Auto-injector kit

Abstract

An auto-injector kit, the auto-injector kit including an auto-injector device, the device including a longitudinal housing extending along a longitudinal axis and having an open proximal end for contacting a trigger site, a distal end opposite the proximal end, and a hollow interior, a barrel body mounted inside the housing, a stopper slidably mounted within the barrel body and movable by a plunger rod from a distal position to a proximal position, a drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position, a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position, and an indicator component that, when triggered, moves distally from an initial position to a display position indicating the state of the auto-injector device, the auto-injector kit including an indicator reset, the housing of the auto-injector device including a reset access opening at the distal end of the longitudinal housing, the indicator reset including a base and a reset protrusion, the reset protrusion being insertable through the reset access opening and contacting the indicator component to force the indicator component to move to the initial position.

Description

Technical Field

[0001] The present invention relates to an autoinjector kit including an autoinjector device, and more particularly to a training or demonstration autoinjector device that can be intended to simulate at least some of the operations of an automatic drug delivery device. The present invention also extends to an autoinjector device and a method of using such a device.

Background Art

[0002] An autoinjector device, sometimes also referred to as an automatic drug delivery device, is known as an example of a medical device. Such an autoinjector device is configured to administer a fluid product such as a drug to a patient. The term autoinjector device, or autoinjector, is used herein to represent not only the above-described automatic drug delivery device, but also a training or demonstration device that can be intended to simulate at least some of the operations of an automatic drug delivery device.

[0003] Examples of such autoinjector 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] Generally, such autoinjector devices provide reliable functionality and can be accurately used by inexperienced persons. Still, there is still a need to train patients and caregivers in the use of such devices, which can be a time-consuming process and may involve multiple demonstrations of the operation of the device. Some autoinjector devices include electronic components that can take trial data for training and provide feedback to the user and / or caregiver. Such devices make it possible to manage and / or monitor training remotely rather than in person.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0005] The present invention provides an autoinjector kit, the autoinjector kit including an autoinjector device, the device comprising: a longitudinal housing having an open proximal end for contacting a trigger site, a distal end opposite the proximal end, and a hollow interior, extending along a longitudinal axis; a barrel body mounted inside the housing; a stopper slidably mounted within the barrel body and movable by a plunger rod from a distal position to a proximal position; a drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position; a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position; an indicator component that moves distally from an initial position to a display position indicating the state of the autoinjector device when triggered; and The autoinjector kit includes an indicator reset. The housing of the autoinjector device includes a reset access opening at the distal end of the longitudinal housing. The indicator reset includes a base and a reset protrusion. The reset protrusion is insertable through the reset access opening and contacts the indicator component to force the indicator component to move to the initial position.

[0006] The indicator component can be any suitable element that, when triggered, moves in a distal direction from an initial position to a display position that indicates the state of the auto-injector device. At the display position, the indicator component can be visible to the user, for example through a window, and can indicate the state of the auto-injector device. When the indicator component reaches the display position, it can provide an audible and / or tactile indication to indicate the state of the auto-injector device. The indicator component can provide a combination of visual, audible, and / or tactile indications regarding the state of the auto-injector device. The state being indicated can be that the operation of the device has ended, for example that a liquid dosage has been delivered. The indicator element can stop at the indicator position or can pass through the indicator position.

[0007] Indicator reset, which may also be referred to as an indicator reset element or an indicator reset device, has a protrusion that can contact the indicator component through a reset access opening in the housing, and by providing an indicator reset, the user can return the indicator component to its initial position. By enabling the user to return the indicator component to its initial position, the reset of the auto-injector device can be performed without removing some or all of the components. When the indicator component is returned to its initial position, it can be held in that initial position until triggered by a subsequent actuation of the auto-injector device.

[0008] The reset access opening may have any shape that allows the indicator component to access the projection of the indicator reset. The reset access opening can be a hole at the distal end of the longitudinal housing, whereby a rod-shaped projection can pass therethrough to move the indicator component. The reset access opening can be an elongated slot extending from the distal end to the proximal end of the housing, and the reset projection can include an elongated wall. It has been found that such an arrangement of the slot and the wall can more easily control, reduce, or avoid deformation of the projection, thereby providing a stronger and more reliable mechanical interaction between the indicator component and the projection.

[0009] The indicator reset may include a case that can accommodate the housing therein. The case can surround a part or substantially all of the longitudinal housing. If, for example, a cap for covering the open proximal end can be attached to the longitudinal housing, the case can also surround a part or all of the cap.

[0010] When the housing is received in the case, the housing can be releasably fixed therein, for example, by one or more releasable clips. The releasable clip can act on the housing, on a cap connected to the housing, or on any other part of the auto-injector device or a component connected thereto. The clip holds the housing by resisting an extraction force that acts to remove the housing from the case. The releasable clip can be deformable such that the clip is released when an extraction force greater than a threshold value is applied. Thereby, the user can easily pull out the housing from the case, for example, by pulling on the housing or a cap connected thereto. In other examples, the releasable clip can prevent the housing from being removed from the case until the user operates a release member, for example, presses a button, slides a release catch, moves a release lever, or performs other operations, until the clip is released.

[0011] The case can be configured such that when the housing is received in the case, a reset protrusion of the case extends through a reset access opening of the housing and forcibly moves the indicator component to an initial position. Since this only requires returning the used autoinjector to its associated case, it can provide a convenient way for the user to reset the indicator component. The case can provide a convenient way for the user to store the autoinjector device.

[0012] The shape of the case and / or the housing can be configured such that the housing can only enter the case in one rotational direction around the longitudinal axis. In this way, the user can insert the housing into the case in one orientation, in which the reset protrusion for indicator reset can be aligned with the reset access opening.

[0013] The indicator reset and / or the case can include a removable indicator. When the indicator reset is fully inserted or the autoinjector device is inserted into the case, the removable indicator interacts with a part of the autoinjector such that the indicator reset is removed, or when the autoinjector device is removed from the case, the state of the components of the autoinjector device changes, whereby the removal of the indicator reset or the removal of the autoinjector device from the case can be detected, for example, by an electronic module of the autoinjector. By facilitating the detection by the electronic module of the removal of the indicator reset or the removal of the autoinjector device from the case, the power-on, startup, and / or initialization of the electronic module before use can be facilitated.

[0014] The electronic module of the autoinjector device can include a power source such as a capacitor or a battery, and the power source can be rechargeable. The power source can be removed from the autoinjector device for charging or can be recharged within the autoinjector housing.

[0015] Recharging of the power supply within the auto-injector housing can be done through wired charging, for example, by plugging the power supply into the auto-injector device or into something, such as a case, in which the auto-injector is set. In some examples, the case for the auto-injector can include a power supply such as a battery or a capacitor for recharging the power supply of the auto-injector device. The case and the auto-injector device can be configured such that when the auto-injector device is set within the case, a wired or wireless connection is established and the power supply of the auto-injector is charged.

[0016] In some examples, the indicator reset can include a portion that contacts the indicator component to reset it and another portion that contacts and moves another component of the auto-injector, such as a trigger component. Removal of the indicator reset can cause the other component to move to its starting position, and such movement can be detected by an electronic module, for example, by a change in the state of a contact switch, movement of a magnetic or other detectable element, or a proximity sensor. The indicator reset can include, for example, a stepped rod or wall, with a first step contacting the indicator component to reset it and another step contacting and moving another component of the auto-injector.

[0017] In some examples, the indicator component can be held in a position proximal to its initial position by the indicator reset and / or the case, and when the indicator reset is removed or the auto-injector device is removed from the case, the indicator component moves distally to its initial position and can remain there until triggered.

[0018] In some examples, the case may include a detectable portion, such as a detectable portion detectable without contact, such as a magnetic or metallic portion, or a detectable portion detectable through contact, such as a protrusion, ridge, or catch. When the autoinjector device is fully inserted into the case, the detectable portion may be detectable by an electronic module of the autoinjector, such as by a sensor or switch. When the autoinjector device is removed from the case, the detectable portion of the case moves away from the electronic module, which means that the electronic module can detect the removal of the autoinjector device from the case.

[0019] The longitudinal housing of the autoinjector device can be of any shape and can be elongate. The longitudinal housing has a hollow interior and extends from an open proximal end along a longitudinal axis to a distal end opposite the proximal end. The longitudinal housing may include a plurality of components.

[0020] The open proximal end will come into contact with the trigger site, and in some examples, the needle guard component of the longitudinal housing may provide the open proximal end and may come into contact with the trigger site. When the longitudinal housing is pressed against the trigger site, the needle guard may move with respect to the shell component of the longitudinal housing, and for example, by pushing the needle guard into the shell component, the operation of the autoinjector device can be triggered. The trigger site may be a body part of a patient, such as the thigh or abdomen, or may be a test pad that mimics a body part.

[0021] The open proximal end allows access through it to the hollow interior, within which are stored components of an auto-injector device including a barrel body mounted within the longitudinal housing. The barrel body can be, for example, a syringe barrel, which can contain, in the case of a drug delivery device, a liquid to be delivered to a patient, such as a liquid medicament. In a demonstration or training device, the barrel body can be a replica of a syringe barrel, for example a component that attempts to reproduce the "look" and / or "feel" of the parts of a syringe barrel that are visible or palpable when using an auto-injector.

[0022] Within the barrel body, 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 it is in the distal position. In a drug delivery device, the stopper can define a variable volume chamber together with the barrel body. When the stopper is moved within the barrel body from the distal position to the proximal position, the volume of the variable volume chamber decreases, and if there is a liquid contained therein, it can be pushed out of the variable volume chamber, for example through a needle connected to or formed integrally with the proximal end of the barrel body.

[0023] The auto-injector device includes a drive mechanism capable of driving a plunger rod to move the stopper from the distal end to the proximal end. Providing a driving force to the drive mechanism can include any suitable energy storage, which can include a mechanical spring, such as a coil or leaf spring, or a gas spring, such as a cushioned gas spring, or a combination thereof.

[0024] In the primed state, the plunger rod is held directly or indirectly against the driving force at a retracted position between the distal end and the stopper in the distal position. In the retracted position, the plunger rod can be spaced apart from the stopper in the distal position. In the primed state, any energy storage is in an energy-stored state, for example, a mechanical spring is compressed and a gas spring is pressurized.

[0025] The moving speed of the gas spring can be specified to control the moving speeds of the plunger rod and the stopper in use. Thereby, it may be easier to manufacture a demonstration or training device that more accurately reproduces the operation of the drug delivery device or the drug delivery device delivers the drug in a predetermined time.

[0026] In the fired state, the plunger rod extends through at least a portion of the barrel body and contacts the stopper when the stopper is in the proximal position. At least a portion of the energy stored in the primed position has already been used to drive the plunger rod to the open proximal end of the longitudinal housing.

[0027] The auto-injector device includes a trigger mechanism operable to release the plunger rod. Thereby, the transition of the drive mechanism from the primed state to the fired state begins, whereby the plunger rod drives the stopper from the distal position to the proximal position. As already suggested, the trigger mechanism can be operated by relative movement between portions of the longitudinal housing, such as the movement of the needle guard with respect to the shell. The trigger mechanism can be operated by a button, switch, catch, or lever operated by the user, which can be attached, for example, to the distal end or side of the longitudinal housing.

[0028] The stopper may include a stopper opening extending through the stopper along the longitudinal axis. The auto-injector kit may further include a reset rod. The reset rod may have a first end which is insertable from the open proximal end of the housing, contacts the plunger rod through the stopper opening, and forcibly moves the plunger rod to its retracted position, thereby shifting the drive mechanism to its primed state. The reset rod may have a second end opposite the first end, which remains outside the longitudinal housing when the plunger rod is moved to its retracted position. This provides a simple reset mechanism for the plunger rod and drive mechanism of the auto-injector device, particularly for demonstration or training devices. When the plunger rod and drive mechanism are returned to their initial states, they may be held until triggered by subsequent actuation of the auto-injector device.

[0029] The reset rod may include a protrusion offset from the first end along the reset rod. The protrusion may be sized such that it cannot pass through the stopper opening and can thus contact the stopper. The protrusion may provide a support surface for contacting the stopper. The protrusion may contact the stopper and move the stopper to a distal position while the plunger rod is being moved to its retracted position.

[0030] A portion of the protrusion extends substantially perpendicular to the longitudinal axis. The protrusion may be of any suitable shape, for example an expanded portion of the reset rod. The protrusion may include a circumferential shoulder. The protrusion may be formed integrally with the reset rod, carried by the reset rod, or another element attached thereto. The circumferential shoulder may provide a continuous support surface, such as a flat support surface, which can maximize control of the position along the reset rod where the protrusion contacts the stopper.

[0031] The displacement between the first end and the protrusion may be greater than the range of the stopper along the longitudinal axis. This can create a space between the plunger rod in the retracted position and the stopper in the distal position.

[0032] In some examples of drug delivery devices, there is a gap between the plunger rod and the stopper when the device is in a ready-to-use state. When the plunger rod is triggered, it moves rapidly towards the stopper and collides with it, generating audible and tactile feedback. In the case of demonstration or training devices, the reproduction of such audible and tactile feedback is advantageous, and a simple mechanical method is provided where the stopper is reset during the resetting of the plunger rod, creating the original gap between the stopper and the plunger rod again. In this way, any audible and tactile feedback provided by the original gap between the plunger rod and the stopper can be reproduced during subsequent operation.

[0033] The second end of the reset rod may include a cap attachable to the proximal end of the housing. In this way, by reattaching the cap to the device after use, the plunger rod and the stopper can be reset to their initial positions. The cap can be rotated to remove it from the housing. By providing a flat support surface for the protrusion, damage to the stopper can be reduced when the reset rod is rotated with respect to the stopper, for example when the cap is rotated to remove it from the housing.

[0034] The auto-injector device may include a guide track for controlling the rotation of the plunger rod and / or the stopper around the longitudinal axis during operation. By controlling the rotation of the plunger rod during operation, the reset operation can be made more reliable or simpler, as circumferentially distributed features, such as catches for holding the plunger rod in the retracted position, can be automatically aligned for re-engagement.

[0035] In some examples, the plunger rod can be fixed to the stopper. The plunger rod can be fixed to the stopper such that rotation of the plunger rod with respect to the stopper is restricted or prevented. The stopper and / or the plunger can include an axial ridge or a circumferential protrusion on the outer surface, which can engage with an axial slot in the barrel body to control rotation of the plunger rod and / or the stopper around the longitudinal axis during operation. The axial slot in the barrel body can provide a guide track, which is used to control rotation of the plunger rod and / or the stop via the stopper.

[0036] As described above, the auto-injector device can include a reset rod, which can be inserted from the open proximal end of the housing and apply a reset force to the plunger rod to move it to its retracted position, thereby shifting the drive mechanism to its primed state. In some examples, the stopper includes a stopper opening extending through the stopper along the longitudinal axis, whereby the reset rod can pass through it and contact the plunger rod. In other examples, the stopper may not include such a stopper opening, and the reset rod can contact the stopper and apply a force thereto, thereby applying the force to the plunger rod.

[0037] The maximum reset force required to move the plunger rod to its retracted position is less than 20 N, less than 10 N, or less than 5 N, as this facilitates resetting of the device. This can be particularly suitable for demonstration or training devices where the drive mechanism does not act on the stopper to drive liquid from the syringe into the patient's body. There can be other advantages for the reset of the device with a relatively weak reset force, as the release catch and the detent can be made more flexible than when restraining a stronger force, such as when they restrain the drive spring required to drive the plunger to eject a certain volume of liquid drug from the needle within an acceptable time.

[0038] The inner dimension perpendicular to the longitudinal axis of the barrel body can increase towards the proximal end of the auto-injector device, such that as the stopper is driven towards the proximal end by the plunger rod, the compression of the stopper is reduced. The stopper can initially be compressed by a first amount when in the proximal position, and this amount can decrease as the stopper moves towards the proximal position.

[0039] The reduction in the compression of the stopper can reduce the force required to slide the stopper within the barrel body. If the plunger is driven by a spring, this can lead to a more consistent movement speed of the stopper. The driving force of the spring can decrease as the spring is extended, and the resistance force provided by the friction between the stopper and the barrel body can be adjusted, for example reduced, which can compensate. Thereby, the movement speed of the plunger can be controlled. In some examples, the stopper can move at a substantially constant speed. This can be particularly suitable for stoppers made of materials such as elastomers or compression rubbers having a relatively high Poisson's ratio. For example, the Poisson's ratio of thermoplastic elastomers and rubbers can be between 0.45 and 0.50.

[0040] The barrel body can be substantially circular in cross-section, and the inner dimension can be the inner diameter of the barrel body. The reduction of the inner dimension can be substantially constant, such that the taper angle with respect to the longitudinal axis is between 0.05° and 0.3°.

[0041] The stopper can be of any suitable shape and can include one or more known features such as ribs or valleys. The stopper can be made from any suitable material, for example from any suitable one or more materials, for example plastic, elastomer, rubber, or silicone, or combinations thereof. The material can be selected to provide the desired deformation resistance and / or the desired coefficient of friction. The deformation resistance and / or the desired coefficient of friction can affect the resistance to the movement of the stopper with respect to the barrel body, for example when the stopper is deformed to fit within the barrel body.

[0042] The stopper and / or the barrel body may have a coating, such as oil or grease applied to the contact surface to regulate the resistance to the movement of the stopper with respect to the barrel body when the stopper is moved within the barrel body. The coating may be a liquid or emulsion of a synthetic oil, such as polydimethylsilicone fluid, which can be applied to the stopper and / or the barrel body. The coating may be a solid film layer, such as PTFE, applied to the stopper, for example.

[0043] The present invention also provides an auto-injector kit, which includes an auto-injector device, which has a longitudinal housing extending along a longitudinal axis, an open proximal end for contacting a trigger site, a distal end opposite the proximal end, and a hollow interior, a barrel body mounted inside the housing, a stopper slidably mounted within the barrel body and movable by a plunger rod from a distal position to a proximal position, a drive mechanism connected to the plunger rod, having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, a trigger mechanism operable to release the plunger rod and initiate a transition from the primed state to the fired state of the drive mechanism, thereby driving the stopper on the plunger rod from the distal position to the proximal position, and The stopper includes a stopper opening that extends into the stopper along the longitudinal axis. The auto-injector kit further includes a reset rod that is insertable from the open proximal end of the housing, contacts the plunger rod through the stopper opening, and has a first end that forces the plunger rod to move back to the retracted position, thereby shifting the drive mechanism to its prime position. The reset rod has a second end opposite the first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position.

[0044] As described above, providing a stopper opening that extends into the stopper provides a convenient way to reset the positions of both the stopper and the plunger rod.

[0045] The present invention further provides an auto-injector device, the auto-injector device comprising a longitudinal housing having an open proximal end that extends along the longitudinal axis and contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, a barrel body attached inside the housing, a stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, a drive mechanism connected to the plunger rod, having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper from the distal position to the proximal position by the plunger rod, and the auto-injector device includes a guide track for controlling rotation of the plunger rod around the longitudinal axis during operation.

[0046] As described above, by controlling the rotation of the plunger rod, the reset of the plunger rod can be facilitated.

[0047] The present invention further provides an auto-injector kit, the auto-injector kit including an auto-injector device, the device comprising: a longitudinal housing extending along a longitudinal axis, having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior; a barrel body mounted inside the housing; a stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod; a drive mechanism connected to the plunger rod, having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position; a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper on the plunger rod from the distal position to the proximal position; and the auto-injector kit includes a reset rod, the reset rod being insertable through the open proximal end of the housing, having a first end that applies a reset force to the plunger rod and moves it to the retracted position, thereby transitioning the drive mechanism to its primed state, the rod having a second end opposite the first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position; The maximum reset force required to move the plunger rod to the retracted position is less than 10 N.

[0048] As described above, by controlling the reset force to be less than a predetermined threshold value, the user may be able to more easily reset the device. The force required to reset parts of the auto-injector device, which may include resetting the indicator, the plunger rod and stopper, and the trigger, and attaching the cap, may be made continuous (sequential) so as to reduce the required peak force.

[0049] The present invention also provides an auto-injector device, the auto-injector device comprising a longitudinal housing extending along a longitudinal axis and having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior, a barrel body attached inside the housing, a stopper slidably attached within the barrel body and movable from the distal end to the proximal end by a plunger rod, a drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position, a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper from the distal position to the proximal position by the plunger rod, comprising the inner dimension of the barrel body perpendicular to the longitudinal axis increases towards the proximal end of the auto-injector device such that the compression of the stopper decreases as the stopper is driven towards the proximal end by the plunger rod.

[0050] As described above, increasing the inner dimension of the barrel body in this way provides a method of controlling the moving speed of the stopper when driven by the plunger rod.

[0051] The present invention may also provide an autoinjector device suitable for use with any of the above kits.

[0052] The present invention also relates to a method of resetting an indicator component within an autoinjector device, the autoinjector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior; a barrel body mounted within the housing; a stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position; a trigger mechanism operable to release the plunger rod and initiate a transition from the primed state to the fired state of the drive mechanism, thereby driving the stopper from the distal position to the proximal position along the plunger rod; an indicator component that moves distally from an initial position to a display position for displaying the state of the autoinjector device when triggered; and the method comprising: inserting a reset protrusion of the indicator reset through a reset access opening at the distal end of the longitudinal housing of the autoinjector device to contact the indicator component; and using the reset protrusion to forcibly move the indicator component to the initial position.

[0053] The user can have an indicator reset at the base and make it easier to insert the reset projection into the reset access opening. The base may include a guide for facilitating alignment of the reset projection and the reset access opening. The base may include a case for the auto-injector device as described above.

[0054] To reset the indicator component by returning it to its initial position, the user aligns the reset access opening of the auto-injector with the reset projection and moves the auto-injector device with respect to the reset projection so that the reset projection enters the reset access opening and contacts the injector component. Further, due to the relative movement between the auto-injector device and the reset projection, the reset projection can force the indicator component to move to its initial position.

[0055] Alignment and relative movement can be achieved, for example, by the user inserting the auto-injector device into a case that includes the reset projection and aligns the auto-injector device with the reset projection. This provides an easy way to reset the indicator component after operation of the device.

[0056] The present invention also includes a method for resetting the plunger rod of an auto-injector device, the auto-injector device comprising a longitudinal housing extending along a longitudinal axis and having an open proximal end that contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, a barrel body attached inside the housing, a stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, a drive mechanism connected to the plunger rod, the plunger rod having a primed state in which it is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position. A trigger mechanism operable to release a plunger rod and initiate a transition of a drive mechanism from a primed state to a fired state, thereby driving a stopper on the plunger rod from a distal position to a proximal position, and comprising, the method inserting a first end of a reset rod through an open proximal end of a housing to contact the plunger rod through a stopper opening, the stopper opening extending through the stopper along a longitudinal axis; using the reset rod to forcefully move the plunger rod to a retracted position, thereby transitioning the drive mechanism to its prime position, wherein a second end of the reset rod, opposite the first end, remains outside the longitudinal housing when the plunger rod is moved to the retracted position.

[0057] The user can hold the reset at the second end, facilitating insertion of the reset rod into the open proximal end of the housing. The second end may include a cap for closing or covering the open proximal end of the housing of the auto-injector device, as described above.

[0058] By inserting the first end of the reset rod into the open proximal end of the housing and using it to forcefully move the plunger rod to the retracted position, the plunger rod and the drive mechanism are reset because the plunger rod is in the retracted position and the drive mechanism is returned to its primed state. If the second end of the reset rod includes a cap, the cap may engage the housing to close or cover the open proximal end of the housing when the plunger reaches the retracted position.

[0059] Therefore, returning the cap to the auto-injector device after use can be a convenient way to reset the plunger rod and the drive mechanism after operation of the device.

[0060] An exemplary usage flow may include the following operations. The user may take the auto-injector out of the case, remove the cap from the auto-injector device, and make the auto-injector device ready for use. These operations can be performed in any order, but in some examples, the case may interfere with removing the cap until the injector device is removed from the case.

[0061] The auto-injector device can then be actuated by pressing the open proximal end against the trigger site.

[0062] When used, the elements of the auto-injector can be reset as described above. This can be achieved, for example, by the user inserting the first end of the reset rod into the open proximal end and / or inserting the reset protrusion of the indicator reset into the reset access opening. In some embodiments, these reset operations can be achieved by returning the auto-injector device to the case and reattaching the cap to the open proximal end. The case may include a guide to facilitate aligning the cap and the auto-injector device. When the auto-injector device is inserted into the case, charging of the power supply of the auto-injector device may also automatically start.

[0063] Here, the present invention will be described by way of example only with reference to the following drawings.

Brief Description of the Drawings

[0064]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

DETAILED DESCRIPTION OF THE INVENTION

[0065] FIG. 1 shows an example of an autoinjector kit 100 including an autoinjector device 1 and a cap 4. The autoinjector device 1 includes a body 2. The cap 4 includes a raised mark 6 that provides information to the user to facilitate removal of the cap 4 from the body 2. In this example, the body 2 is transparent or translucent such that internal components are visible to the user, and a label 8 is wound around a portion of the body 2 to conceal some of the internal components. In other examples, the body may be completely opaque, may partially define a viewing window that is opaque, or the viewing window may be provided through the body 2.

[0066] FIG. 2 shows an example of an autoinjector kit 100 including a case 10 in which the autoinjector device 1 can be stored prior to use, e.g., the autoinjector kit 100 of FIG. 1. In this example, the case 10 surrounds and houses the body 2 of the autoinjector 1 such that the user cannot touch the body 2. In other examples, the case 10 may include a cutout portion.

[0067] The case 10 includes a protrusion 12 that extends across the cap 4. The protrusion 12 includes a catch 14 (visible in FIG. 3), which engages with the raised mark 6 to releasably hold the auto-injector 1 within the case 10. In other examples, a catch or other releasable holding element may be provided elsewhere on the case 10 or the cap 4 such that the auto-injector device 1 can be releasably held within the case 10.

[0068] FIG. 3 shows an exploded view of the auto-injector kit 100 of FIG. 2, with the cap 4, the auto-injector 1, and the case 10 shown separately. The body 2 includes a longitudinal housing 18, which extends along a longitudinal axis 20 and has an open proximal end 22 that contacts a trigger site (not shown in this figure). The housing 18 extends from the open proximal end along the longitudinal axis 20 to a distal end 24 opposite the open proximal end 22. The longitudinal housing 18 has a hollow interior.

[0069] The reset rod 16 extends from the cap 4 and can be inserted into the hollow interior of the housing 18 from the open proximal end 22 of the housing. 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 may contact the stopper directly.

[0070] FIG. 4 shows an example of the auto-injector device 1 removed from the case 10 and having its cap 4 attached, e.g., a cross-sectional view of the auto-injector device 1 and the cap 4 of FIG. 1. In this figure, the hollow interior 30 of the longitudinal housing 18 is visible.

[0071] The barrel body 32 is attached inside the housing 18, and the stopper 34 is slidably attached within the barrel body 32. The stopper 34 is movable by a plunger rod 36 from a distal position (as shown in this figure) to a proximal position (illustrated in FIG. 9) toward the open proximal end 22. The distal position is closer to the distal end 24 of the housing 18 than the proximal position.

[0072] The drive mechanism 38 is connected to the plunger rod 36. In this figure, the drive mechanism 38 is shown in the primed state, and the plunger rod 36 is held in the retracted position between the distal end 24 of the housing 18 and the stopper 34 in the distal position against the driving force.

[0073] The drive mechanism 38 is movable to a fired state (illustrated in FIG. 9) in which the plunger rod 36 extends into at least a portion of the barrel body 32 and contacts the stopper 34 in the proximal position.

[0074] The autoinjector 1 includes a trigger mechanism 40, which is operable to release the plunger rod 36 and initiate the transition of the drive mechanism 38 from the primed state to the fired state, thereby driving the stopper 34 on the plunger rod 36 from the distal position to the proximal position.

[0075] The autoinjector 1 includes an indicator component 42, which moves distally from the initial position (as shown in this figure) to a display position (illustrated in FIG. 9) that displays the state of the autoinjector 1 when triggered.

[0076] FIG. 5 shows a cross-sectional view of an example of the autoinjector device 1 with the cap 4 removed. By removing the cap 4, the needle guard 46 of the housing 18 extends oppositely from the drive mechanism 38 along the longitudinal axis. The needle guard 46 is coupled to the trigger mechanism 40 as outlined below. Detailed examples of a trigger mechanism 40 and associated drive mechanism 38 suitable for use in an autoinjector can be found, for example, in WO 2019 / 224782 pamphlet, WO 2019 / 224783 pamphlet, WO 2019 / 224784 pamphlet, and WO 2019 / 224785 pamphlet.

[0077] FIG. 6 shows a cross-sectional view of an example of an auto-injector device 1 in which a needle guard 46 is pressed against a trigger site 48. In this example, the trigger site 48 is a pad that can reproduce the texture of human tissue into which an injection can be made.

[0078] By pressing the needle guard 46 against the trigger site, the needle guard 46 moves towards the distal end 24 of the housing to activate the trigger mechanism 40, release the plunger rod 36, and initiate the transition of the drive mechanism 38 from a primed state to a fired state, thereby driving the stopper 34 on the plunger rod 36 from a distal position to a proximal position.

[0079] FIG. 7 shows a cross-sectional view of an example of an auto-injector device 1 in which the needle guard 46 is pressed against the trigger site 48 after the trigger mechanism 40 has released the plunger rod 36. The plunger rod 36 is driven towards the proximal end 22 of the auto-injector 1 through the barrel body 32 by a drive spring 50 of the drive mechanism 38, where in this case the drive spring 50 is a coil spring.

[0080] FIG. 8 shows a cross-sectional view of an example of an auto-injector device 1 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 stopper 34 is driven towards the proximal end of the barrel body 32 by the plunger rod 32 and the drive spring 50. The stopper 34 is driven to hit a shoulder 52.

[0081] The auto-injector 1 includes an indicator component 42, which in this example is triggered when the plunger rod 36 reaches or approaches the end of its delivery position where it holds the stopper against the stop 52. The indicator component 42 is triggered and moves distally from its initial position (illustrated in FIG. 4) to a display position (illustrated in this figure and FIG. 9) for indicating the state of the auto-injector device 1. In this case, the indicated state is that the plunger rod 36 has reached or approached the end of its delivery position.

[0082] The indicator component 42 in the indicating position may be visible through a part of the housing 18, such as the end cap 54. Movement of the indicator component 42 to the indicating position and / or collision of the indicator component 42 with the end cap 54 or other components generates auditory or tactile feedback to the user.

[0083] FIG. 9 shows a cross-sectional view of an example of the auto-injector device 1 after end movement of the plunger rod 36. The auto-injector device 1 is separated from the trigger site, whereby the needle guard 46 of the housing 18 can move from the distal end 24.

[0084] FIG. 10 shows a cross-sectional view of an example of an auto-injector kit 100 including the cap 4, the auto-injector device 1, and the case 10. As shown in the figure, the cap is reattached to the proximal end of the housing 18 after use for the auto-injector device 1. The auto-injector device 1 is also placed in the case 10 after use. In some examples, the auto-injector device 1 may be placed in the case 10 before reattaching the cap. The case 10 may guide the housing 18 to a predetermined orientation and position within the case 10, and the case 10 may also guide the cap 4 to the housing 18 to facilitate reattachment of the cap.

[0085] To reattach the cap to the autoinjector device 1, the reset rod 16 is inserted into the open proximal end 22, whereby the end portion 28 contacts the plunger rod 36 through the stopper opening 56 in the stopper. When the cap 4 is pressed against the housing 18, the reset rod 16 forces the plunger rod 36 toward its retracted position until the support element 26 contacts the stopper 34. By continuing to move the cap 4 toward the housing, the plunger rod 36 moves toward its retracted position and the stopper 34 moves to its distal position. The separation distance between the end portion 28 along the longitudinal axis 20 and the support element 26 may be greater than the axial extent of the stopper 34, such that a space is created 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, thereby forcing both the stopper 34 and the plunger rod 36 toward the distal end 24. In other examples, the reset rod 16 may not be integral with the cap 4, whereby either the reset rod 16 and a separate cap 4 are provided or no cap is provided.

[0086] During recapping, in this example, the cap 4 contacts the needle guard 46 and forces it toward the distal end 24. When the cap 4 engages the housing 18, the stopper 34 is in its distal position and the plunger rod 36 is in its retracted position.

[0087] In the distal position, the stopper 34 may be held in place by the frictional force acting between the stopper 34 and the barrel body. In the retracted position, the plunger rod 36 may be held again, such that when the reset rod 16 is removed, the plunger rod 36 is held against the driving force provided by the drive mechanism 38. Thus, the reset rod 16 is used to reset the plunger rod 36, the stopper 34, and the drive mechanism 38.

[0088] Figure 10 shows an auto-injector device 1 within a case 10. The case 10 includes a reset projection 58 at a closed end 60 of the case 10. In this example, the reset access opening 62 is a slot provided in the end cap 54, and the reset projection 58 is a wall extending from the inner wall of the case 10 along the longitudinal axis 20, although other shapes are possible.

[0089] When the auto-injector device 1 is inserted into the case 10, the reset projection 58 passes through the reset access opening 62 at the distal end 24 of the lengthwise housing 18 and contacts the indicator component 42. After the initial contact between the indicator component 42 and the reset projection, when the auto-injector device 1 is further inserted into the case 10, the reset projection 58 further advances within the reset access opening 62 and forcibly moves the indicator component 42 from the display position towards the initial position. When the auto-injector device 1 is fully inserted into the case 10, the indicator component 42 returns to its initial position, and in this way, the indicator component 42 is reset.

[0090] During the reset of the plunger rod 36, the stopper 34, and the drive mechanism 38, and / or during the reset of the indicator component 42, the trigger mechanism 38 is reset. In this example, by reattaching the cap 4 to the auto-injector 1 and inserting the auto-injector 1 into the case 10, the auto-injector 1 is reset for future use.

[0091] Figure 11 shows a cross-sectional view of another example of an auto-injector device 101 with the cap 4 removed. The auto-injector device 101 is similar to the auto-injector 1 of FIG. 8, but the drive mechanism 38 includes a drive spring 150 in the form of an integrated plunger rod 136 and a gas spring 64. In this example, the stopper 134 does not include a stopper opening passing through the stopper 134.

[0092] When the reset rod 16 is used to reset the gas spring 64, the reset rod 16 does not pass through the stopper 134. Instead, it can contact the stopper 134 and, by forcibly moving the stopper 134 to the distal position, the gas spring 64 is also reset to its retracted position. In this example, with the stopper 134 in the distal position and the plunger rod 136 in the retracted position, there is no gap between the stopper 134 and the plunger rod 136.

[0093] In other examples, as described above, a gap may be created between the stopper having the through-hole and the plunger rod 36. The drive spring 150 may include the gas spring 64 and an initial spring. When the drive mechanism is triggered, the initial spring drives the gas spring 64 against the stopper, causing an initial collision with the plunger rod that may occur within the delivery device again. Then, the gas spring 64 can drive the stopper at a controlled speed.

[0094] FIG. 12 shows a cross-sectional view of an example of the barrel body 32. The barrel body 32 includes a stopper 34 therein. The barrel body 32 has a proximal end 66 and a distal end 68. The barrel body 32 defines a channel 70, in this case a cylindrical channel, in which the stopper 34, in this case a cylindrical stopper, can slide. The resistance to the movement of the stopper 34 is determined by the interaction between the stopper 34 and the barrel body 32, for example, frictional force.

[0095] The frictional force between the stopper 34 and the barrel body 32 can be determined by the materials constituting the stopper 34 and the barrel body 32 and / or the surface finish of any contact surfaces. The frictional force between the stopper 34 and the barrel body 32 can be adjusted by including a coating on one or more of the stopper 34 and the barrel body 32. The stopper 34 can be made of an elastically deformable material such as rubber, silicone, or an elastomer material, and the frictional force between the stopper 34 and the barrel body 32 can be adjusted by changing the degree to which the stopper 34 must be deformed or crushed to fit into the barrel body 32.

[0096] In this case, by increasing the diameter of the stopper and / or decreasing the diameter of the channel 70, the amount of deformation of the stopper 34 within the barrel body 32 increases. Increasing the amount of deformation can increase the force between the stopper 34 and the barrel body 32, thereby increasing the resistance force to the movement of the stopper 34 with respect to the barrel body 32. In some examples, instead of the diameter transitioning linearly at different portions of the barrel, the transition may be stepwise. This is used within the first few millimeters of movement to reproduce the "headspace compression" within a prefilled syringe.

[0097] The channel 70 of the barrel body 32 may have a substantially constant diameter, and as a result, the force resisting the movement of the stopper 34 within the barrel body 32 may be substantially constant. The diameter of the channel 70 may vary between the distal end 68 and the proximal end 66 along the channel 70, and the force required to move the stopper can be varied. The diameter of the channel 70 may increase from the distal end 68 to the proximal end 66, and the force required to move the stopper within the barrel body 32 decreases as the stopper 34 moves towards the distal end. The change in the diameter of the channel 70 from the distal end 68 to the proximal end 66 may extend over the entire length of the channel or only over a portion of the channel. The change in the diameter of the channel 70 can be an increase in diameter or a decrease in diameter. As a result of the change in diameter along the channel 70, at least a portion or all of the channel may be conical. In the conical shape, the taper of the channel 70 with respect to the longitudinal axis can be 0.03° to 0.5° or 0.05° to 0.3°.

[0098] In this example of the barrel body 70, the barrel body includes a guide track 82. The guide track 82 may be recessed within or protrude from the barrel body 70 and engage with a corresponding ridge or recess on the stopper 34 and / or the plunger rod 36 to control the rotation of the stopper 34 and / or the plunger rod 36. In some examples, the guide track 82 may be absent, and in other examples, there may be two or more guide tracks 82.

[0099] Figures 13 and 14 show an example of a stopper, for example, a view and a cross-sectional view of the stopper 34 in FIG. 4. The stopper 34 in this example is substantially circular in a cross-section perpendicular to the longitudinal axis, but other shapes can also be used. The stopper 34 in this example has four circumferential ribs 72 having similar sizes and shapes, but the ribs 72 in other examples of the stopper may be more, less, or none. In some examples, some or all of the ribs 72 may have different sizes or shapes compared to other ribs 72.

[0100] Figures 15 and 16 show an example of a stopper, for example, a view and a cross-sectional view of the stopper 134 in FIG. 11. The stopper 134 in this example is substantially circular in a cross-section perpendicular to the longitudinal axis, and includes longitudinal ridges 74 that extend along the outer surface of the stopper 134 at positions circumferentially offset from each other by 180° on the circumference of the stopper 134. One or more such ridges 74 can be included in any example of the stopper 34. The stopper 134 in this example has four circumferential ribs 72 having similar sizes and shapes, but in other examples of the stopper, the ribs 72 may be more, less, or none. In some examples, some or all of the ribs 72 may have different sizes or shapes compared to other ribs 72.

[0101] The stopper 134 does not include a stopper opening 56 and includes a dividing wall 76 that separates the 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 that defines a hollow interior. The end wall may include one or more openings. In other examples, the stopper 34 may have a substantially solid configuration.

[0102] As described above, one or more ridges 74 on the stopper 134 can engage with the recessed guide track 82 of the barrel body 70 to control the rotation of the stopper 134.

[0103] FIG. 17 shows an example of an end cap 54, in which a reset access opening 62 is shown, which is a slot provided in the end cap 54, through which a reset projection 58, e.g., a wall extending from the inner wall of the case 10, extends and can contact the indicator component 42.

[0104] FIG. 18 shows an example of a reset rod 16. In this example, as described with respect to FIG. 4, the reset rod 16 includes an elongated narrow end portion 28, which is for passing through the stopper opening 56 and engaging with the plunger rod 34. As described with respect to FIG. 4, the reset rod 16 and a wider support element 26 for contacting the stopper. In this example, the support element 26 is incorporated into the reset rod, but it may be another element connected to the reset rod 16. The support element 26 can be connected in any suitable manner, e.g., by friction fitting or an adhesive.

[0105] FIG. 19 shows an example of a reset rod 116. In this example, the end portion 128 contacts the stopper 134 directly. In this example, the end portion 128 is sized to fit within the proximal recess 78 of the stopper 134, whereby the stopper 134 guides the position of the reset rod 116, in this case, holding it centered within the barrel bore 32. By controlling the position of the reset rod 116 with respect to the barrel body 32, it may be possible to prevent the reset rod 116 from contacting the barrel body 32, which can prevent or reduce scratches or other wear that can shorten the service life of the device.

[0106] FIG. 20 is an exploded view of an exemplary auto-injector device 1 having a cap 4. The auto-injector device 1 includes a longitudinal housing 18 having an end cap 54. Within the longitudinal housing 18 is a barrel body 32 including a stopper 34. The longitudinal housing 18 also houses a drive mechanism 38 and a trigger mechanism 40. An electronic module 84 including a battery 83, e.g., a button battery, is connected to the drive mechanism 38 and the trigger mechanism 40 of this example. A label 86 is included that wraps around a portion of the longitudinal housing 18.

[0107] Figure 21 is an exploded view of the cap 4 and proximal components of an exemplary autoinjector device 1. The cap 4 includes a reset rod 16 that includes a support element 26. The reset rod 16 is formed within a cap end 87 that is coupled to a cap body 88.

[0108] In this example, the housing 18 includes a needle guard 46. An exemplary needle guard 46 includes a front element 90 that defines an open proximal end 22 of the housing 18. In some examples, the front element 90 may be integral with the needle guard 46. The needle guard 46 of this example includes legs 92 that, in the assembled state, connect the needle guard 46 to the trigger mechanism 40.

[0109] The housing 18 also includes a battery opening, such as a slot 85, through which a battery 83 can be inserted into or removed from an electronic module 84. The battery opening can be disposed on both sides of the housing 18. In some examples, the battery slot 85 can be on one side of the housing 18 and, on the opposite side, a smaller battery opening can be provided into 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 removed from the autoinjector device and recharged by using a separate charger. In some embodiments, the rechargeable battery may be recharged while within the autoinjector device, for example, by wireless or wired charging, and the recharging can occur when the autoinjector device is within a case.

[0110] Figure 22 is an exploded view of an exemplary drive mechanism 38, plunger rod 36, trigger mechanism 40, and housing end cap 54 of an exemplary auto-injector device 1. In this case, end cap 54 includes an inner end cap component 55 attached within end cap 54. End cap 54 may be transparent, and including the inner end cap component 55 may help prevent a user from confusing which end of the auto-injector device is the proximal end and which is the distal end.

[0111] Drive mechanism 38 includes a drive spring 50 and a guide pin 94 that helps prevent deformation of drive spring 50. The trigger mechanism 40 of this example includes a plurality of latch components 96 that, as described above, are operable to hold or release plunger rod 36 and initiate a transition of drive mechanism 38 from a primed state to a fired state.

[0112] The indicator component 42 of this example includes two components interconnected with each other and is biased toward a display position by an indicator spring 98. In other examples, the indicator component may be a single component or may include three or more components.

[0113] Figure 23 is an exploded view of another exemplary drive mechanism 138, plunger rod 136, trigger mechanism 40, and housing end cap 54 of an exemplary auto-injector device 1.

[0114] Drive mechanism 138 includes a gas spring 150 that, in this example, is integral with plunger rod 136. The trigger mechanism 40 of this example includes a plurality of latch components 96 that, as described above, are operable to hold or release plunger rod 136 and initiate a transition of drive mechanism 138 from a primed state to a fired state.

[0115] FIG. 24 is an exploded view of an example of a barrel body 70, a stopper 134, and a plunger rod 236. This exemplary barrel body 70 includes two longitudinal guide channels 82, and the ridge 74 of the stopper 134 engages therewith to control the rotation of the stopper 134 while it moves along the barrel body 70. The exemplary plunger rod 236 includes a stopper contact portion 238, which includes a radial protrusion 240, and the guide channel 82 engages therewith to control the rotation of the plunger rod 236 while it moves along the barrel body 70.

[0116] 〔Embodiment〕 (1) A longitudinal housing having an open proximal end that extends along a longitudinal axis and contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body attached inside the housing, A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the plunger rod being held against a driving force in a primed state at a retracted position between the distal end and the stopper at the distal position, and the plunger rod extending through at least a portion of the barrel body and contacting the stopper at the proximal position, having a firing state, a drive mechanism, A trigger mechanism operable to release the plunger rod and initiate a transition from the primed state to the firing state of the drive mechanism, thereby driving the stopper from the distal position to the proximal position on the plunger rod, An indicator component that, when triggered, moves distally from an initial position to a display position that displays the state of the auto-injector device, An auto-injector kit including an auto-injector device including Including an indicator reset, the housing of the auto-injector device includes a reset access opening at the distal end of the longitudinal housing, the indicator reset includes a base and a reset protrusion, the reset protrusion is insertable through the reset access opening, and contacts the indicator component to forcibly move the indicator component to the initial position. Auto-injector kit. (2) The reset access opening is an elongated slot extending from the distal end to the proximal end of the housing, and the reset protrusion includes an elongated wall. The auto-injector kit according to Embodiment 1. (3) The base of the indicator reset includes a case capable of housing the housing therein. The auto-injector kit according to Embodiment 1 or Embodiment 2. (4) When the housing is housed in the case, the housing is releasably fixed therein. The auto-injector kit according to Embodiment 3. (5) When the housing is releasably fixed in the case by a releasable clip. The auto-injector kit according to Embodiment 4.

[0117] (6) When the housing is housed in the case, the reset protrusion extends through the reset access opening to forcibly move the indicator component to the initial position. The auto-injector kit according to any one of Embodiments 3 to 5. (7) A longitudinal housing having an open proximal end extending along a longitudinal axis and contacting a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body attached inside the housing, A stopper slidably attached inside the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position. A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position. An auto-injector kit including an auto-injector device. The stopper includes a stopper opening extending through the stopper along the longitudinal axis. The auto-injector kit further includes a reset rod. The reset rod is insertable through the open proximal end of the housing and contacts the plunger rod through the stopper opening, forcing the plunger rod to move to the retracted position, thereby transitioning the drive mechanism to its prime state. The reset rod has a first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position, and a second end opposite the first end. Auto-injector kit. (8) The reset rod includes a protrusion offset from the first end along the reset rod. The protrusion is sized to contact the stopper and move the stopper to the distal position when the plunger rod is moved to the retracted position. The auto-injector kit according to embodiment 7. (9) The protrusion includes a circumferential shoulder. The auto-injector kit according to embodiment 8. (10) The displacement between the first end and the protrusion is greater than the range 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, for the auto-injector kit according to embodiment 8 or embodiment 9.

[0118] (11) The second end of the reset rod includes a cap attachable to the proximal end of the housing, for the auto-injector kit according to any one of embodiments 8 to 10. (12) An auto-injector device, A longitudinal housing extending along a longitudinal axis, having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body attached inside the housing, A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper from the distal position to the proximal position along the plunger rod, comprising, A guide track for controlling rotation of the plunger rod around the longitudinal axis during operation, Auto-injector device. (13) The plunger rod is fixed to the stopper, and the stopper includes, on an outer surface, an axial ridge that engages with an axial slot provided in the barrel body to control rotation of the plunger rod around the longitudinal axis during operation. The autoinjector device according to Embodiment 1. (14) A longitudinal housing that extends along a longitudinal axis and has an open proximal end that contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body mounted inside the housing, A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper from the distal position to the proximal position along the plunger rod, An autoinjector kit including an autoinjector device including: Including a reset rod, the reset rod being insertable through the open proximal end of the housing to apply a reset force to the plunger rod, having a first end that forcibly moves the plunger rod to the retracted position, thereby transitioning the drive mechanism to its primed state, and the rod having a second end opposite the first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position, The maximum reset force required to move the plunger rod to the retracted position is less than 10 N. An autoinjector kit. (15) An autoinjector device, comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior; a barrel body mounted inside the housing; a stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod; a drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position; a trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper from the distal position to the proximal position along the plunger rod; comprising: wherein an inner dimension of the barrel body perpendicular to the longitudinal axis increases toward the proximal end of the autoinjector device such that compression of the stopper decreases as the stopper is driven toward the proximal end by the plunger rod; an autoinjector device.

[0119] (16) The autoinjector device according to embodiment 1, wherein the inner dimension is an inner diameter of the barrel body. (17) A method of resetting an indicator component of an autoinjector device, the autoinjector device comprising: a longitudinal housing extending along a longitudinal axis and having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior; a barrel body mounted inside the housing; A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the plunger rod being held against a driving force in a primed state at a retracted position between the distal end and the stopper at the distal position, and the plunger rod extending through at least a portion of the barrel body and contacting the stopper at the proximal position, the drive mechanism having a firing state, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position, An indicator component that, when triggered, moves distally from an initial position to a display position for displaying the state of the auto-injector device, Including, the method comprising: Inserting a reset protrusion of the indicator reset through a reset access opening at a distal end of the longitudinal housing of the housing of the auto-injector device to contact the indicator component, and using the reset protrusion to forcibly move the indicator component to the initial position, A method including. (18) The method according to embodiment 17, wherein the reset protrusion is provided on a case capable of accommodating the auto-injector device therein, and by inserting the auto-injector into the case, the reset protrusion passes through the reset access opening and contacts the indicator component, thereby forcibly moving the indicator component to the initial position. (19) A method for resetting a plunger rod of an auto-injector device, the auto-injector device comprising: A longitudinal housing extending along a longitudinal axis, having an open proximal end in contact with a trigger portion, a distal end opposite the proximal end, and a hollow interior, A barrel body mounted inside the housing, A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper from the distal position to the proximal position along the plunger rod, Including, the method comprising: 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, the stopper opening extending through the stopper along the longitudinal axis, Using the reset rod to forcibly move the plunger rod to the retracted position, thereby transitioning the drive mechanism to its prime position, the 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, Method. (20) The method according to embodiment 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 auto-injector device, and by 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, the plunger rod is moved to the retracted position, thereby transitioning the drive mechanism to its prime state.

Claims

1. A longitudinal housing that extends along a longitudinal axis, has an open proximal end that contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, and A barrel body attached inside the housing, A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper from the distal position to the proximal position along the plunger rod, An indicator component that, when triggered, moves distally from an initial position to a display position that displays the state of the autoinjector device, An autoinjector kit including an autoinjector device including Including an indicator reset, the housing of the autoinjector device includes a reset access opening at the distal end of the longitudinal housing, the indicator reset includes a base and a reset protrusion, the reset protrusion is insertable through the reset access opening, and contacts the indicator component to forcibly move the indicator component to the initial position, An autoinjector kit.

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

3. The autoinjector kit according to claim 1 or claim 2, wherein the base of the indicator reset includes a case capable of housing the housing therein.

4. The autoinjector kit according to claim 3, wherein when the housing is received in the case, the housing is releasably fixed therein.

5. The autoinjector kit according to claim 4, when the housing is releasably fixed in the case by a releasable clip.

6. The autoinjector kit according to claim 3, when the housing is received in the case, the reset projection extends through the reset access opening and forcibly moves the indicator component to the initial position.

7. A longitudinal housing having an open proximal end that extends along a longitudinal axis and contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body attached inside the housing, A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper from the distal position to the proximal position on the plunger rod, An autoinjector kit including an autoinjector device including, The stopper includes a stopper opening extending through the stopper along the longitudinal axis, the autoinjector kit further includes a reset rod, the reset rod is insertable through the open proximal end of the housing, contacts the plunger rod through the stopper opening, and forcibly moves the plunger rod to the retracted position, thereby causing the drive mechanism to transition to its prime state, having a first end, and the reset rod has a second end opposite the first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position, Autoinjector kit.

8. The reset rod includes a protrusion offset from the first end along the reset rod, and the protrusion is sized to contact the stopper and move the stopper to the distal position when the plunger rod is moved to the retracted position. The auto-injector kit according to claim 7.

9. The auto-injector kit according to claim 8, wherein the protrusion includes a circumferential shoulder.

10. 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. The auto-injector kit according to claim 8 or claim 9.

11. The second end of the reset rod includes a cap attachable to the proximal end of the housing. The auto-injector kit according to claim 8.

12. An auto-injector device, A longitudinal housing having an open proximal end that extends along a longitudinal axis and contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body attached inside the housing, A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper from the distal position to the proximal position along the plunger rod, Including, Including a guide track that controls rotation of the plunger rod around the longitudinal axis during operation. An auto-injector device.

13. The plunger rod is fixed to the stopper, and the stopper includes, on an outer surface, an axial ridge that engages with an axial slot provided in the barrel body to control rotation of the plunger rod around the longitudinal axis during operation, the auto-injector device according to claim 1.

14. A longitudinal housing that extends along a longitudinal axis and has an open proximal end that contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body mounted inside the housing, A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod, A drive mechanism connected to the plunger rod, the drive mechanism having a primed state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper in the distal position, and a fired state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper in the proximal position, A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the fired state, thereby driving the stopper from the distal position to the proximal position by the plunger rod, An auto-injector kit including an auto-injector device, Including a reset rod, the reset rod being insertable through the open proximal end of the housing to apply a reset force to the plunger rod, having a first end that forcibly moves the plunger rod to the retracted position, thereby transitioning the drive mechanism to its primed state, and the rod having a second end opposite the first end that remains outside the longitudinal housing when the plunger rod is moved to the retracted position, The maximum reset force required to move the plunger rod to the retracted position is less than 10 N, Auto-injector kit.

15. An auto-injector device, A longitudinal housing that extends along a longitudinal axis and has an open proximal end that contacts a trigger site, a distal end opposite the proximal end, and a hollow interior, A barrel body mounted inside the housing, A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod; A drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position; A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position; comprising; The inner dimension of the barrel body perpendicular to the longitudinal axis increases toward the proximal end of the autoinjector device such that the compression of the stopper decreases as the stopper is driven toward the proximal end by the plunger rod. An autoinjector device.

16. The autoinjector device according to claim 1, wherein the inner dimension is the inner diameter of the barrel body.

17. A method for resetting an indicator component of an autoinjector device, the autoinjector device comprising: A longitudinal housing extending along a longitudinal axis and having an open proximal end in contact with a trigger site, a distal end opposite the proximal end, and a hollow interior; A barrel body mounted within the housing; A stopper slidably mounted within the barrel body and movable from a distal position to a proximal position by a plunger rod; A drive mechanism connected to the plunger rod, the drive mechanism having a prime state in which the plunger rod is held against a driving force at a retracted position between the distal end and the stopper at the distal position, and a firing state in which the plunger rod extends through at least a portion of the barrel body and contacts the stopper at the proximal position; A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the prime state to the firing state, thereby driving the stopper on the plunger rod from the distal position to the proximal position; When triggered, an indicator component that moves distally from an initial position to a display position for displaying the state of the auto-injector device, comprising, the method comprising: inserting a reset projection of an indicator reset through a reset access opening at a distal end of the longitudinal housing of the housing of the auto-injector device to contact the indicator component; and using the reset projection to forcibly move the indicator component to the initial position; A method comprising. [

18. ] The reset projection is provided on a case in which the auto-injector device can be accommodated therein. By inserting the auto-injector into the case, the reset projection passes through the reset access opening and contacts the indicator component, and the method according to claim 17, wherein the indicator component is forcibly moved to the initial position. [

19. ] A method for resetting a plunger rod of an auto-injector device, the auto-injector device comprising: A longitudinal housing extending along a longitudinal axis, having an open proximal end in contact with a trigger portion, a distal end opposite the proximal end, and a hollow interior; A barrel body attached inside the housing; A stopper slidably attached within the barrel body and movable from a distal position to a proximal position by a plunger rod; A drive mechanism connected to the plunger rod, the plunger rod being held against a driving force in a primed state at a retracted position between the distal end and the stopper at the distal position, and the plunger rod extending through at least a portion of the barrel body and contacting the stopper at the proximal position. A drive mechanism having a firing state; A trigger mechanism operable to release the plunger rod and initiate a transition of the drive mechanism from the primed state to the firing state, thereby driving the stopper from the distal position to the proximal position on the plunger rod; comprising, the method comprising: Inserting a first end of the reset rod through the open proximal end of the housing to contact the plunger rod through the stopper opening, the stopper opening extending through the stopper along the longitudinal axis; Using the reset rod to force the plunger rod to move to the retracted position, thereby shifting the drive mechanism to its prime position, wherein a second end of the reset rod, opposite the first end, remains outside the longitudinal housing when the plunger rod is moved to the retracted position; A method. 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 autoinjector device, and the plunger rod is moved to the retracted position by 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, thereby shifting the drive mechanism to its primed state. ​

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