Automatic syringes and related methods of use

Abstract

This invention provides an automatic syringe and related methods of use. [Solution] The automatic syringe comprises a housing having a longitudinal axis and a transverse axis, wherein the dimension along the transverse axis is shorter than the dimension along the longitudinal axis, and the transverse axis is perpendicular to the longitudinal axis; a flow path having a first end and a second end; and a container for containing a first fluid, extending along or parallel to the longitudinal axis from the first end to the second end, movable along or parallel to the longitudinal axis from a first position to a second position, not communicating with the flow path in the first position, and communicating with the flow path in the second position.

Description

Technical Field

[0001] The present disclosure relates to an autoinjector and related methods of use.

Background Art

[0002] In various existing autoinjectors, when actuated by a user, a needle is deployed and fluid is delivered to the user from the needle. For the purpose of improving the user's sense of security, the safety of the needle, and the impression of the product, after the completion of fluid delivery, the needle is retracted.

Summary of the Invention

Problems to be Solved by the Invention

[0003] However, in many autoinjectors, the user needs to perform a separate operation for each of the insertion and extraction of the needle. Also, many of the existing autoinjectors are large in height. For example, an existing pen-type injector in which a drug container is arranged along the injection axis is large in height with respect to the patient's skin. Such an autoinjector may give the patient a sense of unease because, although the actual needle length is relatively short, it often gives the impression that the needle length is large due to its large height. Furthermore, many autoinjectors need to be fixed to the user for a long time, which is not convenient for the user.

Means for Solving the Problems

[0004] In one embodiment, the present disclosure relates to an automatic syringe, the automatic syringe comprising: a housing having a longitudinal axis and a transverse axis, wherein the dimension along the transverse axis is shorter than the dimension along the longitudinal axis, and the transverse axis is perpendicular to the longitudinal axis; a flow path having a first end and a second end; and a container for containing a first fluid, extending from the first end to the second end along or parallel to the longitudinal axis, and movable from a first position to a second position along or parallel to the longitudinal axis, not communicating with the flow path in the first position, and communicating 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 discharge 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 syringe further comprises a fluid source configured to release a pressurized second fluid, the release of the pressurized second fluid from the fluid source allowing the container to move from a first position to a second position, and the release of the pressurized second fluid from the fluid source biases a plunger from the first end of the container toward the second end so that the first fluid is discharged from the container into the flow path. The container has a seal at the second end of the container, and in the first position there is a gap between the seal and the first end of the flow path. When the container moves to the second position the first end of the flow path penetrates the seal and enters the container. As the pressure from the pressurized second fluid on the container decreases, the container becomes 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 syringe further comprises a first elastic member connected to the container, wherein as the container moves from a first position to a second position, the elastic member is compressed, and as the pressure from the pressurized second fluid decreases, the compressed elastic member expands, moving the container to a third position. The automatic syringe includes a carrier, a drive unit connected to a second end of a flow path, the drive unit being slidable relative to the carrier between a retracted position and an extended position, a shuttle configured to move the drive unit between a retracted position and an extended position, and a stopper configured to move from a first position to a second position, the stopper being configured to maintain the drive unit in the extended position, the stopper moving from the first position to the second position allowing the shuttle to move the drive unit from the extended position to the retracted position. Before operation, the drive unit is in contact with an obstacle, which prevents it from moving from the retracted position, and the obstacle is connected to the container. As the container moves from the first position to the second position, the obstacle is moved and no longer in contact with the drive unit, thereby allowing the drive unit to move from the retracted position to the extended position.

[0006] In another embodiment, the present disclosure relates to an auto-injector comprising: a body housing a conduit; a fluid source configured to supply pressurized fluid to the conduit; a container communicating with the conduit, containing a drug and a plunger, and configured to discharge the drug when pressure is applied to the plunger by the pressurized fluid; a pressure limiting section configured to restrict the flow of pressurized fluid in the conduit and defining high-pressure and low-pressure flow regions of the conduit; a valve having a valve inlet and a valve outlet, the valve inlet communicating with the conduit, and configured to control the flow of pressurized fluid from the conduit to the valve outlet; and a flow path extending from the body and configured to deliver the drug from the container to a patient. The direction in which the container discharges the drug is offset from the direction in which the flow path extends from the body.

[0007] The pressurized fluid is a gas. The drug contains a monoclonal antibody. The pressure limiting section contains a porous material or a serpentine channel. The direction in which the container discharges the drug is substantially perpendicular to the direction in which the flow path extends from the body. The container communicates with the low-pressure flow region of the conduit, and the high-pressure flow region of the conduit communicates 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 the flow of pressurized fluid from the conduit to the valve outlet after at least a portion of the drug has been discharged from the container, and is configured to activate an additional mechanism of the autosynergia 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 the pressurized fluid flowing through the valve outlet, and the rod is configured to retract the flow path after being moved a first distance. The automatic syringe further comprises a piston positioned at the valve outlet and movable from a first position to a second position, and a secondary channel connected to a fluid source and the valve outlet. When the piston is in the first position, the secondary channel is sealed to the valve outlet by the piston, and when the piston is in the second position, the secondary channel communicates 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 the flow of pressurized fluid from the conduit to the valve outlet while the container is discharging a drug.

[0008] In yet another aspect, the present disclosure relates to an automatic syringe, the automatic syringe comprising: a conduit; a fluid source configured to supply pressurized fluid to the conduit; a container communicating with the conduit and housing a plunger that is movable from a first position to a second position when pressure is applied from the pressurized fluid; a pressure limiting section configured to restrict the flow of pressurized fluid in the conduit and defining a high-pressure flow region and a low-pressure flow region of the conduit; and a valve having a first valve inlet connecting the high-pressure flow region of the conduit to a first valve cavity, a second valve inlet connecting the low-pressure flow region of the conduit to a second valve cavity, and a valve outlet. The valve is configured to control the flow of pressurized fluid from the low-pressure flow region of the conduit to the valve outlet.

[0009] A first valve cavity and a second valve cavity are separated by a diaphragm or a piston. 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 retaining part or a groove. The valve is configured to allow pressurized fluid to flow 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 the threshold range of the fluid pressure in the high-pressure flow region of the conduit. The valve outlet communicates with a flow retraction mechanism configured to be actuated by the pressurized fluid flowing through the valve outlet. The valve outlet communicates with a vent opening.

[0010] The automatic syringe further includes a fluid source configured to discharge pressurized fluid. Discharge 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 syringe further includes a supply chamber connected to the fluid source and a sliding seal connected to the outer surface of the container and the inner surface of the supply chamber. Discharge of pressurized fluid from the fluid source into the supply chamber biases the entire container and the sliding seal to move along or parallel to the longitudinal axis relative to the supply chamber. The container discharges therapeutic fluid into the flow path along or parallel to the longitudinal axis. Discharge of pressurized fluid is activated only after the lid has been folded or retracted. Discharge of pressurized fluid cannot be stopped after discharge has started, or the discharge of pressurized fluid can be stopped after discharge has started. However, in some examples, the discharge of pressurized fluid from the fluid source is stopped by the expansion of the lid or the retraction of the flow path through the opening in the lid.

[0011] The container has a seal at its 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 has been folded or retracted. The entire container and flow path move along the transverse axis while the lid is being folded or retracted. The flow path of the auto-syringe is non-linear. The auto-syringe further has an actuator connected to a fluid source. Activation of the actuator by the user initiates the discharge of pressurized fluid. The actuator includes a button, switch, trigger mechanism, or a combination thereof. When the actuator is stopped, the discharge of pressurized fluid from the fluid source stops. The auto-syringe is a handheld auto-syringe configured to complete the injection procedure within 30 seconds. The auto-syringe further has a power source configured to move a plunger from the first end of the container to 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, an elastic member, a motor, or a pressurized fluid source.

[0012] In another embodiment, the disclosure relates to an automatic syringe, the automatic syringe comprising: a housing having a longitudinal axis and a transverse axis, wherein the dimension along the transverse axis is shorter than the dimension along the longitudinal axis, the transverse axis is perpendicular to the longitudinal axis, and the housing has a lid configured to fold or retract 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 along or parallel to the longitudinal axis from the first end to the second end. The power source causes the plunger to move from the first end to the second end of the container, thereby discharging 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 in a direction along or parallel to the transverse axis when the lid is folded or retracted. The automatic syringe is a handheld automatic syringe configured to complete an injection procedure within 30 seconds. The power source is configured to operate after the lid has been folded or retracted.

[0013] In another embodiment, the disclosure relates to an injection device comprising a collapsible housing movable between an extended configuration and a folded or retracted configuration; a fluid source configured to release a pressurized fluid; and a flow path having a first end and a second end. The flow path is fully housed 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 folded or retracted configuration. The first and second ends of the flow path extend along axes that are offset from each other. The injection device further comprises a container containing a therapeutic fluid, the container extending from a first end to a second end along or parallel to the longitudinal axis of the container. The container is movable from a first position to a second position by the flow of pressurized fluid from the fluid source. The container does not communicate with the flow path when the collapsible housing is in the extended configuration. The container communicates with the flow path after the collapsible housing is in the compressed configuration and the container has been moved to the second position. The container also has a plunger. After the container is moved to a second position, the plunger is biased from the first end to the second end of the container by further discharge of pressurized fluid from the fluid source, causing the therapeutic fluid to enter the first end of the flow path from the container and to be discharged from the second end of the flow path. The auto-injector is a handheld auto-injector configured to complete the injection procedure within 30 seconds.

[0014] The pressurized fluid is automatically released from the fluid source by moving the folding housing to the folded or retracted position. The folding housing is configured to compress when a force is applied to its outer surface and to expand when the force is released. Alternatively, the folding housing is configured to compress when a force is applied to its outer surface and to remain in the folded or retracted position when the force is released. [Brief explanation of the drawing]

[0015] [Figure 1] A perspective view of an automatic syringe according to an embodiment of the present disclosure. [Figure 1A] Perspective view of an auto-injector according to an embodiment of the present disclosure. [Figure 2] Diagram showing an auto-injector. [Figure 3A] Schematic diagram showing a characteristic part of an auto-injector. [Figure 3B] Schematic diagram showing a characteristic part of an auto-injector. [Figure 3C] Schematic diagram showing a characteristic part of an auto-injector. [Figure 3D] Diagram showing a sliding seal disposed within an auto-injector. [Figure 3E] Diagram showing details of an auto-injector having a plurality of containers. [Figure 3F] Diagram showing details of an auto-injector having a plurality of containers. [Figure 3G] Diagram showing details of an auto-injector having a plurality of containers. [Figure 4A] Schematic cross-sectional view of an exemplary valve used in an auto-injector. [Figure 4B] Schematic cross-sectional view of an exemplary valve used in an auto-injector. [Figure 5] Schematic cross-sectional view showing another exemplary valve used in an auto-injector. [Figure 6] Diagram showing an exemplary flow restriction part used in an auto-injector. [Figure 7A] Diagram showing an exemplary flow restriction part used in an auto-injector. [Figure 7B] Diagram showing an exemplary flow restriction part used in an auto-injector. [Figure 7C] Diagram showing an additional exemplary valve used in an auto-injector. [Figure 7D] Diagram showing an additional exemplary valve used in an auto-injector. [Figure 7E] Diagram showing an additional exemplary valve used in an auto-injector. [Figure 7F] Diagram showing an additional exemplary valve used in an auto-injector. [Figure 7G] Diagram showing an additional exemplary valve used in an auto-injector. <00​A diagram showing an additional exemplary valve used in an automatic syringe. [Figure 7I] A diagram showing the details of the diaphragm. [Figure 7J] A diagram showing the details of the diaphragm. [Figure 7K] A diagram showing the details of the diaphragm. [Figure 7L] A diagram showing the details of the diaphragm. [Figure 7M] A diagram showing the details of the diaphragm. [Figure 7N] A diagram showing the details of the diaphragm. [Figure 7O] A partial exploded view showing another exemplary valve. [Figure 8A] A diagram illustrating an exemplary emission system. [Figure 8B] A diagram illustrating an exemplary emission system. [Figure 8C] A diagram illustrating an exemplary emission system. [Figure 8D] A diagram illustrating an exemplary emission system. [Figure 9A] A diagram illustrating another exemplary emission system. [Figure 9B] A diagram illustrating another exemplary emission system. [Figure 9C] A diagram illustrating another exemplary emission system. [Figure 9D] A diagram illustrating another exemplary emission system. [Figure 9E] A diagram illustrating another exemplary emission system. [Figure 9F] A diagram illustrating another exemplary emission system. [Figure 9G] A diagram illustrating another exemplary emission system. [Figure 9H] A diagram illustrating another exemplary emission system. [Figure 9I] A diagram showing yet another exemplary emission system. [Figure 9J] A diagram showing yet another exemplary emission system. [Figure 9K] A diagram showing yet another exemplary emission system. [Figure 10A] A diagram showing yet another exemplary emission system. [Figure 10B] A diagram showing yet another exemplary emission system. [Figure 10C] A diagram showing yet another exemplary emission system. [Figure 10D] A diagram showing yet another exemplary emission system. [Figure 10E] A diagram showing yet another exemplary emission system. [Figure 10F] A diagram showing yet another exemplary emission system. [Figure 11] A diagram showing the emission mechanism related to this disclosure. [Figure 11A] A diagram showing the emission mechanism related to this disclosure. [Figure 11B] A diagram showing the emission mechanism related to this disclosure. [Figure 11C] A diagram showing the emission mechanism related to this disclosure. [Figure 11D] A diagram showing the emission mechanism related to this disclosure. [Figure 11E] A diagram showing the emission mechanism related to this disclosure. [Figure 11F] A diagram showing the emission mechanism related to this disclosure. [Figure 11G] A diagram showing the emission mechanism related to this disclosure. [Figure 11H] A diagram showing the emission mechanism related to this disclosure. [Figure 12A] A diagram showing the emission mechanism related to this disclosure. [Figure 12B] A diagram showing the emission mechanism related to this disclosure. [Figure 12C] A diagram showing the emission mechanism related to this disclosure. [Figure 13A] A diagram showing the emission mechanism related to this disclosure. [Figure 13B] A diagram showing the emission mechanism related to this disclosure. [Figure 13C] A diagram showing the emission mechanism related to this disclosure. [Figure 13D] A diagram showing the emission mechanism related to this disclosure. [Figure 14A] A diagram showing the emission mechanism related to this disclosure. [Figure 14B] A diagram showing the emission mechanism related to this disclosure. [Figure 15A]A diagram showing the emission mechanism related to this disclosure. [Figure 15B] A diagram showing the emission mechanism related to this disclosure. [Figure 16A] A diagram showing the emission mechanism related to this disclosure. [Figure 16B] A diagram showing the emission mechanism related to this disclosure. [Figure 16C] A diagram showing the emission mechanism related to this disclosure. [Figure 16D] A diagram showing the emission mechanism related to this disclosure. [Figure 16E] A diagram showing the emission mechanism related to this disclosure. [Figure 17] A schematic diagram showing the characteristic features of an automatic syringe. [Figure 18A] An exploded view showing the needle mechanism. [Figure 18B] A schematic diagram showing the various parts of the needle mechanism. [Figure 18C] A schematic diagram showing the various parts of the needle mechanism. [Figure 18D] A schematic diagram showing the various parts of the needle mechanism. [Figure 19] A side view showing the needle mechanism. [Figure 20] A side view showing the needle mechanism. [Figure 21] A side view showing the needle mechanism. [Figure 22] A side view showing the needle mechanism. [Figure 23] A diagram showing part of the needle mechanism. [Figure 23A] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23B] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23C] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23D] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23E] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23F] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23G]A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23H] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23I] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23J] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23K] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23L] A diagram showing the mechanism for initiating needle insertion and / or retraction. [Figure 23M] A schematic diagram of an automatic syringe according to another exemplary embodiment. [Figure 23N] A schematic diagram showing another alternative auto-injector according to a different embodiment. [Figure 23O] A diagram showing another mechanism for initiating needle insertion and / or retraction. [Figure 23P] A diagram showing another mechanism for initiating needle insertion and / or retraction. [Figure 23Q] A diagram showing another mechanism for initiating needle insertion and / or retraction. [Figure 23R] A schematic diagram showing additional features of an automatic syringe according to an embodiment of the present disclosure. [Figure 23S] A schematic diagram showing additional features of an automatic syringe according to an embodiment of the present disclosure. [Figure 23T] A schematic diagram showing additional features of an automatic syringe according to an embodiment of the present disclosure. [Figure 23U] A schematic diagram showing additional features of an automatic syringe according to an embodiment of the present disclosure. [Figure 24] A schematic diagram of an automatic syringe according to another exemplary embodiment. [Figure 25A] A diagram showing the drive system used in an automatic syringe. [Figure 25B] A diagram showing the drive system used in an automatic syringe. [Figure 26A] A diagram showing an alternative mechanism for sealing a container. [Figure 26B] A diagram showing an alternative mechanism for sealing a container. [Figure 27A] A diagram illustrating the mechanism for establishing communication between a container and a fluid conduit. [Figure 27B] A diagram illustrating the mechanism for establishing communication between a container and a fluid conduit. [Figure 28A] A diagram illustrating the mechanism for establishing communication between a container and a fluid conduit. [Figure 28B] A diagram illustrating the mechanism for establishing communication between a container and a fluid conduit. [Figure 29A] A diagram showing a mechanism for sealing the first end of a container. [Figure 29B] A diagram showing a mechanism for sealing the first end of a container. [Figure 30A] A diagram showing the mechanism for operating a fluid source. [Figure 30B] A diagram showing the mechanism for operating a fluid source. [Figure 31A] A diagram showing the mechanism for operating a fluid source. [Figure 31B] A diagram showing the mechanism for operating a fluid source. [Figure 32A] A diagram showing the mechanism for operating a fluid source. [Figure 32B] A diagram showing the mechanism for operating a fluid source. [Figure 32C] A diagram showing an additional mechanism for operating the fluid source. [Figure 32D] A diagram showing an additional mechanism for operating the fluid source. [Figure 32E] A diagram showing an additional mechanism for operating the fluid source. [Figure 32F] A diagram showing an additional mechanism for operating the fluid source. [Figure 32G] A diagram showing an additional mechanism for operating the fluid source. [Figure 32H] A diagram showing an additional mechanism for operating the fluid source. [Figure 32I] A diagram showing an additional mechanism for operating the fluid source. [Figure 32J] A diagram showing an additional mechanism for operating the fluid source. [Figure 32K] A diagram showing an additional mechanism for operating the fluid source. [Figure 32L] A diagram showing an additional mechanism for operating the fluid source. [Figure 32M] A diagram showing an additional mechanism for operating the fluid source. [Figure 32N] A diagram showing an additional mechanism for operating the fluid source. [Figure 32O] A diagram showing an additional mechanism for operating the fluid source. [Figure 32P] A diagram showing an additional mechanism for operating the fluid source. [Figure 32Q] A diagram showing an additional mechanism for operating the fluid source. [Figure 32R] A diagram showing an additional mechanism for operating the fluid source. [Figure 32S] A diagram showing an additional mechanism for operating the fluid source. [Figure 32T] A diagram showing an additional mechanism for operating the fluid source. [Figure 32U] A diagram showing an additional mechanism for operating the fluid source. [Figure 32V] A diagram showing an additional mechanism for operating the fluid source. [Figure 33A] A diagram showing an automatic syringe with a retractable lid. [Figure 33B] A diagram showing an automatic syringe with a retractable lid. [Figure 34A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 34B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 35A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 35B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 36A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 36B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 37A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 37B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 38A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 38B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 39A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 39B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 40A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 40B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 41A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 41B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 41C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 41D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 41E] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 42A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 42B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 42C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 43A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 43B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 43C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 43D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 44A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 44B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 44C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 44D]A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 45A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 45B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 46A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 46B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 46C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 46D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 46E] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 47A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 47B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 47C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 47D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48B] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48E] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48F] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48G] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48H] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 48I] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49A] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49B]A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49C] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49D] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49E] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 49F] A diagram illustrating an exemplary horizontal automatic syringe of this disclosure. [Figure 50A] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50B] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50C] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50D] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50E] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50F] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50G] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50H] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50I] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 50J] A figure showing an example of surface modification of an automatic syringe according to this disclosure. [Figure 51A] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 51B] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 51C] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 51D] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 52A] A diagram showing a peel-off seal and a contact switch in this disclosure. [Figure 52B] A diagram showing a peel-off seal and a contact switch in this disclosure. [Figure 52C]A diagram showing a peel-off seal and a contact switch in this disclosure. [Figure 53A] A diagram showing the indicator for the automatic syringe of this disclosure. [Figure 53B] A diagram showing the indicator for the automatic syringe of this disclosure. [Figure 54A] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54B] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54C] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54D] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54E] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54F] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54G] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54H] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54I] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54J] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54K] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54L] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54M] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 54N] A diagram illustrating the use of indicator flags in the automatic syringe of this disclosure. [Figure 55A] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55B] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55C]A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55D] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55E] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55F] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 55G] A figure illustrating the use of a window coloring or covering in an automatic syringe of this disclosure. [Figure 56A] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 56B] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 56C] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 56D] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 56E] A diagram showing the positions of each label on the auto-injector of this disclosure. [Figure 57A] A diagram showing a feature section for visually displaying the needle insertion depth according to various embodiments. [Figure 57B] A diagram showing a feature section for visually displaying the needle insertion depth according to various embodiments. [Figure 57C] A diagram showing a feature section for visually displaying the needle insertion depth according to various embodiments. [Figure 57D] A diagram showing a feature section for visually displaying the needle insertion depth according to various embodiments. [Figure 57E] A diagram showing a feature section for visually displaying the needle insertion depth according to various embodiments. [Figure 58A] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58B] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58C]A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58D] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58E] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58F] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58G] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 58H] A diagram showing feature parts for visually indicating the stages and / or progress of injection, according to various embodiments of another automatic syringe. [Figure 59A] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59B] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59C] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59D] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59E] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59F] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59G] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59H]A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59I] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59J] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59K] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59L] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59M] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59N] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59O] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59P] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59Q] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 59R] A diagram showing features for restricting the flow of gas or fluid, according to various embodiments of another automatic syringe. [Figure 60A] A perspective view showing an automatic syringe in an initial non-operating state according to one embodiment of the present disclosure. [Figure 60B] A perspective view showing a fluid-operated automatic syringe in an initial non-operating state according to one embodiment of the present disclosure. [Figure 61] A perspective view of the automatic syringe shown in Figure 60B in an intermediate state. [Figure 62] Figure 60B is a perspective view of the auto-injector showing the connection between the drug cartridge and the flow path. [Figure 63] A perspective view showing the automatic syringe in Figure 60B during injection. [Figure 64] Figure 60B is a perspective view showing the automatic syringe after the injection is complete. [Figure 65A] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65B] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65C] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65D] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65E] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65F] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65G] A figure showing a sterile connector according to another embodiment of the present disclosure. [Figure 65H] A figure showing a sterile connector according to another embodiment of the present disclosure. [Modes for carrying out the invention]

[0016] The accompanying drawings are incorporated into this specification, constitute part of this specification, and illustrate the spirit of the embodiments and designs disclosed together with the description herein. Aspects of this disclosure are implementable in relation to embodiments shown in the accompanying drawings. These drawings illustrate various aspects of this disclosure, and similar structures, components, materials, and / or elements in different drawings are appropriately denoted by similar reference numerals. Various combinations of structures, components, and / or elements other than those specifically shown are possible and are understood to be within the scope of this disclosure.

[0017] Furthermore, many embodiments are described and illustrated herein. This disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or substitution of aspects and / or embodiments thereof. Furthermore, each aspect and / or embodiment of this disclosure may be implemented independently or in combination with one or more other aspects of this disclosure and / or embodiments thereof. For brevity, certain substitutions and combinations are not individually described and / or illustrated herein. In particular, embodiments or examples described herein as “exemplary” should not be construed as being preferable or advantageous to other embodiments or examples. Such embodiments are intended to be “examples” of embodiments.

[0018] Many embodiments are described and illustrated herein. This disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or substitution of aspects and / or embodiments thereof. Each aspect and / or embodiment of this disclosure may be implemented independently or in combination with one or more other aspects of this disclosure and / or embodiments thereof. For brevity, many combinations and substitutions are not described individually herein.

[0019] For simplicity and clarity, specific aspects of the drawings illustrate the general structure and / or construction methods of various embodiments. With regard to well-known features and methods, descriptions may be omitted to avoid obscuring other features. Elements in the drawings are not necessarily shown in accurate dimensional proportions, and the dimensions of some features are exaggerated compared to others to aid in understanding the exemplary embodiments. For example, section views do not necessarily have equal dimensional proportions and do not represent proportional relationships between different components. Section views are presented to facilitate the description of the various components of the illustrated assembly and to show their relative positions.

[0020] Details of each embodiment of this disclosure shown in the attached drawings are described below. The same reference numerals are used throughout the drawings for identical or similar parts. In the following description, relative terms such as “approximately,” “substantially,” and “approximately” indicate that the stated values ​​may vary by ±10%.

[0021] As mentioned above, existing auto-injectors often require the user to perform multiple operations to administer a drug, such as separate user operations for deploying the needle and retracting the needle after drug delivery. Such additional operations can complicate self-administration of drugs and may lead to user error or discomfort. Therefore, this disclosure relates to various embodiments of injection devices (e.g., auto-injectors) that simplify user self-administration of drugs or other therapeutic agents. Specifically, in certain embodiments, the auto-injector does not require any additional user operation to withdraw the needle after it has been subcutaneously inserted into the user. Thus, the auto-injectors of this disclosure are simplified and can reduce misuse or user error.

[0022] As mentioned above, existing automatic injectors require multiple components, such as various springs and motor mechanisms, as well as user operation, to administer drugs. These additional components complicate manufacturing and can lead to mechanical failures and user errors. Therefore, this disclosure relates to various embodiments of injection devices (e.g., automatic injectors) that simplify and improve the administration of drugs or other therapeutic agents.

[0023] Figures 1 and 2 show examples of such an auto-injector 2. The auto-injector 2 comprises a housing 3 having a tissue engagement surface (such as a bottom surface) 4. The needle is deployed and retracted through an opening 6 in the tissue engagement surface 4 (Figure 2). The housing 3 has a transparent window 50 so that an observer can see the container placed inside the housing 3. The housing 3 also has an actuator or button 52 configured to activate a drive mechanism (e.g., a fluid source 1366; details will be described later) for delivering the drug (therapeutic fluid) contained in the auto-injector 2 to the patient. In some embodiments, the auto-injector 2 does not have electrical components. In other embodiments, one or more displays or LEDs (not shown) are placed inside the housing 3, and / or the housing 3 has a plurality of openings 51 configured to facilitate the transmission of sound generated within the housing 3 (by a speaker, etc.) (see alternative embodiment in Figure 1A). The auto-injector 2 has any dimensions suitable for carrying and self-wearing by the user. For example, the length of the automatic syringe 2 is approximately 1.27 cm (0.5 inches) to 12.7 cm (5.0 inches), the width is approximately 1.27 cm (0.5 inches) to 7.62 cm (3.0 inches), and the height is approximately 1.27 cm (0.5 inches) to 5.08 cm (2.0 inches). The automatic syringe 2 has a non-slip or adhesive coating on its outer surface so that it becomes a non-slip surface.

[0024] The automatic syringe 2 is oriented around a longitudinal axis 40 (e.g., the X-axis), a transverse axis 42 (e.g., the Y-axis) substantially perpendicular to the longitudinal axis 40, and a transverse axis 44 (e.g., the Z-axis) substantially perpendicular to both the longitudinal axis 40 and the transverse axis 42. In some embodiments, the transverse automatic syringe of the present disclosure has a dimension along the longitudinal axis 40 that is longer than the dimension along the transverse axis 44.

[0025] In a particular embodiment of the automatic syringe 2, for example, if the automatic syringe 2 is a wearable automatic syringe, the automatic syringe 2 has an adhesive patch 12 as shown in Figure 1A. The adhesive patch 12 is connected to the tissue engagement surface 4 to help secure the automatic syringe 2 to the user's body (skin, etc.). The adhesive patch 12 can be formed from cloth or any other suitable material and has an adhesive. The adhesive is a water-based or solvent-based adhesive, or a hot-melt adhesive, etc. Suitable adhesives include acrylic-based, dextrin-based and urethane-based adhesives, as well as natural and synthetic elastomers. In some examples, the adhesive of the patch 12 begins to function when it comes into contact with the user's skin. In yet another example, the patch 12 has a nonwoven polyester substrate and an acrylic or silicone adhesive. The patch 12 may be joined to the housing 3, for example, by double-sided adhesive, or by other methods such as ultrasonic welding. The length of patch 12 (for example, the dimension parallel to the longitudinal axis 40) is greater than the width of the automatic syringe 2 (for example, the dimension parallel to the transverse axis 42).

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

[0027] Furthermore, the handheld auto-injectors described herein are configured to complete the injection procedure, from 1) the moment the user places the auto-injector on the skin, to 2) the moment the user removes the auto-injector from the skin after the injection is complete, in less than approximately 30 seconds, less than approximately 25 seconds, less than approximately 20 seconds, less than approximately 15 seconds, or less than approximately 10 seconds. Wearable auto-injectors take longer than 30 seconds to complete the same steps 1) and 2) described above, i.e., from 1) the moment the auto-injector is placed on the user's skin, to 2) the moment the auto-injector is removed from the skin.

[0028] As shown in Figures 2 and 3A-3C, the automatic syringe 2 comprises a primary container, chamber, syringe, cartridge, or container 1302 having a first end 1304 and a second end 1306. Alternatively, the container 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 assist in closing and / or sealing the second end 1306, allowing a needle 308 (e.g., a supported needle shown in Figures 3A-3C) to be inserted into the container 1302. The cavity 1308 is closed at the first end 1304 by a piston 1316.

[0029] The "nominal capacity" (also called "specified volume" or "specified capacity") of a container refers to the maximum capacity of the container as designated by the container manufacturer or safety standards body. The manufacturer or safety standards body designates the nominal capacity of a container to indicate that, when the container is filled with the specified volume of fluid (with or without aseptic treatment), it can be sealed, sterilized, packaged, transported, and / or used while maintaining the safety, sterility, and / or sterility of the fluid contained within, while keeping the container sealed. When determining the nominal capacity of a container, the manufacturer or safety standards body also takes into account changes that occur during normal filling, sealing, sealing, packaging, transport, and handling procedures. For example, a pre-filled syringe is filled manually or mechanically to its nominal capacity and then sealed using a discharge tube or vacuum without contaminating the syringe contents through contact with filling and sealing devices and instruments. Alternatively, the sealing devices and instruments are sterile or aseptic and come into contact with the syringe contents and / or the syringe itself without causing contamination.

[0030] In some examples, container 1302 has a nominal capacity of approximately 5.0 mL, but may have other suitable nominal capacities depending on the drug to be delivered (e.g., approximately 0.5 mL to approximately 50.0 mL, approximately 2.0 mL to approximately 10.0 mL, approximately 3.0 mL to approximately 6.0 mL, approximately 1.0 mL to approximately 3.0 mL, approximately 2.0 mL to approximately 5.0 mL, or other suitable ranges). In other examples, the nominal capacity of container 1302 is approximately 0.5 mL or more, approximately 2.0 mL or more, approximately 3.0 mL or more, approximately 4.0 mL or more, or approximately 5.0 mL or more. Container 1302 functions to contain and store the drug to be injected into the user and to maintain the sterility of the drug. In one embodiment, container 1302 is configured to deliver a delivery amount of medication (for example, about 0.5 mL to about 4.0 mL, about 1.0 mL to about 3.5 mL, about 3.0 mL, about 3.1 mL, about 3.2 mL, about 3.3 mL, about 3.4 mL, about 3.5 mL, more than about 1.0 mL, more than about 2.0 mL, more than about 3.0 mL, more than about 4.0 mL, more than about 5.0 mL, more than about 10.0 mL, more than about 20.0 mL, or other delivery amounts). The delivery amount is less than the nominal capacity of container 1302. Furthermore, in order to deliver the delivery amount of medication to the user, container 1302 itself is filled with a different amount of medication (i.e., a fill amount). The filling volume is set to be greater than the delivery volume, for example, to compensate for any drug that cannot be delivered from container 1302 to the user due to dead space within container 1302 or fluid conduit 300. Therefore, although the nominal capacity of container 1302 is 5 mL, the filling volume and delivery volume of the drug will be less than 5 mL.

[0031] In one embodiment, when container 1302 is used in a handheld auto-injector, the amount of drug delivered from container 1302 is approximately 0.5 mL to approximately 4.0 mL, approximately 1.0 mL to approximately 3.5 mL, approximately 3.0 mL, approximately 3.1 mL, approximately 3.2 mL, approximately 3.3 mL, approximately 3.4 mL, and approximately 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, in at least some embodiments, with certain viscosities, if the amount of drug is large, it becomes impossible to complete the injection procedure of the auto-injector 2 within an acceptable time (e.g., less than approximately 30 seconds). Therefore, the amount of drug delivered from the auto-injector 2 is set so that the injection procedure, from 1) when the auto-injector is placed on the user's skin to 2) when the auto-injector is removed from the skin, can be completed in less than approximately 30 seconds or other less time (less than approximately 25 seconds, less than approximately 20 seconds, less than approximately 15 seconds, or less than approximately 10 seconds, etc.). If the drug delivery volume and viscosity are too high, the time required to complete the injection procedure will be longer than commercially or clinically acceptable for a handheld device, and therefore the auto-injector 2 may not function as a handheld auto-injector. As mentioned above, in embodiments in which container 1302 is used in a handheld auto-injector, the drug delivery volume from container 1302 is set so that the above injection procedure is completed in a relatively short time, regardless of the nominal capacity of container 1302 (to avoid the need to add features to secure the auto-injector 2 to the user in order to make it function as a wearable auto-injector).

[0032] However, various embodiments of this disclosure relate to wearable auto-injectors, which, unlike handheld auto-injectors, deliver relatively large amounts of medication (e.g., more than about 3.5 mL) and / or complete the injection procedure from 1) when the auto-injector is placed on the user's skin to 2) when the auto-injector is removed from the skin, by a relatively long injection procedure time (e.g., longer than about 30 seconds, longer than about 1 minute, longer than about 2 minutes, longer than about 5 minutes, or longer than about 1 hour).

[0033] Container 1302 has a neck section with a diameter of approximately 13 mm, a length of approximately 45 mm, and an inner diameter of approximately 19.05 mm. In another embodiment, container 1302 is a standard 3 mL container with an 8 mm crimped top, an inner diameter of 9.7 mm, and a length of 64 mm. These values ​​are merely illustrative, and other suitable dimensions may be used. In some examples, 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, container 1302 is a shortened ISO standard 10 mL cartridge.

[0034] The auto-injectors of this disclosure may be configured to deliver high-viscosity liquids to a patient. For example, the auto-injectors of this disclosure are configured to deliver liquids having viscosities 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 consists of uncoated bromobutyl material or another suitable material. Piston 1316 consists of bromobutyl material coated with a fluoropolymer and, in some embodiments, has a conical nose portion to reduce dead space in container 1302. Piston 1316 consists of one or more rubber materials and other materials, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile.

[0036] The piston 1316 is moved by pressurized fluid discharged from a fluid source, such as a fluid source 1366 (Figures 3A-3C). The 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, it acts on the contents of the container 1302 (e.g., drugs, therapeutic agents), and ultimately transmits 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 automatic syringe, the fluid source 1366 and the piston 1316 are offset from each other and not aligned longitudinally.

[0037] The fluid source 1366 has either a latchless or latched can. The fluid source 1366 is configured to supply a liquid propellant that vaporizes outside the fluid source 1366 in order to supply pressurized gas (vapor pressure) acting on the piston 1316. In some embodiments, the latched can is opened so that the entire amount of propellant is supplied once opened. 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 the flow has started.

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

[0039] When the movement of the container 1302 along the longitudinal axis 40 begins, the fluid source 1366 is activated and transitions to an open configuration, and the propellant exits the fluid source 1366 as pressurized gas. In some embodiments, the activation is irreversible and the flow of pressurized gas exiting the fluid source 1366 cannot be stopped.

[0040] In the pre-operation state of the automatic syringe 2 shown in Figure 3A, the needle 308 is separated from the second end 1306 of the container 1302. To move the automatic syringe 2 from the pre-operation state in Figure 3A, the fluid source 1366 is activated as described above, moving the container 1302 toward the needle 308 along the longitudinal axis 40. Since the needle 308 is not yet in communication with the container 1302, the activation of the fluid source 1366 applies pressure to the fluid inside the container 1302, and then to the container 1302 itself. This pressure causes the container 1302 to move toward the needle 308, and finally, the needle 308 penetrates the septum 1314, thereby communicating with the contents of the container 1302. This movement corresponds to the movement of the obstruction 382 relative to the projection 380 (Figures 18B-18D), and this movement causes the obstruction 182 to no longer obstruct the projection 380, thus enabling injection with the needle 306. In other words, the pressurized gas from the fluid source 1366 also drives the movement of the obstruction 382 relative to the projection 380, allowing injection of the needle 306 into the user to begin (details will be described later). When the needle 308 communicates with the container 1302, the piston 1316 moves further toward the second end 1306, thereby biasing the fluid within the needle 308 and the rest of the fluid conduit 300 (Figure 18A).

[0041] Figures 3A-3C show a drive system 3000 that provides the driving force for delivering fluid from container 1302 to the patient. The drive system 3000 comprises a fluid source 1366, a high-pressure (first) line 3002, a low-pressure (second) line 3004, a third line 3006, a flow limiter 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 within a valve seat 3020 that extends into the interior of 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, the pressurized gas flows through the high-pressure line 3002 and the flow limiter 3008 before entering the container 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 toward the conduit 3018 within the valve seat 3020 and seal the conduit 3018 (Figure 3B). Downstream of the pressure limiter 3008, the depressurized gas is sent 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 necessary for the diaphragm 3012 to seal the conduit 3018. Additionally, the low-pressure line 3004 delivers pressurized gas, which moves the container 1302 toward the needle 308, and then pushes the piston 1316 along or parallel to the axis 40, discharging the drug from the container 1302 until the piston 1316 reaches the end of the container 1302 (until it hits the bottom).

[0043] When the piston 1316 hits the bottom at the end of the injection (Figure 3C), the pressure between the high-pressure cavity 3022 and the low-pressure cavity 3024 equalizes, and the diaphragm 3012 is lifted from the valve seat 3020, opening the conduit 3018. This allows the gas from the low-pressure line 3004 to be discharged from the system through the conduit 3018 and the third line 3006.

[0044] Referring to Figure 3D, the mechanism by which the low-pressure line 3004 drives the vessel 1302 and the piston 1316 is described. The fluid source 1366 is configured to contain a sufficient amount of pressurized fluid to move both the vessel 1302 and the piston 1316 by releasing pressurized gas, as will be described in detail later. In some examples, the fluid source 1366 has excess pressurized gas, i.e., more fluid than is required to complete the delivery of the contents of the vessel 1302.

[0045] The automatic syringe 2 further has a cylindrical rail 1370 extending along the longitudinal axis of the automatic syringe 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 positioned inside the lumen formed by the rail 1370. The rail 1370 is spaced apart from the container 1302 so that the container 1302 can slide along the length of the rail 1370.

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

[0047] The sliding seal 1390 is positioned between the container 1302 and the rail 1370 and assists the movement of the container 1302 by preventing pressurized gas from leaking beyond the sliding seal 1390. For example, the sliding seal 1390 is positioned on the inner surface of the rail 1370 and on the outer surface of the container 1302 to assist the movement of the container 1302 along the rail 1370. The container 1302, the sliding seal 1390, and the rail 1370 are arranged concentrically.

[0048] In some embodiments, the sliding seal 1390 is fixed to a predetermined position on the outer surface of the container 1302 and configured to slide along the inner surface of the rail 1370 together 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 is moving relative to the rail 1370. The sliding seal 1390 and the container 1302 move as a single unit from the base portion 1371 of the rail 1370 toward the edge portion 1373 of the rail 1370. In other words, the sliding seal 1390 and the container 1302 move together simultaneously along the rail 1370. 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 fixed relative to the housing 3, and the fluid conduit 300 communicates with the container 1302 by moving through the seal 1314.

[0049] In some examples, one or more stoppers (not shown) are provided on the inner surface of the rail 1370. The stoppers abut against the sliding seal 1390 to stop the movement of the sliding seal 1390 along its longitudinal axis. Alternatively or additionally, one or more stoppers are placed 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, if the movement of the sliding seal 1390 along its longitudinal axis is prevented, the movement of the container 1302 along its longitudinal axis is also stopped. In another example, such stoppers are not required, and when the seal 1314 is punctured by the needle 308, the subsequent movement of the piston 1316 causes the drug to enter the needle 308, thus stopping the longitudinal movement of the container 1302.

[0050] Before use of the automatic syringe 2, the supply chamber 1375 has a first volume. After the operation of the fluid source 1366, the supply chamber 1375 is filled with pressurized fluid released from the fluid source 1366. As the compressed pressurized fluid pushes the piston 1316, the container 1302 and the sliding seal 1390, moving the entire assembly along its longitudinal axis, the supply chamber 1375 expands. As previously described, the sliding seal 1390 and the container 1302 move along or parallel to the longitudinal axis of the automatic syringe 2, in the direction of the edge 1373, until the container 1302 (e.g., seal 1314) makes contact with the needle 308. Contact between the seal 1314 and the needle 308 causes the needle 308 to puncture the seal 1314, and the fluid conduit 300 communicates with the container 1302. The pressurized gas applies pressure to the piston 1316, pushing it within the body of the container 1302. As the piston 1316 moves within the container 1302, its movement pushes the drug through the fluid conduit 300 and delivers it to the patient via the needle 306.

[0051] In one embodiment, in the pre-operation state, the needle 308 is positioned within the seal 1314. In other words, before pressurized gas is released from the fluid source 1366, the end of the needle 308 is positioned 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, which is formed of a first rubber material. The first rubber material is permeable to sterilization gases, such as 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 sterilization gases, the needle 308 positioned within the plug can be sterilized before use. The plug is molded around the needle 308, so that the needle 308 is positioned within the plug. The seal 1314 also has a base portion that is impermeable to sterilization gases in order to prevent contamination and / or deterioration of the drugs contained in the container 1302. The base portion contains an impermeable rubber such as halobutyl (bromobutyl, chlorobutyl, fluorobutyl, etc.) and / or nitrile.

[0052] In some embodiments, the container 1302, rail 1370, and sliding seal 1390 are configured to allow the container 1302 to be replaced. For example, the rail 1370 and sliding seal 1390 have one or more openings into which the container 1302 is inserted.

[0053] The system shown in Figures 3E-3G is similar to the system described above, except that it has multiple containers 1302 (e.g., containers 1302a and 1302b) for containing the drug to be delivered to the patient. Each container 1302 in this embodiment is substantially the same as any of the containers described herein. Furthermore, the low-pressure line 3004 has two branches 3004a and 3004b, each connected to one of the containers 1302. Specifically, each container 1302 is connected to each fluid conduit by moving it along its longitudinal axis using the branches 3004a and 3004b, and then the piston 1316 is moved within each container 1302. As previously mentioned, the system further comprises a fluid source 1366, a high-pressure line 3002, a flow limiter 3008, a valve 3010 with a diaphragm 3012, and a discharge system 2300, all connected by multiple fluid lines or conduits. The discharge system 2300 will be described in detail later. In this embodiment, penetration of the two vessels and the flow of fluid occur substantially simultaneously.

[0054] In this embodiment, the fluid conduit 300 is modified to include a branch at the second end 304. The branch at the second end 304 has multiple needles, each configured to communicate with only one of the containers 1302 by movement. Thus, in this embodiment, where the system includes two containers 1302, the fluid conduit 300 has two substantially parallel needles at the second end 304. The flow from the multiple needles enters a common channel in the fluid conduit 300, and the drug is delivered from a single channel or lumen at the first end 302. Although two containers 1302 and two needles at the second end 304 are shown in the figure, three, four, five or more other suitable numbers of containers and needles may be used.

[0055] In Figures 3F and 3G, within the automatic syringe, the multiple containers 1302, valve 3010, and / or canisters or fluid sources 1366 are arranged substantially parallel to each other. For example, Figure 3F is a side view of the fluid source 1366, valve 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 arrange each container 1302 and fluid conduit 300 to correspond to a dedicated canister 1366.

[0056] Figures 4A and 4B show the valve 3010 in more detail. The valve 3010 is designed to operate at a specific pressure by considering the balance of one or more parameters, including the diaphragm thickness, the diaphragm durometer, the valve seat height h, and / or the diameter d of the high-pressure cavity 3022. In the pressure equalization between the high-pressure cavity 3022 and the low-pressure cavity 3024, a retaining force may arise due to the low pressure in the conduit 3018 that prevents the diaphragm 3012 from returning to the neutral position shown in Figure 4A. This can be avoided by reducing the diameter of the conduit 3018 or by adjusting one or more of the pre-tension, diaphragm thickness, diaphragm diameter, and valve seat height to increase the restorative force of the diaphragm 3012. For example, a flattened diaphragm may move relative to the restorative force of the valve due to the force acting when it flexes, causing it to lose its restorative force.

[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 causes the diaphragm 3012 to be stretched (in a similar manner to a drumhead) when the first body portion 3040 and the second body portion 3042 engage with each other. The first body portion 3040 has retaining ribs 3046 around the tenting boss 3044 that secure the diaphragm 3012 by gripping or fastening portions. The second body portion 3042 has a recess 3048 configured to receive the tenting boss 3044. The recess 3048 has a shape corresponding to the tensile projection 3044, so that when the first body portion 3040 and the second body portion 3042 engage with each other, the outer surface of the tensile projection 3044 lies on the same plane as 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 the sealing rib portion 3052 of the diaphragm 3012. The sealing rib portion 3052 is positioned on the outer circumference of the diaphragm 3012 and increases the thickness of the member, thereby improving the sealing state provided by the diaphragm 3012.

[0058] Figure 5 shows an alternative valve 5010. Valve 5010 is substantially similar to valve 3010 shown in Figures 3A-3C, except that valve 5010 has a piston 5012 instead of a diaphragm 3012. The piston 5012 has a seal 5014 located in a circumferential groove on the 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 valve 5010 defining the low-pressure cavity 3024, and the entire spring 5016 is located within the low-pressure cavity 3024. Figure 5 shows the spring 5016 in its natural state. In its natural state, the piston 5012 is separated from the valve seat 3020, and the conduit 3018 is open. However, when the fluid source 1366 is activated, the pressure in the high-pressure cavity 3022 increases and acts on the piston 5012, so that the spring 5016 is compressed and the piston 5012 strikes the valve seat 3020 and closes the conduit 3018. When the piston 5012 reaches completion of injection (hits the bottom), the pressure in the high-pressure cavity 3022 and the low-pressure cavity 3024 is equalized, so the spring 5016 expands to its natural state and opens 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 the 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, and the piston 5012 seals the conduit 3018.

[0059] Figures 6, 7A, and 7B show an exemplary flow limiting system. The limiting system 6000 shown in Figure 6 can be incorporated into all locations where a flow limiting section 3008 is indicated herein. The flow limiting system 6000 comprises a housing 6001 having an inlet 6002 connected to the output of a fluid source 1366. Pressurized gas is delivered from the inlet 6002 through a conduit 6004 to the high-pressure line 3002 (see Figure 3A). The pressurized gas from the inlet 6002 is simultaneously diverted to a conduit 6006 (flow limiting section) and finally delivered to the low-pressure line 3004 and the container 1302 (see Figure 3A). The path of the conduit 6006 is zigzag or meandering, reducing the pressure of the pressurized gas flowing through the path. This reduced-pressure gas is then delivered to the low-pressure line 3004 and the container 1302, as described with reference to Figures 3A-3C.

[0060] The flow limiting system 7000 shown in Figures 7A and 7B can be incorporated into all locations where a pressure limiting section 3008 is indicated herein. The flow limiting 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 the high-pressure line 3002 (see Figure 3A). The pressurized gas from the inlet 7002 is simultaneously diverted to the flow limiting section (i.e., pressure reduction section) 7006. The flow limiting section 7006 is a frit containing a porous material (e.g., a microporous material or a macroporous material) such as plastic (especially sintered plastic), ceramic or other suitable material. The average pore size of the porous material is about 0.5 to about 15 microns, about 1 to about 10 microns, about 3 to about 6 microns, or about 5 microns in diameter. The porous material reduces the pressure of the pressurized gas flowing through it, and the reduced pressure is sent to the low-pressure line 3004 and 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 limiter 7006 and drives 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, it sends the reduced pressure flow from the flow limiter 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 limiter 7006. The flow limiting system 7000 is less prone to clogging and easier to manufacture than other flow limiters.

[0061] As previously mentioned, the pressurized gas from the inlet 7002 is sent to the flow limiter (pressure reduction section) 7006. The flow limiter 7006 is a frit containing a porous material such as plastic (especially sintered plastic), metal (stainless steel, etc.), ceramic, or other suitable material. Figures 59A to 59R show various alternative flow limiters that can be incorporated into the flow limiting system 7000 shown in Figures 7A and 7B.

[0062] Figure 59A is a cross-sectional view of an exemplary flow limiter 59000A. The flow limiter 59000A is formed of or filled with a granular material. For example, the flow limiter 59000A includes a plurality of fine particles 59002 (e.g., sand particles or other suitable material) and a plurality of gaps 59004 located between adjacent fine particles 59002. Although not shown, the fine particles 59002 may be filled into a pipe, tube or other suitable sealed or partially sealed structure. The gaps 59004 between the fine particles 59002 form a meandering path for gas passing through the flow limiter 59000A, which in turn causes a pressure drop between the two sides of the flow limiter 59000A. The fine particles 59002 can be compressed at various pressures, but the higher the compression pressure, the more densely packed the fine particles 59002 become, and the smaller the gaps 59004 become. Therefore, when the fine particles 59002 are packed more densely, the pressure drop between the two sides of the flow limiting section 59000A increases. Furthermore, the pressure drop between the two sides of the flow limiting section 59000A can be adjusted by varying the size and / or shape of the fine particles 59002. In this way, the flow limiting section 59000A generates a pressure drop between its two sides.

[0063] Figures 59B and 59C show exploded and cross-sectional views of another exemplary flow limiter 59000B. As shown, the flow limiter 59000B has a plurality of plates stacked in series, for example, plates 59010, 59012, and 59014. Plate 59010 has, for example, one or more holes or openings 59010a in the central portion of plate 59010. Plate 59012 has, for example, one or more holes or openings 59012a in the outer or peripheral portion of plate 59012, and plate 59014 has, for example, one or more holes or openings 59014a in the central portion of plate 59010. Plates 59010 and 59014 may have the same configuration or different configurations. The openings of adjacent plates may be offset and / or displaced from each other in the gas flow direction, but in at least some embodiments, certain adjacent plates have the same or similar opening patterns. For example, the first plate (plate 59010, etc.) has a central opening (opening 59010a, etc.), and the second plate (plate 59012, etc.) has an outer opening (opening 59012a, etc.). Therefore, regardless of the rotational position of the plates, the openings formed in adjacent plates do not face each other. However, in some embodiments, at least some adjacent openings face each other, for example, in the longitudinal direction along the assumed gas path.

[0064] As shown in Figure 59C, plates 59010, 59012, and 59014 are stacked to form a flow restriction section 59000B, which forms one or more meandering gas paths 59011 within the flow restriction section 59000B. When the gas flow passes through the flow restriction section 59000B, it must pass through staggered holes 59010a, 59012a, and 59014a. In this way, the flow restriction section 59000B can be used to create a pressure drop between its sides, while simultaneously suppressing clogging. Furthermore, the pressure drop between its sides also helps to hold plates 59010, 59012, and 59014 together.

[0065] As shown in Figure 59B, each plate 59010, 59012, 59014 has four openings in the corresponding portion of each plate 59010, 59012, 59014. Alternatively, although not shown, each plate 59010, 59012, 59014 may have fewer or more openings. Although not shown, the flow limiting section 59000B may have two plates or four or more plates. In these embodiments, the openings of adjacent plates are offset, as described above, in order to create a pressure drop between the two sides of the flow limiting section 59000B. In one example, the flow limiting section 59000B has four or more plates of two different shapes, and in the stack of plates, plates of one shape are offset from each other by plates of the other shape. In one embodiment, the greater the number of plates, the greater the pressure drop between the two sides of the flow limiting section 59000B. Furthermore, although plates 59010, 59012, and 59014 are shown as cylindrical, the disclosure is not limited thereto, and plates 59010, 59012, and 59014 may have different shapes and / or configurations. In addition, openings 59010a, 59012a, and 59014a are formed by etching or any other preferred method. In at least some embodiments, plates 59010, 59012, and 59014 have etched channels. The etched channels form a path for the gas flow to flow from the center of the plate to the outer periphery of the plate and back to the center of the plate. In at least some embodiments, the rotational position of each plate does not need to be controlled so that the multiple plates can function as a pressure limiter regardless of their rotational position. Since each plate has multiple holes, the automatic syringe 2 can function properly even if one or more holes become clogged.

[0066] Figures 59D and 59E show a cross-sectional and schematic view of another exemplary flow limiter 59000C. As shown, the flow limiter 59000C has a plurality of plates, for example, first and second plates 59020 and 59022. The plates 59020 and 59022 are formed of any preferred metal or etchable material and each has an etched pattern (e.g., different etched patterns) which forms a meandering path 59021 through which gas flows. For example, as shown in Figures 59D and 59E, the path 59021 extends along an etched pattern including etchings 59020a, 59020b and 59020c of the first plate 59020 and etchings 59022a, 59022b and 59022c of the second plate 59022. In this way, plates 59020 and 59022 form a meandering flow path 59021 through which the gas flow passes, generating a pressure drop between both sides of the flow restricting section 59000C.

[0067] The flow limiting section 59000C has fewer components (e.g., fewer plates) than the flow limiting section 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 any case, in both embodiments, each plate can generate a pressure drop between the two sides of each flow limiting section.

[0068] Figure 59F shows a cross-sectional view of another exemplary flow limiter 59000D. As shown, the flow limiter 59000D has first and second plates 59030 and 59032 facing each other, with a gap or channel 59033 formed between plates 59030 and 59032 for the flow of gas (not shown). The first and second plates 59030 and 59032 have a roughness value and a plate surface finish and / or surface irregularity that affects the alignment or fitting of the surfaces of plates 59030 and 59032. In at least some embodiments, the surface finish is formed by forming, pressing, machining, knurling, forging, sandblasting, shot blasting, chemical etching or another preferred 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 are the same or similar surface finishes, or different surface finishes. In this embodiment, the channel 59033 between plates 59030 and 59032 forms a meandering and / or restricted path for the gas flow. This results in a pressure drop between both sides of the flow restrictor 59000C.

[0069] Furthermore, one or more springs (such as springs 59034a and 59034b) bias one of plates 59030 and 59032 toward the other. By applying pressure (e.g., pushing plates 59030 and 59032 toward each other), springs 59034a and 59034b form a meandering and / or restricted path for the gas flow, generating a pressure drop between the two sides of the flow limiter 59000C. For example, springs 59034a and 59034b can control the contact pressure between plates 59030 and 59032, thereby repeatedly generating pressure drops and / or gas flow. Furthermore, springs 59034a and 59034b constantly press against one or both of plates 59030 and 59032, applying constant pressure to channel 59033, thereby forming a meandering and / or restricted path for the gas flow. The gas flow path is also determined by the surface finishes 59030a and 59032a. In another embodiment, springs 59034a and 59034b press against one or both of plates 59030 and 59032 to completely block the gas flow through the flow limiter 59000C in a first (pre-actualized) state. When the patient-side needle mechanism is activated, one or both springs are released or the pressure on one or both plates 59030 and 59032 is reduced, resulting in channel 59033 opening and remaining open until the end of the injection. In this state, the surface finishes 59030a and 59032a form a meandering and / or restricted path, resulting in a pressure drop in the flow restrictor 59000D. After the injection is complete and, for example, the patient-side needle is withdrawn from the patient, the constraints on the springs 59034a and 59034b are released, allowing the springs to expand and the flow path to close.

[0070] Figure 59G shows a perspective view of another exemplary flow restrictor 59000E. As shown, the flow restrictor 59000E has a hollow channel, needle, or tube 59040. The tube 59040 extends longitudinally and has one or more lateral openings 59042 that penetrate the side of the tube 59040. These lateral openings 59042 penetrate, for example, two sides of the tube 59040. The flow restrictor 59000E has a solid cylindrical portion or rod 59044 (or other solid obstruction) positioned within the openings 59042 and penetrating a portion of the tube 59040. In this embodiment, the rod 59044 restricts the gas flow 59041 within the tube 59040 by restricting the gas flow.

[0071] Tube 59040 is connected to or supported by disk 59046. Disk 59046 separates the high-pressure region from the low-pressure region, causing a pressure drop between the sides of the flow limiter 59000E. For example, disk 59046 separates the high-pressure region from the low-pressure region by allowing only air / gas / fluid to flow through the narrow channel (e.g., tube 59040). Although disk 59046 is shown as a cylindrical disk, the disclosure is not limited thereto. Disk 59046 may have any shape and / or size that can divide the high-pressure region from the low-pressure region. In this embodiment, the cross-sectional area of ​​tube 59040 is smaller than the cross-sectional area of ​​disk 59046. Thus, the smaller cross-sectional area of ​​tube 59040 restricts the gas flow 59041, making it easier for a pressure drop to occur between the sides of the flow limiter 59000E. Therefore, due to the small cross-sectional area of ​​tube 59040 and the fact that rod 59044, which passes through a portion of tube 59040, acts as an obstacle, a pressure drop is likely to occur between both sides of the flow limiting section 59000E.

[0072] Figures 59H and 59I show cross-sectional views of another exemplary flow limiter 59000F. Figure 59H is a cross-sectional view of the flow limiter 59000F, and Figure 59I is a longitudinal cross-sectional view of a portion of the flow limiter 59000F. As shown, the flow limiter 59000F has an outer pipe, needle, or tube 59050 and a plurality of wires or filaments 59052 arranged 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 meandering and / or restricted path for gas passing through the flow limiter 59000F, resulting in a pressure drop between the two sides of the flow limiter 59000F. The tube 59050 may be compressed, in which case the filaments 59052 are more densely packed within the tube 59050, and the passage 59054 becomes smaller. As a result, when the filaments 59052 are more densely packed, the pressure drop between both sides of the flow limiting section 59000F increases.

[0073] The filament 59052 and passage 59054 shown in Figure 59I extend substantially linearly within the tube 59050, but the disclosure is not limited thereto. For example, the filament 59052 may be formed in a coil (e.g., spiral) shape and / or adjusted to reduce the size of the passage 59054 and affect the pressure drop between the sides of the flow limiting section 59000F. Alternatively or additionally, the filament 59052 may be configured to reduce the size of the passage 59054 and affect the pressure drop between the sides of the flow limiting section 59000F by, for example, being stretched or machined within the tube 59050 after assembly.

[0074] Figures 59J and 59K show cross-sectional views of another exemplary flow limiter 59000G. Figure 59J is a cross-sectional view of the flow limiter 59000G, and Figure 59K is a cross-sectional view of a portion of the flow limiter 59000G. As shown, the flow limiter 59000G has a housing 59062 and a screw structure 59064. The housing 59062 is substantially cylindrical and has a wall 59066. The wall 59066 has a threaded portion 59066a and forms an opening 59066b. The screw structure 59064 has a screw 59064a, which is threaded along the threaded portion 59066a and is inserted into the opening 59066b. The screw structure 59064 also has an inclined or tapered screw head 59064b. The screw head 59064b abuts against the opening 59066b and / or at least partially closes the opening 59066b. Furthermore, the screw structure 59064 has a spring 59068.

[0075] As shown in Figure 59K, with the screw 59064a screwed into the opening 59066b, the flow limiter 59000G forms a meandering path 59061 for the gas flow that flows through a small gap between the screw 59064a and the threaded portion 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 threaded portion 59066a forms a single helical passage 59061 for the gas to flow (Figure 59K). The fastening of the screw 59064a is set to a desired degree of fastening and / or insertion distance in order to control the pressure drop in the flow limiter 59000G to a desired extent. Furthermore, the pitch and / or threads of the screw 59064a and / or thread portion 59066a affect the gas flow passability in the flow limiting section 59000G. For clarity of illustration, the screw head 59064b is not shown in Figure 59K. The spring 59068 facilitates the pushing of the screw 59064a into the opening 59066b and / or facilitates the fixing or fastening of the connection between the screw structure 59064 and the housing 59062. In these embodiments, a pressure drop is generated and / or controlled between the two sides of the flow limiting section 5900G. The spring allows for control of the contact pressure to improve the repeatability of the flow characteristics. The configurations in Figures 59J and 59K are analogous to a needle valve.

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

[0077] The ball bearing 59072 is substantially spherical. The ball bearing 59072 has one or more uneven surfaces that affect contact with the uneven surface 59070b. For example, the uneven surfaces are formed by molding, pressing, machining, knurling, forging, sandblasting, shot blasting, chemical etching or another preferred method. Furthermore, a spring 59074 securely connects the ball bearing 59072 to another part (not shown) of the housing. Thus, both the pressure of the incoming gas (e.g., pressure applied from the wider 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 into the narrower portion 59070d. In some embodiments, the ball bearing 59072 is pressed more strongly against the uneven surface 59070b by increasing the pressure of the incoming gas (e.g., pressure from the wider portion 59070c). Therefore, the ball bearing 59072 restricts the gas flow 59071 into the narrow section 59070d with greater force, resulting in a larger pressure drop between the sides of the flow limiting section 59000H. In these embodiments, the pressure drop is generated and / or controlled between the sides of the flow limiting section 59000H.

[0078] Figure 59M shows a cross-sectional view of another exemplary flow limiter 59000I. This embodiment also has a textured surface formed by molding, pressing, machining, knurling, forging, sandblasting, shot blasting, chemical etching, or another preferred method. As shown, the flow limiter 59000I comprises a plug 59080, a housing 59082, and a spring 59084. The plug 59080 has, for example, a substantially tapered structure and is partially conical (e.g., frustoconical). As shown in Figure 59M, the plug 59080 has a wider portion in the high-pressure region (left side) and a narrower portion in the low-pressure region (right side). The housing 59082 has a shape at least partially complementary to the plug 59080. Furthermore, in some embodiments, the housing 59082 has a rough surface, a threaded surface, or a textured surface 59082a. The plug 59080 is at least partially received within the housing 59082. Furthermore, the spring 59084 presses, for example, a wider portion of the plug 59080, applying pressure to the plug 59080 and helping to secure the plug 59080 within the housing 59082. In these embodiments, the gas flow (not shown) flows through a complex path, a restricted path, and / or a meandering path formed between the plug 59080 and the housing 59082 (e.g., by the uneven surface 59082a). Furthermore, the state of the gas flow path and, consequently, the pressure drop can be controlled by adjusting the insertion distance of the plug 59080 into the housing 59082, the compressive force of the spring 59084, and / or other characteristics. In these embodiments, the pressure drop is generated and / or controlled between the two sides of the flow limiter 59000I.

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

[0080] Figure 59O shows a partial cross-sectional view of another exemplary labyrinth seal flow limiter 59000K. As shown, the flow limiter 59000K has a shaft 59100 and a housing 59102. The gas flow 59101 or fluid path moves within a channel (not indicated) between the shaft 59100 and the housing 59102. Figure 59O shows a portion of the flow limiter 59000K, for example, the upper half. As shown, the shaft 59100 has a number of projections 59100a. Thus, the projections 59100a form a meandering path for the gas flow 59101. For example, because the gas flow 59101 needs to traverse the channel between the projections 59100a and the housing 59102, a pressure drop is likely to occur between the two sides of the flow limiter 59000K. For example, in the labyrinth seal flow limiter 59000K, the gas expands after passing through each tooth (a small gap is formed between the housing 59102 and the tip of each tooth), making it easy for a pressure drop to occur between the sides of the flow limiter 59000K. By adjusting the type and / or size of the projection 59100a, and other aspects of the flow limiter 59000K, the pressure drop between the sides of the flow limiter 59000K can be controlled and / or regulated. In these embodiments, the pressure drop is generated and / or controlled between the sides of the flow limiter 59000K.

[0081] Figure 59P shows a schematic diagram of another exemplary flow limiter 59000L. As shown, the flow limiter 59000L is configured to release pressurized gas 59103 from the gas canister 59110a. Also, frits 59116, slits, holes or other flow limiters described herein are placed in the flow path to generate 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 has passed through the frit 59116 proceeds to the low-pressure line and is used in a preferred manner described herein, for example, to drive a piston 1316 in a vessel 1302. The embodiment in Figure 59P is structurally similar to other frits and / or porous microfilters described herein. However, lower grade or specification structural components may be used in combination with higher viscosity fluids or refrigerants (as opposed to R32 refrigerants, etc.). For example, the material or gas 59103 may be a denser gas (i.e., a gas with higher pressure, atomic weight, etc.). Alternatively, the material or gas 59103 may be a biocompatible liquid (e.g., water, oil, glycerin, etc.) with a higher viscosity and / or density than the gas on the flow limiting section 59000L side.

[0082] If the viscosity of material 59103 is sufficiently high, frit may not be necessary. In other words, the material itself, or the combination of the material and the narrow slit, may be able to generate the desired pressure drop between both sides of the flow limiting section 59000L.

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

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

[0085] Furthermore, the first recess 59120a and the second recess 59122a are fixed to each other by welding or other methods at the connecting portion 59120d, or connected by one or more seals. In this way, 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 connecting portion 59120d prevents the gas flow 59121 from flowing through paths other than those described above and escaping from the limiting portion 59000M.

[0086] The first channel 59120b, the gap between the first recess 59120a and the second recess 59122a including the uneven surface 59120c, and the meandering path through the second channel 59120b allow a pressure drop to be generated between both sides of the flow limiter 59000M. The structure of the flow limiter 59000M allows for a pressure drop by the existing structure of the automatic syringe without the addition of frit or other materials. Furthermore, 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 generated and / or controlled between both sides of the flow limiter 59000M.

[0087] An embodiment of valve 3010 is shown as valve 7100 in Figures 7C and 7D. Valve 7100 can be applied to a container 1302 whose longitudinal axis is perpendicular to the patient's skin surface (for example, not the configuration parallel to the skin surface shown in Figure 2). The housing 7101 of valve 7100 has an inlet 7102 connected to the output of a 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 pressurized gas in the high-pressure cavity 7122 pushes the diaphragm 7112 toward the valve outlet 7120, sealing the valve outlet 7120. The pressurized gas from the inlet 7002 is also diverted to a flow limiter (not shown) and delivered to the low-pressure line 7104 and the container 1302 (via the primary container inlet 7130). The flow limiter used in this embodiment is any preferred flow limiter, including frit and / or meandering conduits as described herein. The flow limiter is located within the inlet 7130 or upstream or downstream of the inlet 7130. Pressurized gas flows from the flow limiter into the vessel 1302 through the low-pressure line 7104 and the primary vessel inlet 7130 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 flow through the low-pressure inlet 7116. The plate cover 7101a is connected to the bottom surface 7101b (Figure 7D) of the housing 7101 by methods such as laser welding or ultrasonic welding. The bottom surface 7101b has the low-pressure line 7104, the low-pressure cavity inlet 7116 and the primary vessel inlet 7130, which are etched into the bottom surface 7101b, respectively. Furthermore, the bottom surface 7101b has a valve outlet 7120 that communicates with the low-pressure cavity of the low-pressure section 7124 and the discharge line 7118. As previously mentioned with reference to Figures 3A and 3C, when the pressure balances between the high-pressure cavity 7122 and the low-pressure cavity, the diaphragm 7112 is lifted out of the valve outlet 7120, opening the valve outlet 7120. As a result, gas / fluid from the low-pressure cavity can move through the valve outlet 7120, the discharge line 7118, and the discharge port 7118a (Figure 7C). A rod (not shown, but substantially the same as the rod 8002 described below) is located inside the discharge port 7118a.In valve 7100, one or more or all of the following are located on the same plane: low-pressure line 7104, low-pressure cavity inlet 7116, primary container inlet 7130, valve outlet 7120, and outlet line 7118.

[0088] Another embodiment of valve 3010 is shown as valve 7200 in Figures 7E and 7F. Valve 7200 can be applied to a container 1302 whose longitudinal axis is perpendicular to the patient's skin surface. The housing 7201 of valve 7200 has an inlet 7202 connected to the output of a 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 within a portion 7222 (Figure 7E) of the housing 7201. The pressurized gas / fluid in the high-pressure cavity 7204 pushes a diaphragm 7212 toward the valve outlet 7220, sealing the valve outlet 7220. The diaphragm 7212 is elliptical or lace-like in shape. The pressurized gas / fluid from the inlet 7002 is simultaneously diverted to a flow limiter (not shown) and sent to a low-pressure line (e.g., low-pressure line 3004 in Figures 3A-3C) and to the container 1302 (via the inlet 7230 in Figure 7F). Specifically, the pressurized gas flows into the container 1302 through the inlet 7230 and drives the piston 1316. In some embodiments, a frit or other flow limiter is located within the inlet 7230. The flow limiter may be located upstream or downstream of the inlet 7230. A low-pressure cavity in portion 7224 of the housing 7201 receives a portion of the depressurized flow through the low-pressure inlet 7216. The plate cover 7101a is connected to the bottom surface 7101b (Figure 7D) of the housing 7201 by methods such as laser welding or ultrasonic welding. 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, respectively. As previously described with reference to Figures 3A and 3C, when the pressure balances between the high-pressure cavity and the low-pressure cavity, the diaphragm 7212 is lifted from the valve outlet 7220, opening the valve outlet 7220. As a result, gas / fluid from the low-pressure cavity can move through the valve outlet 7220 and the discharge port 7218a (Figure 7E). A rod (not shown in the figure, but substantially the same as the rod 8002 described below) is located inside the discharge 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 the automatic syringe 2 equipped with valve 7300. An embodiment of valve 3010 is shown as valve 7300 in Figure 7G. The features and elements of valve 7300 function similarly to the features and elements of the above-mentioned valves, such as valve 7200.

[0090] Valve 7300 can be applied to container 1302. As shown in Figure 7H, valve 7300 has 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 valve 7300. The first housing 7301 has an inlet 7302 (canister inlet, etc.) connected to the output of fluid source 1366 (Figure 5). Pressurized gas / fluid flows from inlet 7302 through high-pressure line 7304 (inside the first housing 7301) (via connection 7320a in the second housing 7303) to high-pressure inlet 7320 (inside the second housing 7303) and is sent to high-pressure cavity 7312b in the second housing 7303. The high-pressure line 7304 has multiple channels arranged in a circuit-like, meandering, or zigzag pattern, for example, extending in various directions. In one embodiment, the channels of the high-pressure line have about 2 to 10 turns, for example, 4 turns. The high-pressure gas / fluid in the high-pressure cavity 7312b pushes the diaphragm 7312 toward the valve seat 7307a, sealing the valve outlet 7307. The diaphragm 7312 is generally circular and substantially similar to the other diaphragms described herein. The pressurized gas / fluid from the inlet 7302 is simultaneously diverted to a flow limiter (not shown) and delivered to the low-pressure line (e.g., low-pressure line 3004 in Figures 3A-3C) and the container (e.g., 1302) via conduit 7309a in the PNM flow channel 7309. In particular, the pressurized gas flows from the high-pressure line 7304 through the connection 7320a before entering the PNM flow channel 7309. Next, the pressurized gas flows from the PNM flow channel 7309 through conduit 7309a to channel 7315, then enters the container 1302 from the container inlet 7330, driving the container 1302 toward the fluid conduit 300 and then driving the piston 1316. In some embodiments, a frit or other flow limiter is located in the inlet 7330 or between conduit 7309a and the inlet 7330. Exemplary frits and flow limiters are described herein. Details of the frit described below may also be applicable to other embodiments.For example, the frit is formed from stainless steel, sintered plastic, or other suitable material. The frit is formed from a material with a pore diameter of about 0.5 microns or more. The length of the frit is up to about 8-12 mm, for example, about 10 mm, and the diameter is about 1-5 mm, for example, about 3 mm. The flow limiter is 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 depressurized flow through the low-pressure inlet 7316.

[0091] The second housing 7303 is connected to the bottom of the first housing 7301 by methods such as laser welding or ultrasonic welding, 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 approximately simultaneously, by two laser welding points. Furthermore, the components of the valve 7300 are welded together, for example, around the channel, about 1 to 2 mm away from the channel, with a weld thickness of about 1 mm.

[0092] Various feature parts of the first housing 7301, the second housing 7303, and the base plate 7305 are etched (or formed or machined) within the 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 the pressure balances between the high-pressure cavity and the low-pressure cavity, the diaphragm 7312 is lifted from the valve seat 7307a, opening the valve seat 7307a. As a result, gas from the low-pressure cavity 7312a can move through the valve outlet 7307 and the discharge port 7318a. A rod (not shown in the figure, but substantially the same as the rod 8002 described below) is located within the discharge port 7318a.

[0093] In one embodiment, the diaphragm 7312 can be formed using various materials and to various thicknesses. In yet another embodiment, the diaphragm 7312 is formed by one or more molding processes that provide a wide range of performance characteristics with respect to, for example, temperature. For example, increasing the temperature increases the pressure in the valve 7300 and / or canister system, changing the pressure difference in the diaphragm 7312. This affects the movement of the diaphragm 7312 and / or the exhaust of the valve 7300. In particular, at high temperatures, separation / lifting of the diaphragm 7312 from the exhaust valve seat 7307a may be prevented or suppressed. Furthermore, the diaphragm 7312 may be formed from a composite material to provide, for example, a rigid central portion (formed by, for example, a two-color molding process). In this case as well, the movement of the diaphragm 7312 is affected, for example, the rigidity of the diaphragm 7312 is higher in the portion where it contacts the valve seat 7307a, making it easier for the diaphragm 7312 to lift off and / or separate from the valve seat 7307a. Furthermore, in one or more embodiments, the lift off and / or separation of the diaphragm 7312 from the valve seat 7307a may be changed / improved, for example, under different pressure and / or temperature environments, by changing the orientation and / or position of the valve seat 7307a. For example, by positioning the valve seat 7307a off-center from the center of the diaphragm 7312, the lift off and / or separation of the diaphragm 7312 from the valve seat 7307a is made easier.

[0094] By optimizing the following features in the valves described herein, a desired combination of functions can be achieved at different temperatures and / or pressures. Off-center placement of the valve seat increases the lift pressure (the pressure required to separate the diaphragm from the valve seat (the pressure of the low-pressure cavity)). Lift pressure increases as the valve seat moves away from the center of the valve or cavity. The diaphragm is stiffer and therefore less flexible closer to the valve wall. Moving the valve seat / diaphragm contact point away from the central portion of the diaphragm, where the diaphragm is more flexible, can increase the lift pressure. Alternatively, the seating pressure (pressure loss) required to seat the diaphragm may be increased. In some examples, approximately 0% to 50% of the diaphragm's diameter is offset from the center.

[0095] Alternatively, the valve seat may be raised, which brings it closer to the diaphragm, thus shortening the distance the diaphragm has to travel to seal the seat. As a result, the seating pressure (pressure loss) required to seat the diaphragm on the valve seat is also reduced. However, in this case, the lift pressure (low-pressure cavity) required to lift the diaphragm off the valve seat is also reduced. In some examples, the valve seat is raised by approximately 0.5 mm to 3 mm, 1 mm to 2 mm, or 1.5 mm.

[0096] The diameter of the valve seat / discharge port / discharge opening can also be adjusted as appropriate. A smaller diameter reduces the area of ​​the diaphragm pulled by the opening, and thus the force pulling the diaphragm is reduced, thereby reducing the lift pressure. As a result, the force required to push up from the lower cavity can also be reduced. Since the discharge opening is open to the atmosphere, which has a lower pressure than the corresponding cavity, a smaller diameter of the discharge opening reduces the effective area that generates the pressure drop (i.e., less air comes into contact with the low-pressure region). The diameter of the opening is approximately 0.1 mm to 1 mm, and anything smaller is incompatible with ease of manufacture. In other embodiments, the diameter of the opening is approximately 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 results in higher flexibility / elasticity. This is beneficial in terms of seating pressure, but may negatively affect lift pressure. For example, the cavity diameters are approximately 10mm to 20mm, 12mm to 18mm, 14mm to 16mm, and 15mm. In some embodiments, the cavity diameter is approximately 12.7mm. In some embodiments, the cavity diameter is approximately 6.35mm to 25.4mm (approximately 0.25 inches to 1.0 inch).

[0098] For example, the composite diaphragms described below, such as the diaphragm shown in Figures 7I-7K, have a more rigid portion that contacts the valve seat. This prevents local deformation of the discharge port / valve seat, thereby increasing the lift pressure (low-pressure cavity). As a result, the flexible portion of the diaphragm is not pulled into the discharge port, preventing seating before high pressure is reached. The diameter of the disc 7412c described below is approximately 0%-90%, 50%-75%, or 60% of the diaphragm diameter. The disc is formed of rigid plastic, and the Shore A durometer hardness of the material of the other parts of the diaphragm is approximately 10-90, 30-60, or 40-50.

[0099] Figures 7I–7K show different illustrations of an exemplary diaphragm 7412. This diaphragm 7412 can be incorporated into valve 7300 or any other valve described herein. Figure 7I is a perspective view of a first surface of the diaphragm 7412. Figure 7J is a perspective view of a second surface of the diaphragm 7412, partially transparently showing a portion of the diaphragm 7412. Figure 7K is a partial cross-sectional view of the diaphragm 7412. The diaphragm 7412 is generally circular. The diaphragm 7412 has an outer edge or gland 7412a extending from the outer circumference of the diaphragm 7412. The gland 7412a shown in Figure 7I extends in one direction from the body of the diaphragm, but the gland 7412a may extend in multiple opposite directions away from the body. The gland 7412a is thicker than the inner portion 7412b of the diaphragm 7412. The ground 7412a has, for example, a circular surface along its entire surface (for example, a surface extending perpendicular to the radial direction of the diaphragm 7412). Furthermore, the diaphragm 7412 has, for example, a disk 7412c positioned and / or connected to the inner portion 7412b at the radial center of the diaphragm 7412. The disk 7412c is generally cylindrical and has approximately the same thickness as the ground 7412a relative to the inner portion 7412b (e.g., thickness in the direction away from the inner portion 7412b), although the thicknesses of the ground 7412a and the disk 7412c may differ. The thickness of each part of the disk 7412c, including the overall thickness of the disk 7412c, is approximately 1 mm, approximately 2 mm, approximately 0.5 mm to approximately 10 mm, approximately 1 mm to approximately 9 mm, approximately 3 mm to approximately 8 mm, approximately 4 mm to approximately 6 mm, or approximately 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 recesses or depressions 7412d, for example, curved recesses extending radially inward from the outer circumferential surface of the disk 7412c. The recesses or depressions 7412d are spaced apart from each other in the circumferential direction of the disk 7412c. However, the disclosure is not limited thereto, and the disk 7412c may have any shape and / or size.

[0100] The disc 7412c is connected to the inner portion 7412b by adhesive and / or other preferred methods, such as molding or other mechanical bonding. In one embodiment, the molding is a two-color molding process. As shown in Figures 7J and 7K, the inner portion 7412b has one or more holes or recesses 7412e, and the disc 7412c has one or more protrusions 7412f. The disc 7412c is connected to the inner portion 7412b by the placement of the protrusions 7412f in the recesses 7412e. The recess 7412e shown in Figure 7K penetrates the entire inner portion 7412b, but the disclosure is not limited thereto. For example, the recess 7412e may extend only to a portion of the inner portion 7412b (e.g., about 50%, 60%, 70%, 80%, etc.). Accordingly, the size of the protrusion 7412f is set to be such that it can be received within the recess 7412f and connect the disk 7412c to the inner portion 7412b. In this way, the recess 7412e and the protrusion 7412f strengthen the mechanical connection between the inner portion 7412b and the disk 7412c. The end of the protrusion 7412f may be located on the same plane as the surface of the inner portion 7412b, may protrude outward from the surface, or may be located within the thickness of the inner portion 7412b. The recess improves the formability of the disk and facilitates the attachment of the disk to the diaphragm.

[0101] The disk 7412c is formed of a monolithic material, single material, composite material, or other suitable material. The disk 7412c is formed of a material that is harder than other parts of the diaphragm 7412. The rigidity of the diaphragm 7412 can be increased by the disk 7412c. As shown in FIGS. 7L and 7M, the diaphragm 7412 with the disk 7412c can withstand greater forces and / or pressures, so that, for example, the diaphragm can bend and / or deform more uniformly. As a result, in a high-pressure state, the lifting from the valve seat 7407a is promoted. As shown in FIG. 7N, in the diaphragm 7412' without a disk, it may deform and / or bend non-uniformly, which may adversely affect the lifting from the valve seat 7407a, or the lifting may be delayed or blocked.

[0102] Furthermore, one or more seals or outlets are formed in the valve 7300 and the container 1302, and each seal or outlet, for example, the valve seat 7307a, may be formed at one or more additional or alternative positions. Further, considering various restrictions on the space plane in different containers 1302, lines such as one or more channels may be rearranged to match the above-described features, and / or the connection ports may be moved, rearranged, reoriented, etc.

[0103] Furthermore, although valve 7300 is illustrated and described as a three-part valve (e.g., first housing 7301, second housing 7303, and base plate 7305), the present disclosure is not limited thereto. For example, valve 7300 may be a four-part valve. The four-part valve has an additional housing, which is, for example, in the vicinity of and / or on the same plane as the first housing 7301 and is disposed between the second housing 7303 and the base plate 7305. Alternatively or additionally, the four-part valve has an additional housing (e.g., similar to a part of the first housing 7301 or the second housing 7303) or an additional base plate. The four-part valve is easy to connect (such as by welding), for example, without the need to perform welding through the holes, openings, or other parts of valve 7300. These components of valve 7300 are welded, for example, by performing laser welding simultaneously or substantially simultaneously on two locations of the outer components. Furthermore, ultrasonic welding is performed on one or more inner layers or inner components (e.g., through holes and high-pressure / low-pressure cavities). Furthermore, the material of the valve can be changed based on its compatibility with the gas or fluid moving inside the valve. Furthermore, the type of welding between various layers may be determined according to the opacity of each layer.

[0104] As previously mentioned, the automatic syringe 2 may have a valve consisting of four parts, for example, valve 7500, as shown in Figure 70. Similar to valve 7300, valve 7500 can be applied to a system with a container 1302 and other valves described herein. As shown in Figure 70, 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 connected to the top surface of the second sub-housing 7503 by ultrasonic welding or the like. The bottom surface of the second sub-housing 7503 is connected to the top surface of the main housing 7501 by laser welding or the like. Furthermore, the second sub-housing 7503 and the main housing 7501 surround the diaphragm 7512 as previously mentioned. The bottom surface of the main housing 7501 is connected to the top surface of the base plate 7505 by laser welding or the like.

[0105] The main housing 7501 has an inlet 7501a (canister inlet, etc.) connected to the output of the fluid source 1366 (Figure 5), as described above. The main housing 7501 also has a push rod cavity 7501b (similar to the PNM flow channel 7309, used to deliver the gas flow to the patient-side needle mechanism, shuttle, etc. of the device) and a dump valve cavity 7501c (used to exhaust the system after balancing the high-pressure and low-pressure sides). The main housing 7501 also has a container mounting portion 7501d for connecting to the container 1302. Furthermore, the main housing 7501 has one or more gaps or spaces, for example, openings 7501e, which facilitate the formation (molding, etc.) of the main housing 7501. The openings 7501e are portions where no material has been formed by methods such as making them hollow. The first sub-housing 7502 forms a high-pressure sliding portion 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 (which also correspond to the high-pressure line 3002), as described above. The base plate 7505 has multiple channels 7505a to 7505c, which correspond to the low-pressure line 3004 as described above. Because the valve is composed of four parts, the push rod cavity 7501b and the dump rod cavity 7501c can be made larger compared to other devices. As a result, the pressure can be distributed over a larger surface area of ​​the larger rod / dump valve body, improving the device performance, especially at low temperatures.

[0106] Thus, the various components of the valve 7500, including the diaphragm 75012, function similarly to the valve 7300 and the diaphragm 7312 to selectively close and / or lift the valve seat (not shown), thereby controlling the gas flow between the high-pressure and low-pressure regions.

[0107] In valve 7500, fluid flow can be formed by a simple channel arrangement. The components of valve 7500 are arranged to facilitate welding when forming valve 7500. Similar to valve 7300, welding is ultrasonic and / or laser welding. Furthermore, because valve 7500 is smaller overall than other valves, it can expand the available space in automatic syringes and / or miniature automatic syringes. The first sub-housing 7502 and the second sub-housing 7503 are joined by ultrasonic welding to form a high-pressure subassembly. The main housing 7501 and the base plate 7504 are joined by laser welding to form a low-pressure subassembly. The high-pressure subassembly is connected to the low-pressure subassembly by connecting the high-pressure subassembly to the main housing 7501 by laser welding or the like. In this embodiment, the diaphragm does not have tensile features, outer ribs, or diaphragm protrusions, but in other embodiments using a four-part valve, the diaphragm may have such features. By omitting these feature parts, the occupied area or surface area of ​​the diaphragm and valve can be reduced, contributing to the overall miniaturization of the automatic syringe 2.

[0108] Different parts of the valve can be welded using various techniques and / or processing sequences based on various parameters. Available materials include clear or black polystyrene, ABS, polycarbonate (not usable with ultrasound), etc. The material of each valve component is selected according to the gas / fluid / liquid selected to drive the device. For example, styrene cannot be used with certain gases, such as HFA. In one embodiment, the low-pressure valve side portion 7501 is made of carbon black or the like and is black. In one embodiment, the high-pressure valve side portion 7503 and the low-pressure sliding portion 7504 are clear.

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

[0110] In another embodiment, the process is carried out in reverse. That is, in the first step, the high-pressure sliding portion 7502 is ultrasonically welded to the high-pressure valve-side portion 7503. The combined feature portion is welded to the low-pressure valve-side portion 7501, and the low-pressure sliding portion 7504 is welded to the low-pressure valve-side portion 7501. The order of welding at these two locations may be reversed.

[0111] In some embodiments, ultrasonic welding, which may generate particulate matter, is performed first, followed by laser welding after the particulate matter has been removed. Alternatively, ultrasonic welding may be performed after laser welding. In this alternative processing sequence, it is desirable to remove dust and other particulate matter from the parts, or preferably to have no dust or substantially no dust, so that dust and particulate matter are not trapped in the valve near the frit.

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

[0113] Figures 8A–8D show one embodiment of the discharge system 8000 according to the present disclosure. The discharge system 8000 has a rod or other actuated member 8002 located in a conduit 3018. The rod 8002 extends from a first end 8002a toward a second end 8002b. The rod 8002 has a seal 8003 located at or near the first end 8002a. Pressurized gas from the conduit 3018 contacts the first end 8002a, not the second end 8002b. The rod 8002 can move from a first position shown in Figures 8A–8C to a second position shown in Figure 8D. In the second position, the rod 8002 contacts and actsuates 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] Figure 8A shows the system before pressurized gas is released from the fluid source 1366. In Figure 8A, the diaphragm 3012 is in a neutral position, and the second end 1306 of the container 1302 is separated from the needle 308. Figure 8B shows the needle 308 communicating with the container 1302 after the pressurized gas has been released from the fluid source 1366. In Figure 8B, the piston 1316 is moving within the container 1302, and the diaphragm 3012 is pressed against the conduit 3018. Figure 8C shows the state at the completion of injection. In Figure 8C, the piston 1316 has completed its movement throughout the entire container 1302 (the piston 1316 is "bottomed out"). As previously mentioned, at this stage the pressures in the high-pressure cavity 3022 and the low-pressure cavity 3024 are balanced, the diaphragm 3012 has returned to a neutral position, and the conduit 3018 is open. Since the fluid source 1366 has more pressurized gas than is needed to complete the injection, the excess pressurized gas needs to be discharged from the auto-syringe 2. The pressurized gas delivered to the conduit 3018 drives the second end 8002b of the rod 8002 into contact with the needle retraction mechanism 8004 (Figure 8D). When the rod 8002 activates the needle retraction mechanism 8004, the needle (e.g., the needle 306 shown in Figures 12A-12C) retracts from an deployed position (inside the patient's body) to a retracted position (inside the auto-syringe 2). In one embodiment, the needle retraction mechanism 8004 has one or more of the stoppers 240 and / or inclined sections 1500, which are shown in more detail below (Figure 23). For example, the rod 8002 pushes the inclined section 1500 and / or stoppers 240 to initiate the retraction of the needle. In such an embodiment, the retraction of the needle 306 from the patient can be initiated without requiring the retraction or movement of the container 1302. In some embodiments, once the retraction of the needle 306 is complete, the flow of pressurized fluid from the fluid source 1366 is stopped, and some pressurized fluid remains in the fluid source 1366. In other embodiments, discharge from the fluid source 1366 is performed by a separate mechanism.

[0115] Figures 9A–9H show a discharge system 9001 according to another embodiment of the present disclosure. The discharge system 9001 has a piston 9002 located in a conduit 3018, which forms a valve. The piston 9002 extends from a first end 9004 (clearly shown in Figures 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 functions 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 motion of the piston 9002 during discharge. The second end 9006 is used to actuate a needle retraction mechanism, as described in other embodiments of the present disclosure (e.g., rod 8002). The piston 9002 is generally rod-shaped, except for the larger diameter projection located 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, allowing gas to flow out from the conduit 3018 along the outer surface of the piston 9002. The piston 9002 has a first seal 9008 located at or near the first end 9004, and a second seal 9010 located between the first end 9004 and the second end 9006. That is, the second seal 9010 is closer to the second end 9006 (further from the first end 9004) than the first seal 9008. The first seal 9008 and the second seal 9010 are located in recesses extending circumferentially on the piston 9002, as shown in Figures 9A to 9G, or 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 discharge).

[0116] The discharge system 9001 also has a secondary channel / line 9012 branched 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 flows into the high-pressure line 3002. The secondary channel 9012 is connected to the 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 into the inner cavity of the autosynergy 2 and / or into the atmosphere. The distance b between 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 Figure 9H, the discharge system 9001 has a larger opening or slot 9015 at the end of the conduit 3018 instead of an outlet 9014. In detail, the opening 9015 is located at the end of the conduit 3018 and is a larger diameter section than the other sections. The opening 9015 has the same or the same function as the outlet 9014 (i.e., it allows the release of pressurized gas from the fluid source 1366 to the inner cavity of the autosynergy 2 and / or to the atmosphere).

[0117] Figure 9A shows the parts of the automatic syringe 2 before pressurized gas is released from the fluid source 1366. In Figure 9A, the diaphragm 3012 is in a neutral position, and the second end 1306 of the container 1302 is separated from the needle 308. Figure 9B shows the needle 308 communicating with the container 1302 after the pressurized gas has been released from the fluid source 1366. In Figure 9B, the piston 1316 is moving within the container 1302, and the diaphragm 3012 is pressed against the conduit 3018. Figure 9C is an enlarged view of Figure 9B, centering on the discharge system 9001. During injection, the piston 9002 is in a first position, and the first end 9004 is located near 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. Therefore, the flow of pressurized gas from the secondary channel 9012 to the outlet 9014 (and the atmosphere) is blocked by the seal 9010.

[0118] Figure 9D shows the state at the completion of injection. In Figure 9D, the piston 1316 has completed its movement throughout the entire vessel 1302 (the piston 1316 is "bottomed out"). As previously mentioned, at this stage the pressures in the high-pressure cavity 3022 and the low-pressure cavity 3024 are balanced, and the diaphragm 3012 returns to its neutral position, opening the conduit 3018. Since the fluid source 1366 has more pressurized gas than is required to complete the injection, the excess pressurized gas is discharged from the auto-injector 2. The pressurized gas delivered to the conduit 3018 drives the piston 9002 away from the valve seat 3020, as shown in Figures 9E-9G. The piston 9002 is moved away from the valve seat 3020 until, for example, the second end 9006 strikes an obstacle (not shown) and the piston 9002 reaches a second position. While the piston 9002 is in the second position shown in Figures 9E-9G, the secondary channel 9012 communicates with the outlet 9014, allowing the pressurized gas to be discharged into the atmosphere. The pressurized gas moves from the secondary channel 9012 between the outer surface of the piston 9002 and the inner surface of the conduit 3018, and exits into the atmosphere through the outlet 9014. This movement is along the flow path 9016 shown in Figure 9G. Figure 9F shows the container 1302 in a retracted position. In this embodiment, a spring 11002 (described later with reference to Figure 17) is configured to retract the container 1302. The discharge system 9001 (including the dump valve) allows for relatively rapid discharge from the fluid source 1366 (and subsequent retraction of the needle 306). For example, if the discharge takes too long, there may be a delay of about 10 seconds, about 15 seconds or more in the retraction of the needle 306 and the completion of the injection procedure.

[0119] Figures 9I–9K show parts of an automatic syringe 2 with additional features of the discharge system 9001 according to another embodiment of the present disclosure. In this embodiment, the dump valve rod and conduit 3018 of Figures 9A–9H are shown in more detail. As previously stated, the discharge system 9001 includes a dump valve having, for example, a dump valve rod 9018 extending within the conduit 3018. As shown, the dump valve rod 9018 and the conduit 3018 are each substantially cylindrical. The conduit 3018 also has a radial recess (recessed area) 9022 that communicates with the outlet 9014. The recess 9022 is a recess on the radial inner surface of the conduit 3018 and functions to release and / or discharge gas (for example, the flow path 9016 described with reference to Figure 9G) from the discharge system 9001 into the atmosphere or the like. In particular, the gas travels from the secondary channel 9012 through the gap between the inner surface of the conduit 3018 and the dump valve rod 9018, the recess 9022, and the outlet 9014. The dump valve rod 9018 has gaps 9022a and 9022b, which receive and / or house one or more seals. The embodiments shown in Figures 9I-9K have the same function as the embodiments shown in Figures 9A-9H but are smaller and more discrete, and therefore fit into smaller device housings. For example, the recess 9022 / outlet 9014 is a fan-shaped channel rather than a through-hole. This structure simplifies the molded parts and facilitates manufacturing.

[0120] Figures 10A to 10D show the discharge system 10000 according to this disclosure. Unlike the discharge systems 8000 and 9001 used with the valve 3010 described above, the discharge system 10000 is configured to be used without the valve 3010. The discharge system 10000 has a line 10002 which is configured to deliver pressurized gas from the fluid source 1366 to the container 1302, to connect the container 1302 with the needle 308, and to drive the piston 1316 within the container 1302. The rod 10004 extends from a first end 10004a (see Figure 10D) toward a second end 10004b, at which the second end 10004b is connected to the rear (non-contact side of the drug) of the piston 1316. Furthermore, the rod 10004 extends through the conduit 10006, as shown in Figures 10A and 10B. While the rod 10004 is positioned in the discharge conduit 10006, the conduit 10006 is sealed, and pressurized gas from the fluid source 1366 acts on the piston 1316, driving the piston 1316 within the container 1302 (see Figure 10B). When the piston 1316 reaches the second end 1306 of the container 1302 (state shown in Figure 10C), the rod 10004 is fully withdrawn from the conduit 10006, so that the conduit 10006 opens, allowing the pressurized gas to be discharged from line 10002 through the conduit 10006. The pressurized gas is discharged while continuing to act on the piston 1316 (against the spring 11002 shown in Figure 17). As a result, the spring force of spring 11002 becomes greater than the force of the pressurized gas acting on piston 1316. At this point, the system is completely evacuated, and the spring expands, causing container 1302 to retract as shown in Figure 10D (or as shown in the alternative embodiment). Spring 11002 returns container 1302 to its original pre-deployment position, or to a different position from its original pre-deployment position (for example, to a position longitudinally displaced from its original pre-deployment position). The displaced position may be closer to or further from needle 308 than the original pre-deployment position.

[0121] Figures 10E and 10F show additional diagrams of the discharge system 10000. Specifically, Figure 10E shows the discharge system 10000 with the first end 10004a of the rod 10004 extending into the conduit 10006, before the drug is discharged from the container 1302 by the piston 1316. Figure 10F shows the discharge 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 withdrawn from the conduit 10006. As shown in Figure 10F, the first end 10004a transitions from the first configuration shown in Figure 10E to the second configuration shown in Figure 10F. In the first configuration, the first end 10004a of the rod 10004 extends along a first axis, and the rest of the rod 10004 also extends along this first axis. In the second configuration shown in Figure 10F, the first end 10004a extends along a second axis that is offset from the first axis. The offset second configuration shown in Figure 10F can prevent the first end 10004a from being accidentally reinserted into the conduit 10006 or from unintentionally interfering with the discharge process. In some embodiments, the first end 10004a is biased towards the offset second configuration. For example, the rod 10004 is made of a shape memory material such as nitinol and is formed in the offset second configuration. In such embodiments, the proximal end 10004a is biased to a first position (for example, held in the first position by the conduit 10006) and returns to a displaced second position when withdrawn from the conduit 10006. The displaced position may be achieved, for example, by a tab, curved plastic or any other preferred structure. In this embodiment, the seal 10010 is positioned on the inner surface of the chamber 10008 so as to surround the container 1302. Furthermore, the outflow 10012 from the conduit 10006 is directed to the surrounding environment / atmosphere or used to actuate other mechanisms described herein. For example, the outflow 10012 is directed to move the rod 8002 to control the retraction of the needle. In the embodiments shown in Figures 10A-10F, the conduit 10006 opens automatically at the end of the injection, so there is no need for a valve 3010 to sense the end of the injection.

[0122] Referring to Figures 11 and 11A-11H, various discharge mechanisms that facilitate discharge from the fluid source 1366 are described below. The discharge system 11004 shown in Figures 11, 11A and 11B has a first straw 11005 and a second straw 11006. The first straw 11005 has a smaller diameter than the second straw 11006 and, in one or more configurations, is housed within the second straw 11006. For example, the first straw 11005 and the second straw 11006 form a telescopic structure. The base end of the first straw 11005 is connected to the fluid source 1366, and the tip of the second straw 11006 is connected to the piston 1316. Figure 11 shows the discharge system 11004 in the state before the fluid source 1366 is activated. In this configuration, the first straw 11005 is completely housed 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 activated, pressurized fluid moves through the lumen of the first straw 11005, driving the piston 1316. In some embodiments, the tip of the first straw 11005 is not directly connected to the piston 1316, and therefore the pressurized fluid biases 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 Figure 11A). At the end of the injection (Figure 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 in the first straw 11005 (not shown; details will be described later with reference to other figures), preventing relative movement between the first straw 11005 and the second straw 11006. At this point, the pressurized fluid flowing in from the fluid source 1366 detaches the base end of the first straw 11005 from the fluid source 1366, stopping the fluid flow from the fluid source 1366. Alternatively, the remaining propellant and pressurized fluid are discharged from the fluid source 1366 into the surroundings. The detachment of the first straw 11005 from the fluid source 1366 removes the only force acting on the container 1302 in the direction from the first end 1304 to the second end 1306. During injection, the force acting from the first end 1304 to the second end 1306 compresses the spring 11002 (see Figure 11B). When the force in that direction is removed, the spring 11002 expands, biasing the container 1302 in the direction from the second end 1306 to the first end 1304 (for example, 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, biasing the container 1302 in the direction from the second end 1306 toward the first end 1304.

[0124] Figures 11C and 11D show in more detail a discharge 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 elongate body portion 11005a with a lumen 11005b extending therein. The fluid source 1366 has a protrusion received by the lumen 11005b such that pressurized fluid exiting 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. For example, a seal 11005e, such as an O-ring, is connected to the proximal side surface of the distal flange 11005d. The second straw 11006 comprises a body portion 11006a having a closed tip and an open base. The second straw 11006 surrounds a space 11006b and has a flange 11006c near its base. Before the fluid source 1366 is actuated, the distal side surface of the proximal flange 11005c abuts and / or is proximate to the proximal side surface 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 toward the second end 1306 of the container 1302. At the end of injection, when the piston 1316 has moved within the container 1302 to the second end 1306 (the state of FIG. 11D), the distal side surface of the flange 11006c abuts the proximal side surface of the seal 11005e and / or the distal flange 11005d. When the piston 1316 hits the bottom, the second straw 11006 and the first straw 11005 (all connected to each other) are pulled away from the fluid source 1366, and the connection between the first straw 11005 and the fluid source 1366 is severed. When the connection between the first straw 11005 and the fluid source 1366 is severed, the flow of pressurized fluid stops or pressurized fluid flowing out of the fluid source 1366 thereafter is discharged to the surroundings and / or the atmosphere.

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

[0127] When the fluid source 1366 is activated, pressurized fluid moves through the lumen 11008b of the first straw 11008, driving the piston 1316. Since the tip of the first straw 11005 is directly connected to the piston 1316, the pressurized fluid moves the piston 1316 and the first straw 11008 toward the second end 1306 of the second container 1302 (see Figure 11F). At the end of the injection (Figure 11F), when the piston 1316 reaches the second end 1306 of the container 1302, the first straw 11008 can no longer move toward the tip. The pressurized gas continuing to be released 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, disconnecting the connection between the second straw 11009 and the fluid source 1366 (not shown). Once the connection between the second straw 11009 and the fluid source 1366 is disconnected, the flow of the pressurized fluid stops, or any pressurized fluid subsequently flowing out of the fluid source 1366 is discharged into the surroundings and eventually into the atmosphere.

[0128] Figures 11G and 11H show examples of features that can be used in either the discharge system 11004 or 11007 described above. Specifically, these figures show a coupling 11118 attached to the outlet of the fluid source 1366. The coupling 11118 is attached to the base end 11114a of the first straw 11114 (which may be the base end of any of the straws). The second straw 11112 is connected to a piston 1316 (not shown in Figures 11G and 11H) and is driven by pressurized fluid from the fluid source 1366. As previously mentioned, at the end of injection, the piston 1316 hits the bottom and reaches the second end 1306 of the container 1302 (not shown in Figures 11G and 11H). Further pressurized fluid released from the fluid source 1366 separates the first straw 11114, the second straw 11112, and the container 1302 from the connector 11118 and / or the fluid source 1366. Although the connector 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 directly receives pressurized gas from the fluid source 1366.

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

[0130] In one embodiment, the base end 11114a includes a shape memory material biased to the second arrangement, such as SMA, smart metal, shape memory metal, shape memory alloy, muscle wire, smart alloy, etc. In another embodiment, the base end 11114a is formed from a brittle material such that it breaks apart from the other part of the first straw 11114 after the first straw 11114 is detached from the connector 11118 and / or the fluid source 1366. In the second arrangement, the first straw 11114 is substantially prevented or inhibited from being reattached to the connector 11118 and / or the fluid source 1366, so that any propellant or pressurized gas remaining in the fluid source 1366 is discharged into the surroundings and eventually into the atmosphere, or the flow of pressurized gas from the fluid source 1366 is completely stopped.

[0131] Figures 12A to 12C show a valve (e.g., a butterfly valve) 11120 that can be used in conjunction with various embodiments disclosed herein, such as the embodiments shown in Figures 3A to 3C. In detail, the valve 11120 is connected to the high-pressure line 3002 and conduit 3018 of the valve 3010. Figure 12B shows the valve 11120 in a closed configuration, in which flow from the high-pressure line 3002 cannot pass 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. In some embodiments, the second inlet 11127 is configured to receive flow from the conduit 3018 of the valve 3010. The valve 11120 has a movable member 11128 configured to move within the housing 11122 and relative to the housing 11122.

[0132] In the closed configuration shown in Figure 12B, the movable member 11128 substantially or completely blocks the flow of pressurized gas from the high-pressure line 3002 via the valve 11120. The movable member 11128 is rotatable within the housing 11122 about its axis and has a movable pin 11130. The movable pin 11130 is located within the lumen 11131 of the movable member 11128 and can reciprocate within the lumen 11131. However, other preferred configurations are possible. For example, the movable pin 11130 may slide against a slot or recess of the movable member 11128. In the closed configuration shown in Figure 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, and as a result, the movable member 11128 rotates or moves to the second position shown in Figure 12C. The valve 11120 shown in Figure 12C is in an open configuration, and pressurized gas from the high-pressure line 3002 flows through the valve 11120, allowing any pressurized gas remaining in the fluid source 1366 to be discharged into the surrounding environment and eventually into the atmosphere.

[0133] Before the automatic syringe 2 is activated, the valve 11120 is in the closed position as shown in Figure 12B, and remains in the closed position after the fluid source 1366 is activated and during injection. That is, the valve 11120 is in the closed position until the piston 1316 is driven in the container 1302 and reaches the second end 1306 (hits the bottom). At the end of injection, the diaphragm 3012 of the valve 3010 (Figures 3A-3C) returns to the neutral position, allowing flow through the conduit 3018. The flow through the conduit 3018 acts on the movable pin 11130 (for example, pushing the movable pin 11130 into the lumen 11131), releasing the movable member 11128 from its locked first position. When the movable member 11128 is released from the locked first position shown in Figure 12B, the pressurized gas flowing through the high-pressure line 3002 moves through the valve 11120 to discharge any remaining propellant from the fluid source 1366.

[0134] Figures 13A to 13D show valve 11140, which can be used in conjunction with various embodiments disclosed herein, such as those shown in Figures 3A to 3C. Valve 11140 can be placed inside the auto-syringe 2, similar to valve 11120. For example, valve 11140 is connected to the high-pressure line 3002 and the conduit 3018.

[0135] Figure 13A shows valve 11140 in a closed configuration, in which flow from high-pressure line 3002 cannot pass through valve 11140. The housing 11142 of valve 11140 has a first inlet 11144 (configured to receive flow from high-pressure line 3002), an outlet 11146, and a second inlet 11148. In some embodiments, the second inlet 11148 is configured to receive flow from conduit 3018 of valve 3010. Valve 11140 has a piston 11150 configured to move within the housing 11142 and relative to the housing 11142. An elongated member, for example, the shaft 11156 of piston 11150, extends from a first end 11152 to a second end 11154. A vane 11157 is positioned on the shaft 11156. The blade section 11157 receives the flow of pressurized gas entering from the second inlet 11148 and rotates the piston 11150 around the longitudinal axis of the shaft 11156. In some embodiments, the blade section 11157 is formed from a woven fabric. The woven fabric consists of nylon, Dacron®, aramid fibers, or other suitable fibers.

[0136] The flange 11158 is positioned at the second end 11154 and connected to the end of the shaft 11156. As shown in Figure 13D, the flange 11158 has a substantially circular cross-section and has one or more recesses 11158a extending radially inward from the outer circumference. In the embodiment shown in Figure 13D, the flange 11158 has two recesses 11158a located on opposite sides of each other, approximately 180 degrees apart. However, it may have any other preferred number of recesses 11158a. The flange 11158 may also have another preferred shape, such as a rectangle or a square.

[0137] As shown in Figure 13A, the housing 11142 has one or more stoppers 11164 configured to abut against the surface of the flange 11158 to maintain the piston 11150 in the closed position shown in Figure 13A. When the piston 11150 is in the closed position, 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 aligns with the stopper 11164. When the recess 11158a aligns with the stopper 11164, the piston 11150 becomes movable longitudinally along the longitudinal axis of the shaft 11156, forming a flow path through the valve 11140 (a flow path from the first inlet 11144 to the outlet 11146).

[0138] Before the automatic syringe 2 is activated, the valve 11140 is in the closed position as shown in Figure 13A, and remains in the closed position after the fluid source 1366 is activated and during injection. That is, the valve 11140 is in the closed position until the piston 1316 is driven in the container 1302 and reaches the second end 1306 (hits the bottom). At the end of injection, the diaphragm 3012 of the valve 3010 (Figures 3A-3C) returns to the neutral position, allowing flow through the conduit 3018. The vanes 11157 receive the flow from the conduit 3018, causing the piston 11150 to rotate around the longitudinal axis of the shaft 11156, aligning the recess 11158a with the stopper 11164. Once 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 formed through valve 11140, and the pressurized gas flowing through high-pressure line 3002 is discharged to the surroundings and / or discharged into the atmosphere via outlet 11146.

[0139] Figures 14A and 14B show valve 11170, which can be used in conjunction with various embodiments disclosed herein, such as the embodiments shown in Figures 3A-3C. Valve 11170 is connected to the high-pressure line 3002 and conduit 3018 of valve 3010. Figure 14A shows valve 11170 in a closed configuration, in which flow from the high-pressure line 3002 cannot pass through valve 11170. The housing 11172 of 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. In some embodiments, the second inlet 11178 is configured to receive flow from the conduit 3018 of valve 3010. Valve 11170 has a piston 11180 configured to move within the housing 11172 relative to the housing 11172. The first seal 11182 and the second seal 11184 are positioned around the outer circumference of the piston 11180. In some embodiments, the first seal 11182 and the second seal 11184 are positioned in circumferential recesses of the piston 11180. However, the first seal 11182 and the second seal 11184 may be positioned around the continuous and uninterrupted outer surface of the piston 11180. In some embodiments, the 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 has an elastic member, such as a spring 11186, connected to the piston 11180. Spring 11186 is connected to the end of housing 11172 furthest from the second inlet 11178 and is biased to the extended configuration shown in Figure 14A. In this embodiment, the force acting on piston 11180 compresses spring 11186, causing valve 11170 to move to the open configuration shown in Figure 14B. In the open configuration shown in Figure 14B, pressurized gas exits valve 11170 through outlet 11176, via the space between housing 11172 and the reduced diameter portion 11185 of piston 11180, from high-pressure line 3002, through inlet 11174, through the space between housing 11172 and the reduced diameter portion 11185 of piston 11180.In an alternative embodiment, the spring 11186 is connected to the end face of the housing 11172 near the second inlet 11178 and is biased to a compressed state when the valve 11170 is in the closed position. In this alternative embodiment, the force acting on the piston 11180 expands the spring 11186, moving the valve 11170 to the open position.

[0140] In the closed configuration shown in Figure 14A, the first seal 11182 substantially or completely blocks the flow of pressurized gas from the high-pressure line 3002 through the valve 11170. Before the automatic syringe 2 is activated, the valve 11170 is in the closed configuration shown in Figure 14A, and remains in the closed configuration after the fluid source 1366 is activated and during injection. That is, the valve 11170 is in the closed configuration until the piston 1316 is driven in the container 1302 and reaches the second end 1306 (hits the bottom). At the end of injection, the diaphragm 3012 of the valve 3010 (Figures 3A-3C) returns to the neutral position, allowing flow through the conduit 3018. The flow from the conduit 3018 acts on the piston 11180, compressing the spring 11186. When valve 11170 moves from the closed configuration shown in Figure 14A to the open configuration shown in Figure 14B, the pressurized gas in the high-pressure line 3002 moves through valve 11170, discharging any remaining propellant in the fluid source 1366.

[0141] Figures 15A and 15B show embodiments that use one or more magnets to initiate discharge from a fluid source 1366 (not shown in Figures 15A and 15B). In one embodiment, a piston 1316 has or is connected to a first magnet 11190. The first magnet 11190 is connected to the outer surface of the piston 1316, embedded in the piston 1316, or connected to the back and trailing surfaces of the piston 1316 (this position is shown as 11190a). A second magnet 11192 (or 11192a) is located on the outside of the container 1302 and moves along the container 1302 as the piston 1316 moves inside the container 1302 due to the attractive force with the first magnet 11190 (or 11190a).

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

[0143] The valve 3010 shown in Figures 16A-16E is characterized to prevent the diaphragm 3012 from resealing the conduit 3018 after it has returned to a neutral position at the end of injection. The valve 3010 has a first locking member 21180 connected to the diaphragm 3012 by a coupling 21181. The first locking member 21180 has a locking recess 21180a configured to receive a locking element of a corresponding shape. As shown in Figure 16A, when the valve 3010 is in its initial position before the operation of the fluid source 1366, the first locking member 21180 is located in or connected to the conduit 3018. The valve 3010 also has an assembly 21185 spaced apart from the conduit 3018. Assembly 21185 has a plurality of arms 21185a spaced apart to define an opening 21187. In detail, each arm 21185a has a stopper 21186 consisting of an inclined surface and a flat surface. The inclined surface of the arm 21185a functions to allow the second locking member 21182 to move in one direction through assembly 21185, details of which will be described later. The second locking member 21182 has an inclined locking member 21183 configured to fit into a 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 activated with the valve 3010 in the first position shown in Figure 16A, the diaphragm 3012 moves downward to seal the conduit 3018. Since the first locking member 21180 is connected to the diaphragm 3012 by the coupling 21181, the first locking member 21180 also moves downward toward the second locking member 21182 (see Figure 16B) so that the inclined locking member 21183 is received in the recess 21180a and the first and second locking members 21180 and 21182 are connected to each other (Figures 16C and 16D). The valve 3010 is maintained in the configuration shown in Figures 16C and 16D while the piston 1316 moves within the container 1302 during injection. At the end of injection, the diaphragm 3012 returns to the neutral position shown in Figure 16E, opening the conduit 3018. At this time, the first and second locking members 21180 and 21183, which are connected to each other and connected 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, pushing the arm 21185a slightly radially outward, temporarily expanding the opening 21187. This causes the first and second locking members 21180 and 21183 to disengage from the opening 21187 (see Figure 16E). In this third arrangement, the stopper 21186 prevents the flange 21184 from moving downward and / or away from the conduit 3018. This prevention also prevents the diaphragm 3012 from moving downward and resealing the conduit 3018.

[0145] The needle mechanism 20 described below with reference to Figures 17, 18A-18D and 19-23 has a carrier 202. The needle mechanism 20 also has a fluid conduit 300 attached to the carrier 202. The fluid conduit 300 is deployed toward the user and retracted by a drive unit 320. A shuttle 340 (e.g., a shuttle actuator) is configured to move the drive unit 320 via a deployment gear 360 and a retraction gear 362. The shuttle 340 is connected to an elastic member (e.g., a spring 370). A cover 390 is connected to the carrier 202 and covers various components of the needle mechanism 20. By using one or more gears in the patient-side needle mechanism (to assist in the deployment and retraction of the needle 308 along the transverse axis), the height or length of the auto-injector 2 can be reduced compared to an auto-injector where the patient-side needle and drug container are aligned in a straight line. For example, the length of the auto-injector according to this disclosure along the longitudinal axis 40 can be shortened.

[0146] As shown in Figure 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 the user. The needle 306 has a sharp and / or beveled tip and generally extends along or parallel to the axis 44. The second end 304 has a needle 308 (see Figures 3A-3C). The needle 308 is substantially similar to the needle 306 but is located inside the auto-injector 2 and penetrates the container 1302 (mentioned above) to access the drug to be injected into the user. The fluid conduit 300 has an intermediate section 310 which includes a first section that extends along or parallel to the axis 40 and a second section that extends along or parallel to the axis 40. The first and second sections of the intermediate section 310 are connected by a coil 312. The coil 312 assists in the bending of the fluid conduit 300 and in the movement of the needle 306 along the axis 44 when the needle 306 is deployed and retracted toward the user. Although the coil 312 is illustrated, other suitable shapes may be used, e.g., serpentine, curved, or other shapes that allow for bending of the fluid conduit 300. The coil 312 or a similar structure acts as a cantilever when the needle 306 is deployed and / or retracted. Once the needle 308 penetrates and communicates with the container 1302 (see Figure 3B, etc.), the drug can move from the container 1302 toward the user through the needle 308, the intermediate section 310, and the needle 306 (which penetrates the user's skin). In some examples, the fluid conduit 300 consists solely of metal or a metal alloy. In other examples, the fluid conduit 300 contains any other suitable material, such as a polymer. Needle 308 and the intermediate section 310 constitute thin-walled needles of gauge 22 or 23, while needle 306 is a needle of gauge 27. In other words, the fluid conduit 300 has varying needle gauges along its length, specifically, needles 306 and 308 have different needle gauges. Needles of other sizes, such as gauge 6 to gauge 34, may be used as appropriate. By using the fluid conduit 300, the amount of components in contact with the drug can be reduced, the number of joints and assembly steps can be reduced, and the amount of sterilization required can be reduced 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 with an opening 206 and support columns 210, 212. The carrier 202 also has an opening 216 through which a needle or other fluid conduit is deployed. The opening 216 is a recessed slot from the end face of the carrier 202, and in an alternative embodiment, the entire outer circumference of the opening 216 is defined by a member of the carrier 202. The carrier 202 also has a drive passage 218. The drive passage 218 is a slot in the carrier 202 extending along or parallel to the axis 44. The drive passage 218 is configured to receive a projection of the drive unit 320, such as a projection 380, which will be described later. The carrier 202 also has a shuttle passage 220 through which the shuttle 340 moves. Further details will be described later.

[0148] The carrier 202 also has a stopper 240 configured to engage with the shuttle 340. The stopper 240 is a cantilever having a fixed end 241 (Figure 19) and a free end 242 (Figure 19). The stopper 240 has an inclined portion 243 (Figures 20 and 23). When the inclined portion 243 is engaged or pressed by the inclined portion 1500 (see Figure 23), it causes the stopper 240 to flex around the fixed end 241. In the first position, the free end 242 prevents or restricts the movement of the shuttle 340, and in the second position, it allows the movement of the shuttle 340. The relationship between the stopper 240 and the shuttle 340 will be described in detail later.

[0149] The drive unit 320 has two racks 322 and 324 positioned parallel to each other and on opposite sides of the drive unit 320 (Figures 18A-18C and 19). The racks 322 and 324 have teeth and are configured to engage with the deployment gear 360 and the retraction gear 362, respectively, to drive rotation. The drive unit 320 has a lumen 326 (or other preferred structure such as a track or recess) configured to receive the needle 306 of the fluid conduit 300 (Figure 18A). The drive unit 320 also has a projection 380 configured to slide within the drive unit passage 218 of the carrier 202 (Figures 17 and 18B-18D). The projection 380 has a hook-like configuration that "hooks" onto obstacles 382. Further details will be described later.

[0150] As shown in Figures 18A-18D, the shuttle 340 has a rack 342 configured to engage with gears 360 and 362. The shuttle 340 also has an end face 344 and a recess 346 that extends along the length of the shuttle 340 in the same direction as the rack 342. A slot 348 (Figure 20) extends longitudinally through the recess 346. The slot 348 penetrates the center of the recess 346 and extends along the entire or substantially entire recess 346.

[0151] The shuttle 340 moves along the track 220 from a first starting position (Figures 18B and 19) to a second intermediate position (Figures 18D, 20, and 21), and then from the second position to a third final position (located between the second and third positions in Figure 22). As the shuttle 340 moves along the track 220, the rack 342 engages first with the deployment gear 360 and then with the retraction gear 362. The rack 342 never engages with both the deployment gear 360 and the retraction gear 362 simultaneously. In some examples, for example, when the rack 342 is positioned longitudinally between the deployment gear 360 and the retraction gear 362, the rack 342 does not engage with either the deployment gear 360 or the retraction gear 362. The shuttle 340 is configured to move in only one direction along only one axis (e.g., 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 as the spring 370 expands, the shuttle 340 moves along the track 220 through the series of positions / arrangements described above. Different features of the automatic syringe 2 directly or indirectly obstruct the movement of the shuttle 340 at various positions. Alternatively, the spring 370 is expanded from its natural state, and as the spring 370 expands, the shuttle 340 moves along the track 220 through the series of positions / arrangements described above. In such embodiments, the shuttle 340 is connected to the opposite side, which is a different side of the shuttle 340, and to the opposite end of the automatic syringe 2.

[0152] The first position of the shuttle 340 shown in Figures 18B and 19 corresponds to the unused, undeployed, and / or new state of the automatic syringe 2. In this first position, the drive unit 320 is undeployed. The shuttle 340 is maintained in the first position by the placement of an obstacle 382 in the path of the projection 380 (Figures 17 and 18B). The obstacle 382 is a projection or other block member or device connected to the container 1302, which prevents the movement of the drive unit 320 by engaging and / or locking the projection 380. Thus, because the drive unit 320, the deployment gear 360, and the rack 342 are interconnected, the movement of the shuttle 340 is also prevented by the obstruction of the drive unit 320. The shuttle 340 can move from the first position to the second position by moving the obstacle 382 relative to the carrier 202 (or vice versa). In one embodiment, when the container 1302 moves due to the pressurized gas from the fluid source 1366 and communicates with the needle 308, the obstacle 382 is also moved (Figure 18C), but the carrier 202 remains stationary.

[0153] When the obstacle 382 is removed from the path of the drive unit 320 (Figure 18C), the spring 370 extends, moving 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, and the rotation of the deployment gear 360 causes the drive unit 320 to move downward along the axis 44 via the rack 322 of the drive unit 320. This downward movement of the drive unit 320 causes the needle 306 to puncture the user's skin. In some examples, the drive unit 320 is configured to move only along the axis 44 relative to the carrier 202.

[0154] The shuttle 340 moves to a position where its end face 344 abuts against the free end 242 of the stopper 240 due to the expansion of the spring 370, and is maintained in the second position shown in Figures 20 and 21. At this time, the free end 242 prevents the spring 370 from expanding any further and prevents the shuttle 340 from moving any further along the track 220. In this second position, the needle 306 is deployed toward the user, and the fluid from the container 1302 is injected toward the user through the fluid conduit 300. Furthermore, while the shuttle 340 is in the second position, the rack 342 engages with the deployment gear 360 to hold the needle 306 in the deployed position. The shuttle 340 becomes movable from the second position to the third position due to the bending of the stopper 240 around the fixed end 241. This bending will be described in detail later with reference to Figure 23. The deflection of the stopper 240 causes the spring 370 to expand further, pushing the shuttle 340 further along the track 220. In some examples, as the shuttle 340 moves from a second position to a third position, the stopper 240 is received in the recess 346 of the shuttle 340 and the inclined portion 243 slides within the slot 348.

[0155] The movement of the shuttle 340 from the second position to the third position corresponds to the retraction of the needle 306 from the user to the housing 3. In detail, the rack 342 engages with the retraction gear 362 and rotates in the same direction as the rotation of the deployment gear 360 (e.g., counterclockwise or clockwise). The rotation of the retraction gear 362 moves the drive unit 320 back to the retracted position via the rack 324. The shuttle 340 reaches the third position with the drive unit 320 fully retracted when the end face 344 engages with 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 drive unit 320 returns from the deployed state to the retracted state, it is prevented from moving from the retracted state. As a result, the needle 306 is prevented from being deployed again to the user. In such a configuration, the automatic syringe 2 is a disposable device (for example, discarded after completing one injection). In other embodiments, the automatic syringe 2 is reused after resetting. Also, in some examples, the automatic syringe 2 does not have any rotating gears other than the deployment gear 360 and the retraction gear 362.

[0157] After the drug / therapy is delivered to the user via the needle 306, the needle 306 is automatically withdrawn from the user. For example, by the expansion (or contraction) of the spring, the container 1302 moves in the opposite direction along the axis 40 (opposite to the direction of fluid delivery and needle 306 insertion). As the container 1302 moves in the opposite direction, the inclined portion 1500 (attached to the wall 1391) in Figure 23 is pressed against the inclined portion 243 of the stopper 240. This causes the stopper 240 to flex in the direction of arrow 240a with the fixed end 241 as the pivot point, and the shuttle 340 moves from the second position to the third position, allowing the needle 306 to retract as described above. In this way, both the withdrawal and insertion of the needle into the patient can be achieved with a single spring in the device.

[0158] Figures 23A–23C show another embodiment of injecting and retracting the needle 306 (or other patient-side needle) as described herein. Figures 23A and 23B show the same process and structure as shown in Figures 18B–18D and 19–21 for injecting the needle 306 into the patient. As previously described with reference to Figures 12A–12C and 23, the retraction of the needle 306 is assisted by the force of the rod 8002 and the gas / fluid from the discharge conduit 3018. That is, after the injection is complete and the pressures of the high-pressure cavity and the low-pressure cavity are balanced (e.g., as described above with respect to valve 3010), the gas / fluid from the fluid source 1366 is discharged through the discharge conduit 3018 to move the rod 8002. The rod 8002 either directly contacts the stopper 240 and moves it away from the path of the shuttle 340 (Figure 23C), or acts on the inclined portion 1500 that is in direct contact with the stopper 240, as shown in Figure 23.

[0159] In the alternative embodiment shown in Figure 23D, a single rotating gear 360a is used for needle insertion and retraction instead of the gears 360 and 362 described above. Needle insertion is initiated in substantially the same manner as described above with respect to Figures 18B-18D and 19-21, with the shuttle 340 moving linearly by the expansion of the spring 370. The linear movement of the shuttle 340 causes the rack gear 342 to rotate the gear 360a. As the gear 360a rotates in the first direction, the drive unit 320 and the needle 306 are deployed downward (towards the skin surface). In this embodiment, the retraction of the needle 306 is performed by returning the shuttle 340 to its initial position. More specifically, pressurized gas / fluid from the discharge conduit 3018 pushes the rod 8002 into contact with the shuttle 340. The action of the rod 8002 on the shuttle 340 compresses the spring 370, returning the shuttle 340 to its initial position. The shuttle 340 returns to its initial position along the same path it traveled (in the reverse direction) to deploy the needle 306. The reverse movement of the shuttle 340 causes the gear 360a to rotate in a second direction opposite to the first direction, retracting the drive unit 320 and the needle 306 from the patient to the auto-injector 2. A lockout feature 8002f connected to the rod 8002 is configured to prevent the rod 8002 from retracting. In this embodiment, if the rod 8002 retracts into the discharge conduit 3018, unintended redeployment of the needle 306 occurs. To suppress such redeployment, the lockout feature 8002f is activated while the needle 306 is retracting. In one embodiment, the lockout feature 8002f is a flexible member, such as an elastic member, extending from the outer circumferential surface of the rod 8002 and biased into an expanded shape. Before retraction begins, the lockout feature 8002f is constrained by the inner surface of the discharge conduit 3018 in which the rod 8002 is positioned. When the rod 8002 is pushed beyond a predetermined point, for example, when the lockout feature 8002f exits the discharge conduit 3018, the lockout feature 8002f is released and self-expands radially outward toward its expanded natural state. Once in its expanded natural state, the lockout feature 8002f cannot re-enter the discharge conduit 3018.The end portion of the channel, for example, end portion 8002g, functions as a stopper for the lockout feature portion 8002f. In yet another embodiment, the lockout feature portion 8002f is a magnet and is configured to be fixed to a magnet on the end portion 8002g of the discharge conduit 3018, or to a magnet located inside or along the discharge conduit 3018. For example, a portion of the inner surface of the discharge conduit 3018 has a magnet.

[0160] Figures 23E-23G show another alternative embodiment in which the needle is inserted and retracted using the rotating gear 360a, and another arrangement of the elements of the system in Figure 23D. As shown in these figures, the shuttle 340 may be above or below the spur gear 360 with respect to the skin. As shown in Figure 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 substantially 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. Furthermore, the shuttle 340 is coupled to and / or integrally combined with the push rod 8002. Needle insertion is initiated by initial pressure from the gas canister, as previously described. The linear movement of the shuttle 340 in the first linear direction causes the rack gear 342 to rotate the gear 360a. As shown in Figure 23F, when gear 360a rotates in the first rotational direction, the drive unit 320 and needle 306 extend downward (towards the skin surface). The linear movement of shuttle 340 and the resulting linear movement of push rod 8002 also compress (or expand in an alternative embodiment) spring 370. Next, as shown in Figure 23G, when the gas force acting on push rod 8002 becomes less than the force of spring 370, spring 370 expands (or compresses in an alternative embodiment) and pushes push rod 8002 and shuttle 340 in a second linear direction opposite to the first linear direction. The linear motion of shuttle 340 in the second linear direction causes gear 360a to rotate in the second rotational direction opposite to the first rotational direction. As gear 360a rotates in the second rotational direction, the drive unit 320 and needle 306 retract upward (away from the skin surface).

[0161] Figures 23H and 23I are further diagrams showing a patient-side needle mechanism performing the steps described above with reference to Figures 23E-23G. As shown, the needle mechanism comprises a push rod 8002, a modified shuttle 340, a drive unit 320, a spur gear 360, a spring 370, and a needle (not shown). The push rod 8002 has, for example, a seal gap 8008 for receiving a seal. As shown in Figure 23I, the shuttle 340 has two parallel sections 340b and 340c. The shuttle 340 also has one or more projections 341, for example, two projections 341. The projections 341 extend perpendicularly from the shuttle 340, for example perpendicularly to sections 340b and 340c. The projections 341 are connected to an indicator (not shown; details will be described later) which moves the indicator, for example, to show the user the progress of the needle mechanism.

[0162] Sections 340b and 340c are connected via section 340d, which is perpendicular to sections 340b and 340c (and projection 341). As shown, section 340d lies in the same plane as sections 340b and 340c and is perpendicular to projection 341. Section 340b has a rack 342 (not shown in Figures 23H and 23I) that can contact and / or engage with the spur gear 360a and, as previously stated, can control the movement of the spur gear 360, the drive unit 320, and the patient-side needle (not shown). Section 340c extends parallel to a portion of section 340b and interacts with the spring 370. For example, section 340c is surrounded by a portion of the spring 370. In another example, not shown, section 340c is fixed to or attached to a portion of the spring 370. In any embodiment, the spring 370 surrounds or is otherwise connected to a spring cover 8010 fixed to the carrier 202. The spring cover 8010 may extend from a carrier such as the carrier 202, be formed by a portion of the cover of the carrier 202, or be otherwise formed inside the auto-syringe 2. In this way, the spring 370 biases the shuttle 340 and the entire push rod 8002 by biasing portion 340c. In this embodiment, the carrier 202 has a button movement portion and also supports at least a portion of the sterile connector shown in Figure 9I.

[0163] In embodiments described with reference to Figures 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 related components are suppressed. Part 340b of the shuttle 340 is positioned parallel to and offset from part 340c, so that the needle can be positioned in a central location, such as below the actuation button. Furthermore, although not shown in Figure 23I, the teeth of the shuttle are located below the spur gear 360a relative to the skin, etc. Furthermore, in Figure 23H, the spur gear 360a is located to the right of the needle drive unit 320 (therefore, the needle drive unit 320 is to the left of the spur gear 360a). Having such embodiments makes it easier to accommodate the needle drive assembly while satisfying constraints on dimensions, space, or placement within the automatic syringe 2. For example, when shuttle 340 is actuated (for example, moved to the right in Figures 23H and 23I by the actuating force of push rod 8002), shuttle 340 rotates spur gear 360a counterclockwise to insert the needle. When shuttle 340 retracts (for example, moved to the left in Figures 23H and 23I by the biasing force of spring 370), shuttle 340 rotates spur gear 360a clockwise to retract the needle. Naturally, one or more directions and orientations can be changed based on the specific application.

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

[0165] Although not shown, one or more additional features described above, such as the lockout feature 8002f, may be incorporated into the embodiments shown in Figures 23E to 23I. By arranging the elements as shown in Figures 23E to 23I, the needle deployment mechanism can be made smaller and / or more individualized, and as a result, it can be easily and / or inexpensively housed in a housing such as the automatic syringe 2.

[0166] Figures 23J-23L show yet another alternative embodiment of needle insertion and retraction. In the embodiments shown in these figures, needle insertion is performed by utilizing a portion of the high-pressure flow (through the high-pressure line 3002) from the fluid source 1366. The carrier 202a has a spur gear 360a and a drive unit 320 as described above. When the gear 360a rotates in a first direction, the drive unit 320 extends, and when the gear 360a rotates in a second direction (opposite to the first direction), the drive unit 320 retracts. The gear 360a is rotated by a shuttle 340a. The shuttle 340a is similar to the shuttle 340 described above, except that the shuttle 340a has a rod 340f positioned in a high-pressure channel 340c configured to receive high-pressure gas / fluid from the high-pressure line 3002. In Figures 23J and 23K, the rod 340f is shown integrally with the shuttle 340a, but the rod 340f and the shuttle 340a may not be integral to each other but may be separate components that move toward and away from each other. If the rod 340f and the shuttle 340a are separate components, their orientation toward 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 the first end 340e (the end furthest from the shuttle 340a). The presence of the seal 340d ensures that the 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 the other parts of the shuttle 340. The length of the rod 340f can be set as appropriate and may be shorter, the same as, or longer than the length of the other parts of the shuttle 340a. For example, the length of the rod 340f is approximately 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, or 4 times the length of the other parts of the shuttle 340a. Of course, other suitable values ​​may also be used. The carrier 202a has an elastic member or spring 370a that is expanded in its natural state as shown in Figure 23J.Spring 370a is connected to the end of shuttle 340a opposite to rod 340f, and the spring force of spring 370a maintains gear 360a in its initial position (so that the needle drive unit 320 and needle 306 are in the retracted / non-deployed position). When pressurized gas / fluid is released from fluid source 1366 (see Figures 3A-3C), the gas / fluid flow through high-pressure line 3002 and channel 340c pushes rod 340f and shuttle 340a against spring 370a, compressing spring 370a. As shuttle 340a moves linearly and compresses spring 370a, rack gear 342 on shuttle 340a rotates gear 360a, deploying drive unit 320 to the deployed / injected position (Figure 23K). Figure 23L shows the completed injection and retraction of drive unit 320 and needle 306. In Figure 23L, the piston 1316 has completed its movement throughout the entire vessel 1302 (the piston 1316 is "bottomed out"). As previously mentioned, at this stage the pressures in the high-pressure cavity 3022 and the low-pressure cavity 3024 are balanced (as previously described with respect to valve 3010), and the gas / fluid is being discharged through the discharge conduit 3018. After balance, the pressures in the high-pressure cavity 3022, the high-pressure line 3002, and the channel 340c become less than the spring force of the spring 370a, allowing the spring 370a to expand to its natural extended state. The expansion of the spring 370a returns the shuttle 340a to its initial position. During this movement of the shuttle 340a to its initial position, the rack 342 rotates the gear 360a in a second direction, which causes the drive unit 320 and the needle 306 to retract into the automatic syringe 2. The container 1302 shown in Figures 23J and 23K is fixed, and in this embodiment, the needle 308 moves so as to penetrate the fixed container 1302 (see Figures 27A and 27B later) to connect the fluid conduit 300 to the container 1302. However, the container 1302 may also be connected to the fluid conduit 300 by moving from the first end 1302 to the second end 1304 and contacting the fixed needle 308 (see Figures 28A and 28B later). Figure 23M shows a drive system 3000a that provides the 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 Figures 3A-3C, but is configured to actuate the patient-side needle mechanism (including the rod 340f, etc.) with the 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, the pressurized gas exits the fluid source 1366 through conduit 3002a and enters the high-pressure channel 340c, pushing the rod 340f. As described above, the pressurized gas acting on the rod 340f ultimately deploys the needle 306 toward the user. Only after the rod 340f has traveled a sufficient distance through the high-pressure channel 340c (for example, a sufficient distance to partially or completely insert the needle 306 toward the user) does the pressurized gas flow from conduit 3002a to the high-pressure line 3002. After traveling a sufficient distance, the pressurized gas flows through the drive system 3000a in substantially the same manner as described above with respect to the drive system 3000 (Figures 3A-3C). This arrangement, in particular by configuring the pressurized gas so that it cannot move within the drive system 3000a until the patient-side needle mechanism has been deployed, prevents the container 1302 and needle 308 (Figure 18A) from unintentionally approaching each other earlier than the appropriate timing. In other words, this arrangement prevents the communication between the container 1302 and the fluid conduit 300 from being established earlier than the appropriate timing, which would cause malfunctions in the auto-injector 2 (e.g., malfunctions due to leakage of medication within the auto-injector 2). The drive system 3000a has a discharge system 2300a (similar to the discharge systems described herein, such as discharge system 9100). For example, the discharge system 2300a has a dump valve.

[0167] Furthermore, the fluid conduit 300 is the only fluid conduit of the auto-injector 2 configured to communicate with the container 1302. Thus, the drug / therapeutic agent in the container 1302 is delivered to the user only through the fluid conduit 300 during the normal operation of the auto-injector 2. In addition, the needle 306 is the only needle of the auto-injector 2 configured to deploy toward the patient. In this way, the fluid is delivered from the container 1302 to the patient using a single (only one) metal or plastic part.

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

[0169] The spring 370b is connected to the container 1302 and / or shuttle 340h and is configured to bias the container 1302 / shuttle 340h to the position shown in Figure 23O, providing the force necessary to return the shuttle 340h toward the initial position (or toward the initial position or a third position near the initial position). In other words, the spring 370b is configured to retract the needle drive unit 320 (e.g., via gear 360a) and provide the force necessary to pull the patient-side end of the needle 306 away 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 connected to the container 1302 and / or shuttle 340h, and the other end of the spring 370b is connected to another fixed or stationary part of the autosynergia 2, such as the housing 3 or carrier 202, to form a spring stopper 371.

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

[0171] Figures 23R-23U are schematic diagrams showing the system flow within the automatic syringe 2t (see Figures 48A-48C, 48H, and 48I for further details). This system flow is substantially similar to the system flow shown in Figures 3A and 23M, etc. As shown, the automatic syringe 2t has a retraction system 23100 similar to the discharge system 2300A. As shown, the retraction system 23100 has a movable cover 23102 relative to the needle 306 and part of the housing 3. Furthermore, the cover 23102 is located near the gas canister or fluid source 1366 and the discharge system 2300. The discharge system 2300 has a dump valve. As previously mentioned, the automatic syringe 2t has a container 1302, a flow limiter 3008, a valve 3010 with a diaphragm 3012, a discharge line 3006, and other components connected via a plurality of conduits.

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

[0173] Another conduit or connection, e.g., conduit 23104, is also provided, connecting the lid 23102 to the discharge system 2300. While the diaphragm 3012 is under high pressure sealing the discharge line 3006, a dump valve in the retraction system 23100 prevents gas from flowing through conduit 23104. When the pressure is balanced and the diaphragm 3012 is lifted from its valve seat, the discharge 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 conduit 23104. Then, as shown in Figures 23T and 48C, the force of the gas flowing through conduit 23104 biases and expands the lid 23102, causing the needle 306 to retract.

[0174] Figure 23U shows another schematic diagram of the automatic syringe 2t. As shown, the lid 23102 is connected to the discharge system 2300 via a physical connection. For example, the discharge system 2300 has a piston or push rod 23106 on a conduit 23104, or is connected to the push rod 23106. The push rod 23106 is movable to control the position of the lid 23102 relative to the housing and needle 306 of the automatic syringe 2t. In this embodiment, the position of the push rod 23106 is controlled by the fluid flow from the fluid source 1366, the valve 3010, the discharge line 3006, and the discharge system 2300, and thus the position of the lid 23102.

[0175] Figure 24 shows another mechanism for inserting the needle 306 into the user / patient. In this embodiment, pressurized gas is diverted from the high-pressure line 3002 towards the housing 18002. A piston 18004 with a seal 18004a is connected to the needle 306 inside the housing 18002. A spring or other elastic member 18006 is connected to the piston 18004 and biases the piston 18004 into a retracted position (e.g., inside 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 spring 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 discharged from the fluid source 1366), the needle 306 retracts.

[0176] Figures 25A and 25B show another configuration of the automatic syringe 19000. In this configuration as well, the automatic syringe 19000 has a container 1302, a piston 1316, and a fluid source 1366. Figures 25A and 25B also show a fluid connection 19003, a secondary cylinder 19004, a hydraulic fluid 19005, a dumbbell-shaped piston 19006, an operating lever 19009, and an operating cylinder 19010. The secondary container 19002 has a port 19002a that penetrates the outer circumferential surface of the secondary container 19002.

[0177] The piston 1316 seals the drug contained in container 1302 from the hydraulic fluid 19005 and functions as a boundary for discharging the drug from container 1302 (for example, discharging from left to right in Figures 25A and 25B). The fluid connector 19003 moves the hydraulic fluid 19005 from the secondary container 19002 to container 1302, thereby moving the piston 1316. The fluid connector 19003 also allows for the diversion of the hydraulic fluid 19005 to the operating cylinder 19010. The operating cylinder 19010 has a piston 19012 configured to operate additional components of the device (e.g., operating or retracting a needle mechanism, operating a sterilization connector, etc.). The dumbbell-shaped piston 19006 in the secondary container 19002 includes a propulsion boundary on which pressurized gas from the fluid source 1366 acts, and functions as a boundary between the fluid source 1366 and the hydraulic fluid 19005. Furthermore, the dumbbell-shaped piston 19006 has two heads 19006a connected to each other by a shaft 19006b. The diameters of each head 19006a are approximately equal. Alternatively, any of the piston configurations described in U.S. Patent Application Publication No. 2016 / 0243309 may be used instead of the dumbbell-shaped piston 19006. Furthermore, the dumbbell-shaped piston 19006 can also be used in other configurations herein as an alternative structure to the piston 1316.

[0178] When pressurized gas from the fluid source 1366 acts, the dumbbell-shaped piston 19006 applies force to the hydraulic fluid 19005. The space between the ends of the dumbbell-shaped piston 19006 may be configured to be small so that a predetermined operation is performed by the actuating lever 19009 before the dumbbell-shaped piston 19006 moves the hydraulic fluid 19005 through the fluid connection 19003. The actuating lever 19009 is configured so that various operations are performed when the lever is moved by the pressure on the propulsion boundary of the dumbbell-shaped piston 19006. For example, the actuating lever 19009 can perform the operation of the needle 306, the retraction of the needle 306, or the movement of the container 1302 (or another preferred container).

[0179] As shown in Figure 25A, the trailing piston head 19006a is initially positioned upstream of port 19004a. For example, port 19004a is positioned longitudinally between the piston heads 19006a, as shown in Figure 25A. Alternatively, port 19004a is positioned downstream of the entire piston 19006. The trailing piston head 19006a is eventually pushed past port 19002a (downstream) (Figure 25B), at which point the pressurized gas from the fluid source 1366 stops pushing the piston 19006 in the secondary container 19002 and is discharged from port 19002a. The discharged pressurized gas flows out into the inside of the automatic syringe 2 and / or into the atmosphere.

[0180] The container 1302 shown in Figures 26A and 26B has a seal 26014 at its second end 1306 instead of a 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 internal void 26016 that communicates with the contents of the container 1302. The void 26016 extends from the second end 1306 of the container 1302 away from the interior of the container 1302. Communication between the container 1302 and the fluid conduit 300a is established by one end of the fluid conduit 300a passing through the seal 26014. The fluid conduit 300a has a needle 306a, an intermediate section 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. Needle 308a extends substantially parallel to needle 306a and is configured to penetrate seal 26014 along a path substantially perpendicular to the longitudinal axis of container 1302. Needle 308a penetrates seal 26014 and enters void 26016, connecting fluid conduit 300a and container 1302 to each other. That is, once needle 308a enters void 26016, the drug flows from container 1302 into void 26016 and needle 308a. The drug then moves towards the user / patient side through the remainder of conduit 300a. Both needle 306a and needle 308a extend substantially perpendicular to the longitudinal axis of container 1302. The intermediate portion 310a connects needle 308a to needle 306a and extends substantially perpendicular to both needle 306a and needle 308a. Therefore, the intermediate section 310a extends approximately parallel to the longitudinal axis of the container 1302, and adjacent straight sections of the fluid conduit 300a are perpendicular to each other. The configuration shown in Figures 26A and 26B reduces the number of bends and corners in the fluid conduit 300a, thereby facilitating fluid flow through the conduit (i.e., reducing the number of bends in the fluid conduit reduces the restriction on fluid flow). The fluid conduit 300a is moved by an expansion spring or by a button directly connected to the fluid conduit 300a, which moves when the button is pressed, causing the needle 308a to penetrate the seal 26014. Alternatively, the fluid conduit 300a is driven by a pressurized fluid / gas flow from the fluid source 1366.Furthermore, the embodiment shown in Figure 26A may be configured such that, regardless of the driving force, the perforation of the seal 26014 by the needle 308a and the extrusion of the needle 306a from the automatic syringe to the user / patient are performed simultaneously with the same force.

[0181] In the embodiments shown in Figures 27A and 27B, the fluid conduit 300b communicates with the fixed container 1302 by moving relative to the container 1302. The fluid conduit 300b has a needle 306b substantially similar to the needles 306 and 306a described above. The needle 308b extends substantially perpendicular to the needle 306b and is configured to penetrate the seal 1314 along a path substantially parallel to the longitudinal axis of the container 1302. The intermediate sections 310b and 311b connect the needles 306b and 308b. After the fluid conduit 300b penetrates the seal 1314, the drug flows from the container 1302 in the following order: needle 308b, intermediate section 311b, intermediate section 310b, and needle 306b. The intermediate section 310b is approximately parallel to the longitudinal axis of the container 1302, while the intermediate section 311b is approximately perpendicular to the longitudinal axis of the container 1302. Similar to the fluid conduit 300a, adjacent straight sections of the fluid conduit 300b are perpendicular to each other. In the embodiments shown in Figures 27A and 27B, the speed is not optimal (the conduit 300a moves faster than the optimal speed) and coring may occur (part of the seal is dislodged by the needle 308, and part of the dislodged portion moves and clogs the fluid conduit), but because the container 1302 is fixed, it is possible to use an internal seal (described later with reference to Figure 29A). By using an internal seal of the container 1302, the overall size of the auto-syringe 2 can be reduced. In other words, when an internal 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 the fixed fluid conduit 300b during the penetration process (described later), thus reducing the housing size of the container 1302 and the corresponding valve (valve 3010, etc.).

[0182] The embodiments shown in Figures 28A and 28B are similar to the embodiments in Figures 27A and 27B, but differ in that the container 1302 moves toward the fixed fluid conduit 300b to connect the container 1302 with the fluid conduit 300b. This particular embodiment requires a seal surrounding the outside of the container 1302 (see Figure 29B, described later). This seal is generally larger than an internal seal with a seal ring inside the container 1302. Also, in the embodiments of Figures 28A and 28B, the target area of ​​the fluid conduit 300b relative to the container 1302 is relatively small, and the container 1302 may wobble, which can cause problems in needle alignment. 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 compared to when the same amount of pressurized gas acts on the fluid conduit 300. This makes it easier to control than the embodiments shown in Figures 27A and 27B.

[0183] Figures 29A and 29B show different mechanisms for sealing the space at the first end 1304 of the container 1302. In the embodiments shown in Figures 29A and 29B, the sealed space is configured to receive gas or fluid from a fluid source 1366, move the container 1302 toward the fluid conduit 300 to establish communication between the container 1302 and the fluid conduit 300, and drive a piston 1316 within the container 1302. In the embodiment shown in Figure 29A, the seal housing 29002 has a circumferential groove 29004 on its outer surface. The seal 29006 is located within the groove 29004. At least a portion of the seal housing 29002, substantially the entire groove 29004, and the seal 29006 are inserted into the first end 1304 of the container 1302. In some embodiments, the seal housing 29002 and seal 29006 are held in place within the container 1302 by press-fit or friction fitting. The seal housing 29002 has a conduit 29008 through which pressurized gas / fluid from the fluid source 1366 flows into the container 1302, pushing the piston 1316 within the container 1302. Although only one seal 29006 and groove 29004 are shown, additional seals and grooves may be present. In some embodiments, particularly when the amount of drug in the container 1302 is relatively large, a relatively small space is formed behind the piston 1316 within the housing 3 (the piston 1316 is located relatively close to the first end 1304 of the container 1302). The embodiment shown in Figure 29A is suitably applicable to a through-mechanism in which the container 1302 is held in a fixed position and the fluid conduit (e.g., fluid conduit 300) moves toward the container 1302. Furthermore, because the inside of the container 1302 is sealed (the ring of the seal 29006 is in contact with the inner circumferential surface of the container 1302), the embodiment in Figure 29A is smaller than other embodiments (for example, a configuration in which the seal is in contact with the outer circumferential surface of the container 1302), allowing the container 1302 to be used in a smaller auto-syringe housing / casing. The seal housing 29002 is fixed to the housing 3 of the auto-syringe 2.

[0184] Although not shown, the container 1302 has a suitable size and / or shape to accommodate, for example, the container 1302 within the housing 3 of the automatic syringe 2. 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 about 6 to 10 mm longer than the fluid cartridge, for example, about 8 mm. The size and / or shape of the container 1302 may be configured to accommodate one or more seals behind the piston, and may also be configured to create additional space (for example, within the container 1302) for the fluid cartridge to slide toward and / or to the needle. Furthermore, the container 1302 may have one or more seals, for example, a dynamic seal on the inside or on an inner portion of the container 1302.

[0185] In the embodiment shown in Figure 29B, the seal housing 29012 has a circumferential groove 29014 on its inner surface. The seal 29016 is located within the groove 29014, and at least a portion of the seal housing 29012, groove 29004, and seal 29006 is located outside the first end 1304 of the vessel 1302. In some embodiments, the seal housing 29012 and seal 29016 are held around the vessel 1302 by press-fit or friction fitting. The seal housing 29012 has a conduit 29018 through which pressurized gas / fluid from a fluid source 1366 flows into the vessel 1302 and pushes a piston 1316 within the vessel 1302. Although only one seal 29016 and groove 29014 are shown, additional seals and grooves may be present. The embodiment shown in Figure 29B is particularly suitable for use with an operating mechanism that moves the container 1302 toward a fixed fluid conduit. In particular, since the seal 29016 is located on the outside of the container 1302, there is no risk of the seal 29016 coming off when the container 1302 moves toward the seal 29016. For example, the seal 29016 can be located near the second end 1306 of the container 1302 without affecting the volume of the drug in the container 1302 (allowing for a longer travel distance of the container 1302). Thus, the seal housing 29012 allows for the storage of more drug in the container 1302 compared to the seal housing 29002, or allows for the placement of a larger container 1302 within a given auto-injector 2. However, the embodiment shown in Figure 29B occupies more space than the embodiment shown in Figure 29A. The seal housing 29012 is fixed to the housing 3 of the auto-injector 2.

[0186] The operating mechanism of the fluid source 1366 shown in Figures 30A and 30B includes, for example, a button 52 that is movable relative to the housing 3 of the automatic syringe 2. In this embodiment, the button 52 has a stopper 52a that maintains the spring 30070 in a compressed position (Figure 30A). While the spring 30070 is in the compressed position, the fluid source 1366 is in a non-operating state (i.e., does not supply fluid or gas). For example, when the spring 30070 is compressed, the valve stem is maintained in a closed position. When the button 52 is pressed (or when relative movement occurs between the button 52 and the housing 3), the stopper 52a is disengaged from the path of the spring 30070, and the spring 30070 expands (Figure 30B). This expansion moves the valve stem into an open position, allowing fluid / gas to flow out of the fluid source 1366. In another embodiment, the valve stem is kept fixed within the automatic syringe 2, and the spring 30070 is connected to a portion of the fluid source 1366 that moves relative to the fixed valve stem, thereby enabling the fluid source 1366 to be activated or deactivated.

[0187] In the operating mechanism of the fluid source 1366 shown in Figures 31A and 31B, pressing button 52 directly activates the fluid source 1366. For example, when button 52 is pressed against the housing 3, button 52 makes direct contact with a part of the fluid source 1366. For example, button 52 contacts the valve stem of the fluid source 1366, moving it to the open position and generating a fluid / gas flow from the fluid source 1366. Alternatively, the valve stem is kept fixed within the automatic syringe 2, and button 52 is connected to a part of the fluid source 1366 that moves relative to the fixed valve stem, thereby activating / deactivating the fluid source 1366.

[0188] Figures 32A and 32B show another mechanism for operating the fluid source 1366. This mechanism has, for example, a button 52 that is movable relative to the housing 3 of the auto-syringe 2. In this embodiment, the button 52 has a stopper 52a that holds a spring 32070 in a compressed position (Figure 32A). The spring 32070 is connected to a fluid conduit (e.g., the fluid conduit 300 described above) and moves the needle 308 or another similar needle to communicate 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 is disengaged from the path of the spring 32070, and the spring 32070 expands (Figure 30B). The expansion of the spring 32070 directly or indirectly drives the patient-side needle mechanism as described above, causing the needle (e.g., needle 306) to exit the auto-syringe and be inserted into the patient. The patient-side needle mechanism is generally shown as patient-side needle mechanism 32100 in Figures 32A and 32B. The patient-side needle mechanism 32100 may be any part of the patient-side needle mechanism described herein, for example, various shuttles, rods, racks, drive units, fluid conduits, carriers, or other movable structures used for needle deployment to the patient. These features can be configured to contact and actuate the canister, for example, by moving the valve stem from a closed position to an open position, or by moving another part of the canister relative to a fixed valve stem.

[0189] Figures 32C to 32H show additional embodiments of another mechanism for activating a fluid source, for example, via a button 52. As shown in Figure 32C, the button 52 is located on or coplanar with the outer surface of the housing 3 of the automatic syringe 2. As shown in more detail in Figures 32D and 32E, the button 52 is connected to a spring 32070 that surrounds a spring carrier 32072, and the spring 32070 is connected to a gas canister 32074. The spring carrier 32072 is substantially cylindrical and has 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] Figure 32F shows the unused or non-operational (pre-operation) state of button 52. As shown in Figure 32F, the carrier post 32072b is blocked by the patient-side needle mechanism carrier and the button stopper 32078 (substantially the same as carrier 202 or other carriers described herein), preventing the release of the spring 32070. Figure 32G shows the operational state (pressed by the user). In this embodiment, when button 52 is activated, the carrier post 32072b is also pressed down (or the spring carrier 32072 rotates, causing the carrier post 32072b to rotate). Figure 32H shows the fully activated state. As shown in Figure 32H, since the carrier post 32072b is detached from the retaining portion and button retaining portion 32078 of the patient-side needle mechanism carrier, the spring 32070 can expand, and the expansion of the spring 32070 pushes the spring carrier 32072 into a portion of the gas canister 32074. In one embodiment, the pushing of the spring carrier 32073 into a portion of the gas canister 32074 provides a force that initiates gas release from the canister 32074. For example, the spring 32070 applies a force of approximately 20-40 N, e.g., approximately 30 N, to the spring carrier 32072.

[0191] Since the above operating system consists of only three components, the system structure is simple. For example, the above operating system can improve ease of assembly and / or manufacturing.

[0192] Figures 32I to 32M show additional embodiments of another mechanism for activating the fluid source via a button 52, etc., located on or inside the outer surface of the housing 3 of the automatic syringe 2. As shown in more detail in Figures 32J to 32M, the button 52 activates the actuation mechanism 32080.

[0193] Figure 32J shows the operating mechanism 32080 in an unused or non-operating state. As shown, the operating mechanism 32080 comprises a carrier 32082 (including one or more feature parts 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 has, for example, a substantially horizontal portion 32084a extending parallel to the outer surface of the button 52. The actuator 32084 also has a substantially vertical portion 32084b. The vertical portion 32084b has two arms 32084c. The movement of the actuator 32084 is also at least partially restricted or blocked by a release tab (not shown) of a release tab boundary portion 32088 located at or near the bottom or tissue engagement surface of the auto-injector 2. The release tab is positioned at least one site on the tissue engagement surface of the auto-injector 2, through which the patient-side needle extends. Although only one is shown in the figure, the actuator 32084 has two snap tabs 32086 positioned on either side of, for example, a vertical section 32084b. The snap tab 32086 has a tapered section oriented downward and radially inward, and an upward-facing shoulder that allows downward movement when the button 52 is first pressed. During this downward movement toward the skin surface and the bottom of the auto-injector 2, the snap tab 32086 is received in the recess 32086a. Next, when the user releases their finger from the button 52, the actuator 32084 moves upward away from the skin surface, but is eventually locked in place by the interaction between the snap tab 32086 and 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. Therefore, since the actuator 32084 is fixed vertically within the automatic syringe 2, the user cannot press down the button 52 again (or nothing happens when pressed). In some embodiments, after the automatic syringe 2 is assembled, the snap tab 32086 is positioned in the first recess 32086a so that the button assembly remains fixed together until activated by the user.Next, when the user presses button 52, the snap tab 32086 locks into an adjacent recess 32086a that is closer to the skin surface (or closer to the bottom of the auto-injector 2).

[0194] The release tab boundary 32088 is located at or near the bottom of the automatic syringe 2. For example, the vertical portion 32084b of the actuator 32084 has a leg portion 32084d that extends to the release tab boundary 32088. Although not shown, the release tab boundary 32088 has an opening 32082h of the carrier 32082 and a release tab. When the release tab is in place, the leg portion 32084d, and therefore the actuator 32084, is prevented from moving through the opening 32082h of the carrier 32082 and cannot move downward. In this way, the release tab prevents the automatic syringe 2 from being unintentionally activated by pressing the button 52 or dropping the automatic syringe 2 before it is removed from the automatic syringe 2.

[0195] As shown in the figure, the actuation mechanism 32080 has a canister actuation section 32090. The canister actuation section 32090 has a cylindrical portion and an enlarged end or flange 32091. Furthermore, the canister actuation section 32090 has one or more (e.g., two) snap arms 32092. The snap arms 32092 interact with a part of the actuator 32084, for example, arm 32084c. For example, downward movement of the actuator 32084 causes the canister actuation section 32090 to move from the locked retracted position shown in Figure 32J to the unlocked extended position shown in Figure 32K. Furthermore, although not shown, a spring is located inside the canister actuation section 32090, which also assists in the movement of the canister actuation section 32090 to the extended position shown in Figure 32K. By placing the spring inside the canister operating part 32090, the spring can be maintained in an aligned state.

[0196] Figure 32L further illustrates the interaction between the snap projection 32092, the carrier 32082, and a portion of the actuator 32084, such as the arm 32084c. As shown, the arm 32084c has a slanted portion 32084e. The carrier 32082 also has a first peg or projection 32082f. In the initial configuration, as shown in Figure 32J, the peg 32082f is received within the opening 32092a of the snap arm 32092. The peg 32082f acts as a stopper, preventing the expansion of the spring in the actuation section 32090 by abutting against the inner surface of the snap arm 32092 surrounding the opening 32092a. However, as shown in Figure 32K, for example, when button 52 is pressed, actuator 32084 is pushed downward, so that the inclined portion 32084e pushes, guides, or otherwise moves 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 unit 32090 moves. As the snap arm 32092 moves in direction T, it moves away from the peg 32082f, so that the movement of the canister actuation unit 32090 in direction L is no longer blocked by the peg 32082f. As a result, the spring inside the canister actuation unit 32090 expands, and the canister actuation unit 32090 moves in direction L away from the carrier 32082, thereby acting the gas canister.

[0197] As previously mentioned, the operating mechanism 32080 shown in Figure 32K is in the operating state, and the needle drive unit 320 is in the deployed position (the patient-side needle is inserted into the patient). In Figure 32K, the release tab has been removed (unlike in Figure 32J), so the leg portion 32084d extends through the opening 32082h of the carrier 32082. The path of the canister operating unit 32090 along direction L is blocked by the second peg or projection 32082g. Therefore, when the button 52 is first pressed and the auto-injector 2 is activated, the canister operating unit 32090 is fixed in the position shown in Figure 32K. In Figure 32K, the actuator 32084 is locked to the carrier 32082 (by the engagement of the snap tab 32086 and the opening 32086a), so that the user cannot press the button 52 again after initially pressing and releasing it. Figure 32M shows the operating mechanism 32080 with the needle drive unit 320 in the retracted position and the patient-side needle withdrawn from the patient. As previously mentioned with reference to Figure 32K, the lock of the snap tab 32086 and recess 32086a prevents the user from pressing the button 52 any further.

[0198] One or more embodiments of the actuation mechanism 32080 are configured to facilitate the movement of the button 52, thereby facilitating the operation of the actuation mechanism 32080. For example, by arranging two snap tabs 32086 on both sides of the actuator 32084, the downward force applied by the user is equalized, making it easier to move the button 52. Furthermore, the position and / or arrangement of various elements of the actuation mechanism 32080 are configured to facilitate the manufacture of the actuation mechanism 32080. For example, by arranging the snap arm 32092 on the outside of the canister actuation part 32090 and the actuation spring on the inside of the actuation part 32090, the components can be molded or manufactured easily, quickly, and at low cost. By arranging two snap tabs 32086 on both sides of the actuator 32084, as described above with reference to Figure 32M, one or more recesses 32086a can be configured to create a lockout position, thereby disabling the pressing of the button 52 (after the button 52 is first pressed and the automatic syringe 2 is activated). Furthermore, the placement of the two snap tabs 32086 applies equal and / or balanced forces to the actuator 32084, which is partially positioned around the button 52 below the button 52. This suppresses bending and / or deformation of the actuator 32084. The release tabs suppress unintended operation (e.g., operation caused by vibration, dropping, impact, or other forces on the actuation mechanism 32080) by blocking the downward path of the actuator 32084 and the button 52. In these embodiments, creep within the button assembly can be suppressed by a more rigid component or wing, such as a snap arm 32092. In addition, the snap tabs 32086 suppress accidental operation of the button 52 caused by dropping, for example, due to friction.

[0199] Figures 32N to 32V show additional features that can be incorporated into the automatic syringe 2. Figures 32N and 32P are perspective views of a portion of the actuation mechanism 32080 in an unused or non-operating state, with the canister actuation mechanism 32090 retracted relative to the carrier 32082. In this embodiment, the actuation mechanism 32080 has another snap tab 32084z extending from the actuator 32084. More specifically, as shown in Figures 32N to 32Q, the snap tab 32084z has a window portion that receives and interacts with a snap peg or projection 32082b on the carrier 32082. The snap peg or projection 32082e is a slanted portion with a downward-facing shoulder portion that allows the actuator 32084 to move downward (towards the skin) while preventing the actuator 32084 from moving upward after it has been initially pressed down. Therefore, as with the embodiments described above with reference to Figures 32I to 32M, the button 52 cannot be pressed again after it has been pressed by the user (or even if pressed, it will not affect the device).

[0200] Figures 32R to 32V show a mechanism to prevent the needle 308 from communicating with the container 1302 prematurely (for example, by accidental dropping). The mechanism shown in Figures 32R to 32V can be used in conjunction with other embodiments disclosed herein. As shown, a fluid conduit 32098 (substantially similar to other fluid conduits described herein, such as fluid conduit 300) is connected to a connector 32002. The connector 32002 is rotatable and has a connector projection 32004. The connector projection 32004 is an outward-facing projection extending radially outward from the outer surface of the connector 32002. The connector 32002 is configured to interact with a sleeve positioned around the container 1302. The sleeve 32008 is connected to the container 1302 and positioned around it. In some configurations, the connector 32002 is movable relative to the sleeve 32008. The sleeve 32008 snaps into place with the container 1302 and is therefore immovable relative to the container 1302. As shown in Figure 32R, the sleeve 32008 has a slot 32010 configured to receive a connector projection 32004. For example, the slot 32010 has a longitudinal portion extending longitudinally through a portion of the sleeve 32008 and a transverse portion extending laterally / circumferentially through a portion of the sleeve 32008. In this embodiment, the connector 32002 and the sleeve 32008 are substantially locked together by the laterally / circumferential portion of the slot 32010 receiving the connector projection 32004, as will be described below. This substantially locked connection between the connector 32002 and the sleeve 32008 allows the connector 32002 to be fixed in place after the injection is completed. Furthermore, the presence of the laterally / circumferential portion of the slot 32010 allows the needle drive unit 320 to retract. The connector projection 32004 prevents accidental or unintended connection between the connector 32002 and the container 1302, even if the user accidentally drops the automatic syringe 2. In particular, the connector projection 32004 functions as a stopper to prevent relative movement between the connector 32002 and the container 1302 until the patient-side needle is deployed by the downward movement of the needle drive unit 320.

[0201] Figure 32S is an enlarged view showing the interaction between the connector 32002 and the sleeve 32008 in the initial or unused state. As shown, the width of the connector projection 32004 is approximately equal to or slightly smaller than the width of the slot 32010. Furthermore, in the initial or unused state, the actuator 32084 is extended, and the connector projection 32004 is not aligned with the slot 32010. In this embodiment, the connector projection 32004 prevents or inhibits the movement of the sleeve 32008 and the container 1302 toward the connector 32002 (or, in other embodiments, inhibits the movement of the connector 32002 toward the container 1302). If such movement occurs, the fluid conduit will penetrate the container 1302, and the drug will be released from the patient-side end of the needle. Therefore, in the initial configuration, the connector projection 32004 inhibits relative movement between the connector 32002 and the sleeve 32008 / container 1302.

[0202] Figure 32T shows the interaction between the connector 32002 and the cartridge sleeve 32008 in the inserted state, for example, when the needle is inserted into the patient by the downward movement of the needle drive unit 320. The downward movement of the needle drive unit 320 (not shown in Figure 32R) that inserts the patient-side end of the fluid conduit 300 into the patient from the housing 3 causes the central portion of the fluid conduit 32098 (and the connector 32002 / connector projection 32004) to rotate in a first direction. As the connector 32002 / connector projection 32004 rotates in the first direction, the connector projection 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 the pressurized gas coming out of the gas canister described herein.

[0203] Figure 32U shows the interaction between the connector 32002 and the sleeve 32008 after these components have moved toward each other to establish communication between the fluid conduit 32098 and the vessel 1302. As shown, the vessel 1302 and the sleeve 32008 are propelled toward the connector 32002 by the fluid force from the gas canister, and the connector projection 32004 is received within the slot 32010.

[0204] Figure 32V shows the interaction between the connector 32002 and the cartridge sleeve 32008 in the retracted state, for example, when the needle drive unit 320 moves upward from the skin surface and the patient-side needle is retracted from the patient. As shown, when the needle retracts, the fluid conduit 32098 and the connector 32002 rotate in a second direction opposite to 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 drive unit 320 moves upward, thus ensuring that the patient-side needle is retracted after the drug has been delivered from the container 1302. That is, if the lateral / circumferential portion of the slot 32010 were not provided, the fluid conduit and the connector 32002 would not be able to rotate in the second direction.

[0205] As described above, the above configuration ensures that fluid is not unintentionally delivered from the container 1302 to the fluid conduit 32098 until the patient-side needle is deployed to the patient. In particular, the connector projection 32004 prevents the fluid conduit 32098 and the container 1302 from communicating with each other earlier than the appropriate timing, thereby preventing the drug from being discharged from the fluid conduit to the patient-side needle before the patient-side needle is deployed to the patient. Furthermore, by rotating the connector 32002 to engage with the container 1302 (via the sleeve 32008), the risk of damage or malfunction of the fluid conduit 32098 due to crimping, bending, etc., can be reduced. In addition, the connector projection 32004 and the slot 32010 may have other configurations, provided that they are complementary to each other. For example, the connector projection 32004 may be a slit, recess, or opening, and the slot 32010 may be a projection extending radially outward from the sleeve 32008 (provided it is in the same shape and path as the slot 32010 shown in the drawing).

[0206] Figures 65A to 65H show another mechanism for preventing premature communication (due to accidental dropping, etc.) between the needle (not shown) and the container 1302. The mechanism shown in Figures 65A to 65H can be used in conjunction with any other embodiments disclosed herein. Although not shown, the fluid conduit is connected to the connector 32012 as previously described with reference to Figures 32R to 32V. The connector 32012 is rotatable and has at least one connector projection 32014. For example, the connector 32012 has two, three, four or more connector projections 32014 that are spaced apart from each other in the circumferential direction and extend from the base portion 32012a of the connector 32012. The connector projections 32014 are longitudinal extensions that extend from the base portion 32012a of the connector 32012 toward the container 1302 and each has an inward projection 32014a. The projection 32014a extends radially inward from the inner surface of the connector projection 32014, for example, from the end of the connector projection 32014. Furthermore, each connector projection 32014 also has a slanted portion 32014b, which is a portion where the thickness is reduced at the end of the connector projection 32014. Each connector projection 32014 also has a planar end portion 32014c. The connector 32012 is configured to interact with a sleeve 32018, which is positioned around or extending from the container 1302. The sleeve 32018 is connected to and / or positioned around a portion of the container 1302 and is immovable relative to the container 1302. In some configurations, the connector 32012 is movable relative to the sleeve 32018, for example, as described above with respect to Figures 32R to 32V.

[0207] As shown in Figures 65B–65E, the connector 32012 is selectively rotatable relative to the sleeve 32018 and movable longitudinally. Although not shown, as previously described with reference to Figures 32R–32V, the rotation is provided by transmission from the fluid conduit 300 and the drive unit 320. Furthermore, Figures 65F–65H show the various parts of the connector 32012 and sleeve 32018 at different stages of assembly and operation. As shown, the sleeve 32018 has one or more grooves 32018a that penetrate the outer circumference of the sleeve 32018. Each groove 32018a extends over the thickness around the sleeve 32018, or each groove 32018a is a circumferential recess formed on the outer circumference of the sleeve 32018. Furthermore, the groove 32018a has a flat portion 32018b (for example, perpendicular to the periphery of the groove 32018a) and an inclined portion 32018c. The inclined portion 32018C is, for example, circumferentially arranged 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 protrusions 32014. The sleeve 32018 has, for example, a projection 32018d at the end of the sleeve 32018 opposite to the container 1302. Furthermore, the sleeve 32018 has, for example, a collar portion 32018e adjacent to the container 1302 at the end opposite the projection 32018d. The collar portion 32018e is fixed to the neck portion of the container 1302 by, for example, snap engagement, interlocking or screw fitting.

[0208] For example, Figure 65B is an enlarged view showing the interaction between the connector 32012 and the sleeve 32018 in an initial or unused state. As shown, the connector projection 32014 snaps into place with the projection 32018d of the sleeve 32018. In this configuration, the connector 32012 is rotatable relative to the sleeve 32018, but its longitudinal movement relative to the sleeve 32018 and the container 1302 is at least partially restricted. In this embodiment, the projection 32018d of the sleeve 32018 prevents accidental or unintended communication between the fluid conduit 300 (which is fixed to the connector 32012) and the container 1302, for example, if the user accidentally drops the automatic syringe. More specifically, the projection 32018d acts as a stopper to restrict relative longitudinal movement between the connector 32012 and the sleeve 32018 (and container 1302) until the patient-side needle is deployed by the downward movement of the needle drive unit 320 (not shown). Although not shown in Figure 65B, the flat portion 32018b interacts with the planar end 32014c to restrict relative longitudinal movement between the connector 32012 and the sleeve 32018 (and container 1302).

[0209] Figure 65C shows the interaction between the connector 32012 and the sleeve 32018 in a patient-side needle insertion state, such as when the needle is inserted into the patient by the downward movement of the needle drive unit (not shown). When the needle drive unit moves downward, the central portion of the fluid conduit 300 (not shown), the connector 32012, and the connector projection 32014 rotate in a first direction. As the connector 32012 / connector projection 32014 rotates in the first direction, the connector projection 32014 aligns longitudinally with the groove 32018a. Furthermore, as the connector 32012 / connector projection 32014 rotates, the inclined portion 32014b of the connector projection 32014 aligns longitudinally with the inclined portion 32018c of the sleeve 32018. As a result, the connector 32012 and the sleeve 32018 / container 1302 are moved toward each other by the force of the pressurized gas from the gas canister, as described above, and the connector projection 32014 is pushed out of the groove 32018a by the inclined portions 32014b and 32018c. In particular, the connector projection 32014 is pushed radially outward by the opposing inclined surfaces of the inclined portions 32014b and 32018c, so that the connector projection 32014 is dislodged from the outer surface of the sleeve 32018, allowing the sleeve 32018 to move longitudinally relative to the connector 32012.

[0210] Figure 65D shows the interaction of the connector 32012 and sleeve 32018 after these components have moved toward each other to establish communication between the fluid conduit 300 (not shown) and the container 1302. As shown, the container 1302 and sleeve 32018 are propelled toward the connector 32012 by the fluid force from the gas canister (not shown), pushing the connector projection 32014 out of the groove (not shown). Furthermore, the connector projection 32014 is fixed to the collar portion 32018e of the sleeve 32018 or received around the collar portion 32018e. In this orientation, the connector 32012 and sleeve 32018 can rotate toward each other, but longitudinal movement of the connector 32012 and sleeve 32018 toward each other, for example, movement in opposite directions, is restricted by the connector projection 32014.

[0211] Figure 65E shows the interaction between the connector 32012 and the cartridge sleeve 32018 when the patient-side needle is retracted, for example, when the needle drive unit 320 (not shown) moves upward so as to move away from the skin surface and withdraws the patient-side end of the needle from the patient, and the patient-side 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 to a 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 the collar portion 32018e (rotatable relative to each other as shown in Figure 65D) ensure that the needle drive unit 320 moves upward, thereby ensuring that the patient-side needle is retracted after the drug has been delivered from the container 1302. In other words, if the connector protrusion 32014 and the collar portion 32018e are not rotatable relative to each other, the fluid conduit and connector 32012 cannot rotate in the second direction.

[0212] Furthermore, as mentioned above, Figures 65F to 65H show the different parts of the connector 32012 and sleeve 32018 at various stages of assembly and operation. For example, Figure 65F shows the configuration of the connector 32012 and sleeve 32018 before assembly. Figure 65G shows the configuration of the assembled connector 32012 and sleeve 32018. As shown, the connector 32012 has connector protrusions 32014, each connector protrusion 32014 having an inward projection 32014a. Furthermore, in the assembled configuration of Figure 65G (similar to the initial state of Figure 65B), the connector protrusions 32014 are locked to the sleeve 32018 (protrusions 32018d, etc.), and their longitudinal movement is restricted by the planar end 32014c of the connector protrusion 32014 and the flat portion 32018b of the groove 32018a, etc. As a result, the relative movement of the connector 32012 and sleeve 32018 (and consequently the container 1302) is suppressed until the patient-side needle is inserted via the patient-side needle mechanism. As shown in Figure 65H, which is a partially enlarged view of the configuration in Figure 65C, the inclined portion 32014b of the connector projection 32014 and the inclined portion 32018c of the groove 32018a are aligned, and the connector 32012 and sleeve 32018 are in the unlocked position. Therefore, as the connector 32012 and sleeve 32018 / container 1302 are moved toward each other by the force of pressurized gas from the gas canister, the inclined portions 32014b and 32018c bias the connector projection 32014 radially outward, pushing it out of the groove 32018a.

[0213] As described above, the above embodiment ensures that fluid is not unintentionally delivered from the container 1302 to the fluid conduit until the patient-side needle is deployed to the patient. In particular, the connector projection 32014 and sleeve 32018 prevent the fluid conduit and container 1302 from communicating with each other earlier than the appropriate timing, thereby preventing the drug from being discharged from the patient-side needle via the fluid conduit before the patient-side needle is deployed to the patient. Furthermore, by rotating the connector 32012 to engage with the container 1302 (via the sleeve 32018), the risk of damage or malfunction of the fluid conduit due to crimping, bending, etc., can be reduced. In addition, the connector projection 32014 and groove 32018a may have other configurations, provided that 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, container 1302, etc. are assembled into a finished assembly. For example, after the connector 32012 and sleeve 32018 are partially assembled, a locked configuration is formed, and then the final assembly is performed. Furthermore, although not shown, the above embodiment facilitates alignment between the cartridge needle and the container 1302.

[0214] Figures 33A and 33B show the configuration of an automatic syringe 2 in which a retractable lid 80 protrudes from the housing 3. The lid 80 is movable relative to the housing 3. The lid 80 retracts into the housing 3 along the transverse axis 44 when the user applies force to the housing 3. The lid 80 has side walls 81 and tissue engagement surfaces (bottom surface, etc.) 82. The side walls 81 retract into the housing 3 (Figure 33B) when force is applied by the user.

[0215] The housing 3 and lid 80 are biased to the initial state shown in Figure 33A by one or more coils, elastic material, pneumatic mechanism, etc. The tissue engagement surface 82 of the lid 80 has an opening 6 through which the needle 306 (or another patient-side needle) is deployed. The retraction of the lid 80 (i.e., the housing 3 and lid 80 moving toward each other) causes the needle 306 to extend from the lid 80 and be inserted into the user / patient through the user / patient's skin 33000. After the injection is complete, the tissue engagement surface 82 is pushed toward the skin 33000 and covers the needle 306 by supplying fluid discharged from a valve described herein (e.g., valve 3010). For example, fluid / gas from a fluid source 1366 discharged through a discharge conduit 3018 is supplied toward the skin along the transverse axis 44. The discharged fluid / gas pushes the lid 80 toward the housing 3 along the transverse axis 44, causing the lid 80 to separate from the housing 3 and return to the configuration shown in Figure 33A. Alternatively, the expelled gas / fluid directly or indirectly activates a spring or other mechanism that pushes the cover 80 away from the housing 3. As a result, the needle 306 retracts and covers it. In some examples, the needle 306 has already been retracted by another mechanism when the expelled air returns the cover 80 to the configuration shown in Figure 33A. The retraction of the cover 80 itself may also cause relative movement between, for example, the valve stem and another part of the fluid source 1366, thereby activating the fluid source 1366.

[0216] Figures 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 illustrate various exemplary transverse auto-injectors according to this disclosure, in which the dimensions along the longitudinal axis (parallel to the skin surface) are greater than the dimensions along the transverse axis (perpendicular to the skin surface). In this respect, these embodiments are similar to auto-injector 2 shown in Figures 1 and 1A. Furthermore, the auto-injectors shown in these figures have dimensions along the transverse axis (parallel to the skin surface but perpendicular to the longitudinal axis) that are greater than the dimensions along the transverse axis. Thus, these embodiments have a “flat” appearance relative to the skin surface.

[0217] While details are described below, the arrangement of the windows 50 and buttons 52 in the horizontal automatic syringe of this disclosure is not particularly limited. For example, the windows 50 and / or buttons 52 may be arranged along the top or side surface of the housing 3 and / or at the boundary between the top and side surfaces of the housing, or at the boundary between a longitudinally extending side surface and a transversely extending side surface. In yet another embodiment, one or more windows 50 and / or buttons 52 are arranged along the skin-contact surface of the bottom of the housing 3. For example, a window 50 on the bottom surface (see Figure 51D) is configured to allow visibility into the inside of the automatic syringe 2 even when another window 50 of the automatic syringe 2 is blocked by a movable flag or the like during use of the automatic syringe 2 (see Figures 54G to 54I, described later). The windows 50 and / or buttons 52 are arranged at the center and / or offset positions on each surface. For example, the window portion 50 and / or button 52 are positioned at the radial center of the top or side surface of the automatic syringe 2, or offset from the radial center of each surface in the longitudinal, transverse, and / or lateral directions. The window portion 50 and / or button 52 may be formed as a recess or protrusion relative to an adjacent surface of the automatic syringe 2, or they may be located on the same plane as an adjacent surface. The specific shape, material, appearance, size, and arrangement of the window portion 50 and button 52 will be described in detail later.

[0218] Button 52 is a button that is pressed with a finger. In some examples, the button itself is connected to a needle (e.g., needle 306) that is deployed to the patient, and when the button is pressed, the needle is inserted into the user's skin. In other examples, button 52 indirectly causes the deployment of the needle and / or the activation of a fluid source 1366. For example, button 52 activates a spring or other force that drives the patient-side needle mechanism. These examples are described in more detail below. Examples of other operating mechanisms that can be used instead of button 52 include sliders, triggers, dials, flip covers, paddles, pull cords, etc.

[0219] The window 50 allows the user to clearly see the container 1302 and / or piston 1316. The window 50 is configured to visualize different dosages used in devices of the same basic structure. The window 50 can cover various surfaces of the autosyner. By modifying and sizing the window 50, it is possible to reduce confusion when a relatively large container 1302 is used for small dosages (details below). In some embodiments, the window 52 is located on the tissue contact surface itself.

[0220] For example, in the automatic syringe 2a shown in Figures 34A and 34B, the housing 3 has a base portion 34000 that is raised relative to the rest of the upper surface of the housing 3. The raised base portion 34000 extends along most of the longitudinal axis of the housing 3, and the button 52 is located at the longitudinal end of the raised base portion 34000. The upper surface of the button 52 is coplanar with the upper surface of the raised base portion 34000, and as a result, in at least some embodiments, the button 52 is not visible when the automatic syringe 2a is viewed from the side. In other configurations, the button 52 is raised or recessed relative to the raised base portion 34000. The window portion 50 in this embodiment extends along most of the longitudinal axis of the automatic syringe 2a and is visible when the automatic syringe 2a is viewed from directly above and from the side. The window portion 52 is located in a recess that extends longitudinally in the housing 3. However, the window portion 52 may be located on the same plane as the surface of the housing 3, or it may be raised from the surface of the housing 3.

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

[0222] In the embodiments of Figures 36A and 36B, the button 52 is positioned on the raised base 36000 of the automatic syringe 2c, similar to the embodiments of Figures 34A and 34B. However, unlike the embodiments of Figures 34A and 34B, in the embodiments of Figures 36A and 36B, the surface area occupied by the raised base 36000 on the upper surface is smaller. As shown, the button 52 occupies almost the entire raised base 36000. Furthermore, the button 52 is positioned at the radial center of the upper surface. In this embodiment, the window 50 is coplanar with the outer surface of the housing 3. The window 50 in this embodiment extends along the longitudinal axis of the automatic syringe 2c and is visible when the automatic syringe 2c is viewed from directly above and from the side.

[0223] The auto-injector 2d in Figures 37A and 37B has a button 52 on the top surface of the housing 3, with the button 52 positioned over substantially the entire length of a raised base 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 so that the user can easily determine the state of the auto-injector 2d. For example, as shown in Figure 37B, when the rocker switch button 52 is in the first position, the user can see the exposed side 37002 of the rocker switch button 52, which is colored green, for example. The user can determine from this green color that the auto-injector 2d is not yet 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 shown to the user. The second exposed side has a different color or appearance from the first exposed side 37002 and is not visible while the auto-syringe 2d is in the first position. For example, the second exposed side is the same color as the rest of the housing 3 (e.g., white) or a different color (e.g., red, blue, etc.). The window 50 of this embodiment is similar to any of the aforementioned window sections and is visible when the auto-syringe 2 is viewed from directly above or from the side.

[0224] In the embodiments shown in Figures 38A and 38B, the button 52 is located at the longitudinal end of the top surface of the auto-syringe 2e, which is a flat or slightly rounded surface. The button 52 may be coplanar with an adjacent surface of the housing 3, or it 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-syringe 2e and is at least partially visible when the auto-syringe 2e is viewed from directly above and / or from the side.

[0225] The embodiments shown in Figures 39A and 39B are similar to the embodiments shown in Figures 38A and 38B, in which the button 52 is located at the longitudinal end of the top surface of the automatic syringe 2f, which is a flat or slightly rounded surface. As shown in Figure 39A, the button 52 is either coplanar with or recessed to an 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 surface of the automatic syringe 2f and is only visible when the automatic syringe 2f is viewed from the side. In this embodiment, when the automatic syringe 2f is viewed from above, the window 50 is not visible.

[0226] The embodiments shown in Figures 40A and 40B are similar to the embodiments shown in Figures 39A and 39B, except that the button 52 is located at the radial center of the top surface of the automatic syringe 2g, which is a flat or slightly rounded surface. Furthermore, when the automatic syringe 2g is viewed from directly above, a recess including the window portion 50 is visible, but the window portion 50 itself is not visible from that viewpoint.

[0227] In the embodiments of Figures 41A and 41B, the button 52 is positioned along a laterally extending side of the auto-injector 2h. In the illustrated example, the button 52 is formed over substantially the entire laterally extending side, but the button 52 may be formed on a smaller portion of this side. The button 52 is raised relative to the adjacent surface of the auto-injector 2h, so that the exposed side 41000 is visible to the user in the pre-operation or un-deployed position. The side 41000 of the button 52 is marked or colored so that the user can easily determine the state of the auto-injector 2h, as previously described with reference to Figures 37A and 37B. For example, as shown in Figures 41A and 41B, when the button 52 is in the pre-operation or un-deployed position, the exposed side 41000 of the button 52 is visible to the user, and this side is colored green, for example. The user can determine from this green color that the auto-injector 2h has not yet been activated or that it contains a dose that can be delivered to the user. When the user presses button 52, the exposed (green) side 41000 becomes invisible, indicating that the device has been activated. Furthermore, after the injection is complete, the observer can determine that the auto-injector 2h has already been used because the previously exposed colored or marked surface is no longer visible when observing button 52. In some embodiments, a locking mechanism or other mechanism prevents 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. Embodiments shown in Figures 41C to 41E are similar to the embodiments shown in Figures 41A and 41B, but an additional status window 50b is provided on the top surface. The status window displays appropriate information regarding the status of the auto-injector 2h. In one embodiment, when the auto-injector 2h is in the pre-operation or non-deployed state, the status window displays the same color or appearance as the exposed side 41000 of button 52. After button 52 is pressed, window 50b displays a different color or appearance to indicate that the automatic syringe 2h has been activated.In one embodiment, the window 50b displays the same color or appearance as the button 52 or other parts of the housing 3 to indicate that the automatic syringe 2 has been used. The types of images and marks displayed in the window 50b will be described in detail later.

[0228] The embodiments shown in Figures 42A and 42B are similar to the embodiments shown in Figures 39A and 39B. However, because the top surface of the automatic syringe 2i is curved, the button 52 can be seen when the automatic syringe 2i is viewed from the side. Furthermore, the window portion 50 can be seen when the automatic syringe 2i is viewed from directly above or from the side.

[0229] The automatic syringe 2j shown in Figure 42C includes a button 52 located on the top surface of the automatic syringe 2j, and the window 50 extends along both the top surface and the adjacent longitudinal side surface. In the automatic syringe 2j, the window 50 and the button 52 are located in close proximity to each other on the top surface of the housing 3.

[0230] In the embodiments shown in Figures 43A to 43D, the button 52 is located on a longitudinally extending side of the automatic syringe 2k. The button 52 is a rocker switch button that is movable between two positions. At least part or all of the button 52 has a different physical appearance, such as a different color from the housing 3. The button 52 can be seen when the automatic syringe 2k is viewed from directly above or from the side. In this embodiment, the window 50 is located in a recess on the top surface of the automatic syringe 2k, and the window 50 is visible when the automatic syringe 2k is viewed from directly above, but not when viewed from the side.

[0231] The auto-injector 2l shown in Figures 44A and 44B has two longitudinally extending buttons 52, each button 52 located on a longitudinally extending side of the auto-injector 2l. The user must press both buttons 52 to begin the needle deployment and drug supply. For example, one of the buttons 52 is connected to a locking mechanism that blocks a predetermined portion of the patient-side needle mechanism, and the other 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 sequence to begin the needle deployment. A longitudinally extending window 50 is located on the top surface of the auto-injector.

[0232] The automatic syringe 2m shown in Figures 44C and 44D includes a slider 44000 located on a recessed top surface. The slider 44000 can move from a first position to a second position. The automatic syringe 2m is in a pre-operation or unextended state when the slider 44000 is in the first position, and when the slider 44000 moves to the second position, the needle is extended and the drug is dispensed. In the first position, the slider 44000 displays a first color, mark, or appearance on the display panel 44002 (for example, displayed below the sliding part itself). For example, a color such as green is displayed to the user to indicate that the automatic syringe is in a pre-operation or unextended state. When the slider 44000 moves to the second position, the slider 44000 displays a second color, mark, or appearance (different from the first color, mark, or appearance) on the second display panel, visually indicating that the automatic syringe 2m has been used. In the second position, the first display panel 44002 is not visible because it is covered by the sliding component of the slider 44000. The window portion 50 in this embodiment is substantially the same as the window portion 50 shown in Figures 35A and 35B.

[0233] The automatic syringe 2n shown in Figures 45A and 45B is equipped with a button 52, such as a snap-on button, on the top surface of the automatic syringe 2. When the automatic syringe 2 is in the pre-operation or un-deployed position, the side 45000 of the button 52, which has a color, mark, or appearance, is exposed, indicating to the user that the automatic syringe 2n is in the pre-operation or un-deployed state. When the button 52 is pressed and moved to the second position, the first color, mark, or appearance of the exposed side 45000 is no longer visible to the user from any angle from the outside, indicating that the automatic syringe 2n has been used. When the button 52 is pressed, the button 52 snaps into place in the second position. The button 52 occupies most or almost the entire top surface of the automatic syringe 2. Furthermore, a window 50 is located on the button 52 itself.

[0234] In the horizontal auto-injector 2o shown in Figures 46A and 46B, the dimensions along the transverse axis 44 (perpendicular to the skin surface) are greater than the dimensions along the transverse axis 42 (parallel to the skin surface). In the horizontal auto-injector 2o, the dimensions along the longitudinal axis 40 (parallel to the skin surface) are the largest. In such embodiments, the container 1302 within 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 each required function, valves described herein (e.g., valve 3010) are positioned near the skin contact surface of the auto-injector 2o. The container 1302 extends along the longitudinal axis 44 of the auto-injector 2o and is positioned above the valve 3010. The auto-injector 2o has a removable seal 46000 positioned on part or all of the skin contact surface of the auto-injector 2o. In some embodiments, the seal 46000 is permeable to a sterilizing agent (e.g., ethylene oxide, vaporized hydrogen peroxide) and is placed on the auto-injector 2o before sterilization. Suitable materials such as Tyvek® may be used for seal 46000. A removable seal (such as seal 46000) that covers part or all of the skin contact surface at the bottom of the autosyringer may be provided in all autosyringers described herein.

[0235] The embodiment of the auto-syringe 2p shown in Figures 46C-46E has a button 52 located at the longitudinal end of the top surface of the auto-syringe. A window 50 extends longitudinally along the top surface near the button 52. The window 50 is also located on each longitudinally extending side of the auto-syringe 2p. Figure 46E shows the tissue engagement surface 46001 at the bottom of the auto-syringe 2p. The tissue engagement surface 46001 has a label 46003 containing various identification information. The label will be described in detail later. The auto-syringe 2p also has a contact detection switch 46002 at the longitudinal end of the tissue engagement surface 46001. The contact switch 46002 must be pressed to deploy the needle. In some examples, when the contact switch 46002 is pressed, a mechanical obstruction is removed from the path of one or more structures within the auto-syringe 2p, for example, the path of the shuttle, needle drive, gear, or other moving parts of the patient-side needle mechanism. For example, when a contact switch is pressed, an obstruction is removed from the path of one or more parts of the patient-side needle mechanism. The inside of the contact switch 46002 is hollow (e.g., annular), allowing the needle 306 to move through the opening 6 of the tissue contact surface 46001 and through the hollow interior of the switch 46002.

[0236] The automatic syringe 2r shown in Figures 47A and 47B uses a lid 47000 to deploy the needle and operate the device. The lid 47000 extends from the housing 3 of the automatic syringe 2r and operates in the same manner as described above with reference to Figures 33A and 33B. The automatic syringe 2r in Figures 47A and 47B has a window 50 that extends longitudinally along the top surface of the automatic syringe 2r. Because the top surface is curved downward, the window 50 is visible when the automatic syringe 2r is viewed from above or from the side. Furthermore, when the automatic syringe 2r is in the pre-operation or undeployed state, the user can see the exposed portion 47002 of the lid 47000 when the automatic syringe 2r is viewed from the side. The exposed portion 47002 has a different color (e.g., green), markings, or appearance from the rest of the automatic syringe 2r (e.g., white). After the automatic syringe 2r is activated (with the lid 47000 retracted), the exposed portion 47002 and its color become invisible. The retraction of the lid 47000 inserts the needle 306 directly or indirectly (see Figure 18A, etc.). For example, the needle 306 is connected to the housing 3 so that the relative movement of the lid 47000 and the housing 3 causes the needle 306 to be inserted into the user (direct insertion). In other examples, the retraction of the lid 47000 activates another mechanism, such as a fluid source, a spring, or another mechanism that drives needle insertion (indirect insertion).

[0237] In the automatic syringe 2s shown in Figures 47C and 47D, similar to the automatic syringe 2o, the dimension along the transverse axis (perpendicular to the skin surface) is larger than the dimension along the transverse axis (parallel to the skin surface). The button 52 is located on the recessed upper surface of the housing 3 and is not visible when the automatic syringe 2s is viewed from the side. The window 50 extends along the longitudinal side of the housing 3 and is not visible when the automatic syringe 2 is viewed from directly above. The bottom 47010 has a non-slip or adhesive coating, such as rubber, to facilitate the user's grip on the automatic syringe 2s and to prevent the automatic syringe 2s from slipping on the skin. The grip covers most or all of the tissue engagement surface at the bottom of the automatic syringe 2s and also extends upward from the tissue engagement surface along the lateral and longitudinal sides of the automatic syringe 2s.

[0238] Figures 48A-48C are schematic diagrams of the “vertical” auto-injector 2t, which has the largest dimensions 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 the fluid source 1366 moves the container 1302 relative to the fixed housing 3 and fluid conduit 300, so that the container 1302 communicates with the fluid conduit 300. A spring 48000 is connected to the second end 1306 of the container 1302 and is in an extended state before the auto-injector 2t is operated (Figure 48A). When the container 1302 moves toward the fluid conduit 300, the spring 48000 is compressed (Figure 48B). The needle 306 of the fluid conduit 300 is deployed by any of the mechanisms described herein (see Figure 48B). Once the injection is complete, the fluid / gas from the fluid source 1366 is discharged rather than sent to the container 1302. At this point, the fluid pressure from the fluid source 1366 is no longer acting on the spring 48000, so the spring 48000 expands, biasing 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 either a button or an actuation mechanism described herein. The auto-injector 2t may have a lid, and the actuation of the fluid source 1366 and the insertion of the needle 306 into the user may be performed 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 extending along the transverse axis of the auto-injector. The auto-injector 2u has a removable cap 48002 (Figures 48D and 48E), and when the cap 48002 is removed, a lid 80 including the needle opening 6 is exposed.

[0239] Figures 48H and 48I show additional features of the system flow within the auto-injector 2t, which is substantially similar to the system flow in Figure 3A. This embodiment also has an ejection or extrusion system 2300 which, after the dose of drug has been delivered, is used to redirect the gas from the auto-injector instead of ejecting it, thereby pushing the lid 23102 out of the rest of the auto-injector 2t.

[0240] As previously mentioned, the retraction of the lid 23102 activates the gas canister 1366. For example, the lid 23102 is connected to the start rod 48012. When the lid 23102 retracts, the start rod 48012 activates the gas canister 1366 in a manner similar to other gas canister operating mechanisms described herein. The gas then flows through the system and valve, pushing the drug through the fluid conduit and within the patient-side needle 300 inserted into the patient, as shown in Figure 48H.

[0241] A conduit or connection 23104 is also located between the lid 48010 and the gas canister / discharge line. While the diaphragm 3012 is under high pressure sealing the valve seat 3020, gas cannot flow through the conduit 23104. When the pressure in the system and valve is balanced and the diaphragm is lifted from the valve seat 3020, the gas flowing through the discharge conduit 3018 energizes the dump valve of the extrusion system 2300, causing the gas to flow from the canister 1366 into the conduit 23104. The force of the gas flowing through the conduit 23104 then energizes and / or presses the lid 48010 via the push rod 23106, moving the lid 48010 to a position where the needle 300 is retracted, as shown in Figures 48C and 48I. Specifically, the piston or push rod 23106 is connected to the lid 48010, as shown in Figures 48H and 48I. The push rod 48014 is received in the conduit 23104 of the auto-injector 2t, and the discharge pressure in the conduit 23104 biases the push rod 23106 to the position shown in Figures 48C and 48I. Moving the lid 23102 to the position shown in Figures 48C and 48I indicates to the user that the injection is complete and also serves as a precaution against accidental injury by the patient-side end of the needle (i.e., a sharpness mitigation or prevention measure).

[0242] Figures 49A–49F show various examples of auto-injectors 2v having a lid. In some examples, as shown in Figures 49A–49D, the lid 49000 constitutes substantially the entire skin contact surface of the auto-injector 2v. In the embodiment shown in Figure 49D, the lid 49000 has a differently colored portion so that the user can determine the approximate location of the needle opening 6. In Figure 49D, the needle opening 6 is located at the radial and longitudinal center of the tissue contact surface of the lid. The central portion 49003 of the lid has a different color, mark or appearance from the adjacent portion 49004 of the lid, and is configured so that the approximate location of the needle deployment portion can be seen even if the needle opening 6 is not in the user's line of sight. In another embodiment, the central portion 49003 is movable relative to the adjacent portion 49004 and retracts into the auto-injector 2v to deploy the patient-side needle. In the embodiments shown in Figures 49E and 49F, the movable part is located on only a portion of the tissue contact surface of the auto-injector 2v. For example, the lid 49000 has a circular projection 49020 (Figure 49E) or an oval projection 49022 (Figure 49F) that retracts into the auto-syringe 2v when it is placed on the skin under pressure. The projection may have other shapes. The projections 49020 or 49022 in Figures 49E and 49F have a different color, mark, or appearance from the rest of the tissue contact surface of the auto-syringe 2v. In the embodiments of Figures 49A to 49F, the user can visually observe each auto-syringe to confirm that the needle is relatively short, which may reduce the user's fear of needles.

[0243] Various surfaces of the auto-injectors disclosed herein may be modified to assist the user in operating the auto-injector. For example, by providing one or more protrusions 50000 (Figure 50F), indentations 50002 (Figures 50C and 50I), and ribs 50004 (Figure 50H) on the button 52, it is possible to clearly indicate to the user that the button 52 is a button for activating the auto-injector, and also to clearly indicate to the user that they are handling the top surface of the auto-injector. Such a surface structure can also guide the user's fingers to the button itself, making it easier to grasp. Furthermore, at least the indentations improve the user's feel when pressing the button 52. Various surface modifications can also be applied to other parts of the outer surface of the auto-injector described herein. For example, the surface of the housing 3 may be provided with one or more of the following: protrusions 50000 (Figures 50A, 50B, and 50E), raised ribs 50005 (Figure 50C), concave ribs 50004 (Figures 50D and 50H), adhesive or rubber surfaces 50008 (Figure 50G), recesses 50009 (Figure 50G), and / or knurling 50006 (Figure 50J). The surface modified portions can be placed in various locations where the user holds / gripping the autosynergia. The surface modified portions may be placed along one or more of the top surface, laterally extending sides, or longitudinally extending sides of the autosynergia.

[0244] Figures 51A to 51D show various positions of the needle relative to the tissue contact surface of the autosyner. For example, the needle opening 6 may be centrally located (e.g., along one or both of the transverse and longitudinal axes of the autosyner), or offset from one or both of the transverse and longitudinal axes. In some embodiments, the needle opening 6 penetrates the movable lid of the autosyner (Figures 51C and 51D) and is located either centrally in the movable lid or offset from one or more axes of the lid (Figures 51C and 51D). As shown in Figures 51A and 51B, the needle opening is located inside 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 penetrates (Figures 51C and 51D). In yet another embodiment, the needle opening 6 is offset from the contact switch 46002. In various embodiments, the contact switch 46002 is formed from a non-slip material or rubber material and / or has surface irregularities (such as ribs) to enhance contact with the skin and prevent slippage.

[0245] In some embodiments, the skin-contacting surface of the auto-injector has one or more non-slip or adhesive 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, such as rubber grips, may be placed on the skin-contacting surface of the auto-injector.

[0246] As shown in Figures 52A-52C, various automatic syringes of this disclosure may have a pull tab or a seal 46000, as previously described with reference to Figures 46A and 46B. The seal 46000 has one or more protrusions 46000a configured to extend into one or more openings 46000b of the housing 3. The protrusions 46000a are located within the openings 46000b, and the automatic syringe 2 is sterilized by a sterilizing agent (such as EtO or VHP) that permeates the seal 46000. The openings 46000b are the same opening through which a contact switch 46002 (see Figures 46C-46E) extending from the housing 3 passes. The contact switch 46002 is biased to extend outside the housing 3 through the openings 46000b, but the entire contact switch 46002 is contained within the housing 3 when the protrusions 46000a are within the openings 46000b. As long as the contact switch 46002 is held within the housing 3 and the protrusion 46000a is positioned within the opening 46000b, the needle 306 of the automatic syringe cannot be deployed or injection cannot be started. That is, in some embodiments, the seal 46000 must be removed before the needle can be deployed. Therefore, for example, if button 52 is pressed with the protrusion 46000a positioned within the opening 46000b, the needle 306 will not be deployed and injection will not be started. For example, the contact switch 46002 is connected to an obstruction that blocks the path of one or more parts of the patient-side needle mechanism, such as the needle drive, shuttle, or gears. When the seal 46000 is removed from the housing 3, the contact switch 46002 extends out of the housing 3 through the opening 46000b (Figure 52B). The contact switch 46002 extending out of the housing 3 operates as described above with reference to Figures 46C-46E. In other words, the automatic syringe is ready to operate when the contact switch 46002 is pressed upon contact with the skin (Figure 52C). For example, the needle 306 will only begin to deploy when button 52 is activated while the contact switch 46002 is pressed. Furthermore, the presence of the seal 46000 on the automatic syringe provides a visually clear indication that the automatic syringe is unused and has not been tampered with.

[0247] Figures 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, indicator 50b displays a first indication, e.g., a first color, mark, or appearance, when the device is in a pre-operation or non-deployed state. When injection and retraction of the needle 306 is complete, indicator 50b displays a second color, mark, or appearance. For example, the second color is "green." Alternatively, the indicator may display letters or symbols such as "Finished," or a check mark indicating completion of the injection. Ind...

Claims

1. It is an automatic syringe, A housing having a longitudinal axis and a transverse axis, wherein the dimension along the transverse axis is shorter than the dimension along the longitudinal axis, and the transverse axis is perpendicular to the longitudinal axis, A flow channel having a first end and a second end, A container for containing a first fluid, the container extending along or parallel to the longitudinal axis from a first end to a second end, movable along or parallel to the longitudinal axis from a first position to a second position, not communicating with the flow path at the first position, and communicating with the flow path at the second position, The container further comprises a plunger configured to move from the first end of the container toward the second end in order to discharge the first fluid from the container into the flow path, An automatic syringe in which a first end of the flow path is insertable into the container, and a 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.

2. The system further comprises a fluid source configured to release a pressurized second fluid, The container is movable from the first position to the second position as the pressurized second fluid is released from the fluid source. The automatic syringe according to claim 1, wherein the plunger is biased from the first end to the second end of the container so that the first fluid is discharged from the container into the flow path by the discharge of the pressurized second fluid from the fluid source.

3. The container has a seal at the second end of the container, The automatic syringe according to claim 2, wherein at the first position, a gap is provided between the seal and the first end of the flow path.

4. The automatic syringe according to claim 3, wherein when the container moves to the second position, the first end of the flow path penetrates the seal and enters the container.

5. The automatic syringe according to claim 3, wherein when the pressure from the pressurized second fluid on the container decreases, the container becomes movable from the second position to the third position.

6. The automatic syringe according to claim 5, wherein the third position is the same as the first position.

7. The automatic syringe according to claim 5, wherein the third position is different from the first position.

8. The container further comprises a first elastic member connected to the container, As the container moves from the first position to the second position, the elastic member is compressed. The automatic syringe according to claim 5, wherein the compressed elastic member expands when the pressure from the pressurized second fluid decreases, thereby moving the container to the third position.

9. Career and, A drive unit connected to the second end of the flow path, the drive unit being slidable relative to the carrier between a retracted position and an extended position, A shuttle configured to move the drive unit between the retracted position and the deployed position, The automatic syringe according to claim 1, further comprising: a stopper configured to move from a first configuration to a second configuration, wherein the stopper is configured to maintain the drive unit in an deployed configuration, and the movement of the stopper from the first configuration to the second configuration allows the shuttle to move the drive unit from the deployed configuration to the retracted configuration.

10. The automatic syringe according to claim 9, wherein, before operation, the drive unit is in contact with an obstacle, the obstacle prevents it from moving from the retracted position, and the obstacle is connected to the container.

11. The automatic syringe according to claim 10, wherein the container moves from the first position to the second position, thereby moving the obstacle away from contact with the drive unit, and thereby enabling the drive unit to move from the retracted position to the deployed position.

12. It is an automatic syringe, The main body that houses the conduit, A fluid source configured to supply pressurized fluid to the conduit, A container communicating with the aforementioned conduit, containing a drug and a plunger, and configured to discharge the drug when pressure is applied to the plunger by the pressurized fluid, A pressure limiting section is configured to restrict the pressurized flow within the conduit and defines a high-pressure flow region and a low-pressure flow region of the conduit, A valve having a valve inlet and a valve outlet, wherein the valve inlet is in communication with the conduit and the valve is configured to control the flow of the pressurized fluid from the conduit to the valve outlet, The system comprises a channel that extends from the main body and is configured to deliver a drug from the container to the patient, An automatic syringe in which the direction in which the container discharges the drug is offset from the direction in which the flow path extends from the main body.

13. The automatic syringe according to claim 12, wherein the pressurized fluid is a gas.

14. The auto-injector according to claim 12, wherein the drug contains a monoclonal antibody.

15. The automatic syringe according to claim 12, wherein the pressure limiting portion includes a porous material or a serpentine channel.

16. The automatic syringe according to claim 12, wherein the direction in which the container discharges the drug is substantially perpendicular to the direction in which the flow path extends from the main body.

17. The automatic syringe according to claim 12, wherein the container is in communication with the low-pressure flow region of the conduit, and the high-pressure flow region of the conduit is in communication with the valve inlet.

18. The automatic syringe according to claim 12, wherein 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 main body when the container is in the second container position.

19. The automatic syringe according to claim 12, wherein the valve is configured to allow the flow of the pressurized fluid from the conduit to the valve outlet after at least a portion of the drug has been discharged from the container, and the pressure applied by the pressurized fluid flowing to the valve outlet activates an additional mechanism of the automatic syringe.

20. The automatic syringe according to claim 19, wherein the additional mechanism is a flow path retraction mechanism.

21. The automatic syringe according to claim 20, wherein the flow path retraction mechanism has a rod that is movable by the pressurized fluid flowing through the valve outlet, and the rod is configured to retract the flow path after it has been moved a first distance.

22. A piston positioned at the valve outlet and movable from a first position to a second position, The system further comprises the fluid source and a secondary channel connected to the valve outlet, When the piston is in the first position, the secondary channel is sealed by the piston against the valve outlet. The automatic syringe according to claim 12, wherein when the piston is in the second position, the secondary channel communicates with the valve outlet, and the pressurized fluid flows from the fluid source through the secondary channel and the valve outlet.

23. The automatic syringe according to claim 12, wherein the valve is configured to block the flow of the pressurized fluid from the conduit to the valve outlet while the container is discharging the drug.

24. It is an automatic syringe, Conduits and A fluid source configured to supply pressurized fluid to the conduit, A container communicating with the aforementioned conduit, which houses a plunger that can move from a first position to a second position when pressure is applied from the pressurized fluid, A pressure limiting section is configured to restrict the flow of the pressurized fluid within the conduit and defines a high-pressure flow region and a low-pressure flow region of the conduit. It is a valve, A first valve inlet that connects the high-pressure flow region of the conduit to the first valve cavity, A second valve inlet connects the low-pressure flow region of the aforementioned conduit to the second valve cavity, A valve having a valve outlet, An automatic syringe in which the valve is configured to control the flow of the pressurized fluid from the low-pressure flow region of the conduit to the valve outlet.

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

26. The automatic syringe according to claim 25, wherein the first valve cavity and the second valve cavity are separated by a diaphragm held in an extended position, and the diaphragm is held in a predetermined position by at least one of a retaining portion or a groove.

27. The automatic syringe according to claim 24, wherein the valve is configured to allow the 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 the threshold range of the fluid pressure in the high-pressure flow region of the conduit.

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

29. The automatic syringe according to claim 24, wherein the valve outlet is in communication with a ventilation opening.

30. It is an automatic syringe, Career and, A needle, A drive unit connected to the needle, the drive unit being slidable relative to the carrier between a first position, a second position and a third position, A shuttle configured to move the drive unit between the first position, the second position and the third position, An automatic syringe comprising an indicator connected to the shuttle, the indicator having a portion of which can be seen from the outside of the automatic syringe and having a first indicator corresponding to a first position of the drive unit, a second indicator corresponding to a second position of the drive unit, and a third indicator corresponding to a third position of the drive unit.

31. It is an automatic syringe, Career and, A container containing the medicine, A sleeve connected to the container, having a slot extending in the longitudinal direction and a slot extending laterally or circumferentially from the longitudinally extending slot, A needle having a first end configured to extend from an automatic syringe and a second end configured to extend into the container, wherein when the automatic syringe is in a first state, the second end of the needle and the container are not in communication with each other. A connector housing connected to the second end of the needle, having a projection, wherein when the automatic syringe is in the first state, the projection abuts against a part of the sleeve to prevent the sleeve and the connector housing from moving relative to each other; The device comprises a drive unit connected to the needle, which is slidable relative to the carrier between a first position, a second position, and a third position, When the automatic syringe transitions from the first state to the second state, the drive unit extends the first end of the needle from the automatic syringe to the second position and rotates the connector housing in the first rotational direction, thereby enabling the projection to extend into the longitudinally extending slot. In the second state described above, the second end of the needle extends into the container and communicates with the container. An automatic syringe in which, when the automatic syringe transitions from the second state to the third state, the drive unit moves to the third position and rotates the connector housing in a second rotation direction opposite to the first rotation direction, thereby enabling the projection to extend into the slot that extends laterally or circumferentially.

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