Locking components for injection devices and injection device trainers

Abstract

The present invention discloses an injection device and an injection device trainer (1) for training a user. Each of the injection device and the injection device trainer includes: a body portion (3); an actuator (9) positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position; a shield (11) positioned toward a distal end of the body portion, the shield being movable between: an initial position; a retracted position closer to the body portion than the initial position; and an extended position farther from the body portion than the initial position; and a locking member (47) rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position.

Description

Technical Field

[0001] This disclosure relates to an injection device for administering Injection 75 and an injection device trainer for training a user to use the injection device. Background Technology

[0002] The aim is to provide a simple and safe way to administer injectable medications when treating patients. A typical syringe for administering injectable medications includes a cartridge for holding the medication, a plunger fitted within the cartridge, and a needle through which the medication is expelled when the plunger is pushed inside the cartridge. Typically, the syringe will have a cap for concealing the needle when the syringe is not being used to administer the injection; this cap can be removed to expose the needle.

[0003] One specific problem with conventional syringes is that patients may accidentally prick themselves or others with the needle before administering the injection. Another specific problem is that it can be difficult to properly align the needle with the target site, and therefore the injection may be administered in the wrong place. Therefore, conventional syringes can be complex and potentially unsafe to use, especially for patients with limited dexterity.

[0004] Injection devices exist designed to overcome these problems of conventional syringes. One such device includes a needle shield and a plunger that can be actuated to force medication from the needle into the patient. The needle shield retracts when pressed against the target site to expose the needle, and the plunger can be simultaneously pressed to administer the injection. This allows for administration of the injection in a single movement by pressing the plunger of the device down onto the target site. This allows patients to administer injections to themselves in a safe and simple manner. Typically, these devices are designed so that they are for single use only, for example by locking the needle shield in place once the injection is complete, covering the needle. This prevents patients from using the needle multiple times, thus promoting hygiene and health.

[0005] A known problem with injection devices is that training patients to use them without actually administering the injection can be difficult. Therefore, appropriate training can be limited to the number of injections required. Alternatively, inactive ingredients can be used as the substance injected during training. However, unnecessary injections into the human body should be avoided for health and hygiene reasons.

[0006] In view of the above, there is a need for a device that can be used to train patients to use the injection device in a simple and safe manner. Furthermore, it is desirable that this device be reusable so that the same device can be used for multiple training sessions. An injection device with a simple construction and reliable operation is also required. Summary of the Invention

[0007] In one aspect of the invention, an injection device trainer is provided for training a user to use an injection device, the injection device trainer comprising: a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position; a shield positioned toward the distal end of the body portion, the shield being movable between: an initial position; a retracted position closer to the body portion than the initial position; and an extended position farther from the body portion than the initial position; and a locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position. The first orientation of the locking member is configured to hold the shield in the initial position, preventing the shield from moving from the initial position to the extended position, and allowing the shield to move from the initial position to the retracted position. The shield is configured to contact the locking member when moving from the initial position to the retracted position, so as to move the locking member from the first orientation to the second orientation. The actuator moves a first distance toward the distal position to unlock the shield from the locking member, allowing the shield to move toward the extended position.

[0008] Therefore, the injection device trainer accurately simulates the use of an injection device to improve the training process. Furthermore, users can practice administering injections more frequently than in situations where training is only possible during actual injections. A locking mechanism provides a means to simulate the use of the injection device.

[0009] In another aspect of the invention, an injection device is provided, comprising: a needle coupled to a chamber for storing fluid; a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle; a shield positioned toward a distal end of the body portion, the shield being movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and a locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position. A first orientation of the locking member is configured to hold the shield in an initial position, preventing the shield from moving from the initial position to an extended position, and allowing the shield to move from the initial position to a retracted position. The shield is configured to contact the locking member when moving from the initial position to the retracted position, thereby moving the locking member from the first orientation to a second orientation. Moving the actuator a first distance toward the distal position unlocks the shield from the locking member, allowing the shield to move toward the extended position.

[0010] This provides the injection device with a construction that contributes to reliability and ease of manufacture.

[0011] In another aspect of the invention, a method for training a user to use an injection device is provided, the method comprising providing an injection device trainer comprising: a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position; a shield positioned toward a distal end of the body portion, the shield being movable between: an initial position; a retracted position closer to the body portion than the initial position; and an extended position farther from the body portion than the initial position; and a locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position. The first orientation of the locking member is configured to hold the shield in the initial position, such that movement of the shield from the initial position to the extended position is prevented, and movement of the shield from the initial position to the retracted position is allowed. The method also includes moving the shield from an initial position to a retracted position, such that the shield contacts the locking member, so as to move the locking member from a first orientation to a second orientation; and moving the actuator toward a distal position a first distance to unlock the shield from the locking member, such that the shield moves toward an extended position.

[0012] In another aspect of the invention, a method of administering an injection is provided, the method comprising providing an injection device including: a needle coupled to a chamber for storing fluid; a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle; a shield positioned toward a distal end of the body portion, the shield being movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and a locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position. The first orientation of the locking member is configured to hold the shield in an initial position, preventing the shield from moving from the initial position to an extended position and allowing the shield to move from the initial position to a retracted position. The method also includes moving the shield from the initial position to the retracted position such that the shield contacts the locking member to move the locking member from the first orientation to a second orientation; and moving the actuator toward a distal position a first distance to unlock the shield from the locking member, such that the shield moves toward the extended position.

[0013] In another aspect of the invention, an injection device trainer is provided for training a user to use an injection device. The injection device trainer includes a main body portion and an actuator positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position. The main body portion includes a main body protrusion, and the actuator includes a latch arranged to engage with the main body protrusion when the actuator is in the distal position, thereby holding the actuator in the distal position.

[0014] In this way, the engagement of the latch with the body protrusion indicates that the actuator has reached the distal position, simulating the completion of an injection administered by an injection device. Therefore, users can be trained to determine that the injection has been correctly administered.

[0015] In another aspect of the invention, an injection device is provided, comprising: a needle coupled to a chamber for storing fluid; a body portion; and an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle. The body portion includes a body protrusion, and the actuator includes a latch arranged to engage with the body protrusion when the actuator is in the distal position, thereby holding the actuator in the distal position.

[0016] In this way, the engagement of the latch with the body protrusion indicates that the actuator has reached the distal position, signifying the completion of the injection administered by the injection device. Therefore, the user can more accurately determine that the injection has been correctly administered.

[0017] In another aspect of the invention, an injection device trainer is provided for training a user to use an injection device. The injection device trainer includes a main body portion and an actuator positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position. The main body portion includes a main body protrusion, and the actuator includes a latch arranged to contact the main body protrusion and emit an audible sound when the actuator is in the distal position.

[0018] In this way, an audible indication that the actuator has reached a distal position simulates the completion of an injection administered by an injection device. This allows the user to be trained to determine that the injection has been correctly administered. The audible sound can have an intensity that allows the user to hear it at a distance of 1 meter from the device, or at least at arm's length from the device. The latch can be configured to emit an audible sound at a distance from the device (e.g., 30 cm) exceeding a predetermined threshold intensity. For example, the predetermined threshold intensity could be 40 dB, such that the emitted sound is stronger than the normal sound intensity in a quiet room. This allows the user to hear the sound in a normal working environment. The predetermined threshold intensity could be 50 dB, 60 dB, or even 70 dB to ensure that the user can hear the sound in a variety of different environments. The sound can be in the form of a "click," a short, sharp sound (e.g., less than one second long). The sound is emitted due to the mechanical interaction between the latch and the body protrusion and is not emitted by electronic devices.

[0019] In another aspect of the invention, an injection device is provided, comprising: a needle coupled to a chamber for storing fluid; a body portion; and an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle. The body portion includes a body protrusion, and the actuator includes a latch arranged to contact the body protrusion and emit an audible sound when the actuator is in the distal position.

[0020] In this way, an audible indicator shows that the actuator has reached the distal position, indicating the completion of the injection administered by the injection device. Therefore, the user can more accurately determine that the injection has been correctly administered.

[0021] In another aspect of the invention, a method for training a user to use an injection device is provided. The method includes providing an injection device trainer comprising a body portion and an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position. The body portion includes a body protrusion, and the actuator includes a latch. The method further includes moving the actuator from the proximal position to the distal position such that the latch engages with the body protrusion when the actuator is in the distal position, thereby holding the actuator in the distal position.

[0022] In another aspect of the invention, a method of administering an injectable agent is provided, the method comprising providing an injection device including: a needle coupled to a chamber for storing fluid; a body portion; and an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle. The body portion includes a body protrusion, and the actuator includes a latch. The method further includes moving the actuator from the proximal position to the distal position such that the latch engages with the body protrusion when the actuator is in the distal position, thereby holding the actuator in the distal position.

[0023] In another aspect of the invention, a method for training a user to use an injection device is provided. The method includes providing an injection device trainer comprising a main body portion and an actuator positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position. The main body portion includes a main body protrusion, and the actuator includes a latch. The method further includes moving the actuator from the proximal position to the distal position such that the latch contacts the main body protrusion and emits an audible sound when the actuator is in the distal position.

[0024] In another aspect of the invention, a method of administering an injectable agent is provided, the method comprising providing an injection device including: a needle coupled to a chamber for storing fluid; a body portion; and an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle. The body portion includes a body protrusion, and the actuator includes a latch. The method further includes moving the actuator from the proximal position to the distal position such that the latch contacts the body protrusion and emits an audible sound when the actuator is in the distal position.

[0025] In another aspect of the invention, an injection device trainer is provided for training a user to use an injection device, the injection device trainer comprising: a main body portion; an actuator positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position; a shield positioned toward a distal end of the main body portion, the shield being movable between: an initial position; an extended position, the extended position being farther from the main body portion than the initial position; and a connector connecting the actuator to the shield such that movement of the actuator from the distal position toward the proximal position pulls the shield from the extended position to the initial position.

[0026] In this way, the injection device trainer can be reset to its initial position, making the trainer usable again. The connector provides the mechanism for achieving this function.

[0027] In another aspect of the invention, an injection device is provided, comprising: a needle coupled to a chamber for storing fluid; a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle; a shield positioned toward a distal end of the body portion, the shield being movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and a connector connecting the actuator to the shield such that movement of the actuator from the distal position toward the proximal position pulls the shield from the extended position to the initial position.

[0028] In this way, the injection device can be reset to its initial position, allowing it to be used more than once. The connector provides the mechanism for achieving this function.

[0029] In another aspect of the invention, a method for training a user to use an injection device is provided. The method includes providing an injection device trainer comprising: a main body portion; an actuator positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position; a shield positioned toward a distal end of the main body portion, the shield being movable between: an initial position; an extended position further away from the main body portion than the initial position; and a connector connecting the actuator to the shield. The method further includes moving the actuator from the distal position toward the proximal position to pull the shield from the extended position to the initial position using the connector.

[0030] In another aspect of the invention, a method of administering an injectable agent is provided, the method comprising providing an injection device including: a needle coupled to a chamber for storing fluid; a body portion; an actuator positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle; a shield positioned toward a distal end of the body portion, the shield being movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and a connector connecting the actuator to the shield. The method further includes moving the actuator from the distal position toward the proximal position to pull the shield from the extended position to the initial position using the connector.

[0031] In another aspect of the invention, an injection device trainer is provided for training a user to use an injection device, the injection device trainer comprising: a main body portion; an actuator assembly positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position, wherein the actuator assembly is coupled to a rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and a damping element coupled to or capable of being coupled to the rotor to suppress rotation of the rotor.

[0032] In this way, the injection device trainer can simulate the resistance provided by the drug in the injection device when the actuator is pressed.

[0033] In another aspect of the invention, an injection device is provided, comprising: a needle coupled to a chamber for storing fluid; a body portion; an actuator assembly positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, wherein the actuator assembly is coupled to a rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and a damping element coupled to or capable of being coupled to the rotor to suppress rotation of the rotor.

[0034] In this way, the injection device can suppress the actuator from advancing toward the distal position, which ensures that fluid is not dispensed from the needle too quickly.

[0035] In another aspect of the invention, a method for training a user to use an injection device is provided. The method includes providing an injection device trainer comprising: a main body portion; an actuator assembly positioned toward a proximal end of the main body portion, the actuator being movable from a proximal position to a distal position, wherein the actuator assembly is coupled to a rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and a damping element coupled to or capable of being coupled to the rotor to suppress rotation of the rotor. The method further includes moving the actuator from the proximal position to the distal position, during which the damping element suppresses rotation of the rotor and thus suppresses movement of the actuator toward the distal position.

[0036] In another aspect of the invention, a method of administering an injectable agent is provided, the method comprising providing an injection device including: a needle coupled to a chamber for storing fluid; a body portion; an actuator assembly positioned toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, wherein the actuator assembly is coupled to a rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and a damping element coupled to or capable of being coupled to the rotor to suppress rotation of the rotor. The method further includes moving the actuator from the proximal position to the distal position, during which the damping element suppresses rotation of the rotor and thus suppresses movement of the actuator toward the distal position.

[0037] The locking member may include an actuator resistance surface arranged to resist movement of the actuator from a proximal position to a distal position when the locking member is in a first orientation. The actuator resistance surface may include a protrusion extending from the locking member. The actuator may include an abutment surface arranged to abut the actuator resistance surface when the actuator is in the proximal position and the locking member is in the first orientation. The abutment surface may include a protrusion extending from the actuator. The locking member may include at least two (or a pair) actuator resistance surfaces. The pair of actuator resistance surfaces may be located on opposite sides of the locking member relative to each other. The actuator may include at least two (or a pair) abutment surfaces. The pair of abutment surfaces may be located on opposite sides of the actuator relative to each other. This simple and reliable mechanism allows the force applied to the locking member by the actuator to be distributed across the diameter of the locking member.

[0038] The locking member may include a cylindrical housing, and the actuator resistance surface may include a protrusion projecting from the surface of the cylindrical housing. The protrusion may only partially traverse the circumference of the cylindrical housing. The locking member may include a ramp. The shield may include a ramp engagement. The ramp engagement of the shield may be arranged to interact with the ramp of the locking member when the shield moves from an initial position to a retracted position, thereby rotating the locking member from a first orientation to a second orientation. This provides a simple and reliable mechanism for rotating the locking member into the second orientation.

[0039] The locking member may include a third orientation in which the shield can be moved from an initial position to an extended position. The actuator may be configured to move a first distance to move the locking member into the third orientation. In this way, the shield is prevented from moving to the extended position until the actuator has been at least partially depressed. The extended position simulates the locked state of the injection device, thereby indicating that the injection has been completed. Therefore, the trainer cannot simulate the completion of the injection procedure until the user has activated the actuator.

[0040] The locking member may include a stop arranged to sit within a recess in the cover, thereby holding the cover in its initial position. This provides a simple and reliable mechanism for holding the cover in its initial position.

[0041] The stop can be arranged to move along a slot in the shield to allow the shield to move to an extended position. The stop can be seated outside the slot in the recess to hold the shield in the initial position when the locking member is in the first orientation. In this way, the stop can be used to allow the shield to move from the initial position to the extended position by moving the stop from the recess into the slot.

[0042] In one embodiment, moving the locking member from a second orientation to a third orientation via an actuator pushes the stop into the slot, allowing the shield to move from an initial position to an extended position. Therefore, pressing down the actuator allows the shield to move to the extended position.

[0043] A stop can be coupled to an elastic member configured to bend so as to move the stop from a resting state toward the longitudinal axis of the trainer to a flexed state. In the resting state, the stop holds the shield in its initial position. In the flexed state, the stop allows it to move into a slot. This provides a reliable mechanism for allowing the shield to move from its initial position to its extended position.

[0044] The trainer may include a biasing element that biases the shield to move distally. Thus, depending on the orientation of the locking member, the shield can automatically move from a retracted position to an initial position or an extended position.

[0045] The actuator resistance surface of the locking member may include a deflector portion. The actuator may be arranged to engage with the deflector portion to move the locking member from a second orientation to a third orientation. Thus, the actuator pushes the deflector portion downward to move the locking member into an orientation that allows the shield to move to an extended position.

[0046] The trainer may include a biasing element arranged to bias the locking member in a first rotational direction. The biasing element may include a torsion spring. The biasing element may bias the locking member away from a second or third orientation toward the first orientation. Therefore, the trainer can be automatically reset.

[0047] The biasing element can bias the locking member toward the fourth orientation, so that once the actuator has moved a certain distance toward the distal position and the shield is in the extended position, the locking member moves into the fourth orientation. The locking member in the fourth orientation prevents the shield from moving from the extended position to the initial position. Therefore, once the actuator is pressed down, the shield can automatically position itself in the locked state.

[0048] The actuator can be configured to impede the locking member when moved from the distal position to the proximal position, causing the locking member to move toward a first orientation, thereby allowing the shield to move from the extended position to the initial position. This allows the user to reset the trainer by moving the actuator from the distal position back to the proximal position.

[0049] The locking member may include a shield resistance surface arranged to resist proximal movement of the shield when the locking member is in the fourth orientation and the shield is in the extended position. The shield may include an abutment surface that abuts the shield resistance surface when the locking member is in the fourth orientation and the shield is in the extended position. This helps to keep the shield in the locked state.

[0050] In one embodiment, the proximal position of the actuator simulates the inactive position of the plunger of the injection device. In one embodiment, the distal position of the actuator simulates the activated position of the plunger of the injection device. In one embodiment, the initial position of the shield simulates the coverage of the needle of the injection device. In one embodiment, the retracted position of the shield simulates the exposure of the needle of the injection device. In one embodiment, the extended position of the shield simulates the locked state of the injection device, in which the shield is prevented from exposing the needle. Therefore, the trainer can accurately simulate the operation of the injection device.

[0051] The latch can be configured to emit an audible sound when engaged with the body protrusion, thereby indicating that the actuator is in the distal position. This audible indication that the actuator has reached the distal position simulates the completion of an injection administered by an injection device, allowing the user to more accurately determine that the injection has been correctly administered when using the injection device.

[0052] The latch can be configured to hold the actuator in the distal position when engaged with the body protrusion. Engagement of the latch with the body protrusion indicates that the actuator has reached the distal position, which simulates the completion of administration of an injection by an injection device, allowing the user to more accurately determine that the injection has been correctly administered when using the injection device.

[0053] The latch may include a resilient member. The latch is movable between an unengaged state in which the latch is not engaged with the body protrusion and an engaged state in which the latch is engaged with the body protrusion. Therefore, the latch can be easily bent to engage with the body portion.

[0054] When a force exceeding a threshold is applied to the actuator during the movement from the distal to the proximal position, the elastic member can be arranged to move from the engaged state to the disengaged state. Therefore, the latch securely holds the actuator in the distal position while allowing the trainer to return to its initial configuration when the user intentionally applies a force exceeding the threshold to the actuator.

[0055] The latch may include a latch deflector portion arranged to engage with a body protrusion to move the latch from an uncoupled state to a coupled state. The latch may include a clamping element that clamps the body portion in the coupled state. In this way, the deflector portion facilitates movement of the latch into coupling with the body, and the clamping element helps maintain the latch and body connected to each other.

[0056] The resilient member may include a deflector portion and / or a clamping element. The deflector portion and the clamping element may be located on opposite sides of the latch. This provides a reliable construction for the latch.

[0057] When the actuator is in the proximal position, the connector resists movement of the shield away from its initial position toward the distal position. In this way, the connector helps to hold the shield in its initial position.

[0058] When the actuator is in the proximal position, the connector allows the shield to move toward the retracted position. In this way, the connector does not obstruct the shield from retracting to the retracted position.

[0059] When the actuator moves toward the distal position, the connector allows the shield to move distally toward the extended position. Therefore, the connector can be used to release the shield.

[0060] The connector may have an actuator engagement portion that abuts a portion of the actuator to resist distal movement of the shield away from the initial position when the actuator is in the proximal position. The actuator engagement portion and the abutment portion of the actuator provide a mechanism for holding the shield in the initial position.

[0061] The actuator engagement portion may abut the actuator's proximal surface. Therefore, when the actuator moves proximal, the connector can be moved by the actuator, but when the actuator moves distally, the connector is not moved by the actuator.

[0062] The connector may have a shield engagement portion that abuts a portion of the shield to resist movement of the shield away from its initial position toward the distal side when the actuator is in the proximal position. This provides a mechanism for holding the shield in its initial position.

[0063] The shield joint may abut the surface of the shield facing the distal direction. Therefore, when the actuator moves proximally, the connector can move the shield, but when the actuator moves distally, the connector does not move the shield.

[0064] In another aspect of the invention, a set of parts is provided, which is configured for assembly into an injection device trainer or injection device as described herein. Attached Figure Description

[0065] Embodiments of the invention will be described by way of example with reference to the following figures, wherein:

[0066] Figure 1 An injection device trainer is shown for training users to use the injection device;

[0067] Figure 2A A cap attached to the distal end of the injection device trainer is shown;

[0068] Figure 2B An injection device trainer is shown, with the actuator in a proximal position and the shield in an initial position;

[0069] Figure 2C The actuator is shown in the proximal position and the shield is shown in the retracted position;

[0070] Figure 2D The actuator is shown moving from the proximal position to the distal position, and the shield is shown in the retracted position;

[0071] Figure 2E The actuator is shown in the distal position and the shield is shown in the retracted position;

[0072] Figure 3A The actuator is shown in the distal position and the shield is shown in the extended position;

[0073] Figure 3B The actuator is shown moving from the distal position to the proximal position, and the shield is shown in the extended position.

[0074] Figure 3C The actuator is shown in the distal position and the shield is shown in the initial position;

[0075] Figure 4 An exploded view of the injection device trainer is shown;

[0076] Figure 5A A side view of the internal components of the injection device trainer is shown, with the actuator in a proximal position and the shield in its initial position;

[0077] Figure 5B A perspective view of the internal components of the injection device trainer is shown, with the actuator in a proximal position and the shield in an initial position;

[0078] Figure 6 An exploded view of the inner protective cover and locking mechanism is shown;

[0079] Figure 7A A side view of the internal components of the injection device trainer is shown, with the actuator in a proximal position and the shield in a retracted position;

[0080] Figure 7BA perspective view of the internal components of the injection device trainer is shown, with the actuator in a proximal position and the shield in a retracted position.

[0081] Figure 8 A perspective view of the internal components of the injection device trainer is shown, with the actuator in a distal position and the shield in an extended position.

[0082] Figure 9 An exploded view of an injection device trainer with connectors is shown;

[0083] Figure 10 An exploded view of an injection device trainer with a latch is shown; and

[0084] Figure 11A A side view of the internal components and damping elements of the injection device trainer is shown; and

[0085] Figure 11B A perspective view of the internal components and damping elements of the injection device trainer is shown.

[0086] Figure 12A A perspective view of the rotor is shown.

[0087] Figure 12B A top view of the rotor is shown, in which angled teeth can be seen.

[0088] Figure 12C A bottom view of the rotor is shown.

[0089] Figure 13A A side view of the rotor is shown.

[0090] Figure 13B A cross-sectional view taken along section AA is shown.

[0091] Figure 14A A second side view of the rotor is shown.

[0092] Figure 14B A cross-sectional view taken along section BB is shown.

[0093] Figure 15 A side view of the rotor and damping elements when fully engaged is shown. Detailed Implementation

[0094] refer to Figure 1 The illustration shows an injection device trainer 1 for training users to use the injection device. The trainer 1 includes a main body 3 having a proximal end 5 and a distal end 7.

[0095] In use, the distal end 7 of the main body 3 is positioned toward the surface of the user's body, which may be the target site where the user will typically apply the injection. In use, the proximal end 5 of the main body 3 is positioned toward the user's hand used to activate the trainer 1. The main body 3 also has windows 12 on each side, which simulate windows in an injection device for observing the medication contained within the device.

[0096] Although the terms “proximal” and “distal” are used herein to describe the device, these terms are used to provide context and are not required for trainer 1 to be used in any particular orientation. The terms “first end” and “second end” may be used in place of the terms “distal end” and “proximal end” without changing the intended meaning.

[0097] The injection device trainer 1 also includes an actuator 9 and a shield 11. The actuator 9 simulates a plunger in an injection device for dispensing medication from a needle. The shield 11 simulates a needle shield in an injection device for covering and exposing the needle.

[0098] The trainer 1 has a removable cover 13 that can be positioned over a shield 11 to prevent accidental retraction of the shield 11. The cover 13 includes a pair of notches 15 on its inner surface. These notches 15 are arranged to be positioned over a pair of protrusions 17 on the outer surface of the distal end 7 of the body portion 3. This holds the cover 13 in place. The distal end 7 of the body portion 3 also includes a pair of nodes 19 on opposite sides of each notch 15, which abut against the surface of the shield 11 to prevent the shield 11 from advancing further toward the proximal end 5 once the notches 15 have engaged with the protrusions 17.

[0099] The features of the injection device trainer 1 described herein may be the same as or substantially the same as the features of the injection device on which the user will train. However, the injection device trainer 1 does not include a needle, so that the user is not injected during the training procedure. The injection device trainer 1 also does not include any fluid (such as a drug) contained therein, but the trainer 1 may include a container that simulates a reservoir for holding a drug in an injection device.

[0100] refer to Figures 2A to 2E There exists a sequence for training users to administer injections using the injection device trainer 1. It can be seen that... Figure 2A As per reference Figure 1 The trainer 1 mentioned above. Figure 2B The trainer 1 is shown with the cover 13 removed to expose the shield 11. (See diagram.) Figure 2B As shown, the shield 11 is in the initial position, which simulates the position of the needle shield of the injection device in which the needle is covered.

[0101] refer to Figure 2CThe user can grasp the trainer 1 using the actuator 9 and position the shield 11 above the target area. The user can then push the actuator 9 towards the distal end 7 of the main body 3. This action causes the shield 11 to move in the direction of the proximal end 5 to its retracted position. When the shield 11 is in its initial position, it prevents the actuator 9 from moving relative to the main body 3 towards the distal end 7. Therefore, the actuator 9 remains in the proximal position and cannot move forward. However, once the shield 11 is in its retracted position, it allows the actuator 9 to move in the distal direction along the longitudinal axis of the trainer 1.

[0102] Figure 2C The shield 11 is shown in its retracted position, which is closer to the main body 3 than its initial position. When in the retracted position, the shield 11 is partially retracted inside the main body 3. This position simulates the position of the needle shield of an injection device, where the needle is exposed for administering the injection.

[0103] refer to Figure 2D and Figure 2E Once the shield 11 is in the retracted position, the actuator 9 is allowed to move to the distal side. Figure 2D The actuator 9 is shown moving toward the distal end 7. Figure 2E The actuator 9 is shown in a distal position, which simulates the position of the plunger in the injection device once the injector has been administered.

[0104] refer to Figures 3A to 3C This illustrates the sequence of resetting the injection device trainer 1 once the injection simulation is complete. (Reference) Figure 3A The user can remove the trainer 1 from the target area, which allows the shield 11 to move distally to an extended position, which is further away from the main body 3 than the initial and retracted positions. The extended position of the shield 11 simulates the locked state of the injection device, which prevents the needle shield of the injection device from exposing the needle.

[0105] refer to Figures 3B to 3C The user can pull the actuator 9 toward the proximal end 5 to reset the trainer 1, making it repeatable. Figures 2A to 2E The order described. Figure 3B The actuator 9 is shown moving toward the proximal position, and Figure 3C The actuator 9 is shown once it has reached the proximal position. When the actuator 9 is pulled to the proximal position, this causes the shield 11 to return to the initial position, making the trainer 1 available for another instance of training.

[0106] Figure 4An exploded view of the injection device trainer 1 is shown. The main body portion 3 includes a base portion 21 connected to the main portion 23, which is enclosed by a first outer portion 25 and a second outer portion 27. In this example, the constituent parts of the main body portion 3 are fitted together to form a main body assembly. However, the main body portion 3 may be formed as a single piece.

[0107] The protective cover 11 of the trainer 1 includes an outer protective cover portion 29 and an inner protective cover portion 31. The outer protective cover portion 29 extends from the base portion 21, while the inner protective cover portion 31 is seated within the main body portion 3. A spring 33 is also present as a biasing element for pushing the protective cover 11 in a distal direction.

[0108] The actuator 9 of the trainer 1 includes an actuator body 35 and an end cap 37. These components form an outer surface with which a user can interact to move the actuator 9. An inner component 39 of the actuator 9 is located within the actuator body 35 and the end cap 37. The inner component 39 is connected to a threaded plunger 41 at its proximal end, while the distal end of the plunger 41 is connected to an end 43 that aligns the plunger 41 with the longitudinal axis of the trainer 1. In this example, the components of the actuator 9 mate together to form an actuator assembly. However, the actuator 9 could be formed as a single piece.

[0109] The plunger 41 is connected to a damping element 45, which is used to suppress the rotation of the plunger 41, thereby suppressing the movement of the actuator 9 toward the distal position.

[0110] The trainer 1 also includes a locking member 47, which comprises a first locking portion 51 and a second locking portion 53. In this example, the first locking portion 51 and the second locking portion 53 are separate components connected together to form the locking member 47. However, in another example, the locking member 47 is formed as a single piece.

[0111] The locking member 47 is rotatable about the longitudinal axis of the trainer 1, allowing it to be positioned in different rotational orientations. The locking member 47 is rotatable but cannot move proximally or distally relative to the main body 3. The locking member 47 has a first orientation in which it resists the actuator 9 from its proximal position (e.g., ...). Figures 2A to 2B (as shown) to the distal position (e.g.) Figure 2E (as shown) movement. Therefore, the first orientation of the locking member 47 is configured to hold the actuator 9 in the reference position. Figures 2A to 2B In the aforementioned configuration, the first orientation of the locking member 47 is configured to hold the shield 11 in its initial position (e.g., Figure 2B As shown), this prevents the shield 11 from moving from its initial position to its extended position (as shown). Figures 3A to 3B(as shown), and allows the shield 11 to move from the initial position to the retracted position (as shown). Figure 2C (As shown).

[0112] The locking member 47 also has a second orientation in which the locking member 47 allows the actuator 9 to move from a proximal position to a distal position. Therefore, the second orientation of the locking member 47 is configured to allow the actuator 9 to move to... Figure 2E The location shown.

[0113] The trainer 1 also includes a biasing element 55, which in this example is a torsion spring. The biasing element 55 biases the locking member 47 in a first rotation direction 57. The first rotation direction 57 can be clockwise or counterclockwise, depending on the orientation of the trainer 1.

[0114] The trainer 1 also includes an inner housing 59 of a syringe that simulates an injection device, and a clamp 61 that holds the inner housing in place.

[0115] Figures 5A to 5B It shows the position relative to the reference. Figures 2A to 2B The trainer 1 of the same configuration has the actuator 9 in a proximal position and the shield 11 in an initial position. In this configuration, the locking member 47 is in a first orientation to prevent the actuator 9 from moving in the distal direction.

[0116] refer to Figures 5A to 5B and Figure 6 The locking member 47 includes an actuator resistance surface 63, which includes a protrusion projecting from a portion of the outer surface of the cylindrical housing of the locking member 47. The actuator resistance surface 63 protrudes from the locking member 47 in a direction remote from the longitudinal axis of the trainer 1. The actuator 9 includes an abutment surface 65, which includes a protrusion projecting from a portion of the inner surface of the actuator 9. The abutment surface 65 protrudes from the actuator 9 in a direction toward the longitudinal axis of the trainer 1. The abutment surface 65 is arranged to abut against the actuator resistance surface 63. Therefore, the actuator resistance surface 63 is arranged to resist movement of the actuator 9 from a proximal position to a distal position when the locking member 47 is in a first orientation.

[0117] In trainer 1, there are two actuator resistance surfaces 63. In this example, the actuator resistance surfaces 63 are located on opposite sides of the locking member 47. This allows the force of downward pressing on the actuator 9 to be distributed across the locking member 47. There are also two corresponding adjacent surfaces 65, which, in this example, are located on opposite sides of the actuator 9.

[0118] The locking member 47 includes a stop 67 arranged to sit within a recess 69 in the inner cover portion 31 of the cover 11. The stop 67 prevents the cover 11 from moving distally from an initial position to an extended position, but allows the cover 11 to move proximally toward a retracted position. In this example, the locking member 47 includes a pair of stops 67 positioned on opposite sides of the locking member 47. The inner cover portion 31 includes a pair of corresponding recesses 69 on opposite sides of the inner cover portion 31. The recesses 69 define a reference... Figure 1 The window 12 has an opening of similar or the same size.

[0119] Figures 7A to 7B It shows the position relative to the reference. Figure 2C The trainer 1 of the same configuration has the actuator 9 in a proximal position and the shield 11 in a retracted position. In this configuration, the locking member 47 has been rotated to a second orientation that allows the actuator 9 to move in a distal direction, as described in more detail below.

[0120] refer to Figure 5A and Figure 6 The locking member 47 includes a ramp 71, which in this example is an angled surface extending from the outer surface of the second locking portion 53. The inner cover portion 31 includes a ramp engagement 73, which in this example is an angled surface in a recess within the inner cover portion 31. The ramp 71 and the ramp engagement 73 are shaped and positioned such that when the cover 11 moves from its initial position to its retracted position, the ramp engagement 73 causes the locking member 47 to rotate. In this example, the ramp 71 and the ramp engagement 73 cause the locking member 47 to rotate in a second rotation direction 75, which is opposite to a first rotation direction 57 in which the locking member 47 is biased.

[0121] Preferably, the locking member 47 includes a pair of ramps 71, and the cover 11 includes two ramp engagements 73. Each ramp 71 may be located on opposite sides of the locking member 47. Each ramp engagement 73 may be located on opposite sides of the cover 11. This helps to reduce friction on the locking member 47 and the cover 11.

[0122] The movement of the protective cover 11 to the retracted position causes the locking member 47 to rotate to the second orientation, such as Figures 7A to 7BAs shown. Here it can be seen that the protrusion formed by the ramp 71 fits inside the recess formed by the ramp joint 73 to hold the shield 11 in the retracted position. When the locking member 47 is in the second orientation, the gap 77 formed at the end of the actuator resistance surface 63 is at least partially rotate-aligned with the adjacent surface 65, allowing the adjacent surface 65 to pass through the gap 77. Therefore, the adjacent surface 65 can move past the actuator resistance surface 63, and the actuator 9 can begin to move from the proximal position to the distal position. The width of the adjacent surface 65 is the same as or less than the width of the gap 65. In the example where there are two adjacent surfaces 65 and two actuator resistance surfaces 63, the same process as described above occurs on opposite sides of the trainer 1.

[0123] refer to Figure 6 The actuator resistance surface 63 of the locking member 47 includes a deflector portion 79 configured to engage with the abutment surface 65 of the actuator when the actuator moves distally. When the abutment surface 65 engages with the deflector portion 79, this causes the locking member 47 to move further from a second orientation to a third orientation in a second rotational direction 75. As the actuator 9 moves a first distance in the distal direction, the abutment surface 65 moves to sit within a gap 77 in the locking member 47. Therefore, the force of the actuator 9 moves the locking member 47 into the third orientation, which moves the stop 67 into a slot 81 in the inner surface of the inner shield portion 31. When the abutment surface 65 sits within the gap 77, this holds the locking member 47 in the third orientation. The abutment surface 65 does not extend to the top of the actuator 9. Therefore, once the adjacent surface 65 has moved past the gap 77 and the shield 11 has moved out of engagement with the locking member 47, the locking member 47 may rotate back in the first rotational direction due to the force applied by the biasing element 55.

[0124] The slot 81 in the inner cover portion 31 forms a track in which the stop 67 can slide. The slot 81 has an opening 83 at the proximal end of the inner cover portion 31. The slot 81 allows the cover 11 to move in the distal direction from a retracted position to an extended position, and once the stop 67 reaches the opening 83, the inner cover portion 31 is released from contact with the locking member 47.

[0125] When the stop 67 disengages from the opening 83 of the slot 81, the shield 11 is allowed to move to the extended position. This allows the shield 11 to move past the locking member 47 to the extended position, which is farther than the position of the locking member 47 and also farther than the initial position. When the shield 11 is in the extended position, the position of the shield 11 relative to the locking member 47 is... Figure 8 As shown in the figure, this is a reference. Figure 3A The aforementioned configuration.

[0126] refer to Figure 6 The stop 67 includes an elastic member 85 configured to flex inward from the inner cover portion 31. Therefore, the elastic member 85 and the stop 67 are movable inward toward the longitudinal axis of the trainer 1. When the actuator 9 forces the locking member 47 to rotate from the second orientation to the third orientation, the stop 67 is forced against the edge of the recess 69. This pushes the stop 67 and the elastic member 85 inward, allowing the stop 67 to enter the slot 81 in the inner cover portion 31. As shown, the stop 67 has an angled surface that facilitates the inward flexing of the elastic member 85.

[0127] When trainer 1 is in Figure 3A and Figure 8 In the indicated state, the actuator 9 no longer holds the locking member 47 in the third orientation, and the ramp 71 may no longer contact the ramp engagement 73. Therefore, the locking member 47 rotates freely in the first rotation direction 57 and is pushed in that direction by the biasing element 55.

[0128] The locking member 47 rotates through the first orientation and into a fourth orientation in which a portion of the actuator 9 abuts the reset deflector 87 on the locking member 47. This holds the locking member 47 in the fourth orientation, preventing the shield 11 from moving proximally from the extended position toward the initial position. Thus, the shield 11 simulates the locked state of the injection device.

[0129] When the locking mechanism 47 is in the fourth orientation, the shield resistance surface 89 abuts against the surface on the proximal end of the inner shield portion 31. In this example, the shield resistance surface 89 is a protrusion extending from the ramp 71. The shield resistance surface 89 blocks the path of the shield 11, preventing the shield from moving proximally from the extended position.

[0130] As referenced above Figures 3A to 3C The user can reset the trainer 1 by pulling the actuator 9 from the distal position back to the proximal position. When the actuator 9 moves in the proximal direction, the adjacent surface 65 intersects with the angled surface of the reset deflector 87 so that the locking mechanism 47 rotates from the fourth orientation to the first orientation.

[0131] When the locking member 47 has rotated a first angular distance toward the first orientation in the second rotation direction 75, the shield resistance surface 89 is no longer located directly above the proximal end of the inner shield portion 31 in the direction of the longitudinal axis of the trainer 1. Instead, the shield resistance surface 89 is located directly above the recess in the inner shield portion 31 in the direction of the longitudinal axis of the trainer 1. Therefore, the shield 11 can move from the extended position toward the initial position.

[0132] As the shield 11 moves back from its extended position toward its initial position, the ramp engagement 73 of the shield 11 applies force to the ramp 71 of the locking member 47. This causes the locking member 47 to move toward the first orientation in the second rotational direction 75. As the inner shield portion 31 moves proximally, this forces the stop 67 and the elastic member 85 to flex inward, causing the stop 67 to pass beneath the proximal end of the inner shield portion 31. As the inner shield portion 31 moves further, the stop 67 moves into the recess 69, which holds the shield 11 in the initial position as described above. Furthermore, once the shield 11 has reached its initial position, the locking member 47 has already rotated into the first orientation as described above. Therefore, the trainer 1 can be reset back to the reference position. Figure 2B The aforementioned configuration.

[0133] The device can be reset by manually moving the shield 11 from its extended position toward its initial position. However, this requires the user to move the actuator 9 to its proximal position while simultaneously moving the shield 11 to its initial position, thus necessitating the use of both hands, which is undesirable. (Reference) Figure 9 A reset connector 91 is provided, which automatically pulls the shield 11 from the extended position to the initial position when the actuator 9 is pulled from the distal position to the proximal position.

[0134] The reset connector 91 is a fixed-length rod that includes an actuator engagement, such as a first hook 93, at its proximal end. The first hook 93 is arranged to engage with a portion of the actuator 9, such as a flange 95 on the inner part 39 of the actuator 9. The flange 95 faces proximal, and therefore, when the flange 95 contacts the first hook 93, movement of the actuator in the proximal direction causes the reset connector 91 to move in the proximal direction. However, movement of the actuator 9 in the distal direction does not force the reset connector 91 to move in that direction because the actuator 9 cannot apply force to the first hook 93 in that direction.

[0135] The reset connector 91 also includes a shield engagement portion, such as a second hook 97 at its distal end. The second hook 97 is arranged to abut a portion of the shield 11, for example, by being received by an aperture 92 in the shield 11. When the reset connector 91 moves in a proximal direction by moving toward a proximal position via an actuator, the proximal end 92a of the aperture 92 contacts the second hook 97. This allows the reset connector 91 to pull the shield 11 toward an initial position to reset the trainer 1.

[0136] like Figure 9 As shown, the orifice 92 can be configured as an elongated orifice extending distally along the inner shroud portion 31. The second hook 97 can be positioned within the orifice at all times during operation of the trainer 1. In these embodiments, as the actuator 9... Figure 2B The proximal position shown moves towards the distal position. Figure 2E As shown in the distal position, and moving from the distal position toward the proximal position toward the proximal position, the second hook 97 travels along the orifice 92 until the second hook 97 contacts the proximal end 92a of the orifice as described above, so as to allow the reset connector 91 to pull the shield 11 toward the initial position in order to reset the trainer 1.

[0137] The aperture 92 may be formed in any suitable portion of the shield 11. For example, the aperture may be formed in the outer shield portion 29 and function in substantially the same manner as described above. The aperture 92 may extend through the portion of the shield in a direction perpendicular to the longitudinal axis of the trainer 1. Alternatively, the aperture may be an etched portion or a notch in the surface of the shield 11.

[0138] In some implementation schemes, including Figure 9 In the illustrated embodiment, the orifice 92 may have a closed distal end. Alternatively, the orifice may be formed as a slot in the distal end of the inner shield portion and / or the outer shield portion, having a second hook 97 abutting a closed proximal end 92a and an open distal end.

[0139] In some embodiments, the orifice may not extend distally along the shield 11, such that the second hook 97 remains positioned within the orifice throughout operation of the trainer 1. For example, the orifice 92 may be configured as a generally circular orifice within the shield 11. The reset lever 91 may be configured such that the second hook 97 is elastically biased into the orifice when the actuator moves toward its proximal position, allowing contact between the second hook 97 and the proximal end 92a of the orifice, and thus allowing the shield 11 to be pulled toward the initial position to reset the trainer 1. The second hook 97 may be shaped at its distal end to cam act on the closed distal end of the orifice. As the reset lever 91 moves in the distal direction by the actuator moving toward the distal position, the cam action between the second hook 97 and the distal end of the orifice overcomes the elastic bias, thereby allowing the second hook 97 to disengage from the engaged orifice 92 as the actuator moves distally.

[0140] refer to Figure 10 The injection device trainer 1 includes a latch 99 configured to attach to the inner part 39 of the actuator 9. In this example, the latch 99 includes a piece of resilient wire formed in a collar 101 arranged to surround a circular protrusion 103 on the inner part 39. Because the latch 99 is resilient, the diameter of the collar 101 can be expanded to position it around the circular protrusion. The collar can then be released, at which point the diameter of the collar 101 contracts, causing the latch to retain the circular protrusion 103. The latch 99 also includes a first extension 105 configured to be located between a pair of retainers 107 that hold the latch 99 in place.

[0141] The latch 99 also includes a second extension 109, which in this example is longer than the first extension 105. The second extension 109 includes a first portion 111 extending in the distal direction and a second portion 113 angled relative to the first portion 111. The second portion 113 forms a deflection portion on its distal side and a clamping element on its proximal side. After the actuator 9 has moved a certain distance from the proximal position to the distal position, the second portion 113 contacts the body protrusion 115 on the main portion 23 of the body portion 3.

[0142] As the actuator 9 moves distally, this causes the resilient latch 99 to move away from the longitudinal axis of the trainer 1 and bend outward over the body protrusion 115. Once the actuator 9 has moved to the distal position, the latch 99 returns to its rest position. In this state, the angled surfaces of the latch 99 (which represent the clamping elements) engage the latch 99 with the body protrusion 115. This holds the actuator 9 in the distal position relative to the body portion 3.

[0143] As actuator 9 moves from the distal position to the proximal position, the body protrusion 115 applies a force to latch 99. When this force exceeds a threshold, the clamping element of the second portion 113 bends in a direction perpendicular to the longitudinal axis extending away from the trainer 1. Thus, the clamping element passes through the body protrusion 115, allowing actuator 9 to be released from the distal position. The threshold force required to bend the latch ensures that actuator 9 is securely held in the distal position. However, once the clamping element releases the body protrusion, the threshold force also allows actuator 9 to quickly return to the proximal position.

[0144] refer to Figures 11A to 11B The reference will be described in more detail below. Figure 4 A brief description of the damping element 45.

[0145] In trainer 1, the plunger 41 of actuator 9 has threads that engage with rotor 117. Rotor 117 may include internal threads 118 configured to engage the threads of plunger 41 to facilitate engagement between plunger 41 and rotor 117. Plunger 41 is fixed to the inner part 39 of actuator 9 such that the plunger does not rotate relative to actuator 9. Rotor 117 engages with the threads, and thus, as plunger 41 moves distally with actuator 9, plunger 41 causes rotor 117 to rotate in a second rotational direction 75. Rotor 117 is engaged with a damping element 45, which in this example is a torsion spring 119 biased toward a coiled state. As rotor 117 rotates, rotor 117 unwinds torsion spring 119, which inhibits rotation of rotor 117 and thus inhibits advance of actuator 9 toward the distal position. The characteristics of spring 119 can be selected according to the desired resistance. For example, if high resistance is desired, spring 119 with a high spring constant can be selected.

[0146] The damping element 45 also includes a ratchet 121 comprising a plurality of angled teeth that engage with angled teeth 130 on the rotor 117. Once the actuator 9 moves a certain distance toward a distal position, the angled teeth of the rotor 117 move to engage with the angled teeth of the ratchet 121. The rotor 117 and the ratchet 121 form an anti-rotation mechanism that allows the rotor 117 to rotate in the second rotation direction 75 but resists movement of the rotor in the first rotation direction 57. In this way, the tension in the torsion spring 119 is maintained when the rotor 117 unwinds the spring 119, preventing the torsion spring 119 from returning to its coiled state.

[0147] The angled teeth 130 of rotor 117 may each include an angled edge 132 (e.g., angled relative to the longitudinal axis of the trainer) and a straight edge 131 (e.g., substantially parallel to the longitudinal axis of the trainer). Rotor 117 may be configured such that the angled edge of each tooth faces the second rotation direction 75. In other words, as rotor 117 rotates due to distal movement of plunger 41 together with actuator 9, the angled edge of each angled tooth leads. The angled teeth of ratchet 121 are approximately checkerboard-shaped with the angled teeth of rotor 117. In other words, the straight edge of each tooth of ratchet 121 faces the second rotation direction 75 such that the straight edge of the tooth of rotor 117 abuts the corresponding straight edge of the tooth of ratchet 121 to resist movement of rotor in the first rotation direction 57. Ratchet 121 may be rotatably fixed relative to actuator 9.

[0148] The damping element 45 and the rotor 117 can be configured according to the desired point of engagement between the rotor 117 and the ratchet 121 during actuator depressurization, and thus the formation of the anti-rotation mechanism. For example, in an embodiment using a spring 119 with a high spring constant, it may be desirable for the anti-rotation mechanism to engage earlier when the actuator 9 is depressed to help the user resist the bias of the spring 119 back to its coiled state. For example, earlier engagement of the anti-rotation mechanism can be achieved by making the angled teeth of the ratchet 121 have a greater height along the longitudinal axis of the trainer 1.

[0149] When actuator 9 is pulled rather than pushed, or in other words, when actuator 9 moves proximally, plunger 41 disengages the angled teeth of rotor 117 from the angled teeth of ratchet 121. This proximal movement of plunger 41 allows the rotor to move in the first rotational direction 57, which returns the spring to its coiled state. The disengagement distance (the distance by which actuator 9, plunger 41, and rotor 117 move proximally to disengage the angled teeth of rotor 117 from the angled teeth of ratchet 121) is greater than the height of the angled teeth of the ratchet along the longitudinal axis of trainer 1. In some embodiments, the disengagement distance may be approximately 2 mm.

[0150] Damping elements can be implemented in the trainer 1 to simulate large-volume and / or high-viscosity doses. Damping elements can also be used in injection devices to force the user to slowly depress the actuator 9 when delivering large doses or low-viscosity substances (which themselves can provide very little resistance to depressurization), in order to reduce the harmful side effects of injecting substances too quickly, such as excessive chafing, pain, accumulation of injected substances in the patient's body, etc.

[0151] In an alternative embodiment of the damping element, the torsion spring may be coupled to a ratchet. As in the aforementioned embodiment, the rotor engages with the plunger threadedly, and thus, as the plunger moves distally together with the actuator, the plunger causes the rotor to rotate in the second rotational direction. In this embodiment, the rotor is configured such that the straight edge of each tooth faces the second rotational direction. In other words, as the rotor rotates distally with the plunger and actuator, the straight edge of each angled tooth leads. In this embodiment, the initial rotation of the rotor does not cause the torsion spring to unwind. Therefore, the initial advance of the actuator toward the distal position is subject to little or no resistance.

[0152] Alternative damping elements include a ratchet coupled to a torsion spring biased toward a coiled state. The ratchet includes a plurality of angled teeth that engage with angled teeth on the rotor. Once the actuator has moved a certain distance toward a distal position, the angled teeth of the rotor move to engage with the angled teeth of the ratchet, causing the straight edges of the rotor teeth to rotate to abut the corresponding straight edges of the ratchet teeth. In this embodiment, once the rotor and ratchet have moved to engage each other, continued rotation of the rotor causes the ratchet to rotate. The rotation of the ratchet causes the torsion spring to unwind, which inhibits the rotation of the ratchet and rotor, and thus inhibits further advance of the actuator toward the distal position. Similarly, the configuration of the damping element and rotor (e.g., spring characteristics and tooth height) can be selected according to the desired drag distribution.

[0153] In some embodiments, the rotor 117 and / or damping element 45 may be replaceable parts of the trainer or injection device. For example, the device may be configured such that the torsion spring 119 can be replaced by another spring with a higher or lower spring constant. This facilitates, for example, a single trainer device for training a user to deliver substances of various viscosities.

[0154] In the context of this application, the injection device may be an automated injection device (auto-injector). In such an injection device, the actuator 9 is operated by or replaced by an automatic actuator in an electric automated injection device, such as a drive spring, a pneumatic piston operated by a compressed gas tank, or a solenoid.

[0155] In such autoinjector devices, damping element 45 can be used to suppress, slow down, or control the force applied by the actuator to the container and / or delivery mechanism (e.g., a plunger on a syringe) containing the substance to be injected. The damping element can be used to adjust the injection rate via the autoinjector without requiring changes to the automatic actuator.

[0156] The damping element can be configured to operate during any portion of the actuation sequence. For example, the damping element can be configured such that the travel of the actuator toward the distal position is inhibited for the entire duration of travel, or only for a selected portion. In some embodiments, the injection device can be configured such that the advance of the actuator is inhibited at the point where the needle on the drug container is fully extended, for example to ensure complete delivery of the injected substance via an autoinjector.

[0157] Unless otherwise specified, each embodiment described herein may be combined with another embodiment described herein.

[0158] It should be understood that the above benefits and advantages may apply to one implementation or several implementations. The implementations are not limited to those that solve any or all of the described problems, or those that have any or all of the described benefits and advantages.

[0159] Any reference to “one” project means one or more of those projects.

[0160] The term “element” in this document may also correspond to “part” for an element that performs the specific function described herein.

[0161] It should be understood that the above description of preferred embodiments is given by way of example only, and various modifications can be made by those skilled in the art. Although various embodiments have been described above with a certain degree of specificity or with reference to one or more individual embodiments, those skilled in the art can make various changes to the disclosed embodiments without departing from the scope of the invention.

[0162] Aspects of the invention that form part of the specification :

[0163] 1. An injection device trainer for training a user to use an injection device, the injection device trainer comprising:

[0164] Main body;

[0165] An actuator is positioned toward the proximal end of the main body portion and is movable from a proximal position to a distal position.

[0166] A protective cover, positioned toward the distal end of the main body portion, is movable between: an initial position; a retracted position closer to the main body portion than the initial position; and an extended position further away from the main body portion than the initial position; and

[0167] A locking member adapted to be rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position.

[0168] The first orientation of the locking member is configured to hold the shield in the initial position, such that the shield is prevented from moving from the initial position to the extended position, and the shield is allowed to move from the initial position to the retracted position;

[0169] The shield is configured to contact the locking member when moved from the initial position to the retracted position, so as to move the locking member from the first orientation to the second orientation; and

[0170] The actuator moving a first distance toward the distal position is configured to unlock the shield from the locking member, thereby allowing the shield to move toward the extended position.

[0171] 2. The injection device trainer according to aspect 1, wherein the locking member includes at least one actuator resistance surface, and the actuator includes at least one adjacent surface; and

[0172] The at least one actuator resistance surface is arranged to abut the at least one adjacent surface to resist movement of the actuator from the proximal position to the distal position when the locking member is in the first orientation.

[0173] 3. The injection device trainer according to aspect 1 or aspect 2, wherein the locking member comprises a pair of actuator resistance surfaces, and the actuator comprises a pair of adjacent surfaces; and

[0174] Each of the pair of actuator resistance surfaces is arranged adjacent to a corresponding adjacent surface in the pair of adjacent surfaces to resist movement of the actuator from the proximal position to the distal position when the locking member is in the first orientation.

[0175] 4. The injection device trainer according to aspect 3, wherein the pair of actuator resistance surfaces are located on opposite sides of the locking member relative to each other.

[0176] 5. The injection device trainer according to aspect 3 or aspect 4, wherein the locking member comprises a cylindrical housing, and each of the pair of actuator resistance surfaces comprises a protrusion projecting from the surface of the cylindrical housing.

[0177] 6. The injection device trainer according to aspect 5, wherein the pair of adjacent surfaces are located on opposite sides of the actuator relative to each other.

[0178] 7. The injection device trainer according to any one of the foregoing aspects, wherein the locking member includes a ramp; and the shield includes a ramp engagement configured to interact with the ramp when the locking member moves from the initial position to the retracted position, thereby causing the locking member to rotate from the first orientation to the second orientation.

[0179] 8. The injection device trainer according to any one of the foregoing aspects, wherein the locking member includes a third orientation in which the shield is allowed to move from the initial position to the extended position.

[0180] 9. The injection device trainer according to aspect 8, wherein the actuator is configured to move a first distance to move the locking member into the third orientation.

[0181] 10. The injection device trainer according to aspect 8 or aspect 9, wherein the locking member includes a deflector portion; and the actuator is arranged to engage with the deflector portion to move the locking member from the second orientation to the third orientation.

[0182] 11. The injection device trainer according to any one of the foregoing aspects, wherein the locking member includes a stop arranged to sit within a recess in the shield, thereby holding the shield in the initial position.

[0183] 12. The injection device trainer according to aspect 11, wherein the stop is arranged to move along a slot in the shield to allow the shield to move to the extended position.

[0184] 13. The injection device trainer according to aspect 12, wherein the stop is arranged to sit outside the slot in the recess, thereby holding the shield in the initial position when the locking member is in the first orientation.

[0185] 14. The injection device trainer according to aspect 12 or aspect 13, wherein the locking member includes a third orientation in which the shield is allowed to move from the initial position to the extended position; and the locking member moving from the second orientation to the third orientation pushes the stop into the slot, which allows the shield to move from the initial position to the extended position.

[0186] 15. An injection device trainer according to any one of aspects 11 to 14, wherein the stop is coupled to an elastic member configured to bend so as to move the stop from a rest state toward a flexural state toward the longitudinal axis of the trainer.

[0187] 16. The injection device trainer according to aspect 15, wherein the stop member in the stationary state holds the shield in the initial position.

[0188] 17. The injection device trainer according to aspect 15 or 16, wherein the stop in the flexed state allows the stop to move into the slot.

[0189] 18. The injection device trainer according to any one of the foregoing aspects further includes a biasing element arranged to bias the shield to move distally.

[0190] 19. The injection device trainer according to any one of the foregoing aspects, wherein the locking member has a fourth orientation in which the locking member resists the shield from moving from the extended position to the initial position.

[0191] 20. The injection device trainer according to aspect 19 further includes a biasing element arranged to bias the locking member toward the fourth orientation such that once the actuator has moved a certain distance toward the distal position and the shield is in the extended position, the locking member moves into the fourth orientation.

[0192] 21. The injection device trainer according to aspect 20, wherein the biasing element comprises a torsion spring.

[0193] 22. An injection device trainer according to any one of aspects 19 to 21, wherein the actuator is configured to engage with the locking member when moved from the distal position to the proximal position, such that the locking member moves from the fourth orientation toward the first orientation, thereby allowing the shield to move from the extended position to the initial position.

[0194] 23. The injection device trainer according to any one of aspects 19 to 22, wherein the locking member includes a shield resistance surface arranged to resist proximal movement of the shield when the locking member is in the fourth orientation and the shield is in the extended position.

[0195] 24. The injection device trainer according to aspect 23, wherein the shield includes an abutment surface arranged to abut the shield resistance surface when the locking member is in the fourth orientation and the shield is in the extended position.

[0196] 25. The injection device according to any one of the preceding aspects, wherein the proximal position of the actuator simulates the inactive position of the plunger of the injection device.

[0197] 26. The injection device according to any one of the preceding aspects, wherein the distal position of the actuator simulates the activated position of the plunger of the injection device.

[0198] 27. The injection device according to any one of the foregoing aspects, wherein the initial position of the shield simulates the coverage of the needle of the injection device.

[0199] 28. The injection device according to any one of the foregoing aspects, wherein the retracted position of the shield simulates exposure of the needle of the injection device.

[0200] 29. The injection device according to any one of the preceding aspects, wherein the extended position of the shield simulates a locked state of the injection device, in which the shield is prevented from exposing the needle.

[0201] 30. The injection device trainer according to any one of the foregoing aspects, wherein:

[0202] The actuator is coupled to the rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and

[0203] The injection device trainer also includes a damping element that is coupled to or can be coupled to the rotor in order to suppress the rotation of the rotor.

[0204] 31. An injection device, comprising:

[0205] A needle, which is connected to a chamber for storing fluid;

[0206] Main body;

[0207] An actuator, positioned toward the proximal end of the body portion, is movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle.

[0208] A shield, positioned toward the distal end of the body portion, is movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and

[0209] A locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position.

[0210] The first orientation of the locking member is configured to hold the shield in the initial position, such that the shield is prevented from moving from the initial position to the extended position, and the shield is allowed to move from the initial position to the retracted position;

[0211] The shield is configured to contact the locking member when moved from the initial position to the retracted position, so as to move the locking member from the first orientation to the second orientation; and

[0212] The actuator moves a first distance toward the distal position to unlock the shield from the locking member, thereby allowing the shield to move toward the extended position.

[0213] 32. The injection device according to aspect 31, wherein:

[0214] The actuator is coupled to the rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor; and

[0215] The injection device also includes a damping element that is coupled to or can be coupled to the rotor in order to suppress the rotation of the rotor.

[0216] 33. A set of parts configured for assembly into an injection device trainer according to any one of aspects 1 to 30 or an injection device according to aspect 31 or 32.

[0217] 34. A method for training a user to use an injection device, the method comprising providing an injection device trainer, the injection device trainer comprising:

[0218] Main body;

[0219] An actuator is positioned toward the proximal end of the main body portion and is movable from a proximal position to a distal position.

[0220] A protective cover, positioned toward the distal end of the main body portion, is movable between: an initial position; a retracted position closer to the main body portion than the initial position; and an extended position further away from the main body portion than the initial position; and

[0221] A locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position.

[0222] The first orientation of the locking member is configured to hold the shield in the initial position, preventing the shield from moving from the initial position to the extended position, and allowing the shield to move from the initial position to the retracted position; and

[0223] The method further includes:

[0224] Move the shield from the initial position to the retracted position such that the shield contacts the locking member, so as to move the locking member from the first orientation to the second orientation; and

[0225] The actuator is moved a first distance toward the distal position to unlock the shield from the locking member, causing the shield to move toward the extended position.

[0226] 35. The method according to aspect 34, wherein:

[0227] The actuator is connected to the rotor such that movement of the actuator from the proximal position to the distal position causes the rotor to rotate;

[0228] The injection device trainer also includes a damping element that can be coupled to the rotor to suppress the rotation of the rotor; and

[0229] The method further includes moving the actuator from the proximal position to the distal position, during which the damping element inhibits the rotation of the rotor and thus inhibits the movement of the actuator toward the distal position.

[0230] 36. A method of administering an injection, the method comprising providing an injection device, the injection device comprising:

[0231] A needle, which is connected to a chamber for storing fluid;

[0232] Main body;

[0233] An actuator, positioned toward the proximal end of the body portion, is movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle.

[0234] A shield, positioned toward the distal end of the body portion, is movable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is closer to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is farther from the body portion than the initial position; and

[0235] A locking member rotatable between: a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member allows the actuator to move from the proximal position to the distal position.

[0236] The first orientation of the locking member is configured to hold the shield in the initial position, preventing the shield from moving from the initial position to the extended position, and allowing the shield to move from the initial position to the retracted position; and

[0237] The method further includes:

[0238] Move the shield from the initial position to the retracted position such that the shield contacts the locking member, so as to move the locking member from the first orientation to the second orientation; and

[0239] The actuator is moved a first distance toward the distal position to unlock the shield from the locking member, causing the shield to move toward the extended position.

[0240] 37. The method according to aspect 36, wherein:

[0241] The actuator is connected to the rotor such that movement of the actuator from the proximal position to the distal position causes the rotor to rotate;

[0242] The injection device further includes a damping element that can be coupled to the rotor to suppress the rotation of the rotor; and

[0243] The method further includes moving the actuator from the proximal position to the distal position, during which the damping element inhibits the rotation of the rotor and thus inhibits the movement of the actuator toward the distal position.

Claims

1. An injection device trainer for training a user to use an injection device, the injection device trainer comprising: Main body; An actuator is positioned toward a proximal end of the main body portion, the actuator being configured to be grasped by a user to move the actuator from a proximal position to a distal position, wherein the actuator is coupled to a rotor such that the movement of the actuator from the proximal position to the distal position causes the rotor to rotate. A damping element, which can be coupled to the rotor to suppress the rotation of the rotor; as well as A protective cover, positioned toward the distal end of the main body portion, the protective cover being movable between: an initial position; The retracted position, for the main body portion, is closer to the initial position; and the extended position, for the main body portion, is farther away from the initial position.

2. The injection device trainer of claim 1, wherein the proximal position of the actuator simulates the inactive position of the plunger of the injection device.

3. The injection device trainer according to claim 1, wherein the distal position of the actuator simulates the activated position of the plunger of the injection device.

4. The injection device trainer of claim 1, wherein the initial position of the shield simulates the coverage of the needle of the injection device.

5. The injection device trainer of claim 1, wherein the retracted position of the shield simulates exposure of the needle of the injection device.

6. The injection device trainer of claim 1, wherein the extended position of the shield simulates the locked state of the injection device, in which the shield prevents the needle from being exposed.

7. The injection device trainer of claim 1, wherein the damping element is a torsion spring biased toward a coiled state, and as the rotor rotates, the rotor unwinds from the torsion spring, the torsion spring inhibiting the rotation of the rotor and thus inhibiting the actuator from advancing toward the distal position.

8. The injection device trainer of claim 1, wherein the damping element comprises a ratchet, the ratchet comprising a plurality of angled teeth intersecting with angled teeth on the rotor.

9. The injection device trainer of claim 8, wherein the rotor and ratchet form an anti-rotation mechanism that allows the rotor to rotate in a second rotational direction but resists movement of the rotor in a first rotational direction opposite to the second rotational direction.

10. An injection device, comprising: A needle, which is connected to a chamber for storing fluid; Main body; An actuator, positioned toward a proximal end of the body portion, is movable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, wherein the actuator is coupled to a rotor such that movement of the actuator from the proximal position to the distal position causes rotation of the rotor. A damping element, which can be coupled to the rotor to suppress the rotation of the rotor; as well as A protective cover, positioned toward the distal end of the main body portion, the protective cover being movable between: an initial position; The retracted position, for the main body portion, is closer to the initial position; and the extended position, for the main body portion, is farther away from the initial position.

11. The injection device of claim 10, wherein in the initial position, the shield covers the needle; in the retracted position, the shield exposes the needle; and in the extended position, the shield covers the needle.

12. The injection device of claim 11, wherein the extended position of the shield simulates a locked state of the injection device, in which the shield prevents the needle from being exposed.

13. The injection device of claim 10, wherein the damping element is a torsion spring biased toward a coiled state, and as the rotor rotates, the rotor unwinds from the torsion spring, the torsion spring inhibiting the rotation of the rotor and thus inhibiting the advance of the actuator toward the distal position.

14. The injection device of claim 10, wherein the damping element comprises a ratchet, the ratchet comprising a plurality of angled teeth intersecting angled teeth on the rotor.

15. The injection device of claim 14, wherein the rotor and ratchet form an anti-rotation mechanism that allows the rotor to rotate in a second rotational direction but resists movement of the rotor in a first rotational direction opposite to the second rotational direction.

16. The injection device of claim 10, wherein the actuator is configured to be grasped by a user to move the actuator toward the distal position.

17. A method for training a user to use an injection device, the method comprising: The user grips the actuator of the injection device trainer, the injection device trainer comprising: Main body; The actuator is positioned toward the proximal end of the main body portion and is movable from the proximal position to the distal position, wherein the actuator is coupled to the rotor such that the movement of the actuator from the proximal position to the distal position causes the rotor to rotate. A damping element, the damping element being coupled to the rotor to suppress the rotation of the rotor; and A protective cover, positioned toward the distal end of the main body portion; and The user causes the shield to move from its initial position to a retracted position, and for the main body, the retracted position is closer to the initial position than the initial position; The user moves the actuator from the proximal position to the distal position, during which time the damping element inhibits the rotation of the rotor and thus inhibits the movement of the actuator toward the distal position; and The user causes the shield to move from the retracted position to the extended position, which, for the main body portion, is further away from the initial position.

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