Method executable on an electronic device for communicating with a drug delivery device, electronic device, and drug delivery device - Patents.com

Abstract

In at least one embodiment, a method executable by an electronic device (200) for communicating with a drug delivery device (100) includes determining whether a user of the electronic device is authorized to operate the drug delivery device based on first information and second information, the first information being indicative of a prescription of a drug for a patient and the second information being indicative of a drug that the drug delivery device is expected to dispense. The method further includes generating an output signal if the user is authorized to use the drug delivery device, the output signal being expected to be communicated to the drug delivery device to enable an operating state of the drug delivery device to be altered.

Description

[Technical field]

[0001] A method executable on an electronic device for communicating with a drug delivery device is provided. Further provided are an electronic device, a computer program, a computer readable data medium, and a drug delivery device. [Background technology]

[0002] The administration of an injection is a process that presents several risks and challenges, both mental and physical, to the user and to medical personnel. Drug delivery devices may aim to make self-injection easier for patients. Safe operation of drug delivery devices is desirable. Summary of the Invention [Problem to be solved by the invention]

[0003] One of the objects to be achieved is to provide an improved method executable on an electronic device for communicating with a drug delivery device, in particular a method that increases safety for a user intending to operate the drug delivery device. Further objects to be achieved are to provide a drug delivery device capable of executing the method, a computer program for executing the method and a computer readable data medium, as well as an improved drug delivery device, in particular a drug delivery device configured to communicate with an electronic device. [Means for solving the problem]

[0004] These objects are achieved, inter alia, by the subject matter of the independent claims. Advantageous embodiments and further developments are the subject matter of the dependent claims and can further be extracted from the following description and the drawings.

[0005] First, the method will be described.

[0006] According to at least one embodiment, the method is executable or performed on an electronic device. The method is performed, for example, to communicate with a drug delivery device, in particular to enable the operation of the drug delivery device. The electronic device may comprise at least one processor. The electronic device may be a computer or a tablet PC or a smartphone or a smartwatch. In particular, the method is a computer-implemented method.

[0007] The drug delivery device and the electronic device are separate devices, for example, the drug delivery device and the electronic device are configured to communicate wirelessly with each other.

[0008] According to at least one embodiment, the method includes determining whether a user of the electronic device has authorization to operate the drug delivery device.

[0009] According to at least one embodiment, determining whether a user of the electronic device has authorization to operate the drug delivery device is based on first information and second information, the first information and second information being specifically digitized information processable by the electronic device.

[0010] According to at least one embodiment, the first information is indicative of a prescription for a medication to a patient. The prescription may be issued by a physician and the first information regarding the prescription may have been transmitted to the electronic device.

[0011] According to at least one embodiment, the second information is indicative of a drug that the drug delivery device is expected to dispense. In particular, the drug delivery device is configured to perform a dispensing process to dispense a drug dose. The drug delivery device may comprise or be configured to accommodate a drug container that contains the drug.

[0012] The first information and the second information may be compared with each other and / or with the user's identity to determine whether the user of the electronic device has the authority to operate the drug delivery device. For example, it may be determined whether the drug prescribed to the patient is the same as the drug that the drug delivery device is expected to dispense. Furthermore, it may be determined whether the user of the electronic device is the patient who has been prescribed the drug. If both conditions are met (the prescribed drug is the drug of the drug delivery device and the user of the electronic device is the patient), it may be determined that the user of the electronic device has the authority to operate the drug delivery device. If at least one of the two conditions is not met, it may be determined that the user does not have the authority to operate the drug delivery device.

[0013] To determine whether the user is actually a patient, the user's identity may be used and compared with the information about the patient stored in the first information. For this purpose, the user may be assumed to be the owner of the electronic device. For example, the identity of the owner of the electronic device may be stored electronically in the electronic device, and this identity may be compared with the patient's identity. Alternatively, it may be determined whether the prescription was actually predicted for this particular electronic device, and if so, it may be determined that the user / owner is a patient.

[0014] As an optional step, the identity of a user of the electronic device is determined prior to determining whether the user is authorized. This may be done, for example, based on a fingerprint, a facial scan, or a password entry. Thus, the electronic device may be configured to use a facial scan, a fingerprint, or a password identification to determine the identity of the user.

[0015] Determining whether the user of the electronic device has the authority to operate the drug delivery device may additionally be based on a dosing regimen to avoid the user administering an overdose or an incorrect dose to himself / herself. For example, the first information may be indicative of the dosing regimen, or third information stored on the electronic device may be indicative of the dosing regimen.

[0016] For example, a prescription may only be valid in a certain time window, and only in this time window may an output signal be generated for a particular drug delivery device. Additionally or alternatively, the generation of output signals for different drug delivery devices may be constrained by a dosing regimen. For example, two consecutive output signals may only be generated with a certain time gap between the two signals. The time gap may be several hours.

[0017] According to at least one embodiment, the method includes a step in which an output signal is generated if the user has authorization to use the drug delivery device, i.e. if it is determined that the user has authorization to use the drug delivery device, the output signal is, for example, not generated if it is determined that the user does not have authorization to operate the drug delivery device.

[0018] According to at least one embodiment, the output signal is expected to be communicated or transmitted to the drug delivery device to enable changing an operating state of the drug delivery device. The output signal is, for example, transmitted from the electronic device using a communication component of the electronic device. In particular, the output signal includes information indicating that the user is authorized to use the drug delivery device. The drug delivery device may be configured to receive the output signal, extract and / or process and / or understand this information, and then enable changing an operating state accordingly.

[0019] The change of the operating state may specifically be a change from a state in which the dispensing process for dispensing a drug dose and / or the setting process for setting a drug dose is prevented to a state in which the dispensing process and / or the setting process is possible. Thus, the user can perform the desired dose setting and / or dose dispensing only after the operating state has changed. Thus, the interaction between the electronic device and the drug delivery device may not lead to an immediate dispense of the drug. The interaction and / or signal exchange between the electronic device and the drug delivery device may occur before the dispense button or setting element is activated by the user.

[0020] In at least one embodiment, a method executable by an electronic device for communicating with a drug delivery device includes determining whether a user of the electronic device is authorized to operate the drug delivery device based on first information and second information, the first information indicative of a prescription of a drug for a patient and the second information indicative of a drug that the drug delivery device is expected to dispense. If the user is authorized to use the drug delivery device, an output signal is generated that is expected to be communicated to the drug delivery device to enable an operating state of the drug delivery device to be altered.

[0021] The safety of prescription drugs often relies on paper-based prescriptions and in-person handover of drugs to the person for whom they are prescribed. For immobile patients, in telemedicine use cases and / or in pandemic situations, this becomes increasingly burdensome, time-consuming and causes additional risks. If drugs are distributed by postal delivery, additional efforts must be made to ensure delivery to the correct recipient, for example to ensure safety for children at home. After all this, the risk of drug mix-up remains unresolved (e.g., mix-up by pharmacists, errors in logistics). The present invention proposes a solution to this problem, among others, for injectable drugs distributed in, for example, disposable needle-based injection system (NIS) pens, autoinjectors, or even inhalers. The above-mentioned problem can be solved, among others, by using an electronic device to determine whether a user has the authority to operate a drug delivery device based on first and second information, and only if so, generate an output signal to enable a change in the operating state of the drug delivery device.

[0022] According to at least one embodiment, the first information may be extracted from a first signal transmitted from an external device to the electronic device. The external device may be a further or second electronic device, such as a computer or a smartphone. In particular, the external device is different from the electronic device for performing the method and different from the drug delivery device.

[0023] According to at least one embodiment, the second information may be extracted from a second signal transmitted from the drug delivery device to the electronic device.

[0024] The method may include receiving the first and / or second signal. To receive the first and / or second signal, the electronic device may comprise one or more communication components or communication interfaces, respectively.

[0025] The method may include a step of generating and / or transmitting a first request signal, which is expected to be transmitted to an external device, for example via a cloud service, to request the first signal. Thus, the electronic device may be configured to generate and / or transmit the first request signal. In response to the first request signal, the first signal may be transmitted to the electronic device. By way of example, to generate and transmit the first request signal, a code, such as a QR code, on the drug delivery device or on a package of the drug delivery device is scanned, for example with the electronic device. The code may be indicative of a drug of the drug delivery device or indicative of a drug that the drug delivery device is expected to dispense. In response to the scanned code, a first request signal may be generated and transmitted to request a prescription for the drug extracted from the code. The step of generating and / or transmitting the first request signal is in particular performed before the step of determining whether a user of the electronic device has the authority to operate the drug delivery device.

[0026] The method may include a step of generating and / or transmitting a second request signal that is transmitted to the drug delivery device to request the second signal. Thus, the electronic device may be configured to generate and / or transmit the second request signal. In response to the request signal, the second signal may be generated. For example, in response to the second request signal, the drug delivery device generates the second signal and transmits it to the electronic device, or the drug delivery device affects the second request signal such that the second request signal is converted into a second signal and then received by the electronic device. The step of generating and / or transmitting the second request signal is in particular performed before the step of determining whether the user of the electronic device has the authority to operate the drug delivery device.

[0027] The communication component / interface of the electronic device may also be configured to generate and / or transmit the request signal.

[0028] According to at least one embodiment, the first signal and / or the second signal are wirelessly transmitted signals, and thus a communication component or a communication interface of the electronic device may be a wireless communication component or a wireless communication interface, respectively.

[0029] According to at least one embodiment, the second signal is an RFID signal. The drug delivery device may comprise an RFID tag, e.g., a passive RFID tag or an active RFID tag. The electronic device may comprise an RFID reading device, e.g., an active reading device or a passive reading device. For example, the second signal is a Near Field Communication (NFC) signal. In that case, the communication component of the electronic device may be an NFC component.

[0030] Alternatively, the second signal may be a Bluetooth signal. Thus, the electronic device and the drug delivery device may each comprise a Bluetooth communication component.

[0031] According to at least one embodiment, the first signal is a long-range communication signal, in particular a mobile communication signal. Additionally or alternatively, the first signal is transmitted by a cloud service. The first signal may be transmitted via Wi-Fi, LTE, 3G, 4G, 5G, or any other mobile communication standard.

[0032] For example, a physician or healthcare professional (HCP) issues a prescription for a drug to a patient, the prescription is transmitted wirelessly in digital format from the physician's or HCP's device to a cloud service, which then transmits a first signal to an electronic device that stores information about the prescription.

[0033] According to at least one embodiment, the first and / or second signal are cryptographically secured, for example via a public key system or via an asymmetric cryptosystem using a private key and a public key, and thus the first and / or second signal may be tamper-proof.

[0034] According to at least one embodiment, extracting the first and / or second information comprises decrypting the first and / or second signals. Thus, the electronic device may be configured to decrypt the first and / or second signals.

[0035] According to at least one embodiment, the first and / or second signal may be authenticated, in particular to check the origin of the first and / or second signal. This may be done before generating the output signal. For example, the output signal is generated only if the origin of the first and / or second signal is trusted or correct. Thus, the electronic device may be configured to authenticate the first and / or second signal.

[0036] According to at least one embodiment, the method includes generating a power signal to transfer energy to the drug delivery device, for example via induction. For example, the power signal is configured to be wirelessly transmitted to the drug delivery device to provide electrical energy to the drug delivery device. Thus, the electronic device can act as an energy source for the locking mechanism and / or as an actuator element of the drug delivery device, and the energy transfer may be via induction.

[0037] For example, the RFID component or the near field communication component is used to transfer energy from the electronic device to the drug delivery device. For this purpose, the drug delivery device may be equipped with a pre-charge capacitor. The second signal may include a power signal.

[0038] Additionally or alternatively, a charging system, for example a smartphone reverse charging system such as a QI system, is used to transfer energy from the electronic device to the drug delivery device.

[0039] It is also possible for the drug delivery device to have its own power source, e.g. a battery, for supplying electrical energy to the drug delivery device. The battery energy can be used alone or in combination with the transmitted energy to operate the drug delivery device.

[0040] According to at least one embodiment, the change in the operating state of the drug delivery device is associated with a mechanical change in a mechanical unit of the drug delivery device, for example, the change in the operating state is associated with a movement of an element of the mechanical unit.

[0041] According to at least one embodiment, the change in operating state is between a state in which setting of a drug dose and / or dispensing of a drug dose is prevented and a state in which setting of a drug dose and / or dispensing of a drug dose is possible.

[0042] According to at least one embodiment, the output signal is generated without a communication connection to an external device or cloud service. For example, the output signal is generated when the electronic device is offline, e.g., not connected wirelessly to the Internet. As an example, a first signal may be received, then the connection to the external device or cloud service may be interrupted, then a second signal is received and / or the output signal is generated.

[0043] For example, a prescription of the first information may be valid for a predefined time period, such as hours or days. If an output signal producible based on this prescription is not produced within the predefined time period, the prescription becomes invalid and it is no longer possible to produce an output signal based on this prescription. A new first signal may then be required.

[0044] According to at least one embodiment, the first information is indicative of multiple prescriptions of the drug to the user. Each prescription may be uniquely assigned to one drug delivery device. The first information may be assigned to a multipack of the drug delivery device. For example, to receive the respective first signal, the user of the electronic device must first scan a code, such as a QR code, on the multipack, and then a first request signal is sent to an external device and / or a cloud service, and in response to the first request signal, a first signal including information about the multiple receipts is generated and sent to the electronic device. The first information of the first signal may then be used offline to generate the output signal.

[0045] Each prescription may be assigned to a certain time window, e.g., an output signal assigned to one prescription can only be generated within this time window, which can avoid overdosing, especially if the time windows assigned to different prescriptions do not overlap or do not overlap at all.

[0046] The method described herein has, among other advantages, the following: - Prevention of drug mix-up: users can only unlock the correct type of drug delivery device. - Safe distribution: personal delivery to the patient is no longer necessary, since only the patient can use the drug. The drug can be made publicly available even outside pharmacies, depending on the market. - Safe postal delivery: no personal delivery is necessary. Parcels can be safely delivered even to children, since children cannot use drug delivery devices. - Support for telemedicine: Prescriptions can be deployed by HCPs remotely via cloud services within a live video session. No personal contact or paper-based prescriptions are required. - Wide compatibility: The concept may use technologies such as NFC and will be compatible with common smartphones. - Emergency medical care: The patient may carry a (dangerous) emergency injector / inhaler (e.g. EpiPen), but the patient must call the patient's health center, which will assess the situation and give special permission to use it (by transmitting a prescription). - Reuse protection: transmitted prescriptions may be invalidated once used by cryptographic means and may not be copied or reused.

[0047] We now specify an electronic device, which is configured to carry out the methods described herein, and therefore all features described in relation to the methods are also disclosed for the electronic device and vice versa.

[0048] According to at least one embodiment, the electronic device comprises at least one processor. The at least one processor may be configured, inter alia, to extract the first and / or second information from the first and / or second signal, and / or to decode the first and / or second signal, and / or to determine whether the user has the authority to operate the drug delivery device, and / or to generate an output signal. The electronic device may be a portable device and / or a wearable device. In particular, the electronic device may be a tablet PC, a smartphone, or a smartwatch.

[0049] According to at least one embodiment, the electronic device comprises one or more communication components configured to receive signals and / or transmit output signals. For example, the communication components are configured to receive wireless signals and / or transmit wireless output signals. Thus, the communication components may be wireless communication components.

[0050] According to at least one embodiment, the electronic device comprises an RFID component, in particular an NFC component. The communication component may be a reading device for reading an RFID tag or an NFC tag.

[0051] According to at least one embodiment, the electronic device comprises at least one long-range communication component, in particular a mobile communication component, for example, the electronic device comprises a Wi-Fi communication component, an LTE communication component, a 3G communication component, a 4G communication component, and / or a 5G communication component.

[0052] According to at least one embodiment, the electronic device includes an inductive charging component, such as a coil.

[0053] Next, a computer program and a computer-readable data medium are described. The computer program and the computer-readable data medium include instructions that, when executed by an electronic device, cause the electronic device to perform the methods described herein. The computer program may be an APP.

[0054] Next, a drug delivery device is specified, which may in particular be a drug delivery device with which the electronic device communicates when performing the method, and therefore all features disclosed in relation to the method are also disclosed for the drug delivery device and vice versa.

[0055] The drug delivery device specified herein may be an injection device, such as a needle-based injection device, or an inhaler. The drug delivery device may be an automatic injector, and / or a variable or fixed dose device, and / or a pen-type device, such as a dial-extension pen. The drug delivery device may be a disposable device.

[0056] According to at least one embodiment, the drug delivery device comprises a mechanical unit.

[0057] The mechanical unit may comprise a dispensing mechanism for dispensing a drug dose and / or a setting mechanism for setting a drug dose.

[0058] The dispensing mechanism and / or the setting mechanism may comprise several elements which interact with each other during dose dispensing or dose setting. For example, when switching from dose setting to dose dispensing or vice versa, a connection between two or more elements of the mechanism unit is changed. For example, two or more elements are splined such that they are rotationally fixed to each other during dose setting, and this spline connection is released during dose dispensing such that the elements rotate relative to each other during dose dispensing.

[0059] For example, the dispensing mechanism comprises a plunger rod configured to act on the drug reservoir to dispense a drug dose. The mechanism unit may be configured such that the plunger rod moves axially in a distal direction during dose dispensing. The plunger rod can also rotate during dose dispensing due to a threaded engagement with a further element of the mechanism unit, such as a drive element. For example, the plunger rod does not move during setting of the drug dose.

[0060] The dispensing mechanism may also include an energy member for providing energy to dispense the drug dose. The energy member may provide energy to move the plunger rod in a distal direction. For example, the energy member is a drive spring, such as a compression or torsion spring, or a gas cartridge, or an electric motor. Alternatively, no additional energy member is used to move the plunger rod. In that case, the force required to move the plunger rod and dispense the drug dose may have to be applied by the user.

[0061] The dispensing mechanism may comprise a drive element, e.g. a drive sleeve. The drive sleeve may circumferentially surround the plunger rod. The drive element may be threadedly engaged to the plunger rod. During dispensing of the drug dose, the drive element may move distally, e.g. without rotation, thereby forcing the plunger rod to rotate and also to move distally.

[0062] The setting mechanism may comprise a setting element, e.g. a dial sleeve and / or a number sleeve. During dose setting, the drive element may be splined to the setting element. For example, during dose setting, the drive element and the setting element move together, e.g. in a helical path in the proximal direction, but may not move relative to each other. During dose dispensing, the splined connection between the drive element and the setting element may be released. For example, during dose dispensing, the setting element again moves distally on a helical path, but the drive element only moves axially in the distal direction without rotation. To achieve the splined connection and to release the splined connection between the drive element and the setting element, the mechanism unit may comprise a clutch and / or a clicker arrangement and / or a clutch spring.

[0063] The mechanism unit may comprise a user interface member configured to be actuated by a user, e.g. to be touched by a user, to dispense a drug dose. For example, the user interface member is a button or a knob. For example, to dispense a drug dose, the user interface member must be pressed in a distal direction by the user. This user interface member may also be referred to as a dose dispensing member.

[0064] The mechanical unit may also comprise a user interface member configured to be actuated by a user, e.g. to be touched by the user, to set the drug dose, e.g., the user must rotate and / or move the user interface member in a proximal direction to set the drug dose, which user interface member may also be referred to as a dose setting member.

[0065] The user interface member for setting a drug dose may simultaneously be a user interface member for dispensing a drug dose.

[0066] According to at least one embodiment, the mechanical unit comprises a housing element. The housing element may be a sleeve. For example, the housing element circumferentially surrounds other elements or all elements of the mechanical unit. The housing element may comprise an outer surface that forms the outer surface of the drug delivery device that is accessible to the user.

[0067] In this specification, unless stated otherwise, movement of a member or element or feature of a drug delivery device means movement especially relative to a housing element.

[0068] The drug delivery device as specified herein may be elongated and / or have a longitudinal axis, e.g., a main axis of elongation. Additionally or alternatively, the drug delivery device may have rotational symmetry with respect to the longitudinal axis. A direction parallel to the longitudinal axis is referred to herein as an axial direction. By way of example, the drug delivery device may be cylindrical.

[0069] Furthermore, the drug delivery device may comprise an end, e.g. a longitudinal end, which may be arranged to face or be pressed against a skin area of ​​the human body. This end is referred to herein as the distal end. A drug or agent may be delivered via the distal end. The opposite end is referred to herein as the proximal end. In use, the proximal end is away from the skin area. The axial direction from the proximal end to the distal end is referred to herein as the distal direction. The axial direction from the distal end to the proximal end is referred to herein as the proximal direction. The distal end of a member or element or feature of a drug delivery device is understood herein to be the end of the most distally located member / element / feature. Thus, the proximal end of a member or element or feature is understood herein to be the end of the most proximal located element / member / feature.

[0070] In other words, "distally" is used herein to designate a direction, end, or surface that is or will be positioned to face or point towards the dispensing end of the drug delivery device or a component thereof and / or that points away from the proximal end, that will be positioned to face away from the proximal end, or that faces away from the proximal end. On the other hand, "proximally" is used herein to designate a direction, end, or surface that is or will be positioned to face or point away from the dispensing end and / or the distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dispensing end and / or the end furthest from the proximal end, and the proximal end may be the end furthest from the dispensing end. The proximal surface may face away from the distal end and / or towards the proximal end, and the distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be, for example, the needle end where the needle unit is or will be attached to the device.

[0071] As used herein, directions perpendicular to and / or intersecting the longitudinal axis are referred to as radial. An inward radial direction is a radial direction that points toward the longitudinal axis. An outward radial direction is a radial direction that points away from the longitudinal axis. As used herein, the terms "angular," "azimuthal," or "rotational" are used synonymously. Such directions are those that are perpendicular to the longitudinal axis and perpendicular to the radial direction.

[0072] According to at least one embodiment, the mechanism unit is configured to be operably coupled to the drug reservoir unit.

[0073] The drug reservoir unit may comprise or be a drug reservoir and / or a drug reservoir holder for holding the drug reservoir. The drug reservoir holder may be configured to hold the drug reservoir such that the drug reservoir cannot move relative to the drug reservoir holder. The drug reservoir may be a cartridge connectable to an injection needle or may be a syringe with an injection needle. The drug reservoir may contain a drug, for example multiple doses of a drug.

[0074] The drug reservoir may have a distal end for dispensing the drug. The distal end may be the end with the needle or the end that will be connected to a needle. The drug reservoir may include a stopper that proximally seals the drug reservoir.

[0075] "Operably coupled" in particular means that the mechanism unit and the drug reservoir unit are mechanically coupled or connected, in particular detachably coupled or connected, respectively. For this purpose, the mechanism unit may comprise an interface feature for forming a connection interface connecting the mechanism unit to the drug reservoir unit. The interface feature may comprise a thread configured to engage with a thread of the drug reservoir unit for forming a connection interface. Alternatively, the interface feature may be configured to establish a snap connection with the drug reservoir unit. When coupled, the drug reservoir unit may be fixed relative to the housing element, for example, such that the drug reservoir unit cannot move axially relative to the housing element. Additionally or alternatively, "operably coupled" may mean that the mechanism unit and the drug reservoir unit are coupled for exchanging information, for example electrical signals or currents.

[0076] According to at least one embodiment, the mechanism unit is configured to enable a dispensing process for dispensing a drug dose, for example a set drug dose. In particular, the mechanism unit may be configured to act on a drug reservoir, in particular on a drug reservoir of the drug reservoir unit, during the dispensing process. When the mechanism unit acts on the drug reservoir, the mechanism unit may push a stopper distally to dispense the drug dose. Thereby, for example, a plunger rod of the mechanism unit abuts against the stopper and pushes the stopper distally. To carry out the dispensing process, a user may need to operate the dose dispensing member.

[0077] According to at least one embodiment, the mechanism unit comprises a configuration for changing an operating state of the mechanism unit, in particular from a first operating state to a second operating state or vice versa, in which at least one function of the mechanism unit that was disabled or not performed in the first operating state is enabled or performed.

[0078] The arrangement for changing the operating state may comprise one or more components interacting with each other. For example, the arrangement comprises mechanical and / or electrical components. By way of example, the arrangement comprises one or more of an electromechanical actuator, a control unit, a display, and an energy source. The control unit may comprise a processor, e.g. an IC chip. The control unit may be a microcontroller. The energy source may be a battery.

[0079] According to at least one embodiment, the mechanical unit comprises a communication component for receiving an output signal transmitted from the electronic device to the drug delivery device. The communication component may be a wireless communication component. The communication component may be a Bluetooth component, or an RFID component, or an NFC component. The communication component may comprise an RFID tag or an NFC tag.

[0080] According to at least one embodiment, the communication component is configured to establish a communication connection or chain with the electronic device, such as an encrypted and / or secure communication connection or chain. The communication component of the drug delivery device may be configured to transmit a second signal to the electronic device, the second signal including information about the drug delivery device, in particular about the drug that the drug delivery device contains or is configured to administer. The drug delivery device may be configured to identify itself, for example in response to a received request signal.

[0081] According to at least one embodiment, the mechanism unit is configured such that activation of the arrangement for changing the operational state of the mechanism unit is prevented unless an output signal from the electronic device is received via the communication component.

[0082] For example, the mechanism unit is configured to enable the actuation of the arrangement to change the operating state, in particular only when the output signal is received. The actuation of the arrangement to change the operating state may occur automatically when the output signal is received. Alternatively, the actuation of the arrangement may additionally require a further process to be performed, such as a manual actuation by a user of the drug delivery device. In particular, receiving the output signal may be a prerequisite for the actuation of the arrangement.

[0083] The mechanism unit may be configured to determine whether an output signal is received and to prevent and / or enable actuation of the arrangement unless or only when an output signal is determined to be received, respectively, e.g., to prevent changing an actuation state if an output signal is not received.

[0084] The mechanism unit may also be configured to authenticate and / or decrypt the output signal, in particular to check the origin of the output signal. This may be done before allowing the configuration to operate. For example, the mechanism unit will only allow the configuration if the origin of the output signal is trusted or correct.

[0085] According to at least one embodiment, the drug delivery device is a device for self-administration. In particular, the use of the drug delivery device can be performed by the patient without professional support.

[0086] According to at least one embodiment, the arrangement comprises an electromechanical actuator, which may comprise an electric motor and / or an electromagnet.

[0087] According to at least one embodiment, actuation of the arrangement for changing the actuation state includes actuation of an actuator, which may be configured to, when actuated, move an actuator element of the actuator between a first position and a second position.

[0088] An electromechanical actuator is understood herein to be an actuator that converts an electrical signal into a movement of an actuator element. For example, the actuator may, when actuated, move an actuator element from a first position to a second position and / or vice versa. The movement between the first and second positions may be an axial and / or rotational and / or radial movement.

[0089] The mechanism unit, in particular its configuration, may comprise a control unit for activating the actuator. For example, to activate the actuator, the control unit sends an electric signal. The control unit may be configured to activate the actuator only when an output signal is received. When the output signal is not received, the actuator may not be activated or may not be operable.

[0090] According to at least one embodiment, the drug delivery device comprises a drug reservoir unit containing the drug and coupled to a mechanism unit.

[0091] Further, a set is specified. The set may comprise an electronic component as specified herein, and a drug delivery device as specified herein.

[0092] In the following, the method, the electronic device and the drug delivery device will be described in more detail based on exemplary embodiments with reference to the drawings. In the individual drawings, the same reference signs indicate similar, similarly functioning or identical elements. However, the size ratios involved are not necessarily constant and the individual elements may rather be shown with exaggerated size for better understanding. [Brief description of the drawings]

[0093] [Figure 1] 1 shows a schematic diagram of an exemplary embodiment of a method, an exemplary embodiment of an electronic device, and a first exemplary embodiment of a drug delivery device. [Diagram 2] A second exemplary embodiment of a drug delivery device is shown in different figures. [Diagram 3] A second exemplary embodiment of a drug delivery device is shown in different figures. [Figure 4] A second exemplary embodiment of a drug delivery device is shown in different figures. [Diagram 5] A second exemplary embodiment of a drug delivery device is shown in different figures. [Figure 6] A second exemplary embodiment of a drug delivery device is shown in different figures. [Figure 7] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 8] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 9] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 10] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 11] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 12] A third exemplary embodiment of a drug delivery device is shown in different figures. [Figure 13]A fourth exemplary embodiment of a drug delivery device is shown in different figures. [Figure 14] A fourth exemplary embodiment of a drug delivery device is shown in different figures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0094] 1 shows a schematic diagram of an exemplary embodiment of the method. The method is performed using an electronic device 200. The electronic device 200 is, for example, a smartphone. The electronic device 200 comprises a processor 201, communication components 202, 203 and an inductive charging component 204.

[0095] The method includes a step of determining whether a user of the electronic device 200 has authorization to operate the drug delivery device 100 based on the first information and the second information. The method further includes a step where an output signal is generated if the user has authorization to use the drug delivery device 100. The output signal is expected to be communicated to the drug delivery device 100 to enable changing an operating state of the drug delivery device 100. These two steps may be executed by the processor 201.

[0096] The first and second information may be extracted from the first and second signals, for example using the processor 201. The first information is indicative of a prescription for a drug to a patient and the second information is indicative of a drug that the drug delivery device 100 is expected to dispense. Communication components 202 and 203 may be used to receive the first and second signals.

[0097] Determining whether the user of the electronic device 200 is authorized to operate the drug delivery device 100 may be done by comparing the identity of the user of the electronic device 200 with the identity of the patient for whom the prescription is to be prescribed, and also comparing the drug that the drug delivery device 100 is expected to dispense with the drug of the prescription. If the user and the patient are the same, and the drug of the prescription and the drug of the drug delivery device 100 are the same, then it is determined that the user is indeed authorized to operate the drug delivery device 100. To provide their identity to the electronic device 200, the user may first need to enter a password, and / or provide a fingerprint, and / or scan their face.

[0098] The communication component 203 may be a long-range communication component, such as a Wi-Fi communication component, an LTE communication component, a 3G communication component, a 4G communication component, or a 5G communication component configured to receive a first signal. The first signal may be wirelessly transmitted from the external device 300 to the electronic device 200 via a cloud service 400. The external device 300 may be assigned to a doctor or medical professional who prescribes a drug to a patient. This prescription or information about this prescription, respectively, is then stored in the first signal. The first signal may be an encrypted signal, and decryption of the signal may be performed by the processor 201 of the electronic device 200.

[0099] The method may also include generating and transmitting a first request signal to request the prescription. This first request signal may be generated and / or transmitted by the communications component 203. The request signal may then be forwarded to the external device 300 via the cloud service 400.

[0100] The communication component 202 may be configured to communicate with the drug delivery device 100. For example, the communication component 202 comprises an RFID communication component, such as a Near Field Communication (NFC) component. The communication component 202 may be configured to transmit a second request signal and receive the second signal. The second request signal and the second signal may be wirelessly transmitted signals. To receive the second signal, a user of the external device 200 may bring the external device 200 close to the drug delivery device 100, and the external device may then transmit a second request signal to the drug delivery device 100 and in response receive a second signal that stores information about the drug delivery device 100, in particular the drug of the drug delivery device 100 or the drug that the drug delivery device 100 is expected to dispense.

[0101] If it is determined that the user has the authority to operate the drug delivery device 100, the communication component 202 may be further configured to transmit the generated output signal.

[0102] The inductive charging component 204 may be configured to supply electrical energy to the drug delivery device 100, particularly via induction.

[0103] The drug delivery device 100 may be an injection device, e.g. an automatic injector and / or a variable dose device. The drug delivery device 100 comprises a communication component 101. The communication component 101 may comprise an RFID communication component, such as an NFC component. The communication component 101 may comprise an RFID tag. The communication component 101 is configured in particular to receive an output signal of the electronic device 200 and / or to affect a second request signal of the electronic device 200 and / or to transmit a second signal to the electronic device 200.

[0104] The drug delivery device 100 is configured to allow a change in its operating state upon receiving an output signal. For this purpose, the drug delivery device 100 comprises an arrangement, in this case comprising an electromechanical actuator 5, a control unit 43A and a battery 43B. The actuator 5 comprises an actuator element 50 which moves when the actuator 5 is actuated. If the electrical energy transmitted from the external device 200 to the drug delivery device 100 is sufficient to actuate the control unit 43A and / or the electromechanical actuator 5, the battery 43B may be omitted. The drug delivery device 100 comprises a pre-charge capacitor 43C for storing the energy transmitted from the external device 200.

[0105] The control unit 43A is configured to actuate the actuator 5 to change the operating state of the drug delivery device 100. For example, the change of the operating state of the drug delivery device 100 is from a state in which a dispensing process for dispensing a drug dose and / or a setting process for setting a drug dose is prevented to a state in which such process(es) are possible. The communication component 101 may be configured to forward the received output signal to the control unit 43A. The control unit 43A is configured to actuate the actuator 5 to change the operating state of the drug delivery device 100, for example, when receiving the forwarded output signal. Otherwise, the actuator 5 is not operating or not operable. Details regarding the structure of the actuator 5 configuration in particular are described further below.

[0106] 2 illustrates in cross-section a second exemplary embodiment of a drug delivery device 100. The drug delivery device 100 is a variable dose device, where different doses of the drug to be dispensed can be set or dialed in by a user. The drug delivery device 100 is a dial extension pen.

[0107] 2 also shows the coordinate system used herein to specify the positions of members or elements or features of the drug delivery device 100. The distal direction D and the proximal direction P run parallel to the longitudinal axis A. The longitudinal axis A is the main axis of elongation of the device 100. The radial direction R is perpendicular to and intersecting the longitudinal axis A. The azimuthal directions C, also called angular or rotational directions, are perpendicular to the radial direction R and to the longitudinal axis A. In the following figures, the different directions and axes are not shown to increase the clarity of the figures.

[0108] The drug delivery device 100 comprises a mechanism unit MU having a setting mechanism and a dispensing mechanism. The setting mechanism is configured to set a drug dose and the dispensing mechanism is configured to dispense a drug dose. The functional principle of the mechanisms is further explained below.

[0109] The mechanical unit MU comprises an inner body 10 and a housing element 11, also referred to below as outer body 11. The inner body 10 and the outer body 11 are fixedly connected to each other, i.e. they cannot rotate or move axially relative to each other. The outer body 11 forms the outer surface of the drug delivery device 100 that can be touched or gripped by a user.

[0110] The drug delivery device 100 comprises a cap 14 and a user interface member 13 in the form of a knob 13. The knob 13 is a dose setting member configured to be actuated by a user to set a drug dose and at the same time a dose dispensing member configured to be actuated by a user to dispense a drug dose.

[0111] A drug reservoir unit RU comprising a reservoir 16 and a reservoir holder 15 is housed in the cap 14. A drug is filled in the reservoir 16. The reservoir 16 is sealed in the proximal direction P by a stopper 17.

[0112] The drug reservoir unit RU is operably coupled or connected to the mechanism unit MU. The mechanism unit MU is configured to act on the drug reservoir 16 to enable a dispensing process for dispensing a drug dose. The stopper 17 is pressed in a distal direction D by a plunger rod 29 of the mechanism unit MU to dispense the drug dose. The coupling between the mechanism unit MU and the reservoir unit RU is realized by the inner body 10 being coupled to the reservoir holder 15 via a connection interface, which may be a snap coupling or a threaded connection. This coupling is preferably reversible. For example, the drug reservoir unit RU is axially and rotationally fixed to the inner body 10 by this coupling.

[0113] The mechanism unit MU further comprises a number sleeve 26 and a dial sleeve 27 fixedly coupled to each other (e.g., they cannot rotate or move axially relative to each other). The dial sleeve 27 may comprise an internal thread that engages with the external thread of the inner body 10. Numbers may be indicated on the outer surface of the number sleeve 26. The user can see the numbers through a window 12 of the mechanism unit MU. The window 12 may comprise a lens. The window 12 is formed in the outer body 11. The numbers visible in the window 12 indicate to the user the set / dialed dose. As will be further explained below, due to the threaded coupling between the dial sleeve 27 and the inner body 10, the dial sleeve 27 and the number sleeve 26 move on a helical path in the proximal direction relative to the bodies 10, 11 during setting of the drug dose and during dispensing of the drug dose.

[0114] The mechanical unit MU also comprises a drive sleeve. The drive sleeve comprises a distal drive sleeve 20, a proximal drive sleeve 21 and a drive sleeve coupler 22 coupling the distal drive sleeve 20 to the proximal drive sleeve 21. To set the drug dose and dispense the drug dose, the distal drive sleeve 20 and the proximal drive sleeve 21 are fixedly coupled to each other via the drive sleeve coupler 22, so that these elements cannot rotate or move axially relative to each other. The distal drive sleeve 20 may comprise an internal thread that engages with the external thread of the plunger rod 29. The external thread of the distal drive sleeve 20 may engage with the internal thread of a final dose nut 30, the function of which will be further explained below.

[0115] Furthermore, the mechanical unit MU comprises a clutch 28 fixedly coupled to the knob 13, so that the clutch 28 and the knob 13 do not rotate or move axially relative to each other during setting of a drug dose and dispensing of a drug dose. The clutch 28 is coupled to the proximal drive sleeve 20 via a splined engagement. This splined engagement allows for some axial movement of the clutch 28 relative to the proximal drive sleeve 21, but does not allow for relative rotation between these two elements.

[0116] Between the clutch 28 and the drive sleeve coupler 22, the distal clicker 23, the proximal clicker 24, and the clutch spring 25 of the mechanism unit MU are disposed. The clutch spring 25 is coupled to the drive sleeve coupler 22 and the distal clicker 23. The distal clicker 23 is configured to abut the proximal clicker 24 in the proximal direction P. The proximal clicker 24 is configured to abut the clutch 28 in the proximal direction P. Thus, the clutch spring 25 is configured to bias the distal clicker 23, the proximal clicker 24, and the clutch 28 against the drive sleeve coupler 22 in the proximal direction P (see also Figures 15 and 17 for more detailed views).

[0117] The distal clicker 23 may be permanently splined to the proximal drive sleeve 21 to prevent relative rotation between the two elements, however some axial movement may be permitted between the distal clicker 23 and the proximal drive sleeve 21. The proximal clicker 24 may be permanently splined to the inner body 10 to prevent relative rotation between the two elements, however some relative axial movement may be permitted.

[0118] Both the distal surface of the clutch 28 and the proximal surface of the proximal clicker 24 may be toothed such that the two surfaces can be engaged within one another. Furthermore, both the distal surface of the proximal clicker 24 and the proximal surface of the distal clicker 23 may be toothed such that the two toothed surfaces can be engaged within one another. The proximal surface 28 of the clutch may be toothed, e.g., canine-like, and may be configured to engage with a toothed, e.g., canine-like, distal surface of the dial sleeve 27.

[0119] FIG. 2 shows the drug delivery device 100 when no dose is set (0 units / 0 units position). Dose setting may be possible in 1 discrete unit, for example from 0 units to 80 units. The user must rotate the knob 13 to set the desired drug dose. This is done without forcing the knob 13 in the distal direction D. A canine-like engagement between the clutch 23 and the drive sleeve 27 is established due to the clutch spring 25, which either biases the clutch 28 in the proximal direction P or at least prevents the clutch 28 from moving in the distal direction D by itself, unless the knob 13 is pressed in the distal direction D. As a result of the canine-like engagement between the clutch 28 and the dial sleeve 27, the two elements are rotationally locked to each other, so that when the knob 13 is rotated, the dial sleeve 27 and the number sleeve 26 also rotate. Because the dial sleeve 27 is threadedly engaged to the inner body 10, rotation of the knob 13 results in the knob 13, clutch 28, dial sleeve 27 and number sleeve 26 moving on a helical path in the proximal direction P relative to the bodies 10, 11, thereby causing the number on the number sleeve 26, as seen through the window 12, to increase.

[0120] Because the proximal drive sleeve 21 is splined to the clutch 28 , the proximal drive sleeve 21 , and thereby the distal drive sleeve 20 and drive sleeve coupler 22 , also move on a helical path in the proximal direction P relative to the inner body 10 .

[0121] The plunger rod 29 has two external threads with overlapping opposing hands. The plunger rod 29 is threadedly engaged with the internal threads of the distal drive sleeve 20. The threads are selected such that the plunger rod 29 is neither rotated nor axially displaced during the helical movement of the distal drive sleeve 20 in the proximal direction P.

[0122] The final dose nut 30 may be splined to the inner body 10 and therefore cannot rotate relative to the inner body 10. Due to the final dose nut 30 being threadedly engaged with the distal drive sleeve 20, the final dose nut 30 is forced to move in the proximal direction P during the setting of the drug dose. Once the maximum dose is set (e.g. 80 units, regardless of whether it is set in one or multiple drug setting processes), the final dose nut 30 establishes a rotation lock interface with the distal drive sleeve 20, so that the final dose nut 30 can no longer rotate relative to the distal drive sleeve 20. As a result of this, the distal drive sleeve 20 can no longer rotate and no further drug doses can be set. The drug delivery device 100 is then reset to its initial state.

[0123] During setting of the drug dose, the facing toothed surfaces of the distal clicker 23 and the proximal clicker 24 move unidirectionally over each other, thereby generating a clicking sound that indicates to the user that the drug dose has been set. For this purpose, the teeth of the two surfaces are preferably formed as shallow triangles, so that relative rotation between the clickers 23 and 24 is possible, leading to slight repeated compression and decompression of the clutch spring 25.

[0124] After the desired dose is set, the user can now press the knob 13 in the distal direction D to dispense the set drug dose. This causes the distally directed force applied to the knob 13 to be transferred from the knob 13 to the proximal clicker 24 and then to the distal clicker 23 via the clutch 28, compressing the clutch spring 25. At this time, the two clickers 23 and 24 press against each other and their toothed surfaces engage. At this time, relative rotation between the two clickers 23, 24 is prevented. Since the proximal clicker 24 is splined to the inner body 10 and the distal clicker 23 is splined to the proximal drive sleeve 21, the proximal drive sleeve 21 can no longer rotate relative to the inner body 10. However, since the proximal drive sleeve 21 is also splined to the clutch 28, the clutch 28 and the knob 13 can no longer rotate relative to the inner body 10 either.

[0125] As already mentioned, applying a force directed in the distal direction to the knob 13 results in the clutch 28 moving slightly in the distal direction D together with the knob 13 relative to the dial sleeve 27, compressing the clutch spring 25. This releases the canine engagement between the dial sleeve 27 and the clutch 28, so that the dial sleeve 27 is no longer rotationally locked by the clutch 28. Thus, when the knob 13 is pressed in the distal direction D, the dial sleeve 27 together with the number sleeve 26 can still rotate relative to the inner body 10. At this time, when the knob 13 moves in the distal direction D, it stops against the dial sleeve 27, and the dial sleeve 27 also moves in the distal direction D. Due to the threaded engagement of the dial sleeve 27 with the inner body 10, the dial sleeve 27 moves on a helical path in the distal direction D together with the number sleeve 26. The number of the number sleeve 26 visible in the window 12 thereby decreases.

[0126] At the same time, the clutch 28, the clickers 23, 24 and the drive sleeves 20, 21, 22 are forced to move (without rotation) in the distal direction D. The threaded engagement between the plunger rod 29 and the distal drive sleeve 20 forces the plunger rod 29 to rotate. A further threaded engagement between the plunger rod 29 and the internal threads of the inner body 10 may then force the plunger rod 29 to move distally to push the stopper 17 in the distal direction D into the cartridge 16 to dispense the set drug dose. Since the distal drive sleeve 20 does not rotate during dispensing, the final dose nut 30 moves in the distal direction D with the distal drive sleeve 20 without changing its position relative to the distal drive sleeve 20.

[0127] After dispensing a set drug dose, and when knob 13 has returned fully to its initial position, a new drug dose can be set by rotating knob 13 again on a helical path in the proximal direction P. During this time, plunger rod 29 does not change its position. Plunger rod 29 moves in the distal direction D only when dispensing a dose.

[0128] As described with respect to Figure 2, one user interface member in the form of knob 13 is used for setting the drug dose as well as for dispensing the drug dose. However, it is also possible to use separate user interface members for setting and dispensing the drug dose.

[0129] Figures 3-6 show the drug delivery device 100 of Figure 2, but from a different perspective and in more detail than Figure 2. Figures 3 and 5 show only a proximal portion of the drug delivery device 100 to better show some details. Figures 4 and 6 show the circled area of ​​Figures 3 and 5.

[0130] As can be seen from Figures 3 and 5, the dial sleeve 27 comprises a conductor path 44. The conductor path 44 comprises a wound or helical conductor track, respectively, which is arranged, for example, on the outer surface of the dial sleeve 27. The pitch of the helical conductor track is preferably the same as the pitch of the helical path travelled by the dial sleeve 27 during setting and dispensing of a drug dose.

[0131] On the proximal face of the dial sleeve 27, a control system is arranged, comprising a control unit 43A, a battery 43B, and a communication component 101. The control unit 43A, the battery 43B, and the communication component 101 may be arranged on a PCB mounted on the proximal face of the dial sleeve 27. The control unit 43A may comprise a processor and / or an IC chip. The control unit 43A and / or the battery 43B may be electrically connected to the conductor path 44. The communication component 101 may be as described in relation to FIG. 1. The communication component may be electrically connected to the control unit 43A.

[0132] As can be seen from Figures 3 and 5, the conductor path 44 actually comprises two parts 44A and 44B. These two parts 44A, 44B are assigned to different elements of the drug delivery device 100. The first part 44A is assigned to the body 10, 11 and is fixed thereto. The second part 44B is assigned to the dial sleeve 27 and is fixed thereto and constantly follows the movements of the dial sleeve 27. The two parts 44A, 44B therefore move relative to each other during the setting of the drug dose and during the dispensing of the drug dose.

[0133] In order to always maintain an electrical connection between the first part 44A and the second part 44B during dose setting and dose dispensing, the first part 44A is provided with a helical conductive path and a sliding contact 45 is realised between the two parts 44A, 44B. The helical conductor track of the first part 44A, assigned to the dial sleeve 27 and having the same pitch as the helical path along which the dial sleeve 27 moves relative to the bodies 10, 11 during dose setting and dose dispensing, in combination with the sliding contact 45, ensures that the two parts 44A, 44B are always electrically connected during dose setting and dose dispensing.

[0134] As can be seen from figures 3 and 5 and in further detail from figures 4 and 6, the mechanical unit MU also comprises an electromechanical actuator 5 having an actuator element 50. The actuator element 50 is a displaceable or movable element 50 in the form of a flexible arm 50. At one longitudinal end, the flexible arm 50 is fixed to the inner body 10, the other longitudinal end of the arm 50 being a free end which can be displaced in the radial direction R. The arm 50 is oriented in the axial direction.

[0135] At its free longitudinal end, the arm 50 is provided with an electromagnet 52 (see detailed view in FIG. 7 showing the circled area in FIG. 6 in more detail). The electromagnet 52 is configured to change its strength of magnetization when the actuator 5 is actuated. The electromagnet 52 is also configured to interact with a magnet 51 of the outer body 11. The magnet 51 is axially and / or rotationally overlapped with respect to the electromagnet 52. By varying the current through the electromagnet 52, its strength of magnetization is changed, allowing the arm 50 to be moved between a first position and a second position.

[0136] Figures 3 and 4 show the arm 50 in the second position (the first state in which the mechanism unit MU is unlocked), while Figures 5 and 6 show the arm 50 in the first position (the second state in which the mechanism unit MU is locked).

[0137] 3-6, the number sleeve 26 is shown to have a number of recesses 54 or grooves 54, which correspond to the amount, setting and pitch of envisaged dose units that can be set by the mechanism unit MU (e.g. 24 units). The arms 50 are provided with radially inwardly facing protrusions 53, which are configured to engage in the recesses 54 to prevent helical movement between the number sleeve 26 and the arms 50. As the arms 50 are rotationally and axially fixed to the inner body 10, this engagement will prevent helical movement of the number sleeve 26 relative to the inner body 10.

[0138] As explained with respect to Figure 2, the setting and dispensing of a drug dose is linked to the helical movement of the numbered sleeve 26. Thus, when the arm 50 is in a first position (see Figures 5 and 6), a blocking interface between the arm 50 and the numbered sleeve 26 prevents the setting and dispensing of a drug dose. The operating state of the mechanical unit MU is locked. When the arm 50 is in a second position (Figures 3 and 4), the blocking interface is released, allowing the setting and dispensing of a drug dose, and the operating state of the mechanical unit MU is unlocked.

[0139] Figures 3 and 5 further show how the actuator 5 can be operated. A conductor path 44 leads from the control unit 43A to the electromagnet 52. By passing a current through the conductor path 44 or by changing the current in the conductor path 44, the magnetization strength of the electromagnet 52 can be changed from a state that repels the magnet 51 to a state that attracts the magnet 51, or vice versa. Controlling the current in the conductor path 44 may be performed by the control unit 43A.

[0140] For example, when an output signal from the electronic device 200 is received via the communication component 101 and forwarded to the control unit 43A, the control unit 43A may be configured to simply enable actuation or simply actuate the actuator 5 by changing the current in the conductor path 44, thereby changing the actuation state of the mechanism unit MU (from locked to unlocked state or vice versa). If no output signal is received, actuation of the actuator 5 is prevented.

[0141] 5 and 6, as an example, the electromagnet 52 is not magnetized so that the electromagnet 52 and the magnet 51 do not magnetically interact. The flexible arm 50 is in a first position, which may be its relaxed state. When the actuator 5 is activated, a current is supplied to the electromagnet 52, which is then attracted by the magnet 51. The flexible arm 50 moves in a radially outward direction to a second position (FIGS. 3 and 4). In this second position, the flexible arm 50 is pre-biased towards its first position. When the activation of the actuator 5 is interrupted by removing the current for the electromagnet 52, the flexible arm automatically returns to its first position.

[0142] 7 to 12 show a third exemplary embodiment of a drug delivery device 100. The functionality, in particular with regard to the setting and dispensing mechanism and the communication component 101, may be essentially the same as with regard to the previous exemplary embodiment. However, the actuator 5 for blocking and releasing the dose setting is different.

[0143] The mechanical unit MU comprises an intermediate element 58 in the form of a blocking sleeve 58, which partially surrounds the distal drive sleeve 20. The blocking sleeve 58 comprises two elongate arms, each having a wedge 58.1 projecting in a radially outward direction (see Figures 8 and 11). The distal drive sleeve 20 comprises a ramp 20.1. The actuator 5 comprises an actuator element 50 in the form of an actuator arm. The actuator arm 50 can be moved by means of an electric motor of the actuator 5. The actuator 5 is coupled to the drive sleeve coupler 22, the actuator arm 50 engaging the blocking sleeve 58. A blocking sleeve spring 59 biases the blocking sleeve 58 in the distal direction D.

[0144] Figure 8 shows a view in section AA of Figure 7. The final dose nut 30 is provided with several recesses on its inner surface. For example, the number of recesses is equal to or equal to the number of dose steps in one revolution of the dose setting. Figure 9 shows a view in section DD of Figure 8.

[0145] 7-9 show the drug delivery device 100 with the actuator arm 50 in a first position. The actuator arm 50 may remain in this first position after a short actuation of the actuator 5. The actuator arm 50 in the first position pulls and / or holds the blocking sleeve 58 in a locked position where the blocking sleeve 58 is pulled over the ramp 20.1 of the distal drive sleeve 20. The arms of the blocking sleeve 58 are thereby forced by the ramp 20.1 to move in a radially outward direction such that the wedge 58.1 engages in a recess of the final dose nut 30. A blocking interface is thereby established which prevents relative rotation between the final dose nut 30 and the blocking sleeve 58. The blocking sleeve 58 is rotationally locked to the distal drive sleeve 20. As the final dose nut 30 cannot rotate relative to the inner body 10, rotation of the distal drive sleeve 20 is prevented by the actuator arm 50 in the first position and the blocking sleeve 58 in the locked position. Setting of a drug dose is therefore prevented. As can be further seen in FIG. 7, with the blocking sleeve 58 in the locked position, the blocking sleeve spring 59 is compressed.

[0146] Figures 10 and 12 show the drug delivery device 100 with the actuator arm 50 in a second position, where it no longer holds the blocking sleeve 58 in its locked position. Figure 11 shows a view at section BB of Figure 20. Figure 12 shows a view at section CC of Figure 21a.

[0147] The blocking sleeve spring 59 urges the blocking sleeve 58 in the distal direction D, so that the arms of the blocking sleeve 58 are no longer held over the ramp 20.1 and can relax in the radially inward released position. In the released position of the arms of the blocking sleeve 58, the wedges 58.1 of the blocking sleeve 58 are no longer engaged in the recesses of the final dose nut 30, so that the blocking interface is released and rotation of the drive sleeve 20 relative to the final dose nut 30 is permitted. Thus, dose setting is possible.

[0148] 7 and 10 also show the electrical connection between the actuator 5 and the control unit 43A or the battery 43B, respectively. The conductor path 44 connecting the actuator 5 to the control unit 43A and / or the battery 43B comprises three parts 44A, 44B, 44C assigned to different elements of the drug delivery device 100. The control unit 43A, the battery 43B and the part 44B are fixed to the knob 13. The part 44A is fixed to the proximal drive sleeve 21. The part 44C is fixed to the drive sleeve coupler 22. The electrical connection between the parts 44A and 44B and between 44A and 44C is maintained by contacts 45 during dose adjustment and dose dispensing.

[0149] The actuation of the actuator 5 may again be controlled by the control unit 43A. This may again be dependent on whether an output signal of the electronic device 200 has been received via the communication component 101.

[0150] 13 and 14 show a fourth exemplary embodiment of a drug delivery device 100. Again, this exemplary embodiment may have essentially the same functionality as the previous exemplary embodiment, especially with regard to the setting and dispensing mechanism and the communication component 101, but deviates from the previous exemplary embodiment in the design of the actuator 5.

[0151] In the fourth exemplary embodiment, the control unit 43A, the battery 43B, and the communication component 101 are coupled to the knob 13 for movement therewith. The actuator 5 is coupled to the dial sleeve 27. The actuator element 50 of the actuator 5 is, for example, a pin that can be moved radially by the actuator 5.

[0152] In Figures 13 and 14 (Figure 14 shows the circled area in Figure 13), the actuator element 50 is in a first position in which it engages with the outer body 11. Due to this engagement, relative axial and rotational movement between the dial sleeve 27 and the outer body 11 is prevented, thereby preventing dose setting and dose dispensing. When the actuator 5 is actuated by the control unit 43A, the actuator element 50 can be moved to a second position in which it no longer engages the outer body 11, thereby allowing dose setting and dose dispensing.

[0153] Again, the actuation of the actuator 5 may be controlled by the control unit 43A depending on whether an output signal of the electronic device 200 is received via the communication component 101.

[0154] Some or all of the actuators 5 described in connection with the previous exemplary embodiments may also be combined.

[0155] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation that includes one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental health. Drugs or agents may be used for a limited duration or periodically for chronic diseases.

[0156] As described below, a drug or agent can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs can include small molecules with 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0157] The drug or agent may be contained within a primary package or "drug container" adapted for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other solid or flexible container configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be 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, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration into the human or animal body. For example, the two chambers may be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0158] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications related to diabetes, such as diabetic retinopathy, thromboembolism, such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, including, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index 15th Edition.

[0159] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be derived formally from the structure of a naturally occurring peptide, e.g., that of human insulin, by deleting and / or substituting at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residue can be either a codable amino acid residue, or other naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids found in the naturally occurring peptide may be deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable amino acids, may be added to the naturally occurring peptide.

[0160] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0161] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0162] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899) exenatide-XTEN and glucagon-Xten.

[0163] Examples of oligonucleotides are, for example: mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0164] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0165] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0166] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, very low molecular weight heparin or derivatives thereof or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof.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 (Synvisc®), sodium hyaluronate.

[0167] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and can fix complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).

[0168] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present 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., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0169] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0170] 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).

[0171] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0172] It will be understood by those skilled in the art that modifications (addition and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0173] Exemplary drug delivery devices may include 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 may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or an integrated non-exchangeable container.

[0174] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0175] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable volume (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable volume (partial expulsion). As also described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable volume (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable volume (partial expulsion).

[0176] The invention described herein is not limited by the description in relation to the exemplary embodiments, but rather includes any novel feature and any combination of features, including any combination of features within the scope of the claims, even if said feature or said combination is not itself explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0177] 5 Actuators 10 Inner body 11 Outer body 12 Windows 13 Knob 14 Cap 15 Cartridge holder 16 Cartridge container 17 Stopper 20 Distal Drive Sleeve 20.1 Lamps 21 Proximal Drive Sleeve 22 Drive sleeve coupler 23 Distal Clicker 24 Proximal Clicker 25 Clutch spring 26 Number Sleeve 27 Dial Sleeve 28 Clutch 29 Plunger rod 30 Final Dose Nut 43A Control Unit 43B battery 43C Capacitor 44A: First portion of conductor path 44 44B: second portion of conductor path 44 44C: Third portion of conductor path 44 45 Sliding Contact 50 Actuator Elements 51 Magnet 52 Magnet 53 Protrusion 54 Recess 58 Blocking Sleeve 58.1 Wedge 59 Blocking sleeve spring 100 Drug delivery device 101 Communication Components 200 Electronic Devices 201 Processor 202 Communication Components 203 Communication Components 204 Charging components 300 External Devices 400 Cloud Services MU Mechanism Unit RU Drug Reservoir Unit D Distal direction P Proximal direction L Longitudinal axis R Radial direction C Azimuth direction / Rotation direction / Angle direction

Claims

1. A method executable by an electronic device (200) for communicating with a drug delivery device (100), comprising: determining whether a user of the electronic device (200) has authorization to operate the drug delivery device (100) based on the first information and the second information; the first information indicating a prescription of a drug for a patient; the second information being indicative of the drug that the drug delivery device (100) is expected to dispense; and generating an output signal that is expected to be communicated to the drug delivery device (100) to enable the user to change an operating state of the drug delivery device (100) if the user is authorized to use the drug delivery device (100); A method comprising:

2. 2. The method of claim 1, further comprising determining whether the user of the electronic device (200) has authorization to operate the drug delivery device (100) based on the first information and the second information by comparing the first information and the second information with each other and / or with the user's identification information.

3. the first information is extracted from a first signal transmitted from an external device (300) to the electronic device (200); The method of claim 1 or 2, wherein the second information is extracted from a second signal transmitted from the drug delivery device (100) to the electronic device (200).

4. 4. The method of claim 3, wherein the first signal and / or the second signal are wirelessly transmitted signals, and optionally the second signal is a short-range wireless communication signal and / or the first signal is a long-range communication signal and / or transmitted via a cloud service (400).

5. the first signal and / or the second signal are authenticated by checking the origin of the first signal and / or the second signal before generating the output signal; and / or teeth the first signal and / or the second signal are cryptographically secured; extracting the first information and / or the second information includes decrypting the first signal and / or the second signal.

3. The method according to claim 1 or 2.

6. generating a power signal for transferring energy via induction to said drug delivery device (100); The method of claim 1 or 2, further comprising:

7. the change in the operating state is associated with a mechanical change in a mechanism unit (MU) of the drug delivery device (100); the change in operating state is between a state in which setting of a drug dose and / or dispensing of a drug dose is prevented and a state in which setting of a drug dose and / or dispensing of a drug dose is enabled; 3. The method of claim 1 or 2, optionally wherein the drug delivery device (100) is an infusion device.

8. An electronic device (200) configured to perform the method according to claim 1 or 2.

9. one or more communication components (202, 203) configured to receive wireless signals and transmit wireless output signals; and / or at least one near field communication component (202); at least one long-range communication component (203); an inductive charging component (204); The electronic device (200) of claim 8, comprising:

10. A computer program comprising instructions which, when executed by an electronic device (200), cause the electronic device (200) to perform the method of claim 1 or 2.

11. 3. A computer readable data medium containing instructions, the instructions causing an electronic device (200) to perform the method of claim 1 or 2 when the program is executed by the electronic device (200).

12. A drug delivery device (100), comprising: a mechanism unit (MU) configured to operably couple to a drug reservoir unit (RU); the mechanism unit (MU) is configured to enable a dispensing process for dispensing a drug; The mechanism unit (MU) comprises a configuration (5, 43A, 43B) for changing the operating state of the mechanism unit (MU), the mechanism unit (MU) comprises a communication component (101) for receiving an output signal transmitted from an electronic device (200) to the drug delivery device (100); A drug delivery device (100), comprising: the mechanism unit (MU) configured such that operation of the configuration (5, 43A, 43B) for changing the operating state of the mechanism unit (MU) is prevented unless an output signal from the electronic device (200) is received via the communication component (101).

13. The mechanism unit (MU) is configured to act on a drug reservoir of the drug reservoir unit (RU) during the dispensing process, and optionally 0) comprises said drug reservoir unit (RU) containing a drug, the drug delivery device (100) is a device for self-administration, the arrangement (5, 41A, 41B) comprises an electromechanical actuator (5); Activating the arrangement (5, 41A, 41B) to change the operating state includes activating the actuator (5). The drug delivery device (100) of claim 12.

14. The drug delivery device (100) of claim 12 or 13, wherein the electronic device (200) is configured to perform the method of claim 1 or 2.

15. The drug delivery device (100) of claim 12 or 13, wherein the mechanism unit (MU) comprises a dispensing mechanism for dispensing a drug dose, the dispensing mechanism comprising an energy member, the energy member configured to supply energy to move the plunger rod (29) distally, and optionally the energy member being a drive spring such as a compression spring or a torsion spring, or a gas cartridge, or an electric motor.

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