Drug delivery device, drug reservoir unit and set

Abstract

Drug delivery device, drug reservoir unit and set. In at least one embodiment, the drug delivery device (100) includes a mechanism unit (MU) having an electric element (41) and an arrangement (5, 41A, 41B) for changing an operational state of the mechanism unit. The mechanism unit is configured to enable a dispensing process for dispensing a drug. The mechanism unit is further configured to be operatively coupled to a selected drug reservoir unit (RU) that, when coupled with the mechanism unit, interacts with the electric element and thereby changes an electrical characteristic of the electric element in a characteristic manner. The mechanism unit is configured such that operation of the arrangement for changing an operational state of the mechanism unit is prevented unless an electrical characteristic of the electric element is changed in at least one characteristic manner.

Description

[Technical field]

[0001] A drug delivery device is provided. Further provided is a drug reservoir unit for the drug delivery device and a set including the drug delivery device and the drug reservoir unit. [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 object to be achieved is to provide an improved drug delivery device, preferably one that is safer to operate and handle for a user. A further object to be achieved is to provide a drug reservoir unit for such a drug delivery device as well as a set comprising such a drug delivery device and such a drug reservoir unit. [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 also be extracted from the following description and the figures.

[0005] First, a drug delivery device is specified.

[0006] The drug delivery device may be an injection device, an automatic injector, and / or a variable or fixed dose device, and / or a pen device, such as a dial-injector pen.

[0007] According to at least one embodiment, the drug delivery device includes a mechanism unit, which may include a dispensing mechanism for dispensing a drug dose and / or a setting mechanism for setting a drug dose.

[0008] The dispensing mechanism and / or the setting mechanism may include multiple elements that interact with each other during dose dispensing or dose setting. For example, the coupling between two or more elements of a mechanism unit is changed when switching from dose setting to dose dispensing or vice versa. For example, two or more elements are splined to be rotatably fixed to each other during dose setting, and the splined coupling is released to allow the elements to rotate relative to each other during dose dispensing.

[0009] For example, the dispensing mechanism includes 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, for example by 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 a drug dose.

[0010] The dispensing mechanism may also include an energy member to provide energy for dispensing the drug dose. The energy member can provide energy for moving the plunger rod in a distal direction. For example, the energy member is a drive spring, such as a compression spring or a torsion spring, or a gas cartridge or an electric motor. Alternatively, no additional energy member is used to move the plunger rod. The force required to move the plunger rod and dispense the drug may then have to be provided by the user.

[0011] The dispensing mechanism may include a drive element, e.g., a drive sleeve. The drive sleeve may circumferentially surround the plunger rod. The drive element may be in threaded engagement with the plunger rod. During dispensing of the drug dose, the drive element may, for example, move in a distal direction without rotating, thereby rotating and also moving the plunger rod in a distal direction.

[0012] The setting mechanism may include 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 may move together in the proximal direction, e.g. on a helical path, 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 moves back on a helical path in the distal direction, but the drive element only moves axially in the distal direction without rotating. To realize the splined connection and to release the splined connection between the drive element and the setting element, the mechanism unit may include a clutch, and / or a clicker arrangement, and / or a clutch spring.

[0013] The mechanism unit may include a user interface member configured to be operated by a user, e.g. 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 has to be pressed in a distal direction by the user. This user interface member may also be referred to as a dose-dispensing member.

[0014] The mechanism unit may also include a user interface member configured to be operated by a user, e.g., touched by a user, to set a drug dose. For example, to set a drug dose, the user needs to rotate and / or move the user interface member in a proximal direction. This user interface member may also be referred to as a dose setting member.

[0015] The user interface member for setting a drug dose may simultaneously be a user interface member for dispensing a drug dose.

[0016] According to at least one embodiment, the mechanical unit includes an electrical element, in particular an element through which an electric current or an electrical signal flows during the intended operation, which may include or consist of one or more of a conductor path, a sensor, an electromechanical switch.

[0017] According to at least one embodiment, the mechanism unit includes an arrangement for changing an operating state of the mechanism unit, in particular from a first operating state to a second operating state or vice versa, the second operating state being in particular a state in which at least one function of the mechanism unit is enabled or executed, which is disabled or not executed in the first operating state.

[0018] The arrangement for changing the operating state may include one or more components that interact with each other. For example, the arrangement may include mechanical and / or electrical components. As an example, the arrangement may include one or more of an electromechanical actuator, a control unit, a display, and an energy source. The control unit may include a processor, e.g., an IC chip. The control unit may be a microcontroller. The energy source may be a battery. The arrangement may be permanently electrically connected to the electrical element.

[0019] 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 a drug reservoir of the drug reservoir unit, during the dispensing process.

[0020] The drug reservoir may have a distal end for dispensing the drug. The distal end may be an end including a needle or an end connected with a needle. The drug reservoir may include a stopper that seals the drug reservoir in a proximal direction. When the mechanism unit acts on the drug reservoir, the mechanism unit may push the stopper in a distal direction to dispense a drug dose. For example, a plunger rod of the mechanism unit may abut against the stopper and push the stopper in a distal direction. Performing the dispensing process may require the user to operate the dose dispensing member.

[0021] According to at least one embodiment, the mechanism unit may be configured to be operatively coupled with a selected drug reservoir unit. The selected drug reservoir unit may include 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 is not movable relative to the drug reservoir holder. The selected drug reservoir unit is specifically a drug reservoir unit specifically intended, foreseen, or selected for the mechanism unit. For example, the selected drug reservoir unit is a drug reservoir unit having an electrical contact element at a correct or predefined position.

[0022] "Operably coupled" in particular means that the mechanism unit and the drug reservoir unit are mechanically coupled or connected, in particular releasably coupled or connected. To this end, the mechanism unit may include an interface feature for forming a connection interface connecting the mechanism unit and the drug reservoir unit. The interface feature may include a thread configured to engage with a thread of the drug reservoir unit to form 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, whereby, for example, the drug reservoir unit is not axially movable relative to the housing element. Additionally or alternatively, "operably coupled" may mean that the mechanism unit and the drug reservoir unit are coupled to exchange information, for example, an electrical signal or current.

[0023] According to at least one embodiment, when the selected drug reservoir unit is coupled with the mechanism unit, the selected drug reservoir unit interacts with the electric element, whereby the selected drug reservoir unit changes in particular the electrical properties of the electric element in a characteristic manner. The selected drug reservoir unit can mechanically and / or electrically and / or signally interact with the electric element. The change in the electrical properties can be a change in the electrical resistance and / or the capacity and / or the inductance of the electric element.

[0024] By changing in a characteristic manner, we mean a change that is characteristic for a particular selected drug reservoir unit. For example, the mechanism unit may also be configured to be operatively coupled with an unselected or unintended drug reservoir unit. This unselected drug reservoir unit may interact with the electrical element and also change the electrical characteristic of the electrical element. However, this change in electrical characteristic is different from the change induced by the selected drug reservoir unit. In this way, the mechanism unit may be able to distinguish between selected and unselected drug reservoir units and / or may be configured to react differently when coupled to a selected drug reservoir unit than when coupled to an unselected drug reservoir unit.

[0025] According to at least one embodiment, the mechanism unit is configured such that operation of the configuration for changing the operational state of the mechanism unit is prevented unless the electrical characteristic of the electric element is changed in at least one characteristic manner. For example, the mechanism unit is configured to enable operation of the configuration for changing the operational state, in particular to only enable operation of the configuration for changing the operational state, when the electrical characteristic of the electric element is changed in at least one characteristic manner. The operation of the configuration for changing the operational state may occur automatically when the electrical characteristic is changed in at least one characteristic manner. Alternatively, enabling the operation of the configuration may additionally require execution of a further enabling process, such as receiving an enable signal from an external device. In particular, the change of the electrical characteristic of the electric element in at least one characteristic manner may be a prerequisite for the operation of the configuration.

[0026] The mechanism unit may be configured to determine whether the electrical characteristics of the electrical element have been changed in at least one characteristic manner, and to prevent and / or enable operation of the configuration, respectively, unless or only if it is determined that the electrical characteristics of the electrical element have been changed in at least one characteristic manner.

[0027] The mechanism unit may be configured to be coupled to different types of selected / intended drug reservoir units, each of which may change the electrical property of the electrical element in a different characteristic way. Thus, there may be one or more characteristic changes in the electrical property of the electrical element. The mechanism unit may then be configured such that operation of the configuration for changing the operational state of the mechanism unit is prevented unless the electrical property of the electrical element is changed in any one of the characteristic ways.

[0028] In at least one embodiment, the drug delivery device includes a mechanism unit having an electrical element and a configuration for changing an operational state of the mechanism unit. The mechanism unit is configured to enable a dispensing process for dispensing a drug. Further, the mechanism unit is configured to be operatively coupled to a selected drug reservoir unit that, when coupled with the mechanism unit, interacts with the electrical element and thereby changes an electrical characteristic of the electrical element in a characteristic manner. The mechanism unit is configured such that operation of the configuration for changing the operational state of the mechanism unit is prevented unless the electrical characteristic of the electrical element is changed in at least one characteristic manner.

[0029] The drug delivery device specified herein allows, among other things, to increase safety for a user of the drug delivery device, as an example, a user can only use the drug delivery device if a drug reservoir unit having a drug intended for the user, e.g., prescribed, is coupled to the mechanism unit.

[0030] Drug delivery devices as specified herein may be elongate and / or include a longitudinal axis, e.g., a main axis of elongation. Additionally or alternatively, the drug delivery device may have rotational symmetry about 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.

[0031] Furthermore, the drug delivery device may include an end, e.g., a longitudinal end, that 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 the drug delivery device is understood herein to be the end of the member / element / feature that is located most distally.

[0032] Thus, in this specification, the proximal end of a member or element or feature is understood to be the end of the element / member / feature that is most proximally located.

[0033] In other words, "distal" 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 points away from the proximal end, or that will be positioned to face away from the proximal end. On the other hand, "proximal" 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 face can face away from the distal end and / or towards the proximal end, and the distal face can face towards the distal end and / or away from the proximal end. The dispensing end may be, for example, the needle end at which the needle unit is attached or attached to the device.

[0034] Directions perpendicular to and / or intersecting the longitudinal axis are referred to herein as radial. Radially inward is a radial direction that points toward the longitudinal axis. Radially outward is a radial direction that points away from the longitudinal axis. The terms "angular", "azimuthal" or "rotational" are used synonymously herein. Such directions are perpendicular to the longitudinal axis and perpendicular to the radial direction.

[0035] According to at least one embodiment, the change in operating state is associated with a mechanical change in a mechanical unit, for example when the arrangement changes operating state an element of the mechanical unit, e.g. an element of the arrangement, e.g. an actuator element of an actuator, is moved.

[0036] Additionally or alternatively to a mechanical change, the change in operating state may be a change in an electrical state of a mechanical unit. For example, when a configuration changes operating state, an electrical signal may be transmitted inside the mechanical unit. For example, when changing operating state, light-emitting elements such as LEDs or displays may be operated in a changed manner.

[0037] According to at least one embodiment, the change of operating state is between a state in which setting of a drug dose and / or dispensing of a drug dose is prevented (locked state) and a state in which setting of a drug dose and / or dispensing of a drug dose is enabled (unlocked state), e.g., setting of a dose and / or dispensing of a dose is prevented unless an electrical characteristic of an electrical element is changed in at least one characteristic way.

[0038] According to at least one embodiment, the electrical element includes a conductive path. The conductive path may be made of metal. For example, a first conductive path is blocked, i.e., not closed, unless a selected drug reservoir unit is coupled with the mechanism unit.

[0039] According to at least one embodiment, the conductor path includes at least one contact for contacting at least one contact element of the drug reservoir unit. The contact may be arranged such that the contact is freely accessible, at least as long as the mechanism unit is not coupled to the drug reservoir unit. The contact may be a conductive area of ​​the mechanism unit. The contact may be arranged at a distal end of the mechanism unit and / or may face in a distal direction.

[0040] For example, the conductor path includes two contacts for electrically contacting the contact element. The conductor path may be interrupted between the two contacts. The two contacts may be spaced apart from each other in the rotational direction. The two contacts may overlap or be aligned in the axial and / or radial directions.

[0041] According to at least one embodiment, when a selected drug reservoir unit having a contact element in a correct position is mated with the mechanism unit, at least one contact electrically contacts the contact element, thereby changing the electrical properties of the conductor path in a characteristic manner, in particular the electrical resistance of the conductor path can thus be changed in a characteristic manner.

[0042] As an example, when an unselected drug reservoir unit that does not have a contact element in the correct position is coupled with the mechanism unit, the electrical properties of the conductor path are not changed in a characteristic way or at all.

[0043] For example, the selected drug reservoir unit includes a contact element having at least one access point, for example two access points. The access point may be a conductive area of ​​the contact element. The access point may constitute an end of the contact element. The access point may be electrically connected via the contact element. The access point may be located at a proximal end of the drug reservoir unit and / or may face in a proximal direction. The selected drug reservoir unit may include a contact element having at least one access point that faces and contacts at least one contact point when the drug reservoir unit is coupled with the mechanism unit. For example, all the access points then face and electrically contact different contact points of the mechanism unit. For example, the access points of the selected drug reservoir unit overlap or are rotationally aligned with the contact points when the drug reservoir unit and the mechanism unit are coupled.

[0044] According to at least one embodiment, the electrical element includes a sensor, for example an inductive or capacitive sensor. When a coupling element, for example a selected drug reservoir unit with a coupling element in a correct position, is coupled to the mechanical unit, this may change the inductance or capacitance of the sensor in a characteristic manner. The coupling element may be a conductive element, for example a metallic element.

[0045] According to at least one embodiment, the arrangement includes an electromechanical actuator. The actuator may include an electric motor and / or an electromagnet.

[0046] According to at least one embodiment, the operation of the arrangement to change the operational state includes operation of an actuator, which may be configured to, when operated, move an actuator element of the actuator between a first position and a second position.

[0047] An electromechanical actuator is understood herein to be an actuator that converts an electrical signal into a movement of an actuator element. For example, when actuated, the actuator may move the 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.

[0048] The mechanical unit may include a control unit for operating the actuator, for example, the control unit sends an electrical signal to operate the actuator.

[0049] For example, to operate the actuator, the actuator must be supplied with an electrical signal or current. Without the electrical signal / current being supplied, the actuator element can remain in the first position. When the actuator element is in the second position and the actuator is no longer operating or the electrical signal / current is no longer supplied, the actuator element automatically returns to the first position. For this purpose, the actuator element in the second position can be pre-biased towards the first position. In other words, the actuator element is in the first position by default and can only leave the first position when the actuator is operated.

[0050] Alternatively, the actuator element may be in the second position without an electrical signal / current being supplied, and when the actuator element is in the first position, the actuator element may automatically return to the second position when the electrical signal / current is no longer supplied to the actuator.

[0051] For example, the mechanism unit may be configured to prevent setting of a drug dose and / or dispensing of a drug dose when the actuator element is in a first position, and to allow setting of a drug dose and / or dispensing of a drug dose when the actuator element is in a second position.

[0052] As an example, the mechanism unit includes a first movable element and a second element, such as a housing element. Dose setting and / or dose dispensing may be associated with a movement of the first movable element relative to the second element in a first direction and / or a second direction. The mechanism unit may be configured to block the movement of the first movable element in the first direction and / or the second direction when the actuator element is in the first position to prevent dose setting and / or dose dispensing, and to allow the movement of the first movable element in the first direction and / or the second direction when the actuator element is in the second position as a precondition for dose setting and / or dose dispensing. For example, the first movable element is one of a drive element, a setting element, a plunger rod, a dose setting member, a dose dispensing member.

[0053] In this specification, unless otherwise stated, movement of a member or element or feature specifically refers to movement relative to a second element and / or housing element.

[0054] According to at least one embodiment, when a selected drug reservoir unit is coupled to the mechanism unit, the conductor path is closed. Closing the conductor path is to change the electrical properties of the conductor path in a characteristic manner. When a drug reservoir unit is not coupled to the mechanism unit or when a non-selected drug reservoir unit is coupled to the mechanism unit, the conductor path may not be closed. The first conductor path may be closed by a contact element of the specifically selected drug reservoir unit.

[0055] According to at least one embodiment, the closed conductor paths electrically connect components of a mechanical unit, in particular components of an arrangement, e.g., the arrangement is operable or operation of the arrangement is possible only when the conductor paths are closed.

[0056] According to at least one embodiment, the closed conductor path electrically connects the actuator of the mechanism unit with the control unit of the mechanism unit. Additionally or alternatively, the closed conductor path can electrically connect the control unit with the energy source of the mechanism unit, and / or electrically connect the actuator with the energy source, and / or electrically connect the output interface of the control unit with the input interface of the control unit. For example, if the conductor path is not closed, the aforementioned components may not be electrically connected.

[0057] By way of example, when a conductor path is closed due to coupling of the mechanism unit with a selected drug reservoir unit, the control unit can transmit a test signal via the output interface along the closed conductor path. The control unit can be configured to receive the test signal via the input interface. The control unit can be configured to operate a configuration, e.g., an actuator, based on or in response to the received test signal. For example, the configuration is operated only when the control unit receives the test signal.

[0058] Another possibility is that the control unit is electrically connected to the energy source and energy is supplied only when the conductor path is closed. Yet another possibility is that the energy source is electrically connected to the actuator when the conductor path is closed and the actuator is then automatically operated without an additional operating signal of the control unit.

[0059] According to at least one embodiment, the conductor path includes at least two sections movably arranged relative to one another, the two sections being electrically connected by a sliding contact.

[0060] According to at least one embodiment, the two sections are arranged to be rotatable and / or axially movable relative to each other.

[0061] The two sections may be assigned to different elements of the mechanism unit, for example arranged on different elements of the mechanism unit. The different elements may be arranged movably relative to each other. For example, the different elements move relative to each other during an operation of the mechanism unit, whereby the two sections of the conductor path also move relative to each other. The operation of the mechanism unit during which the elements move relative to each other may be a dose setting and / or dose dispensing event. For example, during this operation, the two sections move axially and / or rotationally relative to each other. As an example, one section of the first conductor path is assigned to a first movable element.

[0062] According to at least one embodiment, during operation of the mechanism unit, the first section of the conductor path moves on a helical path relative to the second section of the conductor path.

[0063] According to at least one embodiment, the first section includes a spiral conductor track, which may be electrically connected to the second section via a sliding contact.

[0064] According to at least one embodiment, the helical conductor track has the same pitch as the helical path, such that the two sections of the conductor path remain electrically connected during operation of the mechanical unit.

[0065] According to at least one embodiment, the mechanism unit is configured to allow setting the drug dose to be dispensed. For example, the drug delivery device is a variable dose device, where different drug doses can be set or dialed in respectively by a user. Setting the drug dose may require the user to operate an interface member.

[0066] According to at least one embodiment, during setting of a drug dose and / or dispensing of a drug dose, the two sections of the conductor path move relative to each other.

[0067] According to at least one embodiment, the mechanism unit is configured to be coupled with different types of selected drug reservoir units, each type of selected drug reservoir unit being assigned a different drug, and all features disclosed herein for the selected drug reservoir unit are also disclosed for each type of selected drug reservoir unit.

[0068] According to at least one embodiment, each type of selected drug reservoir unit is assigned at least one electrical element of the mechanism unit. The mechanism unit may include multiple electrical elements, each assigned to a different type of selected drug reservoir unit. All features disclosed for an electrical element are also disclosed for the other electrical elements.

[0069] For example, each type of selected drug reservoir unit is assigned at least one electrical element on a one-to-one basis. Alternatively, different types of selected drug reservoir units may be assigned at least one common electrical element. Different electrical elements assigned to different types of drug reservoir units may share common portions, such as common conductor path sections and / or common contacts.

[0070] According to at least one embodiment, each selected drug reservoir type, when coupled with the mechanical unit, alters the electrical properties of at least one assigned electrical element in a characteristic manner.

[0071] According to at least one embodiment, the mechanism unit is configured such that operation of the arrangement for changing the operational state of the mechanism unit is prevented unless an electrical characteristic of at least one electrical element assigned to the selected drug reservoir unit type is changed in at least one characteristic manner, and operation of the arrangement can be enabled if the electrical characteristic of the at least one electrical element is changed in at least one characteristic manner.

[0072] According to at least one embodiment, the mechanism unit includes several electrical elements each having a conductor path. Each of the conductor paths can be assigned to at least one type of selected drug reservoir unit. Each type of selected drug reservoir unit can be assigned at least one conductor path on a one-to-one basis. Different conductor paths can have a common conductor track section.

[0073] The different conductor paths may be interrupted and each may include two contacts where the conductor path is interrupted. The different conductor paths may share one contact (second contact) and associated conductor path section. The different conductor paths may differ in the other contact (first contact) and associated conductor path section. For example, the first contacts of the different conductor paths may be offset / spaced apart from each other in the rotational direction. The first contacts of the different conductor paths may overlap or be aligned in the axial and / or radial directions.

[0074] Thus, different types of selected drug reservoir units may differ from each other, for example, by the position of their contact elements, in particular the position of their respective access points, for example by a rotational offset.

[0075] According to at least one embodiment, when a selected drug reservoir unit having a contact element in a correct position is mated with the mechanism unit, the electrical properties of the assigned conductor path are changed in a characteristic manner, e.g., the assigned conductor path is closed.

[0076] According to at least one embodiment, the mechanism unit includes a guide structure for interacting with the guide structure of the drug reservoir unit, such that when the drug reservoir unit is coupled to the mechanism unit, the position of the drug reservoir unit relative to the mechanism unit, in particular the position relative to the electrical element, is fixed by the interaction between the guide structure and the guide structure, for example, when the reservoir unit is coupled to the mechanism unit, the interaction between the guide structure and the guide structure prevents relative rotation between the reservoir unit and the electrical element.

[0077] The guidance structure may be configured to engage with the guide structure. For example, the guidance structure may include a groove and the guide structure may include a rib, or vice versa. The groove and rib may be axially oriented.

[0078] According to at least one embodiment, the mechanism unit further includes a communication module for communicating with an external device. The external device may include a processor. For example, the external device is a computer or a smartphone or a smart watch.

[0079] The communication module may be electrically coupled to the control unit. The communication module may be configured for wireless communication, such as Bluetooth communication, with an external device.

[0080] According to at least one embodiment, the mechanism unit is configured such that operation of the configuration to change the operational state of the mechanism unit is prevented unless an enable signal from an external device is received via the communication module, which then transmits the enable signal to the control unit, which in response to the enable signal can transmit an operation signal to operate the configuration, e.g., to operate an actuator.

[0081] For example, operation of the configuration to change the operational state is enabled or is operated to change the operational state only if an electrical characteristic of at least one electrical element is changed in at least one characteristic manner and an enable signal is received.

[0082] For example, the external device may be used to first identify the drug reservoir unit coupled with the mechanism unit, in particular to identify the drug in the drug reservoir unit. For this purpose, the drug reservoir unit may include a code, such as a QR code, that is characteristic for the drug reservoir unit or a type of drug reservoir unit. The QR code may be read by the external device to identify the drug reservoir unit. The external device may then be configured to determine whether the drug reservoir unit is the correct drug reservoir unit for the user of the external device, e.g. whether it contains a prescribed drug. Only if this is the case, an enable signal may be transmitted by the external device.

[0083] In this way, it is possible to provide one mechanism unit foreseen for different kinds of selected drug reservoir units, but the operation of the arrangement for changing the operating state of the mechanism unit is only possible when the selected drug reservoir unit is coupled with the mechanism unit and the selected drug reservoir unit is really for the user, which can further increase safety for the user.

[0084] According to at least one embodiment, the drug delivery device includes a drug reservoir unit coupled to the mechanism unit. The drug reservoir unit may include a drug-filled drug reservoir and / or a drug reservoir holder. The drug reservoir unit may be a selected drug reservoir unit.

[0085] Next, a drug reservoir unit for a specified drug delivery device is described. The drug reservoir unit may be a selected drug reservoir unit, particularly as specified herein. Thus, all features disclosed for the selected drug reservoir unit are also specified for the drug reservoir unit described below, and vice versa.

[0086] According to at least one embodiment, the drug reservoir unit includes a drug reservoir filled with a drug. Additionally or alternatively, the drug reservoir unit may include 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 is not movable relative to the drug reservoir holder.

[0087] According to at least one embodiment, the drug reservoir unit includes a coupling element, e.g., a contact element, that is arranged to change an electrical characteristic of an electrical element in a characteristic manner when the drug reservoir unit is coupled with a mechanical unit of a drug delivery device described herein.

[0088] For example, the coupling element in the form of a contact element includes two access points. The two access points may be located at the proximal end of the drug reservoir unit and / or may face in the proximal direction. The two access points may be electrically connected to each other via the contact element. The access points may be freely accessible as long as the drug reservoir unit is not coupled with the mechanism unit. The access points may be configured to be electrically connected to contacts of the mechanism unit to close a conductor path of the mechanism unit.

[0089] For example, the access points may be rotationally spaced apart from one another, and the access points may be overlapped or aligned radially and / or axially.

[0090] Next, a set is specified. The set includes a drug delivery device as specified herein and a drug reservoir unit as specified herein. The drug reservoir unit and the mechanism may or may not be coupled to each other.

[0091] The drug delivery device, drug reservoir unit and set described herein will be described in more detail below with reference to the drawings based on exemplary embodiments. The same reference numerals indicate similar, similar functions or the same elements in the individual figures. However, the size ratios involved are not necessarily to scale, and individual elements may be shown in exaggerated size for better understanding. [Brief description of the drawings]

[0092] [Figure 1] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Diagram 2] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Diagram 3] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 4] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Diagram 5] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 6] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 7] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 8] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 9] 1 shows a first exemplary embodiment of a drug delivery device in different views. [Figure 10] 2A-2C show a second exemplary embodiment of a drug delivery device in different views. [Figure 11] 2A-2C show a second exemplary embodiment of a drug delivery device in different views. [Figure 12] 2A-2C show a second exemplary embodiment of a drug delivery device in different views. [Figure 13] 2A-2C show a second exemplary embodiment of a drug delivery device in different views. [Figure 14]11A-11C show a third exemplary embodiment of a drug delivery device in different views. [Figure 15] 11A-11C show a third exemplary embodiment of a drug delivery device in different views. [Figure 16] 11A-11C show a third exemplary embodiment of a drug delivery device in different views. [Figure 17] 11A-11C show a third exemplary embodiment of a drug delivery device in different views. [Figure 18] 11A-11C show a fourth exemplary embodiment of a drug delivery device in different views. [Figure 19] 11A-11C show a fourth exemplary embodiment of a drug delivery device in different views. [Figure 20] 11A-11C show a fourth exemplary embodiment of a drug delivery device in different views. [Figure 21] 11A-11C show a fourth exemplary embodiment of a drug delivery device in different views. [Figure 22] 11A-11C show a fifth exemplary embodiment of a drug delivery device in different views. [Figure 23] 11A-11C show a fifth exemplary embodiment of a drug delivery device in different views. [Figure 24] 11A-11C show a fifth exemplary embodiment of a drug delivery device in different views. [Diagram 25] 11A-11C show a fifth exemplary embodiment of a drug delivery device in different views. [Figure 26] 11A-11C show a sixth exemplary embodiment of a drug delivery device in different views. [Figure 27] 11A-11C show a sixth exemplary embodiment of a drug delivery device in different views. [Figure 28] 11A-11C show a sixth exemplary embodiment of a drug delivery device in different views. [Figure 29] 1 illustrates an exemplary embodiment of a drug delivery device in cross-sectional view. [Diagram 30] 1A-1C show exemplary embodiments of a drug reservoir unit, each in cross-sectional view. [Diagram 31] 11A-11C show cross sections of a second exemplary embodiment of a drug delivery device in different states. [Diagram 32]11A-11C show cross sections of a second exemplary embodiment of a drug delivery device in different states. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0093] 1 illustrates in cross-section a first exemplary embodiment of a drug delivery device 100. The drug delivery device 100 is a variable dose device, where different doses of drug to be dispensed can be set or dialed respectively by a user. The drug delivery device is a dial expansion pen.

[0094] 1 also shows the coordinate system used herein to specify the position of members or elements or features. 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 extension of the device 100. The radial direction R is perpendicular to and intersecting the longitudinal axis A. The azimuthal direction C, also called the angular or rotational direction, is perpendicular to the radial direction R and to the longitudinal axis A. To increase the clarity of the figures, the different directions and axes are not shown in the following figures.

[0095] The drug delivery device 100 includes 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. In the following the functional principle of the mechanisms is further explained.

[0096] The mechanical unit MU comprises an inner body 10 and a housing element 11, hereinafter also referred to as an outer body 11. The inner body 10 and the outer body 11 are fixedly coupled to each other, i.e. cannot rotate or move axially relative to each other. The outer body 11 forms the outer surface of the drug delivery device 100, which can be touched or held by a user.

[0097] The drug delivery device 100 further includes 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 operated by a user to set a drug dose and at the same time a dose dispensing member configured to be operated by a user to dispense a drug dose.

[0098] A drug reservoir unit RU, comprising a reservoir 16 and a reservoir holder 15, is received in the cap 14. Drug is filled into the reservoir 16. The reservoir 16 is sealed in the proximal direction P by a stopper 17.

[0099] The drug reservoir units RU are operably coupled or connected to respective mechanism units MU. The mechanism units MU are configured to act on the drug reservoirs 16 to enable a dispensing process for dispensing a drug dose. To dispense a drug dose, the stopper 17 is pressed in a distal direction D by a plunger rod 29 of the mechanism unit MU. The coupling between the mechanism units MU and the reservoir units RU is realized by coupling the inner body 10 to the reservoir holder 15 via a connection interface, which may be a snap connection or a threaded connection. The coupling is preferably reversible. For example, the drug reservoir units RU are axially and rotatably fixed to the inner body 10 by the coupling.

[0100] The mechanism unit MU further comprises a number sleeve 26 and a dial sleeve 27 fixedly coupled to each other (e.g., unable to rotate or move axially relative to each other). The dial sleeve 27 and the number sleeve 26 may be implemented by one unitary component. Thus, any reference herein to a number sleeve should be considered as a reference to a dial sleeve and vice versa. The number sleeve 26 may comprise an internal thread that is engaged with an external thread of the inner body 10. On the outer surface of the number sleeve 26, a number suitable for indicating, for example, the size of the currently set dose may be displayed. The number is visible to the user through a window 12 of the mechanism unit MU. The window 12 may be made of a lens. The window 12 is formed in the outer body 11. The number visible in the window 12 indicates to the user the set / dialed dose. The threaded coupling between the number sleeve 26 and the inner body 10 causes the dial sleeve 27 and the number sleeve 26 to be moved on a helical path in the proximal direction relative to the bodies 10, 11 during drug dose setting and drug dose dispensing, as will be further explained below.

[0101] The mechanical unit MU also includes a drive sleeve. The drive sleeve includes a distal drive sleeve 20, a proximal drive sleeve 21, and a drive sleeve coupler 22 that couples the distal drive sleeve 20 to the proximal drive sleeve 21. For drug dose setting and drug dose dispensing, 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 during dose setting and dispensing. The distal drive sleeve 20 may include an inner thread that is engaged with an outer thread of the plunger rod 29. The outer thread of the distal drive sleeve 20 may be engaged with an inner thread of a final dose nut 30, the function of which will be further described below. The distal drive sleeve and the proximal drive sleeve may be decoupled for a reset operation, for example, to move the plunger rod back to an initial position and reuse the mechanical unit MU for a new reservoir. For example, decoupling for resetting by moving teeth of the distal and proximal drive sleeves out of engagement can be accomplished to allow the distal drive sleeve to rotate relative to the proximal drive sleeve, thereby allowing movement of the plunger rod to its initial position. Thus, the drug delivery device can be a reusable device.

[0102] Furthermore, the mechanism unit MU includes a clutch 28 fixedly coupled to the knob 13, so that during drug dose setting and drug dose dispensing, the clutch 28 and the knob 13 do not rotate or move axially relative to each other. For this purpose, a clutch coupler 31 may be provided. The clutch coupler 31 advantageously rotationally and / or axially locks the knob 13 and the clutch 28 to each other. The clutch 28 and the knob 13 may also be formed integrally. Couplings between the clutch and the knob different from the depicted clutch coupler 31 are also possible. The clutch coupler 31 has parts with different outer diameters. In a first part, the clutch coupler may be connected or engaged to the clutch 28. For example, an inner surface of the clutch coupler 31 may extend along an outer surface of the clutch 28. The clutch 28 or a part thereof may be received in the first part of the clutch coupler. The second part may protrude from the first part in a central region of the first part and / or extend proximally, e.g., toward the proximal end of the knob, and have an outer diameter smaller than that of the first part. The second part may have a rod-like configuration. In the second part, the clutch coupler may extend through an opening in an element provided in the knob 13 and / or on the dial sleeve 27. This element may be or may include a conductor carrier or a circuit board (not shown in FIG. 1, see element 43C further below). The clutch 28 is coupled to the proximal drive sleeve 21 via a splined engagement. This splined engagement may allow a certain axial movement of the clutch 28 relative to the proximal drive sleeve 21, but does not allow relative rotation between these two elements.

[0103] The distal clicker 23, the proximal clicker 24 and the clutch spring 25 of the mechanism unit MU are disposed between the clutch 28 and the drive sleeve coupler 22. The clutch spring 25 is coupled to the drive sleeve coupler 22 and the distal clicker 23. The distal clicker 23 is configured to engage with the proximal clicker 24 in the proximal direction P. The distal clicker and the proximal clicker may be configured to be coupled via a toothed interface, for example, via an engageable set of circumferentially arranged teeth (which may be provided on the inner radius or circumference of the clickers 23, 24). The toothed interface may allow rotation of one of the clickers relative to the other of the clickers under simultaneous axial displacement, with the clickers 23, 24 biased to engage via the clutch spring 25 (thereby providing a clicking noise due to the rotating teeth). The proximal clicker 24 is configured to abut against 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. The mechanism of the device described herein operates like the device disclosed in WO 2015 / 028441 A1, the entire disclosure of which is incorporated herein by reference for all purposes. The dial and number sleeves and the remainder of the mechanism are illustrated slightly differently in the drawings of the present application, but may nevertheless be implemented as depicted and / or described in WO 2015 / 028441 A1.

[0104] The distal clicker 23 may be permanently splined to the proximal drive sleeve 21 such that relative rotation between these two elements is prevented, however, some relative axial movement between the distal clicker 23 and the proximal drive sleeve 21 may be permitted. The proximal clicker 24 may be permanently splined to the inner body 10 such that relative rotation between these two elements is prevented, however, some relative axial movement may be permitted.

[0105] The distal surface of the clutch 28 and the proximal surface of the proximal clicker 24 may both be toothed such that these two surfaces can engage with each other. Furthermore, the distal surface of the proximal clicker 24 and the proximal surface of the distal clicker 23 may both be toothed such that these two toothed surfaces can engage with each other. The proximal surface of the clutch 28 may be toothed, for example canine, and may be arranged to engage with a distal surface of the dial sleeve 27 that is toothed, for example canine.

[0106] FIG. 1 shows the drug delivery device 100 when no dose is set (0 units / 0 units position). Dose setting may be allowed in discrete units of 1, for example 0-80 units. To set the desired drug dose, the user must rotate the knob 13. This is done without forcing the knob 13 in the distal direction D. Unless the knob 13 is pressed in the distal direction D, a canine-tooth engagement between the clutch 28 and the dial sleeve 27 is established, with the clutch spring 25 either biasing the clutch 28 in the proximal direction P or at least preventing the clutch 28 from moving in the distal direction D on its own. The canine-tooth engagement between the clutch 28 and the dial sleeve 27 results in the two elements being rotationally locked to one another, such that as the knob 13 is rotated, the dial sleeve 27 and the number sleeve 26 are also rotated. Because the number sleeve 26 is threadably engaged with the inner body 10, rotating the knob 13 results in the knob 13, clutch 28, dial sleeve 27 and number sleeve 26 moving in a helical path in the proximal direction P relative to the bodies 10, 11. Thereby, the numbers on the number sleeve 26 visible through the window 12 increase, for example, as the set dose increases.

[0107] The proximal drive sleeve 21 is splined to the clutch 28 so that the proximal drive sleeve 21 , and with it the distal drive sleeve 20 and drive sleeve coupler 22 , move on a helical path in the proximal direction P relative to the inner body 10 .

[0108] The plunger rod 29 includes two opposing, overlapping external threads. The plunger rod 29 is threadably engaged with the internal threads of the distal drive sleeve 20. The threads are selected such that the plunger rod 29 does not rotate or move axially during helical movement of the distal drive sleeve 20 in the proximal direction P.

[0109] 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 threaded engagement of the final dose nut 30 with the distal drive sleeve 20, the final dose nut 30 is forced to move in the proximal direction P during setting of the drug dose. Once the maximum dose is set (e.g. 80 units (regardless of whether it is set in only one drug setting process or in multiple drug setting processes)), the final dose nut 30 establishes a rotation lock interface with the distal drive sleeve 20, whereby the final dose nut 30 can no longer rotate relative to the distal drive sleeve 20. As a result, the distal drive sleeve 20 can no longer rotate and no further drug doses can be set. The drug delivery device 100 must then be reset to its initial state.

[0110] During setting of the drug dose, the toothed surfaces of the mutually facing distal and proximal clickers 23, 24 ratchet against 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, which allow relative rotation between the clickers 23 and 24, which causes slight repeated compression and expansion of the clutch spring 25.

[0111] After the desired dose has been set, the user can now press the knob 13 in the distal direction D to dispense the set drug dose. Thereby, a distal force on the knob 13 is transmitted from the knob 13 via the clutch 28 to the proximal clicker 24 and from there to the distal clicker 23, which compresses the clutch spring 25. The two clickers 23 and 24 are now pressed against each other and their tooth flanks are engaged. When the knob 13 is pressed distally, the proximal clicker 24 is advantageously splined with the proximal drive sleeve 21 to which the distal clicker 23 is already permanently splined. Thus, when the knob 13 is pressed, the proximal drive sleeve 21 can be splined to both clickers. Relative rotation between the two clickers 23, 24 is then prevented. Because 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, because 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.

[0112] A distally directed force applied 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, which, as already mentioned, compresses the clutch spring 25. This releases the canine engagement between the dial sleeve 27 and the clutch 28, which means that the dial sleeve 27 is no longer rotationally locked relative to 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. If the knob 13 is now moved in the distal direction D, the stop for the dial sleeve 27 forces the dial sleeve 27 to move in the distal direction D as well. Due to the threaded engagement of the number sleeve 26 with the inner body 10, the dial sleeve 27 moves in a spiral path together with the number sleeve 26 in the distal direction D. This causes the number of the number sleeve 26 visible in the window 12 to decrease.

[0113] At the same time, the clutch 28, clickers 23, 24 and drive sleeves 20, 21, 22 are forced to move (without rotating) 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. Further threaded engagement between the plunger rod 29 and the inner threads of the inner body 10 can then force the plunger rod 29 to also move in the distal direction D to press the stopper 17 inside the cartridge 16 in the distal direction D 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 together with the distal drive sleeve 20 without changing its position relative to the distal drive sleeve 20.

[0114] After dispensing a set drug dose, when the knob 13 is fully returned to its initial position, a new drug dose can be set by rotating the knob 13 again on a helical path in the proximal direction P. During this time, the plunger rod 29 does not change its position. Only when dispensing a dose is the plunger rod 29 moved in the distal direction D.

[0115] As described with respect to Figure 1, one user interface member in the form of knob 13 is used for setting the drug dose and for dispensing the drug dose, however, it is also possible to use separate user interface members for setting and dispensing the drug dose.

[0116] Figures 2 and 3 show the drug delivery device 100 of Figure 1, but in different views and in more detail. Figure 3 shows only a proximal portion of the drug delivery device 100 to better illustrate some details. As can be seen, the dial sleeve 27 includes conductor paths 41, 44. The conductor paths 41, 44 each include a wound or helical conductor track disposed 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 that the dial sleeve 27 travels during setting and dispensing a drug dose.

[0117] On the proximal face of the dial sleeve 27, a control system is arranged, including a control unit 43A and a battery 43B. The control unit 43A and the battery 43B may be arranged on a PCB 43C (or a conductor carrier) mounted on the proximal face of the dial sleeve 27. The control unit 43A may include a processor and / or an IC chip. The control unit 43A and / or the battery 43B may be electrically connected to the conductor paths 41, 44. The elements 43A-43C may be mounted on the dial sleeve 27. Thus, they can rotate relative to the knob 13 during a dose delivery operation.

[0118] As best seen in Fig. 3, the conductor path 41 actually comprises two sections 41A, 41B. These two sections 41A, 41B are assigned to different elements of the drug delivery device 100. The first section 41A is assigned to the dial sleeve 27 and is fixed thereto so as to constantly follow the movements of the dial sleeve 27. The second section 41B is assigned to the body 10, 11 and is fixed thereto. Thus, the two sections 41A, 41B move relative to each other during drug dose setting and drug dose dispensing.

[0119] In order to constantly maintain an electrical connection between the first section 41A and the second section 41B during dose setting and dose dispensing, a sliding contact 42 is realised between the two sections 41A, 41B. This sliding contact 42 is best shown in figures 4 and 5. Figure 4 is a cross-sectional view on the plane AA of figure 3, while figure 5 is a detailed view showing the circled area of ​​figure 4.

[0120] The helical conductor track of the first section 41A, which is assigned to the dial sleeve 27 and has 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 42 ensures that the two sections 41A, 41B remain electrically connected at all times during dose setting and dose dispensing.

[0121] As can be further seen in Figures 2 and 3, the second section 41B of the conductor path 41 includes a contact 40 configured to electrically connect to the contact element 4 of the drug reservoir unit RU. The contact 40 is a conductive area, for example facing in the distal direction D. When a selected drug reservoir unit RU having the contact element 4 in the correct position, in particular having the access point of the contact element 4 in the correct position, is coupled to the mechanism unit MU, the contact 40 is electrically connected to the contact element 4. This affects the electrical properties, i.e. the electrical resistance, of the conductor path 41. In this case, the conductor path 41 is then closed by the contact element 4. Further details regarding the contact element 4 and the contact 40 are described in relation to Figures 29 and 30.

[0122] The closed conductor path 41 can for example electrically connect the control unit 43A to the battery 43B. Alternatively, the control unit 43A can be configured to send an electrical test signal via its output interface through the conductor path 41, which test signal is returned to the control unit 43A via its input interface only when the conductor path 41 is closed with the aid of the contact element 4 of the selected drug reservoir unit RU. In this way, it can be determined by the mechanism unit MU that a selected drug reservoir unit RU, having a contact element 4 in the correct position, is coupled to the mechanism unit MU. This is then used to enable a change of the operating state of the mechanism unit MU, as will be further explained below.

[0123] As can be seen in Figure 2 and more specifically in Figures 6 to 9, 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 is a free end that can be displaced in the radial direction R. The arm 50 is oriented axially.

[0124] At its free longitudinal end, the arm 50 comprises an electromagnet 52 (see the detailed view of FIG. 7, which illustrates in more detail the area circled in FIG. 6). The electromagnet 52 is configured to change its magnetization when the actuator 5 is actuated. The electromagnet 52 is configured to interact with a magnet 51 in the outer body 11. The magnet 51 overlaps the electromagnet 52 in the axial and / or rotational direction. By changing the current through the electromagnet 52, its magnetization is changed and the arm 50 can be moved between a first position and a second position. FIGS. 6 and 7 show the arm 50 in the second position (unlocked, first state of the mechanical unit MU). FIGS. 8 and 9 show the arm 50 in the first position (locked, second state of the mechanical unit MU).

[0125] The number sleeve 26 is shown in Figures 6-9 to include a number of recesses 54 or grooves 54 corresponding to the amount, set positions and pitch of possible dosage units (e.g. 24 units) that can be set by the mechanism unit MU. The arms 50 include radially inwardly directed protrusions 53 that are configured to engage with the recesses 54 to prevent helical movement between the number sleeve 26 and the arms 50. This engagement prevents helical movement of the number sleeve 26 relative to the inner body 10, since the arms 50 are rotatably and axially fixed relative to the inner body 10.

[0126] As explained with respect to Figure 1, the setting and dispensing of a drug dose is associated with the spiral movement of the numbered sleeve 26. Thus, with the arm 50 in a first position (see Figures 8 and 9), 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 in a locked state. When the arm 50 is in a second position (Figures 6 and 7), the blocking interface is released, allowing the setting and dispensing of a drug dose, and the operating state of the mechanical unit MU is in an unlocked state.

[0127] 6 and 8 further show how the actuator 5 can be operated. The conductor path 44 is led from the control unit 43A to the electromagnet 52. By sending a current through the conductor path 44 or by changing the current in the conductor path 44, the magnetization 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. The control of the current in the conductor path 44 can be performed by the control unit 43A. For example, the control unit 43A is configured to operate the actuator 5 only by changing the current in the conductor path 44, thereby changing the operating state of the mechanism unit MU (from a locked state to an unlocked state or vice versa), when a selected drug reservoir unit RU having a contact element 4 in the correct position is coupled with the mechanism unit MU, as explained above.

[0128] Instead of using a control unit 43A to operate the actuator 5, it is also possible for the actuator 5 to be operated automatically, e.g. supplied with current, when the conductor path 41 is closed so that a current is transmitted to the electromagnet 52, causing its magnetization to change.

[0129] As an example, in Figures 8 and 9, 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 a relaxed state. Upon operating the actuator 5, a current is supplied to the electromagnet 52, which is then attracted by the magnet 51. The flexible arm 50 moves radially outward to a second position (Figures 6 and 7). In this second position, the flexible arm 50 is pre-biased towards its first position. When operation of the actuator 5 is interrupted by interrupting the current to the electromagnet 52, the flexible arm automatically returns to its first position.

[0130] As can be further seen in Figs. 6-9, the conductor path 44 from the control unit 43A to the electromagnet 52 comprises two sections 44A, 44B which move relative to each other during setting and dispensing of the drug. The first section 44A is assigned to the inner body 10 and is fixed thereto. The second section 44B is assigned to the dial sleeve 27 and the number sleeve 26 and moves on a helical path during setting and dispensing of the drug dose. In order to always have an electrical contact between the two sections 44A, 44B of the conductor path 44, a sliding contact 45 connects the two sections 44A, 44B. The first section 44A of the conductor path 44 comprises a helical conductor track arranged in the inner body 11, which has the same pitch as the helical path along which the dial sleeve 27 and the number sleeve 26 move during setting and dispensing of the drug dose.

[0131] It may be advantageous to at least partially use the same conductor path, e.g. the same helical conductor path, for the conductor path 41 and the conductor path 44. In this case, the control unit 43A may be configured to distinguish between a current for operating the actuator 5 and a current for checking whether a selected drug reservoir unit RU is coupled to the mechanism unit MU. This distinction may be based on different frequencies of the different currents. However, it is noted that a system using only one of the conductor paths 41 and 44 is also within the scope of the present disclosure.

[0132] In addition to or instead of coupling the selected drug reservoir unit RU, the operation of the actuator 5 may require the mechanism unit MU to receive an enable signal from an external device, such as a smartphone or a smartwatch. For this purpose, the mechanism unit MU may include, for example, a communication module arranged on a PCB. The communication module may be a wireless communication module, such as a Bluetooth module. If the communication module receives an enable signal from the external device, the control unit 43A may operate or enable the operation of the actuator 5. For example, the external device may first be used to read a code, such as, for example, a QR code, on the drug reservoir unit RU. The external device may then evaluate, based on the read code, whether the drug reservoir unit RU is really for the user and then send an enable signal to operate the actuator 5.

[0133] Considering that the dial sleeve 27 and the number sleeve 26 may conveniently be axially and rotationally fixed to one another or implemented by one single component, it should be noted that the conductor paths 41, 44 or sections thereof may also be included by the number sleeve 26.

[0134] Figures 10-13 show a second exemplary embodiment of a drug delivery device 100. Figures 11 and 13 show cross-sectional views on the planes AA and BB of Figures 10 and 12, respectively. The functionality of this second exemplary embodiment, especially with regard to the setting and dispensing mechanism, may be essentially the same as the first exemplary embodiment. However, the actuator 5 for blocking dose setting and / or dose dispensing is different from that of the first exemplary embodiment.

[0135] In a second exemplary embodiment of the drug delivery device 100, the control unit 43A, the battery 43B and also the PCB are coupled and fixed to the knob 13 for movement therewith during setting and dispensing of a drug dose. The actuator 5 includes an actuator element 50 in the form of an elliptical disk 50. This elliptical disk 50 can be rotated with the aid of an electric motor of the actuator 5. The electric motor is electrically coupled to the control unit 43A, such that the control unit 43A can operate the electric motor to rotate the elliptical disk 50.

[0136] 10 and 11 show the elliptical disc 50 in a first position, in which the elliptical disc 50 holds an intermediate element 55 in the form of a clamp in the respective locked position. The clamp 55 is coupled to the knob 13 in such a way that it is fixed to the knob 13 in the axial and rotational directions, but is movable relative to the knob 13 in the radial direction. For example, the clamp 55 is pivotally suspended on the knob 13. This is achieved by connecting the clamp 55 to the knob 13 via a joint connection, such that the clamp 55 can be pivoted relative to the knob 13.

[0137] When the elliptical disc 50 is in the first position, both longitudinal ends of the elliptical disc 50 abut radially outwardly against the clamp 55 holding the clamp 55 in a locked position. In this locked position, the distal end of the clamp 55 engages within a recess 56 in the outer body 11, thereby forming a blocking interface that prevents axial movement of the knob 13 relative to the outer body 11. As explained in relation to FIG. 1, axial movement of the knob 13 relative to the outer body 11 is required for setting and dispensing a drug dose. The blocking interface formed between the clamp 55 held in the locked position and the outer body 11 therefore prevents setting and dispensing a drug dose.

[0138] In Figures 12 and 13, the actuator 5 has been operated to rotate the elliptical disc 50 from a first position to a second position in which the elliptical disc 50 no longer holds the clamps 55 in their locked position. The mechanism unit MU has thereby changed its operating state from a locked state to an unlocked state. This allows the clamps 55 to move from their locked position to the unlocked position. The movement of the clamps 55 may occur automatically if the clamps 55 are pre-biased towards the unlocked position. With the clamps 55 no longer held in the locked position, the engagement between the distal end of the clamps 55 and the recess 56 may be released such that the blocking interface is released and accordingly the movement of the knob 13 in the proximal direction P and / or distal direction D for dose setting or dose dispensing, respectively, is allowed.

[0139] With respect to the first exemplary embodiment, operation of the actuator 5 may be enabled only when a selected drug reservoir unit RU, for example having a contact element 4 in the correct position, is coupled to the mechanism unit MU such that the conductor path 41 is closed and / or when an enable signal of an external device is received by the mechanism unit MU.

[0140] 14-17 show a third exemplary embodiment of a drug delivery device 100. Again, the functionality, especially with regard to the setting and dispensing mechanism, may be essentially the same as in the previously described exemplary embodiment. However, the actuator 5 for blocking and releasing the dose setting is different.

[0141] Figure 14 shows the proximal section of the drug delivery device 100 and Figure 15 shows the circular area of ​​Figure 14 in more detail. The actuator 5 in this case includes an actuator element 50 in the form of a spindle nut. The actuator 5 is coupled to the clutch 28. The actuator 5 further includes a spindle 57 that is rotatable by an electric motor of the actuator 5. The spindle 57 and the spindle nut 50 are threadedly engaged, whereby rotation of the spindle 57 causes axial movement of the spindle nut 50 in either the distal direction D or the proximal direction P depending on the direction of rotation of the spindle 57.

[0142] As can be seen in Figures 14 and 15, the actuator 5 is electrically connected to the control unit 43A via a conductor track 44 which includes several sections, in the embodiment shown three sections 44A, 44B, 44C. These sections 44A, 44B, 44C are assigned to different elements of the mechanical unit MU. In this case, the first section 44A is assigned to the clutch 28 and the third section 44C is assigned to the control unit 43A, the PCB 43C and / or the battery 43B. Section 44C advantageously extends inside the knob 13. Section 44B may be assigned to a drive sleeve, for example the proximal drive sleeve 21. The sections may be electrically connected to each other by contacts 45, for example by sliding contacts or by non-sliding contacts which allow axial and / or rotational movement of the connected components while maintaining the conductive connection between the sections of the conductor track 44. Section 44C may be connected to section 44B via a sliding contact 45 that allows relative rotation and preferably allows limited relative axial movement, e.g. due to the elasticity of its conductor element or a separate spring element, e.g. sufficient relative axial movement to rotationally disengage dial sleeve 27 from clutch 28 for dose delivery. Section 44B may include or be connected to one or more wires that bridge the gap to sliding contact 45. Rotation sliding contact 45 may be located between the proximal face of clutch coupler 31 and the distal face of control unit or battery or PCB or conductor carrier 43C. Sections 44A and 44B are conveniently connected by another contact 45, e.g. a sliding contact (such as an axial sliding contact) or a non-sliding contact. Via the contact and the section, current may be transmitted to actuator 5. Control unit 43A, battery 43B, PCB 43C are located in knob 13. The control unit and battery may in this embodiment be secured to the dial sleeve 27, for example by securing a conductor carrier or PCB 43C to the dial sleeve 27.That is, the knob 13 is in this embodiment axially and / or rotationally movable relative to the battery and / or control unit, and the control unit and / or battery (together with the PCB) is rotatable relative to the knob. The relative axial movement between the knob 13 and the dial sleeve 27 or the PCB, the control unit and / or the battery may be used to rotationally decouple the clutch from the drive sleeve, as further described above. The relative rotational movement may occur during a dose delivery operation. To provide coupling between the clutch 28 and the knob 13, the clutch coupler extends through an opening in the PCB or conductor carrier 43C. The conductive connection between the section 44B of the conductor track 44 and the (sliding) contact 45, which may be positioned proximally offset from the drive sleeve, for example the proximal drive sleeve 21, may be effected via an opening in the clutch coupler 31, for example by a wire extending through the opening.

[0143] 14 and 15, the spindle nut 50 is in a first position in which it presses the intermediate element 24, i.e. the proximal clicker 24, in the distal direction D to the locked position. The proximal clicker 24 thereby presses the distal clicker 23 in the distal direction D as well, all against the force of the clutch spring 25, thereby compressing the clutch spring 25. As a result, the clutch spring 25 presses the distal clicker 24 in the proximal direction P, and thus the distal clicker 24 and the proximal clicker 25 are pressed against each other. Since the faces of the clickers 23, 24 facing each other are toothed, the two clickers 23, 24 pressed against each other cannot rotate against each other. Furthermore, because the proximal clicker 24 is splined to the inner body 10, the distal clicker 23 is splined to the drive sleeve 21, and the drive sleeve 21 must be rotated during dose setting, dose setting is prevented with the spindle nut 50 in this first position.

[0144] It should be emphasized at this point that distal movement of the proximal clicker 24 relative to the proximal drive sleeve 21, such as occurs when the spindle nut 50 is in the first position and / or when the knob 13 is pressed in the distal direction D, may also spline the proximal clicker 24 to the proximal drive sleeve 21, which further prevents rotation of the proximal drive sleeve 21 relative to the inner body 10. This may be the case in all exemplary embodiments described herein.

[0145] 16 and 17 show the spindle nut 50 in a second position after the actuator 5 has been operated such that the spindle nut 50 is moved in the proximal direction P. The clutch spring 25 is extended, so that the clickers 23 and 24 are no longer pressed against each other and / or the proximal clicker 24 is no longer splined to the proximal drive sleeve 21. As a result, rotation of the proximal drive sleeve 21 and thus the dose setting is no longer prevented by the actuator 5.

[0146] The operation of the actuator 5 may again be controlled by the control unit 43A, depending on whether a selected drug reservoir unit RU is coupled to the mechanism unit MU and / or depending on whether an enable signal of an external device is received.

[0147] 18-21 show a fourth exemplary embodiment of a drug delivery device 100. Again, the functionality, especially with regard to the setting and dispensing mechanism, may be essentially the same as in the previous exemplary embodiment. However, the actuator 5 for blocking and releasing the dose setting is different.

[0148] The mechanical unit MU comprises an intermediate element 58 in the form of a blocking sleeve 58 partially surrounding the distal drive sleeve 20. The blocking sleeve 58 comprises two elongated arms each having a radially outwardly projecting wedge 58.1 (see Figs. 19a and 21a). 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 with the aid of an electric motor of the actuator 5. The actuator 5 is coupled to the drive sleeve coupler 22, the actuator arm 50 being engaged in the blocking sleeve 58. A blocking sleeve spring 59 biases the blocking sleeve in the distal direction D.

[0149] Figure 19a shows a view on the cross-sectional plane AA of Figure 18. The final dose nut 30 includes a number of recesses on its inner surface. For example, the number of recesses is equal to or an integer fraction of the number of dose steps in one dose setting revolution. Figure 19b shows a view on the cross-sectional plane DD of Figure 19a.

[0150] 18 and 19 show the drug delivery device 100 with the actuator arm 50 in a first position. The actuator arm 50 can remain in this first position even after a short energization of the actuator 5. The actuator arm 50 in the first position pulled and / or held the blocking sleeve 58 in a locked position where the blocking sleeve 58 is pulled onto 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 radially outward, whereby the wedge 58.1 engages with a recess in the final dose nut 30. A blocking interface is thereby established that prevents relative rotation between the final dose nut 30 and the blocking sleeve 58. The blocking sleeve 58 is rotatably locked to the distal drive sleeve 20. The final dose nut 30 cannot rotate relative to the inner body 10, and therefore with the actuator arm 50 in the first position and the blocking sleeve 58 in the locked position, rotation of the distal drive sleeve 20 is prevented. Thus, setting of a drug dose is prevented.As can be further seen in Figure 18, with the blocking sleeve 58 in the locked position, the blocking sleeve spring 59 is compressed.

[0151] Figures 20 and 21 show the drug delivery device 100 in a second position in which the actuator arm 50 no longer holds the blocking sleeve 58 in its locked position. Figure 21a is a view on cross section BB of Figure 20. Figure 21b is a view on cross section CC of Figure 21a.

[0152] 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 on the ramp 20.1 and can relax radially inwards to the release position. In the release position of the arms of the blocking sleeve 58, the wedges 58.1 of the blocking sleeve 58 no longer engage the recesses of the final dose nut 30, thereby releasing the blocking interface and allowing rotation of the drive sleeve 20 relative to the final dose nut 30. In this way, dose setting is possible.

[0153] 18 and 20 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 with the control unit 43A and / or the battery 43B comprises three sections 44A, 44B, 44C that are assigned to different elements of the drug delivery device 100. The control unit 43A, the battery 43B and the section 44B are arranged on the knob 13 and / or connected to the conductor carrier 43C or PCB. The section 44A is fixed to the proximal drive sleeve 21. The section 44C is fixed to the drive sleeve coupler 22. The electrical connection between the sections 44A and 44B and 44A and 44C is maintained during dose dialing and / or dose dispensing by contacts 45, e.g. sliding or non-sliding contacts, as further explained above in relation to Figs. 14-17. The control unit and battery may be secured to the dial sleeve 27 in this embodiment, as described above in the context of Figures 14-17, for example via a carrier / PCB 43C.

[0154] The operation of the actuator 5 may again be controlled by the control unit 43A, depending on whether a selected drug reservoir unit RU is coupled to the mechanism unit MU and / or depending on whether an enable signal of an external device is received.

[0155] 22-25 show a fifth exemplary embodiment of a drug delivery device 100. The functionality, especially with regard to the setting and dispensing mechanism, may be essentially the same as in the previous exemplary embodiment. However, the actuator 5 is different.

[0156] In the fifth exemplary embodiment, the actuator 5 is similar to the actuator 5 of the first exemplary embodiment. Here again, the actuator 5 comprises an actuator element 50 in the form of a flexible arm having one longitudinal end fixed to the outer body 11 and one free longitudinal end. A magnet 51 is arranged at the free longitudinal end of the arm 50. An electromagnet 52 is coupled to the outer body 11 and is configured to interact with the magnet 51 of the arm 50.

[0157] One difference with respect to the actuator 5 of the first exemplary embodiment is that the arm 50 according to the fifth exemplary embodiment is oriented circumferentially instead of axially. For example, the arm 50 extends over at least 90° or at least 150°. A further difference is that the electromagnet 52 is not arranged on the arm 50 but is fixed to the outer body 11. However, an arrangement in which the electromagnet 52 is coupled to the arm 50 and the magnet 51 is assigned to the outer body 11 is also conceivable.

[0158] 22 and 23 show the drug delivery device 100 with the arm 50 in a first position. FIG. 23 is a view on the cross-sectional plane BB of FIG. 22. In the first position, the radially inward protrusions 53 of the arm 50 engage with the recesses 54 of the numbered sleeve 26. The recesses 54 of the numbered sleeve 26 correspond to the amount and pitch of possible dose units that can be set with the mechanism unit MU. The arm 50 can be in its relaxed state and / or can be held in the first position by the repulsive interaction between the magnets 51, 52. With the arm 50 in the first position engaged with the numbered sleeve 26, relative rotation between the numbered sleeve 26 and the outer body 11 is prevented, thereby preventing dose setting and / or dose dispensing.

[0159] Figures 24 and 25 show the drug delivery device 100 of Figures 22 and 23 in the same view as Figures 22 and 23, but now with the arm 50 in a second position. The arm 50 can be moved to this second position when the actuator 5 is operated such that the magnetization of the electromagnet 52 is changed. For example, the magnetization of the electromagnet 52 is now changed such that the two magnets 51, 52 attract each other, whereby the arm 50 is moved radially outward by the attractive force between the magnets 51, 52. Thereby, the engagement between the protrusion 53 and the recess 54 is released and the number sleeve 26 is no longer prevented from rotating relative to the outer body 11. Thus, dose setting and / or dose dispensing is possible.

[0160] 22 and 24 also show the design of the conductor path 44 from the control unit 43A and / or the battery 43B to the electromagnet 52. As in the first exemplary embodiment, the control unit 43A, the battery 43B and the PCB are fixed to the dial sleeve 27. The conductor path 44 comprises two sections 44A and 44B which are movable relative to each other during dose setting and dose dispensing and which are electrically connected via a sliding contact 45. The first section 44A of the conductor path 44 comprises a helical conductor track having the same pitch as the helical path along which the dial sleeve 27 and the number sleeve 26 move during dose setting and / or dose dispensing.

[0161] The operation of the actuator 5 may again be controlled by the control unit 43A, depending on whether a selected drug reservoir unit RU is coupled to the mechanism unit MU and / or depending on whether an enable signal of an external device is received.

[0162] 26-28 show a sixth exemplary embodiment of the drug delivery device 100. Again, this exemplary embodiment may have essentially the same functionality as the previous exemplary embodiment, particularly with regard to the setting and dispensing mechanism, but deviates from the previous exemplary embodiment in the design of the actuator 5.

[0163] In a sixth exemplary embodiment, the control unit 43A and / or the battery 43B are coupled to the knob 13 for moving together with the knob 13. The actuator 5 is also part of the knob 13. The actuator element 50 of the actuator 5 is, for example, a pin that can be moved radially by the actuator 5.

[0164] In Figure 26, the pin 50 is in a first position in which it engages with the recess 54, in particular the ring groove 54, of the dial sleeve 27 (see also Figure 28). This engagement prevents relative axial movement between the knob 13 and the dial sleeve 27. As a result, dose dispensing is prevented, since the spline interface between the clutch 28 and the dial sleeve 27 cannot be released.

[0165] 27 shows the drug delivery device 100 with the pin 50 in a second position where the pin 50 is no longer engaged in the recess 54. Relative axial and rotational movement between the knob 13 and the dial sleeve 27 is permitted, thus enabling dose dispensing.

[0166] 28 shows the configuration with knob 13 pressed distally. Knob 13 has been moved slightly in distal direction D relative to dial sleeve 27, which disengages the splined interface between clutch 28 and dial sleeve 27, which is necessary for drug dispensing.

[0167] Again, the operation of the actuator 5 may be controlled by the control unit 43A, again depending on whether a selected drug reservoir unit RU is coupled to the mechanism unit MU and / or depending on whether an enable signal of an external device is received.

[0168] Some or all of the actuators 5 described in relation to the first to sixth exemplary embodiments may also be combined.

[0169] FIG 29 shows an exemplary embodiment of the drug delivery device 100 or the mechanical unit MU, respectively. Shown is a cross-sectional view on a plane running perpendicular to the longitudinal axis. FIG 29 may show any one of the first to sixth exemplary embodiments.

[0170] The mechanism unit MU is configured to be coupled with three different types of selected drug reservoir units RU and prevents the actuator 5 from operating unless a selected drug reservoir unit RU is coupled to it and / or enables the actuator 5 to operate if any one of the three selected drug reservoir units RU is coupled to it. For this purpose, the mechanism unit includes three different conductor paths 41, each having a first contact 40.1 and a second contact 40.2. The second contact 40.2 (lower one in FIG. 29) and the associated conductor path section are the same for all three conductor paths 41. The first contacts 40.1 (upper one in FIG. 29) and the associated conductor path section of the different conductor paths 41 are different. In particular, the first contacts 40.1 of the different conductor paths 41 are offset relative to each other in the rotational direction but overlap in the radial and axial directions.

[0171] When a selected drug reservoir unit RU having contact elements 4, in particular having access points 4.1, 4.2, is coupled with the mechanism unit MU in the correct position (see Fig. 30), one of the three conductor paths 41 is closed, which can be recognized by the control unit 43A of the mechanism unit MU, e.g. as described in connection with the first exemplary embodiment. The control unit 43A can then operate the actuator 5 of the mechanism unit MU to change the operating state of the mechanism unit MU, e.g. from a locked state, in which dose setting and / or dose dispensing is prevented, to an unlocked state, in which dose setting and / or dose dispensing is enabled.

[0172] If a drug reservoir unit with the contact element 4 not in the correct position is coupled with the mechanism unit MU, the change of operating state cannot be prevented.

[0173] It should be emphasized that the structure of the mechanism unit MU including multiple conductor paths 41 and associated contacts 40 for different types of selected drug reservoir units RU can be realized in all of the exemplary embodiments described above.

[0174] Fig. 30 shows a cross-sectional view of an exemplary embodiment of three different kinds of selected drug reservoir units RU for the mechanism unit MU of Fig. 29. Each of the three selected drug reservoir units RU has a contact element 4 in a different position, in particular the access points 4.1, 4.2 of the contact element 4 in different positions. The second access point 4.2 of each contact element 4 is always in the same position, while the first access point 4.1 of the contact element 4 is in a different position, in particular a different angular position. The access points 4.1, 4.2 of the drug reservoir units RU can be electrically connected via the contact elements 4.

[0175] The positions of the access points 4.1, 4.2 of a selected drug reservoir unit RU coincide with the positions of the contacts 40.1, 40.2 of one conductor path 41 so that when the selected drug reservoir unit RU is coupled to the mechanism unit MU, this conductor path 41 is closed via the contact elements 4 of the drug reservoir unit RU.

[0176] To ensure that the orientation, especially the rotational direction, of the drug reservoir unit RU is correct when coupling a selected drug reservoir unit RU with the mechanical unit MU, the mechanical unit MU includes a guiding structure 46 in the form of a guide groove (see FIG. 29 ) configured to engage with a guide structure 47 in the form of a guide rib of the drug reservoir unit RU, thereby ensuring that the access points 4.1, 4.2 always contact the associated contacts 40.1, 40.2 when the selected drug reservoir unit RU is coupled to the mechanical unit MU.

[0177] Figures 31 and 32 show in more detail the circled areas of Figures 12 and 10, respectively. These figures illustrate the functional principle of the locking mechanism 6, which is configured to prevent the disengagement or separation of the drug reservoir unit RU from the mechanism unit MU when a drug dose has been set but not fully dispensed.

[0178] The inner body 10 comprises an interface feature 70, for example in the form of an inner thread 70. The drug reservoir unit RU, in this case the reservoir holder 15 of the drug reservoir unit RU, comprises an interface feature 71, for example in the form of an outer thread. The two threads 70, 71 can be engaged, thereby establishing a connection interface 7 in the form of a thread interface, via which the drug reservoir unit RU is releasably connected to the mechanical unit MU. To release the connection and the connection interface 7, it may be necessary to rotate and / or move the drug reservoir unit RU in a proximal direction P or a distal direction D relative to the body 10, 11.

[0179] However, in Fig. 31 release of the connection interface 7 is prevented by the locking mechanism 6 being in a locked state. The locking mechanism 6 comprises a coupling element 60 in a locked position engaging with the reservoir holder 15. The coupling element 60 comprises a coupling feature in the form of a protrusion at its distal end which engages with a coupling feature, i.e. a recess or groove, of the reservoir holder 15. This engagement prevents the drug reservoir unit RU from being able to be moved axially, and optionally also rotationally, relative to the body 10, 11, thereby preventing opening of the connection interface 7.

[0180] The coupling element 60 is pivotally suspended in the mechanism unit MU via a joint connection 61 with the inner body 10. This joint connection 61 allows the coupling element 60 to be pivoted from a locked position in FIG. 31 to an unlocked position shown in FIG.

[0181] The coupling element 60 is an elongated element, having a main section running essentially axially and a further section 62 running perpendicular to the main section and relative to an axis of rotation about which the coupling element 60 can rotate. The coupling element 60 forms part of the locking mechanism 6 and is arranged in such a way that the number sleeve 26, which moves axially during dose setting and dose dispensing, when it reaches a first position (see Fig. 32), can hit the coupling element 60, which is radially offset from the joint connection 61, in order to exert a torque on the coupling element 60. This torque causes the coupling element 60 to move from the locked position to the released position of Fig. 32. This happens purely mechanically through a leverage effect.

[0182] 32, when the numbered sleeve 26 is in the first position and the coupling element 60 is accordingly in the released position, the coupling element 60 is no longer engaged with the drug reservoir unit RU, allowing the release of the connection interface 7. This state of the locking mechanism 6 is called the released state. A user can now separate the drug reservoir unit RU from the mechanism unit MU, for example to replace the drug reservoir unit RU. When the numbered sleeve 26 is moved in the proximal direction P, for example during dose setting, the coupling element 60 automatically returns to its locked position and the release of the connection interface 7 is prevented again.

[0183] 31 and 32 is particularly useful for preventing a user from altering the drug reservoir unit RU when a drug dose is set. As mentioned, setting of a drug dose is associated with movement of the number sleeve 26 in the proximal direction P. This locking mechanism 6 may be used in any of the exemplary embodiments of the drug delivery device described herein.

[0184] The concepts proposed in the present disclosure, such as those for blocking dose setting and / or dispensing or the remaining concepts, may be applied, for example, to the device architectures described above in most detail in connection with Figure 1 and related embodiments, but may also be applied to other drug delivery devices. In particular, one or more of the presently proposed concepts may be applied to the devices disclosed in WO 2021 / 059202 A1 or the devices disclosed in EP 3 049 132 B1, referring to claim 1, for example, to perform the functions described in

[0237] thereof.

[0185] The terms "medicament" or "drug" are used synonymously herein to refer to a pharmaceutical formulation containing 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 medicines are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental well-being. Drugs or medicines may be used for a limited duration or periodically for chronic diseases.

[0186] As described below, a drug or pharmaceutical product may 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 may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also contemplated.

[0187] 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 to the human or animal body. For example, the two chambers may be configured to be in fluid communication with one another (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user prior to administration, if desired. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components to the human or animal body.

[0188] 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 associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and agents 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.

[0189] 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 insulin analogs or derivatives, glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists or analogs or derivatives thereof, dipeptidyl peptidase-4 (DPP4) inhibitors or pharma- ceutically acceptable salts or solvates thereof or any mixtures 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 residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. 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-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0190] 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.

[0191] 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.

[0192] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, 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®), exendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, HM-15211, CM-3, GLP-1 receptor agonists, and the like. LP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Biador-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.

[0193] Examples of oligonucleotides include, for example: mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0194] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0195] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0196] 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 pharma- ceutically acceptable salts thereof. An example of a pharma-ceutically 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.

[0197] 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. The antibody may 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, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody may be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., the antibody has a mutated or deleted 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).

[0198] 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.

[0199] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in 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 in 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 in 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 in the CDR to interact with the antigen.

[0200] 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).

[0201] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or pharmaceutical agent in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0202] 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.

[0203] 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 categorized 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.

[0204] 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 the size may be fixed or variable (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 the size may be fixed or variable (pre-set by the user).

[0205] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an exchangeable 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-exchangeable 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).

[0206] 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, and in particular any combination of features in the claims, even if that feature or combination itself is not explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0207] 4 Contact Elements 4.1 First Access Point 4.2 Secondary Access Point 5 Actuators 6 Locking mechanism 7 Connection Interface 10 Inner body 11 Outer body 12. Windows 13 Dose button 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 31 Clutch coupler 40 Contacts 40.1 First Contact 40.2 Second Contact 41 Conductor Path 41A First section of conductor path 41 41B Second section of conductor path 41 42 Slide Contact 43A Control Unit 43B Battery 43C Conductor Carrier / PCB 44 Conductor Path 44A: First section of conductor path 44 44B Second section of conductor path 44 44C Third section of conductor path 44 45 Slide Contact 46 Guidance Structure 47 Guide Structure 50 Actuator Elements 51 Magnet 52 Magnet 53 Protrusion 54 Recess 55 Clamp 56 Recess 57 Spindle 58 Blocking Sleeve 58.1 Wedge 59 Blocking sleeve spring 60 Joint Elements 61 Joint connection part 62 Section of coupling element 60 70 Interface Features 71 Interface Features 100 Drug delivery device 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 mechanism unit (MU), an electric element (41), - an arrangement (5, 41A, 41B) for changing the operating state of said mechanism unit (MU); A drug delivery device (100) comprising a mechanism unit (MU) having: - enabling a dispensing process for dispensing a drug; - configured to be operatively coupled to a selected drug reservoir unit (RU) that, when coupled to said mechanical unit (MU), interacts with said electrical element (41) and thereby changes the electrical properties of said electrical element (41) in a characteristic way; - a drug delivery device (100) whereby operation of said arrangement (5, 41A, 41B) for changing said operating state of said mechanism unit (MU) is prevented unless said electrical properties of said electrical element (41) are changed in at least one characteristic way.

2. the change in the operating state is associated with a mechanical change in the mechanism unit (MU); - The drug delivery device (100) of claim 1, wherein the change in the operating state is a change 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. - said electrical element (41) comprises a conductor path (41); said conductor path (41) comprises at least one contact (40) for contacting at least one contact element (4) of the drug reservoir unit (RU), thereby when a selected drug reservoir unit (RU) with a contact element (4) in the correct position is coupled with said mechanism unit (MU), said at least one contact (40) makes electrical contact with said contact element (4), thereby changing said electrical properties of said conductor path (41) in a characteristic way; and / or - said arrangement (5, 41A, 41B) comprises an electromechanical actuator (5); - the operation of said arrangement (5, 41A, 41B) to change said operating state is The drug delivery device (100) of claim 1 or 2, comprising the operation of an actuator (5).

4. - when a selected drug reservoir unit (RU) is coupled to said mechanism unit (MU), said conductor path (41) is closed; - The drug delivery device (100) of claim 3, wherein the closed conductor path (41) electrically connects the actuator (5) of the mechanism unit (MU) to the control unit (43A) of the mechanism unit (MU), and / or electrically connects the control unit (43A) to the energy source (43B) of the mechanism unit (MU), and / or electrically connects the actuator (5) to the energy source (43B), and / or the closed conductor path (41) electrically connects the output interface of the control unit (43A) to the input interface of the control unit (43A).

5. - said conductor path (41) comprises at least two sections (41A, 41B) movably arranged relative to each other and electrically connected by means of sliding contacts (42); A drug delivery device (100) according to claim 3 or 4, wherein said two sections (41A, 41B) are arranged rotatably and / or axially displaceable relative to each other.

6. - during operation of said mechanical unit (MU), the first section (41A) of said conductor path (41) moves on a helical path relative to the second section (41B) of said conductor path (41); - said first section (41A) comprises a spiral conductor track electrically connected to said second section (41B) via said sliding contact (42); - A drug delivery device (100) as described in claim 5, wherein the spiral conductor track has the same pitch as the spiral path so that the two sections (41A, 41B) of the conductor path (41) remain electrically connected during operation of the mechanism unit (MU).

7. - said mechanism unit (MU) is adapted to allow setting the dose of the drug to be dispensed; A drug delivery device (100) according to claim 6, wherein during setting of a drug dose and / or dispensing of a drug dose, the two sections (41A, 41B) of the conductor path (41) move relative to each other.

8. - said mechanism unit (MU) is adapted to be coupled with different types of selected drug reservoir units (RU), each type of selected drug reservoir unit (RU) comprising: - assigned at least one electrical element (41) of said mechanical unit (MU), - when coupled to said mechanical unit (MU), it changes in a characteristic way the electrical properties of said at least one assigned electrical element (41); - A drug delivery device (100) as described in any one of claims 1 to 7, wherein the mechanism unit (MU) is configured such that operation of the configuration (5, 41A, 41B) for changing the operating state of the mechanism unit (MU) is prevented unless the electrical characteristics of at least one electrical element (41) assigned to the type of selected drug reservoir unit are changed in at least one characteristic way.

9. said mechanical unit (MU) comprises several electrical elements (41) each having a conductor path (41), and each of said conductor paths (41) is assigned to at least one type of selected drug reservoir unit (RU); - A drug delivery device (100) as described in claim 8, wherein when a selected drug reservoir unit (RU) having a contact element (4) in the correct position is coupled with the mechanism unit (MU), the electrical properties of the assigned conductor path (41) are changed in a characteristic way.

10. - said mechanism unit (MU) comprises a guide structure (46) for interacting with a guide structure (47) of a drug reservoir unit (RU), whereby, when said drug reservoir unit (RU) is coupled with said mechanism unit (MU), the position of said drug reservoir unit (RU) relative to said electrical element (41) is fixed by said interaction between said guide structure (46) and said guide structure (47); and / or said mechanism unit (MU) further comprises a communication module for communicating with external devices; - A drug delivery device (100) as described in any one of claims 1 to 9, wherein the mechanism unit (MU) is configured such that operation of the configuration for changing the operating state of the mechanism unit (MU) is prevented unless an enable signal from the external device is received via the communication module.

11. A drug reservoir unit (RU) for a drug delivery device, comprising: a drug reservoir (16) filled with a drug and / or a drug reservoir holder (15), a coupling element (4) arranged such that when the drug reservoir unit (RU) is coupled with the mechanical unit (MU) of the drug delivery device (100) according to any one of claims 1 to 10, the coupling element (4) changes the electrical properties of the electrical element (41) in a characteristic way. A drug reservoir unit (RU) comprising:

12. a drug reservoir unit (RU) coupled to said mechanism unit (MU), said drug reservoir unit (RU) comprising a drug reservoir (16) filled with a drug or being a drug reservoir unit (RU) according to claim 11; The drug delivery device (100) of any one of claims 1 to 10, further comprising:

13. A set comprising a drug delivery device (100) according to any one of claims 1 to 10 and a drug reservoir unit (RU) according to claim 11.

14. A mechanism unit (MU), an electric element (41), - an arrangement (5, 41A, 41B) for changing the operating state of said mechanism unit (MU); A drug delivery device (100) comprising a mechanism unit (MU) having: - enabling a dispensing process for dispensing a drug; - configured to be operatively coupled to a selected drug reservoir unit (RU) that, when coupled to said mechanism unit (MU), interacts with said electrical element (41) and thereby changes the electrical properties of said electrical element (41) in a characteristic manner depending on said selected drug reservoir unit (RU); - whereby operation of said arrangement (5, 41A, 41B) for changing the operating state of said mechanical unit (MU) is prevented unless said electrical properties of said electrical element (41) are changed in at least one characteristic way; The electrical element may include or consist of one or more of a conductor path, a sensor, and an electromechanical switch.

15. - said electrical element (41) comprises a conductor path (41); said conductor path (41) comprises at least one contact (40) for contacting at least one contact element (4) of the drug reservoir unit (RU), thereby when a selected drug reservoir unit (RU) with a contact element (4) in the correct position is coupled with said mechanism unit (MU), said at least one contact (40) makes electrical contact with said contact element (4), thereby changing said electrical properties of said conductor path (41) in a characteristic way; and / or - The drug delivery device (100) of claim 14, wherein the mechanism unit (MU) includes a guide structure (46) for interacting with a guide structure (47) of the drug reservoir unit (RU), whereby when the drug reservoir unit (RU) is coupled to the mechanism unit (MU), the position of the drug reservoir unit (RU) relative to the electrical element (41) is fixed by the interaction between the guide structure (46) and the guide structure (47).

Images