end of the flow path. When the container is moved to the second position, the first end of the flow path penetrates the seal and enters the container. When pressure from the pressurized second fluid on the container is reduced, the container is movable from the second position to a third position. The third position is the same as the first position. The third position is different from the first position. The automatic injector further includes a first resilient member coupled to the container, the resilient member being compressed as the container moves from the first position to the second position, and the compressed resilient member expanding to move the container to the third position when pressure from the pressurized second fluid is reduced. The automatic injector includes a carrier, a driver coupled to a second end of the fluid passage, the driver slidable relative to the carrier between a retracted configuration and a deployed configuration, a shuttle configured to move the driver between the retracted configuration and the deployed configuration, and a stopper configured to move from the first configuration to the second configuration, the stopper configured to maintain the driver in the deployed configuration, and movement of the stopper from the first configuration to the second configuration allows the shuttle to move the driver from the deployed configuration to the retracted configuration. Prior to actuation, the driver is in contact with an obstacle and is prevented from moving from the retracted configuration by the obstacle, the obstacle being coupled to the container. Movement of the container from the first position to the second position moves the obstacle out of contact with the driver, thereby allowing the driver to move from the retracted configuration to the deployed configuration.

[0006] In another aspect, the disclosure relates to an automatic injector comprising a body containing a conduit, a fluid source configured to provide pressurized fluid to the conduit, a container in communication with the conduit, the container containing a medicament and a plunger configured to expel the medicament upon application of pressure to the plunger by the pressurized fluid, a pressure limiter configured to restrict flow of the pressurized fluid in the conduit and defining high and low pressure flow regions in the conduit, a valve having a valve inlet and a valve outlet, the valve inlet in communication with the conduit and configured to control flow of the pressurized fluid from the conduit to the valve outlet, and a flow path extendable from the body and configured to deliver the medicament from the container to a patient, wherein a direction in which the container expels the medicament is offset from a direction in which the flow path extends from the body.

[0007] The pressurized fluid is a gas. The medication comprises a monoclonal antibody. The pressure limiting portion comprises a porous material or a serpentine channel. The direction in which the container expels the medication is generally perpendicular to the direction in which the flow path extends from the body. The container is in communication with a low pressure flow region of the conduit, and a high pressure flow region of the conduit is in communication with the valve inlet. The container is movable from a first container position to a second container position and further comprises a spring mechanism configured to extend the flow path from the body when the container is in the second container position. The valve is configured to allow flow of pressurized fluid from the conduit to the valve outlet after at least a portion of the medication is expelled from the container, and an additional mechanism of the auto-injector is configured to be actuated by pressure applied from the pressurized fluid flowing through the valve outlet. The additional mechanism is a flow path retraction mechanism. The flow path retraction mechanism has a rod movable by pressurized fluid flowing through the valve outlet, and is configured to retract the flow path after the rod has been moved a first distance. The auto-injector further comprises a piston disposed in the valve outlet and movable from a first position to a second position, and a secondary channel coupled to the fluid source and the valve outlet. When the piston is in the first position, the secondary channel is sealed against the valve outlet by the piston, and when the piston is in the second position, the secondary channel is in communication with the valve outlet and pressurized fluid flows from the fluid source through the secondary channel and the valve outlet. The valve is configured to prevent flow of pressurized fluid from the conduit to the valve outlet while the container is discharging medicament.

[0008] In yet another aspect, the disclosure relates to an automatic injector including a conduit, a fluid source configured to provide pressurized fluid to the conduit, a container in communication with the conduit, the container housing a plunger movable from a first position to a second position upon application of pressure from the pressurized fluid, a pressure limiter configured to limit flow of the pressurized fluid in the conduit and defining high and low pressure flow regions of the conduit, and a valve having a first valve inlet communicating the high pressure flow region of the conduit with a first valve cavity, a second valve inlet communicating the low pressure flow region of the conduit with a second valve cavity, and a valve outlet, the valve configured to control flow of the pressurized fluid from the low pressure flow region of the conduit to the valve outlet.

[0009] The first and second valve cavities are separated by a diaphragm or piston. The first and second valve cavities are separated by a diaphragm held in an extended configuration, the diaphragm held in place by at least one of a catch or a groove. The valve is configured to permit flow of pressurized fluid from the low pressure flow region of the conduit to the valve outlet when the fluid pressure in the low pressure flow region of the conduit is within a threshold range of the fluid pressure in the high pressure flow region of the conduit. The valve outlet is in communication with a flow path retraction mechanism configured to be actuated by the pressurized fluid flowing through the valve outlet. The valve outlet is in communication with a vent opening.

[0010] The automatic injector further includes a fluid source configured to eject pressurized fluid. The ejection of pressurized fluid from the fluid source moves the entire container from a first position to a second position in a direction along or parallel to the longitudinal axis of the housing. The automatic injector further includes a supply chamber coupled to the fluid source and a sliding seal coupled to an outer surface of the container and an inner surface of the supply chamber. The ejection of pressurized fluid from the fluid source into the supply chamber urges the entire container and the sliding seal to move along or parallel to the longitudinal axis relative to the supply chamber. The container ejects therapeutic fluid into the flow path along or parallel to the longitudinal axis. The ejection of pressurized fluid is activated only after the lid is folded or retracted. The ejection of pressurized fluid cannot be stopped after ejection has begun. Alternatively, the ejection of pressurized fluid is stopped after ejection has begun. However, in some instances, the ejection of pressurized fluid from the fluid source is stopped by the extension of the lid or the retraction of the flow path through the opening in the lid.

[0011] The container has a seal at the second end, and when the container is moved to the second position, the first end of the flow path penetrates the seal. The second end of the flow path is extendable from the housing only after the lid is folded or retracted. The entire container and flow path move along the transverse axis during the lid is folded or retracted. The flow path of the auto-injector is non-linear. The auto-injector further has an actuator coupled to the fluid source. Activation of the actuator by a user initiates the ejection of pressurized fluid. The actuator may include a button, a switch, a trigger mechanism, or a combination thereof. Deactivation of the actuator stops the ejection of pressurized fluid from the fluid source. The auto-injector is a handheld auto-injector configured to complete an injection procedure within 30 seconds. The auto-injector further has a power source configured to move the plunger from the first end of the container toward the second end. Activation of the power source moves the container from a first position along the longitudinal axis to a second position along the longitudinal axis. The power source may include a spring, a resilient member, a motor, or a source of pressurized fluid.

[0012] In another aspect, the disclosure relates to an auto-injector comprising a housing having a longitudinal axis and a transverse axis, the housing having a dimension along the transverse axis that is shorter than the dimension along the longitudinal axis and perpendicular to the longitudinal axis, the housing having a lid configured to be folded or retracted along the transverse axis, a power source, a flow path having a first end and a second end, and a container containing a therapeutic fluid and a plunger, the container extending from the first end to the second end along or parallel to the longitudinal axis. Activation of the power source moves the plunger from the first end to the second end of the container to expel the therapeutic fluid from the container into the flow path. The second end of the flow path is extendable from the housing through an opening in the lid when the lid is folded or retracted in a direction along or parallel to the transverse axis. The auto-injector is a handheld auto-injector configured to complete an injection procedure within 30 seconds. The power source is configured to activate after the lid is folded or retracted.

[0013] In another aspect, the disclosure relates to an injection device, the injection device comprising a collapsible housing movable between an extended configuration and a collapsed or retracted configuration, a fluid source configured to release pressurized fluid, and a flow path having a first end and a second end. The flow path is entirely contained within the collapsible housing in the extended configuration. The second end of the flow path is configured to extend from the collapsible housing in the collapsed or retracted configuration. The first end of the flow path and the second end of the flow path extend along axes that are offset from one another. The injection device further comprises a container containing a therapeutic fluid, the container extending from the first end to the second end along or parallel to a longitudinal axis of the container. The container is movable from the first position to the second position by a flow of pressurized fluid from the fluid source. The container is not in communication with the flow path when the collapsible housing is in the extended configuration. The container is in communication with the flow path after the collapsible housing is in the compressed configuration and the container is moved to the second position. The container further has a plunger. After the container is moved to the second position, further discharge of pressurized fluid from the fluid source urges the plunger from the first end of the container toward the second end thereof, causing the therapeutic fluid to flow from the container into the first end of the flow path and out of the second end of the flow path. The auto-injector is a handheld auto-injector configured to complete an injection procedure within 30 seconds.

[0014] By moving the collapsible housing to the collapsed or retracted configuration, pressurized fluid is automatically released from the fluid source. The collapsible housing is configured to compress by applying a force to an outer surface of the collapsible housing and to expand when the force on the outer surface is released. Alternatively, the collapsible housing is configured to compress by applying a force to an outer surface of the collapsible housing and to remain in the collapsed or retracted configuration when the force on the outer surface is released. [Brief description of the drawings]

[0015] [Figure 1] 1 is a perspective view of an automatic injector according to an embodiment of the present disclosure; [Figure 1A] 1 is a perspective view of an automatic injector according to an embodiment of the present disclosure; [Diagram 2] FIG. 1 shows an auto-injector. [Figure 3A] Schematic diagram showing features of an auto-injector. [Figure 3B] Schematic diagram showing features of an auto-injector. [Figure 3C] Schematic diagram showing features of an auto-injector. [Figure 3D] FIG. 1 illustrates a sliding seal disposed within an auto-injector. [Figure 3E] FIG. 1 shows details of an auto-injector with multiple reservoirs. [Figure 3F] FIG. 1 shows details of an auto-injector with multiple reservoirs. [Figure 3G] FIG. 1 shows details of an auto-injector with multiple reservoirs. [Figure 4A] 1 is a schematic cross-sectional view of an exemplary valve for use in an auto-injector. [Figure 4B] 1 is a schematic cross-sectional view of an exemplary valve for use in an auto-injector. [Diagram 5] 1 is a schematic cross-sectional view illustrating another exemplary valve for use in an auto-injector. [Figure 6] 1A-1C show an exemplary flow restrictor for use in an auto-injector. [Figure 7A] 1A-1C show an exemplary flow restrictor for use in an auto-injector. [Figure 7B] 1A-1C show an exemplary flow restrictor for use in an auto-injector. [Figure 7C] 13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7D] 13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7E] 13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7F] 13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7G] 13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7H]13A-13C illustrate additional exemplary valves for use in an auto-injector. [Figure 7I] FIG. 13 shows the diaphragm in detail. [Figure 7J] FIG. 13 shows the diaphragm in detail. [Figure 7K] FIG. 13 shows the diaphragm in detail. [Figure 7L] FIG. 13 shows the diaphragm in detail. [Figure 7M] FIG. 13 shows the diaphragm in detail. [Figure 7N] FIG. 13 shows the diaphragm in detail. [Figure 7O] FIG. 4 is a partially exploded view of another exemplary valve. [Figure 8A] FIG. 1 illustrates an exemplary exhaust system. [Figure 8B] FIG. 1 illustrates an exemplary exhaust system. [Figure 8C] FIG. 1 illustrates an exemplary exhaust system. [Figure 8D] FIG. 1 illustrates an exemplary exhaust system. [Figure 9A] FIG. 1 illustrates another exemplary exhaust system. [Figure 9B] FIG. 1 illustrates another exemplary exhaust system. [Figure 9C] FIG. 1 illustrates another exemplary exhaust system. [Figure 9D] FIG. 1 illustrates another exemplary exhaust system. [Figure 9E] FIG. 1 illustrates another exemplary exhaust system. [Figure 9F] FIG. 1 illustrates another exemplary exhaust system. [Figure 9G] FIG. 1 illustrates another exemplary exhaust system. [Figure 9H] FIG. 1 illustrates another exemplary exhaust system. [Figure 9I] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 9J] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 9K] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10A] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10B] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10C] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10D] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10E] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 10F] FIG. 13 illustrates yet another exemplary exhaust system. [Figure 11] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11A] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11C] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11D] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11E] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11F] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11G] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 11H] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 12A] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 12B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 12C] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 13A] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 13B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 13C] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 13D] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 14A] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 14B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 15A]1 illustrates a discharge mechanism according to the present disclosure. [Figure 15B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 16A] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 16B] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 16C] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 16D] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 16E] 1 illustrates a discharge mechanism according to the present disclosure. [Figure 17] Schematic diagram showing features of an auto-injector. [Figure 18A] Exploded view showing the needle mechanism. [Figure 18B] FIG. 2 is a schematic diagram showing parts of the needle mechanism. [Figure 18C] FIG. 2 is a schematic diagram showing parts of the needle mechanism. [Figure 18D] FIG. 2 is a schematic diagram showing parts of the needle mechanism. [Figure 19] FIG. [Figure 20] FIG. [Figure 21] FIG. [Figure 22] FIG. [Figure 23] FIG. [Figure 23A] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23B] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23C] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23D] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23E] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23F] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23G]FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23H] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23I] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23J] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23K] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23L] FIG. 13 illustrates a mechanism for initiating needle insertion and / or retraction. [Figure 23M] 1 is a schematic diagram of an auto-injector according to another exemplary embodiment. [Figure 23N] 13 is a schematic diagram illustrating another alternative auto-injector according to another embodiment. [Figure 23O] FIG. 13 illustrates an alternative mechanism for initiating needle insertion and / or retraction. [Figure 23P] FIG. 13 illustrates an alternative mechanism for initiating needle insertion and / or retraction. [Figure 23Q] FIG. 13 illustrates an alternative mechanism for initiating needle insertion and / or retraction. [Figure 23R] 1 is a schematic diagram illustrating additional features of an automatic injector according to an embodiment of the present disclosure. [Figure 23S] 1 is a schematic diagram illustrating additional features of an automatic injector according to an embodiment of the present disclosure. [Figure 23T] 1 is a schematic diagram illustrating additional features of an automatic injector according to an embodiment of the present disclosure. [Figure 23U] 1 is a schematic diagram illustrating additional features of an automatic injector according to an embodiment of the present disclosure. [Figure 24] 1 is a schematic diagram of an auto-injector according to another exemplary embodiment. [Figure 25A] FIG. 1 illustrates a drive system used in an auto-injector. [Figure 25B] FIG. 1 illustrates a drive system used in an auto-injector. [Figure 26A] FIG. 13 illustrates an alternative mechanism for sealing the container. [Figure 26B] FIG. 13 illustrates an alternative mechanism for sealing the container. [Figure 27A] FIG. 13 illustrates a mechanism for establishing communication between a container and a fluid conduit. [Figure 27B] FIG. 13 illustrates a mechanism for establishing communication between a container and a fluid conduit. [Figure 28A] FIG. 13 illustrates a mechanism for establishing communication between a container and a fluid conduit. [Figure 28B] FIG. 13 illustrates a mechanism for establishing communication between a container and a fluid conduit. [Figure 29A] FIG. 2 illustrates a mechanism for sealing a first end of a container. [Figure 29B] FIG. 2 illustrates a mechanism for sealing a first end of a container. [Figure 30A] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 30B] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 31A] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 31B] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 32A] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 32B] FIG. 2 shows a mechanism for actuating a fluid source. [Figure 32C] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32D] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32E] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32F] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32G] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32H] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32I] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32J] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32K] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32L] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32M] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32N] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32O] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32P] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32Q] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32R] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32S] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 32T] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig.32U] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Fig. 32V] FIG. 13 illustrates an additional mechanism for actuating the fluid source. [Figure 33A] FIG. 1 illustrates an auto-injector having a retractable cap. [Figure 33B] FIG. 1 illustrates an auto-injector having a retractable cap. [Figure 34A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 34B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 35A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 35B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 36A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 36B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 37A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 37B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 38A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 38B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 39A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 39B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 40A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 40B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 41A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 41B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 41C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 41D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 41E] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 42A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 42B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 42C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 43A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 43B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 43C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig. 43D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 44A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 44B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 44C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig.44D]FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 45A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 45B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 46A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 46B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 46C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 46D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 46E] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 47A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 47B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 47C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 47D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48B] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48E] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig.48F] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 48G] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig. 48H] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig.48I] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 49A] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 49B]FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 49C] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 49D] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 49E] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Fig.49F] FIG. 1 illustrates an exemplary lateral auto-injector of the present disclosure. [Figure 50A] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50B] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50C] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50D] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50E] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50F] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50G] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 50H] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Fig. 50I] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Fig. 50J] 1A-1D show examples of surface modifications of auto-injectors of the present disclosure. [Figure 51A] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 51B] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 51C] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Fig. 51D] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 52A] 1 illustrates a peel seal and contact switch of the present disclosure. [Figure 52B] 1 illustrates a peel seal and contact switch of the present disclosure. [Figure 52C]1 illustrates a peel seal and contact switch of the present disclosure. [Figure 53A] 1 illustrates an indicator of the auto-injector of the present disclosure. [Figure 53B] 1 illustrates an indicator of the auto-injector of the present disclosure. [Figure 54A] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54B] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54C] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54D] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54E] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54F] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54G] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54H] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54I] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54J] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54K] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54L] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 54M] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Fig. 54N] 13A-13C illustrate the use of an indicator flag in an auto-injector of the present disclosure. [Figure 55A] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Figure 55B] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Figure 55C]13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Fig. 55D] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Figure 55E] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Fig. 55F] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Figure 55G] 13A-13C illustrate the use of a window stain or covering strip in an auto-injector of the present disclosure. [Figure 56A] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 56B] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 56C] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 56D] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 56E] 1A-1D depict the locations of labels on an auto-injector of the present disclosure. [Figure 57A] 13A-13D illustrate features for visually indicating needle insertion depth, according to various embodiments. [Figure 57B] 13A-13D illustrate features for visually indicating needle insertion depth, according to various embodiments. [Figure 57C] 13A-13D illustrate features for visually indicating needle insertion depth, according to various embodiments. [Fig. 57D] 13A-13D illustrate features for visually indicating needle insertion depth, according to various embodiments. [Figure 57E] 13A-13D illustrate features for visually indicating needle insertion depth, according to various embodiments. [Figure 58A] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Figure 58B] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Figure 58C]11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Fig. 58D] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Figure 58E] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Fig. 58F] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Figure 58G] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Fig. 58H] 11A-11C show features for visually indicating the stage and / or progress of an injection according to various embodiments of another auto-injector. [Figure 59A] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59B] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59C] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59D] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59E] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59F] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59G] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59H]13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59I] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59J] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59K] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59L] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59M] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59N] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Fig. 59O] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59P] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59Q] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 59R] 13A-13D illustrate features for restricting the flow of gas or fluid according to various embodiments of another auto-injector. [Figure 60A] FIG. 1 is a perspective view of an automatic injector in an initial, unactivated state, according to one embodiment of the present disclosure. [Figure 60B] FIG. 1 is a perspective view of a fluid-actuated auto-injector in an initial, unactuated state, according to one embodiment of the present disclosure. [Figure 61] FIG. 60C is a perspective view of the auto-injector of FIG. 60B in an intermediate state. [Figure 62] FIG. 60C is a perspective view of the auto-injector of FIG. 60B showing the connection between the drug cartridge and the fluid path. [Figure 63] FIG. 60C is a perspective view of the auto-injector of FIG. 60B during an injection. [Figure 64] FIG. 60C is a perspective view of the auto-injector of FIG. 60B after an injection has been completed. [Figure 65A] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Figure 65B] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Figure 65C] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Fig. 65D] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Figure 65E] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Fig.65F] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Figure 65G] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. [Fig. 65H] FIG. 13 illustrates a sterile connector according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate illustrative examples which, together with the written description, explain the principles of the disclosed examples and embodiments. Aspects of the present disclosure can be implemented in conjunction with the embodiments illustrated in the accompanying drawings, which illustrate various aspects of the present disclosure, and in which similar structures, components, materials and / or elements in different figures are appropriately labeled with similar numbers. It will be understood that various combinations of structures, components and / or elements other than those specifically shown are possible and within the scope of the present disclosure.

[0017] Furthermore, many embodiments are described and illustrated herein. The present disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or permutation of aspects and / or embodiments. Moreover, each aspect and / or embodiment of the present disclosure may be practiced alone or in combination with one or more of the other aspects of the present disclosure and / or embodiments thereof. For the sake of brevity, certain permutations and combinations are not individually described and / or illustrated herein. In particular, an embodiment or example described herein as "exemplary" should not be construed as preferred or advantageous over other embodiments or examples. Such embodiments are intended to be "exemplary" embodiments.

[0018] Many embodiments are described and illustrated herein. The present disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or permutation of aspects and / or embodiments. Each aspect and / or embodiment of the present disclosure may be implemented alone or in combination with one or more of the other aspects of the present disclosure and / or embodiments thereof. For the sake of brevity, many combinations and permutations are not described individually herein.

[0019] For simplicity and clarity of illustration, certain aspects of the figures show the general structure and / or construction of various embodiments. Well-known features and methods may be omitted to avoid obscuring other features. Elements of the figures are not necessarily shown to scale, and dimensions of some features may be exaggerated relative to other elements to aid in understanding the illustrative embodiments. For example, cross-sectional views are not necessarily drawn to scale and do not represent the proportional relationship between different components. Cross-sectional views are presented to facilitate description of the various components of the illustrated assemblies and to show their relative positions to one another.

[0020] The details of each embodiment of the present disclosure shown in the accompanying drawings are described below. The same reference numerals are used throughout the drawings to refer to the same or similar parts. In the following description, relative terms such as "about," "substantially," and "approximately" imply a possible variation of ±10% of the stated numerical value.

[0021] As previously discussed, existing auto-injectors often require multiple user actions to administer a medication, for example, separate user actions for deploying the needle and retracting the needle after delivery of the medication. The need for these additional actions can complicate self-administration of medication and may lead to user error or discomfort. Thus, the present disclosure relates to various embodiments of injection devices (e.g., auto-injectors) that simplify a user's self-administration of a medication or other therapeutic agent. Specifically, in certain embodiments, the auto-injector does not require additional user action to withdraw the needle after it has been subcutaneously inserted into the user. Thus, the auto-injector of the present disclosure is simplified and less susceptible to misuse or user error.

[0022] As previously discussed, existing auto-injectors require multiple components, such as various springs and motor mechanisms, and user actions to deliver medication. These additional components add manufacturing complexity and can lead to mechanical failure and user error. Thus, the present disclosure relates to various embodiments of injection devices (e.g., auto-injectors) that simplify and improve the delivery of medication or other therapeutic agents.

[0023] An example of such an auto-injector 2 is shown in Figures 1 and 2. The auto-injector 2 includes a housing 3 having a tissue-engaging surface (such as a bottom surface) 4. The needle is deployed and retracted through an opening 6 in the tissue-engaging surface 4 (Figure 2). The housing 3 includes a transparent window 50 to allow an observer to view a reservoir disposed within the housing 3. The housing 3 also includes an actuator or button 52 configured to activate a drive mechanism (e.g., a fluid source 1366, described in more detail below) for delivering a medication (therapeutic fluid) contained within the auto-injector 2 to a patient. In some embodiments, the auto-injector 2 does not include electrical components. In other embodiments, one or more displays or LEDs (not shown) are disposed within the housing 3 and / or the housing 3 includes a number of openings 51 configured to aid in the transmission of sound generated within the housing 3 (such as by a speaker) (see alternative embodiment in Figure 1A). The auto-injector 2 can have any suitable dimensions for portability and self-application by a user. For example, the auto-injector 2 has a length of about 0.5 inches to about 5.0 inches, a width of about 0.5 inches to about 3.0 inches, and a height of about 0.5 inches to about 2.0 inches. The auto-injector 2 has a non-slip or adhesive coating such that the exterior surface of the auto-injector 2 provides a non-slip surface.

[0024] The auto-injector 2 is oriented about a longitudinal axis 40 (e.g., the X-axis), a lateral axis 42 (e.g., the Y-axis) that is generally perpendicular to the longitudinal axis 40, and a transverse axis 44 (e.g., the Z-axis) that is generally perpendicular to both the longitudinal axis 40 and the transverse axis 42. In some embodiments, in the lateral auto-injectors of the present disclosure, the dimension along the longitudinal axis 40 is longer than the dimension along the transverse axis 44.

[0025] In certain embodiments of the autoinjector 2, for example when the autoinjector 2 is a wearable autoinjector, the autoinjector 2 has an adhesive patch 12 as shown in FIG. 1A. The adhesive patch 12 is coupled to the tissue-engaging surface 4 to help secure the autoinjector 2 to the user's body (such as the skin). The adhesive patch 12 can be formed of fabric or any other suitable material and has an adhesive. The adhesive can be a water-based or solvent-based adhesive, or a hot melt adhesive, or the like. Suitable adhesives include acrylic-, dextrin-, and urethane-based adhesives, as well as natural and synthetic elastomers. In some examples, the adhesive of the patch 12 begins to function upon contact with the user's skin. In yet another example, the patch 12 has a non-woven polyester substrate and an acrylic or silicone adhesive. The patch 12 can be attached to the housing 3, for example, by a double-sided adhesive, or by other techniques such as ultrasonic welding. The length (eg, the dimension parallel to the longitudinal axis 40 ) of the patch 12 is greater than the width (eg, the dimension parallel to the transverse axis 42 ) of the auto-injector 2 .

[0026] In other embodiments of the present disclosure, the auto-injector 2 does not have an adhesive patch. For example, the auto-injector 2 may be a handheld auto-injector (e.g., FIG. 1) rather than a wearable auto-injector (e.g., FIG. 1A). In at least some embodiments, a handheld auto-injector requires the user to hold the auto-injector on their skin throughout the injection procedure. In contrast, a wearable auto-injector has features that secure the wearable auto-injector on the skin. For example, the wearable auto-injector has one or more features for securing it to the user, such as an adhesive patch (e.g., adhesive patch 12) or a strap. In some embodiments, a handheld auto-injector according to the present disclosure is configured to deliver a drug volume of less than 3.5 mL (or a drug volume of about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, about 3.5 mL), while a wearable auto-injector is configured to deliver a drug volume of more than 3.5 mL, more than 4.0 mL, or more than 5.0 mL.

[0027] Additionally, handheld auto-injectors according to the present disclosure are configured to complete an 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 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 completed. Wearable auto-injectors take longer than 30 seconds to complete the same steps 1) and 2) above, i.e., 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.

[0028] As shown in Figures 2 and 3A-3C, the auto-injector 2 includes a primary container, chamber, syringe, cartridge or vessel 1302 having a first end 1304 and a second end 1306. Alternatively, the vessel 1302 has an opening at the first end 1304 and a cavity 1308 extending toward the second end 1306. The second end 1306 has a seal 1314 configured to aid in closing and / or sealing the second end 1306 so that a needle 308 (e.g., the supported needle shown in Figures 3A-3C) can be inserted into the vessel 1302. The cavity 1308 is closed at the first end 1304 by a piston 1316.

[0029] The "nominal capacity" of a container (also referred to as the "designated volume" or "designated capacity") refers to the maximum capacity of the container as designated by the manufacturer of the container or a safety standards organization. The manufacturer or safety standards organization designates the nominal capacity of a container to indicate that the container can be filled with the designated volume of fluid (with or without aseptic procedures) and closed, stoppered, sterilized, packaged, transported, and / or used while maintaining the container in a closed state and maintaining the safety, sterility, and / or sterility of the fluid contained therein. In determining the nominal capacity of a container, the manufacturer or safety standards organization also takes into account changes that occur during normal filling, closing, stoppering, packaging, transport, and management procedures. As an example, a prefill syringe is manually or mechanically filled with fluid to the nominal capacity and then stoppered using a discharge tube or vacuum without contaminating the contents of the syringe through contact with the filling and stoppering equipment and tools. Alternatively, the stoppering equipment and tools are sterile or aseptic and contact the contents of the syringe and / or the syringe itself without introducing contamination.

[0030] The container 1302 has a nominal volume of about 5.0 mL in some examples, but may have other suitable nominal volumes (e.g., about 0.5 mL to about 50.0 mL, about 2.0 mL to about 10.0 mL, about 3.0 mL to about 6.0 mL, about 1.0 mL to about 3.0 mL, about 2.0 mL to about 5.0 mL, or other suitable ranges) depending on the medication to be delivered. In other examples, the nominal volume of the container 1302 is about 0.5 mL or more, about 2.0 mL or more, about 3.0 mL or more, about 4.0 mL or more, or about 5.0 mL or more. The container 1302 functions to contain and store the medication to be injected into the user and to maintain sterility of the medication. In one embodiment, the container 1302 is configured to deliver a delivery volume (e.g., about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, about 3.5 mL, 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 other delivery volume) of the drug. The delivery volume is less than the nominal volume of the container 1302. Furthermore, in order to deliver the delivery volume of the drug to the user, the container 1302 itself is filled with a volume of the drug different from the delivery volume (i.e., a fill volume). The fill volume is set to a larger amount of drug than the delivered volume, for example, to compensate for drug that cannot be delivered from the container 1302 to the user due to dead space in the container 1302 or the fluid conduit 300. Thus, although the container 1302 has a nominal volume of 5 mL, the fill volume and delivered volume of drug will be less than 5 mL.

[0031] In one embodiment, when the container 1302 is used in a handheld auto-injector, the amount of drug delivered from the container 1302 is 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. The amount of drug delivered also depends on the viscosity of the drug and the characteristics of the handheld configuration of the auto-injector 2. That is, at least in some embodiments, a large amount of drug at a particular viscosity may not allow the auto-injector 2 to complete the injection procedure within an acceptable time (e.g., less than about 30 seconds). Thus, the amount of drug delivered from the auto-injector 2 is set to allow the injection procedure from 1) the time the auto-injector is placed on the skin of the user to 2) the time the auto-injector is removed from the skin to be completed in less than about 30 seconds or other times (e.g., less than about 25 seconds, less than about 20 seconds, less than about 15 seconds, or less than about 10 seconds). If the medication delivery volume and viscosity is too high, the autoinjector 2 may not function as a handheld autoinjector because the time required to complete the injection procedure will be longer than is commercially or clinically acceptable for a handheld device. As previously mentioned, in embodiments in which the container 1302 is used in a handheld autoinjector, the delivery volume of medication from the container 1302 is set such that the injection procedure described above is completed in a relatively short time, regardless of the nominal volume of the container 1302 (to avoid the need for additional features to secure the autoinjector 2 to the user in order to enable the autoinjector 2 to function as a wearable autoinjector).

[0032] However, various embodiments of the present disclosure relate to wearable auto-injectors that, unlike handheld auto-injectors, deliver relatively large volumes of medication (e.g., greater than about 3.5 mL) and / or have relatively long injection procedure times (e.g., greater than about 30 seconds, greater than about 1 minute, greater than about 2 minutes, greater than about 5 minutes, or greater than about 1 hour) to complete the injection procedure 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.

[0033] The container 1302 has a neck diameter of about 13 mm, a length of about 45 mm, and an internal diameter of about 19.05 mm. In another embodiment, the container 1302 is a standard 3 mL container with an 8 mm crimp top, an internal diameter of 9.7 mm, and a length of 64 mm. These values ​​are merely exemplary and other suitable dimensions may be used. In some examples, the container 1302 is constructed using conventional materials and is shorter than existing devices, making the auto-injector 2 cost effective and compact. In some embodiments, the container 1302 is a shortened length ISO standard 10 mL cartridge.

[0034] The auto-injector of the present disclosure may be configured to deliver a highly viscous liquid to a patient. For example, the auto-injector of the present disclosure may be configured to deliver a liquid having a viscosity of about 0 to about 0.1 Pascal seconds (about 0 cP to about 100 cP), about 0.005 to about 0.045 Pascal seconds (about 5 cP to about 45 cP), about 0.01 to about 0.04 Pascal seconds (about 10 cP to about 40 cP), about 0.015 to about 0.035 Pascal seconds (about 15 cP to about 35 cP), about 0.02 to about 0.03 Pascal seconds (about 20 cP to about 30 cP), or about 0.025 Pascal seconds (about 25 cP).

[0035] Septum 1314 is made of an uncoated bromobutyl material or another suitable material. Piston 1316 is made of a bromobutyl material coated with a fluoropolymer and in some embodiments has a conical nose to reduce dead space within vessel 1302. Piston 1316 is made of one or more rubber materials and other materials, such as, for example, halobutyls (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile.

[0036] The piston 1316 is driven by pressurized fluid discharged from a fluid source, such as, for example, fluid source 1366 (FIGS. 3A-3C). Pressurized gas discharged from the fluid source 1366 moves the piston 1316 and the container 1302 toward the second end 1306. As the piston 1316 moves toward the second end 1306, the piston 1316 acts against the contents (e.g., medication, therapeutic agent) within the container 1302, ultimately transmitting a force to the second end 1306 of the container 1302, causing the container 1302 to move along the longitudinal axis 40. In some embodiments of the horizontal auto-injector, the fluid source 1366 and the piston 1316 are offset and not longitudinally aligned.

[0037] The fluid source 1366 may have an unlatched canister or a latched canister. The fluid source 1366 is configured to provide a liquid propellant that vaporizes outside of the fluid source 1366 to provide pressurized gas (vapor pressure) acting on the piston 1316. In some embodiments, the latched canister is opened so that once opened, the entire amount of propellant is delivered. Alternatively, in some embodiments, the fluid source 1366 is selectively controlled and can be selectively activated and deactivated. For example, in another embodiment, the flow of pressurized gas from the fluid source 1366 can be stopped after flow begins.

[0038] The fluid from the fluid source 1366 is any suitable propellant to provide the vapor pressure that drives the piston 1316. In certain embodiments, the propellant is a liquefied gas that vaporizes to provide the vapor pressure. In certain embodiments, the propellant is or includes a hydrofluoroalkane (HFA), such as HFA134a, HFA227, HFA422D, HFA507, or HFA410A. In certain embodiments, the propellant is or includes a hydrofluoroolefin (HFO), such as HFO1234yf or HFO1234ze. In some embodiments, the fluid source 1366 is a high-pressure canister configured to hold a compressed gas.

[0039] Upon initiating movement of the container 1302 along the longitudinal axis 40, the fluid source 1366 is actuated and transitioned to an open configuration, and the propellant exits the fluid source 1366 as pressurized gas. In some embodiments, the actuation is irreversible, and the flow of pressurized gas exiting the fluid source 1366 cannot be stopped.

[0040] In the pre-actuated state of the auto-injector 2 shown in Figure 3A, the needle 308 is spaced from the second end 1306 of the container 1302. To move the auto-injector 2 from the pre-actuated state of Figure 3A, the fluid source 1366 is actuated as described above to move the container 1302 along the longitudinal axis 40 toward the needle 308. Because the needle 308 is not yet in communication with the container 1302, actuation of the fluid source 1366 applies pressure to the fluid within the container 1302, which in turn applies pressure to the container 1302 itself. This pressure moves the container 1302 toward the needle 308, eventually causing the needle 308 to pierce the septum 1314, thereby placing the needle 308 in communication with the contents of the container 1302. This movement corresponds to the movement of the obstruction 382 relative to the protrusion 380 (FIGS. 18B-18D), which causes the obstruction 182 to unobstruct the protrusion 380, thereby allowing the needle 306 to inject. In other words, the pressurized gas from the fluid source 1366 also drives the movement of the obstruction 382 relative to the protrusion 380, allowing the needle 306 to begin injecting the user (as will be described in more detail below). Once the needle 308 is in communication with the container 1302, further movement of the piston 1316 towards the second end 1306 urges fluid through the needle 308 and the remainder of the fluid conduit 300 (FIG. 18A).

[0041] 3A-3C show a drive system 3000 that provides a driving force for delivering fluid from a container 1302 to a patient. The drive system 3000 includes a fluid source 1366, a high pressure (first) line 3002, a low pressure (second) line 3004, a third line 3006, a flow restriction 3008, and a valve 3010. The valve 3010 has a diaphragm 3012, a high pressure (first) inlet 3014, a low pressure (second) inlet 3016, and a conduit 3018. The conduit 3018 is formed in a valve seat 3020 that extends into the valve 3010. Within the valve 3010, the diaphragm 3012 defines a high pressure (first) cavity 3022 and a low pressure (second) cavity 3024.

[0042] When the fluid source 1366 is activated, pressurized gas flows through the high pressure line 3002 and the flow restriction 3008 before entering the vessel 1302. A portion of the pressurized gas from the high pressure line 3002 is also diverted to the high pressure cavity 3022 via the high pressure inlet 3014. This causes the diaphragm 3012 to move towards the conduit 3018 in the valve seat 3020 and seal the conduit 3018 (FIG. 3B). Downstream of the pressure restriction 3008, reduced pressure gas is directed to the low pressure cavity 3024 via the low pressure line 3004 and the low pressure inlet 3016. The pressure difference between the high pressure cavity 3022 and the low pressure cavity 3024 provides the force required for the diaphragm 3012 to seal the conduit 3018. The low pressure line 3004 also delivers pressurized gas to move the container 1302 towards the needle 308 and then push the piston 1316 along or parallel to the axis 40, expelling the drug from the container 1302 until the piston 1316 reaches the end of the container 1302 (hits the bottom).

[0043] When the piston 1316 bottoms out at the end of the injection (FIG. 3C), pressure equalizes between the high pressure cavity 3022 and the low pressure cavity 3024, causing the diaphragm 3012 to lift off the valve seat 3020 and open the conduit 3018. This allows gas from the low pressure line 3004 to exit the system through the conduit 3018 and the third line 3006.

[0044] 3D, the mechanism by which the low pressure line 3004 drives the reservoir 1302 and the piston 1316 will be described. The fluid source 1366, described in more detail below, is configured to contain a sufficient amount of pressurized fluid such that the release of pressurized gas can move both the reservoir 1302 and the piston 1316. In some examples, the fluid source 1366 has an excess of pressurized gas, i.e., more fluid than is necessary to complete the delivery of the contents of the reservoir 1302.

[0045] The auto-injector 2 further includes a rail 1370 having a cylindrical structure extending along a longitudinal axis of the auto-injector 2. The inner surface of the rail 1370 defines a lumen. The rail 1370 coaxially surrounds at least a portion of the container 1302. For example, the container 1302 is disposed inside the lumen formed by the rail 1370. The rail 1370 is spaced from the container 1302 such that the container 1302 can slide along the length of the rail 1370.

[0046] Rail 1370 has a base 1371 and an edge 1373. Base 1371 has a conduit 1355 configured to receive pressurized gas from low pressure line 3004. The pressurized gas is delivered from conduit 1355 to a supply chamber (cavity) 1375 formed by the inner surface of rail 1370, sliding seal 1390, piston 1316 and the outer wall of container 1302.

[0047] A sliding seal 1390 is disposed between the vessel 1302 and the rail 1370 to aid in the movement of the vessel 1302 by preventing pressurized gas from leaking past the sliding seal 1390. For example, the sliding seal 1390 is disposed on an inner surface of the rail 1370 and on an outer surface of the vessel 1302 to aid in the movement of the vessel 1302 along the rail 1370. The vessel 1302, the sliding seal 1390 and the rail 1370 are arranged concentrically.

[0048] In some embodiments, the sliding seal 1390 is fixed in position on the outer surface of the container 1302 and configured to slide along the inner surface of the rail 1370 with the container 1302. For example, the positional relationship between the sliding seal 1390 and the container 1302 does not change while the container 1302 moves relative to the rail 1370. The sliding seal 1390 and the container 1302 move as a unit from the base 1371 of the rail 1370 toward the edge 1373 of the rail 1370. In other words, the sliding seal 1390 and the container 1302 move together along the rail 1370 at the same time. In another embodiment, the relative positions of the rail 1370 and the sliding seal 1390 do not change and the container 1302 moves toward the needle 308. In yet another embodiment, the sliding seal 1390 moves relative to both the rail 1370 and the container 1302. In some embodiments, the position of the container 1302 is stationary relative to the housing 3 and the fluid conduit 300 moves through the seal 1314 to provide communication between the container 1302 and the fluid conduit 300 .

[0049] In some examples, the rail 1370 is provided with one or more stops (not shown) on the inner surface thereof. The stopper abuts against the sliding seal 1390 to stop the movement of the sliding seal 1390 along the longitudinal axis. Alternatively or additionally, one or more stops are disposed on the outer surface of the container 1302 to stabilize or stop the movement of the container 1302. Since the sliding seal 1390 is in communication with the container 1302, when the sliding seal 1390 is prevented from moving along the longitudinal axis, the movement of the container 1302 along the longitudinal axis is also stopped. In another example, no such stopper is required, and when the seal 1314 is pierced by the needle 308, the longitudinal movement of the container 1302 is stopped as the subsequent movement of the piston 1316 allows the drug into the needle 308.

[0050] Prior to use of the auto-injector 2, the supply chamber 1375 has a first volume. After actuation of the fluid source 1366, the supply chamber 1375 is filled by pressurized fluid released from the fluid source 1366. The supply chamber 1375 expands as the compressed pressurized fluid pushes the piston 1316, the reservoir 1302 and the sliding seal 1390, moving the entire assembly along the longitudinal axis. As previously described, the sliding seal 1390 and the reservoir 1302 move along or parallel to the longitudinal axis of the auto-injector 2 toward the edge 1373 until the reservoir 1302 (e.g., the seal 1314) contacts the needle 308. Contact between the seal 1314 and the needle 308 causes the needle 308 to pierce the seal 1314 and place the fluid conduit 300 in communication with the reservoir 1302. The pressurized gas applies pressure to the piston 1316, which pushes the piston 1316 within the body of the container 1302. As the piston 1316 moves within the container 1302, the movement of the piston 1316 forces the medication to flow through the fluid conduit 300 and through the needle 306 to the patient.

[0051] In one embodiment, in a pre-activation state, the needle 308 is disposed within the seal 1314. In other words, prior to the release of pressurized gas from the fluid source 1366, the end of the needle 308 is disposed within the seal 1314 but is not in communication with the container 1302. In such an embodiment, the seal 1314 comprises a solid plug without holes, recesses or openings, the plug being formed of a first rubber material. The first rubber material is permeable to a sterilizing gas, such as, for example, ethylene oxide or vaporized hydrogen peroxide. For example, the first rubber material includes one or more of isoprene, ethylene propylene diene monomer (M class) rubber (EPDM) and styrene butadiene. Because the first rubber material is permeable to a sterilizing gas, the needle 308 disposed within the plug can be sterilized prior to use. The plug is molded around the needle 308 such that the needle 308 is disposed within the plug. Seal 1314 also has a base that is impermeable to sterilizing gases to prevent contamination and / or alteration of the drug contained within container 1302. The base includes an impermeable rubber, such as, for example, halobutyl (bromobutyl, chlorobutyl, fluorobutyl, etc.) and / or nitrile.

[0052] In some embodiments, the vessel 1302, rail 1370, and sliding seal 1390 are configured to allow replacement of the vessel 1302. For example, the rail 1370 and sliding seal 1390 have one or more openings through which the vessel 1302 is inserted.

[0053] The system shown in Figures 3E-3G is similar to the system described above, except that it has a plurality of containers 1302 (e.g., containers 1302a and 1302b) that contain the drug to be delivered to the patient. Each container 1302 in this embodiment is substantially similar to any of the containers described herein. In addition, the low pressure line 3004 has two tributaries 3004a and 3004b, each of which is connected to one of the containers 1302. Specifically, the tributaries 3004a and 3004b are used to move each container 1302 along a longitudinal axis to place the container 1302 in communication with each fluid conduit, and then the piston 1316 is moved within each container 1302. As previously described, the system further includes a fluid source 1366, a high pressure line 3002, a flow restriction 3008, a valve 3010 with a diaphragm 3012, and an evacuation system 2300, which are communicated by a number of fluid lines or conduits, as described in more detail below. In this embodiment, the penetration of the two vessels and the flow of fluid occurs substantially simultaneously.

[0054] In this embodiment, the fluid conduit 300 is modified to include a bifurcation at the second end 304. The bifurcation at the second end 304 has multiple needles, each configured to move into communication with only one of the reservoirs 1302. Thus, in this embodiment in which the system includes two reservoirs 1302, the fluid conduit 300 has two generally parallel needles at the second end 304. The multiple needle flows enter a common channel in the fluid conduit 300, and the agent is delivered from a single channel or lumen at the first end 302. Although two reservoirs 1302 and two needles at the second end 304 are shown in the figures, other suitable numbers of reservoirs and needles may be used, such as three, four, five or more.

[0055] In Figures 3F and 3G, the multiple containers 1302, valves 3010 and / or canisters or fluid sources 1366 are arranged generally parallel to one another in the auto-injector. For example, Figure 3F is a side view of the fluid source 1366, valves 3010 and containers 1302a, 1302b, and Figure 3G is an end view of the fluid source 1366 and containers 1302a, 1302b. However, in some embodiments, one or more of the multiple containers 1302 and / or canisters 1366 are arranged along offset axes. Furthermore, one or more canisters 1366 may be used to position each container 1302 and fluid conduit 300 corresponding to a dedicated canister 1366.

[0056] 4A and 4B show the valve 3010 in further detail. The valve 3010 is designed to operate at a particular pressure by balancing one or more of the parameters including diaphragm thickness, diaphragm durometer, seat height h and / or high pressure cavity 3022 diameter d. At pressure equalization between the high pressure cavity 3022 and the low pressure cavity 3024, a holding force may be created due to low pressure in the conduit 3018 that prevents the diaphragm 3012 from returning to the neutral stage shown in FIG. 4A. This can be avoided by reducing the diameter of the conduit 3018 and / or by adjusting one or more of the pretension, diaphragm thickness, diaphragm diameter and seat height to increase the restoring force of the diaphragm 3012. For example, a flat stamped diaphragm may move relative to the rest of the valve and lose restoring force due to the forces acting on it upon deflection.

[0057] The valve 3010 has a first body portion 3040 and a second body portion 3042. The first body portion 3040 has a high pressure cavity 3022 and a tenting boss 3044 located around the high pressure cavity 3022. The tenting boss 3044 tensions the diaphragm 3012 (in a manner similar to a drum head) when the first body portion 3040 and the second body portion 3042 engage with each other. The first body portion 3040 has a retaining rib portion 3046 around the tensioning boss 3044 that secures the diaphragm 3012 by a gripping or retaining portion. The second body portion 3042 has a recess 3048 configured to receive the tensioning boss 3044. The recess 3048 has a shape corresponding to the tension protrusion 3044 such that when the first body portion 3040 and the second body portion 3042 are engaged with one another, the outer surface of the tension protrusion 3044 is flush with the inner surface of the recess 3048 (when the diaphragm 3012 is not inserted between the first body portion 3040 and the second body portion 3042). The second body portion 3040 has a sealing groove 3050 configured to receive a sealing rib portion 3052 of the diaphragm 3012. The sealing rib portion 3052 is disposed around the periphery of the diaphragm 3012 to increase the thickness of the member, thereby improving the seal provided by the diaphragm 3012.

[0058] An alternative valve 5010 is shown in FIG. 5. The valve 5010 is substantially similar to the valve 3010 shown in FIGS. 3A-3C, except that the valve 5010 has a piston 5012 instead of a diaphragm 3012. The piston 5012 has a seal 5014 disposed in a circumferential groove in an outer surface of the piston 5012. The seal 5014 is configured to prevent the high pressure cavity 3022 from communicating with the low pressure cavity 3024. A spring 5016 is connected to the end of the piston 5012 facing the low pressure cavity 3024. The spring 5016 is also connected to the side of the valve 5010 that defines the low pressure cavity 3024, and is entirely disposed within the low pressure cavity 3024. The spring 5016 is shown in a natural state in FIG. 5. In the natural state, the piston 5012 is spaced from the valve seat 3020, and the conduit 3018 is open. However, when the fluid source 1366 is actuated, the pressure in the high pressure cavity 3022 increases and acts against the piston 5012, compressing the spring 5016 and causing the piston 5012 to abut against the valve seat 3020 and close the conduit 3018. When the piston 5012 reaches the end of the injection (bottoms out), the pressures in the high pressure cavity 3022 and the low pressure cavity 3024 equalize and the spring 5016 expands to its natural state, opening the conduit 3018. Alternatively, the spring 5016 may extend from the end of the piston 5012 facing the high pressure cavity 3022 and extend through the high pressure cavity 3022 to the opposite end of the high pressure cavity 3022, connecting the end of the piston 5012 facing the high pressure cavity 3022 with a surface defining the opposite end of the high pressure cavity 3022. In this alternative embodiment, when the high pressure cavity 3024 is filled with pressurized gas from the fluid source 1366 , the spring 5016 expands from its natural state causing the piston 5012 to seal against the conduit 3018 .

[0059] An exemplary flow restriction system is shown in Figures 6, 7A and 7B. The restriction system 6000 shown in Figure 6 can be incorporated wherever a flow restriction 3008 is shown herein. The flow restriction system 6000 comprises a housing 6001 having an inlet 6002 connected to the output of a fluid source 1366. Pressurized gas is sent from the inlet 6002 through a conduit 6004 to a high pressure line 3002 (see Figure 3A). The pressurized gas from the inlet 6002 is also simultaneously diverted to a conduit 6006 (flow restriction) and finally sent to a low pressure line 3004 and a vessel 1302 (see Figure 3A). The path of the conduit 6006 is zigzag or serpentine, which reduces the pressure of the pressurized gas flowing through the path. This reduced pressure gas is then sent to the low pressure line 3004 and the vessel 1302 as described with reference to Figures 3A-3C.

[0060] The flow restriction system 7000 shown in Figures 7A and 7B can be incorporated wherever a pressure restriction 3008 is shown herein. The flow restriction system 7000 is a cartridge 7001 having an inlet 7002 connected to the output of a fluid source 1366. Pressurized gas is delivered from the inlet 7002 through a conduit 7004 to a high pressure line 3002 (see Figure 3A). The pressurized gas from the inlet 7002 is simultaneously diverted to a flow restriction (i.e., pressure reduction) 7006. The flow restriction 7006 is a frit comprising a porous material (e.g., a microporous or macroporous material), such as a plastic (particularly a sintered plastic), a ceramic, or other suitable material. The average pore size of the porous material is about 0.5 to about 15 microns, about 1 micron to about 10 microns, about 3 microns to about 6 microns, or about 5 microns in diameter. The porous material reduces the pressure of the pressurized gas flowing therethrough, and the reduced pressure gas is delivered to the low pressure line 3004 and to the vessel 1302 as described with reference to Figures 3A-3C. Specifically, as shown in more detail in Figure 7B, the pressurized gas flows into the vessel 1302 through the flow restriction 7006, driving the piston 1316. The low pressure inlet 3024 receives a portion of the reduced pressure flow. Although the low pressure line 3004 is omitted in Figure 7B, the low pressure line 3004 delivers the reduced pressure flow from the flow restriction 7006 to the low pressure inlet 3016. As shown, the low pressure inlet 3024 is an opening in the housing located near 1) the first end 1304 of the vessel 1302 and 2) the outlet of the flow restriction 7006. The flow restriction system 7000 is less prone to clogging and is easier to manufacture than other flow restrictions.

[0061] As previously discussed, pressurized gas from the inlet 7002 is delivered to a flow restriction (pressure reducer) 7006. The flow restriction 7006 is a frit comprising a porous material such as plastic (particularly sintered plastic), metal (such as stainless steel), ceramic or other suitable material. Figures 59A-59R show various alternative flow restrictions that can be incorporated into the flow restriction system 7000 shown in Figures 7A and 7B.

[0062] FIG. 59A is a cross-sectional view of an exemplary flow restriction 59000A. The flow restriction 59000A is formed of or filled with a granular material. For example, the flow restriction 59000A includes a plurality of granules 59002 (e.g., particles of sand or other suitable material) and a plurality of gaps 59004 located between adjacent granules 59002. Although not shown, the granules 59002 may be filled into a tube, pipe or other suitable enclosed or partially enclosed structure. The gaps 59004 between the granules 59002 form a tortuous path for gas passing through the flow restriction 59000A, thereby creating a pressure drop between both sides of the flow restriction 59000A. The granules 59002 can be compressed at various pressures, with the higher the compression pressure, the tighter the granules 59002 will be packed and the smaller the gaps 59004 will be. Thus, the more densely packed the granules 59002 are, the greater the pressure drop between the two sides of the flow restriction 59000A. Also, the pressure drop between the two sides of the flow restriction 59000A can be adjusted by varying the size and / or shape of the granules 59002. In this manner, the flow restriction 59000A creates a pressure drop between the two sides of the flow restriction 59000A.

[0063] 59B and 59C show exploded and cross-sectional views of another exemplary flow restriction 59000B. As shown, the flow restriction 59000B includes multiple plates, e.g., plates 59010, 59012, and 59014, stacked in series. Plate 59010 includes one or more holes or openings 59010a, e.g., in a central portion of plate 59010. Plate 59012 includes one or more holes or openings 59012a, e.g., in an outer or peripheral portion of plate 59012, and plate 59014 includes one or more holes or openings 59014a, e.g., in a central portion of plate 59010. Plates 59010 and 59014 may have the same or different configurations. The openings of adjacent plates may be offset and / or displaced from one another in the gas flow direction, although in at least some embodiments, certain adjacent plates have the same or similar opening patterns. For example, a first plate (such as plate 59010) has a central opening (such as opening 59010a) and a second plate (such as plate 59012) has an outer opening (such as opening 59012a). Thus, regardless of the rotational position of the plates, the openings formed in adjacent plates are not opposed. However, in some embodiments, at least some adjacent openings are opposed along an expected gas path, e.g., longitudinally.

[0064] As shown in FIG. 59C, plates 59010, 59012, and 59014 are stacked to form flow restriction 59000B, forming one or more serpentine paths 59011 through which gas flows. To pass through flow restriction 59000B, gas flow must pass through staggered holes 59010a, 59012a, and 59014a. In this manner, flow restriction 59000B can be used to create a pressure drop between the two sides of flow restriction 59000B, while at the same time reducing the occurrence of clogging. Additionally, the pressure drop between the two sides of flow restriction 59000B also helps hold plates 59010, 59012, and 59014 together.

[0065] As shown in FIG. 59B, each plate 59010, 59012, 59014 has four openings in the corresponding portion of each plate 59010, 59012, 59014. Alternatively, each plate 59010, 59012, 59014 may have fewer or more than four openings, although not shown. Although not shown, the flow restriction portion 59000B may have two plates or more than four plates. In these embodiments, the openings of adjacent plates are offset as described above to create a pressure drop between both sides of the flow restriction portion 59000B. In one example, the flow restriction portion 59000B has four or more plates of two shapes, with the plates of one shape being offset by the plates of the other shape in the plate stack. In one embodiment, the greater the number of plates, the greater the pressure drop between both sides of the flow restriction portion 59000B. Additionally, while plates 59010, 59012, and 59014 are shown as cylindrical, the disclosure is not limited thereto and plates 59010, 59012, and 59014 may be of different shapes and / or configurations. Additionally, openings 59010a, 59012a, and 59014a may be formed by etching or any other suitable method. In at least some embodiments, plates 59010, 59012, and 59014 have etched channels. The etched channels provide a path for gas flow from the center of the plate to the periphery of the plate and back to the center of the plate. In at least some embodiments, multiple plates may function as pressure limiters in any rotational position, and thus the rotational position of each plate need not be controlled. The multiple holes in each plate allow the autoinjector 2 to function properly even if one or more of the holes become clogged.

[0066] 59D and 59E show cross-sectional and schematic views of another exemplary flow restriction 59000C. As shown, the flow restriction 59000C includes multiple plates, e.g., first and second plates 59020 and 59022. The plates 59020 and 59022 are formed of any suitable metal or etchable material and each have an etched pattern (e.g., different etched patterns) that form a serpentine path 59021 through which gas flows. For example, as shown in FIG. 59D and 59E, the path 59021 extends along an etched pattern that includes etches 59020a, 59020b, and 59020c of the first plate 59020 and etches 59022a, 59022b, and 59022c of the second plate 59022. In this manner, plates 59020 and 59022 form a serpentine flow path 59021 for the gas flow to create a pressure drop between the two sides of flow restriction 59000C.

[0067] Flow restriction 59000C has fewer components (e.g., fewer plates) than flow restriction 59000B, but each component (e.g., plates 59020 and 59022) has a larger surface area and more material (e.g., metal, etchable material, etc.). In either case, in both embodiments, each plate can create a pressure drop between the two sides of each flow restriction.

[0068] 59F illustrates a cross-sectional view of another exemplary flow restriction 59000D. As illustrated, the flow restriction 59000D includes first and second plates 59030 and 59032 facing each other with gaps or channels 59033 formed between the plates 59030 and 59032 for gas flow (not shown). The first and second plates 59030 and 59032 have plate surface finishes and / or surface textures that affect roughness values ​​and the alignment or fit of the surfaces of the plates 59030 and 59032. In at least some embodiments, the surface finishes are formed by molding, pressing, machining, knurling, forging, sand blasting, shot blasting, chemical etching, or another suitable method. For example, the first plate 59030 has a first surface finish 59030a and the second plate 59032 has a second surface finish 59032a. The first surface finish 59030a and the second surface finish 59030b can be the same or similar surface finishes or can be different surface finishes. In this embodiment, a tortuous and / or restricted path for gas flow is created by the channel 59033 between the plates 59030 and 59032. This creates a pressure drop between the two sides of the flow restriction 59000C.

[0069] Additionally, one or more springs (such as springs 59034a and 59034b) bias one of plates 59030 and 59032 toward the other of plates 59030 and 59032. Springs 59034a and 59034b apply pressure (e.g., pushing plates 59030 and 59032 toward each other) to create a tortuous and / or restricted path for gas flow and create a pressure drop between the sides of flow restriction 59000C. For example, springs 59034a and 59034b can control the contact pressure between plates 59030 and 59032 to create a repeatable pressure drop and / or gas flow. Additionally, springs 59034a and 59034b constantly push against one or both of plates 59030 and 59032 to provide constant pressure on channel 59033, creating a tortuous and / or restricted path for gas flow. The path of gas flow is also dependent on surface finish 59030a and 59032a. In another embodiment, springs 59034a and 59034b push against one or both of plates 59030 and 59032 to completely block gas flow through flow restriction 59000C in a first (pre-actuation) state. When the patient-side needle mechanism is actuated, one or both springs are released or the pressure on one or both plates 59030 and 59032 is reduced, so that channel 59033 opens and remains open until the end of the injection. In this state, surface finishes 59030a and 59032a create a tortuous and / or restricted pathway, resulting in a pressure drop across flow restriction 59000D. After the injection is completed, e.g., after the patient needle is withdrawn from the patient, the constraint on springs 59034a and 59034b is released, allowing the springs to expand and close the flow pathway.

[0070] FIG. 59G shows a perspective view of another exemplary flow restriction 59000E. As shown, the flow restriction 59000E includes a hollow channel, needle, or tube 59040. The tube 59040 has one or more lateral openings 59042 extending longitudinally and penetrating a side of the tube 59040. The lateral openings 59042 may, for example, penetrating two sides of the tube 59040. The flow restriction 59000E includes a solid cylinder or rod 59044 (or other solid obstruction) disposed within the opening 59042 and penetrating a portion of the tube 59040. In this embodiment, the rod 59044 restricts the gas flow, thereby restricting the gas flow 59041 in the tube 59040.

[0071] The tube 59040 is connected to or supported by a disk 59046. The disk 59046 separates the high pressure and low pressure regions, creating a pressure drop between the two sides of the flow restriction 59000E. For example, the disk 59046 separates the high pressure and low pressure regions by allowing only air / gas / fluid to flow through a narrow channel (e.g., the tube 59040). Although the disk 59046 is shown as a cylindrical disk, the disclosure is not so limited. The disk 59046 may have any shape and / or size capable of separating the high pressure and low pressure regions. In this embodiment, the cross-sectional area of ​​the tube 59040 is smaller than the cross-sectional area of ​​the disk 59046. This reduced cross-sectional area of ​​the tube 59040 restricts the gas flow 59041, facilitating a pressure drop between the two sides of the flow restriction 59000E. Thus, due to the small cross-sectional area of ​​tube 59040 and the presence of rod 59044 passing through a portion of tube 59040, which acts as an obstruction, a pressure drop is likely to occur between the two sides of flow restriction 59000E.

[0072] 59H and 59I show cross-sectional views of another exemplary flow restriction 59000F. FIG. 59H shows a cross-sectional view of the flow restriction 59000F, and FIG. 59I shows a longitudinal cross-sectional view of a portion of the flow restriction 59000F. As shown, the flow restriction 59000F includes an outer pipe, needle or tube 59050 and a plurality of wires or filaments 59052 disposed within the tube 59050. The plurality of filaments 59052 form a number of gaps or passages 59054 between adjacent filaments 59052. The passages 59054 between the filaments 59052 form a tortuous and / or restricted path for gas through the flow restriction 59000F, resulting in a pressure drop between the two sides of the flow restriction 59000F. The tube 59050 may be compressed, in which case the filaments 59052 are packed more closely together within the tube 59050, resulting in smaller passages 59054. Thus, the more closely packed the filaments 59052 are, the greater the pressure drop across the flow restriction 59000F.

[0073] 59I shows filament 59052 and passageway 59054 extending generally linearly within tube 59050, although the disclosure is not so limited. For example, filament 59052 may be coiled (e.g., helical) and / or tailored to reduce passageway 59054 and affect the pressure drop between the sides of flow restriction 59000F. Alternatively or additionally, filament 59052 may be stretched or machined within tube 59050, for example after assembly, to reduce passageway 59054 and affect the pressure drop between the sides of flow restriction 59000F.

[0074] 59J and 59K show cross-sectional views of another exemplary flow restriction 59000G. FIG. 59J is a cross-sectional view of the flow restriction 59000G, and FIG. 59K is a cross-sectional view of a portion of the flow restriction 59000G. As shown, the flow restriction 59000G includes a housing 59062 and a screw structure 59064. The housing 59062 is substantially cylindrical and includes a wall 59066. The wall 59066 includes a threaded portion 59066a and defines an opening 59066b. The screw structure 59064 includes a screw 59064a that is threaded along the threaded portion 59066a and is inserted into the opening 59066b. The screw structure 59064 also includes an angled or tapered screw head 59064b. The screw head 59064b abuts and / or at least partially closes the opening 59066b.

[0075] As shown in FIG. 59K, with the screw 59064a threaded into the opening 59066b, the flow restriction 59000G creates a serpentine path 59061 for the gas flow through a small gap between the screw 59064a and the threads 59066a of the wall 59066. For example, the opening 59066b is a standard threaded through hole and the screw 59064a is a standard machine screw. The small gap between the screw 59064a and the threads 59066a creates a single helical passage 59061 for the gas to flow (FIG. 59K). The tightening of the screw 59064a is set to a desired tightening degree and / or insertion distance to control the pressure drop across the flow restriction 59000G to a desired degree. Additionally, the pitch and / or thread of the screw 59064a and / or threads 59066a affect the gas flow permeability of the flow restriction 59000G. For clarity of illustration, the screw head 59064b is not shown in FIG. 59K. The spring 59068 facilitates forcing the screw 59064a into the opening 59066b and / or facilitates securing or tightening the connection between the screw structure 59064 and the housing 59062. In these embodiments, the pressure drop is generated and / or controlled between the two sides of the flow restriction 5900G. The spring allows the contact pressure to be controlled to improve repeatability of the flow characteristics. The configurations of FIGS. 59J and 59K are similar to needle valves.

[0076] FIG. 59L shows a cross-sectional view of another exemplary flow restricting portion 59000H. As shown, the flow restricting portion 59000H includes a housing 59070, a ball bearing 59072, and a spring 59074 that form a serpentine path for the gas flow 59071. The housing 59070 includes an inclined side 59070a that at least partially abuts a portion of the ball bearing 59072. For example, the inclined side 59070a is generally conical and has a circular cross-sectional shape. In this embodiment, the housing 59070 includes, for example, a wide portion 59070c for receiving high pressure gas and a narrow portion 59070d for releasing gas with reduced pressure. Furthermore, the inclined side 59070a includes a rough or uneven surface 59070b.

[0077] The ball bearing 59072 is generally spherical. The ball bearing 59072 has one or more uneven surfaces that affect the contact with the uneven surface 59070b. For example, the uneven surface is formed by molding, pressing, machining, knurling, forging, sand blasting, shot blasting, chemical etching, or another suitable method. In addition, the spring 59074 securely couples the ball bearing 59072 to another portion of the housing (not shown). Thus, both the pressure of the incoming gas (e.g., the pressure from the wide portion 59070c) and the force of the spring press the ball bearing 59072 against the uneven surface 59070b, forming a partial seal and restricting the flow of gas entering the narrow portion 59070d. In some embodiments, increasing the pressure of the incoming gas (e.g., the pressure from the wide portion 59070c) presses the ball bearing 59072 harder against the uneven surface 59070b. Thus, the ball bearings 59072 restrict the gas flow 59071 entering the narrow portion 59070d with greater force, resulting in a greater pressure drop between the two sides of the flow restriction 59000H. In these embodiments, a pressure drop is created and / or controlled between the two sides of the flow restriction 59000H.

[0078] FIG. 59M illustrates a cross-sectional view of another exemplary flow restrictor 59000I. This embodiment also has a textured surface formed by molding, pressing, machining, knurling, forging, sandblasting, shot blasting, chemical etching, or another suitable method. As illustrated, the flow restrictor 59000I includes a plug 59080, a housing 59082, and a spring 59084. The plug 59080 has, for example, a substantially tapered configuration and is partially conical (e.g., frustoconical). As shown in FIG. 59M, the plug 59080 has a wide portion in the high pressure region (left side) and a narrow portion in the low pressure region (right side). The housing 59082 has a shape that is at least partially complementary to the plug 59080. Furthermore, in some aspects, the housing 59082 has a roughened, threaded, or textured surface 59082a. The plug 59080 is at least partially received within the housing 59082. Additionally, the spring 59084 may, for example, push against a wide portion of the plug 59080 to exert pressure on the plug 59080 and aid in securing the plug 59080 within the housing 59082. In these embodiments, the gas flow (not shown) may flow through a complex, restricted, and / or serpentine path formed between the plug 59080 and the housing 59082 (e.g., by the uneven surface 59082a). Additionally, by adjusting the insertion distance of the plug 59080 into the housing 59082, the compression force of the spring 59084, and / or other characteristics, the condition of the gas flow path, and thus the pressure drop, may be controlled. In these embodiments, the pressure drop is generated and / or controlled between the two sides of the flow restriction 59000I.

[0079] 59N illustrates a cross-sectional view of another exemplary flow restriction 59000J. As illustrated, the flow restriction 59000J has a first side 59090 and a second side 59092. For example, if the flow restriction 59000J is substantially cylindrical, the first side 59090 and the second side 59092 are located in a longitudinal cross-section. Alternatively, the flow restriction 59000J may be rectangular, in which case the first side 59090 and the second side 59092 are formed by opposing sides of the flow restriction 59000J. In these embodiments, the first side 59090 and the second side 59092 extend generally parallel to one another, forming, for example, a gap or channel 59094 for receiving a gas flow (not shown). First side 59090 has a first coating 59090a and second side 59092 has a second coating 59092a, for example forming a chromatography column. In some embodiments, first coating 59090a and second coating 59092a have predetermined properties. The coatings are selected to have an opposite polarity to the gas or fluid flowing through the channel in use. For example, coatings 59090a and 59092a are hydrophobic, hydrophilic, polar, etc. In one example, the fluid flowing through flow restriction 59000J is hydrophilic and coatings 59090a and 59092a are hydrophobic. In another example, the fluid flowing through flow restriction 59000J is hydrophobic and coatings 59090a and 59092a are hydrophilic. In these embodiments, a pressure drop is generated and / or controlled between both sides of flow restriction 59000H. For example, the coating described with reference to Figure 59N may be incorporated into other flow restrictions described herein.

[0080] FIG. 59O illustrates a partial cross-sectional view of another exemplary labyrinth seal flow restriction 59000K. As illustrated, the flow restriction 59000K includes a shaft 59100 and a housing 59102. A gas flow 59101 or fluid path travels in a channel (not labeled) between the shaft 59100 and the housing 59102. FIG. 59O illustrates a portion of the flow restriction 59000K, e.g., the top half. As illustrated, the shaft 59100 includes a number of protrusions 59100a. Thus, the protrusions 59100a form a serpentine path for the gas flow 59101. For example, the gas flow 59101 must traverse a channel between the protrusions 59100a and the housing 59102, which may create a pressure drop between the two sides of the flow restriction 59000K. For example, in a labyrinth seal flow restriction 59000K, gas expands after passing through each tooth (a small gap is formed between the housing 59102 and the tip of each tooth), which tends to create a pressure drop between the two sides of the flow restriction 59000K. By adjusting the type and / or size of the protrusions 59100a, as well as other aspects of the flow restriction 59000K, the pressure drop between the two sides of the flow restriction 59000K can be controlled and / or adjusted. In these aspects, a pressure drop is created and / or controlled between the two sides of the flow restriction 59000K.

[0081] FIG. 59P shows a schematic diagram of another exemplary flow restriction 59000L. As shown, the flow restriction 59000L is configured to release pressurized gas 59103 from a gas canister 59110a. Also, a frit 59116, slit, small hole or other flow restriction device as described herein is disposed within the flow path to create a pressure drop. As shown, the material or gas 59103 is dense before reaching the frit 59116 and becomes less dense after passing through the frit 59116. The low pressure fluid that passes through the frit 59116 proceeds to a low pressure line and is used in a suitable manner as described herein, for example, to drive a piston 1316 within a vessel 1302. The embodiment of FIG. 59P is structurally similar to other frits and / or porous microfilters described herein. However, structural components of lower grades or specifications may be used in combination with higher viscosity fluids or refrigerants (as opposed to refrigerants such as R32 refrigerant). For example, material or gas 59103 may be a denser gas (i.e., a gas with higher pressure, atomic weight, etc.), or material or gas 59103 may be a liquid (e.g., water, oil, glycerin, etc.) that is biocompatible and has a higher viscosity and / or density than the gas on the flow restriction 59000L side.

[0082] If the viscosity of material 59103 is high enough, a frit may not be necessary; the material itself, or a combination of the material and a narrow slit, may be able to create the desired pressure drop between the two sides of flow restriction 59000L.

[0083] Figures 59Q and 59R show cross-sectional views of another exemplary flow restriction 59000M. Figure 59Q is a cross-sectional view of the flow restriction 59000M, and Figure 59R is an enlarged view of a portion of Figure 59Q. As shown, the flow restriction 59000M includes a first housing 59120 and a second housing 59122. The first housing 59120 and the second housing 59122 are formed, for example, from an injection molded plastic material, a machined metal material, or another material. The first housing 59120 and the second housing 59122 may be substantially abutting at an interface 59124 (e.g., an interference fit or other suitable mating condition). The first housing 59120 includes a first recess 59120a, and the second housing 59122 includes a second recess 59122a. As shown in FIG. 59Q, the second recess 59122a is received within the first recess 59120a, for example, forming at least a partially sealed portion between the periphery of the second recess 59122a and an inner portion of the first recess 59120a.

[0084] As shown in more detail in FIG. 59R, the first recess 59120a has a first channel 59120b. Furthermore, the second recess 59122a has a second channel 59122b. The first channel 59120b and the second channel 59122b are arranged offset from each other in the fluid flow direction, but communicate with each other through a gap between the first recess 59120a and the second recess 59122a, for example at the boundary portion 59124. Thus, the gas flow 59121 or the fluid flows from the first channel 59120b to the second channel 59122b through the gap. Furthermore, the first recess 59120a and / or the second recess 59122a have an uneven surface. For example, as shown in FIG. 59R, the first recess 59120a has a gap and a textured surface 59120c facing the second recess 59122a. Although not shown, the second recess 59122a may also have a similar or complementary textured surface. In at least some embodiments, the textured surface is formed by molding, pressing, machining, knurling, forging, sand blasting, shot blasting, chemical etching, or another suitable method.

[0085] Furthermore, the first recess 59120a and the second recess 59122a are fixed to each other at the connection 59120d by a method such as welding or are connected by one or more seals. In this manner, the gas flow 59121 flows through the first channel 59120b, the gap between the first recess 59120a and the second recess 59122a including the uneven surface 59120c, and the second channel 59122b. The connection 59120d prevents the gas flow 59121 from exiting the flow restriction 59000M by any route other than the above.

[0086] The first channel 59120b, the gap between the first recess 59120a and the second recess 59122a including the uneven surface 59120c, and the tortuous path through the second channel 59120b can create a pressure drop between the two sides of the flow restriction 59000M. The structure of the flow restriction 59000M allows the pressure drop to be achieved by the existing structure of the auto-injector without the need for additional frits or other materials. Additionally, the size of the first opening 59120b, the size of the gap between the first recess 59120a and the second recess 59122a, the unevenness of the uneven surface 59120c, and the size of the second opening 59122b can be adjusted to affect the path of the gas flow 59121. In these embodiments, the pressure drop is created and / or controlled between the two sides of the flow restriction 59000M.

[0087] An embodiment of the valve 3010 is shown as valve 7100 in Figures 7C and 7D. The valve 7100 is applicable to a container 1302 whose longitudinal axis is perpendicular to the patient's skin surface (e.g., not parallel to the skin surface configuration shown in Figure 2). The housing 7101 of the valve 7100 has an inlet 7102 connected to the output of the fluid source 1366. Pressurized gas is delivered from the inlet 7102 to the high pressure line 3002 (see Figure 3A, not shown in Figures 7C and 7D) and to the high pressure cavity 7122 shown in Figure 7C. The high pressure gas in the high pressure cavity 7122 pushes the diaphragm 7112 towards the valve outlet 7120, sealing it. The pressurized gas from the inlet 7002 is also simultaneously diverted to a flow restriction (not shown) and delivered to the low pressure line 7104 and container 1302 (via the primary container inlet 7130). The flow restriction used in this embodiment is any suitable flow restriction including frits and / or serpentine conduits as described herein. The flow restriction is located in the inlet 7130 or upstream or downstream of the inlet 7130. Pressurized gas flows from the flow restriction through the low pressure line 7104 and the primary vessel inlet 7130 into the vessel 1302 to drive the piston 1316. The low pressure section 7124 of the housing 7101 has a low pressure cavity that receives a portion of the reduced pressure flow through the low pressure inlet 7116. The plate cover 7101a is coupled to the bottom surface 7101b (FIG. 7D) of the housing 7101 by laser welding, ultrasonic welding, or other methods. The bottom surface 7101b has the low pressure line 7104, the low pressure cavity inlet 7116, and the primary vessel inlet 7130, each etched into the bottom surface 7101b. In addition, the bottom surface 7101b has a valve outlet 7120 in communication with the low pressure cavity of the low pressure section 7124 and the exhaust line 7118. As described above with reference to Figures 3A and 3C, when the pressure is equalized between the high pressure cavity 7122 and the low pressure cavity, the diaphragm 7112 is lifted from the valve outlet 7120 to open the valve outlet 7120. As a result, gas / fluid from the low pressure cavity can travel through the valve outlet 7120, the exhaust line 7118 and the exhaust port 7118a (Figure 7C). A rod (not shown, but substantially similar to the rod 8002 described below) is disposed within the exhaust port 7118a.In the valve 7100, one or more, or all of the low pressure line 7104, low pressure cavity inlet 7116, primary reservoir inlet 7130, valve outlet 7120 and exhaust line 7118 are located on the same plane.

[0088] Another embodiment of the valve 3010 is shown as valve 7200 in Figures 7E and 7F. The valve 7200 is applicable to a container 1302 whose longitudinal axis is perpendicular to the patient's skin surface. The housing 7201 of the valve 7200 has an inlet 7202 connected to the output of the fluid source 1366. Pressurized gas / fluid is delivered from the inlet 7202 to a high pressure line 7204, a high pressure inlet 7214 (Figure 7F) and a high pressure cavity located in a portion 7222 of the housing 7201 (Figure 7E). The high pressure gas / fluid in the high pressure cavity 7204 pushes the diaphragm 7212 towards the valve outlet 7220, sealing it. The diaphragm 7212 is elliptical or lacy in shape. Pressurized gas / fluid from inlet 7002 is also diverted to a flow restriction (not shown) and sent to a low pressure line (such as low pressure line 3004 in FIGS. 3A-3C) and to the vessel 1302 (via inlet 7230 in FIG. 7F). Specifically, pressurized gas flows through inlet 7230 into the vessel 1302 and drives the piston 1316. In some embodiments, a frit or other flow restriction is disposed within inlet 7230. The flow restriction may be disposed upstream or downstream of inlet 7230. A low pressure cavity in portion 7224 of housing 7201 receives a portion of the reduced pressure flow via low pressure inlet 7216. Plate cover 7101a is coupled to bottom surface 7101b (FIG. 7D) of housing 7201 by laser welding, ultrasonic welding, or the like. The bottom surface 7101b has a high pressure line 7202, a high pressure cavity inlet 7214 and a primary vessel inlet 7230, which are etched into the bottom surface 7201b. As described above with reference to Figures 3A and 3C, when pressure is balanced between the high pressure cavity and the low pressure cavity, the diaphragm 7212 lifts from the valve outlet 7220 to open the valve outlet 7220. As a result, gas / fluid from the low pressure cavity can travel through the valve outlet 7220 and the exhaust port 7218a (Figure 7E). A rod (not shown, but substantially similar to rod 8002 described below) is located within the exhaust port 7218a. In the valve 7200, one or more or all of the high pressure line 7202, the high pressure cavity inlet 7214 and the inlet 7230 are located on the same plane.

[0089] Figures 7G and 7H show perspective and exploded views of auto-injector 2 with valve 7300. An embodiment of valve 3010 is shown in Figure 7G as valve 7300. The features and elements of valve 7300 function similarly to the features and elements of the valves described above, such as valve 7200.

[0090] The valve 7300 can be applied to the container 1302. As shown in FIG. 7H, the valve 7300 includes a first housing 7301, a second housing 7303, and a base plate 7305. The second housing 7303 is connected to the bottom of the first housing 7301, and the base plate 7305 is connected to the bottom of the second housing 7303 to form the valve 7300. The first housing 7301 has an inlet 7302 (such as a canister inlet) connected to the output of the fluid source 1366 (FIG. 5). Pressurized gas / fluid flows from the inlet 7302 through a high pressure line 7304 (in the first housing 7301) to a high pressure inlet 7320 (in the second housing 7303) (via a connection 7320a in the second housing 7303) to a high pressure cavity 7312b in the second housing 7303. The high pressure line 7304 has multiple channels arranged in a circuit, serpentine or zigzag fashion, for example, extending in various directions. In one embodiment, the channels of the high pressure line have about 2 to 10 laps, for example 4 laps. High pressure gas / fluid in the high pressure cavity 7312b presses the diaphragm 7312 against the valve seat 7307a to seal the valve outlet 7307. The diaphragm 7312 is generally circular and substantially similar to other diaphragms described herein. Pressurized gas / fluid from the inlet 7302 is also simultaneously diverted to a flow restriction (not shown) and delivered to a low pressure line (such as low pressure line 3004 in FIGS. 3A-3C) and a reservoir (such as 1302) via a conduit 7309a in the PNM flow channel 7309. In particular, the pressurized gas flows from the high pressure line 7304 through a connection 7320a and then into the PNM flow channel 7309. Pressurized gas then flows from PNM flow channel 7309 through conduit 7309a to channel 7315 and then into vessel 1302 at vessel inlet 7330 to drive vessel 1302 towards fluid conduit 300 and then drive piston 1316. In some embodiments, a frit or other flow restriction is disposed in inlet 7330 or between conduit 7309a and inlet 7330. Exemplary frits and flow restrictions are described herein. Details of frits described below may be applicable to other embodiments.For example, the frit may be formed of stainless steel, sintered plastic, or other suitable material. The frit may be formed of a material with a pore size of about 0.5 microns or greater. The length of the frit may be up to about 8-12 mm, e.g., about 10 mm, and the diameter may be about 1-5 mm, e.g., about 3 mm. The flow restriction may be located upstream or downstream of the inlet 7330. The low pressure cavity 7312a of the portion 7324 of the first housing 7301 receives a portion of the reduced pressure flow via the low pressure inlet 7316.

[0091] The second housing 7303 is connected to the bottom of the first housing 7301 by laser welding, ultrasonic welding, or the like, and the base plate 7305 is connected to the bottom of the second housing 7303 in a similar manner. These components of the valve 7300 can be welded together, for example, simultaneously or nearly simultaneously, by two laser welds. Furthermore, the components of the valve 7300 can be welded together around the periphery of the channel, for example, about 1-2 mm away from the channel, with the weld thickness being about 1 mm.

[0092] Various features of the first housing 7301, the second housing 7303 and the base plate 7305 are etched (or molded or machined) into portions of the first housing 7301, the second housing 7303 and the base plate 7305. As previously described with reference to Figures 3A and 3C, when pressure is balanced between the high pressure cavity and the low pressure cavity, the diaphragm 7312 is lifted from the valve seat 7307a to open the valve seat 7307a. As a result, gas from the low pressure cavity 7312a can travel through the valve outlet 7307 and the exhaust port 7318a. A rod (not shown, but substantially similar to the rod 8002 described below) is disposed within the exhaust port 7318a.

[0093] In one embodiment, the diaphragm 7312 can be formed with a variety of materials and thicknesses, etc. In yet another embodiment, the diaphragm 7312 is formed by one or more molding processes that provide a wide range of performance characteristics, e.g., with respect to temperature, etc. For example, increasing the temperature increases the pressure in the valve 7300 and / or canister system, changing the pressure differential across the diaphragm 7312. This also affects the movement of the diaphragm 7312 and / or the exhaust of the valve 7300. In particular, increasing the temperature may prevent or inhibit the diaphragm 7312 from lifting off / lifting off the exhaust valve seat 7307a. Additionally, the diaphragm 7312 may be formed of a composite material, e.g., formed by an overmolding process, to provide a rigid center portion, for example. Again, this affects the movement of the diaphragm 7312, e.g., the diaphragm 7312 is more rigid where it contacts the valve seat 7307a, making it easier to lift and / or separate from the valve seat 7307a. Additionally, in one or more embodiments, the orientation and / or position of the valve seat 7307a may be altered to change / improve the lift and / or separation of the diaphragm 7312 from the valve seat 7307a, e.g., under different pressure and / or temperature environments. For example, positioning the valve seat 7307a off-center on the diaphragm 7312 makes it easier for the diaphragm 7312 to lift and / or separate from the valve seat 7307a.

[0094] The following features of the valves described herein can be optimized to achieve a desired combination of functions at different temperatures and / or pressures: By placing the valve seat off-center, the lift-off pressure (the pressure required to move the diaphragm away from the valve seat (pressure in the low pressure cavity)) is increased. As the seat moves away from the center of the valve or cavity, the lift-off pressure increases. The diaphragm is stiffer and therefore deflects less near the valve wall. By moving the seat / diaphragm contact point away from the central portion of the diaphragm where deflection is greater, the lift-off pressure can be increased. The seating pressure (pressure loss) at which the diaphragm seats may also be increased. In some examples, about 0% to about 50% of the diameter is placed off-center of the diaphragm.

[0095] The seat may also be made higher, which brings the seat closer to the diaphragm so that the diaphragm has to travel a shorter distance to seal against the seat. As a result, the seating pressure (pressure loss) required to seat the diaphragm on the seat is also reduced. However, in this case, the lift-off pressure (low pressure cavity) required to lift the diaphragm off the seat is also reduced. In some examples, the seat is raised by about 0.5 mm to about 3 mm, about 1 mm to about 2 mm, or about 1.5 mm.

[0096] The diameter of the valve seat / exhaust port / exhaust opening can also be adjusted accordingly. A smaller diameter reduces the area of ​​the diaphragm pulled by the opening, and the force pulling the diaphragm is also smaller, thereby reducing the lift pressure. As a result, the force required to push up from the lower cavity can also be reduced. Since the outlet is open to the atmosphere, which has a lower pressure than the corresponding cavity, a smaller diameter of the outlet also reduces the effective area causing a pressure drop (i.e., less atmosphere comes into contact with the low pressure area). The diameter of the opening is about 0.1 mm to about 1 mm, and a smaller range is not compatible with ease of manufacture. In another embodiment, the diameter of the opening is about 0.5 mm.

[0097] The effective diameter of the diaphragm and / or cavity can also be optimized. Increasing the diameter reduces the effective stiffness of the diaphragm. For example, lower stiffness means higher flexibility / elasticity. This can be beneficial in terms of seating pressure, but can also negatively affect lift pressure. For example, the cavity is about 10 mm to about 20 mm, about 12 mm to about 18 mm, about 14 mm to about 16 mm, about 15 mm. In some embodiments, the cavity has a diameter of about 12.7 mm. In some embodiments, the cavity has a diameter of about 6.35 mm to about 25.4 mm (about 0.25 inch to about 1.0 inch).

[0098] Composite diaphragms, such as those described below with reference to Figures 7I-7K, have a stiffer portion that contacts the valve seat. This prevents localized deformation of the exhaust port / seat, which increases lift-off pressure (low pressure cavity). As a result, the softer portion of the diaphragm is not pulled into the exhaust port, which prevents seating before high pressure is reached. The diameter of disk 7412c described below is about 0%-90%, about 50%-75%, or about 60% of the diameter of the diaphragm. The disk is made of a rigid plastic, and the Shore A durometer hardness of the material of the remaining portions of the diaphragm is about 10-90, about 30-60, or about 40-50.

[0099] 7I-7K are different views of an exemplary diaphragm 7412 that may be incorporated into valve 7300 or any other valve described herein. FIG. 7I is a perspective view of a first side of diaphragm 7412. FIG. 7J is a perspective view of a second side of diaphragm 7412, partially see-through, showing a portion of diaphragm 7412. FIG. 7K is a partial cross-sectional view of diaphragm 7412. Diaphragm 7412 is generally circular. Diaphragm 7412 has an outer edge or gland 7412a that extends around the periphery of diaphragm 7412. Although gland 7412a is shown in FIG. 7I extending in one direction from the body of the diaphragm, gland 7412a may extend in multiple opposing directions away from the body. Gland 7412a is thicker than an inner portion 7412b of diaphragm 7412. The gland 7412a has, for example, a circular surface (e.g., a surface extending perpendicular to the radial direction of the diaphragm 7412) along the entire surface of the gland 7412a. Additionally, the diaphragm 7412 has a disk 7412c disposed on and / or coupled to the inner portion 7412b, for example, at the radial center of the diaphragm 7412. The disk 7412c is generally cylindrical and has approximately the same thickness (e.g., thickness in a direction away from the inner portion 7412b) as the thickness of the gland 7412a relative to the inner portion 7412b, although the thicknesses of the gland 7412a and the disk 7412c may be different. The thickness of each portion of the disk 7412c, including the entire thickness of the disk 7412c, is about 1 mm, about 2 mm, about 0.5 mm to about 10 mm, about 1 mm to about 9 mm, about 3 mm to about 8 mm, about 4 mm to about 6 mm, or about 5 mm. In some embodiments, the thickness of the disk 7412c is at least 1 mm for ease of manufacture. As shown, the disk 7412c has one or more depressions or recesses 7412d, e.g., curved depressions, extending radially inward from the outer circumferential surface of the disk 7412c. The depressions or recesses 7412d are spaced apart from one another circumferentially around the disk 7412c. However, the disclosure is not limited in this respect and the disk 7412c may have any shape and / or size.

[0100] The disk 7412c is coupled to the inner portion 7412b by adhesive and / or other suitable methods, such as molding or other mechanical interlocking. In one embodiment, the molding is an overmolding process. As shown in FIGS. 7J and 7K, the inner portion 7412b has one or more holes or recesses 7412e, and the disk 7412c has one or more protrusions 7412f. The protrusions 7412f are disposed in the recesses 7412e, thereby coupling the disk 7412c to the inner portion 7412b. Although the recesses 7412e shown in FIG. 7K extend through the entire inner portion 7412b, the disclosure is not limited thereto. For example, the recesses 7412e may extend only a portion (e.g., about 50%, 60%, 70%, 80%, etc.) of the inner portion 7412b. Accordingly, the size of the protrusion 7412f is set so that it can be received in the recess 7412f to couple the disk 7412c to the inner part 7412b. In this way, the recess 7412e and the protrusion 7412f strengthen the mechanical coupling between the inner part 7412b and the disk 7412c. The end of the protrusion 7412f may be flush with the surface of the inner part 7412b, may protrude outward from the surface, or may be within the thickness of the inner part 7412b. The recess improves the moldability of the disk and facilitates attachment of the disk to the diaphragm.

[0101] The disk 7412c may be formed of a unitary, single, composite, or other suitable material. The disk 7412c may be formed of a material that is harder than the rest of the diaphragm 7412. The disk 7412c may increase the stiffness of the diaphragm 7412. As shown in FIGS. 7L and 7M, the diaphragm 7412 with the disk 7412c may be subjected to a greater force and / or pressure, for example, allowing the diaphragm to bend and / or deform more uniformly, which may promote lifting from the valve seat 7407a under high pressure conditions. As shown in FIG. 7N, a diaphragm 7412′ without a disk may bend and / or deform non-uniformly, which may adversely affect, or even delay or prevent, lifting from the valve seat 7407a.

[0102] Additionally, one or more seals or vents are formed in the valve 7300 and the vessel 1302, although each seal or vent, e.g., valve seat 7307a, may be formed in one or more additional or alternative locations. Additionally, one or more channels or other lines may be repositioned to align with the above features and / or connection ports may be moved, repositioned, reoriented, etc., to account for various space constraints in different vessels 1302.

[0103] Additionally, although the valve 7300 is shown and described as a three-part valve (e.g., first housing 7301, second housing 7303, and base plate 7305), the disclosure is not so limited. For example, the valve 7300 may be a four-part valve. A four-part valve has an additional housing, e.g., adjacent and / or flush with the first housing 7301, and disposed between the second housing 7303 and the base plate 7305. Alternatively or additionally, a four-part valve has an additional housing (e.g., similar to a portion of the first housing 7301 or the second housing 7303) or an additional base plate. A four-part valve is easier to connect (e.g., welded), e.g., without the need to weld through holes, openings, or other portions of the valve 7300. These components of the valve 7300 are welded, e.g., by performing simultaneous or near-simultaneous laser welding on two portions of the outer component. Additionally, one or more of the inner layers or components (e.g., through holes and high / low pressure cavities) may be ultrasonically welded. Additionally, the material of the valve may be varied based on compatibility with the gas or fluid moving through the valve. Additionally, the type of weld between the various layers may be determined based on the opacity of each layer.

[0104] As previously described, the auto-injector 2 may have a four-part valve, e.g., valve 7500, as shown in FIG. 7O. Similar to valve 7300, valve 7500 may be applied to a system with container 1302 and other valves described herein. As shown in FIG. 7O, valve 7500 has a main housing 7501, a first sub-housing 7502, a second sub-housing 7503, and a base plate 7505. For example, the bottom surface of the first sub-housing 7502 is coupled to the top surface of the second sub-housing 7503, such as by ultrasonic welding. The bottom surface of the second sub-housing 7503 is coupled to the top surface of the main housing 7501, such as by laser welding. Additionally, the second sub-housing 7503 and the main housing 7501 enclose a diaphragm 7512, as previously described. The bottom surface of the main housing 7501 is coupled to the top surface of the base plate 7505, such as by laser welding.

[0105] The primary housing 7501 has an inlet 7501a (e.g., a canister inlet) that is connected to the output of the fluid source 1366 (FIG. 5) as previously described. The primary housing 7501 has a push rod cavity 7501b (similar to the PNM flow channel 7309 and used to direct gas flow to the patient-side needle mechanism, shuttle, etc. of the device) and a dump valve cavity 7501c (used to vent the system after balancing between the high and low pressure sides). The primary housing 7501 also has a container attachment 7501d for connection to a container 1302. Additionally, the primary housing 7501 has one or more gaps or spaces, e.g., openings 7501e, that facilitate forming (e.g., molding) the primary housing 7501. The openings 7501e are portions where no material has been formed, such as by being hollowed out. The first secondary housing 7502 forms the high pressure slide and has one or more channels 7502a (i.e., channels corresponding to the high pressure line 3002). The second sub-housing 7503 has one or more channels 7503a (also corresponding to the high pressure line 3002) as previously described. The base plate 7505 has multiple channels 7505a-c which correspond to the low pressure line 3004 as previously described. The four section valve construction allows the push rod cavity 7501b and dump rod cavity 7501c to be larger compared to other devices. This allows the pressure to be distributed over a larger surface area of ​​the larger rod / dump valve body improving device performance, especially at low temperatures.

[0106] In this manner, the various components of valve 7500, including diaphragm 75012, function similarly to valve 7300 and diaphragm 7312 to selectively close and / or lift against a valve seat (not shown) to control gas flow between high and low pressure regions.

[0107] The valve 7500 allows for a simple channel arrangement to provide fluid flow. The components of the valve 7500 are arranged to facilitate welding to form the valve 7500. As with the valve 7300, the welding is ultrasonic and / or laser welding. Additionally, the valve 7500 is generally smaller than other valves, thereby expanding the available space in an auto-injector and / or miniature auto-injector. The first sub-housing 7502 and the second sub-housing 7503 are connected by ultrasonic welding to form a high pressure sub-assembly. The main housing 7501 and the base plate 7504 are connected by laser welding to form a low pressure sub-assembly. The high pressure sub-assembly is connected to the main housing 7501 by laser welding or the like, thereby connecting the high pressure sub-assembly to the low pressure sub-assembly. In this embodiment, the diaphragm does not have tensile features, external ribs, or diaphragm irregularities, although in other embodiments using a four-part valve, the diaphragm may have such features. By omitting these features, the footprint or surface area of ​​the diaphragm and valve may be reduced, contributing to a smaller overall size of the auto-injector 2.

[0108] Different parts of the valve can be welded by different techniques and / or different processing sequences based on different parameters. Possible materials include clear or black polystyrene, ABS, polycarbonate (not usable with ultrasonics), etc. The material of each valve part is selected depending on the gas / fluid / liquid selected to drive the device. For example, styrene cannot be used with certain gases, e.g., HFA. In one embodiment, the low pressure valve side part 7501 is black, made of carbon black, etc. In one embodiment, the high pressure valve side part 7503 and the low pressure slider 7504 are clear.

[0109] In one embodiment, in a first step, the high pressure valve side part 7503 and the low pressure slide 7504 are welded to the low pressure valve side part 7501 by laser welding. The order in which the high pressure valve side part 7503 or the low pressure slide 7504 are welded to the low pressure valve side part 7501 may be reversed. In a second step, the high pressure slide 7502 is ultrasonically welded to the high pressure valve side part 7503.

[0110] In another embodiment, it is done in the reverse manner: in a first step, the high pressure slide 7502 is ultrasonically welded to the high pressure valve side portion 7503. The combined features are welded to the low pressure valve side portion 7501, and the low pressure slide 7504 is welded to the low pressure valve side portion 7501. The order of welding these two points may be reversed.

[0111] In some embodiments, ultrasonic welding, which may generate particulate matter, is performed first, and the particulate matter is removed before laser welding. Alternatively, ultrasonic welding may be performed after laser welding. In this alternative processing sequence, it may be desirable to remove dust and other particulate matter from the parts, or preferably be free or substantially free of dust, to prevent dust and particulate matter from being trapped in the valve near the frit.

[0112] In another embodiment, high pressure valve side portion 7503 and low pressure valve side portion 7501 are black, opaque or dark colored, such as carbon black, and high pressure sliding portion 7502 and low pressure sliding portion 7504 are transparent. In this embodiment, high pressure valve side portion 7503 and low pressure valve side portion 7501 are ultrasonically welded together, and then high pressure sliding portion 7502 and low pressure sliding portion 7504 are laser welded together.

[0113] 8A-8D show one embodiment of an evacuation system 8000 according to the present disclosure. The evacuation system 8000 includes a rod or other actuatable member 8002 disposed within a conduit 3018. The rod 8002 extends from a first end 8002a to a second end 8002b. The rod 8002 includes a seal 8003 located at or near the first end 8002a. Pressurized gas from the conduit 3018 contacts the first end 8002a but not the second end 8002b. The rod 8002 is movable from a first position shown in FIGS. 8A-8C to a second position shown in FIG. 8D. In the second position, the rod 8002 contacts and actuates a needle retraction mechanism 8004. The seal 8003 is configured to ensure that pressurized fluid moving within the conduit 3018 displaces the rod 8002 (rather than simply moving around the rod 8002).

[0114] FIG. 8A shows the system before pressurized gas is released from the fluid source 1366. In FIG. 8A, the diaphragm 3012 is in a neutral state and the second end 1306 of the reservoir 1302 is spaced from the needle 308. FIG. 8B shows the needle 308 in communication with the reservoir 1302 after pressurized gas has been released from the fluid source 1366. In FIG. 8B, the piston 1316 is moving through the reservoir 1302 and the diaphragm 3012 is pressing against the conduit 3018. FIG. 8C shows the state at the completion of the injection. In FIG. 8C, the piston 1316 has completed its movement across the reservoir 1302 (the piston 1316 has "bottomed out"). As previously mentioned, at this stage the pressures in the high pressure cavity 3022 and the low pressure cavity 3024 are in equilibrium and the diaphragm 3012 has returned to a neutral state, opening the conduit 3018. Since the fluid source 1366 has more pressurized gas than is needed to complete the injection, the excess pressurized gas must be evacuated from the auto-injector 2. Pressurized gas delivered to the conduit 3018 drives the second end 8002b of the rod 8002 into contact with the needle retraction mechanism 8004 (FIG. 8D). When the needle retraction mechanism 8004 is actuated by the rod 8002, the needle (e.g., the needle 306 shown in FIGS. 12A-12C) is retracted from a deployed configuration (within the patient's body) to a retracted configuration (within the auto-injector 2). In one embodiment, the needle retraction mechanism 8004 has one or more of the stopper 240 and / or the ramp 1500 shown in more detail below (FIG. 23). For example, the rod 8002 pushes the ramp 1500 and / or the stopper 240 to initiate needle retraction. In such an embodiment, retraction of the needle 306 from the patient can be initiated without the need for retraction or movement of the container 1302. In some embodiments, once retraction of the needle 306 is complete, the flow of pressurized fluid from the fluid source 1366 is stopped, leaving some pressurized fluid within the fluid source 1366. In other embodiments, drainage from the fluid source 1366 is accomplished by another mechanism.

[0115] 9A-9H show an ejection system 9001 according to another embodiment of the present disclosure. The ejection system 9001 has a piston 9002 disposed within a conduit 3018 to form a valve. The piston 9002 extends from a first end 9004 (clearly shown in FIGS. 9C and 9G) to a second end 9006. The piston 9002 has a larger diameter at the second end 9006 than at the first end 9004. The larger diameter second end 9006 acts as a stopper to restrict the movement of the piston 9002. For example, an obstacle (not shown) can be placed to precisely limit the range of movement of the piston 9002 during ejection. The second end 9006 is used to actuate the needle retraction mechanism as described in other embodiments of the present disclosure (e.g., rod 8002). The piston 9002 is generally rod-like except for the larger diameter protrusion at the second end 9006. The diameter of the rod-shaped portion of the piston 9002 is slightly smaller than the diameter of the conduit 3018, so that gas can flow out of the conduit 3018 along the outer surface of the piston 9002. The piston 9002 has a first seal 9008 disposed at or near the first end 9004, and a second seal 9010 disposed between the first end 9004 and the second end 9006. That is, the second seal 9010 is closer to the second end 9006 (farther from the first end 9004) than the first seal 9008. The first seal 9008 and the second seal 9010 are disposed in recesses extending in the circumferential direction of the piston 9002 as shown in FIGS. 9A-9G, or are disposed on the flat outer surface of the piston 9002. The diameter of the piston 9002 between the first seal 9008 and the second seal 9010 may be smaller than the diameter of the adjacent portion of the piston 9002 (to facilitate ejection).

[0116] The exhaust system 9001 also has a secondary channel / line 9012 branching off from the inlet that receives pressurized gas from the fluid source 1366. The secondary channel 9012 receives the pressurized gas before (or after) it enters the high pressure line 3002. The secondary channel 9012 is connected to a portion of the conduit 3018 downstream of the inlet of the conduit 3018. The conduit 3018 has an outlet 9014 through which the pressurized gas is released to the inner cavity of the auto-injector 2 and / or to the atmosphere. The distance b between the seals 9008 and 9010 is greater than the distance c between the outlet of the secondary channel 9012 and the outlet 9014 of the conduit 3018. In an alternative embodiment shown in FIG. 9H, the exhaust system 9001 has a larger opening or slot 9015 at the end of the conduit 3018 instead of the outlet 9014. In particular, the opening 9015 is located at the end of the conduit 3018 and is a portion of the conduit 3018 that has a larger diameter than the other portions. The opening 9015 has a similar or identical function as the outlet 9014 (i.e., allowing the release of pressurized gas from the fluid source 1366 to the inner cavity of the auto-injector 2 and / or to the atmosphere).

[0117] FIG. 9A shows the parts of the auto-injector 2 before the pressurized gas is released from the fluid source 1366. In FIG. 9A, the diaphragm 3012 is in a neutral state and the second end 1306 of the reservoir 1302 is spaced from the needle 308. FIG. 9B shows the needle 308 in communication with the reservoir 1302 after the pressurized gas is released from the fluid source 1366. In FIG. 9B, the piston 1316 is moving within the reservoir 1302 and the diaphragm 3012 is pressing against the conduit 3018. FIG. 9C is an enlarged view of FIG. 9B, focusing on the ejection system 9001. During an injection, the piston 9002 is located in a first position and the first end 9004 is adjacent to or in contact with the valve seat 3020. In this position, the second seal 9010 is located between the outlet of the secondary channel 9012 and the outlet 9014 of the conduit 3018. Thus, the flow of pressurized gas from the secondary channel 9012 to the outlet 9014 (and atmosphere) is blocked by the seal 9010.

[0118] FIG. 9D shows the state at the completion of the injection. In FIG. 9D, the piston 1316 has completed its travel across the reservoir 1302 (the piston 1316 has "bottomed out"). As previously described, at this stage the pressures in the high pressure cavity 3022 and the low pressure cavity 3024 are in equilibrium and the diaphragm 3012 has returned to a neutral state, opening the conduit 3018. Since the fluid source 1366 has more pressurized gas than is needed to complete the injection, the excess pressurized gas is vented from the auto-injector 2. The pressurized gas delivered to the conduit 3018 drives the piston 9002 within the conduit 3018 away from the valve seat 3020, as shown in FIGS. 9E-9G. The piston 9002 is moved away from the valve seat 3020 until, for example, the second end 9006 abuts against an obstruction (not shown) and the piston 9002 reaches a second position. While the piston 9002 is in the second position shown in FIGS. 9E-9G, the secondary channel 9012 communicates with the outlet 9014, allowing the pressurized gas to be vented to atmosphere. The pressurized gas travels from the secondary channel 9012 between the outer surface of the piston 9002 and the inner surface of the conduit 3018, and out the outlet 9014 to atmosphere. This travel is along the flow path 9016 shown in FIG. 9G. FIG. 9F shows the reservoir 1302 in a retracted configuration. In this embodiment, a spring 11002 (described below with reference to FIG. 17) is configured to retract the reservoir 1302. The drainage system 9001 (including the dump valve) allows for a relatively quick drainage from the fluid source 1366 (and subsequent retraction of the needle 306). For example, if the drainage takes too long, a delay of about 10 seconds, about 15 seconds, or more may occur in the retraction of the needle 306 and completion of the injection procedure.

[0119] 9I-9K show portions of an auto-injector 2 with additional features of an exhaust system 9001 according to another embodiment of the present disclosure. In this embodiment, the dump valve rod and conduit 3018 of FIGS. 9A-9H are shown in more detail. As previously described, the exhaust system 9001 includes a dump valve having, for example, a dump valve rod 9018 extending through a conduit 3018. As shown, the dump valve rod 9018 and the conduit 3018 are each generally cylindrical. The conduit 3018 also includes a radial recess (recessed area) 9022 in communication with the outlet 9014. The recess 9022 is a recess in the radially inner surface of the conduit 3018 and functions to vent and / or exhaust gas (e.g., flow path 9016 described with reference to FIG. 9G) from the exhaust system 9001 to the atmosphere or the like. In particular, gas travels from secondary channel 9012 through gaps between the inner surface of conduit 3018 and dump valve rod 9018, recess 9022, and outlet 9014. Dump valve rod 9018 has gaps 9022a and 9022b that receive and / or house one or more seals. The embodiment shown in Figures 9I-9K has the same functionality as the embodiment shown in Figures 9A-9H, but is smaller and more discrete, and therefore fits into smaller device housings. For example, recess 9022 / outlet 9014 is a fan-shaped channel rather than a through hole. This configuration allows for simplified molded parts and is easy to manufacture.

[0120] 10A-10D show an ejection system 10000 according to the present disclosure. Unlike the ejection systems 8000 and 9001 used with the valve 3010 described above, the ejection system 10000 is configured to be used without the valve 3010. The ejection system 10000 includes a line 10002 configured to deliver pressurized gas from a fluid source 1366 to a container 1302 to communicate the container 1302 with the needle 308 and to drive a piston 1316 within the container 1302. The rod 10004 extends from a first end 10004a (see FIG. 10D) to a second end 10004b, and is connected at the second end 10004b to a rear (non-drug contact) side of the piston 1316. The rod 10004 also extends within the conduit 10006 as shown in Figures 10A and 10B. While the rod 10004 is disposed in the discharge conduit 10006, the conduit 10006 is sealed and pressurized gas from the fluid source 1366 acts on the piston 1316 to drive it within the container 1302 (see Figure 10B). When the piston 1316 reaches the second end 1306 of the container 1302 (as shown in Figure 10C), the rod 10004 is fully withdrawn from the conduit 10006, thereby opening the conduit 10006 and allowing the pressurized gas to be discharged from the line 10002 through the conduit 10006. The pressurized gas continues to act on the piston 1316 (against the spring 11002 shown in Figure 17) while simultaneously being discharged. As a result, the spring force of the spring 11002 becomes greater than the force of the pressurized gas acting on the piston 1316. At this point, the system is fully evacuated, and the spring expands, causing the container 1302 to retract as shown in FIG. 10D (or retract as shown in an alternative embodiment). The spring 11002 returns the container 1302 to its original pre-deployment position, or to a position different from its original pre-deployment position (e.g., to a longitudinally offset position from its original pre-deployment position). The offset position may be closer or farther from the needle 308 than the original pre-deployment position.

[0121] 10E and 10F show additional views of the ejection system 10000. Specifically, FIG. 10E shows the ejection system 10000 with the first end 10004a of the rod 10004 extending within the conduit 10006 and prior to the ejection of the drug from the container 1302 by the piston 1316. FIG. 10F shows the ejection system 10000 after the completion of the injection, with the piston 1316 moving to the second end 1306 of the container 1302 and the first end 10004a of the rod 10004 being withdrawn from the conduit 10006. As shown in FIG. 10F, the first end 10004a transitions from the first position shown in FIG. 10E to the second position shown in FIG. 10F. In the first configuration, the first end 10004a of the rod 10004 extends along a first axis, along which the remainder of the rod 10004 also extends. In the second configuration, shown in FIG. 10F, the first end 10004a extends along a second axis offset from the first axis. The offset second configuration, shown in FIG. 10F, can inhibit the first end 10004a from being accidentally reinserted into the conduit 10006 and from unintentionally disrupting the drainage process. In some embodiments, the first end 10004a is biased into the offset second configuration. For example, the rod 10004 is made of a shape memory material, such as Nitinol, and is formed into the offset second configuration. In such an embodiment, the proximal end 10004a is biased to a first configuration (e.g., held in the first configuration by the conduit 10006) and returns to a biased second configuration when withdrawn from the conduit 10006. The biased configuration may be achieved, for example, by a tab, curved plastic, or any other suitable structure. In this embodiment, a seal 10010 is disposed on the inner surface of the chamber 10008 to surround the container 1302. Additionally, the outflow 10012 from the conduit 10006 may be directed to the surrounding environment / atmosphere or may be used to actuate other mechanisms described herein. For example, the outflow 10012 may be directed to move the rod 8002 described above to control needle retraction. In the embodiment shown in Figures 10A-10F, no valve 3010 is required to sense the end of the injection since the conduit 10006 automatically opens at the end of the injection.

[0122] Various ejection mechanisms for facilitating ejection from the fluid source 1366 are described below with reference to Figures 11 and 11A-11H. The ejection system 11004 shown in Figures 11, 11A and 11B includes a first straw 11005 and a second straw 11006. The first straw 11005 has a smaller diameter than the second straw 11006 and is housed within the second straw 11006 in one or more configurations. For example, the first straw 11005 and the second straw 11006 form a telescopic structure. The proximal end of the first straw 11005 is coupled to the fluid source 1366 and the distal end of the second straw 11006 is coupled to the piston 1316. Figure 11 shows the ejection system 11004 before the fluid source 1366 is activated. In this configuration, the first straw 11005 is completely contained within the second straw 11006. In at least some embodiments, the lengths of the first straw 11005 and the second straw 11006 are the same, although the lengths of the first straw 11005 and the second straw 11006 may be different.

[0123] When the fluid source 1366 is actuated, pressurized fluid travels through the lumen of the first straw 11005, driving the piston 1316. The tip of the first straw 11005, in some embodiments, is not directly connected to the piston 1316, and thus the pressurized fluid urges the piston 1316 and the second straw 11006 (which is directly connected to the piston 1316) toward the second end 1306 of the second container 1302 (see FIG. 11A). At the end of the injection (FIG. 11B), the piston 1316 reaches the second end 1306 of the container 1302 and the base end of the second straw 11006 catches on an obstruction (not shown, described in more detail below with reference to other figures) on the first straw 11005, preventing relative movement between the first straw 11005 and the second straw 11006. At this point, further pressurized fluid from the fluid source 1366 will cause the base end of the first straw 11005 to be disconnected from the fluid source 1366, stopping the flow of fluid from the fluid source 1366, or allowing the remaining propellant and pressurized fluid to be expelled from the fluid source 1366 into the environment. The disconnection of the first straw 11005 from the fluid source 1366 removes the only force acting on the reservoir 1302 in the direction from the first end 1304 to the second end 1306. During an injection, the force acting in the direction from the first end 1304 to the second end 1306 compresses the spring 11002 (see FIG. 11B). With the force removed in that direction, the spring 11002 expands, urging the reservoir 1302 in the direction from the second end 1306 to the first end 1304 (e.g., in the opposite direction). Alternatively, the spring 11002 may be configured to expand during injection, in which case when the force is released, the spring 11002 compresses, urging the container 1302 in a direction from the second end 1306 toward the first end 1304.

[0124] 11C and 11D show in more detail the ejection system 11004 in which pressurized fluid from a fluid source 1366 moves an outer second straw 11006 relative to an inner first straw 11005. The first straw 11005 has an elongated body portion 11005a with a lumen 11005b extending therefrom. The fluid source 1366 has a protrusion that is received by the lumen 11005b such that pressurized fluid leaving the fluid source 1366 flows directly into the lumen 11005b. The first straw 11005 also has a proximal flange 11005c and a distal flange 11005d. A seal 11005e, such as an O-ring, is coupled to the proximal side of the distal flange 11005d. The second straw 11006 includes a body portion 11006a having a closed distal end and an open proximal end. The second straw 11006 encloses a space 11006b and has a flange 11006c near its proximal end. Prior to activation of the fluid source 1366, the distal side of the proximal flange 11005c abuts and / or is adjacent to the proximal side of the flange 11006c.

[0125] When the fluid source 1366 is actuated, pressurized fluid flows through the lumen 11005b of the first straw 11005 and acts on the closed tip of the second straw 11006, moving the straw 11006 and the piston 1316 towards the second end 1306 of the container 1302. At the end of the injection, as the piston 1316 moves within the container 1302 to the second end 1306 (as shown in FIG. 11D ), the distal side of the flange 11006c abuts against the proximal side of the seal 11005e and / or the distal flange 11005d. When the piston 1316 bottoms out, the second straw 11006 and the first straw 11005 (all connected together) are pulled away from the fluid source 1366, and the connection between the first straw 11005 and the fluid source 1366 is broken. When the connection between the first straw 11005 and the fluid source 1366 is broken, the flow of pressurized fluid stops or any pressurized fluid subsequently flowing out of the fluid source 1366 is vented to the surroundings and / or atmosphere.

[0126] The embodiment of the ejection system 11007 shown in Figures 11E and 11F is similar to the ejection system 11004 shown in Figures 11C and 11D, except that in the ejection system 11007, an inner first straw 11008 is driven relative to an outer second straw 11009 by a fluid source 1366. The inner first straw 11008 has an elongate body portion 11008a with a lumen 11008b extending therethrough. The body portion 11008a has a narrow proximal end 11008c, and the distal end of the body is connected to the proximal side of the piston 1316. A seal 11008d, such as an O-ring, is disposed around at least a portion of the body portion 11008a. The second straw 11009 has a body portion 11009a that surrounds a space 11009b through which the first straw 11008 passes. The proximal end of the second straw 11009 has an opening 11009c configured to receive a conduit of the fluid source 1366. The distal end of the second straw 11009 is coupled to and closed by the first end 1304 of the container 1302.

[0127] When the fluid source 1366 is actuated, pressurized fluid travels through the lumen 11008b of the first straw 11008, driving the piston 1316. Because the tip of the first straw 11005 is directly connected to the piston 1316, the pressurized fluid drives the piston 1316 and the first straw 11008 towards the second end 1306 of the second container 1302 (see FIG. 11F). At the end of the injection (FIG. 11F), the piston 1316 reaches the second end 1306 of the container 1302 and the first straw 11008 cannot move any further distally. Continued release of pressurized gas from the fluid source 1366 pushes the container 1302, the first straw 11008, and the second straw 11009 (all connected together) away from the fluid source 1366, causing the connection between the second straw 11009 and the fluid source 1366 to be broken (not shown). Once the connection between the second straw 11009 and the fluid source 1366 is broken, the flow of pressurized fluid stops, or any pressurized fluid subsequently flowing from the fluid source 1366 is vented to the surroundings and ultimately to the atmosphere.

[0128] 11G and 11H show examples of features that can be used in either of the ejection systems 11004 or 11007 described above. Specifically, these figures show a coupling 11118 attached to the outlet of a fluid source 1366. The coupling 11118 is attached to the proximal end 11114a of a first straw 11114 (which may be the proximal end of either of the straws described above). A second straw 11112 is coupled to a piston 1316 (not shown in FIGS. 11G and 11H) and is driven by pressurized fluid from the fluid source 1366. As previously described, at the end of an injection, the piston 1316 bottoms out and reaches the second end 1306 of the container 1302 (not shown in FIGS. 11G and 11H). Further release of pressurized fluid from the fluid source 1366 causes each of the first straw 11114, second straw 11112, and container 1302 to decouple from the connection 11118 and / or the fluid source 1366. Although connection 11118 is shown in Figures 11G and 11H, in at least some embodiments, the first straw 11114 is directly connected to the fluid source 1366 and receives pressurized gas directly from the fluid source 1366.

[0129] After the proximal end 11114a of the first straw 11114 is disconnected from the coupling 11118 and / or the fluid source 1366, the proximal end 11114a transitions from the first configuration shown in FIG. 11G to the second configuration shown in FIG. 11H. In some embodiments, the proximal end 11114a is biased to the second configuration. While connected to the coupling 11118 and / or the fluid source 1366, the proximal end 1366 is maintained in the first configuration by the shape of the coupling 11118 and / or the fluid source 1366. For example, the proximal end 11114a is constrained in the first configuration by being inserted into a conduit of the coupling 11118 and / or the fluid source 1366, and upon removal from the coupling 11118 and / or the fluid source 1366, the proximal end 11114a returns to the second configuration shown in FIG. 11H.

[0130] In one embodiment, the proximal end 11114a comprises a shape memory material, such as an SMA, smart metal, shape memory metal, shape memory alloy, muscle wire, smart alloy, etc., biased to the second configuration. In another embodiment, the proximal end 11114a is formed from a frangible material such that it breaks away from the remainder of the first straw 11114 after the first straw 11114 is disconnected from the coupling 11118 and / or fluid source 1366. In the second configuration, the first straw 11114 is substantially prevented or inhibited from reattaching to the coupling 11118 and / or fluid source 1366, thereby allowing any propellant or pressurized gas remaining in the fluid source 1366 to be vented to the environment and ultimately to the atmosphere, or the flow of pressurized gas from the fluid source 1366 is stopped entirely.

[0131] 12A-12C illustrate a valve (e.g., a butterfly valve) 11120 that can be used in conjunction with various embodiments disclosed herein, such as the embodiments illustrated in FIGS. 3A-3C. In particular, the valve 11120 is coupled to the high pressure line 3002 and the conduit 3018 of the valve 3010. FIG. 12B illustrates the valve 11120 in a closed configuration, which prevents flow from the high pressure line 3002 from passing through the valve 11120. The housing 11122 of the valve 11120 has a first inlet 11124 (configured to receive flow from the high pressure line 3002), an outlet 11126, and a second inlet 11127. The second inlet 11127 is configured, in some embodiments, to receive flow from the conduit 3018 of the valve 3010. The valve 11120 has a movable member 11128 configured to move within and relative to the housing 11122 .

[0132] In the closed configuration shown in FIG. 12B, the movable member 11128 substantially or completely blocks the flow of pressurized gas from the high pressure line 3002 through the valve 11120. The movable member 11128 is rotatable within the housing 11122 about an axis and has a movable pin 11130. The movable pin 11130 is disposed within a lumen 11131 of the movable member 11128 and is reciprocable within the lumen 11131. However, other suitable configurations may be used. For example, the movable pin 11130 may slide relative to a slot or recess in the movable member 11128. In the closed configuration shown in FIG. 12B, the flow of fluid through the second inlet 11127 is blocked by the movable pin 11130 located at the second inlet 11127. As shown in Figure 12C, the movable pin 11130 slides within the lumen 11131 of the movable member 11128, releasing the movable member 11128 from the first position shown in Figure 12B, causing the movable member 11128 to rotate or move to the second position shown in Figure 12C. Figure 12C shows the valve 11120 in an open configuration, allowing pressurized gas from the high pressure line 3002 to flow through the valve 11120 and allowing any pressurized gas remaining in the fluid source 1366 to be vented to the surrounding environment and ultimately to atmosphere.

[0133] Prior to actuation of the auto-injector 2, the valve 11120 is in the closed configuration shown in FIG. 12B and remains in the closed configuration after actuation of the fluid source 1366 and during injection. That is, the valve 11120 is in the closed configuration until the piston 1316 is driven within the container 1302 to reach (bottom out) the second end 1306. At the end of the injection, the diaphragm 3012 (FIGS. 3A-3C) of the valve 3010 returns to a neutral state, allowing flow through the conduit 3018. Flow through the conduit 3018 acts on the movable pin 11130 (e.g., pushing the movable pin 11130 into the lumen 11131), releasing the movable member 11128 from the locked first position. When the movable member 11128 is released from the locked first position shown in FIG. 12B, pressurized gas flowing through the high pressure line 3002 travels through the valve 11120 to expel any propellant remaining in the fluid source 1366.

[0134] 13A-13D show a valve 11140 that can be used in conjunction with various embodiments disclosed herein, such as the embodiment shown in Figures 3A-3C. The valve 11140 can be disposed within the auto-injector 2 similar to the valve 11120. For example, the valve 11140 is coupled to the high pressure line 3002 and the conduit 3018.

[0135] 13A illustrates the valve 11140 in a closed configuration, in which flow from the high pressure line 3002 is prevented from passing through the valve 11140. The housing 11142 of the valve 11140 has a first inlet 11144 (configured to receive flow from the high pressure line 3002), an outlet 11146, and a second inlet 11148. The second inlet 11148 is configured to receive flow from the conduit 3018 of the valve 3010 in some embodiments. The valve 11140 has a piston 11150 configured to move within and relative to the housing 11142. An elongate member, e.g., a shaft 11156 of the piston 11150 extends from a first end 11152 to a second end 11154. Wings 11157 are disposed on the shaft 11156. The wings 11157 receive a flow of pressurized gas from the second inlet 11148 to rotate the piston 11150 about the longitudinal axis of the shaft 11156. The wings 11157 are formed from a woven fabric in some embodiments. The fabric may be made of nylon, Dacron, aramid fiber, or other suitable fibers.

[0136] The flange 11158 is disposed at the second end 11154 and is coupled to the end of the shaft 11156. As shown in FIG. 13D, the flange 11158 has a generally circular cross-section and has one or more recesses 11158a extending radially inward from the outer periphery. In the embodiment shown in FIG. 13D, the flange 11158 has two recesses 11158a located on opposite sides approximately 180 degrees from each other. However, other suitable numbers of recesses 11158a may be included. The flange 11158 may also have another suitable shape, such as, for example, a rectangle, a square, etc.

[0137] As shown in FIG. 13A, the housing 11142 has one or more stoppers 11164 configured to abut a surface of the flange 11158 to maintain the piston 11150 in the closed configuration shown in FIG. 13A. When the piston 11150 is in the closed configuration, the valve 11140 is closed, preventing pressurized gas from the high pressure line 3002 from flowing through the valve 11140. When the piston 11150 is rotated (e.g., about 90 degrees), the recess 11158a is aligned with the stopper 11164. When the recess 11158a is aligned with the stopper 11164, the piston 11150 is allowed to move longitudinally along the longitudinal axis of the shaft 11156, forming a flow path through the valve 11140 (from the first inlet 11144 to the outlet 11146).

[0138] Prior to actuation of the auto-injector 2, the valve 11140 is in the closed configuration shown in FIG. 13A and remains in the closed configuration after actuation of the fluid source 1366 and during injection. That is, the valve 11140 is in the closed configuration until the piston 1316 is driven within the container 1302 and reaches (bottoms out) the second end 1306. At the end of the injection, the diaphragm 3012 (FIGS. 3A-3C) of the valve 3010 returns to a neutral state, allowing flow through the conduit 3018. The wings 11157 receive flow from the conduit 3018 and rotate the piston 11150 about the longitudinal axis of the shaft 11156, aligning the recess 11158a with the stopper 11164. When the recess 11158a is aligned with the stopper 11164, pressurized gas from the high pressure line 3002 pushes the piston 11150 along the longitudinal axis of the shaft 11156. As a result, a flow path is created through valve 11140 and pressurized gas flowing through high pressure line 3002 is vented to the environment and / or to the atmosphere via outlet 11146 .

[0139] 14A and 14B illustrate a valve 11170 that can be used in conjunction with various embodiments disclosed herein, such as those illustrated in FIGS. 3A-3C. The valve 11170 is coupled to the high pressure line 3002 and the conduit 3018 of the valve 3010. FIG. 14A illustrates the valve 11170 in a closed configuration, which prevents flow from the high pressure line 3002 from passing through the valve 11170. The housing 11172 of the valve 11170 has a first inlet 11174 (configured to receive flow from the high pressure line 3002), an outlet 11176, and a second inlet 11178. The second inlet 11178 is configured in some embodiments to receive flow from the conduit 3018 of the valve 3010. The valve 11170 has a piston 11180 configured to move within and relative to the housing 11172. The first seal 11182 and the second seal 11184 are disposed around the outer circumference of the piston 11180. In some embodiments, the first seal 11182 and the second seal 11184 are disposed in circumferential recesses of the piston 11180. However, the first seal 11182 and the second seal 11184 may be disposed around a continuous, uninterrupted outer surface of the piston 11180. In some embodiments, an inner portion 11185 located between the first seal 11182 and the second seal 11184 has a smaller diameter than the rest of the piston 11180 and also has a smaller diameter than the inner surface of the housing 11172. The valve 11170 includes a resilient member, such as a spring 11186, coupled to the piston 11180. A spring 11186 is coupled to the end of the housing 11172 furthest from the second inlet 11178 and is biased to the expanded configuration shown in Figure 14A. In such an embodiment, a force acting on the piston 11180 compresses the spring 11186 and transitions the valve 11170 to the open configuration shown in Figure 14B. In the open configuration shown in Figure 14B, pressurized gas passes from the high pressure line 3002, through the inlet 11174, through the space between the housing 11172 and the reduced diameter portion 11185 of the piston 11180, and out of the valve 11170 via the outlet 11176.In an alternative embodiment, the spring 11186 is coupled to an end face of the housing 11172 proximate the second inlet 11178 and is biased to a compressed state when the valve 11170 is in the closed configuration. In this alternative embodiment, a force acting on the piston 11180 causes the spring 11186 to expand, moving the valve 11170 to the open configuration.

[0140] In the closed configuration shown in FIG. 14A, the first seal 11182 substantially or completely blocks the flow of pressurized gas from the high pressure line 3002 through the valve 11170. Prior to actuation of the auto-injector 2, the valve 11170 is in the closed configuration shown in FIG. 14A and remains in the closed configuration after actuation of the fluid source 1366 and during the injection. That is, the valve 11170 is in the closed configuration until the piston 1316 is driven within the container 1302 and reaches (bottoms out) the second end 1306. At the end of the injection, the diaphragm 3012 (FIGS. 3A-3C) of the valve 3010 returns to a neutral state, allowing flow through the conduit 3018. Flow from the conduit 3018 acts on the piston 11180, compressing the spring 11186. When the valve 11170 is moved from the closed position shown in FIG. 14A to the open position shown in FIG. 14B, pressurized gas in the high pressure line 3002 moves through the valve 11170, expelling any propellant remaining in the fluid source 1366.

[0141] 15A and 15B show an embodiment utilizing one or more magnets to initiate drainage from a fluid source 1366 (not shown in FIGS. 15A and 15B). In one embodiment, the piston 1316 has or is coupled to a first magnet 11190. The first magnet 11190 is coupled to the outer surface of the piston 1316, embedded within the piston 1316, or coupled to the rear and trailing surface of the piston 1316 (this position is shown as 11190a). The second magnet 11192 (or 11192a) is positioned outside the vessel 1302 and moves along the vessel 1302 as the piston 1316 moves within the vessel 1302 due to the attractive force with the first magnet 11190 (or 11190a).

[0142] At the end of the injection, the piston 1316 is positioned at the second end 1306 of the container 1302 and the second magnet 11192 (or 11192a) is moved into contact or alignment with the actuator 11194 (or 11194a). The actuator 11194 is a magnetically actuated switch and is configured to initiate ejection and / or retraction of the needle 306 in embodiments described herein. In another embodiment, the second magnet 11192 (or 11192a) is coupled to electrical contacts that interact with corresponding electrical contacts of the actuator 11194 (or 11194a) to initiate ejection and / or retraction of the needle as described above.

[0143] The valve 3010 shown in Figures 16A-16E includes features to prevent the diaphragm 3012 from resealing the conduit 3018 after the diaphragm 3012 returns to a neutral state at the end of an injection. The valve 3010 includes a first locking member 21180 coupled to the diaphragm 3012 by a connection 21181. The first locking member 21180 includes a locking recess 21180a configured to receive a correspondingly shaped locking element. As shown in Figure 16A, when the valve 3010 is in an initial position prior to actuation of the fluid source 1366, the first locking member 21180 is disposed within or coupled to the conduit 3018. The valve 3010 also includes an assembly 21185 spaced from the conduit 3018. The assembly 21185 has a plurality of arms 21185a spaced apart to define an opening 21187. In particular, each arm 21185a has a stopper 21186 consisting of an angled surface and a flat surface. The angled surface of the arms 21185a functions to allow unidirectional movement of the second locking member 21182 through the assembly 21185, as will be described in more detail below. The second locking member 21182 has an angled locking member 21183 configured to fit into the recess 21180a of the first locking member 21180. The second locking member 21182 also has a flange 21184.

[0144] When the fluid source 1366 is actuated while the valve 3010 is in the first position shown in FIG. 16A, the diaphragm 3012 moves downward to seal the conduit 3018. Because the first locking member 21180 is connected to the diaphragm 3012 by the connection 21181, the first locking member 21180 also moves downward toward the second locking member 21182 (see FIG. 16B) such that the angled locking member 21183 is received in the recess 21180a and the first and second locking members 21180 and 21182 are connected to each other (FIGS. 16C and 16D). The valve 3010 is maintained in the configuration shown in FIG. 16C and 16D while the piston 1316 moves within the container 1302 during an injection. At the end of the injection, the diaphragm 3012 returns to the neutral state shown in FIG. 16E, opening the conduit 3018. At this time, the first and second locking members 21180 and 21183, which are connected to each other and to the diaphragm 3012 by the connecting portion 21181, move together with the diaphragm 3012. Specifically, the movement of the connected first and second locking members 21180 and 21183 causes the flange 21184 to slide on the inclined surface of the arm 21185a and slightly push the arm 21185a radially outward, temporarily widening the opening 21187. This causes the first and second locking members 21180 and 21183 to come out of the opening 21187 (see FIG. 16E). In this third arrangement, the stopper 21186 prevents the flange 21184 from moving downward and / or away from the conduit 3018. This also prevents the diaphragm 3012 from moving downward to reseal the conduit 3018.

[0145] The needle mechanism 20, described below with reference to Figures 17, 18A-18D and 19-23, includes a carrier 202. The needle mechanism 20 also includes a fluid conduit 300 attached to the carrier 202. The fluid conduit 300 is deployed to a user and retracted by a driver 320. A shuttle 340 (e.g., a shuttle actuator) is configured to move the driver 320 via a deployment gear 360 and a retraction gear 362. The shuttle 340 is coupled to a resilient member (such as a spring 370). A cover 390 is coupled to the carrier 202 and covers various components of the needle mechanism 20. The use of one or more gears in the patient needle mechanism (to aid in the deployment and retraction of the needle 308 along a transverse axis) can reduce the height or length of the auto-injector 2 compared to an auto-injector in which the patient needle and drug container are aligned. For example, the length of an auto-injector according to the present disclosure along the longitudinal axis 40 can be reduced.

[0146] As shown in FIG. 18A, the fluid conduit 300 extends from a first end 302 to a second end 304. The first end 302 has a needle 306 configured to be injected into a user. The needle 306 has a sharp and / or beveled tip and extends generally along or parallel to the axis 44. The second end 304 has a needle 308 (see FIGS. 3A-3C). The needle 308 is substantially similar to the needle 306, but is disposed within the auto-injector 2 to penetrate the reservoir 1302 (described above) to access the medication to be injected into the user. The fluid conduit 300 has an intermediate portion 310 including a first portion extending along or parallel to the axis 40 and a second portion extending along or parallel to the axis 40. The first and second portions of the intermediate portion 310 are connected by a coil 312. The coil 312 aids in bending of the fluid conduit 300 and movement of the needle 306 along the axis 44 as the needle 306 is deployed and retracted relative to the user. Although the coil 312 is shown, it may be of other suitable shapes, such as serpentine, curved, or other shapes that allow bending of the fluid conduit 300. The coil 312 or similar structure acts as a cantilever when the needle 306 is deployed and / or retracted. When the needle 308 penetrates and communicates with the reservoir 1302 (see, e.g., FIG. 3B), the drug can be transferred from the reservoir 1302 through the needle 308, the intermediate portion 310, and the needle 306 (which penetrates the user's skin) to the user. In some examples, the fluid conduit 300 is made of only a metal or metal alloy. In other examples, the fluid conduit 300 includes any other suitable material, such as, for example, a polymer. Needle 308 and intermediate section 310 comprise thin-walled needles of gauge 22 or 23, while needle 306 is a gauge 27 needle. That is, fluid conduit 300 has a varying needle gauge along its length, specifically, needles 306 and 308 have different needle gauges. Other ranges of needle sizes may be used as appropriate, such as, for example, gauge 6 to gauge 34. Use of fluid conduit 300 reduces the amount of material in contact with the drug, reduces bonding sites and assembly steps, and requires less sterilization compared to conventional devices.

[0147] The carrier 202 is formed of plastic (such as injection molded plastic), metal, metal alloy, etc., and has a flange 204 and posts 210, 212 with an opening 206 formed therein. The carrier 202 also has an opening 216 through which a needle or other fluid conduit is deployed. The opening 216 is a slot recessed from an end face of the carrier 202, and in an alternative embodiment, the entire circumference of the opening 216 is defined by a member of the carrier 202. The carrier 202 also has a driver passage 218. The driver passage 218 is a slot in the carrier 202 that extends along or parallel to the axis 44. The driver passage 218 is configured to receive a protrusion of the driver 320, such as protrusion 380, described below. The carrier 202 also has a shuttle passage 220 through which the shuttle 340 travels, described in more detail below.

[0148] The carrier 202 also has a stopper 240 configured to engage the shuttle 340. The stopper 240 is a cantilever having a fixed end 241 (FIG. 19) and a free end 242 (FIG. 19). The stopper 240 has an angled ramp 243 (FIGS. 20 and 23). The ramp 243 deflects the stopper 240 about the fixed end 241 when engaged or pushed by the ramp 1500 (see FIG. 23). In a first position, the free end 242 prevents or inhibits movement of the shuttle 340 and in a second configuration, allows movement of the shuttle 340. The relationship between the stopper 240 and the shuttle 340 is described in more detail below.

[0149] The driver 320 has two racks 322 and 324 arranged parallel to each other and on opposite sides of the driver 320 (FIGS. 18A-18C and 19). The racks 322 and 324 have teeth and are configured to engage and drive rotation with the deployment gear 360 and the retraction gear 362, respectively. The driver 320 has a lumen 326 (or other suitable structure, such as a track, recess, etc.) configured to receive the needle 306 of the fluid conduit 300 (FIG. 18A). The driver 320 also has a protrusion 380 configured to slide within the driver passage 218 of the carrier 202 (FIGS. 17 and 18B-18D). The protrusion 380 has a hook-like configuration that "hooks" onto an obstruction 382, ​​as will be described in more detail below.

[0150] 18A-18D, shuttle 340 has a rack 342 configured to engage gears 360 and 362. Shuttle 340 also has an end face 344 and a recess 346 that extends along the length of shuttle 340 in the same direction as rack 342. A slot 348 (FIG. 20) extends along the length of recess 346. Slot 348 penetrates the center of recess 346 and extends all or nearly all of recess 346.

[0151] The shuttle 340 moves along the track 220 from a first starting position (FIGS. 18B and 19) to a second intermediate position (FIGS. 18D, 20 and 21) and from the second position to a third final position (located between the second and third positions in FIG. 22). As the shuttle 340 moves along the track 220, the rack 342 first engages the deployment gear 360 and then engages the retraction gear 362. The rack 342 is not engaged with both the deployment gear 360 and the retraction gear 362 at the same time. In some examples, for example, when the rack 342 is longitudinally disposed between the deployment gear 360 and the retraction gear 362, the rack 342 is not engaged with either the deployment gear 360 or the retraction gear 362. The shuttle 340 is configured to move only in one direction along only one axis (such as axis 40). The force required to move the shuttle 340 along the track 220 is provided by the expansion of the spring 370. The spring 370 is compressed from its natural state and the expansion of the spring 370 causes the shuttle 340 to move along the track 220 through the sequence of positions / configurations described above. Different features of the auto-injector 2 directly or indirectly block the movement of the shuttle 340 at various positions. Alternatively, the spring 370 is expanded from its natural state and the compression of the spring 370 causes the shuttle 340 to move along the track 220 through the sequence of positions / configurations described above. In such an embodiment, the shuttle 340 is coupled to opposing ends of the auto-injector 2 on different sides of the shuttle 340.

[0152] The first position of the shuttle 340, shown in Figures 18B and 19, corresponds to an unused, undeployed and / or new state of the auto-injector 2. In this first position, the driver 320 is in an undeployed state. The shuttle 340 is maintained in the first position by the placement of an obstacle 382 in the path of the protrusion 380 (Figures 17 and 18B). The obstacle 382 is a protrusion or other blocking member or device connected to the container 1302, which engages and / or locks the protrusion 380, thereby preventing the movement of the driver 320. In this manner, since the driver 320, the deployment gear 360 and the rack 342 are interconnected, blocking the driver 320 also blocks the movement of the shuttle 340. The shuttle 340 can be moved from the first position to the second position by moving the obstacle 382 relative to the carrier 202 (or vice versa). In one embodiment, pressurized gas from fluid source 1366 moves reservoir 1302 into communication with needle 308, causing obstruction 382 to move (FIG. 18C), while carrier 202 remains stationary.

[0153] When the obstruction 382 is removed from the path of the drive 320 (FIG. 18C), the spring 370 expands to move the shuttle 340 along the track 220. This linear movement of the shuttle 340 rotates the deployment gear 360 counterclockwise (or clockwise in other examples) via the rack 342, which in turn moves the drive 320 downward along the axis 44 via the rack 322 of the drive 320. This downward movement of the drive 320 causes the needle 306 to pierce the skin of the user. In some examples, the drive 320 is configured to move only along the axis 44 relative to the carrier 202.

[0154] The expansion of the spring 370 moves the shuttle 340 to a position where the end surface 344 abuts the free end 242 of the stopper 240, and the shuttle 340 is maintained in the second position shown in Figures 20 and 21. The free end 242 then prevents the spring 370 from expanding further and the shuttle 340 from moving further along the track 220. In this second position, the needle 306 is deployed to the user and fluid from the container 1302 is injected into the user through the fluid conduit 300. Additionally, while the shuttle 340 is in the second position, the rack 342 engages the deployment gear 360 to maintain the needle 306 in the deployed configuration. The shuttle 340 is movable from the second position to the third position by the stopper 240 deflecting about the fixed end 241, which will be described in more detail below with reference to Figure 23. Deflection of stopper 240 causes spring 370 to expand further, pushing shuttle 340 further along track 220. In some examples, stopper 240 is received in recess 346 of shuttle 340 and ramp 243 slides within slot 348 as shuttle 340 moves from the second position to the third position.

[0155] Movement of the shuttle 340 from the second position to the third position corresponds to retraction of the needle 306 from the user into the housing 3. In particular, the rack 342 engages the retraction gear 362 to rotate it in the same direction as the rotation of the deployment gear 360 (e.g., counterclockwise or clockwise). The rotation of the retraction gear 362 urges the driver 320 back to the retracted position via the rack 324. The shuttle 340 reaches the third position, with the driver 320 fully retracted, when the end face 344 engages the wall of the carrier 202, when the free end 242 of the stopper 240 reaches the end of the recess 346, and / or when the spring 370 reaches its natural state.

[0156] In some embodiments, when the driver 320 returns from the deployed state to the retracted state, it is prevented from moving out of the retracted state, thereby preventing the needle 306 from being redeployed to the user. In such a configuration, the auto-injector 2 is a disposable device (e.g., discarded after completing one injection). In other embodiments, the auto-injector 2 is reusable after reconfiguration. Also, in some examples, the auto-injector 2 does not have any rotating gears other than the deployment gear 360 and the retraction gear 362.

[0157] After the drug / therapeutic agent is delivered to the user through the needle 306, the needle 306 is automatically withdrawn from the user. For example, the expansion (or contraction) of the spring causes the container 1302 to move in the opposite direction along the axis 40 (the opposite direction relative to the fluid delivery and needle 306 insertion). The opposite movement of the container 1302 causes the ramp 1500 (attached to the wall 1391) of FIG. 23 to press against the ramp 243 of the stopper 240. This causes the stopper 240 to deflect in the direction of the arrow 240a about the fixed end 241, and the shuttle 340 to move from the second position to the third position, allowing the needle 306 to be retracted as described above. In this manner, both withdrawal and insertion of the needle into the patient can be accomplished with a single spring in the device.

[0158] 23A-23C show another embodiment for injecting and retracting the needle 306 (or other patient needle) as described herein. FIGS. 23A and 23B show the same steps and structures for injecting the needle 306 into the patient as shown in FIGS. 18B-18D and 19-21. As described above with reference to FIGS. 12A-12C and 23, retraction of the needle 306 is assisted by the rod 8002 and the force of gas / fluid from the exhaust conduit 3018. That is, after the injection is completed and the pressures of the high and low pressure cavities are equalized (e.g., as described above with respect to the valve 3010), gas / fluid from the fluid source 1366 is exhausted via the exhaust conduit 3018 to move the rod 8002. The rod 8002 either directly contacts the stopper 240 and moves it out of the path of the shuttle 340 (FIG. 23C) or acts against a ramp 1500 which is in direct contact with the stopper 240 as shown in FIG.

[0159] In an alternative embodiment shown in FIG. 23D, needle insertion and retraction are accomplished using a single rotating gear 360a instead of the gears 360 and 362 described above. Needle insertion is initiated in a manner substantially similar to that described above with respect to FIGS. 18B-18D and 19-21, with the expansion of spring 370 causing linear movement of shuttle 340. The linear movement of shuttle 340 causes rack gear 342 to rotate gear 360a. As gear 360a rotates in a first direction, driver 320 and needle 306 deploy downward (towards the skin surface). In this embodiment, retraction of needle 306 is accomplished by returning shuttle 340 to its initial position. More specifically, pressurized gas / fluid from exhaust conduit 3018 pushes rod 8002 into contact with shuttle 340. The action of rod 8002 on shuttle 340 compresses spring 370, returning shuttle 340 to its initial position. The shuttle 340 returns to its initial position along the same path (in the reverse direction) that the shuttle 340 traveled to deploy the needle 306. The reverse path movement of the shuttle 340 rotates the gear 360a in a second direction opposite to the first direction, retracting the driver 320 and the needle 306 from the patient into the auto-injector 2. The lockout feature 8002f coupled to the rod 8002 is configured to prevent retraction of the rod 8002. In this embodiment, if the rod 8002 retracts into the exhaust conduit 3018, unintended redeployment of the needle 306 occurs. To prevent such redeployment, the lockout feature 8002f is activated during retraction of the needle 306. In one embodiment, the lockout feature 8002f is a flexible member, such as an elastic member, extending from the outer periphery of the rod 8002 and biased into the expanded shape. Before retraction begins, the lockout feature 8002f is restrained by the inner surface of the exhaust conduit 3018 in which the rod 8002 is disposed. Once the rod 8002 is pushed past a predetermined point, for example when the lockout feature 8002f exits the exhaust conduit 3018, the lockout feature 8002f is released to self-expand radially outward toward its natural expanded state. Once in its natural expanded state, the lockout feature 8002f cannot re-enter the exhaust conduit 3018.An end of the channel, for example end 8002g, acts as a stop for the lockout feature 8002f. In yet another embodiment, the lockout feature 8002f is a magnet and is configured to be secured to a magnet at end 8002g of the exhaust conduit 3018 or to a magnet disposed in or along the exhaust conduit 3018. For example, an inner surface of a portion of the exhaust conduit 3018 has a magnet thereon.

[0160] 23E-23G show another alternative embodiment in which the rotating gear 360a is used to insert and retract the needle, and another arrangement of the elements of the system of FIG. 23D. As shown in these figures, the shuttle 340 may be either above or below the spur gear 360 relative to the skin. As shown in FIG. 23E, the shuttle 340 is positioned below the gear 360a (closer to the tissue contact surface / injection site), and the push rod 8002 and spring 370 are generally parallel to at least a portion of the shuttle 340. The push rod 8002 may be in contact with a portion of the spring 370, as previously described. Additionally, the shuttle 340 is coupled to and / or integrally assembled with the push rod 8002. Needle insertion is initiated by an initial pressure of gas from a gas canister, as previously described. Linear movement of the shuttle 340 in a first linear direction causes the rack gear 342 to rotate the gear 360a. As shown in FIG. 23F, the gear 360a rotates in a first rotational direction, causing the driver 320 and needle 306 to deploy downward (towards the skin surface). The linear movement of the shuttle 340 and the resulting linear movement of the push rod 8002 also compresses (or expands in an alternative embodiment) the spring 370. Then, as shown in FIG. 23G, when the gas force acting on the push rod 8002 becomes less than the force of the spring 370, the spring 370 expands (or compresses in an alternative embodiment) and pushes the push rod 8002 and shuttle 340 in a second linear direction opposite the first linear direction. The linear movement of the shuttle 340 in the second linear direction causes the gear 360a to rotate in a second rotational direction opposite the first rotational direction. The rotation of the gear 360a in the second rotational direction causes the driver 320 and needle 306 to retract upward (away from the skin surface).

[0161] 23H and 23I are further views of the patient-side needle mechanism performing the steps previously described with reference to FIGS. 23E-23G. As shown, the needle mechanism includes a push rod 8002, a modified shuttle 340, a driver 320, a spur gear 360, a spring 370, and a needle (not shown). The push rod 8002 includes a seal gap 8008 for receiving a seal, for example. As shown in FIG. 23I, the shuttle 340 includes two parallel portions 340b and 340c. The shuttle 340 also includes one or more projections 341, for example two projections 341. The projections 341 extend perpendicularly from the shuttle 340, for example perpendicular to the portions 340b and 340c. The projections 341 are connected to an indicator (not shown, described in more detail below), for example to move the indicator to indicate to the user the progress of the needle mechanism.

[0162] Portions 340b and 340c are connected via portion 340d, which is perpendicular to portions 340b and 340c (and protrusion 341). As shown, portion 340d is in the same plane as portions 340b and 340c and perpendicular to protrusion 341. Portion 340b has a rack 342 (not shown in FIGS. 23H and 23I) that can contact and / or engage with spur gear 360a, and control the movement of spur gear 360, driver 320, and patient needle (not shown), as previously described. Portion 340c extends parallel to a portion of portion 340b and interacts with spring 370. For example, portion 340c is surrounded by a portion of spring 370. In another example, not shown, portion 340c is secured or attached to a portion of spring 370. In either embodiment, the spring 370 surrounds or is otherwise connected to a spring cover 8010 that is fixed relative to the carrier 202. The spring cover 8010 may extend from a carrier, such as the carrier 202, may be formed by a portion of the cover of the carrier 202, or may be otherwise formed within the auto-injector 2. In this manner, the spring 370 biases the shuttle 340 and the entire push rod 8002 by biasing the portion 340c. The carrier 202, which in this embodiment includes a button travel portion, also supports at least a portion of the sterile connector shown in FIG. 9I.

[0163] In the embodiment described with reference to Figs. 23H and 23I, the biasing force of the spring 370 is applied along the push rod 8002. As a result, creep and / or bending of the shuttle and / or associated components is inhibited. The portion 340b of the shuttle 340 is offset and parallel to the portion 340c, which allows the needle to be positioned in a central location, such as below the actuator button. Furthermore, although not shown in Fig. 23I, the shuttle teeth are below the spur gear 360a relative to the skin, etc. Furthermore, the spur gear 360a is located to the right of the needle driver 320 in Fig. 23H (and thus the needle driver 320 is to the left of the spur gear 360a). Such an embodiment may facilitate accommodating the needle driver assembly within dimensional, space, or placement constraints within the auto-injector 2. For example, when shuttle 340 is actuated (e.g., moved to the right in FIGS. 23H and 23I by the actuation force of push rod 8002), shuttle 340 rotates spur gear 360a counterclockwise to insert the needle. When shuttle 340 retracts (e.g., moved to the left in FIGS. 23H and 23I by the biasing force of spring 370), shuttle 340 rotates spur gear 360a clockwise to retract the needle. Of course, one or more of the directions and orientations can be changed based on the particular application.

[0164] The push rod 8002 and shuttle 340, including portions 340b, 340c and 340b, are formed from one, two, three or more pieces or components. In one embodiment, the push rod 8002 is formed from a single piece and the shuttle 340 is also formed from a single piece. In this embodiment, the push rod 8002 is included in a valve subassembly and the shuttle 340 is included in a patient-side needle mechanism subassembly. These subassemblies improve ease of assembly and / or manufacturing.

[0165] Although not shown, one or more of the additional features described above, such as lockout feature 8002f, may be incorporated into the embodiment shown in Figures 23E-23I. By arranging the elements as shown in Figures 23E-23I, the needle deployment mechanism may be made smaller and / or more discrete, making it easier and / or less expensive to accommodate within a housing, such as within the auto-injector 2.

[0166] 23J-23L show yet another alternative embodiment for needle insertion and retraction. In the embodiment shown in these figures, needle insertion is performed using a portion of the high pressure flow (via high pressure line 3002) from fluid source 1366. Carrier 202a has spur gear 360a and driver 320 as described above. Rotation of gear 360a in a first direction deploys driver 320, and rotation of gear 360a in a second direction (opposite the first direction) retracts driver 320. Gear 360a is rotated by shuttle 340a. Shuttle 340a is similar to shuttle 340 described above, except shuttle 340a has rod 340f disposed in high pressure channel 340c configured to receive high pressure gas / fluid from high pressure line 3002. Although the rod 340f is shown integral with the shuttle 340a in Figs. 23J and 23K, the rod 340f and the shuttle 340a may be separate components that are not integral with each other and move toward and away from each other. If the rod 340f and the shuttle 340a are separate components, their orientation relative to each other is constrained by other parts of the auto-injector 2, such as one or more channels formed in the carrier 202a. The rod 340f has a seal 340d located at or near a first end 340e (the end furthest from the shuttle 340a). The seal 340d is positioned to ensure that pressurized fluid moving through the high pressure channel 340c displaces the rod 340f (rather than simply moving around the rod 340f). The rod 340f protrudes from other parts of the shuttle 340. The length of the rod 340f can be set as desired and can be shorter, the same, or longer than the length of other parts of the shuttle 340a. For example, the length of the rod 340f may be about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, about 1, about 2, about 3, or about 4 times the length of the remaining portions of the shuttle 340a. Of course, other suitable values ​​are also possible. The carrier 202a has a resilient member or spring 370a that is expanded in its natural state as shown in FIG. 23J.A spring 370a is coupled to the end of the shuttle 340a opposite the rod 340f, and the spring force of the spring 370a maintains the gear 360a in the initial position (so that the needle driver 320 and needle 306 are in the retracted / non-deployed position). When pressurized gas / fluid is released from the fluid source 1366 (see FIGS. 3A-3C), the flow of gas / fluid through the high pressure line 3002 and channel 340c pushes the rod 340f and shuttle 340a against the spring 370a, compressing the spring 370a. As the shuttle 340a moves linearly to compress the spring 370a, the rack gear 342 on the shuttle 340a rotates the gear 360a, deploying the driver 320 to the deployed / injection position (FIG. 23K). FIG. 23L shows the driver 320 and needle 306 after injection and retraction are complete. In FIG. 23L, the piston 1316 has completed its travel across the container 1302 (the piston 1316 has "bottomed out"). As previously described, at this stage the pressures in the high pressure cavity 3022 and the low pressure cavity 3024 are in equilibrium (as previously described with respect to the valve 3010) and gas / fluid is exhausted via the exhaust conduit 3018. After equilibration, the pressures in the high pressure cavity 3022, the high pressure line 3002 and the channel 340c are less than the spring force of the spring 370a, allowing the spring 370a to expand to its natural, expanded state. The expansion of the spring 370a returns the shuttle 340a to its initial position. During this movement of the shuttle 340a back to its initial position, the rack 342 rotates the gear 360a in a second direction, which causes the driver 320 and the needle 306 to retract into the auto-injector 2. The container 1302 shown in Figures 23J and 23K is fixed and in this embodiment the needle 308 is moved through the fixed container 1302 (described below with reference to Figures 27A and 27B) to place the fluid conduit 300 in communication with the container 1302. However, the container 1302 may also be moved from the first end 1302 towards the second end 1304 to abut the fixed needle 308, thereby placing the container 1302 in communication with the fluid conduit 300 (described below with reference to Figures 28A and 28B). Figure 23M shows a drive system 3000a that provides a driving force for delivering fluid from the container 1302 to the patient.The drive system 3000a is substantially similar to the drive system 3000 shown in FIGS. 3A-3C, but is configured to actuate the patient-side needle mechanism (including rod 340f, etc.) with pressurized gas from the fluid source 1366 before the pressurized gas from the fluid source 1366 reaches the high pressure line 3002 (used to establish communication between the container 1302 and the fluid conduit 300). Thus, after the pressurized gas leaves the fluid source 1366 via the conduit 3002a, it enters the high pressure channel 340c and pushes the rod 340f. As previously described, the pressurized gas acting on the rod 340f ultimately deploys the needle 306 to the user. Only after the rod 340f has traveled a sufficient distance through the high pressure channel 340c (e.g., a sufficient distance to partially or fully insert the needle 306 into the user) does the pressurized gas flow from the conduit 3002a to the high pressure line 3002. After a sufficient distance has been traveled, the pressurized gas flows through the drive system 3000a in a manner substantially similar to that described above with respect to the drive system 3000 (FIGS. 3A-3C). This arrangement, and in particular the fact that the pressurized gas is only allowed to travel through the drive system 3000a after the patient-side needle mechanism has been deployed, prevents the container 1302 and the needle 308 (FIG. 18A) from unintentionally approaching each other prematurely. In other words, this arrangement prevents communication between the container 1302 and the fluid conduit 300 from being established prematurely, which would cause operational problems with the auto-injector 2 (e.g., due to leakage of medication within the auto-injector 2). The drive system 3000a includes an exhaust system 2300a (similar to the exhaust systems described herein, such as the exhaust system 9100). For example, the exhaust system 2300a includes a dump valve.

[0167] Additionally, the fluid conduit 300 is the only fluid conduit of the auto-injector 2 configured to communicate with the container 1302. Thus, the medication / therapeutic agent in the container 1302 is delivered to a user only via the fluid conduit 300 during normal operation of the auto-injector 2. Additionally, the needle 306 is the only needle of the auto-injector 2 configured to be deployed to a patient. In this manner, fluid is delivered from the container 1302 to the patient using a single (only one) metal or plastic part.

[0168] 23N-23Q show yet another alternative embodiment for needle insertion and retraction. In this alternative embodiment, the shuttle is directly coupled to the container 1302. For example, as shown in FIG. 23N, the shuttle 340h is coupled to the container 1302 via a collar 340z that extends from the body of the shuttle 340h and surrounds the neck of the container 1302. Other suitable connection methods may be used. Furthermore, in one or more embodiments, the collar 340z corresponds to or couples to the sleeve 32008 shown in FIGS. 32R-32V. Thus, it is also possible to combine the shuttle (the shuttle of the patient-side needle mechanism) with a sterile connector. Furthermore, the collar 340z may be wrapped or coupled to another portion of the container 1302, for example, around the body of the container 1302. In some embodiments, the shuttle 340h is coupled to a standard container or cartridge. In other embodiments, a specially configured container 1302 is used, such as a container 1302 having one or more protrusions, recesses or other features configured to interact with and secure shuttle 340h. Shuttle 340h may have other features described herein in connection with other shuttles, such as a rack gear, multiple offset and / or parallel extensions, a rod or peg connected to a display system as shown in Figures 58A-58H, etc.

[0169] The spring 370b is coupled to the container 1302 and / or the shuttle 340h and is configured to bias the container 1302 / shuttle 340h to the position shown in FIG. 23O and to provide the force required to return the shuttle 340h to the initial position (or to a third position at or near the initial position). That is, the spring 370b is configured to provide the force required to retract the needle driver 320 (e.g., via the gear 360a) and to retract the patient end of the needle 306 from the patient. The spring 370b is configured to compress when the container 1302 / shuttle 340h moves from the initial (first) position to the deployed (second) position. One end of the spring 370b is coupled to the container 1302 and / or the shuttle 340h and the other end of the spring 370b is coupled to another fixed or stationary part of the auto-injector 2, such as, for example, the housing 3 or the carrier 202, to form a spring stopper 371.

[0170] As shown in Figures 23O-23Q, the shuttle 340h is positioned below the gear 360a (closer to the tissue contact surface / injection site). However, the shuttle 340h may be positioned above the gear 360a (farther from the tissue contact surface / injection site). Needle insertion is initiated by initial pressure of gas from the gas canister / fluid source 1366, as previously described. Linear movement of the shuttle 340h in a first linear direction causes the rack gear 342 to rotate the gear 360a, as previously described with reference to Figure 23E, etc. As the gear 360a rotates in the first rotational direction, the driver 320 and the needle 306 deploy downward (towards the skin surface), as shown in Figure 23P. The initial linear movement also compresses the spring 370b. Next, as shown in FIGURE 23Q, when the force of the gas acting on the container 1302 / shuttle 340h becomes less than the force of spring 370b, spring 370b expands and pushes the container 1302 / shuttle 340h in a second linear direction opposite the first linear direction. The linear motion of shuttle 340h in the second linear direction causes gear 360a to rotate in a second rotational direction opposite the first rotational direction. Rotation of gear 360a in the second rotational direction causes driver 320 and needle 306 to retract upward (away from the skin surface).

[0171] 23R-23U are schematic diagrams showing the system flow in the auto-injector 2t (described in detail below with reference to FIGS. 48A-48C, 48H and 48I). The system flow is substantially similar to the system flow shown in FIGS. 3A and 23M, etc. As shown, the auto-injector 2t has a retraction system 23100 similar to the ejection system 2300A. As shown, the retraction system 23100 has a lid 23102 that is movable relative to the needle 306 and a portion of the housing 3. In addition, the lid 23102 is located in the vicinity of the gas canister or fluid source 1366 and the ejection system 2300. The ejection system 2300 has a dump valve. As previously described, the auto-injector 2t has a container 1302, a flow restrictor 3008, a valve 3010 with a diaphragm 3012, an ejection line 3006 and other components connected via multiple conduits.

[0172] In Figure 23S, retraction of the lid 23102 relative to the housing 3 actuates the fluid source 1366. For example, as shown in Figures 48H and 48I, an initiator rod 48012 is coupled to the lid 23102, and as the lid 23102 is retracted, the fluid source 1366 is actuated by the initiator rod 48012 in a manner similar to the other gas canister or fluid source actuation mechanisms described above. Gas then flows through the system and valve 3010, pushing medication through the fluid conduit and the patient needle 306, which extends from the lid 23102 and is inserted into the patient as shown in Figure 23S.

[0173] Another conduit or connection, for example, conduit 23104, is also provided connecting the lid 23102 and the exhaust system 2300. A dump valve in the retraction system 23100 prevents gas from flowing through the conduit 23104 during high pressure conditions with the diaphragm 3012 sealing the exhaust line 3006. When the pressure is equalized and the diaphragm 3012 lifts off its seat, the exhaust line 3006 moves the dump valve in the retraction system 23100 to a position that allows gas to flow from the fluid source 1366 to the conduit 23104. The force of the gas flowing through the conduit 23104 then urges the lid 23102 to expand and the needle 306 to a retracted state, as shown in FIGS. 23T and 48C.

[0174] 23U shows another schematic diagram of the auto-injector 2t. As shown, the cap 23102 is coupled to the ejection system 2300 via a physical connection. For example, the ejection system 2300 includes or is coupled to a piston or push rod 23106 of a conduit 23104. The push rod 23106 is movable to control the position of the cap 23102 relative to the housing and needle 306 of the auto-injector 2t. In this embodiment, the flow of fluid from the fluid source 1366, the valve 3010, the ejection line 3006 and the ejection system 2300 controls the position of the push rod 23106, which in turn controls the position of the cap 23102.

[0175] FIG. 24 illustrates another mechanism for inserting the needle 306 into the user / patient. In this embodiment, pressurized gas is diverted from the high pressure line 3002 toward the housing 18002. A piston 18004 having a seal 18004a is coupled to the needle 306 in the housing 18002. A spring or other resilient member 18006 is coupled to the piston 18004 and biases the piston 18004 to a retracted state (e.g., within the housing 18002). When the fluid source 1366 is activated, the pressurized gas acts on the piston 18004, compressing the spring 18006 and causing the needle 306 to exit the housing 18002 and be inserted into the user / patient. When the force of the spring 18006 becomes greater than the force of the pressurized gas acting on the piston 18004 (e.g., after most of the propellant has been expelled from the fluid source 1366), the needle 306 retracts.

[0176] Figures 25A and 25B show another configuration of an auto-injector 19000. In this configuration, the auto-injector 19000 still includes a reservoir 1302, a piston 1316, and a fluid source 1366. Also shown in Figures 25A and 25B are a fluid connection 19003, a secondary cylinder 19004, hydraulic fluid 19005, a dumbbell piston 19006, an actuation lever 19009, and an actuation cylinder 19010. The secondary reservoir 19002 includes a port 19002a extending through the outer periphery of the secondary reservoir 19002.

[0177] The piston 1316 seals the drug contained in the container 1302 from the hydraulic fluid 19005 and acts as an interface for expelling the drug from the container 1302 (e.g., expelling from left to right in Figs. 25A and 25B). The fluid connection 19003 moves the hydraulic fluid 19005 from the secondary container 19002 to the container 1302 to move the piston 1316. The fluid connection 19003 also allows for the shunting of the hydraulic fluid 19005 to the actuation cylinder 19010. The actuation cylinder 19010 has a piston 19012 configured to actuate additional components of the device (e.g., actuate or retract a needle mechanism, actuate a sterile connector, etc.). The dumbbell-shaped piston 19006 in the secondary container 19002 includes a propulsion interface against which pressurized gas from the fluid source 1366 acts and acts as an interface between the fluid source 1366 and the hydraulic fluid 19005. Additionally, the dumbbell piston 19006 has two heads 19006a connected to each other by a shaft 19006b. The diameters of the heads 19006a are approximately equal. Additionally, any of the piston configurations described in U.S. Patent Application Publication No. 2016 / 0243309 may be used in place of the dumbbell piston 19006. Additionally, the dumbbell piston 19006 may be used in other configurations herein as an alternative structure for the piston 1316.

[0178] When acted upon by pressurized gas from the fluid source 1366, the dumbbell piston 19006 exerts a force on the hydraulic fluid 19005. The dumbbell piston 19006 may be configured to have a small space between the ends such that a predetermined action is performed by the actuating lever 19009 before the dumbbell piston 19006 displaces the hydraulic fluid 19005 through the fluid connection 19003. The actuating lever 19009 is configured to perform various actions when pressure against the thrust boundary of the dumbbell piston 19006 moves the lever. For example, the actuating lever 19009 may actuate the needle 306, retract the needle 306, or displace the container 1302 (or another suitable container).

[0179] As shown in FIG. 25A, the trailing piston head 19006a is initially positioned upstream of the port 19004a. For example, the port 19004a is longitudinally positioned between the piston heads 19006a as shown in FIG. 25A. Alternatively, the port 19004a is positioned downstream of the entire piston 19006. The trailing piston head 19006a is eventually pushed (downstream) beyond the port 19002a (FIG. 25B), at which point the pressurized gas from the fluid source 1366 ceases to push the piston 19006 within the secondary container 19002 and is exhausted from the port 19002a. The exhausted pressurized gas flows into the auto-injector 2 and / or into the atmosphere.

[0180] The container 1302 shown in Figures 26A and 26B has a seal 26014 at the second end 1306 instead of the seal 1314. The seal 26014 is, for example, a plug made of the same material as the seal 1314. However, the seal 26014 has an inner cavity 26016 that communicates with the contents of the container 1302. The cavity 26016 extends from the second end 1306 of the container 1302 in a direction away from the interior of the container 1302. An end of the fluid conduit 300a penetrates the seal 26014, thereby establishing communication between the container 1302 and the fluid conduit 300a. The fluid conduit 300a has a needle 306a, an intermediate portion 310a, and a needle 308a. The needle 306a is similar to the needle 306 described above and is configured to be inserted into a patient. The needle 308a extends generally parallel to the needle 306a and is configured to penetrate the seal 26014 along a path generally perpendicular to the longitudinal axis of the container 1302. The needle 308a penetrates the seal 26014 and enters the gap 26016, connecting the fluid conduit 300a and the container 1302 to each other. That is, when the needle 308a enters the gap 26016, the drug flows from the container 1302 into the gap 26016 and the needle 308a. The drug then travels through the remainder of the conduit 300a to the user / patient side. Both the needle 306a and the needle 308a extend generally perpendicular to the longitudinal axis of the container 1302. The intermediate portion 310a connects the needle 308a to the needle 306a and extends generally perpendicular to both the needle 306a and the needle 308a. Thus, the intermediate portion 310a extends generally parallel to the longitudinal axis of the container 1302, and adjacent straight portions of the fluid conduit 300a are perpendicular to each other. The configuration shown in Figures 26A and 26B allows the fluid conduit 300a to have fewer bends and corners, thereby allowing fluid to flow more easily through the conduit (i.e., reducing the number of bends in the fluid conduit reduces the restriction of fluid flow). The fluid conduit 300a is moved by an expansion spring or by a button directly connected to the fluid conduit 300a, which, when pressed, moves the fluid conduit 300a and causes the needle 308a to pierce the seal 26014. Alternatively, the fluid conduit 300a is driven by a flow of pressurized fluid / gas from the fluid source 1366.Furthermore, the embodiment shown in FIG. 26A may be configured such that it is not dependent on a driving force, and the needle 308a pierces the seal 26014 and the needle 306a is pushed out of the auto-injector and into the user / patient simultaneously with the same force.

[0181] In the embodiment shown in Figures 27A and 27B, the fluid conduit 300b communicates with the container 1302 by moving relative to the fixed container 1302. The fluid conduit 300b has a needle 306b substantially similar to the needles 306 and 306a described above. The needle 308b extends generally perpendicular to the needle 306b, and the needle 308b is configured to penetrate the seal 1314 along a path generally parallel to the longitudinal axis of the container 1302. The intermediate portions 310b and 311b communicate the needles 306b and 308b. After the fluid conduit 300b penetrates the seal 1314, the drug flows from the container 1302 through the needle 308b, intermediate portion 311b, intermediate portion 310b, and needle 306b. The intermediate portion 310b is generally parallel to the longitudinal axis of the container 1302, while the intermediate portion 311b is generally perpendicular to the longitudinal axis of the container 1302. As with the fluid conduit 300a, adjacent straight portions of the fluid conduit 300b are perpendicular to each other. The embodiment shown in FIGS. 27A and 27B may have less than optimal speed (conduit 300a moves faster than optimal) and coring (portions of the seal are dislodged by needle 308 and some of the dislodged portions move and clog the fluid conduit) compared to other embodiments, but because the container 1302 is fixed, an internal seal (described below with reference to FIG. 29A) can be used. The use of a seal on the inside of the container 1302 can reduce the overall size of the auto-injector 2. In other words, when an inner seal is used, the height and width of the valve can be reduced compared to a configuration in which the container 1302 moves relative to a fixed fluid conduit 300b during the penetration process (described below), thereby reducing the housing size of the container 1302 and corresponding valve (such as valve 3010).

[0182] The embodiment shown in Figures 28A and 28B is similar to the embodiment of Figures 27A and 27B, except that the container 1302 moves toward the fixed fluid conduit 300b to place the container 1302 in communication with the fluid conduit 300b. This particular embodiment requires a seal that surrounds the outside of the container 1302 (described below with reference to Figure 29B). This seal is generally larger than an inner seal with a seal ring on the inside of the container 1302. The embodiment of Figures 28A and 28B may also have problems with needle alignment because the target area of ​​the fluid conduit 300b relative to the container 1302 is relatively small and the container 1302 may wobble. However, in this embodiment, the pressurized gas acts on the container 1302, which is heavier than the fluid conduit 300, so the container 1302 moves more slowly than if the same amount of pressurized gas were acting on the fluid conduit 300. This makes it easier to control than the embodiment shown in Figures 27A and 27B.

[0183] 29A and 29B show different mechanisms for sealing the space at the first end 1304 of the container 1302. In the embodiment shown in FIG. 29A and 29B, the sealed space is configured to receive gas or fluid from the fluid source 1366 and move the container 1302 toward the fluid conduit 300 to establish communication between the container 1302 and the fluid conduit 300 and drive the piston 1316 within the container 1302. In the embodiment shown in FIG. 29A, the seal housing 29002 has a circumferential groove 29004 on an outer periphery of the seal housing 29002. The seal 29006 is disposed within the groove 29004. At least a portion of the seal housing 29002, the groove 29004, and substantially the entire seal 29006 are inserted into the first end 1304 of the container 1302. In some embodiments, the seal housing 29002 and seal 29006 are maintained within the container 1302 by a pressurized or friction fit. The seal housing 29002 includes a conduit 29008 through which pressurized gas / fluid from the fluid source 1366 enters the container 1302 and pushes the piston 1316 within the container 1302. Although only one seal 29006 and groove 29004 are shown, additional seals and grooves may be included. In some embodiments, a relatively small space is created within the housing 3 behind the piston 1316 (the piston 1316 is located relatively close to the first end 1304 of the container 1302), especially when the amount of drug in the container 1302 is relatively large. The embodiment shown in FIG. 29A is suitable for a penetration mechanism in which the container 1302 remains stationary and a fluid conduit (such as the fluid conduit 300) moves toward the container 1302. Additionally, by sealing the inside of the reservoir 1302 (with the ring of seal 29006 against the inner periphery of the reservoir 1302), the embodiment of FIG. 29A is smaller than other embodiments (e.g., where the seal is against the outer periphery of the reservoir 1302), allowing the reservoir 1302 to be used in a smaller auto-injector housing / enclosure. The seal housing 29002 is fixed relative to the housing 3 of the auto-injector 2.

[0184] Although not shown, the container 1302 may have a suitable size and / or shape to accommodate the container 1302 within the housing 3 of the auto-injector 2, for example. For example, the container 1302 may be sized and / or shaped to accommodate a 3 mL fluid cartridge, with the length of the container 1302 being approximately 6-10 mm, e.g., approximately 8 mm, longer than the fluid cartridge. The size and / or shape of the container 1302 may be configured to accommodate one or more seals behind the piston and / or to provide additional space (e.g., within the container 1302) for the fluid cartridge to slide toward and / or up to the needle. Additionally, the container 1302 may have one or more seals, e.g., a dynamic seal on the interior or interior portion of the container 1302.

[0185] In the embodiment shown in FIG. 29B, the seal housing 29012 has a circumferential groove 29014 on the inner periphery of the seal housing 29012. A seal 29016 is disposed within the groove 29014, and at least a portion of the seal housing 29012, groove 29004, and seal 29006 are disposed outside the first end 1304 of the container 1302. In some embodiments, the seal housing 29012 and seal 29016 are maintained around the container 1302 by a press fit or friction fit. The seal housing 29012 has a conduit 29018 through which pressurized gas / fluid from the fluid source 1366 enters the container 1302 and pushes the piston 1316 within the container 1302. Although only one seal 29016 and groove 29014 are shown, additional seals and grooves may be included. The embodiment shown in FIG. 29B is particularly suitable for use with an actuation mechanism that moves the container 1302 toward a fixed fluid conduit. In particular, the seal 29016 is located outside the container 1302, so that there is no risk of the seal 29016 becoming dislodged when the container 1302 moves relative to the seal 29016. For example, the seal 29016 can be located closer to the second end 1306 of the container 1302 (allowing the container 1302 to move a greater distance) without affecting the volume of medication in the container 1302. Thus, the seal housing 29012 allows for a larger amount of medication to be accommodated in the container 1302, or allows a larger container 1302 to be placed in a given auto-injector 2, as compared to the seal housing 29002. However, the embodiment shown in FIG. 29B takes up more space than the embodiment of FIG. 29A. The seal housing 29012 is fixed relative to the housing 3 of the auto-injector 2.

[0186] The actuation mechanism of the fluid source 1366 shown in Figures 30A and 30B includes, for example, a button 52 movable relative to the housing 3 of the auto-injector 2. In this embodiment, the button 52 includes a stopper 52a that maintains the spring 30070 in a compressed configuration (Figure 30A). While the spring 30070 is in the compressed configuration, the fluid source 1366 is in an inactivated state (i.e., does not deliver fluid or gas). For example, when the spring 30070 is compressed, the valve stem is maintained in a closed configuration. When the button 52 is pressed (or relative movement occurs between the button 52 and the housing 3), the stopper 52a is removed from the path of the spring 30070, causing the spring 30070 to expand (Figure 30B). This expansion moves the valve stem to an open configuration, allowing fluid / gas to flow out of the fluid source 1366. In other embodiments, the valve stem remains fixed within the auto-injector 2 and the spring 30070 is coupled to a portion of the fluid source 1366 that moves relative to the fixed valve stem to activate / deactivate the fluid source 1366.

[0187] 31A and 31B, the actuation mechanism for the fluid source 1366 is such that pressing the button 52 directly activates the fluid source 1366. For example, pressing the button 52 relative to the housing 3 causes the button 52 to directly contact a portion of the fluid source 1366. For example, the button 52 contacts and moves a valve stem of the fluid source 1366 to an open configuration, generating a flow of fluid / gas from the fluid source 1366. Alternatively, the valve stem remains fixed within the auto-injector 2 and the button 52 is coupled to a portion of the fluid source 1366 that moves relative to the fixed valve stem to activate / deactivate the fluid source 1366.

[0188] 32A and 32B show another mechanism for actuating the fluid source 1366. This mechanism includes, for example, a button 52 movable relative to the housing 3 of the auto-injector 2. In this embodiment, the button 52 includes a stopper 52a that maintains a spring 32070 in a compressed configuration (FIG. 32A). The spring 32070 is coupled to a fluid conduit (such as the fluid conduit 300 described above) and moves the needle 308 or another similar needle into communication with the container 1302. When the button 52 is pressed (or when relative movement occurs between the button 52 and the housing 3), the stopper 52a moves out of the way of the spring 32070, causing the spring 32070 to expand (FIG. 30B). The expansion of the spring 32070 directly or indirectly drives a patient-side needle mechanism as described above, causing a needle (such as needle 306) to exit the auto-injector and be inserted into the patient. The patient-side needle mechanism is generally shown in Figures 32A and 32B as patient-side needle mechanism 32100. The patient-side needle mechanism 32100 may be any part of a patient-side needle mechanism described herein, such as various shuttles, rods, racks, drivers, fluid conduits, carriers or other moveable structures used for needle deployment to the patient. These features may be configured to contact and actuate the canister, for example, by moving the valve stem from a closed to an open position, or by moving another part of the canister relative to a fixed valve stem.

[0189] 32C-32H show additional embodiments of another mechanism for actuating a fluid source, for example, via a button 52. As shown in FIG. 32C, the button 52 is disposed on or flush with the exterior surface of the housing 3 of the auto-injector 2. As shown in more detail in FIGS. 32D and 32E, the button 52 is coupled to a spring 32070 that surrounds a spring carrier 32072, which in turn is connected to a gas canister 32074. The spring carrier 32072 is generally cylindrical with an enlarged circular end 32072a at one end. At the other end of the spring carrier 32072, a carrier post 32072b extends laterally outward from the cylindrical portion of the spring carrier 32072.

[0190] FIG. 32F shows the button 52 in an unused or unactuated state (before actuation). As shown in FIG. 32F, the carrier post 32072b is blocked by the patient side needle mechanism carrier and button block 32078 (substantially similar to the carrier 202 or other carriers described herein) to prevent the release of the spring 32070. FIG. 32G shows the button 52 in an actuated state (pressed by a user). In this embodiment, when the button 52 is actuated, the carrier post 32072b is also depressed (or the spring carrier 32072 rotates to rotate the carrier post 32072b). FIG. 32H shows the fully actuated state. As shown in FIG. 32H, the carrier post 32072b is disengaged from the patient needle mechanism carrier blocking portion and the button blocking portion 32078, allowing the spring 32070 to expand, which in turn pushes the spring carrier 32072 into a portion of the gas canister 32074. In one embodiment, the spring carrier 32073 pushes into a portion of the gas canister 32074, providing a force that can initiate release of gas from the canister 32074. For example, the spring 32070 exerts a force of about 20-40 N on the spring carrier 32072, e.g., a force of about 30 N.

[0191] The above actuation system has only three components, and therefore the structure of the system is simple. For example, the above actuation system can improve the ease of assembly and / or manufacturing.

[0192] Figures 32I-32M show additional embodiments of another mechanism for actuating a fluid source, such as via a button 52 disposed on or in the exterior surface of the housing 3 of the auto-injector 2. The button 52 actuates an actuation mechanism 32080, as shown in more detail in Figures 32J-32M.

[0193] 32J shows the actuation mechanism 32080 in an unused or unactuated state. As shown, the actuation mechanism 32080 includes a carrier 32082 (including one or more features of other patient-side needle carriers disclosed herein) and an actuator 32084. The actuator 32084 is coupled to and controlled (e.g., moved) by the button 52. The actuator 32084 includes, for example, a generally horizontal portion 32084a extending parallel to the outer surface of the button 52. The actuator 32084 also includes a generally vertical portion 32084b. The vertical portion 32084b includes two arms 32084c. Additionally, movement of the actuator 32084 is at least partially restricted or prevented by a peel tab (not shown) of a peel tab border 32088 located at or near the bottom or tissue-engaging surface of the auto-injector 2. The peel tab is located at least at a portion of the tissue-engaging surface of the auto-injector 2 through which the patient needle extends. Although only one is shown in the figures, the actuator 32084 has two snap tabs 32086, for example located on either side of the vertical portion 32084b. The snap tab 32086 has a tapered portion oriented downward and radially inward and an upward shoulder that allows downward movement when the button 52 is first pressed. During this downward movement towards the skin surface and the bottom of the auto-injector 2, the snap tab 32086 is received in the recess 32086a. Then, when the user releases the button 52, the actuator 32084 moves upward away from the skin surface, but is eventually locked in place by the interaction of the snap tab 32086 with the surface surrounding the recess 32086a. Alternatively, the snap tab 32086 is locked in the recess 32086a as soon as it enters the recess 32086a. Thus, the user cannot depress the button 52 again (or does nothing) as the actuator 32084 becomes longitudinally fixed within the auto-injector 2. In some embodiments, after assembly of the auto-injector 2, the snap tab 32086 is located in the first recess 32086a, thereby keeping the button assembly fixed together until activation by the user.When the user then presses the button 52, the snap tab 32086 locks into the adjacent recess 32086a closer to the skin surface (or closer to the bottom of the auto-injector 2).

[0194] The peel tab boundary 32088 is located at or near the bottom of the auto-injector 2. For example, the vertical portion 32084b of the actuator 32084 has a leg 32084d that extends to the peel tab boundary 32088. Although not shown, the peel tab boundary 32088 has an opening 32082h in the carrier 32082 and a peel tab. When the peel tab is in place, the leg 32084d, and therefore the actuator 32084, is prevented from moving through the opening 32082h in the carrier 32082 and cannot move downward. In this manner, the peel tab prevents the auto-injector 2 from being unintentionally activated, such as by pressing the button 52 or dropping the auto-injector 2, prior to removal from the auto-injector 2.

[0195] As shown, the actuation mechanism 32080 includes a canister actuation portion 32090. The canister actuation portion 32090 includes a cylindrical portion and an enlarged end or flange 32091. Additionally, the canister actuation portion 32090 includes one or more (e.g., two) snap arms 32092. The snap arms 32092 interact with a portion of the actuator 32084, e.g., arm 32084c. For example, downward movement of the actuator 32084 transitions the canister actuation portion 32090 from a locked retracted position shown in FIG. 32J to an unlocked extended position shown in FIG. 32K. Additionally, although not shown, a spring is disposed inside the canister actuation portion 32090, which also assists in transition of the canister actuation portion 32090 to the extended position shown in FIG. 32K. By placing the spring within the canister actuation portion 32090, the spring can be kept aligned.

[0196] FIG. 32L illustrates in more detail the interaction between the snap projection 32092, the carrier 32082, and a portion of the actuator 32084, such as the arm 32084c. As illustrated, the arm 32084c has a ramped portion 32084e. The carrier 32082 also has a first peg or projection 32082f. In an initial position, as shown in FIG. 32J, the peg 32082f is received within the opening 32092a of the snap arm 32092. The peg 32082f acts as a stopper to prevent the expansion of the spring within the actuation portion 32090 by abutting against the inner surface of the snap arm 32092 surrounding the opening 32092a. However, as shown in FIG. 32K, for example, when the button 52 is pressed, the actuator 32084 is pushed downward, causing the inclined portion 32084e to push, guide or otherwise move a portion of the snap projection 32092 outward in a direction T that is substantially perpendicular to the direction L in which the canister actuation portion 32090 moves. The movement of the snap arm 32092 in the direction T causes the snap arm 32092 to move away from the peg 32082f, so that the movement of the canister actuation portion 32090 in the direction L is no longer blocked by the peg 32082f. This causes the spring in the canister actuation portion 32090 to expand, causing the canister actuation portion 32090 to move in the direction L away from the carrier 32082 to actuate the gas canister.

[0197] As previously described, the actuation mechanism 32080 shown in FIG. 32K is in an actuated state and the needle driver 320 is in a deployed position (the patient needle is inserted into the patient). In FIG. 32K, the peel tab has been removed (different from FIG. 32J), so that the leg 32084d extends through the opening 32082h of the carrier 32082. The path of the canister actuation part 32090 along the direction L is blocked by the second peg or protrusion 32082g. Thus, when the button 52 is first pressed to actuate the auto-injector 2, the canister actuation part 32090 is fixed in the position shown in FIG. 32K. In FIG. 32K, the actuator 32084 is locked to the carrier 32082 (by the engagement of the snap tab 32086 with the opening 32086a), so that the user cannot press the button 52 again after the first time the button 52 is pressed and released. Figure 32M shows the actuation mechanism 32080 with the needle driver 320 in the retracted position and the patient needle withdrawn from the patient. As previously described with reference to Figure 32K, the locking of the snap tab 32086 and recess 32086a prevents the user from further depressing the button 52.

[0198] One or more embodiments of the actuation mechanism 32080 are configured to facilitate the transition of the button 52 and, therefore, the actuation of the actuation mechanism 32080. For example, by locating two snap tabs 32086 on either side of the actuator 32084, the downward force applied by the user is evened out, facilitating the movement of the button 52. Additionally, the location and / or arrangement of the various elements of the actuation mechanism 32080 are configured to aid in the manufacture of the actuation mechanism 32080. For example, by locating the snap arms 32092 on the outside of the canister actuation portion 32090 and the actuation portion spring on the inside of the actuation portion 32090, the components can be easily, quickly, and inexpensively molded or manufactured. By locating two snap tabs 32086 on either side of the actuator 32084, the one or more recesses 32086a can be configured to provide a lockout position, as described above with reference to FIG. 32M, to disable the depression of the button 52 (after the button 52 is initially pressed to activate the auto-injector 2). Additionally, the placement of the two snap tabs 32086 provides equal and / or balanced forces to the actuator 32084, which is located partially below and partially around the button 52. This inhibits bending and / or deformation of the actuator 32084. The peel tab inhibits unintended actuation (e.g., actuation caused by vibration, dropping, impact or other forces on the actuation mechanism 32080) by blocking a downward path for the actuator 32084 and the button 52. In these embodiments, creep within the button assembly can be inhibited by, for example, a stronger component or wing, such as the snap arm 32092. Additionally, the snap tab 32086 inhibits accidental actuation of the button 52, such as, for example, by dropping due to friction.

[0199] 32N-32V show additional features that can be incorporated into the auto-injector 2. FIGS. 32N and 32P are perspective views of a portion of the actuation mechanism 32080 in an unused or unactuated state, with the canister actuation portion 32090 retracted relative to the carrier 32082. The actuation mechanism 32080 in this embodiment has another snap tab 32084z extending from the actuator 32084. More specifically, as shown in FIGS. 32N-32Q, the snap tab 32084z has a window that receives and interacts with a snap peg or protrusion 32082b on the carrier 32082. The snap peg or protrusion 32082e is a sloped portion with a downward shoulder that allows the actuator 32084 to move downward (towards the skin) while preventing the actuator 32084 from moving upward after it is initially depressed. Thus, similar to the embodiment described above with reference to Figures 32I-32M, button 52 cannot be pressed again (or, if pressed, has no effect on the device) after it has been pressed for the first time by a user.

[0200] 32R-32V illustrate a mechanism for preventing premature communication between the needle 308 and the container 1302 (e.g., in the event of accidental dropping). The mechanism illustrated in FIG. 32R-32V can be used with other embodiments disclosed herein. As illustrated, a fluid conduit 32098 (substantially similar to other fluid conduits described herein, such as the fluid conduit 300) is coupled to a connector 32002. The connector 32002 is rotatable and has a connector protrusion 32004. The connector protrusion 32004 is an outward protrusion that extends radially outward from an outer surface of the connector 32002. The connector 32002 is configured to interact with a sleeve disposed about the container 1302. The sleeve 32008 is coupled to and disposed about the container 1302. The connector 32002 is moveable relative to the sleeve 32008 in some configurations. The sleeve 32008 is snap-engaged with the container 1302 and is therefore immobile relative to the container 1302. As shown in FIG. 32R, the sleeve 32008 has a slot 32010 configured to receive the connector projection 32004. For example, the slot 32010 has a longitudinal portion extending longitudinally through a portion of the sleeve 32008 and a lateral portion extending laterally / circumferentially through a portion of the sleeve 32008. In this embodiment, the lateral / circumferential portion of the slot 32010 receives the connector projection 32004, thereby substantially locking the connector 32002 and the sleeve 32008 together, as described below. The substantial locking of the connector 32002 and the sleeve 32008 allows the connector 32002 to be secured after the completion of the injection. Additionally, the lateral / circumferential portion of the slot 32010 allows the needle driver 320 to be retracted. The connector protrusions 32004 inhibit accidental or unintended connection between the connector 32002 and the reservoir 1302, such as if a user accidentally drops the auto-injector 2. In particular, the connector protrusions 32004 act as a stopper that prevents relative movement between the connector 32002 and the reservoir 1302 until the patient needle is deployed by downward movement of the needle driver 320.

[0201] FIG. 32S is a close-up view showing the interaction of the connector 32002 and the sleeve 32008 in an initial or unused state. As shown, the width of the connector protrusion 32004 is approximately equal to or slightly less than the width of the slot 32010. Furthermore, in the initial or unused state, the actuator 32084 is expanded and the connector protrusion 32004 is not aligned with the slot 32010. In this aspect, the connector protrusion 32004 prevents or inhibits the sleeve 32008 and the container 1302 from moving toward the connector 32002 (or in other embodiments, inhibits the connector 32002 from moving toward the container 1302). If such movement were to occur, the fluid conduit would penetrate the container 1302 and release the medicament from the patient end of the needle. Thus, in the initial position, the connector protrusion 32004 inhibits relative movement between the connector 32002 and the sleeve 32008 / container 1302.

[0202] FIG. 32T illustrates the interaction of the connector 32002 and cartridge sleeve 32008 in an inserted state, for example, when the needle is inserted into a patient by downward movement of the needle driver 320. Downward movement of the needle driver 320 (not shown in FIG. 32R), causing the patient end of the fluid conduit 300 to be inserted from the housing 3 into the patient, rotates a central portion of the fluid conduit 32098 (and the connector 32002 / connector protrusion 32004) in a first direction. When the connector 32002 / connector protrusion 32004 is rotated in the first direction, the connector protrusion 32004 is longitudinally aligned with the slot 32010, and the connector 32002 and sleeve 32008 / container 1302 move toward each other, for example, by the force of pressurized gas from a gas canister as described herein.

[0203] 32U illustrates the interaction of the connector 32002 and sleeve 32008 after these components have moved toward one another to establish communication between the fluid conduit 32098 and the container 1302. As shown, the container 1302 and sleeve 32008 have been advanced toward the connector 32002 by the force of fluid from the gas canister, with the connector projections 32004 being received within the slots 32010.

[0204] FIG. 32V illustrates the interaction of the connector 32002 with the cartridge sleeve 32008 in a retracted state, e.g., the needle driver 320 has moved upward from the skin surface and the patient needle has been retracted from the patient. As illustrated, as the needle is retracted, the fluid conduit 32098 and the connector 32002 rotate in a second direction opposite the first direction. For example, if the first direction is clockwise, the second direction is counterclockwise. In other embodiments, the first direction is counterclockwise and the second direction is clockwise. The lateral / circumferential portion of the slot 32010 ensures that the needle driver 320 can move upward, and thus retract the patient needle after delivering the medicament from the container 1302. That is, if the lateral / circumferential portion of the slot 32010 was not provided, the fluid conduit and the connector 32002 would not be able to rotate in the second direction.

[0205] As previously discussed, the above embodiments ensure that fluid is not unintentionally delivered from the reservoir 1302 to the fluid conduit 32098 until the patient needle is deployed to the patient. In particular, the connector protrusions 32004 prevent the fluid conduit 32098 and reservoir 1302 from prematurely communicating with each other, which would cause medication to be expelled from the fluid conduit to the patient needle before the patient needle is deployed to the patient. Additionally, by rotating the connector 32002 (via the sleeve 32008) into engagement with the reservoir 1302, the risk of damage or failure of the fluid conduit 32098, e.g., by crimping, bending, etc. Additionally, the connector protrusions 32004 and slots 32010 may have other complementary configurations. For example, the connector protrusion 32004 may be a slit, recess or opening, and the slot 32010 may be a protrusion extending radially outward from the sleeve 32008 (but disposed in the same shape and path as the slot 32010 shown in the drawings).

[0206] 65A-65H illustrate another mechanism for preventing premature communication (such as by accidental dropping) between the needle (not shown) and the container 1302. The mechanism illustrated in FIGS. 65A-65H can be used with any of the other embodiments disclosed herein. Although not illustrated, the fluid conduit is coupled to the connector 32012 as previously described with reference to FIGS. 32R-32V. The connector 32012 is rotatable and has at least one connector protrusion 32014. For example, the connector 32012 may have two, three, four or more connector protrusions 32014 spaced apart from one another circumferentially and extending from a base portion 32012a of the connector 32012. The connector protrusions 32014 are longitudinal extensions extending from the base portion 32012a of the connector 32012 toward the container 1302 and each have an inward projection 32014a. The projections 32014a extend radially inward from an inner surface of the connector projection 32014, e.g., an end of the connector projection 32014. Additionally, each connector projection 32014 also has a tapered portion 32014b, e.g., a portion of reduced thickness at an end of the connector projection 32014. Each connector projection 32014 also has a planar end 32014c. The connector 32012 is configured to interact with a sleeve 32018, which is disposed about or extends from the container 1302. The sleeve 32018 is coupled to and / or disposed about a portion of the container 1302 and is immobile relative to the container 1302. The connector 32012 is movable relative to the sleeve 32018 in some configurations, e.g., as described above with respect to FIGS. 32R-32V.

[0207] As shown in FIGS. 65B-65E, the connector 32012 is selectively rotatable and longitudinally movable relative to the sleeve 32018. Although not shown, the rotation is provided by transmission from the fluid conduit 300 and the driver 320, as described above with reference to FIGS. 32R-32V. Additionally, FIGS. 65F-65H show portions of the connector 32012 and the sleeve 32018 at various stages of assembly and operation. As shown, the sleeve 32018 has one or more grooves 32018a extending through the periphery of the sleeve 32018. Each groove 32018a extends through the periphery of the sleeve 32018 or is a circumferential recess formed in the periphery of the sleeve 32018. Further, the groove 32018a has a flat portion 32018b (e.g., perpendicular to the periphery of the groove 32018a) and an inclined portion 32018c. The inclined portion 32018c is, for example, circumferentially disposed in the groove 32018a. The sleeve 32018 has any number of grooves 32018a, for example, a number of grooves 32018a corresponding to the number of connector projections 32014. The sleeve 32018 has a protrusion 32018d, for example, at an end of the sleeve 32018 opposite the container 1302. Further, the sleeve 32018 has a collar portion 32018e adjacent the container 1302, for example, at an end opposite the protrusion 32018d. The collar portion 32018e is secured to the neck of the container 1302, for example, by a snap engagement, an interference fit, or a threaded engagement.

[0208] For example, FIG. 65B is a close-up view showing the interaction of the connector 32012 and the sleeve 32018 in an initial or unused state. As shown, the connector projection 32014 is snap-engaged with the protrusion 32018d of the sleeve 32018. In this configuration, the connector 32012 is rotatable relative to the sleeve 32018, but is at least partially restricted from longitudinal movement relative to the sleeve 32018 and the container 1302. In this embodiment, the protrusion 32018d of the sleeve 32018 inhibits accidental or unintended communication between the fluid conduit 300 (which is secured to the connector 32012) and the container 1302, for example, if a user accidentally drops the auto-injector. More specifically, the protrusion 32018d functions as a stopper that inhibits relative longitudinal movement between the connector 32012 and the sleeve 32018 (and the container 1302) until the patient needle is deployed by downward movement of the needle driver 320 (not shown). Although not shown in FIG. 65B, the flat portion 32018b interacts with the planar end 32014c to inhibit relative longitudinal movement between the connector 32012 and the sleeve 32018 (and the container 1302).

[0209] 65C illustrates the interaction of the connector 32012 and sleeve 32018 in a patient-side needle insertion state, such as when the needle is inserted into the patient by downward movement of the needle driver (not shown). The downward movement of the needle driver rotates the central portion of the fluid conduit 300 (not shown), the connector 32012, and the connector protrusion 32014 in a first direction. The rotation of the connector 32012 / connector protrusion 32014 in the first direction aligns the connector protrusion 32014 longitudinally with the groove 32018a. Additionally, the rotation of the connector 32012 / connector protrusion 32014 aligns the angled portion 32014b of the connector protrusion 32014 longitudinally with the angled portion 32018c of the sleeve 32018. As a result, the connector 32012 and sleeve 32018 / container 1302 are moved toward one another, such as by the force of pressurized gas from a gas canister, as previously described, causing the ramps 32014b and 32018c to push the connector protrusion 32014 out of the groove 32018a. In particular, the opposing ramped surfaces of the ramps 32014b and 32018c push the connector protrusion 32014 radially outward, disengaging the connector protrusion 32014 from the outer surface of the sleeve 32018 and allowing longitudinal movement of the sleeve 32018 relative to the connector 32012.

[0210] 65D illustrates the interaction of the connector 32012 and sleeve 32018 after these components have moved toward one another to establish communication between the fluid conduit 300 (not shown) and the container 1302. As illustrated, the container 1302 and sleeve 32018 are advanced toward the connector 32012 by the force of fluid from the gas canister (not shown), forcing the connector protrusion 32014 out of the groove (not shown). Additionally, the connector protrusion 32014 is secured to or received about the collar portion 32018e of the sleeve 32018. In this orientation, the connector 32012 and sleeve 32018 can rotate relative to one another, but longitudinal movement of the connector 32012 and sleeve 32018 relative to one another, e.g., in the opposite direction, is restricted by the connector protrusion 32014.

[0211] FIG. 65E illustrates the interaction of the connector 32012 and the cartridge sleeve 32018 with the patient needle retracted, e.g., the needle driver 320 (not shown) moves upward away from the skin surface to remove the patient end of the needle from the patient and the patient needle is retracted from the patient. As shown, when the needle is retracted, the fluid conduit 300 (not shown) and the connector 32012 rotate in a second direction opposite the first direction. For example, if the first direction is clockwise, the second direction is counterclockwise. In other embodiments, the first direction is counterclockwise and the second direction is clockwise. The connector projection 32014 and collar portion 32018e (which are rotatable relative to each other as shown in FIG. 65D) ensure that the needle driver 320 moves upward, thereby ensuring that the patient needle is retracted after delivering the medicament from the container 1302. That is, if the connector projection 32014 and collar portion 32018e were not rotatable relative to one another, the fluid conduit and connector 32012 would not be able to rotate in the second direction.

[0212] Further, as previously discussed, FIGS. 65F-65H show portions of the connector 32012 and sleeve 32018 at various stages of assembly and actuation. For example, FIG. 65F shows the connector 32012 and sleeve 32018 in a configuration prior to assembly. FIG. 65G shows the assembled connector 32012 and sleeve 32018 configuration. As shown, the connector 32012 has connector protrusions 32014, each connector protrusion 32014 having an inward protrusion 32014a. Further, in the assembled configuration of FIG. 65G (similar to the initial state of FIG. 65B), the connector protrusions 32014 are locked to the sleeve 32018 (protrusions 32018d, etc.) and are restricted from longitudinal movement by the planar end 32014c of the connector protrusions 32014 and the flat portion 32018b of the groove 32018a, etc. As a result, relative movement of the connector 32012 and sleeve 32018 (and thus the container 1302) is inhibited until the patient needle is inserted via the patient needle mechanism. As shown in FIG. 65H, which is a close-up partial view of the configuration of FIG. 65C, the ramps 32014b of the connector protrusion 32014 and the ramps 32018c of the groove 32018a are aligned and the connector 32012 and sleeve 32018 are in an unlocked configuration. Thus, as the connector 32012 and sleeve 32018 / container 1302 are moved toward one another, such as by the force of pressurized gas from a gas canister, the ramps 32014b and 32018c urge the connector protrusion 32014 radially outwardly, pushing it out of the groove 32018a.

[0213] As previously discussed, the above aspects ensure that fluid is not inadvertently delivered from the reservoir 1302 to the fluid conduit until the patient needle is deployed to the patient. In particular, the connector projection 32014 and sleeve 32018 prevent the fluid conduit and reservoir 1302 from prematurely communicating with each other, which would cause medication to be expelled from the patient needle via the fluid conduit before the patient needle is deployed to the patient. Furthermore, by rotating the connector 32012 (via the sleeve 32018) into engagement with the reservoir 1302, the risk of breaking or failing the fluid conduit, e.g., by crimping, bending, etc., can be reduced. Additionally, the connector projection 32014 and groove 32018a can have other configurations, as long as they are complementary to each other. In the above embodiment, the connector 32012 can be locked to the sleeve 32018 before the connector 32012, sleeve 32018, reservoir 1302, etc. are assembled into a complete assembly. For example, the connector 32012 and sleeve 32018 may be partially assembled and then formed into a locked configuration prior to final assembly. Additionally, although not shown, the above embodiments facilitate alignment of the cartridge needle with the reservoir 1302.

[0214] Figures 33A and 33B show a configuration of an auto-injector 2 having a retractable lid 80 protruding from the housing 3. The lid 80 is movable relative to the housing 3. The lid 80 is retracted into the housing 3 along the transverse axis 44 by the application of a force to the housing 3 by a user. The lid 80 has a side wall 81 and a tissue engaging surface (such as a bottom surface) 82. The side wall 81 is retracted into the housing 3 (Figure 33B) upon application of a force by the user.

[0215] The housing 3 and the lid 80 are biased to an initial state shown in FIG. 33A by one or more coils, elastic materials, pneumatic mechanisms, etc. The tissue engaging surface 82 of the lid 80 has an opening 6 through which the needle 306 (or another patient needle) is deployed. Retraction of the lid 80 (i.e., the housing 3 and the lid 80 move toward each other) causes the needle 306 to extend from the lid 80 and be inserted into the user / patient through the skin 33000 of the user / patient. After completion of the injection, the tissue engaging surface 82 is pushed toward the skin 33000 to cover the needle 306 by sending fluid to be exhausted from a valve described herein (such as valve 3010). For example, fluid / gas from the fluid source 1366 exhausted through the exhaust conduit 3018 is directed toward the skin along the transverse axis 44. The exhausted fluid / gas pushes the lid 80 along the transverse axis 44, causing the lid 80 to move away from the housing 3 and return to the configuration shown in FIG. 33A. Alternatively, the expelled gas / fluid may directly or indirectly actuate a spring or other mechanism to push the lid 80 away from the housing 3, thereby retracting and covering the needle 306. In some instances, when the expelled air returns the lid 80 to the configuration of FIG. 33A, the needle 306 has already been retracted by another mechanism. Retraction of the lid 80 itself may also cause, for example, relative movement between the valve stem and another portion of the fluid source 1366, thereby actuating the fluid source 1366.

[0216] 34A and 34B, 35A and 35B, 36A and 36B, 37A and 37B, 38A and 38B, 39A and 39B, 40A and 40B, 41A-41E, 42A-42C, 43A-43D, 44A-44D, and 45A and 45B show various exemplary horizontal auto-injectors according to the present disclosure, which have a larger dimension along the longitudinal axis (parallel to the skin surface) than along the transverse axis (perpendicular to the skin surface). In the above respects, these embodiments are similar to the auto-injector 2 shown in FIG. 1 and FIG. 1A. Moreover, the auto-injector shown in these figures has a larger dimension along the transverse axis (parallel to the skin surface but perpendicular to the longitudinal axis) than along the transverse axis. Thus, these embodiments have a "flat" appearance relative to the skin surface.

[0217] As will be described in detail below, the placement of the window 50 and button 52 in the horizontal auto-injector of the present disclosure is not particularly limited. For example, the window 50 and / or button 52 may be located along the top or side of the housing 3 and / or at the boundary between the top and side of the housing, or at the boundary between the longitudinal and transverse sides. In yet other embodiments, one or more windows 50 and / or buttons 52 are located along the bottom skin-contacting surface of the housing 3. For example, the bottom window 50 (see FIG. 51D) is configured to allow viewing of the interior of the auto-injector 2 even when another window 50 of the auto-injector 2 is blocked by a movable flag or the like (described below with reference to FIGS. 54G-54I) during use of the auto-injector 2. The window 50 and / or button 52 are located at a central and / or offset position on each surface. For example, the window 50 and / or button 52 may be radially centered on the top or side of the auto-injector 2, or may be longitudinally, transversely and / or laterally offset from the radial center of each side. The window 50 and / or button 52 may be recessed or protruding relative to the adjacent surface of the auto-injector 2, or may be flush with the adjacent surface. The specific shape, material, appearance, size and location of the window 50 and button 52 are described in more detail below.

[0218] The button 52 is a finger-press button. In some examples, the button itself is coupled to a needle (e.g., needle 306) that is to be deployed to the patient, and when the button is pressed, the needle is inserted into the skin of the user. In other examples, the button 52 indirectly causes deployment of a needle and / or activation of the fluid source 1366. For example, the button 52 activates a spring or other force that actuates a patient-side needle mechanism. Examples of these are described in more detail below. Examples of other actuation mechanisms that can be used in place of the button 52 include a slider, trigger, dial, flip lid, paddle, pull cord, etc.

[0219] The window 50 allows the user to clearly view the reservoir 1302 and / or the piston 1316. The window 50 is configured to allow visualization of different doses used with the same basic device. The window 50 can cover various surfaces of the auto-injector. The window 50 can be modified and sized to reduce confusion when a relatively large reservoir 1302 is used for small doses (as described in more detail below). In some embodiments, the window 52 is located on the tissue contacting surface itself.

[0220] For example, in the auto-injector 2a shown in FIGS. 34A and 34B, the housing 3 has a raised platform 34000 relative to the remainder of the top surface of the housing 3. The raised platform 34000 extends along a majority of the longitudinal axis of the housing 3, and the button 52 is located at a longitudinal end of the raised platform 34000. The top surface of the button 52 is flush with the top surface of the raised platform 34000, such that, in at least some embodiments, the button 52 is not visible when the auto-injector 2a is viewed from the side. In another configuration, the button 52 is raised or recessed relative to the raised platform 34000. The window 50 in this embodiment extends along a majority of the longitudinal axis of the auto-injector 2a and is visible when the auto-injector 2a is viewed from the top and from the side. The window 52 is located within a longitudinal recess in the housing 3. However, the window portion 52 may be located flush with the surface of the housing 3 or may be raised from the surface of the housing 3 .

[0221] In the embodiment of Figures 35A and 35B, the button 52 is located at the longitudinal end of the recessed top surface of the auto-injector 2b. The outer periphery 52d of the button 52 has a visually different appearance from the surrounding portion of the top surface of the auto-injector 2b and from the button 52. For example, the outer periphery 52d has a different color (i.e., the outer periphery 52d is black while the top surface and the button 52 are white). Alternatively, the outer periphery 52d is formed from a different material, for example, the outer periphery is formed from a clear plastic and the top surface and the button 52 are formed from an opaque plastic. In this embodiment, the window 50 extends longitudinally along the side of the auto-injector 2b and is at least partially visible when the auto-injector 2b is viewed from directly above and / or from the side.

[0222] In the embodiment of Figures 36A and 36B, the button 52 is located on the raised platform 36000 of the auto-injector 2c, similar to the embodiment of Figures 34A and 34B. However, unlike the embodiment of Figures 34A and 34B, in the embodiment of Figures 36A and 36B, the raised platform 36000 occupies a smaller surface area on the top surface. As shown, the button 52 occupies substantially the entire raised platform 36000. Furthermore, the button 52 is located radially centered on the top surface. In this embodiment, the window 50 is flush with the outer surface of the housing 3. The window 50 in this embodiment extends along the longitudinal axis of the auto-injector 2c and is visible when the auto-injector 2c is viewed from above and from the side.

[0223] The auto-injector 2d of Figs. 37A and 37B has a button 52 on the top surface of the housing 3, the button 52 being located substantially over a raised platform 37000 at the longitudinal end of the top surface. In this embodiment, the button 52 is a rocker switch button that is movable between two different positions. The sides of the rocker switch button 52 are marked or colored to allow the user to easily determine the state of the auto-injector 2d. For example, as shown in Fig. 37B, when the rocker switch button 52 is in a first position, the exposed side 37002 of the rocker switch button 52 is visible to the user, and is colored, for example, green. The user can determine from this green color that the auto-injector 2d has not yet been activated or that it contains a dose that can be delivered to the user. When the user presses the button 52, the first exposed (green) side 37002 becomes invisible and instead a second exposed side (not shown) is presented to the user. The second exposed side has a different color or appearance than the first exposed side 37002 and is not visible while the auto-injector 2d is in the first position. For example, the second exposed side may be the same color (e.g., white) as the rest of the housing 3 or may be a different color (e.g., red, blue, etc.). The window 50 in this embodiment is similar to any of the windows previously described and is visible when the auto-injector 2 is viewed from directly above or the side.

[0224] In the embodiment shown in Figures 38A and 38B, the button 52 is located at a longitudinal end of the flat or slightly rounded top surface of the auto-injector 2e. The button 52 may be flush with the adjacent surface of the housing 3 or may be slightly recessed. When this embodiment is viewed from the side, the button 52 is not visible. Furthermore, in this embodiment, the window 50 extends longitudinally along the side of the auto-injector 2e and is at least partially visible when the auto-injector 2e is viewed from the top and / or the side.

[0225] The embodiment shown in Figures 39A and 39B is similar to the embodiment shown in Figures 38A and 38B, in that the button 52 is located at the longitudinal end of the flat or slightly rounded top surface of the autoinjector 2f. As shown in Figure 39A, the button 52 is flush or recessed with the adjacent surface of the housing 3. When this embodiment is viewed from the side, the button 52 is not visible. Furthermore, in this embodiment, the window 50 extends longitudinally along the recessed side of the autoinjector 2f and is only visible when the autoinjector 2f is viewed from the side. In this embodiment, the window 50 is not visible when the autoinjector 2f is viewed from the top.

[0226] The embodiment shown in Figures 40A and 40B is similar to the embodiment shown in Figures 39A and 39B, except that the button 52 is located radially centered on the flat or slightly rounded top surface of the auto-injector 2g. Furthermore, when the auto-injector 2g is viewed from directly above, the recess containing the window 50 is visible, but the window 50 itself is not visible from that perspective.

[0227] In the embodiment of Figs. 41A and 41B, the button 52 is disposed along a laterally extending side of the auto-injector 2h. In the illustrated example, the button 52 is formed over substantially the entirety of one laterally extending side, although the button 52 may be formed over a smaller portion of this side. The button 52 is raised relative to the adjacent surface of the auto-injector 2h such that in the pre-activated or undeployed position, the exposed side 41000 is visible to the user. The side 41000 of the button 52 is marked or colored as described above with reference to Figs. 37A and 37B so that the user can easily determine the status of the auto-injector 2h. For example, as shown in Figs. 41A and 41B, when the button 52 is in the pre-activated or undeployed position, the exposed side 41000 of the button 52 is visible to the user, and is colored, for example, green. The green color allows the user to determine that the auto-injector 2h has not yet been activated or contains a dose that can be delivered to the user. When the user presses the button 52, the exposed (green) side 41000 is no longer visible, indicating that the device has been activated. Furthermore, after the injection is completed, the button 52 is observed without revealing the previously exposed colored or marked surface, allowing the observer to determine that the auto-injector 2h has been used. In some embodiments, a locking or other mechanism prevents the button 52 from returning to its initial position (with the colored or marked side 41000 exposed) after it has been pressed. Such a locking mechanism improves the reliability of visual confirmation of the auto-injector 2h. The embodiment shown in Figures 41C-41E is similar to the embodiment shown in Figures 41A and 41B, but includes an additional status window 50b located on the top surface. The status window displays appropriate information regarding the status of the auto-injector 2h. In one embodiment, the status window displays the same color or appearance as the exposed side 41000 of the button 52 when the auto-injector 2h is in a pre-activated or undeployed state. After the button 52 is pressed, the window 50b displays a different color or appearance to indicate that the auto-injector 2h has been activated.In one embodiment, window 50b displays the same color or appearance as button 52 or other portions of housing 3 to indicate that auto-injector 2 has been used. The types of images and markings that may be displayed in window 50b are described in more detail below.

[0228] The embodiment shown in Figures 42A and 42B is similar to the embodiment shown in Figures 39A and 39B, except that the top surface of the auto-injector 2i is curved so that the button 52 is visible when the auto-injector 2i is viewed from the side. Additionally, the window 50 is visible when the auto-injector 2i is viewed from the top or side.

[0229] 42C includes a button 52 located on the top surface of the auto-injector 2j, with a window 50 extending along both the top surface and an adjacent longitudinal side. In the auto-injector 2j, the window 50 and the button 52 are located adjacent to each other on the top surface of the housing 3.

[0230] In the embodiment shown in Figures 43A-43D, the button 52 is located on a longitudinal side of the auto-injector 2k. The button 52 is a rocker switch button that is movable between two positions. At least a portion or all of the button 52 has a different physical appearance, such as a different color, than the housing 3. The button 52 is visible when the auto-injector 2k is viewed from directly above or from the side. In this embodiment, the window 50 is located in a recess in the top surface of the auto-injector 2k, and is visible when the auto-injector 2k is viewed from directly above, but is not visible when viewed from the side.

[0231] The auto-injector 21 shown in FIGS. 44A and 44B has two longitudinally extending buttons 52, each located on a longitudinal side of the auto-injector 21. A user must press both of the two buttons 52 to initiate needle deployment and medicament delivery. For example, one of the buttons 52 is connected to a locking mechanism that blocks a portion of the patient-side needle mechanism, and another portion of the locking mechanism is configured to activate the fluid source 1366. In some embodiments, the two buttons 52 must be pressed simultaneously or in a specific order to initiate needle deployment. A longitudinally extending window 50 is located on the top surface of the auto-injector.

[0232] The auto-injector 2m shown in Figs. 44C and 44D includes a slider 44000 disposed on a recessed upper surface. The slider 44000 is movable from a first position to a second position. The auto-injector 2 is in a pre-activated or undeployed state when the slider 44000 is in the first position, and needle deployment and drug delivery commences when the slider 44000 is moved to the second position. In the first position, the slider 44000 displays a first color, marking or appearance on the display panel 44002 (e.g., displayed under the slide component itself). For example, a color such as green is displayed to the user to indicate that the auto-injector is in a pre-activated or undeployed state. When the slider 44000 is moved to the second position, the slider 44000 displays a second color, marking or appearance (different from the first color, marking or appearance) on the second display panel to visually indicate that the auto-injector 2m has been used. In the second position, the first display panel 44002 is not visible as it is covered by the sliding component of the slider 44000. The window 50 in this embodiment is substantially similar to the window 50 shown in Figures 35A and 35B.

[0233] The autoinjector 2n shown in Figs. 45A and 45B includes a button 52, such as a snap-on button, on the top surface of the autoinjector 2. When the autoinjector 2 is in a pre-activated or undeployed position, a side 45000 of the button 52 having a color, marking or appearance is exposed, indicating to the user that the autoinjector 2n is in a pre-activated or undeployed state. When the button 52 is pressed and moved to a second position, the first color, marking or appearance of the exposed side 45000 is no longer visible to the user from any angle when viewed from the outside, indicating that the autoinjector 2n has been used. When the button 52 is pressed, it snaps into the second position. The button 52 occupies most or substantially the entire top surface of the autoinjector 2. Additionally, a window 50 is disposed on the button 52 itself.

[0234] The horizontal auto-injector 2o shown in FIGS. 46A and 46B has a larger dimension along a transverse axis 44 (perpendicular to the skin surface) than along a horizontal axis 42 parallel to the skin surface. The horizontal auto-injector 2o has a largest dimension along a longitudinal axis 40 parallel to the skin surface. In such an embodiment, the container 1302 in the horizontal auto-injector 2o is oriented substantially parallel to the skin surface and the longitudinal axis of the horizontal auto-injector 2o. To perform the required functions, a valve (such as valve 3010) as described herein is disposed near the skin-contacting surface of the auto-injector 2o. The container 1302 extends along the longitudinal axis 44 of the auto-injector 2o and is disposed above the valve 3010. The auto-injector 2o has a removable seal 46000 disposed over a portion or the entire skin-contacting surface of the auto-injector 2o. In some embodiments, the seal 46000 is permeable to a sterilant (such as ethylene oxide, vaporized hydrogen peroxide, etc.) and is disposed on the auto-injector 2o prior to sterilization. A suitable material such as Tyvek® is used for seal 46000. A removable seal (such as seal 46000) covering some or all of the bottom skin-contacting surface of the auto-injector may be provided with any of the auto-injectors described herein.

[0235] The embodiment of the auto-injector 2p shown in Figures 46C-46E includes a button 52 located at a longitudinal end of the top surface of the auto-injector. A window 50 extends longitudinally along the top surface adjacent the button 52. A window 50 is also located on each longitudinal side of the auto-injector 2p. Figure 46E shows a bottom tissue-engaging surface 46001 of the auto-injector 2p. The tissue-engaging surface 46001 includes a label 46003 that includes various identifying information, which will be described in more detail below. The auto-injector 2p also includes a contact detection switch 46002 at a longitudinal end of the tissue-engaging surface 46001. In order to deploy the needle, the contact switch 46002 must be pressed. In some instances, pressing the contact switch 46002 clears a mechanical obstruction from the path of one or more structures within the auto-injector 2p, such as a shuttle, a needle driver, a gear, or other moving part of the patient-side needle mechanism. For example, when the contact switch is pressed, an obstruction is removed from the path of one or more portions of the patient-side needle mechanism. The interior of the contact switch 46002 is hollow (e.g., annular) to allow movement of the needle 306 through the opening 6 in the tissue contacting surface 46001 and through the hollow interior of the switch 46002.

[0236] The auto-injector 2r shown in Figures 47A and 47B uses a cap 47000 to deploy the needle and activate the device. The cap 47000 extends from the housing 3 of the auto-injector 2r and operates in a manner similar to that described above with reference to Figures 33A and 33B. The auto-injector 2r of Figures 47A and 47B has a window 50 that extends longitudinally along the top surface of the auto-injector 2r. The top surface curves downwards such that the window 50 is visible when the auto-injector 2r is viewed from above or the side. Additionally, when the auto-injector 2r is in a pre-activated or undeployed state, the exposed portion 47002 of the cap 47000 is visible to the user when the auto-injector 2r is viewed from the side. The exposed portion 47002 has a different color (e.g., green), marking or appearance than the remainder of the auto-injector 2r (e.g., white). After the auto-injector 2r is actuated (with the cap 47000 retracted), the exposed portion 47002 and its color are no longer visible. Retraction of the cap 47000 inserts the needle 306, either directly or indirectly (see, e.g., FIG. 18A ). For example, the needle 306 is coupled to the housing 3 such that relative movement of the cap 47000 and the housing 3 inserts the needle 306 into the user (direct insertion). In other examples, retraction of the cap 47000 activates another mechanism, such as a fluid source, a spring, or other mechanism that drives needle insertion (indirect insertion).

[0237] The autoinjector 2s shown in FIGS. 47C and 47D, like the autoinjector 2o, has a larger dimension along a transverse axis (perpendicular to the skin surface) than along a lateral axis parallel to the skin surface. The button 52 is located on the recessed top surface of the housing 3 and is not visible when the autoinjector 2s is viewed from the side. The window 50 extends along the longitudinal side of the housing 3 and is not visible when the autoinjector 2 is viewed from the top. The bottom 47010 has a non-slip or adhesive coating, such as rubber, to facilitate gripping of the autoinjector 2s by the user and to inhibit slipping of the autoinjector 2s across the skin. The gripping portion covers most or all of the tissue-engaging surface of the bottom of the autoinjector 2s and also extends upward from the tissue-engaging surface along the lateral and longitudinal sides of the autoinjector 2s.

[0238] 48A-48C are schematic diagrams of a "vertical" auto-injector 2t, the dimension of which is greatest along a transverse axis perpendicular to the skin surface. The auto-injector 2t has the same or similar components as any of the auto-injectors described above. For example, fluid from a fluid source 1366 moves the container 1302 relative to the fixed housing 3 and fluid conduit 300, with which the container 1302 is in communication (FIG. 48A) with the spring 48000, which is coupled to the second end 1306 of the container 1302 and is in an expanded state prior to actuation of the auto-injector 2t. As the container 1302 moves toward the fluid conduit 300, the spring 48000 is compressed (FIG. 48B). The needle 306 of the fluid conduit 300 is deployed by any of the mechanisms described herein (see FIG. 48B). Once the injection is complete, the fluid / gas from the fluid source 1366 is expelled, rather than pumped to the container 1302. At this point, the pressure of the fluid from the fluid source 1366 is no longer acting against the spring 48000, which expands and biases both the container 1302 and the fluid conduit 300 away from the skin surface (i.e., the needle 306 retracts). The fluid source 1366 is actuated by a button or any of the actuation mechanisms described herein. The auto-injector 2t may have a lid, and actuation of the fluid source 1366 and insertion of the needle 306 into the user may be accomplished by applying pressure to the auto-injector 2t on the skin to retract the lid. The vertical auto-injector 2u shown in Figures 48D-48F has a window 50 that extends along the transverse axis of the auto-injector. The auto-injector 2u has a removable cap 48002 (Figures 48D and 48E) that, when removed, exposes the lid 80 containing the needle opening 6.

[0239] Figures 48H and 481 show additional features of the system flow within the auto-injector 2t that are substantially similar to the system flow of Figure 3A. This embodiment also has an ejection or extrusion system 2300 that utilizes gas to redirect, rather than eject, the auto-injector after a dose of medication has been delivered, to push the cap 23102 out of the rest of the auto-injector 2t.

[0240] As previously discussed, retraction of the lid 23102 actuates the gas canister 1366. For example, the lid 23102 is coupled to an actuation rod 48012. As the lid 23102 is retracted, the actuation rod 48012 actuates the gas canister 1366 in a manner similar to other gas canister actuation mechanisms described herein. Gas then flows through the system and valves, pushing medication through the fluid conduit and the patient needle 300 inserted into the patient, as shown in FIG. 48H.

[0241] A conduit or connection 23104 is also disposed between the lid 48010 and the gas canister / exhaust line. During high pressure conditions with the diaphragm 3012 sealing against the valve seat 3020, gas cannot flow through the conduit 23104. When pressure is balanced in the system and the valve and the diaphragm is lifted from the valve seat 3020, gas flowing through the exhaust conduit 3018 biases the dump valve of the extrusion system 2300, allowing gas to flow from the canister 1366 to the conduit 23104. The force of the gas flowing through the conduit 23104 then biases and / or pushes the lid 48010 through the push rod 23106, moving the lid 48010 to a position where the needle 300 is retracted, as shown in FIGS. 48C and 48I. Specifically, as shown in FIGS. 48H and 48I, the piston or push rod 23106 is coupled to the lid 48010. The push rod 48014 is received in the conduit 23104 of the auto-injector 2t, and ejection pressure within the conduit 23104 causes the push rod 23106 to bias the cap 23102 into the position shown in Figures 48C and 48I. Moving the cap 23102 to the position shown in Figures 48C and 48I can indicate to the user that the injection is complete and also acts as a precaution against accidental injury from the patient end of the needle (i.e., sharps mitigation or prevention).

[0242] Various examples of auto-injectors 2v having a cap are shown in Figs. 49A-49F. In some examples, as shown in Figs. 49A-49D, the cap 49000 comprises substantially the entire skin-contacting surface of the auto-injector 2v. In the embodiment of Fig. 49D, the cap 49000 has different colored portions to allow the user to determine the approximate location of the needle opening 6. In Fig. 49D, the needle opening 6 is located at the radial and longitudinal center of the tissue-contacting surface of the cap. The central portion 49003 of the cap has a different color, marking, or appearance than adjacent portions 49004 of the cap to allow the user to view the approximate location of the needle deployment portion even when the needle opening 6 is not in the user's line of sight. In another embodiment, the central portion 49003 is movable relative to adjacent portions 49004 and retracts into the auto-injector 2v to deploy the patient needle. In the embodiment shown in Figs. 49E and 49F, the movable parts are located on only a portion of the tissue-contacting surface of the auto-injector 2v. For example, the cap 49000 has a circular protrusion 49020 (FIG. 49E) or an oval protrusion 49022 (FIG. 49F) that retracts into the autoinjector 2v when placed on the skin with pressure applied to the autoinjector 2v. The protrusions may be other shapes. The protrusions 49020 or 49022 in FIGS. 49E and 49F have a different color, marking, or appearance than the rest of the tissue contacting surface of the autoinjector 2v. The embodiments of FIGS. 49A-49F allow the user to visually inspect each autoinjector to determine that the needle is relatively short, potentially reducing the user's fear of needles.

[0243] Various surfaces of the auto-injectors disclosed herein may be modified to aid the user in manipulating the auto-injector. For example, one or more protrusions 50000 (FIG. 50F), indentations 50002 (FIGS. 50C and 50I), and ribs 50004 (FIG. 50H) on the button 52 may clearly indicate to the user that the button 52 is for activating the auto-injector and may clearly indicate to the user that they are handling the top surface of the auto-injector. Such surface structures may also guide the user's fingers to the button itself, making it easier to grasp. Additionally, at least the indentations may provide a better feel for the user when pressing the button 52. Various surface modifications may also be applied to other portions of the exterior of the auto-injectors described herein. For example, the surface of the housing 3 may be provided with one or more of protrusions 50000 (FIGS. 50A, 50B and 50E), raised ribs 50005 (FIG. 50C), recessed ribs 50004 (FIGS. 50D and 50H), adhesive or rubbery surfaces 50008 (FIG. 50G), recesses 50009 (FIG. 50G) and / or knurling 50006 (FIG. 50J). The surface modifications may be located at various locations where the user holds / grabs the auto-injector. The surface modifications may be located along one or more of the top, transverse or longitudinal sides of the auto-injector.

[0244] 51A-51D show various positions of the needle relative to the tissue contacting surface of the auto-injector. For example, the needle opening 6 may be centrally located (e.g., along one or both of the transverse or longitudinal axes of the auto-injector) or offset from one or both of the transverse or longitudinal axes. In some embodiments, the needle opening 6 passes through the movable lid of the auto-injector (FIGS. 51C and 51D) and is either centrally located in the movable lid or offset from one or more axes of the lid (FIGS. 51C and 51D). As shown in FIGS. 51A and 51B, the needle opening is located within the hollow interior of an annular contact switch, so that the needle 306 must pass through the interior of the contact switch when deployed to the patient. In other embodiments, the contact switch 46002 is a solid button through which the needle opening 6 passes (FIGS. 51C and 51D). In still other embodiments, the needle opening 6 is offset from the contact switch 46002. In various embodiments, the contact switch 46002 is made from a non-slip or rubber material and / or has surface irregularities (such as ribs) to improve contact with the skin and prevent slipping.

[0245] In some embodiments, the skin-contacting surface of the auto-injector has one or more non-slip or sticky surfaces to stabilize the auto-injector against the skin during use. For example, as shown in Figures 51C and 51D, one or more grips 51000, e.g., rubber grips, may be disposed on the skin-contacting surface of the auto-injector.

[0246] As shown in FIGS. 52A-52C, various auto-injectors of the present disclosure may have a pull tab or seal 46000, as previously described with reference to FIGS. 46A and 46B. The seal 46000 has one or more protrusions 46000a configured to extend into one or more openings 46000b in the housing 3. The protrusions 46000a are disposed within the openings 46000b, and the auto-injector 2 is sterilized by a sterilant (such as EtO or VHP) that permeates the seal 46000. The openings 46000b are the same openings through which the contact switch 46002 (see FIGS. 46C-46E) extends from the housing 3. The contact switch 46002 is biased to extend outside the housing 3 through the openings 46000b, but when the protrusions 46000a are within the openings 46000b, the entire contact switch 46002 remains within the housing 3. While the contact switch 46002 is retained in the housing 3 and the protrusion 46000a is located in the opening 46000b, the needle 306 of the auto-injector cannot be deployed or an injection cannot be initiated. That is, in some embodiments, a step of removing the seal 46000 is required before the needle can be deployed. Thus, for example, pressing the button 52 with the protrusion 46000a located in the opening 46000b will not deploy the needle 306 or initiate an injection. For example, the contact switch 46002 is coupled to an obstacle that blocks the path of one or more parts of the patient needle mechanism, such as a needle driver, shuttle, gears, etc. When the seal 46000 is removed from the housing 3, the contact switch 46002 extends out of the housing 3 through the opening 46000b (FIG. 52B). The contact switch 46002 extending out of the housing 3 operates as described above with reference to FIGS. 46C-46E. That is, the auto-injector is primed for actuation by contacting the skin and depressing the contact switch 46002 (FIG. 52C). For example, only when the button 52 is actuated with the contact switch 46002 depressed will deployment of the needle 306 begin. Additionally, the presence of the seal 46000 on the auto-injector provides a clear visual indication that the auto-injector is unused and has not been tampered with.

[0247] 53A and 53B show another example of a status indicator 50b configured to help a user or observer visually determine the status of the device. For example, the indicator 50b displays a first indication, e.g., a first color, mark, or appearance, when the device is in a pre-activated or non-deployed state. Once the injection and retraction of the needle 306 is complete, the indicator 50b displays a second color, mark, or appearance. For example, the second color is "green." Alternatively, the indicator may display a word or symbol such as "Done" or a check mark to indicate the completion of the injection. The indicator 50b may have one or more other colors, marks, or appearances to indicate other conditions. For example, a certain color may be displayed when the seal 46000 is attached to the autoinjector and another color may be displayed after the seal 46000 is removed from the autoinjector. Yet another different color may be displayed when the contact switch 46002 is pressed but the injection has not yet started. The indicator 50b may indicate the progress of the injection in real time. For example, when transitioning from a first color to a second color, the indicator 50b gradually decreases the area of ​​the display window occupied by the first color while gradually increasing the area of ​​the display window occupied by the second color. This transition continues until the end of the injection, at which point the indicator window displays only the second color and not the first color. The change in indicator state is initiated by pressing the button 52, as described above. The change in indicator state may be caused by gas flowing from the valve. For example, the indicator may be moved from the first position to the second position by diverting a portion of the gas from the fluid source 1366. In one embodiment, the movement of the push rod 8002 (driven by the exhaust gas) is used to transition the indicator from the first position to the second position. The indicator 50b is adjusted to the expected injection time to display a step-by-step progress as described above. Alternatively, the diverted gas may cause a change in the binomial display from the first state (indicating a pre-actuation state) to the second state (indicating completion).

[0248] 54A-54C illustrate various status flag indicators 54000 that may be used in conjunction with the disclosed auto-injector to allow an observer to visually determine the status of the auto-injector. The flag 54000 is a partially tubular structure extending from a first end 54002 to a second end 54004. The first end 54002 of the structure has a generally tubular portion 54006 that extends completely around the circumference of the flag 54000. The second end 54004 of the structure has a partially tubular portion 54008 that extends only partially around the circumference of the flag 54000. The partially tubular portion 54008 extends an arc length of approximately 180 degrees around a radial center of the flag 54000. The radially outer surface 54008a of the partial tubular portion 54008 has a first color, and the radially outer surface 54006a of the generally tubular portion 54006, which extends along the same arc as the partial tubular portion 54008, also has a first color. The first color of the outer surfaces 54006a and 54008a indicates through the window 50 that an injection is completed (or in progress). The inner surface 54008b of the partial tubular portion 54008 has a second color that is different from the first color. Additionally, the outer surface 54006b of the generally tubular portion 54006, which does not share the same arc as the partial tubular portion 54008, also has a second color. The second color may be a color that provides contrast to allow the contents of the container 1302 to be identified and inspected. The inner surface 54008b of the partially tubular portion 54008 and the outer surface 54006b of the generally tubular portion 54006 are simultaneously visible through the window 50 of the auto-injector. The indicator may be opaque or translucent and may have a frosted finish.

[0249] Prior to actuation of the auto-injector, only the second color of the outer surface 54006b or the outer surface 54008b is visible through the window 50. As the medication is delivered from the container 1302, the flag 54000 rotates around the container 1302, and the first color is gradually displayed in the window 50 as the injection progresses and the injection is completed. Once the injection is completed, only the first color is displayed to the user through the window 50 (e.g., only the outer surface 54008a of the partially tubular portion 54009 and the outer surface 54006a of the generally tubular portion 54006 are visible). The indicator rotates gradually to provide a real-time indication of the progress of the injection. In other embodiments, the flag 54000 functions as a binomial indication and does not rotate until the injection is completed. When functioning as a binomial indication, the rotation is driven by gas exhausted from the fluid source 1366 via the exhaust conduit 3018 or the like. Examples of binomial indications are shown in Figures 54F-54I. For example, while an injection is in progress (FIGS. 54F and 54H), the flag 54000 is in an initial position. When the injection is completed (FIGS. 54G and 54I), the flag 54000 rotates to fill the entire viewing area of ​​the window 50. FIGS. 54H and 54I show the position of the partially tubular portion 54008 relative to the window 50 prior to actuation (FIG. 54H) and upon completion of the injection (FIG. 54I).

[0250] The length of the generally tubular portion 54006 can be adjusted to accommodate different doses set in the container 1302. For example, different doses of medication may be delivered using the same model and type of auto-injector 2 and container 1302. For smaller doses, the same type of container 1302 (e.g., with the same specifications) is used, but with a smaller amount of medication. For this reason, there is an unused space behind the piston 1316 moving toward the first end 1304 of the container 1302. This unused empty space, and the piston 1316 being located toward the center of the container 1302, may cause concern to the user during injection. For example, if the piston 1316 is located in the center of the container 1302 and the window 50 at the start of an injection, it may confuse the user. That is, the user may think that the device has already been activated, that it has not been properly filled, or that some other malfunction has occurred. By adjusting the length of the generally tubular portion 54006 of the flag 54000, such confusion of the user can be reduced. Alternatively, the window 50 or certain portions of the container 1302 may be matte or painted to cover the unused space within the container 1302. Containers 1302 containing larger doses have less unused space and are therefore us...

Claims

1. 1. An auto-injector comprising: a housing having a longitudinal axis and a transverse axis, the dimension along the transverse axis being less than the dimension along the longitudinal axis, the transverse axis being perpendicular to the longitudinal axis; a flow channel having a first end and a second end; a vessel containing a first fluid, the vessel extending from a first end to a second end along or parallel to the longitudinal axis, the vessel being movable along or parallel to the longitudinal axis from a first position to a second position, the vessel being out of communication with the flow path in the first position, and being in communication with the flow path in the second position; the container further comprising a plunger configured to move from the first end toward the second end of the container to expel the first fluid from the container into the flow path; An automatic injector, wherein a first end of the flow passage is insertable into the container and a second end of the flow passage is extendable from the housing through an opening in the housing in a direction along or parallel to the transverse axis.

2. further comprising a fluid source configured to emit a pressurized second fluid; the container is movable from the first position to the second position by releasing the pressurized second fluid from the fluid source; 2. The automatic injector of claim 1, wherein release of the pressurized second fluid from the fluid source urges the plunger from the first end toward the second end of the container such that the first fluid is expelled from the container into the flow path.

3. the container having a seal at the second end of the container; 3. The automatic injector of claim 2, wherein in the first position, a gap is provided between the seal and the first end of the flow passage.

4. 4. The automatic injector of claim 3, wherein a first end of the flow passage passes through the seal and into the container when the container is moved to the second position.

5. 4. The automatic injector of claim 3, wherein a reduction in pressure from the pressurized second fluid on the container allows the container to move from the second position to a third position.

6. 6. The automatic injector of claim 5, wherein the third position is the same as the first position.

7. 6. The automatic injector of claim 5, wherein the third position is different from the first position.

8. a first resilient member coupled to the container; the resilient member is compressed by moving the container from the first position to the second position; 6. The automatic injector of claim 5, wherein the compressed resilient member expands to move the reservoir to the third position upon reduction in pressure from the pressurized second fluid.

9. Career and a drive coupled to a second end of the flow channel, the drive being slidable relative to the carrier between a retracted configuration and a deployed configuration; a shuttle configured to move the drive between the retracted and deployed configurations; 2. The automatic injector of claim 1, further comprising a stopper configured to move from a first configuration to a second configuration, the stopper configured to maintain the driver in a deployed configuration, and movement of the stopper from the first configuration to the second configuration enabling the shuttle to move the driver from the deployed configuration to the retracted configuration.

10. 10. The automatic injector of claim 9, wherein prior to actuation, the driver is in contact with an obstacle and is prevented from moving from the retracted position by the obstacle, the obstacle being coupled to the container.

11. 11. The automatic injector of claim 10, wherein movement of the container from the first position to the second position moves the obstruction out of contact with the drive member, thereby allowing the drive member to move from the retracted position to the deployed position.

12. 1. An auto-injector comprising: a body housing the conduit; a fluid source configured to supply pressurized fluid to the conduit; a container in communication with the conduit, the container containing a medicament and a plunger configured to expel the medicament upon application of pressure to the plunger by the pressurized fluid; a pressure restriction configured to restrict the flow of the pressurized fluid within the conduit and defining high and low pressure flow regions in the conduit; a valve having a valve inlet and a valve outlet, the valve inlet in communication with the conduit and configured to control flow of the pressurized fluid from the conduit to the valve outlet; a flow path extendable from the body and configured to deliver a drug from the container to a patient; An automatic injector, wherein the direction in which the reservoir expels medication is offset from the direction in which the flow passage extends from the body.

13. 13. The automatic injector of claim 12, wherein the pressurized fluid is a gas.

14. 13. The automatic injector of claim 12, wherein the medication comprises a monoclonal antibody.

15. The automatic injector of claim 12, wherein the pressure limiting portion comprises a porous material or a serpentine channel.

16. 13. The automatic injector of claim 12, wherein the direction in which the reservoir expels medication is substantially perpendicular to the direction in which the flow passage extends from the body.

17. 13. The automatic injector of claim 12, wherein the container is in communication with a low pressure flow region of the conduit and a high pressure flow region of the conduit is in communication with the valve inlet.

18. 13. The automatic injector of claim 12, wherein the container is movable from a first container position to a second container position, further comprising a spring mechanism configured to cause the flow passage to extend from the body when the container is in the second container position.

19. 13. The automatic injector of claim 12, wherein the valve is configured to permit flow of the pressurized fluid from the conduit to the valve outlet after at least a portion of the medicament has been expelled from the container, and wherein an additional mechanism of the automatic injector is configured to be actuated by the application of pressure from the pressurized fluid flowing to the valve outlet.

20. 20. The automatic injector of claim 19, wherein the additional feature is a flow path retraction feature.

21. 21. The automatic injector of claim 20, wherein the flow path retraction mechanism includes a rod movable by the pressurized fluid flowing through the valve outlet, the rod configured to retract the flow path after being moved a first distance.

22. a piston disposed at the valve outlet and movable from a first position to a second position; a secondary channel coupled to the fluid source and the valve outlet, when the piston is in the first position, the secondary channel is sealed against the valve outlet by the piston; 13. The automatic injector of claim 12, wherein when the piston is in the second position, the secondary channel is in communication with the valve outlet and the pressurized fluid flows from the fluid source through the secondary channel and the valve outlet.

23. 13. The automatic injector of claim 12, wherein the valve is configured to prevent flow of the pressurized fluid from the conduit to the valve outlet while the container is discharging medicament.

24. 1. An auto-injector comprising: A conduit and a fluid source configured to supply pressurized fluid to the conduit; a container in communication with the conduit, the container containing a plunger movable from a first position to a second position upon application of pressure from the pressurized fluid; a pressure restriction configured to restrict flow of the pressurized fluid within the conduit and defining high and low pressure flow regions in the conduit; A valve, a first valve inlet communicating a high pressure flow region of the conduit with a first valve cavity; a second valve inlet communicating a low pressure flow region of the conduit with a second valve cavity; a valve having a valve outlet; and The automatic injector, wherein the valve is configured to control the flow of the pressurized fluid from a low pressure flow region of the conduit to the valve outlet.

25. 25. The automatic injector of claim 24, wherein the first valve cavity and the second valve cavity are separated by a diaphragm or a piston.

26. 26. The automatic injector of claim 25, wherein the first valve cavity and the second valve cavity are separated by a diaphragm held in an extended position, the diaphragm being held in place by at least one of a catch or a groove.

27. 25. The automatic injector of claim 24, wherein the valve is configured to allow flow of the pressurized fluid from the low pressure flow region of the conduit to the valve outlet when the fluid pressure in the low pressure flow region of the conduit is within a threshold range of the fluid pressure in the high pressure flow region of the conduit.

28. 25. The automatic injector of claim 24, wherein the valve outlet is in communication with a flow path retraction mechanism configured to be actuated by pressurized fluid flowing through the valve outlet.

29. 25. The automatic injector of claim 24, wherein the valve outlet is in fluid communication with a vent opening.

30. 1. An auto-injector comprising: Career and Needle and a driver coupled to the needle, the driver being slidable relative to the carrier between a first position, a second position, and a third position; a shuttle configured to move the drive between the first position, the second position, and a third position; an indicator coupled to the shuttle, a portion of which is visible from outside the automatic injector, the indicator having a first indicia corresponding to a first position of the driver, a second indicia corresponding to a second position of the driver, and a third indicia corresponding to a third position of the driver.

31. 1. An auto-injector comprising: Career and a container having a medicament therein; a sleeve connected to the container, the sleeve having a longitudinally extending slot and a transversely or circumferentially extending slot from the longitudinally extending slot; a needle having a first end adapted to extend from the automatic injector and a second end adapted to extend into the container, the second end of the needle not in communication with the container when the automatic injector is in a first state; a connector housing coupled to the second end of the needle, the connector housing having a protrusion, the protrusion abutting a portion of the sleeve when the automatic injector is in the first position to prevent the sleeve and the connector housing from moving relative to each other; a driver coupled to the needle, the driver being slidable relative to the carrier between a first position, a second position, and a third position; When the automatic injector transitions from the first condition to the second condition, the actuator moves the first end of the needle out of the automatic injector to a second position and rotates the connector housing in a first rotational direction to allow the projection to extend into the longitudinally extending slot; In the second state, the second end of the needle extends into and communicates with the container; When the automatic injector transitions from the second state to a third state, the drive portion moves to the third position, and the connector housing is rotated in a second rotational direction opposite to the first rotational direction, thereby enabling the protrusion to extend into the laterally or circumferentially extending slot.

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