Switch assembly for an electronic system of a drug delivery device

Abstract

The present invention relates to a switch assembly (20, 30) for an electronic system of a drug delivery device (1). The switch assembly includes a chassis (19) supporting a PCBA (110) including at least a first electrical contact (23a), a second electrical contact (23b), a third electrical contact (23c), and a fourth electrical contact (23d), and a ring (21) having a ratchet profile (22). The chassis (19) moves axially relative to the ring (21) from a first axial position to a second axial position during a first switch operating mode. The chassis (19) and the ring (21) are configured such that the ring (21) rotates relative to the chassis (19) during a second switch operating mode. The first electrical contact (23 a) and the second electrical contact (23 b) are arranged such that an electrical connection between the first electrical contact (23 a) and the second electrical contact (23 b) is closed when the chassis (19) moves axially toward the ring (21) during a first switch operation mode. Furthermore, an elastically deformable arm (24) is disposed radially between the ratchet profile (22) of the ring (21) and the chassis (19), and is guided on the ratchet profile (22) such that the arm (24) elastically deforms radially toward the chassis (19) during at least a second switch operation mode, thereby alternately opening and closing the electrical connection between the third electrical contact (23 c) ​​and the fourth electrical contact (23 d) via the arm (24).

Description

Technical Field

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

Background Art

[0002] Pen-type drug delivery devices have uses where regular injections are administered by people who have not received formal medical training. This is becoming increasingly common among diabetics, and such patients can effectively manage their disease through self-treatment. In practice, in such drug delivery devices, it is possible for the user to individually select and dispense multiple user-variable doses of the drug.

[0003] Basically, there are two types of drug delivery devices: namely, resettable devices (i.e., reusable) and non-resettable (i.e., disposable) devices. For example, disposable pen delivery devices are supplied as standalone devices. Such standalone devices do not include a removable pre-filled cartridge. Conversely, a pre-filled cartridge cannot be removed and replaced from these devices without destroying the device itself. Therefore, such disposable devices do not need to have a resettable dose setting mechanism. The present invention is applicable to both disposable devices and reusable devices.

[0004] In the case of such devices, the function of recording the dose dialed and delivered from the pen is valuable for a wide variety of device users, as a memory aid or to support detailed logging of the dosing history. Therefore, drug delivery devices that use electronic devices are becoming increasingly common in the pharmaceutical industry, as well as for users or patients. For example, a drug delivery device is known from Patent Document 1 that includes an electronically controlled capture system for capturing data related to the amount of drug discharged from a reservoir by a discharge means.

[0005] However, especially when the device is designed as a stand-alone device, i.e., without a connector for connection to a power source necessary to provide power for the operation of the device, the management of the power source resources integrated into the device is particularly important.

[0006] Unpublished Patent Document 2 and Patent Document 3 disclose advantageous embodiments of an electronic system for a drug delivery device with improved power management. These electronic systems include a switch assembly for activating / deactivating the power consumption function of the electronic system.

[0007] An alternative rotary encoder is known from Patent Document 4, which includes several electrical switches that are selectively opened and closed by a mechanical wave generator in the form of a profile having valleys and peaks that engage and operate the switch.

[0008] Such drug delivery devices are typically manufactured on a large scale, and therefore efficient and simple assembly is an important issue in order to keep the production cost reasonably low.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

Problems to be Solved by the Invention

[0010] The object of the present disclosure is to provide an improvement example for a drug delivery device including one or more electronic systems for a drug delivery device that reliably activates / deactivates the functions of the electronic system and enables efficient assembly.

Means for Solving the Problem

[0011] This object is solved, for example, by the subject matter defined in the independent claims. Advantageous embodiments and improvements are in accordance with the dependent claims. However, it should be noted that the present disclosure is not limited to the subject matter defined in the appended claims. On the contrary, the present disclosure can include improvements in addition to, or as an alternative to, the subject matter defined in the independent claims that will become apparent from the following description.

[0012] One aspect of the present disclosure relates to a switch assembly for an electronic system of a drug delivery device. The switch assembly includes a chassis that supports a PCBA having a distal face including at least a first electrical contact, a second electrical contact, a third electrical contact, and a fourth electrical contact. The switch assembly further includes a ring including a ratchet profile, such as an encoder ring of a rotational sensor. The ratchet profile can include a bottom section and a top section and is disposed, for example, facing radially inward of the ring. The chassis and the ring are preferably arranged and applied such that during a first switch operation mode, for example during a transition from a dose setting operation to a dose delivery operation of the drug delivery device or when the chassis is depressed in a 0U dial setting state of the drug delivery device, the chassis moves axially relative to the ring from a first, for example more distant, axial position to a second, for example closer, axial position. Further, the chassis and the ring are configured such that during a second switch operation mode, for example during a dose delivery operation of the drug delivery device, the ring rotates relative to the chassis. Reliable switching in both switching modes can be obtained when the first electrical contact and the second electrical contact are arranged such that an electrical connection between the first electrical contact and the second electrical contact closes when the chassis moves axially towards the ring during the first switch operation mode. Additionally, an elastically deformable arm can be placed between the ratchet profile of the ring and the chassis in the radial direction. The arm is axially and non-rotatably constrained to the chassis and is preferably guided over the ratchet profile such that the arm elastically deforms radially towards the chassis at least during the second switch operation mode, thereby alternately opening and closing an electrical connection between the third electrical contact and the fourth electrical contact via the arm.

[0013] This arrangement of the switch assembly has the further advantage that, to form the switch assembly, the chassis, the PCBA with contacts on the distal side, the ring, and the contacts can be attached to each other from the same direction. This significantly increases the assembly efficiency compared to alternative means that require the attachment of component members from different directions. Additionally, the number of additional component members required to construct the switch assembly is relatively small. For example, in a drug delivery device having an electronic system including a ring, a chassis, and a PCBA, only the provision of a metal component including an arm is required. Thus, only the ring and the PCBA need to be modified to provide the switch assembly according to the present disclosure. The small number of additional component members contributes to making the assembly process very efficient.

[0014] According to a further independent aspect of the invention, a round metal piece is provided, which is scalable with respect to diameter, thickness, and height, and thus adjustable to various pharmaceutical pens and / or their respective connection modules, and one or more spring elements are incorporated. During the rotational movement of the members of the pen and / or the connection module, the spring elements can interact with their respective counterparts. According to this aspect of the invention, the round metal member can be fixed or rotated, and then the counterpart can also be rotated or fixed. The overall force for rotating the rotating member of this application example relative to the fixed member can be adjusted by selecting the spring accordingly. This aspect of the invention is based on the concept that when the spring element interacts with the counterpart, the spring bends reversibly and can be used as a trigger signal, for example, by opening and closing an electrical contact. The rotational movement between the spring element and the counterpart can be used in both directions. As a further benefit, the relative rotational movement between the two members can be used to generate a tactile and / or audible patient feedback signal.

[0015] In the switch assembly, the arm can include at least one detent or protrusion applied to engage the ratchet profile of the ring. More specifically, the detent or protrusion can fit within the bottom section of the ratchet profile when the ring rotates relative to the chassis and the arm, and can slide over the top section of the ratchet profile. The ratchet profile and the detent can be applied to each other to allow relative rotation in only one direction and prevent relative rotation in the opposite direction. 。

[0016] If the arm is part of a substantially annular conductive spring member, biased to abut against the ratchet profile of the ring, and can be at least partially deflected radially inward into the annular space between the ring and the chassis, the attachment of the switch assembly can be facilitated. For example, the spring member can be a slotted ring, and can be fixed within the space between the ring and the chassis by elastically expanding or elastically restraining the spring member.

[0017] If the third electrical contact and the fourth electrical contact are provided on a flexible flap or flex board section of the PCBA that extends distally from the PCBA to a position between the ring and the chassis, the rotary switch of the switch assembly can be easily and reliably established. In other words, the third and fourth contacts can be arranged adjacent to each other on the flap or flex board section, and thus the contact between the flap or flex board section and the arm electrically bridges and connects the third electrical contact and the fourth electrical contact. For example, during the second switch operation mode, the arm alternately contacts the bottom section and the top section of the ratchet profile, thereby elastically deflecting to connect to and disconnect from the third electrical contact and the fourth electrical contact.

[0018] The axial switch of the switch assembly can include a first electrical contact that can be a first lever having one end attached to the PCBA and a free end on the opposite side, and a second electrical contact that can be a second lever having one end attached to the PCBA and a free end on the opposite side. For example, the free end of the lever is arranged such that when the chassis moves axially towards the ring during the first switch operation mode, at least the first lever is deflected relative to the second lever, closing the electrical connection between the first electrical contact and the second electrical contact. More specifically, the first lever can extend through the chassis, and its free end projects from the chassis, where, when the chassis moves axially towards the ring during the first switch operation mode, the ring or a component member connected to the ring, such as a part of the dial assembly, deflects the first lever. In this example, the first lever and the second lever can be located within a space formed radially inside the ring within the chassis.

[0019] Alternatively, the axial switch of the switch assembly can further include a housing and a dial grip or dose knob. For example, the axial movement of the chassis towards the ring during the first switch operation mode can be caused by the axial displacement of at least a part of the dial grip or dose knob relative to the housing, thereby closing the gap between the first electrical contact and the second electrical contact. In this example, the first electrical contact and the second electrical contact can be arranged on the proximal side of the PCBA facing away from the ring.

[0020] According to a further aspect of the present disclosure, a method of assembling a drug delivery device is provided, the drug delivery device including a dosage setting and drive mechanism and an electronic system having a switch assembly including a chassis, the PCBA having contacts on a distal surface, the ring having an annular ratchet profile and first and second conductive arms, and these component members of the drug delivery device being attached to each other and / or to the outside of each other from a single direction, preferably from the proximal button end of the drug delivery device towards the distal dosing end. Some of these component members can be attached as pre-assembled sub-units, and the sub-units themselves may or may not be attached from the same single direction.

[0021] These examples of switch assemblies are particularly applicable to drug delivery devices including an electronic system. The present invention is applicable to manual devices, such as devices driven by a user applying force to an injection button, devices driven by a spring, etc., and devices combining these two concepts, i.e., spring-assisted devices that also require the user to apply an injection force. Spring-based devices involve a pre-loaded spring and a spring loaded by the user during dosage selection. Some energy storage devices use a combination of a pre-loaded spring and additional energy provided by the user, for example, during dosage setting.

[0022] According to one aspect of the present disclosure, a drug delivery device can include an electronic system having the switch assembly described above. For example, the drug delivery device can include a dose setting and driving mechanism and a button module. More specifically, the dose setting and driving mechanism can be configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose. The dose setting and driving mechanism preferably includes a ring of the switch assembly. Further, the button module can include an electronic control unit on the PCBA, a rotation sensor having, for example, a light source and a corresponding light sensor, a communication unit having a wireless communication interface for communicating with another device, and a usage detection unit including the switch assembly. The electronic control unit is preferably configured to control the operation of the electronic system.

[0023] According to a further aspect of the present disclosure, the button module and the dose setting and driving mechanism can be configured such that the dose dial assembly rotates relative to the button module during the dose delivery operation but does not rotate relative to the button module during the dose setting operation, and the button module moves axially relative to the dose dial assembly during the transition from the dose setting operation to the dose delivery operation or when the button module is pressed in the 0U dial setting state.

[0024] According to a further aspect of the present disclosure, when the electronic system closes the electrical connection between the first electrical contact and the second electrical contact during the first switch operation mode, the communication unit is switched from the sleep mode to the operation mode, and the communication unit is configured to initiate manual synchronization and / or pairing with another device. Additionally or alternatively, when the electronic system closes the electrical connection between the second electrical contact and the third electrical contact via the arm during the second switch operation mode, the rotation sensor is switched from the sleep mode to the operation mode, and the rotation sensor is configured to initiate motion detection.

[0025] The present disclosure provides advantageous embodiments relating to integrating a mechanically actuated electronic switch to initiate different device functions. At least one switch assembly can form, or be part of, a usage detection unit of an electronic system. Such a usage detection unit can include the use of a rotationally actuated electronic switch (rotary switch) to activate an electronically encoded module attached to an injection device, and / or the use of an axially actuated electronic switch (axial switch), such as a rotary sensor having another smart electronic device attached to the injection device, to initiate a pairing function of the encoded module. The mechanically actuated electronic switch can be part of, or form part of, an electrical usage detection unit operably connected to an electronic control unit. The electrical usage detection unit can be configured to generate a first signal indicating that a user has initiated or terminated relative movement between a dose setting and drive mechanism and a button module. Thus, according to the present invention, an injection device can maintain a low power state when excitation or pairing of an encoding sensor is not required, but can be activated when any function is required. This is particularly applicable to devices where the module rotates axially relative to an adjacent mechanical component during dose delivery, but does not rotate relative to that component during dial setting, and / or where the button module is depressed during the transition from a dial setting state to a dosing state, or in the 0U dial setting state, i.e., the state after completion of dose administration and before selecting a new dose.

[0026] According to one aspect of the present disclosure, an electronic system includes a dose setting and driving mechanism configured to perform a dose setting operation for setting a dose to be delivered by a drug delivery device and a dose delivery operation for delivering the set dose. The dose setting and driving mechanism includes at least one ring, and the at least one ring can be made operable by a user, preferably indirectly, during the dose setting operation and / or the dose delivery operation. For example, the dose setting and driving mechanism can include one or more of components such as a dial grip, a dial, or a display member (e.g., a numeric sleeve), a driver, a clutch, a piston rod, an inner and / or outer housing component. The dose setting and driving mechanism of the present invention can be based on the dose setting and driving mechanism disclosed in EP2890435.

[0027] According to a further aspect of the present invention, the electronic system includes a button module including at least one electronic control unit, and the at least one electronic control unit is made of, for example, a PCBA or includes a PCBA and is configured to control the operation of the electronic system. The button module can be permanently or removably attached to a trigger, a button, or a dial grip, for example, at or near the proximal end of the drug delivery device. The button module and / or the electronic control unit can have a distal face facing the dose setting and driving mechanism to provide, for example, an interface for mechanical interaction and / or electrical connection with further component members of the system.

[0028] In one embodiment, the electronic system has a first state and a second state. The first state and the second state can be different operating states of the electronic system. The electronic control unit can have at least a first, preferably low-power consumption state, and a second, preferably high-power consumption state. In the first state, the system can be in an idle state, and the system cannot operate with a desired function assigned to the electronic system, such as usage detection, motion detection, encoding, synchronization, and / or pairing. In other words, at least one function is not activated in this first state. In the second state, the system can be in a state ready to operate with the desired function, for example when the system is triggered to start operating and / or when a dosing operation and / or a dosing delivery operation is being performed in the second state. The electronic system can have an increased power consumption in the second state compared to the first state. For example, in the second state, one or more electrical or electronic units of the electronic system can be switched to a state of higher power consumption, such as an on state, compared to the first state, in which each unit can be put in a low-power sleep state or an off state with no power consumption, for example because the connection to the power supply is interrupted. For example, in this second state, a communication unit and / or an encoding module, such as a rotation sensor, can be activated.

[0029] The symbolization module or unit is typically suitable for detecting the movement of specific component members of the dosage setting and drive mechanisms and generating a signal indicative of the amount of movement of this component member. For example, the symbolization module or unit can detect the rotational movement of an encoder attached to the dial sleeve during the dosage setting operation and / or during the dosage delivery operation, and the encoder is preferably a ring of the switch assembly. According to one aspect of the present disclosure, the symbolization module includes a rotational sensor for detecting rotational movement. The rotational sensor can include a light source having a corresponding optical sensor, preferably two light sources having two corresponding optical sensors, for detecting the rotational movement of a component member having a pattern. Alternatively, the rotational sensor can use other detection techniques. For example, the rotational sensor can include electrical sliding contacts, mechanical switching arrangements, and / or magnetic sensors.

[0030] For example, the encoder can further include a pattern provided at least on its outer surface, and the pattern can be detected by the rotational sensor. According to one aspect, the rotational sensor includes a primary sensor and a secondary sensor configured to target a specially applied area, for example, at the proximal end of the dial sleeve, such as in the encoder. In this example, the primary sensor and the secondary sensor can be optical reflection sensors. Thus, the specially applied proximal area of the dial sleeve or encoder can be divided into at least one reflective area and at least one non-reflective (or absorptive) area. The rotational sensor can be an optical sensor that emits light from an LED, and the light of the LED is reflected by the reflective area of the encoder, and the sensor detects the reflected light. The sensor then converts the detected light into an electrical output. The encoding or motion sensing unit can include one or more of such optical rotational sensors, for example, one of two optical rotational sensors circumferentially spaced around the encoder.

[0031] The electronic system can further include an encoding or motion sensing unit that enters a sleep mode in a first low power consumption state and is activated in a second high power consumption state, and / or a communication unit for communicating with another device, where the communication unit enters a sleep mode in the first low power consumption state and is activated in the second high power consumption state. In an exemplary embodiment of the present disclosure, the electronic system can include an encoding or motion sensing unit and a communication unit, and either unit can be independently activated or put into a sleep mode. Thus, there can be three or more power consumption states, namely a state where both units are in a stopped state or sleep mode, a state where only the encoding or motion sensing unit is activated, a state where only the communication unit is activated, and a state where both units are activated. The power consumption of the electronic system can be different for each of these four states. Nevertheless, for the sake of simplicity of explanation, only the first low power consumption state and the second high power consumption state are discussed herein.

[0032] In one embodiment, the electronic system can be suitable for using an encoding or motion sensing unit to collect or measure dosage data corresponding to, for example, a set dosage or a dispensed dosage. Such dosage data can be collected only in the second state of the system. In one embodiment, the encoding or motion sensing unit can be operable to collect motion data or measurement data regarding the movement of, for example, a dial member, a driver, and / or a piston rod when in an active state. The electronic control unit can be configured to convert this data into dosage data representing, for example, the size of the dosage set or delivered in each operation. The encoding or motion sensing unit can be designed as described in Patent Document 1 and Patent Document 2 which are not publicly available, and the disclosures of these patent documents are incorporated herein by reference.

[0033] The communication unit can include a wireless communication interface for communicating with another device, and the electronic system is switched from a first state to a second state by an electronic control unit in response to a first signal, whereby the communication unit is configured to initiate manual synchronization and / or pairing with another device.

[0034] In response to receiving the first signal, the electronic control unit can issue a command, such as a signal, to another unit of the electronic system to switch this unit on or into an operating state. This unit can be a communication unit for communicating with another device, such as a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth (registered trademark), or further, an interface for a wired communication link such as a socket for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. The electronic system preferably includes an RF, WiFi, and / or Bluetooth unit as the communication unit. The communication unit can be provided as a communication interface between the system or drug delivery device and other electronic devices, such as external devices like mobile phones, personal computers, laptops, etc. For example, the communication unit can transmit dosage data to an external device. The dosage data can be used for a dosage log or dosage history established within the external device.

[0035] In one embodiment, the communication unit includes a wireless communication interface for communicating with another device, and the electronic system is switched from a first state to a second state by an electronic control unit in response to a first signal of at least one switch of a usage detection unit, whereby the communication unit is configured to initiate manual synchronization and / or pairing with another device or to initiate a mode for modifying the settings of the electronic system.

[0036] According to one aspect of the present invention, an electronic system includes a dosage setting and driving mechanism, a power source, such as a rechargeable or non-rechargeable battery, an electronic control unit, an electrical usage detection unit and an encoding or motion sensing unit, and / or a communication unit for communicating with another device.

[0037] In one embodiment, the device or electronic system includes an electronic control unit, which includes, for example, a microprocessor or a microcontroller. The electronic control unit can be configured to control the operation of the drug delivery device or electronic system. The electronic control unit can be disposed on a conductor carrier and conductively connected to a conductor on the conductor carrier. The conductor carrier can be a circuit board such as a printed circuit board. The conductor carrier can be held inside a user interface member of the system or device. The power source can be disposed inside the electronic system, such as inside the user interface member.

[0038] According to one aspect of the present disclosure, it is advantageous that the electronic system is applicable to limit the battery capacity requirements of the injection device and can put the device in a low power state when no electronic functions are required. This can be achieved by a mechanical switch activated by relative movement between components adjacent to the electronic button module as needed, for example, by the encoding exemplified above as part of a dial sleeve assembly.

[0039] According to one aspect of the present disclosure, the manual synchronization function is initiated by pressing the button module when the device is dialed to 0U. In any device state, when the button module is pressed, the button module translates distally relative to the dial sleeve assembly, for example, together with a clutch. The nominal axial stroke can be limited to, for example, less than 3 mm of the button module relative to the dial sleeve (and the encoding), for example, a stroke of 1.5 mm to 2.0 mm, and further relative axial movement is restricted. The axial switch of one embodiment of the usage detection unit is attached to the lower surface of the button module and is triggered by utilizing the relative axial displacement between the button module and the dial sleeve assembly. It is possible to use the duration for which the button module is held in the depressed state to initiate a plurality of different functions by the same switch, for example, manual synchronization for a short duration of pressing and releasing, or pairing for a longer duration of pressing and releasing.

[0040] According to a further aspect of the present disclosure, for example, the encoding function needs to be started only when the device is dispensing. For example, in the device disclosed in EP2890435, during dose setting, for example, a dial sleeve assembly consisting of a dial sleeve and an encoder, and a button module extend helically (translate) from the device. Therefore, no relative rotation occurs between the button module and the dial sleeve assembly during dose setting. To start dose delivery, for example, the button module and the clutch are translated distally relative to the device housing. After the clutch has translated a predetermined distance, for example less than 2.0 mm, for example nominally 1.20 mm, the clutch is disengaged from the dial sleeve and the delivery mechanism enters the dispensing (dose delivery) mode. In this dispensing mode, while the dial sleeve assembly retracts into the device along a helical path, the button module does not rotate and retracts only by axial movement until it engages the 0U stopper and dosing is complete. Thereby, relative rotation of the button module with respect to the dial sleeve assembly occurs during dosing. In an exemplary embodiment of the rotation switch of the usage detection unit, this rotation switch can be attached to the lower surface of the button module and is triggered using the relative rotation between the button module and the dial sleeve assembly.

[0041] In this exemplary application to the device disclosed in EP2890435, the axial switch is also triggered when the button module is depressed as part of a dosing event. However, in the described embodiments, the relative order of the state changes of the rotational and axial switches cannot be guaranteed. Up to the clutch disengaging point, e.g., the translational movement of the button module of 1.2 mm, the axial switch is not triggered, and thus some rotation of the dial sleeve assembly may occur before the state change of the axial switch. By using a rotational switch to initiate, for example, an optical encoding system, it is ensured that the delivered dose is accurately recorded regardless of the axial position of the button module. If it is not necessary to trigger until the clutch disengages, the maximum deflection of the axial switch contacts, and thus the force, stress, and package space of this axial switch, can be minimized.

[0042] According to a further aspect of the present disclosure, the usage detection unit includes an axial switch and a rotational switch, and the electronic control unit is adapted to switch the encoding or motion sensing unit to its low power consumption state in response to a signal that the axial switch has switched from its first electrical state, e.g., an electrically open circuit, to its second electrical state, e.g., an electrically closed circuit. More specifically, when the user releases the button module at the end of dosing (or during a dosing event), the button module and the clutch translate proximally relative to the device, e.g., under the influence of a clutch spring force. During this movement, the axial switch state changes, but the rotational switch state does not. The change in the state of the axial switch after a dosing event provides the controller (electronic control unit) with information that the user has released the button module. Without this information, the system would have to wait until it has confirmed the absence of further rotational switch signals to determine whether the dose has been completed, which would increase the delay period required until the dosing dose reading is displayed. This should have an adverse effect on battery life and the user experience. Thus, the usage detection unit can include only the axial switch or only the rotational switch, but the combination of the axial switch and the rotational switch provides additional benefits that exceed the possibility of triggering two different functions by two different switches.

[0043] The present invention further relates to a drug delivery device including the electronic system described above. The drug delivery device can include a container receptacle releasably attached to the dose setting and drive mechanism. Alternatively, the container receptacle can be permanently attached to the dose setting and drive mechanism. The container receptacle is adapted to receive a container containing a medicament, e.g., a cartridge.

[0044] The terms "drug" or "medication" are used synonymously herein and describe a pharmaceutical formulation that includes one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medication is used to treat, cure, prevent, or diagnose a disease or, alternatively, to improve physical or mental well-being. A drug or medication can be used for a limited duration or, in the case of a chronic disorder, periodically.

[0045] As described below, a drug or medication can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0046] A drug or medicament 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 containing one or more drugs (e.g., short-term or long-term containment). For example, in some cases, the chamber can be designed to contain a 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 contain a drug for about one month to about two years. The containment can be carried out at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately contain in each chamber two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a 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, optionally, allow mixing of the two components by the user before dosing. Alternatively or additionally, the two chambers can be configured to allow mixing upon dosing of the components into a human or animal body.

[0047] The drugs or agents included 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 thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic agents) or 86 (oncological agents)) or the Merck Index, 15th edition.

[0048] 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, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example the structure of human insulin, by deletion and / or exchange 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 exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example the molecular structure of human insulin in which one or more organic substituents (such as 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-codable amino acids, or amino acids are added including those non-codable for the naturally occurring peptide.

[0049] Examples of insulin analogs 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 at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and the Lys at 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.

[0050] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, Levemir (registered trademark)); 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 (registered trademark)); 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.

[0051] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligens, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-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, tildesatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0052] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0053] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0054] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0055] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in a polysulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hylan G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0056] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has a reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to an Fc receptor, e.g., having a mutation or deletion in the Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODVs) having a crossover binding region orientation.

[0057] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may include a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or polyvalent antibody fragments, such as divalent, trivalent, tetravalent and polyvalent antibodies, minibodies, chelated 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.

[0058] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of the CDR sequences to enable antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0059] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0060] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use in the drug or agent in the drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0061] Without departing from the full scope and spirit of the present invention, modifications (additions and / or deletions) can be made to the various components of the APIs, configurations, devices, methods, systems, and embodiments described herein, and it will be understood by those skilled in the art that the present invention encompasses such modifications and any equivalents thereof.

[0062] Exemplary drug delivery devices can include needle-based injection systems 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 (partial or complete discharge) container systems. The container can be an interchangeable container or an integrated non-interchangeable container.

[0063] As further described in ISO11608-1:2014(E), multi-dose container systems can include needle-based injection devices with interchangeable containers. In such systems, each container holds multiple doses, and the dose size can be fixed or variable (preset by the user). Another multi-dose container system can include needle-based injection devices with integrated non-interchangeable containers. In such systems, each container holds multiple doses, and the dose size can be fixed or variable (preset by the user).

[0064] As further described in ISO11608-1:2014(E), a single-dose container system can include a needle-based injection device having an exchangeable container. In one example for such a system, each container holds a single dose and the entire volume deliverable thereby is discharged (complete discharge). In a further example, each container holds a single dose and a portion of the volume deliverable thereby is discharged (partial discharge). Also as described in ISO11608-1:2014(E), a single-dose container system can include a needle-based injection device having an integrated non-exchangeable container. In one example for such a system, each container holds a single dose and the entire volume deliverable thereby is discharged (complete discharge). In a further example, each container holds a single dose and a portion of the volume deliverable thereby is discharged (partial discharge).

[0065] As used herein, the terms "axial", "radial", or "circumferential" can be used with respect to the major longitudinal axis of a device, cartridge, housing, or cartridge holder, e.g., an axis extending through the proximal and distal ends of a cartridge, cartridge holder, or drug delivery device.

[0066] Exemplary and non-limiting embodiments of the invention will now be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0067]

Figure 1

Figure 2a

Figure 2b

Figure 2c

Figure 2d

Figure 2e

Figure 3a

Figure 3b

Figure 4

[0068] In these figures, the same elements, elements having the same function, or elements of the same type may be provided with the same reference numerals.

[0069] Hereinafter, several embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications, and can be equally well introduced into injection devices configured to discharge other drugs, or generally drug delivery devices, preferably pen-type devices and / or injection devices.

[0070] Embodiments are provided in connection with injection devices, particularly variable-dose injection devices, that record and / or track data regarding the dose delivered thereby. These data can include the size of the selected dose, and / or the size of the dose actually delivered, the date and time of administration, the duration of administration, and the like. The configurations described herein include the arrangement of sensing elements and power management techniques (e.g., to facilitate a small battery and / or enable efficient power usage).

[0071] Certain embodiments herein are shown with respect to an injection device disclosed in EP2890435 that combines an injection button and a grip (dose setting member or dose setting unit). The injection button can provide a user interface member for initiating and / or performing a dose delivery operation of a drug delivery device. The grip or knob can provide a user interface member for initiating and / or performing a dose setting operation. These devices are of the dial extension type, i.e., the length of these devices increases during dose setting. Other injection devices having the same kinematic behavior of the dial extension and the button during dose setting and dose ejection operation modes are known, for example, as the Kwikpen® device commercially available from Eli Lilly, and the Novopen® 4 device commercially available from Novo Nordisk. Therefore, it is considered straightforward to apply the general principles to these devices, and further explanation is omitted. However, the general principles of the present disclosure are not limited to their kinematic behavior. It is also possible to consider certain other embodiments for application to the Sanofi SoloSTAR® injection device, which has separate injection button and grip components / dose setting members. Thus, there can be two separate user interface members, one for the dose setting operation and one for the dose delivery operation.

[0072] As used herein, "distal" refers to the direction, end, or surface that is oriented or arranged to point towards or indicate the dosing end of a drug delivery device or its components, and / or away from the proximal end, and is arranged or intended to be arranged to face away from the proximal end, or is used to specify the direction, end, or surface that faces away from the proximal end. On the other hand, "proximal" is used to specify the direction, end, or surface that is oriented or arranged to point away from the dosing end and / or distal end of a drug delivery device or its components, or is arranged or intended to be arranged to face away from the dosing end. The distal end can be the end that is closest to the dosing end and / or farthest from the proximal end, and the proximal end can be the end that is farthest from the dosing end. The proximal surface can face away from the distal end and / or towards the proximal end. The distal surface can face towards the distal end and / or away from the proximal end. The dosing end can be, for example, the end of the needle if a needle unit is attached or intended to be attached to the device.

[0073] Figure 1 is an exploded view of a medicament delivery device or a drug delivery device. In this example, the medicament delivery device is an injection device 1, such as a pen-type syringe like the injection pen disclosed in EP2890435.

[0074] The injection device 1 of FIG. 1 is an injection pen including a housing 10 and includes a container 14, such as an insulin container, or a receptacle for such a container. The container can contain a drug. A needle 15 can be 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 and an outer needle cap 17 or another cap 18. The insulin dose scheduled to be discharged from the injection device 1 can be set, programmed, or “dialed in” by turning the dose knob 12, and then the currently programmed or set dose is displayed, for example, in multiples of units, via the dose window 13. The markings displayed in the window can be provided on a number sleeve or a dial sleeve. For example, if the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called international units (IU), where 1 IU is biologically equivalent to about 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can also be used in injection devices for delivering analog insulin or other agents. Note that the selected dose can be displayed equally well in a form different from that shown in the dose window 13 of FIG. 1.

[0075] The dose window 13 can be in the form of an aperture within the housing 10, and the aperture enables the user to view a limited portion of a dial sleeve assembly configured to move when the dial grip 12 is turned to provide a visual indication of the currently set dose. The dial grip 12 is rotated on a helical path relative to the housing 10 when setting the dose.

[0076] In this example, the dial grip 12 includes one or more formations to facilitate attachment of the data collection device. In particular, the button module 11 can be arranged to be attached onto the dial grip 12. Alternatively, the dial grip can include such a button module of the electronic system.

[0077] The injection device 1 can be configured to cause a mechanical click sound by turning the dial grip 12 and provide acoustic feedback to the user. In this embodiment, the dial grip 12 also acts as an injection button. When the needle 15 pierces the patient's skin portion and then the dial grip 12 and / or the attached button module 11 is axially pushed, the insulin dose displayed in the display window 13 is discharged from the injection device 1. After the dial grip 12 is pushed and the needle 15 of the injection device 1 remains in the skin portion for a specific time, the dose is injected into the patient's body. The discharge of the insulin dose can also cause a mechanical click sound, but this sound can be different from the sound generated when the dial grip 12 is rotated during the dial setting of the dose.

[0078] In this embodiment, during the delivery of the insulin dose, the dial grip 12 is returned to its initial position by axial movement rather than rotation, and the dial sleeve assembly is rotated back to its initial position to display, for example, a dose of 0 units. Figure 1 shows the injection device 1 in this 0U dial setting state. As described above, the present disclosure should not be limited to insulin, but should include all drugs in the drug container 14, particularly liquid drugs or drug formulations.

[0079] The injection device 1 can be used for several injection processes until the insulin container 14 is empty or until the expiration date of the drug in the injection device 1 (for example, 28 days after the first use) is reached. In the case of a reusable device, it is possible to replace the insulin container.

[0080] Furthermore, before using the injection device 1 for the first time, in order to remove air from the insulin container 14 and the needle 15, for example, it may be necessary to perform a so-called "prime shot" by selecting, for example, 2 units of insulin and pressing the dial grip 12 while holding the injection device 1 with the needle 15 facing upward. To simplify the presentation, hereinafter, it is assumed that the amount discharged substantially corresponds to the dosage injected, and thus, for example, the amount of drug discharged from the injection device 1 is equal to the dosage received by the user. Nevertheless, it may also be necessary to take into account the difference (e.g., loss) between the amount discharged and the dosage injected.

[0081] As described above, the dial grip 12 also functions as an injection button, and thus the same component is used for dial setting / setting of the dosage and dosing / delivery of the dosage. Alternatively (not shown), a separate injection button can also be used, and such a separate injection button is axially displaceable relative to the dial grip 12 by at least a limited distance in order to perform or trigger dosing of the dosage.

[0082] Hereinafter, the electronic system 100 according to the present invention will be described with reference to FIG. 4 with respect to exemplary embodiments. The electronic system 100 can be part of the dosing and drive mechanism that can be part of the injection device 1 shown in FIG. 1, and includes a power supply 150 shown in FIG. 4, for example, a rechargeable or non-rechargeable battery. The electronic system 100 further includes an electronic control unit 110, which includes, for example, consists of, or is part of a PCBA, and is configured to control the operation of the electronic system 100 having a first state and a second state, and the electronic system 100 has increased power consumption in the second state compared to the first state. The electronic system 100 further includes an encoding and motion sensing unit 120, such as a rotation sensor, and an electricity usage detection unit 130, and the electricity usage detection unit 130 is operably connected to the electronic control unit 110 and is configured to generate at least a first signal indicating that the user performs an operation. An example of such an operation is that the user of the injection device and / or the electronic system enters the manual synchronization or pairing mode of the electronic system 100, and / or the user starts a dose administration. The electronic system 100 is configured to be switched from the first state to the second state by the electronic control unit 110 in response to the first signal. The electronic system further includes a communication unit 140 for communicating with another device. When the communication unit 140 is in an active state for performing a manual synchronization or pairing mode, the electronic system 100 is in its second state. The PCBA of the electronic control unit 110 can be disposed on and / or in the module chassis 19 of the button module 11 (see FIGS. 2b and 3b).

[0083] Although not explicitly shown, the electronic system 100 can preferably include a permanent and / or non-volatile storage device or memory unit, and such a memory unit can store data related to the operation of the drug delivery device, such as dose history data, for example.

[0084] Unless otherwise specifically disclosed separately below, the electronic system 100 can have the functions described in Patent Document 1 and Patent Document 2 that are not publicly available, and can be arranged and / or designed as described in Patent Document 1 and Patent Document 2 that are not publicly available, and the disclosures of these patent documents are incorporated herein by reference.

[0085] A first embodiment of the switch assembly 20 is shown in FIGS. 2a-2e.

[0086] In the switch assembly 20, the button module 11 is disposed within the dial grip 12, includes a module chassis 19, and the PCBA of the electronic control unit 110 is disposed on the module chassis 19. The module chassis 19 has an outer annular portion retained within the dial grip 12 and an inner tubular portion extending into the encoding 21 of the dial sleeve assembly. In the illustrated embodiment, the encoding 21 is a separate component member fixed to the proximal end of the dial sleeve as shown in FIG. 2a. Alternatively, the encoding 21 can also be an integral member of the dial sleeve.

[0087] The encoding 21 includes a ratchet profile 22 facing radially inward of the ring 21. The ratchet profile 22 includes teeth forming a bottom section and a top section. A substantially cylindrical portion of the chassis 19 is located within the circular space defined by the ring 21.

[0088] The distal face of the PCBA of the electronic control unit 110 includes a first electrical contact 23a, a second electrical contact 23b, a third electrical contact 23c (FIG. 3b), and a fourth electrical contact 23d (FIG. 3b). In the illustrated exemplary embodiment, each of the electrical contacts 23a, 23b is formed as an elastically deflectable lever, one end of the lever being permanently attached and connected to the PCBA 110, and the opposite free end being deflectable. The free end of the first lever forming the first contact 23a projects through an opening in the chassis 19 towards the ring 21 and the dose dial component attached to the ring 21.

[0089] A substantially annular spring member is disposed between the ring 21 and the chassis 19, and the free end of the spring member forms a detent 25 or an arm 24 having a projection. The detent 25 is applied to the shape of the ratchet profile 22 such that the detent 25 can enter the bottom section and slide over the top section of the ratchet profile 22. The annular spring member is axially and non-rotatably constrained to the chassis 19, so that when the ring 21 and the ratchet profile 22 rotate relative to the chassis 19, the arm maintains its position relative to the chassis 19.

[0090] The third electrical contact 23c and the fourth electrical contact 23d are disposed on a flex board section 26 (FIG. 3b) of the PCBA 110 that extends distally into the space between the ring 21 and the chassis 19. On this flex board section 26, the third electrical contact 23c and the fourth electrical contact 23d are arranged side by side but separated from each other.

[0091] In the default state of the drug delivery device, i.e., when the drug delivery device is not being actuated or operated by the user, the chassis 19, the ring 21, the arm 24, and the lever are arranged in the state shown in FIG. 2b. In this default state, as will be described below, both the axial switch and the rotational switch of the switch assembly 20 are open.

[0092] In the embodiments shown in these figures, at the default position, the first electrical contact 23a and the second electrical contact 23b are spaced apart from each other such that the circuit between the first electrical contact 23a and the second electrical contact 23b is open. Further, the third electrical contact 23c and the fourth electrical contact 23d are separated from each other and spaced apart from the arm 24 such that the circuit between the third electrical contact 23c and the fourth electrical contact 23d is open.

[0093] During dose setting, i.e., when the user selects to dispense a larger or smaller dose from the drug delivery device 1, the dial grip 12 is rotated relative to the housing 10 by the user. This causes the simultaneous rotation of the chassis 19 and the encoder ring 21 which are non-rotatably coupled to each other via a clutch (not shown) in the dose setting and drive mechanism of the drug delivery device 1. Due to the simultaneous rotational movement of the chassis 19 and the encoder ring 21, the relative arrangement of the chassis 19, the ring 21, and the levers and arms remains the same as in the default state shown in Figure 2b. During dose setting, as the selected dose is increased, the dial grip 12 having the chassis 19 and the encoder ring 21 moves along a helical path and is thereby extended from the housing 10.

[0094] With the dose set on the dial, the user can initiate dose dispensing by axially pressing the proximal end of the dial grip 12. This causes the clutch to disengage, rotatably decoupling the chassis 19 and the encoder ring 21 and non-rotatably coupling the dial grip 12 having the chassis 19 to the housing 10 of the drug delivery device 1. This axial movement includes a limited relative axial movement of the chassis 19 with respect to the encoder ring 21. Figure 2c shows the switch assembly 20 after this limited relative axial movement.

[0095] Due to this limited axial movement of the chassis 19 with respect to the encoder ring 21, the first lever having the first electrical contact 23a abuts against a component member connected to the ring 21, and thus the free end of the first lever is deflected proximally (upward in the figure). The second lever of the second electrical contact 23b remains in its position. Due to the relative movement of the levers, the levers abut against each other, thereby closing the circuit by connecting the first electrical contact 23a and the second electrical contact 23b.

[0096] With only axial movement, the position of the arm 24 with respect to the third electrical contact 23c and the fourth electrical contact 23d does not change. Thus, the rotary switch remains open.

[0097] Closing the axial switch of the switch assembly 20 occurs not only during this transition from the dose setting operation to the dose delivery operation of the drug delivery device 1, but also in the 0U dial setting state of the drug delivery device 1, i.e., before dose setting, when the dial grip 12, and thus the chassis 19, is pressed and moves axially with respect to the encoder ring 21.

[0098] This first switch operation mode is preferably used to activate the communication unit 140, i.e., to switch the communication unit 140 from the sleep mode to the operation mode and to initiate manual synchronization and / or pairing of the communication unit 140 with another device. This can be caused by the electronic control unit 110 in response to a signal generated by closing the axial switch between the levers forming the first contact 23a and the second contact 23b.

[0099] When the dial grip 12 is further depressed, the dial grip 12 having the chassis 19 is axially pushed back into the housing 10, and the encoder ring 21 rotates back into the housing 10 again along the spiral path. In other words, by dosage dispensing, a relative rotational movement of the encoder ring 21 with respect to the chassis 19 is caused. During this rotational movement, the first and second contacts 23a, 23b remain connected. However, during this rotation, the rotary switch changes between an open state where the arm 24 is not in contact with the flex board section 26 holding the third electrical contact 23c and the fourth electrical contact 23d, and a closed state where the arm 24 is deflected radially inward toward the flex board section 26, thereby connecting the third electrical contact 23c and the fourth electrical contact 23d via the arm 24. When the ring 21 rotates relative to the chassis 19, the arm detent 25 alternately engages with the bottom section of the ratchet profile 22, thereby opening the rotary switch, or engages with the top section of the ratchet profile 22, thereby deflecting the arm 24 to bridge the third electrical contact 23c and the fourth electrical contact 23d, thereby closing the rotary switch. Thereby, the second switch operation mode of the switch assembly 20 is configured. The rebound of the detent 25 into the bottom section of the ratchet profile 22 during this dosage dispensing operation can generate tactile and / or audible feedback to the user.

[0100] When the electronic system closes the electrical connection between the third electrical contact 23c and the fourth electrical contact 23d via the arm 24 during this second switch operation mode, it is preferable that the rotation sensor 120 is switched from the sleep mode to the operation mode and configured to start motion detection. This can be done by the electronic control unit 110 in response to a signal generated by alternately closing the rotary switch. The axial switch remains continuously engaged throughout the rotational movement of the encoder ring 21.

[0101] When the user releases the dial grip 12, both the axial switch and the rotational switch of the switch assembly 20 open, and subsequently the operations described above are reversed.

[0102] A second embodiment of the switch assembly 30 is shown in FIGS. 3a - 3b.

[0103] In the switch assembly 30, the arrangement of the button module 11 with the PCBA of the electronic control unit 110, the dial grip 12, and the module chassis 19, as well as the arrangement of the encoding 21 having the ratchet profile 22 and the arm 24, are the same as those of the switch assembly 20. However, the lever forming the first and second contacts 23a, 23b is moved from the distal surface of the PCBA 110 to the proximal surface of the PCBA 110 (not shown). An axial switch is formed near or at the proximal end of the dial grip 12.

[0104] It will be appreciated that the operation of the switch assembly 30 is substantially the same as the operation described above with respect to the switch assembly 20. In other words, both the axial switch and the rotational switch are open in the default state and during dose setting.

[0105] Furthermore, during the transition from the dose setting operation to the dose delivery operation of the drug delivery device 1, or in the 0U dial setting state of the drug delivery device 1, i.e., before dose setting, when the dial grip 12, and thus the chassis 19, is pressed and moves axially with respect to the encoding 21, the rotational switches 23c, 23d, 24 remain open, but the axial switch is closed. This first switch operation mode is preferably used to activate the communication unit 140, i.e., to switch the communication unit 140 from the sleep mode to the operation mode and initiate manual synchronization and / or pairing of the communication unit 140 with another device.

[0106] Furthermore, during the dose delivery operation, the axial switch remains closed while the rotational switch opens and closes alternately. Preferably, when the electronic system closes the electrical connection between the third electrical contact 23c and the fourth electrical contact 23d during this second switch operation mode, the rotational sensor 120 is switched from the sleep mode to the operation mode so that the rotational sensor 120 starts motion detection.

[0107] Although mainly described with respect to a drug delivery device having a working principle similar to that of the device disclosed in EP2890435, the electronic system is applicable to any other type of drug delivery device having component members that perform relative axial and / or rotational movement under defined conditions or states.

Description of the reference numerals

[0108] 1 Device 10 Housing 11 Button module 12 Dial grip 13 Dosage window 14 Container / container receptacle 15 Needle 16 Inner needle cap 17 Outer needle cap 18 Cap 19 Module chassis 20 Switch assembly 21 Encoding 22 Ratchet profile 23a - 23d Electrical contacts 24 Arm 25 Check valve 26 Flexible board section 30 Switch assembly 100 Electronic system 110 Electronic control unit (PCBA) 120 Encoding and motion sensing unit 130 Usage detection unit 140 Communication unit 150 Power supply

Claims

Claim 1 A switch assembly for an electronic system of a drug delivery device (1), comprising: a chassis (19) supporting a PCBA (110) including at least a first electrical contact (23a), a second electrical contact (23b), a third electrical contact (23c), and a fourth electrical contact (23d); a ring (21) having an annular ratchet profile (22); wherein the chassis (19) moves axially relative to the ring (21) from a first axial position to a second axial position during a first switch operating mode or when the chassis (19) is depressed in a 0U dial setting state of the drug delivery device (1), and the chassis (19) and the ring (21) are configured such that the ring (21) rotates relative to the chassis (19) during a second switch operating mode; the first electrical contact (23a) and the second electrical contact (23b) are arranged such that an electrical connection between the first electrical contact (23a) and the second electrical contact (23b) closes when the chassis (19) moves axially towards the ring (21) during the first switch operating mode; an elastically deformable arm (24) is placed radially between the ratchet profile (22) of the ring (21) and the chassis (19), and is axially and non-rotatably constrained to the chassis (19), and the arm (24) elastically deforms radially towards the chassis (19) at least during the second switch operating mode, thereby alternately opening and closing an electrical connection between the third electrical contact (23c) and the fourth electrical contact (23d) via the arm (24) as it is guided over the ratchet profile (22), characterized in that the switch assembly. Claim 2 The switch assembly according to claim 1, wherein the first axial position is an axial position further away from the ring (21), and the second axial position is an axial position closer to the ring (21). Claim 3 The switch assembly according to claim 1 or 2, wherein the first switch operating mode is a mode related to the transition of the drug delivery device (1) from a dose setting operation to a dose delivery operation, and the second switch operating mode is a mode related to the dose delivery operation of the drug delivery device (1). Claim 4 The switch assembly according to any one of claims 1 to 3, wherein the arm (24) includes a detent (25) or a protrusion applied to engage with the ratchet profile (22) of the ring (21).

5. The switch assembly according to any one of claims 1 to 4, wherein the arm (24) is part of a substantially annular conductive spring member, biased to abut against the ratchet profile (22) of the ring (21), and can be at least partially deflected radially inward into the annular space between the ring (21) and the chassis (19).

6. The switch assembly according to any one of claims 1 to 5, wherein the third electrical contact (23c) and the fourth electrical contact (23d) are provided on a flexible flap or flex board section (26) of the PCBA (110) that extends distally from the PCBA (110) to a position between the ring (21) and the chassis (19).

7. The switch assembly according to claim 6, wherein the arm (24) alternately contacts the bottom section and the top section of the ratchet profile (22) during the second switch operation mode, thereby elastically deflecting to connect to the third electrical contact (23c) and the fourth electrical contact (23d) and disconnecting from the third electrical contact (23c) and the fourth electrical contact (23d).

8. The switch assembly according to any one of claims 1 to 7, wherein the first electrical contact (23a) is a first lever having one end attached to the PCBA (110) and a free end on the opposite side, and the second electrical contact (23b) is a second lever having one end attached to the PCBA (110) and a free end on the opposite side. The free ends of the levers are arranged such that when the chassis (19) moves axially towards the ring (21) during the first switch operation mode, at least the first lever is deflected with respect to the second lever to close the electrical connection between the first electrical contact (23a) and the second electrical contact (23b).

9. The first lever extends through the chassis (19), and its free end protrudes from the chassis (19). At this position, when the chassis (19) moves axially towards the ring (21) during the first switch operation mode, the ring (21) or a component member connected to the ring (21) deflects the first lever. The switch assembly according to claim 8.

10. The first lever and the second lever are located within a space formed radially inside the ring (21) within the chassis (19). The switch assembly according to claim 8 or 9.

11. Further including a housing (10) and a dial grip (12), the axial movement of the chassis (19) towards the ring (21) during the first switch operation mode is caused by an axial displacement of at least a portion of the dial grip (12) relative to the housing (10), thereby closing the gap between the first electrical contact (23a) and the second electrical contact (23b). The switch assembly according to any one of claims 1 to 7.

12. The first electrical contact (23a) and the second electrical contact (23b) are arranged on the proximal side of the PCBA (110) facing away from the ring (21). The switch assembly according to claim 11.

13. A drug delivery device including an electronic system (100) having a switch assembly (20, 30) according to any one of claims 1 to 12, comprising: A dose setting operation for setting a dose to be delivered by the drug delivery device, and a dose delivery operation for delivering the set dose, and a dose setting and drive mechanism including a ring (21), An electronic control unit (110) on the PCBA, a rotation sensor (120), a communication unit (140) having a wireless communication interface for communicating with another device, and a usage detection unit (130) including a chassis (19). A button module (11), wherein the electronic control unit (110) is configured to control the operation of the electronic system, and including the button module. Here, the button module (11) and the dosage setting and driving mechanism are configured such that the dosage dial assembly connected to the ring (21) rotates with respect to the button module (11) during the dosage delivery operation, does not rotate with respect to the button module (11) during the dosage setting operation, and the button module (11) moves axially with respect to the dosage dial assembly during the transition from the dosage setting operation to the dosage delivery operation or when the button module (11) is pressed in the 0U dial setting state. When the electronic system closes the electrical connection between the first electrical contact (23a) and the second electrical contact (23b) during the first switch operation mode, the communication unit (140) is switched from the sleep mode to the operation mode, and the communication unit (140) is configured to start manual synchronization and / or pairing with another device. When the electronic system closes the electrical connection between the third electrical contact (23c) and the fourth electrical contact (23d) via the arm (24) during the second switch operation mode, the rotation sensor (120) is switched from the sleep mode to the operation mode, and the rotation sensor (120) is configured to start motion detection. The drug delivery device.

14. The drug delivery device according to claim 13, wherein the rotation sensor (120) includes a light source and a corresponding optical sensor.

15. The drug delivery device according to claim 13 or 14, wherein the rotation sensor (120) includes an encoding (21).

16. The drug delivery device according to any one of claims 13 to 15, further comprising a container receptacle (14) that is permanently or releasably connected to the dosage setting and driving mechanism and is adapted to receive a container containing a drug.

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