Labels for injection devices

Abstract

The present disclosure relates to a label for an injection device. The label includes a flexible substrate configured to be attached to a body. The label further includes a first label area on the substrate having first information content, the first information content including at least one visual symbol or character. The label further includes a second label area on the substrate that does not overlap the first label area, the second label area including an electronic display configured to display the second information content. The label further includes a processor connected to the electronic display and configured to modify at least the second information content.

Description

[Technical field]

[0001] The present disclosure relates to the technical field of labels for injection devices. In particular, the present disclosure relates to a multi-function label for an injection device configured to change its visual appearance. In another aspect, the label is configured to remind and / or assist a user to perform an injection procedure when utilizing the injection device. In another aspect, the present disclosure relates to an adapter for attaching a label to an injection device. [Background technology]

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are known per se in the art. In general, such devices have a purpose substantially similar to that of a conventional syringe.

[0003] Drug delivery devices such as pen injectors must meet a number of user-specific requirements. For example, in the case of patients with chronic diseases such as diabetes, the patient may be physically frail and may also have visual impairments. Therefore, a suitable drug delivery device, especially intended for home drug therapy, must be robust in construction and easy to use. Furthermore, the operation of the device and its components as well as the overall handling must be straightforward and easily understandable. Such an injection device should allow for the setting of variable sized drug doses and their subsequent dispensing. Furthermore, the procedure for dose setting and dose dispensing must be easy to operate and clear.

[0004] Typically, such devices comprise a housing or a specific cartridge holder adapted to receive a cartridge at least partway filled with the medicament to be dispensed. The device further comprises a drive mechanism, which typically comprises a displaceable piston rod for operatively engaging a bung or piston of the cartridge, by means of which the bung or piston of the cartridge can be displaced in a distal or dispensing direction and thus expel a predefined amount of medicament via a piercing assembly, for example in the form of a syringe needle, which is releasably coupled to a distal end section of the housing of the drug delivery device.

[0005] The medicament dispensed by the drug delivery device may be provided and contained in a multi-dose cartridge. Such cartridges typically comprise a glass barrel that is sealed distally by a pierceable seal and proximally by a bung. In a reusable drug delivery device, the empty cartridge can be replaced with a new one. In contrast, a disposable drug delivery device is to be discarded in its entirety when dispensing of the medicament in the cartridge is completed or depleted.

[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 his or her thumb to apply distal pressure to 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 be able to accurately, reliably, and semi-automatically monitor and / or collect data regarding the injection during use of the injection device. Furthermore, there is an increasing need to assist users with the proper and correct handling of such drug delivery or injection devices. For successful treatment, a well-defined, e.g. user-specific, amount of drug, i.e., drug dose, must be administered according to a given prescription schedule, e.g., based on a regular time. In some instances, the patient may forget or not be aware if the prescribed dose was recently injected. Furthermore, the patient may not always be aware of the size of the dose to be set and injected. This is particularly relevant for patients who are at least somewhat forgetful and / or mentally and / or physically frail. Summary of the Invention [Problem to be solved by the invention]

[0008] There is therefore a need for information about the medication and / or about the proper or intended handling of the injection device to be clearly and conspicuously visible on the outside of the injection device. The medication-related and / or handling-related information should be provided in a durable and persistent manner. However, in some use situations, some information should be provided dynamically and / or on demand, e.g. to assist the user in or during handling or use of the injection device.

[0009] The objective is therefore to provide an improved label for an injection device, which on the one hand provides durable and lasting information about the medicament and on the other hand provides supplementary information as required regarding the proper and / or intended use of the injection device. The implementation and understanding of the label should be easy and intuitive. The label should be produced at reasonable or low cost, allowing the improved label to be retrofitted to existing injection devices. The label should achieve a space-saving design and should fit the geometry of the injection device housing. [Means for solving the problem]

[0010] In one aspect, the present disclosure relates to a label for an injection device. The label includes a flexible substrate. The flexible substrate is configured to be attached to a body. For example, the flexible substrate is configured to be attached to a body of a housing of an injection device. The label includes a first label area on the substrate. The first label area comprises a first information content. The first information content includes at least one visual symbol or character. The label further includes a second label area on the substrate. The second label area does not overlap with the first label area. The second label area includes an electronic display. The electronic display is configured to display the second information content.

[0011] Typically, the first label area and the second label area are arranged on the substrate so as not to overlap. Thus, the first label area and the second label area are arranged next to each other on the substrate. Furthermore, at least one of the first label area and the second label area may be at least partially surrounded by the other of the first label area and the second label area. In some examples, the geometric dimensions and shapes of the first label area and the second label area may be more or less the same or similar. In some other examples, the geometric dimensions and shapes of the first label area are different from the size and geometric dimensions of the second label area.

[0012] The label further includes a processor connected to the electronic display. The processor is configured to modify at least a second information content to be provided by the electronic display of the second label area. Thus, the label provides two functions. Typically, the first label area is configured to provide the first information content persistently or unalterably. Typically, the first information content indicates the type of medication located or stored in the injection device. The second label area is reconfigurable. Thus, the second information content may change on demand. Typically, the second label area is configured to change and modify the second information content deterministically, on demand, or depending on at least one environmental or ambient condition.

[0013] Typically, the second information content to be provided by the electronic display of the second label area may provide information suitable to assist a user in the proper or intended handling of the injection device and / or in using the medicament located therein. In a typical example, the second information content indicates at least one of the following: the time when the next use of the device or injection is scheduled, the dose to be set and / or the amount or size of the dose to be dispensed by the injection device, the current state or configuration of the injection device, or instructions for use indicating the correct handling of the injection device for the purposes of setting and / or expelling or dispensing a dose of medicament.

[0014] Typically, the first label area and the second label area are of different types. The first label area is particularly configured to provide information about the type of drug and / or the drug's properties, in a persistent and / or unalterable manner. The second label area is particularly configured to provide dynamic information about the correct use and handling of the drug and / or the injection device. At least the second label area is configured to provide information content that changes over time. Thus, a processor connected to the electronic display of the second label area is configured to modify the visual appearance of the second label area and / or modify the second information content over time.

[0015] The label is not limited to attachment to an injection device. The label is generally also suitable for attachment to other medical devices, such as an infusion device, an infusion pump, an injection pump, an inhaler, or a portable medical analysis device, such as a blood glucose meter. Each of these devices typically includes a body, for example implemented as a component of a device housing. The respective body or housing is configured to engage or receive a flexible substrate, which allows the label, and therefore the flexible substrate, to be attached to the body of the medical device. The medical device can be implemented as an injection device, for example as a handheld injection device, as an infusion device, as a drug delivery pump, as an inhaler, or as a portable medical analysis device, such as a blood glucose meter.

[0016] Typically, the body is elongated in shape. In some examples, the body comprises a tubular shaped body. In some examples, the body comprises a mechanically rigid structure. In some examples, the body comprises an injection molded plastic component.

[0017] According to a further example, the first label area includes an electronic display of a first display type. The electronic display of the second label area is an electronic display of a second display type. The first display type and the second display type are different display types. Typically, the electronic display of the first label area is a first electronic display. The electronic display of the second label area is a second electronic display. The first and second electronic displays are of different display types. The first electronic display of the first electronic display type is particularly configured to provide a first information content in a persistent and durable, e.g. non-erasable, manner. The second display and / or the second display type is configured to provide a dynamically changed or dynamically modified second information content to the second label area and thus to the second electronic display.

[0018] By providing two different types of electronic displays, one and the same substrate and / or one and the same label provides two different functions. Regulatory provisions usually require that at least the type or name of the drug is persistently and / or indelibly visible on the outside of the injection device. The first electronic display and / or the first display type can fulfill this requirement. Usually, the first display type and / or the first electronic display can persistently provide the first information content even without the supply of electrical energy. The first electronic display and / or the first display type can be characterized by a fairly low power consumption. Usually, the power consumption of the first display is less than the power consumption of the second display.

[0019] The second electronic display, and thus the second display type, can be configured to provide a dynamically changing second information content. The second information content, providing instructions or information regarding the use of the injection device, is allowed to disappear if sufficient electrical energy is not provided to the label to drive or operate the second electronic display. Nevertheless, since the first display is of the persistent type, the absence of electrical energy does not adversely affect the persistence, durability, and / or readability of the first information content provided by the first electronic display of the first label area.

[0020] According to another example, the first display type is one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light emitting diode display. Similarly, the second display type is one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light emitting diode display. The first and second display types are different.

[0021] Typically, the first display type consumes less power than the second display type. In some examples, the first electronic display and the first display type are also connected to a processor or have separate processors. Thus, the first display may also be reconfigurable, allowing the first information content to change over time. However, the first information content may always be compliant with regulatory provisions. Each available appearance of the first information content satisfies legal and / or regulatory requirements regarding the visual display of a drug located or disposed on the injection device or a drug intended for use with the injection device.

[0022] According to further examples, the first display type is an electrophoretic display and the second display type is a light emitting diode display. Thus, the first display is an electrophoretic display and the second display is a light emitting diode display. Typically, the second display is an organic light emitting diode display. Both the first display and the second display may be of a flexible type. Both the first display and the second display may include a flexible sheet display. The first display and / or the second display may include multiple display layers that are flexible. In some examples, the first display and / or the second display include flexible display layers stacked on top of each other. Both the first display and the second display may be disposed on a common flexible substrate.

[0023] Implementing the first display as an electrophoretic display can provide a persistent and durable first information content in the first label area even when the label is insufficiently supplied with electrical energy. Implementing the second display, and thus the second label area, as a light-emitting diode display can provide excellent contrast readability and brightness. Furthermore, light-emitting diode displays can have relatively high resolution, 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.

[0024] According to another example, the first information content is printed or engraved on the first label area. In this example, the first label area does not have an electronic display. Rather, the first label area is printed with the first information content in a durable and / or persistent manner. Here, drug-related information such as drug name, drug type, manufacturing date or manufacturing lot is provided in printed or engraved form on the first label area. Here, the first label area and the second label area with the electronic display are provided on one and the same flexible substrate.

[0025] By having the printed or engraved first label area and the electronic display constituting the second label area on one and the same flexible substrate, the benefit is realized that only one label, i.e., one common flexible substrate, needs to be attached to the injection device to provide both persistent, non-erasable drug-related information to the user and dynamically modifiable information or instructions to the user, thus improving and simplifying the manufacture and assembly of the injection device.

[0026] According to another example, the electronic display of the second label area includes an organic light emitting diode (OLED) display, where the first information content can be printed or imprinted on the first label area, while the second label area comprises or is comprised by the organic light emitting diode display.

[0027] In some other examples, the label of the injection device may not have a first label area on the substrate. Here, the flexible substrate may include an organic light-emitting diode display connected to and driven or operated by the processor to provide a reconfigurable second information content. If the second label area includes an organic light-emitting diode display, the label may even not have a first label area. The organic light-emitting diode display is flexible and / or bendable. The organic light-emitting diode display can conform to the shape of the flexible substrate when attached and / or wrapped around the body, which may be tubular. The organic light-emitting diode display further provides excellent readability, contrast, brightness, and resolution.

[0028] According to another example, the electronic display of the second label area includes a color display configured to visualize at least one of the second information content and the information background in at least two different colors. Here, the second electronic display is a color display. In a further example, the electronic display of the second label area, and thus the second electronic display, is configured to modify the brightness of at least one of the second information content and the information background.

[0029] In a further example, the processor connected to the second electronic display can be configured to switch off or shut down the second electronic display, thus reducing the power consumption of the second electronic display to a minimum. The processor can be further configured to wake up or switch on the second display, thus providing the second information content selectively, i.e., only in circumstances where the second information content should be displayed and provided to the user.

[0030] In some examples, the processor includes a power manager. The power manager may be operable to switch on and / or off the electronic display, e.g., the second electronic display, deterministically, e.g., after a predefined time interval has elapsed. The power manager may be configured to switch on and / or off the respective electronic display upon request, e.g., when a user interacts with the label and / or the processor, e.g., via the input unit.

[0031] Moreover, in a further example, the power manager can be configured to switch on and / or switch off the electronic display, e.g., the second electronic display, in response to various ambient conditions. To this end, the power manager can be connected to at least one sensor, such as an ambient sensor configured to detect various ambient conditions, such as ambient brightness, temperature, humidity, acceleration, and / or various air pressures.

[0032] Instead of switching off the respective electronic display, the power manager may be further operable to dim the electronic display, thus reducing the brightness of at least one of the information content and the information background, thus reducing the power consumption of the respective electronic display, i.e. at least the second electronic display.

[0033] According to another example, the label includes at least one of a device sensor and an ambient sensor. The device sensor is 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. The ambient sensor is configured to determine at least one of ambient brightness, acceleration, ambient temperature, and various ambient air pressures. A signal generated and acquired from at least one of the device sensor and the ambient sensor is transmitted to a processor of the label. The signal of the at least one of the device sensor and the ambient sensor is processable by the processor to modify the visual appearance of at least one of the first display and the second display.

[0034] Thus, the processor is operable to receive and process signals of at least one of the device sensor and / or the ambient sensor. Each sensor signal indicates a modification or change in at least one of the position or orientation of at least one of the dose tracker and the piston rod. Additionally or alternatively, the sensor signal may indicate changes in ambient brightness, acceleration, temperature, or various ambient air pressures. Thus, in response to signals received from the ambient sensor and / or the device sensor, the processor modifies the visual appearance of at least one of the first label area and the second label area.

[0035] In a further example, the processor is operable to modify at least one of the first information content and the second information content in response to an electrical signal received from at least one of the device sensor and the ambient sensor. Here, a signal obtained from the device sensor that may indicate an instantaneous state or condition of the injection device may be processed and displayed on the second electronic display. For example, a dose size currently set and / or detected by the device sensor may be visually displayed on the second electronic display and thus on the second label area of ​​the label. Additionally or alternatively, the second information content may provide instructions for proper handling of the injection device for setting and / or dispensing a dose.

[0036] A particular acceleration detected by the ambient sensor may be indicative of the injection device undergoing a movement, for example, when the injection device is grasped or picked up by the user. Detection of an acceleration above a predefined threshold may be used to wake up the processor and / or the second electronic display. For example, the processor may be configured to switch on the second electronic display or increase the brightness of the second electronic display when the injection device is grasped and / or picked up or rotated.

[0037] Moreover, according to a further example, the ambient sensor is integrated into the power management unit of the label. If the ambient sensor detects a change in the ambient conditions, such as ambient brightness, ambient temperature, ambient humidity, acceleration, or ambient air pressure, the processor may put the label and / or the device sensor into an activated state. If the ambient conditions are not otherwise changing over time and / or do not undergo any change for a time interval exceeding a predefined sleep time interval, the processor and / or the power management unit may configure the label, for example the processor itself and / or the second electronic display, into a sleep or idle mode. In the sleep or idle mode, only the ambient sensor may be kept active.

[0038] When a variation in the ambient conditions is detected, the processor may be operable to activate the device sensor for at least a predefined time interval, i.e., an activation time interval, during which signals generated by and / or obtained from the device sensor are processed by the processor to monitor and / or assist in setting and / or dispensing a dose at the injection device.

[0039] The signal received from the ambient sensor can be used to wake up the processor and / or at least one of the first and second electronic displays. For example, when the ambient sensor detects an acceleration above a predefined threshold (which acceleration indicates, for example, that the injection device has been gripped or turned over by a user when the label is attached to the injection device), the appearance of the second label area and / or the appearance of the first label area can be subject to a change. Thus, the wake-up of the processor can be visually indicated to a user of the device. Furthermore, based on the electrical signal received from the ambient sensor, the processor can be configured to modify a first information content of the first label area, for example, modifying information content on a first electronic display of the first label area.

[0040] Here, when the injection device is gripped and / or lifted, a first portion of the medication-related information and a second portion of the medication-related information can be alternately shown and provided on the first electronic display. In this way, the readability of the first information content can be increased. The first information content can be reproduced in enlarged symbols or letters. In this way, the medication-related information can be provided on the first electronic display in a size that would normally exceed the display size. By alternating or modifying the first information content on the first electronic display, the medication-related information can be divided into at least first and second information, which are alternately displayed on the first electronic display. In this way, the readability of the medication-related information can be increased and improved.

[0041] In a further example, the processor is operable to rotate or flip the orientation of at least one of the first and second information content in response to an electrical signal received from the ambient sensor. The ambient sensor can be implemented as an orientation sensor and / or a tilt sensor. In this way, the orientation of the label and / or the injection device to which the label is attached can be determined with respect to the direction of the surrounding gravitational field. The processor is operable to rotate or flip the orientation of at least one of the first and second information content when the user grips the injection device and / or when the user rotates or flips the injection device into a direction or orientation in which the first and / or second information content is entirely unreadable.

[0042] In this way, the first and / or second information content of the first and second label areas, and thus the visual appearance of the information content on the first and second electronic displays, can be dynamically adapted to the momentary orientation of the label and / or the injection device, thus ensuring that the label, i.e. the first and second information content, can be read in any available or possible orientation of the label.

[0043] In another embodiment, a label for an injection device is provided. The label includes a flexible substrate configured to be attached to a tubular-shaped body. The label includes a first label area on the substrate. The first label area includes a first electronic display configured to display a first information content in the first label area. The label further includes a processor, the processor is connected to the first electronic display and configured to modify at least the first information content to be provided to the first electronic display. The label further includes an orientation sensor configured to identify an orientation of the label relative to an ambient gravitational field.

[0044] The processor is configured to modify the orientation of the first information content of the first electronic display, in particular to rotate or flip it, depending on the signal received from the orientation sensor. This particular label for an injection device may include all the features of the labels described above and below, but with only one electronic display. This particular label may not have a second label area and / or may not have the first information content printed or imprinted on the substrate.

[0045] 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 electrical capacitance, electric field, and magnetic field. Typically, the injection device comprises and / or includes a dose tracker, the position or orientation of which relative to the housing or body of the injection device indicates the size of the dose currently being set or dispensed. The dose tracker may comprise 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 injection device during handling and manipulation of the injection device to set and / or dispense a dose of a medicament.

[0046] 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 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 electric capacitance, the electric field, and the magnetic field allows for non-contact identification and / or quantitative measurement of the position or orientation of the dose tracker of the injection device relative to the housing or the body of the injection device when the label is attached to the injection device.

[0047] According to a further example, the electronic display includes at least one conductive grid electrode that at least partially spatially overlaps with 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 may provide two functions: the conductive grid electrode is operable to drive and / or operate the first electronic display and / or the second electronic display. At the same time, the conductive grid electrode serves to block and / or shield the electrode structure of the device sensor that is normally located underneath it.

[0048] In the label laminate, the device sensor electrode structure is provided on the top side of the flexible substrate. Typically, at least one conductive grid electrode is disposed on top of the device sensor electrode structure. Thus, the device sensor electrode structure is located between the flexible substrate and the at least one conductive grid electrode.

[0049] In another example, the device sensor electrode structure is located or disposed on the underside of the flexible substrate, with at least one conductive grid electrode located on the topside or outward facing portion of the flexible substrate, in either case the device sensor electrode structure is effectively shielded from environmental electromagnetic or electrostatic perturbations.

[0050] The flexible substrate is particularly configured to wrap around at least a portion of the body or housing of the injection device. The body or housing may comprise a more or less cylindrical or tubular structure. Thus, the flexible substrate may conform or deform to the sidewall of the tubular shaped housing of the injection device. The flexible substrate allows for a fairly common attachment of the label to a number of different injection devices. The label may be commonly applicable and / or attachable to different types of injection devices.

[0051] Also, the label may be fairly thin or flat and may be permanently attached to the housing of the injection device. The injection device with the label attached may be wrapped or packaged in the device's packaging, for example for transport and / or storage. If so, the label, when attached to the housing of the injection device, has only a minor effect on the outer contour and / or geometry of the injection device. The label may further impart a fairly attractive design to the injection device.

[0052] The flexible substrate may comprise a flexible plastic foil or a flexible metal foil, for example a plastic foil made from polyethylene (PE) or polyethylene terephthalate (PET).

[0053] The flexible substrate, the electronic display, and thus the entire label, may have 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 may have a thickness of less than 1 mm or less than 0.5 mm.

[0054] Typically, in many instances, the label includes an electronic circuit located on the substrate. The electronic circuit is electrically connected to a processor and an electronic display. The electronic circuit can be disposed directly on the flexible substrate. The electronic display and / or processor are integrated into the electronic circuit.

[0055] The electronic circuit may comprise a flexible electronic circuit, such that the conductive structures of the electronic circuit are bendable or flexible, thereby following 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 shaped housing.

[0056] The electronic circuitry can be printed onto the substrate. The electronic circuitry can be printed onto the flexible substrate with one or more inks made of carbon-based compounds. Additionally, the electronic circuitry can be deposited onto the flexible substrate by solution or vapor deposition processes. The electronic circuitry printed onto the substrate allows for low-cost mass production of the labels.

[0057] In another example, the underside of the flexible substrate can be at least partially provided with adhesive. The underside of the flexible substrate can be provided with an adhesive layer. The entire underside of the flexible substrate can be provided with adhesive, or only a portion thereof. In order to allow a permanent attachment of the label to the housing of the injection device, adhesive can be provided, in particular in a border area of ​​the underside of the flexible substrate. The adhesive on the underside of the flexible substrate can provide an adhesive fixation of the label to the body or housing of the injection device or adapter. This is quite space-saving and can be implemented at reasonable or low cost.

[0058] According to another example, the electronic circuit further includes a battery. The battery is usually connected to the processor and / or the electronic display. The processor and / or the battery can be printed on a flexible substrate. The processor and / or the battery can also have a degree of flexibility, which allows and supports the deformation of the flexible substrate when assembled and attached to the housing of the injection device.

[0059] 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.

[0060] In a further example, the electronic circuitry includes data storage or memory configured to store at least one of the number of user actions and the time point of the user action or the time points of multiple user actions. The electronic circuitry and / or processor may further comprise a clock for generating an indication of time to enable the time point of a user action to be stored, for example when a user touches or presses a touch-sensitive area of ​​the label. In the absence of a clock on the label, the electronic circuitry may simply be configured to count the number of such user actions. In this way, a kind of dosage counter may be provided by the label.

[0061] According to another example, the electronic circuit includes an antenna for wireless communication of electronic signals with an external electronic device. The antenna is typically connected to the processor. With the antenna, the processor is configured to communicate with the external electronic device. 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 further allows for communication with a personal computer or similar computing device.

[0062] The antenna and its interaction with the processor further allows for the transfer of data previously stored in the data storage of the electronic circuit to an external electronic device. The antenna allows the external electronic device to be configured to read the contents of the data storage of the label. Typically, the data storage is integrated into the electronic circuit. In other examples, the data storage can be provided separately and thus offset from the electronic circuit. Wireless communication of electronic signals between the processor and the external electronic device further allows for reconfiguration of the processor and / or the electronic display.

[0063] Using the external electronic device and wireless communication of the electronic signal, the label can be reconfigured using the external electronic device. Thus, at least one indicator can be replaced with a second indicator. Furthermore, the entire appearance of the electronic display can be reconfigured according to the electronic signal received from the external electronic device. Thus, at least one electronic display can be individually configured for different usage situations and / or for use with different injection devices.

[0064] The data stored in the data storage of the electronic circuitry can be transmitted to an external electronic device, allowing for monitoring and post-dosage evaluation of user behavior recorded in the data storage during the time intervals that the label was disconnected from the external electronic device.

[0065] Although the labels described herein are particularly configured for attachment to an injection device, the labels may equally be attachable to the body of any other or further medical device, such as an infusion device, an infusion pump, an injection pump, an inhaler, or a portable medical analysis device such as a blood glucose meter, etc. Any reference to an injection device may thus be considered as a reference to the respective medical device.

[0066] According to another aspect, the present disclosure also relates to an injection device for setting and injecting a dose of a drug. The injection device can be configured as a handheld pen injector or as a drug pump. The injection device includes a housing configured to accommodate a drug container. The injection device further includes a drive mechanism configured to draw or expel the dose of the drug from the drug container. The drive mechanism is further configured to inject the dose of the drug into the biological tissue. The injection device further includes a label as described above. The label is attached to the housing or body of the injection device. Typically, the body of the injection device is a part of the housing of the injection device. The body of the injection device may be a proximal part of the housing.

[0067] The drive mechanism of the injection device typically comprises a longitudinally displaceable piston rod adapted for operative engagement with a piston of a cartridge containing the injectable medicament, the distal end of the cartridge being provided with a pierceable seal, typically penetrable by a double-ended injection needle, opposite the piston rod.

[0068] A label attached to the outside of the injection device housing allows all mechanically implemented injection devices, such as disposable or reusable injection pens, to be retrofitted with memory aids or reminders, thus assisting the user with the proper handling and operation of the injection device.

[0069] In a further example, the present disclosure relates to a medical device such as an infusion device, an infusion pump, an injection pump, an inhaler, or a portable medical analysis device such as a blood glucose meter. The medical device further comprises a label as described above. The label is attached to a housing or body of the medical device. The body of the medical device may be a part of the housing of the respective medical device.

[0070] According to a further example, a medicament container, for example 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. When the injection device is distributed to a customer or patient, the medicament container filled with medicament can be easily assembled inside the injection device.

[0071] 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 depleted or has exceeded its recommended expiration date. In other examples, the injection device may be implemented as a reusable injection device, allowing for exchange and replacement of a medication-filled medication cartridge or medication container.

[0072] In some examples, the injection device is a fixed dose injection device that sets and injects only one of the predefined dose sizes, in other examples, the injection device is implemented as a variable dose injection device, where the user may individually set different sized doses for injection.

[0073] 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, the rigid body including an outer surface and including a mating locking feature configured to releasably mechanically engage a correspondingly or complementary shaped locking feature of the housing of the injection device. The adapter further includes a label as described above attached to the outer 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 conventionally printed label.

[0074] In some examples, the rigid body includes a tubular-shaped sleeve configured to receive at least a portion of the housing of the injection device inside the sleeve. The label can be adhesively attached to an outer surface of the rigid body. The label can be pre-fixed to an outer surface of the rigid body. The label is fixed and attached to the rigid adapter body in a well-defined position and / or orientation. The adapter provided with a label on its outer surface is particularly configured for retrofitting a label to an existing injection device, e.g. without the need to adhesively attach the label to the injection device.

[0075] In various examples, when the label comprises a device sensor, it may be important that the label is correctly and / or accurately attached and secured in a well-defined position and / or orientation relative to the housing of the injection device. This may comprise a mating locking feature of the rigid body configured to engage with a locking feature of the injection device.

[0076] The locking feature may include at least one of a radial protrusion or a radial recess, which may engage with a correspondingly shaped radial recess or a radial protrusion of the mating locking feature. The locking feature and the mating locking feature may be implemented as mutually corresponding snap features. Furthermore, only one of the mating locking feature and the locking feature may be implemented as a snap feature, while the other of the mating locking feature and the locking feature 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.

[0077] In a further example, the rigid body of the adapter includes a cap fixing feature configured to engage with a protective cap of the injection device. This is particularly beneficial when the fixing feature of the housing of the injection device is implemented as a cap fixing feature configured to engage with a mating fixing feature of the protective cap of the injection device. The cap fixing feature of the housing of the injection device may for example originally be configured to releasably attach and / or releasably fix the protective cap of the injection device covering the distal end of the housing of the injection device.

[0078] The mating locking feature of the rigid body may mimic or replace the mating locking feature of the protective cap of the injection device. The mating locking feature of the rigid body may engage with the locking feature of the housing of the injection device instead of the locking feature of the protective cap. A rigid body implemented for example as a tubular sleeve can be applied to receive the proximal housing part of the injection device such that the mating locking feature 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 locking feature that engages with the mating locking feature of the protective cap. Now, when the adapter is engaged with the locking feature of the housing of the injection device, the protective cap originally supplied with the injection device can be replaced with another protective cap configured to engage with the rigid body of the adapter.

[0079] In this context, the term "distal" or "distal end" refers to the end of the injection device that faces towards the injection site of a person or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest away from the injection site of a person or animal.

[0080] The term "drug" or "medicament" as used herein means a pharmaceutical preparation containing at least one pharma- ceutical active compound; wherein in one embodiment the pharma- ceutical active compound has a molecular weight of up to 1500 Da and / or is a peptide, a protein, a polysaccharide, a vaccine, DNA, RNA, an enzyme, an antibody or a fragment thereof, a hormone, or an oligonucleotide, or a mixture of the abovementioned pharma-ceutical active compounds, wherein in a further embodiment the pharma- ceutically active compound is useful for the treatment and / or prophylaxis of diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis, Wherein in a further embodiment the pharma- ceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy, Wherein, in a further embodiment, the pharma- ceutical active compound comprises at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin-4 or an analog or derivative of exendin-3 or exendin-4.

[0081] Insulin analogues are, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline in position B28 is 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.

[0082] Insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; 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-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0083] Exendin-4 means, for example, exendin-4(1-39), a peptide with the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0084] Exendin-4 derivatives include, for example, the compounds listed below: H-(Lys)4-desPro36,desPro37 Exendin-4(1-39)-NH2, H-(Lys)5-desPro36,desPro37 Exendin-4(1-39)-NH2, desPro36 exendin-4(1-39), desPro36[Asp28]exendin-4(1-39), desPro36[IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14,Asp28]Exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]Exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39); or desPro36[Asp28]exendin-4(1-39), desPro36[IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14,Asp28]Exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]Exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39), (wherein the group -Lys6-NH2 may be attached to the C-terminus of the exendin-4 derivative);

[0085] Or an exendin-4 derivative of the following sequence: desPro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010), H-(Lys)6-desPro36[Asp28]Exendin-4(1-39)-Lys6-NH2, desAsp28Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro38[Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2; H-(Lys)6-desPro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2, desMet(O)14 Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-desPro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, desPro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2; or a pharma- ceutically acceptable salt or solvate of any one of the aforementioned exendin-4 derivatives. is selected from.

[0086] Hormones are, for example, the pituitary or hypothalamic hormones or regulatory active peptides listed in the Rote Liste, 2008 edition, chapter 50, and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropines (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

[0087] The polysaccharides are, for example, glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or the above-mentioned polysaccharides in sulfated, e.g. polysulfated, form, and / or pharma- ceutically acceptable salts thereof. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

[0088] Antibodies are globular plasma proteins (approximately 150 kDa) also known as immunoglobulins that share a common basic structure. They are glycoproteins because they have sugar chains attached to the amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only Ig units), and secretory antibodies can be dimers with two Ig units, such as IgA, tetramers with four Ig units, such as IgM in bony fish, or pentamers with five Ig units, such as IgM in mammals.

[0089] An Ig monomer is a "Y" shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains joined by disulfide bonds between cysteine ​​residues. Each heavy chain is approximately 440 amino acids long, and each light chain is approximately 220 amino acids long. The heavy and light chains each contain intrachain disulfide bonds that stabilize these folded structures. Each chain is composed of structural domains called Ig domains. These domains contain 70-110 amino acids and are classified into different categories (e.g., variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two beta sheets create a "sandwich" shape held together by interactions between conserved cysteines and other charged amino acids.

[0090] There are five types of mammalian Ig heavy chains, designated α, δ, ε, γ, and μ. The type of heavy chain present defines the antibody's isotype, and these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0091] The different heavy chains differ in size and composition, with α and γ containing approximately 450 amino acids, δ containing approximately 500 amino acids, and μ and ε containing approximately 550 amino acids. Each heavy chain is composed of two regions: the constant region (C H ) and variable region (V H ) in a species. The constant region is essentially identical in all antibodies of the same isotype, but different in antibodies of different isotypes. Heavy chains gamma, alpha, and delta have constant regions made up of three tandem Ig domains and a hinge region to add flexibility, while heavy chains mu and epsilon have constant regions made up of four immunoglobulin domains. The variable region of the heavy chains differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is about 110 amino acids long and is made up of a single Ig domain.

[0092] In mammals, there are two types of immunoglobulin light chains, designated λ and κ. Light chains have two consecutive domains, one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 211-217 amino acids. Each antibody contains two light chains that are always identical, and for each antibody in a mammal, there is only one type of light chain, κ or λ.

[0093] Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) region, as detailed above. More specifically, three variable loops for each light chain (VL) and three for each heavy chain (VH) are involved in binding to the antigen, i.e., its antigen specificity. These loops are called complementarity determining regions (CDRs). Since the CDRs from both the VH and VL domains contribute to the antigen binding site, it is the combination of the heavy and light chains that determines the final antigen specificity, not either one alone.

[0094] An "antibody fragment" contains at least one antigen-binding fragment as defined above and exhibits essentially the same function and specificity as the complete antibody from which it is derived. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing one complete L chain and approximately half of the H chain, are the antigen-binding fragments (Fab). The third fragment, which is comparable in size but contains the carboxyl termini at half of both heavy chains with interchain disulfide bonds, is the crystallizable fragment (Fc). Fc contains carbohydrate, complementary binding sites, and FcR sites. Limited pepsin digestion yields a single F(ab')2 fragment that contains both the Fab piece and the hinge region, including the HH interchain disulfide bond. F(ab')2 is bivalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. Additionally, the variable regions of the heavy and light chains can be fused to form single chain variable fragments (scFv).

[0095] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, alkali or alkaline salts, for example salts with cations selected from Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), where R1-R4 are each independently: hydrogen, an optionally substituted C1-C6 alkyl group, an optionally substituted C2-C6 alkenyl group, an optionally substituted C6-C10 aryl group, or an optionally substituted C6-C10 heteroaryl group. Further examples of pharma-ceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17th edition, edited by Alfonso R. Gennaro, Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.

[0096] Pharmaceutically acceptable solvates are, for example, hydrates.

[0097] It will be further apparent to those skilled in the art that various modifications and changes may be made to the present disclosure without departing from the scope of the present disclosure.Furthermore, it should be noted that any reference signs used in the appended claims should not be considered as limiting the scope of the present disclosure.The label, injection device, and adapter are not limited to a specific embodiment or example, but include any combination of elements of different embodiments or examples.Thereby, the present disclosure covers any combination of claims, and any technically feasible combination of the disclosed configurations related to different examples or embodiments.

[0098] In the following, a number of examples of containers and injection devices are described in more detail with reference to the drawings. [Brief description of the drawings]

[0099] [Figure 1] FIG. 1 illustrates an example of an injection device. [Diagram 2] FIG. 2 is an exploded perspective view of the injection device of FIG. 1. [Diagram 3] FIG. 2 is a diagram of the injection device of FIG. 1 with a touch-sensitive label attached to the housing of the injection device. [Figure 4] FIG. 2 is an enlarged view showing one configuration of the label. [Diagram 5] FIG. 13 further illustrates a label in another configuration. [Figure 6] 13A-13C show further configurations of the label. [Figure 7] FIG. 13 is a diagram showing another configuration of the label. [Figure 8] 13A-13C show further configurations of labels having first and second information content in a flipped or rotated orientation. [Figure 9] FIG. 1 is a perspective view of an injection device with an adapter holding a label, the label in a pre-assembled configuration. [Figure 10] FIG. 2 is a longitudinal cross-sectional view of an assembly of an injection device with an adapter. [Figure 11] FIG. 2 illustrates a multi-layer structure of a touch-sensitive label. [Figure 12] 1 is a cross-sectional view of an example of a touch-sensitive label. [Figure 13] FIG. 2 is a block diagram showing the electronic circuitry of the touch-sensitive label. [Figure 14] FIG. 13 shows another example of a touch-sensitive label with a sensor. [Figure 15] FIG. 1 is a cross-sectional view of an injection device with a touch-sensitive label attached. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0100] The injection device 1 shown in Figures 1 and 2 is a disposable, pre-filled injection device, which includes a housing 10 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, which is configured to surround and protect a distal section of the housing 10 of the injection device 1. The housing 10 may include or form a main housing member configured to accommodate a drive mechanism 8 shown in Figure 2. The injection device 1 may further include a distal housing component, shown as a cartridge holder 14. The cartridge holder 14 is permanently or releasably connected to the main housing 10. The cartridge holder 14 is configured to accommodate a cartridge 6, which is typically filled with a liquid medicament. The cartridge 6 includes a cylindrical or tubular barrel 25, which is sealed in a proximal direction 3 by a bung 7 located inside the barrel 25. The bung 7 is displaceable in a distal direction 2 by a piston rod 20 relative to the barrel 25 of the cartridge 6. The distal end of the cartridge 6 is sealed by a pierceable seal 26, which is configured as a septum and is pierceable by the proximally facing tip of the injection needle 15. The cartridge holder 14 includes a threaded socket 28 at its distal end for threadedly engaging a corresponding threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is pierced, thereby establishing a fluid transfer path to the interior of the cartridge 6.

[0101] When 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 is displayed in so-called international units (IU, where 1 IU is the biological equivalent of approximately 45.5 μg (1 / 22 mg) of pure crystalline insulin). The dose dial 12 may comprise or form a dose dial.

[0102] 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 the user to view a limited portion of the number sleeve 80 that is configured to move when the dose dial 12 is turned, providing a visual indication of the currently set dose. The dose dial 12 rotates along a helical path relative to the housing 10 when turned during dose setting and / or dispensing or expelling.

[0103] The injection device 1 may be configured such that turning the dose knob 12 produces a mechanical click sound to provide auditory feedback to the user. The number sleeve 80 mechanically interacts with the piston of the insulin cartridge 6. When the needle 15 is inserted into the patient's skin area and the trigger 11 or injection button is pressed, the insulin dose displayed in the viewing window 13 will be released from the injection device 1. If the needle 15 of the injection device 1 remains in the skin area for a certain period of time after the trigger 11 is pressed, a high percentage of the dose is actually injected into the patient's body. The release of the insulin dose may also produce a mechanical click sound, but this sound is different from the sound produced when using the dose dial 12.

[0104] In this embodiment, during delivery of an insulin dose, the dose dial 12 is brought to its initial position with an axial movement, i.e., without rotation, while the number sleeve 80 rotates back to its initial position, e.g., to display a dose of zero units.

[0105] The injection device 1 can be used for multiple injection processes until the cartridge 6 is empty or until the expiry date of the medication in the injection device 1 (eg 28 days after first use).

[0106] Furthermore, before the first use of the injection device 1, it may be necessary to perform a so-called "prime shot" by selecting, for example, two units of drug and pressing the trigger 11 while holding the injection device 1 with the needle 15 at the top, to remove any air from the cartridge 6 and the needle 15. For ease of explanation, it is assumed below that the ejected amount substantially corresponds to the injected dose, whereby, for example, the amount of drug ejected from the injection device 1 is equal to the dose accepted by the user.

[0107] An example of the drive mechanism 8 is shown in more detail in FIG. 2. FIG. 2 includes a number of mechanically interacting components. The flange-like support of the housing 10 includes a threaded axial through-hole that threadably engages with a first or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a bearing 21 on 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 proximally facing thrust receiving surface of the bung 7 of the cartridge 6. During a dosing movement, the piston rod 20 rotates relative to the housing 10, thereby resulting in a distally advancing movement relative to the housing 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 housing 10.

[0108] The piston rod 20 further includes at its proximal end a second thread 24. The distal thread 22 and the proximal thread 24 have opposite thread senses.

[0109] Further, a drive sleeve 30 is provided having a hollow interior for receiving the piston rod 20. The drive sleeve 30 includes an internal thread that threadably engages the proximal thread 24 of the piston rod 20. Further, the drive sleeve 30 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 predefined axial distance from the distal flange portion 32. Between the two flange portions 32, 33, a final dose limiter 35 in the form of a semicircular nut is provided having an internal thread that meshes with the threaded section 31 of the drive sleeve 30.

[0110] The final dose limiter 35 further includes a radial recess or protrusion on its outer periphery for engaging a complementary recess or protrusion on the inside of the side wall of the housing 10. The final dose limiter 35 is thus splined to the housing 10. Rotating the drive sleeve 30 in the dose increment direction 4 or clockwise direction during successive dose setting procedures causes a cumulative axial displacement of the final dose limiter 35 relative to the drive sleeve 30. Furthermore, an annular spring 40 is provided which axially abuts against a proximally facing surface of the flange portion 33. Furthermore, a tubular shaped clutch 60 is provided. At a first end, the clutch 60 is provided with a series of circumferentially oriented sawtooths. Towards an opposite second end of the clutch 60, a radially inwardly oriented flange is located.

[0111] Further, a dose dial sleeve is provided, also shown as number sleeve 80. Number sleeve 80 is provided outside spring 40 and clutch 60 and is located radially inside housing 10. A helical groove 81 is provided around the outer surface of number sleeve 80. Housing 10 is provided with dose window 13 through which a portion of the outer surface of number 80 is visible. Housing 10 is further provided with a helical rib on an inner sidewall portion of insert piece 62, which fits into helical groove 81 of number sleeve 80. Tube-shaped insert piece 62 is inserted into the proximal end of housing 10. Insert piece 62 is axially fixed to be non-rotatable relative to housing 10. First and second stops are provided on housing 10 to limit the dose setting procedure to a helical motion of number sleeve 80 rotating relative to housing 10.

[0112] 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 generally corresponds to and matches the outer diameter of the housing 10. The dose dial 12 is fixed to the number 80 to prevent relative movement therebetween. The dose dial 12 includes a central opening.

[0113] The trigger 11, also indicated as a dose button, is substantially T-shaped. The trigger 11 is provided at the proximal end of the injection device 10. A stem 64 of the trigger 11 extends through an opening in the dose dial 12, through the inner diameter of the length of the drive sleeve 30, and into a receiving recess in the proximal end of the piston rod 20. The stem 64 is held against axial movement within the drive sleeve 30 and against rotation relative thereto. 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 fit into a proximally accessible annular recess of the dose dial 12.

[0114] To dial in a dose, the user rotates the dose dial 12. With the spring 40 also acting as a clicker, the clutch 60 and the number sleeve 80 rotate together with the dose dial 12, with the clutch 60 engaged with the drive sleeve 30, the spring or the clicker 40. Audible and tactile feedback of the dose being dialed in is provided by the spring 40 and the clutch 60. Torque is transferred between the spring 40 and the clutch 60 via the sawtooth. The spiral groove 81 of the number sleeve 80 and the spiral groove of the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the housing 10 and the drive sleeve 30 to move up the piston rod 20 at the same rate. At the limit of travel, the radial stop of the number sleeve 80 engages either the first stop or the second stop on the housing 10, preventing further movement in the first rotational direction, e.g. the dose increase direction 4. Since the entire driven thread on the piston rod 20 is in the opposite direction, the piston rod 20 is prevented from rotating.

[0115] A final dose limiter 35, which is keyed to the housing 10 or body, advances along the threaded section 31 by rotation of the drive sleeve 30. Upon reaching the final dose dispensed position, 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 both the final dose limiter 35 and the drive sleeve 30.

[0116] In case the user inadvertently dials in excess of the desired dose, the injection device 1 configured as a pen injector can dial in a lower dose without dispensing any medicament from the cartridge 6. For this, the dose dial 12 is simply rotated in the opposite direction. 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, generating a clicking sound corresponding to the dialed-in dose reduction. Typically, the sawtooths are arranged such that the circumferential extent of each sawtooth corresponds to a unit dose. Here, the clutch may act as a ratchet mechanism.

[0117] Alternatively or additionally, the ratchet mechanism 90 may include at least one ratchet feature 91, such as a flexible arm on the side wall of the tubular clutch 60. The at least one ratchet feature 91 may include, for example, a radially outwardly extending protrusion on the free end of the flexible arm. The protrusion is configured to engage a correspondingly shaped mating ratchet structure on the inside of the number sleeve 80. The inside of the number sleeve 80 may include an elongated shaped groove or protrusion characterized by a sawtooth profile. During dialing or setting of the dose, the ratchet mechanism 90 allows and supports the rotation of the number sleeve 80 relative to the clutch 60 along the second rotation direction 5, which rotation is accompanied by a regular clicking sound of the flexible arm of the clutch 60. The angular momentum applied to the number sleeve 80 along the first rotation direction is transferred unchanged to the clutch 60. Here, torque transmission from the number sleeve 80 to the clutch 60 is achieved by the mutually corresponding ratcheting function of the ratchet mechanism 90 .

[0118] Once the desired dose has been dialed in, the user may dispense the set dose by simply depressing the trigger 11. This causes the clutch 60 to be displaced axially relative to the number sleeve 80, disengaging its canines. However, the clutch 60 remains keyed to the drive sleeve 30 during rotation. The number sleeve 80 and dose dial 12 are now free to rotate following the helical groove 81.

[0119] The axial movement ensures that the flexible arms of spring 40 cannot deform to overhaul the sawtooth during dispensing. This prevents rotation of drive sleeve 30 relative to housing 10, but drive sleeve 30 is still free to move axially relative to the housing. This deformation is then used to urge spring 40 and clutch 60 back along drive sleeve 30 to restore coupling between clutch 60 and number sleeve 80 when distally directed dispensing pressure is removed from trigger 11.

[0120] Longitudinal axial movement of the drive sleeve 30 rotates the piston rod 20 through a through-hole in the support of the housing 10, thereby advancing the bung 7 within the cartridge 6. When the dialed dose has been dispensed, at least one stop extending from the dose dial 12 contacts at least one corresponding stop on the housing 10, thereby preventing further rotation of the number sleeve 80. The zero dose position can be identified by one of the axially extending edges or stops of the number sleeve 80 abutting at least one or several corresponding stops on the housing 10.

[0121] In the example shown, the number sleeve 80 is 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 10 or body of the injection device 1 indicates the currently set size. The dose tracker 50 includes a tracking stop feature 51 which is operable to engage a mating stop of the housing 10, for example when a zero dose configuration or a maximum dose configuration is reached.

[0122] The number sleeve 80 is just one example of a dose tracker 50. Similarly, the piston rod 20 may also act as or be used as a dose tracker 50.

[0123] The ejection or drive mechanism 8 described above is merely illustrative of one of several different configurations of drive mechanisms that may typically be implemented in a disposable pen injector. The drive mechanisms 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.

[0124] The dose setting mechanism 9 shown in Figure 2 includes at least the dose dial 12 and the number sleeve 80. When the dose dial 12 is rotated during and for setting 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 of the inner surface of the housing.

[0125] During dose setting, when the drive mechanism 8 or dose setting mechanism 9 is in dose setting mode, the drive sleeve 30 rotates in unison with the dose dial 12 and the number sleeve 80. The drive sleeve 30 is in threaded engagement with the piston rod 20, which is stationary relative to the housing 10 during dose setting. The drive sleeve 30 is therefore subject to a threading or helical movement during dose setting. When the dose dial rotates in a first rotational or dose increase direction 4, e.g. in a clockwise direction, the drive sleeve 30 starts to move in a proximal direction. To adjust or modify the size of the dose, the dose dial 12 is rotatable in an opposite second rotational direction, and thus in a dose decrease direction 5, e.g. in a counterclockwise direction.

[0126] 3 to 15 show several examples of a label 100 configured to be attached to the tubular shaped housing 10 or body of an injection device 1. As further shown in Figures 9 and 10, the label 100 of the injection device 1 can be configured to be attached to an outer surface 211 of a rigid body 210 of an adapter 200, which is configured to releasably mechanically engage a locking feature 96 of the housing 10 of the injection device 1. To this end, the adapter 200 includes a mating locking feature 216 shaped correspondingly or complementarily to the locking feature 96.

[0127] The label 100 comprises a flexible substrate 101 as shown in Figure 11. Provided on the flexible substrate 101 are a first label area 110 and a second label area 120 as shown in more detail in the succession of Figures 3-8. The first label area 110 is provided with a first information content 111. The first information content 111 comprises at least one visual symbol 114 or character. The second label area 120 does not overlap the first label area 110.

[0128] The second label area 120 is configured to display or provide second informational content 121. The first informational content 111 and the second informational content 121 are different. The second label area 120 includes an electronic display 122. The electronic display 122 is configured to display the second informational content 121. The label 100 further includes a processor 140, as shown generally in the block diagram of the label 100 in FIG. 13. The processor 140 is connected to the electronic display 122. The processor 140 is configured and operable to modify at least the second informational content 121 shown on or displayed by the electronic display 122.

[0129] Typically, the first and second label areas 110, 120 are located above the substrate 101. The label 100, or at least the electronic display 122 of the label 100, includes a multi-layer structure as shown in Figures 11 and 12. Thus, the electronic display 122 can include a multi-layer structure, for example a thin film multi-layer structure.

[0130] The flexible substrate 101 or base substrate may be any material known for the production of printed electronic labels, such as PET film or office paper. Other plastic materials, e.g. PVC, are also suitable. The base substrate has an adhesive on one side for fixing the label to the pen body, which may be, for example, permanent or removable, depending on the choice of adhesive.

[0131] The label 100 may include a mechanically flexible structure that is bendable or wrapable around the outer periphery or outer surface of the body 10 of the injection device and / or the rigid body 210 of the adapter 200, which is shown in Figures 9 and 10.

[0132] Thus, electronic display 122 is a flexible electronic display. Electronic display 122 may include one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light emitting diode display, in particular an organic light emitting diode display (OLED). Such displays are known to be flexible and bendable.

[0133] In some cases, label 100, e.g., second label area 120, may include an input 128, e.g., implemented as a touch-sensitive area of ​​second label area 120. Touch-sensitive area or input 128 may be implemented as a portion of second label area 120. In some examples, the entire electronic display 122 may be implemented as touch-sensitive area 128. Thus, touch-sensitive area 128 may overlap electronic display 122. In other words, electronic display 122 may be implemented as a touch-sensitive electronic display.

[0134] The input 128 is connected to the processor 140. A mechanical engagement, for example, touching the input 128, can prompt the processor 140 to modify or alter the second information content 121 on the second label area 120. In some examples, the input 128 or touch-sensitive area of ​​the electronic display 122 includes a capacitive switch manufactured in a technology for printing electronics. 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 comes into close proximity to the capacitor. This proximity affects a measurable characteristic of the capacitor, for example its capacitance. This change in the capacitor can be measured and / or detected by the processor 140.

[0135] In some embodiments, for example as shown in Figures 4 and 5, the first information content 111 is printed or imprinted in the first label area 110. Here, the first information content 111 can include a printing color or ink provided directly or indirectly on the upper or outer surface of the flexible substrate 101. The flexible substrate 101 can be provided with a printing layer that is particularly suitable for the deposition of a printing ink or similar printable visual substance that is used to print or implement the first information content 111 in the first label area. As shown in Figures 4-8, the first information content 111 includes at least one visual symbol 114 or character. In the examples shown, the first information content 111 includes information about a drug or type of drug in the first label area 110, such as the name of the drug.

[0136] 4-8, the first information content 111 typically indicates or includes information about a drug or general characteristics of a drug. The first information content 111 may include information such as drug type, drug name, drug concentration, date of manufacture, recommended expiration date, manufacturer name, place of manufacture, and / or lot number.

[0137] The first information content 111 is persistent and durable when printed or imprinted in the first label area 110. The first information content 111 is provided in the first label area 110 in a non-erasable or non-modifiable manner. In this manner, the label 100 is able to meet regulatory requirements in terms of pharmaceutical labeling.

[0138] The second information content 121 shown and provided in the second label area 120 is modifiable by the processor 140. The electronic display 122 is typically configured to visualize or show at least one visual symbol 124. The visual symbol 124 may include instructions to the user, such as dial, set, inject, hold, injection complete, due date or time, etc. Additionally or alternatively, the electronic display 122 may visually indicate the size of the dose, e.g., a series of numbers or digits indicating the international unit of the size of the drug dose to be set, dialed and / or injected. Furthermore, the second information content 121 may include a date or time indicating to the user when the next event or next use of the injection device is currently scheduled. Furthermore, the second information content 121 may include a time interval or duration indicating, for example, a holding time or remaining holding time for the injection needle to remain at the patient's injection site after the dose injection process is completed.

[0139] As becomes apparent from a comparison of Figures 4 and 5, the electronic display 122 is a color display 126. The color of at least one of the information background 125 and the visual symbols 124 presented on the electronic display 122 is modifiable. In Figures 4 and 5, different patterns of the information background 125 represent different colors, different brightness, or different contrast. Furthermore, the color, brightness, and contrast of the visual symbols 124 displayed or provided on the electronic display 122 can be subject to respective modification as required.

[0140] In the configuration of FIG. 4, the second information content 121 indicates to the user that a dose is currently scheduled to be dialed or set. To identify or measure the size of the dose currently set on the injection device 1 when the label 100 is attached to the housing 10 of the injection device 1, the label 100 may include a device sensor 170, the details of which are described below. When the label 100 detects that a dose of the prescription has been dialed, the second information content 121 may reflect or indicate the correct dose dial setting. The second information content 121 may provide a respective confirmation, for example by changing the color of at least one of the visual symbol 124 and the information background 125. For example, the color may switch from red to green. Alternatively or additionally, at least one of the brightness and contrast of the information content 121 may be subject to a respective modification.

[0141] Additionally or alternatively, the information content 121 may blink to visually indicate to the user that the prescribed dose size is set correctly. Shown in Figure 5 is a situation where, after setting the correct dose, the label informs the user to trigger injection of the dose, for example by pressing trigger 11.

[0142] After the end of the injection procedure, the information content 121 switches or is modified again. The information content 121 may indicate to the user that the injection needle should remain inside the pierced skin for a holding time. The holding time, e.g. 5 or 10 seconds, may be visually indicated in the information content 121. The indicated holding time may be dynamically indicated to the user of the label 100. The holding time may include a countdown scheme, visualizing the current remaining holding time until the injection needle can be withdrawn from the patient's injection site.

[0143] The information content 121 may then be modified again to indicate to the user that the injection is complete. The information content 121 may then switch to the configuration shown in Figure 6, where the information content 121 now indicates the time when the next event, e.g., the next injection of medication, is scheduled.

[0144] 6 shows a further implementation of flexible label 100, where first label area 110 includes first electronic display 112. In this case, electronic display 122 is considered a second electronic display and must be designated as such. First electronic display 112 may be provided with information content 111. As previously mentioned, information content 111 includes at least one visual symbol or character 114.

[0145] Typically, the first electronic display 112 and the second electronic display 122 are different display types. The first electronic display 112 is a first display type, and the second electronic display 122 is a second display type. The first display type and the second display type are different display types. The first display 112 is one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light-emitting diode display, particularly an organic light-emitting diode display. The second display 122 is also one of an electroluminescent display, an electrophoretic display, a liquid crystal display, and a light-emitting diode display, particularly an organic light-emitting diode display. In some examples, the first display 112, and thus the first display type, is an electrophoretic display, and the second display 122 or the second display type is a light-emitting diode display, particularly an organic light-emitting diode display.

[0146] The electrophoretic display of the first display 112 is particularly configured to provide drug-related information at all times in order to comply with regulatory requirements in terms of drug labeling. For this reason, electrophoretic displays are particularly advantageous. Even when there is no electrical energy on the label, the first information content 111 is still persistently visible in the first label area 110. The electrophoretic display of the first electronic display 112 provides excellent readability with high contrast, even when exposed to fairly direct illumination of a bright light source, such as sunlight.

[0147] When the first label area 110 is provided with the first electronic display 112, the electronic display 112 can also be connected to the processor 140. Thus, the first information content 111 of the first label area can also be modified by the processor 140. The modification of the first and / or second information content 111, 121 can be triggered semi-automatically, for example after a predefined time interval. The modification of the first and / or second information content 111, 121 can be triggered by a user input, for example by activating the input 128.

[0148] Furthermore, modification of the information content 111, 121 can be triggered by at least one of the device sensor 170 and the ambient sensor 190 connected to the processor 140. Here, at least one of the first and second information content 111, 121 is modifiable in response to a signal received from at least one of the device sensor 170 and the ambient sensor 190. In this way, the label 100 dynamically reacts to various ambient conditions or changing configurations of the injection device 1.

[0149] The ambient sensor 190 integrated into the label 100 and / or disposed on the flexible substrate 101 is one of an ambient brightness sensor, an acceleration 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 when the label undergoes acceleration, movement, or reorientation with respect to a gravitational field.

[0150] In response to the generation of such a sensor signal, the processor 140 may be configured to wake up and activate or switch on the second electronic display 122. In this way, semi-automatic wake-up or activation of the label 100 can be implemented.

[0151] In response to a sensor signal obtained from the ambient sensor 190, at least one of the first electronic display 112 and the second electronic display 122 may change its appearance. In an idle or sleep mode, the label 100 may provide basic information about the medication in the first label area 110. Here, the first information content 111 may provide basic medication-related information in the first label area 110, which medication information complies with regulatory provisions. The processor 140 may be configured to modify or change the first information content 111 and / or the second information content 121 when the label is woken up and / or activated via a signal generated and / or provided by the ambient sensor 190. For example, the medication name may disappear, instead of instructions for use or other medication-related information such as information about the medication's use, pharmaceutical stability, or shelf life, as becomes clear by comparing the first information content 111 shown in FIG. 6 and FIG. 7.

[0152] Upon wake-up or activation of the label 100, the second information content 121 may also be subject to respective modifications.

[0153] Further, as shown by a comparison of Figures 7 and 8, the processor 140 is operable to rotate or flip the orientation of at least one of the first informational content 111 and the second informational content 121 based on electrical signals received from the ambient sensor 190, which may be implemented as an acceleration sensor or an orientation sensor. The instantaneous orientation of the first informational content 111 and / or the second informational content 121 with respect to the local gravitational field may be determined. If the label 100 is to be oriented upside down, the processor 140 is configured to flip or rotate the orientation of the first informational content 111 and / or the second informational content 121 as shown in Figure 8.

[0154] Thus, when the label 100 is attached to the injection device 1 in a predefined manner, the label 100 and the injection device 1 can be used by right-handed and left-handed people alike. When used by a left-handed person, the information content 111, 121 of the label 100 is rotated upside down compared to the configuration of the label 100 when the respective injection device 1 is used by a right-handed person or patient.

[0155] The example of electronic circuitry 130 in FIG. 13 is in no way limiting, but is for the example of FIGS. 3-15. Electronic display 112 and / or electronic display 122 may overlap electronic circuitry 130. Thus, at least one or both of electronic displays 112, 122 may entirely overlap the underlying electronic circuitry 130. At least one or both of electronic displays 112, 122 may include a multi-layer structure as shown in FIGS. 11 and 12. Electronic circuitry 130 may be implemented in one or some of the various layers 103, 104, 105, 106 of flexible label 100. Typically, electronic circuitry 130 is entirely provided by conductive layer 103.

[0156] The input 128 or touch-sensitive area may be visually indicated on the electronic display 112, 122 or on a separate portion outside the electronic display 112, 122. The input 128 and electronic display 112, 122 are configured to interact such that when the input 128 or touch-sensitive area is touched or pressed, at least the second electronic display 122 changes its visual appearance. The electronic display 112, 122 may be switchable between a default or idle mode and activation.

[0157] In a further example, when the input 128 is touched and pressed, the processor 140 can be configured to record the user action and / or the time of the user action in the electronic storage 144 or memory of the electronic circuitry. The electronic storage 144 can include capacity to store data for multiple events, e.g., 30, 100, 1000 events, including timestamps.

[0158] In a further example, the electronic circuit includes an antenna that provides a data transmission element, for example an antenna that enables NFC, Wi-Fi, or RF data transmission. Thus, the data 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, where active implementation requires an energy source, for example a battery, to power the electronic device. The battery can be implemented in printing technology.

[0159] 13 shows an example of an electronic circuit 130 of a touch-sensitive label 100. The electronic circuit 130 may be printed directly on a flexible substrate 101. The electronic and / or conductive structures of the electronic circuit 130 may also be flexible or bendable. The integrity or functionality of the electronic circuit 130 is not substantially affected by bending or flexing the flexible substrate 101 and / or the electronic circuit 130.

[0160] The electronic circuit 130 typically includes a battery 150 with multiple battery cells 152. The individual battery cells 152 are electrically connected together. They may 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 may include printed electronic structures. Thus, the battery 150 and / or the battery cells 152 are printed batteries or battery cells and may be placed on the substrate 101 by printing.

[0161] The processor 140 is connected to a battery 150 and an electronic display 122. The interconnection between the battery 150 and the processor 140 can be interrupted by a switch 154 in conjunction with the input 128. By pressing the switch 154, the electrical connection between the battery 150 and the processor 140 can be connected or disconnected.

[0162] The processor 140 includes a central processing unit (CPU) 142 and a storage 144. The storage 144 can store a plurality of predefined information contents 111, 121 for showing on at least one of the electronic displays 112, 122. Upon recording the closing or opening of the switch 154, the respective information content 121 can be shown or displayed on the electronic display 122. If the data storage 144 is provided, the processor 140 can further be configured to count the number of touching actions of the touch-sensitive area. If the processor 140 further comprises a clock, a timestamp can further be assigned to each input or touch instance, thus making it possible to record the administration history or to record the time when the input 128 is appropriately touched by the user of the injection device 1.

[0163] The electronic circuit 130 may further include an antenna 160 connected to the processor 140. The antenna 160 may be configured to perform wireless data communication. The antenna 160 may be configured as a receiving antenna and / or 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 in accordance with a conventional wireless communication standard, such as Bluetooth, NFC, or IEEE 802.11 (WLAN). The antenna 160 may be configured to exchange data with an external electronic device 300, such as a smart watch, a smartphone, a tablet computer, or a personal computer.

[0164] The processor 140 can be reconfigured by signals obtained from the external electronic device 300 via the antenna 160. Thus, the external electronic device 300 can be used to modify or reconfigure the processor 140 and thus the content of the display of at least one of the first and second electronic displays 112, 122. Additionally or alternatively, the external electronic device 300 can be further configured to read the data storage 144 of the electronic circuitry 130. In this way, the administration history and use of the label 100 can be accurately monitored and transmitted to the external electronic device 300 for further processing and / or evaluation.

[0165] The entire electronic components of the electronic circuit 130, such as the wired connection between the battery 150 and the battery cells 152, the switches 154 or touch-sensitive areas forming the inputs 128, the antenna 160, and the processor 140, may include or be formed by a printing process on the substrate 101. In this way, separate assembly and placement of multiple electronic components on the substrate 101 is substantially unnecessary. This allows for cost-effective mass production of the touch-sensitive label 100.

[0166] The underside of the substrate 101 may be provided with adhesive. The adhesive may be provided in an adhesive layer 102 to cover the entire or at least a portion of the underside of the substrate 101 opposite the conductive layer 103 on which the electronic circuitry 130 is located. In FIG. 12, a stack of multiple layers 103, 104, 105, 106 configured to form one of the electronic displays 112, 122 is exemplarily shown. The stack structure of FIG. 12 is a thin-film electroluminescent display 112. The substrate 101 may be flexible and may include or consist of one of the following: foldable office paper, transparent or opaque PET film, leather, wood, ceramic, and metal foil. The electroluminescent display is configured to actively emit light.

[0167] 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 105, for example in the form of a phosphor layer. When an AC signal of suitable voltage and suitable current is applied, the electroluminescent layer 105 emits photons.

[0168] The stack of layers 103, 104, 105, 106 need only add 100-150 μm to the thickness of substrate 101. Thus, electronic display 110 can be made very thin.

[0169] In another example, the flexible electronic display 110 is implemented as an electrophoretic display, which is based on rearranging charged pigment particles by applying an electric field. Here, titanium dioxide particles, suitably 1 μm in diameter, may be 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 electrophoretically migrate towards the plate that carries the opposite charge to that of the particles.

[0170] When the particles are located on the front or viewing side of the display, the light is scattered back towards the viewer by the high refractive index titania particles, causing the display to appear white. When the particles are located on the rear side of the display, the incident light is absorbed by the colored dyes, causing the display to appear dark. 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, creating a pattern of reflective and absorptive areas. Electrophoretic displays are considered a prime example of the e-paper category due to their paper-like appearance and low power consumption.

[0171] The label 100 only possibly comprises an antenna 160. In one implementation, the label 100 may not have an antenna 160 and may be operable to indicate a well-defined or predefined information content 111 and to provide switching between a sleep mode and an activation mode.

[0172] A further example of a flexible label 100 is shown in Figures 14 and 15. The label 100 can be implemented with or without an antenna 160. The label 100 includes a flexible substrate 101 having at least one electronic display 112, 122. Typically, the label 100 of Figure 14 also includes a processor 140, a CPU 142, data storage 144, and a battery 150 as described above in connection with Figure 13. Additionally, the label 100 of Figures 14 and 15 includes a device sensor 170.

[0173] When the label 100 is attached to the housing 10 in a predefined manner, the device sensor 170 is configured to determine or identify a position and / or a rotational state of a dose tracker 176 of the injection device 1, where the dose tracker 176 may coincide with or represent the dose tracker 50 described above in relation to Figs. 1-2. Alternatively, the dose tracker 176 may be represented by any other component of the injection device 1. The dose tracker 176 may be represented for example by the piston rod 20, or by any optional component of the drive mechanism 8, or by 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.

[0174] For positioning the label 100 on the housing 10, the housing 10 may include at least one or several position marks 180, shown in Fig. 15 as protrusions on the outer surface of the housing 10. The label 100 must be properly attached to the housing 10 in an area 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 with respect to the housing 10, is detectable by the device sensor 170.

[0175] 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 not have a protrusion or recess in the outer surface of the housing 10. The position mark 180 may simply include a visual indicator, such as a border area within which the label 100 should be secured, e.g., attached by adhesive.

[0176] In one example, the device sensor 170 includes a plurality of separate sensor segments 171, 172, 173 separated along a direction of movement of the indicator 175 and / or the dose tracker 176 relative to the housing 10. When the dose tracker 176 is subjected to a rotational and / or sliding movement relative to the housing 10, the indicator 175, e.g., initially overlapping the first sensor segment 171, moves towards the second sensor segment 172 and further towards, e.g., the third sensor segment 173. The movement of the indicator 175 relative to the plurality of sensor segments 171, 172, 173 is detectable by the device sensor 170, which is electrically connected to the processor 140. Thus, the processor 140 and the device sensor 170 are configured to identify and detect the actual position and / or rotational state of the indicator 175, and thus the dose tracker 176, relative to the housing 10.

[0177] The position or rotational state of the dose tracker 176 visibly corresponds to the size of the dose actually set by the injection device 1. Thus, when the label 100 is properly connected to the housing 10, the processor 140 can be configured to identify or measure the size of the dose actually set by the injection device 1. The identified longitudinal or rotational position of the dose tracker 176 may thus be compared with a predefined position indicated, for example, 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.

[0178] The specific implementation of the device sensor 170 and the indicator 175 may vary. As shown in Fig. 15, 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 the respective sensor segments 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.

[0179] In another example, the indicator 175 may be magnetically encoded, and the sensor segments 171, 172, 173 may be configured to detect the magnetic field of the indicator 175 when the indicator 175 is subjected to a longitudinal and / or rotational movement. In a further example, the indicator 175 and the sensor segments 171, 172, 173 may be electrostatically implemented, where the multiple sensor segments 171, 172, 173 may be configured to determine or detect a change in an electric field caused by the indicator 175. Furthermore, the sensor segments 171, 172, 173 may include a capacitance measuring element configured to measure a change in an electric field or an electric capacitance in the vicinity of the respective sensor segments 171, 172, 173. Magnetic, electrostatic, and capacitance measuring procedures may be particularly beneficial since they do not require a through hole 178 or a recess in the side wall of the housing 10. In such an implementation, the label 100 may simply be adhesively attached to the outer surface of the housing 10 within a given position mark.

[0180] In the example shown in Fig. 11 and Fig. 12, 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 above-mentioned sensor segments 171, 172, 173 may belong to or constitute the electrode structure 174. The electrode structure 174 may be located between the adhesive layer 102 and at least one of the conductive layers 103, 106. The electrode structure 174 may 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 an electric capacitance, an electric field, and a magnetic field in the vicinity of the substrate 101. Typically, the electrode structure 174 is configured to identify or quantitatively measure the position and / or rotational state of at least one device component, for example a dose tracker 176 of the injection device 1.

[0181] In a further example, the electrode structure 174 can be configured to determine the longitudinal position of the piston rod 20 relative to the barrel of the cartridge 6 and / or the longitudinal position of the bung 7 or piston of the cartridge relative to the housing or body 10 of the injection device 1.

[0182] 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, due to the spatial overlap between the conductive grid electrodes 103, 106 and 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 way, the 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.

[0183] As shown in FIG. 14, the conductive grid electrode 103 spatially overlaps with an electrode structure 174 and a number of sensor segments 171 , 172 , 173 of a device sensor 170 .

[0184] 9 and 10, an adapter 200 is shown that is configured to be releasably attached to the housing or body 10 of the injection device 1. The adapter 200 has a rigid body 210. The rigid body 210 comprises a tubular shaped hollow sleeve that is configured to receive at least a distal portion of the housing 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. As shown in FIG. 10, the rigid body 210, and therefore the sleeve, is also sized to receive the proximal housing or body 10 of the injection device 1. In the final assembled configuration shown in FIG. 10, the proximal end of the rigid body 210 may be located near or adjacent to the distal end of the dose dial 12.

[0185] The adapter 200 and its body 210 include at least one mating locking feature 216 for engaging with a locking feature 96 of the housing 10 of the injection device 1. As shown in Fig. 10, the locking feature 96 may include a radially outwardly extending protrusion. The protrusion may for example include at least one of a pin and a radially outwardly extending rim at the proximal end of the cartridge holder 14. Typically, the locking feature 96 is configured to engage with a respective mating locking feature of the protective cap 18 shown in Figs. 1 and 2.

[0186] To fix the adapter 200 here to the housing 10 of the injection device, the adapter 210 includes a mating locking feature 216 inside its hollow sleeve. The mating locking feature 216 may typically be located at or near the distal end of the rigid body 210. The mating locking feature 216 may include a recess or groove in the inner surface of the elongated sleeve of the rigid body 210. Thus, the mating locking feature 216 and the locking feature 96 may engage by a snap-fit ​​engagement. They may engage by a friction fit or by a form fit. Thus, the body 210 of the adapter 200 can be fixed to the outside of the housing 10 of the injection device 1 in a well-defined and precise manner. The body 210 includes an outer surface 211 to which the above-mentioned label 100 is fixed securely or removably. Typically, the label 100 is attached to the outer surface 211 by adhesion.

[0187] The adapter 200 is engageable with a fastening feature 96 of the injection device 1, which fastening feature 96 was originally intended for fastening the protective cap 18 shown in Figures 1 and 2, so that the protective cap 18 can be 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, which is configured and operable to engage with a mating cap fastener 228 provided on the replacement protective cap 218.

[0188] At least one of the cap fastener 220 and the mating cap fastener 228 includes a radial protrusion that is complementarily shaped to a respective radial recess of the other of the cap fastener 220 and the mating cap fastener 228. In this way, a replacement protective cap 218 can be attached and fixed to a distal portion or end of the adapter 200 when the adapter 200 is fitted into the original fastening feature 96 of the housing 10 of the injection device 1. [Explanation of symbols]

[0189] 1. Injection device 2 Distal direction 3 Proximal direction 4. Dose escalation 5 Direction of dose reduction 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 Convex 20 Piston rod 21 Bearing part 22 1st thread 23 Press 24 Second Thread 25 barrels 26 Sealing part 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 stopper function 60 Clutch 62 Insert piece 64 Stem 80 Number Sleeve 81 Groove 90 Ratchet mechanism 91 Ratchet function 95 Preselector 96 Fixed functions 100 Labels 101 Substrate 102 Adhesive layer 103 Conductive layer 104 Dielectric layer 105 Electroluminescent Layer 106 Transparent electrode layer 107 Electromagnetic Shielding 108 Recess 110 Label Area 111 Information Content 112 Electronic Display 114 Visual symbols 120 Label Area 121 Information Content 122 Electronic Display 124 Visual symbols 125 Information background 126 Color Display 128 Input section 130 Electronic circuits 140 processors 142 CPU 144 Storage 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 Outer surface 216 Fixed function on the other side 218 Protective Cap 220 Cap Fixture 228 Counterpart cap fixing tool 300 Electronic Devices

Claims

1. 1. A label for an injection device comprising: A flexible substrate (101) configured to be attached to a body (10, 210); a first label area (110) on a substrate (101) with a first information content (111), the first information content (111) including at least one visual symbol (114) or character; a second label area (120) on the substrate (101) not overlapping the first label area (110), the second label area (120) including an electronic display (122) configured to display second information content (121); a processor (140) connected to the electronic display (122) and configured to modify at least the second information content (121); the first label area (110) includes an electronic display (112) of a first display type and the electronic display (122) of the second label area (120) is an electronic display of a second display type, the first display type and the second display type being different display types; The first display type is one of an electroluminescent display and an electrophoretic display, and the second display type is one of a liquid crystal display and a light emitting diode display. A label for the injection device.

2. 10. The label of claim 1, wherein the first display type is an electrophoretic display and the second display type is a light emitting diode display.

3. The label of claim 1 or 2, wherein the electronic display (122) of the second label section (120) comprises an organic light emitting diode display.

4. The label of any one of claims 1 to 3, wherein the electronic display (122) of the second label area (120) comprises a color display configured to visualize at least one of the second information content (121) and the information background (125) in at least two different colors.

5. The label of any one of claims 1 to 4, further comprising at least one of a device sensor (170) and an ambient sensor (190), wherein the device sensor (170) is configured to determine at least one of a position or orientation of at least one of a dose tracker (176) and a piston rod (20) of the injection device (1) relative to a housing or body (10) of the injection device (1), and the ambient sensor (190) is configured to determine at least one of fluctuations in ambient brightness, acceleration, temperature, and ambient air pressure.

6. 6. The label of claim 5, wherein the processor (140) is operable to modify at least one of the first information content (111) and the second information content (121) in response to electrical signals received from at least one of the device sensor (170) and the ambient sensor (190).

7. 7. A label according to claim 5 or 6, wherein the device sensor (170) comprises an electrode structure (174) on the substrate (101) configured to measure at least one of an electrical capacitance, an electric field, and a magnetic field.

8. 8. The label of claim 7, wherein the electronic display (112, 122) includes at least one conductive grid electrode (103, 106) that at least partially spatially overlaps with an electrode structure (174) of the device sensor (170), the at least one conductive grid electrode (103, 106) providing an electromagnetic shield (107) for the electrode structure (174) of the device sensor (170).

9. A label according to any one of the preceding claims, wherein the processor (140) comprises a power manager operable to switch on and / or off the electronic display (122).

10. 10. The label of claim 9, wherein the power management is configured to switch on, switch off and / or dim the electronic display (122) in response to various ambient conditions.

11. 1. An injection device for setting and injecting a dose of a medication, comprising: a housing (10) configured to accommodate a medicament container (6); a drive mechanism (8) configured to withdraw or expel a dose of drug from the drug container (6) and configured to inject the dose of drug into biological tissue; A label (100) according to any one of claims 1 to 10 attached to a housing (10); 13. The injection device comprising:

12. The injection device according to claim 11, further comprising a medicament container (6) arranged inside the housing (10).

13. 1. An adapter (200) configured to be releasably attached to a housing (10) of an injection device (1), comprising: a rigid body (210) including an outer surface (211) and including a mating locking feature (216) configured for releasable mechanical engagement with a locking feature (96) of a housing (10) of the injection device (1); A label (100) according to any one of claims 1 to 10 attached to an outer surface (211); The adapter comprising:

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