Autoinjector kit

Abstract

An autoinjector kit, the autoinjector kit comprising an autoinjector device, the autoinjector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting a trigger site, a distal end opposite the proximal end, and a hollow interior; the cylinder body is arranged in the shell body; a stopper slidably mounted within the barrel and movable by the plunger rod from a distal position to a proximal position; a drive mechanism connected to the plunger rod, the drive mechanism having a stand-by state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a driving force, and an excited state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against the driving force. A plunger rod extending through at least a portion of the barrel and contacting the stopper in a proximal position; a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the standby state to the energized state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; an indicator member that, when triggered, moves distally from an initial position to an indication position to indicate a state of the autoinjector device; wherein the autoinjector kit comprises an indicator reset, and the housing of the autoinjector device comprises a reset access opening in the distal end of the longitudinal housing, the indicator reset comprising a base and a reset projection, the reset tab is insertable through the reset access opening to contact the indicator member and push the indicator member into an initial position.

Description

[0001] The present invention relates to autoinjector kits including autoinjector devices, and more particularly to autoinjector kits including training or demonstration autoinjector devices that may be intended to simulate at least some operation of an automatic drug delivery device. The present invention extends to autoinjector devices and methods of using such devices.

[0002] An automatic injector device (sometimes also referred to as an automatic drug delivery device) is a known example of a medical device. Such an automatic injector device is configured to dispense a fluid product, such as a medicament, to a patient. The term "automatic injector device" or "autoinjector" is used herein to describe not only the automatic drug delivery device described above, but also a training or demonstration device that may be intended to simulate at least some of the functions of such an automatic drug delivery device.

[0003] Examples of such automatic injector devices for drug delivery are described, for example, in WO 2019 / 224782, WO 2019 / 224783, WO 2019 / 224784 and WO 2019 / 224785 (the contents of which are incorporated herein by reference).

[0004] In general, such auto-injector devices provide reliable functionality and can be used accurately even by inexperienced individuals. However, there is still a need to train the patient or caregiver on the use of such devices, and this can be a potentially time-consuming process and can involve multiple demonstrations of the operation of the device. Some auto-injector devices may include electronic components that allow training attempts to be captured and can provide feedback to the user and / or care provider. Such devices offer the potential to manage and / or monitor training remotely rather than face-to-face.

[0005] The present invention provides an automatic injector kit, the automatic injector kit comprising an automatic injector device, the automatic injector device comprising:

[0006] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0007] A cylinder, the cylinder being installed in the shell;

[0008] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0009] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in the retracted position between a distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position;

[0010] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position;

[0011] an indicator member that moves distally from an initial position to an indicating position when triggered to indicate a status of the auto-injector device; wherein

[0012] The auto-injector kit includes an indicator reset member, and the housing of the auto-injector device includes a reset member access opening on the distal end of the longitudinal housing, the indicator reset member includes a base and a reset member protrusion, and the reset member protrusion can be inserted through the reset member access opening to contact the indicator component and push the indicator component into an initial position.

[0013] The indicator component can be any suitable element that moves distally from the initial position to the indication position when triggered to indicate the state of the automatic injector device. In the indication position, the indicator component can be visible to the user, such as through a window, to indicate the state of the automatic injector device. When the indication position is reached, the indicator component can provide an audible and / or tactile indication to indicate the state of the automatic injector device. The indicator component can provide a combination of visible indication, audible indication and / or tactile indication about the state of the automatic injector device. The state of positive indication can be that the device operation has been completed, such as a liquid dose has been delivered, or the stopper has reached a predetermined position, such as a proximal position. The indicator element can stop at the indicator position or can pass through the indicator position.

[0014] The provision of an indicator reset member (which may be referred to as an indicator reset element or indicator reset device, whose protrusion is able to reach the opening through the reset member of the housing to contact the indicator component) allows the user to move the indicator component back to the initial position. By allowing the user to move the indicator component back to its initial position, the automatic injector device can be reset without disassembling some or all of the components. When the indicator component is moved back to the initial position, the indicator component can be maintained in this initial position until triggered by a subsequent actuation of the automatic injector device.

[0015] The reset member access opening may have any shape that allows the projection of the indicator reset member to access the indicator component. The reset member access opening may be a hole on the distal end of the longitudinal housing that allows the rod-shaped projection to pass through the hole and move the indicator component. The reset member access opening may be an elongated slot extending from the distal end of the housing toward the proximal end, and the reset member projection may include an elongated wall. It has been found that this arrangement of the slot and the wall can provide a stronger and more reliable mechanical interaction between the indicator component and the projection because deformation of the projection can be more easily controlled, reduced or avoided.

[0016] The indicator reset may include a cover into which the housing may fit. The cover may enclose some or substantially all of the longitudinal housing. If the longitudinal housing may be fitted with a cap, for example to cover the open proximal end, the cover may also enclose some or all of the cap.

[0017] When the housing is fitted into the cover, the housing can be releasably fixed therein, for example, by one or more releasable clips. The releasable clip can act on the housing, on the cap connected to the housing, or on any other part of the automatic injector device or on the part connected thereto. The clip holds the housing by resisting a removal force, which will be used to remove the housing from the cover. The releasable clip can be deformable so that if a removal force higher than a threshold value is applied, the clip is released. This can allow the user to simply pull the housing from the cover, for example, by pulling on the housing or the cap connected to the housing. In other examples, the releasable clip can prevent the housing from being removed from the cover until the clip is released by the user manipulating the release member (e.g., pressing a button, sliding the release catch, moving the release lever or other manipulations).

[0018] The cover may be configured so that as the housing is fitted into the cover, the cover reset member projection extends through the cover reset member to access the opening and push the indicator member into the initial position. This may provide a convenient way for the user to reset the indicator member when they simply return the used autoinjector to the associated cover. The cover may provide a convenient way for the user to store the autoinjector device.

[0019] The shape of the cover and / or housing can be configured so that the housing can only enter the cover in one rotational orientation about the longitudinal axis. In this way, the user can insert the housing into the cover in a single orientation in which the reset protrusion of the indicator reset can be aligned with the reset access opening.

[0020] The indicator reset member and / or the housing may include a removal indicator. When the indicator reset member is fully inserted or the auto-injector device is inserted into the housing, the removal indicator may interact with a portion of the auto-injector such that removal of the indicator reset member or removal of the auto-injector device from the housing causes a change in state of a component of the auto-injector device, thereby allowing, for example, detection of the removal of the indicator reset member or removal of the auto-injector device from the housing by an electronic module of the auto-injector. Facilitating detection of the removal of the indicator reset member or removal of the auto-injector device from the housing by the electronic module may facilitate opening, waking up, and / or initializing the electronic module prior to use.

[0021] The electronic module of the auto-injector device may include a power source, such as a capacitor or a battery, and the power source may be rechargeable. The power source may be removed from the auto-injector device for charging, or may be recharged in the auto-injector housing.

[0022] The power source in the housing of the auto-injector can be recharged by wired charging, such as by inserting the power source into the auto-injector device, or into something (e.g., a cover) in which the auto-injector is placed. In some examples, the cover of the auto-injector can include a power source, such as a battery or capacitor, for recharging the power source of the auto-injector device. The cover and the auto-injector device can be configured so that when the auto-injector device is placed in the cover, a wired or wireless connection is made so that the power source of the auto-injector is charged.

[0023] In some examples, the indicator reset member may include a portion that contacts and resets the indicator component, and another portion that contacts and moves another component of the automatic injector (e.g., a trigger component). Removal of the indicator reset member may cause the other component to move to its starting position, and this movement may be detected by the electronic module, for example, by a change in state of a contact switch, movement of a magnetic element or other detectable element, or by a proximity sensor. The indicator reset member may include, for example, a stepped rod or wall, wherein a first step contacts and resets the indicator component, and another step contacts and moves another component of the automatic injector.

[0024] In some examples, the indicator component can be retained in a position proximal to its initial position by the indicator reset member and / or the housing, such that removal of the indicator reset member, or removal of the autoinjector device from the housing, causes the indicator component to move distally to its initial position, in which the indicator component can be retained until triggered.

[0025] In some examples, the housing may include a detectable portion, such as a detectable portion that can be detected without contact, such as a magnetic or metallic portion, or a detectable portion that can be detected by contact, such as a protrusion, ridge, or catch. When the autoinjector device is fully inserted into the housing, the detectable portion can be detected by the electronic module of the autoinjector, such as by a sensor or switch. Removal of the autoinjector device from the housing moves the detectable portion of the housing away from the electronic module, meaning that the electronic module can detect removal of the autoinjector device from the housing.

[0026] The longitudinal housing of the autoinjector device may be of any suitable shape and may be elongated. The longitudinal housing has a hollow interior and extends along a longitudinal axis from an open proximal end to a distal end opposite the proximal end. The longitudinal housing may include a plurality of components.

[0027] The open proximal end is used to contact the trigger site. In some examples, the needle guard component of the longitudinal housing can provide the open proximal end and can contact the trigger site. Pressing the longitudinal housing against the trigger site can cause the needle guard to move relative to the shell component of the longitudinal housing. For example, pushing the needle guard to move into the shell component can trigger actuation of the automatic injector device. The trigger site can be a part of the patient's body, such as a thigh or stomach, or can be a test pad that can simulate a body part.

[0028] The open proximal end allows access therethrough into a hollow interior that houses components of the autoinjector device, including a barrel mounted within the longitudinal housing. The barrel can be, for example, a syringe barrel that, for a drug delivery device, can contain a liquid to be delivered to a patient, such as a liquid drug. In a demonstration or training device, the barrel can be a replica of a syringe barrel, such as a component intended to replicate the "look" and / or "feel" of those portions of a syringe barrel that can be seen or felt when using an autoinjector.

[0029] In the barrel, the stopper is slidably mounted and can slide from a distal position to a proximal position. In the proximal position, the stopper is closer to the open proximal end of the longitudinal housing than when in the distal position. In the drug delivery device, the stopper can define a variable volume chamber together with the barrel. When the stopper moves from the distal position to the proximal position in the barrel, the volume of the variable volume chamber decreases, and any liquid contained therein can be discharged from the variable volume chamber, for example, through a needle, which can be connected to the proximal end of the barrel or formed integrally therewith.

[0030] The automatic injector device comprises a drive mechanism which can drive the plunger rod to cause the stopper to move from a distal position to a proximal position. In order to provide a driving force to the drive mechanism, any suitable energy storage device may be included and may include a mechanical spring (e.g., a coil spring or a leaf spring) or a gas spring (e.g., a damped gas spring) or a combination thereof.

[0031] In the standby state, the plunger rod is held in a retracted position between the distal end and the stopper in the distal position, directly or indirectly against a driving force. In the retracted position, the plunger rod may be spaced apart from the stopper in the distal position. In the standby state, any energy storage device may be in an energized state, such as a mechanical spring being compressed or a gas spring being pressurized.

[0032] The speed of movement of the gas spring can be predetermined to control the speed of movement of the plunger rod and stopper during use. This can facilitate the production of a demonstration or training device that more accurately replicates the action of a drug delivery device, or a drug delivery device that delivers drug within a predetermined time.

[0033] In the activated state, the plunger rod extends through at least a portion of the barrel and contacts the bung when the bung is in the proximal position. At least some of the energy stored in the inactive position has been used to drive the plunger rod toward the open proximal end of the longitudinal housing.

[0034] The automatic injector device includes a trigger mechanism that is operable to release the plunger rod. This initiates the transition of the drive mechanism from the standby state to the activated state, so that the plunger rod drives the stopper from the distal position to the proximal position. As described above, the trigger mechanism can be operated by relative movement between parts of the longitudinal housing (e.g., movement of the needle guard relative to the housing). The trigger mechanism can be operated by a user-operated button, switch, buckle or joystick, which can be mounted, for example, on the distal end or side of the longitudinal housing.

[0035] The stopper may include a stopper opening extending through the stopper along the longitudinal axis. The automatic syringe kit may further include a reset rod. The reset rod may have a first end that can be inserted through the open proximal end of the housing to contact the plunger rod through the stopper opening and push the plunger rod into the retracted position, and thereby convert the drive mechanism to its standby state. The reset rod may have a second end opposite to the first end that is held outside the longitudinal housing when the plunger rod moves to the retracted position. This provides a simple reset mechanism for the plunger rod and the drive mechanism, the automatic syringe device, and particularly a demonstration or training device. When the plunger rod and the drive mechanism move back to their initial state, they can be held until triggered by subsequent actuation of the automatic syringe device.

[0036] The reset rod may include a protrusion that is offset along the reset rod relative to the first end. The protrusion may be sized so that the protrusion cannot pass through the stopper opening and may therefore contact the stopper. The protrusion may provide a bearing surface to contact the stopper. When the plunger rod is moved into the retracted position, the protrusion may contact the stopper and move the stopper to the distal position.

[0037] A portion of the protrusion may extend substantially perpendicular to the longitudinal axis. The protrusion may be of any suitable shape, such as a raised portion of the reset rod. The protrusion may include a circumferential shoulder. The protrusion may be integrally formed with the reset rod, or may be a separate element carried by or attached to the reset rod. The circumferential shoulder may provide a continuous bearing surface, such as a flat bearing surface, which may provide greater control over the position along the reset rod where the protrusion contacts the plug.

[0038] The offset between the first end and the projection may be greater than the extent of the stopper along the longitudinal axis. This may create a space between the plunger rod in the retracted position and the stopper in the distal position.

[0039] In some examples of drug delivery devices, when the device is ready for use, there may be a gap between the plunger rod and the stopper. When triggered, the plunger rod can move quickly toward the stopper and hit the stopper, thereby generating auditory and tactile feedback. For demonstration or training devices, it is beneficial to regenerate this auditory and tactile feedback, so a simple mechanical way is provided, wherein, when the plunger rod is reset, the stopper is also reset and the original gap between the stopper and the plunger rod is regenerated. In this way, subsequent actuation can regenerate any auditory and tactile feedback provided by the original gap between the plunger rod and the stopper.

[0040] The second end of the reset rod may include a cap mountable to the proximal end of the housing. In this way, re-capping the device after use may reset the plunger rod and stopper to their initial position. The cap may be rotated to remove the cap from the housing. Providing a flat bearing surface for the protrusion may reduce damage to the stopper if the reset rod is rotated relative to the stopper, for example if the cap is rotated to remove it from the housing.

[0041] The autoinjector device may include a guide track to control the rotation of the plunger rod and / or stopper about the longitudinal axis during operation. Controlling the rotation of the plunger rod during operation may make the resetting operation more reliable or simpler, as circumferentially distributed features (e.g., catches for holding the plunger rod in the retracted position) may automatically align for reengagement.

[0042] In some examples, the plunger rod can be fixed to the stopper. The plunger rod can be fixed to the stopper so as to limit or prevent the rotation of the plunger rod relative to the stopper. The stopper and / or the plunger can include an axial ridge or circumferential protrusion on the outer surface, which can engage with an axial slot in the barrel to control the rotation of the plunger rod and / or the stopper around the longitudinal axis during operation. The axial slot in the barrel can provide a guide track for controlling the rotation of the plunger rod and / or the stopper via the stopper.

[0043] As described above, the automatic injector device may include a reset rod that can be inserted through the open proximal end of the housing to apply a reset force to the plunger rod to move it into the retracted position and thereby transition the drive mechanism to its standby state. In some examples, the stopper may include a stopper opening extending through the stopper along the longitudinal axis so that the reset rod can pass therethrough and contact the plunger rod. In other examples, the stopper may not include such a stopper opening, and the reset rod may contact the stopper and apply a force thereto to thereby apply a force to the plunger rod.

[0044] The maximum resetting force required to move the plunger rod into the retracted position may be less than 20N, less than 10N or less than 5N, as this facilitates resetting the device. This may be particularly suitable for demonstration or training devices, where the drive mechanism does not act on the stopper to drive the liquid from the syringe into the patient. A relatively low resetting force may have other advantages for resetting the device, as the releasable catch and catch may be more flexible than if they constrain a stronger force (such as constraining a drive spring), which may be required to drive the plunger to dispense a certain volume of liquid drug through the needle within an acceptable time.

[0045] The inner dimension of the barrel perpendicular to the longitudinal axis can increase toward the proximal end of the automatic injector device so that as the stopper is driven toward the proximal end by the plunger rod, the compression of the stopper decreases. When in the distal position, the stopper can be initially compressed by a first amount, and this amount can decrease as the stopper moves toward the proximal position.

[0046] The reduction of the compression of the stopper can reduce the force required to slide the stopper in the barrel. If the plunger is driven by a spring, this can produce a more consistent stopper movement speed. The driving force of the spring can be reduced as it expands, and the resistance provided by the friction of the stopper and the barrel can be adjusted (e.g., reduced), and this can be compensated. This allows the movement speed of the stopper to be controlled. In some examples, the stopper can move at a substantially constant speed. This can be particularly relevant for a stopper made of an elastomer or a compressible rubber-like material with a relatively high Poisson's ratio. For example, thermoplastic elastomers and rubbers can have a Poisson's ratio of 0.45 to 0.50.

[0047] The cross-section of the barrel may be substantially circular and the internal dimension may be the inner diameter of the barrel.The rate of reduction of the internal dimension may be substantially constant, resulting in a draft angle of between 0.05° and 0.3° relative to the longitudinal axis.

[0048] The stopper can be made into any suitable shape and can include one or more known features, such as ribs and valleys. The stopper can be made of any suitable material, such as any suitable one or more materials, such as plastic, elastomer, rubber or silicone or a combination thereof. The material can be selected to provide a desired deformation resistance and / or a desired friction coefficient. For example, when the stopper is deformed to fit into the barrel, the deformation resistance and / or the desired friction coefficient affect the resistance of the stopper to movement relative to the barrel.

[0049] The stopper and / or barrel may have a coating, such as an oil or grease applied to the contact surface to adjust the resistance of the stopper to movement relative to the barrel as the stopper moves within the barrel. The coating may be a synthetic oily liquid or emulsion, such as polydimethylsiloxane liquid, which may be applied to the stopper and / or barrel. The coating may be, for example, a solid film layer, such as PTFE, applied to the stopper.

[0050] The present invention also provides an automatic injector kit, the automatic injector kit comprising an automatic injector device, the automatic injector device comprising:

[0051] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0052] A cylinder, the cylinder being installed in the shell;

[0053] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0054] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; and

[0055] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein

[0056] The stopper includes a stopper opening extending through the stopper along the longitudinal axis, and the autoinjector kit further includes a reset rod having a first end insertable through the open proximal end of the housing to contact the plunger rod through the stopper opening and urge the plunger rod into the retracted position and thereby transition the drive mechanism to its standby state, the reset rod having a second end opposite the first end, the second end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position.

[0057] As mentioned above, providing a stopper opening extending through the stopper provides a convenient way of resetting the position of both the stopper and the plunger rod.

[0058] The present invention further provides an automatic injector device, the automatic injector device comprising:

[0059] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0060] A cylinder, the cylinder being installed in the shell;

[0061] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0062] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; and

[0063] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein

[0064] The autoinjector device includes a guide track to control rotation of the plunger rod about the longitudinal axis during operation.

[0065] As described above, controlling the rotation of the plunger rod may facilitate resetting of the plunger rod.

[0066] The present invention further provides an automatic injector kit, the automatic injector kit comprising an automatic injector device, the automatic injector device comprising:

[0067] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0068] A cylinder, the cylinder being installed in the shell;

[0069] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0070] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position;

[0071] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; and

[0072] The autoinjector kit includes a reset rod having a first end insertable through the open proximal end of the housing to apply a reset force to the plunger rod to move the plunger rod into the retracted position and thereby transition the drive mechanism to a standby state, the reset rod having a second end opposite the first end, the second end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position; wherein

[0073] The maximum return force required to move the plunger rod into the retracted position is below 10N.

[0074] As described above, controlling the reset force to be below a predetermined threshold can make it easier for the user to reset the device. The force required to reset parts of the auto-injector device (which can include reset of the indicator, plunger rod and stopper, and trigger) and attaching the cap can be in series (sequential) to reduce the peak force required.

[0075] The present invention also provides an automatic injector device, the automatic injector device comprising:

[0076] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0077] A cylinder, the cylinder being installed in the shell;

[0078] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0079] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; and

[0080] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein

[0081] An inner dimension of the barrel perpendicular to the longitudinal axis increases toward a proximal end of the autoinjector device such that compression of the bung decreases as the bung is driven toward the proximal end by the plunger rod.

[0082] As discussed above, increasing the internal dimensions of the barrel in this manner provides a means of controlling the speed of movement of the stopper when driven by the plunger rod.

[0083] The present invention may also provide an autoinjector device suitable for use with any of the above-described kits.

[0084] The present invention extends to a method of resetting an indicator component in an auto-injector device, the auto-injector device comprising:

[0085] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0086] A cylinder, the cylinder being installed in the shell;

[0087] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0088] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position;

[0089] a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; and

[0090] an indicator component that moves distally from an initial position to an indicating position when triggered to indicate a status of the automatic injector device; wherein the method comprises:

[0091] Inserting a reset member protrusion of an indicator reset member through a reset member access opening in a distal end of a longitudinal housing of a housing of the autoinjector device to contact the indicator member, and using the reset member protrusion to push the indicator member into the initial position.

[0092] The user may hold the indicator device reset member by the base to facilitate insertion of the reset member protrusion through the reset member access opening. The base may include a guide to facilitate alignment of the reset member protrusion and the reset member access opening. The base may include a cover for an automatic injector device as described above.

[0093] In order to reset the indicator component by returning the indicator component to its initial position, the user can align the reset member access opening of the automatic injector with the reset member protrusion, and move the automatic injector device relative to the reset member protrusion so that the reset member protrusion enters the reset member access opening and contacts the indicator component. Further relative movement between the automatic injector device and the reset member protrusion can cause the reset member protrusion to force the indicator component into the initial position.

[0094] Alignment and relative movement may be achieved, for example, by a user inserting the autoinjector device into a housing comprising a reset protrusion and aligning the autoinjector device with the reset protrusion.This provides a simple way of resetting the indicator member after operation of the device.

[0095] The present invention may also include a method of resetting a plunger rod of an automatic injector device, the automatic injector device comprising:

[0096] a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior;

[0097] A cylinder, the cylinder being installed in the shell;

[0098] a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod;

[0099] a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; and

[0100] a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein the method comprises:

[0101] inserting a first end of a reset rod through the open proximal end of the housing to contact the plunger rod through a stopper opening extending through the stopper along the longitudinal axis; and

[0102] The reset rod is used to push the plunger rod into the retracted position and thereby shift the drive mechanism to a standby state, a second end of the reset rod opposite the first end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position.

[0103] The user can hold the reset member by the second end to facilitate the insertion of the reset rod through the open proximal end of the housing.The second end may include a cap, which is used to close or cover the open proximal end of the housing of the automatic injector device as described above.

[0104] By inserting the first end of the reset rod through the open proximal end of the housing and using the reset rod to push the plunger into the retracted position, the plunger rod and the drive mechanism are reset when the plunger rod returns to the retracted position and the drive mechanism returns to its inactive state. If the second end of the reset rod includes a cap, the cap can engage with the housing to close or cover the open proximal end of the housing when the plunger reaches the retracted position.

[0105] Thus, returning the cap to the autoinjector device after use may comprise a convenient way of resetting the plunger rod and drive mechanism after operation of the device.

[0106] An example usage sequence may include the following actions. The user may remove the auto-injector from the housing and remove the cap from the auto-injector device to prepare the auto-injector device for use. These actions may occur in any order, but in some examples, the housing may prevent the removal of the cap before the auto-injector device is removed from the housing.

[0107] The autoinjector device may then be actuated by pressing the open proximal end against the trigger site.

[0108] Once used, the elements of the automatic injector can be reset as described above. This can be achieved by, for example, the user inserting the first end of the reset rod into the open proximal end and / or inserting the reset member protrusion of the indicator reset member into the reset member contact opening. In some embodiments, these reset actions can be achieved by returning the automatic injector device to the cover and putting the cap back on the open proximal end. The cover may include a guide to facilitate alignment between the cap and the automatic injector device. Inserting the automatic injector device into the cover can also automatically start charging of the power supply of the automatic injector device.

[0109] The present invention will now be described, by way of example only, with reference to the following accompanying drawings, in which:

[0110] Figure 1 An example of an autoinjector device prior to use is shown;

[0111] Figure 2 An example of an autoinjector device is shown in a housing prior to use;

[0112] Figure 3 An example of an autoinjector device is shown removed from its housing and with its cap removed, ready for use;

[0113] Figure 4 shows a cross-section of an example of an autoinjector device prior to use;

[0114] Figure 5 shows a cross section of an example of an autoinjector device with the cap removed;

[0115] Figure 6 shows a cross section of an example of an autoinjector device in which a needle guard member of the housing is pressed against a trigger site at the beginning of the plunger rod movement;

[0116] Figure 7 shows a cross section of an example of an autoinjector device in which a needle guard member of the housing presses against a trigger site during movement of an operating plunger rod;

[0117] Figure 8 shows a cross section of an example of an autoinjector device in which a needle guard member of the housing presses against a trigger site at the end of the plunger rod movement;

[0118] Fig. 9 shows a cross section of an example of an autoinjector device after movement of a plunger rod, wherein a needle guard member of the housing moves away from a triggering site;

[0119] Fig.10 shows a cross section of an example of an autoinjector device that has been placed into a housing and recapped after use;

[0120] Fig.11 shows cross-sections of various examples of autoinjector devices with the cap removed;

[0121] Fig.12 is the cross-section of the barrel of the auto-injector device;

[0122] Fig.13 is a view of an example stopper;

[0123] Fig.14 yes Fig.13 Example of a cross section of a plug;

[0124] Fig.15 is a view of an example stopper;

[0125] Fig.16 yes Fig.15 Example of a cross section of a plug;

[0126] Fig.17 is a view of an example end portion of a housing;

[0127] Fig.18 is a view of an example of an end portion of a reset rod;

[0128] Fig.19 are views of different examples of the end of a reset rod;

[0129] Fig. 20 is an exploded view of an example autoinjector device;

[0130] Fig.21 is an exploded view of the cap and proximal components of an example autoinjector device;

[0131] Fig. 22 is an exploded view of an example drive mechanism, plunger rod, and housing end cap of an example automatic injector device;

[0132] Fig.23 is an exploded view of another example drive mechanism, plunger rod, and housing end cap of an example automatic injector device; and

[0133] Fig.24 is an exploded view of an example of a barrel, stopper, and plunger rod.

[0134] Figure 1An example of an autoinjector kit 100 including an autoinjector device 1 and a cap 4 is shown. The autoinjector device 1 includes a body 2. The cap 4 includes raised markings 6 to provide information to the user and facilitate removal of the cap 4 from the body 2. In this example, the body 2 is transparent or translucent so that the user can see the internal components, and a label 8 is wrapped around a portion of the body 2 to hide some of the internal components. In other examples, the body can be completely opaque, or opaque in a portion that can define a viewing window, or the body 2 can be perforated with a viewing window.

[0135] Figure 2 An automatic injector kit 100 (eg, Figure 1 The present invention provides an example of an auto-injector kit 100 of the present invention, which includes a cover 10 in which the auto-injector device 1 can be stored before use. In this example, the cover 10 surrounds and contains the body 2 of the auto-injector 1 so that the user cannot touch the body 2. In other examples, the cover 10 may include a cutout portion.

[0136] The housing 10 includes projections 12 which extend across the cap 4. The projections 12 include snaps 14 (at Figure 3 ), these snaps engage with the raised markings 6 to releasably retain the autoinjector 1 in the housing 10. In other examples, snaps or other releasable retaining elements may be provided elsewhere on the housing 10 or cap 4 so that the autoinjector device 1 may be releasably retained in the housing 10.

[0137] Figure 3 Shows Figure 2 1 is an exploded view of an autoinjector kit 100, wherein the cap 4, the autoinjector device 1 and the cover 10 are shown separately. The body 2 includes a longitudinal housing 18 extending along a longitudinal axis 20 and having an open proximal end 22 for contacting a triggering site (not shown in this figure). The housing 18 extends along the longitudinal axis 20 from the open proximal end to a distal end 24 opposite the open proximal end 22. The longitudinal housing 18 has a hollow interior.

[0138] The reset rod 16 extends from the cap 4 and can be inserted into the hollow interior of the housing through the open proximal end 22 of the housing 18. In this example, the reset rod 16 includes an end portion 28 for engaging a plunger rod (not shown in this figure) and a wider support element 26 for contacting a stopper (not shown in this figure). In other examples, the end portion 28 can directly contact the stopper.

[0139] Figure 4 A cross section of an example of an autoinjector device 1 is shown, which is removed from the housing 10 and has its cap 4 opened, e.g. Figure 1The automatic injector device 1 and the cap 4. In this figure, the hollow interior 30 of the longitudinal housing 18 can be seen.

[0140] The barrel 32 is mounted in the housing 18, and the plug 34 is slidably mounted in the barrel 32. The plug 34 can be moved from a distal position (as shown in this figure) toward the open proximal end 22 to a proximal position (as shown in this figure) by a plunger rod 36. Fig. 9 The distal position is closer to the distal end 24 of the housing 18 than the proximal position.

[0141] The drive mechanism 38 is connected to the plunger rod 36. In this figure, the drive mechanism 38 is shown in an inactive state, wherein the plunger rod 36 is held in a retracted position against a drive force between the distal end 24 of the housing 18 and the bung 34 in a distal position.

[0142] The drive mechanism 38 can be moved to an excited state (eg Fig. 9 ), wherein the plunger rod 36 extends through at least a portion of the barrel 32 and contacts the stopper 34 in a proximal position.

[0143] The autoinjector 1 comprises a trigger mechanism 40 operable to release the plunger rod 36 and initiate transition of the drive mechanism 38 from the arming state to the fired state to thereby cause the plunger rod 36 to drive the bung 34 from the distal position to the proximal position.

[0144] The automatic injector 1 comprises an indicator member 42 which, when triggered, moves distally from an initial position (as shown in this figure) to an indication position (as shown in this figure). Fig. 9 ) to indicate the status of the automatic injector device 1.

[0145] Figure 5 A cross section of an example of an autoinjector device 1 is shown with the cap 4 removed. Removal of the cap 4 allows the needle guard 46 of the housing 18 to extend away from the drive mechanism 38 along the longitudinal axis. The needle guard 46 is coupled to a trigger mechanism 40 as will be outlined below. Detailed examples of trigger mechanisms 40 and associated drive mechanisms 38 suitable for use in autoinjectors can be found in, for example, WO 2019 / 224782, WO 2019 / 224783, WO 2019 / 224784 and WO 2019 / 224785.

[0146] Figure 6 A cross section of an example of an autoinjector device 1 is shown, wherein a needle guard 46 is pressed against a trigger site 48. In this example, the trigger site 48 is a pad that may replicate the texture of human tissue into which an injection may be made.

[0147] Pressing the needle guard 46 into the trigger site moves the needle guard 46 toward the distal end 24 of the housing and activates the trigger mechanism 40, thereby releasing the plunger rod 36 and initiating the transition of the drive mechanism 38 from the arming state to the fired state to thereby cause the plunger rod 36 to drive the stopper 34 from the distal position to the proximal position.

[0148] Figure 7 A cross section of an example of an autoinjector device 1 is shown in which a needle guard 46 is pressed against a trigger site 48 after the trigger mechanism 40 releases the plunger rod 36. The plunger rod 36 is driven through the barrel 32 towards the proximal end 22 of the autoinjector 1 by a drive spring 50 of the drive mechanism 38, which in this case is a coil spring.

[0149] Figure 8 A cross section of an example of an autoinjector device 1 is shown in which the needle guard 46 is pressed against the trigger site 48 at the end of the movement of the plunger rod 36 by the drive mechanism 38. In this example, the bung 34 has been driven to the proximal end of the barrel 32 by the plunger rod 32 and the drive spring 50. The bung 34 has been driven against the shoulder 52.

[0150] The autoinjector 1 comprises an indicator member 42 which, in this example, has been triggered by the plunger rod 36 reaching or approaching its final delivery position in which it holds the stopper against the stopper 52. The indicator member 42 which has been triggered has moved from its initial position (e.g. Figure 4 ) to the indicated position (as shown in this figure and Fig. 9 ) to indicate the state of the automatic injector device 1. In this case, the state being indicated is that the plunger rod 36 has reached or is close to the end position of its delivery position.

[0151] Indicator member 42 may be visible through a portion of housing 18 (e.g., end cap 54) in the indicated position. Movement of indicator member 42 to the indicated position and / or impact of indicator member 42 with end cap 54 or other components may generate audible or tactile feedback for the user.

[0152] Fig. 9 A cross section of an example of the autoinjector device 1 is shown after the final movement of the plunger rod 36. The autoinjector device 1 has moved away from the triggering site, which allows the needle guard 46 of the housing 18 to move away from the distal end 24.

[0153] Fig.10A cross section of an example of an auto-injector kit 100 is shown, which includes a cap 4, an auto-injector device 1, and a cover 10. As shown, the auto-injector device 1 is recapped after use by replacing the cap 4 on the proximal end of the housing 18. The auto-injector device 1 has also been placed into the cover 10 after use. In some examples, the auto-injector device 1 can be placed into the cover 10 before recapping. The cover 10 can guide the housing 18 to a predetermined orientation and position within the cover 10, and the cover 10 can also guide the cap 4 onto the housing 18 to facilitate recapping.

[0154] To recap the auto-injector device 1, the reset rod 16 is inserted through the open proximal end 22 so that the end portion 28 passes through the stopper opening 56 on the stopper to contact the plunger rod 36. When the cap 4 is pressed onto the housing 18, the reset rod 16 pushes the plunger rod 36 toward its retracted position until the support element 26 contacts the stopper 34. Continued movement of the cap 4 onto the housing moves the plunger rod 36 toward its retracted position and moves the stopper 34 toward its distal position. The spacing of the end portion 28 and the support element 26 along the longitudinal axis 20 may be greater than the axial extent of the stopper 34, thereby creating a space between the stopper 34 and the plunger rod 36. In other examples, there may be substantially no space between the stopper 34 and the plunger rod 36. In other examples, there may be no stopper opening 56, and the end portion 28 of the reset rod 16 may contact the stopper 34 and thereby push both the stopper 34 and the plunger rod 36 toward the distal end 24. In other examples, the reset lever 16 may not be integrated with the cap 4, so the reset lever 16 and a separate cap 4 may be provided or no cap may be provided.

[0155] During recapping, in this example, the cap 4 contacts the needle guard 46 and pushes it towards the distal end 24. When the cap 4 is engaged with the housing 18, the stopper 34 is in the distal position and the plunger rod 36 is in the retracted position.

[0156] In the distal position, the stopper 34 can be held in place by friction forces acting between the stopper 34 and the barrel. In the retracted position, the plunger rod 36 can be retained again so that when the reset rod 16 is removed, the plunger rod 36 is retained against the driving force provided by the drive mechanism 38. In this way, using the reset rod 16, the plunger rod 36, the stopper 34 and the drive mechanism 38 are reset.

[0157] Fig.10 The autoinjector device 1 is shown in a housing 10. The housing 10 includes a reset protrusion 58 at a closed end 60 of the housing 10. In this example, the reset access opening 62 is a slot in the end cap 54, and the reset protrusion 58 is a wall extending from an inner wall of the housing 10 along the longitudinal axis 20, but other geometries are possible.

[0158] When the auto-injector device 1 is inserted into the housing 10, the reset member protrusion 58 passes through the reset member access opening 62 on the distal end 24 of the longitudinal housing 18 and contacts the indicator component 42. After the initial contact between the indicator component 42 and the reset member protrusion, when the auto-injector device 1 is further inserted into the housing 10, the reset member protrusion 58 further passes through the reset member access opening 62 and pushes the indicator component 42 from the indicating position toward the initial position. When the auto-injector device 1 is fully inserted into the housing 10, the indicator component 42 has returned to its initial position, and in this case, the indicator component 42 is reset.

[0159] The trigger mechanism 38 is reset during the reset of the plunger rod 36, stopper 34 and drive mechanism 38 and / or reset of the indicator member 42. In this example, placing the cap 4 back on the autoinjector 1 and placing the autoinjector 1 in the housing 10 resets the autoinjector 1 for future use.

[0160] Fig.11 A cross section of a different example of an auto-injector device 101 is shown with the cap 4 removed. The auto-injector device 101 is similar to Figure 8 The invention relates to an automatic injector 1 of the invention, but the drive mechanism 38 comprises an integrated plunger rod 136 and a drive spring 150 in the form of a gas spring 64. In this example, the stopper 134 does not comprise a stopper opening extending therethrough.

[0161] If the reset rod 16 is used to reset the gas spring 64, the reset rod 16 may not pass through the stopper 134, but may contact the stopper 134, and by pushing the stopper 134 back to the distal position, the gas spring 64 is also reset to its retracted position. In this example, when the stopper 134 is in the distal position and the plunger rod 136 is in the retracted position, there is no gap between the stopper 134 and the plunger rod 136.

[0162] In other examples, as described above, a gap may be created between the stopper having a through hole and the plunger rod 136. The drive spring 150 may include a gas spring 64 and an initial spring that, when the drive mechanism is triggered, drives the gas spring 64 to the stopper to recreate the initial impact of the plunger rod that may occur in the delivery device, and the gas spring 64 may then drive the stopper at a controlled rate.

[0163] Fig.12A cross section of an example of a barrel 32 is shown. The barrel 32 includes a plug 34 therein. The barrel 32 has a proximal end 66 and a distal end 68. The barrel 32 defines a passage 70, in this case a cylindrical passage, through which the plug 34 (in this case a cylindrical plug) can slide. The resistance to movement of the plug 34 is determined by the interaction between the plug 34 and the barrel 32, such as by friction.

[0164] The friction between the plug 34 and the barrel 32 can be determined by the materials that constitute the plug 34 and the barrel 32 and / or the surface finish of any contacting surfaces. The friction between the plug 34 and the barrel 32 can be changed by including a coating on one or more of the plug 34 and the barrel 32. The plug 34 can be made of an elastically deformable material, such as rubber, silicone, or an elastomeric material, and the friction between the plug 34 and the barrel 32 can be changed by changing the degree to which the plug 34 must be deformed or flattened to fit within the barrel 32.

[0165] In this case, increasing the diameter of the stopper and / or decreasing the diameter of the passage 70 will increase the deformation of the stopper 34 within the barrel 32. The increased deformation can increase the force between the stopper 34 and the barrel 32, and this can increase the resistance to the movement of the stopper 34 relative to the barrel 32. In some examples, instead of a linear transition between diameters at different sections of the barrel, the transition can be stepped. This is useful in the initial few mm of travel to recreate "head space compression" within a pre-filled syringe.

[0166] The passage 70 of the barrel 32 can have a substantially constant diameter, and this can result in a substantially constant force that resists the movement of the plug 34 within the barrel 32. The diameter of the passage 70 can vary between the distal end 68 and the proximal end 66 along the passage 70 to change the force required to move the plug. The diameter of the passage 70 can increase from the distal end 68 to the proximal end 66 so that when the plug 34 moves to the distal end, the force required to move the plug within the barrel 32 is reduced. The change in the diameter of the passage 70 from the distal end 68 to the proximal end 66 can occur over the entire length of the passage, or over a portion of the passage. The change in the diameter of the passage 70 can be an increase in diameter or a decrease in diameter. The result of the change in the diameter along the passage 70 can result in at least a portion of the passage or all of the passage having a conical shape. The conical shape can have a draft angle of the passage 70 between 0.03° to 0.5° or 0.05° to 0.3° relative to the longitudinal axis.

[0167] In this example of the barrel 70, the barrel includes a guide track 82. The guide track 82 may be recessed into the barrel 70 or protrude from the barrel and may engage with corresponding ridges or recesses on the stopper 34 and / or on the plunger rod 36 to control the rotation of the stopper 34 and / or the plunger rod 36. In some examples, there may be no guide track 82, and in other examples, there may be more than one guide track 82.

[0168] Fig.13 and Fig.14 The plug (e.g. Figure 4 1 and 2. The plug 34 of this example is substantially circular in cross-section perpendicular to the longitudinal axis, but other shapes may be used. The plug 34 of this example has four circumferential ribs 72 that are of similar size and shape, but other examples of the plug may have more, fewer, or no ribs 72. In some examples, some or all of the ribs 72 may be different in size or shape when compared to other ribs 72.

[0169] Fig.15 and Fig.16 The plug (e.g. Fig.11 1 and 2. The plug 134 of this example is substantially circular in cross-section perpendicular to the longitudinal axis and includes longitudinal ridges 74 extending along the exterior of the plug 134 at locations offset 180° from one another around the circumference of the plug 134. One or more such ridges 74 may be included in any example of the plug 34. The plug 134 of this example has four circumferential ribs 72 that are of similar size and shape, but other examples of the plug may have more, fewer, or no ribs 72. In some examples, some or all of the ribs 72 may differ in size or shape when compared to other of the ribs 72.

[0170] The stopper 134 does not include a stopper opening 56, but instead includes a dividing wall 76 that separates proximal and distal recesses 78, 80. The proximal recess 78 is sized to receive the end portion 28 of the reset rod 16. The distal recess 80 is sized to receive the end of the plunger rod 16. In other examples of the stopper 34, the stopper 35 may not include one or both of the proximal and distal recesses 78, 80, for example, the stopper may have an end wall defining a hollow interior. The end wall may include one or more openings. In other examples, the stopper 34 may have a substantially solid construction.

[0171] One or more ridges 74 on the plug 134 may engage with the recessed guide track 82 in the barrel 70 to control rotation of the plug 134 as discussed above.

[0172] Fig.17 An example of an end cap 54 is shown and a reset access opening 62 is shown, which in this example is a slot on the end cap 54 through which the reset protrusion 58 (e.g., a wall extending from the inner wall of the housing 10) can extend and contact the indicator component 42.

[0173] Fig.18 An example of a reset rod 16 is shown. In this example, the reset rod 16 includes an elongated narrow end portion 28 for passing through the stopper opening 56 and engaging the plunger rod 34, as shown in conjunction with Figure 4 The reset rod 16 and the wider support element 26 are used to contact the plug, such as in combination with Figure 4 In this example, the support element 26 is integrated into the reset lever, but may be a separate element connected to the reset lever 16. The support element 26 may be connected in any suitable manner, such as by a friction fit or by an adhesive.

[0174] Fig.19 An example of a reset rod 116 is shown. In this example, the end 128 directly contacts the plug 134. In this example, the end 128 is sized to fit within the proximal recess 78 in the plug 134 so that the plug 134 guides the position of the reset rod 116, in this example, keeping it centered within the barrel bore 32. Controlling the position of the reset rod 116 relative to the barrel 32 can prevent the reset rod 116 from contacting the barrel 32, and this can prevent or reduce scratches or other wear that could shorten the useful life of the device.

[0175] Fig. 20 is an exploded view of an example autoinjector device 1 with a cap 4. The autoinjector device 1 includes a longitudinal housing 18 having an end cap 54. Within the longitudinal housing 18, there is a barrel 32 that contains a plug 34. The longitudinal housing 18 also contains a drive mechanism 38 and a trigger mechanism 40. Coupled to the drive mechanism 38 and the trigger mechanism 40 of this example is an electronic module 84 that includes a battery 83, such as a button cell. A label 86 is included to wrap around a portion of the longitudinal housing 18.

[0176] Fig.21 is an exploded view of the cap 4 and proximal components of an example autoinjector device 1. The cap 4 comprises a reset rod 16 comprising a bearing element 26. The reset rod 16 forms a cap end 87 which is coupled to a cap body 88.

[0177] In this example, the housing 18 includes a needle guard 46. The example needle guard 46 includes a front element 90 that defines the open proximal end 22 of the housing 18. In other examples, the front element 90 can be integral with the needle guard 46. The needle guard 46 of this example includes legs 92 that connect the needle guard 46 to the trigger mechanism 40 when assembled.

[0178] The housing 18 also includes a battery opening, such as a slot 85, through which the battery 83 can be inserted into or removed from the electronic module 84. The battery openings can be arranged on both sides of the housing 18. In some examples, a battery slot 85 can be provided on one side of the housing 18, and a smaller battery opening can be provided on the opposite side, through which a tool can be inserted to push the battery 83 out of the battery slot 85. In some examples, the battery 83 can be a rechargeable battery. The rechargeable battery can be recharged by removing the battery from the automatic injector device and using a separate recharger. In some embodiments, the rechargeable battery can be recharged while still in the automatic injector device, for example, by wireless or wired charging, and the recharging can be performed when the automatic injector device is in the cover.

[0179] Fig. 22 is an exploded view of an example drive mechanism 38, plunger rod 36, trigger mechanism 40, and housing end cap 54 of an example autoinjector device 1. In this case, the end cap 54 includes an end cap internal component 55 that fits within the end cap 54. The end cap 54 can be transparent, and including the end cap internal component 55 can help the user avoid confusion as to which end of the autoinjector device is the proximal end and which end is the distal end.

[0180] The drive mechanism 38 includes a drive spring 50 and a guide pin 94 that helps prevent deformation of the drive spring 50. The trigger mechanism 40 of this example includes a plurality of latch components 96 that are operable to retain or release the plunger rod 36 and initiate transition of the drive mechanism 38 from the arming state to the firing state, as previously discussed.

[0181] The indicator member 42 of this example includes two parts that are coupled together and is biased toward the indicating position by an indicator spring 98. In other examples, the indicator member may be a single part, or may include more than two parts.

[0182] Fig.23 is an exploded view of another example drive mechanism 138 , plunger rod 136 , trigger mechanism 40 , and housing end cap 54 of an example autoinjector device 1 .

[0183] The drive mechanism 138 includes a gas spring 150, which in this example is integral with the plunger rod 136. The trigger mechanism 40 of this example includes a plurality of latch components 96 that are operable to retain or release the plunger rod 136 and initiate transition of the drive mechanism 138 from the arming state to the firing state, as previously discussed.

[0184] Fig.24 is an exploded view of an example of a barrel 70, a plug 134, and a plunger rod 236. The example barrel 70 includes two longitudinal guide channels 82 with which the ridges 74 of the plug 134 engage to control rotation of the plug as the plug 134 moves along the barrel 70. The example plunger rod 236 includes a plug contact portion 238 including radial protrusions 240 that engage with the guide channels 82 to control rotation of the plunger rod as the plunger rod 236 moves along the barrel 70.

Claims

1. An automatic injector kit, the automatic injector kit comprising an automatic injector device, the automatic injector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; an indicator member that moves distally from an initial position to an indicating position when triggered to indicate a status of the auto-injector device; wherein The autoinjector kit includes an indicator reset member, and the housing of the autoinjector device includes a reset member access opening on the distal end of the longitudinal housing, the indicator reset member includes a base and a reset member protrusion, and the reset member protrusion can be inserted through the reset member access opening to contact the indicator component and push the indicator component into the initial position.

2. The autoinjector kit of claim 1, wherein: The reset member access opening is an elongated slot extending from the distal end of the housing toward the proximal end, and the reset member protrusion includes an elongated wall.

3. The autoinjector kit of claim 1 or 2, wherein: The base of the indicator reset includes a cover into which the housing can fit.

4. The autoinjector kit of claim 3, wherein: When the housing is fitted into the casing, the housing is releasably secured in the casing.

5. The autoinjector kit of claim 4, wherein: The housing is releasably secured in the casing by a releasable clip.

6. The autoinjector kit according to any one of claims 3 to 5, wherein: When the housing is fitted into the cover, the reset member protrusion extends through the reset member access opening and pushes the indicator component into the initial position.

7. An auto-injector kit, the auto-injector kit comprising an auto-injector device, the auto-injector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; as well as a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein The stopper includes a stopper opening extending through the stopper along the longitudinal axis, and the autoinjector kit further includes a reset rod having a first end insertable through the open proximal end of the housing to contact the plunger rod through the stopper opening and urge the plunger rod into the retracted position and thereby transition the drive mechanism to its standby state, the reset rod having a second end opposite the first end, the second end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position.

8. The autoinjector kit of claim 7, wherein: The reset rod includes a protrusion offset along the reset rod relative to the first end, the protrusion being sized to contact the stopper and move the stopper to the distal position when the plunger rod is moved into the retracted position.

9. The autoinjector kit of claim 8, wherein: The protrusion includes a circumferential shoulder.

10. The autoinjector kit of claim 8 or 9, wherein: The offset between the first end and the protrusion is greater than the extent of the stopper along the longitudinal axis to create a space between the plunger rod in the retracted position and the stopper in the distal position.

11. The autoinjector kit according to any one of claims 8 to 10, wherein: The second end of the reset rod includes a cap mountable to the proximal end of the housing.

12. An automatic injector device, comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; as well as a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein The autoinjector device includes a guide track to control rotation of the plunger rod about the longitudinal axis during operation.

13. The automatic injector device of claim 1, wherein: The plunger rod is secured to the stopper, the stopper including an axial ridge on an outer surface that engages an axial slot in the barrel to control rotation of the plunger rod about the longitudinal axis during operation.

14. An auto-injector kit, the auto-injector kit comprising an auto-injector device, the auto-injector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; and The autoinjector kit includes a reset rod having a first end insertable through the open proximal end of the housing to apply a reset force to the plunger rod to move the plunger rod into the retracted position and thereby transition the drive mechanism to a standby state, the reset rod having a second end opposite the first end, the second end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position; wherein The maximum return force required to move the plunger rod into the retracted position is below 10N.

15. An automatic injector device, comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; as well as a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; in An inner dimension of the barrel perpendicular to the longitudinal axis increases toward a proximal end of the autoinjector device such that compression of the bung decreases as the bung is driven toward the proximal end by the plunger rod.

16. The automatic injector device of claim 1, wherein: The inner dimension is the inner diameter of the barrel.

17. A method of resetting an indicator component in an automatic injector device, the automatic injector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the armed state to the fired state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; as well as an indicator component that moves distally from an initial position to an indicating position when triggered to indicate a status of the automatic injector device; wherein the method comprises: Inserting a reset member protrusion of an indicator reset member through a reset member access opening in a distal end of a longitudinal housing of a housing of the autoinjector device to contact the indicator member, and using the reset member protrusion to push the indicator member into the initial position.

18. The method of claim 17, wherein: The reset member protrusion is provided in a housing into which the autoinjector device can be fitted, and inserting the autoinjector into the housing causes the reset member protrusion to pass through the reset member access opening to contact the indicator component to push the indicator component into the initial position.

19. A method for resetting a plunger rod of an automatic injector device, the automatic injector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end contacting the trigger site, a distal end opposite the proximal end, and a hollow interior; A cylinder, the cylinder being installed in the shell; a stopper slidably mounted within the barrel and movable from a distal position to a proximal position by the plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a standby state in which the plunger rod is held in a retracted position between the distal end and the stopper in the distal position against a drive force, and an activated state in which the plunger rod extends through at least a portion of the barrel and contacts the stopper in the proximal position; as well as a trigger mechanism operable to release the plunger rod and initiate transition of the drive mechanism from the arming state to the firing state, thereby causing the plunger rod to drive the stopper from the distal position to the proximal position; wherein the method comprises: inserting a first end of a reset rod through the open proximal end of the housing to contact the plunger rod through a stopper opening extending through the stopper along the longitudinal axis; and The reset rod is used to push the plunger rod into the retracted position and thereby shift the drive mechanism to a standby state, a second end of the reset rod opposite the first end remaining outside the longitudinal housing when the plunger rod is moved to the retracted position.

20. The method of claim 19, wherein: The second end of the reset rod includes a cap for closing or covering the open proximal end of the housing of the automatic injector device, and inserting the first end of the reset rod through the open proximal end of the housing and engaging the cap with the open proximal end of the housing moves the plunger rod into the retracted position and thereby transitions the drive mechanism to a standby state.

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