ELECTRONIC SYSTEM FOR DRUG DELIVERY DEVICE AND DRUG DELIVERY DEVICE - Patent application

Abstract

An electronic system (1000) for a drug delivery device (1) is provided, the electronic system comprising at least one user interface member (1600) configured to be operated by a user to perform a dose operation, e.g. a dose setting operation for setting a dose of a drug to be delivered by the drug delivery device and / or a dose delivery operation for delivering the set dose, and an electronic control unit (1100) configured to control the operation of the electronic system, the electronic system having a first state and a second state, the electronic system having a higher power consumption in the second state compared to the first state, wherein the user interface member comprises an external operating surface (1620) arranged to be touched by a user for the dose operation, the user interface member being coupled to a user proximity detection unit (1300) and a user proximity detection unit (1300). 00, 1670), the user proximity detection unit configured to generate an electrical signal when a user approaches or touches the external operating surface, the user proximity detection unit includes a movable member (1670), the movable member arranged to be moved by a user relative to the external operating surface away from an initial position towards an operating position before the user reaches the external operating surface, the user proximity detection unit further includes an electrical signal transmitting unit (1300), the user proximity detection unit configured to provide an electrical signal when the movable member is moved away from the initial position, e.g. when the movable member is in the operating position or during movement away from the initial position towards the operating position, and the electronic system configured such that the electronic control unit is responsive to the electrical signal to switch the electronic system from a first state to a second state.

Description

[Technical field]

[0001] The present disclosure relates to an electronic system for a drug delivery device.The present disclosure further relates to a drug delivery device, preferably a drug delivery device including an electronic system. [Background technology]

[0002] Drug delivery devices using electronic devices are becoming more and more popular in the pharmaceutical industry, as well as among users or patients. However, especially when the device is designed to be self-contained, i.e., there is no connector for connecting to an external power source required to provide power for the operation of the device, it is particularly important to integrate the management of power resources into the device while maintaining reliable operability of the system. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present disclosure to provide new and preferably improved electronic systems or drug delivery devices. [Means for solving the problem]

[0004] This object is achieved by the subject matter of the independent claims. Advantageous embodiments and refinements are subject to the dependent claims. It is to be noted that the present disclosure is not limited to what is claimed in this specification, but may include subject matter only in the descriptions that may comply with the scope of the claims.

[0005] One aspect of the present disclosure relates to an electronic system for a drug delivery device. Another aspect of the present disclosure relates to a drug delivery device, preferably a drug delivery device including an electronic system. Thus, features disclosed in relation to a drug delivery device, or a unit therefor, also apply to the electronic system and vice versa.

[0006] In one embodiment, the electronic system includes at least one user interface member. The user interface member may be arranged or configured to be operated, e.g. touched and / or moved, by a user, e.g. a user of the drug delivery device, such as a patient. The user interface member may be provided for performing a dose operation, e.g. a dose setting operation for setting a dose of a drug to be delivered by the drug delivery device, and / or a dose delivery operation for delivering a set dose, preferably a dose pre-set during a dose setting operation. The dose operation may be an operation related to a dose to be delivered by the drug delivery device, whether a dose delivery operation or a dose setting operation. The dose operation may include, in addition to the dose setting operation, a dose adjustment operation, preferably increasing or decreasing a pre-set dose, preferably not yet delivered, by manipulating the user interface member. Performing a dose operation may require the user to continuously contact the user interface member, in particular its external operating surface (see below), throughout the operation. The dose operation may involve a movement of the user interface member relative to the housing of the drug delivery device, e.g. the housing of a drug delivery device unit to which the electronic system may be connected, or the housing of the drug delivery device.

[0007] In one embodiment, the user interface member includes an external operating surface. The external operating surface may be an outer surface of the user interface member. The external operating surface may be arranged and / or configured to be touched by a user, particularly for a dose operation. To perform a dose operation, for example to initiate the operation and / or to maintain contact with the external operating surface throughout the dose operation to complete the dose operation, it is necessary to touch the surface. The external operating surface may be a setting surface for a dose setting operation and / or a delivery surface for a dose delivery operation. The setting surface and the delivery surface may face in different directions. The setting surface may face radially. The delivery surface may face axially, for example in a proximal direction. The setting surface may extend circumferentially around an axis of the user interface member, for example an axis of rotation about which the user interface member is rotatable for a dose setting operation. The delivery surface may be arranged obliquely or perpendicular to the axis. The setting surface may also be used for a dose adjustment operation.

[0008] In one embodiment, the electronic system includes an electronic control unit. The electronic control unit may be configured to control the operation of the electronic system. The electronic control unit may be or may include an electronic processor, for example a microcontroller or an ASIC. The electronic system may have a first state, for example in which the system is in a dormant or idle state, and a second state, for example in which the system is in an operational state. The electronic system may have a higher power consumption in the second state compared to the first state. In the first state, one or more electric or electronic units of the electronic system may be in a sleep mode or may be powered off so as to consume little or no power. For example, in the second state, the motion sensing unit may be active, i.e., capable of operating or operating, and in the first state, this unit is inactive, i.e., capable of operating or not operating. The motion sensing unit is described in more detail below. Alternatively or additionally, the communication unit may be inactive in the first state and active in the second state. The communication unit is described in more detail below.

[0009] In one embodiment, the electronic system, preferably the user interface member, includes a user proximity detection unit. The user proximity detection unit may be operably connected to the electronic control unit. The user proximity detection unit may be configured to generate an electrical signal, e.g., a use signal, when a user approaches or touches an external operating surface of the user interface member. The electrical signal may indicate, or may be deemed by, e.g., the electronic control unit to indicate, that a dose operation is about to begin.

[0010] In one embodiment, the electronic system includes a movable member. The movable member may be part of a user interface member. The movable member may be part of a user proximity detection unit. An external operating surface of the user interface member may be formed by a user interface member body. The movable member may protrude from the external operating surface of the user interface member, e.g. at least in an initial position, and / or a contact area of ​​the movable member may be higher than the external operating surface of the user interface member. The movable member may be configured and arranged relative to the external operating surface such that a user has to move the movable member until he or she can touch the external operating surface with, e.g., a thumb.

[0011] In one embodiment, the moveable member must be moved relative to the external operating surface away from an initial position towards, preferably to, the operating position before the user can reach the external operating surface.

[0012] In one embodiment, the electronic system includes an electrical signal transmission unit. The signal transmission unit can be operably connected to the electronic control unit. The signal transmission unit can be part of the user proximity detection unit. The movable member can be designed to, for example, mechanically cooperate with the signal transmission unit to trigger the generation of an electrical signal. The signal transmission unit can be configured to provide an electrical signal, for example an electrical signal that the user proximity detection unit is configured to generate, which signal indicates that a user has approached or touched the external operating surface.

[0013] In one embodiment, the signal transmission unit is fixed relative to the external operating surface, e.g., such that it cannot move away from and / or towards the external operating surface. The signal transmission unit can be non-rotatably and axially fixed relative to the external operating surface.

[0014] In one embodiment, the user proximity detection unit is configured to provide a signal, preferably only when the movable member is moved away from the initial position, e.g. towards the operating position. The user proximity detection unit can be configured to provide a signal in response to movement of the movable member away from the initial position. The user proximity detection unit can be configured to provide a signal when, preferably only when, the movable member is in the operating position or during movement away from the initial position towards the operating position. The movable member and the signal transmission unit can be arranged such that the movable member cooperates with the signal transmission unit to trigger the signal transmission unit to provide a signal in response to movement away from the initial position. The movable member can be movable relative to an external operating surface and / or the signal transmission unit. No signal is generated by the signal transmission unit unless the movable member is moved towards or into the operating position relative to the operating surface.

[0015] In one embodiment, in the operating position, the movable member protrudes less from the external operating surface than in the initial position. That is, the direction from the initial position to the operating position can be from an end of the movable member that is located outside the movable member, away from the external operating surface, toward the external operating surface. The direction of movement can be, for example, a distal direction, particularly if the external operating surface is a delivery surface.

[0016] In one embodiment, the electronic control unit is configured to switch the electronic system from a first state to a second state, for example by issuing a corresponding command or signal. The electronic control unit can be configured to switch the electronic system from the first state to the second state in response to at least one electrical signal, preferably directly in response to a signal generated in response to a movement of the movable member away from the initial position. The signal provided by the user proximity detection unit can be processed by the electronic control unit, which in response to the signal can switch the electronic system from a first state with low power consumption to a second state with higher power consumption. The signal provided by the user proximity detection unit can indicate a dose operation, for example a dose delivery operation. The electronic control unit can be configured to switch the system to the second state in direct and / or immediate response to reception of a signal, for example reception of only one signal pulse, or only one change in an electrical characteristic, for example voltage or current, for example by issuing a corresponding command or signal. In this way, complex signal patterns of subsequent signals or changes in characteristics to initiate switching to the second state can be avoided. The signal may be a change in voltage or current detected by the electronic control unit.

[0017] Providing the movable member as an object or obstacle that the user must move before he can touch the external operating surface has the advantage that the position of the movable member relative to the external operating surface can be used as an indicator as to whether the user has approached or touched the surface. In this way, an electrical signal can be provided that triggers the switching of the electronic system from a first state to a second state very early during preparation of the dose operation, for example just before the dose operation is initiated and / or before or when the external operating surface is touched to perform the dose operation. Thus, a signal indicative of the operation to be performed can be generated before the operation is actually initiated. Initiating the dose operation can require, for example, moving the user interface member relative to the housing or other components of the drug delivery device or drug delivery device unit, for example in the distal axial direction, while touching the external operating surface. The signal is preferably generated by a signal sending unit before the user moves the user interface member for the dose operation. On the other hand, requiring a movement of the movable member reduces the risk of unintended power consumption compared to, for example, a contactless switch that can be operated without movement.

[0018] In one embodiment, the electronic control unit is configured to switch the electronic system to the second state in response to unidirectional movement of the movable member from the initial position to the operating position, e.g., in response to distal movement or movement of a user contact area of ​​the movable member towards an external operating surface.

[0019] In one embodiment, the user interface member includes a user interface member body. The user interface member body may define or form the external operating surface. A portion of the movable member may be arranged in the user interface member body and may preferably be movably held. This portion of the movable member may be the portion that is displaced from an initial position towards the operating position before a user touches the external operating surface. Inside the user interface member (body), a signal sending unit and / or an electronic control unit may be arranged and may for example be axially and non-rotatably fixed relative to the body. The inside of the user interface member body may preferably include a sealed compartment that is sealed from the outside at least when the electronic system is in an operating state in the drug delivery device.

[0020] In one embodiment, the external operating surface defines the extent of at least one opening laterally or circumferentially. In other words, the external operating surface can be interrupted by at least one opening. A portion of the movable member can protrude through the opening, for example from the interior of the user interface member (body) to the exterior. The movable member can be operatively connectable to an element inside the user interface member body, in particular to a signal transmission unit that can be provided under the external operating surface. The movable member can be actuable from the exterior, such as by a user moving the movable member relative to the user interface member body. The portion of the movable member protruding through the opening can define a user contact area or contact surface that the user can touch to move the movable member relative to the user interface member body. The user contact surface can face in the same direction as the external operating surface, for example proximally. The initial position of the movable member and the operating position of the movable member can be the position of the user contact area relative to the user interface member body, for example an axially offset position. The movable member can be axially guided relative to the user interface member body. That is, the moveable member can only move axially relative to the user interface member body and cannot rotate.

[0021] In one embodiment, the external operating surface defines a plurality of separate openings. The openings may be circumferentially bounded by the user interface member body or the external operating surface, i.e., the openings are not connected. The openings may be distributed across the external operating surface. A portion of the movable member may protrude from each of the openings in the external operating surface, which effectuates different contact areas between the user and the movable member across the external operating surface.

[0022] In one embodiment, each portion of the movable member may originate from a body of the movable member. In the case of multiple portions, the body may be a common body. The body may be located within the user interface member body. From that body, each portion may extend through a respective opening towards and beyond the external operating surface. The body may be movably retained within the user interface member body.

[0023] In one embodiment, the protruding portion of the movable member that protrudes or rises from the external operating surface in the initial position, and the opening through which the movable member passes to connect the protruding portion to an internal portion of the movable member within the user interface member body, are adjusted to be able to receive the entire protruding portion within the opening, particularly when the movable member is moved from the initial position to the operating position, thereby facilitating the movable member being flush or less than flush with the external operating surface when in the operating position, and / or facilitating user contact with the external operating surface when the movable member is in the operating position.

[0024] In one embodiment, the movable member is arranged such that when the user wishes to touch the external operating surface for dose actuation, the user moves the movable member from the initial position towards the operating position, in particular by moving the part that protrudes through the opening. In the operating position of the movable member, the user can touch the external operating surface, preferably the movable member. In the initial position of the movable member, the user can move away from the external operating surface, preferably when touching the movable member.

[0025] In one embodiment, the operating position is displaced from the initial position in a direction toward the external operating surface, e.g., in a plan view of the external operating surface. In the operating position, the movable member may not protrude from the external operating surface as much as in the initial position, or may be flush or less flush with the external operating surface. The operating position may be displaced axially, e.g., distally, relative to the initial position.

[0026] In one embodiment, during a dose actuation, the movable member may be in an operative position, preferably throughout the entire dose actuation. A user may maintain the movable member in the operative position relative to an external actuation surface during the dose actuation.

[0027] In one embodiment, in the initial position of the movable member, the user contact area of ​​the movable member, preferably the surface of the part that protrudes through the opening, e.g. the surface away from the external operating surface, is elevated with respect to the external operating surface and / or with respect to an envelope surface defined by the external contour of the external operating surface or the user interface member body. Thus, the movable member can provide an elevated contact area for contacting the user before the user touches the external operating surface. The envelope surface can cover the opening and can be formed by the external operating surface in the area where no opening is provided. In the area of ​​the opening, the envelope surface can continue the contour of the external operating surface. In the operating position of the movable member, the user contact area of ​​the movable member, preferably all the user contact areas, can be recessed with respect to the external operating surface and / or the envelope surface, preferably in a direction away from the initial position. In other words, the user contact area can be less than flush with the external operating surface in the operating position. The user contact area can be located below the external operating surface or can be offset from the initial position by a distance that is greater than the distance between the user contact area and the external operating surface in the initial position. The recessed arrangement of the user contact area can be achieved by the user's finger flexibly extending partially into the opening. When the movable member is recessed relative to the external operating surface in the operating position, it is advantageous that most of the dose operation force that must be applied to the user interface member to perform the dose operation can be guided through the user interface member body and not via the movable member that can provide for mechanical contact with the electronic unit of the system. This reduces the risk of damage to the electronic control unit or other electronic or electrical units or components in the system by forces being transmitted from the user to the unit via the movable member.

[0028] In one embodiment, the electrical signal is generated in response to a movement of the movable member relative to the signal transmission unit, the movable member being movable relative to the signal transmission unit from a non-signal transmitting position to a signal transmitting position in which signal generation is triggered, the movable member being in an operating position relative to an external operating surface, or being displaced from the operating position, for example towards an initial position.

[0029] In one embodiment, the system is configured such that an electrical signal is generated during movement of the movable member from an initial position to an operating position relative to the external operating surface. Thus, the signal transmitting position and the non-signal transmitting position can be the same as the operating position and the initial position, respectively. In this case, the signal transmitting unit can be fixedly mounted relative to the external operating surface.

[0030] In one embodiment, the electrical signal is generated in response to a movement of the external operating surface and the movable member relative to the signal transmission unit, preferably only when the movable member is in an operating position relative to the external operating surface. The relative movement can be a movement towards the signal transmission unit, e.g. a distal movement. In this case, to trigger the generation of the signal, first the movable member must be moved from an initial position to an operating position, and then the external operating surface and the movable member are displaced towards the signal transmission unit. In this case, the external operating surface can be movable relative to the signal transmission unit.

[0031] In one embodiment, the signal transmission unit is configured such that the movable member cooperates with the signal transmission unit to trigger the generation of the electrical signal. To cooperate with the signal transmission unit, the movable member must be moved away from the initial position, preferably to the operating position, i.e. to trigger the generation of the electrical signal, the movable member must be in the operating position.

[0032] In one embodiment, the signal transmitting unit includes an electrical switch. The switch may be arranged to be triggered by the movable member, for example when the movable member is moved from a non-signal transmitting position to a signal transmitting position. When triggered, the switch may cause the generation of an electrical signal.

[0033] In one embodiment, the movable member is biased toward the initial position by a member biasing mechanism or biasing member when the movable member is in the operative position. The initial position may thus be a standard position of the movable member relative to an external operating surface. The member biasing mechanism may be biased or loaded during movement of the movable member from the initial position to the operative position, for example by a force provided by a user.

[0034] In one embodiment, a member biasing mechanism is provided that acts against movement of the movable member away from the initial position and / or towards the operative position. The member biasing mechanism may be the same mechanism as in the previous paragraph. The member biasing mechanism may ensure that the initial position is a standard position for the movable member and / or that the movable member protrudes from the external operative surface in the initial position. To move the movable member towards the operative position, the biasing force of the biasing mechanism must be overcome.

[0035] In one embodiment, the member biasing mechanism includes a spring, for example a compression spring.

[0036] In one embodiment, the dose operation is a dose delivery operation.

[0037] In one embodiment, the external operating surface is a delivery surface arranged to be touched by a user to perform a dose delivery operation. The delivery surface can be a proximally facing surface of the user interface member body. The dose delivery force applied to the surface can be a force required to perform a dose delivery operation, for example a force transmitted from a user through the user interface member to a piston rod of the dose setting and driving mechanism through one or more mechanism members of the dose setting and driving mechanism. This force can be provided to drive a dosing operation to dispense liquid from a reservoir.

[0038] In one embodiment, to perform a dose operation, a dose actuation force, e.g., a distally directed force for a dose delivery operation, must be applied by the user to the user interface member. The user interface member can be designed such that during a dose actuation, the portion of the dose actuation force acting on the external actuation surface is greater than the portion of the actuation force acting on the movable member. The user can contact both the external actuation surface and the movable member during a dose actuation. The dose actuation force can be directed in the same direction as the movement from the initial position to the actuation position. For example, the preference of the external actuation surface over the movable member can be assisted by making the contact area between a finger, e.g., the user's thumb, and the external actuation surface greater than the contact area between the finger and the movable member when a dose actuation is performed and / or when the movable member is in the actuation position.

[0039] In one embodiment, when the movable member is in the operating position, it can be moved further away from the initial position, for example against the force of the member biasing mechanism. In other words, the electronic system may not have end stops to define the operating positions. The end stops should limit the movement of the movable member further away from the initial and operating positions. Since there are no end stops and the movable member can still be moved further away from the initial position in the operating position, the forces transmitted to the system via the movable member rather than the external operating surface are preferably small. This can help or be responsible for prioritizing the transmission of forces via the external operating surface and preventing excessive force transmission via the movable member.

[0040] In one embodiment, in the operating position, the movable member is still movable against the bias of the member biasing mechanism, e.g. away from the initial position. Thus, in the operating position, the biasing force provided by this mechanism is the force transmitted to the system via the movable member. The user can react to the biasing force in the operating position. The biasing force in the operating position can be 1 N or less. The electronic system can be configured such that the biasing force is less than the residual portion of the dose actuation force (RP), i.e. less than the force that the user still has to apply on the user interface member to perform the dose actuation after the movable member has been moved to the operating position. This residual portion of force can include the contribution of the drive force (DF), i.e. the force required to actuate the dose actuation, and / or the clutch switching force (CSF), i.e. the force that has to be applied to switch the state of the clutch and / or to switch the dose setting and drive mechanism from the setting configuration to the delivery configuration. The biasing force can be less than or equal to one of the following values: RP / 5, RP / 6, RP / 7, RP / 8, RP / 9, RP / 10, DF / 5, DF / 6, DF / 7, DF / 8, DF / 9, DF / 10, CSF / 5, CSF / 6, CSF / 7, CSF / 8, CSF / 9, CSF / 10.

[0041] In one embodiment, in plan or top view of the external operating surface, the area included in the external operating surface (preferably not included in the movable member) is greater than the area included in the movable member, e.g. its user contact area. For example, the ratio between the area included in the movable member and the area of ​​the external operating surface may be less than or equal to any one of the following values: 0.4, 0.3, 0.25, 0.2, 0.15, 0.1, 0.05, 0.01, 0.005, 0.004. Alternatively or additionally, this ratio may be greater than or equal to any one of the following values: 0.001, 0.002, 0.003, 0.004, 0.005, 0.007, 0.01.

[0042] In one embodiment, in a plan or top view of the external operating surface, the protruding portion of the movable member and the external operating surface do not overlap in the initial position and in the operating position.

[0043] In one embodiment, the exterior operating surface is a continuous surface interrupted only by one or more openings.

[0044] In one embodiment, when the movable member is in the operating position, the force applied by the user to the movable member is resolved by the user interface member body, in particular via a force transmission path that bypasses the signal transmission unit and / or the electronic control unit. In other words, when the movable member is in the operating position, there may be an abutment between the movable member and the user interface member body or a component that is rigidly, e.g. axially and / or non-rotatably fixed to the body. Forces applied to the movable member or the operating surface, e.g. for a dose operation, are preferably not guided to the electronic unit, the signal transmission unit and / or a carrier for these units, e.g. a conductor carrier, since they are resolved or reacted by the user interface member body in this case.

[0045] In one embodiment, the user interface member or electronic system is connected to a mechanism member, e.g. a dose and / or injection button, or a drive member, e.g. a drive sleeve, of a dose setting and drive mechanism of a drug delivery device, or configured to be connected to such a mechanism member, e.g. configured to be non-rotatably and / or axially locked. The user interface member or electronic system can be operatively connected to the mechanism member such that a force, in particular a force acting on an external operation surface, e.g. a dose operation force, can be transmitted from the external operation surface to the mechanism member. The force can be a distally directed force and / or the dose operation can be a dose delivery operation. The electronic system or user interface member, e.g. an interface member body, or a member, e.g. rigidly or movably connected to the interface member body, can have a connection feature for connecting to the mechanism member.

[0046] In one embodiment, the electronic system or user interface member includes a shuttle member. The shuttle member may be moveable relative to an external operating surface. The shuttle member may be movably retained within the user interface member body. The shuttle member may be axially moveable relative to the user interface member body. Relative rotational movement between the shuttle member and the user interface member body may be prevented. The shuttle member may be splined to the user interface member body such that (e.g. limited) relative axial movement between the shuttle member and the user interface member body is possible, but relative rotational movement is prevented. The shuttle member may be retained within the user interface member body, for example such that the shuttle member cannot be removed from the user interface member body.

[0047] In one embodiment, the electronic system includes a shuttle member biasing system, e.g., a compression spring, which may be arranged to bias the shuttle member away from the external operating surface and / or the moveable member.

[0048] In one embodiment, the electronic system includes a carrier, such as a conductor carrier, e.g. a circuit board. The electronic control unit and / or the signal transmission unit can be arranged on the carrier, preferably mounted on the carrier. The carrier can be fixed, e.g. axially and / or non-rotatably, to the user interface member body. In this case, the operating position can be the signal transmission position. Alternatively, the carrier can be fixed to the shuttle member such that the carrier always moves together with the shuttle member relative to the external operating surface.

[0049] In one embodiment, the shuttle member is located in a force transmission path from the external operating surface to the mechanism member, particularly during a dose delivery operation. The external operating surface must be moved relative to the shuttle member before forces can be transferred from the shuttle member to the mechanism member. The shuttle member biasing system must be biased before or until the mechanism member is moved for a dose operation.

[0050] In one embodiment, the electronic system is configured such that the user interface member is operably connectable to the mechanism member via the dose operation interface to drive the movement of the mechanism member during the dose operation. The electronic system can be configured such that the external operating surface must be displaced from a first position relative to the mechanism member and / or shuttle member to a second position relative to the mechanism member and / or shuttle member to establish the dose operation interface. The direction from the first position to the second position can be axial, e.g. distal, and / or a direction of movement of the movable member from the initial position to the operating position. In the second position, an abutment can be established in a force transmission path between the external operating surface and the shuttle member, e.g. by an interface member body or a component fixed to the interface member body abutting the shuttle member axially, the force transmission path engaging the shuttle member to the external operating surface or the user interface member body, e.g. axially. The shuttle member biasing system can be configured to be biased during the movement from the first position to the second position. The shuttle member can be preloaded, which must be overcome to move the external operating surface to the second position. The electronic system can be configured such that a signal is generated only when the movable member is in an operating position relative to the external operating surface, for example because only in that position can the movable member trigger a switch of the signal sending unit. The signal can be generated only before or after the external operating surface is moved towards the second position. The signal can be generated before or when the external operating surface of the user interface member body reaches the second position. When the mechanism member is coupled to the user interface member body or the external operating surface, for example via a shuttle member, a dose operation can be performed by a user by moving the mechanism member via the external operating surface. Integrating the shuttle member with the shuttle member biasing system into the electronic system ensures that a signal is generated in all tolerance conditions before the mechanism member is operated for the dose operation or before the piston rod moves.The shuttle member biasing system can provide a defined pre-load, thus ensuring that a signal can always be generated before the dose setting and drive mechanism is switched to the dose delivery configuration.

[0051] In one embodiment, the mechanism member is the second member. The dose setting and drive mechanism can include a first member, e.g., a number sleeve or a dial sleeve. The first member and the second member can be configured to be movable relative to each other, such as by switching a state of the clutch coupling, e.g., from an engaged state to a disengaged state or vice versa, to switch the dose setting and drive mechanism from a dose setting configuration to a dose delivery configuration. The engaged clutch coupling can non-rotatably lock the first member to the second member. When the clutch coupling is released, the second member can be rotatable relative to the first member. The electronic system can be configured such that a signal is generated, e.g., via a user interface member, before the dose setting and drive mechanism is switched from the dose setting configuration to the dose delivery configuration. This facilitates the electronic system being switched on in a timely manner sufficient to perform an action during a dose delivery operation. The force that a user must apply to generate an electrical signal, e.g. to overcome the biasing force of a member biasing mechanism, is preferably less than the force, e.g. a clutch switching force, that must be applied to a user interface member or external operating surface to switch the dose setting and drive mechanism from a dose setting configuration to a dose delivery configuration.

[0052] In one embodiment, the movable member is rigid, in which case a separate member biasing system must be provided to bias the movable member towards its initial position when the movable member is in the operative position.

[0053] In one embodiment, the movable member is elastically deformable, in which case an elastic restoring force can be used to urge the movable member towards its initial position when it is in the operating position.

[0054] In one embodiment, the movable member is configured to establish a sealing interface to seal the interior of the user interface member body from the outside. To form the sealing interface, a sealing portion of the movable member can be held, e.g. clamped, between two members of the user interface member, e.g. between a body defining the external operating surface and a further member. The sealing portion can be elastically or plastically deformed to provide a sealing engagement with one or both of these members.

[0055] In one embodiment, the user interface member body is rigid.

[0056] In one embodiment, the body of the movable member is movably held within the user interface member. For example, the rigid body may be provided with a sealing member for sealingly engaging an inner wall of the user interface member. The body may for example seal the interior of the user interface member body from the outside.

[0057] In one embodiment, each seal is waterproof and / or dirt-resistant.

[0058] In one embodiment, the movement of the movable member relative to the external operating surface from the initial position to the operating position that may be required to enable a signal to be generated via the signal transmitting unit is unidirectional, in this way complex multi-directional movements for signal generation can be avoided.

[0059] In one embodiment, the user interface member is movable, e.g. axially, from a first position to a second position relative to a housing, e.g. a housing of a system or a drug delivery device. The first position may be an initial position that the user interface member has relative to the housing, e.g. before a dose setting operation and / or a dose delivery operation is initiated. The second position may be a position that the user interface member assumes when a user force, e.g. a distally directed force, is applied to the user interface member, moving the user interface member away from the first position, e.g. for a dose delivery operation. The first and second positions may be axially displaceable. The movement from the first position to the second position may involve only axial movement.

[0060] In one embodiment, the electronic system or drug delivery device includes a dose setting and driving mechanism. The first member and / or the second member can be configured to move relative to the housing of the electronic system or drug delivery device during a dose setting operation and / or a dose delivery operation. The first member can be a dose member or a dial member of the dose setting and / or driving mechanism, e.g., a dial sleeve or a number sleeve, and is moved to set a dose. The second member can be a driving member, e.g., a dose knob and / or an injection button, engaged with a piston rod of the dose setting and / or driving mechanism or a device user interface member. The first member and / or the second member can be movably coupled or held within the housing. In a dose setting operation, the first mechanism member and / or the second mechanism member can be displaced axially relative to the housing, e.g., away from a proximal end of the housing. The distance the first member and / or the second member are displaced, e.g., axially, relative to the housing during a dose setting operation can be determined by the size of the dose set. In other words, the drug delivery device may be of the dial-extending type, i.e. the device increases its length during the dose setting operation by an amount proportional to the size of the set dose.

[0061] In one embodiment, in the dose setting operation and / or the dose delivery operation, the first member moves, e.g. rotates and / or moves axially, relative to the second member. For example, the first member can rotate relative to the second member during the dose delivery operation, e.g. only during the dose delivery operation. Both the first member and the second member can move axially during the dose delivery operation. The first member can rotate relative to the second member and the housing during the dose setting operation and / or the dose delivery operation. The second member can be non-rotatably locked or rotatably guided relative to the housing, e.g. by a delivery clutch, during the dose delivery operation. The first member and the second member can be non-rotatably locked relative to each other during the dose setting operation. Accordingly, the first member and the second member can rotate relative to the housing in the dose setting operation. The first member and the second member can be coupled to each other during the dose setting operation, e.g. via a coupling interface, e.g. a setting clutch. The coupling interface can non-rotatably lock the first and second members to each other during a dose setting operation. When the coupling interface is engaged or established, the first and second members can be non-rotatably locked to each other, such as by direct engagement of the coupling interface features. The first and second members can include mating coupling interface features. The coupling interface can be released during a dose delivery operation, for example by axially displacing the second member relative to the first member. Thus, the second member can be non-rotatably locked to the housing during dose delivery, and the first member can rotate relative to the housing during dose delivery. The coupling interface can be released when switching the dose setting and / or drive mechanism from a dose setting configuration to a dose delivery configuration. This can be achieved when the user interface member is moved from a first position to a second position. In the first position, the mechanism can be in a dose setting configuration. In the second position, the mechanism can be in a dose delivery configuration.

[0062] In one embodiment, the first member and the second member rotate relative to each other only during one of the dose setting and dose delivery operations. One of the first member and the second member, e.g. the first member, can rotate relative to the housing during both operations. One of the first member and the second member, e.g. the second member, can rotate relative to the housing only during one of these operations, e.g. during dose setting or dose delivery.

[0063] In one embodiment, the dose setting action involves a rotational movement of the user interface member in a dose setting direction relative to a housing, e.g. a housing of a drug delivery device, i.e. both the movable member and the user interface member body can rotate during dose setting.

[0064] In one embodiment, in order to set a dose in the dose setting operation, the user interface member must be rotated relative to the housing, e.g., in a dose setting direction. This rotation may be an integer multiple of a unit setting increment angle. The unit setting increment may be the smallest dose that can be set to be delivered by the drug delivery device. The unit setting increment angle may be the angle through which the user interface member must be rotated relative to the housing, e.g., to set the smallest possible dose.

[0065] In one embodiment, the electronic system includes at least one, any selected number, or all of the following units or components: - An electrical motion sensing unit, the motion sensing unit being described in more detail below. - A communication unit. The communication unit may be provided for establishing a communication interface between the electronic system and another device, e.g. a portable device, e.g. a portable or non-portable computer, a mobile phone, or an electronic device such as a tablet. The communication unit may be a wireless unit, e.g. a RF communication unit such as a Bluetooth unit. The communication unit may be provided for transmitting dose data, e.g. information regarding the amount of drug delivered by the device in a delivery operation, from the electronic system to the other device. - a memory unit. The memory unit may be provided for storing executable program code and / or data relating to dosage information calculated by the electronic system, preferably dosage data relating to one or more delivered doses. The dosage data may be determined via the motion sensing unit. This data may be retrievable from the memory unit, for example for transmission to another device via the communication unit.

[0066] In one embodiment, the motion sensing unit is configured to generate one or more electrical motion signals. The motion signals are suitable for quantifying relative motion between the first member and the second member, for example during a dose setting or dose delivery operation, to obtain dose data, such as the size of a delivered dose. The first member and / or the second member may be members of an electronic system and / or a drug delivery device, such as a dose setting and / or drive mechanism, as further discussed above. The relative motion may be a relative rotational motion. For example, the first member may rotate relative to the second member during dose delivery.

[0067] In one embodiment, the electronic system is configured such that the motion sensing unit is switched from a first state to a second state, for example, by the electronic control unit and / or in response to a signal provided by the signal transmitting unit in response to movement of the first part to the signal transmitting position. In the first state, the motion sensing unit can be inoperative to sense movement of the first member relative to the second member. In the second state, the motion sensing unit can be operable. In the second state, the motion sensing unit can have a power consumption greater than the first state. The increased power consumption of the motion sensing unit contributes to or defines the increased power consumption of the electronic system in the second state.

[0068] In one embodiment, the motion sensing unit is configured to operate during the dose delivery operation, preferably only during the dose delivery operation. The motion sensing unit can be configured to monitor the dose delivery operation, for example the rotation of the first member relative to the second member. Thus, from the motion signal, position information regarding the relative position between the first member and the second member can be collected. Alternatively or additionally, it is also possible to collect position information between the two members in a dose setting operation. However, it is advantageous to monitor the movement during the dose delivery operation by the motion sensing unit in order to calculate dose information or data regarding the dose delivery during the dose delivery operation.

[0069] In one embodiment, the electronic control unit or electronic system is configured to utilize the motion signals generated by the motion sensing unit to calculate dose information or data. As mentioned above, the dose information is preferably information regarding the size of the dose delivered in the dose delivery operation.

[0070] In one embodiment, the motion sensing unit includes one or more sensors and / or one or more emitters, such as one or more photoelectron emission sensors or detectors and / or one or more photoelectron emission emitters. The sensors can be configured to generate a motion signal in response to a motion of the first member relative to the second member. The emitters can excite a sensor signal.

[0071] In one embodiment, during the dose setting operation, the dose can be set, for example between a settable minimum dose and a settable maximum dose, preferably in an amount corresponding to an integer multiple of one unit dosage increment.

[0072] In one embodiment, the separation distance, e.g., axial separation distance, between the first and second positions of the user interface member, e.g., relative to the housing, is determined by, e.g., clutch release distance, e.g., equal to, such a switching distance. The switching distance can be the distance that the second member of the dose setting and driving mechanism must be moved relative to the first member of the dose setting and driving mechanism to switch the dose setting and driving mechanism from a dose setting configuration of the mechanism to a dose delivery configuration of the mechanism. In the first position, the dose setting and driving mechanism can be in a dose setting configuration. In the second position, the dose setting and driving mechanism can be in a dose delivery configuration. For example, in the dose setting configuration or in the first position, the members of the dose setting and driving mechanism can be locked against rotation, as further discussed above. In the dose delivery configuration or in the second position, relative rotation is permitted, e.g., the first member can rotate relative to the second member and the housing during dose delivery. During a dose delivery operation, the second member can be locked against rotation relative to the housing.

[0073] In one embodiment, the separation distance, e.g., axial separation distance, between the first position and the second position is greater than or equal to the distance the second member must be moved, e.g., axially, relative to the first member to release the rotation lock. Specifically, the rotation lock can be released by displacing the second member axially, e.g., distally, relative to the first member during movement of the user interface member from the first position to the second position. The distance for releasing the rotation lock can correspond to or be greater than the switching distance. As soon as the member is moved from the first position to the second position, a signal can be provided and / or the electronic system can be switched to the second state.

[0074] In one embodiment, the electronic system includes a power source, for example a rechargeable or non-rechargeable battery.

[0075] In one embodiment, in the second state, the electronic system is configured to collect information or data related to the size of the currently dispensed or delivered dose during the delivery operation, e.g., via the motion sensing unit, such that the motion sensing unit can be configured to contribute to retrieving dose data related to the dose delivered in the delivery operation, e.g., the dose currently being delivered during the dose delivery operation.

[0076] In one embodiment, in the second state, the electronic system is configured to store the dose data in a dose memory or memory unit of the electronic system. The memory can be temporary or non-temporary. The dose data is preferably derived using measurements or signals of the motion sensing unit.

[0077] In one embodiment, in the second state, the electronic system is configured to transmit, by the communication unit, the dosage data, e.g. the dosage data retrieved from the memory, to another device or system, such as a computing device, e.g. a mobile phone or a portable or non-portable computing unit.

[0078] In one embodiment, the electronic system includes one user interface member, for example one integral member, for the dose setting and dose delivery operations, or two different user interface members, one of which is a user interface member for dose setting and the other is a user interface member for dose delivery. The two different members are preferably movable relative to each other, for example to switch between a dose setting configuration and a dose delivery configuration. If one interface member is used for dose setting and dose delivery, this interface member may have a setting surface and a delivery surface, which are preferably not movable relative to each other, in particular not movable relative to each other for or during dose delivery and / or for or during dose setting. If two different user interface members are used, the setting surface and the delivery surface may be located on different members and may be movable relative to each other for or during dose delivery and / or for or during dose setting.

[0079] In one embodiment, the electronic system includes a timer unit. The timer unit may be configured to put the motion sensing unit and / or other motorized units of the electronic system into a deactivated state after a predefined period of time has elapsed, preferably when no motion signal is generated within this period of time. The timer unit may trigger or cause the electronic system to be switched from the second state back to the first state. In other words, the electronic system may be configured to switch from the second state back to the first state when no motion signal is generated and / or received by the electronic control unit, preferably for a predefined time.

[0080] In one embodiment, the user interface member is a dose setting and / or injection button of or for a drug delivery device.

[0081] In one embodiment, the electronic system includes a feedback unit. The feedback unit can be configured to generate feedback perceptible to a user. The feedback can enable a user to determine whether the system is in a first state or a second state. Preferably, in the first state, no perceptible feedback is provided and the feedback indicates the second state. The feedback can be a feedback signal, for example, a light signal. The feedback signal can be provided by a light source, such as a light emitting diode. The light source can be operated in a pulsed or flashed manner to provide the feedback.

[0082] In one embodiment, the device is a manually operated device, for example operated by a user.

[0083] In one embodiment, the drug delivery device includes a reservoir, e.g. a reservoir holder for holding a cartridge, with the drug, and / or the device includes a reservoir with the drug, which may contain sufficient drug for multiple doses, preferably user settable doses, to be delivered by the drug delivery device.

[0084] In one embodiment, the drug delivery device is a pen device.

[0085] In one embodiment, the electronic system is configured as an accessory, preferably a reusable accessory, for the drug delivery device unit. The system can be configured to be attached to the drug delivery device unit. That is, the electronic system can be configured to be used with multiple drug delivery device units. Each drug delivery device unit can be a disposable drug delivery device unit and / or each drug delivery device unit can be fully operational to perform dose setting and dose delivery operations. The drug delivery device unit can include a reservoir.

[0086] In one embodiment, the power supply is non-replaceable.

[0087] In one embodiment, a kit for a drug delivery device includes a drug delivery device unit and an electronic system. The system can be attached to the device unit to form a drug delivery device. The features disclosed above and below with respect to the drug delivery device, especially those not directly related to the electronic system, should also apply to the drug delivery device unit and vice versa.

[0088] In this specification, "distal" is used to designate a direction, end, or surface that is or will be positioned to face or point towards the dosing end of the drug delivery device or a component thereof and / or points away from the proximal end, and that is or will be positioned to face or point away from the proximal end. On the other hand, "proximal" is used to designate a direction, end, or surface that is or will be positioned to face or point away from the dosing end and / or 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 the end furthest from the proximal end, and the proximal end can be the end furthest from the dosing end. The proximal face can face away from the distal end and / or towards the proximal end. The distal face can face towards the distal end and / or away from the proximal end. The dosing end can be the end of a needle, e.g. a needle unit is attached or will be attached to the device.

[0089] In a particularly advantageous embodiment, an electronic system for a drug delivery device comprises: - at least one user interface member configured to be operated by a user to perform a dose operation, such as a dose setting operation for setting a dose of a drug to be delivered by the drug delivery device and / or a dose delivery operation for delivering the set dose; - an electronic control unit configured to control operation of an electronic system, the electronic system having a first state and a second state, the electronic system having a higher power consumption in the second state compared to the first state, wherein: - the user interface member includes an exterior operating surface arranged to be touched by a user for dose operation; - the user interface member includes a user proximity detection unit, the user proximity detection unit being configured to generate an electrical signal when a user approaches or touches the external operating surface; - the user proximity detection unit includes a movable member, the movable member being arranged to be moved by a user away from an initial position towards an operating position relative to the external operating surface before the user reaches the external operating surface; - the user proximity detection unit further comprises an electrical signal transmission unit, the user proximity detection unit being configured to provide an electrical signal when the movable member is moved away from the initial position, e.g. when the movable member is in the operating position or during a movement away from the initial position towards the operating position; The electronic system is configured such that the electronic control unit is responsive to an electrical signal to switch the electronic system from a first state to a second state.

[0090] Configurations disclosed with respect to different aspects and embodiments can be combined with each other, even if such combination is not explicitly discussed above or below. Further aspects, embodiments, and advantages will become apparent from the following description of exemplary embodiments in conjunction with the drawings. [Brief description of the drawings]

[0091] [Figure 1] FIG. 1 illustrates an embodiment of a drug delivery device. [Diagram 2] FIG. 2 illustrates a schematic of an electronic system for a drug delivery device, such as the drug delivery device of FIG. 1. [Diagram 3]FIG. 2 illustrates a schematic diagram of one embodiment of an electronic system for a drug delivery device, such as the drug delivery device of FIG. 1. [Figure 4] 4A-4C are schematic diagrams illustrating one embodiment of an electronic system. [Diagram 5] 5A-5C are schematic diagrams illustrating one embodiment of an electronic system. [Figure 6] 6A-6C are schematic diagrams illustrating one embodiment of an electronic system. [Figure 7] 7A-7C are schematic diagrams illustrating one embodiment of an electronic system. [Figure 8] 8A-8C are schematic diagrams illustrating one embodiment of an electronic system. [Figure 9] FIG. 1 is a schematic diagram of one embodiment of an electronic system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0092] In the drawings, the same reference numbers may be provided for identical features, features of the same type, or features that act the same or similarly.

[0093] In the following, some concepts are described with reference to an insulin injection device, in which the system described herein can be implemented or used as an accessory module to the device, but the present disclosure is not limited to such applications and can be used equally well for or in injection devices configured to deliver other medicaments, or in drug delivery devices in general, preferably pen-type devices and / or injection devices.

[0094] Provided below are embodiments related to injection devices, particularly variable dose injection devices, that record and / or track data related to the delivered dose. These data can include the size of the selected dose and / or the size of the actual delivered dose, the date and time of administration, the duration of administration, etc. Configurations described herein can include power management techniques (e.g., facilitating small batteries and / or enabling efficient power usage).

[0095] Herein, a specific embodiment is illustrated for an injection device with a combined injection button and grip (dose setting member or dose setter), similar to, for example, Sanofi's ALLSTAR® device. The injection button can provide a user interface member for initiating and / or executing the dose delivery operation of the drug delivery device. The grip or knob can provide a user interface member for initiating and / or executing the dose setting operation. The device can be of the dial extension type, i.e. the length of the device increases during dose setting. Other injection devices with the same kinematic behavior of the dial extension and button during the dose setting and dose ejection operation modes are known, for example, as the Kwikpen® or Savvio® devices sold by Eli Lilly, and the FlexPen®, FlexTouch® or Novopen® devices sold by Novo Nordisk. It is therefore considered straightforward to apply the general principles to these devices and further description will be omitted. However, the general principles of the present disclosure are not limited to their kinematic behavior. Certain other embodiments are envisaged for application to injection devices provided with separate injection buttons and grip components / dose setting members, for example Sanofi's SoloSTAR®. The present disclosure therefore also relates to a system having two separate user interface members, one for the dose setting operation and one for the dose delivery operation. To switch between the dose setting and dose delivery configurations of the device, the user interface member for dose delivery can be moved relative to the user interface member for dose setting. If one user interface member is provided, this user interface member can be moved distally relative to the housing. In the course of each movement, a clutch between the two members of the dose setting and drive mechanisms of the device changes its state, for example from an engaged state to a released state, or vice versa.A clutch, for example formed by sets of interlocking teeth on the two members, can lock the two members against rotation relative to each other when engaged, and can allow one of the members to rotate relative to the other of the two members when disengaged or released. One of the members can be a drive member or drive sleeve that engages with a piston rod of the dose setting and drive mechanism. The drive sleeve can be designed to rotate relative to the housing during dose setting and can be locked against rotation relative to the housing during dose delivery. The engagement between the drive sleeve and the piston rod can be a threaded engagement. Thus, since the drive sleeve cannot rotate during dose delivery, an axial movement of the drive sleeve relative to the housing causes the piston rod to rotate. This rotation can be translated into an axial displacement of the piston rod by the threaded connection between the piston rod and the housing during the delivery operation.

[0096] The injection device 1 of FIG. 1 is an injection pen, which includes a housing 10 and houses a container 14, e.g. an insulin container, or a receptacle for such a container. The container can contain a drug, e.g. insulin. The container can be a cartridge or a receptacle for a cartridge, which can house or be configured to receive a cartridge. A needle 15 is attached to the container or receptacle. The container can be a cartridge, and the receptacle can be a cartridge holder. The needle is protected by an inner needle cap 16, which is further protected by either an outer needle cap 17 or another cap 18. The insulin dose to be expelled from the injection device 1 can be set, programmed, or "dialed" by turning the dose knob 12, and the currently programmed or set dose is then displayed, e.g., in multiples of units, via the dose window 13. The units can be determined only in integer multiples of one unit set increments that can define one dose increment, by a dose setting mechanism that can allow relative rotation of the knob 12 with respect to the housing 10. This can be achieved, for example, by a suitable ratchet system. The markings displayed in the window can be provided on the number sleeve or on the dial sleeve 70. For example, if the injection device 1 is configured to administer human insulin, the dosage can be displayed in so-called international units (IU), 1 IU being bioequivalent to approximately 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. In injection devices for delivering analog insulin or other drugs, other units can also be used. It is noted that the selected dose can be displayed equally well in a manner different from that shown in the dosage window 13 of FIG. 1.

[0097] The dose window 13 may be in the form of an aperture in the housing 10 or a transparent separate component inserted into an aperture in the housing, which may incorporate a magnifying lens. The dose window 13 allows the user to view a restricted portion of the dial sleeve 70 that is configured to move as the dose knob 12 is turned to provide a visual indication of the currently programmed dose. The dose knob 12 is rotated on a helical path relative to the housing 10 as it is turned during programming.

[0098] In this example, the dose knob 12 includes one or more formations 71a, 71b, 71c to facilitate attachment of a data collection device or electronic system. The electronic system, which may be attachable to a user interface member (knob 12 and / or button 11), or generally to an element or member of the dose setting and drive mechanism of the drug delivery device 1, is described in more detail below. The electronic system may for example be provided within the user interface member. The electronic system, which is described in more detail below, may also be configured as an accessory for a drug delivery device unit, for example the unit shown in FIG. 1. In this case, the electronic system is preferably configured to be used with multiple drug delivery device units. Each drug delivery device unit is preferably disposable.

[0099] The injection device 1 can be configured such that turning the dose knob 12 produces a mechanical click sound to provide acoustic feedback to the user. In this embodiment, the dose knob or dose button 12 also acts as the injection button 11. When the needle 15 is inserted into the patient's skin area and then the dose knob 12 / injection button 11 is pressed axially, the insulin dose displayed in the display or dose window 13 is expelled from the injection device 1. When the needle 15 of the injection device 1 remains in the skin area for a period of time after the dose knob 12 is pushed back, the dose has been injected into the patient's body. The expulsion of the insulin dose can also produce a mechanical click sound, but this sound is different from the sound produced when the dose knob 12 is rotated during the dialing of the dose.

[0100] In this embodiment, during delivery of the insulin dose, the dose knob 12 is returned to its initial position by axial movement rather than rotation, and the dial or number sleeve 70 rotates back to its initial position, e.g., to display a dose of zero units. As previously mentioned, the present disclosure is not limited to insulin, but should encompass all drugs within the drug container 14, particularly liquid drugs or drug formulations.

[0101] The injection device 1 can be used for several injection processes until the insulin container 14 is empty or until the expiry date of the drug in the injection device 1 is reached (eg, 28 days after first use).

[0102] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" to ensure that fluid is flowing correctly from the insulin container 14 and needle 15, e.g. by selecting 2 units of insulin and depressing the dose knob 12 while holding the injection device 1 with the needle 15 pointing up. For ease of presentation, it is assumed below that the expelled amount substantially corresponds to the injected dose, thus e.g. the amount of drug expelled from the injection device 1 is equal to the dose received by the user.

[0103] As explained above, the dose knob 12 also functions as the injection button 11, so that the same component is used for dialing / setting the dose and dispensing / delivering the dose. Again, it is noted that a configuration with two different user interface members, which are preferably only in a limited way movable relative to each other, is also possible. However, in the following discussion, attention is focused on a single user interface member providing dose setting and dose delivery functions. In other words, the setting surface of the member touched by the user for the dose setting operation and the dose delivery surface touched by the user for the dose delivery operation are immovably connected. Alternatively, if different user interface members are used, they can be movable relative to each other. During the respective operations, the user interface members are preferably moved relative to the body or housing of the device. During dose setting, the user interface members move proximally and / or rotate relative to the housing. During dose delivery, the user interface members move axially, e.g. distally, and preferably do not rotate relative to the housing or body.

[0104] Below, a general setup for an electronic system for a drug delivery device is disclosed.

[0105] FIG. 2 shows a schematic arrangement of elements of an electronic system 1000 that can be used within or for a drug delivery device, such as the device or device unit 1 discussed further above, or within or for a different device.

[0106] The electronic system 1000 includes an electronic control unit 1100. The control unit may include a processor, for example a microcontroller or an ASIC. The control unit 1100 may also include one or more memory units, such as a program memory and / or a main memory. The program memory may be designed to store a program code that, when executed by the system, controls the operation of the system and / or the electronic control unit. The control unit 1100 is preferably designed to control the operation of the electronic system 1000. The control unit 1100 may communicate with further units of the electronic system 1000 via a wired or wireless interface. The control unit 1100 may transmit signals containing commands and / or data to the respective units and / or may receive signals and / or data from the respective units. The connections between these units and the electronic control unit 1100 are shown by lines in FIG. 2. However, there may also be connections between the units, which are not explicitly shown. The control unit 1100 may be arranged on a conductor carrier, for example a (printed) circuit board (see FIG. 3, reference 3000). Other units of the electronic system may include one or more components similarly disposed on the conductor carrier, or possibly disposed on additional conductor carriers.

[0107] The electronic system 1000 further includes an electrical motion sensing unit 1200. The motion sensing unit 1200 may include one sensor, e.g. only one sensor, or multiple sensors. The motion sensing unit is preferably designed to generate a motion signal, such as an electrical signal, indicative of a movement of one member of the electronic system or drug delivery device relative to another member, e.g. a movement of a dial sleeve or number sleeve relative to a drive sleeve or button / knob in the devices further discussed above, and the sensor may be fixedly connected to one of the members, e.g. a knob or button. The relative movement preferably occurs during a dose delivery operation. Each sensor may be an optoelectronic sensor. The optoelectronic sensor may sense radiation that strikes the sensor from a member moving relative to the sensor to excite a sensor signal or motion signal in the sensor, e.g. an optical encoder component. The radiation may be radiation that strikes the member from a photoelectron radiation source, e.g. a radiation source such as an LED, reflected by the member. The radiation source may be an IR source (IR-LED, infrared light emitting diode). The radiation source may be part of a sensor arrangement that includes at least one sensor. One possible embodiment of the sensor is an IR sensor configured to detect infrared light. The light source and the sensor can be located on the same component or member. The general features of an optoelectronic sensor arrangement suitable for the electronic system discussed herein are disclosed in WO2019 / 101962A1, the entire disclosure of which is expressly incorporated herein by reference for all purposes, in particular with respect to different sensor arrangements and configurations. However, it should be noted that other sensor arrangements, such as arrangements using magnetic sensors, can be used as well. Power consumption can be particularly high in motion sensing units having electrically powered sensors and / or electrically powered sources for stimulating the sensors, such as radiation emitters and associated sensors, and therefore appropriate power management of the power available to power the system can be particularly impactful.The motion sensing unit 1200 can be designed to detect, and preferably measure or quantify, the relative motion of a dose setting and driving mechanism of a drug delivery device or one member of a dose setting and driving mechanism for a drug delivery device with respect to another member of the dose setting and driving mechanism or the housing 10 during a dose delivery operation. For example, the motion sensing unit can measure or detect the relative rotational motion of two movable members of the dose setting and driving mechanism with respect to each other. Based on the motion data received or calculated from the signal of the unit 1200, the electronic system, e.g. a control unit, can calculate dose data, e.g. data related to the currently delivered dose. The motion sensing unit 1200 is preferably configured to quantify the relative motion between a first member and a second member of the electronic system or the drug delivery device. The relative motion can be indicative of the delivered dose. The relative motion can be a relative rotational motion. For example, the first member can rotate with respect to the second member, such as during dose delivery. The motion sensing unit is preferably suitable for quantifying the relative motion in integer multiples of one unit setting increment angle. The unit setting increment can be or can be defined by an angle greater than or equal to one of the following values: 5°, 10°. The unit setting increment can be or can be defined by an angle less than or equal to one of the following values: 25°, 20°. The unit setting increment can be, for example, 5° to 25°. The unit setting increment can correspond, for example, to a relative rotation of 15°. The unit setting increment angle can be the rotation required to set the minimum dose that can be set to be delivered by the device. The increment can be, for example, defined by a ratchet system. As explained above, the amount or distance of relative (rotational) movement between the first and second members determined by the motion sensing unit is specific to the currently set dose in a dose setting operation or the currently dispensed dose in a dose delivery operation.The size of the delivered dose may be determined by or may correspond to the distance that the piston rod of the dose setting and drive mechanism is displaced distally relative to the housing during the dose delivery operation.

[0108] The electronic system 1000 further includes a signal transmission unit 1300. The signal transmission unit may be associated with one or more user interface members (knobs 12 or buttons 11 in the device discussed above). Via the signal transmission unit 1300, manipulation of the members for setting and / or delivering a dose may be detected or indicated. The signal transmission unit is configured to generate an electrical signal indicating that the user interface member, e.g. an external operating surface of its body, is being touched or that a user is in close proximity to this surface. The user interface member may have a setting surface arranged to be touched by a user to perform a dose setting operation and / or a delivery surface arranged to be touched by a user to perform a dose delivery operation. The setting surface may face in a radial direction and the delivery surface may face in an axial direction, e.g. a proximal direction. The signal generation requires a movement of at least a portion of the user interface member, e.g. relative to another portion of the user interface member and / or the housing 10. The signal transmission unit may be part of a user proximity detection unit configured to provide an electrical signal, preferably only when a user touches an external operating surface of the user interface member, e.g. a setting surface for a setting operation and / or a delivery surface for a delivery operation. The user proximity detection unit further comprises an accessible movable member at its outer surface, to which the proximity of the user should be detected and which preferably protrudes from said surface. Examples for the movable member are further described below. The movable member and the signal transmission unit are preferably arranged such that the signal transmission unit can provide a signal only when the movable member is displaced away from an initial position relative to the external operating surface (e.g. protruding from the surface) towards said surface, e.g. towards or into an operating position, i.e. a position which it assumes during an operation performed by manipulation of the interface member via the external operating surface.Preferably, the movable member is arranged such that it must be moved until the user can touch the external operating surface and / or until a signal can be provided by the signal transmission unit. Thus, if an operation of the user interface member is performed without moving the movable member towards or into the operating position, no signal can be generated by the signal transmission unit. In order to generate a signal, the movable member must be in the operating position or the signal can be generated before reaching the operating position. The movable member can remain in the operating position throughout the operation performed by the user to perform an operation, e.g. dose setting or delivery. The embodiment with a movable member is described in more detail below. The element generating the signal or causing the generation of the signal can be an electric sensor or switch, e.g. a microswitch. The signal generated by the signal transmission unit in response to the operation can make it possible to distinguish between different surfaces of the user interface member operated by the user. In this case, multiple switches can be provided, one for the setting surface and one for the delivery surface. The signal sending unit is preferably configured such that the electrical signal that the signal sending unit is configured to generate in response to an operation allows for gathering information regarding which operation is currently being performed or intended to be performed, e.g., a dose setting operation or a dose delivery operation. The signal generated by the signal sending unit 1300 can be a start-up prompt signal or a usage signal. The signal sending unit 1300 is, for example, operably connected to the electronic control unit 1100. The signal provided by the signal sending unit can be received and / or processed by the electronic control unit 1100.

[0109] The electronic system 1000 further includes a communication unit 1400, e.g., an RF, WiFi, and / or Bluetooth unit. The communication unit can be provided as a communication interface between the system or the drug delivery device and external devices, such as other electronic devices, e.g., mobile phones, personal computers, laptops, etc. For example, the communication unit can transmit dose data to the external device and / or synchronize with the device. The dose data can be used for a dose log or dose history established in the external device. The communication unit can be provided for wireless communication.

[0110] The occurrence of a signal generated by the signal transmission unit 1300 allows the electronic control unit 1100 to switch the electronic system 1000 from a first or rest state (e.g. the state of the system when not needed, e.g. a rest state, the rest state being optimized with respect to low power consumption) to a second state of higher power consumption, for example by activating the motion sensing unit 1200 and / or the communication unit 1400. For this purpose, the control unit 1100 can send an activation signal to the respective unit. In the second state, the motion sensing unit and / or the communication unit can become operational. In the first state, the motion sensing unit and / or the communication unit are preferably not operable. In this way, the functionality of the motorized unit can be made available when needed. Advantageously, the power consumption required for the signal transmission unit to become operational in the first state is less than the power consumption when the communication unit and / or the motion sensing unit are operational. The activation prompt or the usage signal can be generated in response to the manipulation of a part of the user interface member, for example a movable member. Actuation may involve only unidirectional movement of the movable member, e.g. distal movement for a dose delivery actuation. Actuation may involve only linear and / or axial movement of the movable member relative to an external operating surface.

[0111] The electronic system 1000 further includes a power source 1500, such as a rechargeable or non-rechargeable battery, which is capable of providing power to each unit of the electronic system.

[0112] In one embodiment, the power consumption, in particular the maximum power consumption, of the electronic system in the first state, e.g. before the generation of a use or wake-up prompt signal, may be less than or equal to one of the values ​​300nA, 250nA, 200nA (nA: nanoamperes). Alternatively or additionally, in the second state of the electronic system, the power consumption, in particular the minimum power consumption, may be greater than or equal to one of the values ​​0.5mA, 0.6mA, 0.8mA (mA: milliamperes). This difference may be due to the power consumption of the motion sensing unit 1200 and / or the communication unit 1400, which are active or operable in the second state of the electronic system 1000 and switched off or to a sleep state in the first state.

[0113] In one embodiment, the power consumption P2, e.g., minimum or maximum power consumption, in the second state may be greater than or equal to at least one of the following values: 2*P1, 3*P1, 4*P1, 5*P1, 10*P1, 20*P1, 30*P1, 40*P1, 50*P1, 100*P1, 500*P1, 1000*P1, 2000*P1, 5000*P1, 10000*P1, where P1 is the power consumption in the first state. In the second state, the motion sensing unit may be active and / or the communication unit may be active, e.g., for wireless communication.

[0114] When the system is in a first state, e.g., when neither the motion sensing unit nor the communication unit is active, the current consumption may be 200 nA. When the motion sensing unit (only) is active, the power consumption may be 0.85 mA. When the motion sensing unit plus the communication unit are active, or when only the communication unit is active, the power consumption may be 1.85 mA.

[0115] Although not explicitly shown, the electronic system preferably includes, for example, a permanent and / or non-volatile storage or memory unit, which is capable of storing data related to the operation of the drug delivery device, such as, for example, dosage (history) data.

[0116] In one embodiment, the electronic control unit 1100 is configured to reduce the power consumption of the respective unit, i.e. to switch the unit back to the first state. This is suitable, for example, if after the unit has been switched from the first state to the second state and / or after a use signal has been generated, no event related to that unit, for example a motion sensing event (motion signal) for the motion sensing unit, has occurred within a predefined time interval. The monitoring of the time interval can be realized by a timer unit operatively connected to the electronic control unit (not explicitly shown). If no signal has been generated by the motion sensing unit within a predefined time interval after a use or activation prompt signal, the whole system can be switched back to the first state. This time interval can be greater than or equal to one of the following values: 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds. Alternatively or additionally, the time interval may be less than or equal to one of the following values: 180 seconds, 150 seconds, 120 seconds, 90 seconds, 80 seconds, 70 seconds, 60 seconds, 50 seconds, 45 seconds, 40 seconds, 35 seconds, 30 seconds. The time interval may be between 5 and 180 seconds, for example 30 seconds or 180 seconds. If no motion signal is generated within the predefined time interval, the entire system may be switched back to the first state. The predefined time interval is preferably constant.

[0117] In one embodiment, the electronic system includes a feedback unit (not explicitly shown). The feedback unit is configured to generate feedback perceptible to a user. The feedback can enable the user to determine whether the system is in a first state or a second state. Preferably, in the first state, no perceptible feedback is provided and / or the feedback indicates the second state. The feedback can be a feedback signal, for example a light signal. The feedback signal can be provided by a light source, such as a light emitting diode. The light source can be operated in a pulsed or flash-like manner to provide the feedback.

[0118] Each of the above-mentioned units may be integrated into a user interface member of an electronic system, which is discussed in further detail below in connection with various embodiments.

[0119] Of course, the electronic system 1000 can include additional electronic units other than those shown, such as other sensing units that sense or detect quantities or events different from the relative motion detected by the motion sensing unit.

[0120] Below, some more detailed embodiments of the electronic system are described, and it should be noted that the configurations discussed above also apply to these embodiments.

[0121] FIG. 3 shows a schematic representation of an embodiment of the electronic system 1000. The system 1000 includes a user interface member 1600. The user interface member is designed to be operated by a user during a dose setting operation and / or a dose delivery operation. The user interface member 1600 has different external operating surfaces. These operating surfaces can be defined by an external surface accessible from the outside of the housing or body 1605 of the user interface member, preferably when the user interface member is connected to a drug delivery device unit or integrated into a unit or device such as the device discussed in connection with FIG. 1. The user interface member 1600 has a setting surface 1610 arranged to be grasped by a user with two fingers, for example the index finger and thumb, for dose setting. The setting surface is a radially facing surface and defines the extent of the user interface member 1600 to the outside, preferably in the circumferential direction. The user interface member 1600 also has a delivery surface 1620. The delivery surface is positioned to be contacted, e.g., pressed and / or moved distally, by a user for dose delivery. Delivery surface 1620 is an axially oriented surface, e.g., a proximally facing surface. As discussed above, embodiments of the present disclosure can use different user interface members for setup and delivery.

[0122] A number of additional elements or units of an electronic system are housed within the user interface member 1600, e.g., within an internal hollow defined by the user interface member body 1605. In particular, the electronic system includes an electronic control unit 1100. The system also includes a conductor carrier 3000, e.g., a circuit board such as a printed circuit board. Conductors on the conductor carrier can conductively connect the electronic control unit to further electrical or electronic units or members of the system. The carrier can be connected to the user interface member body 1605, e.g., axially and / or non-rotatably fixed relative to the body 1605.

[0123] The electronic system 1000 includes a signal transmission unit 1300. The electronic control unit and / or the signal transmission unit, or at least components thereof, are arranged on a conductor carrier, e.g. mounted on the carrier. In the illustrated embodiment, the signal transmission unit has at least one sensor or switch or a plurality of sensors or switches 1310. In the illustrated embodiment, at least one switch 1310 is associated with the setting surface 1610. Alternatively or additionally, at least one switch 1310 is associated with the delivery surface 1620 (the switches are only shown diagrammatically in this embodiment). Each switch is preferably configured to generate an electrical usage signal or switch signal when (and only when) a user touches the setting surface to perform a dose setting operation (a sensor or switch is preferably associated with the setting surface) or the delivery surface for a dose delivery operation (a sensor or switch is preferably associated with the delivery surface). The signal of the present disclosure can consist of only one signal pulse, e.g. a voltage or current pulse, or only one change in an electrical characteristic, e.g. a voltage or current change, caused by triggering the signal sending unit 1300, e.g. the switch 1310. For a dose setting operation, the user interface member 1600 can be rotated relative to the housing 10. For a dose delivery operation, the user interface member can be moved axially towards the housing to switch the clutch, e.g. from a state in which the dial sleeve and the drive member are locked against rotation for dose setting, to a state in which relative rotation is possible for dose delivery. The user interface member is preferably biased, e.g. by a clutch spring (not shown) and / or relative to the housing 10, to a position that it has for dose setting, which position can be displaced proximally by a clutch switching distance relative to a position for dose delivery. The clutch switching distance (the distance the user interface member must be moved to switch the clutch) is e.g. 1.5 mm or more.

[0124] The electrical signal generated by the signal sending unit, i.e. the use or activation prompt signal, can directly trigger the electronic control unit 1100 to switch the system from the first state to the second state. The movement that triggers the generation of this signal is preferably unidirectional, i.e. only a movement in one direction is required to switch the system to the second state. In this way, complex manipulations of the user interface member 1600 or elements thereof, e.g. the movable members discussed further below, for switching the system to the second state can be avoided.

[0125] The system further includes a motion sensing unit 1200, represented only diagrammatically, which preferably includes one or more photoelectron sensors and / or one or more associated radiation emitters, e.g., IR sensors and IR emitters. The motion sensing unit can be bidirectionally conductively connected to the electronic control unit 1100, as suggested by the double arrow. One direction can be the direction in which an activation signal is transmitted from the electronic control unit to the motion sensing unit. In the other direction, a motion signal can be transmitted from the motion sensing unit to the control unit, which can further process the signal, e.g., to calculate dose information or data. The motion sensing unit 1200 can be located on the side of the conductor carrier 3000 facing away from the control unit 1100 or the delivery surface 1620.

[0126] The system 1000 further includes a power source 1500, e.g. a battery such as a coin cell. The power source can be configured to provide a total charge of about 25-500 mAh at a voltage of about 1.4-3 V. This can be achieved or assisted by stacking multiple coin cells, for example. The power source 1500 is conductively connected or connectable to other components of the electronic system that require power for operation. The conductive connection is not explicitly shown in FIG. 3. A metal press can be provided to connect the power source 1500 to the conductor carrier 3000, which can distribute the power to further elements via conductors on the carrier (not explicitly shown). However, the power source can be arranged to extend along one major surface of the conductor carrier 3000 as shown. The power source is arranged between the conductor carrier 3000 and the delivery surface 1620 in the illustrated embodiment. This facilitates the formation of a compact form of the user interface member 1600.

[0127] The radial width or diameter of the user interface member 1600 as viewed from the outside of the member, for example in a top view of the delivery surface, may be less than or equal to one of the following values: 2 cm, 1.5 cm. Alternatively or additionally, the radial width or diameter of the user interface member may be greater than or equal to one of the following values: 0.5 cm, 0.7 cm. The radial extension may be determined relative to the axis of rotation of the user interface member during dose setting or the main longitudinal axis of the user interface member, which may coincide. The length or axial extension of the user interface member 1600 may be less than or equal to one of the following values: 2.5 cm, 2 cm, 1.5 cm. Alternatively or additionally, the length or axial extension of the user interface member 1600 may be greater than or equal to one of the following values: 0.5 cm, 0.7 cm.

[0128] The electronic system 1000 is configured to be connected, preferably releasably connected, to a drug delivery device unit that is an accessory unit or module. The drug delivery device unit may be electronic-free. All electronics and / or all conductive or electrically conductive components may be provided accordingly in the electronic system. The drug delivery device unit may be disposable, i.e., the unit may be discarded after the unit's reservoir has been emptied using a drug delivery device that includes the unit and the system 1000. The electronic system 1000 may also be reused for another drug delivery device unit. The drug delivery device unit is preferably configured as being fully functional on its own, i.e., operable for setting a dose to be delivered and for delivering the set dose. One exemplary unit is the unit shown in FIG. 1. The electronic system may be a pure accessory to an otherwise fully functional unit. Alternatively, the drug delivery device may include the electronic system as an integral part, i.e., a part that is discarded with the rest of the device and / or a part that is necessary to be able to operate the device to set and deliver a dose of drug. For example, without the electronic system, the drug delivery device unit lacks a user-accessible surface for performing dose setting or dose delivery operations. For connection to the drug delivery device unit, the electronic system 1000 may include one or more connection features 1615, e.g., snap features. Each connection feature may be located within a distal portion of the user interface member 1600, e.g., within the member.

[0129] The system 1000 is preferably configured to be permanently or detachably / releasably mechanically connected to a member of the dose setting and drive mechanism, e.g. a member of the drug delivery device unit, such as the drive sleeve or dose knob and / or injection button of the unit discussed in connection with FIG. 1. The system can be non-rotatably and axially locked to the member of the drug delivery device unit, e.g. via the user interface member body 1605. The member to which the system is connected can be movable relative to the housing 10 during dose setting and / or dose delivery, e.g. rotatably and / or axially movable during setting and e.g. only axially movable during delivery. The member can be engaged, e.g. threadedly engaged, to the piston rod. The dose knob and drive sleeve of the unit of FIG. 1 can be integrally formed or can act as a single member during dose setting and dose delivery. During dose setting, the drive sleeve can be selectively non-rotatably locked to the dial sleeve of the dose setting and drive mechanism, such that during dose setting, e.g. by a clutch, the dial sleeve and the drive sleeve rotate at the same speed, and during dose delivery, the dial sleeve rotates relative to the drive sleeve. The dial sleeve can be a number sleeve. The relative rotation between the dial sleeve and the drive sleeve during dose delivery can be measured by a motion sensing unit. However, it will be readily apparent to one skilled in the art that the disclosed concepts also function as dose setting and drive mechanisms having different operating methods and / or different configurations.

[0130] The following embodiments show implementations of a user proximity detection unit including a signal transmission unit 1300 and a movable member 1670. In each case, the signal transmission unit 1300 is configured to provide or generate a signal, for example a use signal or a wake-up prompt signal. These embodiments rely on moving the movable member relative to the external operating surface, in particular the delivery surface, before the operating surface is contacted by the user. The signal can be provided when the movable member is in the operating position or only when the movable member is moved by the user away from an initial position to an operating position relative to the external operating surface. The signal can be generated during the movement of the movable member relative to the external operating surface from the initial position to the operating position, for example by triggering a switch 1310. The switch and / or the signal transmission unit can have a fixed position relative to the external operating surface in this case. Alternatively, the movable member in the operating position can be moved together with the external operating surface, for example by triggering a switch, to trigger signal generation. In this case, the relative position between the signal transmission unit and the external operating surface can be variable, preferably within specified limits. The system is preferably configured such that a signal is generated before the dose setting and drive mechanism is switched from the dose setting configuration to the dose delivery configuration, i.e. before the clutch is released. The user proximity detection unit discussed in the following embodiments uses the delivery surface as the external operating surface. However, it should be understood that a corresponding structure may also be implemented for the setting surface.

[0131] 4A-4C show an embodiment of an electronic system utilizing such a user proximity detection unit with a movable member 1670. FIG. 4A shows a schematic cross-sectional view of a proximal section of an electronic system 1000 of or for a drug delivery device 1 with a user interface member 1600. In the illustrated embodiment, the movable member 1670 protrudes proximally from a delivery surface 1620 of the user interface member 1600 through an opening in the user interface member body 1605 in the initial position shown in FIG. 4A. The delivery surface is formed by the user interface member body 1605. As described, the delivery surface 1620 is merely an example of an external operating surface, and the proposed concept should also function with the setting surface as an external operating surface. Thus, the reference to a delivery surface should not be construed as limiting. However, if the electronic system 1000 is designed to operate during a dose delivery operation, it is preferable to wake up the system by monitoring or ensuring the proximity of a user to the delivery surface, since the surface must be touched for the delivery operation. Having to move the movable member 1670 before the surface is touched ensures that the requirements for signal generation and accordingly waking up the system by switching it to a second state are met before or when the user touches the surface, preferably before the external operating surface is moved relative to the housing 10 or another component of the device. The movable member 1670 extends from the interior to the exterior of the user interface member body 1605 through an opening in the user interface member body. In FIG. 4A, the protruding portion 1672 rises from the delivery surface or the envelope surface of the user interface member body defined by the outer contour of the delivery surface. Thus, the contact surface 1675 of the movable member 1670 is higher than the delivery surface.

[0132] When the delivery surface 1620 is viewed from a top view, the contact surface area provided by the movable member 1670 (e.g., proximal surface of the protruding portion) is smaller than the surface area of ​​the delivery surface 1620. In other words, the movable member can occupy a surface area smaller than the surface area formed by the delivery surface 1620 of the user interface member 1600. The area of ​​the delivery surface is preferably equal to or greater than the total contact surface area CA formed or defined by the movable member 1670. The area of ​​the delivery surface 1620 can be greater than or equal to one of 3 CA, 5 CA, 7 CA, 10 CA, 15 CA, 20 CA, 30 CA, 40 CA, 50 CA, 75 CA, 100 CA, 200 CA. The total surface area takes into account that there may be more than one protruding portion of the movable member accessible at the delivery surface, and the total contact surface area includes the sum of all the contact surface areas of the portions of the movable member accessible at the delivery surface. A corresponding relationship is also valid for the total opening area of ​​this area included in the openings through which the movable member can communicate with the interior of the user interface member body. If one movable member is provided with a delivery surface that is planar and has a circular shape with a diameter of 15 mm and has a planar circular contact surface with a diameter of 1 mm, and the movable member projects through the delivery surface through an opening of the same diameter as the movable member, the delivery surface is 224 times the total contact surface area, i.e. the area included in the movable member. It will be appreciated that other configurations are possible depending on the number of contact surfaces available.

[0133] In a first or initial position shown in FIG. 4A, the movable member 1670 protrudes from the external operating surface 1620. The initial position is the position the movable member has relative to the delivery surface before it is displaced by the user. In the initial position, the movable member 1670 can protrude from the delivery surface 1620 by a distance greater than or equal to one of the following values: 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm. In the first position, the movable member 1670 can protrude from the delivery surface by a distance less than or equal to one of the following values: 2 mm, 1.5 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm.

[0134] The movable member 1670 is movable from an initial position in a distal direction (downward in FIG. 4A ) relative to the delivery surface 1620 of the user interface member 1600 toward a second or operating position (see FIGS. 4B and 4C ). In the operating position, the portion of the movable member that protrudes from the delivery surface 1620 to the initial position (which is the portion that provides the user contact surface 1675) is preferably flush with the delivery surface (i.e., axially aligned) or recessed or less than flush with respect to an envelope surface of the user interface member body defined by the delivery surface 1620 and / or the area of ​​the body 1605 adjacent the opening through which the portion of the movable member protrudes. If multiple portions protrude through an opening, all of the portions can be recessed or less than flush with respect to the adjacent area of ​​the delivery surface. The less than flush position of a portion of the movable member in the operating position can be achieved by dimensioning the opening such that the elasticity of the user's skin on the user's finger pressing down on the movable member is sufficient to move that portion of the movable member below the delivery surface while maintaining contact with the delivery surface to exert a force on that surface, e.g., to drive a dose delivery operation. Thus, in the operating position, the contact surface 1675 can be offset distally from the delivery surface. This is not explicitly shown in Figs. 4B and 4C, which show a flush position. However, a less than flush position can nevertheless be achieved. In the second or operating position, the proximal end of the movable member 1670 and / or its contact surface 1675 can be offset distally from the delivery surface and / or away from the initial position by a distance greater than 0 mm, e.g., greater than 0.05 mm, and less than or equal to one of the following values: 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm.

[0135] In the illustrated embodiment, the movable member 1670 is generally pin-shaped. The movable member also has one or more radially protruding features 1671 arranged to abut features on the user interface member body, thereby preventing the movable member from being removed from the user interface member body. However, it should be noted that other configurations are possible. Also, the movable member 1670 protrudes from the delivery surface 1620 in only one location in the illustrated embodiment. It should be noted that the movable member can also protrude from the delivery surface in multiple, preferably different and / or separate locations. The movable member 1670 is preferably constructed and arranged such that a user contacts the movable member before the user contacts the delivery surface. The system is configured such that the user must move the movable member distally away from the first position until the user can contact the delivery surface. The system is further configured such that a switch 1310 carried within the user interface member body, e.g. fixed relative to its body 1605, is triggered by movement of the movable member from an initial position to an operating position to provide an activation signal to the electronic control unit, e.g. preferably the system causes the electronic control unit to power up the motion sensing unit. The sensor or switch 1310 is shown diagrammatically in Figure 4A. The switch 1310 may be a momentary switch, e.g. an axial microswitch. In the position of Figure 4B the switch is triggered.

[0136] The system 1000 is configured such that the movable member 1670 is biased towards the first position. That is, when the movable member 1670 is in the second position, the bias tends to move the member towards the first position, which is therefore the standard position when no force is applied. For this purpose, a biasing member 1680 is provided, in the illustrated embodiment a spring, for example a helical compression spring. During the movement of the movable member away from the initial position, the biasing can be increased or the member can be loaded. The force exerted on the biasing member 1680 via the movable member can be reacted by the inner surface of the user interface member body 1605. The force required to move the movable member from the initial position to the operating position relative to the external operating surface is preferably smaller than the force required to axially move the user interface member or delivery surface for the dose delivery operation. This makes it easier to move the movable member to the operating position before the user interface member is moved. In the operating position, it is preferably possible to further move the movable member away from the initial position, i.e., distally. The system does not include a distal end stop for the movable member, and the biasing member 1680 may be further biased or compressed in the operating position. However, such (distal) movement of the movable member in the operating position does not occur because the user's skin will only deflect or deform to a certain extent depending on the size and shape of the opening through which the movable member protrudes. The size of the opening limits the distance the user's skin can protrude into the opening.

[0137] In this embodiment, the user interface member 1600 / electronic system 1000 is shown attached to a drug delivery device unit or integrated in the drug delivery device. The drug delivery device (unit) is shown by an element that can be the housing 10 or member 1710 of the dose setting and drive mechanism of the device (unit). However, it should be understood that the representation in FIG. 4 is rather schematic and the user interface member body can also be provided as an attachment to the drug delivery device unit by a connection feature for a releasable connection. The connection between the drive mechanism and the user interface member is not explicitly shown here since the nature of the connection is not important for the general operation of the system described herein. However, the connection is configured to transmit a dose setting force or torque or a delivery force or torque from the respective operating surface to the member 1710.

[0138] The electronic system 1000 is preferably configured such that a use signal is generated and / or the system is switched to a second state before movement of the members of the dose setting and drive mechanisms relative to one another occurs, which movement is required to perform a dose delivery operation causing distal movement of the piston rod to drive the dosing operation to dispense medicament from the container. The movement required for the dose delivery operation may for example be a relative rotational movement between the dial sleeve and drive sleeve of the device as discussed further above.

[0139] The use signal can be generated before the user interface member body is moved at all through the delivery surface. For example, the use signal can be generated before the user interface member 1600 is moved relative to the housing 10 or member 1710 to initiate a dose delivery operation. Alternatively, the use signal can be generated after the movement of the user interface member relative to the housing 10 or member 1710 is initiated, e.g. after a distal movement, but before a clutch interface that couples, e.g. locks non-rotatably, two members of the dose setting and drive mechanism to each other during a dose setting operation is released for the dose delivery operation. The clutch interface can be formed between at least one member of the dose setting and drive mechanism that is arranged in a force transmission chain from the delivery surface to the piston rod of the dose setting and drive mechanism, and another component, e.g. the housing 10 or another member of the dose setting and drive mechanism. In FIG. 4A, the clutch interface can be established. The user interface member is moved a distance d relative to the housing 10 or member 1710 to switch the clutch interface from the situation shown in FIG. 4A, e.g. from an established state to a released state. c4A. A clutch biasing member 1690, e.g. a spring such as a helical compression spring, is provided which tends to maintain the clutch interface in one state, e.g. an engaged state or a disengaged state. In the illustrated embodiment, the two members connected by the clutch interface are represented by a drive mechanism member 1700 of the drug delivery device, e.g. a drive sleeve, and a member 1710, e.g. a number sleeve or dial sleeve (a member having markings such as numbers indicating the currently set dose). The member 1700 is shown as an integral part of the user interface member. This illustrates the situation where an electronic system is integrated into the device. However, it should be noted that the user interface member can also be connected to the member 1700 and can be, e.g. axially and non-rotatably locked relative to that member. This also applies to an electronic system provided as an accessory, e.g. for manufacturing reasons, or a system integrated into the device. In the position shown in FIG. 4A, the members 1700 and 1710 can be non-rotatably locked to each other. The d of the member 1700 relative to the other member 1710 can be easily adjusted. c Axial movement of the member 1710 may release the rotational lock, thus allowing rotational movement of the member 1710 relative to a housing (not shown, but which in this case may laterally surround the member 1710), further members of the dose setting and drive mechanism, and / or the user interface member 1600.

[0140] In the illustrated embodiment, the force exerted by the user on the movable member 1670 is transferred to the drive mechanism member 1700 and / or the clutch biasing member 1690 even before the user touches the delivery surface 1620. As a result, there is a risk that the drive mechanism member 1700 is significantly moved by the movement of the movable member, which is preferably performed only for the purpose of user proximity detection. To reduce the risk of too much movement of the drive mechanism member 1700, for example in the distal direction, the clutch biasing member 1690 and the biasing member 1680 can be adjusted relative to each other such that the clutch biasing member 1690 has a spring strength or spring force greater than the biasing member 1680. The clutch biasing member 1690 can be designed such that when compressed, for example when the clutch switches state, the force is greater than 1 N, for example in the range of 1 N to 3 N. The force to move or hold the movable member in the operating position can be smaller, for example 0.5 N.

[0141] By appropriately configuring the system, the distance d between the two members 1700 and 1710 can be c It can be ensured that the switch 1310 is triggered / the engage signal is generated before any movement occurs. Thus, the engage signal can be generated when the two members have already begun to move relative to one another, but not quite the distance required to release the clutch engagement.

[0142] The system is preferably designed such that the minimum force that must be applied to the delivery surface to perform a dose delivery operation is greater than the force that must be applied to the moveable member to trigger a use signal.

[0143] 4A-4C illustrate the operation of the system described in relation to FIG. 4A by showing different stages of operation. In FIG. 4A, the system is in a configuration in which a dose delivery operation can be initiated, e.g. a dose has been set in a previous dose setting operation. In the case of a dial extension type device, the user interface member 1600 has been displaced proximally relative to the housing (not shown) by a distance proportional to the size of the set dose. In a non-dial extension type device, the user interface member can be in the same axial position relative to the housing 10 as in the previous stage when the dose setting operation was initiated. Thus, in FIG. 4A, the system / device is in a state before the user intends to perform a delivery operation. When the user intends to initiate a dose delivery operation, the user must displace the user interface member 1600 (at least a distance d c The user approaches the delivery surface 1620 to move the movable member 1670 (only one position) relative to the delivery surface 1620. Before this movement is performed, the user reaches the movable member 1670, touches the contact surface 1675, and moves the movable member from a first or initial position relative to the delivery surface 1620 to a second or operating position, the operating position being shown in FIG. 4B. While the movable member is being displaced, there is no movement or at least significant movement of the user interface member relative to the housing 10 or another component 1710 of the dose setting and drive mechanism. The dose setting and drive mechanism is still in the dose setting configuration. While moving the movable member 1670 towards or into the operating position, a use signal is generated, as indicated by the closed sensor or switch symbol 1310. Also, the biasing member 1680 is biased, tending to move the movable member proximally or towards the initial position. The portion of the movable member contacted by the user may be flush or less than flush with the delivery surface, so that at least a majority of the user's force for the delivery operation is exerted on and reacted by the delivery surface (thereby reducing the risk of damaging electronics in the system). When the movable member is moved to the operating position, the user may initiate a delivery operation by touching the delivery surface and moving the movable member and user interface member distally to switch the mechanism to a dose delivery configuration. This movement is performed over a distance dc 4C with the release of the clutch engagement shown in FIG. 4C by the movement of the user interface member body and the movable member to 10, 1710 only occurred. The clutch biasing member 1690 is compressed during this movement. From the situation in FIG. 4C, a dose delivery operation can be performed by transmitting the user's force from the user interface member (body) to the piston rod (not explicitly shown) via the dose setting and drive mechanism. When the user releases the user interface member 1600, particularly its delivery surface, for example after completing a delivery operation for the set dose, the movable member 1670 is returned proximally by the biasing member 1680 towards its initial position relative to the delivery surface and protrudes proximally from the delivery surface 1620 again as shown in FIG. 4A. Also, the clutch biasing member 1690 relaxes, re-establishing the clutch interface and the system / device is once again in the situation in FIG. 4A. The electronic system can then be powered off and is ready to wake up again for the next delivery operation via the signal sending unit (switch 1310).

[0144] Figures 5A-5C show another embodiment of the electronic system. This system is very similar to the system discussed above in relation to Figures 4A-4C. The following discussion will therefore focus on the differences. The representation in Figure 5A corresponds to the representation in Figure 4A, where the movable member 1670 is in a first or initial position relative to the user interface member 1600 and its delivery surface 1620. Figure 5B shows a situation where the movable member has been moved to a second or operating position, but the dose setting and drive mechanism is still in the dose setting configuration. Figure 5C shows a situation where the mechanism has been switched to the dose delivery configuration.

[0145] 5A-5C, the system is configured such that the mechanism member 1700 and the movable member 1670 are decoupled from one another, such that movement of the movable member 1670 from an initial position to an operating position relative to the delivery surface 1620, or forces for that movement, is not transmitted or transmissible from the movable member to the drive mechanism member 1700. To this end, relative movement, e.g., axial movement, between the user interface member body 1605 and the mechanism member 1700 may be permitted, for example, by an opening in the user interface member body through which the mechanism member 1700 protrudes. A biasing member 1680 may surround the member 1700 or may be supported on an edge of the body 1605 that bounds the opening.

[0146] Starting from the initial position in FIG. 5A, first the movable member 1670 is moved from the initial position relative to the delivery surface 1620 to the operating position shown in FIG. 5B. During this movement, a use signal is generated as discussed above and the system can be switched to a state with higher power consumption by the electronic control unit, which in this embodiment, similar to FIGS. 4A-4C, is not explicitly shown. In the operating position, the movable member 1670 can be operatively connected to the mechanism member 1700, for example via abutment. Further movement of the user interface member 1600 to switch the dose setting and drive mechanism to a dose delivery configuration can involve relative movement between the user interface member body 1605 and the movable member, for example in the distal direction, such that the movable member again protrudes from the delivery surface 1620. During this relative movement, the switch 1310 is moved relative to the movable member 1670 such that the switch 1310 can again change its state, for example from a closed state to an open state, thereby reducing the power consumption of the system. From the situation shown in Fig. 5C where the movable member 1670 again protrudes proximally from the delivery surface 1620, a dose delivery operation can be performed when a force is applied in the distal direction. The movable member again protrudes from the delivery surface in the dose delivery configuration of the dose setting and drive mechanism. This provides tactile feedback to the user that they have successfully switched the system or mechanism to the dose delivery configuration. After the movable member and / or user interface member are released by the user, for example due to relaxation of the biasing member as described above, the original situation between the members of the system shown in Fig. 5A can be re-established.

[0147] It should be noted that instead of using the mechanical member 1700 to abut the movable member 1670 as shown in FIG. 5B, an axial stop axially fixed to the housing 10 or to the member 1710 can be used to limit the movement of the movable member during switching to the dose delivery configuration, achieving the same effect as having the movable member protrude from the delivery surface again in the dose delivery configuration.

[0148] This embodiment therefore provides a system in which the movable member is moved to an operating position relative to the delivery surface to generate a signal, and when the user interface member body is moved to switch the dose setting and drive mechanism from the dose setting configuration to the dose delivery configuration, the user interface member body moves distally relative to the movable member and thus takes up its initial position relative to the delivery surface. As described, this provides feedback to the user regarding the state of the system and may also reduce power consumption of the signal sending unit / switch 1310.

[0149] Figures 6A-6C show another embodiment of an electronic system, which is very similar to the system discussed above in relation to Figures 4A-5C, and therefore the following discussion will focus on the differences.

[0150] In FIG. 6A, the user interface member 1600 is shown in a perspective view of the delivery surface 1620. FIG. 6A shows the movable member 1670 in its initial position raised from the delivery surface 1620. In this embodiment, the movable member 1670 has multiple portions 1672 that protrude from the delivery surface 1620 at different locations on the surface. Each portion protrudes through a dedicated opening in the user interface member body 1605, which opening has a circumferentially closed edge or boundary. Exemplary sections are shown in FIG. 6A as 1670a-1670c. All these sections belong to the same movable member 1670. Specifically, these sections are connected to a common body 1673 provided inside the user interface member body 1605. Accordingly, when a user touches one of the sections and moves this section relative to the delivery surface, the entire movable member is moved towards the delivery surface. Again, this movement can be used to trigger the generation of a usage signal in a signal sending unit, for example, in the switch 1310. The movable member 1670 is preferably rigid, so that it is not elastically deformed when moved from an initial position to an operating position. The delivery surface, or the user interface member body 1605 which forms that surface, is likewise preferably rigid.

[0151] These portions of the movable member are disposed at various locations on the delivery surface 1620. The portions further from the center of the delivery surface 1620 may have a greater extension, particularly in the circumferential or angular direction, than the portions closer to the center. In the illustrated arrangement, the angular or circumferential extension of the portion 1670c is greater than that of the portion 1670b and / or the portion 1670a. The radial extension of each portion may be constant along the angular extension and / or may be equal between sections disposed at different radial positions but the same angular location. The portion 1672a may be disposed at the center of the delivery surface 1620. Several angularly separated rows or lines of the portions 1672b and 1672c start from the central portion 1672a and are oriented radially. Of course, other configurations of the protruding portions 1672 may ensure that the movable member is reliably moved before the user touches the surface.

[0152] The electronic system 1000 or the user interface member 1600 can again be an attachment to the device unit or can be integrated into the device. In this embodiment, the user interface member 1600 or the electronic system 1000 is an attachment for the drug delivery device unit and includes a connection feature 1615 designed to interact with a member of the drug delivery device unit, such as a dose knob or a dose button, to lock the user interface member rigidly, preferably axially and non-rotatably, to a member of the device. The connection feature 1615 can be designed, for example, for a snap-fit ​​connection. The connection can be releasable so that the electronic system can be used with two or more drug delivery devices, or it can be permanent when the system is to be discarded after one use cycle with the device. The connection feature 1615 is shown in FIG. 6B, which shows a schematic cross-sectional view of the electronic system in the same situation as shown in FIG. 6A. The connection feature 1615 is preferably located inside the user interface member body 1605. The user interface member body 1605 is preferably connected to the members of the dose setting and drive mechanism when the system is connected to the members to transmit force or torque to the members.

[0153] The user interface member 1600 or system further includes a user interface member portion 1720. The user interface member portion 1720 is rigidly, preferably non-rotatably and axially connected or fixed to the user interface member body, for example by snap-fit ​​or welding. The user interface member portion may be cup-shaped. The user interface member portion 1720 serves as a carrier for one or more electronic or electrical components in the system. The respective components may be disposed within a space delimited by the outer wall of the portion 1720. As a non-limiting and non-exhaustive example, a conductor carrier 3000 and a power source 1500 are shown in FIG. 6B, in which an electronic control unit (not shown) is disposed. The respective components may be disposed on the user interface member portion 1720, for example on its proximal surface, and preferably fixed thereto. Electrical interconnections are not shown, but may be provided in the user interface member body if desired. A connection feature 1615 is provided on the user interface member portion 1720 and may protrude distally. The connection feature may be disposed within a cavity defined by the user interface member body.

[0154] As is evident from the cross-sectional view of FIG. 6B, the signal sending unit 1300, in particular the switching mechanism 1310, is associated with the movable member 1670. The switching mechanism can be a switch, such as a force switch. The signal sending unit can be located on a conductor carrier 3010 different from the conductor carrier 3000, for example on a circuit board. The power source can be located between the conductor carriers 3000 and 3010. The conductor carrier 3010 is preferably located closer to the external operating surface than the conductor carrier 3000. Both conductor carriers can be rigid. Each conductor carrier 3000, 3010 can be axially and non-rotatably fixed relative to the user interface member body 1605, for example the portion 1720. The signal sending unit 1300 is preferably conductively connected to the electronic control unit 1100, which can be provided on the conductor carrier 3000.

[0155] When a user moves the movable member 1670 toward the delivery surface 1620, corresponding to a distal movement in the illustrated embodiment, the switch 1310 is triggered. To trigger the switch 1310, mechanical contact is established between the movable member 1670, e.g., a distally directed protrusion thereof, and the switch 1310.

[0156] The shape of the envelope defined by the portions 1672 of the movable member 1670 matches the shape of the envelope of the delivery surface 1620 in this embodiment. The radial extension of each portion 1672 is preferably selected such that when the movable member 1670 is moved relative to the delivery surface 1620, the user's fingers primarily contact the delivery surface and / or such that the primary user load acting on the user interface member is preferably reacted by and transferred to the delivery surface 1620 rather than the movable member 1670. Alternatively or additionally, there is no distal end stop to define an operating position in the system as already described above.

[0157] In the situation where the movable member 1670 is moved distally to the operating position (see FIG. 6C), the switch 1310 is triggered. The movable member may have a switching feature 1674 protruding distally from an inner surface of the body 1673 to interact with the switch 1310. When triggered, the switch provides an usage signal to the electronic control unit 1100 (not shown in this figure) to switch the system to a second state with higher power consumption, as further outlined above. In the operating position, the contact surface 1675 between the movable member and the user (i.e., the proximally facing surface of the portion of the movable member that protrudes or rises from the delivery surface 1620) is recessed relative to the delivery surface 1620, for example by at least 0.1 mm or at least 0.2 mm and / or at most 0.8 mm or at most 0.7 mm, for example 0.5 mm. This helps to place the main load for the delivery operation on the delivery surface and not on the movable member 1670, preferably without end stops. This can be seen in FIG. 6C. Again, the movable member may be biased towards its initial position shown in FIG. 6A, for example by a biasing member which is not explicitly shown in FIG. 6 but may be present.

[0158] Each portion 1672 of the movable member 1670 that protrudes from the delivery surface may be delimited from all other portions of the movable member that protrude from the delivery surface, in other words, the protruding portions are preferably separate on the exterior of the user interface member (body) and connected to the body 1673 preferably on the interior of the user interface member (body).

[0159] The body may have a sealing interface with the inner walls of the user interface member, e.g. the walls of the interface member body 1605 and / or the interface member portion 1720. For this purpose, a sealing member (not shown), e.g. an o-ring, may be provided along the entire periphery of the body 1673. In this way, the compartment inside the user interface member holding the electric or electronic component or unit may be sealed against the outside, e.g. against the ingress of moisture or dirt, despite the movable member being provided through the opening in the delivery surface. It is also expressly noted that in other embodiments discussed herein such a sealing member may also be provided on the movable member, e.g. its body, although it is generally envisaged that the configurations of the different embodiments may be combined with each other, unless mutually exclusive solutions are concerned.

[0160] In this embodiment, the switch 1310 is mounted below the movable member and is preferably fixed axially and / or non-rotatably relative to the user interface member body 1605. The switch 1310 preferably has a very light operating force to ensure that the switch operates before the axial disengagement of the clutch interface for switching the dose setting and drive mechanism from the dose setting configuration to the dose delivery configuration already discussed. A low force micro-switch can be used as the switch 1310. The force required to act on the movable member to trigger the switch can be less than the force that must be overcome to switch the clutch interface, for example, from an established state (clutch function engaged) to a released state (clutch function disengaged) or vice versa. As mentioned above, the force to switch the clutch interface can be 1-3 N. The force to trigger the switch or to displace the movable member can be less, for example 0.5 N.

[0161] In its initial or first position, the movable member 1670 presents a number of contact surfaces 1675 raised from the top surface or delivery surface 1620 of the user interface member body 1605. In its operating or second position, these contact surfaces 1675 are less than flush with the delivery surface or body 1605. Each contact surface 1675 is preferably small enough that after the movable member moves axially to operate the signal sending unit (by triggering the switch 1310), the user's finger, e.g., thumb, then presses only or mainly against the delivery surface and not against the contact surface. This ensures or assists that the main load path from the user's finger to the user interface member and then to the dose setting and drive mechanism does not pass through electronic components, e.g., switches, but instead passes through a rigid body or components held therein designed to transmit the delivery forces required to operate the device to perform the delivery operation.

[0162] Figures 7A-7C show another embodiment of an electronic system that is very similar to the system discussed above in relation to Figures 4A-6C, and therefore the following discussion will focus on the differences.

[0163] FIG. 7A shows a perspective view of the delivery surface 1620 of the user interface member 1600. Again, as in the previous embodiment, a movable member 1670 is provided. In particular, at least one portion 1672 thereof (only one portion in the illustrated embodiment, but multiple portions are possible) protrudes through an opening in the delivery surface 1620 to provide a contact surface 1675 or pad for contact by the user. The contact surface 1675 in the initial position (FIGS. 7A and 7B) is elevated and / or proximally offset from the delivery surface 1620. The previous embodiment relies on a rigid movable member 1670. In contrast, this embodiment utilizes a deformable, in particular elastically deformable, movable member 1670. In this embodiment, the movable member 1670 may be elastomeric. The movable member may be deformed or bent to contact the switch 1310 before or as it is flush or less than flush with the delivery surface 1620 to be in the operating position (see FIG. 7C). Thus, when a user contacts the delivery surface, the movable member is in an active position and an engagement signal is provided by a signal sending unit 1300 that includes a switch 1310 .

[0164] The movable member 1670 is preferably an elastically deformable member. Thus, the member can be elastically deformed and when deformed, tends to recover its undeformed shape due to an elastic recovery force. Accordingly, when an elastically deformable movable member 1670 is used, a separate biasing member (see biasing member 1680, discussed further above) can be omitted and the elastic recovery force can be used to establish the initial position of the movable member. For example, the member 1670 is a single piece. In other words, all parts can be of the same material.

[0165] As is evident from the cross-sectional view of FIG. 7B, the movable member 1670 has a protruding contact portion 1676 that can form a contact surface 1675. The contact portion 1676 preferably has a greater stiffness and / or thickness along an axial direction in an initial position than one or more other portions of the member 1670, e.g., one or more internal portions within the user interface member body. The axial direction can be a direction that separates the initial and operative positions of the movable member, e.g., in a distal direction. One or more elastically deformable portions 1677 of the movable member are connected, e.g., adjacently, e.g., radially adjacent, to the contact portion 1676. The deformable portions 1677 can always be located inside the user interface member body 1605, i.e., in the operative and initial positions of the movable member or its contact surface 1675. When the movable member is moved towards the operative position, the deformable portions can bend and deform to a greater extent than the contact portion 1676. The contact portion 1676 is arranged by its inner or distal surface to cooperate with a switch 1310, which is preferably arranged on a conductor carrier 3000 fixed axially relative to the delivery surface 1620. Other arrangements for the signal sending unit are possible, for example as in Figs. 6A-6C. Thus, the contact portion 1676 can trigger the switch 1310 when the member 1670 is displaced towards the operating position shown in Fig. 7C to provide a signal. The force required to elastically deform the movable member 1670 and move the member 1670 to the operating position is preferably less than the force required to switch the mechanism from the dose setting configuration to the dose delivery configuration.

[0166] The use of an elastomeric member, for example of rubber or similar material, for the movable member provides the possibility of using the movable member to tightly seal and establish a seal with electronic components within a system. For this purpose, the movable member 1670 can be sealingly engaged with one or more internal surfaces of the user interface member (body). The sealing engagement can be reinforced by a mechanical force that maintains a contact area between the internal surface and the movable member under the effect of a compressive force to maintain a tight seal. The seal can protect internal components, such as electronic components, from the ingress of water and dirt. In the illustrated embodiment, the movable member includes a sealing portion 1678. The sealing portion 1678 is preferably an edge of the movable member that delimits the movable member 1670 laterally or radially. The sealing portion 1678 is preferably a radial end of the movable member. In the illustrated embodiment, the sealing portion 1678 extends circumferentially around the movable member. The deformable portion 1677 can extend circumferentially around the contact portion 1676. The sealing portion 1678 is connected to the contact portion 1676 via a deformable portion 1677. The sealing portion 1678 is preferably clamped between two members 1601 and 1602 of the user interface member (main body). The members 1601 and 1602 can maintain the sealing portion 1678 in a deformed or clamped state when the movable member is assembled to the user interface member body. The members 1601 and 1602 can be connected to each other, for example, via a thread as suggested in Figures 7B and 7C. Both members can belong to the user interface member body. In this case, both members can form at least a part of the outer surface of the user interface member. In this embodiment, the member 1601 forms the delivery surface 1620 (possibly part of the setting surface 1610) and the member 1602 forms the setting surface 1610 (at least a part of it). Alternatively, one member can be an internal member of the user interface member, or both members can be internal members. Thus, the interior section of the user interface member 1600 located on the side of the moveable member away from the delivery surface 1620 is sealed against the delivery surface.Again, the opening in the delivery surface 1620 through which the movable member protrudes is preferably configured to be small enough that at least a majority of the force applied by the user during a dose delivery operation is reacted by the delivery surface and not by the movable member, thereby protecting the internal components of the user interface member from higher loads.

[0167] In this embodiment, the contact surface 1675, preferably a small surface, is raised from the delivery surface in the initial position. The contact surface is preferably designed to be displaced again with a small force and to operate the switch 1310, e.g. a micro-switch. When fully deflected, the movable member is designed to be less than flush with the delivery surface 1620 of the user interface member body. The flexible surface area is preferably small enough that a user's finger, e.g. the user's thumb, will hit the surrounding rigid delivery surface after the movable member is deflected to be less than flush with respect to that surface. The contact area is preferably small enough that after deflection, the user then presses only or at least mainly against the delivery surface of the user interface member body and not against the contact surface of the movable member. This ensures that the main load path generated by the user during delivery does not pass through the electronics, e.g. the switch, but instead passes through the rigid body to the dose setting and drive mechanism of the device. The elastomeric movable member further provides an opportunity to form a sealed assembly and protect the electronic component and its surroundings, e.g., printed circuit boards or conductors, from ingress of water and / or dirt, etc., without the need for a separate sealing member, such as an o-ring.

[0168] Figures 8A-8C show another embodiment of an electronic system 1000. This system is very similar to the system discussed above in connection with Figures 4A-7C, and therefore the following discussion will focus on the differences.

[0169] 8A shows a perspective view of the delivery surface 1620. The movable member 1670 includes multiple protruding portions (eight portions in the illustrated embodiment) in the initial state shown in FIG. 8A. Portions 1670a and 1670b are highlighted because they are oriented in different directions. Portion 1670a is angularly oriented. Portion 1670b is radially oriented. The radially and angularly oriented portions of the movable member 1670 can alternate in the circumferential or angular directions. It should be understood that the arrangement of the portions of the movable member 1670 that protrude from the delivery surface 1620 can also vary, as can their number.

[0170] Unlike the embodiment discussed above, in this embodiment, a shuttle member 1730 is provided. The shuttle member 1730 is preferably part of the electronic system and is movably connected to the user interface member body 1605 and / or the external operating or delivery surface 1620. The shuttle member 1730 can be permanently held in the user interface member body. For this purpose, a distal movement can be provided that limits the distal end stop of the shuttle member relative to the user interface member body. The shuttle member 1730 is preferably provided to be located in a force transmission path between the external operating surface (delivery surface 1620) and a member of the dose setting and driving mechanism, such as a driving sleeve or an injection button, as further discussed above. If the electronic system is an accessory module for the drug delivery device unit, the shuttle member 1730 can be a member of the electronic system configured to have a connection feature 1615 for connecting the electronic system to the drug delivery device unit. Alternatively, the shuttle member can be a mechanism member, especially if the electronic system is integrated into the drug delivery device. The shuttle member 1730, when operably connected to the dose setting and driving mechanism, is axially, preferably non-rotatably, locked relative to the member of the dose setting and driving mechanism to which it is connected. In particular, as a result of an axial force transmitted from the external operating surface 1620 to the shuttle member 1730, a force can be transmitted to the dose setting and driving mechanism via the shuttle member, in particular for a dose delivery operation. The shuttle member is preferably non-rotatably locked to the user interface member body 1605. In this way, a dial torque can be transmitted from the setting surface 1610 to the mechanism member. The shuttle member can have a continuous distal surface. The interface between the shuttle member 1730 and the inner wall of the user interface member body 1605 is preferably sealed, for example via an o-ring.

[0171] A shuttle biasing member 1740 is operably arranged between the interface of the electronic system with the dose setting and drive mechanism and the external operating surface (delivery surface 1620) or the movable member 1670. The shuttle biasing member 1740, e.g. a compression spring such as a helical spring, may be arranged such that it must be biased, e.g. compressed, until a force can be transferred from the delivery surface 1620 to the dose setting and drive mechanism for a delivery operation. This facilitates that the movable member 1670 is always displaced to an operating position or a signal is generated before the dose setting and drive mechanism can be operated, e.g. before switching from a dose setting configuration to a dose delivery configuration. For example, the biasing member 1740 may be operably coupled between the shuttle member 1730 and the external operating surface (delivery surface 1620). The biasing force or preload of the shuttle biasing member 1740, e.g. when fully compressed and / or when the movable member is in the operating position, is preferably less than the force provided by the clutch biasing member in the dose setting and drive mechanism, e.g. when the clutch interface is released (see further description above). In the illustrated embodiment, as is clear from FIG. 8B, the biasing member 1740 is operably arranged between the user interface member portion or carrier 1720 and the shuttle member 1730. The carrier 1720 can be provided as a carrier for one or more electronic components or units of the system. In the illustrated embodiment, the carrier can serve as a carrier for the conductor carrier 3000 (with the electronic control unit 1100), the power source 1500, and / or the conductor carrier 3010 with the signal transmission unit 1300 represented by the switch 1310. The described components or units can be axially fixed to the carrier 1720. The carrier 1720 can be axially and non-rotatably fixed to the user interface member body 1605. Carrier 1720 corresponds to the user interface member portion of the embodiment described in connection with Figures 7A-7C.

[0172] 8B shows the movable member 1670 moved to the operating position. The member can be biased towards its initial position as discussed above, and in this embodiment no biasing member is shown. The operating position can be defined by an abutment or axial end stop of the movable member 1670 against the user interface member body or an external operating surface. In this embodiment, this end stop is provided by the carrier 1720. However, it should be noted that the end stop can also be provided by another component or system. The contact surface 1675 still rises above the delivery surface in the operating position, but does not protrude from that surface as much as in the initial position. Alternatively, the contact surface 1675 can be flush or less than flush with the delivery surface 1620. In this position before the dose setting and driving mechanism is switched from the dose setting configuration to the dose delivery configuration, the biasing member 1740 still needs to be biased until it can transmit the force applied to the external operating surface to the shuttle member, for example via the axial abutment between the carrier 1720 and the shuttle member 1730 in the area 1750 (see the free space between the carrier and the shuttle member in FIG. 8B and the abutment in FIG. 8C). Thus, similar to FIG. 8B, when the movable member is in the operating position, the biasing member 1740 still has to be biased until the dose setting and driving mechanism can switch its configuration to the dose delivery configuration and drive the dose delivery operation. The biasing member 1740 can provide a known preload that the user has to overcome before the mechanism can be switched to the dose delivery configuration. The biasing member can be biased already in the initial position of the movable member. The biasing member 1740 can bias the delivery surface 1620 away from the shuttle member in the initial position of the movable member. The biasing member may be dimensioned or configured such that the use signal is generated / switch 1310 is triggered before the mechanism is switched to the dose delivery configuration, but the user must act against the biasing member 1740 until the driving engagement or dose delivery interface can be established by the shuttle member and / or mechanism member.

[0173] The carrier 1720 may act as or include a light guide for guiding light originating from an optoelectronic light source of the motion sensing unit and toward a sensing or encoder surface on a mechanical member whose motion is to be monitored by the motion sensing unit. The motion sensing unit is preferably disposed on the conductor carrier 3000. It should be noted that the arrangement of the power source and the conductor carriers 3000 and 3010 is merely one possible implementation of arranging components within a user interface member. This implementation may be optimized for space requirements such that the components can fit into the user interface member 1600, for example, in one of the dimensions further specified above.

[0174] From the situation in FIG. 8B, when the delivery surface is displaced distally relative to the shuttle member, the biasing member 1740 is further biased, e.g. compressed, to produce the situation shown in FIG. 8C, in which the carrier 1720 abuts the shuttle member 1730, establishing a force transmission engagement by transmitting the delivery force from the delivery surface to the dose setting and drive mechanism.

[0175] An increase in user force (required to bias the biasing member 1740) can be tolerated because it is guaranteed that in all tolerance conditions (taking into account tolerances of the dose setting and drive mechanisms and electronic systems) a signal is generated before the dose delivery operation is initiated, e.g. before one mechanism member is moved relative to the other to switch the clutch interface, or at least before the clutch interface is switched. After overcoming the biasing spring force of the biasing member, any additional force provided by the user acts to drive the dose delivery operation.

[0176] Similar to the previous embodiment, the switch 1310 is mounted under a movable member 1670 that is designed to move relative to one or more of the electronic components of the system, for example relative to the switch when a user applies a distal load to the delivery surface 1620. The switch, e.g., a microswitch, preferably has a very light actuation force to ensure that the switch operates before disengagement or release of a clutch in the device. Unlike the previous embodiment, a shuttle member 1730 and biasing member are added to ensure that the switch can be reliably actuated with less force than that required to axially displace an injection button or another component of the dose setting and drive mechanism of the device.

[0177] The shuttle member 1730, when connected to the dose setting and drive mechanism, can be biased axially (by a biasing member 1740 in this embodiment) in a distal direction against the delivery face 1620. The biasing member 1740 can be configured to provide a preload in all tolerance conditions to bias the user interface member body 1605, the carrier 1720 and / or the electronic components proximally with a known force. The system is preferably designed such that in all tolerance conditions, connection of the electronic system to the dose setting and drive mechanism, e.g. its dose button, causes some compression of the shuttle member against the biasing member 1740, thereby creating a (known) preload.

[0178] The user interface member 1600 cannot move axially to operate the drive mechanism until the preload is exceeded. Movement of the user interface member relative to the shuttle member without moving the mechanism member to operate the dose setting and drive mechanisms is possible. The movable member 1670 can be reliably designed to engage the switch 1310 with a force less than the preload, thereby ensuring that the dose delivery operation is not initiated or started until the switch is operated. This concept can be achieved with an elastomeric or rigid movable member.

[0179] As an alternative to the shuttle member being movable relative to the user interface member body and the signal sending unit being fixed relative to the user interface member body, the external operating surface can be movable relative to the signal sending unit when the user interface member body is moved to switch the mechanism to the dose delivery configuration. In this case, the shuttle member can be a member fixed to the user interface member body. The biasing member 1740 can bias the carrier 1720 towards the operating surface 1620. To generate a signal via the switch 1310, the movable member 1670 needs to be in the operating position. In addition, movement of the external operating surface towards the signal sending unit or the switch 1310 can be required.

[0180] The embodiments described above often utilized portions of the movable member 1670 that protruded from the exterior operating surface in an initial position and these portions comprised a contiguous area of ​​the surface of the user interface member when the delivery surface 1620 was viewed in a top view, i.e., no portion of the movable member encompassed an area of ​​the delivery surface 1620 when that surface was viewed in a top view.

[0181] 9 illustrates, using a top view of the delivery surface, an embodiment in which the protruding portion 1672 of the movable member 1670 on the delivery surface 1620 has a ring-like configuration. This portion therefore generally surrounds an area of ​​the delivery surface. This is to highlight that different configurations of the protruding portion are possible. The remaining operating principles discussed above remain with this embodiment.

[0182] It is noted that the above disclosed embodiments are not all possible. The above-mentioned embodiments enable the generation of a signal to trigger the switching of the system to a state with higher power consumption when the movable member reaches an operating position, or at least before the dose setting and drive mechanism is switched to the dose delivery configuration, possibly after the external operating surface and / or the movable member are displaced distally relative to the signal sending unit and / or the mechanism member.

[0183] Those skilled in the art will understand that various combinations of features from different embodiments are within the scope of the present disclosure, unless such combinations are expressly excluded by inconsistencies between the embodiments.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] 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.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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.

[0192] 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.

[0193] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0194] 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.

[0195] 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.

[0196] 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.

[0197] 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.

[0198] 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.

[0199] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0200] 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.

[0201] It will be understood by those skilled in the art that modifications (additions and / or deletions) can be made to the various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and all equivalents thereof.

[0202] 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 (partially or fully expelled) container systems. The container can be an exchangeable container or an integrated non-exchangeable container.

[0203] 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).

[0204] 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).

[0205] The scope of protection is not limited to the examples given herein above: the invention disclosed herein is embodied in each and every novel feature and each combination of features, and such features specifically include all combinations of features recited in the claims, even if that feature or combination of features is not explicitly recited in the claims or examples. [Explanation of symbols]

[0206] 1. Injection device, drug delivery device, or device unit 10. Housing 12 Dosage knob 11 Injection button 13. Windows 14 Container 15 needles 16 Inner needle cap 17 Outer needle cap 18 Cap 70 Dial or Number Sleeve 71a~71c formations 1000 Electronic Systems 1100 Electronic Control Unit 1200 Motion Sensing Unit 1300 Signal Transmitting Unit 1310 Switch 1400 Communication Unit 1500 power supply 1600 User interface components 1605 User interface component body 1610 Setting surface 1615 Connectivity 1620 Delivery surface 1670 Movable parts 1671 Features 1672 parts 1672a part 1672b part 1672c part 1673 Main unit 1674 Switching Function 1675 Contact surface 1676 Contact part 1677 Transformable Part 1678 Sealing part 1680 Pressing member 1690 Clutch biasing member 1700 parts 1710 Parts 1720 User interface component part 1730 Shuttle parts 1740 Pressing member 1750 area 3000 Conductor Carrier 3010 Conductor carrier d c distance

Claims

1. An electronic system (1000) for a drug delivery device (1), comprising: at least one user interface member (1600) configured to be operated by a user to perform a dose operation, such as a dose setting operation for setting a dose of a drug to be delivered by the drug delivery device and / or a dose delivery operation for delivering the set dose; and an electronic control unit (1100) configured to control operation of the electronic system, the electronic system having a first state and a second state, the electronic system having a higher power consumption in the second state compared to the first state, wherein: The user interface member includes an exterior operating surface (1620) arranged to be touched by a user for dose operation; The user interface member includes a user proximity detection unit (1300, 1670) configured to generate an electrical signal when a user approaches or touches the external operating surface; the user proximity detection unit includes a movable member (1670) arranged to be moved by a user away from an initial position towards an operating position relative to the external operating surface before the user reaches the external operating surface; The user proximity detection unit further includes an electrical signal transmission unit (1300), the user proximity detection unit being configured to provide an electrical signal when the movable member is moved away from the initial position, e.g. when the movable member is in the operating position or during a movement away from the initial position towards the operating position; The electronic system, wherein an electronic control unit is configured to switch the electronic system from a first state to a second state in response to an electrical signal.

2. The user interface member (1600) includes a user interface member body (1605) defining an exterior operating surface (1620), the exterior operating surface defining at least one opening, a portion of the movable member protruding through the opening. The electronic system of claim 1 .

3. the exterior operating surface (1620) defines a plurality of separate openings, a portion of the movable member protruding through each opening, the portion originating from a common body of the movable member disposed within the user interface member body; The electronic system of claim 2.

4. In an initial position of the movable member (1670), a user contact area (1675) of the movable member is elevated relative to the external operating surface (1620), and in an operating position of the movable member, the user contact area is less than flush with the external operating surface. The electronic system according to any one of claims 1 to 3.

5. The electrical signal is generated in response to movement of the movable member (1670) relative to the signal transmission unit (1300); and / or The signal sending unit (1300) includes an electric switch (1310), which is arranged to be triggered during the movement from the initial position to the operating position. An electronic system according to any one of claims 1 to 4.

6. When the movable member (1670) is in the operating position, it is biased toward the initial position by a member biasing mechanism (1680); and / or The external operating surface (1620) is the delivery surface that is touched by the user to perform a dose delivery operation as a dose operation. An electronic system according to any one of claims 1 to 5.

7. When the movable member (1670) is in the operating position, e.g. during a dose operation, a force applied to the movable member by a user is resolved by the user interface member body (1605) via a force transmission path that bypasses the signal transmission unit (1300) and / or the electronic control unit (1100); An electronic system according to any one of the preceding claims.

8. the user interface member (1600) is connected or configured to be connected to a mechanism member of a dose setting and drive mechanism of a drug delivery device such that forces can be transmitted from the external operating surface (1620) to the mechanism member; and / or The electronic system (1000) includes a shuttle member (1730) that is movable relative to the external operating surface (1620), and the electronic system includes a shuttle member biasing system (1740) that is configured to bias the shuttle member away from the external operating surface and / or the movable member (1670); An electronic system according to any one of the preceding claims.

9. the electronic system (1000) is configured such that the user interface member (1600) is operably connectable to the mechanism member via a dose operation interface to drive movement of the mechanism member during dose operation, the electronic system is configured such that in order to establish the dose operation interface, the external operating surface (1620) must be displaced from a first position relative to the mechanism member to a second position relative to the mechanism member, the shuttle member biasing system (1740) is configured to be biased during movement from the first position to the second position, and / or the dose operation is a dose delivery operation, the mechanism member is a second member, the dose setting and drive mechanism includes a first member, the first member and the second member are configured to be movable relative to each other to switch the dose setting and drive mechanism from a dose setting configuration to a dose delivery configuration, e.g. by switching a state of a clutch engagement, and the electronic system is configured such that a signal is generated before the dose setting and drive mechanism is switched from the dose setting configuration to the dose delivery configuration; 9. The electronic system of claim 8.

10. The electronic system (1000) is configured as an accessory module for the drug delivery device unit (1), An electronic system according to any one of the preceding claims.

11. In a plan view or top view of the external operating surface (1620), the area included in the external operating surface is greater than the area included in the movable member (1670), and the ratio between the area included in the movable member and the area of ​​the external operating surface is 0.4 or less. An electronic system according to any one of the preceding claims.

12. When the movable member (1670) is in the operating position, the movable member can still be moved further away from the initial position. An electronic system according to any one of the preceding claims.

13. the signal transmission unit (1300) is fixed relative to the external operating surface (1620) so as not to move away from and / or towards the external operating surface; An electronic system according to any one of the preceding claims.

14. the movable member (1670) is constructed and arranged relative to the external operating surface (1620) such that a user must move the movable member before being able to touch the external operating surface; An electronic system according to any one of the preceding claims.

15. An electronic system (1000) according to any one of claims 1 to 14, and / or a reservoir holder for holding a reservoir having a drug; and / or A reservoir containing a drug (14) A drug delivery device (1).

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