Electronic labels for drug delivery devices
The electronic label on drug delivery devices addresses the challenge of clear and dynamic information display by using a flexible substrate and processor-controlled display to show multiple types of information, improving readability and usability for users.
Patent Information
- Application Number
- JP2022524973
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-10-28
- Filing Date
- 2020-10-26
- Publication Date
- 2024-12-13
- Estimated Expiration
- 2040-10-26
AI Technical Summary
Existing drug delivery devices face challenges in providing clear and unambiguous information to users, particularly for physically frail or mentally impaired individuals, with limited space for electronic displays affecting readability and the need for dynamic and user-specific information during device handling.
An electronic label with a flexible substrate and display that can separately, simultaneously, or sequentially show multiple types of information, including drug-specific and user-specific information, using a processor to control the display and switch between different content based on user interaction or predefined schedules, with sensors to detect device usage and orientation.
Enhances readability and usability by maximizing information display without spatial overlap, providing clear and dynamic information support for drug delivery device handling, ensuring easy operation and compliance with user-specific needs.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present disclosure relates to the field of electronic labels, in particular electronic labels for drug delivery devices such as injection devices. Furthermore, the present disclosure relates to a multi-functional label configured to change visual appearance automatically or in response to user interaction. In another aspect, the present disclosure relates to a drug delivery device comprising an electronic label. In yet another aspect, the present disclosure relates to a method for visualizing multiple information contents of different information types on an electronic label used in a drug delivery device. [Background technology]
[0002] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medication are per se well known in the art. In general, such devices have substantially the same purpose as a conventional syringe.
[0003] Drug delivery devices such as pen injectors must meet many user-specific requirements. For example, for patients suffering from chronic diseases such as diabetes, the patient may be physically frail and may also have poor eyesight. Therefore, a suitable drug delivery device, especially intended for home medication, must be robust in construction and easy to use. Furthermore, the operation and overall handling of the device and its components must be straightforward and easily understood. Such an injection device should provide for the setting and subsequent dispensing of variable-sized doses of medication. Furthermore, the dose setting, along with the procedure for dose dispensing, should be easy to operate and must be clear.
[0004] Typically, such devices include a housing or a specific cartridge holder adapted to receive a cartridge at least partially filled with the medicament to be dispensed. The device typically further includes a drive mechanism having a displaceable piston rod operatively engaged with a bung or piston of the cartridge. By means of the drive mechanism and its piston rod, the bung or piston of the cartridge can be displaced in a distal direction, i.e., in the dispensing direction, thus expelling a predetermined amount of medicament through a piercing assembly, e.g. in the form of a syringe needle, which is releasably coupled with the distal end of the housing of the drug delivery device.
[0005] The medicament to be dispensed by the drug delivery device can be provided and contained in a multi-dose cartridge. Such cartridges typically include a glass barrel that is sealed distally by a pierceable seal and further sealed proximally by a bung. In a reusable drug delivery device, the empty cartridge can be replaced with a new cartridge. In contrast, a disposable type drug delivery device is completely discarded when the medicament in the cartridge has been dispensed or used up.
[0006] In some drug delivery devices, such as pen injection devices, the user must set equal or variable size doses by rotating a dose dial in a clockwise or dose increment direction relative to the body or housing of the injection device. To inject and expel a dose of liquid medication, the user must depress a trigger or dose button in a distal direction, and thus toward the body or housing of the injection device. Typically, the user uses their thumb to apply distally directed pressure against the dose dial and the dose button, which may be located at the proximal end of the dose dial sleeve, while holding the housing of the injection device with the remaining fingers of the same hand.
[0007] For mechanically implemented injection devices, it is desirable to enable accurate, reliable, semi-automated monitoring and / or collection of injection-related data during use of the injection device. Furthermore, there is an increasing demand for user assistance for proper and regular handling of such drug delivery or injection devices. For successful treatment, a clear, e.g. user-specific amount of drug, i.e. a dose of drug, should be administered, e.g. at regular times, according to a given prescription schedule. In some circumstances, the patient may forget or may not be aware if the prescribed dose was recently injected. Furthermore, the patient may not always know regarding the size of the dose to be set and injected. This is particularly relevant in the case of forgetful patients and / or patients who are at least to some extent mentally and / or physically frail.
[0008] In general, electronic displays offer the possibility of providing individualized, relevant, and user- or device-specific information to a user of a drug delivery device. Electronic displays, including somewhat rigid and inflexible display structures, are difficult to attach to the housing or body of a drug delivery device, especially when the drug delivery device is embodied as a portable or handheld drug delivery device, such as an injection pen.
[0009] By limiting the dimensions or size of an electronic display, the legibility of the information content provided on the display can be severely affected. Summary of the Invention [Problem to be solved by the invention]
[0010] Therefore, there is a demand for different types of information to be unambiguously and clearly visible on the exterior of the injection device, such as information regarding the proper or intended handling of the medicament and / or drug delivery device. The medicament-related information and / or device handling-related information should be provided in a durable and permanent manner. However, in some usage scenarios, some information should be provided dynamically and / or on demand, for example to assist the user when or during handling or use of the injection device.
[0011] It is therefore an object to provide an improved display for drug delivery devices, in particular for injection devices such as handheld injection devices. The display should provide device-specific or drug-specific answers or user-specific information to facilitate the use and handling of the drug delivery device. The display should provide a somewhat user-friendly method of operation and handling of the drug delivery device. Furthermore, the patient should be given the possibility to be comprehensively informed about the proper operation of the drug delivery device and about the drug to be administered by the drug delivery device. The implementation and use of the display should be somewhat easy, intuitive and self-explanatory. The display should be manufacturable at moderate or low cost and suitable for retrofitting existing drug delivery devices. The display should provide a space-saving design and should fit the shape of the housing of the injection device. [Means for solving the problem]
[0012] In one aspect, the present disclosure relates to an electronic label for a drug delivery device, the drug delivery device being configured to administer, for example, dispense or inject, a medication to a patient. The drug delivery device can be implemented as an infusion device, as an injection device, or as an inhaler, or as a portable medical analysis device, such as a blood glucose meter. The electronic label is configured to be attached to a body of the drug delivery device. To that extent, the electronic label includes a flexible substrate configured to be attached to the body of the drug delivery device, typically to the body of a housing of the drug delivery device. The electronic label further includes an electronic display. The electronic display is located on the flexible substrate. Typically, the electronic display is also flexible. The electronic display is configured to display at least a first information content of a first information type, at least a second information content of a second information type, and at least a third information content. The third information content is the first information type or the second information type.
[0013] The electronic label further includes a processor connected to the electronic display and configured to modify or control the visual appearance of the electronic display, the processor being configured in particular to visualize or display separately, simultaneously, sequentially or alternatingly at least a portion of the first information content and at least a portion of the third information content on the electronic display.
[0014] To that extent, the processor and the electronic display are configured to visualize or display various information contents of different information types on the electronic display separately, i.e. in consecutive temporal order, or simultaneously, i.e. at the same point in time but without spatial overlap. When a portion of the first information content and a portion of the third information content are provided or shown separately, sequentially or alternately on the electronic display, the respective portions of the first and / or third information content can be spread across the entire available display surface.
[0015] By showing a part of the first information content and a part of the third information content separately, and therefore sequentially or alternately, the size of the characters or symbols representing the first, second or third information content can be increased to a maximum. In this way, an information content, consisting for example of a relatively large number of characters or words, can be separated or divided into a large number of parts, for example a first part, a second part and a third part of the first, second or third information content, respectively. The processor can then be configured to separately and sequentially visualize or display on the electronic display the temporal sequence of the first, second and third parts, for example of the first information content. In this way, the size of the information content to be visualized or displayed on the electronic display can be increased without any negative effects on the legibility or the displayed size of the characters or symbols representing the respective information content.
[0016] Moreover, the processor and the electronic display are configured to simultaneously or separately and sequentially visualize or display different types of information. In so far, the electronic label is a multifunctional electronic label, for example configured to provide multiple information contents of a first information type and to provide multiple information contents of a second information type. In so far, the electronic label is configured to provide drug-specific, device-specific or user-specific information contents on the electronic display.
[0017] The processor is configured to reconfigure the visual appearance of the electronic display. In some examples, for example, when the third information content is the first information type, the processor is configured to visualize or display at least two different information contents in common, for example, of the first information type. These two information contents can be provided separately, i.e., sequentially or alternately, on the electronic display. The switching between the first information content and the third information content can be autonomously triggered by the processor according to a predefined schedule. In other examples, when the third information content is the first information type, the processor can also be configured to visualize or display the first and third information contents simultaneously, but without spatial overlap, on the electronic display.
[0018] In situations or instances where the processor visualizes or displays the first and third information content separately, sequentially, or alternatingly, the first and third information types may be provided in spatially overlapping regions of the electronic display. Because the first and third information content are not shown or provided simultaneously, each piece of information may be provided in the exact same region of the electronic display or in overlapping regions.
[0019] In another example, when the third information content is a second information type, the respective first and third information contents may be provided simultaneously, and thus without spatial overlap, on the electronic display. And, the electronic display may visualize or display at least two different types of information simultaneously on the electronic display. When the processor is configured to visualize or display the first and third information contents separately, e.g., sequentially or alternatingly, on the electronic display, the respective first and third information contents, each representing a different type of information, may be presented and shown in the same area of the electronic display or in spatially overlapping areas.
[0020] In an alternative approach to the electronic label, the processor is configured to visualize or display on the electronic display at least a portion of the second information and at least a portion of the third information content separately, simultaneously, sequentially or alternately. The processor can be configured to visualize or display only the information content of the second information type, thus avoiding showing the information content of the first information type. This may be particularly beneficial when the first information type is somewhat static information that does not require modification or reconfiguration during use of the drug delivery device.
[0021] The information content of the first information type and the information content of the second information type, i.e., when the third information content is the second information type, can be visualized or displayed simultaneously, sequentially, or alternately by visualizing at least a portion of the second information content and at least a portion of the third information content separately, simultaneously, sequentially, or alternately on the electronic display. In other configurations where the third information content is the second information type, the electronic label can be limited to visualizing or displaying different information contents of the second information type separately, simultaneously, sequentially, or alternately on the electronic display.
[0022] In either embodiment, the electronic label can be reconfigured according to drug-specific, device-specific or user-specific requirements.
[0023] According to a further example, the electronic label further includes a data storage device connected to or integrated in the processor. The data storage device is a digital data storage device. The data storage device is configured to store a large number of information contents of a first information type and to store a large number of information contents of a second information type. It can provide storage space for a somewhat larger amount of information contents of either the first type or the second type. The data storage device can be implemented as a non-volatile data storage device. The data storage device can include memory blocks of a read-only memory type (ROM). The data storage device can further include memory blocks of an erasable programmable read-only memory type (EPROM). In some examples, the information contents of the first information type are stored in ROM memory blocks. In some examples, the information contents of the second information type are stored in EPROM memory blocks. To that extent, the information contents of the first information type can be stored unalterably in the data storage device. The information contents of the second information type can be erased or modified by the processor. In particular, the information contents of the second information type can represent reconfigurable information that is dynamically changed when the electronic label and / or the drug delivery device are in use.
[0024] According to a further example, the first information type includes comprehensive information about the drug. Typically, the first information type is limited to comprehensive information about the drug. The first information type may include information such as drug name, lot number, date of manufacture, place of manufacture, suitable storage temperature, volume of drug container, concentration of active ingredient, and shelf life. The information content listed above is non-limiting, and the information content of the first information type may include further information characterizing the drug or drug located within the drug delivery device or intended to be used in the drug delivery device. In particular, the first information type may include regulatory information regarding the proper use of the drug located within the drug delivery device.
[0025] According to further examples, the second information type includes information on the momentary status of the drug delivery device, on the actual use or on previous use. In particular, the second information type is indicative of the handling of the drug delivery device and / or of the intended use and purpose characteristics of the drug to be administered by the drug delivery device. Typically, the second information type includes information contents such as the battery level of the electronic label, user instructions such as "remove the cap", "set a dose of a certain size", "inject the dose", time information on the previous or preceding dose injection, time information indicating when the next dose injection is scheduled, information on the remaining contents of the drug in the container, further instructions and information for the user such as waiting for a certain time interval before removing the needle from the injection site when administering a dose of the drug by injection into a living tissue with an indication that the dose injection has occurred or is finished.
[0026] Since the electronic label is provided with two different types of information, each information type can be processed and shown on the electronic display in close association with typical and characteristic scenarios of use. For example, when the electronic label is attached to the drug delivery device and when the drug delivery device is not in use, the electronic label can be configured to show only a minimum, e.g., regulatory information, and thus only a limited amount of information content of the first information type. For example, in a default or idle mode, the electronic label can be configured to show only the name of the drug located inside the drug delivery device. Then, only in use or upon wake-up of the processor, further information content, e.g., of the first information type and / or the second information type, is provided on the electronic display to assist and / or instruct the user to set and / or administer a dose of the drug.
[0027] According to a further example, the electronic label includes a clock generator. The clock generator is connected to or integrated in the processor. The processor is configured to visualize or display at least a portion of one of the first and second information content for a predetermined time interval. After the predetermined time interval, the processor is configured to switch or change the visual appearance of the electronic display. Typically, after the predetermined time interval, the processor is configured to visualize or display at least a portion of a third information content. The third information content is either the first information type or the second information type.
[0028] In some examples, the third informational content is displayed or visualized in place of the first informational content after a predetermined time interval has elapsed.
[0029] Typically, according to a further example, the third information content may also be visualized, displayed or shown for a further predetermined time interval. After the passage of the further predetermined time interval, the processor is configured to visualize or display at least a portion of the fourth information content, where the fourth information content is the first information type or the second information type. The time interval and the further time interval may be of equal or different duration.
[0030] After a further predetermined time interval, the processor may be configured to visualize or display at least a portion of one of the first and second information contents again. Thus, the processor may be configured to visualize or display different display contents in a loop. Thus, the processor may be configured to visualize or display the first display form for a first predetermined time interval. After the first predetermined time interval, the processor may switch to a second display form. The second display form may be shown for a second predetermined time interval. The processor may then be configured to autonomously switch the electronic display to visualize or display a third display form, and so on. After showing a series of different display forms, the processor may be configured to switch back to the first display form to start or restart the loop of the multiple different display forms from the beginning.
[0031] Here, the processor can be configured to switch between the display forms according to given regulatory requirements. When switching between different display forms, a part of the information content visualized or displayed during the first display form can also be included in the second display form, etc. To that extent, the processor can be configured to permanently show, for example, at least a part of the first information type. By switching between the first and second display forms, a part of the first information type can remain unchanged, while another part of the display, showing, for example, the first or second information content, is visually changed.
[0032] As an example, the medication name may be permanently presented on the electronic display even when the display is switched from a first configuration to a second configuration. By switching the display from the first configuration to the second configuration, the further information content shown simultaneously with the medication name may be visually altered. For example, the further information content visualized or displayed simultaneously with the medication name may be switched from information content such as "time of last dose" to another information content such as "next dose due."
[0033] According to another example, the processor is configured to switch the electronic display between an idle mode and a wake-up mode. When the electronic display is in the idle mode, it consumes less electrical energy than when it is in the wake-up mode. Here, the processor can be configured to autonomously switch the electronic display from the wake-up mode to the idle mode, typically after a predetermined time interval. Furthermore, the processor can be connected to an input or to a sensor, or can communicate with an external electronic device. When and as long as it is in the wake-up mode, the processor can be configured to monitor user-induced actuation of a user input, monitor electronic signals of sensors such as on-board ambient sensors, or monitor communication with an external electronic device, such as a handheld external electronic device implemented as, for example, a smartphone, tablet computer, or smartwatch.
[0034] In the situation where the processor does not detect an input for a predetermined time interval, this is a clear indication that the electronic label and / or drug delivery device is not currently in use. Then, for the purpose of saving electrical energy, the processor is configured to autonomously switch the electronic display from a wake-up mode to an idle mode. When switching to the idle mode, the brightness of the electronic display can be reduced compared to the wake-up mode. Furthermore, when the electronic display is switched from the wake-up mode to the idle mode, the information density and / or amount of information on the electronic display can be reduced.
[0035] The processor may be further configured to switch the electronic display from the idle mode back to the awake mode upon detecting, for example, at least one of a user input, a sensor output, or communication and / or data exchange with an external electronic device. Any of these actions, which may be user-induced, may cause the sensor and / or electronic display to wake up and provide predetermined visual information to the user on the electronic display.
[0036] According to a further example, the electronic label includes at least one ambient sensor, the ambient sensor being connected to a processor, the ambient sensor being further configured to determine at least one of ambient brightness, magnetic field, acceleration, orientation, temperature, and ambient air pressure variations, the processor being configured to visualize, display, and / or modify at least a portion of one of the first information content and the second information content on an electronic display upon receiving a sensor signal, e.g. an electronic signal from the ambient sensor.
[0037] When implemented as a magnetic field sensor and / or as an acceleration sensor, the ambient sensor is configured to monitor or detect the movement and / or orientation of the electronic label with respect to the gravitational field. For example, if the ambient sensor detects a first movement after a somewhat longer period in which no movement is detected, this is a clear indication that the user has picked up the drug delivery device to which the electronic label is attached. By detecting a sensor signal indicative of a movement or acceleration of the electronic label and / or the drug delivery device, the processor is configured to switch the electronic display from an idle mode to a wake-up mode. Furthermore, when a movement is detected, the electronic label can provide at least a part of the second information content of the second information type. Furthermore, according to a predefined time interval and / or according to a further sensor signal, the processor can be configured to provide a sequence of information content of the second information type indicative of a number of successive steps for the intended handling of the drug delivery device. In this way, the electronic label can help the user to set and administer a dose of the medicine.
[0038] Instead of or in addition to an acceleration sensor, the ambient sensors may be equipped with an air pressure sensor which may equally be used to detect or quantitatively determine movement of the electronic label and / or the drug delivery device to which the electronic label is attached.
[0039] According to a further example, the processor is operable to turn or reverse the orientation of at least one of the first and second information content in response to an electrical signal received from the surrounding sensor. This function of the processor applies in particular when the surrounding sensor is one of a magnetic field sensor, an acceleration sensor and an air pressure sensor. These types of sensors allow the orientation of the electronic label relative to the gravitational field to be determined. According to the orientation of the electronic display relative to the gravitational field, the processor is operable to switch or reverse the orientation of at least one of the first and second information content. Typically, the processor is configured to reverse or change the orientation of the entire content of the electronic display according to the orientation of the electronic label relative to the gravitational field.
[0040] In this way, the visual appearance of the multiple information contents of either the first information type and / or the second information type can be dynamically adapted to the momentary orientation of the electronic label and / or the injection device, thus substantially ensuring that the label, and in particular its information content, is readable in any of the available or possible orientations of the label.
[0041] According to another example, the electronic label includes at least one input connected to the processor and actuable by a user of the drug delivery device. Here, the processor is configured to change the visual appearance of the electronic display when the at least one input is actuated. The input can be provided as a touch-sensitive area on the electronic display. In another example, the input is provided as a separate button on the top surface of the flexible substrate outside the area of the electronic display. Furthermore, if the electronic display is configured to communicate with an external electronic device, the input can also be provided via the external electronic device. This applies especially when the external electronic device is paired with the electronic label, for example, when the external electronic device establishes a data link, for example a wireless data link, with the electronic label. Non-limiting examples of wireless data links include various radio frequency-based communication standards such as BlueTooth, Bluetooth Low Energy (BLE), WIFI, IEEE802.11, and RFID or Near Field Communication (NFC).
[0042] In this way, the user has the control to change the visual appearance of the electronic display on demand. For example, by actuating the input, the user can trigger the switching of the electronic label, in particular its electronic display, from idle mode to activated mode. Furthermore, the user can cause the switching of the electronic display from activated mode to idle mode. Depending on the duration of the actuation, for example the duration of the depression of the input, different switching scenarios or switching directions can be triggered. For example, a somewhat short actuation of the input can temporarily increase the brightness of the electronic display, which can further be used to trigger the switching of the display from idle mode to activated mode. A somewhat longer actuation or depression of the input can be interpreted by the processor to switch the electronic display to idle mode, for example with the purpose of saving electrical energy.
[0043] The input and the processor may be further configured to trigger a switch from the first to the second display form, thus providing the user with the possibility to trigger the display of a sequence of different information content of either the first information type and / or the second information type.
[0044] According to another example, the electronic label includes a battery connectable to a processor. In some examples, the battery can be permanently connected to the processor. The processor is configured to determine or measure a charge level of the battery. The processor is further operable to switch the electronic display to a power saving mode when the charge level of the battery drops below a predetermined minimum. When in the power saving mode, the brightness of the display can be reduced by default. Moreover, it is further contemplated that in the power saving mode, the electronic display is at least temporarily turned off. For example, the display can be turned off for a predetermined time interval to conserve power or energy.
[0045] In some examples, the power saving mode may be activated even while various information contents are being shown in a loop, and thus alternating between different information contents, where the display may be temporarily turned off between successive different display configurations.
[0046] In the power saving mode, the processor and display may be configured to visually indicate to the user that the electronic label is low on power. In some examples, when in the power saving mode, the electronic label may be configured to autonomously shut down some power consuming functions.
[0047] In the power saving mode, the processor and the electronic display may be further configured to show a display prompting the user to replace the electronic label, charge the battery, or replace the battery.
[0048] According to a further example, the electronic label includes a planar warning buzzer connected to the processor. The warning buzzer is configured to generate an audible sound when activated by the processor. The processor can be configured to detect or identify a number of warning or alarm conditions, such as when the currently set dose is greater than the prescribed dose, when the battery is running low on power, when the next dose setting and / or injection is currently overdue, etc. The warning buzzer is configured to be activated by the processor in response to the detection or identification of the alarm. The warning buzzer can be planar and can include a limited height on the flexible substrate. The warning buzzer can include a piezoelectric transducer configured to generate an audible warning when activated by the processor. The thickness or height of the warning buzzer can be less than 5 mm, less than 3 mm, or even less than 2 mm along a direction parallel to the surface normal of the substrate.
[0049] According to further examples, the electronic display is one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light emitting diode (LED) display. When implemented as a light emitting diode display, the display can include an organic light emitting diode (OLED) display. Such OLED displays can be of the bendable type and are suitable for use with flexible substrates. Thus, the electronic display can include a flexible sheet display. The electronic display can include multiple display layers that are flexible. The electronic display can include flexible display layers that are stacked on top of each other.
[0050] In another example, when the electronic display is implemented as an electrophoretic display, the display can provide a persistent and permanent display form and respective information content on the electronic display even when the electronic label is not fully supplied with electrical energy, where only the switching of the electronic display between different display forms consumes power or electrical energy. Electrophoretic displays are particularly suitable for use scenarios where the electronic label should provide a rather long life span, which may exceed several months or years.
[0051] Implementing the electronic display as a light emitting diode display provides excellent contrast readability and brightness. Additionally, light emitting diode displays can be provided with relatively high resolutions, such as greater than 50 pixels per inch (ppi), greater than 70 ppi, greater than 100 ppi, greater than 120 ppi, greater than 140 ppi, or even greater than 150 ppi.
[0052] According to another example, the electronic display includes a color display configured to visualize or display at least one of the second information content and the information background in at least two different colors. Thus, the electronic display is a color display. In a further example, the electronic display is configured to vary the brightness of the first and / or at least one of the information content and the information background.
[0053] In some examples, the electronic label includes at least one device sensor configured to determine at least one of a position or orientation of at least one of a dose tracker and a piston rod of the injection device relative to a housing or body of the injection device when the electronic label is attached to the injection device.
[0054] According to another example, the device sensor of the label includes an electrode structure on a substrate. The electrode structure is configured to measure at least one of an electric capacitance, an electric field and a magnetic field. Typically, the drug delivery device comprises and / or includes a dose tracker, the position and orientation of which with respect to the housing or body of the drug delivery device indicates the size of the dose currently being set or dispensed. The dose tracker can be provided with electronically, electrically and / or magnetically detectable features. Thus, the device sensor with the electrode structure is configured and / or operable to determine the position and / or orientation of the dose tracker of the drug delivery device during handling and manipulation of the injection device to set and / or dispense a dose of a medicament.
[0055] The device sensor may be a non-contact sensor. The electrode structure may be embedded in the flexible substrate. The electrode structure may be disposed on the upper side of the flexible substrate. The lower side of the flexible substrate may be provided with an adhesive for attaching the flexible substrate, and thus the label, to the body. The electrode structure for measuring at least one of the capacitance, electric field and magnetic field allows for non-contact determination and / or quantitative measurement of the position or orientation of the dose tracker of the injection device relative to the housing or body of the drug delivery device when the label is attached to the drug delivery device.
[0056] According to a further example, the electronic display includes at least one conductive grid electrode that at least partially spatially overlaps the electrode structure of the device sensor. The at least one conductive grid electrode provides an electromagnetic shield for the electrode structure of the device sensor. This is particularly advantageous when the electrode structure is susceptible to ambient electric or electromagnetic fields. Here, the conductive grid electrode of the electronic display can provide a dual function. The conductive grid electrode can be operable to drive and / or operate the electronic display. At the same time, the conductive grid electrode serves to screen and / or shield the electrode structure of the device sensor that is typically located directly underneath.
[0057] In the label layer stack, the electrode structure of the device sensor is provided on the upper side of the flexible substrate. Typically, at least one conductive grid electrode is disposed on top of the electrode structure of the device sensor. Thus, the electrode structure of the device sensor is located between the flexible substrate and the at least one conductive grid electrode.
[0058] In another example, the device sensor electrode structure is located or disposed on the underside of the flexible substrate, and at least one conductive grid electrode is located on the topside or outward facing portion of the flexible substrate, either way the device sensor electrode structure is effectively shielded against environmental electromagnetic or electrostatic perturbations.
[0059] The flexible substrate is specifically configured to wrap around at least a portion of the body or housing of the injection device. The body or housing may include a somewhat cylindrical or tubular structure. Thus, the flexible substrate may conform to or be customized to the sidewall of the tubular housing of the injection device. The flexible substrate allows for a somewhat universal attachment of the label to a number of different injection devices. The label may be universally applicable and / or attachable to different types of injection devices.
[0060] The label may also be somewhat thin or flat and may be permanently attached to the housing of the injection device. The injection device with the attached label may be wrapped or packaged in a device packaging, for example for transport and / or storage. When the label is attached to the housing of the injection device, it has little, if any, effect on the outer contour and / or shape of the injection device. The label may further provide a somewhat attractive design to the injection device.
[0061] The flexible substrate may comprise a flexible plastic foil or a flexible metal foil. The flexible substrate may comprise a plastic foil, for example made from polyethylene (PE) or polyethylene terephthalate (PET).
[0062] The flexible substrate, electronic display, and thus the entire label, can include a total thickness of less than 5 mm, less than 4 mm, less than 3 mm, or less than 2 mm. In some examples, the label includes a thickness of less than 1 mm or less than 0.5 mm.
[0063] Typically, in many instances, the label includes an electronic circuit located on the substrate. The electronic circuit is electrically connected to a processor and to an electronic display. The electronic circuit can be disposed directly on the flexible substrate. The electronic display and / or processor can be integrated into the electronic circuit.
[0064] The electronic circuit may comprise a flexible electronic circuit, such that the conductive structures of the electronic circuit are bendable or pliable to follow the flexible deformation of the substrate, e.g. during the process of attaching the flexible substrate to the housing of the injection device, e.g. by wrapping the label around a tubular housing.
[0065] The electronic circuitry can be printed onto the substrate. The electronic circuitry can be printed onto the flexible substrate by one or more inks composed of carbon-based compounds. Additionally, the electronic circuitry can be deposited onto the flexible substrate by a solution-based or vapor-based deposition process. The printed electronic circuitry on the substrate allows the label to be manufactured in large quantities at low cost.
[0066] In another example, at least at least a portion of the underside of the flexible substrate is provided with adhesive. The underside of the flexible substrate can be provided with an adhesive layer. The entire underside of the flexible substrate or only a portion thereof can be provided with adhesive. In particular, an edge region of the underside of the flexible substrate is provided with adhesive to allow permanent attachment of the label to the housing of the injection device. The adhesive on the underside of the flexible substrate can provide an adhesive-based fixation of the or applied label to the body or housing of the injection device. This can be implemented somewhat space-saving and at moderate or low cost.
[0067] According to another example, the electronic circuit further includes a battery. The battery is typically connected to the processor and / or to the electronic display. The processor and / or the battery can be printed on a flexible substrate. The processor and / or the battery can also be flexible to some extent, thus allowing and supporting deformation of the flexible substrate when assembled and attached to the housing of the injection device.
[0068] The processor is connected to an electronic display and also to a battery. The processor is powered by electrical energy provided by the battery. Typically, both the processor and the battery include or are made from printed electronic components.
[0069] In a further example, the electronic circuitry includes a data storage device or memory configured to store at least one of the multiple user actions and the time of one or multiple user actions. In combination with the processor's clock, a time indication can be derived and thus the time of the user action can be stored, for example, when the user activates, for example touches or presses down, an input on the label. If the label does not have a clock, the electronic circuitry can be configured to simply count multiple such user actions. In this way, the label can provide a kind of dose counter.
[0070] According to another example, the electronic circuit includes an antenna for wireless transmission of electronic signals with the external electrode device. The antenna is typically connected to the processor. The processor is configured to communicate with the external electronic device by means of the antenna. The processor can be configured to transmit data to the external electronic device. The processor can be configured to receive data from the external electronic device. The external electronic device can include a handheld external electronic device, such as a smartphone, a smartwatch or a tablet computer. The antenna can further provide communication with a personal computer or similar computing device.
[0071] The antenna, and its interaction with the processor, further allows data previously stored in the data storage device of the electronic circuit to be transferred to an external electronic device. The antenna allows the external electronic device to be configured to read the contents of the data storage device of the label. Typically, the data storage device is integrated into the electronic circuit. In other examples, the data storage device may be provided separately and thus offset from the electronic circuit. Wireless transmission of electronic signals between the processor and the external electronic device further allows reconfiguration of the processor and / or the electronic display.
[0072] The label can be reconfigured using the external electronic device via wireless transmission of electronic signals to the external electronic device. In this way, at least one indicia can be replaced with a second indicia. In addition, the overall appearance of the electronic display can be reconfigured according to electronic signals received from the external electronic device. In this way, the at least one electronic display can be individually configured for different usage scenarios and / or for use with different injection devices.
[0073] Transmitting the data stored in the data storage device of the electronic circuit to an external electronic device allows monitoring and post-dosage evaluation of the user's actions recorded in the data storage device during the time intervals when the label is isolated from the external electronic device.
[0074] A label as described herein may be particularly configured for attachment to an injection device, but may likewise be attachable to the body of any other or further medical device, such as an infusion device, an infusion pump, an infusion pump, an inhaler, or a portable medical analysis device such as a blood glucose meter, etc. To that extent, any reference to an injection device may be regarded as a reference to the respective medical device, respectively.
[0075] According to another aspect, the present disclosure also relates to a drug delivery device for administering a drug to a patient. The drug delivery device can be configured to administer, e.g., inject, an injectable drug by setting and dispensing a dose of the drug to a patient. The drug delivery device can be configured as a handheld injection device, such as a handheld pen injector or as a drug pump. The drug delivery device includes a housing. The housing includes or comprises a body. The housing is configured to accommodate a drug container filled with the drug to be administered. The drug delivery device further includes a drive mechanism configured to draw or expel a dose of the drug from the drug container.
[0076] The drive mechanism is further configured to administer a dose of the drug to the patient. Furthermore, the drug delivery device is provided with a label as described above. The label is attached to the housing or to the body of the drug delivery device. The body of the delivery device is part of the housing of the delivery device. It may be or constitute a proximal part of the housing of the drug delivery device, located at the end of the delivery device facing away from the drug outlet or the dosing end of the drug delivery device.
[0077] In some examples, when the drug delivery device is implemented as an injection device, the drive mechanism includes a piston rod displaceable along a longitudinal direction. The longitudinal direction can be coincident with or can extend parallel to a longitudinal axis of a housing of the injection device. The piston rod is configured to operably engage with a piston of a drug container. The drug container can be implemented as a cartridge proximally sealed by the piston. The cartridge contains an injectable drug. At a distal end of the cartridge opposite the piston rod, a pierceable seal is provided, typically penetrable by a double-tipped injection needle.
[0078] In a further example, the present disclosure relates to a medical device such as an infusion device, an infusion pump, an infusion pump, an inhaler, or a portable medical analysis device such as a blood glucose meter. The medical device is further provided with an electronic label as described above. The label is attached to the housing or to the body of the medical device. The body of the medical device may be part of the housing of the respective medical device.
[0079] According to a further example, a medicament container, e.g. in the form of a cartridge containing a medicament, is arranged inside the housing of the injection device. The injection device can be configured as a disposable injection device. The medicament container filled with medicament can be easily assembled inside the injection device when the injection device is handed over to a customer or patient.
[0080] The injection device may be implemented as a disposable injection device that is intended and / or configured to be discarded in its entirety after use and / or when the medication is exhausted or has exceeded its shelf life. In other examples, the injection device is implemented as a reusable injection device, where a medication-filled medication cartridge or medication container can be replaced and replaced.
[0081] In some examples, the injection device is a fixed dose injection device that provides for setting and injecting only predetermined dose sizes, in other examples, the injection device is implemented as a variable dose injection device, where the user can individually set doses of different sizes for injection.
[0082] In a further aspect, the present disclosure also relates to an adapter configured to be releasably attached to a housing of an injection device. The adapter includes a rigid body including an exterior surface and including a counter fastening mechanism configured to releasably mechanically engage with a correspondingly or complementary shaped fastening mechanism of the housing of the injection device. The adapter further includes an electronic label as described above attached to the exterior surface of the rigid body. Here, the injection device itself may not have a label as described above. The injection device may include only a conventional printed label.
[0083] In some examples, the rigid body includes a tubular sleeve configured to receive at least a portion of the housing of the injection device therein. The label can be adhesively attached to the exterior surface of the rigid body. The label can be pre-fixed to the exterior surface of the rigid body. The label is fixed and attached to the rigid applied body in a well-defined location and / or orientation. An adapter with a label on its exterior surface is particularly configured to retrofit a label to an existing injection device, for example, without the need to adhesively attach the label to the injection device.
[0084] In many examples, where the label comprises a device sensor, it may be important that the label is accurately and / or precisely attached and secured in a well-defined position and / or orientation relative to the housing of the injection device. This may be provided by a counter fastening mechanism of the rigid body configured to engage with a fastening mechanism of the injection device.
[0085] The fastening mechanism may include at least one of a radial protrusion or a radial recess that engages with a correspondingly shaped radial recess or radial protrusion of the counterfastening mechanism. The fastening mechanism and the counterfastening mechanism may be implemented as corresponding snap mechanisms. Furthermore, only one of the counterfastening mechanism and the fastening mechanism may be implemented as a snap mechanism, and the other of the counterfastening mechanism and the fastening mechanism is implemented as a raised ridge or groove on the outside of the housing of the injection device or on the inside of the rigid body of the adapter.
[0086] In a further example, the rigid body of the adapter includes a cap fastening mechanism configured to engage with a protective cap of the injection device. This is particularly beneficial if the fastening mechanism of the housing of the injection device is implemented as a cap fastening mechanism configured to engage with a counter fastening mechanism of the protective cap of the injection device. The cap fastening mechanism of the housing of the injection device can be configured to initially releasably attach and / or releasably secure the protective cap of the injection device, e.g. covering the distal end of the housing of the injection device.
[0087] The counter fastening mechanism of the rigid body can be similar to or replace the counter fastening mechanism of the protective cap of the injection device. The counter fastening mechanism of the rigid body can engage with the fastening mechanism of the housing of the injection device instead of the fastening mechanism of the protective cap. The rigid body, for example embodied as a tubular sleeve, can be adapted to receive the proximal housing part of the injection device such that the counter fastening mechanism of the rigid body is located at the distal end of the rigid body. The distal end of the rigid body can then be provided with a cap fastening mechanism that engages with the counter fastening mechanism of the protective cap. Here, the protective cap with which the injection device is initially provided can be replaced with another protective cap configured to engage with the rigid body of the adapter when the adapter engages with the fastening mechanism of the housing of the injection device.
[0088] According to another aspect, the present disclosure also relates to a method of visualizing a first information content of a first information type and a second information content of a second information type on an electronic display of an electronic label as described above, the method comprising the steps of visualizing at least a part of the first information content of the first information type on the electronic display and separately, simultaneously, sequentially or alternately visualizing at least a part of a third information content on the electronic display, where the third information content is the first information type or the second information type.
[0089] In particular, the method of visualizing the first and second information contents on the electronic display of the electronic label is closely or directly correlated to the use of the electronic label as described above, and to that extent the configurations, effects and benefits obtained by the electronic label and drug delivery device as described above apply equally to the method of visualizing the first and second information contents and vice versa.
[0090] In the present context, the term "distal" or "distal end" refers to the end of the injection device that faces towards the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest from the injection site of a human or animal.
[0091] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.
[0092] As described below, drugs or agents may include at least one API or combinations thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
[0093] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.
[0094] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.
[0095] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue or another naturally occurring residue or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, e.g., the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.
[0096] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
[0097] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
[0098] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.
[0099] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.
[0100] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.
[0101] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.
[0102] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.
[0103] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.
[0104] 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 can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present disclosure 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.
[0105] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.
[0106] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).
[0107] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.
[0108] Those skilled in the art will understand that modifications (addition and / or removal) of various components of the APIs, formulas, apparatus, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present disclosure, which encompasses such modifications and any and all equivalents thereof.
[0109] In the following a number of examples of electronic labels without a drug delivery device and in combination with a drug delivery device are described in more detail with reference to the drawings. [Brief description of the drawings]
[0110] [Figure 1] FIG. 1 illustrates an example of an injection device. [Diagram 2] FIG. 2 shows an exploded perspective view of the injection device of FIG. 1. [Diagram 3] FIG. 2 shows the injection device of FIG. 1 with a sensitive electronic label attached to the housing of the injection device. [Figure 4] FIG. 2 illustrates a number of examples of information content of a first information type and a second information type. [Diagram 5] FIG. 2 is a diagram showing a first display form at a first time point. [Figure 6] FIG. 13 is a diagram showing a second display form at a second time point. [Figure 7] FIG. 13 shows further display forms at further points in time. [Figure 8] FIG. 13 shows another display form at a further point in time. [Figure 9] FIG. 2 illustrates another display at a first point in time, the display providing information content of first and second information types. [Figure 10] FIG. 13 shows further display forms at further points in time. [Figure 11] FIG. 13 shows further display forms at further points in time. [Figure 12] FIG. 13 shows further display forms at further points in time. [Figure 13] FIG. 13 is a diagram showing another display form. [Figure 14] FIG. 14 shows the display form of FIG. 13 in a reversed or inverted orientation. [Figure 15] FIG. 2 is a diagram showing the display appearance when the display is in idle mode or power saving mode. [Figure 16] FIG. 2 is a perspective view of a drug delivery device provided with an adapter carrying a label, the adapter being in a pre-assembled configuration. [Figure 17] FIG. 2 shows a flowchart of an example of a method for visualizing first and second information content on an electronic display. [Figure 18] FIG. 4 shows a further flow chart of the method. [Figure 19] FIG. 13 depicts a flow chart illustrating a further example of a method. [Figure 20] FIG. 13 illustrates a further example of a method for visualizing first and second information content on an electronic display. [Figure 21] FIG. 2 shows a longitudinal section of an assembly of an injection device with an adapter. [Figure 22] FIG. 2 shows the multi-layer structure of an electronic label. [Figure 23] FIG. 1 is a cross-sectional view of an example of an electronic label. [Figure 24] FIG. 2 is a block diagram showing the electronic circuitry of the electronic label. [Diagram 25] FIG. 13 shows another example of an electronic label equipped with a sensor. [Figure 26]FIG. 1 shows a cross-section of an injection device with an electronic label attached. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0111] Like reference numbers indicate like elements.
[0112] The injection device 1 as shown in Figures 1 and 2 is a pre-filled, disposable injection device comprising a housing to which an injection needle 15 can be attached. The injection needle 15 is protected by an inner needle cap 16 and either an outer needle cap 17 or a protective cap 18 configured to seal and protect the distal part of the housing of the injection device 1. The housing typically comprises at least a body 10 forming a main housing part configured to accommodate a drive mechanism 8 as shown in Figure 2. The injection device 1 may further comprise a distal housing component shown as a cartridge holder 14. The cartridge holder 14 may be permanently or releasably coupled to the body 10. The cartridge holder 14 is typically configured to accommodate a cartridge 6 to be filled with a liquid medicament. The cartridge 6 comprises a cylindrical or tubular barrel 25, which is sealed in the proximal direction 3 by a bung 7 located inside the barrel 25. The bung 7 is displaceable in the distal direction 2 relative to the barrel 25 of the cartridge 6 by a piston rod 20. The distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and pierceable by a proximally directed tipped end of the injection needle 15. The cartridge holder 14 includes a threaded socket 28 at its edge for threaded engagement with a correspondingly threaded portion of the injection needle 15. By mounting the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is pierced, thereby establishing fluid transfer access to the interior of the cartridge 6.
[0113] If the injection device 1 is configured to administer, for example, human insulin, the dose set by the dose dial 12 at the proximal end of the injection device 1 can be displayed in so-called international units (IU, 1 IU being the biological equivalent of approximately 45.5 μg pure crystalline insulin (1 / 22 mg)). The dose dial 12 can include or form a dose dial.
[0114] 1 and 2, the housing 10 includes a dose window 13, which may be in the form of an aperture in the housing 10. The dose window 13 allows a user to view a limited portion of a number sleeve 80 that is configured to move when the dose dial 12 is turned to provide a visual indication of the dose currently set. The dose dial 12 rotates on a helical path relative to the body 10 when turned during dose setting and / or dispensing or expelling.
[0115] The injection device 1 can be configured such that turning the dose dial 12 induces a mechanical click sound to provide acoustic feedback to the user. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 penetrates the patient's skin area and when the trigger 11 or injection button is pressed, 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 period of time after the trigger 11 is pressed, the majority of the dose has actually been injected into the patient's body. The expulsion of the insulin dose can also induce a mechanical click sound, but this click sound is different from the sound produced when the dose dial 12 is used.
[0116] In this embodiment, during delivery of an insulin dose, the dose dial 12 is returned to its initial position with axial movement, i.e., without rotation, and the number sleeve 80 rotates back to its initial position, e.g., to display a dose of zero units.
[0117] The injection device 1 can be used for several injection processes until the cartridge 6 is empty or until the expiry date of the drug in the injection device 1 is reached (eg 28 days after first use).
[0118] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" in order to remove any air from the cartridge 6 and needle 15, e.g. by selecting two units of medication and depressing the trigger 11 while holding the injection device 1 with the needle 15 pointing upwards. In what follows, for simplicity of presentation, it will be assumed that the expelled amount substantially corresponds to the injected dose, whereby e.g. the amount of medication expelled from the injection device 1 is equal to the dose received by the user.
[0119] An example of the drive mechanism 8 is shown in more detail in FIG. 2. The drive mechanism 8 comprises a number of mechanically interacting components. A flange-like support of the body 10 comprises an axially threaded through-hole that is threadedly engaged with a first or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 comprises a bearing 21 in which a presser 23 is free to rotate about the longitudinal axis of the piston rod 20. The presser 23 is configured to axially abut against a thrust-receiving proximally facing surface of the bung 7 of the cartridge 6. During a dosing movement, the piston rod 20 rotates relative to the housing 10, thereby moving distally forward relative to the body 10 and thus relative to the barrel 25 of the cartridge 6. As a result, the bung 7 of the cartridge 6 is displaced in the distal direction 2 by a well-defined distance due to the threaded engagement of the piston rod 20 with the body 10.
[0120] The piston rod 20 is further provided at its proximal end with a second thread 24. The distal thread 22 and the proximal thread 24 are counter-rotating.
[0121] A drive sleeve 30 is further provided having a hollow interior for receiving the piston rod 20. The drive sleeve 30 includes an internal thread that threadingly engages the proximal thread 24 of the piston rod 20. The drive sleeve 30 further includes an externally threaded section 31 at its distal end. The threaded section 31 is axially limited between a distal flange portion 32 and another flange portion 33 located at a predetermined axial distance from the distal flange portion 32. Between the two flange portions 32, 33 is provided a final dose limiter 35 in the form of a semicircular nut having an internal thread that mates with the threaded section 31 of the drive sleeve 30.
[0122] The final dose limiter 35 further includes a radial recess or protrusion on its outer periphery, which engages with a complementary recess or protrusion on the inside of the side wall of the body 10 or housing. Thus, the final dose limiter 35 is splined to the body 10. Rotation of the drive sleeve 30 in the dose increment direction 4 or clockwise direction during successive dose setting procedures causes cumulative axial displacement of the final dose limiter 35 relative to the drive sleeve 30. An annular spring 40 is further provided, which axially abuts the proximal facing surface of the flange portion 33. Furthermore, a tubular clutch 60 is provided. At a first end, the clutch 60 is provided with a series of circumferentially oriented sawtooths. Towards a second opposite end of the clutch 60 is a radially inwardly oriented flange.
[0123] Further, a dose dial sleeve, also shown as number sleeve 80, is provided. The number sleeve 80 is provided outside the spring 40 and the clutch 60 and is located radially inside the body 10. The number sleeve 80 is provided with a helical groove 81 around its outer surface. The body 10 is provided with a dose window 13 through which a portion of the outer surface of the number sleeve 80 is visible. The body 10 is further provided with a helical rib on an inner wall portion of the insert piece 62, which will seat in the helical groove 81 of the number sleeve 80. The tubular insert piece 62 is inserted into the proximal end of the body 10. The insert piece 62 is non-rotatably and axially fixed to the body 10. First and second stops are provided on the body 10 to limit the dose setting procedure to a helical rotation of the number sleeve 80 relative to the body 10.
[0124] A dose dial 12 in the form of a dose dial grip is disposed about the outer surface of the proximal end of the number sleeve 80. The outer diameter of the dose dial 12 typically corresponds to and matches the outer diameter of the body 10. The dose dial 12 is secured to the number sleeve 80 in a manner that prevents relative movement between the dose dial 12 and the number sleeve 80. The dose dial 12 is provided with a central opening.
[0125] The trigger 11, also shown as a dose button, is substantially T-shaped. The trigger 11 is provided at the proximal end of the injection device 1. The stem 64 of the trigger 11 extends through an opening in the dose dial 12, through the inner diameter of the extension of the drive sleeve 30, and into a receiving recess in the proximal end of the piston rod 20. The stem 64 limits axial movement within the drive sleeve 30 and is held against rotation relative to the drive sleeve 30. The head of the trigger 11 is generally circular. A side wall or skirt of the trigger extends from the periphery of the head and is further adapted to seat in an annular recess accessible from the proximal side of the dose dial 12.
[0126] To dial in a dose, the user rotates the dose dial 12. With the spring 40 also acting as a clicker and the clutch 60 engaged, the drive sleeve 30, the spring or clicker 40, the clutch 60 and the number sleeve 80 rotate together with the dose dial 12. Audible and tactile feedback that the dose has been dialed in is provided by the spring 40 and the clutch 60. Torque is transferred via the sawtooth between the spring 40 and the clutch 60. The helical groove 81 on the number sleeve 80 and the helical groove in the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the body 10 and the drive sleeve 30 to move up the piston rod 20 at the same speed. At the limit of travel, a radial stop on the number sleeve 80 engages with either a first stop or a second stop provided on the body 10 to prevent further movement in a first rotational direction, e.g., dose increment direction 4. The overall drive thread direction on the piston rod 20 is opposed, thereby preventing the piston rod 20 from rotating.
[0127] A final dose limiter 35, which is latched to the body 10 or housing, advances along the threaded section 31 by rotation of the drive sleeve 30. When the final dose dispensing position is reached, a radial stop formed on the surface of the final dose limiter 35 abuts a radial stop on the flange portion 33 of the drive sleeve 30 preventing further rotation of either the final dose limiter 35 or the drive sleeve 30.
[0128] If the user inadvertently dials in excess of the desired dose, the injection device 1 configured as a pen injector allows the dose to be dialed down without dispensing the medication from the cartridge 6. For this, the dose dial 12 simply rotates backwards. This causes the system to work in reverse. The flexible arm of the spring or clicker 40 then acts as a ratchet that prevents the spring 40 from rotating. The torque transmitted through the clutch 60 causes the sawtooth to ride over each other, resulting in a click that corresponds to the reduction of the dialed dose. Typically, the sawtooth are arranged such that the circumferential extent of each sawtooth corresponds to a unit dose. Here, the clutch can act as a ratchet mechanism.
[0129] Alternatively or in addition, the ratchet mechanism 90 may include at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular clutch 60. The at least one ratchet feature 91 may include a protrusion extending radially outward, for example at the free end of the flexible arm. The protrusion is configured to engage a correspondingly shaped counter ratchet structure on the inside of the number sleeve 80. The inside of the number sleeve 80 may include a longitudinally shaped groove or protrusion with a sawtooth profile. During dialing or setting of a dose, the ratchet mechanism 90 allows and supports the number sleeve 80 to rotate along the second rotation direction 5 relative to the clutch 60, with the rotation being accompanied by a regular click of the flexible arm of the clutch 60. Angular momentum applied to the number sleeve 80 along the first rotation direction is transferred invariably to the clutch 60. Here, the mutually corresponding ratchet features of the ratchet mechanism 90 provide torque transfer from the number sleeve 80 to the clutch 60.
[0130] When the desired dose has been dialed in, the user can simply dispense the set dose by depressing the trigger 11. This causes the clutch 60 to displace axially relative to the number sleeve 80, disengaging its canines. However, the clutch 60 remains latched against rotation relative to the drive sleeve 30. The number sleeve 80 and dose dial 12 are then free to rotate, following the helical grooves 81.
[0131] This axial movement ensures that the flexible arms of spring 40 do not deform which could loosen the sawtooth during dispensing. This prevents drive sleeve 30 from rotating relative to body 10, but drive sleeve 30 is still free to move axially relative to body 10. When distally directed dispensing pressure is then removed from trigger 11, said deformation is used to urge spring 40 and clutch 60 rearwardly along drive sleeve 30, restoring coupling between clutch 60 and number sleeve 80.
[0132] Longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through a through hole in the support of the housing 10, thereby advancing the bung 7 within the cartridge 6. When the dial set dose has been dispensed, further rotation of the number sleeve 80 is prevented by contact of at least one stop extending from the dose dial 12 with at least one corresponding stop on the housing 10. A zero dose position can be determined by abutment of one of the axially extending edges or stops of the number sleeve 80 with at least one or several corresponding stops on the body 10.
[0133] In the example shown herein, the number sleeve 80 represents a dose tracker 50 indicating the currently set dose size, where the longitudinal and / or rotational position of the dose tracker 50 relative to the housing or body 10 of the injection device 1 indicates the currently set size. The dose tracker 50 includes a tracking stop feature 51 operable to engage a counter stop on the body 10, for example, when a zero dose configuration or a maximum dose configuration is reached.
[0134] The number sleeve 80 is just one example of a dose tracker 50. Similarly, the piston rod 20 can also act as or be used as a dose tracker 50.
[0135] The ejection or drive mechanism 8 as described above is merely illustrative of one of several different configurations of drive mechanisms that may be implemented within a disposable pen injector in general. Drive mechanisms as described above are described in more detail, for example, in WO2004 / 078239A1, WO2004 / 078240A1 or WO2004 / 078241A1, which are incorporated herein by reference in their entirety.
[0136] The dose setting mechanism 9 as shown in Figure 2 includes at least the dose dial 12 and the number sleeve 80. During and when the dose dial 12 is turned to set a dose, the number sleeve 80 begins to rotate relative to the housing along a helical path defined by the threaded engagement of its external thread or helical groove 81 with a correspondingly shaped threaded section on the inner surface of the housing.
[0137] During dose setting, when the drive mechanism 8 or dose setting mechanism 9 is in a dose setting mode, the drive sleeve 30 rotates together with the dose dial 12 and the number sleeve 80. The drive sleeve 30 threadably engages with the piston rod 20, which is stationary relative to the body 10 during dose setting. The drive sleeve 30 thus threads or helices during dose setting. The drive sleeve 30 starts to move in a proximal direction when the dose dial is turned in a first rotational or dose increment direction 4, e.g., clockwise. To adjust or correct the size of the dose, the dose dial 12 is rotatable in an opposite second rotational direction, and thus in a dose decrement direction 5, e.g., counterclockwise.
[0138] Figures 3-26 show a number of examples of electronic labels 100 configured to be attached to the body 10 of a drug delivery device, embodied herein as an injection device 1. As further shown in Figures 16-21, the label 100 can also be configured to be attached to an outer surface 211 of a rigid body 210 of an adapter 200. The adapter 200 is configured to releasably and mechanically engage with a fastening feature 96 of the housing or body 10 of the injection device 1. To this end, the adapter 200 includes a counter fastening feature 216 that is shaped to correspond or be complementary to the fastening feature 96.
[0139] The electronic label 100 comprises a flexible substrate 101 as shown in Fig. 22. On the flexible substrate 101, an electronic display 110 is provided. The electronic display 110 is a two-dimensional display. The electronic label 100 further comprises a processor 140 connected to the electronic display 110 and configured to modify or control the visual appearance of the electronic display 110. The electronic display 110 is configured to display at least a first information content 411 of a first information type 410 and to display at least a second information content 451 of a second information type 450. The electronic display is further configured to display at least a third information content 412, 452. The third information content 412, 452 is the first information type 410 or the second information type 450. In Fig. 4, a number of examples of first, second and third information contents that are different, i.e. the first information type 410 and the second information type 450, are shown as non-limiting examples.
[0140] The processor 140, as shown generally in the block diagram of FIG. 24, is configured to modify or control the visual appearance of the electronic display 110 by visualizing at least a portion of the first information content 411 and at least a portion of the third information content 412, 452 separately, simultaneously, sequentially or alternatingly on the electronic display 110.
[0141] Typically, electronic display 110 is located above substrate 101. Label 100, and at least electronic display 110 of label 100, includes a multi-layer structure as shown in Figures 22 and 23. Thus, electronic display 110 can include a multi-layer structure, for example a thin-film multi-layer structure.
[0142] The flexible substrate 101 or base substrate can be any material known for producing printed electronic labels, such as PET film or office paper. Other plastic materials, e.g. PVC, are also feasible. The base substrate has an adhesive on one side to, for example, fix the label to the pen body, either permanently or removably depending on the choice of adhesive.
[0143] The label 100 may include a mechanically flexible structure, such that the label 100 may be foldable or wrapable around the circumference or outer surface of the body 10 of the injection device and / or the rigid body 210 of the adapter 200, the latter of which is shown in Figures 16 and 21.
[0144] Thus, electronic display 110 is a flexible electronic display. Electronic display 110 may include one of an electroluminescent display, an electrophoretic display 118, a liquid crystal display, and a light emitting diode display 119, in particular an organic light emitting diode display (OLED). Such displays are known to be flexible and foldable.
[0145] Optionally, label 100 can be provided with an input 128, which can be implemented, for example, as a touch-sensitive area of electronic display 110. Touch-sensitive area or input 128 can be implemented as part of second label area 110. In some examples, the entire electronic display 110 can be implemented as input area 128 that is touch-sensitive. Thus, the touch-sensitive area can completely or at least partially overlap electronic display 110. In other words, electronic display 110 can be implemented as a touch-sensitive electronic display 110.
[0146] The input 128 is connected to the processor 140. By mechanically engaging the input 128, for example by touching it, the processor 140 can be prompted to change or partially change the information content on the electronic display 110. In some examples, the input 128 or touch-sensitive area of the electronic display 110 includes a capacitive switch manufactured with printed electronics technology. The input 128 can be implemented as an electrode that is part of a capacitor. The capacitor can be detuned when an object, such as a finger, approaches and is in close proximity to the capacitor. This approach affects a measurable characteristic of the capacitor, for example its capacitance. This change in the capacitor is measurable and / or detectable by the processor 140.
[0147] In the illustrated example, the first information type 410 includes or is limited to comprehensive information regarding the medication to be administered by the medication delivery device 1. The first information type 410 includes a first information content 411, such as the name of the medication or drug. The first information content further includes information content 412, which represents the lot number of the medication container in which the medication or drug is provided. Information content 413 indicates the date of manufacture. Information content 414 indicates the place of manufacture of the medication. Information content 415 indicates the indicated or recommended storage temperature at which the medication should be stored during shipment and when not in use. Information content 416 indicates the volume of the medication or drug container. Information content 417 indicates the concentration of the medication or active ingredient of the medication. Information content 418 indicates the shelf life or expiration date of the medication provided in the medication container.
[0148] The multiple example information content 411, 412, 413, 414, 415, 416, 417, 418 are non-exclusive and represent multiple example information content of a first information type that is limited to generic or specific information related to medications.
[0149] The information content of the second information type includes information about the momentary status, about the actual use or about previous use of the drug delivery device or of the respective drug. For example, information content 451 indicates the battery level of the battery 150 of the electronic label 100. Information content 452 indicates instructions to the user to remove the protective cap of the drug delivery device 1. Information content 453 includes instructions to the user to set a dose of drug of a certain size X. Information content 454 indicates instructions to inject the dose. Information content 455 indicates information when the last or previous dose of drug was dispensed or administered.
[0150] Further information content 456 indicates when the next dose is scheduled to be administered. Information content 457 of the second information type 450 indicates the medication or remaining contents of medication in the medication container. Further information content 458 indicates that the dose administration process, e.g. the dose injection process, is complete, and further information content 459 of the second information type 450 includes instructions for a user of the drug delivery device to wait a number of seconds after completion of the dose before withdrawing the needle from the injection site.
[0151] To that extent, and as shown in FIG. 4, the numerous information contents 411, 412, 413, 414, 415, 416, 417, 418 of the first information type 410 can represent comprehensive or basic information about the medication. The first information type, in particular the information content of the first information type, is limited to a specific type and individual or comprehensive characteristics of the medication. The information contents 451, 452, 453, 454, 455, 456, 457, 458 and 459 of the second information type 450 relate to the use and handling of the medication and / or the drug delivery device. They can include dynamically changing information contents, such as the time of the previous dose or the time of setting and administering the next dose. The information content of the second information type can be limited to information about the use and / or momentary situation of the medication and / or the drug delivery device.
[0152] In the sequence of Figures 5-8, a number of display configurations of the visual appearance of electronic display 110 are shown at different times t0-t3.
[0153] 5 shows a first configuration of electronic display 110 at time t0, where multiple information contents are simultaneously provided on electronic display 110, namely information contents 411, 413 and 418. Here, information content 411 indicates the name of the drug. Information content 413 indicates the date of manufacture and information content 418 indicates the best before date. Electronic display 410 can be implemented as a color display 120. Electronic display 410 can include an information background 122 whose color and / or brightness is differentiated from information contents 411, 413, 418. In the example of FIG. 5, display 110 includes an LED display 119.
[0154] At time t1, the processor 140 is configured to autonomously or automatically switch the configuration of the electronic display 110 as shown in Fig. 6. The information content 411 remains in the electronic display 110, but the information contents 413, 418 as shown in Fig. 5 have been replaced by other information contents 415, 417. Here, the information contents 413, 418, which are the first information type 410, are replaced by other information contents 415, 417, which are also the first information type 410. Now, instead of the production date 413, the storage temperature 415 is shown. Instead of the best-before date 418, the concentration 417 of the active ingredient is shown.
[0155] FIG. 7 shows another configuration of the electronic display 110. Here, the processor 140 is configured to automatically switch from, for example, a display form as shown in one of FIG. 5 or FIG. 6 to a display form as shown in FIG. 7. Here, the drug name 411 is still shown on the electronic display 110. In addition, a first part 415' of the information content 415 of the first information type 410 is shown simultaneously with the information content 411. The first part 415' of the information content 415 is visually indicated by relatively large letters or symbols. For example, the information content 415 indicating the recommended storage temperature may include a series of letters or words, such as "Keep refrigerated at 2°C to 8°C". To provide good legibility of this rather large information content 415, the processor 140 is configured to separate the information content 415 into at least two or multiple parts 415', 415''.
[0156] As becomes clear from a comparison of Figs. 7 and 8, the processor 140 is then configured to show only one of the first portion 415' of the information content 415 and the second portion 415'' of the respective information content 415 at a time, either separately, sequentially or alternately. Thus, at time t2, the first portion 415 of the information content 415 is shown on the display 110. At a later time, at time t3, the second portion 415'' of the respective information content 415 is shown on the electronic display 110. The switching between the display forms as shown in Figs. 7 and 8 can be triggered automatically, for example after a predetermined time interval. Furthermore, the processor 140 can be configured to show multiple portions 415', 415'' of the information content 415 alternately. Thus, at time t3 and after a further predetermined time interval, the processor 140 can be configured to return to the display form as shown in Fig. 7.
[0157] By separating the information content 415 into multiple portions 415', 415'', the illustrated size of each portion on the electronic display can be increased to visualize a series of each portion. In this manner, a somewhat wider range of information content can be displayed on the electronic display 110 in a time-series manner.
[0158] The switching between the multiple display forms can be triggered by the processor 140 according to a predetermined schedule. In other examples, the switching between the multiple display forms can be triggered by sensors, such as the device sensor 170 and / or the ambient sensor 190. Furthermore, the electronic label 100 can be provided with user-actuable inputs 128, 129, for example as shown in FIG. 24, so that the switching between the multiple predefined display forms can be triggered by the user himself. Here, the input 128 can be implemented in a switch 154, so that the battery 150 can be separated from the processor 140, for example to conserve battery power. In some examples, a separate input 129 can be provided, connected to the processor 144 located outside the electronic display 110. In other examples, a touch-sensitive area of the display 110 can serve as the input 128.
[0159] The sequence of Figs. 5-8 illustrates a situation where the processor is configured to exclusively display the information content of the first information type 410. In general, the processor 140 is in no way limited to displaying or showing only one of the at least two available information types. The processor 140 can be further configured to cause the visualization or illustration of the information content of the first information type and the information content of the second information type separately, simultaneously, or sequentially. This is illustrated, for example, in the sequence of Figs. 9-12, where an example of an input 128 is also shown in Fig. 9. The input 128 can be implemented as a touch-sensitive area of the electronic display. In some examples, the entire electronic display 110 can be implemented as a touch-sensitive area. Thus, by simply touching the input 128, the user can trigger the switching of the electronic display 110 between multiple display forms.
[0160] Further examples of multiple display forms in time succession are shown in the sequence of Figures 9 to 12. In Figure 9, at time t0, the processor 140 controls the display 110 such that a first information content 411 of a first information type 410 is shown simultaneously with a second information content 451 of a second information type 450. In addition, further information content 452 of the second information type 450 is provided. The information content 451 indicates the charge level of the battery 150. The information content 451 includes respective visual symbols 116 that indicate the charge level of the battery 150.
[0161] The information content 411, 452 each includes a number of visual symbols or characters 114 which, in the case of the information content 411, indicate the name of the drug and, in the case of the information content 452, indicate a command directed to the user of the device, i.e. to remove the protective cap 18.
[0162] As shown in the series of Figures 9-12, information content 411 of a first information type 410 remains on the electronic display 110 at all times during a series of different presentation forms at times t1, t2 and t3.
[0163] At time t1, it is exclusively the further information content 452 that changes to another information content 453. At a later time t2, the information content 453 of the second information type switches to another information content 453, also of the second information type. Then, as shown in FIG. 12, at time t3, the information content 454 switches to simultaneously display information contents 458, 459. As an example, the information content 453 as shown in FIG. 10 indicates a user command prompting the user to set a dose of a certain size X. The information content 454, also of the second information type 450, indicates to the user that the dose should now be injected, for example by depressing the trigger 11 of the drug delivery device. Then, at time t3, as shown in FIG. 12, the electronic display 110 simultaneously visualizes information contents 458, 459 indicating the current status of the drug delivery device 1. The information content 458 indicates that the injection procedure is completed. Further information content 459 provides instructions to the user to wait a number of seconds before withdrawing the needle from the punctured tissue.
[0164] Switching between multiple display forms as shown in Figures 9-12 can be triggered by the user, for example by activating or depressing the input 128, each time a particular step of use of the drug delivery device 1 is performed. Additionally or alternatively, the electronic label 100, in particular the processor 140, can be connected to at least one of the device sensor 170 and the ambient sensor 190. For example, the device sensor 170 is configured to assign and / or determine a position and / or a rotational state of the dose tracker 176 of the drug delivery device 1 when the electronic label 100 is attached to the body 10 in a predefined manner.
[0165] The ambient sensor, typically integrated in the label 100 and / or disposed on the flexible substrate 101, is one of an ambient brightness sensor, an acceleration sensor, a magnetic sensor, an orientation sensor, a temperature sensor or an air pressure sensor. When implemented as an orientation sensor, an acceleration sensor or an ambient air pressure sensor, the ambient sensor 190 is configured to generate at least one electrical signal that can be processed by the processor 140, in particular when the electronic label 100 accelerates and moves or reorients relative to the gravitational field. By means of at least one of the device sensor 170 and the ambient sensor 190, different configurations or states of the drug delivery device 1 can be autonomously monitored and detected. According to the electrical signal obtained from at least one of the device sensor 170 and the ambient sensor 190, the processor 140 is configured to switch between a number of display forms as shown in a series of Figs. 9-12.
[0166] Moreover, as shown by a comparison of Fig. 13 and Fig. 14, the processor 140 is operable to turn or flip the orientation of at least one of the information contents 411, 456, which may be of the same or different information types 410, 450. Typically, the processor 140 is configured to flip or reorient the entire visual appearance of the display 110 based on the electrical signals received from the surroundings sensor 190. For this purpose, the surroundings sensor 190 can be implemented as an acceleration sensor or an orientation sensor. The instantaneous orientation of the first information content 111 and / or the further information content 456 is flipped by 90°, 180° or 270°. For example, the instantaneous orientation can be turned upside down if the respective signals from the surroundings sensor 190 indicate a respective turning of the electronic label 100 with respect to the gravitational field.
[0167] The orientation of the multiple information contents 411, 456 on the display 110 can closely follow the instantaneous orientation of the label 100 in the gravitational field. In some examples, the variable orientation of the multiple information contents 411, 456 can be aligned parallel to the lateral edges of the electronic display 110, which can be rectangular.
[0168] In Figure 15, an idle or power saving mode of electronic display 110 is shown. Compared to a configuration of electronic display 110 as shown in, for example, one of Figures 5-14, the brightness of electronic display 110 is reduced and the information content 411 shown on the display is reduced to a minimum. The information content 411 may be reduced to just the name of the medication.
[0169] In Fig. 17 an example of a method for visualizing a first information content of a first information type 510 and a second information content of a second information type 450 on an electronic display 110 of an electronic label 100 is shown. Here, in a first step 500, a first information content, e.g. a drug or medication name 411, is shown on the display, which is an information content of the first information type 410. The processor 140 is then configured to wait for a predefined or default time in step 502. For this purpose, the processor 141 comprises a clock generator 141. In a further step 504 and after the predefined or default time interval has elapsed, the processor 140 switches somewhat autonomously to a further display form. Thus, in step 504, the further display form shows on the display 110 the second information content of the first information type. The processor 140 then waits again for a default or predefined time interval in step 506. The method may then return to step 500 and the display 110 may return to the initial display configuration.
[0170] In step 504, instead of displaying the second information content of the first information type, processor 140 may also show a third information content that is of the second information type. The second information content or the third information content as displayed in step 504 may be displayed in addition to the first information content already present in step 500. In some examples, the second information content and / or the third information content in step 504 replaces the first information content on the electronic display 110.
[0171] A further example of the method is shown in Fig. 18. Here, in a first step 510, the processor 140 is configured to display a first information content of a first information type. The method then proceeds to step 512. Here, the processor 140 monitors or waits for a user input or a sensor input. As soon as a user input or a sensor input is detected, the method proceeds to step 514, where the first information content of a second information type is shown on the display 110. If there is no user input or sensor input in step 512, the method returns to step 510. Thus, the first information content as displayed in step 510 remains on the electronic display 110 until a user input or a sensor input is detected.
[0172] Instead of displaying the first information content 415 of the second information type 450, or at the same time, or instead of providing the information content 451 of the second information type 450, another information content of the first information type can be provided. The method then proceeds to step 516, where the processor 140 again waits for a user input or a signal from at least one of the ambient sensor 190 and the device sensor 170. As soon as a user input or a sensor input is detected in step 516, the method proceeds to step 518, thereby switching the display form to display the second information content of the second information type 450. Alternatively or in addition, the second information content of the first information type can also be shown in step 518. As long as there is no input from either the user or the sensor in step 516, the method returns to step 514.
[0173] In the absence of user and sensor input, the loop of steps 514, 516 can be interrupted by the processor 140 after a further predetermined time interval. To this end, the processor 140 can be configured to start a counter when the method jumps from step 512 to step 514. In the absence of user and sensor input, the processor 140 can be configured to switch from step 516 back to step 510 when the timer reaches a predetermined maximum time in step 516. In this way, the display configuration of step 514 can last only temporarily and for a maximum time interval as defined by the timer or counter of the processor 140. In the absence of user and sensor input for the predetermined time interval in step 516, the method returns to step 510, where the default display configuration is shown.
[0174] In Fig. 19 a further flow chart illustrating the working principle of the electronic label 100 is shown, where in a first display form in step 520 a first information content of a first information type is shown, such as the name of a medication 511. In the following step 522 the processor 140 monitors user input or sensor input for a predefined time interval. If there is no user input during the predefined time interval the method proceeds to step 524 and switches the display to an idle mode.
[0175] 19, if, prior to step 522, processor 140 detects a battery level that is below a predetermined acceptable minimum battery level, then the display may be switched to a power saving mode in step 524. In yet another example, while in step 522, processor 140 detects or identifies an alarm condition that may activate warning buzzer 146 in step 524.
[0176] 20 shows a situation where the electronic display 110 is in an idle or power saving mode in step 530. Here, the display 110 provides only a minimal first information content, e.g., a drug name or other information content of a first information type, to meet regulatory requirements for electronic labels. In step 532, a user input and / or a signal of one of the sensors 170, 190 is detected. This is treated as a wake-up signal, after which the processor 140 is configured to switch the display to an active mode in step 534.
[0177] As shown in FIG. 24, different types of information 410, 450 can be stored separately in the memory 144 of the processor 140 or the electronic circuit 130. For this purpose, the memory 144 can include a memory block 145 of read-only memory type (ROM) and a memory block 147 of erasable programmable read-only memory type (EEPROM). In some examples, the information content of the first information type is stored in the ROM memory block 145. In some examples, the information content of the second information type is stored in the EPROM memory block 147. To that extent, the information content of the first information type 410 can be stored unalterably in the data storage device (ROM). The information content of the second information type 450 can be dynamically changed or overwritten by the processor 140.
[0178] The example of electronic circuitry 130 in FIG. 24 is in no way limiting with respect to the examples in FIGS. 3-26. The electronic display 110 can be superimposed on the electronic circuitry 130. Thus, the electronic display 110 can completely overlap the electronic circuitry 130 located directly below. The electronic display 110 can include a multi-layer structure as shown in FIGS. 22 and 23. The electronic circuitry 130 can be implemented in one or some of the various layers 103, 104, 105, 106 of the flexible label 100. Typically, the electronic circuitry 130 is completely provided by the conductive layer 103.
[0179] The input 128 or touch-sensitive area may be visually indicated on the electronic displays 110, 112, or on a separate portion outside the electronic display 110. The input 128 and electronic display 110 are configured to interact such that when the input 128, i.e., the touch-sensitive area, is touched or depressed, at least the second electronic display 110 changes its visual appearance. The electronic display 110 may be switchable between a default or idle mode and an activated mode.
[0180] In a further example, when input 128 is touched or depressed, processor 140 can be configured to record the user action and / or the time of the user action in electronic storage 144 or memory of the electronic circuitry. Electronic storage 144 can include capacity to store data related to multiple events, including timestamps.
[0181] In a further example, the electronic circuit includes an antenna 160 providing a data transmission element, for example enabling NFC, WIFI or RF data transmission. The data thus stored in the memory can be read by an external device using the respective wireless communication protocol. The NFC or RF communication can be implemented passively or actively, the latter requiring an energy source, for example a battery, to power the electronic circuit. The battery can be implemented with printing technology.
[0182] 24 shows one example of the electronic circuit 130 of the electronic label 100. The electronic circuit 130 may be printed directly on the flexible substrate 101. The electronic and / or conductive structures of the electronic circuit 130 may also be bendable or flexible. The integrity or functionality of the electronic circuit 130 is not substantially affected by bending or flexing of the flexible substrate 101 and / or the electronic circuit 130.
[0183] The electronic circuit 130 includes a battery 150 that typically comprises a number of battery cells 152. The individual battery cells 152 are electrically connected. They can be connected in series or in parallel depending on the voltage provided by the individual battery cells 152 and depending on the voltage required by the processor 140. The battery 150 and / or the battery cells 152 can include printed electronic structures. Thus, the battery 150 and / or the battery cells 152 are printed batteries or battery cells and can be disposed on the substrate 101 by printing.
[0184] The processor 140 is connected to a battery 150 and to the electronic display 110. The interconnection between the battery 150 and the processor 140 can be interrupted by a switch 154 that corresponds to the input 128. Depressing the switch 154 can connect or disconnect the electrical connection between the battery 150 and the processor 140.
[0185] The processor 140 includes a central processing unit (CPU) 142 and a memory device 144. The memory device 144 can store a number of predefined information contents 411, 412, 413, 451, 452, 453 to be shown on the electronic display 110. When the opening and closing of the switch 154 is registered, the predefined information content 411, such as the name of the drug, can be shown or displayed on the electronic display 110. If the processor 140 includes a data storage device 144, the processor 140 can further be configured to count the number of touching actions of the input 128. If the processor 140 further includes a clock generator 141, every input or touching moment can further be associated with a timestamp, thus recording a dosing history or recording the time when the user of the injection device 1 properly touches the input 128.
[0186] The antenna 160 is typically connected to the processor 140 and configured for wireless data transmission. The antenna 160 may be configured as a receiving antenna and / or as a broadcasting antenna. The antenna 160 may be configured to transmit electromagnetic signals in the RF frequency band. The antenna 160 may include an RFID antenna. The antenna 160 may be configured according to conventional wireless communication standards such as Bluetooth, NFC or IEEE802.11 (WIFI). The antenna 160 is configured to exchange data with an external electronic device 300, such as a smart watch, a smartphone, a tablet computer or a personal computer.
[0187] The processor 140 may be reconfigurable by signals obtained from the external electronic device 300 via the antenna 160. In this manner, the external electronic device 300 may be used to modify or reconfigure the processor 140 and thus modify and reconfigure the content of the electronic display 110. Additionally or alternatively, the external electronic device 300 may be further configured to read the data storage 144 of the electronic circuitry 130. In this manner, administration history and usage of the label 100 may be closely monitored and transmitted to the external electronic device 300 for further processing and / or evaluation.
[0188] All of the electronic components of the electronic circuit 130, such as the wired connections between the battery 150 and the battery cells 152, the switches 154 or touch-sensitive areas forming the inputs 128, the processor 140 together with the antenna 160, can be included on the substrate 101 or formed by a printing process. In this way, separate assembly and placement of multiple electronic components on the substrate 101 is substantially eliminated. This allows for cost-effective mass production of the label 100.
[0189] An adhesive can be provided on the underside of the substrate 101. The adhesive can be provided in an adhesive layer 102, completely or at least partially covering the underside of the substrate 101 opposite the conductive layer 103 on which the electronic circuitry 130 is located. In FIG. 23, a stack of multiple layers 103, 104, 105, 106 configured to form an electronic display 110 is exemplarily shown. The stack structure of FIG. 23 can represent a thin-film electroluminescent electronic display. The substrate 101 can be flexible and can include or consist of one of foldable office paper, transparent or opaque PET film, leather, wood, ceramic and metal foil. The electroluminescent display is configured to actively emit light.
[0190] A segment of the display consists of two overlapping electrodes acting as a capacitor. The opposing electrodes are provided with a conductive layer 103 and a transparent electrode layer 106. Between these layers 103, 106 are provided a dielectric layer 104 and an electroluminescent layer, for example in the form of a phosphor layer. When a suitable voltage and current AC signal is applied, the electroluminescent layer 105 emits photons.
[0191] The stack of layers 103, 104, 105, 106 may add only 100-150 μm to the thickness of substrate 101. In this manner, electronic display 110 can be extremely thin.
[0192] In another example, the flexible electronic display 110 is implemented as an electrophoretic display based on rearrangement of charged pigment particles by application of an electric field. Here, titanium dioxide particles, suitably 1 μm in diameter, are dispersed in a hydrocarbon oil. A dark dye is added to the oil, along with a surfactant and a charging agent that causes the particles to carry an electric charge. This mixture is placed between two parallel conductive plates separated by a gap of 10 to 100 μm. When a voltage is applied to the two plates, the particles move by electrophoresis to the plate that carries the opposite charge to that of the particles.
[0193] When the particles are located on the front or viewing side of the display, they appear white because light is backscattered by the high index titania particles towards the viewer. When the particles are located on the rear side of the display, they appear dark because the incident light is absorbed by the colored dye. If the rear electrode is divided into multiple small picture elements or pixels, an image can be formed by applying appropriate voltages to each area of the display resulting in a pattern of reflective and absorbing areas. Electrophoretic displays are considered an important example of the e-paper category because of their paper-like appearance and low power consumption.
[0194] The label 100 may optionally only comprise an antenna 160. In one embodiment, the label 100 may lack the antenna 160 and may be operable to indicate distinct or predefined information content 411, 451 and to provide switching between sleep and awake modes.
[0195] A further example of a flexible label 100 is shown in Figures 25 and 26. The label 100 can be implemented with or without an antenna 160. The label 100 includes a flexible substrate 101 having an electronic display 110. Typically, the label 100 of Figure 25 also includes a processor 140, a CPU 142, a data storage device 144 and a battery 150 as described above in connection with Figure 24. In addition, the label 100 of Figures 25 and 26 includes a device sensor 170.
[0196] The device sensor 170 is configured to assign or determine a position and / or rotational state of a dose tracker 176 of the injection device 1 when the label 100 is attached to the housing 10 in a predetermined manner. Here, the dose tracker 176 can coincide with or represent the dose tracker 50 as described above in relation to Figures 1 and 2. Alternatively, the dose tracker 176 can be represented by any other component of the injection device 1. The dose tracker 176 can be represented, for example, by the piston rod 20 or by any optional component of the drive mechanism 8 or the dose setting mechanism 9, where the position and / or orientation of the respective device component relative to the housing 10 indicates the size of the dose currently being set or dispensed.
[0197] To place the label 100 on the housing 10, the housing 10 may include at least one or several position marks 180, shown in FIG. 26 as protrusions on the outer surface of the housing 10. The label 100 must be properly attached to the housing 10 in an area as defined by the at least one or several position marks 180. The dose tracker 176 may match or be formed by the number sleeve 80 of the injection device 1. The dose tracker 176 includes an indicator 175, the position state of which, i.e., longitudinal position and / or rotational orientation, relative to the housing 10 is detectable by the device sensor 170.
[0198] The position mark 180 may protrude from a sidewall of the housing 10 or may include a recess in the housing 10. Alternatively, the position mark 180 may be neither a protrusion nor a recess in the exterior surface of the housing 10. The position mark 180 may simply include a visual indication, such as a border area within which the label 100 should be fastened, e.g., attached with an adhesive.
[0199] In one example, the device sensor 170 includes multiple individual sensor segments 171, 172, 173 that are separated along a direction of movement of the indicator 175 and / or the dose tracker 176 relative to the housing 10. Upon rotational and / or sliding movement of the dose tracker 176 relative to the housing 10, the indicator 175, e.g., initially overlapping the first sensor segment 171, moves toward the second sensor segment 172, and further, e.g., toward the third sensor segment 173. The movement of the indicator 175 relative to the multiple sensor segments 171, 172, 173 is detectable by the sensor 170, which is electrically connected to the processor 140. In this manner, the processor 140 and the sensor 170 are configured to determine and detect the actual position and / or rotational state of the indicator 175, and thus the dose tracker 176, relative to the housing 10.
[0200] The position or rotational state of the dose tracker 176 unambiguously corresponds to the dose size actually set by the injection device 1. Thus, the processor 140 can be configured to determine or measure the size of the dose actually set by the injection device 1 when the label 100 is properly coupled to the housing 10. Thus, the determined longitudinal or rotational position of the dose tracker 176 can be compared with a predefined position, e.g. indicated by the second information content 111 on the electronic display 112. The dose actually set by the injection device can further be indicated through the dose window 13.
[0201] The specific implementation of the device sensor 170 and the indicator 175 may vary. As shown in Fig. 26, the housing 10 may include a through hole 178 or recess through which the position of the indicator 175 may be detected, for example mechanically or electrically, for example by a number of contact pins provided on each sensor segment 171, 172, 173. To this end, a direct mechanical contact may be established between the indicator 175 and at least one of the sensor segments 171, 172, 173.
[0202] In another example, the indicator 175 can be magnetically encoded and the sensor segments 171, 172, 173 can be configured to detect the magnetic field of the indicator 175 as it moves longitudinally and / or rotationally. In a further example, the indicator 175 and the sensor segments 171, 172, 173 can be implemented electrostatically. Here, the multiple sensor segments 171, 172, 173 can be configured to assign or detect changes in the electric field induced by the indicator 175. Furthermore, the sensor segments 171, 172, 173 can include a capacitance measuring element configured to measure changes in the electric field or capacitance in the vicinity of the respective sensor segments 171, 172, 173. The magnetic, electrostatic and capacitance measuring procedures can be particularly beneficial since no through holes 178 or recesses in the side walls of the housing 10 may be required. In such an embodiment, the label 100 can simply be attached by adhesive within a given position mark on the outer surface of the body 10.
[0203] In the example as shown in Fig. 22 and Fig. 23, at least one electrode structure 174 of the device sensor 170 can be provided on the flexible substrate 101. At least one or all of the sensor segments 171, 172, 173 as described above can belong to or constitute the electrode structure 174. The electrode structure 174 can be located between the adhesive layer 102 and at least one of the conductive layers 103, 106. The electrode structure 174 can belong to or be part of the device sensor 170. The electrode structure 174 on the substrate 101 is configured to measure at least one of the capacitance, electric field and magnetic field in the vicinity of the substrate 101. Typically, the electrode structure 174 is configured to determine or quantitatively measure the position and / or rotational state of at least one device component, for example the dose tracker 176 of the injection device 1.
[0204] In a further example, the electrode structure 174 can be configured to determine the longitudinal position of the piston rod 20 and / or the longitudinal position of the bung 7 or piston of the cartridge 6 with respect to the barrel of the cartridge 6 and / or with respect to the housing or body 10 of the injection device 1.
[0205] At least one or both of the conductive layer 103 and the transparent electrode layer 106 include conductive grid electrodes that at least partially spatially overlap with the electrode structure 174 of the device sensor 170. Here, by virtue of the conductive grid electrodes 103, 106 spatially overlapping with the electrode structure 174 of the device sensor 170, the conductive grid electrodes 103, 106 provide an electromagnetic shield 107 for the device sensor 170. In this manner, electromagnetic compatibility (EMC) of the label 100 can be increased and the position or orientation of the at least one dose tracker 176 can be measured and defined with high accuracy.
[0206] As shown in FIG. 25, the conductive grid electrode 103 spatially overlaps an electrode structure 174 and multiple sensor segments 171 , 172 , 173 of the device sensor 170 .
[0207] 16 and 21 show an adapter 200 configured to be releasably attached to the housing or body 10 of the injection device 1. The adapter 200 includes a rigid body 210. The rigid body 210 includes a tubular hollow sleeve sized to receive at least a distal portion of the body 10 of the injection device 1. In particular, the inner diameter of the body 210 is sized to receive the cartridge holder 14 of the injection device 1. The rigid body 210, and therefore the sleeve, can also be sized to receive the proximal housing or body 10 of the injection device 1 as shown in FIG. 21. In the final assembled form as shown in FIG. 21, the proximal end of the rigid body 210 can be located or can be adjacent to the distal end of the dose dial 12.
[0208] The adapter 200 and its body 210 include at least one counter fastening feature 216 that engages with the fastening feature 96 of the housing 10 of the injection device 1. As shown in FIG. 21 , the fastening feature 96 may include a radially outwardly extending protrusion. The protrusion may include at least one of a pin and a radially outwardly extending rim, for example, at the proximal end of the cartridge holder 14. Typically, the fastening feature 96 is configured to engage with a respective counter fastening feature of a protective cap 18 as shown in FIGS. 1 and 2 .
[0209] In this case, the adapter 210 includes a counter fastening feature 216 inside its hollow sleeve for fastening the adapter 200 to the housing 10 of the injection device. The counter fastening feature 216 is typically located at or near the distal end of the rigid body 210. The counter fastening feature 216 can include a recess or groove on the inner surface of the elongated sleeve of the rigid body 210. In this way, the counter fastening feature 216 and the fastening feature 96 can be engaged by a snap-fit engagement. They can be engaged by friction or by form-fitting. In this way, the body 210 of the adapter 200 can be fastened in a well-defined and precise manner to the outside of the housing 10 of the injection device 1. The body 210 includes an outer surface 211 to which the label 100 as described above can be fastened firmly or removably. Typically, the label 100 is attached to the outer surface 211 by adhesive.
[0210] The adapter 200 is engageable with the fastening feature 96 of the injection device 1, which is originally intended to fasten with the protective cap 18 as shown in Figures 1 and 2, so that the protective cap 18 can be exchanged and / or is actually replaced or replaced with a replacement protective cap 218, which is slightly larger in size, at least in the area that overlaps with the fastening feature 96 of the housing or body 10. The body 210 of the adapter 200 includes a cap fastener 220 configured and operable to engage with a counter cap fastener 228 provided on the replacement protective cap 218.
[0211] At least one of the cap fastener 220 and the counter cap fastener 228 includes a radial protrusion that is complementary in shape to a respective radial recess of the other of the cap fastener 220 and the counter cap fastener 228. In this manner, the replacement protective cap 218 can be attached and fastened to a distal portion or end of the adapter 200 when the adapter 200 occupies the original fastening feature 96 of the housing 10 of the injection device 1. [Explanation of symbols]
[0212] 1. Injection device 2 Distal direction 3 Proximal direction 4 Dose Increment Direction 5 Dose decrement direction 6 Cartridges 7 Stopper 8 Driving mechanism 9 Dose setting mechanism 10. Housing 11 Trigger 12 Dose Dial 13 Dosage window 14 Cartridge holder 15 Syringe needle 16 Inner needle cap 17 Outer needle cap 18 Protective Cap 19 Protrusion 20 Piston rod 21 Bearing part 22 1st thread 23 Press 24 Second Thread 25 barrels 26 Seal 28 Threaded Socket 30 Drive sleeve 31 Threaded Section 32 Flange 33 Flange 35 Final Dose Limiter 36 Shoulder 40 Spring 41 Recess 50 Dose Tracker 51 Tracking Stop Feature 60 Clutch 62 Insert 64 Mandrel 80 Number Sleeve 81 Groove 90 Ratchet mechanism 91 Ratchet function 95 Preselector 96 Fastening Function 100 Labels 101 Substrate 102 Adhesive layer 103 Conductive layer 104 Dielectric layer 105 Electroluminescent Layer 106 Transparent electrode layer 107 Electromagnetic Shielding 110 Electronic Display 114 Visual Signs 116 Visual Symbols 118 Electrophoretic Display 119 Light Emitting Diode Display 120 Color Display 122 Information background 128 Input section 129 Input section 130 Electronic circuits 140 processors 141 Clock Generator 142 CPU 144 Storage device 146 Warning Buzzer 150 Battery 152 Battery Cell 154 Switch 160 Antenna 170 Device Sensors 171 Sensor Segments 172 sensor segments 173 Sensor Segments 174 Electrode structure 175 Indicator 176 Dose Tracker 178 Through Hole 180 Position Mark 190 Ambient Sensor 200 Adapter 210 Main unit 211 Exterior 216 Opposite Fastening Function 218 Protective Cap 220 Cap Fastener 228 Counter Cap Fastener 300 Electronic Devices 410 Information Type 411 Information Content 412 Information Content 413 Information Content 414 Information Content 415 Information Content 416 Information Content 417 Information Content 418 Information Content 450 Information Type 451 Information Content 452 Information Content 453 Information Content 454 Information Content 455 Information Content 456 Information Content 457 Information Content 458 Information Content 459 Information Content
Claims
1. An electronic label (100) for a drug delivery device (1) configured for administering a medication to a patient, comprising: A flexible substrate (101) configured to be attached to a body (10; 210); an electronic display (110) located on the flexible substrate (101), configured to display at least a first information content (411) of a first information type (410), to display at least a second information content (451) of a second information type (450), and to display at least a third information content (412, 452), the third information content (412, 452) being the first information type (410) or the second information type (450); a processor (140) connected to the electronic display (110) and configured to modify or control the visual appearance of the electronic display (110) by visualizing, separately, simultaneously, sequentially, or alternatingly, at least a portion of the first information content (411) and at least a portion of the third information content (412, 452) on the electronic display (110); Including, The first information type (410) includes general information about the medication; A second information type (450) of said electronic label contains information relating to the momentary status, actual use or previous use of the drug delivery device (1).
2. 2. The electronic label (100) of claim 1, wherein the processor (140) is configured to visualize at least a portion of the second information content (451) and at least a portion of the third information content (412, 452) separately, simultaneously, sequentially or alternatingly on the electronic display (110).
3. 3. An electronic label (100) according to claim 1 or 2, further comprising a data store (144) connected to or integrated in the processor (140), wherein the data store (144) is adapted to store a number of first information contents (411, 412, 413) of a first information type (410) and to store a number of second information contents (451, 452, 453) of a second information type (450). 。
4. An electronic label (100) as described in any one of claims 1 to 3, wherein the first information type includes at least one of drug name, lot number, date of manufacture, place of manufacture, preferred storage temperature, volume of drug container, concentration of active ingredient, shelf life, and regulatory information regarding the proper use of the medication located within the drug delivery device (1).
5. An electronic label (100) as described in any one of claims 1 to 4, wherein the second information type includes at least one of the following: a battery level of the electronic label, user instructions, time information regarding the last or preceding dose injection, time information indicating when the next dose injection is scheduled, information regarding the remaining contents of drug in the container, an indication that the dose injection has occurred or is completed, and instructions and information for the user.
6. 6. An electronic label (100) according to any one of claims 1 to 5, further comprising a clock generator (141) connected to or integrated in the processor (140), wherein the processor (140) is configured to visualize at least a part of one of the first information content (411) and the second information content (451) during a predetermined time interval, and to visualize at least a part of the third information content (412, 452) after the passage of the predetermined time interval.
7. 7. An electronic label (100) as claimed in any one of claims 1 to 6, wherein the processor (140) is configured to switch the electronic display (110) between an idle mode and a wake-up mode, the electronic display (110) consuming less electrical energy when in the idle mode compared to when in the wake-up mode.
8. 8. An electronic label (100) according to any one of claims 1 to 7, further comprising at least one ambient sensor (190) connected to a processor (140), the ambient sensor (190) being configured to determine at least one of ambient brightness, magnetic field, acceleration, temperature and variations in ambient air pressure, the processor (140) being configured to visualize or modify at least a part of one of the first information content (411, 412, 430) and the second information content (451, 452, 453) on the electronic display (110) upon receiving a sensor signal from the ambient sensor (190).
9. 9. The electronic label (100) of claim 8, wherein the processor (140) is operable to redirect or reverse the orientation of at least one of the first information content (411) and the second information content (451) in response to an electrical signal received from the ambient sensor (190).
10. An electronic label (100) as claimed in any one of claims 1 to 9, further comprising at least one input (128) connected to a processor (140) and operable by a user of the drug delivery device (1), wherein the processor (140) is configured to change the visual appearance of the electronic display (110) when the at least one input (128) is activated.
11. 11. An electronic label (100) according to any one of claims 1 to 10, further comprising a battery (150) connectable to the processor (140), wherein the processor (140) is configured to determine or measure a charge level of the battery (150), and wherein the processor (140) is operable to switch the electronic display (110) into a power saving mode when the charge level of the battery (150) falls below a predetermined minimum value.
12. a planar warning buzzer (146) connected to the processor (140), 12. An electronic label (100) according to any one of claims 1 to 11, wherein the warning buzzer (146) is configured to emit an audible sound when activated by the processor (140).
13. The electronic label (100) of any one of the preceding claims, wherein the electronic display (110) is one of an electroluminescent display (118), an electrophoretic display, a liquid crystal display, and a light emitting diode display (119).
14. A drug delivery device (1) for administering a medicament to a patient, comprising: a housing including or forming a body (10) and configured to receive a medicament container (6); a drive mechanism (8) configured to withdraw or expel a dose of drug from the drug container (6) and to administer the dose of drug to a patient; An electronic label (100) attached to a body (10) according to any one of claims 1 to 13; The drug delivery device comprising:
15. A method for visualising a first information content (411) of a first information type (410) and a second information content (451) of a second information type (450) on an electronic display (110) of an electronic label (100) according to any one of the preceding claims, comprising: visualizing at least a portion of a first information content (411) of a first information type (410) on an electronic display (110); Visualizing at least a portion of a third information content (411, 452) separately, simultaneously, sequentially or alternately on the electronic display (110), the third information content (412, 452) being the first information type (410) or the second information type (450); The method comprising:
Citation Information
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