Medical device including an alarm generator that takes into account environmental signals

Abstract

The injection device includes an acoustic sensor configured to detect an environmental 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 characteristics selected based on the detected environmental acoustic signal. The feedback system includes: a first device including the acoustic signal generator operable to generate an acoustic signal; and a second device including the acoustic sensor configured to detect the environmental acoustic signal and the controller configured to control the acoustic signal generator of the first device to generate an alert having acoustic characteristics selected based on the detected environmental acoustic signal, wherein one of the first device and the second device is an injection device and the other of the first device and the second device is a handheld device or a controller device.

Description

Technical Field

[0001] The present disclosure relates to an apparatus for providing an audible alert to a user, and more particularly, to an apparatus for providing an audible alert related to the status of a drug delivery device.

Background Art

[0002] There are various diseases that require regular treatment by injection of a drug with a medical device. Such injections can be performed using an injection device applied by a medical practitioner or the patient himself / herself. As an example, type 1 and type 2 diabetes can be treated by the patient himself / herself, for example, by injecting insulin doses once or several times a day. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can also be used. With a reusable pen, it is possible to replace an empty drug cartridge with a new one. A set of one-way needles is attached to any pen, and these needles are replaced each time before use. Then, for example, by turning a dose knob and observing the actual dose from a dose window or display of the insulin pen, the insulin dose to be injected can be manually selected with the insulin pen. Then, the needle is inserted into a suitable skin portion, and the dose is injected by pressing an injection button of the insulin pen.

[0003] However, the administration of an injection is a process that presents several risks and challenges, both mentally and physically, to the user and the medical practitioner. The patient may forget to administer the drug according to his / her dosing regimen, or may have difficulty in determining information regarding the status and / or use of the drug delivery device from the drug delivery device.

[0004] As an attempt to assist the user, there is described a drug delivery device, such as an injection device, having an acoustic signal generator configured to generate an acoustic signal regarding the operating status of the injection device as feedback to the user. Further, there is also described providing a tactile signal generator that provides tactile feedback, for example, by vibration, as a means of feedback to the user.

[0005] However, audible feedback is difficult to verify against international standards, especially when the signal is generated by mechanical action. In addition, there is no guarantee that the user will recognize or understand the provided feedback.

[0006] Therefore, there is still a need for an improved device that can provide effective feedback to the user, as well as an improved medical device combined with a management device that can provide effective feedback to prevent incorrect handling of the medical device and / or to keep track of the dosing regimen. Summary of the Invention Problems to be Solved by the Invention

[0007] It is an object to provide an apparatus that provides further patient assistance and promotes an improved user experience when managing a dosing regimen, including medical devices. Further, it is an object to provide a system in which the apparatus operates with a second device to provide such patient assistance. For example, assisting the user to make a more certain, or more accurate, or more consistent, or more effective determination of when the device should be used and / or the operating status of the drug delivery device, or improving other aspects of the process of managing the dosing regimen. Means for Solving the Problems

[0008] According to one aspect of the present disclosure, there is provided a medical device including: 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 alarm having acoustic characteristics selected based on the detected ambient acoustic signal.

[0009] This can improve the certainty of the feedback alarm output from the device because the generated signal is specifically customized to the ambient environmental conditions to improve the possibility of recognition and understanding of the alarm. This can assist the user in more reliably managing their own medical condition.

[0010] The medical device can further include a vibration element configured to generate a tactile feedback. The alarm can further include a tactile feedback.

[0011] This is advantageous as it provides an additional mechanism that enables the selection of alarms considering the ambient environmental conditions. This improves the possibility of recognizing the alarm. This can be particularly beneficial for persons with hearing impairments in that additional types of alarms can improve the possibility of alarm recognition.

[0012] Alternatively, the acoustic characteristics of the alarm are additionally selected based on a predetermined setting. This enables the customization of the type of alarm taking into account not only the ambient environmental conditions but also the specific requirements of the user so as to improve the possibility of recognition and understanding of the alarm.

[0013] The predetermined setting can include any one or more of feedback preference, acoustic preference, auditory limit, visual limit, and tactile limit. This makes it possible to take into account various limitations when selecting an appropriate alarm.

[0014] The medical device further includes a photoelectric element configured to detect the ambient light level, and thus, the acoustic characteristics of the alarm are additionally selected based on the detected ambient light level.

[0015] This provides an additional mechanism that can customize the alarm according to the ambient environmental conditions to improve the possibility of alarm recognition and understanding.

[0016] The controller of the medical device is configured to control the acoustic signal generator to generate an alarm having a frequency spectrum, pitch, or tone color selected based on the detected environmental acoustic signal.

[0017] In addition, or alternatively, the controller is configured to control the acoustic signal generator to generate an alarm within a frequency band selected based on the detected environmental acoustic signal.

[0018] In addition, the controller is configured to control the acoustic signal generator to generate an alarm of the amplitude within each of the multiple frequency bands selected based on the detected environmental acoustic signal.

[0019] In addition, or alternatively, the controller is configured to control the acoustic signal generator to generate an alarm at a volume selected based on the detected environmental acoustic signal.

[0020] The ability of the controller to select specific acoustic characteristics ensures that the alarm is customized according to the ambient environmental conditions so as to improve the possibility of alarm recognition and understanding. becomes.

[0021] The acoustic characteristics of the alarm are additionally selected based on the status of the medical device.

[0022] This ensures that the alarm is associated with the operation of the medical device so that the user can more reliably manage their medical condition.

[0023] The medical device can further include a second acoustic signal generator, where the controller is further configured to control the second acoustic signal generator to generate a reference noise arranged to remove ambient noise, in addition to the alarm.

[0024] This provides a noise cancellation mechanism that enables the user to better hear the alarm generated by the primary acoustic signal generator, thereby advantageously improving the effectiveness of the alarm.

[0025] The medical device may be any of a drug delivery device, an auxiliary device comprising a member for connecting to a drug delivery device, or a blood glucose meter.

[0026] The medical device can be an injection device. The injection device may be an injection pen or an auxiliary device comprising a member for connecting to an injection pen.

[0027] According to another aspect of the present disclosure, a feedback system is provided that includes a first device including an acoustic signal generator operable to generate an acoustic signal; an acoustic sensor configured to detect an environmental acoustic signal; and a controller configured to control the acoustic signal generator of the first device to generate an alarm having an acoustic characteristic selected based on the detected environmental acoustic signal, and a second device including the controller.

[0028] This is advantageous because by combining the first and second devices in one system, the components for generating the alarm can be distributed between the devices such that their operations are performed more efficiently. This can help the user more reliably manage their dosing regimen.

[0029] One of the first device and the second device may be an injection device, and the other of the first device and the second device may be a portable device or a controller device.

[0030] The first device may be an injection pen or an auxiliary device comprising a member for connecting to an injection pen, and the second device may be a portable device.

[0031] The first device may be any one of a medical device, a portable device, and a controller device, and the second device may be another one of a medical device, a portable device, and a controller device.

[0032] The first device may be a drug delivery device or an auxiliary device comprising a member for connecting to a drug delivery device, and the second device may be a portable device.

[0033] The first device or the second device may further include a vibration element configured to generate tactile feedback, and the alarm may further include tactile feedback.

[0034] The acoustic characteristics of the alarm are additionally selected based on a predetermined setting.

[0035] The first device or the second device may further include a photoelectric element configured to detect the ambient light level. The acoustic characteristics of the alarm are additionally selected based on the detected ambient light level.

[0036] The first device and the second device may further include a wireless unit. The second device is configured to receive status information from the first device, and the controller is further configured to generate an alarm having acoustic characteristics additionally selected based on the status information in response to the reception of the status information.

[0037] In addition, a method for generating an alarm in a medical device is disclosed, including detecting ambient sound and generating an alarm having acoustic characteristics selected based on the detected environmental condition.

[0038] The alert can further include tactile feedback.

[0039] The acoustic characteristics of the alert are additionally selected based on a predetermined setting. The predetermined setting can include any one or more of feedback preference, acoustic preference, auditory limit, visual limit, and tactile limit.

[0040] The method can further include receiving information regarding the status of a medical device and generating an alert having acoustic characteristics additionally selected based on the status information.

[0041] Additionally, a computer program is disclosed that includes machine-readable instructions that, when executed by a controller, cause the controller to execute a method of generating an alert with a medical device.

[0042] Next, with reference to the accompanying drawings, embodiments of the present disclosure will be described by way of example only.

Brief Description of the Drawings

[0043]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Mode for Carrying Out the Invention

[0044] Hereinafter, embodiments of the present disclosure will be described with reference to a device that provides an audible alarm, that is, an automatic sound generator, implemented as a medical device. Specifically, the medical device is described as a drug delivery device. However, the present disclosure is not limited to such applications, and the device can be similarly well implemented in other devices such as other medical devices or portable devices.

[0045] 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. Specifically, the medical device 10 can be an injection device 1 in the form of an injection pen. FIG. 1 is a schematic diagram showing the internal components of the medical device 10.

[0046] Medical device 10 includes a plurality of components in combination with an automatic sound generator. Medical device 10 includes a display 22 (e.g., LCD, TFT (thin film transistor), OLED (organic light emitting diode), ePaper). The display 22 can be a touch-sensitive display having a display member 24 and a touch interface member 26. The display member 24 can be any type of resistive touch screen or capacitive touch screen. Alternatively, in some examples, the display member 24 may not be a touch screen and instead may be a liquid crystal display (LCD).

[0047] Medical device 10 further includes a communication interface 28, which is a wireless communication interface such as a Bluetooth interface, for example. Medical device 10 further houses a battery 30 to supply power to medical device 10 by a power source 32.

[0048] Medical device 10 further includes a controller 20. The controller 20 controls the operation of other hardware components of medical device 10. The controller 20 and other hardware components can be connected via a system bus (not shown). Each hardware component can be directly or via an interface connected to the system bus.

[0049] Medical device 10 includes a memory 40, that is, a working or volatile memory such as a random access memory (RAM), and a non-volatile memory. Examples of the volatile memory include any type of RAM such as static RAM (SRAM), dynamic RAM (DRAM), or flash memory. The controller 20 can access the RAM to process data and can control the storage of data in the memory 40. Examples of the non-volatile memory include any type of memory such as read-only memory (ROM), flash memory, and magnetic drive memory. The non-volatile memory stores the operating system 42 and one or more software modules 44, and also stores data files and related metadata. The software modules 44 can be different separate applications provided to the medical device 10 at the time of manufacture or downloaded by the user to the medical device 10 from, for example, an application marketplace or an application store.

[0050] The controller 20 is configured to send signals to and receive signals from 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 a signal from the tactile interface 26 as a result of user input.

[0051] The controller 20 operates under the control of the operating system 42. The operating system 42 can include hardware such as the display 22 and the communication interface 28, as well as code related to the basic operation of the medical device 10. The operating system 42 can further cause the startup of other software modules stored in the memory 40.

[0052] ​The medical device 10 includes an acoustic sensor 12. A 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.

[0053] The acoustic sensor 12 is configured to detect various acoustic signals from various environments, such as acoustic signals at a train station, an airport, or other types of transportation hubs or restaurants. These are merely examples, and the acoustic sensor 12 can equally well detect acoustic signals from other environments. In other words, the acoustic sensor 12 can detect the ambient environmental conditions characterized by the acoustic signals emitted in these environments. The acoustic signal 12 or the controller 20 can equally well handle the processing and analysis of the detected acoustic signals.

[0054] The medical device 10 includes 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 electro-acoustic signal generator capable of emitting a synthesized audio signal. For example, the acoustic signal generator 14 can be a speaker.

[0055] The controller 20 controls the acoustic signal generator 14 to issue an audible alarm to the user. The audio alarm provides an acoustic feedback 203a. The audible alarm can be any suitable alarm form, such as a beep sound, a clicking sound, or a piece of music. The alarm can be a pre-recorded sound. Alternatively, the alarm may be synthesized by the acoustic signal generator 14 under the control of the controller 20. The pre-recorded sound can be stored in the memory 40 of the medical device 10.

[0056] The medical device 10 may include a photoelectric element 17 (or photosensor), but this is not essential. The controller 20 is configured to control the photoelectric element 17. The photoelectric element 17 can be of any suitable type capable of detecting the ambient light level. For example, the photoelectric element 17 is a photosensor such as a photodiode, a phototransistor, or a photore resistor. The photosensor 17 is configured to detect the optical signal or ambient light level of the surrounding environment. In other words, the photosensor 17 is configured to detect the ambient environmental state characterized by the light level detected in these environments. The photosensor 17 or the controller 20 can similarly perform well in processing and analyzing the detected ambient light level.

[0057] The medical device 10 may include a vibration element 16, but this is not essential. The controller 20 also controls the vibration element 16. The vibration element 16 can be of any suitable type capable of generating a tactile or haptic feedback 203b. For example, the vibration element 16 can be a mechanical or electronic device (e.g., piezoelectric or movable coil).

[0058] The vibration element 16 is configured to provide not only tactile feedback but also structure-borne sound. The vibration element 16 can function in combination with the acoustic signal generator 14 to provide structure-borne sound in addition to the acoustic signal generated by the acoustic signal generator 14. The vibration element 16 can provide, for example, additional rumbling sounds such as acoustic feedback. Alternatively, the vibration element 16 may provide a silent vibration that provides only tactile feedback. The silent vibration can be selected as an option, for example, when the medical device 10 is configured to operate in a private mode or a silent mode.

[0059] The medical device 10 may further include a switch 18, but this is not essential. The controller 20 controls the switch 18. The switch 18 can be of any suitable type, such as a mechanical switch (such as a slider, rocker or push button switch), an electronic switch (a touch sensor), or a software-implemented switch (activated through a graphical user interface provided on a touch-sensitive display for example).

[0060] The switch 18 is configured to control whether an acoustic signal is output by the medical device 10. In other words, the switch 18 is configured to act as a mute switch. When the switch 18 is in the first position, for example, the acoustic signal generator 14 of the medical device 10 can generate an audible alarm. When the switch 18 is in the second position, for example, the acoustic signal generator 14 of the medical device 10 is muted and prevented from generating an audible signal. In one example, the first position is the on position and the second position is the off position.

[0061] 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 combination with the acoustic signal generator 14. When the switch 18 is in the first position, for example, the vibration element 16 generates an alarm (structure-borne sound) and the acoustic signal generator 14 generates an alarm. When the switch 18 is in the second position, for example, the vibration element 16 generates an alarm but the acoustic signal generator 14 cannot 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 a 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 also control the vibration element 16 to generate an alarm of "weak vibration" that is not as strong as the alarm generated under normal operation. The weak vibration alarm can represent a private mode.

[0062] Acoustic sensor 12 and acoustic signal generator 14 are representative of the components of an automatic sound generating device. Vibration element 16, photoelectric element 17 and switch 18 are additional optional components of the automatic sound generating device. Other suitable components may also be included.

[0063] Other standard or optional components of the medical device 10, such as light sources (LEDs) or user input transducers (eg, buttons, switches, touch-sensitive), are omitted.

[0064] As indicated above, the controller 20 controls the acoustic signal generator 14 to generate the alarm 50. The generation of the alarm 50 is described in more detail below with reference to Figure 2. Figure 2 is a flow diagram illustrating the generation of the alarm 50 according to an embodiment of the present disclosure.

[0065] 2, operation begins at step 200, where, for example, acoustic sensor 12 detects an environmental acoustic signal 60. At step 202, controller 20 determines acoustic characteristics of the acoustic signal to be generated and output as alarm 50. The acoustic signal includes various acoustic characteristics that can be varied to produce different sounds. The acoustic characteristics can include, for example, a frequency spectrum with multiple frequency bands, pitch, timbre, intensity, and amplitude. At step 202, controller 20 determines an acoustic signal, such as those described above, based on the environmental conditions detected by acoustic sensor 12. The selection of the acoustic characteristics contributes to providing the acoustic feedback 203a. In step 204, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having the acoustic characteristics as selected in step 202.

[0066] The controller 20 is configured to control the acoustic signal generator 14 to generate an alarm 50 having acoustic characteristics such as a specific frequency spectrum, pitch, or timbre. Specifically, the controller 20 is configured to control the acoustic signal generator 14 to generate an alarm 50 having a frequency spectrum, pitch, or timbre selected based on the detected ambient acoustic signal 60. For example, the alarm 50 is generated within a frequency band selected based on the detected ambient acoustic signal 60. Additionally, for example, an alarm 50 of the amplitude within each of multiple frequency bands selected based on the detected ambient acoustic signal 60 may be generated. Alternatively, an alarm 50 of the volume selected based on the detected ambient acoustic signal 60 may be generated.

[0067] In generating the alarm 50, the controller 20 can also synthesize a new audio signal according to the acoustic characteristics selected based on the detected ambient acoustic signal 60. Alternatively, in generating the alarm 50, the controller 20 can also modify the acoustic characteristics of a pre-stored audio signal based on the detected ambient acoustic signal 60.

[0068] In other words, the medical device 10 can generate an alarm 50 adapted to the ambient environmental conditions. By the acoustic sensor 12 detecting the environmental acoustic signal 60, it becomes possible to evaluate the ambient environmental conditions. The medical device 10 can determine whether it is in a noisy or bustling environment such as a railway station. In such an environment, a large number of different sounds are generated from various sound sources (e.g., people, trains, announcements in the venue) each having different acoustic characteristics. Alternatively, the medical device 10 may be in a quiet or calm environment such as a restaurant, library or theater. Therefore, the method of generating the alarm 50 can be customized according to the environmental conditions surrounding it. When the medical device 10 is at an airport, for example, it may be beneficial for the alarm 50 to feature a high-frequency band so that it can be heard above the background ambient noise. Conversely, when the medical device 10 is in a library, a more discrete alarm is required, for example, an intermediate frequency band is selected instead.

[0069] Figure 2 further shows that in some embodiments, optionally, the controller can control the vibration element 16 to generate a haptic feedback 203b in combination with the acoustic feedback 203a provided by the acoustic signal generator 14. The haptic feedback 203b may include structure-borne sound in combination with the tactile feedback. Alternatively, the haptic feedback 203b may provide only the tactile feedback. As shown above, in some embodiments, the configuration of the switch 18 determines the type of the acoustic feedback 203a provided by the acoustic signal generator 14 in combination with or instead of the haptic feedback 203b provided by the vibration element 16.

[0070] In the above example, the alarm 50 is generated based on the detected environmental acoustic signal 60. However, the present disclosure is not limited to such an example, and the acoustic characteristics of the alarm 50 can be similarly well selected based on other characteristics.

[0071] For example, according to the second group of embodiments, the acoustic characteristics of the alarm 50 are selected based on a predetermined setting 70 in addition to the detected environmental acoustic signal 60. The predetermined setting 70 can include, for example, a user group 72 and / or a user-specified setting 74. The predetermined setting 70 can be provided at the time of manufacture, or downloaded, or assigned by the user. The predetermined setting 70 can be selected, modified, updated, and set by the user through a series of interfaces or menus accessible through the display of the medical device 10. The controller 20 can receive a signal, for example, as a result of user input from the tactile interface 26.

[0072] The predetermined setting 70 can be related to any one or more of the (user's) feedback preferences, acoustic preferences, auditory limits, visual limits, and tactile limits. Therefore, the predetermined setting 70 is provided to enable the user to configure the medical device 10 such that the generated acoustic signal operates in a manner that meets the specific needs of that user. For example, the predetermined setting 70 configures the medical device 10 such that the characteristics of the generated alarm are optimized according to the user's preferences and physical requirements so as to increase the likelihood that the user will detect the alarm.

[0073] Figure 3 is a flowchart showing the selection of a predetermined setting 70 related to a user group according to an embodiment of the present disclosure. The predetermined user group setting can include one or more of gender, age, or hearing impairment. These are merely examples, and other settings can also be provided. For example, settings related to visual impairment or tactile impairment. In Figure 3, the operation begins, for example, at step 300 of accessing the setting 70 of the medical device 10 through the display 22 of the medical device 10. At step 302, the user group 62 setting is selected. This selection leads to a series of sub-settings or options that can be selected, set, modified, and stored.

[0074] In step 304, select the gender setting and input and store the appropriate gender, i.e., male or female. Alternatively, in step 305, do not select this setting. In step 306, select the age setting and input and store the user's age. Alternatively, in step 307, do not select this setting. In step 308, select the hearing impairment setting. This enables the setting of specific hearing impairments such as tinnitus. As an alternative or in addition, this setting further enables the selection of audio preferences based on general hearing or audio requirements. This can include various audio options such as, for example, sound, melody, frequency, and volume. Alternatively, in step 309, do not select this setting. In step 310, confirm and store the user group 62 setting.

[0075] Figure 4 is a flowchart showing the selection of a predetermined setting 70 related to user designation 64 according to an embodiment of the present disclosure. The predetermined user designation 64 setting can include one or more of a hearing test, audio settings, or device operation. This is merely an example, and other settings can also be provided. In Figure 4, the operation begins, for example, with step 400 of accessing the settings 70 of the medical device 10 through the display 22 of the medical device 10. In step 402, select the user designation setting. This selection leads to a series of sub-settings or options that can be selected, set or modified, and stored. In step 404, select the hearing test setting. This performs a hearing test to determine the user's general listening ability. This hearing test can be any suitable type of test that can be performed on the medical device 10. The hearing test can be performed, for example, by connecting headphones to the medical device 10. The hearing test can be performed, for example, in various environments. The results of the hearing test are stored. Alternatively, in step 405, do not select this setting.

[0076] In step 406, select the audio settings. This setting determines the type and format of the audio signal that is to be used when generating the alert 50. FIG. 5 schematically shows an example of such audio settings. For example, the sound of an alert in the form of a chirp or beep can be selected from, for example, pre-stored recordings. In addition, the melody of the audio signal for the alert can be selected from pre-stored recordings. Or it may be possible to import or download recordings stored in the memory 40 of the medical device 10 from the Internet via an external device, such as a web browser. Alternatively, in step 407, do not select this setting.

[0077] In step 408, select the device operation settings. This setting determines which operations are assigned to the alert. FIG. 6 schematically shows an example of such device operations. As shown in FIG. 6, the device operations can include a series of functions, such as a notification function and a status function.

[0078] The notification function can be targeted at providing an alert in response to a specific action or operation of the medical device 10. As shown in FIG. 6, the notification function can include options such as a reminder setting and a key feedback setting. The reminder setting can be related to, for example, a clock alarm, an event, or other similar tasks. In one example, the reminder can be related to the user's dosing regimen and can be configured to bring about an alert when, for example, the user needs or may need a dose of medication. These are only examples and other options can also be provided. The key feedback setting can notify the user, for example, when a region of the display 22 of the medical device 10 receives an input signal or when a mechanical button provided on the medical device 10 receives a touch input. The device operation settings enable the notification function to be turned on or off according to the audio requirements. These are only examples and other options can also be provided.

[0079] As shown in FIG. 6, the status function can be directed to providing an alert regarding or in response to the status of the medical device 10. For example, if the medical device 10 is a drug delivery device, the status function can inform the user of the status of the drug delivery device. The status of the drug delivery device can include options such as completion of the dose dial setting, completion of the dose delivery (e.g., completion of an injection), completion of a prime shot, warnings regarding the remaining drug amount, and warnings regarding unintended use or errors in the use of the drug delivery device. However, these are merely examples and can also result in other options and other medical devices.

[0080] As described above, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having acoustic characteristics based on the detected ambient acoustic signal 60 and additionally a predetermined setting 70. Below, the generation of the alert 50 will be described in more detail with reference to FIG. 7. FIG. 7 is a flowchart showing the generation of the alert 50 based on the detected ambient acoustic signal 60 and the predetermined setting 70.

[0081] In FIG. 7, the operation begins at step 700 where the acoustic sensor 12 detects the ambient acoustic signal 60. This is substantially the same as step 200 with respect to FIG. 2. At step 702, the controller 20 searches the memory 40 of the medical device 10 for the predetermined setting 70 that was preselected and set as described above. At step 704, the controller 20 selects acoustic characteristics based on the environmental conditions detected by the acoustic sensor 12 and additionally the predetermined setting 70. In other words, the acoustic characteristics of the alert are selected based on the combination of both the detected environmental conditions and the searched predetermined setting 70. At step 706, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having the acoustic characteristics selected at step 704.

[0082] FIG. 7 further shows that 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 that described above with respect to FIG. 2, and thus a detailed description will not be repeated.

[0083] A user's ability to recognize and understand an alert can vary depending on gender, age, or existing hearing or vision. Thus, by providing a predetermined setting 70 for a particular user group as described above, the controller 20 can vary the acoustic characteristics of the alert based on the stored setting. This is advantageous because the device can operate to generate a customized alert that takes into account the ambient environmental conditions as well as complements the particular physiological and / or medical condition of the user.

[0084] Similarly, each user's requirements can vary, and thus it is beneficial for the device configuration to operate according to these requirements. For example, it may be necessary to provide an alert only for a portion of the operation of the medical device 10, i.e., it may not be required to provide an alert for all of the operation of the medical device 10. Alternatively, a particular type of alert associated with a particular operation of the medical device 10 may be required. Additionally, an alert regarding the status of the drug delivery device may not be required. Alternatively, only some alerts regarding the selected status of the drug delivery device may be required.

[0085] In this way, by providing the predetermined setting 70 regarding the device operation as described above, the controller 20 can change the acoustic characteristics of the alarm 50 based on the stored settings. This is advantageous because the device can operate to generate a customized alarm 50 that not only takes into account the ambient environmental conditions but also conforms to the operating requirements of the medical device 10. This plays a role in improving the possibility for the user to recognize and understand the nature of the alarm 50.

[0086] In the above example, the alarm is generated based on the detected environmental acoustic signal 60, or based on the detected environmental acoustic signal 60 and the predetermined setting 70. However, the present disclosure is not limited to these examples, and the acoustic characteristics of the alarm 50 can similarly be well selected based on other characteristics.

[0087] According to a third group of embodiments, for example, the acoustic characteristics of the alarm 50 are selected based on the optical signal detected by the photoelectric element 17 in addition to the detected environmental acoustic signal 60.

[0088] FIG. 8 is a flowchart showing the generation of the alarm 50 according to a third group of embodiments of the present disclosure. As shown above, the acoustic characteristics of the alarm 50 are selected based on the detected environmental acoustic signal 60 and the predetermined setting 70, in addition to the detected light level or the ambient environmental light condition.

[0089] In FIG. 8, step 800 and step 802 are substantially the same as step 700 and step 702 described above with respect to FIG. 7, respectively, and thus detailed descriptions will not be repeated. However, briefly stated, in step 800, the acoustic sensor 12 detects the environmental acoustic signal 60, and in step 802, the controller 20 searches for the predetermined setting 70. In step 804, the optical sensor 17 detects the optical signal.

[0090] In operation 806, the controller 20 determines the acoustic characteristics of the acoustic signal that is to be generated and output as the alert 50. Specifically, in operation 806, the controller 20 selects the acoustic characteristics based on the environmental conditions detected by the acoustic sensor 12 and the optical sensor 17 and the predetermined settings 70. The acoustic characteristics are substantially the same as those described above with respect to operation 202 of FIG. 2, and thus a detailed description will not be repeated. In operation 808, the controller 20 controls the acoustic signal generator 14 to generate an alert 50 having the acoustic characteristics as selected in operation 806.

[0091] FIG. 8 further shows that in some embodiments, optionally, the controller 20 can also control the vibration element 16 to generate a tactile feedback 203b in combination with the acoustic feedback 203a provided by the acoustic signal generator 14. This feedback is substantially the same as that described above with respect to FIG. 2, and thus a detailed description will not be repeated.

[0092] In the example above, the device is described as the medical device 10. Specifically, the medical device 10 is an injection device 1 such as an injection pen. However, the present disclosure is not limited to such an implementation.

[0093] According to a fourth group of embodiments of the present disclosure, one or more components of the device are implemented in a first device and one or more other components of the device are implemented in a second device. These components can include one or more of the acoustic sensor 12, the acoustic signal generator 14, the vibration element 16, the optoelectronic element 17, or the switch 18 included in the automatic sound generator. However, other components may also be included.

[0094] The first device and the second device are separate and distinct devices. The operation of the first device and the operation of the second device together form a feedback system that provides an audible alarm. The first and second devices can be any suitable devices having at least a controller, a memory, and wireless communication capabilities. These components may be substantially the same as those described and illustrated with respect to FIG. 1. Other components may be included depending on the type of device. These are added to one or more components of the automatic sound generator. The second device can send and / or receive data to and / or from the first device in order to control the operation of the automatic sound generator. The data can include information about the first device and / or the automatic sound generator. For example, the first device can be any of a medical device (e.g., a drug delivery device such as an injection pen, or an auxiliary device including a member for connecting to a drug delivery device such as an injection pen), a portable device, and a controller device, and the second device can be another one of a medical device, a portable device, and a controller device.

[0095] In the following, a fourth group 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 such applications, and various combinations of one or more components in each device can be envisioned. For example, more than one of the components of the automatic sound generator can be equally well included in either the first device or the second device. Alternatively, all of the components of the automatic sound generator can be included in one device, and the operation of the automatic sound generator is controlled by the other device.

[0096] In the following example, the first device is the medical device 10. Specifically, the medical device 10 is a drug delivery device, for example, the injection device 1. Specifically, the injection device 1 is an injection pen. In the following example, the second device is the portable device 100, for example, a mobile phone.

[0097] Figure 9 is a schematic diagram of a portable device 100 operable with an exemplary drug delivery device according to an embodiment of the present disclosure. As shown in Figure 9, a drug delivery device such as an injection device 1 in the form of an injection pen is shown. Figure 9A shows an example in which an acoustic signal generator 14 is integrally formed with the injection device 1. Figure 9B shows an example in which the acoustic signal generator 14 is implemented in an auxiliary device 2 detachably attached to the injection device 1. One or more other components of the automatic sound generator are provided within the portable device 100 are provided.

[0098] For example, the drug delivery device is configured to record information regarding the state and / or use of the drug delivery device and transmit that information to the portable device 100. The information can relate, for example, to the status of the drug delivery device. As shown in Figure 6, the status information can notify the user, for example, of the completion of the dose dial setting, the completion of the dose delivery (e.g., the completion of the injection), the completion of the prime shot, a warning regarding the remaining drug amount, and a warning regarding an unintended use or an error in the use of the drug delivery device. However, these are merely examples and other options can also be provided.

[0099] Accordingly, the drug delivery device can further include at least one or more sensors for providing information indicating, for example, how the drug delivery device is being used. The controller 20 is configured to analyze the usage information, the wireless unit 28 is configured to transmit the usage information to the portable device 100, and the memory 40 is configured to store the usage information. The drug delivery device can be, for example, the injection device 1.

[0100] As shown in Figure 9, the portable device 100 is configured to receive status information from the drug delivery device via the communication interface of the portable device 100.

[0101] In the above example, the alarm is generated based on the detected environmental acoustic signal 60, or the environmental acoustic signal 60 and a predetermined setting 70, and / or the detected optical signal. However, the present disclosure is not limited to these examples, and the acoustic characteristics of the alarm 50 may similarly be preferably selected based on other characteristics.

[0102] According to a fourth group of embodiments, the acoustic characteristics of the alarm 50 are selected based on the detected environmental acoustic signal 60 and additionally status information received from a drug delivery device.

[0103] Hereinafter, the generation of the alarm 50 will be described in more detail with reference to FIG. 10. FIG. 11 is a flowchart showing the generation of the alarm 50 based on the detected environmental acoustic signal 60 and the predetermined setting 70 and / or status information received from the drug delivery device.

[0104] In FIG. 10, the operation starts from step 900 in the portable device 100 where, for example, the acoustic sensor 12 detects the environmental acoustic signal 60. In step 902, the controller 20 selects acoustic characteristics based on the environmental state detected by the acoustic sensor 12. In step 904, a predetermined setting 70 preselected and set as described above is retrieved from the memory 40 of the portable device 100. In step 906, the controller 20 additionally selects acoustic characteristics based on the predetermined setting 70. In step 908, the controller 20 receives, via the communication interface 28, status information regarding the status of the drug delivery device from the injection device 1 or the auxiliary device 2 (FIG. 9) associated with the drug delivery device. In step 910, in response to the reception of the status information from the drug delivery device, the controller 20 additionally selects acoustic characteristics based on the status information. In step 912, the controller 20 controls the acoustic signal generator 14 of the medical device 10 to generate the alarm 50 having the acoustic characteristics selected in steps 902, 906, and 910.

[0105] Alternatively, if none of the predetermined settings 70 are set in step 905, the operation can proceed to step 908. In this example, in step 912, the controller 20 controls the acoustic signal generator 14 of the medical device 10 to generate an alarm 50 having the acoustic characteristics selected in steps 902 and 910.

[0106] Alternatively, if status information is not received from the drug delivery device in step 909, an alarm is still generated in response to the operation of the medical device 10 or the portable device 100. As described above, the medical device 10 includes many operations that may require an alarm. Thus, in this example, in step 912, the controller 20 controls the acoustic signal generator 14 of the medical device 10 to generate an alarm 50 having the acoustic characteristics selected in steps 902 and 906.

[0107] Alternatively, if none of the predetermined settings 70 are set and status information is not received from the drug delivery device, in step 912, the controller 20 controls the acoustic signal generator 14 to generate an alarm 50 having the acoustic characteristics selected in step 902. That is, the controller 20 controls the acoustic signal generator 14 to generate an alarm 50 having acoustic characteristics selected based on the detected ambient acoustic signal 60. This is substantially the same as the process shown in FIG. 2.

[0108] A fourth group of embodiments is directed to an apparatus capable of generating an alarm 50 in response to the status of a drug delivery device while considering the ambient environmental conditions. The apparatus can further customize these alarms according to specific user requirements as defined by the predetermined settings 70. This is advantageous because it improves the likelihood that the user will recognize and understand the alarm 50. This helps the user more reliably and accurately determine when the device should be used and / or the operating status of the drug delivery device, and ultimately improves the implementation of the required dosing regimen.

[0109] Although not shown in FIG. 10, in some embodiments, optionally, the vibration element 16 can generate a tactile feedback 203b in combination with an acoustic feedback 203a provided by the acoustic signal generator 14. This feedback is substantially the same as that described above with respect to FIG. 2, and thus a detailed description will not be repeated. Similarly, although not disclosed in FIG. 10, the acoustic characteristics may additionally be selected based on the detected optical signal as shown in FIG. 8.

[0110] Various alternative and modified forms will be apparent to those skilled in the art. Next, some such variations and modifications will be described.

[0111] For example, although the device has been described as a medical device, specifically a drug delivery device, however, the present disclosure is not limited to such applications, and the medical device may equally well be an infusion device, an injection device or a pump device. Alternatively, the device may be a portable device such as any type of mobile phone, PDA or tablet computer. In the case of a mobile phone, the mobile phone may be a smart phone.

[0112] Although the medical device 10 has been described as having one acoustic signal generator 14, the device may equally well include a second or multiple acoustic signal generators 15 in addition to the first or primary acoustic signal generator 14. The additional one or more acoustic signal generators 15 can have the same or different capabilities as the primary acoustic signal generator 14.

[0113] The second acoustic signal generator 15 is for removing or reducing environmental sound and noise. Thus, the second acoustic signal generator 15 is configured to function as a noise cancellation mechanism. In this way, the user can better hear the feedback sound generated by the primary acoustic signal generator 14.

[0114] The second acoustic signal generator 15 is configured to capture the ambient acoustic signal 60. This is achieved automatically. The additional second acoustic signal generator 15 is further configured to generate an acoustic signal that removes or reduces noise. The second acoustic signal generator 15 is configured to remove sound in multiple directions. Thus, the second acoustic signal generator 15 can provide a surround sound effect. The operation of the second acoustic signal generator 15 can be controlled by the user with an independent predetermined setting. If there are multiple additional acoustic signal generators 15, each acoustic signal generator 15 is configured to remove or reduce a specific individual ambient acoustic signal 60.

[0115] Similarly, although the acoustic sensor 12 and the optoelectronic element 17 have been described as operating under the control of the controller 20, alternatively, these components may operate to automatically detect ambient signals when the device is turned on.

[0116] In addition, the switch 18 can be configured to provide various optional combinations regarding the vibration element 16, the acoustic signal generator 14, and the intensity of the alarm generated by the vibration element 16.

[0117] Although hearing impairment has been used as an example of the predetermined setting 70, settings regarding visual or tactile impairments can also be provided equally well. These settings enable the selection of specific visual or physical impairments such as tunnel vision. This enables the selection of audio and / or vibration preferences based on requirements determined from general vision and tactile abilities or settings.

[0118] Although specific combinations have been described above, it will be apparent that the acoustic characteristics selected based on the detected ambient acoustic signal 60 can additionally be selected based on any combination of the predetermined setting 70, the optical signal, and the status of the medical device 10.

[0119] The terms "drug" or "medication" are used synonymously herein and describe a pharmaceutical formulation comprising one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, optionally together with a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicine is used to treat, cure, prevent, or diagnose a disease or, alternatively, to improve physical or mental well-being. A drug or medication can be used for a limited duration or, in the case of chronic disorders, periodically.

[0120] As described below, a drug or medication can contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0121] A drug or medication can be contained in a primary package or "drug container" that is adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storing one or more drugs (e.g., for short-term or long-term storage). For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. The filling can be carried out at room temperature (e.g., about 20 °C) or refrigeration temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or include a dual-chamber cartridge configured to individually store one by one two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing during dosing of the components into a human or animal body.

[0122] The drugs or agents included in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic agents) or 86 (oncological agents)) or the Merck Index, 15th edition.

[0123] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms “analog” and “derivative” refer to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, a molecular structure of human insulin in which one or more organic substituents (such as fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids including non-codable amino acids, or amino acids are added including those non-codable for the naturally occurring peptide.

[0124] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28 - B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0125] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, Levemir (registered trademark)); B29 - N - palmitoyl - des(B30) human insulin; B29 - N - myristoyl human insulin; B29 - N - palmitoyl human insulin; B28 - N - myristoyl LysB28ProB29 human insulin; B28 - N - palmitoyl - LysB28ProB29 human insulin; B30 - N - myristoyl - ThrB29LysB30 human insulin; B30 - N - palmitoyl - ThrB29LysB30 human insulin; B29 - N - (N - palmitoyl - gamma - glutamyl) - des(B30) human insulin, B29 - N - omega - carboxypentadecanoyl - gamma - L - glutamyl - des(B30) human insulin (insulin degludec, Tresiba (registered trademark)); B29 - N - (N - lithocholyl - gamma - glutamyl) - des(B30) human insulin; B29 - N - (ω - carboxyheptadecanoyl) - des(B30) human insulin and B29 - N - (ω - carboxyheptadecanoyl) human insulin.

[0126] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia (registered trademark)), exenatide (exendin-4, Byetta (registered trademark), Bydureon (registered trademark), a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza (registered trademark)), semaglutide, taspoglutide, albiglutide (Syncria (registered trademark)), dulaglutide (Trulicity (registered trademark)), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligens, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0127] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro (registered trademark)), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0128] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0129] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0130] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in poly-sulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hylan G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0131] ​As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of complement fixation. In some embodiments, the antibody has reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment, or mutant having a mutation or deletion in the Fc receptor-binding region that does not support binding to an Fc receptor. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODVs) having a crossover binding region orientation.

[0132] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may include a cleaved portion of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or multivalent antibody fragments, such as divalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0133] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of the CDR sequences to enable antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0134] 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).

[0135] Any pharmaceutically acceptable salts of the APIs described in this specification are contemplated for use in drugs or agents in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0136] Those skilled in the art will appreciate that changes (additions and / or deletions) to the various components of the APIs, formulas, devices, methods, systems, and embodiments described in this specification can be made without departing from the full scope and spirit of the present invention, and it is understood that the present invention encompasses such changes and any and all equivalent forms thereof.

[0137] Exemplary drug delivery devices can include needle-based injection systems as described in Table 1 of Section 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly distinguished into multiple-dose container systems and single-dose (partial or complete discharge) container systems. The container can be an exchangeable container or an integral non-exchangeable container.

[0138] Furthermore, as described in ISO11608-1:2014(E), multiple-dose container systems can include needle-based injection devices that contain exchangeable containers. In such systems, each container holds multiple doses and its size can be fixed or variable (predetermined by the user). Other multiple-dose container systems can include needle-based injection devices that contain integral non-exchangeable containers. In such systems, each container holds multiple doses and its size can be fixed or variable (predetermined by the user).

[0139] Furthermore, as described in ISO 11608-1:2014(E), a single-dose container system can include a needle-based injection device with an interchangeable container. In one example of such a system, each container holds a single dose such that the entire deliverable volume is expelled (fully expelled). In a further example, each container holds a single dose such that a portion of the deliverable volume is expelled (partially expelled). Also as described in ISO 11608-1:2014(E), a single-dose container system can include a needle-based injection device with an integral non-interchangeable container. In one example of such a system, each container holds a single dose such that the entire deliverable volume is expelled (fully expelled). In a further example, each container holds a single dose such that a portion of the deliverable volume is expelled (partially expelled).

Claims

1. An injection device comprising: an acoustic signal generator operable to generate an acoustic signal; a wireless unit; a controller configured to transmit status information to a portable device using the wireless unit wherein the acoustic signal generator is configured to be controlled by the portable device to generate an alarm having a frequency spectrum, pitch or timbre selected by the portable device based on both the status information and an ambient acoustic signal detected by the portable device, and / or to generate an alarm within a frequency band selected by the portable device based on both the status information and the ambient acoustic signal detected by the portable device.

2. The injection device according to claim 1, further comprising a vibration element configured to generate a tactile feedback, wherein the alarm further comprises a tactile feedback.

3. The acoustic characteristics of the alarm are additionally selected based on a predetermined setting, wherein the predetermined setting optionally includes any one or more of feedback preference, acoustic preference, auditory limit, visual limit and tactile limit. The injection device according to claim 1 or 2.

4. The injection device according to any one of claims 1 to 3, further comprising a photoelectric element configured to detect an ambient light level, wherein the acoustic characteristics of the alarm are additionally selected based on the detected ambient light level.

5. The injection device according to any one of claims 1 to 4, wherein the controller is configured to control the acoustic signal generator to generate an alarm of an amplitude within each of a plurality of frequency bands selected based on the detected ambient acoustic signal and / or to generate an alarm at a volume selected based on the detected ambient acoustic signal.

6. The injection device according to any one of claims 1 to 5, further comprising 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 remove ambient noise in addition to the alarm.

7. The injection device according to any one of claims 1 to 6, which is an injection pen or an auxiliary device provided with a member for connecting to an injection pen.

8. A feedback system comprising: ​ ​ ​ ​ a first device including an acoustic signal generator operable to generate an acoustic signal; a second device including 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 alarm having an acoustic characteristic selected based on the detected ambient acoustic signal; comprising wherein the controller is configured to control the acoustic signal generator to generate an alarm having a frequency spectrum, pitch or timbre selected based on the detected ambient acoustic signal and / or to generate an alarm within a frequency band selected based on the detected ambient acoustic signal; wherein the first device is an injection device and the second device is a portable device; the first device and the second device further include a wireless unit, and the second device is configured to receive status information from the first device through the wireless unit; the controller of the second device is further configured to generate an alarm having an acoustic characteristic additionally selected based on the status information in response to the reception of the status information; said feedback system.

9. either the first device or the second device further includes a vibration element configured to generate a tactile feedback; the alarm further includes a tactile feedback; The feedback system according to claim 8.

10. The feedback system according to claim 8 or 9, wherein the acoustic characteristic of the alarm is additionally selected based on a predetermined setting.

11. either the first device or the second device further includes a photoelectric element configured to detect an ambient light level; the acoustic characteristic of the alarm is additionally selected based on the detected ambient light level; The feedback system according to any one of claims 8 to 10.

Images