Medical device including an alarm generator that considers environmental signals

Abstract

An injection device comprising an acoustic sensor configured to detect an ambient acoustic signal; an acoustic signal generator operable to generate an acoustic signal; and a controller configured to control the acoustic signal generator to generate an alert having acoustic properties selected based on the detected ambient acoustic signal. A feedback system comprising a first device comprising an acoustic signal generator operable to generate an acoustic signal; and a second device comprising an acoustic sensor configured to detect an ambient acoustic signal, and a controller configured to control the acoustic signal generator of the first device to generate an alert having acoustic properties selected based on the detected ambient acoustic signal; one of the first device and the second device being an injection device, and the other of the first device and the second device being a mobile device or a controller device.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a device for providing audible alarms to a user, and in particular to a device for providing audible alarms related to the status of a drug delivery device. BACKGROUND

[0002] There are a number of diseases that require regular treatment by injection of a medicament by a medical device. Such injections can be performed by using an injection device, either by medical personnel or by the patient himself. For example, type 1 and type 2 diabetes can be treated by patients themselves by injection of insulin doses, e.g. once or several times a day. For example, pre-filled disposable insulin pens can be used as injection devices. Alternatively, reusable pens can be used. Reusable pens allow for replacing an empty medicament cartridge with a new one. Either pen can be supplied with a set of disposable needles, which are replaced before each use. The insulin dose to be injected can then be manually selected, e.g. on an insulin pen by turning a dose knob and can be observed from a dose window or display of the insulin pen. The dose is then injected by inserting the needle into a suitable skin site and pressing an injection button of the insulin pen.

[0003] However, administering an injection is a process that presents a number of risks and challenges, both mentally and physically, for the user and for healthcare professionals. Patients can forget to administer a medicament according to their dosage regimen, or they can find it difficult to determine information related to the condition and / or use of the drug delivery device from the drug delivery device.

[0004] In an attempt to and to assist the user, it has been described to provide a drug delivery device, such as an injection device, with an acoustic signal generator configured to produce an acoustic signal related to the operational status of the injection device as feedback to the user. It has also been described to provide a haptic signal generator to provide haptic feedback, such as by vibration, as a means of feedback to the user.

[0005] However, audible feedback is difficult to verify according to international standards, in particular where the signal is generated by a mechanical action. Furthermore, it cannot be guaranteed that the user will acknowledge or understand the provided feedback.

[0006] Therefore, there is still a need for an improved device that can provide effective feedback to a user, as well as an improved medical device in combination with a management device that can provide effective feedback to prevent mis handling of the medical device and / or to document a dosage regimen.

[0007] It is an object to provide a device that provides further patient support in managing a dosage regimen involving a medical device and to facilitate an improved user experience. It is a further object to provide a system in which a device operates in conjunction with a second device to provide such patient support. For example, to help a user to more reliably, or more accurately, or more consistently, or more usefully determine when the device should be used and / or determine an operational status of a drug delivery device, or to improve another aspect of the process of managing a dosage regimen. SUMMARY

[0008] According to an aspect of the present disclosure, there is provided a medical device comprising: an acoustic sensor configured to detect an ambient acoustic signal; an acoustic signal generator operable to generate an acoustic signal; and a controller configured to control the acoustic signal generator to generate an alert having acoustic properties selected based on the detected ambient acoustic signal.

[0009] This can increase the reliability of the feedback alert output from the device, as the generated signal is specifically tailored to the ambient environmental conditions in a way that increases the likelihood that the alert is recognised and understood. This in turn can help a user to more reliably manage their medical condition.

[0010] The medical device can further comprise a vibration element configured to generate haptic feedback. The alert can further comprise the haptic feedback.

[0011] This is advantageous as it provides an additional mechanism by which the alert can be selected to take into account ambient environmental conditions. This increases the likelihood that the alert is recognised. This can be particularly beneficial for those with hearing impairments, as the additional type of alert increases the likelihood that the alert is recognised.

[0012] Alternatively, the acoustic properties of the alert can be additionally selected based on predetermined settings. This enables the type of alert to be customised to take into account ambient environmental conditions and specific requirements of a user, thereby increasing the likelihood that the alert is recognised and understood.

[0013] The predetermined settings can comprise any one or more of a feedback preference, an acoustic preference, a hearing limitation, a visual limitation and a haptic limitation. This enables various limitations to be taken into account when selecting an appropriate alert.

[0014] The medical device can further comprise a photoelectric element configured to detect an ambient light level, such that the acoustic properties of the alert are additionally selected based on the detected ambient light level.

[0015] This provides an additional mechanism by which the alert can be tailored to ambient environmental conditions in a way that increases the likelihood that the alert is recognised and understood.

[0016] The controller of the medical device can be configured to control the acoustic signal generator to generate an alert having a frequency spectrum, tone or timbre selected based on the detected environmental acoustic signal.

[0017] Additionally or alternatively, the controller can be configured to control the acoustic signal generator to generate an alert within a frequency band range selected based on the detected environmental acoustic signal.

[0018] Further, the controller can be configured to control the acoustic signal generator to generate the alert having an amplitude within each of a plurality of frequency bands selected based on the detected environmental acoustic signal.

[0019] Additionally or alternatively, the controller can be configured to control the acoustic signal generator to generate an alert at a volume selected based on the detected environmental acoustic signal.

[0020] The ability of the controller to select particular acoustic properties ensures that the alert can be tailored to ambient environmental conditions in a way that increases the likelihood that the alert is recognised and understood.

[0021] The acoustic properties of the alert can be selected additionally based on a status of the medical device.

[0022] This ensures that the alert is associated with the operation of the medical device, enabling the user to manage their medical condition more reliably.

[0023] The medical device can further comprise a second acoustic signal generator, wherein the controller is further configured to control the second acoustic signal generator to generate a reference noise arranged to cancel ambient noise other than the alert.

[0024] This is advantageous because it provides a noise cancellation mechanism that enables the user to hear the alert generated by the primary acoustic signal generator better, thereby increasing the efficacy of the alert.

[0025] The medical device can be any one of a drug delivery device, a supplemental device provided with a portion for coupling the supplemental device to a drug delivery device, or a flash glucose meter.

[0026] The medical device can be an injection device. The injection device can be an injection pen or a supplemental device provided with a portion for coupling the supplemental device to an injection pen.

[0027] According to another aspect of the present disclosure, there is provided a feedback system comprising: a first device comprising an acoustic signal generator operable to generate an acoustic signal; and a second device comprising an acoustic sensor configured to detect an ambient acoustic signal; and a controller configured to control the acoustic signal generator of the first device to generate an alert, the alert having an acoustic property selected based on the detected ambient acoustic signal.

[0028] This is advantageous as the combination of the first device and the second device in the system enables components for generating the alert to be distributed between the devices, enabling their operation to be more efficiently implemented. This can help the user to more reliably manage their dosage regimen.

[0029] The first device and the second device can be injection devices, and the other of the first device and the second device is a mobile device or a controller device.

[0030] The first device can be an injection pen or a supplemental device provided with a portion for coupling the supplemental device to an injection pen, and the second device can be a mobile device.

[0031] The first device can be any one of a medical device, a mobile device and a controller device, and the second device can be a different one of a medical device, a mobile device and a controller device.

[0032] The first device can be a drug delivery device or a supplemental device provided with a portion for coupling the supplemental device to a drug delivery device, and the second device can be a mobile device.

[0033] The first device or the second device can further comprise a vibration element configured to generate haptic feedback, and the alert can further comprise the haptic feedback.

[0034] The acoustic property of the alert can be additionally selected based on a predetermined setting.

[0035] The first device or the second device can further comprise a photoelectric element configured to detect an ambient light level. The acoustic property of the alert is additionally selected based on the detected ambient light level.

[0036] The first device and the second device can further comprise a wireless unit, and the second device is configured to receive status information from the first device, and the controller can be further configured to generate an alert in response to receiving the status information, the alert having acoustically properties additionally selected based on the status information.

[0037] Additionally, a method of generating an alert at a medical device is disclosed, the method comprising: detecting an environmental sound; and generating an alert, the alert having acoustically properties selected based on the detected environmental condition.

[0038] The alert can further comprise haptic feedback.

[0039] The acoustically properties of the alert can be additionally selected based on predetermined settings. The predetermined settings can comprise any one or more of feedback preferences, acoustic preferences, auditory limitations, visual limitations, and haptic limitations.

[0040] The method can further comprise receiving information related to the status of the medical device; and generating an alert, the alert having acoustically properties additionally selected based on the status information.

[0041] Additionally, a computer program is disclosed, the computer program comprising machine readable instructions which, when executed by a controller, cause the controller to perform a method of generating an alert at a medical device.

[0042] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0043] In the drawings:

[0044] Fig. 1 is a schematic diagram illustrating internal components of a mobile device with an apparatus according to embodiments of the present disclosure.

[0045] Fig. 2 is a flowchart illustrating the operation of an apparatus according to embodiments of the present disclosure.

[0046] Fig. 3 is a flowchart illustrating the selection of predetermined settings, in particular user group settings, according to embodiments of the present disclosure.

[0047] Fig. 4 is a flowchart illustrating the selection of predetermined settings, in particular user specified settings, according to embodiments of the present disclosure.

[0048] Fig. 5 is a schematic diagram illustrating various audio settings selectable in Fig. 4 according to embodiments of the present disclosure.

[0049] Figure 6 is a schematic diagram illustrating various device operations that can be selected in Figure 4, according to an embodiment of the present disclosure.

[0050] Figure 7 is a flow chart illustrating the operation of a device, according to an embodiment of the present disclosure.

[0051] Figure 8 is a flow chart illustrating the operation of a device, according to an embodiment of the present disclosure.

[0052] Figure 9 is a schematic diagram illustrating a mobile device in wireless communication with a drug delivery device, according to other embodiments of the present disclosure. In Figure 9A, the acoustic signal generator is integrated with the injection device. In Figure 9B, the acoustic signal generator is integrated with a supplemental device that is releasably attached to the injection device. In Figure 9, the injection device is an injection pen.

[0053] Figure 10 is a flow chart illustrating the operation of a device, according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0054] In the following, embodiments of the present disclosure will be described with reference to a device implemented as a medical device for providing an audible alarm, i.e. an automatic sound generator. In particular, the medical device is described as a drug delivery device. However, the present disclosure is not limited to such an application and the device can equally well be implemented in another medical device or an alternative device, such as a mobile device.

[0055] According to a first group of embodiments, the device is implemented in a medical device 10. The medical device 10 is a drug delivery device, such as an injection device 1. In particular, the medical device 10 can be an injection device 1 in the form of an injection pen. Figure 1 is a schematic diagram illustrating internal components of the medical device 10.

[0056] The medical device 10 comprises a number of components in conjunction with the automatic sound generator. The medical device 10 comprises a display 22, e.g. an LCD, TFT (Thin Film Transistor), OLED (Organic Light Emitting Diode), e-paper. The display 22 can be a touch sensitive display having a display portion 24 and a touch interface portion 26. The display portion 24 can be any type of resistive or capacitive touch screen. Alternatively, in some examples, the display portion 24 can not be a touch screen and instead can be a liquid crystal display (LCD).

[0057] The medical device 10 further comprises a communication interface 28, e.g. a wireless communication interface such as a Bluetooth interface. The medical device 10 further houses a battery 30 to power the medical device 10 via a power supply 32.

[0058] The medical device 10 also includes a controller 20. The controller 20 controls the operation of the other hardware components of the medical device 10. The controller 20 and the other hardware components can be connected via a system bus (not shown). Each hardware component can be connected to the system bus directly or via an interface.

[0059] The medical device 10 includes a memory 40, i.e., a working or volatile memory such as a random access memory (RAM), and a non-volatile memory. The volatile memory can be any type of RAM, for example, static RAM (SRAM), dynamic RAM (DRAM), or flash memory. The controller 20 can access the RAM in order to process data and can control the storage of data in the memory 40. The non-volatile memory can be any type of memory such as read-only memory (ROM), flash memory, or magnetic drive memory. The non-volatile memory stores an operating system 42 and one or more software modules 44, as well as storing data files and associated metadata. The software modules 44 can be different discrete applications that can be set in the medical device 10 at the time of manufacture or that can be downloaded into the medical device 10 by the user, for example, from an application market or application store.

[0060] The controller 20 is configured to send signals to and receive signals from the other components in order to control the operation of the other components. For example, the controller 20 controls the display of content on the display 22 and receives signals as a result of user input from the touch-sensitive interface 26.

[0061] The controller 20 operates under the control of the operating system 42. The operating system 42 can include code related to the hardware, such as the display 22 and the communication interface 28, and the basic operation of the mobile device 10. The operating system 42 can also cause the activation of other software modules stored in the memory 40.

[0062] The medical device 10 includes an acoustic sensor 12. The controller 20 controls the acoustic sensor 12. The acoustic sensor 12 is configured to detect an ambient acoustic signal 60. The acoustic sensor 12 can be any suitable type of acoustic sensor capable of detecting the ambient acoustic signal 60. For example, the acoustic sensor 12 can be a microphone, such as a moving-coil or dynamic microphone, a condenser microphone, or a piezoelectric microphone.

[0063] The acoustic sensor 12 is configured to detect various acoustic signals from different environments, for example acoustic signals at a train station, an airport or other type of transportation hub or at a restaurant. These are just examples and the acoustic sensor 12 can equally well detect acoustic signals from other environments. In other words, the acoustic sensor 12 is able to detect ambient environmental conditions characterized by the sound signals emitted in those environments. The acoustic sensor 12 or the controller 20 can equally well be responsible for processing and analyzing the detected acoustic signals.

[0064] The medical device 10 comprises an acoustic signal generator 14. The controller 20 also controls the acoustic signal generator 14. The acoustic signal generator 14 can be any suitable type of electroacoustic signal generator capable of emitting a synthesized audio signal. For example, the acoustic signal generator 14 can be a loudspeaker.

[0065] The controller 20 controls the acoustic signal generator 14 to emit an audible alarm to the user. The audio alarm provides acoustic feedback 203a. The audible alarm can be any appropriate form of alarm, for example a beep or a click or a piece of music. The alarm can be a pre-recorded sound. Alternatively, the alarm can be synthesized by the acoustic signal generator 14 under control of the controller 20. The pre-recorded sound can be stored in the memory 40 of the medical device 10.

[0066] The medical device 10 can also comprise a photoelectric element 17 (or a photosensor), although this is not essential. The controller 20 is configured to control the photoelectric element 17. The photoelectric element 17 can be any suitable type capable of detecting ambient light levels. For example, the photoelectric element 17 is a photosensor such as a photodiode, a phototransistor or a photoresistor. The photosensor 17 is configured to detect a light signal or ambient light level in the ambient environment. In other words, the photosensor 17 is configured to detect ambient environmental conditions characterized by the light levels detected in those environments. The photosensor 17 or the controller 20 can equally well be responsible for processing and analyzing the detected ambient light levels.

[0067] The medical device 10 can also comprise a vibration element 16, although this is not essential. The controller 20 also controls the vibration element 16. The vibration element 16 is any suitable type capable of emitting a haptic feedback or tactile feedback 203b. For example, the vibration element 16 can be a mechanical device or an electronic device (e.g. piezoelectric or moving coil).

[0068] The vibration element 16 is configured to provide structural sound and not just tactile feedback. In addition to the acoustic signal generated by the acoustic signal generator 14, the vibration element 16 can work in conjunction with the acoustic signal generator 14 to provide structural sound. For example, the vibration element 16 can provide additional hum as acoustic feedback. Alternatively, the vibration element 16 can provide silent vibration to provide only tactile feedback. For example, silent vibration can be selected as an option when the medical device 10 is configured to operate in a private mode or silent mode.

[0069] The medical device 10 can also include a switch 18, although this is not essential. The controller 20 controls the switch 18. The switch 18 can be of any suitable type, for example a mechanical switch (such as a slider, rocker or button switch), or an electronic switch (touch sensor), or a software implemented switch (for example activated by a graphical user interface provided on a touch sensitive display).

[0070] The switch 18 is configured to control whether or not acoustic signals are output at the medical device 10. In other words, the switch 18 is configured to act as a mute switch. For example, when the switch 18 is in a first position, the acoustic signal generator 14 of the medical device 10 is able to produce audible alarms. For example, when the switch 18 is in a second position, the acoustic signal generator 14 of the medical device 10 is muted and prevented from producing audible signals. In one example, the first position is an ON position and the second position is an OFF position.

[0071] The switch 18 can also be configured to control the output of the vibration element 16. The switch 18 can control the output of the vibration element 16 instead of, or in conjunction with, the acoustic signal generator 14. For example, when the switch 18 is in a first position, the vibration element 16 generates an alarm (structural sound) and the acoustic signal generator 14 generates an alarm. For example, when the switch 18 is in a second position, the vibration element 16 generates an alarm but the acoustic signal generator 14 is unable to generate an alarm. In other words, the switch 18 can control the medical device 10 to operate in a vibration only mode. This can be a private mode or silent mode. Alternatively, the switch 18 can be configured to control the degree of feedback (intensity of the alarm) emitted by the vibration element 16. For example, the switch 18 can control the vibration element 16 to generate a "soft vibration" alarm which is not as strong as an alarm generated under normal operation. The soft vibration alarm can indicate a private mode.

[0072] The acoustic sensor 12 and the acoustic signal generator 14 represent components of an auto sound generator device. The vibration element 16, the optoelectronic element 17 and the switch 18 are additional, optional components of the auto sound generator device. Other suitable components can also be included.

[0073] Other standard or optional components of the medical device 10, such as a light source (LED) or a user input transducer (e.g. push button, switch, touch sensitive) are omitted.

[0074] As described above, the controller 20 controls the acoustic signal generator 14 to generate the alert 50. In the following, the generation of the alert 50 is described in more detail with reference to Fig. 2. Fig. 2 is a flowchart illustrating the generation of the alert 50 according to an embodiment of the present disclosure.

[0075] In Fig. 2, the operation starts for example at step 200, in which the acoustic sensor 12 detects the environmental acoustic signal 60. In step 202, the controller 20 determines the acoustic properties of the acoustic signal to be generated and output as the alert 50. The acoustic signal comprises a plurality of acoustic properties, which are variable to produce different sounds. The acoustic properties can include for example a frequency spectrum with a plurality of frequency bands, a tone, a timbre, an intensity and an amplitude. In step 202, the controller 20 selects the acoustic properties such as those described above based on the environmental conditions detected by the acoustic sensor 12. The selected acoustic properties contribute to the acoustic feedback 203a provided. In step 204, the controller 20 controls the acoustic signal generator 14 to generate the alert 50 with the acoustic properties as selected in step 202.

[0076] The controller 20 is configured to control the acoustic signal generator 14 to generate the alert 50 with acoustic properties such as a specific frequency spectrum, tone or timbre. In particular, the controller 20 is configured to control the acoustic signal generator 14 to generate the alert 50 with a frequency spectrum, tone or timbre selected based on the detected environmental acoustic signal 60. For example, the alert 50 can be generated within a frequency band selected based on the detected environmental acoustic signal 60. Further, the alert 50 can be generated with an amplitude in each of a plurality of frequency bands selected based on the detected environmental acoustic signal 60. Alternatively, the alert 50 can be generated at a volume selected based on the detected environmental acoustic signal 60.

[0077] In generating the alert 50, the controller 20 can synthesize a new audio signal according to the acoustic properties selected based on the detected environmental acoustic signal 60. Alternatively, in generating the alert 50, the controller 20 can modify acoustic properties of a pre-stored audio signal based on the detected environmental acoustic signal 60.

[0078] In other words, the medical device 10 is able to generate an alert 50 that is adapted to the ambient environmental conditions. The ambient environmental conditions can be assessed when the acoustic sensor 12 detects an ambient acoustic signal 60. It can be determined whether the medical device 10 is located in a noisy or busy environment, such as a train station. In such an environment, a large number of different sounds originate from various sources (e.g. people, trains, Tannoy announcements), each sound having different acoustic properties. Alternatively, the medical device 10 can be located in a quiet or calm environment, such as a restaurant or library or theatre. Thus, the way in which the alert 50 is generated can be tailored to the ambient environmental conditions. If the medical device 10 is at an airport, for example, in order for the alert 50 to be heard above the background environmental noise, it can be beneficial to characterise the alert 50 in a high frequency band. Conversely, if the medical device 10 is in a library, a more discrete alert is required and, for example, a mid-frequency band can be selected instead.

[0079] Figure 2 also shows that, optionally in some embodiments, the controller can control the vibration element 16 to generate haptic feedback 203b in conjunction with the acoustic feedback 203a provided by the acoustic signal generator 14. The haptic feedback 203b can comprise structural sound in conjunction with tactile feedback. Alternatively, the haptic feedback 203b can provide tactile feedback only. As described above, in some embodiments, the configuration of the switch 18 determines the type of haptic feedback 203b provided by the vibration element 16 in conjunction with or instead of the acoustic feedback 203a provided by the acoustic signal generator 14.

[0080] In the above example, the alert 50 is generated based on the detected ambient acoustic signal 60. However, the present disclosure is not limited to such an example and can equally well select the acoustic properties of the alert 50 based on other properties.

[0081] For example, according to a second set of embodiments, the acoustic properties of the alert 50 can be selected based on predetermined settings 70 in addition to the detected ambient acoustic signal 60. The predetermined settings 70 can comprise, for example, a user group 72 and / or a user specified setting 74. The predetermined settings 70 can be provided at the time of manufacture, or can be downloaded, or can be assigned by the user. The predetermined settings 70 can be selected or modified or updated and set by the user via a series of interfaces or menus that can be accessed via the display of the medical device 10. For example, the controller 20 can receive a signal as a result of user input from the tactile interface 26.

[0082] The predetermined settings 70 can involve any one or more of (user) feedback preferences, acoustic preferences, hearing limitations, vision limitations, and touch limitations. Thus, the predetermined settings 70 are provided to enable the user to configure the medical device 10 to operate in a manner that the generated acoustic signals are suitable for the specific needs of the user. For example, the predetermined settings 70 configure the medical device 10 such that the characteristics of the generated alert are optimized according to the preferences and physical requirements of the user, such that the likelihood of the user detecting the alert is increased.

[0083] Fig. 3 is a flow chart illustrating the selection of predetermined settings 70 related to a user group, according to an embodiment of the present disclosure. The predetermined user group settings can include one or more of gender, age, or hearing impairment. These are just examples, and other settings can also be provided. For example, settings related to vision impairment or touch impairment. In Fig. 3, the operation is started, for example at step 300, in which the settings 70 of the medical device 10 are accessed via the display 22 of the medical device 10. In step 302, the user group settings 62 are selected. This selection results in a series of sub-settings or options, which can be selected and set or modified, and stored.

[0084] In step 304, the gender setting is selected, and the appropriate gender, i.e. male or female, is entered and stored. Alternatively, this setting is not selected in step 305. In step 306, the age setting is selected, and the age of the user is entered and stored. Alternatively, this setting is not selected in step 307. In step 308, the hearing impairment setting is selected. This enables the selection of a specific hearing impairment, such as tinnitus. Alternatively, or in addition, this setting also enables the selection of audio preferences based on general hearing ability or audio requirements. This can include various audio options, such as tone, melody, frequency, and loudness. Alternatively, this setting is not selected in step 309. In step 310, the user group settings 62 are confirmed and stored.

[0085] FIG. 4 is a flowchart showing selection of predetermined settings 70 related to user specified settings 64, according to an embodiment of the present disclosure. The predetermined user specified settings 64 can include one or more of an auditory test, an audio setting, or a device operation. These are just examples, and other settings can also be provided. In FIG. 4, operation begins, for example, at step 400, in which settings 70 of the medical device 10 are accessed via the display 22 of the medical device 10. In step 402, a user specified setting is selected. This selection results in a series of sub-settings or options that can be selected and set or modified, and stored. In step 404, an auditory test setting is selected. This performs an auditory test that determines the general auditory ability of the user. The auditory test can be of any suitable type that can be performed with the medical device 10. For example, the auditory test can be performed by connecting headphones to the medical device 10. The auditory test can be performed in various environments, for example. The results of the auditory test can be stored. Alternatively, in step 405, this setting is not selected.

[0086] In step 406, an audio setting is selected. This setting determines the type and style of audio signal that will be used in generating the alert 50. FIG. 5 is a schematic diagram of an example of such an audio setting. For example, the alert sound can be selected from pre-stored recordings, in the form of a chirp or a beep. In addition, the melody of the audio signal for the alert can be selected from pre-stored recordings. Alternatively, the recordings stored in the memory 40 of the medical device 10 can be imported or can be downloaded from an external device, for example from the internet via a web browser. Alternatively, in step 407, this setting is not selected.

[0087] In step 408, a device operation setting is selected. This setting determines which operations are assigned to the alert. FIG. 6 is a schematic diagram of an example of such a device operation. As shown in FIG. 6, the device operation can include a series of functions, such as a notification function and a status function.

[0088] The notification function can involve providing an alert in response to a particular action or operation of the medical device 10. As shown in FIG. 6, the notification function can include options such as an alarm settings and a key feedback settings. For example, the alarm settings can involve a clock alarm, an event, or other similar tasks. In one example, the alarm can involve a user's dosage regimen and can be configured to provide an alert, for example, each time a user needs or can need a dose of medication. These are just examples, and other options can also be provided. For example, the key feedback settings can notify the user when an area of the display 22 of the medical device 10 has received an input signal or if a mechanical button provided at the medical device 10 has received a touch input. The device operation settings enable the notification function to turn on or off according to audio requirements. These are just examples, and other options can also be provided.

[0089] As shown in FIG. 6, the status function can involve providing an alert regarding or in response to a status of the medical device 10. For example, if the medical device 10 is a medication delivery device, the status function can notify the user of a status of the medication delivery device. The status of the medication delivery device can include options such as a completed dose dialing, a completed dose delivery (e.g., injection completion), a completed initial injection, a warning regarding a remaining dose of medication, and a warning regarding an accidental use or error in use of the medication delivery device. However, these are just examples, and other options and other medical devices can also be provided.

[0090] As described above, the controller 20 controls the acoustic signal generator 14 to generate the alert 50 having the acoustic property based on the detected environmental acoustic signal 60 and additionally based on the predetermined setting 70. In the following, the generation of the alert 50 is described in more detail with reference to FIG. 7. FIG. 7 is a flowchart illustrating the generation of the alert 50 based on the detected environmental acoustic signal 60 and the predetermined setting 70.

[0091] In FIG. 7, the operation starts, for example, at step 700, in which the acoustic sensor 12 detects the environmental acoustic signal 60. This is substantially the same as regarding step 200 of FIG. 2. In step 702, the controller 20 retrieves the predetermined setting 70, which has been previously selected and set as described above, from the memory 40 of the medical device 10. In step 704, the controller 20 selects the acoustic property based on the environmental condition detected by the acoustic sensor 12 and additionally based on the predetermined setting 70. In other words, the acoustic property of the alert is selected based on a combination of the detected environmental condition and the retrieved predetermined setting 70. In step 706, the controller 20 controls the acoustic signal generator 14 to generate the alert 50 having the acoustic property as selected in step 704.

[0092] Fig. 7 also shows that the controller 20 can control the vibration element 16 to generate a haptic feedback 203b, in some embodiments optionally in combination with the acoustic feedback 203a provided by the acoustic signal generator 14. This feedback is essentially the same as the feedback described above with respect to Fig. 2 and will not be explained in detail again.

[0093] The ability of a user to acknowledge and understand an alarm can differ depending on gender, age or existing hearing or vision capabilities. Therefore, providing predetermined settings 70 as described above related to specific groups of users enables the controller 20 to change the acoustic properties of the alarm based on the stored settings. This is advantageous because the device is operable to produce a customized alarm that not only takes into account the ambient environmental conditions but also compensates for the specific physiological and / or medical condition of the user.

[0094] Similarly, the requirements of each user can differ and it is therefore beneficial to configure the device operation according to these requirements. For example, it can only be required to provide an alarm for some or not all operations of the medical device 10. Alternatively, it can be required that a specific type of alarm is associated with a specific operation of the medical device 10. Furthermore, it can not be required to have an alarm regarding the status of the drug delivery device. Alternatively, it can only be required to have some alarms regarding selected states of the drug delivery device.

[0095] Therefore, providing predetermined settings 70 as described above related to the operation of the device enables the controller 20 to change the acoustic properties of the alarm 50 based on the stored settings. This is advantageous because the device is operable to produce a customized alarm 50 that not only takes into account the ambient environmental conditions but also meets the operational requirements of the medical device 10. This helps to improve the likelihood of the user acknowledging and understanding the nature of the alarm 50.

[0096] In the above examples, the alarm is generated based on the detected ambient acoustic signal 60 or the detected ambient acoustic signal 60 and the predetermined settings 70. However, the present disclosure is not limited to these examples and can equally well select the acoustic properties of the alarm 50 based on other properties.

[0097] According to a third group of embodiments, the acoustic properties of the alarm 50 can be selected based on a light signal detected by the optoelectronic element 18, e.g. in addition to the detected ambient acoustic signal 60.

[0098] Fig. 8 is a flowchart illustrating the generation of an alarm 50 according to a third group of embodiments of the present disclosure. As described above, the acoustic properties of the alarm 50 are selected based on the detected light level or ambient light conditions in addition to the detected ambient acoustic signal 60 and the predetermined settings 70.

[0099] In Fig. 8, step 800 and step 802 are substantially the same as step 700 and step 702, respectively, as disclosed above in relation to Fig. 7, and will not be repeated in detail. Briefly, however, in step 800, the acoustic sensor 12 detects the ambient acoustic signal 60, and in step 802, the controller 20 retrieves the predetermined settings 70. In step 804, the light sensor 17 detects the light signal.

[0100] In step 806, the controller 20 determines the acoustic properties of the acoustic signal to be generated and output as the alert 50. Specifically, in step 806, the controller 20 selects the acoustic properties based on the ambient conditions detected by the acoustic sensor 12 and the light sensor 17, and the predetermined settings 70. The acoustic properties are substantially the same as those described above in relation to step 202 of Fig. 2, and will not be repeated in detail. In step 808, the controller 20 controls the acoustic signal generator 14 to generate the alert 50 having the acoustic properties as selected in step 806.

[0101] Fig. 7 also shows that, optionally, in some embodiments, the controller 20 can control the vibration element 16 to generate haptic feedback 203b in combination with the acoustic feedback 203a provided by the acoustic signal generator 14. This feedback is substantially the same as the feedback described above in relation to Fig. 2, and will not be repeated in detail.

[0102] In the above examples, the device is described as a medical device 10. In particular, the medical device 10 is an injection device 1, such as an injection pen. However, the present disclosure is not limited to this implementation.

[0103] According to a fourth group of embodiments of the present disclosure, one or more components of the device can be implemented in a first apparatus, and one or more other components of the device can be implemented in a second apparatus. These components can include one or more of the acoustic sensor 12, the acoustic signal generator 14, the vibration element 16, the photoelectric element 17, or the switch 18, which can be included in an automatic sound generator device. However, other components can also be included.

[0104] The first and second devices are separate, discrete devices. The combination of the first and second devices operates to form a feedback system that provides an audible alert. The first and second devices can be any suitable devices having at least a controller, a memory, and wireless communication capabilities. These components can be substantially the same as those described and shown in relation to Figure 1. Other components can be included depending on the type of device. These are in addition to one or more components of the automated sound generator. The second device is capable of sending data to and / or receiving data from the first device in order to control the operation of the automated sound generator. The data can include information related to the first device and / or the automated sound generator. For example, the first device can be any one of a medical device (e.g. a drug delivery device such as an injection pen or a supplemental device having a portion for coupling the supplemental device to a drug delivery device such as an injection pen), a mobile device, and a controller device, and the second device can be a different one of a medical device, a mobile device, and a controller device.

[0105] In the following, the fourth set of embodiments will be described with reference to the acoustic signal generator 14 implemented in the first device. However, the present disclosure is not limited to this application and various combinations of one or more components can be envisaged in each device. For example, more than one component of the automated sound generator can equally well be comprised in the first device or the second device. Alternatively, all components of the automated sound generator can be comprised in one device and the operation of the automated sound generator is controlled by the other device.

[0106] In the following example, the first device is a medical device 10. In particular, the medical device 10 is a drug delivery device, e.g. an injection device 1. In particular, the injection device 1 is an injection pen. In the following example, the second device is a mobile device 100, e.g. a mobile phone.

[0107] Figure 9 shows schematic views of a mobile device 100 operable with an exemplary drug delivery device, according to embodiments of the present disclosure. Figure 9 shows a drug delivery device that is an injection device 1 in the form of an injection pen. Figure 9A shows an example where the acoustic signal generator 14 is integrally formed within the injection device 1. Figure 9B shows an example where the acoustic signal generator 14 is implemented in a supplemental device 2 that is releasably attachable to the injection device 1. Other one or more components of the automated sound generator are provided in the mobile device 100.

[0108] For example, the drug delivery device is configured to record information related to a condition and / or use of the drug delivery device and to transmit this information to the mobile device 100. The information can for example relate to a status of the drug delivery device. As shown in Fig. 6, the status information can inform the user for example: about a completed dose dialing, about a completed dose delivery (e.g. injection completed), about a completed initial display, about a warning regarding a remaining dose of medicament, and about a warning regarding an unexpected use or a mistake in the use of the drug delivery device. However, these are just examples and other options can also be provided.

[0109] Thereby, the drug delivery device can further comprise for example at least one or more sensors for providing information indicative of how the drug delivery device is used. The controller 20 is configured to analyze this usage information and the wireless unit 28 is configured to transmit this usage information to the mobile device 100 and the memory 40 is configured to store the usage information. For example, the drug delivery device can be an injection device 1.

[0110] As shown in Fig. 9, the mobile device 100 is configured to receive the status information from the drug delivery device via the communication interface of the mobile device 100.

[0111] In the above examples, the alert is generated based on the detected ambient acoustic signal 60 or the detected ambient acoustic signal 60 and the predetermined settings 70 and / or the detected light signal. However, the present disclosure is not limited to these examples and the acoustic properties of the alert 50 can equally well be chosen based on other properties.

[0112] According to a fourth group of embodiments, the acoustic properties of the alert 50 are chosen based on the detected ambient acoustic signal 60 and additionally based on status information received from the drug delivery device.

[0113] In the following, the generation of the alert 50 is described in more detail with reference to Fig. 10. Fig. 11 is a flow chart illustrating the generation of the alert 50 based on the detected ambient acoustic signal 60 and the predetermined settings 70 and / or the status information received from the drug delivery device.

[0114] In Fig. 10, the operation starts at step 900, for example at the mobile device 100, where the acoustic sensor 12 detects an ambient acoustic signal 60. In step 902, the controller 20 selects an acoustic property based on the ambient conditions detected by the acoustic sensor 12. In step 904, the controller 20 retrieves from the memory 40 of the mobile device 100 a predetermined setting 70 that has been previously selected and set as described above. In step 906, the controller 20 additionally selects an acoustic property based on the predetermined setting 70. In step 908, the controller 20 receives via the communication interface 28 state information from the injection device 1 or from a supplementary device 2 associated with the drug delivery device (Fig. 9) related to the status of the drug delivery device. In step 910, in response to receiving the state information from the drug delivery device, the controller 20 additionally selects an acoustic property based on the state information. In step 912, the controller 20 controls the acoustic signal generator 14 at the medical device 10 to generate an alert 50 having the acoustic properties selected in steps 902, 906 and 910.

[0115] Alternatively, in step 905, if no predetermined setting 70 has been set, the operation can proceed to step 908. In this case, in step 912, the controller 20 controls the acoustic signal generator 14 at the medical device 10 to generate an alert 50 having the acoustic properties selected in steps 902 and 910.

[0116] Alternatively, in step 909, if no state information is received from the drug delivery device, an alert can still be generated in response to an operation of the medical device 10 or the mobile device 100. As described above, the medical device 10 comprises a number of operations that can require an alert. Thus, in this case, in step 912, the controller 20 controls the acoustic signal generator 14 at the medical device 10 to generate an alert 50 having the acoustic properties selected in steps 902 and 906.

[0117] Alternatively, if no predetermined setting 70 has been set and no state information is received from the drug delivery device, in step 912, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having the acoustic properties selected in step 902. That is, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having acoustic properties selected based on the detected ambient acoustic signal 60. This is substantially the same as the steps shown in Fig. 2.

[0118] A fourth set of embodiments relates to a device that is able to generate alarms 50 in response to the status of the drug delivery device, while taking into account the surrounding environmental conditions. The device is also able to customize those alarms according to specific user requirements, as defined by a pre-determined setting 70. This is advantageous as it increases the likelihood of the user to acknowledge and understand the alarms 50. This will help the user to more reliably and accurately determine when the device should be used and / or determine the operational status of the drug delivery device, and ultimately improve the implementation of the required dosage regimen.

[0119] Although not shown in Fig. 10, vibration element 16 can optionally generate haptic feedback 203b in some embodiments, in combination with the acoustic feedback 203a provided by acoustic signal generator 14. This feedback is essentially the same as the feedback described above in relation to Fig. 2, and will not be explained in detail again. Similarly, although not disclosed in Fig. 10, the acoustic properties can additionally be selected based on the detected light signal, as shown in Fig. 8.

[0120] Various alternatives and modifications will be apparent to the person skilled in the art. Some such variants and modifications will now be described.

[0121] For example, although the device has been described as a medical device, and in particular as a drug delivery device, the present disclosure is not limited to such applications and the medical device can equally well be an infusion device, an injector device, or a pump device. Alternatively, the device can be a mobile device, such as a mobile phone, a PDA or any kind of tablet computer. In the case of a mobile phone, the mobile phone can be a smart phone.

[0122] Although the medical device 10 is described as having one acoustic signal generator 14, the device can equally well comprise a second or a plurality of acoustic signal generators 15 in addition to the first or primary acoustic signal generator 14. The additional acoustic signal generator(s) 15 can have the same or different capabilities as the primary acoustic signal generator 14.

[0123] The second acoustic signal generator 15 is used to cancel or reduce ambient sound and noise. The second acoustic signal generator 15 is thereby configured to act as a noise cancellation mechanism. In this way, the user can better hear the feedback sound produced by the primary acoustic signal generator 14.

[0124] The second acoustic signal generator 15 is configured to pick up ambient acoustic signals 60. This can be done automatically. The additional second acoustic signal generator 15 is further configured to generate noise cancelling or noise reducing acoustic signals. The second acoustic signal generator 15 can be configured to emit sound in multiple directions. The second acoustic signal generator 15 can thereby provide a surround sound effect. The operation of the second acoustic signal generator 15 can be controlled by the user through independent predetermined settings. In case of multiple additional acoustic signal generators 15, each additional acoustic signal generator can be configured to cancel or reduce a specific individual ambient acoustic signal 60.

[0125] Similarly, although the acoustic sensor 12 and the photoelectric element 17 are described as operating under the control of the controller 20, these components can alternatively operate automatically to detect ambient signals when the device is switched on.

[0126] Furthermore, the switch 18 can be configured to produce various combinations of options regarding the intensity of the vibrating element 16, the acoustic signal generator 14 and the alarm generated by the vibrating element 16.

[0127] Although a hearing impairment is used as an example of a predetermined setting 70, settings relating to visual or tactile impairments can equally well be provided. These settings enable a specific visual or physical impairment to be selected, such as tubular vision. This enables audio and / or vibration preferences to be selected based on the general visual and tactile abilities or requirements determined from the settings.

[0128] Although specific combinations are described above, it will be apparent that the acoustic properties selected based on the detected ambient acoustic signals 60 can additionally be selected based on any combination of the predetermined settings 70, the light signals and the state of the medical device 10.

[0129] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active drug ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose a disease or used to otherwise enhance physical or mental well-being. A drug or medicament can be used for a limited duration, or on a regular basis for chronic disorders.

[0130] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API can include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0131] A drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber can be designed to store a drug for at least one day (e.g., 1 day to at least 30 days). In some instances, the chamber can be designed to store a drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some instances, the drug container can be or can include a dual-chamber cartridge configured to separately store two or more components of a drug formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such instances, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers can be configured such that they are in fluid communication with one another (e.g., by a conduit between the two chambers), and allow the user to mix the two components upon desire prior to dispensing. Alternatively, or additionally, the two chambers can be configured to allow mixing as the components are being dispensed into the human or animal body.

[0132] The drugs or medicaments contained in the drug delivery device as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus (diabetic retinopathy), thromboembolic disorders (deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, e.g. but not limited to, main groups 12 (antidiabetika) or 86 (onkologische

[0133] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide 1 (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refer to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide, and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can be a codable amino acid residue or other natural residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituent, e.g., a fatty acid, is bound to one or more amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0134] Examples of insulin analogues are Gly(A21 ), Arg(B25), Arg(B26) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0135] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detear, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl Lys B28Pro B29 human insulin; B28-N-palmitoyl- Lys B28Pro B29 human insulin; B30-N-myristoyl-Thr B29Lys B30 human insulin; B30-N-palmitoyl-Thr B29Lys B30 human insulin; B29-N-(N- palmitoyl-Y-glutamyl)-des(B30) human insulin, B29-N-ooxocarboxypentadecanoyl-Y- L-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxocarboxyheptadecanoyl)-des(B30) and B29-N-(ooxocarboxyheptadecanoyl) human insulin.

[0136] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlirapen Exenatide (Exendin-4, a 39 amino acid peptide produced by the salivary glands of the Gila monster), liraplutide Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR 709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0137] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterollowering antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0138] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0139] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and antagonists thereof, such as gonadotropins (follitropin, luteinizing hormone, chorionic gonadotropin, menotropin), somatropine (growth hormone), desmopressin, terlipressin, goserelin, triptorelin, leuprolide, buserelin, nafarelin and goserelin.

[0140] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g. polysulfated versions of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0141] The term "antibody", as used herein, refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be of an isotype or subtype, an antibody fragment or mutant that does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding molecule based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or a dual variable region antibody-like binding protein with cross-over binding region orientation (CODV).

[0142] The term "fragment" or "antibody fragment" refers to polypeptides derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that do not comprise a full-length antibody polypeptide, but that still comprise at least a portion of a full- length antibody polypeptide that is capable of binding to antigen. Antibody fragments can comprise a cleavage portion of a full-length antibody polypeptide, although the term is not limited to such cleavage fragments. Antibody fragments that are useful in the present application include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0143] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to allow for antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0144] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0145] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in the drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0146] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein can be made without departing from the full scope and spirit of the present application, which encompass such modifications and any and all equivalents thereof.

[0147] Example drug delivery devices can involve needle-based injection systems as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (with partial or full discharge) container systems. The containers can be replaceable containers or integrated non-replaceable containers.

[0148] As further described in ISO 11608-1 :2014(E), multi-dose container systems can involve needle-based injection devices with replaceable containers. In such systems, each container holds multiple doses, which can be of fixed or variable (pre-set by the user) size. Another multi-dose container system can involve needle-based injection devices with integrated non-replaceable containers. In such systems, each container holds multiple doses, which can be of fixed or variable (pre-set by the user) size.

[0149] As further described in ISO 11608-1 :2014(E), single-dose container systems can involve needle-based injection devices with replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In another example, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge). As also described in ISO 11608-1 :2014(E), single-dose container systems can involve needle-based injection devices with integrated non-replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In another example, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge).

Claims

1. A feedback system comprising: a first device comprising a first acoustic signal generator operable to generate an acoustic signal; and a second device comprising: an acoustic sensor configured to detect an ambient acoustic signal; and a controller configured to control the first acoustic signal generator of the first device to generate an alert having acoustic properties selected based on the detected ambient acoustic signal, wherein the first device is an injection pen or a supplementary device provided with a portion for coupling the supplementary device to an injection pen, and the second device is a mobile device, wherein the first device and the second device further comprise a wireless unit, and the second device is configured to receive status information from the first device via the wireless unit, wherein the controller of the second device is further configured to generate an alert having acoustic properties additionally selected based on the status information in response to receiving the status information, wherein the injection pen or supplementary device further comprises a second acoustic signal generator, and wherein the controller is further configured to: control the second acoustic signal generator to generate a reference noise arranged for cancelling ambient noise other than the alert, and control the first acoustic signal generator to generate the alert within a frequency band selected based on the detected ambient acoustic signal.

2. The feedback system of claim 1, wherein, the first device or the second device further comprises a vibration element configured to generate a haptic feedback, and wherein the alert further comprises the haptic feedback.

3. The feedback system of claim 1 or 2, wherein, the acoustic properties of the alert are additionally selected based on predetermined settings.

4. The feedback system of claim 1 or 2, wherein, the first device or the second device further comprises a photoelectric element configured to detect an ambient light level, and wherein the acoustic properties of the alert are additionally selected based on the detected ambient light level.

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