Electrical system for a drug delivery device and drug delivery device

Abstract

An electrical system for a drug delivery device (1) is proposed, the electrical system including an electrical liquid sensing unit (160), the electrical liquid sensing unit including at least one liquid sensing arrangement (163), the electrical liquid sensing unit configured to react to exposure of the liquid sensing arrangement to liquid (50), and the electrical system configured to change its state from a normal state to an error state in response to exposure of the at least one liquid sensing arrangement to liquid.

Description

[Background technology]

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

[0002] Drug delivery devices that include or are configured to be operated with one or more electronic components are becoming increasingly popular within the industry and with users as they provide various advantages over traditional drug delivery devices that rely solely on mechanical systems rather than using electrical devices. An example of such a drug delivery device is disclosed in WO 2019 / 101962 A1. Here, a sensor system is used to determine the size of the delivered dose based on an optically performed measurement of the rotation of one member of the dose setting and driving mechanism of the drug delivery device relative to another member of the dose setting and driving mechanism during a dose delivery operation. The determined dose can be used to generate a dose log regarding the doses delivered from the device by the user. Devices with electronic components are naturally more sensitive to external environmental effects on the electronic components, such as exposure to liquids, compared to devices without electronics. 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 electrical systems for drug delivery devices and devices including such systems.

[0004] This object is achieved, for example, by the subject matter of the independent claims, but the present disclosure should not be understood as being limited to the subject matter claimed in the independent claims. Further advantages, advantages and improvements of the present disclosure are set forth below and in the dependent claims. [Means for solving the problem]

[0005] One aspect of the disclosure relates to an electrical system for a drug delivery device. Another aspect of the disclosure relates to a drug delivery device including the electrical system. Thus, features disclosed herein with respect to the electrical system are also disclosed with respect to the device and vice versa.

[0006] In one embodiment, the electrical system includes at least one electrical unit. The electrical unit may be, for example, an electronic unit including at least one electronic component, or a non-electronic unit, for example a power supply. The system may include multiple electrical units.

[0007] In one embodiment, the electrical system includes a liquid sensing unit, in particular an electrical liquid sensing unit. The liquid sensing unit may be arranged and configured to operate in response or reaction to exposure of the electrical system, preferably the liquid sensing unit, to a liquid. By means of the liquid sensing unit, the electrical system may induce or bring about a change in its state. The change in state may be brought about by the liquid sensing unit and its exposure to a liquid.

[0008] In one embodiment, the liquid sensing unit includes at least one liquid sensing arrangement. The liquid sensing arrangement may be arranged and configured to be exposed, e.g. directly exposed, to the liquid. The liquid sensing arrangement may be specifically arranged where the liquid tends to enter the electrical system, e.g. approach the exterior of the system. The liquid sensing arrangement may be positioned in or along a path between the exterior of the electrical system and an electrical unit, e.g. an electronic unit, of the electrical system. In this way, the liquid sensing arrangement is exposed to the liquid before the liquid reaches the electrical unit. As a result, an appropriate measurement may be taken or triggered in response to the exposure. The liquid sensing unit may be configured to react to the exposure of the liquid sensing arrangement to the liquid.

[0009] In one embodiment, the electrical system is configured to change its state in response to exposure of at least one liquid-sensing arrangement to liquid. The system may be configured to change its state from a normal state to an error state. In the normal state, the electrical system is operable. In short, the electrical system may perform the functions envisaged during (dose delivery) operation of the drug delivery device, e.g. performing recording or collection of dose information. In the error state, the electrical system may be fully operable or not fully operable, e.g. not operable or operable but with one or more selectively disabled electrical units.

[0010] The electrical system may be configured to indicate that the electrical system has been exposed to liquid, preferably if the electrical system is capable of operating in an error state. The indication may be or may include an error code generated by the system. The indication may be transmitted, for example wirelessly, to another device, for example a PC, laptop, smartphone or smartwatch, and / or may be recorded in a memory, preferably a non-volatile memory, of the system. Via the indication, information may be retrieved from the electrical system or provided by the electrical system that the functionality of the electrical system has been affected by exposure of a component of the electrical system, for example its electronic unit, to liquid. Instead of or in addition to an error code, the indication may include an alarm, for example a visual, audible or tactile alarm, which may be generated by the electrical system in response to exposure of the liquid-sensing arrangement to liquid. Now that it is known that the electrical system has been exposed to liquid, appropriate measures may be taken, for example by the user and / or medical personnel, by inquiring about the accuracy of the dosage information collected by the electrical system.

[0011] If the electrical system is not fully operable in the error state, the electrical system may be configured to switch off one or more functions or units of the electrical system, e.g. only temporarily or permanently, as long as the liquid sensing unit provides information about continued exposure to liquid. If the electrical system is not operable in the error state, the system may be unpowered. For example, switching from a normal state to an error state may be achieved by draining power from a power source of the electrical system, preferably only from the power source of the system. Power may be drained from the power source through the liquid sensing unit when the unit is exposed to liquid. The power source may be a rechargeable or non-rechargeable battery. In the error state, the power source may be unpowered. In short, the power source may not have enough power stored therein to operate the electrical system.

[0012] In one embodiment, the liquid sensing unit, e.g., at least one liquid sensing arrangement, is configured to respond to exposure to a conductive liquid, e.g., non-distilled water. Most liquids to which the delivery device is exposed are usually conductive. In particular, a user of the drug delivery device may accidentally place the device in an area exposed to liquid or spill liquid on the device. The conductivity of the liquid may be utilized to detect that the liquid sensing arrangement is exposed to the liquid and / or to switch the system to an error state.

[0013] In one embodiment, the liquid sensing unit, e.g., at least one liquid sensing arrangement, is configured to be insensitive to exposure to non-conductive liquids, e.g., distilled water. Since non-conductive liquids are very rare in the normal use environment of drug delivery devices, having a system that only responds to conductive liquids should cover almost all practical liquid exposure situations.

[0014] In one embodiment, the liquid sensing unit is configured to respond to exposure of the liquid sensing arrangement to liquid by changing an electrical property of the liquid sensing unit. The electrical property may be an electrical resistance, for example between conductors of the liquid sensing arrangement (see further below). Exposure to liquid may result in a lowering of the resistance due to the conductive liquid contributing to the electrical conductivity of the liquid sensing arrangement or liquid sensing circuit of the liquid sensing unit. The liquid may conductively connect two conductors of the liquid sensing arrangement.

[0015] In one embodiment, the liquid sensing arrangement includes a first surface. The liquid sensing arrangement may include a second surface. Each surface may be electrically conductive. The first surface may be a surface of a first conductor. The second surface may be a surface of a second conductor. The first and second surfaces may face in the same direction. The first and / or second surfaces may be planar. The first and / or second surfaces may be arranged and configured to be contacted by a liquid, for example by a droplet of a liquid. In other words, the first and second surfaces may be exposed. The first and second surfaces may be arranged to be contacted simultaneously by a liquid, for example by a droplet of a liquid such as water. Exposure of the surface or conductor to a liquid may change an electrical characteristic or property, for example a resistance, of the liquid sensing unit or the liquid sensing arrangement. This change may cause the electrical system to switch its state, for example from a normal state to an error state.

[0016] In one embodiment, the first surface and the second surface are electrically insulated or electrically isolated from each other. The first conductor and the second conductor may be conductors at different potentials or at the same potential during operation of the system.

[0017] In one embodiment, the system includes a conductor carrier, e.g. a circuit board such as a printed circuit board. The at least one liquid sensing arrangement may be provided on the conductor carrier. The first surface and the second surface may be provided and / or extend along the conductor carrier. The first conductor and / or the second conductor may be provided on the conductor carrier. For the first conductor and the second conductor, the conductor carrier may be a common conductor carrier. In other words, both conductors may be provided on the conductor carrier. The first surface and the second surface may be arranged on the same side or surface of the conductor carrier.

[0018] In one embodiment, the first and second surfaces may be electrically conductively connected by a conductive liquid, e.g., a droplet of the liquid, e.g., bridging a gap between the first and second surfaces. When the first and second surfaces are conductively connected, the first conductor and the second conductor are also conductively connected.

[0019] In one embodiment, the first and second surfaces are arranged such that the maximum distance between the first and second surfaces is equal to or less than one of the following values: 2 mm, 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm. This distance may specify the size of the gap between the first and second surfaces. The smaller the distance, the higher the sensitivity to droplets or drops of liquid may be. Furthermore, the smaller the distance, the less space is consumed by the liquid sensing arrangement, for example on a conductor carrier or a circuit board.

[0020] In one embodiment, the electrical system includes a system housing. The first surface and / or the second surface may be disposed inside the system housing. The liquid sensing unit, preferably the entire liquid sensing unit, may be disposed inside the system housing. The system housing may be or may include a user interface member body of a user interface member of a drug delivery device or a user interface member body of a user interface member for a drug delivery device. In other words, the electrical system may be or may include a user interface member for a drug delivery device, such as a knob and / or a button. The user interface member body of the user interface member may be operated by a user, for example by touching an external surface of the user interface member body, for a dose setting operation and / or a dose delivery operation of the drug delivery device. The operation may involve a movement of the user interface member, for example relative to a device housing of the drug delivery device and / or relative to a drug reservoir or a drug reservoir container of the drug delivery device. The movement may involve an axial movement (e.g. for dose delivery) and / or a rotational movement (e.g. for dose setting) of the user interface member.

[0021] In one embodiment, the first conductive surface extends, for example circumferentially, along the (outer) circumference of the second conductive surface or second conductor, preferably along the entire circumference of the second surface or second conductor, and / or when the first surface and / or second surface are viewed from above. Between the outer circumference of the second surface or conductor and the inner circumference of the first surface or conductor, a gap may be formed that the liquid can bridge to trigger the liquid sensing unit, for example to switch from a normal state to an error state. The first surface may circumferentially surround the entire second surface, so that liquid sensing can occur along the entire (outer) circumference of the second surface.

[0022] In an embodiment, at least one of the first and / or second conductive surfaces defines or delimits an interior, for example when the first and second surfaces are viewed from above and / or when the conductor carrier is viewed from above. Preferably, the first and second surfaces define or delimit an interior. The second surface may be disposed in the interior defined or delimited by the first surface. The first and / or second surfaces may be circumferentially closed. The first and / or second surfaces may be ring-shaped. For example, the first and second surfaces may extend along the periphery or edge of the conductor carrier. At least one electrical component may be disposed in the interior defined by the first and / or second surfaces. The electrical component may be an electronic component or a non-electronic component. The component may be mounted on the conductor carrier. The liquid sensing arrangement may thus surround the component. Hence, exposure of the system to liquid may be detected before the liquid reaches the component. The component is advantageously sensitive, for example being damaged or no longer functioning properly when exposed to liquid. The components may include any one or any selected multiple or all of the components of the respective electrical units or any one or more of the components described further below.

[0023] In one embodiment, the first surface and / or the second surface is provided or formed by a conductive coating, e.g. a metal or alloy coating. The coating may cover a portion of the conductor associated with the surface, i.e. the first conductor for the first surface or the second conductor for the second surface. The covered portion of the conductor may not be exposed, i.e. the covered portion of the conductor may not be accessible to liquid. Preferably, the coating is less susceptible to oxidation than the portion of the conductor underneath the conductive coating (i.e. the covered portion of the conductor covered with the conductive coating). The coating may be made of or include a noble metal, e.g. gold. The portion underneath the coating may be made of or include a non-noble metal, e.g. copper. The coating may form the entire exposed surface of the liquid sensing arrangement. Providing a coating promotes stability of the liquid sensing properties of the liquid sensing arrangement even when the arrangement can be or is exposed to an oxygen-containing environment, such as during storage or use. Without the coating, the first surface and / or the second surface may easily become oxidized, which may alter the electrical properties of the liquid sensing arrangement, resulting in inconsistent liquid detection or response to liquid exposure over time. The electrical system may have to be ready for operation for an extended period of time, such as one or more years, or more, such as three or more years or more. During that period, the liquid sensing unit should reliably respond to exposure to liquid in a consistent manner, regardless of how long the electrical system is used or stored.

[0024] In an embodiment, the first surface and the second surface are separated by an insulating region. The insulating region may be an electrically insulating region. The insulating region may be formed from an electrically insulating member. The insulating region may be a region of the conductor carrier. The insulating region may be arranged between the first surface and the second surface. The insulating region may directly connect the first surface and the second surface. In short, when the arrangement with the first surface, the insulating region and the second surface is viewed from above (e.g. when the conductor carrier is viewed from above), the insulating region may directly adjoin the first surface and the second surface. The insulating region may extend between the first surface and the second surface, e.g. when the conductor carrier is viewed from above, preferably along the entire (inner) periphery of the first surface and / or along the entire (outer) periphery of the second surface. The insulating region may be part of the liquid sensing arrangement.

[0025] In one embodiment, the surface of the conductor carrier within the insulating region, including the first surface, the insulating region, and the second surface, is non-planar, eg, contoured.

[0026] In one embodiment, the insulating region protrudes with respect to at least one of the first surface and the second surface. The insulating region may protrude with respect to the first surface (only) or the second surface (only) or both surfaces. Thus, the surface of the conductor carrier may have a contoured or structured surface in the area of ​​the liquid sensing configuration. The non-planar surface configuration of the liquid sensing configuration may enhance the formation of droplets or the confinement of droplets in the area with the contoured surface. As the contoured surface is provided in the area of ​​the liquid sensing configuration, liquids can be more easily held in certain appropriate places and can be used to trigger a reaction of the liquid sensing unit by their presence.

[0027] In one embodiment, the insulating region is recessed relative to at least one of the first surface and the second surface. The insulating region may be recessed relative to the first surface (only) or the second surface (only) or both surfaces. This may also assist in forming a contoured surface.

[0028] In one embodiment, the liquid sensing unit includes a plurality of liquid sensing configurations. The liquid sensing configurations may be separated from each other. The liquid sensing configurations may be arranged in different regions of the electrical system, for example in different regions of the conductor carrier. The liquid sensing unit may include a number of liquid sensing configurations that are 2, 3, 4, 5, 6, 7, 8 or more. The liquid sensing unit may include a number of liquid sensing configurations that are 14, 13, 12, 11, 10, 9, 8 or less. Each liquid sensing configuration may have a first conductive surface and / or a second conductive surface. The first conductive surfaces of the different liquid sensing configurations may be spatially separated from each other. The same may apply to the second conductive surfaces of the different liquid sensing configurations. Each liquid sensing configuration may be configured as described above. The plurality of liquid sensing configurations may be distributed, for example uniformly and / or circumferentially or angularly, on one surface of the conductor carrier. The circumferential or angular orientation may be determined with respect to a vertical plane of the main surface of the conductor carrier, for example through the center of the geometry of that plane. At least one liquid sensing arrangement may be provided on one surface of the conductor carrier (e.g. the first major surface of the conductor carrier) and at least one liquid sensing arrangement may be provided on another, preferably opposite, surface of the conductor carrier (e.g. the second major surface of the conductor carrier). The first conductive surfaces of the different liquid sensing arrangements may be formed by a common first conductor. In short, the first conductive surfaces may be directly conductively interconnected and / or of the same potential when the liquid sensing unit is operated. Of course, it is also possible that different conductors are used to provide the respective first conductive surfaces. It may be more efficient to have one conductor, which provides different first conductive surfaces to the different liquid sensing arrangements. The second conductive surfaces of the different liquid sensing arrangements may be formed by a common second conductor. Again separate conductors may provide the second conductive surfaces of the respective liquid sensing arrangements.

[0029] In one embodiment, the liquid sensing configurations are distributed around the electrical components, preferably on the conductor carrier. The components may be electronic or non-electronic components. Alternatively or additionally, the liquid sensing configurations may be distributed along the circumference of the conductor carrier. In this way, multiple sensing components may be surrounded by a group of liquid sensing configurations. The components may again be any one of the electrical components or electrical units discussed further below, such as, for example, a component of one of the units described below. Also, two or more components on the conductor carrier may be surrounded by liquid sensing configurations, for example, components of the same group.

[0030] In one embodiment, the at least one electric unit includes at least one, any selected plurality or all of the following: - an electronic control unit. The electronic control unit may include a processor, e.g. a microcontroller or an ASIC (Application Specific Integrated Circuit). The electronic control unit may control the operation of the electrical system and perform various functions of the electrical system, such as directing the electrical system to measure the relative movements of the members of the dose setting and drive mechanism of the drug delivery device. The electrical system may be configured to calculate dosage information, e.g. within the electronic control unit, from the results of the measured relative movements. A communication unit. The communication unit may be an electronic unit. The communication unit may be a wireless communication unit. The communication unit may be configured to provide an interface to an external device, such as a PC, a laptop, a smartphone or a smartwatch. - a memory unit. The memory unit may be an electronic unit. The memory unit may be configured to store the dosage information. The memory unit may be or include a non-volatile electronic memory. - A power source. The power source may be an electric unit. The power source advantageously provides power to the electric system for operating the electric system. The power source may be connected to the electronic control unit. The power source may be pre-charged. The power source may be a rechargeable or non-rechargeable battery. a feedback unit, e.g. an optoelectronic unit; the feedback unit may be configured to provide feedback or an alert, e.g. a visual feedback or alert, to a user about the status of the system, e.g. whether the system is in a normal state or in an error state. The feedback unit may include one or more light emitting diodes. - a sensing unit, e.g. a motion sensing unit. The (motion) sensing unit may include a sensor, e.g. one or more sensors. The (respective) sensor may be an electronic sensor, e.g. an optoelectronic sensor. The (respective) sensor may provide a measurement or reading that is sensitive to the presence of liquid, e.g. at the sensor or in a detection area covered by the sensor. In other words, liquid may have a detrimental effect on the performance of the sensor and / or the accuracy of its readings. The (respective) sensor may be an electrical and / or optical motion sensor, e.g. a radiation detector. The motion sensing unit may be configured to provide information of the size of the set and / or the delivered dose based on the readings taken by the sensor during operation of the system and / or the drug delivery device.

[0031] In one embodiment, the first conductive surface and / or the second conductive surface or associated conductors are preferably directly conductively connected to an electrical unit, which may be part of the liquid sensing unit. In this way, when the liquid sensing arrangement is exposed to a liquid, the liquid may provide a conductive connection between the first and second surfaces that did not exist before the liquid was exposed.

[0032] The electrical unit may be a power source. A conductive connection between the first surface and the second surface preferably shorts, thereby discharging the power source. When the power source is discharged, the electrical system may be unable to operate. This provides a fail-safe response of the electrical system to exposure to liquid, since exposure to liquid drains power from the power source, and power is no longer provided to the electrical system. When power is completely drained due to continued presence of liquid, the system can no longer operate. When the electrical system is unable to operate, functionality of the drug delivery device, including the electrical system for setting and delivering a dose of drug, may still be available. However, dose information can no longer be collected and / or recorded by the electrical system.

[0033] Alternatively or in addition, the electrical unit may be or include an electronic control unit. The conductive connection between the first and second conductive surfaces may be detectable by the electronic control unit, for example, by a change in an electrical characteristic of the first and second surfaces and a circuit that preferably includes the electronic control unit. The change in the electrical characteristic may be detectable by and / or can be evaluated in the electronic control unit. The electrical characteristic, for example, resistance, may be monitored by the electronic control unit. If the electronic control unit indicates, based on the monitored characteristic, that the liquid sensing arrangement has been exposed to liquid (which may mean a lower resistance detectable by the electronic control unit), the electronic control unit may react to the liquid exposure. For example, the electronic control unit may generate a corresponding error code, which may be transmitted to an external device and / or stored in a memory unit to indicate that the electrical system has been exposed to liquid. Alternatively or in addition, selected units that may be affected by liquid may be disabled, or all electrical functions or units are disabled. If the system's electrical or electronic functions are exposed to liquid, then calculations such as the delivered dose from the data generated by the motion sensing unit may not be performed properly. Once liquid exposure is detected via the liquid sensing unit, appropriate measures can be taken, such as by not considering the calculated dose information for the dose history or by correcting the dose information. In response to detecting liquid exposure, the electronic control unit may command the feedback unit to generate a visual signal indicating an error condition of the system.

[0034] In one embodiment, the drug delivery device is a pen device and / or an injection device.

[0035] In one embodiment, the drug delivery device is of the dial-extension type, i.e. the user interface member that is moved during the dose setting operation is displaced away from the housing of the drug delivery device by an amount proportional to the size of the set dose (setting the dose is also called dialing the dose).

[0036] In one embodiment, the drug delivery device includes a drug reservoir and / or a reservoir container, e.g., a cartridge holder, for receiving the drug reservoir. The reservoir, e.g., a cartridge, may hold a drug. The reservoir container may be releasably coupled to the housing of the drug delivery device for replacing a used reservoir with a new one. Alternatively, the reservoir container may be permanently coupled to the housing.

[0037] In one embodiment, the drug delivery device comprises a drug delivery device unit, and the electrical system may be preferably releasably attached to the drug delivery device unit, where the drug delivery device unit has a reservoir container that is preferably permanently coupled to the housing.

[0038] In one embodiment, the electrical system may be integrated into the drug delivery device, e.g., such that it is permanently removable from the device. In this case, the reservoir container or reservoir is preferably releasably coupled to the housing so that a new reservoir can be operably coupled to the dose setting and drive mechanism of the drug delivery device.

[0039] In one embodiment, the drug delivery device is a portable device, which is a device that is carried by a user, for example in a bag, for use when needed, and therefore these devices are particularly prone to exposure to liquids.

[0040] In one embodiment, the drug delivery device is a self-administration device, This type of device is used by persons who are not medically trained to administer drugs.

[0041] It is to be noted that the features described above or below in connection with different aspects or embodiments may be combined with each other.

[0042] In a particularly advantageous embodiment, an electrical system for a drug delivery device comprises: an electric liquid sensing unit, the electric liquid sensing unit comprising at least one liquid sensing arrangement, the electric liquid sensing unit being configured to respond to exposure of the liquid sensing arrangement to a liquid; The electrical system is configured to change a state of the at least one liquid sensing arrangement from a normal state to an error state in response to exposure of the at least one liquid sensing arrangement to liquid.

[0043] Further features, advantageous embodiments and advantages of the subject matter of the present disclosure are described below in conjunction with the drawings. [Brief description of the drawings]

[0044] [Figure 1] 1 illustrates an embodiment of a drug delivery mechanism. [Diagram 2] 1 illustrates an embodiment of an electronic system. [Diagram 3] 1 shows an embodiment of a liquid sensing unit. [Figure 4] 1 shows another embodiment of the liquid sensing unit. [Figure 5A-5B] 1 shows an embodiment of a liquid sensing unit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Identical features, identically acting features, and features of the same type may be provided with the same reference numbers in the drawings.

[0046] In the following, some embodiments are described with reference to insulin infusion devices. However, the present disclosure is not limited to such applications and may be equally deployed with infusion devices configured to dispense other medicaments or drug delivery devices in general, preferably pen-type devices and / or infusion devices. Embodiments are provided relating to infusion devices, and in particular to variable dose infusion devices, which record and / or track data relating to the doses delivered by the device. These data may include the size of the selected dose and / or the size of the actual delivered dose, the time and date of administration, the duration of administration, etc.

[0047] Some embodiments of this document are shown in the context of an injection device in which an injection button and a grip (dose setting member or dose setter) are combined. Such devices are disclosed, for example, in WO 2014 / 033195 A1 or WO 2014 / 033197 A1, the disclosure contents of which are incorporated herein in their entirety for all purposes. The injection button may provide a user interface member for initiating and / or executing a dose delivery operation of the drug delivery device. The grip or knob may provide a user interface member for initiating and / or executing a dose setting operation. Both 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 button during dose setting and dose ejection operating modes are known, for example the Kwikpen® device marketed by Eli Lilly and the Novopen® 4 device marketed by Novo Nordisk. The application of the general principles to these devices is therefore clearly straightforward and will not be further described. However, the general principles of the present disclosure are not limited to its kinematic behavior. Certain other embodiments can be devised for application to injection devices in which there is a separate injection button and grip component / dose setting member (e.g. the device disclosed in WO 2004 / 078239 A1, the disclosure of which is incorporated herein in its entirety for all purposes). Thus, there may be two separate user interface members, one for the dose setting operation and one for the dose delivery operation.

[0048] In this specification, "distal" is used to designate a direction, end or surface that is or will be positioned to face or face toward the dosing end of the drug delivery device or a component thereof and / or faces 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 away from the dosing 10 end and / or distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dosing end and / or furthest from the proximal end, and the proximal end may be the end furthest from the dosing end. The proximal face may face away from the distal end and / or toward the proximal end. The distal face may face toward the distal end and / or away from the proximal end. The dosing end may be, for example, the needle end where the needle unit is or will be attached to the device.

[0049] 1 is an exploded view of a medication or drug delivery device 1. In this example, the medication delivery device is an injection device 1, e.g. a pen-type injector such as an injection pen. The device may be as or correspond to that also disclosed in WO 2019 / 101962 A1, the disclosure of which is incorporated by reference in its entirety into the present application, in particular with regard to the dose setting and drive mechanisms and electronic functions disclosed therein.

[0050] The injection device 1 of Fig. 1 is an injection pen including a housing 10 and containing a container 14, e.g. an insulin container, or a receptacle for the container 14, e.g. with the container receptacle ...

[0051] As used herein, the terms "drug" or "medicament" are used interchangeably to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof and, optionally, a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease or otherwise enhance physical or mental comfort. Drugs or agents may be used for a limited period of time or on a regular basis for chronic conditions.

[0052] As described below, the drug or medicament may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with 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 DNA and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes and oligonucleotides. The nucleic acid may be incorporated into a molecular delivery system such as a vector, a plasmid or a liposome. Mixtures of one or more drugs are also contemplated.

[0053] The drug or agent may be placed in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs), one in each chamber. In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0054] The drugs or agents contained in the drug delivery device as described herein may be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs) and the Merck Index, 15th edition.

[0055] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g. human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or a GLP-1 receptor agonist or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor or a pharma-ceutically acceptable salt or solvate thereof or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that 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 addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0056] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0057] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0058] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, C M-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, Z P-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0059] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0060] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0061] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0062] 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 polysulfated forms of the above polysaccharides and / or pharmaceutically acceptable salts thereof.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0063] 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 functions and can fix complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).

[0064] 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 a full-length antibody polypeptide but comprises at least a portion of a full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0065] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0066] 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).

[0067] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or pharmaceutical preparation in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0068] It will be understood by those skilled in the art that modifications (additions and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0069] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or may be an integrated non-exchangeable container.

[0070] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0071] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an exchangeable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable dose to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable dose to be expelled (partial expulsion). As also described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable dose to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable dose to be expelled (partial expulsion).

[0072] 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 either by an inner needle cap 16 and an outer needle cap 17 and / or another cap 18. The insulin dose to be expelled from the injection device 1 can be programmed or "dialed" by turning the dose knob 12, and the currently programmed or set dose is then displayed via the dose window 13, for example in multiples. 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), with 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 medications, other units can be employed. It should be noted that the selected dose can likewise be displayed differently from that shown in the dose window 13 of FIG. 1. The dose window 13 may be in the form of an opening in the housing 10 that allows a user to view a limited portion of the dial sleeve 20 or number sleeve that is configured to move as the dose knob 12 is turned to provide a visual indication of the dose currently set. The dose knob 12 rotates in a helical path relative to the housing 10 when setting a dose.

[0073] In this example, the dose knob 12 includes one or more formations to facilitate attachment of a data collection device or electronic system. Alternatively, the electronic system may be integrated into the device.

[0074] The injection device 1 may be configured such that turning the dose knob 12 produces a mechanical click sound to provide audio feedback to the user. In this embodiment, the dose knob or dose button 12 also functions as the injection button 11. When the needle 15 is driven into the patient's skin area and the dose knob 12 / injection button 11 is pressed axially, the insulin dose displayed in the viewing 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 certain period of time after the dose knob 12 is pressed, the dose is injected into the patient's body. The ejection of the dose may also produce a mechanical click sound, which may be different from the sound produced by rotating the dose knob 12 while dialing the dose.

[0075] In this embodiment, during drug delivery of an insulin dose, the dose knob 12 moves axially and does not rotate back to its original position, while the dial sleeve 20 rotates back to its original position, e.g., to indicate a dose of zero units. As already mentioned, the present disclosure is not limited to insulin, but should encompass all drugs in the drug container 14, particularly liquid drugs or drug formulations.

[0076] The injection device 1 can be used for several injection processes until the insulin container 14 is empty or the expiry date of the drug in the injection device 1 is reached (e.g. 28 days after first use). In case of a reusable device, the insulin container can be replaced. If the electronic system is integrated into the device, the device is preferably reusable. If the electronic system is configured to be an accessory that can be connected to a drug delivery device unit, the unit may be a reusable unit with or for example a replaceable container or a disposable unit.

[0077] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot", for example by holding the injection device 1 with the needle 15 facing upwards, selecting 2 units of insulin and pressing the dosage knob 12, in order to remove air from the container 14 and the needle 15.

[0078] As explained above, the dose knob 12 also functions as the injection button 11 such that the same component or user interface member is operated for dialing / setting the dose and expelling / delivering the set dose.

[0079] A schematic representation of an embodiment of the electronic system is shown in Figure 2. The system 100 may include a dose setting and drive mechanism that may be part of the injection device 1 as depicted in Figure 1 or may be configured to be mechanically connected to a device unit having such a mechanism as an accessory module. The module may provide electronic functionality to a device having an electronic free drug delivery device unit (hence all electrical or electronic components may be contained in the accessory module). The exterior of the system may be defined by buttons 11 and / or knobs 12 that may form the user interface member body.

[0080] The electronic system 100 includes an electronic control unit 110. The control unit may be a control device. In particular, the control unit may include a processor arrangement, for example a microcontroller or an ASIC. The control unit 110 may also include one or more memory units, such as a program memory and a main memory. The control unit 110 is advantageously designed to control the operation of the electronic system 100. The control unit 110 may communicate with further units of the system 100 via a wired or wireless interface. The control unit 110 may transmit signals containing commands and / or data to the units and / or receive signals and / or data from the respective units. The connections between the units and the electronic control unit are symbolized by lines in FIG. 2. However, there may also be connections between the units that are not explicitly shown. The control unit 110 may be arranged on a conductor carrier, for example a (printed) circuit board (see reference number "30" in FIGS. 3 and 4). The other units of the system may include one or more components that are also arranged on a conductor carrier.

[0081] The electronic system 100 may further include a motion sensing unit 120. The motion sensing unit 120 may include one or more sensors. If an optoelectronic sensor that detects electromagnetic radiation, such as an IR sensor, is used, the motion sensing unit may additionally include a radiation emitter that emits radiation that is detected by the sensor. It should be noted, however, that other sensor systems, such as magnetic sensors, may also be utilized. A motion sensing unit with an electrically operated sensor and an electrically operated source for stimulating the sensor, such as a radiation emitter and an associated sensor, may have a particularly high power consumption and therefore power management may be particularly impactful, since the capacity of the power supply may be limited. Each sensor may have an associated radiation emitter. The motion sensing unit 120 may be designed to detect and preferably measure the relative movement of two movable members of the dose setting and driving mechanism of the drug delivery device or for the drug delivery device during a dose setting operation and / or a dose delivery operation. For example, the motion sensing unit may measure or detect the relative rotational movement of two moveable members of the dose setting and drive mechanism relative to each other, e.g. a dose dial member and a user interface member or button. Based on the motion data received or calculated from the signal of unit 120, dose information may be calculated, for example by control unit 110. The dose information may be data based on the size of the delivered dose.

[0082] The electronic system 100 may further include a usage detection unit 130. The usage detection unit may be associated with a user interface member, e.g. a button 11, such that manipulation of the member for setting and / or delivering the dose may be detected. When manipulation is detected, the usage detection unit generates or triggers the generation of a usage signal. The usage signal may be transmitted to the electronic control unit 110. In response to the signal, the electronic control unit may issue a command or signal to one, an arbitrarily selected number or all of the other electrically operated units of the system. For example, the control unit may switch each unit from a first state, e.g. a sleep or idle state with lower power consumption or an off state with no power consumption, to a second state with increased power consumption, e.g. a state in which the respective unit is operating. The switching may be performed by a corresponding switching command or signal issued by the electronic control unit to each unit. In response to the usage signal, all units may be switched to the second state or only selected units. If only selected units are switched to a second state of higher power consumption, it is advantageous that these units are intended to be used during an operation that is intended to be initiated by a user or that is initiated when manipulation of a user interface member is detected. Motion sensing and / or communication units may have particularly high power consumption. It is therefore particularly advantageous to switch one or both of these units (e.g. the motion sensing unit or the communication unit) to a state of higher power consumption, e.g. a state in which they can operate in response to a usage signal or operate as intended.

[0083] The electronic system 100 may further include a communication unit 140, e.g., an RF, WiFi and / or Bluetooth unit. The communication unit may be provided as a communication interface between the system or the drug delivery device and the outside, e.g., other electronic devices, e.g., mobile phones, personal computers, laptops, smart watches, etc. For example, dose information may be transmitted to the external device by the communication unit. The dose information may be used for a dose log or dose history established in the external device. The communication unit may provide wireless or wired communication.

[0084] The electronic system may further include a power source 150, such as a rechargeable or non-rechargeable battery. The power source 150 may provide power to each unit of the electronic system.

[0085] Although not explicitly depicted, the electronic system may preferably include a permanent and / or non-volatile storage or memory unit, which may store data related to the operation of the drug delivery device, such as, for example, dosage data or historical data.

[0086] The system 100 may further include a feedback unit, for example an optical feedback unit (not explicitly shown in FIG. 2). The feedback unit may include one or more light emitting diodes. The light emitting diodes may be disposed on a conductor carrier (see below).

[0087] Drug delivery devices are often carried by their users and / or stored for long periods of time. During storage or carrying or even use, there is a risk that liquids, e.g. water, may enter the device. Liquids entering a purely mechanically operated device are less critical, as mechanical drug delivery devices are usually robust against liquid exposure. However, when electrically powered components or units are used in the drug delivery device, the situation is fundamentally different. For example, when a system with one or more electrically operated units is utilized, there is an increased risk that the system will no longer operate properly when exposed to liquid. Components may be damaged or the functioning of the electronic parts of the device may be adversely affected. For example, measurements made via an optically operable motion sensing unit may be distorted or the communication unit may become inoperable.

[0088] Furthermore, the system may need to interface with mechanical elements of the drug delivery device. Such interface may conveniently be via mechanical contact, where a mechanical switch can change state during use of the device. The switch may be part of the use detection unit described further above. The state change of the switch can be implemented at low cost and with very low power consumption when the device is not in use. Alternatively, remote (non-contact) sensing may require higher power consumption to continuously or periodically monitor the state of the device while not in use, via a sensing system that requires energy to obtain a reading. Mechanical contact may then require openings in the electrical system, for example near the dose setting and drive mechanism components of the drug delivery device, such as the drive members. These openings can be sealed, but this tends to add size, complexity, cost, and may inhibit the elements of the switch from moving freely. Therefore, a preferred solution for detecting when the device is in use may require openings in the housing of the system.

[0089] The functional requirements of the device may require a rigid connection between the components of the system and the dose setting and drive mechanisms of the device, where the mechanisms may operate without electricity and / or between the internal components of the system. Achieving a rigid connection often requires openings in the components to form sharp or undercut clip faces without adding additional complexity to the manufacturing of the tool. Additional components or steps can add seals to each of these openings, but these additional components would add cost, size and design complexity, and may themselves introduce additional hazards. Therefore, a preferred solution for a rigid mechanical connection may require openings in the electrical system.

[0090] Capturing and / or recording the dial setting and / or dispensing or delivering the dose (e.g., via the motion sensing unit 120), as well as detecting whether the device is intended to be used (e.g., via the use detection unit 130), may require additional sensors. Capturing and / or recording the dose may be accomplished via a remote sensing system, which should only need to be activated when a state change sensor or switch (preferably in the use detection unit) is triggered. A number of sensing systems can be considered, including, but not limited to, optical, magnetic, acceleration, and dose-dependent. For a low-cost, small, and reliable device, it may be preferable to utilize sensors that give a consistent output in all operating conditions and are not affected by external factors. It may also be preferable to utilize sensor technologies that do not add complexity to the mechanical parts of the device, which are typically manufactured from injection-molded plastic components. Optical sensors that detect changes in color or reflectance of elements of the dose setting and drive mechanisms of the device may be a particularly low-cost, reliable solution. It may be preferable to position the optical sensor close to an element of the dose setting and drive mechanism to ensure that no interference occurs between the optical sensor and the target element of the dose setting and drive mechanism, such as the drive member or the dose dial member or the number sleeve. Such a solution may also require an opening in the system.

[0091] Thus, for various reasons, openings may be necessary in the electrical system (although ideally there would be no openings for protection against liquid ingress), with each opening representing a potential path through which liquid may enter the electrical system. It is therefore desirable to include functionality in the electrical system for a drug delivery device or a device including such a system, suitable for detecting and / or reducing the effects of liquid ingress into the system. The liquid to which the system is most likely to be exposed is, for example, (non-distilled) water from the environment. Also, most of the liquids to which the system is likely to be exposed are conductive liquids.

[0092] In the following, some outlines and units are proposed to detect and / or reduce the effects of liquid intrusion into the electrical system. The electrical system may include the electronic system further disclosed above. The electrical system may be integrated into the drug delivery device or configured to be attached to the drug delivery device to form the drug delivery device. In the latter case, the system may have interface features, e.g. snap features, to attach to the drug delivery device unit. In particular, liquid exposure may have a significant adverse effect on pen injection devices that contain systems for determining, recording, and / or communicating typical handling data of the device, e.g. the size of the delivered or set dose. The device may be intended for daily use in a patient setting (rather than a medical or well-controlled environment). As a result, it may be inevitable that the device may be exposed to water (or other liquids) at some point during its life. It is therefore advantageous to provide a means to reduce the risk of this exposure or to detect if exposure has occurred so that the functionality of the device is not compromised.

[0093] The present disclosure proposes an electrical system having an electrical liquid sensing unit. The liquid sensing unit may sense and / or react to conductive liquids, e.g. conductive liquids only. In particular, the liquid sensing unit may use the electrical conductivity of the liquid as an indicator or trigger that liquid is present. The unit may detect if exposure to liquid has occurred and / or the unit may be designed such that the effects of liquid are reduced. The system may be configured such that if liquid exposure is detected, an error code is generated and / or the electronic control unit commands one or more units of the electronic system to power down and / or send data to an external device different from the drug delivery device indicating that the system has been exposed to liquid. The effects of liquid exposure may be reduced by disabling one or more units exposed to liquid, such as by the electronic control unit 110, which may send a command to the unit accordingly in response to detecting that the liquid sensing arrangement has been exposed to liquid.

[0094] FIG. 3 shows a schematic representation of one embodiment of the liquid sensing unit 160. FIG. 3 shows the user interface member or dose knob 12 on the base in a cross-sectional view. The view in FIG. 3 is a view from the proximal end of the electrical system on the inside of the user interface member / dosage knob 12, i.e. from the side or proximal end of the electrical system of the injection button 11 (see FIG. 1). Inside the user interface member a conductor carrier 30 is arranged. The conductor carrier 30 is preferably a printed circuit board with different conductor tracks. One or more electrical or electronic units of the system may be arranged on the conductor carrier 30, electrically connected or mounted on the conductor carrier 30. In the depicted embodiment, two components 40 and 41 are shown. However, any other number of components may be arranged on the conductor carrier 30, e.g. one component or more than two components. The components 40 and 41 may be light-emitting diodes configured to provide a visual indication by emitted light to the user about the status of the system or device, e.g. whether the communication unit is working and / or whether the motion sensing unit is currently working. The components may belong to the feedback unit described above. In other embodiments, the components 40 and 41 may include, for example, the electronic control unit 110, the motion sensing unit 120 (or at least one sensor thereof), one or more sensors (e.g., sensors not necessarily belonging to the motion sensing unit), and / or the communication unit 140.

[0095] The liquid sensing unit 160 includes a liquid sensing arrangement 163. The liquid sensing arrangement 163 includes a first conductive surface 161 and a second conductive surface 162. Each conductive surface is accessible on the surface of the conductor carrier 30 on which the component 40 or 41 is provided. The first conductive surface 161 may be formed by an exposed portion of a first conductor or conductor track 31 of the conductor carrier 30. The second conductive surface 161 may be formed by an exposed portion of a second conductor or conductor track 32 of the conductor carrier 30. The first and second conductors or the first and second surfaces, respectively, are electrically isolated from each other. On the main surface of the conductor carrier 30 on which the conductive surfaces are accessible, there is no electrical interconnection between these elements. The conductors 31, 32 may be of different potentials during operation of the electrical system, for example of opposite sign or polarity. Alternatively, the conductors may be of the same potential during operation of the electrical system.

[0096] The first surface 161 surrounds the entire second surface 162 when the major surfaces of the conductor carrier 30 are viewed from above (as shown in FIG. 3 ). In other words, the second surface 162 is disposed in an interior defined by the first surface 161 when the major surfaces of the conductor carrier 30 are viewed from above. The respective components 40, 41 are also disposed in an interior defined by the first surface. The first surface may circumferentially surround the components 40, 41 when the conductor carrier is viewed from above. The second surface 162 defines an interior and / or surrounds the entire components in a circumferential direction, similar to the first surface 161.

[0097] The liquid sensing arrangement 163 (formed by the surfaces 161 and 162) extends in a ring around the component. The liquid sensing ring may thus delimit the interior of the liquid sensing arrangement from the exterior. The respective conductive surfaces 161, 162 of the liquid sensing arrangement 163 extend along the periphery or edge 34 of the conductor carrier 30. The liquid sensing arrangement is advantageously placed close to the edge or periphery 34 of the conductor carrier 30 and extends along the edge or periphery. In particular, the liquid sensing arrangement may be located at a distance of 0.5 cm or less from the edge or periphery of the conductor carrier, preferably on the main surface and along the entire extension of the liquid sensing arrangement. Given the fact that liquid intrusion usually comes from outside the electrical system, liquid tends to reach the edge area of ​​the conductor carrier before it reaches the (respective) components 40, 41. Exposure to liquid tends to occur at the liquid sensing arrangement 163 before the electrical components of the electrical system are exposed to liquid. Therefore, once the liquid sensing arrangement is exposed to liquid, appropriate measurements can be taken in a timely manner.

[0098] The first and second conductive surfaces 161, 162 of the liquid sensing arrangement 163 are arranged such that a conductive liquid, e.g. a droplet of liquid, can bridge the space or gap between the conductive surfaces 161 and 162. This changes an electrical property of the liquid sensing unit 160, e.g. the electrical resistance between the conductors 31 and 32 or between the conductive surfaces 161 and 162. The change in electrical property can trigger a response of the electrical system to exposure to liquid.

[0099] In one embodiment, the liquid sensing arrangement 163 may be operatively coupled, e.g. conductively connected, to the electronic control unit 110 or a dedicated liquid sensing unit control unit. The conductors 31 and 32 may be connected, e.g. to different ports, of the control unit. The control unit may detect exposure to liquid through a change in the electrical properties of the liquid sensing arrangement or in the liquid sensing arrangement. For example, a reduction in electrical resistance or an increase in conductivity between the conductors or conductive surfaces indicates exposure of the liquid sensing arrangement to liquid. The change in resistance may be detected by a change in voltage or current via the control unit. When exposure to liquid is detected, the system is configured to react to the exposure, advantageously, e.g. by switching the system from a normal state to an error state. The reaction may be controlled by the electronic control unit or a dedicated control unit, preferably by issuing relevant commands. The reaction may include any one or any combination of the following, e.g. - generating an error code, which can be stored in the system's memory and / or transmitted to an external device, such as a smartphone or smartwatch, so that software that may collect or transmit data via one or more units of the system can be informed that liquid exposure has occurred; - disabling one or more electrical, e.g. electronic, components or units of the electrical system, including at least one component, e.g. a motion sensing unit, that is assigned a liquid sensing configuration indicative of exposure to liquid or that is specifically sensitive to liquid exposure. Only some units may be disabled, or the entire electrical system may be disabled. Providing feedback of the system to the user, e.g. visual feedback, via a feedback unit such as a light of a particular color or with a predefined lighting pattern. The feedback may indicate exposure to liquid.

[0100] When the liquid exposure is no longer present, for example when the liquid has dried, the system can be switched from the error state to its normal state, for example by an electronic control unit, or can remain in the error state.

[0101] In an alternative embodiment, i.e. instead of connection to the control unit, the liquid sensing arrangement may be conductively connected, preferably directly, to a power source. The first surface 161 or the first conductor 31 may be connected to a first end of the power source. The second surface 162 or the second conductor 32 may be conductively connected to a second end of the power source. The first and second ends are advantageously of opposite polarity. Hence, exposure to liquid causes a short circuit of the power source, which is quickly drained. The power source is advantageously the power source for all electrically operating units of the system, or at least for units that should no longer operate when the system is exposed to liquid, e.g. the motion sensing unit 120 or the communication unit 140. Thus, the system can be depowered when exposed to liquid. This provides a fail-safe state for the electrical system, since it can no longer operate. Thus, malfunctions due to the ingress of liquid, e.g. incorrectly determined dose size, can be avoided. But contrary to the connection of the liquid sensing arrangement to the control unit, in this embodiment the electrical system or the respective unit is rendered irreversibly inoperable. This is, of course, unless additional power is provided to the power source, for example by recharging a battery.

[0102] FIG. 4 shows another embodiment of the liquid sensing unit 160. In general, the functionality corresponds to that disclosed above in relation to FIG. 3. Therefore, the following will focus on the differences. The most notable difference is that the liquid sensing unit 160 includes a plurality of liquid sensing configurations 163. The configurations 163 are distributed around the components 41 or 40, which may be located along the periphery or edge 34 of the conductor carrier 30 and / or near the center of the conductor carrier 30. Each liquid sensing configuration 163 includes a first conductive surface 161 and a second conductive surface 162. Again, the first conductive surface 161 surrounds the second surface 162. The second conductive surface 162 may be continuous without defining an interior, or may be ring-shaped. The first surface 161 in the depicted embodiment follows a circular line, although other configurations are possible in this case. Contrary to the configuration of FIG. 3, this configuration may encourage the droplet to be trapped or restrained in the liquid sensing configuration 163. The first conductive surfaces 161 of the different liquid sensing configurations may, for example, be directly conductively connected to the interior of the conductor carrier 30 and / or may be formed by the same first conductor 31. Alternatively or in addition, the second conductive surfaces 162 of the different liquid sensing configurations 163 may, for example, be directly conductively connected to the interior of the conductor carrier 30 and / or may be formed by the same second conductor 32.

[0103] The liquid sensing arrangements 163 may be dimensioned to accommodate a droplet of liquid, advantageously a droplet capable of bridging the gap between the conductive surfaces 161 and 162. For example, the maximum distance between diametrically opposed points on the outer edge of the first conductive surface or first conductor of each liquid sensing arrangement 163 may be equal to or smaller than one of the following values: 3 mm, 2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.1 mm, 0.05 mm. In other words, the (maximum) diameter of each liquid sensing arrangement 163 may be equal to or smaller than the values ​​specified above.

[0104] In the following, features are disclosed which apply to all of the liquid sensing units described herein, in particular the features illustrated in Figures 3 and 4.

[0105] In each liquid sensing arrangement, the distance between adjacent conductive surfaces of a liquid sensing arrangement is preferably less than or equal to one of the following values: 2 mm, 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm. The distance may be constant along each liquid sensing arrangement and / or equal across all liquid sensing arrangements if multiple arrangements are provided.

[0106] When viewed perpendicular to the direction of extension on the conductor carrier, the width (or radial dimension) of each conductive surface or conductor portion may be less than or equal to one of the following values: 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm.

[0107] The dimensions given above may be particularly suitable for holding a liquid, for example water, in the respective liquid sensing arrangement.

[0108] At least one liquid sensing arrangement 163 of the liquid sensing unit 160 may be provided on an opposing major surface of the conductor carrier 30. In particular, the opposing major surfaces of the conductor carrier 30 may be provided with a liquid sensing arrangement 163, such as an arrangement as shown in Figure 3 and / or Figure 4. In this manner, detection or response to liquid exposure is less dependent on the orientation of the system or device, as both sides of the opposing major surfaces of the conductor carrier may be provided with liquid sensing.

[0109] Each conductive surface 161 or 162 may be formed by a coating, for example a gold coating. A portion of the conductors 31, 32 beneath the conductive surface coating may be made of a different conductive material, for example copper. By having a different material on the exposed surfaces of the associated conductors, for example a material that is less prone to oxidation such as gold, homogeneity of liquid sensing may be improved over time.

[0110] 5A and 5B show an embodiment of the liquid sensing arrangement 163, such as those described above. FIGS. 5A and 5B are cross-sectional views through the conductor carrier 30. When the conductor carrier 30 is viewed from above, an insulating portion 33 of the conductor carrier is provided between the first conductive surface 161 and the second conductive surface 162. In FIG. 5A, the insulating portion 33 is raised relative to the conductors 31 and 32. In FIG. 5B, the portion 33 is recessed relative to the conductors 31 and 32. It is also possible that the portion 33 is raised or recessed relative to only one of the surfaces 161, 162, or recessed relative to one of the surfaces 161 and 162 and raised relative to the other. The contoured area of ​​the major surface of the conductor carrier 30 thus formed may facilitate that droplets such as the droplet 50 may be more easily confined by the liquid sensing arrangement 163.

[0111] The liquid sensing unit 160 may be switched from a first or non-operational state to a second or operation state in response to the use detection unit generating a (use) signal. Thus, the liquid sensing unit may only operate when the system is expected to perform a system operation, such as determining and / or transmitting dose information, since dose setting and actuation operations are expected. Alternatively, the liquid sensing unit may also operate when there is no upcoming operation expected.

[0112] In the proposed scheme, if liquid ingresses into the electrical system, the drug delivery device including the system may go into a "fail-safe" mode rather than the device continuing to attempt function with the risk of dose recording error. Thus, if liquid ingress is detected, for example a "fail-safe" mode may be generated or an appropriate permanent error code may be generated.

[0113] As explained above, detection of liquid intrusion can be done using exposed (copper or copper clad) tracks on the conductor carrier. Typical types of fluids that can enter a system during its life tend to be sufficiently conductive to be detected by the system's electronics and software. The proposed scheme involves the addition of exposed (copper) tracks in areas of the conductor carrier (PCB) close to where fluids or liquids can enter the device. An optional (gold) plate or cladding has the effect of maintaining conductivity over life so that the effectiveness of detecting water does not change over time.

[0114] The present disclosure is not limited by the description in connection with the exemplary embodiments, but rather includes any novel feature and any combination of features, and in particular any combination of features in the claims, even if that feature or combination itself is not explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0115] 1 Device 10. Housing 11 Injection button 12 Dosage knob 13 Dosage window 14 Containers / Container Receptacles 15 needles 16 Inner needle cap 17 Outer needle cap 18 Cap 20 Dial Sleeve 30 Conductor Carrier 31 First Conductor 32 Second Conductor 33 part 34 Edge / perimeter 40 Components 41 Components 50 droplets 100 Systems 110 Electronic Control Unit 120 Motion sensing unit 130 Use detection unit 140 Communication Unit 150 Power supply 160 Liquid sensing unit 161 First Conductive Surface 162 Second Conductive Surface 163 Liquid Sensing Configuration

Claims

1. An electrical system for a drug delivery device (1), comprising: An electrical liquid sensing unit (160), said electrical liquid sensing unit including at least one liquid sensing arrangement (163), said electrical liquid sensing unit configured to respond to exposure of said liquid sensing arrangement to a liquid (50). Including, The electrical system is configured to change a state of the at least one liquid sensing arrangement from a normal state to an error state in response to the exposure of the at least one liquid sensing arrangement to liquid.

2. The electrical system of claim 1 , wherein in the error condition, the electrical system is configured to indicate that the electrical system has been exposed to liquid, or wherein in the error condition, the electrical system is unpowered.

3. The electrical system of claim 1 or 2, wherein the liquid sensing unit is configured to respond to the exposure of the liquid sensing arrangement (163) to liquid by modifying an electrical characteristic of the liquid sensing unit (160).

4. The electrical system of any one of claims 1 to 3, comprising a user interface member (11, 12) for a drug delivery device, and the liquid sensing unit (160) is disposed within a user interface member body of the user interface member.

5. 5. The electrical system of claim 1, wherein the liquid sensing arrangement (163) comprises a first surface (161) and a second surface (162), a first conductor (31) having the first surface and a second conductor (32) having the second surface, both surfaces being contactable by a liquid (50).

6. 6. The electrical system of claim 5, wherein the first surface (161) and the second surface (162) are arranged such that a conductive liquid (50), e.g., a droplet of liquid, can bridge a gap between the first surface and the second surface, thereby conductively connecting the first conductor (31) and the second conductor (32).

7. 7. The electrical system of claim 5 or 6, wherein the first surface (161) extends along the entire periphery of the second surface (162).

8. The electrical system of any one of claims 5 to 7, wherein the second surface (162) defines an interior, and an electronic component (40, 41) is disposed in the interior.

9. 9. The electrical system of claim 5, wherein the first surface (161) and / or the second surface (162) are provided by a conductive coating, the coating being less susceptible to oxidation than a portion of the conductor (31, 32) beneath the conductive coating, the portion being associated with the same conductor as the coating.

10. The electrical system of any one of claims 5 to 10, wherein the first surface (161) and the second surface (162) are disposed on a conductor carrier (30).

11. 11. The electrical system of claim 10, wherein the first surface (161) and the second surface (162) are separated by an insulating region (33), the insulating region protruding with respect to at least one of the first surface and the second surface, and / or the insulating region recessed with respect to at least one of the first surface and the second surface.

12. The electrical system of claim 10 or 11, comprising a plurality of liquid sensing arrangements (163) each having a first surface (161) and a second surface (162), the liquid sensing arrangements being distributed around an electronic component (40, 41) on the conductor carrier (30) and / or along a circumference of the conductor carrier (30).

13. The electrical system of any one of claims 5 to 12, wherein the first surface (161) and the second surface (162) are directly conductively connected to a power source such that exposure of the liquid sensing arrangement (163) to liquid results in a short circuit between the first conductor (31) and the second conductor (32) and a discharge of the power source (150) of the electrical system.

14. The electrical system of any one of claims 5 to 12, wherein the first surface (161) and the second surface (162) are directly conductively connected to an electrical unit of the electrical system, the electrical unit being an electronic control unit (110).

15. The electrical system according to any one of claims 4 to 14, wherein the user interface members (11, 12) are knobs (12) and / or buttons (11).

16. The electrical system according to any one of claims 5 to 15, wherein the first surface (161) and / or the second surface (162) are circumferentially closed.

17. The electrical system of any one of claims 8 to 16, wherein the components (40) and (41) are light emitting diodes configured to provide a visual indication by emitted light to the user about the status of the system or the drug delivery device (1).

18. 18. The electrical system of claim 11, wherein the insulating region (33) extends between the first surface (161) and the second surface (162), along the entire periphery of the first surface and / or along the entire periphery of the second surface.

19. A drug delivery device (1) comprising the electrical system according to any one of claims 1 to 18, wherein the drug delivery device is a pen-type injection device and the drug delivery device comprises a drug reservoir and / or a reservoir container with a drug.

20. The drug delivery device (1) according to claim 19, wherein the drug delivery device is a dial-extended type device.

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