HK1214396B - Training device for medicine injection devices and reset device for resetting such a training device - Google Patents

Description

A training device for a medical injection device and a reset device for resetting the training device

Technical Field

The present invention relates to the field of medical injection training devices and resetting devices for such training devices.

Background Art

Correctly injecting medication via an injection device such as a syringe requires training in order to administer the medication appropriately. For example, self-injection requires training and also requires testing for feasibility, e.g., for patients with limited manual motor skills, such as those with rheumatism, arthritis, gout, or similar disorders.

Summary of the Invention

In a first aspect of the present invention, a training device for a medical injection device is provided. The training device includes a body having a proximal end and a distal end, and a cavity formed in the body. The training device also includes a guard having a proximal end and a distal end. The guard is slidably attached to the body and is slidable between a retracted position, exposing a spike disposed at the distal end of the body and guided thereby, and an extended position, covering the spike. A spring is coupled to the body and the guard. The spring biases an anti-slip member to advance the guard toward the extended position. The training device also includes a releasably engaged first locking member on the body and the guard, which engages to retain the guard in the retracted position, and a releasably engaged second locking member on the body and the guard, which engages to retain the guard in the extended position. The training device also includes a plunger slidably disposed in the cavity of the body. The plunger includes a compressible element, preferably disposed at the distal end of the plunger. The compressible element is adapted to exert a force on the plunger as the plunger moves within the cavity toward the distal end of the body. The force corresponds to the injection resistance of the drug being injected into the patient. Thereby, the injection resistance generated when administering the drug, ie when the drug is pushed through the needle and into the patient, is simulated.

The simulated injection resistance in the training device is adapted to be preferably identical or at least very similar to the injection resistance of a real injection device used for the specific medication administration in order to simulate a real injection as closely as possible.

In a real device, injection resistance is caused by the drug being pressed through the needle and into the patient's tissue.

The compressible element of the training device according to the present invention is designed and adapted to simulate a real injection resistance (i.e., interact with the cavity). Thus, when the plunger moves in the cavity of the device, the resistance of the plunger is generally higher than the resistance of the plunger in a real injection device with a corresponding injection resistance.

Real injection devices may include a plunger with a stopper at its distal end. The stopper may comprise a material having a certain degree of flexibility. However, the stopper functions to seal the medication chamber and provides no or minimal resistance. Any additional resistance from the stopper may be a negative factor, as it makes the medication injection procedure more difficult.

The force applied to the plunger of the training device can correspond to the resistance caused by, for example, the friction between the compressible element and the inner wall of the cavity of the body. This force can also be, for example, the axial guiding force generated by the axially compressible element. By way of example only, this axially compressible element can be one or more springs integrated in the plunger or in the cavity or a reversible compressible material arranged in the cavity or forming a part of the plunger. Preferably, the compressible element forms an integral part of the plunger. However, the compressible element can also be a separate component attached to the plunger or connected with the plunger, such as, for example, a mechanical spring acting directly on the plunger. By utilizing, for example, a compressible device that compresses or expands in the cavity in the corresponding body or guides along the cavity in the corresponding body to simulate injection resistance, the movement of the plunger and the time required for the plunger to be fully administered or administered on demand can be simulated. The force applied to the plunger may be affected by the design or physical properties of the compressible element or the design and physical properties. Accordingly, the change in force can be achieved by changing these parameters to simulate different injection resistances. The compressible element compresses or extends to a certain extent in the cavity and thereby exerts a certain force on the plunger as it moves along the cavity. In particular, if the force corresponds to the resistance between the compressible element of the plunger and the cavity, that is, the wall defining the radial extension of the cavity, then this resistance can be selected and adjusted by appropriate selection of materials. Preferably, the compressible element can be changed without changing other features of the training device. For example, the flexibility, elasticity, or bending stiffness of the material used for the compressible element can be selected according to the required force or resistance. In addition, the friction between the compressible element and the cavity wall can be defined and varied by the material and surface properties of the compressible element and the cavity wall. By being able to simulate different injection resistances, the training device can be used to simulate the use of drugs with different viscosities. This allows users to be trained to inject drugs or apply them at specific injection locations. If the user is able to operate the injection device, then simulating different injection resistances is advantageous in testing. For example, the user may be able to perform self-application of a drug with low viscosity (high fluidity) rather than a drug with high viscosity.

The needle guard system of an actual injection device is simulated by providing a spike and a shield covering the spike, or by allowing the spike to extend from the distal end of the shield. Preferably, in the training device, the spike has a rounded distal tip and is made of a plastic material. While the risk of injury from the exposed spike is eliminated in the training device, the mechanism of an injection device, such as one with an exposed and covered needle, can be simulated realistically. Therefore, a releasable locking member is provided in the training device, allowing the training device body and the shield to be locked and released in either the retracted or extended position. However, locking the shield in the extended position, covering the used needle of the injection device, is not releasable, at least in disposable injection devices. Since the training device according to the present invention should be reusable, the locking member is configured as a releasable locking member that can be reset, for example, using a reset device according to the present invention, as described further below.

The training device according to the present invention can simulate the shape, in particular the external form, application steps, and device behavior (actuation force, injection resistance), preferably including mechanics and ergonomics, of a real injection device. The training device according to the present invention can even be adapted to simulate the appearance and application behavior of a specific injection device, preferably also associated with the administration of a specific medication at a specific injection site. Furthermore, by providing a releasable locking member, the training device is reusable, meaning it can be reset after use and placed in a repeatable situation. Therefore, this training device is particularly suitable, but not limited to, for people with limited manual motor skills, such as rheumatism or arthritis patients, and for those who need to train in the operation of an injection device, and in particular to test whether they can perform this operation for self-administration of medication, for example, medication for diseases such as arthritis or rheumatism. However, the training device is generally suitable for training medication administration for any type of user, such as patients, caregivers, and healthcare professionals.

According to aspects of the training device according to the present invention, the compressible element comprises a leaf spring mounted to the distal end of the plunger. The leaf spring extends radially outwardly along a portion of the plunger and from the plunger. The leaf spring is simple to manufacture and cost-effective. In addition, the resistance between the leaf spring and the inner wall of the cavity can be easily adjusted. For example, by changing the material of the leaf spring, the resistance between the wall and the leaf spring can be changed. For example, a material with low flexibility can be selected for high resistance and a material with high flexibility can be selected for low resistance. In addition, by appropriately selecting the material for the leaf spring or the material of the leaf spring surface, the friction (and thus the resistance) between the leaf spring portion in contact with the inner wall of the cavity can be influenced accordingly. It is also possible to adjust the friction or resistance by appropriately selecting the material of the inner surface of the body or cavity. By way of example only, the leaf spring or cavity can be covered, coated or overmolded, for example, by an elastomer or plastic material such as rubber.

According to another aspect of the training device according to the present invention, the compressible element applies a force to the plunger, and this force moves substantially along the longitudinal axis of the plunger. This force moving substantially in the longitudinal direction is preferably realized by an elastic device. The elastic device can be, for example, one or more mechanical springs or a reverse compressible material such as a foam of a plastic material acting axially on the plunger. The spring device can, for example, be arranged in the cavity between the cavity distal end and the plunger distal end. When the plunger is pushed into the cavity, the spring device is compressed and applies a force to the plunger to simulate the injection resistance. The spring device in the form of a mechanical spring can also be arranged outside the cavity, for example, between the plunger head and the proximal end of the body, so that the spring is compressed when the plunger is pushed into the cavity.

In certain embodiments, the compressible material is a gas, such as air, and the compressible element is formed by a cavity containing the gas. The distal end of the plunger then forms an airtight connection with the inner wall of the cavity. The cavity, or preferably the airtight connection, is provided with a leak of defined size. By pushing the plunger into the cavity, the gas in the cavity is compressed and forced to exit the cavity through the defined leak. By retracting the plunger outside the cavity, the cavity can be refilled with gas through the leak.

The compressible element in the form of elastic means may also be arranged to extend, such as when the plunger is pushed into the cavity.For example, a mechanical spring may be attached to the distal end of the plunger and the proximal end of the cavity or body, respectively.

By appropriate choice of material, design and arrangement of the resilient means, a substantially continuous force may be generated to compress or extend the resilient means to simulate a continuous injection resistance.

Preferably, the spring means forms an integral part or is integrated into the plunger. For example, the plunger may be made of or include a compressible material, for example the distal portion may be made of such a compressible material. For example, the form of the cavity may also be varied, for example the cavity may be formed as a tapered cylinder with a narrow diameter towards the distal end of the cavity, so that the more the compressible element of the plunger is compressed, the further the plunger is inserted into the cavity.

The compressible element providing friction between the plunger and the cavity wall may also be combined with an elastic device, in particular a mechanical spring. For example, the distal end of the plunger may be provided with radial extensions that contact the cavity wall. These radial extensions may be, for example, resiliently biased plungers of solid material or resiliently biased wheels that rub or roll along the cavity wall as the plunger moves along the cavity.

Preferably, the compressible element is arranged completely inside the cavity so as to be visible to a user of the training device.

According to another aspect of the training device according to the present invention, the body is provided with a docking portion at its distal end. The docking portion is adapted to cooperate with an end stop provided on the plunger to prevent the plunger from being completely removed from the cavity when the plunger moves in the proximal direction. In training devices that need to be reset several times for repeated use, it is necessary to retract the plunger from the cavity. By providing the docking portion in the body in which the plunger moves and by providing a corresponding end stop on the plunger, it is possible to prevent the plunger from falling outside the proximal end of the cavity when the end stop and the docking portion engage with each other. Since the plunger does not need to be reinserted into the cavity of the body in order to reuse the training device, the retaining mechanism for the plunger facilitates operation of the training device. In addition, the retaining mechanism also defines the precise reset position of the plunger in the cavity, thereby ensuring high repeatability. Preferably, the docking portion and the end stop are integrally formed with the body and the piston or a component thereof.

In some embodiments, the abutment portion is a recessed portion in the inner wall of the body, and the end stop is the proximal end of the compressible element. Due to the elastic properties of the compressible element, the proximal end can extend into the recessed portion. For example, the end stop can be the proximal end of a leaf spring. This embodiment of the retaining mechanism can be implemented using a simple device and can be integrated into the compressible element.

According to another aspect of the training device according to the present invention, the nail is slidably arranged in a nail mounting element, preferably attached to the body of the training device. The nail mounting element includes a nail biasing member that is suitable for tensioning when the nail is moved in the proximal direction. In this way, the injection resistance of the needle injected into the patient's skin can be simulated. In addition, the feeling of injection on the skin can be provided without the skin being injured or painful. The nail is neither used nor suitable for penetrating the patient's skin. In addition to simulating the initial resistance that the needle may have when penetrating the skin, the sight of the "disappearing" needle is also simulated (in the case of a real device, the needle penetrates the patient, in the training device, the nail is retracted into the protective member due to the compression of the biasing member).

According to another aspect of the training device according to the present invention, the first locking member includes a release latch arranged at the proximal end of the guard. The release latch can be deflected outwardly to disengage the first locking member, thereby allowing the guard to advance to the extended position. Preferably, the outward deflection is initiated by the movement of the plunger in the distal direction. Preferably, the disengagement action is performed when the end point of the injection simulation is reached (corresponding to the complete implementation of the medicine). Preferably, this is the case when the plunger reaches the end position. At this end position, preferably, the plunger head for pushing the plunger along the cavity and entering the body presses on the release latch to force the release latch to deflect outwardly, thereby releasing the first locking device. The first locking device can, for example, be a docking surface on the release latch that docks with a corresponding docking surface on the body.

According to another aspect of the training device according to the present invention, the training device also includes a reset base. The reset base includes a release inclined portion for disengaging the second locking member when the reset base is assembled with the training device and preferably abuts against each other. Thus, the release inclined portion can apply a certain force to the locking member of the body or the guard so that the second locking member can be disengaged. By disengaging the second locking member, the guard can be moved to the retracted position and the training device is thereby reset. Preferably, the disengagement of the second locking member is performed by inserting the training device into a reset base with a corresponding volume and by further pushing the training device or its components into the reset base, for example, by pushing the training device and the reset base against each other. Preferably, this pushing action is achieved manually. However, it can also be achieved electrically by an electronic reset device provided with a suitable retaining device for holding the training device and the reset base and an actuating device for pushing the two components against each other.

According to aspects of the training device including a reset base, the training device also includes a reset cover. The reset cover includes a pushing element to push the body of the training device toward the distal end of the reset base and into the guard. The pushing element provided in the reset cover can facilitate resetting the training device. By pushing the reset base and the reset cover against each other, the second locking member of the training device passes the release inclined portion of the reset base. This releases the second locking member, and the body guard can be moved relative to and against each other to a retracted position of the guard. This relative movement of the guard and the body against each other can be performed until the first locking device engages with each other and the guard is locked in the retracted position again, and the pins extend from the guard due to the biasing force of the pin biasing member. Preferably, the reset cover and the reset base can have an ergonomic shape, making the operation of the reset device more convenient and thereby further facilitating resetting the training device.

Preferably, the pushing element extends from the inner wall of the reset cover. Preferably, when the reset cover is assembled with the training device, the pushing element only acts on the body of the training device. The pushing element can be formed as a protrusion extending from the inner side wall of the reset cover. When moving in the direction of the reset base and into the reset base, the protrusion on the inner side wall can, for example, be guided longitudinally and laterally past the plunger. However, the pushing element can also be arranged, for example, in the form of one or more pins or hollow tubes, extending from the inner proximal end of the reset cover. The pushing element extending from the inner proximal end is arranged, for example, so as to pass through the plunger head and preferably near and along the plunger rod. Accordingly, the plunger head is provided with one or more openings corresponding to the pushing element passing through the plunger head. Preferably, the pushing element extending from the inner proximal end of the reset cover is provided when the body of the training device has a cross-sectional size or shape substantially corresponding to the extension of the plunger head. Since the pushing element is arranged to push against the body of the training device, the narrow shape of the body can provide a sufficient contact surface for the pushing element to act on the body.

According to another aspect of the training device according to the present invention, the plunger includes a plunger head disposed at the proximal end of the plunger, and the plunger head has a radial extension at least equal to the extension of the proximal end of the reset base opening. Thus, when the body of the training device is pushed toward the distal end of the reset base, the plunger head abuts against the edge of the proximal end of the reset base opening. This allows the plunger to be simultaneously retracted from the cavity, preferably to the same or similar extent as the body was inserted into the guard. Thus, when the reset cap and reset base are moved against each other, preferably along a linear motion, not only the guard can be reset to its initial retracted position, but the plunger can also be reset to its initial extended position, allowing the training device to be used again. Preferably, the extension of the plunger head, such as its diameter, is equal to the extension of the proximal edge of the proximal end of the reset base. If the plunger head extends radially outward from the proximal end of the reset base, it is preferably still smaller than the inner extension of the reset cap, allowing the reset cap to be placed over the training device. Preferably, the reset base and reset cap have a substantially elliptical or non-uniform cross-section. The radial extension of the plunger head then preferably abuts the proximal edge at the minimum extension of the oval or non-uniform cross-section.

According to another aspect of the present invention, a reset device for a training device of the aforementioned medical injection device is provided. The reset device includes a reset base and a reset cover. The reset base includes a hollow body having an open proximal end for accommodating the distal portion of the training device, and a release ramp disposed on the inner sidewall of the hollow body of the reset base for disengaging the locking member of the training device. This allows the guard of the training device to move to a retracted position. The reset cover includes a hollow body having an open distal end for receiving the proximal portion of the training device, and a push element disposed within the reset cover so that the body of the training device can be pushed further into the reset base when the reset device and the training device are assembled.

The advantages of resetting the device have already been described above with reference to aspects of the training device and will therefore not be repeated.

According to aspects of the reset device according to the present invention, the reset base further includes an alignment element disposed at a distal end thereof to align the spike guard within the reset base. The spike guard can be inserted into the reset base and held in place within the reset base by the alignment element. If a training device to be reset is inserted into the reset base provided with the spike guard, the spike guard is attached to the spike using the same process steps as resetting the training device. The provision of the spike guard further allows the training device to be adapted to simulate a one-way, ready-to-use injection device typically provided with a needle guard.

According to another aspect of the reset device according to the present invention, the pushing element of the reset cover comprises a protrusion extending from an inner side wall of the reset cover or a longitudinal spike extending from an inner proximal end wall of the reset cover. The pushing element is configured to push against the body of the training device when the reset cover is assembled with the reset base provided with the training device.

According to another aspect of the present invention, a method for resetting a training device according to the present invention is provided. This method comprises the steps of inserting a used training device into the hollow body of a reset base, placing a reset cover over the proximal end portion of the training device, and pushing the reset base and the reset cover against and preferably over each other. This pushes the body of the training device toward the distal end of the reset base, thereby disengaging the second locking member of the training device and allowing the guard of the training device to advance to a retracted position in which the guard is locked.

According to an aspect of the method according to the invention, the method further comprises the step of bringing the plunger head of the proximal end of the plunger attached to the training device into contact with the proximal end of the reset base, whereby the plunger is withdrawn from the body when the body is pushed in the direction of the distal end of the reset base. Furthermore, by withdrawing the plunger outside the body during the resetting method, i.e., by pushing the reset cap and the reset base against each other, the training device can be completely reset without further manipulation and placed in a condition for reuse.

According to another aspect of the method according to the present invention, the step of pushing the body of the training device in the direction of the distal end of the reset base is performed by providing a pushing element arranged inside the reset cover. In addition, the step of disengaging the second locking member of the training device is performed by pressing a release ramp arranged on the inner side wall of the reset base against the second locking member of the training device.

In some embodiments of the method according to the invention, to perform pushing the body, the pushing element may laterally pass the plunger head of the training device before pushing on the body. The pushing element may also pass through the plunger head to reach a body arranged remote from the plunger head.

According to another aspect of the method according to the invention, the method further comprises the step of inserting a spike protector into the reset base before inserting the training device, preferably in the use state, into the reset base.

The advantages of the aspects of the method for resetting a training device have already been described above with reference to the aspects of the training device and with reference to the aspects of the resetting device and will therefore not be repeated.

The training device according to the present invention is used to simulate the injection of a drug into a patient. Preferably, the simulation is used to simulate the injection of a drug into a human. More preferably, the simulation is used to simulate the injection of a drug for treating arthritis, rheumatism or gout.

The training device may be provided with an extended finger flange portion. This allows the training device to simulate a real injection device equipped with an extended finger flange, either as an integral component of the injection device or as a separate component attached to the injection device, to facilitate use of the real injection device. The extended finger flange is a portion extending laterally, preferably radially, from the training device. Most injection devices are provided with a finger portion. The finger portion holds the injection device in place during administration, i.e., when operating the plunger. The extended finger flange according to the present invention is preferably part of a guard, which ensures that the training device is well held when the plunger is pushed into the body. Preferably, the extended finger flange is an enlarged finger portion, preferably with an ergonomic shape for receiving one or more fingers. The enlarged finger flange may be integrally formed with the guard or may be a separate component. As a separate component, the extended finger flange is preferably clipped, clamped, or otherwise temporarily and removably attached to the training device. The removable finger flange can be removed after use of the training device, for example, for storage during reset. Preferably, the resetting device, such as the resetting base, provides sufficient space for storing the extended finger flange in the base when the training device is not in use. Preferably, the removable finger flange is also adapted to be attached to a real injection device. This facilitates handling of the injection device and allows the same extended finger flange to be used for both the training device and the real injection device.

The training device or the reset device according to the invention can be provided as part of a training system comprising the training device according to the invention and the reset device according to the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, embodiments of a training device according to the invention and a resetting device according to the invention are shown by means of the accompanying drawings, wherein:

FIG1 shows an exploded view of an embodiment of a training device;

FIG2 shows an exploded view of another embodiment of the training device;

3 is a cross-sectional view of the training device with the training device in a position ready for use and an enlarged portion of the guard and the proximal end of the body in the retracted position of the guard;

4-8 are perspective views illustrating a sequence of operation of the training device of FIG. 1 from a ready-to-use position to a use position;

9-14 are perspective views illustrating a sequence of reset operations of the training device of FIG. 1 including corresponding reset devices;

15-19 are perspective views illustrating a sequence of operation of the training device of FIG. 2 from a ready-to-use position to a use position;

20-25 are perspective views illustrating a sequence of reset operations of the training device of FIG. 2 including corresponding reset devices;

FIG. 26 shows an exercise device including extended finger flanges.

DETAILED DESCRIPTION

A first embodiment of the training device is shown in an exploded view in Figure 1. The training device comprises an outer guard 1 for accommodating a spring 3, a nail guard 49 comprising an outer nail protection cover 490 and an inner nail protection cover 491, a nail housing 25 for accommodating a nail 48 and a soft spring 47, and a body 2 for accommodating a plunger 43.

The guard 1 has a generally square hollow body member 10 provided with longitudinally extending slots 11 on each side (front and rear) for receiving and guiding corresponding protrusions 241 of flexible legs 24 provided at the distal end of the body 2. The body 2 includes a generally square hollow body member 20. The flexible legs 24 are arranged on both sides (front and rear) of the body 2. The loose ends of the legs 24 are provided with outwardly directed protrusions 241.

In addition, the guard 1 is provided with snap-fit slots 12 disposed on each side (front and rear) of the body member 10 adjacent to the longitudinally extending slots 11 so as to accommodate the protrusions 241 of the flexible legs 24 and lock the guard 1 and the body 2 when the guard 1 is in the extended position.

At the proximal end of the guard 1, the guard 1 is provided with two flexible tongues 13 for engaging the body 2 and retaining the guard 1 in the retracted position. In the retracted position, the proximal free ends of the tongues 13 extend through two flanges 22 provided at the proximal end of the body member 20 of the body 2. The flexible tongues 13 include projections 130. When the guard 1 is in the retracted position, the lower edges of the projections 130 of the flexible tongues 13 are intended to rest on corresponding upper edges (not shown) of the two flanges 22 provided on the body member 20. This snap-fit connection can be released by pressing the flexible tongues 13 radially outward.

A coil spring 3 is arranged between the body 2 and the guard 3. In the retracted position, in which the body 2 remains within the guard 1, the spring 3 is compressed. In the extended position of the guard 1, the spring 3 is released and the body 2 is pushed in the proximal direction.

The guard 1 also includes an open distal end so that the spike 48 extends through the open distal end when the guard is in the retracted position.

The nail housing 25 is provided with a protrusion 210 that is slidable and guided in the longitudinally extending slot 11 of the guard 1, so as to provide a stop when the guard 1 is in the retracted position while cooperating with the proximal end of the longitudinally extending slot. The nail housing 25 also includes a locking device 250 for (non-releasable) snap-fit connection with the body 2. A soft spring 47 is arranged in the nail housing 25 between the enlarged proximal end 480 of the nail 48 and the closed bottom 23 of the body 2 at the distal end of the body 2.

The plunger 43 includes two leaf springs 44, which can be made of a single piece of material and are arranged on two opposite (lateral) sides of the plunger at its distal end. The leaf springs 44 extend from the distal end of the plunger along a portion of the plunger and extend radially from the distal end. The leaf springs 44 are elastically compressible along the direction of the plunger rod 431, thereby applying a certain force that can be adjusted by the selection and form of the leaf springs 44. The force required to compress and move the leaf springs along the cavity in the body member 20 when the plunger is assembled with the body 2 represents and simulates the injection resistance of a real injection device caused by the administration of the drug.

Another embodiment of the training device is shown in an exploded view in Figure 2. The same reference numerals have been used for identical or similar elements. Reference is made to features that differ from the first embodiment of Figure 1 .

The body member 10 of the guard 1 has a circular hollow body. The guard locking member for locking the guard 1 in the retracted position is formed as two short cantilevered arms 14 arranged in two flanges 15 at the proximal end of the guard 1 and on both sides of the guard 1. The cantilevered arms 14 have protrusions 141 at their distal ends and are flexible and bendable radially outward. The lower edges of the protrusions 141 of the cantilevered arms 14 are adapted to rest on corresponding upper edges 270 of protrusions 27 arranged at the periphery of the body member 20 of the body 2.

The protrusion 210 of the nail housing 25 is formed as a flap that is guided outward from the proximal end of the nail housing 25 and to the proximal end of the nail housing 25. This protrusion 210 is slidable and guided in the longitudinally extending slot 11 of the guard 1 and provides a stop when the guard 1 is in the retracted position while cooperating with the proximal end of the longitudinally extending slot 11.

The body 2 can be completely inserted into the guard 1. Therefore, the proximal end of the body 2 has a substantially circular shape with a sufficiently small diameter so that the body 2 is completely immersed in the flange 15 of the guard 1. The plunger 43 includes a plunger head 430 having an open structure so that a push element of a reset device passes through the plunger head and is guided close to the plunger rod 431, which will be described in detail below.

The simulation of the injection resistance is further described and illustrated in FIG3 with reference to the embodiment according to FIG1 . However, the simulation of the injection resistance can be implemented in the same or similar manner independently of the implementation of the other features of the training device. The left-hand side of FIG3 schematically shows the training device in an assembled state ready for use. The plunger 43 is inserted into a cavity formed inside the main body member 20 of the body 2. A leaf spring 44, preferably formed from a single piece of sheet metal, extends radially from the plunger and is guided to the proximal end of the plunger 43. The leaf spring is attached to the distal end of the plunger 43. Preferably, the leaf spring is sheared and permanently attached to the plunger by a permanently deformed pin 441. This can be achieved, for example, by ultrasonic welding, for example using a pin and preferably also using a plunger or distal plunger end made of or containing a thermoplastic material. However, it is also possible to provide a pin made of thermoplastic material and a plunger material having an open structure so that the molten material of the pin can pass through the material of the plunger to provide a form lock. Furthermore, the attachment of the leaf spring may be achieved by other means, such as by screws, rivets or mechanical clamps or any other method suitable for attaching a leaf spring, such as a press fit.

In the extended position of the plunger 43 as shown in Figure 3, the proximal end 440 of the leaf spring 44 is located in a recess 201 formed on the inner wall of the body member 20 and at the proximal end of the body member 20. The proximal end 440 of the leaf spring 44 is provided with an end stop for docking with a mechanical stop 202 arranged at the proximal end of the recess 201. This prevents the plunger 43 from being unfavorably removed from the body member 20 when the plunger 34 is pulled to the extended position (for example, as part of a reset action). In addition, the starting position for the injection simulation is defined and reproducible. Until now, the plunger 43 has been pressed into the distal direction of the training device via the plunger head 430, the leaf spring 44 is compressed and it simulates the injection resistance against the resistance of the inner side wall of the body member 20.

Figures 4 to 8 illustrate the operation of the training device according to Figure 1, simulating the use of a real injection device. In Figure 4, the training device represents a disposable, ready-to-use injection device with a spike guard 49 attached to the training device. The guard 1 and body 2 are locked against each other in the extended position of the guard 1. The protrusions 130 on the flexible legs 13 engage corresponding edges inside the flange 22 of the body 2.

The spike guard 49 is removed ( FIG. 5 ) and the training device is placed on the user's skin. When pressure is applied to the tip of the spike 48, the spring 47 is compressed (see also FIG. 1 ) and the spike 48 partially moves into the spike housing 25 (not shown in FIG. 6 ).

The plunger 43 is accordingly moved within the body member 20 by pressing the plunger head 430 in a direction toward the distal end of the training device or guard 1. When the plunger head 430 reaches the outer end of the tongue 13, this corresponds to the end of the simulated administration of the appropriate amount of medication. The larger diameter of the plunger head 430 then causes the tongue 13 to bend outward, thereby releasing the guard 1 from its defined retracted position. The spring 3 then releases pressure and moves the body 2 and the spike 48 in the proximal direction ( FIG. 7 ; accordingly, the body 2 is not fully retracted or the guard 1 is not fully extended). The guided movement of the body 2 relative to the guard 1 continues until the protrusion 241 reaches the snap-fit slot 12 and engages therein to form a snap fit ( FIG. 8 ). The spike is now fully disposed within the guard 1, simulating needle protection when the guard 1 is in the extended position. The training device is now in a used state, representing a discarded situation for a real injection device. However, the training device can be reset to a condition for reuse, and this reset mechanism is shown in Figures 9 to 14.

In order to reset the training device, the locking mechanism that locks the guard 1 in the extended position covering the spikes 48 must be released ( FIG. 8 ). Furthermore, the plunger 43 must be moved to its extended position outside the body 2 ( FIG. 4 and FIG. 14 ). In FIG. 9 to FIG. 14 , the direction of movement of the training device, the reset device, or a component of these devices is indicated by an open arrow 100.

To reset a used training device, the nail guard 49 is inserted into the oval reset base 5. The end of the nail guard 49 for receiving the nail 48 (not shown) is guided to the proximal end of the reset device (Figure 9). The nail guard 49 is aligned with and retained in the circular protrusion 51 extending from the inner bottom wall of the reset base 5. The used training device is inserted into the reset base 5 (Figure 10). The oval reset cover 6 is placed above the training device in the reset base 5 (Figures 11 and 12) and pushed in the direction of the distal end of the reset base 5. The reset cover 6 includes longitudinally extending ribs 61 arranged on two opposite sides of the reset cover 6 (only one side is shown). The distal end 610 of the longitudinal rib 61 abuts the proximal edge 220 of the flange 22 of the body 2. As a result, the training device is pushed further into the reset base 5 until the plunger head 430 docks with the proximal edge 54 of the reset base 5. The body 2, but not the plunger 43, is then pushed further into the guard 1 against the force of the coil spring 3 (see Figure 1). As a result, the body 2 presses inwardly on the protrusion 241 of the leg 24 as it passes the release ramp 55 arranged on the inner sidewall of the base 5. The release ramp 55 presses on the protrusion 241, allowing it to pass through the locking slot 12 and release the lock between the guard 1 and the body 2. The guard 1 and body 2 are then repositioned into the guard's retracted position. Through the same movement, the plunger 43 is pulled out of the body 2, making the training device usable again. The plunger 43 is guided by the reset cover 6. When the training device in the reset device is ready for use again, the reset base 5 is provided with an opening 57 into which the protrusion 241 extends. The reset base 5 and reset cover 6 are essentially hollow tubes with closed distal and proximal ends, respectively. They also form a storage device for resetting or ready-to-use training devices. Therefore, it may be advantageous to keep the legs 24 of the body 2 in a decompressed state. The reset base 5 and the reset cover 6 are provided with cooperating snap-fit means 56 to form a releasable snap fit between the base and the reset cover 6 so as to retain them in an assembled state.

15 to 19 illustrate the operation of the training device according to FIG. 2 . Again, the protective spike 49 is removed from the training device and the plunger head 430 is pushed into the body 2. In the extended position, the plunger head 430 is fully inserted into the flange 15 of the guard 1 and presses against the protrusions 141 on the cantilever 14 ( FIG. 17 ). These are pushed radially outward to release the lock between the guard 1 and the body 2. The force of the spring 3 moves the body 2 and the guard 1 relative to each other into the extended position of the guard 1, while guiding the protrusions 241 along the longitudinal slots 11 ( FIG. 18 ). This movement is performed until the protrusions 241 engage in the engaging slots 12 and lock the guard and the body 2 in the extended position of the guard 1.

Figures 20-25 illustrate the reset mechanism of the training device according to Figures 2 and 19. In this embodiment, the reset base 5 is provided with a peripherally extending reset ramp 58 protruding from the inner sidewall of the reset base 5 (Figure 20). The plunger head 430 is provided with four through-holes 4301 (Figure 21). The through-holes are arranged around the center of the plunger head 430 so that four pins 62 extending from the proximal inner end wall of the reset cover 6 can extend through the through-holes and guide to the adjacent plunger rod 431 (Figures 22-24). When the training device is pushed into the reset base 5, the plunger head 430 docks with the proximal edge 54 of the reset base 5. Once again, the body 2, rather than the plunger 43, is further pushed into the guard 1 by the pushing action of the pins 62 against the force of the coil spring 3. As a result, the body 2 presses the protrusion 241 of the leg 24 inwardly when it passes the release ramp. The lock between the guard 1 and the body 2 is released and the guard 1 and the body 2 are brought back into the retracted position of the guard 1 so that the cantilevered projection 141 interlocks with the upper edge 227 of the projection 27 of the body ( FIG. 25 ). By the same movement, the plunger 43 is pulled out of the body 2 and guided by the pin 62 of the reset cover 6.

FIG26 shows a training device with an extended finger flange 7. The extended finger 7 is provided as a separate component (shown in the bottom left portion of FIG26 ) that can be removably attached to the training device. The extended finger flange 7 is in the form of a portion of a disc-shaped element. When the extended finger flange 7 is attached to the training device, i.e., to the guard 1, the extended finger flange 7 extends laterally from the training device. It extends in two opposing lateral directions. By using the extended finger flange 7, the flange 22 of the guard 1 for clamping the device can be extended when the plunger 43 is pushed into the body of the device. This facilitates the gripping and thus the operation of the training device. Furthermore, if a real injection device is provided with an extended finger flange, the simulation of this real device can be performed in a more realistic manner.

Claims (15)

1. A training device for a medical injection device, the training device comprising: Body (2), having a proximal end and a distal end and a cavity formed therein; A protective element (1) having a proximal end and a distal end, the protective element (1) being slidably attached to the body (2) and being slidable between a retracted position and an extended position, wherein the retracted position exposes a pin (48) disposed at the distal end of the body (2) and guided from the distal end of the body; and the extended position covers the pin (48). A spring (3) is attached to the body (2) and the guard (1), the spring biasing the guard (1) so that the guard can move toward the extended position; A releasable first locking member (27, 13, 14) is located on the body and the guard to engage with the body and the guard to hold the guard (1) in the retracted position; and Releasable second locking members (241, 12) are located on the body (2) and the guard (1) to engage with the body (2) and the guard (1) to hold the guard in the extended position; The training equipment also includes: A plunger (43), slidably disposed within the cavity of the body (2), the plunger (43) comprising a compressible element (44) adapted to apply a force to the plunger as it moves within the cavity toward the distal end of the body, the force corresponding to the injection resistance of a drug injected into the patient. The nail (48) is slidably arranged in a nail mounting element (25), wherein the nail mounting element includes a nail biasing member (47) adapted to be tensioned when the nail (48) moves in a proximal direction. 2. The training device according to claim 1, wherein the compressible element includes a leaf spring (44) mounted to the distal end of the plunger (43), wherein the leaf spring (44) extends radially outward along a portion of the plunger and from the plunger (43). 3. The training device according to claim 1, wherein the body (2) has a docking portion (201, 202) at its proximal end, the docking portion (201, 202) being adapted to cooperate with an end stop (440) disposed at the plunger (43) to prevent the plunger from being completely removed from the cavity when the plunger (43) moves in the proximal direction. 4. The training device according to claim 3, wherein the docking portion is a recess (201) in the inner wall of the body (2), and the end stop is the proximal end (440) of the compressible element (44). 5. The training device according to any one of claims 1 to 4, wherein the releasable first locking member (27, 13, 14) includes a release latch (13, 14) disposed at the proximal end of the protective member (1), the release latch being outwardly deflectable to disengage the releasable first locking member (27, 13, 14) and thereby allowing the protective member (1) to advance to the extended position. 6. The training device according to any one of claims 1 to 4 further includes a reset base (5), the reset base (5) including a release tilt (55, 58) for disengaging the releasable second locking member (241, 12) when the reset base (5) is assembled with the training device. 7. The training device according to claim 6 further includes a reset cover (6), the reset cover (6) including push elements (61, 62) for pushing the body (2) of the training device toward the distal end of the reset base (5) and into the protective member (1). 8. The training device according to claim 7, wherein the plunger (43) includes a plunger head (430) disposed at the proximal end of the plunger, and wherein the radial extension of the plunger head (430) is at least equal to the extension of the proximal end of the opening of the reset base (5), such that when the body (2) of the training device is pushed toward the distal end of the reset base (5), the plunger head abuts against the edge (54) of the proximal end of the opening forming the reset base. 9. A reset device for a training device for a medical injection device according to any one of claims 1-8, the reset device comprising a reset base (5) and a reset cover (6), The reset base (5) includes: A hollow body having an open proximal end for accommodating the distal portion of the training device; Release tilting parts (55, 58), which are arranged on the inner sidewall of the hollow body of the reset base (5), are used to disengage the releasable second locking member (241, 12) of the training device, thereby allowing the protective member (1) of the training device to move to the retracted position. The reset cover (6) includes: A hollow body having an open distal end for accommodating a proximal portion of the training device; A pushing element (61, 62), which is arranged inside the reset cover (6), is used to further push the body (2) of the training device into the reset base (5) when the reset device is assembled with the training device. 10. The reset device according to claim 9, wherein the reset base (5) further includes an alignment element (51) disposed at a distal end of the reset base for aligning the nail protector (49) in the reset base (5). 11. The reset device according to claim 9 or 10, wherein the pushing element (61, 62) of the reset cover (6) includes a protrusion (61) extending from the inner sidewall of the reset cover (6) or includes a longitudinal pin (62) extending from the inner proximal wall of the reset cover (6). 12. A method for resetting a training device according to any one of claims 1-8, Insert the training device, which is in a used state, into the hollow body of the reset base (5); Place the reset cover (6) above the proximal portion of the training device; The reset base (5) and the reset cover (6) are pushed against each other, thereby pushing the body (2) of the training device toward the distal end of the reset base, thereby disengaging the releasable second locking member (241, 12) of the training device to allow the protective member (1) of the training device to advance to the retracted position and lock the protective member (1) in the retracted position. 13. The method according to claim 12, further comprising the step of bringing the plunger head (430) of the proximal end of the plunger (43) attached to the training device against the proximal end of the reset base (5), thereby retracting the plunger (43) from the body (2) when the body (2) is pushed toward the distal end of the reset base (5). 14. The method according to claim 12 or 13, wherein the step of pushing the body (2) of the training device toward the distal end of the reset base (5) is performed by providing a pushing element (61, 62) disposed inside the reset cover (6), and wherein the step of disengaging the releasable second locking member (241, 12) of the training device is performed by pressing a release tilt (55, 58) disposed on the inner sidewall of the reset base (5) against the releasable second locking member (241, 12) of the training device. 15. The method according to claim 12 or 13, further comprising the step of inserting a nail protector (49) into the reset base (5) before inserting the training device into the reset base (5).