Drug Delivery Devices

Abstract

In at least one embodiment, the drug delivery device (100) includes a mechanism unit (MU) having a housing element (11), a first movable element (26, 13) movably arranged relative to the housing element, and an electromechanical actuator (5) that, when actuated, moves the actuator element (50) between a first position and a second position. The mechanism unit is operably coupled to the drug reservoir unit (RU) and configured to enable a dispensing process for dispensing a drug dose. Furthermore, the mechanism unit is configured to enable setting a drug dose to be dispensed, the setting of the drug dose being associated with a movement of the first movable element in a first direction. Furthermore, the mechanism unit is configured to block a movement of the first movable element in the first direction when the actuator element is in the first position to prevent setting the drug dose, and to enable a movement of the first movable element in the first direction when the actuator element is in the second position as a prerequisite for setting the drug dose.

Description

[Technical field]

[0001] A drug delivery device is provided. [Background technology]

[0002] Administering an injection is a process that poses multiple risks and challenges, both mental and physical, for the user and for the medical personnel. Drug delivery devices can 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 offers safe operation for the user.

[0004] This object is achieved, inter alia, by the subject matter of the independent claims. Advantageous embodiments and further developments are subject to the dependent claims and can also be derived from the following description and figures. [Means for solving the problem]

[0005] The drug delivery device as specified herein may be an injection device. The drug delivery device may be an auto-injector and / or a variable or fixed dose device and / or a pen-type device, such as a dial extension pen.

[0006] 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.

[0007] The dosing mechanism and / or the setting mechanism may include several elements that interact with each other during dose dosing or dose setting. For example, the connection between two or more elements of a mechanism unit is changed when switching from dose setting to dose dosing or vice versa. For example, two or more elements are splined such that they are non-rotatably fixed to each other during dose setting, and the splined connection is released for dose dosing such that the elements rotate relative to each other during dose dosing.

[0008] For example, the dispensing mechanism includes a plunger rod configured to act on the drug reservoir to dispense a drug dose. The mechanism unit can 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 of a drug dose.

[0009] The dispensing mechanism may also include an energy member to provide energy for dispensing the drug dose. The energy member may provide energy for moving the plunger rod in a distal direction. For example, the energy member may be a drive spring, such as a compression or torsion spring, or a gas cartridge or an electric motor. Alternatively, no additional energy member is used to move the plunger rod. In that case, the force required to move the plunger rod and dispense the drug dose may have to be provided by the user.

[0010] The dispensing mechanism can include a drive element, e.g., a drive sleeve. The drive sleeve can circumferentially surround the plunger rod. The drive element can be in threaded engagement with the plunger rod. During dispensing of a drug dose, the drive element can move distally, e.g., without rotating, thereby forcing the plunger rod to both rotate and move distally.

[0011] 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 achieve 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.

[0012] 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, the user interface member must be pushed in a distal direction by the user to dispense a drug dose. This user interface member may also be referred to as a dose dispensing member.

[0013] The mechanism unit may also include a user interface member configured to be manipulated by a user, e.g., touched by a user, to set a drug dose. For example, to set a drug dose, the user must 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.

[0014] The user interface member for setting a drug dose may simultaneously be a user interface member for dispensing a drug dose.

[0015] According to at least one embodiment, the mechanical unit includes a housing element. The housing element may be a sleeve. For example, the housing element circumferentially surrounds other elements or all elements of the mechanical unit. The housing element may include an outer surface that forms the outer surface of the drug delivery device that is touchable by the user.

[0016] According to at least one embodiment, the mechanism unit includes a first movable element. The first movable element is in particular arranged to be movable relative to the housing element. For example, the first movable element is arranged to be rotatable and / or axially movable relative to the housing element. The first movable element can be assigned to the setting mechanism and / or the dispensing mechanism. 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.

[0017] In this specification, unless stated otherwise, movement of a member or element or arrangement means in particular movement relative to a housing element.

[0018] According to at least one embodiment, the mechanism unit includes an electromechanical actuator that, when actuated, can be configured to move an actuator element of the actuator between a first position and a second position.

[0019] An electromechanical actuator is understood herein to be an actuator that converts an electrical signal into a movement of an actuator element. For example, the actuator, when actuated, 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.

[0020] The mechanism unit may include a control unit for operating the actuator. The control unit may include a processor and / or an IC chip. The control unit may be a microcontroller. For example, the control unit sends an electrical signal to operate the actuator.

[0021] For example, an electrical signal or current must be provided to the actuator in order for it to be operated. If no electrical signal / current is provided, the actuator element can remain in the first position. If the actuator element is in the second position and the actuator is not operated or an electrical signal / current is no longer provided to the actuator, the actuator element can automatically return 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 can be in the first position by default and can only move away from the first position when the actuator is operated.

[0022] Alternatively, the actuator element may be in the second position when no electrical signal / current is provided. When the actuator element is in the first position and no electrical signal / current is provided to the actuator, the actuator element may automatically return to the second position.

[0023] According to at least one embodiment, the mechanism unit is configured to be operatively coupled to the drug reservoir unit.

[0024] The drug reservoir unit may be or include a drug reservoir and / or a drug reservoir holder that holds 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 drug reservoir may be a cartridge that can be coupled to an injection needle, or may be a syringe that includes an injection needle. The drug reservoir may contain a drug, for example, several doses of a drug.

[0025] The drug reservoir can have a distal end for dispensing the drug. The distal end can be the end that includes the needle or the end that is intended to connect to the needle. The drug reservoir can include a stopper that proximally seals the drug reservoir.

[0026] "Operably coupled" in particular means that the mechanism unit and the drug reservoir unit are mechanically coupled or coupled, in particular releasably coupled or coupled, respectively. To this end, the mechanism unit may include an interface feature for forming a coupling interface for coupling the mechanism unit to 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 coupling interface. Alternatively, the interface feature may be configured to establish a snap coupling to the drug reservoir unit. When coupled, the drug reservoir unit may be fixed relative to the housing element, such that, 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, electrical signals or currents.

[0027] According to at least one embodiment, the mechanism unit is configured to activate a dispensing process for dispensing a drug dose, for example a set drug dose. In particular, the mechanism unit can be configured to act on a drug reservoir, in particular a drug reservoir of the drug reservoir unit, during the dispensing process. When the mechanism unit acts on the drug reservoir, the mechanism unit can push a stopper in a distal direction to dispense the drug dose. For example, a plunger rod of the mechanism unit thereby abuts against the stopper and pushes the stopper in a distal direction. To execute the dispensing process, a user may need to operate the dose dispensing member.

[0028] According to at least one embodiment, the mechanism unit is configured to enable setting a drug dose to be administered. In other words, the mechanism unit can be configured to enable a setting process for setting a drug dose to be administered. For example, the drug delivery device is a variable dose device in which different drug doses can be set or dialed in by a user, respectively. To set the drug dose, the user may need to operate a dose setting member.

[0029] According to at least one embodiment, the setting of the drug dose is associated with a movement of the first movable element in a first direction, for example, without a movement of the first movable element in the first direction, the drug dose cannot be set, the first direction may be axial and / or rotational and / or radial.

[0030] According to at least one embodiment, the mechanism unit is configured to block movement of the first movable element in the first direction when the actuator element is in the first position to prevent setting the drug dose, this operating state of the mechanism unit is also referred to herein as a locked state.

[0031] By way of example, the actuator element in the first position is configured to block movement of the first movable element. In this case, a blocking interface can be formed between the actuator element in the first position and the first movable element. Alternatively, it is also possible to form a blocking interface between the first movable element and an intermediate element different from the actuator element to block movement of the first movable element. The actuator element in the first position can hold the intermediate element in a locked position in which a blocking interface is established.

[0032] According to at least one embodiment, the mechanism unit is configured to allow the movement of the first movable element in the first direction when the actuator element is in the second position. The movement of the first movable element in the first direction is in particular a prerequisite for setting a drug dose. For example, when the actuator element is in the second position, dose setting is possible. Alternatively, the mechanism unit may include a further blocking mechanism that prevents dose setting, and dose setting is possible only when the actuator element is in the second position and the further blocking mechanism is released. The operating state of the mechanism unit that allows the setting of a drug dose is also referred to herein as an unlocked state.

[0033] In at least one embodiment, the drug delivery device includes a mechanism unit having a housing element, a first movable element movably arranged relative to the housing element, and an electromechanical actuator that, when actuated, moves the actuator element between a first position and a second position. The mechanism unit is operably coupled to the drug reservoir unit and configured to enable a dispensing process for dispensing a drug dose. Furthermore, the mechanism unit is configured to enable setting a drug dose to be dispensed, where the setting of the drug dose is associated with a movement of the first movable element in a first direction. Furthermore, the mechanism unit is configured to block the movement of the first movable element in the first direction when the actuator element is in the first position to prevent setting the drug dose, and to enable the movement of the first movable element in the first direction when the actuator element is in the second position as a prerequisite for setting the drug dose.

[0034] A mechanism unit having an electromechanical actuator used to prevent or release dose setting makes the drug delivery device safer because setting of a drug dose can be linked, for example, to a condition that a selected drug reservoir unit is connected to the mechanism unit and that said drug reservoir unit contains a prescribed drug, or that a user of the drug delivery device has the authority to set the dose.

[0035] The drug delivery device as defined herein may be elongate and / or may 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. The direction parallel to the longitudinal axis is referred to herein as the axial direction. By way of example, the drug delivery device may be cylindrical.

[0036] Furthermore, the drug delivery device may include an end, e.g., a longitudinal end, which may be provided to face or press 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 through the distal end. The opposite end is referred to herein as the proximal end. The proximal end is away from the skin area during use. 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 configuration of a drug delivery device is herein understood to be the end of the most distally located member / element / configuration. Thus, the proximal end of a member or element or configuration is herein understood to be the end of the most proximally located element / member / configuration.

[0037] In other words, distally is used herein to designate a direction, end, or surface that is or will be positioned to face or face toward the dosing end of the drug delivery device or a component thereof, and / or that faces or will be positioned to face away from the proximal end. Proximal, on the other hand, is used herein to designate a direction, end, or surface that is or will be positioned to face or face away from the dosing end and / or away from the distal end of the drug delivery device or a component thereof. The distal end can be the end closest to the dosing end and / or farthest from the proximal end, and the proximal end can be the end farthest from the dosing end. The proximal surface can face away from the distal end and / or toward the proximal end, and the distal surface can face toward the distal end and / or away from the proximal end. The dosing end can be, for example, the needle end at which the needle unit is or will be attached to the device.

[0038] Directions perpendicular to and / or intersecting the longitudinal axis are referred to herein as radial directions. Inward radial directions are radial directions pointing toward the longitudinal axis. Outward radial directions are radial directions pointing 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.

[0039] According to at least one embodiment, the mechanism unit is configured to prevent dispensing the drug dose when the actuator element is in the first position. Additionally or alternatively, the mechanism unit can be configured to allow dispensing the drug dose when the actuator element is in the second position.

[0040] Alternatively, the mechanical unit may be configured to allow dispensing a drug dose independently of the position of the actuator element.

[0041] According to at least one embodiment, dispensing of the drug dose is associated with a movement of the first movable element in a second direction. The second direction can be different from the first direction, e.g., opposite to the first direction. For example, dispensing of the drug dose is not possible without a movement of the first movable element in the second direction.

[0042] According to at least one embodiment, the mechanism unit is configured to block movement of the first movable element in the second direction when the actuator element is in the first position. Additionally or alternatively, the mechanism unit may be configured to allow movement of the first movable element in the second direction when the actuator element is in the second position. Movement of the first movable element in the second direction may be a prerequisite for dose dispensing.

[0043] Alternatively, the mechanism unit may be configured to allow movement of the first movable element in the second direction independent of the position of the actuator element.

[0044] According to at least one embodiment, the mechanism unit is configured such that operation of the actuator is prevented unless a selected drug reservoir unit is coupled with the mechanism unit. The selected drug reservoir unit is specifically a drug reservoir unit that is specifically intended, anticipated or selected for the mechanism unit. For example, the actuator element remains in the first position unless the selected drug reservoir unit is coupled with the mechanism unit. For example, the selected drug reservoir unit is a drug reservoir unit in which the electrical contact element is in the correct or predetermined position.

[0045] According to at least one embodiment, the mechanism unit is configured such that coupling of the mechanism unit to a selected drug reservoir unit is a prerequisite for the operation of the actuator and / or for moving the actuator element from the first position to the second position. For example, the actuator operation is enabled or the actuator operates automatically only if the mechanism unit is coupled to the selected drug reservoir unit. If the mechanism unit is not coupled to the selected drug reservoir unit, the actuator operation can be disabled.

[0046] According to at least one embodiment, the mechanism unit includes a first conductor path. The first conductor path can include a metal. For example, the first conductor path is interrupted, i.e., not closed, unless a selected drug reservoir unit is coupled with the mechanism unit.

[0047] According to at least one embodiment, the first conductor path includes at least one contact for electrically contacting at least one contact element of the drug reservoir unit. The contact can be arranged so as to be freely accessible at least as long as the mechanism unit is not coupled to the drug reservoir unit. The contact can be a conductive area of ​​the mechanism unit. The contact can be arranged at a distal end of the mechanism unit and / or can face in a distal direction.

[0048] For example, the first conductor path includes two contacts in electrical contact with the contact element. The first conductor path can be interrupted between the two contacts. The two contacts can be spaced apart from one another in the rotational direction. The two contacts can overlap or be aligned in the axial and / or radial directions.

[0049] According to at least one embodiment, when a selected drug reservoir unit with the contact element in the correct position is coupled with the mechanism unit, at least one contact is electrically contacted with the contact element, which changes the electrical properties of the first conductor path in a characteristic manner, in particular the electrical resistance of the first conductor path can be changed in this characteristic manner.

[0050] As an example, when an unselected drug reservoir unit is coupled to the mechanism unit without the contact element being in the correct position, the electrical characteristics of the first conductor path do not change in a characteristic manner or do not change at all.

[0051] For example, the selected drug reservoir unit includes a contact element having at least one access point, e.g., 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 therefore face and are in electrical contact with 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.

[0052] According to at least one embodiment, the mechanism unit is configured such that operation of the actuator is prevented and / or movement of the actuator element from the first position to the second position is prevented unless the electrical characteristics of the first conductor path are altered in at least one characteristic manner.

[0053] According to at least one embodiment, when a selected drug reservoir unit is coupled with the mechanism unit, the first conductor path is closed. Closing the first conductor path may change the electrical properties of the first conductor path in a characteristic manner. When the drug reservoir unit is not coupled with the mechanism unit or when a non-selected drug reservoir unit is coupled with the mechanism unit, the first conductor path cannot be closed. The first conductor path may be closed in particular by a contact element of the selected drug reservoir unit.

[0054] According to at least one embodiment, the closed first conductor path electrically connects components of the mechanical unit, for example, an actuator is operable or activation of the actuator is enabled only when the first conductor path is closed.

[0055] According to at least one embodiment, the closed first conductor path electrically connects the actuator with a control unit of the mechanism unit. Additionally or alternatively, the closed first conductor path may electrically connect the control unit with an energy source of the mechanism unit, and / or may electrically connect the actuator with an energy source, and / or may electrically connect an output interface of the control unit with an input interface of the control unit. For example, if the first conductor path is not closed, the aforementioned components cannot be electrically connected.

[0056] As an example, when the first conductor path is closed due to coupling of the mechanism unit with the selected drug reservoir unit, the control unit can transmit a test signal via the output interface along the closed first 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 the actuator based on or in response to the received test signal. For example, the actuator operates only when the control unit receives the test signal.

[0057] Another possibility is that the control unit is electrically connected to the energy source only when the first conductor path is closed, and only then is the control unit supplied with energy. Yet another possibility is that when the first conductor path is closed, the energy source is electrically connected to the actuator, and the actuator then operates automatically without an additional operating signal of the control unit.

[0058] According to at least one embodiment, the first conductor path includes at least two sections movably arranged relative to one another, the two sections being electrically connectable by means of sliding contacts.

[0059] According to at least one embodiment, the two sections are arranged rotatably and / or axially movable relative to each other.

[0060] The two sections can be assigned to, for example arranged on, different elements of the mechanical unit. The different elements can be arranged movably relative to each other. For example, the different elements move relative to each other during an operation of the mechanical unit, whereby the two sections of the first conductor path also move relative to each other. The operation of the mechanical unit during which the elements move relative to each other can be a dose setting process and / or a dose dispensing process. For example, during this operation, the two sections move axially and / or rotatably relative to each other. As an example, one section of the first conductor path is assigned to the first movable element.

[0061] According to at least one embodiment, during operation of the mechanical unit, the first section of the first conductor path moves on a helical path relative to the second section of the first conductor path.

[0062] According to at least one embodiment, the first section includes a spiral conductor track, which can be electrically connected to the second section via a sliding contact.

[0063] According to at least one embodiment, the spiral conductor track has the same pitch as the spiral path, so that during operation of the mechanical unit the two sections of the first conductor track remain electrically connected.

[0064] 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 may be a computer, a smartphone, or a smart watch.

[0065] The communication module may be electrically coupled to the control unit. The communication module may be configured for wireless communication, for example Bluetooth communication, with an external device.

[0066] According to at least one embodiment, the mechanism unit is configured such that operation of the actuator is prevented unless an enable signal from an external device is received via the communication module, whereby the communication module can transmit the enable signal to the control unit, and the control unit can transmit an operation signal to the actuator in response to the enable signal to operate the actuator.

[0067] For example, operation of the actuator is enabled or operates only if the electrical characteristics of the first conductor path are altered in at least one characteristic manner and only if an enable signal is received.

[0068] For example, an external device may first be used to identify a drug reservoir unit coupled with the mechanism unit, in particular to identify the drug of the drug reservoir unit. For this purpose, the drug reservoir unit may include a code, such as a QR code, that is characteristic of the drug reservoir unit or the type of drug reservoir unit. To identify the drug reservoir unit, the QR code may be read with the external device. 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 may an enable signal be sent from the external device.

[0069] In this way, one mechanism unit can be provided that is foreseen for different types of selected drug reservoir units. However, the operation of the actuator to enable the setting of the drug dose is only effective when the selected drug reservoir unit is coupled with the mechanism unit, and only when this selected drug reservoir unit is actually the one intended for the user. This can further improve safety for the user.

[0070] The different types of selected drug reservoir units may differ from each other, for example, by the positions of their contact elements, in particular by the positions of the respective access points, for example by rotational offsets. The mechanism unit may include different first conductor paths for each type of selected drug reservoir unit whose contacts are in the respective positions.

[0071] According to at least one embodiment, the first movable element rotates and / or moves axially when moved in a first direction during setting a drug dose, for example, the first movable element moves on a helical path during dose setting.

[0072] According to at least one embodiment, the mechanism unit further comprises an intermediate element displaceable between a locked position and a released position, the intermediate element being in particular different from the actuator element and / or from the first movable element.

[0073] According to at least one embodiment, movement of the actuator element from a first position to a second position enables movement of the intermediate element from a locked position to a released position and / or vice versa.

[0074] For example, when the actuator element is moved from the first position to the second position, the intermediate element is automatically moved from the locked position to the released position, for which purpose the intermediate element in the locked position may be pre-biased towards the released position.

[0075] Alternatively, the intermediate element may be automatically moved from the released position to the locked position when the actuator element is moved from the second position to the first position, and for this purpose the intermediate element in the released position may be pre-biased towards the locked position.

[0076] According to at least one embodiment, the intermediate element in the locked position is configured to block movement of the first movable element in the first direction, in particular, a blocking interface is formed between the intermediate element in the locked position and the first movable element.

[0077] According to at least one embodiment, the path along which the actuator element moves between the first and second positions is different from the path along which the intermediate element moves between the locked and released positions, e.g., the path or path direction along which the actuator element moves is perpendicular or at least partially perpendicular to the path or path direction along which the intermediate element moves.

[0078] According to at least one embodiment, the drug delivery device includes a dose setting member configured to be manipulated by a user to set a drug dose. The dose setting member may be a user interface member as described above, in particular a knob. The dose setting member is in particular configured to be touched by a user to set a drug dose.

[0079] According to at least one embodiment, during dose setting the dose setting member is moved relative to the housing element, for example the dose setting member is moved on a helical path in a proximal direction relative to the housing element.

[0080] According to at least one embodiment, the energy source and / or the control unit for operating the actuator and / or the actuator element are moved during setting the drug dose. For example, the energy source and / or the control unit and / or the actuator element are coupled to the dose setting member and move together with the dose setting member. The energy source and / or the control unit can be fixed, e.g. axially and / or non-rotatably, to the dose setting member. Alternatively, the energy source and / or the control unit may be fixed, e.g. axially and / or non-rotatably, to the setting element (see above, e.g. the setting element formed by a number sleeve or a dial sleeve). The dose setting member and the setting element can be non-rotatably and / or axially locked to each other during dose setting (i.e. during the setting process). During dose delivery (i.e. during the dosing process), a relative rotational movement (and / or a relative axial movement) between the setting element and the dose setting member may be possible. Thus, during dose delivery, the energy source and / or the control unit may or may not rotate relative to the dose setting member (or the user interface member).

[0081] According to at least one embodiment, the mechanism unit further includes a second conductor path for guiding an electrical signal to the actuator, for example, the second conductor path electrically connecting the actuator to the control unit and / or the battery.

[0082] According to at least one embodiment, the second conductor path includes at least two sections, which are movably disposed relative to one another and electrically connected by a sliding contact.

[0083] All configurations disclosed in relation to the first conductor path are also disclosed for the second conductor path and vice versa. In particular, one section of the second conductor path may comprise a spiral conductor track.

[0084] According to at least one embodiment, the actuator comprises a magnet and an electromagnet, the electromagnet being coupled or fixed to the actuator element and the magnet being coupled or fixed to a further element of the mechanism unit, in particular to a housing element, or vice versa.

[0085] According to at least one embodiment, when the actuator is actuated, the magnetic properties of the electromagnet change.

[0086] According to at least one embodiment, a magnetic interaction between the magnet and the electromagnet causes the actuator element to move between a first position and a second position when the actuator is actuated. For example, the magnetic interaction alone is responsible for the movement of the actuator element when the actuator is actuated. The interaction between the electromagnet and the magnet can change from attraction to repulsion or vice versa when the actuator is actuated.

[0087] Additionally or alternatively, the magnetic interaction between the magnet and the electromagnet can hold the actuator element in the first position, for example, unless the actuator is actuated, at which point the magnetic interaction can be turned off, after which the actuator element can automatically move to the second position because it has been pre-biased toward the second position.

[0088] According to at least one embodiment, the mechanism unit is configured to block the movement of the first movable element in the first direction when the actuator element is in the first position and when a drug dose has not been set and / or when a drug dose has already been set. For example, the mechanism unit is configured to block the movement of the first movable element in the first direction when the actuator element is in the first position at different positions of the first movable element. Similarly, the mechanism unit can be configured to block the movement of the first movable element in the second direction when a dose has not been set and / or when a drug dose has already been set.

[0089] According to at least one embodiment, the actuator element is radially movable between a first position and a second position. Additionally or alternatively, the actuator element may be axially and / or rotationally movable between the first and second positions. When the actuator element is radially, axially or rotationally movable between the first and second positions, the magnets may be arranged opposite each other in the radial, axial or rotational directions, respectively, and may be arranged to overlap in each of the other two directions.

[0090] According to at least one embodiment, the actuator element is elongate. The actuator element can be, for example, axially and / or rotationally oriented. This means in particular that the actuator element can extend along an axial and / or rotational direction.

[0091] According to at least one embodiment, the actuator element is an arm. One end of the arm can be a displaceable free end. The other end of the arm can be fixed to an element of the mechanical unit, for example to a housing element or to an element fixed relative to the housing element. A magnet assigned to the arm can be arranged at the free end, for example closer to the free end than the other longitudinal end.

[0092] According to at least one embodiment, the actuator element and the first movable element are configured to engage with each other when the actuator element is in the first position. For example, one of the actuator element and the first movable element includes a protrusion and the other of the actuator element and the first movable element includes a recess. Upon engagement, the protrusion protrudes into the recess. The prevention of movement of the first movable member in the first and / or second direction may be by abutment between the protrusion and an inner surface defining the recess.

[0093] Similarly, if an intermediate element is used, the intermediate element and the first movable element can be configured to engage one another when the intermediate element is in the locked position.

[0094] According to at least one embodiment, the actuator includes an electric motor that moves an actuator element.

[0095] According to at least one embodiment, the actuator element is coupled to a first movable element, in particular such that movement of the first movable element in a first and / or second direction can cause the actuator element to move in the same direction.

[0096] According to at least one embodiment, the intermediate element and / or the actuator element are configured to engage with the housing element or an element fixed relative to the housing element when in the locked position or the first position, respectively.

[0097] According to at least one embodiment, the actuator includes a spindle. The actuator element can be a spindle nut that is moved by the spindle.

[0098] According to at least one embodiment, the intermediate element moves radially and / or axially between the released and locked positions. For example, the intermediate element can move axially and radially outward when being moved from the released to the locked position.

[0099] According to at least one embodiment, the drug delivery device includes a drug reservoir unit coupled with the mechanism unit. The drug reservoir unit can include a drug reservoir filled with a drug and / or a drug reservoir holder. The drug reservoir unit can be a selected drug reservoir unit.

[0100] According to at least one embodiment, the actuator element is a displaceable or movable element. The displaceable or movable element may be in the form of a flexible arm. The flexible arm may include, for example at its free longitudinal end, an electromagnet.

[0101] According to at least one embodiment, the flexible arms are axially oriented.

[0102] According to at least one embodiment, the flexible arms are circumferentially oriented.

[0103] According to at least one embodiment, the actuator includes an actuator element in the form of an elliptical disk.

[0104] The drug delivery device will now be described in more detail with reference to the drawings based on exemplary embodiments. The same reference numerals indicate similar, similarly acting or identical elements in the individual figures. However, the size ratios involved are not necessarily to scale and individual elements may be shown in somewhat exaggerated sizes for a better understanding. [Brief description of the drawings]

[0105] [Figure 1] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Diagram 2] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Diagram 3] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 4]1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Diagram 5] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 6] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 7] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 8] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 9] 1A-1D are different views of a first exemplary embodiment of a drug delivery device. [Figure 10] 2A-2C are different views of a second exemplary embodiment of a drug delivery device. [Figure 11] 2A-2C are different views of a second exemplary embodiment of a drug delivery device. [Figure 12] 2A-2C are different views of a second exemplary embodiment of a drug delivery device. [Figure 13] 2A-2C are different views of a second exemplary embodiment of a drug delivery device. [Figure 14] 11A-11C show different views of a third exemplary embodiment of a drug delivery device. [Figure 15] 11A-11C show different views of a third exemplary embodiment of a drug delivery device. [Figure 16] 11A-11C show different views of a third exemplary embodiment of a drug delivery device. [Figure 17] 11A-11C show different views of a third exemplary embodiment of a drug delivery device. [Figure 18] 13A-13C are different views of a fourth exemplary embodiment of a drug delivery device. [Figure 19] 13A-13C are different views of a fourth exemplary embodiment of a drug delivery device. [Figure 20] 13A-13C are different views of a fourth exemplary embodiment of a drug delivery device. [Figure 21] 13A-13C are different views of a fourth exemplary embodiment of a drug delivery device. [Figure 22]13A-13C are different views of a fifth exemplary embodiment of a drug delivery device. [Figure 23] 13A-13C are different views of a fifth exemplary embodiment of a drug delivery device. [Figure 24] 13A-13C are different views of a fifth exemplary embodiment of a drug delivery device. [Diagram 25] 13A-13C are different views of a fifth exemplary embodiment of a drug delivery device. [Figure 26] 13A-13C are different views of a sixth exemplary embodiment of a drug delivery device. [Figure 27] 13A-13C are different views of a sixth exemplary embodiment of a drug delivery device. [Figure 28] 13A-13C are different views of a sixth exemplary embodiment of a drug delivery device. [Figure 29] 1A-1D are cross-sectional views of an exemplary embodiment of a drug delivery device. [Diagram 30] 1A-1D are cross-sectional views of an exemplary embodiment of a drug reservoir unit. [Diagram 31] 11A-11C are cross-sectional views of a second exemplary embodiment of a drug delivery device in different states. [Diagram 32] 11A-11C are cross-sectional views of a second exemplary embodiment of a drug delivery device in different states. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0106] 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, in which different doses of a drug to be administered can be set or dialed in, respectively, by a user. The drug delivery device is a dial extension pen.

[0107] 1 also shows the coordinate system used herein to specify the position of a member or element or configuration. The distal direction D and the proximal direction P run parallel to the longitudinal axis A. The longitudinal axis A is the main axis of elongation of the device 100. The radial direction R is perpendicular to and intersecting the longitudinal axis A. The azimuthal direction C, also called the angular or rotational direction, is perpendicular to the radial direction R and to the longitudinal axis A. In the following figures, the different directions and axes are not shown in order to increase the clarity of the figures.

[0108] 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. The functioning principles of these mechanisms are further described below.

[0109] 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 connected to each other, i.e. they cannot rotate or move axially relative to each other. The outer body 11 forms the outer surface of the drug delivery device 100 that can be touched or grasped by the user.

[0110] 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.

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

[0112] The drug reservoir unit RU is operably coupled or connected to the mechanism unit MU, respectively. The mechanism unit MU is configured to enable a dispensing process for dispensing a drug dose by acting on the drug reservoir 16. To dispense a drug dose, the stopper 17 is pushed in a distal direction D by a plunger rod 29 of the mechanism unit MU. The coupling between the mechanism unit MU and the reservoir unit RU is realized by coupling the inner body 10 to the reservoir holder 15 via a coupling interface, which may be a snap coupling or a screw coupling. The coupling is preferably reversible. For example, the drug reservoir unit RU is axially and non-rotatably fixed to the inner body 10 by the coupling.

[0113] The mechanism unit MU further includes a number sleeve 26 and a dial sleeve 27 that are fixedly connected to each other (e.g., cannot rotate or move axially relative to each other). The dial sleeve 27 and the number sleeve 26 can be implemented by one unitary component. Thus, any reference to the number sleeve in this specification should be considered as a reference to the dial sleeve and vice versa. The number sleeve 26 can include an internal thread that engages with an external thread of the inner body 10. On the outer surface of the number sleeve 26, numbers can be displayed, suitable for example to indicate the size of the currently set dose. The numbers can be seen by the user through a window 12 of the mechanism unit MU. The window 12 can include a lens. The window 12 is formed in the outer body 11. The numbers visible in the window 12 indicate to the user the set / dial set dose. Due to the threaded connection between the number sleeve 26 and the inner body 10, the dial sleeve 27 and the number sleeve 26 move on a helical path in a proximal direction relative to the bodies 10, 11 during setting of the drug dose and during dispensing of the drug dose, as further described below.

[0114] 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. To set a drug dose and dispense a drug dose, the distal drive sleeve 20 and the proximal drive sleeve 21 are fixedly coupled to each other via the drive sleeve coupler 22, such 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 internal thread that engages with an external thread of a plunger rod 29. The external thread of the distal drive sleeve 20 may be engaged with an internal 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 disengaged for a reset operation, for example, to return the plunger rod to an initial position for reuse of the mechanical unit MU on a new reservoir. Decoupling for resetting, for example by moving teeth of the distal and proximal drive sleeves out of engagement, can 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.

[0115] Furthermore, the mechanical unit MU includes a clutch 28, which is fixedly connected to the knob 13, so that the clutch 28 and the knob 13 do not rotate or move axially relative to each other during setting the drug dose and during dispensing the drug dose. For this purpose, a clutch coupler 31 may be provided. The clutch coupler 31 advantageously locks the knob 13 and the clutch 28 non-rotatably and / or axially relative to each other. The clutch 28 and the knob 13 may also be formed integrally. A coupling between the clutch and the knob different from the clutch coupler 31 shown is also possible. The clutch coupler 31 has parts with different outside diameters. In a first part, the clutch coupler can couple or engage with the clutch 28. For example, the inner surface of the clutch coupler 31 may extend along the outer surface of the clutch 28. The clutch 28 or a part of it may be received in the first part of the clutch coupler. The second portion, which may protrude from the first portion in a central region thereof and / or extend in a proximal direction, e.g., toward the proximal end of the knob, has an outer diameter smaller than that of the first portion. The second portion may have a rod-like configuration. In the second portion, the clutch coupler may extend through an opening in an element provided in the knob 13 and / or on the dial sleeve 27. The element may be or include a conductor carrier or circuit board (not shown in FIG. 1, see element 43C, discussed further below). The clutch 28 is coupled to the proximal drive sleeve 21 via a splined engagement. This splined engagement may allow some axial movement of the clutch 28 relative to the proximal drive sleeve 21, but does not allow relative rotation between these two elements.

[0116] Between the clutch 28 and the drive sleeve coupler 22, the distal clicker 23, the proximal clicker 24, and the clutch spring 25 of the mechanical unit MU are arranged. The clutch spring 25 is connected 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 can be configured to couple 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 can allow one of the clickers to rotate relative to the other of the clickers under simultaneous axial displacement (thereby providing a clicking sound due to the rotating teeth) while the clickers 23 and 24 are biased to engage via the clutch spring 25. 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 in the proximal direction P relative to the drive sleeve coupler 22. The mechanism of the device described herein operates like the device disclosed in WO2015 / 028441A1, the entire disclosure of which is incorporated herein by reference for all purposes. The remaining members of the mechanism, together with the dial sleeve and number sleeve, are shown slightly differently in the figures of the present application, but may nevertheless be implemented as depicted and / or described in WO2015 / 028441A1.

[0117] The distal clicker 23 may be permanently splined to the proximal drive sleeve 21 such that relative rotation between these two elements is prevented, but some 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, but some relative axial movement may be permitted.

[0118] 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. Additionally, 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 with dog teeth, and may be arranged to engage with a toothed, for example with dog teeth, distal surface of the dial sleeve 27.

[0119] FIG. 1 shows the drug delivery device 100 when no dose is set (0 units / 0 units position). Setting of the dose can be possible in discrete increments of 1, for example, from 0 to 80 units. To set the desired drug dose, the user must rotate the knob 13. This is done without pushing the knob 13 in the distal direction D. Unless the knob 13 is pushed in the distal direction D, the clutch spring 25 biases the clutch 28 in the proximal direction P, or at least prevents the clutch 28 from moving naturally in the distal direction D, so that a dog-tooth engagement between the clutch 28 and the distal sleeve 27 is established. The dog-tooth engagement between the clutch 28 and the dial sleeve 27 results in the two elements being locked against rotation with respect to each other, so that when the knob 13 rotates, the dial sleeve 27 and the number sleeve 26 also rotate. Because the number sleeve 26 is threadably engaged with the inner body 10, rotation of the knob 13 results in the knob 13, clutch 28, dial sleeve 27 and number sleeve 26 moving on a helical path in the proximal direction P relative to the bodies 10, 11. This causes the numbers on the number sleeve 26 visible through the window 12 to increase, for example as the set dose increases.

[0120] 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 .

[0121] The plunger rod 29 includes two overlapping external threads of opposite winding sense that are in threaded engagement with the internal threads of the distal drive sleeve 20. These threads are selected such that the plunger rod 29 does not rotate or move axially during the helical movement of the distal drive sleeve 20 in the proximal direction P.

[0122] The final dose nut 30 may be splined to the inner body 10 and therefore cannot rotate relative to the inner body 10. Because the final dose nut 30 is threadedly engaged with the distal drive sleeve 20, the final dose nut 30 is forced to move in the proximal direction P during setting the drug dose. When the maximum dose is set (e.g., a maximum dose of 80 units is set, whether set in a single or multiple drug setting processes), the final dose nut 30 establishes a rotation lock interface with the distal drive sleeve 20, which prevents the final dose nut 30 from rotating any further relative to the distal drive sleeve 20. As a result, the distal drive sleeve 20 cannot rotate any further and no further drug doses can be set. The drug delivery device 100 must then be reset to its initial state.

[0123] During setting of the drug dose, the mutually facing toothed surfaces of the distal clicker 23 and the proximal clicker 24 ride over each other in a ratcheting manner, thereby producing 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, causing the clutch spring 25 to undergo slight repeated compression and expansion.

[0124] After setting the desired dose, the user can now push the knob 13 in the distal direction D to dispense the set drug dose. This transfers a distally directed force on the knob 13 from the knob 13 via the clutch 28 to the proximal clicker 24 and from the proximal clicker 24 to the distal clicker 23, compressing the clutch spring 25. Now the two clickers 23 and 24 are pressed against each other and their toothed surfaces engage. When the knob 13 is pushed 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 pushed, the proximal drive sleeve 21 can be splined to both clickers. Relative rotation between the two clickers 23, 24 is 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 is prevented from further rotation 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 are also prevented from further rotation relative to the inner body 10.

[0125] A distally directed force applied to the knob 13 results in the clutch 28 moving slightly with the knob 13 in the distal direction D relative to the dial sleeve 27, as already mentioned, thereby compressing the clutch spring 25. This releases the dog tooth engagement between the dial sleeve 27 and the clutch 28, so that the dial sleeve 27 is no longer locked against further rotation relative to the clutch 28. Thus, when the knob 13 is pushed in the distal direction D, the dial sleeve 27 together with the number sleeve 26 can still rotate relative to the inner body 10. Now, when the knob 13 is moved in the distal direction D, the stop on the dial sleeve 27 forces the dial sleeve 27 to also move in the distal direction D. Due to the threaded engagement of the number sleeve 26 with the inner body 10, the dial sleeve 27 moves on a helical path in the distal direction D together with the number sleeve 26. This causes the number of the number sleeve 26 visible in the window 12 to decrease.

[0126] At the same time, the clutch 28, the clickers 23, 24 and the 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. Then, further threaded engagement between the plunger rod 29 and the internal thread of the inner body 10 can force the plunger rod 29 to also move in the distal direction D to push 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.

[0127] After dispensing the set drug dose, when the knob 13 has been 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.

[0128] As described with respect to Figure 1, one user interface member in the form of knob 13 is used for both setting the drug dose and dispensing the drug dose, however, it is also possible to use separate user interface members for setting and dispensing the drug dose.

[0129] Figures 2 and 3 show the drug delivery device 100 of Figure 1 in a different view and in more detail than Figure 1. Figure 3 shows only a proximal portion of the drug delivery device 100 to better illustrate some of the details. As can be seen in the figure, the dial sleeve 27 includes conductor paths 41, 44. The conductor paths 41, 44 each include a winding or helical conductor track that is 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 the drug dose.

[0130] A control system including a control unit 43A and a battery 43B is arranged on the proximal face of the dial sleeve 27. The control unit 43A and the battery 43B can be arranged on a PCB 43C (or a conductor carrier) attached to the proximal face of the dial sleeve 27. The control unit 43A can include a processor and / or an IC chip. The control unit 43A and / or the battery 43B can be electrically connected to the conductor paths 41, 44. The elements 43A-43C can be attached to the dial sleeve 27. They can thus rotate relative to the knob 13 during the dose delivery operation.

[0131] As can be best seen in Fig. 3, the conductor path 41 actually comprises two sections 41A and 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. The two sections 41A, 41B therefore move relative to each other during setting the drug dose and during dispensing the drug dose.

[0132] In order to maintain an electrical connection between the first section 41A and the second section 41B at all times during dose setting and dose dispensing, a sliding contact 42 is realised between the two sections 41A, 41B. This sliding contact 42 can be best seen in figures 4 and 5. Figure 4 is a cross-sectional view in plane AA of figure 3, while figure 5 is a detailed view showing the circled area of ​​figure 4.

[0133] 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 that 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 always remain electrically connected during dose setting and dose dispensing.

[0134] As can be further seen in Fig. 2 and Fig. 3, the second section 41B of the conductor path 41 includes a contact 40, which is 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, with the contact element 4 in the correct position, in particular with 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 Figs. 29 and 30.

[0135] The closed conductor path 41 can for example electrically connect the control unit 43A to the battery 43B. Alternatively, the control unit 43A may be configured to send an electrical test signal through the conductor path 41 via the output interface, and the test signal is returned to the control unit 43A via its input interface only when the conductor path 41 is closed with the contact element 4 of the selected drug reservoir unit RU. In this way, the mechanism unit MU can determine that the selected drug reservoir unit RU with the contact element 4 in the correct position is coupled to the mechanism unit MU. This can then be used to enable a change in the operating state of the mechanism unit MU, as will be further explained below.

[0136] As can be seen in Fig. 2 and more particularly in Figs. 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 being a free end that can be displaced in the radial direction R. The arm 50 is oriented in the axial direction.

[0137] At its free longitudinal end, the arm 50 comprises an electromagnet 52 (see the detailed view in FIG. 7 showing the circled area in FIG. 6 in more detail). The electromagnet 52 is configured to change its magnetization when the actuator 5 is actuated. The electromagnet 52 is also configured to interact with the magnet 51 in the outer body 11. The magnet 51 overlaps the electromagnet 52 axially and / or rotationally. By changing the current through the electromagnet 52, the magnetization of the electromagnet 52 changes 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 position, first state of the mechanism unit MU). FIGS. 8 and 9 show the arm 50 in the first position (locked position, second state of the mechanism unit MU).

[0138] 6-9 it is shown that the number sleeve 26 includes several recesses 54 or grooves 54 corresponding to the amount, setting position and pitch of possible dosage units (e.g. 24 units) that can be set by the mechanism unit MU. The arm 50 includes a radially inwardly directed protrusion 53 configured to engage within the recess 54 to prevent a spiraling movement between the number sleeve 26 and the arm 50. This engagement will prevent a spiraling movement of the number sleeve 26 relative to the inner body 10, since the arm 50 is non-rotatably and axially fixed to the inner body 10.

[0139] As explained with respect to Fig. 1, the setting and dispensing of a drug dose is linked to the spiral movement of the number sleeve 26. Thus, when the arm 50 is in a first position (see Figs. 8 and 9), a blocking interface between the arm 50 and the number sleeve 26 prevents the setting and dispensing of a drug dose. The operating state of the mechanical unit MU is a locked state. When the arm 50 is in a second position (Figs. 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 an unlocked state.

[0140] 6 and 8 further show how the actuator 5 can be operated. A conductor path 44 is guided 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 repelling the magnet 51 to attracting 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 and thereby change the operating state of the mechanism unit MU (from locked to unlocked or vice versa) when a selected drug reservoir unit RU with the contact element 4 in the correct position is coupled with the mechanism unit MU, as explained above.

[0141] Instead of using a control unit 43A to operate the actuator 5, it may also be possible for the actuator 5 to operate automatically, e.g. by supplying a current to the actuator 5, when the conductor path 41 is closed such that a current is transmitted to the electromagnet 52 which changes its magnetization.

[0142] As an example, in Figures 8 and 9, the electromagnet 52 is not magnetized so that there is no magnetic interaction between the electromagnet 52 and the magnet 51. The flexible arm 50 is in a first position, which may be its relaxed state. Upon actuation of the actuator 5, a current is supplied to the electromagnet 52, which is then attracted to the magnet 51. The flexible arm 50 moves radially outward into a second position (Figures 6 and 7). In this second position, the flexible arm 50 is pre-biased towards its first position. When actuation of the actuator 5 is interrupted by removing the current to the electromagnet 52, the flexible arm automatically returns to its first position.

[0143] 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 a drug dose. 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 when setting and dispensing a drug dose. A sliding contact 45 connects the two sections 44A, 44B, so that there is always electrical contact between the two sections 44A, 44B of the conductor path 44. 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 a drug dose.

[0144] It may be advantageous to use at least partly the same conductor track, for example the same helical conductor track, 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.

[0145] In addition to or instead of coupling the selected drug reservoir unit RU, the operation of the actuator 5 may require the mechanical unit MU to receive an enable signal from an external device, such as a smartphone or a smartwatch. For this purpose, the mechanical unit MU may include a communication module, for example arranged on the 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 the actuator 5 or enable the operation of the actuator 5. For example, the external device may first be used to read a code, such as a QR code, for example on the drug reservoir unit RU. The external device may then evaluate whether the drug reservoir unit RU is actually intended for the user based on the read code and then send an enable signal to operate the actuator 5.

[0146] It should be noted that, provided that the dial sleeve 27 and the number sleeve 26 are conveniently axially and non-rotatably fixed to one another or can be implemented as one single component, the conductor paths 41, 44 or sections thereof can also be constituted by the number sleeve 26.

[0147] Figures 10-13 show a second exemplary embodiment of a drug delivery device 100. Figures 11 and 13 show cross-sectional views in 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.

[0148] In a second exemplary embodiment of the drug delivery device 100, the control unit 43A, the battery 43B and the PCB are also coupled and fixed to the knob 13 to move with the knob 13 during setting and dispensing of the drug dose. The actuator 5 includes an actuator element 50 in the form of an elliptical disk 50. The elliptical disk 50 can be rotated by 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.

[0149] 10 and 11 show the elliptical disk 50 in a first position. In this first position, the elliptical disk 50 holds an intermediate element 55 in the form of a clamp in a respective locked position. The clamp 55 is connected 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 in 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 pivot relative to the knob 13.

[0150] When the elliptical disc 50 is in the first position, both longitudinal ends of the elliptical disc 50 abut the clamp 55 in a radially outward direction that holds 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. This creates a blocking interface that prevents axial movement of the knob 13 relative to the outer body 11. As described 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. Thus, the blocking interface formed between the clamp 55 held in the locked position and the outer body 11 prevents setting and dispensing a drug dose.

[0151] In Figures 12 and 13, the actuator 5 is operated to rotate the elliptical disc 50 from a first position to a second position where the elliptical disc 50 no longer holds the clamps 55 in their respective locked positions. The mechanism unit MU thereby changes its operating state from a locked state to an unlocked state. This allows the clamps 55 to move from their locked positions to their released positions. This movement of the clamps 55 can occur automatically if the clamps 55 are pre-biased towards the released position. With the clamps 55 no longer held in the locked position, the engagement between the distal ends of the clamps 55 and the recesses 56 can be released, thereby releasing the blocking interface and accordingly allowing the movement of the knob 13 in the proximal direction P and / or the distal direction D for dose setting or dose dispensing, respectively.

[0152] With regard to the first exemplary embodiment, operation of the actuator 5 can be enabled only when, for example, the contact element 4 is in the correct position, the selected drug reservoir unit RU is coupled to the mechanism unit MU such that the conductor path 41 is closed, and / or an enable signal of an external device is received by the mechanism unit MU.

[0153] 14-17 show a third exemplary embodiment of a drug delivery device 100. Here 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.

[0154] 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 rotatable by an electric motor of the actuator 5. The spindle 57 and the spindle nut 50 are threadedly engaged such that rotation of the spindle 57 causes the spindle nut 50 to move axially in a distal direction D or a proximal direction P depending on the direction of rotation of the spindle 57.

[0155] As can be seen in Figs. 14 and 15, the actuator 5 is electrically connected to the control unit 43A via a conductor track 44 that includes several sections, i.e. three sections 44A, 44B, 44C in the illustrated embodiment. 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. The section 44C advantageously extends into the knob 13. The section 44B can be assigned to a drive sleeve, for example the proximal drive sleeve 21. The sections can be electrically connected to each other by contacts 45, which can be, for example, by sliding contacts that allow relative axial and / or rotational movement of the connected components while maintaining the conductive connection between the sections of the conductor track 44, or by non-sliding contacts. Section 44C can be coupled to section 44B via a sliding contact 45, which allows relative rotation and preferably limited relative axial movement, e.g. due to the resilience of its conductor elements or separate spring elements, sufficient to rotatably decouple, e.g., dial sleeve 27 from clutch 28 for dose delivery. Section 44B can include or be coupled to one or more wires spanning the gap to sliding contact 45. Rotational sliding contact 45 can 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. Through those contacts and those sections, current can be transmitted to actuator 5. Control unit 43A, battery 43B, and 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 rotatably movable relative to the battery and / or control unit, and the control unit and / or battery (together with the PCB) are rotatable relative to the knob. Relative axial movement between the knob 13 and the dial sleeve 27 or the PCB, the control unit and / or the battery can be used to rotatably decouple the clutch from the drive sleeve, as further described above. Relative rotational movement can occur during 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 can be positioned proximally offset from the drive sleeve, e.g. the proximal drive sleeve 21, can be effected via an opening in the clutch coupler 31, e.g. by a wire extending through said opening.

[0156] In Figures 14 and 15, the spindle nut 50 is in a first position, which pushes the intermediate element 24, i.e. the proximal clicker 24, into a locked position in the distal direction D. The proximal clicker 24 thereby pushes the distal clicker 23 in the distal direction D as well, all this 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. The faces of the clickers 23, 24 facing each other are toothed, so that the two clickers 23, 24 pressed against each other cannot rotate relative to 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 because the drive sleeve 21 must be rotated during dose setting, dose setting is prevented with the spindle nut 50 in this first position.

[0157] 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 pushed 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.

[0158] 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 decompressed, 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 impeded by the actuator 5.

[0159] The operation of the actuator 5 can again be controlled by the control unit 43A, again depending on whether a selected drug reservoir unit RU is coupled to the mechanical unit MU and / or whether an enable signal of an external device is received.

[0160] 18-21 show a fourth exemplary embodiment of a drug delivery device 100. Here 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.

[0161] 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 wedge 58.1 projecting in a radially outward direction (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 by an electric motor of the actuator 5. The actuator 5 is connected to the drive sleeve coupler 22, the actuator arm 50 being engaged with the blocking sleeve 58. A blocking sleeve spring 59 biases the blocking sleeve in the distal direction D.

[0162] Figure 19a shows a view in 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 the number of dose steps in one dose setting rotation or an integer fraction thereof. Figure 19b shows a view in the cross-sectional plane DD of Figure 19a.

[0163] 18 and 19 show the drug delivery device 100 with the actuator arm 50 in a first position. The actuator arm 50 may remain in this first position after a short energization of the actuator 5. The actuator arm 50 in the first position pulls and / or holds the blocking sleeve 58 in a locked position, where the blocking sleeve 58 is pulled on 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 in a recess of the final dose nut 30. This establishes a blocking interface that prevents relative rotation between the final dose nut 30 and the blocking sleeve 58. The blocking sleeve 58 is non-rotatably locked to the distal drive sleeve 20. 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 because the final dose nut 30 cannot rotate relative to the inner body 10, thus preventing the setting of a drug dose. As can be further seen in Figure 18, with the blocking sleeve 58 in the locked position, the blocking sleeve spring 59 is compressed.

[0164] Figures 20 and 21 show the drug delivery device 100 with the actuator arm 50 in a second position, where the actuator arm 50 no longer holds the blocking sleeve 58 in its locked position. Figure 21a is a view in the cross-sectional plane BB of Figure 20. Figure 21b is a view in the cross-sectional plane CC of Figure 21a.

[0165] 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 a 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 in 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. Thus, dose setting is possible.

[0166] 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 to the control unit 43A and / or the battery 43B includes 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 disposed in 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 between the sections 44A and 44C is maintained during dose dialing and / or dose dispensing by contacts 45, e.g., sliding or non-sliding contacts, as further described above in relation to FIGS. 14-17. The control unit and battery may be secured to the dial sleeve 27 in this embodiment, for example via a carrier / PCB 43C, as described above in relation to Figures 14-17.

[0167] The operation of the actuator 5 can again 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 whether an enable signal of an external device is received.

[0168] 22 to 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.

[0169] 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, which is fixed at one longitudinal end to the outer body 11 and has one free longitudinal end. A magnet 51 is arranged at the free longitudinal end of the arm 50. An electromagnet 52 is connected to the outer body 11 and is configured to interact with the magnet 51 of the arm 50.

[0170] 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 is also conceivable in which the electromagnet 52 is connected to the arm 50 and the magnet 51 is assigned to the outer body 11.

[0171] 22 and 23 show the drug delivery device 100 with the arm 50 in a first position. FIG. 23 is a view in the cross-sectional plane BB of FIG. 22. In the first position, the radially inward protrusion 53 of the arm 50 engages in the recess 54 of the number sleeve 26. The recess 54 of the number sleeve 26 corresponds to the amount and pitch of possible dose units that can be set with the mechanism unit MU. The arm 50 may be in its relaxed state and / or may be held in the first position due to the repulsive interaction between the magnets 51, 52. With the arm 50 in the first position engaged with the number sleeve 26, relative rotation between the number sleeve 26 and the outer body 11 is prevented, thereby preventing dose setting and / or dose dispensing.

[0172] 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 then changed such that the two magnets 51 and 52 attract each other, whereby the arm 50 moves in a radially outward direction due to 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.

[0173] 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 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.

[0174] The operation of the actuator 5 can again 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 whether an enable signal of an external device is received or not.

[0175] 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, especially with regard to the setting and dispensing mechanism, but deviates from the previous exemplary embodiment in the design of the actuator 5.

[0176] In the sixth exemplary embodiment, the control unit 43A and / or the battery 43B are coupled to the knob 13, so that they move 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.

[0177] In Figure 26 the pin 50 is in a first position, where it is engaged in a recess 54, in particular in 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, the splined interface between the clutch 28 and the dial sleeve 27 cannot be released, thus preventing dose dispensing.

[0178] 27 shows the drug delivery device 100 with the pin 50 in a second position, where it is no longer engaged with the recess 54. Relative axial and rotational movement between the knob 13 and the dial sleeve 27 is permitted, thus allowing dose dispensing.

[0179] 28 shows the knob 13 in a distally pushed configuration. The knob 13 has moved slightly in the distal direction D relative to the dial sleeve 27, which is necessary for drug dispensing as this releases the splined interface between the clutch 28 and the dial sleeve 27.

[0180] Again, the operation of the actuator 5 can 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 whether an enable signal of an external device is received.

[0181] Some or all of the actuators 5 described in connection with the first to sixth exemplary embodiments may also be combined.

[0182] Fig. 29 shows an exemplary embodiment of the drug delivery device 100 or the mechanism unit MU, respectively. Shown is a cross-sectional view in a plane extending perpendicular to the longitudinal axis. Fig. 29 can show any one of the first to sixth exemplary embodiments.

[0183] The mechanism unit MU is configured to be coupled with three different types of selected drug reservoir units RU to prevent the actuator 5 from operating unless a selected drug reservoir unit RU is coupled to the mechanism unit MU and / or to enable the actuator 5 to operate if any one of the three selected drug reservoir units RU is coupled to the mechanism unit MU. 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 contact in FIG. 29) and the associated conductor path section are the same for all three conductor paths 41. The first contacts 40.1 (upper contact 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.

[0184] When a selected drug reservoir unit RU with the contact elements 4 in the correct position, in particular the access points 4.1, 4.2 in the correct position (see Fig. 30), is coupled with the mechanism unit MU, one of the three conductor paths 41 is closed, which can be recognized, for example, by the control unit 43A of the mechanism unit MU as described in connection with the first exemplary embodiment. The control unit 43A can then operate the actuator 5 of the mechanism unit MU in order to change the operating state of the mechanism unit MU, for example, 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 possible.

[0185] If a drug reservoir unit with the contact element 4 not in the correct position is coupled with the mechanism unit MU, a change in operating state cannot be prevented.

[0186] It should be emphasized that the structure of the mechanism unit MU including several 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.

[0187] Figure 30 shows a cross-sectional view of an exemplary embodiment of three different types of selected drug reservoir units RU for the mechanism unit MU of Figure 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 are in different positions. The second access point 4.2 of each of the contact elements 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 in a different angular position. The access points 4.1, 4.2 of the drug reservoir units RU may be electrically connected via the contact elements 4.

[0188] The positions of the access points 4.1, 4.2 of the 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 connected to the mechanism unit MU, this conductor path 41 is closed via the contact elements 4 of the drug reservoir unit RU.

[0189] To ensure that the orientation, especially the rotational orientation, of the drug reservoir unit RU is correct when coupling the selected drug reservoir unit RU to the mechanical unit MU, the mechanical unit MU comprises a guiding structure 46 in the form of a guide groove (see Fig. 29) which is configured to engage with a guiding structure 47 in the form of a guide rib of the drug reservoir unit RU. This ensures that the access points 4.1, 4.2 always contact the associated contact points 40.1, 40.2 when the selected drug reservoir unit RU is coupled with the mechanical unit MU.

[0190] Figures 31 and 32 show in more detail the circled areas of Figures 12 and 10, respectively. These figures show the functional principle of the locking mechanism 6, which is configured to prevent the drug reservoir unit RU from being uncoupled or separated from the mechanism unit MU when a drug dose has been set but not fully dispensed.

[0191] The inner body 10 comprises an interface feature 70, for example in the form of an internal 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 external thread. The two threads 70, 71 can be engaged, thereby establishing a coupling interface 7 in the form of a screw interface, via which the drug reservoir unit RU is releasably coupled to the mechanical unit MU. To couple and release the coupling interface 7, the drug reservoir unit RU may have to be rotated and / or moved in a proximal direction P or a distal direction D relative to the bodies 10, 11.

[0192] However, in Fig. 31 the locking mechanism 6 is in a locked state, thereby preventing the connection interface 7 from being released. The locking mechanism 6 comprises a coupling element 60, which is in a locked position engaged with the reservoir holder 15. The coupling element 60 comprises at its distal end a coupling feature in the form of a protrusion that engages with a coupling feature, i.e. a recess or groove, of the reservoir holder 15. This engagement allows the drug reservoir unit RU to be moved axially, possibly rotationally, relative to the body 10, 11, thereby preventing the connection interface 7 from being released.

[0193] The connecting element 60 is pivotally suspended within the mechanism unit MU via a joint connection 61 with the inner body 10. This joint connection 61 allows the connecting element 60 to rotate from a locked position in FIG. 31 to a released position shown in FIG.

[0194] The connecting element 60 is an elongate element having a main section extending substantially axially and a further section 62 extending perpendicular to the main section and to the axis of rotation about which the connecting element 60 can rotate. The connecting element 60 forms part of the locking mechanism 6 and is arranged such that the number sleeve 26, which moves axially during dose setting and dose dispensing, can strike the connecting element 60 radially offset from the articulation connection 61 when it reaches a first position (see FIG. 32) in order to apply a torque to the connecting element 60. This torque moves the connecting element 60 from the locked position to the released position of FIG. 32. This happens purely mechanically via the leverage effect.

[0195] As can be seen in Fig. 32, when the number 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 coupling interface 7. This state of the locking mechanism 6 is called the released state. A user can separate the drug reservoir unit RU from the mechanism unit MU, for example to replace the drug reservoir unit RU. When the number 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 coupling interface 7 is prevented again.

[0196] The locking mechanism 6 described in relation to Figures 31 and 32 is particularly useful for preventing the user from changing the drug reservoir unit RU when a drug dose has been set. As mentioned above, setting of the drug dose is associated with the movement of the number sleeve 26 in the proximal direction P. This locking mechanism 6 can be used in any of the exemplary embodiments of the drug delivery device described herein.

[0197] The concepts proposed in this disclosure, e.g., for blocking dose setting and / or dosing, or the remaining concepts, can be applied to the device architectures described above, e.g., in most detail in connection with FIG. 1 and related embodiments, but also to other drug delivery devices. In particular, one or more of the concepts proposed herein can be applied to devices disclosed in WO2021 / 059202A1, e.g., to implement the functionality described in

[0237] therein, or to devices disclosed in EP3049132B1 (see claim 1).

[0198] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0199] As described below, drugs or agents may include at least one API or combinations 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.

[0200] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel 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 can 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 can be designed to store the drug for about one month to about two years. Storage can 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 can 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 can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0201] 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 drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0202] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue or another naturally occurring residue or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, e.g., the molecular 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 present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0203] 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 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0204] 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. ; B30-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.

[0205] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0206] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0207] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0208] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0209] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. 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 G-F20 (Synvisc®), sodium hyaluronate.

[0210] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.

[0211] 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 can 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.

[0212] 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 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.

[0213] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0214] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0215] Those skilled in the art will understand that modifications (addition and / or removal) of the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, which encompasses such modifications and any and all equivalents thereof.

[0216] Exemplary drug delivery devices can include needle-based injection systems as described in Table 1 of Chapter 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose container systems (with partial or complete ejection). The container can be an exchangeable container or an integrated non-exchangeable container.

[0217] As further described in ISO11608-1:2014(E), a multi-dose container system can include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the dose size can be fixed or variable (pre-set by the user). Another multi-dose container system can include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the dose size can be fixed or variable (pre-set by the user).

[0218] As further described in ISO11608-1:2014(E), the single-dose container system can include a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). Also as described in ISO11608-1:2014(E), the single-dose container system can include a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0219] The invention described herein is not limited by the description in relation to the exemplary embodiments, but rather includes any novel feature as well as any combination of features, including any combination of features specifically recited in the claims, even if said feature or combination itself is not explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0220] 4 Contact elements 4.1 First Access Point 4.2 Second Access Point 5 Actuators 6 Locking mechanism 7 Connecting 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 Inclined section 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 coupling 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 Sliding 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 Sliding 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 Connected Elements 61 Joint connection part 62 Section of connecting element 60 70 Interface Functions 71 Interface Functions 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 drug delivery device (100), comprising: The mechanism unit (MU) includes: a housing element (11); a first movable element (26, 13) arranged to be movable relative to said housing element (11); an electromechanical actuator (5) that, when actuated, moves the actuator element (50) between a first position and a second position; and The mechanism unit (MU) comprises: operatively coupled to a drug reservoir unit (RU) to effect a dispensing process for dispensing a drug dose; enabling the setting of a drug dose to be administered, wherein the setting of the drug dose is associated with a movement of the first movable element (26, 13) in a first direction; blocking movement of the first movable element (26, 13) in a first direction when the actuator element (50) is in a first position to prevent setting of a drug dose; allowing movement of the first movable element (26, 13) in a first direction when the actuator element (50) is in a second position as a prerequisite for setting a drug dose; The drug delivery device is configured as follows.

2. the mechanism unit (MU) is configured to prevent dispensing of the drug dose when the actuator element (50) is in the first position; The drug delivery device (100) of claim 1.

3. dispensing the drug dose is associated with movement of the first movable element (26, 13) in the second direction; The mechanism unit (MU) is configured to prevent movement of the first movable element (26, 13) in the second direction when the actuator element (50) is in the first position. The drug delivery device (100) of claim 2.

4. The mechanism unit (MU) preventing operation of the actuator (5) unless the selected drug reservoir unit (RU) is coupled with the mechanism unit (MU); The coupling of the mechanism unit (MU) with the selected drug reservoir unit (RU) is a prerequisite for the operation of the actuator (5). It is configured so that, in some cases, The mechanism unit (MU) includes a first conductor path (41); The first conductor path (41) includes at least one contact (40), which is in electrical contact with at least one contact element (4) of the drug reservoir unit (RU), When a selected drug reservoir unit (RU) with the contact element (4) in the correct position is coupled with the mechanism unit (MU), at least one contact (40) is in electrical contact with the contact element (4), thereby modifying the electrical properties of the first conductor path (41) in a characteristic manner. It is like this, wherein the mechanism unit (MU) is configured such that operation of the actuator (5) is prevented unless the electrical characteristics of the first conductor path (41) are altered in at least one characteristic manner. A drug delivery device (100) according to any one of claims 1 to 3.

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

6. The first conductor path (41) includes at least two sections (41A, 41B), which are movably arranged relative to each other and electrically connected by a sliding contact (42). The drug delivery device (100) of claim 4.

7. The mechanism unit (MU) further includes a communication module for communicating with an external device; The mechanism unit (MU) is configured to prevent operation of the actuator (5) unless an enable signal from an external device is received via the communication module; and / or The first movable element (26, 13) rotates and / or moves axially when moved in a first direction during setting of a drug dose. A drug delivery device (100) according to any one of claims 1 to 3.

8. The mechanism unit (MU) further includes an intermediate element (55, 24, 58) displaceable between a locked position and a released position; movement of the actuator element (50) from the first position to the second position allows movement of the intermediate element (55, 24, 58) from the locked position to the released position and / or vice versa; The intermediate element (55, 24, 58) in the locked position is configured to prevent movement of the first movable element (26, 13) in a first direction, and optionally the path along which the actuator element (50) moves between the first and second positions is different from the path along which the intermediate element (55, 24, 58) moves between the locked and released positions; A drug delivery device (100) according to any one of claims 1 to 3.

9. The drug delivery device (100) includes a dose setting member (13) configured to be manipulated by a user to set a drug dose; During dose setting, the dose setting member (13) is moved relative to the housing element (10) and / or the energy source (43B) and / or the control unit (43A) for operating the actuator (5) and / or the actuator element (50) are activated during setting of the drug dose; A drug delivery device (100) according to any one of claims 1 to 3.

10. The mechanism unit (MU) further includes a second conductor path (44) for guiding an electrical signal to the actuator (5); The second conductor path (44) includes at least two sections (44A, 44B), which are movably arranged relative to each other and electrically connected by a sliding contact (45). A drug delivery device (100) according to any one of claims 1 to 3.

11. The actuator (5) includes a magnet (51) and an electromagnet (52) whose magnetization changes when the actuator (5) is operated; a magnetic interaction between the magnet (51) and the electromagnet (52) that causes the actuator element (50) to move between the first and second positions when the actuator (5) is actuated, and / or that holds the actuator element (5) in the first position; A drug delivery device (100) according to any one of claims 1 to 3.

12. The actuator element (50) is a displaceable or movable element in the form of a flexible arm, said flexible arm including at its free longitudinal end an electromagnet (52), and optionally The drug delivery device (100) of any one of claims 1 to 3, wherein the flexible arms are oriented axially or circumferentially.

13. the actuator (5) comprises an actuator element (50) in the form of an elliptical disc, or The drug delivery device (100) according to any one of claims 1 to 3, wherein the actuator (5) comprises a spindle (57) and the actuator element (50) is a spindle nut moved by the spindle (57).

14. A drug delivery device (100) according to any one of claims 1 to 3, wherein the mechanism unit (MU) includes a first conductor path (41) that is interrupted unless a selected drug reservoir unit (RU) is coupled to the mechanism unit (MU).

15. the drug delivery device is an injection device such as an auto-injector and / or a variable or fixed dose device and / or a pen-type device, e.g., a dial extension pen; and / or The drug delivery device (100) includes a drug reservoir unit (RU), which contains a drug and / or The drug delivery device (100) of any one of claims 1 to 3, wherein the mechanism unit (MU) includes a dispensing mechanism for dispensing a drug dose, the dispensing mechanism including a plunger rod (29) and an energy member, the energy member being configured to provide energy for moving the plunger rod (29) in a distal direction, and optionally the energy member being a drive spring, a gas cartridge or an electric motor.

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