Activation and detection system for an auxiliary device attached to a medicament delivery device

Abstract

The present disclosure relates to an activation system for an add-on device attached to a medicament delivery device of an existing design, wherein a movement applied on a cap or other cover of the medicament delivery device triggers an activation mechanism of the add-on device to reestablish an electrical contact to close an electrical circuit between a battery module and a power source, thereby activating the battery module. The activation mechanism is configured not to disturb the sterile state of the dose delivery outlet. Thus, the add-on device can be activated at any time before the cap or other cover is removed. The add-on device can also have a transmitter for transmitting information about the use of the medicament delivery device to an external device, e.g. a smart device. A memory storage element with unique identification data can also be included. The present disclosure also relates to a medicament delivery device with an add-on device attached.

Description

Technical Field

[0001] This invention relates to an event detection mechanism and activation of an auxiliary device capable of attaching to a drug delivery device, wherein the auxiliary device can serve as an information providing device capable of transmitting unique information about the drug delivery device. The auxiliary device is activated by removing a protective cover from the drug delivery device. Movement of the protective cover relative to the medical delivery device is detectable. The protective cover of the drug delivery device may include components of a rigid and / or flexible needle shield and a needle shield remover. The auxiliary device is capable of monitoring the use or movement of the protective cover of the drug delivery device and is capable of communicating with external smart devices. Background Technology

[0002] Medication delivery devices, especially those designed for self-administered medication, have been on the market for many years. To enable these devices to be operated by non-professionals, they must be easy to use and intuitive. Furthermore, because many medications are essential or at least very important to patients, physicians and other professionals require information about whether patients are taking medications according to prescribed regimens. The required information may include the type of medication, delivery time, date, dosage, and safety information such as sterility. Equally important is whether the medication or device itself is counterfeit or tampered with. Methods and systems for detecting open containers while maintaining the ability of the tag and device to communicate wirelessly are known. For example, US9,519,904B2 discloses a method for radio frequency (RF and / or RFID) and near field communication (NFC) tags and devices having a mechanism for detecting an open package or container, wherein the continuous state of the package or container is determined to be open when at least one protective line is broken. Alternatively, the continuous state of the package or container can be determined to be closed or sealed when one or more protective lines are not broken.

[0003] However, a drawback of the approach in US 9,519,904 B2 is that the power supply can continuously power the sensors and circuitry, rather than being triggered by an action that initiates power supply to the system. Therefore, the power supply (i.e., the battery) may have a limited lifespan. Another drawback is that activation only occurs after the protective line is disconnected (in other words, after the sterility barrier is breached). Therefore, activating the device before the sterility barrier is breached is impractical, and information may not be transmitted to external devices at that stage. However, in some cases, information about the device is beneficial or necessary before the sterility is compromised.

[0004] Similarly, information that may be helpful to doctors involves whether the correct procedure was used and the instructions for use were followed; whether the medication was kept at the prescribed temperature before and during delivery; and whether the correct injection depth and injection rate were used if the delivery device is a syringe.

[0005] Systems for obtaining information from a drug delivery device are known. For example, WO 2004 / 084116 discloses a system for presenting and transmitting drug information, wherein the drug delivery device is equipped with a communication mechanism that supports communication with external devices such as cellular or mobile phones or personal digital assistants (PDAs). A preferred communication standard is Bluetooth. The drug delivery device is equipped with multiple sensors for monitoring and recording dosage delivery sequences, etc. The idea is to use the functionality of external devices, such as displays, processors, keyboards, etc., rather than providing such features to the drug delivery device. Transferring this functionality to external devices reduces the cost of the drug delivery device compared to one with such functionality.

[0006] However, a drawback of the WO 2004 / 084116 scheme is that the Bluetooth circuitry or other wireless communication systems (such as ANT or ZigBee) are integrated into the housing of the drug delivery device. Communication systems with batteries powering their circuitry require dedicated space within the drug delivery device. Modifying existing device designs to accommodate additional battery modules could raise unforeseen regulatory issues. Another problem with known data collection devices is that power is directly connected to the electronic circuitry during the manufacture of the battery module and its attachment to the drug delivery device. This can lead to premature battery depletion. Furthermore, such systems require a separate, specific step by the user to activate the battery module, which may not always be successful. Therefore, sterility breaches may go undetected after the battery is depleted or the user fails to activate it successfully.

[0007] Therefore, it is not easy to modify the existing design or to easily provide the additional functionality that the communication system can offer to the existing design. Therefore, there is a need for an automatic activation system that executes before the sterile barrier is breached as part of the normal use of the drug delivery device, and a detection mechanism activated by the removal sequence of the protection unit before the sterile barrier is removed, thereby activating auxiliary devices to record and send a signal notifying the drug delivery device that the sterile barrier has been breached. Summary of the Invention

[0008] The object of this invention is to provide an event detection system for an auxiliary device that can be attached to an existing drug delivery device, the event detection system being triggered by an integrated activation mechanism of the drug delivery device before the sterile barrier is breached. The attachment does not require modification or alteration of the existing design of the drug delivery device. A particularly preferred auxiliary device is an information providing device that can be used on and in conjunction with many different drug delivery devices, especially configured for use on drug delivery devices for self-dosing. Preferably, a drug delivery device equipped with such an information providing device can be used in conjunction with common commercially available external smart devices and is used by most patients operating drug delivery devices for self-dosing.

[0009] In this disclosure, the term "distal direction" refers to the direction away from the dose delivery site during use of the drug delivery device. The term "distal portion / distal end" refers to the portion / end of the delivery device or its components that is furthest from the drug delivery site when the drug delivery device is in use. Correspondingly, the term "proximal direction" refers to the direction towards the dose delivery site during use of the drug delivery device. The term "proximal portion / proximal end" refers to the portion / end of the drug delivery device or its components that is closest to the drug delivery site when the drug delivery device is in use.

[0010] In addition, the terms “longitudinal,” “axial,” or their grammatical variations refer to the direction in which the device or its components extend from the proximal end to the distal end, typically along the longest extension direction of the device and / or component.

[0011] Similarly, the term "horizontal" or its grammatical variations refer to a direction roughly perpendicular to the longitudinal direction.

[0012] As used herein, the term "medication" is intended to cover any flowable pharmaceutical preparation containing a drug that can be delivered in a controlled manner via a delivery device (e.g., a cannula or a hollow needle), such as a liquid, solution, gel, or particulate suspension. Representative pharmaceutical preparations include drugs such as peptides, proteins, and hormones in solid (dispensed) or liquid forms, bioderived or active formulations, hormone- and gene-based formulations, nutritional formulations, and other substances. In the description of exemplary embodiments, the use of insulin will be described with reference to these embodiments. Accordingly, the term "subcutaneous" infusion or injection is intended to cover any method of percutaneous delivery to a subject.

[0013] In this disclosure, the term "module" is intended to cover an independent unit or article that performs a specified task on its own and can be linked with other such units to form a larger system, such as an electronic component or an assembly of electronic components and associated circuitry.

[0014] According to a key aspect of the invention, the auxiliary device is battery-powered, initially in a disconnected state, thus neither supplying nor receiving power from the auxiliary device. The activation mechanism of the auxiliary device is preferably associated with normal use of the drug delivery device. A cap removal sequence performed by the user triggers the activation element during movement of the protective capping device. The cap removal sequence for activating the auxiliary device precedes the axial movement of the needle shield towards the proximal end away from the needle tip. The cap removal sequence required to activate the auxiliary device is acceptable, and the sterile barrier is not removed or compromised by the movement. In other words, the activation mechanism does not compromise the sterility of the delivery outlet.

[0015] According to one key aspect, the activation mechanism reconnects the battery to power the auxiliary device before breaching the sterile barrier. The battery is held in an isolated or open state by a switch or insulating material, which is generally referred to below as the activation element. Removing the activation element between the electrical contacts is similar to closing a conventional circuit switch. Keeping a normally closed switch open can be achieved through mechanical, spatial, or functional construction applied to the switch. Similarly, the removal of the insulating material causes the electrical contacts to close or otherwise come together to form an electrical connection, allowing power from the battery to flow through and between the contacts, thereby closing or connecting circuits to other electrical components.

[0016] Preferably, the auxiliary device can be attached to the drug delivery device in a non-energized state before use (e.g., during manufacturing or assembly), in which the battery is temporarily electrically isolated from electrical connections with other components of the auxiliary device.

[0017] The activation element is configured to contact the housing or cap of the drug delivery device when the auxiliary device is mounted on it. In the case where a mechanical switch is configured as the activation element, the switch is arranged to slidably contact a surface proximal to the drug delivery device. When the auxiliary device is mounted on an existing injection device (e.g., an autoinjector) with a cap, the cap surrounds and closes a separate needle sheath or shield, and moves towards the proximal end of the device when the user applies a pulling or twisting motion to the cap.

[0018] The portion of the cap that moves axially toward the proximal end of the device creates a gap between the housing and the cap. The cap abuts against the proximal end of the housing, causing the switch to mechanically contact the housing of the drug delivery device. As the cap moves toward the proximal end of the delivery device, the switch, triggered by the cap's movement, slides along the housing of the drug delivery device. When the switch reaches the distal portion of the proximal end of the housing, it can slide vertically into the space created by the distance between the cap and the housing of the drug delivery device. This vertical movement relative to the longitudinal axis of the drug delivery device triggers the switch back to its default position and closes the circuit, thus forming an electrical connection. This allows current from the battery to flow through and between the contacts, thereby closing circuits connected to or charging other electrical components.

[0019] Alternatively, circumferential or axial movement of the cap, or a combination of axial and circumferential movement, involves removing an activating element (e.g., an insulating sheet or strip) from an electrical contact that is in direct contact with the battery, which is part of the circuitry of the auxiliary device. This circuitry may include a switch operatively connected to the battery and the contact pad, with a portion of the switch directly connected to the cap.

[0020] The physical removal or movement of the needle cap is preferably performed as part of the steps required for using the drug delivery device. For example, in the case of a drug delivery device, it is typically necessary to remove the needle cap or other covering from the dose delivery outlet component before using the device. Combining the activation procedure with the removal procedure of the needle cap is a preferred mechanism because it eliminates the need for the user of the device to perform a separate step or procedure, and the auxiliary device can be activated before the needle shield is moved. Especially in the case of an injection needle with its own axially fixed flexible needle shield to the needle cap, movement of the needle cap away from the device housing causes the needle shield to move axially away from the proximal end of the needle, which disrupts sterility.

[0021] The connection between the cap and the needle shield remover can be configured to allow a predetermined axial displacement of the cap relative to the needle shield remover, and this axial movement does not engage the needle shield remover to remove the needle shield. One example includes additional spacing between the cap's gripping member and the needle shield remover. In other words, the cap can slide along the needle shield remover in an axial and / or rotational manner, thereby defining axial displacement, after which the needle shield gripping member and the cap's gripping member can engage with each other. When the gripping members are engaged, any further axial and / or rotational movement of the cap translates into movement of the needle shield remover and the attached rigid or flexible needle shield.

[0022] One embodiment can be configured to provide an additional peripheral member to the needle shield remover. This peripheral member includes a protrusion on its outer surface configured to engage with an engagement member of the cap. During assembly of the cap and the needle shield remover, the cap and the peripheral member engage with the engagement member. When axial and / or rotational movement is applied to the cap, the cap can undergo a predetermined axial displacement relative to the needle shield as the peripheral member engaged with the cap slides along the needle shield remover until it engages with a gripping or engagement member of the needle shield. Therefore, the sliding movement of the peripheral member relative to the needle shield remover stops, and any further movement applied to the cap will act on the needle shield remover.

[0023] By connecting the activation component to a cap or other cover located on the drug delivery device, it is possible to combine the removal sequence of the cap or cover from the drug delivery device with the activation of the auxiliary device.

[0024] Removing the cap from the proximal end of the housing of the drug delivery device can be accomplished by making the cap move purely linearly or circumferentially relative to the housing, or by making the cap rotate purely or by a combination of rotational and axial movement. Regardless of how the cap separates from the proximal end of the housing, the activation mechanism of this disclosure is configured such that the activation member attached to the cap remains firmly attached to the cap during cap removal. This ensures that the normally closed switch can return to its default position, or that electrical contact is formed by removing the insulating material, resulting in circuit closure, allowing the auxiliary device to be charged by and receive power from the battery.

[0025] A cap or cover portion of a drug delivery device is configured and adapted to cover the dosage delivery outlet, for example, when mounted on a drug delivery device or fixed to a drug container. In the case of a pen syringe, the cap preferably has a generally elliptical cavity configured to receive an elliptical portion of the proximal portion of the syringe. In some cases, it may be necessary or desirable to allow a small amount of relative axial movement between the cap and the end of the proximal portion of the drug delivery device housing.

[0026] One possible embodiment of this disclosure relates to a system for activating an auxiliary device attached to a drug delivery device, wherein the drug delivery device includes a housing having a proximal end, a drug container disposed within the housing, and a dose delivery outlet accessible through the proximal end. The dose delivery outlet is surrounded by a needle shield serving as a sterile barrier and attached to a needle shield remover mechanically coupled to a removable cap. The auxiliary device includes a battery module attached to the housing (preferably to the proximal end of the housing), an activation component, and a communication module, wherein movement of the cap acts on the activation component to activate the auxiliary device. The auxiliary device is configured to determine whether the cap has moved relative to the needle shield. The communication module is configured to transmit data to an external device, wherein the data includes information directly related to the state of the activation component and / or the movement of the removable cap.

[0027] In one embodiment, the cap is coupled to a needle shield remover and configured to be movable axially and / or circumferentially, wherein an initial sequence of movement of the cap activates an auxiliary device but does not move the needle shield remover.

[0028] The cap is typically assembled with a needle shield remover or closure member of the drug delivery device and engages with the needle shield, which protects the needle by sealing it shut. The needle shield may include a flexible rubber member in which the needle is embedded, i.e., a flexible needle shield (FNS). For some applications, the FNS is equipped with a rigid housing, i.e., a rigid needle shield (RNS). To allow removal of the needle shield before use of the drug delivery device, the needle shield remover is provided with a gripping member that engages with the needle shield. Because the needle shield remover is attached to the cap and the gripping member engages with the needle shield, removal of the cap also pulls the needle shield off the needle. The removable cap is attached to the proximal end of the housing, making the dose delivery outlet inaccessible unless the cap and needle shield assembly are completely removed from the device.

[0029] In one instance, after the initial movement sequence of the cap, a continuous movement sequence of the cap needs to be performed to remove the needle shield from the dose delivery outlet.

[0030] The activating component is a switch or an insulating pad.

[0031] In one embodiment, the battery module or the communication module includes one or more sensors configured to detect movement of at least one component of the drug delivery device.

[0032] One possible embodiment also includes a sensor module that can be connected to any other module, and said sensor module includes one or more sensors configured to detect movement of at least one component of the drug delivery device.

[0033] In one embodiment, the switch is initially in a first state (A), in which the communication module is prevented from receiving power from the battery, and movement of the cap unit relative to the proximal end of the drug delivery device causes the switch to change to a second state (B), in which the battery supplies power to the communication module.

[0034] Furthermore, the communication module may be connected to or included as part of the battery module and is configured to transmit data to external devices. A recorder may be included as part of the battery module or as part of the communication module, and the recorder is configured to acquire and store information about the drug delivery device. The switch is preferably initially in a first state in which the recorder is blocked / cannot receive power from the battery, and movement of the cap proximally relative to the housing changes the switch to a second state in which the battery supplies power to the recorder and / or the communication module.

[0035] In one possible embodiment, the activation element is configured to activate the auxiliary device only once and to indicate potential breach of the sterile barrier of the drug delivery device when the switch is in the second state (B) or the insulating pad has been removed.

[0036] The switch can be configured such that it can only be in the first state once. This is preferably achieved by configuring the switch to be prevented / cannot transition from the second state back to the first state. An alternative configuration to prevent such transition involves using a normally closed switch that is physically held in a temporarily open position, or by using a sheet, strip, or bar of material operably connected between the battery and the contact pad.

[0037] The communication module, battery module, or auxiliary device includes a recorder configured to acquire and store data information about the drug delivery device.

[0038] Data transmission begins when the recorder receives power from the battery, initiated by the communication module.

[0039] In some cases where normally closed mechanical switches are used, a gap is created between the cap and the end edge of the housing when the cap is pulled away from the attached drug delivery device housing, thereby moving the auxiliary device attached to the housing towards the proximal end of the housing. The switch, moving with the cap, can slide along a portion of the housing it contacts, such that upon reaching the end edge of the housing, the switch can extend into the gap between the housing and the cap. It is conceivable that the auxiliary device of this disclosure can be provided separately; that is, it does not require an assembly including the drug delivery device and the covering portion or cap. In other words, it can be provided as a standalone unit.

[0040] The activation system disclosed herein is formed by completing two steps. One step involves attaching the auxiliary device to the cap of the drug delivery device, and the other step is removing the cap or other cover, which must be removed before the drug delivery device is finally used for its intended design purpose.

[0041] In another embodiment, the auxiliary device may include two or more integrated or separate modules that can be attached to each other, any of which can be removed from the housing and can be reused.

[0042] For example, the first battery module can be configured to be permanently attached (i.e., non-releasable) to the housing or cap of the drug delivery device. Adhesive bonding, welding, or one-way snap-fit ​​are methods to achieve this permanent attachment. Component modules such as communication modules, sensor modules, and logging modules may contain other electrical components, such as recorders. In one example, the component module can be configured to be removably attached to the battery module, allowing it to be reused and attached to another battery module later. In this case, the first battery module is discarded along with the housing or cap of the first drug delivery device, and the removed component module is then attached to a second battery module containing a new battery. This can occur before or after the second battery module is attached to the housing or cap of the second drug delivery device. One end of insulating material is then secured to the cap or other cover, which is attached to the housing of the second drug delivery device.

[0043] The auxiliary device may be placed on the cap by the manufacturer of the medication delivery device, the healthcare provider, or the user of the device. The shape of the auxiliary device is preferably matched to or conforms to the shape of the cap of the medication delivery device to which it is attached.

[0044] Before the auxiliary device is activated by connecting the battery to a circuit containing other electronic components, the transmission of information from the auxiliary device is blocked / cannot occur. Once activated, information about the status of the drug delivery device can be transmitted to the auxiliary device via electrical or non-electrical means (such as sound, optics, vibration, or electromagnetic means).

[0045] The drug delivery mechanism can be mechanical or substantially mechanical (i.e., electromechanical) and may also include some electronic components. Auxiliary devices may include, but are not limited to, means for transmitting data to external devices, such as via wireless IR, RF, or optical means.

[0046] The auxiliary device may also include a sensor, such as a sound sensor, capable of detecting the rotational sound of a dose-setting mechanism (e.g., a dose drum). A processing unit may also be arranged to process output signals from optical sensors or other sensors included in the auxiliary device. When dose setting is manually initiated by rotating a knob, the sound sensor may be adapted to activate the processing unit. It may also include a memory (e.g., RAM random access memory or another type of memory) integrated into the processing unit or as a separate unit. The memory unit is arranged to receive and record data from one or more sensors located in the auxiliary device. The sound sensor detects the sound of movement of the dose-setting mechanism, or, for example, the rotational sound of the dose-setting drum can be selected from one of a microphone, accelerometer, and vibration sensor.

[0047] The auxiliary device may also include a communication module for transmitting and sending dosage data to an external device, which may be a mobile device (e.g., a mobile phone or cellular phone), a computer, or a remote server (e.g., the cloud), for recording, storing, and monitoring injected or inhaled drug delivery data, such as dosage, delivery time, date, frequency, and drug. A memory unit may also be arranged in the auxiliary device. The auxiliary device may also include a reset button that allows for manual reset of the auxiliary device. This reset feature is advantageous if the auxiliary device or a portion thereof is to be reused, for example, on another drug delivery device.

[0048] According to another aspect of the invention, a method is provided for collecting and recording drug delivery data from a drug delivery device, such as dosage information, delivery time, frequency, drug, date, etc. The drug delivery device may be a pen injector, auto-injector, or inhaler, having a dosage setting mechanism with a dosage indicator, such as a dosage setting drum. If the dosage indicator has a dosage value indication on its surface and / or a dosage display window or opening for displaying the dosage value on the circumferential surface of the drug delivery device, the method may include the steps of detecting sound from movement of the dosage indicator via a sound sensor and activating a processing unit via the sound sensor, the sound being, for example, a rotational sound from the dosage setting drum or another type of setting mechanism.

[0049] The auxiliary device may include a control module and a communication module, wherein any of these modules includes one or more sensors configured to detect movement of at least one component of the drug delivery device. Alternatively, the auxiliary device may include a sensor module that can be connected to any other module, and this sensor module includes one or more sensors configured to detect movement of at least one component of the drug delivery device. The sensor module may also be included as part of any other module (e.g., a battery module or a communication module). Similarly, the auxiliary device may also include a recording module that can be connected to or included as part of any other module (e.g., a battery module, a communication module, or a sensor module). The recording module is configured to track user behavior of the drug delivery device based on movement detected by the one or more sensors. By tracking the movement of the drug delivery device, the tracking of user behavior for research, training, or compliance is improved, which is beneficial for drug delivery.

[0050] As used in this disclosure, one or more sensors can generally refer to any type of sensor capable of detecting motion. Preferably, the one or more sensors can be one or more of the following sensors: magnetometer, gyroscope, and / or accelerometer, which improves the high-precision tracking of motion.

[0051] The system also includes a memory module that can be connected to or incorporated into any other module. The memory module is configured to store data, and the communication module is configured to wirelessly transmit the data to an external device. Preferably, the memory module is configured to store data from the recording module, facilitating tracking by its user. The memory module may include non-volatile memory. According to one embodiment, the communication module can be configured to transmit data (wirelessly or wiredly) from the recorder, recording module, or memory module, enabling real-time visualization of the tracking. The battery module is activated when a cap or other cover attached to the proximal end of the drug delivery device is moved relative to the proximal end.

[0052] The drug delivery device can be an actual delivery device for injecting drugs, or it can be a model demonstration device for human factor research or training.

[0053] According to another aspect, the system disclosed herein may be a drug delivery device coupled to an auxiliary device, and further includes a computer device separate from the drug delivery device and the auxiliary device, such as a mobile phone with a display device. In this case, the communication module may be configured to wirelessly and / or wiredly transmit real-time data from the recording module to the computer device and / or remote location separate from the drug delivery device for later analysis. The communication module may also be configured to wirelessly and / or wiredly transmit data stored in a memory module from the recording module to the computer device or remote location separate from the drug delivery device for later analysis.

[0054] For the reasons stated above, it may be desirable for the auxiliary device to include a recorder component as part of or supplement to a sensor assembly that collects data related to the relative axial movement of the cap. In other words, activation of the auxiliary device can be directly associated with the movement or complete removal of the cap. In such a design, the activated auxiliary device can be programmed to send a signal to an external device via its communication component, providing notification that relative movement of the cap has occurred. This notification can be programmed to occur automatically and immediately upon activation of the auxiliary device.

[0055] Manipulating the length of the activating component and / or placing the auxiliary device on the proximal end of the housing can allow activation based on the predetermined separation of the cap from the end of the housing. Control components in the auxiliary device can be adapted to detect this predetermined event pattern and provide notification to external devices that the event has occurred. The control components can also create a time log that represents the detected events as a function of time.

[0056] The battery that can be used in the activation system of this disclosure is preferably a button cell battery, sometimes also called a coin cell battery or watch battery. This battery can be disposable or rechargeable. Preferably, the battery should have a storage or idle life of at least several years, most preferably at least four years. Furthermore, the battery should be able to provide power to sustain operation for approximately 30 days and no less than three weeks when activated. A battery cover may be provided, which allows the user to access the battery when the auxiliary device is attached to the drug delivery device housing.

[0057] The system disclosed herein can communicate with external devices, such as computers or handheld personal digital assistants (PDAs), like smartphones and tablets, via a communication component or module in an auxiliary device. Data transmission by the communication module can begin immediately after the communication module or recorder receives power from the battery. This data transmission to the external device can be wireless or via a wired connection. In the above system, data transmission between the drug delivery device and the data collection device can be wireless, such as RF, IR, capacitive or inductive, or via electromagnetic radiation within the optical range. Data transmission can be performed automatically when the data collection device and the drug delivery device are close to each other, for example, within a given range.

[0058] The electronic circuitry may be adapted to perform one or more functions selected from the group consisting of: generating data representing the magnitude of a dose set by the drug dispensing mechanism, generating data representing the magnitude of a dose dispensed by the drug dispensing mechanism, generating and storing a time log representing the magnitude of a dose set by the drug dispensing mechanism, generating and storing a time log representing the magnitude of a dose dispensed by the drug dispensing mechanism, transmitting data to an external receiver, receiving data from an external transmitter, controlling a display adapted to display user-readable information, controlling an indicator adapted to indicate when the auxiliary power supply needs to be recharged, and controlling a control device adapted to prevent the set or dispensing dose from being set when the auxiliary power supply needs to be recharged.

[0059] The external or data collection device may be in the form of one of the following: BGM, CGM, drug delivery device, mechanically controlled drug delivery device, electronically controlled drug delivery device, PDA, mobile phone, key ring device, credit card-sized device, medical hub, router, necklace, smartwatch, or disposable monitoring unit.

[0060] In another embodiment of this disclosure, a method for activating an auxiliary device is proposed, wherein data containing information related to the drug delivery device is transmitted when a cap or other cover attached to a proximal portion of the drug delivery device is axially moved relative to the proximal portion of the drug delivery device housing or is completely removed from the drug delivery device housing. This method involves removing an activation member from electrical contacts in direct contact with a battery, which is part of the auxiliary device's circuitry, which may include a switch operatively connected to the battery, a portion of which is directly connected to the cap. The activation member may be an insulating pad. A recorder may be configured to acquire and store information about the drug delivery device, and a communication module may be used to transmit the data recorded by the recorder to an external device.

[0061] The switch is initially in a first state in which the control module is prevented from receiving power from the battery. Movement of the cap proximally relative to the housing changes the switch to a second state in which the battery powers the battery module and, if a communication module is included, the communication module. Power from the battery powers the battery module, enabling it to receive information about the drug delivery device. In some cases, information or data is recorded in a recorder and then further transmitted by the communication module to an external device. The auxiliary device may also have a feedback signal triggered when the battery module is activated. This feedback may be an audible and / or tactile signal. Circuitry, a power source (battery), a switch, a speaker unit, and / or a piezoelectric unit can all be used to generate the feedback signal. Furthermore, according to another aspect of this disclosure, the auxiliary device may be a control unit with a clock function. Another aspect may involve a control unit that measures the duration of the simulated dose delivery and compares it to a predetermined time value, and controls the feedback signal to indicate to the user whether a correct or incorrect simulated dose delivery has occurred. To further improve the quality of feedback provided to the user, the electronic circuitry can be arranged not only to instruct the user to begin acupuncture and / or dose delivery, but also to instruct the necessary time to press the training device at the training injection site.

[0062] The auxiliary device may also include an antenna operatively connected to the communication module and a memory storage element containing unique identification data associated with the drug delivery device.

[0063] The auxiliary device may also include an optical module operatively connected to the communication module and a memory storage element containing unique identification data associated with the drug delivery device.

[0064] Therefore, one of the main ideas of this disclosure is that the auxiliary device is inactive before activation. Depending on the type of technology used, inactivity may mean that the circuit is not connected at all before the battery supplies power to the circuit. While a conventional coin cell battery has been described, within the scope of this disclosure, the power source or energy source used to activate the auxiliary device may be derived from less conventional sources, such as photovoltaic panels.

[0065] According to another advantageous embodiment, the auxiliary device can be arranged within the housing of the protective cap. Using this approach, the auxiliary device can be easily added to the outer surface of the housing of an existing drug delivery device. Thus, the auxiliary device does not necessarily have to be built into the drug delivery device.

[0066] Regarding available technologies, the electronic circuitry of the auxiliary device can include Bluetooth technology, which offers several advantages. A Bluetooth transmitter can communicate with a smart device that doesn't need to be within such close range as with technologies like NFC. Most smart devices today have Bluetooth communication circuitry, which facilitates the transmission of information from the transmitter to the smart device. Another advantage of Bluetooth is the ability to bind the transmitter of a medication delivery device provided to a particular user to that specific user's smart device. Therefore, a close connection exists between the medication delivery device received and intended for use by the user and their personal smart device. Consequently, information from a specific medication delivery device is only transmitted to that specific smart device. These and other aspects of the invention, as well as its advantages, will become more apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0067] The present invention will now be described in detail with reference to the accompanying drawings, in which:

[0068] Figure 1A This is a side view schematic diagram of a possible embodiment of the present disclosure in the initial state of the activated component, wherein, for clarity, the housing and functional connections of the cap are not shown.

[0069] Figure 1B This is a side view schematic diagram of a possible embodiment of the present disclosure in the final state of the activated component, wherein, for clarity, the housing and functional connections of the cap are not shown.

[0070] Figure 2A The schematic diagram illustrates the switching unit and the protective cap in the position of... Figure 1B The final state shown is the shape of the cap shell, which is not shown for clarity.

[0071] Figure 2B The overall circuit diagram of this disclosure is shown schematically, wherein, for clarity, the drug delivery device is not shown.

[0072] Figure 3A The diagram schematically illustrates the configuration of the activating element and the cap in their initial state before the switch is in the cap's movement, wherein, for clarity, the housing portion and functional connections of the cap are not shown.

[0073] Figure 3B yes Figure 3A A partial cross-sectional view, wherein the cap unit has a needle shield remover or closure member, and the activator is in its initial state before the movement of the cap and before any movement of the needle shield remover.

[0074] Figure 4AThe diagram schematically illustrates the configuration of the activating element and the cap after the cap has been moved and before any movement of the needle guard, with the switch in the activated state. For clarity, a portion of the cap's housing and functional connections are not shown.

[0075] Figure 4B Before the sterile barrier is removed Figure 4A A partial cross-sectional view, in which the cap unit has a needle shield remover or closure component.

[0076] Figure 5A The configuration of the activating element and the cap after the cap has moved and the needle shield has moved is schematically shown, with the switch in the activated state. For clarity, a portion of the cap's housing and functional connections are not shown.

[0077] Figure 5B After the sterile barrier is removed Figure 5A A partial cross-sectional view, in which the cap unit has a needle shield remover or closure component.

[0078] Figure 6A An exploded view of the cap unit with auxiliary devices is shown.

[0079] Figure 6B This is a schematic diagram of an alternative embodiment, in which the auxiliary device is mounted on the housing and the activating member is an isolation pad in its initial state.

[0080] Figure 7 This disclosure illustrates a functional scenario in which the auxiliary device is integrated with the user and external devices. Detailed Implementation

[0081] In the following description, the term "smart device" will be used. In the context of this document, a smart device may include an electronic device having a processor or processing circuitry capable of running computer programs and storage space for storing programs and data acquired from various external sources. The processing circuitry may be, for example, any combination of one or more of a suitable central processing unit (CPU), multiprocessor, microcontroller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc., capable of performing the operations disclosed herein regarding data detection and transmission. It should also be understood that a smart device has a communication system capable of communicating with a data network to access various databases. It should be understood that the databases may include databases accessed via the Internet (so-called cloud services) and / or databases directly connected to and accessed via a local area network (LAN). It should also be understood that, in the context of this document, a smart device includes a human-machine interface (HMI) for bidirectional communication. The HMI may include a display, keyboard, microphone, speaker, and I / O ports for connecting peripheral devices. Furthermore, a smart device may have an antenna for wireless communication with a network. Additionally, a smart device may be equipped with a receiving and transmitting system capable of communicating with NFC tags and a program capable of establishing and processing communication with NFC tags. In addition, smart devices can be equipped with receiving and transmitting mechanisms capable of communicating via Li-Fi (Light Fidelity) technology.

[0082] Furthermore, the term "medication delivery device" is used in the following description. In the context of this document, a medication delivery device can include devices capable of delivering a specific amount of medication to a user, such as injection devices with or without needles, various inhalation devices (e.g., powder or aerosol-driven sprayers with mouthpieces or nasal inhalers), and dispensing devices for dispensing tablets. The medication delivery device can be disposable or reusable and can have a medication container suitable for containing a specific form of a specific medication.

[0083] Please refer to Figure 1A and Figure 1B This illustrates a possible configuration 10 of the activation system for a drug delivery device 20, wherein an auxiliary device 1 is attached to a cap 21 of the drug delivery device 20, the drug delivery device 20 having a housing 24 housing a drug container 65 having a dose delivery outlet 60 (i.e., a fixed needle covered by a needle guard 62). A needle guard remover 61 is attached to the cap 21, wherein removing the cap 21 from the housing 24 necessarily results in removing the needle guard 62 from the needle, as... Figure 3B , 4B As shown in 5B. Figure 1AA side view of the drug delivery device is shown, in which the activation member 8 is attached to the auxiliary device 1 mounted on the cap 21, wherein, for clarity, the housing surrounding the activation member 8 is not shown.

[0084] Figure 1A Also shown is a configuration 10 in which the activating member 8 is preferably initially in a first state, in which the recorder is blocked / does not receive power from the battery 2, and the movement of the cap 21 proximally relative to the housing 24 changes the activating member 8 to... Figure 1B The second state shown is in which the battery supplies power to the recorder and / or communication module.

[0085] The activating element 8 can be configured such that it can only be in the first state once. This is best achieved by configuring the activating element 8 to be prevented / unable to transition from the second state back to the first state. One possible configuration to prevent such a transition involves using a normally closed switch that is physically held in the temporarily open position.

[0086] The activating component 8 is configured to contact the housing 24 of the drug delivery device 20 when the auxiliary device 1 is mounted on the drug delivery device 20. In other words, as Figure 1A and Figure 3A As shown, the activation member 8 is arranged to slidably contact the surface of the proximal end of the drug delivery device 20. When the auxiliary device 1 is mounted on an existing injection device (e.g., an autoinjector) with a cap 21, the cap surrounds and closes the individual needle sheath or shield 62, and moves towards the proximal end of the device 20 when the user applies a pulling or twisting motion to the cap 21.

[0087] like Figure 1B , Figure 4A and Figure 5A As shown, this axial movement of the cap 21 toward the proximal end of the device 20 creates a gap 12 between the housing 24 and the cap 21. The cap 21 abuts against the proximal end of the housing 24, such that the activating member 8 (a switch in this example) mechanically contacts the housing 24 of the drug delivery device 20, as... Figure 1A and Figure 3A As shown, as the protective cap 21 moves toward the proximal end of the delivery device, the switch 8, triggered by the movement of the protective cap 21, slides along the housing 24 of the drug delivery device 20. When the switch 8 reaches the edge of the proximal end of the housing 24, the switch can slide vertically into the space 12 created by the distance between the protective cap 21 and the housing 24 of the drug delivery device 20, as shown. Figure 1B , Figure 4A and Figure 5AAs shown. This vertical movement relative to the longitudinal axis of the drug delivery device triggers switch 8 back to its default position and closes the circuit, thereby forming an electrical connection. This allows current from the battery to flow through and between the contacts, thus closing circuits connected to or energizing other electrical components. The normally closed switch 8 may have alternative spatial or functional configurations collectively referred to as the activating element.

[0088] In one embodiment, the connection between the cap 21 and the needle shield remover 62 can be configured to allow a predetermined axial displacement of the cap 12 relative to the needle shield remover 62, and such axial movement does not act on the needle shield remover 62 to remove the needle shield.

[0089] One example may include an additional extension between the cap's gripping member and the needle shield remover. In other words, the cap 21 can slide along the needle shield remover 62 in an axial and / or rotational manner, thereby defining an axial displacement 12, after which the needle shield gripping member and / or the cap 21 gripping member can engage with each other. When the gripping members are engaged, any further axial and / or rotational movement of the cap 21 translates into movement of the needle shield remover 62 and the attached rigid or flexible needle shield.

[0090] One embodiment may be configured to provide an additional peripheral member 26 to the inner circumferential side of the needle shield remover 62 or the cap 21. The peripheral member 26 includes a protrusion on an outer or inner surface configured to engage with an engagement member of the cap 21 or the needle shield remover 62. During assembly of the cap 21 and the needle shield remover 62, the cap and the peripheral member 26 engage with the engagement member. When axial and / or rotational movement is applied to the cap 21, the cap 21 may be axially displaced 12 relative to the needle shield as the peripheral member engaged with the cap 21 slides along the needle shield remover until it engages with a gripping or engagement member of the needle shield. Therefore, the sliding movement of the peripheral member relative to the needle shield remover stops, and any further movement applied to the cap 21 will act on the needle shield remover 62.

[0091] Alternatively, the peripheral member is coupled to the needle shield remover 62, and the cap 21 can slide on the peripheral member 26 until it abuts against the gripping or engaging member and the sliding movement of the peripheral member relative to the cap 21 stops, and any further movement applied to the cap 21 acts on the needle shield remover 62.

[0092] Activating the auxiliary devices 1 and 3 before removing the caps 21 and 31 and the needle shield 62 can be used to check the status of the medication delivery system using an external device. For example, information about the contents and the medication can be stored and / or displayed on the external device. When the auxiliary devices are activated and the data has been transmitted wirelessly or via a wired connection to the external device, the external device can verify the status of the contents, i.e., temperature (if the sensor includes a temperature sensor), manufacturing date, verify whether the contents are safe to use, or, if patient data is available, display a personalized dosing schedule.

[0093] One advantage is the added layer of security, as it allows for verification of sterility breaches, temperature breaches, or unsafe use of the contents from an external device, transmitting this information to the user. For example, temperature records throughout the device's lifespan can be wirelessly transmitted, and the shelf life of the medication can be calculated based on the transmitted data. The external device can then notify the user whether the medication is still safe to use and for how long. In some cases, temperature conditions may accelerate or slow down the degradation or contamination of certain medications, thus potentially shortening or extending their shelf life. This can be a significant advantage in areas where medication delivery devices are stored in environments with fluctuating temperatures.

[0094] Another possible use of the activation mechanism is to verify whether sterility has been compromised, whether the medication is the intended one, and whether the administration was correct before removing the cap. For example, users with visual and / or mental impairments may not be able to distinguish between multiple medication delivery devices containing different medications or dosages by sight or touch, or may not remember their personal dosing schedule. Such users could activate the assistive device and verify that the medication is the intended one before self-administering.

[0095] For example, in a healthcare environment with a large number of drug delivery devices and users, the activation of an auxiliary device can be coupled to an external device to verify and monitor the dosing plans of multiple users, thereby minimizing the accidental or incorrect administration of drugs contained in the drug delivery device.

[0096] like Figure 4B As shown, the axial displacement of the cap triggers the activation component 8, which is in the initial default state A, to move to the second state B. This establishes a connection to the power supply and thereby activates... Figure 2A and Figure 2B The auxiliary device 1 is shown. This initial movement sequence of the cap activates the auxiliary device 1 without causing any movement of the needle shield remover. In other words, the initial movement sequence that activates the auxiliary device is not projected as a movement sequence onto the needle shield remover 62.

[0097] Especially in the case of sterile drug delivery systems that rely on the dose delivery outlet, the permissible amount of cap movement is very small before auxiliary devices are activated. For example... Figure 4B As shown, a small cap movement is required to activate the auxiliary device 1 without triggering any displacement or movement of the needle shield remover 62. This cap movement translates into an axial movement of the cap unit toward the proximal end of the medical device. Any additional displacement or movement of the cap beyond the sequence of motion required to activate the auxiliary device may trigger the needle shield remover 62. This is especially true when the dose delivery outlet is an injection needle with its own independent flexible needle shield axially fixed to the cap. In other words, additional axial movement of the cap away from the device housing may cause axial movement of the needle shield away from the proximal end of the needle, which could compromise sterility, such as... Figure 5B As shown.

[0098] Figure 6A An embodiment comprising multiple electronic components is shown, such as a communication module 13 including a communication unit 1b, a recorder 1d having a data storage device, and a processor or control unit 1c. All these components / modules are electrically connected via a circuit board 1e and are enclosed by a sheath 1a. Additionally, a battery module 18 is shown, which includes an activation component communicatively connected to an energy source shown as a button cell 2, while the communication module 13 is not shown in the figure.

[0099] The communication unit 1b included in the auxiliary device 1 of the present invention can also utilize radio frequency identification (RFID) technology. In particular, high-frequency RFID offers many advantages in communication. The possibilities for using HF RFID are numerous, especially for providing near-field communication (NFC). NFC is particularly suitable because it is a set of standards used to establish radio communication for smartphones and other smart devices. NFC is a set of short-range wireless technologies, typically requiring a distance of 10 centimeters or less. NFC operates at 13.56 MHz on the ISO / IEC 18000-3 air interface, with rates ranging from 106 kbit / s to 424 kbit / s. NFC always involves an initiator and a target; the initiator actively generates a radio frequency field capable of powering a passive target. This allows NFC targets to take very simple forms, such as tags, patches, keychains, or cards that do not require batteries.

[0100] In the following description of the technology used, the term NFC tag may be used. In the context of this invention, it should be understood that an NFC tag includes an NFC chip connected to circuitry and an antenna. NFC tags are not limited to being integrated into patches or tags, but can be standalone units or integrated into materials used in the manufacture of pharmaceutical delivery devices. Furthermore, NFC tags may include additional features and components necessary for the desired or desired purpose and application, as will become apparent in the following description.

[0101] NFC tags contain data and are typically read-only, but can be rewritten. They can be custom-coded by the manufacturer or use specifications provided by the NFC Forum, an industry association responsible for promoting the technology and developing key standards. Tags can securely store personal data such as debit and credit card information, loyalty program data, personal identification numbers (PINs) and online contacts, as well as other information.

[0102] Regarding the drug delivery devices, they can be equipped with NFC tags to perform various tasks. NFC tags can be arranged as part of the aforementioned auxiliary devices of the present invention and can be easily integrated into the tag, which is attached to the outer surface of the housing of the drug delivery device.

[0103] Types of short-range wireless technologies (SRWT) that can be used in assistive devices include ANT+, RFID, Zigbee, and Bluetooth. One advantageous technology is Bluetooth. Bluetooth operates in the unlicensed Industrial, Scientific, and Medical (ISM) band of 2.4 to 2.485 GHz, using spread-spectrum, frequency-hopping, full-duplex signals with a nominal rate of 1600 hops / second. The 2.4 GHz ISM band is available in most countries without requiring a license. In particular, Bluetooth Low Energy or Bluetooth Smart can be used in conjunction with pharmaceutical delivery devices and the required functionality. The Bluetooth circuitry includes a transmitter capable of transmitting unique identification numbers or data, and recording timestamps. The Bluetooth circuitry is preferably powered by the aforementioned power source (e.g., a button battery), and is activated only when the state of the pharmaceutical delivery device is present or changes.

[0104] Alternatively, Li-Fi technology, based on light generated by LEDs rather than the radio spectrum generated by Wi-Fi, can be used in situations where Wi-Fi or other radiation may interfere with or disrupt other equipment in a specific area (e.g., a hospital). The communication module 1b included in the auxiliary device 1 of the present invention can also utilize a photodetector and an LED bulb.

[0105] Please see Figure 2BThe diagram schematically illustrates the basic circuit of the auxiliary device 1 that can be used in this activation system. A power source 2, shown as a coin cell battery, is electrically connected to a control module 1c, which can be connected to or integrated with a communication module 13. This communication module may include one or more sensors / sensor modules as described above, a communication unit 1b for transmitting data to external devices, a recorder or storage module, and a controller 1c (control unit). The sensors may include magnetometers, gyroscopes, and / or accelerometers. Magnetometers can be used to detect the position of the auto-injector needle of the drug delivery device attached to the auxiliary device. Gyroscopes can be used to detect the position of the drug delivery device, and accelerometers can be used to detect movement along a specific direction. High-precision tracking can be achieved by using a combination of a gyroscope and three accelerometers. Figure 2B The auxiliary device also includes an energy isolation structure comprising a normally closed mechanical switch mechanism that mechanically remains open until the cap is removed, which subsequently causes the switching circuit to complete.

[0106] When a memory module is present, it can be a non-volatile memory for storing data from the sensor / sensor module and / or from the recording module. The non-volatile memory can be, for example, a read-only memory, flash memory, ferroelectric RAM (F-RAM), most types of magnetic computer storage devices (e.g., hard disks, floppy disks, and magnetic tapes), or optical disk. The non-volatile memory can be removable for insertion into a reader of an external device. The auxiliary device may also have a contact interface to allow the upload of stored data to an external device via a cable connection. When a communication module is present, it allows the upload of real-time data and / or stored data to an external device. The communication module is configured (wirelessly and / or wired) to transmit real-time data from the logging module or to transmit stored data from the memory module. For example, the communication module can be equipped with Wi-Fi, Bluetooth, BLE, or Li-Fi.

[0107] Removing the cap 21 from the housing 24 causes movement relative to the longitudinal axis of the drug delivery device. This movement triggers the switch 8 to return to its default position, representing a translation of the activating component. This then closes the circuit, allowing the battery 2 to activate and power electronic components such as the communication module 1b, the recorder 1d with a data storage device, and the processor or control unit 1c.

[0108] In another possible embodiment of the currently disclosed activation system, the auxiliary device is designed to be removed from and reused from the drug delivery device 20.

[0109] Figure 6BAn embodiment of an alternative activation system and a possible configuration 30 representing an activation system for a drug delivery device 20 is shown, wherein an auxiliary device 3 is attached to a cap 31 of the drug delivery device 20, the drug delivery device 20 having a housing 24 containing a drug container 65 having a dose delivery outlet 60, i.e., a fixed needle covered by a needle shield 62. A needle shield remover 61 is attached to the cap 31, wherein removing the cap 31 from the housing 24 necessarily results in the removal of the needle shield 62 from the needle. Figure 6B A side view of the drug delivery device 20 is shown, wherein the activation member 38 is attached to the auxiliary device 3, which is mounted on the housing 24 of the drug delivery device 20 and connected to the cap 31.

[0110] Figure 6B The auxiliary device 3 is also shown to include multiple electrical components, such as a communication module 3b, a recorder 3d with a data storage device, and a processor or control unit 3c. All these components / modules are electrically connected via a circuit board 3e and are enclosed by a sheath 3a. Furthermore, a battery module is shown as a coin cell battery 2. The battery module may include a contact pad 38 and a switch 48 operatively connected to the battery 2 and the contact pad 38, wherein when the battery module is attached to the housing 24, a portion of the switch 48 is directly connected to a removable cap 31, or, when the battery module is attached to the cap 31, a portion of the switch is directly connected to the housing.

[0111] In another embodiment of this disclosure, a method for activating the auxiliary device 3 is proposed, wherein data transmission containing information related to the drug delivery device occurs when a cap 31 or other cover attached to a proximal portion of the drug delivery device 20 is axially moved relative to the proximal portion of the drug delivery device housing or is completely removed from the drug delivery device housing. The method includes removing an activation member (e.g., an insulating sheet or tape) from electrical contacts in direct contact with a battery that is part of the circuitry of the auxiliary device 3. This circuitry may include a switch 48 operatively connected to the battery 2 and a contact pad 38, a portion of which is directly connected to the cap 31. A recorder may be configured to acquire and store information about the drug delivery device 20, and a communication module may be used to transmit data recorded by the recorder to an external device.

[0112] Figure 7A possible logic flowchart representing the activation system of this disclosure is shown. The circuitry can be connected to multiple modules or components within the auxiliary device to provide status information. This status information may include the end of dose delivery. For example, it is important for the user to know when the injection procedure ends and whether it is safe to remove the device from the injection site. In this case, at the end of dose delivery, the circuitry may be affected by a moving part, where the circuitry acts as a switch. The switch information detected by the SRWT is transmitted to a smart device, which is arranged to indicate to the user that it is safe to remove the device. Furthermore, this information confirms that the device has been used.

[0113] Circuits and switches can also be used as interactive, step-by-step instructions. For example, a smart device can have an instruction application that shows the user how to operate the device step-by-step. After a step has been performed, and a circuit has been affected and detected by the SRWT and transmitted to the smart device, the smart device provides an OK or positive response and displays this response to the user. The instruction application then displays the next steps to be taken. In this way, all steps affect different circuits, which sequentially provide status information to the SRWT chip. This status information is sequentially transmitted to the smart device, and the instruction application displays the appropriate information to the user.

[0114] By integrating medication delivery devices enhanced by assistive devices with smart devices, further information can be collected to enhance understanding of the effectiveness of specific treatment regimens (e.g., disease monitoring). Programs or applications used in smart devices integrated with medication delivery devices can also include questionnaires completed by the user in conjunction with dose delivery operations. These questionnaires can include numerous questions about the patient's current state and are preferably configurable based on treatment, disease, and user needs. Potential areas covered include quality of life, cognitive function, pain, fatigue, nausea, mental health, etc. The questionnaire responses, along with information collected via SWRT tags, can then be transmitted from the smart device to an external database for processing and evaluation to identify positive or negative correlations between treatment regimens and medication types related to the patient's perceived status.

[0115] Furthermore, if the smart device is not equipped with an NFC reader, such an NFC reader can be included in the accessory, thereby adding functionality to the smart device. Due to the tight connection between the medication delivery device and the smart device and the real-time reading of the NFC tag, the integration of the medication delivery device and the smart device also provides real-time interactive user instructions and accurate injection time, date, and dosage. Injection time, date, and dosage can be directly recorded in the smart device for further processing or transmission.

[0116] Many smart devices are equipped with three-dimensional motion sensors whose functionality can be combined with the operation of drug delivery devices. For example, a smart device can detect how it and the drug delivery device are being held. This can be important for certain types of drugs and certain types of drug delivery devices because the drug delivery device must be held in a specific way during certain steps of use. For example, a drug delivery device might be one using a so-called dual-chamber drug container, where how the container is held is important during mixing and pre-injection. In this way, the smart device's motion sensors can be used to detect how the drug delivery device is being held, and can inform the user how to hold the device, and warn the user if the device is not held as instructed.

[0117] Other features of smart devices that can be used with integrated medication delivery systems include the use of a camera, typically an integral part of the smart device. This allows the camera to receive light-fidelity signals or take photographs of the contents of a typically transparent medication container to obtain information about the medication's condition. For example, the color or opacity of the medication might indicate that it has been exposed to adverse conditions (such as temperature outside the recommended range), rendering it unsuitable for use. Comparisons of color or opacity can be performed directly by the user within an application on the smart device, or the smart device can send images to an external location where a technician can compare the images, warn the patient of any defects in the medication, and provide advice on how to proceed.

[0118] Regarding adherence and patient responsibility, the features and functions of smart devices can be utilized. Some medications and treatment regimens are very expensive for national healthcare institutions, and much of the responsibility falls on the user to ensure genuine adherence. The following issue has been discussed in many countries around the world: if patients do not adhere to expensive treatments, they should be compelled to pay all or part of the cost of continuing treatment, as those who are not sufficiently interested in treatment should bear the cost. Information obtained from NFC tags and medication delivery history can be used to monitor adherence.

[0119] In this regard, biometric sensors on smart devices (such as fingerprint sensors, eye and / or facial recognition via cameras) can provide evidence of a user of a specific drug delivery device, thus providing evidence that a legitimate user has activated the drug delivery device to deliver the dosage. Biometric sensors can also be used to determine whether the device has been prevented / cannot be accidentally or intentionally used by a third party.

[0120] For example, if a larger battery is used, the NFC tag can utilize a temperature sensor built into the NFC chip. This can be advantageous because it allows for monitoring and recording of the temperature of the medication delivery device and / or medication container, for example, during transport. This is important for many temperature-sensitive medications, ensuring that the quality of the medication is not affected by temperature variations beyond permissible limits. Furthermore, the temperature sensor can be used to provide information when the medication reaches the target delivery temperature. This information is then transmitted to a smart device that provides the user with processing and temperature information.

[0121] It should be understood that the embodiments described above and shown in the accompanying drawings should be considered as non-limiting examples of the present invention, and various modifications can be made within the scope of patent protection.

Claims

1. A drug delivery system (10, 30), comprising: - A drug delivery device (20) comprising a drug container (65) located within a housing (24), a dose delivery outlet (60) accessible through the end of the housing (24), and a needle shield (62) serving as a sterile barrier, the needle shield being coupled to a needle shield remover (61). -Auxiliary devices (1, 3) include a battery module (18), an activation component (8, 38) and a communication module (13, 3b); - A movable cap (21, 31) is connected to the needle cover remover (61), wherein the movement of the cap (21, 31) acts on the activation member (8, 38) to activate the auxiliary device (1, 3); The auxiliary devices (1, 3) are configured to determine whether the cap (21, 31) has moved relative to the needle guard (62), and the communication modules (13, 3b) are configured to transmit data to an external device, wherein the data includes information directly related to the state of the activation member (8, 38) and / or the movement of the removable cap (21, 31). The caps (21, 31) are configured to move axially and / or circumferentially when connected to the needle shield remover (61). The activation members (8, 38) are initially in a first state (A), in which the communication modules (13, 3b) are prevented from receiving power from the battery module. Movement of the caps (21, 31) relative to the proximal end of the drug delivery device (20) causes the activation members (8, 38) to change to a second state (B), in which the battery module supplies power to the communication modules (13, 3b). The initial movement sequence of the cap activates the auxiliary devices (1, 3) but does not move the needle cover remover (61), and the activation member (8, 38) is configured to activate the auxiliary devices (1, 3) only once, and the activation member (8, 38) is prevented from transitioning from the second state back to the first state.

2. The drug delivery system (10, 30) as claimed in claim 1, wherein access to the dose delivery outlet (60) is prevented unless the cap (21, 31) is completely removed from the drug delivery device (20), wherein a continuous sequence of movement of the cap (21, 31) is required after the initial movement sequence of the cap to remove the needle shield (62) from the dose delivery outlet (60).

3. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein the battery module (18, 2) or communication module (13, 3b) includes one or more sensors configured to detect movement of at least one component of the drug delivery device (20).

4. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein the system further comprises a sensor module capable of being connected to any other module, and wherein the sensor module comprises one or more sensors configured to detect movement of at least one component of the drug delivery device (20).

5. The drug delivery system (10, 30) as claimed in claim 1, wherein the activating member (8, 38) is one of a switch (8) or an insulating pad (38).

6. The drug delivery system (10, 30) as claimed in claim 5, wherein the switch being in the second state (B) or the insulation pad (38) being removed indicates potential damage to the sterile barrier of the drug delivery device (20).

7. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein the communication module (13) or battery module (18) or auxiliary device (3) includes a recorder (1d, 3d) configured to acquire and store data information about the drug delivery device (20).

8. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein data transmission of the communication module (13, 3b) begins when the recorder (1d, 3d) receives power from the battery (2).

9. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein any of the modules is removable from the housing (24) and is reusable.

10. The drug delivery system (10, 30) as claimed in claim 1 or 2, wherein the system further comprises a recording module that can be connected to or included as part of any other module, and wherein the recording module is configured to begin tracking the movement of the drug delivery device when the cap (21, 31) is removed.

11. The drug delivery system (10, 30) of claim 1 or 2, wherein the system further comprises a memory module that can be connected to or included as part of any other module, wherein the memory module is configured to store data, and the communication module is configured to wirelessly transmit the data to an external device.

12. The drug delivery system (10.30) of claim 1, wherein the communication module includes means for wireless data transmission and signaling means for activating the status of the components (8, 38) and / or the movement of the caps (21, 31).

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