Training devices, systems, and methods

Abstract

A system is provided, comprising a training drug delivery device and a user device, the training drug delivery device comprising a body, a cap, and a delivery activation button, the training drug delivery device further comprising a controller, a memory, a wireless unit for communicating with the user device, a driver for simulating a haptic response of a drug delivery device, and at least one sensor for measuring attachment of the cap and pressing of the delivery activation button; the user device comprising a controller, a memory, and a wireless unit; the training drug delivery device being adapted for: connecting to the user device using the wireless unit; and transmitting sensor measurements to the user device; the user device being configured for: connecting to the training drug delivery device using the wireless unit; receiving the sensor measurements from the training drug delivery device; and providing feedback to a user regarding operating the training drug delivery device based at least in part on the received sensor measurements.

Description

Technical Field

[0001] This disclosure relates to a training device, a training system, and a method of operating the training device and system. Background Technology

[0002] Medication delivery devices (such as pen-type drug delivery devices, insulin pumps, blood glucose monitoring devices, and auto-injectors) are used in situations where routine injections are performed by people without formal medical training. This is becoming increasingly common among people with diabetes, for whom self-management allows for effective management of their diabetes.

[0003] For example, a pre-filled disposable insulin pen can be used as a drug delivery device. Alternatively, a reusable pen can be used. A reusable pen allows empty cartridges to be replaced with new ones. Either type of pen may come with a set of needles, which must be replaced before each use. The insulin dose to be injected can then be manually selected, for example, at the insulin pen by turning the dose dial and observing the actual dose through the insulin pen's dose window. The dose is then injected by inserting the needle into the appropriate skin site and pressing the injection button on the insulin pen.

[0004] Typically, users of drug delivery devices are patients who have not received any formal medical training. It is desirable to provide these users with training on the use of the drug delivery device. Different users prefer different learning and instruction methods and respond to different training models. However, available training tools (e.g., existing written manuals or videos) may not provide training that a particular user will find comprehensive enough and / or easy to remember.

[0005] Therefore, training tools need to be improved. Summary of the Invention

[0006] In a first aspect, a system is provided comprising a training drug delivery device and a user device, the training drug delivery device comprising a body, a cap, and a delivery activation button, the training drug delivery device further comprising a controller, a memory, a wireless unit for communicating with the user device, a driver for simulating tactile responses of the drug delivery device, and at least one sensor for measuring attachment of the cap and pressing of the delivery activation button; the user device comprising the controller, the memory, and the wireless unit; the training drug delivery device being adapted to: connect to the user device using the wireless unit; and transmit sensor measurement results to the user device; the user device being configured to: connect to the training drug delivery device using the wireless unit; receive sensor measurement results from the training drug delivery device; and provide feedback to the user regarding operation of the training drug delivery device, at least in part based on the received sensor measurement results.

[0007] In various implementations, one or more of the following features may be used:

[0008] - The training drug delivery device includes at least one of the following: an injection mechanism, a dose dial for selecting a dose, a dose window for displaying the selected dose, and a needle;

[0009] - The training drug delivery device further includes at least one sensor for measuring one or more of the following: the position of the training drug delivery device, the orientation of the training drug delivery device, the torque applied to the dosing dial, the force applied to the injection mechanism, the attachment of the cap covering at least a portion of the body, the attachment of the cap covering the needle, and the attachment of the needle.

[0010] - Provide the feedback to the user using augmented reality or virtual reality provided by the user device;

[0011] - The training drug delivery device includes at least one window-shaped region defined on the body, the window-shaped region being adapted to support augmented reality / virtual reality projection;

[0012] -The user device is configured to project information onto a drug window or a dosage window or both;

[0013] - The user device is adapted to transmit tactile response parameters to the training drug delivery device, and the training drug delivery device is adapted to receive the tactile response parameters from the user device;

[0014] - The tactile response parameters include parameters that define the response of the dosage dial and / or the injection mechanism;

[0015] - The tactile response parameters define the dosage dial's response to being rotated and / or the injection mechanism's response to being pressed, with a click or resistance, wherein the resistance is provided by the actuator;

[0016] - The drug delivery device is configured to: use the at least one sensor to detect user operation of the training drug delivery device; transmit the sensor indication to the user device using the wireless module, the sensor indication corresponding to the user operation of the training drug delivery device, the sensor indication including at least one of the following: position of the training drug delivery device, torque applied to the dosing dial, force applied to the injection mechanism, attachment of the cap covering at least a portion of the body, attachment of the cap covering the needle, and attachment of the needle; and wherein the user device is configured to: in response to receiving the sensor indication, indicate to the user whether the user operation of the training drug delivery device is correct;

[0017] - The training drug delivery device includes a container adapted for filling with liquid, or wherein the training drug delivery device is adapted for containing a drug cartridge;

[0018] - The system further includes a training pad that simulates the user's skin;

[0019] - The tactile response of the drug delivery device is based on parameters of the tactile response received from the user device;

[0020] The training drug delivery device further includes a needle shield and a needle shield activation button.

[0021] In a second aspect, a training drug delivery device is provided, the training drug delivery device including a body, a cap and a delivery activation button, the training drug delivery device further including a controller, a memory, a wireless unit for communicating with the user device, a driver for simulating tactile responses of the drug delivery device, and at least one sensor for measuring attachment of the cap and pressing of the delivery activation button; the training drug delivery device is adapted to: connect to the user device using the wireless unit; and transmit sensor indications to the user device.

[0022] In a third aspect, a training drug delivery device is provided, which is adapted for use with any implementation of the system described in conjunction with the first aspect.

[0023] In a fourth aspect, a user device is provided, the user device including a controller, a memory, and a wireless unit; the user device is configured to: connect to the training drug delivery device using the wireless unit; receive sensor indications from the training drug delivery device; transmit tactile response parameters to the training drug delivery device; and provide feedback to the user regarding the use of the training drug delivery device, at least in part based on the received sensor measurements.

[0024] In a fifth aspect, a user device is provided that is adapted for use with any implementation of the system described in conjunction with the first aspect.

[0025] By utilizing the features described above, the system, apparatus, and method offer the following advantages.

[0026] The user training can be standardized, providing the same training to every user (patient). The training can be independent of the specific healthcare professional providing the training or other individual circumstances. Users can easily return to sections of training they feel they need to repeat (e.g., because the user did not correctly understand a particular part of the training). This can encourage users to complete the training correctly while fully understanding the operation of the drug delivery device.

[0027] Once the user completes the training, a certificate can be issued automatically. This certificate can serve as proof, for the user and / or for the drug manufacturer, that the user has been properly trained on the use of the drug delivery device.

[0028] The system described above allows for enhancements in differentiation testing. Typically, differentiation testing (i.e., testing whether a drug delivery device differs from other similar drug delivery devices and is therefore identifiable to the user) is part of the design process for the drug delivery device and can be inferred using only a small to medium-sized set of users. Using the systems, devices, and methods described above, each user can undergo differentiation testing. The results can be collected for statistical purposes. This differentiation testing helps the user understand the differences between their drug delivery device and other drug delivery devices (belonging to the same user or other users), thereby reducing the risk of administering the wrong medication and / or the wrong dosage. With the aid of augmented reality or virtual reality, differentiation testing can be performed on each user under adverse conditions (e.g., simulating the appearance of the drug delivery device in dim lighting). In this way, the risk of the user making an error when selecting the correct drug delivery device under adverse conditions can be reduced. Attached Figure Description

[0029] Figure 1a is an exploded view of the training drug delivery device;

[0030] Figure 1b illustrates a system for training a drug delivery device, a user device, and augmented reality (AR) or virtual reality (VR) glasses;

[0031] Figure 2 is a schematic diagram of the electronic components of the training drug delivery device;

[0032] Figure 3 is a flowchart of an example training process using a system for training drug delivery devices, user devices, and / or augmented reality (AR) or virtual reality (VR) glasses;

[0033] Figure 4 is a flowchart of the drug delivery device recognition training from Figure 3;

[0034] Figure 5 is a flowchart of the operation training of the drug delivery device from Figure 3;

[0035] Figure 6 is a flowchart of drug and drug device training from Figure 3;

[0036] Figure 7 is a flowchart of the supervised first use of the drug delivery device from Figure 3;

[0037] Figure 8 is a flowchart of the training of the refilled drug delivery device from Figure 3;

[0038] Figure 9 is a flowchart of an example setup and training process for a system using a training drug delivery device, user device, and / or augmented reality (AR) or virtual reality (VR) glasses;

[0039] Figures 10 to 14 show examples of distinguishing features. Detailed Implementation

[0040] Figure 1a is an exploded view of the training drug delivery device 1, which may represent Sanofi's Solostar™ insulin pen.

[0041] Figure 1b is a schematic diagram of a training system, which includes a training drug delivery device 1 and two user devices 2 and 3: a mobile device 2 and augmented reality (AR) or virtual reality (VR) glasses 3.

[0042] User devices 2 and 3 can be, for example, electronic devices such as mobile phones or tablet computers (more generally, mobile devices). User device 2 can be a desktop PC, laptop computer, or tablet computer. User device 2 includes a screen 23. At least one camera 21 is associated with user device 2. Camera 23 can be an integral part of user device 2. Camera 21 can be a front-facing camera or a rear-facing camera. Camera 21 can be an external camera, such as a webcam.

[0043] User devices 2 and 3 can be, for example, AR / VR glasses 3. AR / VR glasses 3 can be a head mount for mobile device 2. AR / VR glasses 3 can be a device independent of mobile device 2. If AR / VR glasses 12 are independent of the mobile device, then mobile device 2 can be optional.

[0044] The training drug delivery device 1 is shown in detail in FIG1a. The training drug delivery device 1 includes a housing 10. Typically, the housing 10 is provided with a delivery activation button. The delivery activation button is often provided in the form of an injection mechanism (e.g., an injection button) 11. The body 10 of the training drug delivery device 1 in the figure further includes a dose dial 12, a dose window 13, and a container area 14.

[0045] Needle 15 may be attached to container area 14. Needle 15 may be a genuine disposable needle, or it may be a training needle, for example having the same overall shape but without a sharp end and not capable of penetrating the skin (not shown).

[0046] The housing 10 is further provided with a cap 18 that covers the container area 14 when the training drug delivery device 1 is not in use. The needle 15 is not attached when the training drug delivery device 1 is not in use. The cap 18 must be removed before attaching the needle 15 to the housing 1.

[0047] The housing 10 is provided with a container region 14 to which the needle 15 can be attached. In one embodiment, the container region 14 contains a container. The container may be refillable and may be adapted to be filled with a suitable liquid, such as water or a training alternative to insulin. In one embodiment, it is not possible to fill the container. In one embodiment, the container region 14 may be adapted to receive a training medication cartridge (not shown), such as a training insulin cartridge. In one embodiment, the container region 14 does not contain a container.

[0048] Container area 14 may include a drug window 14a. Drug window 14a may be a real window (i.e., an opening through which a user can see the container and / or its contents). In embodiments, the drug window is a simulated window. The simulated window may be a window-shaped area defined on container area 14. Window-shaped area 14a may be filled with a neutral color (e.g., gray, green, or blue) to support keying or other suitable video, augmented reality, or virtual reality projection. Window-shaped area 14a can therefore be adapted for interaction with augmented reality or virtual reality sets (described below).

[0049] In this embodiment, the training drug delivery device 1 has the same size and weight as the actual drug delivery device. In this embodiment, the size, color, and design of each element of the training drug delivery device 1 correspond to the size, color, and design of the elements of the actual drug delivery device 1. In this embodiment, the training drug delivery device 1 is provided in a neutral color (e.g., gray, green, or blue to support keying or other suitable video, augmented reality, or virtual reality projection), and user devices 2 and 3 are adapted to project the colors and designs of the elements of the actual drug delivery device onto the training drug delivery device 1.

[0050] The appropriate dose of medication can be selected by rotating the dosage dial 12. In the training drug delivery device 1, the dosage dial 12 can be connected to a driver 55 (see Figure 2) that provides a tactile response simulating the response provided by a real drug delivery device (e.g., an insulin pen). More generally, the driver 55 can provide mechanical force and / or resistance simulation. The driver 55 can function as a mechanical force and / or mechanical resistance generator.

[0051] The dosage dial 12 can also be connected to the torque sensor 56 and the counter 57, and is adapted to detect the selected or reselected dosage. In response, user devices 2 and 3 can indicate to the user whether the selected dosage is correct.

[0052] The selected dose can be displayed via a dose window 13, for example, as a multiple of an insulin dose in so-called International Units (IU), where one IU is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). An example of a selected dose displayed in dose window 13 could be, for example, 30 IU, as shown in Figure 1. Dose window 13 can be a physical window with a digital or analog display. In an embodiment, dose window 13 is an analog window. The analog window can be a window-shaped area defined near the dose dial 12. The window-shaped area can be filled with a neutral color (e.g., gray, green, or blue) to support keying or other suitable video, augmented reality, or virtual reality projection. The window-shaped area can thus be adapted for interaction with AR / VR glasses 3.

[0053] Rotating the dosing dial 12 can cause a mechanical clicking sound to provide a tactile and acoustic response to the user. In this embodiment, the tactile and acoustic response provided to the user is the same as that provided by a real drug delivery device. In this embodiment, rotating the dosing dial 12 increases the distance between the dosing dial 12 of the drug delivery device 1 and the body 10.

[0054] The housing 10 includes an injection mechanism 11. This injection mechanism may be, for example, an injection button 11. In one embodiment, pressing the injection button 11 provides a tactile and acoustic response to the user. For example, the distance between the dosage dial 12 of the drug delivery device 1 and the body 10 decreases when the injection button 11 is pressed, as is the case with a real drug delivery device. Alternatively or additionally, a mechanical clicker may also produce a sound when the injection button 11 is pressed, similar to a real drug delivery device. In this embodiment, the tactile and acoustic response provided to the user is the same as that provided by a real drug delivery device. Pressing the injection button 11 simulates drug delivery.

[0055] In a preferred embodiment, the training drug delivery device 1 does not contain an actual drug. The training drug delivery device 1 may contain water or a placebo. The training drug delivery device 1 may contain any suitable liquid without pharmacological activity (e.g., saline). The training drug delivery device 1 may not contain any liquid; for example, the training drug delivery device 1 may contain air, or no container may be provided, and the training drug delivery device 1 may not contain any fluid.

[0056] The needle 15 is protected by an inner needle cap 16 and an outer needle cap 17. The needle 15 can be screwed or pressed onto the needle tip 14b of the container area 14. The needle tip 14b may be provided with an attachment sensor 61, which measures the position and correct attachment of the needle 15.

[0057] Figure 2 is a schematic representation of the electronic features of the training drug delivery device 1. The training drug delivery device 1 includes an on / off switch 51, a controller 52, a memory 62, and a battery 53. The training drug delivery device 1 also includes a wireless unit 54, such as a Bluetooth unit or a Wi-Fi unit. The wireless unit 54 enables the training drug delivery device 1 to be connected to user devices 2 and 3.

[0058] The training drug delivery device 1 preferably includes a driver 55, a torque sensor 56, and a counter 57. The driver 55, torque sensor 56, and counter 57 are connected to a dose dial 12 and an injection button 11. The driver 55 may be, for example, a motor, a generator, a stepper motor that generates DC pulses for each unit selected on the dose dial 55, or an electromechanical (E / M) driver.

[0059] When the dosing dial 12 is turned to select a dose and / or when the injection button 11 is pressed to release the dose, the actuator 55 may provide a tactile response to the user. For example, a click and / or resistance similar to, or the same as, that of a real drug delivery device when the dosing dial is turned and / or the injection button is pressed.

[0060] Preferably, the training drug delivery device 1 is capable of providing the user with a tactile response (feedback) similar to or identical to that of a real drug delivery device. Since this depends on which specific type of real drug delivery device the user needs to be trained on, the training drug delivery device 1 can be programmed to simulate several different drug delivery devices. User devices 2, 3 can, for example, transmit a set of tactile response parameters to the training drug delivery device 1 based on the selection of the device the user is being trained on. Preferably, the tactile response parameters include parameters defining the response of the dosage dial 12, injection button 11, and other features. Preferably, these parameters can be adjusted according to the user being trained on the drug delivery device and / or the user being trained on the drug and / or other considerations.

[0061] For example, the force required to press the injection button 11 may vary depending on the specific device and / or the viscosity of the specific drug; the force required to press the injection button 11 in the training drug delivery device may be adjusted accordingly based on which device the user is trained for and / or which drug the user is being trained for.

[0062] For example, the force required to turn the dosage dial 12 and thus select a particular dosage may depend on the specific drug delivery device. The force can be adjusted accordingly based on the specific drug delivery device the user is training with.

[0063] In one example, the injection button 11 can be blocked, i.e., set so that it cannot be pressed, to simulate a blocked needle. In this case, the user may need to replace the needle.

[0064] Actuator 55 can be adapted to lower and lock the needle guard. In some drug delivery devices, needle 15 is a safety needle (not shown). A safety needle is a needle protected by a guard after use. The guard may be, for example, spring-loaded and can be lowered and locked in place once the drug dose has been administered. Actuator 55 can be adapted to release the needle guard. The release of the needle guard can occur upon command from user devices 2, 3.

[0065] Driver 55 can be adapted to further emulate one or more of the following:

[0066] - The force required to press the injection button 11 depends on the viscosity of the specific drug and the specific drug delivery device;

[0067] - The time required for a drug delivery device to inject the full dose of medication depends on the viscosity of the specific drug and the specific drug delivery device.

[0068] - The primary pack stopper of pen injectors and auto-injectors moves (i.e., the maximum dose back stop and the last dose back stop corresponding to the maximum amount that the pen can select (e.g., 80 units), the back stop being a mechanical stop that prevents more dose than the remaining dose in the cartridge from being selected).

[0069] - In some drug delivery devices, a clicking sound is provided to the user as feedback to indicate that the drug has begun to be delivered (first click) and that the drug delivery has been completed (second click).

[0070] - The clicking sound and force required to turn the dosage dial 12;

[0071] - Locking and / or unlocking is provided in some drug delivery devices for the needle guard lock, which drops and locks in place after a successful full dose of medication to protect the (used) needle 15.

[0072] The actuator 55 can be further adapted to reset the training drug delivery device 1 to its original position after the user's operation (user training) is completed.

[0073] Torque sensor 56 and counter 57 can be adapted to measure the dose selected by the user by rotating the dose dial 12. Information obtained from torque sensor 56 and counter 57 can be sent to user devices 2 and 3 for further processing. For example, user devices 2 and 3 can be adapted to correctly assess whether the user has selected the correct dose based on pre-stored or pre-programmed data.

[0074] The training drug delivery device 1 also includes one or more sensors 58-61. For example, the training drug delivery device 1 may have a force sensor 58, a position sensor 59, a position sensor 60, and an attachment sensor 61.

[0075] A force sensor 58 can be connected to the injection button 11 to detect the force applied by the user when pressing the injection button 11. Information obtained from the force sensor 58 can be sent to user devices 2 and 3 for further processing. For example, user devices 2 and 3 can be adapted to assess whether the user pressed the injection button 11 with the correct force and for the correct duration to release the full dose of medication. For example, the time required to release the full dose of medication can be between 5 and 15 seconds. This time can depend on the specific drug delivery device and / or the specific drug. Preferably, for a specific combination of drug and drug delivery device, the time required to release the full dose of medication is stored in user devices 2 and 3.

[0076] Multiple position sensors 59 and 60 can be configured. Two position sensors 59 and 60 are shown in Figure 2. There can be one position sensor, or there can be more than two. Position sensors 59 and 60 are adapted to detect the position of the training drug delivery device 1. Position sensors 59 and 60 measure the position of the training drug delivery device 1 and changes in that position (indicating user actions on the training drug delivery device 1). The position of the training drug delivery device 1 detected by position sensors 59 and 60 is transmitted to user devices 2 and 3. User devices 2 and 3 can use the information transmitted from position sensors 59 and 60 in AR / VR processing. For example, the position of the training drug delivery device 1 can be used to correctly align information displayed on the dosage window 13, drug window 14a, etc.

[0077] At least one of position sensors 58 and 59 can be adapted for detecting the removal and / or reattachment of the cap 18. At least one of position sensors 58 and 59 can be adapted for detecting the attachment and / or removal and / or lowering of the sheath of the needle 15. Suitable sensors adapted for detecting the removal and / or reattachment of the cap 18 can be, for example, switches or capacitive sensors. Suitable sensors adapted for detecting the attachment and / or removal and / or lowering of the sheath of the needle 15 can be, for example, switches, capacitive sensors, proximity sensors, or contact-based sensors (e.g., piezoelectric sensors).

[0078] The attachment sensor 61 can be adapted to detect the position of the needle 15 on the needle tip 14b of the container area 14. The detected position of the needle 15 on the needle tip 14b of the container area 14 can be transmitted to user devices 2 and 3, where it is used to assess whether the user has attached the needle 15 in the correct position and / or in the correct manner. A suitable sensor adapted to detect the position of the needle 15 on the needle tip 14b of the container area 14 can be, for example, a switch or a capacitive sensor.

[0079] User devices 2 and 3 may provide various training or support options. The training provided may focus, for example, on: identifying the correct drug delivery device to be used (e.g., the correct selection among several different drug delivery devices); operating the drug delivery device; training related to the drug to be injected with the drug delivery device; and assisting (supervising) the first use of the drug delivery device.

[0080] In the implementation scheme, training can be organized in consecutive blocks. An example is shown in Figure 3. First, the user is provided with drug delivery device recognition training 100. After successfully completing drug delivery device recognition training 100, the user proceeds to drug delivery device operation training 200. After successfully completing drug delivery device operation training 200, the user proceeds to drug / device training 300. After successfully completing drug training 300, the user proceeds to supervised first use of the drug delivery device 400.

[0081] In some embodiments, drug / device training 300 may be provided prior to drug delivery device recognition training 100. In some embodiments, drug / device training 300 may be provided prior to drug delivery device training 200. In some embodiments, drug / device training 300 may be provided prior to steps 202 and 203 of drug delivery device training 200. In some embodiments, drug / device training 300 may be provided multiple times.

[0082] Any one of blocks 100, 200, 300, 400, and 500 may be provided together (before or after) with any other block among blocks 100, 200, 300, 400, and 500. Any one of blocks 100, 200, 300, 400, and 500 may be optional.

[0083] Figure 4 illustrates an example of drug delivery device recognition training 100. Drug delivery device recognition training 100 can use the training drug delivery device 1 described above. Drug delivery device recognition training 100 can also use only user devices 2 and 3. In use, the user can first be prompted to select the correct medication 101 (based on their condition, their current situation, and previous advice and / or operating guidelines from a healthcare professional). For example, a diabetic user may be asked to choose between several types of insulin (practicable insulin, long-acting insulin, etc.).

[0084] Once the step of selecting the correct medication 101 is successfully completed, the user proceeds to the correct device selection training 102. In the correct device selection training 102, the user may be prompted to identify the correct medication delivery device. User devices 2 and 3 may offer the opportunity to choose from several (e.g., three) different devices. Based on the characteristics of the medication delivery device (such as label, size, shape, color, etc.), the user selects the medication delivery device. The selection can be made using the screen of mobile device 2.

[0085] To provide training 102 for selecting the correct device, user devices 2 and 3 can collaborate with the training drug delivery device 1. The training drug delivery device 1 is placed on a surface, such as a table. The position of the training drug delivery device 1 is detected by user devices 2 and 3 using position sensors 59 and 60 of the training drug delivery device 1. In the augmented reality or virtual reality displayed by user devices 2 and 3, the correct device can be projected onto the training drug delivery device 1. The training drug delivery device 1 can be displayed among multiple (e.g., two) different drug delivery devices. The user is then prompted to identify the correct drug delivery device; the user can do so by reaching towards the training drug delivery device 1.

[0086] If the user makes an incorrect selection, the drug delivery device identification training 100 can be paused. User devices 2 and 3 can then provide the user with additional training or guidance. For example, user devices 2 and 3 can display some or all of the characteristics that distinguish the correct drug delivery device from the one selected by the user. Such characteristics could be, for example, the shape of a specific part of the corresponding drug delivery device, the color of a specific part of the corresponding drug delivery device, the size of the corresponding drug delivery device, etc. For example, drug delivery devices may differ in terms of label, body color, dosage dial color, button color, and the shape and position of the cap and features provided on said cap. In response to the user selecting an incorrect drug delivery device, all these differences can be pointed out to the user.

[0087] After the user successfully completes the correct device selection training 102, the user may be asked or suggested to complete the correct device selection training 103 under different environmental conditions. The correct device selection training 103 under different environmental conditions can present the user with training similar to the correct device selection training 102. However, the drug delivery device presented to the user is presented with a different set of simulated conditions. For example, the drug delivery device may be presented such that, as if it were in a dimly lit environment, some or all of its distinguishing features (e.g., label, size, shape, color, etc.) are not so obvious and therefore less easily noticed and evaluated by the user.

[0088] Figure 5 illustrates an example of drug delivery device operation training 200. After successfully completing drug delivery device recognition training 100, the user may be offered or required to complete drug delivery device operation training 200. The user may be offered or required to complete drug delivery device operation training 200 as stand-alone training (i.e., without further conditions, such as completing any other training first).

[0089] In the drug delivery device operation training 200, user devices 2 and 3 can guide the user step-by-step through the typical procedures necessary for injecting drugs and safely storing the drug delivery device. User devices 2 and 3 cooperate with the training drug delivery device 1 to complete the drug delivery device operation training 200.

[0090] In each step described below, the user can be guided through the corresponding steps using user devices 2 and 3. For example, an instructional video showing how to complete each task can be displayed to the user. Once the video has been played back to the user, the user may be prompted to try and complete the task independently.

[0091] Example drug delivery device operation training 200 begins with the user holding the training drug delivery device 1 in their hand and within the field of view of the camera 21 of the user devices 2 and 3. Optionally, the user devices 2 and 3 project information onto the training drug delivery device 1. For example, if the dosage window 13 and / or the drug window 14a are simulated windows, the user devices 2 and 3 can project a selected dose and / or simulated content of the drug contained in the container area 14.

[0092] User devices 2 and 3 prompt the user to remove the cap 201 of the training drug delivery device 1. When the user completes this task, position sensors 59 and 60 can indicate to user devices 2 and 3 that the cap 18 has been removed from the training drug delivery device 1. Alternatively or additionally, user devices 2 and 3 can use images of the training drug delivery device 1 captured by camera 21. The position of the body 10 and / or cap 18 in the captured images can be determined based on one or more distinguishing features set on the cap 18 and / or body 10 of the training drug delivery device 1. The distinguishing features are described below with reference to Figures 10 to 14.

[0093] In response to the user devices 2 and 3 detecting the position of the cap 18, the user devices 2 and 3 may (e.g., by displaying a green color, a hook icon, or in any other suitable manner) indicate to the user that the task has been successfully completed.

[0094] User devices 2 and 3 can then prompt the user to attach pin 202. Attaching pin 202 may require several sub-steps, such as attaching pin 15 protected by inner pin cap 16 and outer pin cap 17, and subsequently removing outer pin cap 17 and inner pin cap 16. Attachment sensor 61 can indicate to user devices 2 and 3 whether the task has been successfully completed. Attachment sensor 61 can also be able to indicate the most common errors, such as pin 15 being only partially attached. Alternatively or additionally, user devices 2 and 3 can use gesture control to assess whether pin 15 has been successfully attached. Alternatively or additionally, user devices 2 and 3 can use an image captured by camera 21 to assess whether the pin has been successfully attached, similar to what is described above in conjunction with step 201. User devices 2 and 3 can then indicate the status (e.g., task successfully completed) to the user, as described above.

[0095] Once needle 15 is in place, user devices 2 and 3 can prompt the user to select the correct dose 203. The user can be guided to rotate the dose dial 12 until the correct dose is displayed in the dose window 13. The rotation of the dose dial 12 and the resulting selected dose are detected by torque sensor 56 and counter 57 and transmitted to user devices 2 and 3, which can then display this information in the dose window 13 as augmented reality / virtual reality.

[0096] When the dosage dial 12 is turned and the correct dosage is selected, the driver 55 preferably provides the tactile response (tactile feedback) expected in this case from the actual drug delivery device (e.g., the same click and / or resistance as when the dosage dial of the actual drug delivery device is turned).

[0097] User devices 2 and 3 can determine that the user has completed rotating the dose dial 12 and selected the correct dose if the user has not rotated the dose dial 12 for a predetermined period of time (e.g., 3 seconds). Alternatively or additionally, the user may be required to confirm to user devices 2 and 3 that they have completed rotating the dose dial 12 and selected the correct dose.

[0098] Once the user has completed rotating the dosage dial 12 and selected the correct dosage, user devices 2 and 3 evaluate the selected dosage and indicate whether the selected dosage is correct. The evaluation and indication can be performed as described above. Specifically, user devices 2 and 3 can use any one or more of sensor data, captured images, and gesture controls to evaluate whether the task has been successfully completed, and user devices 2 and 3 can then use any of the means described above to indicate the correct completion of the task.

[0099] Once the user has selected the correct dosage, the user will be prompted to inject dose 204.

[0100] In one embodiment, the user presses the injection button 11 of the training drug delivery device 1 without inserting the needle 15 into a portion of the patient's skin. The training drug delivery device 1 preferably provides the tactile response (tactile feedback) expected in this case from a real drug delivery device (e.g., resistance depending on the drug viscosity, the same as the resistance in an actual drug delivery device when the dosing dial 12 is set to a given dose and a given drug is selected).

[0101] In one implementation, the training drug delivery device 1 may contain a liquid to simulate the drug contained in container area 14.

[0102] In one embodiment, a training pad (not shown) is provided. The training pad is a device that simulates a portion of a user's skin. It can be attached to an area of ​​the user's body where the user is most likely to inject medication. For example, the training pad can be adapted for attachment to the user's thigh or around the user's waist. Using a training pad enhances the tactile response provided to the user and can provide a more realistic training experience. The training pad can be made of absorbent material.

[0103] In one embodiment, when the needle 15 is inserted into the training pad and the injection button 11 is then pressed, liquid (corresponding to the simulated insulin dose displayed in the dosage window 13) is sprayed from the training drug delivery device 1 into the training pad. In another embodiment, when the needle 15 is inserted into the training pad and the injection button 11 is then pressed, air is sprayed from the training drug delivery device 1 into the training pad. In yet another embodiment, the needle 15 is inserted into the training pad and the injection button 11 is pressed without any movement of any mechanical parts (such as a plunger) and without the dispensing of any fluid or liquid.

[0104] Pressing the injection button 11 of the training drug delivery device 1 can produce a mechanical clicking sound, which is different from the sound produced when using the dosage dial 12.

[0105] During injection of dose 204, the training drug delivery device 1, together with user devices 2 and 3, preferably monitors at least one of the following: the force applied by the user to press the injection button 11; the time spent by the user pressing the injection button 11; and the angle at which the user inserts the needle 15 into the training pad. Based on this measured data, user devices 2 and 3 assess whether the user has correctly injected the dose. The data can preferably be measured as described above, i.e., user devices 2 and 3 can use any one or more of sensor data, captured images, and gesture controls to assess whether the task has been successfully completed. Successful completion of dose injection 204 can be indicated by user devices 2 and 3, as described above.

[0106] Once the dosing step 204 is successfully completed, the user may be asked or prompted to proceed to needle removal 205. Needle removal 205 may require several sub-steps. For example, the user may need to attach the inner needle cap 16 and the outer needle cap 17 before removing needle 15. Attachment sensor 61 indicates to user devices 2, 3 whether the task has been successfully completed. Alternatively or additionally, user devices 2, 3 may use any one or more of sensor data, captured images, and gesture controls to assess whether the task has been successfully completed. User devices 2, 3 may then indicate the status (e.g., task successfully completed) to the user, as described above.

[0107] Once needle 15 has been successfully removed, the user can be asked or prompted to attach cap 206. The position sensors 59 and 60 can indicate to user devices 2 and 3 that cap 18 has been attached to training drug delivery device 1. Alternatively or additionally, user devices 2 and 3 can use any one or more of sensor data, captured images, and gesture controls to assess whether the task has been successfully completed. User devices 2 and 3 can then indicate the status (e.g., task successfully completed) to the user, as described above.

[0108] User devices 2 and 3 can be adapted to detect whether a user is attempting to attach cap 18 while pin 15 is still attached, and to alert the user.

[0109] In some implementations, the user may also need to safely dispose of the used needle 207. A container (not shown) for disposing of sharp objects may be provided. The user may need to discard the needle 15 in the container and confirm that this has been done. Alternatively or additionally, user devices 2, 3 may use captured images and gesture controls to assess whether the task has been successfully completed. User devices 2, 3 may then indicate the status (e.g., task successfully completed) to the user, as described above.

[0110] The drug delivery device training 200 described above can have several levels of difficulty. For example, a user operating the drug delivery device for the first time can be reminded of the next step at each stage of training, or can be given more guidance when operating the training drug delivery device 1, and so on. For example, little or no guidance can be given to users who have reviewed the training many times or are more experienced in operating the drug delivery device. Similar considerations apply to the processes described in Figures 6 through 8.

[0111] The training drug delivery device 1, together with user devices 2 and 3, is preferably adapted to detect errors and mistakes. For example, the user may attempt to select a dose and then inject the drug without needle 15 attached, or the user may attempt to attach cap 18 while needle 15 is still attached. In this case, user devices 2 and 3 may interrupt the training (keeping or not keeping the position as appropriate) and provide the user with further guidance (e.g., playing the instruction video again). Similar considerations apply to the processes described in Figures 6 through 8.

[0112] Once the user successfully completes the training, user devices 2 and 3 can issue a certificate of successful training completion. Successful training can be assessed based on a threshold number of training sessions completed without errors (e.g., if the user completes training 200 through the entire drug delivery device three times without errors, or completes training 200 at least once with minimal or no guidance, etc.). Similar considerations apply to the processes described in Figures 6 through 8.

[0113] An exemplary drug training 300 is shown in Figure 6. After each step, the user may be asked whether they understand the training content and / or confirm that they wish to continue to the next step.

[0114] In the first step, the user may be provided with assistance in reading the drug brochure 301. This assistance may include reading aloud. It may also include supervised reading. For example, assistance may include assessing whether the user has read and / or understood the contents of the brochure. This assessment may be based on, for example, monitoring the user's eye movements. Eye movements may refer to one or more of the following: the direction of the user's gaze, the speed of the user's eye movements, the direction of the user's eye movements, the time the user spends focusing (reading or watching) the content, the timing of the user's blinks, the rate of the user's blinks, the duration of pupillary fixation, the number of pupillary fixations, the visual path, the pupil diameter, and pressure load; and the dwell time (per piece of content).

[0115] In the next step 302, the dosing regimen and / or dosage may be explained to the user. The explanation may be based on information from the brochure, on the advice of a healthcare professional, or both.

[0116] In the next step 303, the user may receive an explanation of the correct operation of the device. For example, an operation guide video explaining all steps 201 to 207 and 401 to 407 may be shown to the user. The user may receive instructions on how to remove the cap of the device, attach the needle, select the correct dose, administer the injection dose (including in which area of ​​the user's body to administer the dose and how to treat the skin before, during, and after the injection), remove the needle, attach the cap, and discard the needle.

[0117] Users can further receive explanations about the proper storage of the drug delivery device. For example, the device needs to be stored within a specific temperature range (e.g., between 2°C and 8°C) and under specific light conditions (e.g., in a dark place, away from direct sunlight).

[0118] In the following steps 304 and 305, the user may receive further explanation on how to operate and / or how not to operate the drug delivery device. For example, the user may be warned to avoid the most common mistakes when operating the device. For example, the device needs to be stored between 2°C and 8°C and should be heated at room temperature for at least 45 minutes before use; the user may be informed of this requirement and warned not to attempt to heat the drug delivery device, for example, by using direct sunlight or placing the drug delivery device on a heater.

[0119] In step 306, the user may receive instructions on further support available. For example, the user may receive a list of healthcare centers that specialize in handling their type of medical condition, pharmacies that sell the medication delivery devices and / or medications used by the user, or personnel who may be able to help with troubleshooting.

[0120] Figure 7 illustrates a typical procedure for the assisted first use of the drug delivery device 400. Steps 401 to 407 correspond to steps 201 to 207. The main difference between procedure 200 and procedure 400 is that, unlike procedure 200, procedure 400 is performed using a real drug delivery device loaded with a drug that the user injects into their skin, rather than injecting it into a training pad.

[0121] The assistance provided by user devices 2 and 3 during the supervised first use of the drug delivery device 400 can be similar to the assistance described above in conjunction with Figure 5. For example, user devices 2 and 3 can prompt the user to perform each step 401 to 407. Before continuing with the steps, the user can be given the opportunity to view training content (e.g., an instruction video) associated with said / each step.

[0122] User devices 2 and 3 can use specific distinguishing features to locate the position and orientation of the drug delivery device, and can use this data to monitor whether the user correctly performs steps 401 to 407, whether the user operates the drug delivery device correctly, etc. Alternatively or additionally, the user can be asked to indicate when they have completed each step 401 to 407 so that user devices 2 and 3 can proceed to the next step. To perform this function, user devices 2 and 3 can monitor the user's eye movements (described above in conjunction with step 301). Alternatively or additionally, user devices 2 and 3 can monitor the distinguishing features of the training drug delivery device 1 (described below).

[0123] Specifically, in step 401, the user may be asked to remove the cap 401 of the drug delivery device. Based on the identification of distinguishing features on the body and cap of the device, the user devices 2 and 3 can detect that the step has been completed. Alternatively or additionally, the user may indicate that the cap has been removed and that the user is ready to proceed to the next step.

[0124] In step 402, the user may be prompted to attach the needle. If the user is unsure how to proceed, they may receive additional instructions (e.g., a video instructional video may be played back for them). If attaching the needle requires several sub-steps (e.g., attaching the needle and subsequently removing the outer and inner needle caps), user devices 2 and 3 may guide the user through all of these sub-steps. User devices 2 and 3 may remind the user to perform the sub-steps in the correct order (e.g., attaching the needle first and then removing the needle cap, rather than removing the needle cap and then attaching the needle). As in step 401, user devices 2 and 3 may detect that the step has been completed and / or the user may indicate that the needle has been attached.

[0125] In step 403, the user may be prompted to select the correct dose. If the user is unsure how to proceed, they may receive additional operating instructions (e.g., an operating instructions video may be played back for them). User devices 2 and 3 may be able to detect the selected dose based on recognizing the number displayed in the dose window set on the drug delivery device. Alternatively or additionally, the user may be asked to enter that number into user devices 2 and 3 for verification. Based on the selected dose, user devices 2 and 3 may indicate whether the dose is correct or incorrect. If the dose is incorrect, the user may be guided by user devices 2 and 3 to select the correct dose.

[0126] In step 404, the user may be prompted to inject the selected dose. The user may be guided to avoid the most common mistakes. For example, the user may be prompted to keep pressing the injection button down. The user may be guided to keep pressing the injection button for a certain period of time (e.g., 5 to 15 seconds) and / or keep the needle in their skin for a certain period of time. Once the user can withdraw the needle from their skin and / or stop pressing the injection button, the user can receive an instruction from user devices 2 and 3. As in the previous steps, user devices 2 and 3 may detect that the step has been completed and / or that the user can indicate that the dose has been injected. For example, user devices 2 and 3 may detect that the drug delivery device returns to the field of vision after being out of sight for a period of time.

[0127] In step 405, the user may be prompted to remove the needle. If the needle removal step requires several sub-steps (e.g., attaching the outer and inner needle caps and then removing the needle), user devices 2 and 3 may guide the user through all of these sub-steps. User devices 2 and 3 may remind the user to perform the sub-steps in the correct order (e.g., attaching the needle cap first and then removing the needle, rather than removing the needle and then attaching the needle cap). As in the previous steps, user devices 2 and 3 may detect that a step has been completed and / or the user may indicate that the needle has been removed.

[0128] In step 406, the user may be prompted to attach the cap of the drug delivery device. Based on the identification of distinguishing features on the body of the device and the cap, the user devices 2 and 3 can detect that the step has been completed. Alternatively or additionally, the user may indicate that the cap has been attached.

[0129] In step 407, the user may be prompted to safely dispose of the used needle. The user may be guided, for example, to discard the used needle into a container for disposing of sharp objects.

[0130] Figure 8 illustrates an example of a refillable drug delivery device training 500. The example is described from the perspective of a drug delivery device 1 having a replaceable cartridge (not shown) disposed in container area 14.

[0131] In step 501, the user may be prompted to remove the cap 18 of the drug delivery device 1 (if the cap 18 is attached) or remove the needle 15 (if the needle is attached). User devices 2 and 3 may be adapted to identify whether the cap 18 or the needle 15 is attached and prompt the user accordingly. User devices 2 and 3 may detect that the step has been completed and / or that the user may indicate that the cap or the needle has been removed.

[0132] In step 502, user devices 2 and 3 may prompt the user to open container area 14. The two components of container area 14 may be joined together, for example, by a threaded connection, snap-fit, or press-fit. User devices 2 and 3 may be adapted to guide the user and provide instructions on how to open and close container area 14, enabling the user to complete the task. User devices 2 and 3 may detect that a step has been completed and / or that the user may indicate that the container area has been opened.

[0133] In step 503, user devices 2 and 3 may prompt the user to remove the first cartridge (not shown) from container area 14. The first cartridge may be considered empty or nearly empty, or it may be considered to contain medication that is no longer useful (e.g., it is cloudy). As in the previous steps, user devices 2 and 3 may detect that the step has been completed and / or the user may indicate that the cartridge has been removed.

[0134] In step 504, user devices 2 and 3 may prompt the user to insert a second cartridge (not shown). User devices 2 and 3 may provide support to the user to help them insert the cartridge correctly. To this end, user devices 2 and 3 may indicate to the user distinguishing features provided on the cartridge, such as a colored end, one end being wider than the other, etc. User devices 2 and 3 may detect that the step has been completed and the cartridge has been correctly inserted. Alternatively or additionally, the user may indicate that the cartridge has been inserted and optionally indicate how the cartridge was inserted.

[0135] In step 505, user devices 2 and 3 may prompt the user to close container area 14. If the cartridge is inserted incorrectly, the container area may not be able to close. User devices 2 and 3 may detect this and suggest to the user that the cartridge needs to be placed correctly and / or may instruct the user on how to properly remove and replace the cartridge. User devices 2 and 3 may detect that the step has been completed and / or the user may indicate that the container area has been closed.

[0136] In step 506, user devices 2 and 3 may prompt the user to change cap 18 or attachment pin 15 as appropriate (and optionally continue any other training 100, 200, 300, 400).

[0137] Figure 9 illustrates an example of a system for operating a training drug delivery device 1 and user devices 2, 3. The process shown in Figure 9 is divided into two main blocks: setup phase 600 and training 200. Training 200 is provided as an example only. Training 200 can be replaced by one or more of the following: drug delivery device recognition training 100, drug training 300, supervised first use 400, or refilling drug delivery device 500.

[0138] In step 601, the user acquires and activates user devices 2 and 3.

[0139] In step 602, the user connects to the training drug delivery device 1 using, for example, the wireless unit 54 of the training drug delivery device 1 and corresponding wireless units (not shown) located in user devices 2 and 3. User devices 2 and 3 can be adapted to automatically detect the training drug delivery device 1. User devices 2 and 3 can be adapted to automatically connect to the training drug delivery device 1. User devices 2 and 3 can connect to the training drug delivery device 1 after receiving approval from the user.

[0140] In step 603, the user activates the training application. The training application is a software application that provides training and assistance to the user in operating the training drug delivery device 1 and the actual drug delivery device.

[0141] In step 604, user devices 2 and 3 use a training app to detect and train drug delivery device 1.

[0142] In step 605, user devices 2 and 3 may prompt the user to select a drug and / or drug delivery device for the training. In the subsequent step 606, the user indicates their selection.

[0143] For example, user devices 2 and 3 can provide users with three different drug options: long-acting insulin; rapid-acting insulin; and a GLP-1 / Glu dual agonist. Based on the user's choice, user devices 2 and 3 provide training 200.

[0144] For example, user devices 2 and 3 can provide users with a choice of three different drug delivery devices: device A for delivering long-acting insulin; device B for delivering rapid-acting insulin; and device C for delivering GLP-1 / Glu dual agonists. Based on the user's choice, user devices 2 and 3 provide training 200.

[0145] For example, based on the user's selection, user devices 2 and 3 can select tactile response parameters of the training drug delivery device 1 corresponding to the selected device and / or the selected drug (e.g., the response of the dosage dial 12 or injection button 11 of the training drug delivery device 1, as these depend on the device and the drug, as described above). The selected tactile response can be transmitted from user devices 2 and 3 to the training drug delivery device 1 using wireless unit 54.

[0146] For example, based on the user's choice, user devices 2 and 3 can select appropriate AR / VR images and overlay these images onto the training drug delivery device 1 to simulate the contents of the dosage window 13 and the drug window 14a, as well as to simulate the color and design of the selected drug delivery device.

[0147] In step 607, user devices 2 and 3 may instruct the user to bring the training drug delivery device 1 in front of camera 21, and thus into the field of view of user devices 2 and 3. In step 608, user devices 2 and 3 may detect the position, orientation, or both of the training drug delivery device 1. User devices 2 and 3 may detect the position and / or orientation of the training drug delivery device 1. The detection may be based on data received from one or more sensors 58 to 61 of the training drug delivery device 1. Alternatively or additionally, the detection may be based on one or more distinguishing features (as described above).

[0148] In step 609, user devices 2 and 3 may prompt the user to bring the needle 15 and training pad (not shown) to the front of the camera 21 of user devices 2 and 3. In step 610, user devices 2 and 3 may detect the needle 15 and training pad. The detection may be based on any one or more of the following: different shapes of the needle 15 and training pad; different colors of the needle 15 and / or training pad; detection of an NFC tag disposed in the needle 15 and / or training pad; or an attachment sensor disposed in the needle 15.

[0149] The drug delivery device 1 has one or more distinguishing features 101 to 112, L1 to L6, and D1 to D3. User devices 2 and 3 store suitable software that enables them to identify the distinguishing features 101 to 112, L1 to L6, and D1 to D3 and compare them with a predetermined set of distinguishing features associated with a specific device. User devices 2 and 3 are thus able to identify the drug delivery device 1. The distinguishing features 101 to 112, L1 to L6, and D1 to D3 also enable user devices 2 and 3 to identify the state of the drug delivery device 1.

[0150] Preferably, user devices 2 and 3 store more than one distinguishing feature 101 to 112, L1 to L6, D1 to D3 of a given drug delivery device 1. If user devices 2 and 3 store more than one distinguishing feature 101 to 112, L1 to L6, D1 to D3 of a given drug delivery device 1, then user devices 2 and 3 can more accurately identify the drug delivery device 1. If user devices 2 and 3 store more than one distinguishing feature 101 to 112, L1 to L6, D1 to D3 of a given drug delivery device 1, then it may be possible to identify one or more of the following: the position of the drug delivery device 1; the orientation of the drug delivery device 1 relative to user devices 2 and 3; the distance of the drug delivery device 1 from user devices 2 and 3, etc. Alternatively or additionally, if the user uses user devices 2 and 3 to capture video instead of still images, then it may be possible to identify the movement of the drug delivery device 1, its position, orientation, changes in distance from user devices 2 and 3, etc.

[0151] Example features that can be used as distinguishing features 101 to 112, L1 to L6, and D1 to D3 are shown in Figures 10 to 14. Distinguishing features 101 to 112, L1 to L6, and D1 to D3 can be, for example:

[0152] - The outer shape 101a of the body 10 of the drug delivery device 1 and the outer shape 101b of the cap 18, the cap being positioned on the container region 14;

[0153] - The external shape 101a of the main body 10 of the drug delivery device 1 and the external shapes 101c, 101d of the container region 14 (i.e., with the cap 18 removed).

[0154] - The external shape of the main body 10, container area 14 and needle 15 of the drug delivery device 1;

[0155] - The shape 102 of the latch 18a (the latch 18a is disposed on the cap 18);

[0156] - The color of the main body 10 of the drug delivery device 1;

[0157] - Dots or pixels 103 having a different color from the rest of the body 10 of the drug delivery device 1;

[0158] - A code 104 (such as a data matrix code or a QR code) set on the body 10, on the cap 18, or on both the body 10 and the cap 18;

[0159] - The shape and / or color 105 of the dose window 13;

[0160] - The shape and / or color 106 of the dosing dial 12;

[0161] - The shape and / or color 107 of the injection button 11;

[0162] - The shape and / or color 108 of the drug window 14a;

[0163] - The distance L6 between the dosing dial 12 of the drug delivery device 1 and the main body 10;

[0164] - A closed feature 110 on the corresponding part of the cap 18 and the body 10 (see Figure 13);

[0165] - A notch or protrusion 111 provided on the cap 18, the body 10, or both the cap 18 and the body 10 (see Figure 13);

[0166] - The number and location of the notches 112 on the dosing dial 12 (see Figure 14);

[0167] - The length L1 of the drug delivery device 1, including the cap 18 (see Figure 10);

[0168] - The length L2 of the drug delivery device 1 without the cap 18 and without the needle 15 (see Figure 11);

[0169] - In the absence of cap 18 and without inner needle cap 16 and outer needle cap 17, but with attached needle 15 (not shown), the length L3 of the drug delivery device 1;

[0170] - In the case where there is no cap 18, but one or both of the attached inner needle cap 16 and outer needle cap 17 (not shown) are present, the lengths L4 and L5 of the drug delivery device 1 are:

[0171] - The diameter D1 of the main body 10 of the drug delivery device 1 (see Figure 10);

[0172] - The diameter D2 of injection button 11;

[0173] - The diameter D3 of the dosing dial 12 (see Figure 11);

[0174] - The ratio of any two of lengths L1 to L6 and / or diameters D1 to D3 (typically, any one of the ratios Lx / Ly, Dx / Dy or Lx / Dy, where x and y represent the numbers of the corresponding lengths or diameters);

[0175] - The distance (not shown) between any two of the distinguishing features 101 to 112 listed above and / or the ratio of any two of these distances;

[0176] - One or more NFC tags (e.g., RFID tags) (not shown) are affixed to the cap 18, body 10, or both the cap 18 and body 10 of the drug delivery device 1.

[0177] Distinguishing features 101 to 112, L1 to L6, and D1 to D3 can be used individually or in combination. User devices 2 and 3 can identify one or more features in a given drug delivery device 1. Any of the features 101 to 112, L1 to L6, and D1 to D3 listed above can be combined with any other feature 101 to 112, L1 to L6, and D1 to D3 to be used to identify the drug delivery device. User devices 2 and 3 can store any subset of the distinguishing features 101 to 112, L1 to L6, and D1 to D3 listed above. The identification of any distinguishing feature 101 to 112, L1 to L6, and D1 to D3 by user devices 2 and 3 can be combined with the identification of any other distinguishing feature 101 to 112, L1 to L6, and D1 to D3 by user devices 2 and 3. The drug delivery device 1 may be provided with any subset of the distinguishing features 101 to 112, L1 to L6, and D1 to D3 listed above. The drug delivery device 1 may be provided with any one of the features 101 to 112, L1 to L6, and D1 to D3 listed above, combined with any other feature among the features 101 to 112, L1 to L6, and D1 to D3.

[0178] User devices 2 and 3 store predefined distinguishing features of a given drug delivery device 1 (such as any one of distinguishing features 101 to 112, L1 to L6, D1 to D3, a subset of distinguishing features 101 to 112, L1 to L6, D1 to D3 listed above, or all of distinguishing features 101 to 112, L1 to L6, D1 to D3 listed above). User devices 2 and 3 can compare the distinguishing features measured from images or videos captured by camera 21 with the predefined distinguishing features stored in the memory 25 of user devices 2 and 3 to identify which drug delivery device 1 is presented to camera 21.

[0179] In step 611, user devices 2 and 3 begin training 200. Training 200 may begin when user devices 2 and 3 confirm that the training drug delivery device 1 is connected, set up, and fully functional.

[0180] The process then continues with training 200. Training 200 and steps 201 to 207 have been discussed above. Training 200 can be replaced by one or more of the following: drug delivery device recognition training 100, drug training 300, supervised first use 400, or refilling drug delivery device 500.

[0181] The terms "drug" or "pharmaceutical preparation" are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients (APIs) or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease, or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited period of time or periodically for chronic diseases.

[0182] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also considered.

[0183] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components of the drug formulation to be administered (e.g., API and diluent, or two different drugs), one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0184] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0185] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other natural or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0186] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0187] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0188] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langelatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYO G-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tezapatide (LY3298176), bamadotide (SAR425899), exenatide-XTEN, and glucagon-XTEN.

[0189] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome.

[0190] Examples of DPP4 inhibitors include linagliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0191] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, gonadotropin), growth hormone (Somatropin), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0192] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0193] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, whole-human antibodies, non-human antibodies (e.g., mouse antibodies), or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, they have mutagenic or missing Fc receptor-binding regions. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or bivariate antibody-like binding proteins (CODVs) with cross-binding region orientation.

[0194] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide), excluding full-length antibody polypeptides but still including at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may comprise cleaved portions of a full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Additional examples of antigen-binding antibody fragments are known in the art.

[0195] The term "complementary defined region" or "CDR" refers to a short polypeptide sequence within the variable region of both the heavy and light chain polypeptides, which are primarily responsible for mediating specific antigen recognition. The term "frame region" refers to the amino acid sequence within the variable region of both the heavy and light chain polypeptides; these are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame regions of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0196] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0197] Pharmaceutically acceptable salts of any API described herein are also intended for use in drugs or pharmaceutical preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0198] Those skilled in the art will understand that various modifications (additions and / or removals) can be made to the APIs, formulations, instruments, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, which covers such variations and any and all equivalents thereof.

[0199] Example drug delivery devices may involve needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multi-dose container systems and single-dose (with partial or full discharge) container systems. Containers may be replaceable containers or integrated, non-replaceable containers.

[0200] As further described in ISO 11608-1:2014(E), a multi-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multi-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0201] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, thereby discharging the entire deliverable volume (complete discharge). In a further example, each container contains a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integrated, non-replaceable container. In one example of such a system, each container contains a single dose, thereby discharging the entire deliverable volume (complete discharge). In a further example, each container contains a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

Claims

1. A system comprising a training drug delivery device and a user device, The training drug delivery device includes a main body, a cap, a dosage dial, and a delivery activation button. The training drug delivery device further includes a controller, a memory, a wireless unit for communicating with the user device, a driver for simulating the tactile responses of several different drug delivery devices, and at least one sensor for measuring the attachment of the cap and the pressing of the delivery activation button. The user device includes a controller, a memory, and a wireless unit; The training drug delivery device is adapted for: Use the wireless unit to connect to the user device; Receive a set of tactile response parameters, the tactile response parameters including at least parameters defining the response of the dosage dial and the delivery activation button; as well as Transmit sensor measurement results to the user device; The user device is configured to: Receive the user's selection of the type of drug delivery device being trained; The wireless unit is used to connect to the training drug delivery device; A set of tactile response parameters is transmitted to the training drug delivery device, the tactile response parameters including at least parameters defining the response of the dosage dial and the delivery activation button; Receive sensor measurement results from the training drug delivery device; as well as Feedback on operating the training drug delivery device is provided to the user, at least in part, based on the received sensor measurements.

2. The system according to claim 1, wherein, The training drug delivery device includes at least one of the following: a dose window for displaying the selected dose and a needle. The at least one of the sensors is further configured to measure one or more of the following: the position of the training drug delivery device, the orientation of the training drug delivery device, the torque applied to the dosage dial, the force applied to the delivery activation button, the attachment of the cap covering at least a portion of the body, the attachment of the cap covering the needle, and the attachment of the needle.

3. The system according to claim 1 or claim 2, wherein, The feedback is provided to the user using augmented reality or virtual reality provided by the user device.

4. The system according to any one of claims 1-2, wherein, The training drug delivery device includes at least one window-shaped region defined on the body, the window-shaped region being adapted to support augmented reality / virtual reality projection.

5. The system according to claim 4, wherein, The user device is configured to project information onto a drug window or a dosage window or both.

6. The system according to claim 1, wherein, The tactile response parameters include parameters that define the response of the delivery activation button.

7. The system according to claim 1 or claim 6, wherein, The tactile response parameters define the dosage dial's response to being rotated and / or the delivery activation button's response to being pressed with a click or resistance, wherein the resistance is provided by the actuator.

8. The system according to any one of claims 1-2, wherein, The training drug delivery device includes a container adapted for filling with liquid, or wherein the training drug delivery device is adapted for containing a drug cartridge.

9. The system according to any one of claims 1-2, further comprising a training pad that simulates the user's skin.

10. The system according to any one of claims 1-2, wherein, The training drug delivery device further includes a needle shield and a needle shield activation button.

11. A training drug delivery device comprising a body, a cap, a dosage dial, and a delivery activation button, the training drug delivery device further comprising a controller, a memory, a wireless unit for communicating with a user device, a driver for simulating tactile responses of several different drug delivery devices, and at least one sensor for measuring attachment of the cap and pressing of the delivery activation button. The training drug delivery device is adapted for: Use the wireless unit to connect to the user device; Receive a set of tactile response parameters, the tactile response parameters including at least parameters defining the response of the dosage dial (12) and the delivery activation button (11); and Transmit sensor indications to the user device.

12. A user device comprising a controller, a memory, and a wireless unit; The user device is configured to: Receive the user's selection of the type of drug delivery device being trained; The wireless unit is used to connect to the training drug delivery device; A set of tactile response parameters is transmitted to the training drug delivery device, the tactile response parameters including at least the parameters of the response of the dose-limiting dial and the delivery activation button; Receive sensor indications from the training drug delivery device; as well as Feedback on the use of the training drug delivery device is provided to the user, at least in part, based on the received sensor measurements.

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