RU2806296C2 - Latch for injection device and training injection device - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to injection devices and training injection devices for training the user to use an injection device. Each injection device and training injection device may include the following: a body portion; and an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position; wherein the body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to engage with the housing protrusion when the actuator is in a distal position, thereby holding the actuator in the distal position.

EFFECT: obtaining a latch for injection device and training injection device.

23 cl, 15 dwg

Description

Technical field

[001] The present invention relates to an injection device for administering an injection and an injection training device for preparing a user to use the injection device.

Prerequisites for creating the invention

[002] When treating patients, it is necessary to use an optimally simple and safe method of administering injections. A typical injection syringe includes a barrel containing a drug, a plunger corresponding to the barrel, and a needle through which the drug is injected when the plunger is pressed into the barrel. As a rule, the syringe is equipped with a protective cap. It is placed on the needle when the syringe is not in use and is removed when injecting.

[003] A specific problem with a conventional syringe is that the patient may accidentally prick himself with the needle before administering the injection. Another specific problem is the difficulty of properly aligning the needle with the target site, and thus the injection may not be administered correctly. Therefore, the use of conventional syringes can be difficult and potentially dangerous, especially for patients with impaired motor coordination.

[004] There are injection devices that solve these problems associated with the use of conventional syringes. One such device includes a needle cap and a plunger that can be activated to deliver medication from the needle into the patient's body. The needle cap, when pressed against the target area, retracts, exposing the needle. At the same time as this action, you can press the plunger to administer the injection. This allows the injection to be given in one motion by pressing the plunger of the device aimed at the target area. This allows the patient to receive injections in a safe and simple manner. Often these devices are designed in such a way that they can only be used once, for example by locking the needle cap in a position where the needle is closed after administration of the injection. This prevents the needle from being used more than once, ensuring compliance with hygiene standards.

[005] The problem with prior art injection devices is that it can be difficult to train a patient to use the devices without actually administering the injection. Thus, proper training may be limited to periods when injection is required. In addition, an inactive substance can be used during injection training. However, for health and hygiene reasons, unnecessary injections should be avoided.

[006] In light of the above, there is a need for a device that can be used to train a patient to use an injection device in a simple and safe manner. In addition, it is advisable that such a device be reusable: using the same device, many learning processes could be performed. There is also a need for a simple design and reliable operation of an injection device.

Short description

[007] In one aspect of the invention, an injection training device is provided for training a user to use an injection device that includes a body portion, an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal to a distal position, a cap located at towards the distal end of the body portion, the cap being movable between its original position; an abducted position, which is more proximal relative to the body portion than in the original position; as well as an extended position that is more distal to the body portion than in the original position, and a latch rotatable between a first orientation in which it resists movement of the actuator from a proximal position to a distal position; and a second orientation in which the lock allows the actuator to move from a proximal position to a distal position. The first orientation of the latch is configured to hold the cap in the retracted position such that the cap cannot move from the retracted position to the retracted position and also allows the cap to be moved from the retracted position to the retracted position. The cap is configured to contact the latch when moved from the rest position to the retracted position to move the latch from the first orientation to the second. Moving the actuator the first distance to the distal position will release the cap latch so that the cap can move to the extended position.

[008] Thus , the injection training device accurately simulates the use of the injection device, which improves the learning process. In addition, the user can practice injecting many times, compared to a situation in which learning is only possible when actually injecting. The latch provides the functioning of the mechanism for simulating the use of the injection device.

[009] In another aspect of the invention, there is provided an injection device that includes a needle coupled to a fluid storage chamber, a body portion, an actuator disposed toward a proximal end of the body portion, the actuator being movable from a proximal to a distal position for dispensing the fluid contained in the chamber and supplied through the needle, a cap located towards the distal end of the body portion, the cap being movable between an initial position in which the cap covers the needle; a retracted position in which the cap exposes the needle, the retracted position being more proximal to the body portion than the original position; and an extended position in which the cap covers the needle, the extended position being more distal to the housing portion than the original position, the lock being rotatable between a first orientation in which it resists movement of the actuator from a proximal to a distal position; and a second orientation in which the lock allows the actuator to move from a proximal position to a distal position. The first orientation of the latch is configured to hold the cap in the retracted position such that the cap cannot move from the retracted position to the retracted position and also allows the cap to be moved from the retracted position to the retracted position. The cap is configured to contact the latch when moved from the rest position to the retracted position to move the latch from the first orientation to the second. Moving the actuator the first distance toward the distal position will release the cap latch so that the cap can move to the extended position.

[010] This design makes the injection device reliable and easy to manufacture.

[011] In another aspect of the invention, a method is provided for training a user to use an injection device, the method including providing a training injection device that includes a body portion, an actuator disposed toward a proximal end of the body portion, an actuator configured to move from proximal to distal position, the cap located towards the distal end of the body portion, the cap being movable between the original position; an abducted position, which is more proximal relative to the body portion than in the original position; as well as an extended position that is more distal to the body portion than in the original position, and a latch rotatable between a first orientation in which it resists movement of the actuator from a proximal position to a distal position; and a second orientation in which the lock allows the actuator to move from a proximal position to a distal position. The first orientation of the latch is configured to hold the cap in the retracted position such that the cap cannot move from the retracted position to the retracted position and also allows the cap to be moved from the retracted position to the retracted position. The method further includes moving the cap from a home position to a retracted position such that the cap contacts the latch, moving it from a first orientation to a second orientation, and moving the actuator a first distance to a distal position to unlock the cap latch so that it moves into direction of the extended position.

[012] In another aspect of the invention, there is provided a method of administering an injection, which includes providing an injection device consisting of a needle connected to a fluid storage chamber, a body portion, an actuator disposed toward a proximal end of the body portion, and movable from a proximal to a distal position for dispensing fluid contained in the chamber and supplied through the needle, a cap located towards the distal end of the body portion, the cap being movable between an initial position in which the cap covers the needle; a retracted position in which the cap exposes the needle, the retracted position being more proximal to the body portion than the original position; and an extended position in which the cap covers the needle, the extended position being more distal to the housing portion than the original position, the lock being rotatable between a first orientation in which it resists movement of the actuator from a proximal to a distal position; and a second orientation in which the lock allows the actuator to move from a proximal position to a distal position. The first orientation of the latch is configured to hold the cap in the retracted position such that the cap cannot move from the retracted position to the retracted position and also allows the cap to be moved from the retracted position to the retracted position. The method further includes moving the cap from a home position to a retracted position such that the cap contacts the latch, moving it from a first orientation to a second orientation, and moving the actuator a first distance to a distal position to unlock the cap latch such that the cap moves to direction of the extended position.

[013] In another aspect of the invention, there is provided an injection training device for training a user to use an injection device that includes a body portion and an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position. The body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to engage with the housing protrusion when the actuator is in a distal position, thereby holding the actuator in the distal position.

[014] Thus, the connection of the latch with the housing protrusion indicates that the actuator has reached the distal position. This simulates the end of the injection process using the injection device. This will allow the user to learn how to determine if the injection has been given correctly.

[015] In another aspect of the invention, an injection device is provided that includes a needle coupled to a fluid storage chamber, a body portion, and an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position to dispensing the fluid located in the chamber through a needle. The body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to engage with the housing protrusion when the actuator is in a distal position, thereby holding the actuator in the distal position.

[016] Thus, the connection of the latch with the housing protrusion indicates that the actuator has reached the distal position. This indicates the end of the injection process using the injection device. This will allow the user to learn to more accurately determine whether an injection has been given correctly.

[017] In another aspect of the invention, there is provided an injection training device for training a user to use an injection device that includes a body portion and an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position. The housing section is equipped with a protrusion, and the actuator is equipped with a latch, which is configured to connect with the housing protrusion when the actuator is in the distal position, and to reproduce an audible signal.

[018] Thus, the audible signal indicates that the actuator has reached the distal position, which simulates the end of the injection process using the injection device. This will allow the user to learn how to determine if the injection has been given correctly. The intensity of the sound signal allows the user to hear it at a distance of 1 m from the device, or at least at arm's length from the device. The latch may be configured to produce an audible signal above a predetermined intensity threshold at a specified distance from the device (eg, 30 cm). For example, a given intensity threshold may be 40 dB such that the sound will be above the standard level in a quiet room. This allows the user to hear sound under normal operating environment conditions. The specified threshold intensity can be 50 dB, 60 dB or even 70 dB to ensure that the user can hear the sound in different environmental conditions. The sound signal may be a "click", which is a short sound signal (lasting, for example, less than a second). The sound signal is reproduced due to the mechanical interaction of the latch and the housing protrusion without the participation of electronic devices.

[019] In another aspect of the invention, there is provided an injection device that includes a needle coupled to a fluid storage chamber, a body portion, and an actuator disposed toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position. a position for dispensing fluid contained in the chamber through a needle. The housing section is equipped with a protrusion, and the actuator is equipped with a latch, which is configured to connect with the housing protrusion when the actuator is in the distal position, and to reproduce an audible signal.

[020] Thus, an audible signal indicates that the actuator has reached the distal position. This indicates the completion of the injection process using the injection device. This will allow the user to learn to more accurately determine whether an injection has been given correctly.

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

[022] In another aspect of the invention, a method of administering an injection is provided which includes providing an injection device comprising a needle coupled to a fluid storage chamber, a body portion, and an actuator disposed toward a proximal end of the body portion, wherein the actuator is configured to moving from a proximal position to a distal position to dispense the fluid contained in the chamber through the needle. The body section is equipped with a protrusion, and the actuator is equipped with a latch. The method further includes moving the actuator from a proximal position to a distal position such that the latch engages with the body projection when the actuator is in the distal position, holding the actuator in the distal position.

[023] In another aspect of the invention, there is provided a method for training a user to use an injection device, which comprises providing a training injection device comprising a body portion and an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal position to a distal position. The body section is equipped with a protrusion, and the actuator is equipped with a latch. The method further includes moving the actuator from a proximal position to a distal position such that the latch contacts the housing protrusion when the actuator is in the distal position and produces an audible signal.

[024] In another aspect of the invention, a method of administering an injection is provided which includes providing an injection device comprising a needle coupled to a fluid storage chamber, a body portion, and an actuator disposed toward a proximal end of the body portion, wherein the actuator is configured to moving from a proximal position to a distal position to dispense the fluid contained in the chamber through the needle. The body section is equipped with a protrusion, and the actuator is equipped with a latch. The method further includes moving the actuator from a proximal position to a distal position such that the latch contacts the housing protrusion when the actuator is in the distal position and produces an audible signal.

[025] In another aspect of the invention, there is provided an injection training device for training a user to use an injection device that includes a body portion, an actuator located toward a proximal end of the body portion, the actuator being movable from a proximal to a distal position, a cap located at towards the distal end of the body portion, the cap being movable between its original position; an extended position that is more distal to the body portion than the rest position, and a connector that connects the actuator to the cap such that moving the actuator from the distal position to the proximal position causes the cap to be pulled from the extended position to the rest position.

[026] In this way, it is possible to return the training injection device to its original position for repeated use. The connector provides the mechanism to perform this function.

[027] In another aspect of the invention, there is provided an injection device that includes a needle coupled to a fluid storage chamber, a body portion, an actuator disposed toward a proximal end of the body portion, the actuator being movable from a proximal to a distal position for dispensing the fluid contained in the chamber and supplied through the needle, a cap located towards the distal end of the body portion, the cap being movable between an initial position in which the cap covers the needle; a retracted position in which the cap exposes the needle, the retracted position being more proximal to the body portion than the original position; and an extended position in which the cap covers the needle, wherein the extended position is more distal to the body portion than the original position, and a connector that connects the actuator to the cap such that movement of the actuator from the distal position to the proximal position causes the cap to be pulled out from the extended position to the original position.

[028] Thus, the ability to return the injection device to its original position allows it to be used more than once. The connector provides the mechanism to perform this function.

[029] In another aspect of the invention, a method is provided for training a user to use an injection device, the method including providing a training injection device that includes a body portion, an actuator disposed toward a proximal end of the body portion, an actuator configured to move from proximal to distal position, a cap located towards the distal end of the body portion, the cap being movable between the original position; an extended position that is more distal to the body portion than the original position, and a connector that connects the actuator to the cap. The method further includes moving the actuator from a distal position to a proximal position to pull the cap from the extended position to the rest position using the connector.

[030] In another aspect of the invention, there is provided a method of administering an injection, comprising providing an injection device comprising a needle coupled to a fluid storage chamber, a body portion, an actuator disposed toward a proximal end of the body portion, an actuator configured to move from a proximal positioning to a distal position for dispensing fluid contained in the chamber through a needle, a cap disposed toward a distal end of the housing portion, the cap being movable between a home position in which the cap covers the needle; a retracted position in which the cap exposes the needle, the retracted position being more proximal to the body portion than the original position; and an extended position in which the cap covers the needle, the extended position being more distal to the body portion than the original position, and a connector that connects the actuator to the cap. The method further includes moving the actuator from a distal position to a proximal position to pull the cap from the extended position to the rest position using the connector.

[031] In another aspect of the invention, a method of administering an injection is provided which includes providing an injection device consisting of a needle connected to a fluid storage chamber, a body portion, an actuator disposed toward a proximal end of the body portion and movable from a proximal to a distal position for dispensing fluid contained in the chamber and supplied through the needle, a cap located towards the distal end of the body portion, the cap being movable between an initial position in which the cap covers the needle;

[032] Thus, the training injection device can simulate the resistance exerted by the drug in the injection device when the actuator is pressed.

[033] In another aspect of the invention, there is provided an injection device that includes a needle coupled to a fluid storage chamber in a body portion, an actuator assembly located toward a proximal end of the body portion, the actuator assembly being movable from a proximal position to a distal position for dispensing fluid contained in the chamber through a needle, wherein the actuator assembly is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor and a damping element connected or configured to be connected to the rotor to slow down its rotation.

[034] Thus, the injection device can slow the advancement of the actuator toward the distal position, which ensures that fluid is not delivered from the needle too quickly.

[035] In another aspect of the invention, there is provided a method of training a user to use an injection device, which includes providing a training device comprising a body portion, an actuator assembly located toward a proximal end of the body portion, the actuator assembly being movable from a proximal position to a distal position, wherein the actuator assembly is connected to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor, and a damping element connected or configured to be connected to the rotor to slow its rotation. The method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and, therefore, movement of the actuator to the distal position.

[036] In another aspect of the invention, a method of administering an injection is provided which includes providing an injection device comprising a needle coupled to a fluid storage chamber in a body portion, an actuator assembly located toward a proximal end of the body portion, the actuator assembly being movable from a proximal position to a distal position for dispensing fluid contained in the chamber through a needle, wherein the actuator assembly 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 a damping element connected or configured to connections to the rotor to slow down its rotation. The method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and, therefore, movement of the actuator to the distal position.

[037] The latch may include an actuator resistance surface that is configured to resist movement of the actuator from a proximal position to a distal position when the latch is in a first orientation. The actuator resistance surface may include a projection extending from the detent. The actuator may include a support surface that is positioned to abut a resistance surface of the actuator when the actuator is in a proximal position and the latch is in a first orientation. The support surface may include a projection extending from the actuator. The latch may comprise at least two (or a pair) of actuator resistance surfaces. A pair of actuator resistance surfaces may be located on opposite sides of the retainer relative to each other. The actuator may include at least two (or a pair) of support surfaces. A pair of support surfaces may be located on opposite sides of the actuator relative to each other. This simple and reliable mechanism allows you to distribute the force exerted by the actuator on the latch along its diameter.

[038] The detent may include a cylindrical body, and the actuator resistance surface may include a protrusion that projects forward from a surface of the cylindrical body. The protrusion can only partially cover the circumference of the cylindrical body. The lock may include a slope. The cap may include an inclined contact element. The inclined contact element of the cap may be configured to interact with the inclined surface of the latch when moved from a home position to a retracted position to rotate the latch from a first orientation to a second orientation. This provides a simple and reliable mechanism for rotating the latch to a second orientation.

[039] The latch may include a third orientation in which the cap can be moved from the rest position to the extended position. The actuator may be movable a first distance to move the latch to a third orientation. Thus, the cap cannot be moved to the extended position until the actuator is at least partially depressed. The extended position simulates the locked state of the injection device, which indicates completion of the injection process. Thus, the training device cannot simulate completion of the injection process until the actuator is activated by the user.

[040] The lock may include a stop that is located within the recess of the cap, thereby holding it in its original position. This provides a simple and reliable mechanism for holding the cap in its original position.

[041] The stopper may be movable along a slot in the cap to allow it to move into an extended position. The stop may be located outside the slot in the recess, thereby holding the cap in its original position when the stop is in the first orientation. Thus, the stopper may be used to cause the cap to move from the rest position to the extended position as the stopper moves from the recess to the slot.

[042] In one embodiment of the invention, moving the detent from the second to the third orientation by the actuator pushes the detent into the slot, allowing the cap to move from the rest position to the extended position. Thus, the cap can be moved to the extended position by pressing the actuator.

[043] The stop may be coupled to an elastic member that is flexible to move the stop inward from a resting state toward the longitudinal axis of the training device to a flexed state. When at rest, the stopper holds the cap in its original position. The stopper when bent allows the stopper to move into the groove. This provides a reliable mechanism to allow the cap to move from the resting position to the extended position.

[044] The training device may include a biasing element that biases the cap in a distal direction. Thus, the cap can automatically move from the retracted position to the home or extended position depending on the orientation of the latch.

[045] The resistance surface of the latch actuator may include a deflector portion. The actuator may be configured to interact with the deflector portion to move the latch from a second orientation to a third orientation. Thus, the actuator pushes down the baffle portion to move the lock into an orientation that allows the cap to move to the extended position.

[046] The training device may include a bias element configured to bias the latch in a first direction of rotation. The biasing element may include a torsion spring. The biasing element may bias the latch to rotate from the second or third position to the first. In this way, the training device can be returned to its original state automatically.

[047] The biasing element may bias the latch into the fourth orientation such that once the actuator moves to the distal position and the cap is in the extended position, the latch will move to the fourth orientation. The lock in the fourth orientation may prevent the cap from moving from the extended position to the original position. In this way, the cap can be automatically set to a locked state after the actuator is pressed.

[048] The actuator may be configured to lock the latch when moved from a distal position to a proximal position to move the latch to a first orientation, thereby allowing the cap to move from the extended position to the home position. This allows the user to reset the training device by moving the actuator back to a proximal position from a distal position.

[049] The latch may include a cap with a resistance surface that is configured to resist proximal movement of the cap in a proximal direction when the latch is in a fourth orientation and the cap is in an extended position. The cap may include a support surface that abuts the resistance surface of the cap when the latch is in a fourth orientation and the cap is in an extended position. This helps keep the cap locked.

[050] In an embodiment of the invention, the proximal position of the actuator simulates the non-activated position of the injection device piston. In an embodiment of the invention, the distal position of the actuator simulates the activated position of the piston of the injection device. In an embodiment of the invention, the initial position of the cap simulates the exposure of the needle of the injection device. In an embodiment of the invention, the retracted position of the cap simulates exposure of the needle of the injection device. In an embodiment of the invention, the extended position of the cap simulates a locked state of the injection device in which the cap cannot prevent the needle from being exposed. In this way, the training device can accurately simulate the operation of the injection device.

[051] The latch may be designed such that an audible signal upon engagement with the housing protrusion indicates that the actuator is in the distal position. An audible signal indicates that the actuator has reached a distal position, which simulates the end of the injection with the injection device, so that the user can more accurately determine whether the injection has been administered in the proper manner when using the injection device.

[052] The latch may be configured to hold the actuator in a distal position when coupled to the housing protrusion. The engagement of the latch with the body projection indicates that the actuator has reached a distal position that simulates the end of the injection device injection process so that the user can more accurately determine that the injection administered using the injection device has been completed correctly.

[053] The latch may include a resilient element. The latch is movable between a disengaged position in which it is not coupled to the housing protrusion and a connected position in which the latch is coupled to the housing protrusion. Therefore, the latch can simply be bent so that it can be connected to the body portion.

[054] The elastic element may be configured to transition from a connected state to a disconnected state when a force greater than a threshold value is applied to the actuator while moving the actuator from a distal position to a proximal position. In this way, the latch can securely hold the actuator in a distal position, allowing the training device to return to its original position when the user deliberately applies a force above a threshold to the actuator.

[055] The latch may include a baffle portion that is configured to engage with the housing protrusion to move the latch from a disconnected position to a connected position. The latch may include a gripping element that engages the body portion in a connected position. Thus, the baffle portion helps to move the latch into engagement with the housing, and the gripping member helps to hold the latch and housing in engagement with each other.

[056] The resilient element may include a deflector portion and/or a gripping element. Opposite sides of the latch may include both a deflector portion and a gripping element. This ensures a reliable latch design.

[057] The connector may prevent the cap from moving distally from its home position when the actuator is in the proximal position. Thus, the connector helps to maintain the cap in its original position.

[058] The connector may cause the cap to move to a retracted position when the actuator is in a proximal position. Thus, the connector does not prevent the cap from being retracted into its retracted position.

[059] The connector may allow the cap to be moved distally toward the extended position as the actuator moves toward the distal position. In this way, the connector can serve to remove the cap.

[060] The connector may be provided with an actuator contact surface that abuts a portion of the actuator to prevent the cap from moving distally from its home position when the actuator is in the proximal position. The actuator contact surface stop and the actuator ensure the functioning of the mechanism for holding the cap in its original position.

[061] The actuator contact surface may be adjacent to an actuator surface that faces proximally. The connector can move the cap in a distal direction from its original position when the actuator is in a proximal position.

[062] The connector may be provided with a cap contact surface that abuts a portion of the cap to prevent the cap from moving distally from its home position when the actuator is in the proximal position. This ensures the functioning of the mechanism for holding the cap in its original position.

[063] The contact surface of the cap may be adjacent to a surface of the cap that faces in a distal direction. Thus, the connector can move the cap as the actuator moves proximally, but cannot move the cap as it moves distally.

[064] In another aspect of the invention, there is provided a set of components configured to assemble a training injection device or injection device described herein.

Brief description of graphic materials

[065] Embodiments of the invention are described by way of example with reference to the accompanying drawings, in which:

[066] In FIG. 1 shows a training injection device for training a user to use the injection device;

[067] In FIG. 2A shows a cap attached to the distal end of the instructor of the injection device;

[068] In FIG. 2B shows the injection training device with the actuator in the proximal position and the cap in the rest position.

[069] In FIG. 2C shows the actuator in the proximal position and the cap in the retracted position;

[070] In FIG. 2D shows the actuator moved distally from the proximal position and the cap in the retracted position.

[071] In FIG. 2E shows the actuator in the distal position and the cap in the retracted position.

[072] In FIG. 3A shows the actuator in the distal position and the cap in the extended position.

[073] In FIG. 3B shows the actuator as it moves in a proximal direction to a distal position and the cap in the extended position;

[074] In FIG. 3C shows the actuator in the distal position and the cap in the rest position;

[075] In FIG. Figure 4 shows the training injection device in disassembled form;

[076] In FIG. 5A is a side view of the internal components of the training injection device with the actuator in the proximal position and the cap in the rest position;

[077] In FIG. 5B is a perspective view of the internal components of the training injection device with the actuator in the proximal position and the cap in the rest position;

[078] In FIG. Figure 6 shows the components of the internal section of the cap and the retainer in disassembled form;

[079] In FIG. 7A is a side view of the internal components of the training injection device with the actuator in the proximal position and the cap in the retracted position;

[080] In FIG. 7B is a perspective view of the internal components of the training injection device with the actuator in the proximal position and the cap in the retracted position;

[081] In FIG. 8 is a perspective view of the internal components of the training injection device with the actuator in the distal position and the cap in the extended position;

[082] In FIG. Figure 9 shows an disassembled view of the injection training device with a connector;

[083] In FIG. 10 shows an disassembled view of the training injection device with a latch; And

[084] In FIG. 11A is a side view of the internal components of the training injection device and the damping member; And

[085] In FIG. 11B shows the internal components of the training injection device and the damping member is a perspective view.

[086] In FIG. 12A is a perspective view of the rotor.

[087] In FIG. Figure 12B shows the rotor showing the corner teeth - top view.

[088] In FIG. 12C shows the rotor - bottom view.

[089] In FIG. 13A shows the rotor in a side view.

[090] In FIG. 13B is a sectional view of line AA.

[091] In FIG. 14 A shows the rotor - view from the second side.

[092] In FIG. 14 B shows line BB - sectional view.

[093] In FIG. Figure 15 shows the rotor and damping element in a fully engaged state - side view.

Detailed description

[094] In order to train a user to use the injection device, a training injection device 1 is provided, as shown in FIG. 1. The training device 1 contains a body section 3 with a proximal end 5 and a distal end 7.

[095] In use, the distal end 7 of the body portion 3 is positioned toward the surface of the user's body, which is the target site for injection. In use, the proximal end 5 of the body portion 3 is positioned in the direction of the user's hand with which he activates the training device 1. On each side of the body portion 3 there is a window 12 that simulates the window of an injection device for monitoring the drug contained in the device.

[096] Although the terms “proximal” and “distal” are used herein to describe the device, they provide context and do not require the training device 1 to be used in any particular orientation. The terms "first end" and "second end" may be used instead of the terms "distal end" and "proximal end" without changing the intended meaning.

[097] The training injection device 1 also includes an actuator 9 and a cap 11. The actuator 9 models the piston of the injection device, which is used to dispense a drug through a needle. The cap 11 simulates the needle cap of an injection device, which is used to cover and expose the needle.

[098] The training device 1 is equipped with a removable cover 13 that can be positioned over the cap 11 to prevent accidental retraction of the cap 11. A pair of recesses 15 are located on the inner surface of the cap 13. These recesses 15 are arranged to be positioned over a pair of protruding portions 17 on the outer surface of the distal end 7 of body section 3. In this case, cap 13 is held in place. The distal end 7 of the body portion 3 also includes a pair of assemblies 19 on opposite sides of each recess 15 that abut the surface of the cap 11, preventing further advancement of the cap 11 toward the proximal end 5 after the recesses 15 have engaged the protruding portions 17.

[099] The elements of the injection training device 1 described herein may be identical or substantially identical to the elements of the injection device whose use is to be trained. However, the injection training device 1 does not contain a needle, so the user does not perform an injection during the training procedure. Although the training injection device 1 may contain a container that simulates a container of a drug injection device, it does not contain any fluid.

[0100] As shown in FIG. 2 A-E, there is a sequence for teaching a user to administer an injection using the injection training device 1. As can be seen in FIG. 2A shows a training device 1 as described in FIG. 1. In Fig. 2B shows the training device 1 with the cover 13 removed, which exposes the cap 11. As shown in FIG. 2B, the cap 11 is in an initial position that simulates the position of the needle cap of an injection device in which the needle is closed.

[0101] As shown in FIG. 2C, the user can hold the training device 1 by the actuator 9 and position the cap 11 over the target area. The user can then push the actuator 9 towards the distal end 7 of the body portion 3. This will force the cap 11 into a retracted position and move it towards the proximal end 5. When the cap 11 is in its home position, the actuator 9 cannot move towards the distal end 7 relative to the body portion 3. Thus, the actuator 9 is held in a proximal position and cannot be moved forward. However, once the cap 11 is in the retracted position, the actuator 9 can move distally along the longitudinal axis of the training device 1.

[0102] In FIG. 2C shows the cap 11 in a retracted position, which is more proximal to the body portion 3 than the original position. The cap 11 in the retracted position is partially retracted into the body portion 3. This position simulates the position of the needle cap of an injection device, in which the needle is exposed for administering an injection.

[0103] As shown in FIG. 2D and 2E, the actuator 9 can be moved in a distal direction once the cap 11 is in the retracted position. In FIG. 2D shows the actuator 9 moving towards the distal end 7. FIG. 2E shows the actuator 9 in a distal position, which simulates the position of the piston of the injection device after administration of the injection.

[0104] In FIG. 3A-C show the sequence of returning the training device 1 to its original position after completing the injection simulation. As shown in FIG. 3A, the user can remove the training device 1 from the target area. This will allow the cap 11 to move distally to an extended position, which is more distal to the body portion 3 than the original and retracted position. The extended position of the cap 11 simulates the locked state of the injection device, in which it is impossible to expose the needle cap of the injection device.

[0105] As shown in FIG. 3B-C, the user can press the actuator 9 towards the proximal end 5 to return the training device 1 to its original position so that the sequence described in FIG. 2A-E. In FIG. 3B shows the actuator 9 moving towards the proximal position, and FIG. 3 C shows the actuator 9 in a proximal position. When the actuator 9 is retracted to the proximal position, the cap 11 returns to its original position so that the training device 1 can be reused.

[0106] In FIG. 4 shows the components of the training device 1 in disassembled form. The body portion 3 includes a base portion 21 that connects to a base portion 23 enclosed by a first outer portion 25 and a second outer portion 27. In this example, the component parts of the body portion 3 are combined with each other to form a body assembly. However, the body portion 3 may be a single piece.

[0107] The cap 11 of the training device 1 includes an outer portion 29 and an inner portion 31. The outer portion 29 extends from the base portion 21 while the inner portion 31 is located within the body portion 3. A spring 33 is also provided which functions as a bias member for pushing out the cap 11 in the distal direction.

[0108] The actuator 9 of the training device 1 includes an actuator housing 35 and an end cap 37. These components form an outer surface with which a user can interact to move the actuator 9. An internal portion 39 of the actuator 9 is located within the actuator housing 35 under the end cap. cover 37. The internal member 39 is connected to a threaded piston 41 at the proximal end of the piston 41, and the distal end of the piston 41 is connected to a tip 43, which holds the piston 41 in alignment with the longitudinal axis of the training device 1. In this example, the components of the actuator 9 are connected together to form the actuator assembly. However, the actuator 9 may be a single piece.

[0109] The piston 41 is connected to a damping element 45, which is used to slow down the rotation of the piston 41, which in turn slows down the movement of the actuator 9 in the distal direction.

[0110] The training device 1 further includes a latch 47 comprising a first locking portion 51 and a second locking portion 53. In this example, the first and second locking portions 51, 53 are separate components that are joined together to form the latch 47. However, in another example, the latch 47 is one piece.

[0111] The latch 47 is rotatable about the longitudinal axis of the training device 1 so that the latch 47 can be placed in different rotational orientations. The latch 47 can be rotated, but cannot be moved proximally or distally relative to the body portion 3. In the first orientation, the latch 47 resists movement of the actuator 9 from its proximal position (as shown in FIGS. 2A-B) to a distal position (as shown in FIG. 2E). Therefore, the first orientation of the latch 47 is configured to hold the actuator 9 in the configuration described in FIG. 2A-B. In addition, the first orientation of the latch 47 is configured to hold the cap 11 in the home position (as shown in Fig. 2B), so that the cap 11 cannot move from the home position to the extended position (as shown in Fig. 3A-B), and allows the cap 11 to move from the home position to the retracted position (as shown in Fig. 2C).

[0112] There is a second orientation of the latch 47 in which the latch 47 allows the actuator 9 to move from a proximal position to a distal position. Therefore, the second orientation of the latch 47 is configured to move the actuator 9 to the position shown in FIG. 2E.

[0113] The training device 1 also includes a bias element 55, which in this example is a torsion spring. The biasing member 55 biases the latch 47 in a first direction of rotation 57. Depending on the orientation of the training device 1, the first direction of rotation 57 may be clockwise or counterclockwise.

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

[0115] In FIG. 5A-B show the training device 1 in the configuration according to FIG. 2A-2B with the actuator 9 in the proximal position and the cap 11 in the original position. In this configuration, the lock 47 is in a first orientation that prevents the actuator 9 from moving distally.

[0116] As shown in FIG. 5A-B and Fig. 6, the latch 47 includes an actuator resistance surface 63 that includes a protrusion from a portion of the outer surface of the cylindrical body of the latch 47. The actuator resistance surface 63 projects from the latch 47 in a direction away from the longitudinal axis of the training device 1. The actuator 9 includes a support surface 65 that includes a protrusion from a portion of the inner surface of the actuator 9. The support surface 65 projects from the actuator 9 in the direction towards the longitudinal axis of the training device 1. The support surface 65 is configured to abut the resistance surface 63 of the actuator. Thus, the actuator resistance surface 63 is configured to resist movement of the actuator 9 from a proximal position to a distal position when the latch 47 is in the first orientation.

[0117] The training device 1 includes two actuator resistance surfaces 63. In this example, the actuator resistance surfaces 63 are located on opposite sides of the latch 47 relative to each other. This allows the force of the actuator 9 to be distributed across the latch 47. There are also two corresponding support surfaces 65, which in this example are located on opposite sides of the actuator 9 relative to each other.

[0118] The retainer 47 includes a stop 67 configured to be positioned within a recess 69 in the inner portion 31 of the cap 11. The stop 67 prevents distal movement of the cap 11 from the retracted position while allowing the cap 11 to move proximally toward the retracted position. In this example, the retainer 47 includes a pair of stops 67 located on opposite sides of the retainer 47. The interior of the cap 31 includes a pair of corresponding recesses 69 located on opposite sides of the interior of the cap 31. The recesses 69 are openings of the same or similar size as the window 12 according to FIG. 1.

[0119] In FIG. 7A-B show the training device 1 in the configuration according to FIG. 2C with the actuator 9 in the proximal position and the cap 11 in the retracted position. In this configuration, the latch 47 is rotated to a second orientation that allows the actuator 9 to move in a distal direction, as described in detail below.

[0120] As shown in FIG. 5 A and 6, the lock 47 includes a slope 71, which in this example is an angular surface extending from the outer surface of the second locking portion 53. The inner portion of the cap 31 includes an inclined contact element 73, which in this example is an angular surface in the recess of the inner portion of the cap 31. The slope 71 and the inclined contact element 73 are shaped and positioned such that when the cap 11 is moved from the original position to the retracted position, the inclined contact element 73 causes the latch 47 to rotate. In this example, the slope 71 and the inclined contact element 73 cause the latch 47 rotate in a second direction of rotation 75 that is opposite to the first direction of rotation 57 toward which the lock 47 is biased.

[0121] Preferably, the latch 47 includes a pair of ramps 71, and the cap 11 includes two inclined contact elements 73. Each inclined contact element 71 can be on the opposite side of the latch 47. Each inclined contact element 73 can be located on the opposite side of the latch 11. This helps reduce friction forces acting on the clamp 47 and cap 11.

[0122] Moving the cap 11 to the retracted position causes the latch 47 to rotate to a second position, which is shown in FIG. 7A-B. Here it can be seen that the protrusion formed by the slope 71 fits inside the recess formed by the slope 73 to hold the cap 11 in the retracted position. When the latch 47 is in the second orientation, the gap 77 formed at the end of the actuator resistance surface 63 is at least partially aligned in the circumferential direction with the support surface 65, such that the support surface 65 can extend through the gap 77. Thus, the support surface 65 may move past the actuator resistance surface 63, and the actuator 9 may begin to move from a proximal position to a distal position. The width of the support surface 65 is equal to or less than the width of the gap 65. In the example with two support surfaces 65 and two resistance surfaces 63 of the actuator, the same process occurs on opposite sides of the training device 1.

[0123] As shown in FIG. 6, the resistance surface 63 of the actuator of the latch 47 includes a deflector portion 79 configured to interact with the actuator support surface 65 during distal movement of the actuator. When the support surface 65 interacts with the deflector portion 79, the latch 47 moves further in the second direction of rotation 75 from the second orientation to the third orientation. As the actuator 9 moves a first distance in the distal direction, the support surface 65 moves into the gap 77 of the latch 47. Thus, the force of the actuator 9 moves the latch 47 to a third position, which moves the stop 67 into the groove 81 in the inner surface of the inner portion of the cap 31. When the support surface 65 is located within the gap 77, it holds the latch 47 in the third orientation. The support surface 65 does not extend to the top portion of the actuator 9. Thus, after the support surface 65 has moved past the gap 77 and the cap 11 has moved out of engagement with the latch 47, the latch 47 can rotate back in the first direction of rotation under the influence of the force applied by the biasing mechanism. element 55.

[0124] The groove 81 in the inner portion of the cap 31 forms a guide, allowing the stop 67 to slide along it. The slot 81 has an opening 83 at the proximal end of the inner portion of the cap 31. The slot 81 allows the cap 11 to move distally from a retracted position to an extended position, and after the stopper 67 reaches the opening 83, the inner portion of the cap 31 is released from contact with the latch 47.

[0125] The cap 11 may be moved to an extended position when the stopper 67 exits the opening 83 of the slot 81. This allows the cap 11 to move past the latch 47 to an extended position that is more distal than the position of the latch 47 and the original position. The location of the cap 11 relative to the latch 47 when the cap 11 is in the extended position is shown in FIG. 8, which is the configuration described with reference to FIG. 3A.

[0126] As shown in FIG. 6, the stop 67 includes an elastic element 85 configured to bend inwardly in the inner portion of the cap 31. Thus, the elastic element 85 and the stop 67 can move inwardly towards the longitudinal axis of the training device 1. The stop 67 is pressed against the edge of the recess 69 when the actuator 9 causes the latch 47 to rotate from the second orientation to the third orientation. This pushes the stopper 67 and the resilient member 85 inward so that the stopper 67 can fit into a groove 81 in the inner portion of the cap 31. As shown, the stopper 67 has an angled surface that allows the resilient member 85 to flex inward.

[0127] When the training device 1 is in the state shown in FIG. 3A and FIG. 8, the actuator 9 no longer holds the latch 47 in the third position, and the slope 71 can no longer contact the inclined contact element 73. Thus, the latch 47 can be freely rotated in the first direction of rotation 57 and pushed in that direction by the biasing element 55.

[0128] While passing the first orientation, the latch 47 rotates to a fourth orientation, in which a portion of the actuator 9 abuts the reset deflector 87 on the latch 47. This holds the latch 47 in the fourth orientation to prevent proximal movement of the cap 11 from the extended position to the home position. position. Thus, the cap 11 simulates the locked state of the injection device.

[0129] When the latch 47 is in the fourth orientation, the resistance surface of the cap 89 abuts a surface at the proximal end of the inner portion of the cap 31. In this example, the resistance surface of the cap 89 is a protrusion extending from the slope 71. The resistance surface of the cap 89 blocks the path of the cap 11 such that it cannot move proximally from its extended position.

[0130] As described above with reference to FIG. 3A-C, the user can return the training device 1 to its original position by pulling the actuator 9 from the distal position back to the proximal position. As the actuator 9 moves proximally, the support surface 65 mates with the corner surface of the reset deflector 87 to rotate the latch 47 from the fourth orientation to the first orientation.

[0131] When the latch 47 is rotated a first angular distance in the second direction of rotation 75 to the first orientation, the resistance surface of the cap 89 is no longer directly above the proximal end of the inner portion of the cap 31 in the direction of the longitudinal axis of the training device 1. Instead, the resistance surface of the cap 89 is located immediately above the recess in the inner portion of the cap 31 in the direction of the longitudinal axis of the training device 1. Thus, the cap 11 is capable of moving to a home position from the extended position.

[0132] As the cap 11 moves from the extended position back to the original position, the inclined contact element 73 of the cap 11 exerts a force on the slope 71 of the latch 47. This causes the latch 47 to move in the second direction of rotation 75 to the first orientation. As the inner portion of the cap 31 moves proximally, the stopper 67 and the elastic member 85 expand inward so that the stopper 67 passes under the proximal end of the inner portion of the cap 31. As the inner portion of the cap 31 moves further, the stopper 67 engages in a recess 69 that retains cap 11 in its original position, as described above. In addition, once the cap 11 reaches its home position, the latch 47 is rotated to the first orientation as described above. In this way, it is possible to return the training device 1 to the original position described with reference to FIG. 2B.

[0133] You can manually move the cap 11 from the extended position towards the home position to return the device to the home position. However, to do this, the user must simultaneously move the actuator 9 to the proximal position and move the cap 11 to its original position. This operation requires the use of both hands. As shown in FIG. 9, a reset connector 91 is provided that automatically pulls the cap 11 from the extended position to the rest 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 contact member, such as a first hook 93 located at its proximal end. The first hook 93 is configured to interact with a portion of the actuator 9, such as a rack 95 on the inner portion 39 of the actuator 9. The protrusion 95 faces in the proximal direction and, therefore, movement of the actuator in the proximal direction moves the connector to return to the original position 91 in proximally when the protrusion 95 contacts the first hook 93. However, moving the actuator 9 in the distal direction does not cause the reset connector 91 to move in that direction because the actuator 9 cannot exert force on the first hook 93 in that direction.

[0135] The remainder of connector 91 also includes a cap contact element, such as a second hook 97 located at its distal end. The second hook 97 is configured to abut a portion of the cap 11, such as when inserted into an opening 92 on the cap 11. When the reset connector 91 is moved proximally when the actuator is moved to the proximal position, the proximal end 92a of the opening 92 contacts by a second hook 97. This allows the reset connector 91 to pull the cap 11 to its original position to reset the training device 1.

[0136] Hole 92 may be configured as shown in FIG. 9, in the form of an elongated hole extending distally along the inner portion of the cap 31. The second hook 97 may be located within the hole at all times during operation of the training device 1. In these embodiments, the second hook 97 extends along the hole 92 as the actuator 9 moves distally from the proximal position shown in FIG. 2B to the distal position shown in FIG. 2E, and moves proximally from the distal position to the proximal position until the second hook 97 comes into contact with the proximal end 92a of the hole, as described above, allowing the reset connector 91 to pull the cap 11 to the home position to reset the training devices 1.

[0137] The opening 92 may be formed in any suitable portion of the cap 11. For example, the opening may be provided on the outer portion of the cap 29 and function in substantially the same manner as described above. The hole 92 may extend in a direction perpendicular to the longitudinal axis of the training device 1 through the portion of the cap in which it is formed. Alternatively, the hole may be an etched area, or depression, on the surface of the cap 11.

[0138] In some embodiments of the invention, including those shown in FIGS. 9, opening 92 may have a closed distal end. Alternatively, the opening may be configured as a groove in the distal end of the inner and/or outer portion of the cap with a closed proximal end 92a into which the second hook 97 abuts and an open distal end.

[0139] In some embodiments, the opening may not extend along the cap 11 in a distal direction such that the second hook 97 is always located within the opening during operation of the training device 1. For example, the opening 92 may be configured as an approximately circular hole in the cap 11. The reset rod 91 may be configured such that the second hook 97 is resiliently displaced into the hole as the actuator is moved to its proximal position to provide contact between the second hook 97 and the proximal end 92a of the hole and therefore retract the cap. 11 to the initial position for resetting the training device 1. The second hook 97 at the distal end may be shaped to engage the cam with the closed distal end of the hole. When the reset rod 91 is moved distally as the actuator moves to the distal position, the cam between the second hook 97 and the distal end of the hole overcomes the elastic displacement, allowing the second hook 97 to disengage from the hole 92 as the actuator moves distally.

[0140] As shown in FIG. 10, the training injection device 1 includes a latch 99, which is configured to be attached to the internal part 39 of the actuator 9. In this example, the latch 99 includes a length of elastic wire in the form of a loop 101, configured to be placed around the circular projection 103 on the internal part 39. Since the latch 99 is resilient, the diameter of the loop 101 can be increased and the loop can be placed around the circular projection. The loop can then be released, after which the diameter of the loop 101 is compressed such that the latch retains the circular protrusion 103. The latch 99 also includes a first protruding portion 105 that is located between a pair of holders 107 that hold the latch 99 in place.

[0141] The latch 99 further includes a second projection portion 109, which in this example is longer than the first projection portion 105. The second projection portion 109 includes a first portion 111 that extends distally and a second portion 113 that is angled relative to the first portion. portion 111. The second portion 113 defines a deflector portion on the distal side and a gripping member on the proximal side. After the actuator 9 moves a certain distance from a proximal position to a distal position, the second portion 113 comes into contact with the body projection 115 on the main portion 23 of the body portion 3.

[0142] As the actuator 9 moves distally, the elastic latch 99 bends outward away from the longitudinal axis of the training device 1 and the top of the body protrusion 115. Once the actuator 9 has moved to the distal position, the latch 99 returns to the non-operating position. In this state, the angular surface of the latch 99, which is a gripping member, connects the latch 99 to the protrusion of the housing 115. This holds the actuator 9 in a distal position relative to the housing portion 3

[0143] When the actuator 9 moves from a distal position to a proximal position, the protrusion of the housing 115 applies a force to the latch 99. When this force exceeds a threshold value, the gripping element of the second portion 113 bends in a direction perpendicular to the direction extending from the longitudinal axis of the training device 1. In this way, the gripping element extends through the housing protrusion 115 so that the actuator 9 can be released from the distal position. The threshold force required to bend the latch ensures that the actuator 9 is securely held in the distal position. However, the threshold force also allows the actuator 9 to return back to the proximal position after the gripping element releases the housing protrusion.

[0144] In FIG. 11A-B damping element 45 is briefly described with reference to FIG. 4 is described in more detail below.

[0145] In the training device 1, the piston 41 of the actuator 9 has threads coupled to the rotor 117. The rotor 117 may include an internal thread 118 configured to engage the threads of the piston 41 to facilitate connection of the piston 41 and the rotor 117. The piston 41 is attached to the interior 39 of the actuator 9 such that the piston cannot rotate relative to the actuator 9. The rotor 117 engages the threads, and therefore the piston 41 causes the rotor 117 to rotate in the second direction of rotation 75 as the piston 41 distally moves with the actuator mechanism 9. The rotor 117 is connected to a damping element 45, which in this example is a torsion spring 119 biased to a twisted state. As the rotor 117 rotates, it unwinds the torsion spring 119, which dampens its rotation and thus slows the advancement of the actuator 9 to the distal position. The properties of the spring 119 can be selected according to the required resistance. For example, if high resistance is required, a 119 spring with a high spring rate may be selected.

[0146] The shock-absorbing element 45 also includes a ratchet mechanism 121 including a plurality of corner teeth that overlap with the corner teeth 130 on the rotor 117. After the actuator 9 is moved some distance to the distal position, the corner teeth of the rotor 117 move into engagement with the corner teeth of the ratchet mechanism. 121. The rotor 117 and the ratchet 121 form an anti-rotation mechanism that allows the rotor 117 to rotate in the second direction of rotation 75, but prevents the rotor from moving in the first direction of rotation 57. Thus, the tension of the torsion spring 119 is maintained as the rotor 117 unwinds it. , since it cannot move back to its curled state.

[0147] Each of the angled teeth 130 of the rotor 117 may include an angled edge 132 (eg, angled with respect to the longitudinal axis of the trainer) and a straight edge 131 (eg, parallel to the longitudinal axis of the trainer). The rotor 117 may be configured such that the corner edge of each tooth faces in the second direction of rotation 75. In other words, the corner edge of each corner tooth leads when the rotor 117 is driven to rotate as the piston 41 moves distally with the actuator 9. Angular the teeth of the ratchet 121 are approximately aligned with the angled teeth of the rotor 117. In other words, the straight edges of each tooth of the ratchet 121 face in the second direction of rotation 75 such that the straight edges of the teeth of the rotor 117 abut the corresponding straight edge of the teeth of the ratchet 121, preventing movement of the rotor in the first direction of rotation 57. The ratchet mechanism 121 can be rotated relative to the actuator 9.

[0148] The damping member 45 and the rotor 117 may be configured to correspond to a point at which pressing the actuator requires the rotor 117 and the ratchet 121 to engage and thereby form an anti-rotation mechanism. For example, in embodiments of the invention that utilize a high spring rate spring 119, it may be desirable for the anti-rotation mechanism to engage earlier when the actuator 9 is pressed to assist the user in resisting the spring 119's movement into a curled state. Pre-existing engagement of the anti-rotation mechanism can be achieved, for example, by using angular teeth of the ratchet mechanism 121 with a large height along the longitudinal axis of the training device 1.

[0149] When the actuator 9 is pulled rather than pushed out, or in other words, when the actuator 9 is moved proximally, the piston 41 moves the corner teeth of the rotor 117 out of engagement with the corner teeth of the ratchet mechanism 121. This allows the rotor to move in the first direction of rotation 57 at moving the piston 41 proximally and moving the spring back to a coiled state. Disengagement distance—the distance that actuator 9, piston 41, and rotor 117 move proximally to move the corner teeth of rotor 117 out of engagement with the corner teeth of ratchet 121—this distance is greater than the height of the corner teeth of ratchet 1. In some embodiments of the invention The detachment distance can be approximately 2mm.

[0150] A damping element may be incorporated into the training device 1 to simulate high volume and/or high viscosity dose delivery. A damping element may also be used in injection devices to cause the user to slowly press the actuator 9 when administering a large dose or low viscosity substance (which itself may have low pressure resistance) to mitigate the negative side effects associated with too rapid injection. injection of a substance, for example, bruising, pain, accumulation of the injected substance in the patient’s body, etc.

[0151] In an alternative embodiment of the damping element, a torsion spring may be coupled to a ratchet mechanism. As in the previous embodiment, the rotor engages the threads of the piston and, therefore, the piston causes the rotor to rotate in the second direction of rotation as the piston/actuator moves distally. In this embodiment of the invention, the rotor is configured such that the straight edges of each tooth surface face the second direction of rotation. In other words, the straight edge of each corner tooth guides when the rotor is driven to rotate as the rotor moves distally with the actuator. The initial rotation of the rotor in this embodiment of the invention does not cause the torsion spring to unwind. Thus, the initial movement of the actuator toward the distal position is achieved by little or no resistance.

[0152] The alternative damping element includes a ratchet mechanism coupled to a torsion spring in a coiled state. The ratchet mechanism contains a plurality of corner teeth that mate with the corner teeth on the rotor. After the actuator is moved some distance to the distal position, the corner teeth of the rotor are moved to engage the corner teeth of the ratchet such that the straight edges of the rotor teeth rotate to abut the corresponding straight edge of the ratchet teeth. In this embodiment, once the rotor and ratchet are engaged with each other, continuous rotation of the rotor causes the ratchet to rotate. Rotation of the ratchet causes the torsion spring to unwind, which slows the rotation of the ratchet and rotor and thus slows further movement of the actuator toward the distal position. Again, the configuration of the damping element and rotor, such as spring properties and tooth height, can be selected to suit the desired resistance profile.

[0153] In some embodiments, the rotor 117 and/or the damping element 45 may be replacement parts for the training device or injection device. For example, the device may be designed such that the torsion spring 119 can be replaced by another spring with a higher or lower spring rate. This makes it easier, for example, to use a single training device to train a user to administer substances of different viscosities.

[0154] In the context of the present application, the injection device may be an automatic injection device. In such electrically driven injection devices, the actuator 9 is actuated or replaced by an automatic actuator, such as an actuator spring, a pneumatic piston actuated by a compressed gas reservoir, or a solenoid.

[0155] In such automatic injection devices, damping element 45 may be used to dampen, slow, or regulate the force applied by the actuator to the container containing the injection agent and/or the delivery mechanism, such as the plunger of a drug container such as a syringe. . The damping element can be used to adjust the speed of the automatic injection device without changing the parameters of the automatic actuator.

[0156] The damping element may be configured to operate at any point in the actuation sequence. For example, the damping element may be configured to slow the advancement of the actuator toward the distal position throughout the entire advance or only for a selected portion. In some embodiments of the invention, the injection device may be configured such that deceleration of the actuator advance begins at the point of full needle extension on the medication container, for example, to ensure complete administration of the injectable agent using an automatic injection device.

[0157] Unless otherwise indicated, each embodiment of the invention described herein can be combined with another embodiment described herein.

[0158] It should be understood that the intended benefits and advantages described above may apply to one or more embodiments of the invention. Embodiments of the invention are not limited to those that solve any or all of the above problems or to those with any or all of the stated benefits and advantages.

[0159] References to the term “element” refer to one or more of these elements.

[0160] References herein to the term “element” may further correspond to the term “means” for an element performing a specific function as defined herein.

[0161] It should be understood that the above description of a preferred embodiment of the invention is provided by way of example only and that various modifications may be made by those skilled in the art. Although various embodiments of the invention have been described above in some detail or with reference to one or more individual embodiments, those skilled in the art will be able to make many changes to the described embodiments without departing from the scope of the present invention.

Aspects of the invention that form part of the specification

1. A training injection device for training a user to use the injection device, comprising:

body section; And

an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position;

wherein the body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to engage with the housing protrusion when the actuator is in a distal position, thereby holding the actuator in the distal position.

2. The injection training device of aspect 1, wherein the latch is configured to emit an audible signal when the latch is engaged with the housing protrusion.

3. An injection training device for training a user to use the injection device, comprising:

body section; And

an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position;

wherein the housing section is equipped with a protrusion, and the actuator is equipped with a latch, which is configured to connect with the housing protrusion when the actuator is in the distal position, and to reproduce an audible signal.

4. The injection training device of aspect 3, wherein the latch holds the actuator in a distal position when the latch is connected to the body projection.

5. The injection training device according to any one of the preceding aspects, wherein the latch includes an elastic element.

6. The injection training device of any one of the preceding aspects, wherein the latch is movable between a disengaged position in which it is not coupled to the body protrusion and a connected position in which the latch is coupled to the body protrusion.

7. The injection training device of aspect 5 or aspect 6, wherein the elastic member is configured to transition from a connected state to a disconnected state when a force greater than a threshold value is applied to the actuator while moving the actuator from a distal to a proximal position.

8. The injection training device according to any one of the preceding aspects, wherein the latch includes a deflector portion that is configured to engage with the body projection to move the latch from a disconnected position to a connected position.

9. The injection training device of aspect 8, wherein the latch includes an elastic member that includes a latch deflector portion.

10. The injection training device according to any one of the preceding aspects, wherein the latch includes a gripping element configured to grip the housing portion in a connected state.

11. The injection training device of aspect 10, wherein the latch includes an elastic element that includes a gripping element.

12. The injection training device of aspect 8 and aspect 10, wherein the deflector portion of the latch and the gripping member are on opposite sides of the latch.

13. The training injection device according to any one of aspects 1-12, wherein:

the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; And

the injection training device further comprises a damping element connected or configured to be connected to the rotor to slow down the rotation of the rotor.

14. An injection device containing:

a needle connected to a fluid storage chamber;

body section; And

an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle;

wherein the body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to engage with the housing protrusion when the actuator is in a distal position, thereby holding the actuator in the distal position.

15. An injection device containing:

a needle connected to a fluid storage chamber;

body section; And

an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle;

wherein the housing portion is equipped with a protrusion, and the actuator is equipped with a latch, which is configured to connect with the housing protrusion when the actuator is in the distal position and reproduce an audio signal.

16. Injection device according to claim 14 or claim 15, in which:

the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; And

the injection device further comprises a damping element connected or configured to be connected to the rotor for the purpose of slowing down the rotation of the rotor.

17. A kit consisting of individual components for assembling a training injection device according to any one of aspects 1 to 13 or an injection device according to any one of aspects 14 to 16.

18. A method for training a user to use an injection device, comprising a training injection device containing:

body section; And

an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position;

wherein the body section is equipped with a protrusion, and the actuator is equipped with a latch; And

the method additionally includes the steps:

moving the actuator from a proximal position to a distal position such that the latch engages with the body projection when the actuator is in the distal position, holding the actuator in the distal position.

19. A method of administering an injection, including an injection device containing:

a needle connected to a fluid storage chamber;

body section; And

an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle;

wherein the body section is equipped with a protrusion, and the actuator is equipped with a latch; And

the method additionally includes the steps:

moving the actuator from a proximal position to a distal position such that the latch engages the body projection when the actuator is in the distal position, holding the actuator in the distal position.

20. A method for training a user to use an injection device, comprising a training injection device containing:

body section; And

an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position;

wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And

the method additionally includes the steps:

moving the actuator from a proximal position to a distal position such that the latch engages with the housing projection when the actuator is in the distal position and emits an audible signal when the latch engages with the housing projection.

21. A method of administering an injection, including an injection device containing:

a needle connected to a fluid storage chamber;

body section; And

an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle;

wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And

the method additionally includes the steps:

moving the actuator from a proximal position to a distal position such that the latch engages with the housing projection when the actuator is in the distal position and emits an audible signal when the latch engages with the housing projection.

22. The method according to claim 18 or claim 20, in which:

the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor;

the training injection device further contains a damping element with the ability to connect to the rotor to slow down the rotation; And

the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position.

23. The method according to claim 19 or 21, in which:

the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor;

the injection device further comprises a damping element configured to be connected to the rotor to slow down the rotation of the rotor; And

the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position.

Claims (84)

1. A training injection device for training a user to use the injection device, comprising: body section; And an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position; wherein the body portion is provided with a projection, and the actuator is provided with a latch, which is configured to engage with the housing projection when the actuator is in a distal position, thereby holding the actuator in the distal position, the latch includes a resilient member configured to be deflectable from a resting position when the resilient member moves from a disconnected state in which the latch is not connected to the housing projection to a connected state in which the latch is coupled to the housing projection, and the elastic element is configured to transition from a connected state to a disconnected state when a force exceeding a threshold value is applied to the actuator when moving the actuator from a distal position to a proximal position, so that the elastic element returns to its original position. 2. The training injection device according to claim 1, in which the latch is configured to emit an audible signal when the latch is connected to the protrusion of the housing. 3. An injection training device for training a user to use the injection device, comprising: body section; And an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position; wherein the housing section is equipped with a protrusion, and the actuator is equipped with a latch, which is configured to connect with the housing protrusion when the actuator is in the distal position, and to reproduce an audible signal, the latch includes an elastic element made with being deflectable from the initial position when the elastic member moves from a disconnected state in which the latch is not connected to the housing projection to a connected state in which the latch is connected to the housing projection, and the elastic element is configured to transition from a connected state to a disconnected state when a force exceeding a threshold value is applied to the actuator when moving the actuator from a distal position to a proximal position, so that the elastic element returns to its original position. 4. The injection training device of claim 3, wherein the latch holds the actuator in a distal position when the latch is engaged with the body projection. 5. The injection training device according to claim 1 or 3, wherein the latch includes a deflector portion that is configured to engage with the housing protrusion to move the latch from a disconnected position to a connected position. 6. The injection training device according to claim 5, wherein the latch includes an elastic element that contains a deflector portion of the latch. 7. Training injection device according to claims. 1, 3 or 5, in which the latch includes a gripping element configured to grip a portion of the housing in a connected state. 8. The injection training device of claim 7, wherein the latch includes an elastic element that includes a gripping element. 9. The training injection device according to claims 5 and 7, in which the deflector section of the latch and the gripping element are on opposite sides of the latch. 10. Training injection device according to claim 1 or 3, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; And the injection training device further comprises a damping element connected or configured to be connected to the rotor to slow down the rotation of the rotor. 11. An injection device containing: a needle connected to a fluid storage chamber; body section; And an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle; wherein the body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to (i) bend outward from the longitudinal axis of the injection device and over the protrusion of the body when the actuator is moved toward the distal position, and (ii) return inward toward the longitudinal position axis to a resting position to engage with the housing projection when the actuator is in the distal position, thereby holding the actuator in the distal position. 12. Injection device according to claim 11, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; And the injection device further comprises a damping element connected or configured to be connected to the rotor for the purpose of slowing down the rotation of the rotor. 13. An injection device containing: a needle connected to a fluid storage chamber; body section; And an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle; wherein the body portion is provided with a protrusion, and the actuator is provided with a latch, which is configured to (i) bend outward from the longitudinal axis of the injection device and over the protrusion of the body when the actuator is moved toward the distal position, and (ii) return inward toward the longitudinal position axis to the rest position to contact the housing protrusion when the actuator is in the distal position and produce an audible signal. 14. Injection device according to claim 13, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; And the injection device further comprises a damping element connected or configured to be connected to the rotor for the purpose of slowing down the rotation of the rotor. 15. A kit consisting of individual components for assembling a training injection device according to any one of paragraphs. 1 or 3 or an injection device according to claim 11 or 13. 16. Method of using a training injection device containing: body section; And an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position; wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And method includes: moving the actuator from a proximal position to a distal position such that the latch engages with the housing protrusion when the actuator is in the distal position, holding the actuator in the distal position, the process of connecting the latch including deflecting the elastic element of the latch from its original position when the elastic element moves from a disconnected state, in which the latch is not connected to the housing projection, to a connected state, in which the latch is connected to the housing projection; And application to the actuator of a force exceeding a threshold value, leading to movement of the actuator from a distal position to a proximal position and the transition of the elastic element from the connected state to the disconnected state, so that the elastic element returns to its original position. 17. The method according to claim 16, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; the training injection device further contains a damping element with the ability to connect to the rotor to slow down the rotation; And the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position. 18. Method of using an injection device containing: a needle connected to a fluid storage chamber; body section; And an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle; wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And method includes: moving the actuator from a proximal position to a distal position such that the latch (i) flexes outward from the longitudinal axis of the injection device and over the body projection as the actuator moves toward the distal position, and (ii) returns inward toward the longitudinal axis at a resting position for coupling to the body projection when the actuator is in the distal position, holding the actuator in the distal position. 19. The method according to claim 18, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; the injection device further comprises a damping element configured to be connected to the rotor to slow down the rotation of the rotor; And the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position. 20. Method of using a training injection device containing: body section; And an actuator located towards the proximal end of the body portion, the actuator being movable from a proximal position to a distal position; wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And method includes: moving the actuator from a proximal position to a distal position such that the latch engages with the housing protrusion when the actuator is in the distal position and emits an audible signal when the latch engages with the housing protrusion, the latch engaging process including deflecting the elastic element of the latch from its original position a position where the elastic member moves from a disconnected state in which the latch is not connected to the housing projection to a connected state in which the latch is connected to the housing projection; And application to the actuator of a force exceeding a threshold value, leading to movement of the actuator from a distal position to a proximal position and the transition of the elastic element from the connected state to the disconnected state, so that the elastic element returns to its original position. 21. The method according to claim 20, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; the training injection device further contains a damping element with the ability to connect to the rotor to slow down the rotation; And the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position. 22. Method of using an injection device containing: a needle connected to a fluid storage chamber; body section; And an actuator located towards the proximal end of the body portion, movable from a proximal position to a distal position for dispensing a fluid stored in the chamber through a needle; wherein the body portion is equipped with a protrusion, and the actuator is equipped with a latch; And method includes: moving the actuator from a proximal position to a distal position such that the latch (i) flexes outward from the longitudinal axis of the injection device and over the body projection as the actuator moves toward the distal position, and (ii) returns inward toward the longitudinal axis at a resting position for coupling to the housing lug when the actuator is in the distal position, and emits an audible signal when the latch engages with the housing lug. 23. The method according to claim 22, in which: the actuator is coupled to the rotor such that movement of the actuator from a proximal position to a distal position causes rotation of the rotor; the injection device further comprises a damping element configured to be connected to the rotor to slow down the rotation of the rotor; And the method further includes moving the actuator from a proximal position to a distal position, during which time the damping element slows rotation of the rotor and therefore moving the actuator to the distal position.

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