Electronic system

Abstract

An electronic system (20) for measuring a parameter of a drug delivery device (1), the electronic system comprising: a sensing unit (23) configured to provide information about a maintenance condition of a spatial position of the electronic system; a positioning unit (25) for assisting the positioning of the electronic system; and a processor unit (24) operatively connected to the sensing unit and to the positioning unit, where the processor unit is configured to: based on a comparison of information provided by the sensing unit with predefined criteria, determine whether the spatial position is changed or not when information provided by the sensing unit about a change in the spatial position meets the predefined criteria; the positioning unit is caused to switch to a condition in which a user is notified of the position of the electronic system.

Description

Background Technology

[0001] This disclosure relates to an electronic system for a drug delivery device.

[0002] Handheld drug delivery devices (such as injection pens) are widely used in the medical field, and the demand for these devices is rapidly increasing. With the increasing complexity of the drug delivery devices used and the associated manufacturing costs, the ability to reuse the devices or at least their components multiple times is desired. To achieve sustainable use of these drug delivery devices, it is particularly desirable to avoid the accidental disposal of reusable devices or at least their components. Summary of the Invention

[0003] The purpose of this disclosure is to achieve improvements in drug delivery devices, and in particular in preventing the accidental disposal of reusable drug delivery devices or their components.

[0004] This objective is achieved by the disclosed subject matter, for example, by the subject matter defined in the appended independent claims. Advantageous improvements and extensions are defined in the dependent claims and / or set forth in the description below.

[0005] One aspect of this disclosure relates to an electronic system. This electronic system can be configured to measure the injection dose and / or other parameters of a drug delivery device. These parameters may include the expiration date of the drug, the planned injection dose, the type of drug, and / or the temperature of the drug. The electronic system may include a sensing unit configured to provide information regarding the maintenance of the spatial position of the electronic system. The spatial position may be the absolute spatial position of the electronic system. This information may in particular include acceleration, angular velocity, velocity, and / or vibration values ​​detected by the sensing unit. The maintenance of the spatial position may be that the position of the electronic system does not change. The maintenance of the spatial position may be that the position of the electronic system relative to the drug delivery device does not change. A change may be a downward movement of the electronic system. A change may be a downward movement of the electronic system in the direction of Earth's gravity. The electronic system may further include a positioning unit for assisting in the positioning of the electronic system, and a processor unit operatively connected to the sensing unit and the positioning unit. The processor unit can be configured to, based on a comparison of information provided by the sensing unit regarding the maintenance of the electronic system's spatial location with a predefined standard, cause the positioning unit to switch to a state where, for example, the positioning unit notifies the user of the electronic system's location, when the information provided by the sensing unit regarding the maintenance of the electronic system's spatial location meets the predefined standard. The maintenance of the electronic system's spatial location indicates that the electronic system is no longer in operation, typically when it has been discarded in a trash can. Therefore, if the electronic system is accidentally discarded, it can assist the user in finding it.

[0006] In one embodiment, the comparison between the information provided by the sensing unit regarding the maintenance of the spatial position of the electronic system and a predefined standard can be performed by the processor unit.

[0007] In this embodiment, the comparison of information provided by the sensing unit regarding the maintenance of the spatial position of the electronic system with a predefined standard can be performed by a processor different from the processor unit. This processor, different from the processor unit, may not be part of the electronic system. It may be part of an external device. The external device may be one of a smartphone, smartwatch, and / or tablet computer.

[0008] In this embodiment, the electronic system is a reusable attachment that can be repeatedly and detachably attached to the drug delivery device.

[0009] In one embodiment, the electronic system includes an electronic system housing. The electronic system housing may enclose the sensing unit, positioning unit, and processor unit. The electronic system housing may be a housing for an auxiliary device. The electronic system housing may differ from the drug delivery device housing.

[0010] In this embodiment, the sensing unit is configured to provide information regarding the maintenance of the spatial position of the electronic system housing. The sensing unit may be configured to provide information regarding the maintenance of the spatial position of the outer surface of the electronic system housing. The outer surface of the electronic system housing may have a user-touchable surface. The sensing unit may be configured to provide information regarding the maintenance of the spatial position of the touchable surface. The touchable surface may be a surface that requires user touch to trigger the dispensing process of the drug delivery device.

[0011] The term "spatial position" refers to the location or placement of an electronic system in three-dimensional space. It describes the position of the electronic system relative to its coordinates or its relationship to other objects. Spatial position can be defined by specifying length, width, and height coordinates, distance from a reference point, or other suitable methods.

[0012] In an embodiment, the predefined criteria include information indicating predefined kinematic events of the electronic system. The term "kinematic event" can refer to information related to the motion and position of the electronic system, whether it is, in particular, a vector, an acceleration value, or a velocity value.

[0013] In an embodiment, the sensing unit includes an inertial sensor or is configured to use inertial sensor technology.

[0014] In one embodiment, the sensing unit is configured to provide information about the maintenance of the spatial position of the electronic system by measuring the acceleration value of the electronic system. The sensing unit may include an accelerometer.

[0015] In one embodiment, the sensing unit is configured to provide information about the maintenance of the electronic system's spatial position by measuring the angular velocity value of the electronic system. The sensing unit may include a gyroscope sensor.

[0016] In this embodiment, the predefined criteria include the absence of information indicating a predefined kinematic event. The predefined criteria may include the absence of information indicating a predefined kinematic event within a predefined time period. The predefined time period may be greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 seconds.

[0017] In this embodiment, the information indicating a predefined kinematic event is an acceleration value detected by a sensing unit. The acceleration value can be greater than or equal to 1, 2, 3, 4, 5, 6, 7, 8, or 9 m / s². 2 Information indicating a predefined kinematic event could be the detection of an acceleration exceeding a certain value.

[0018] In this embodiment, the information indicating a predefined kinematic event is the angular velocity value detected by the sensing unit. The angular velocity value can be greater than or equal to 10, 20, 30, 40, 50, 60, 70, 80, or 90° / s (degrees per second). The information indicating a predefined kinematic event can be the detection of an angular velocity exceeding the value.

[0019] In one embodiment, the electronic system includes a timer. A processor unit may be operatively connected to the timer. The timer may be configured to assist the processor unit in detecting the expiration of a predefined time.

[0020] In one embodiment, the electronic system includes an interface configured to detect movement of an external object relative to the electronic system. The interface can be configured to detect the presence and / or absence of an external object suitable for attachment to the electronic system. The external object may include a body or component located outside the electronic system or its housing. The external object may include a body or component that is not part of the electronic system, such as a component of a drug delivery device. A processor unit may be operatively connected to the interface. Predefined criteria may include the absence of information indicating a predefined kinematic event within a predefined time period following the detection of movement of the external object relative to the electronic system. The interface can be configured to detect movement of a component of the drug delivery device relative to the electronic system when the electronic system is attached. A processor unit may be operatively connected to the interface. Predefined criteria may include the absence of information indicating a predefined kinematic event within a predefined time period following the detection of movement of a component of the drug delivery device relative to the electronic system. In this way, premature switching to notify the user of the electronic system's location due to movement of a component of the drug delivery device relative to the electronic system can be avoided before a dose of drug has been set or delivered.

[0021] In one embodiment, the electronic system may be a presence sensor. The presence sensor may be configured to detect whether the electronic system is attached to the drug delivery device.

[0022] In an embodiment, the electronic system is configured to have a first state and a second state, wherein in the first state, the sensing unit, processor unit, and positioning unit are inactive, and in the second state, the sensing unit, processor, and positioning unit are operational. The electronic system can be configured such that when the electronic system is attached to the drug delivery device, the electronic system changes from the first state to the second state. The electronic system can be configured such that when the electronic system is detached from the drug delivery device, the electronic system remains in the second state. Therefore, the electronic system provides support to the user regardless of whether it is placed in the trash along with the drug delivery device (i.e., attached to the drug delivery device) or separately from the drug delivery device.

[0023] In an embodiment, the electronic system is configured such that when the interface detects one or more movements of components of the drug delivery device relative to each other and / or relative to the electronic system or the electronic system housing, the electronic system changes from a first state to a second state. These one or more movements may include the following:

[0024] - The movement of the plunger,

[0025] - Movement of the needle cannula

[0026] - Movement of the dosage dial,

[0027] - Movement of a medicine container, wherein the medicine container may be a syringe.

[0028] - The movement of the stopper in the medicine container.

[0029] - The movement of the needle,

[0030] - The movement of the hat and / or

[0031] - The movement of energy storage units (such as driving springs).

[0032] In one embodiment, the electronic system includes a transmission unit configured to receive external signals. A processor unit may be operatively connected to the transmission unit. Predefined criteria may include information indicating the absence of a predefined kinematic event within a predefined time period following the transmission unit receiving the external signal.

[0033] External signals can be provided by smartphones, smartwatches, and / or tablets.

[0034] Therefore, if, for example, a user has realized that the electronic system has been mistakenly placed in the trash, the user can intentionally initiate a change to inform the user of the electronic system's location.

[0035] In an embodiment, the positioning unit is configured to be detectable visually, audibly, tactilely, and / or electronically when, for example, the positioning unit notifies the user of the location of the electronic system. The positioning unit may also be configured not to be detectable visually, audibly, tactilely, and / or electronically until the positioning unit switches to notifying the user of the electronic system's location.

[0036] In an embodiment, optionally, to support the detectability of the positioning unit, the positioning unit includes a transmitter, a receiver, and / or a transceiver. Alternatively or additionally, the positioning unit may include a lamp, a speaker, and / or a vibrating element.

[0037] In one embodiment, the positioning unit is configured to be physically sensed after switching to the position of the user notification electronic system. The positioning unit can also be configured to be physically insensible before switching to the position of the user notification electronic system. The positioning unit can also be configured to emit light, vibrate, and / or emit audible signals after switching to the position of the user notification electronic system. Alternatively, the positioning unit can be configured not to emit light, vibrate, and / or emit audible signals before switching to the position of the user notification electronic system.

[0038] In this embodiment, the positioning unit is configured to be physically insensible after switching to a location notification system for the user. The positioning unit may be configured to transmit and / or receive signals after switching to a location notification system for the user. The positioning unit may also be configured not to transmit and / or receive signals before switching to a location notification system for the user. Signals may be configured to be detectable and / or transmitted by an external device. Signals may be wireless signals. Signals may be Bluetooth signals. Signals may be WLAN (Wi-Fi) signals. External devices may be smartphones, smartwatches, and / or tablets.

[0039] In one embodiment, the electronic system is configured to output a warning signal upon detachment from the drug delivery device. The positioning unit may be configured to output the warning signal. Alternatively, the electronic system may include a warning unit configured to output a warning signal, wherein the warning unit and the positioning unit are distinct entities.

[0040] In an embodiment, the electronic system is configured to output a warning signal when the electronic system is detached from the drug delivery device, and when a predetermined time has elapsed since the detachment. The predetermined time can be greater than 5 seconds. The predetermined time can be equal to or greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 seconds. The electronic system can be configured to output a warning signal when the electronic system is detached from the drug delivery device and is not reattached to the drug delivery device within the predetermined time.

[0041] In an embodiment, the sensing unit includes a vibration sensor, a pressure sensor, and / or an acoustic sensor.

[0042] Another aspect of this disclosure relates to a drug delivery device including the aforementioned electronic system. The drug delivery device can be configured to contain a drug container with a drug, or may include a drug container with a drug. The drug delivery device can be a full-function drug delivery device. The drug can be a pharmaceutical preparation. The drug delivery device can be an autoinjector. In an autoinjector, energy for the drug delivery operation can be pre-stored in an energy storage component. That is, for example, when preparing the drug delivery device for use, the user does not need to provide energy for the drug delivery operation. Instead, this energy can be pre-loaded into the drug delivery device by the manufacturer. For example, a drive spring (e.g., a helical spring or a flat helical spring) can be pre-stressed or pre-biased to provide energy for the drug delivery operation. Alternatively, the drug delivery device may not be an autoinjector, meaning the user must apply force to eject the drug from the container.

[0043] Another aspect of this disclosure relates to a method for assisting the positioning of an electronic system. This method may be a computer-implemented method. The method may include: providing information regarding the maintenance of the spatial position of the electronic system; comparing the information regarding the maintenance of the spatial position of the electronic system with predefined criteria; and, when the information regarding the maintenance of the spatial position meets the predefined criteria, causing the electronic system to switch to a state that notifies the user of the electronic system's position. The method may also include comparing the information regarding the maintenance of the spatial position of the electronic system with predefined criteria; and, when the maintenance of the spatial position does not meet the predefined criteria, preventing the positioning unit from switching to a state that notifies the user of the electronic system's position. The process step of switching the electronic system to a state that notifies the user of the electronic system's position can be performed by switching the positioning unit to a state that notifies the user of the electronic system's position, as described above.

[0044] Another aspect of this disclosure relates to a computer program product, such as a computer program or a computer-readable storage medium, comprising instructions that, when executed by a processor, cause an electronic system to perform the method. The computer-readable storage medium may be a hardware memory component. The processor may be different from a processor unit. Unlike a processor unit, a processor may not be part of the electronic system. Alternatively, the processor may be a processor unit.

[0045] In this invention, for ease of reading the specification and claims, singular expressions such as "a sensing unit" and "a localization unit" are used. However, since components according to the invention "comprise" or "have" corresponding parts or features, such singular expressions do not limit the number of parts or features involved. Rather, unless the context otherwise indicates, such singular expressions are intended to be understood as "at least one sensing unit," "at least one localization unit," etc.

[0046] A particularly advantageous embodiment relates to an electronic system for measuring parameters of a drug delivery device, wherein the electronic system includes: a sensing unit configured to provide information on the maintenance of the spatial position of the electronic system; a positioning unit for assisting in the positioning of the electronic system; and a processor unit operatively connected to the sensing unit and the positioning unit, wherein the processor unit is configured to: based on a comparison of the information provided by the sensing unit with a predefined criterion, when the information provided by the sensing unit on the maintenance of the spatial position meets the predefined criterion, cause the positioning unit to switch to a state of notifying the user of the position of the electronic system.

[0047] Another particularly advantageous embodiment relates to a drug delivery device including the electronic system.

[0048] One particularly advantageous method relates to a method for positioning an auxiliary electronic system, the method comprising the following steps:

[0049] - Provide information on the maintenance of the electronic system's spatial position;

[0050] - Compare the information regarding the maintenance of the spatial position of the electronic system with predefined criteria;

[0051] - When the information regarding the maintenance of the spatial location meets the predefined criteria, the electronic system switches to a state where it notifies the user of the system's location.

[0052] It should be noted that the features described above and below in conjunction with different embodiments or aspects can be combined with each other, even if such combinations are not expressly disclosed herein. Further features, advantages, and conveniences of this disclosure, and in particular the proposed concepts, will become clear from the following description of exemplary embodiments in conjunction with the accompanying drawings. Attached Figure Description

[0053] Figure 1 An exploded view of a drug delivery device for use with an electronic system, according to an embodiment of the present invention, is shown.

[0054] Figure 2 Showing attachment to Figure 1 The electronic system of the drug delivery device;

[0055] Figure 3 Showing Figure 2 The diagram shows the block diagram of the electronic system and its external devices;

[0056] Figure 4 Showing Figure 1 A three-dimensional view of a portion of a drug delivery device;

[0057] Figure 5 Showing Figure 1 A perspective view of the movable dosing setting component of a drug delivery device;

[0058] Figure 6 Showing Figure 3 electronic systems and Figure 1 A cross-sectional view of the drug delivery device when its parts are attached together;

[0059] Figure 7 A graph was displayed, showing the curves formed by... Figure 3 The intensity of light received by sensors in an electronic system;

[0060] Figure 8 A graph was displayed, showing the results based on... Figure 7 The received light intensity and sensor arrangement output are shown; and

[0061] Figure 9 The system was showcased, and it came from... Figure 3 The data from the electronic system is transmitted to another device. Detailed Implementation

[0062] In the following description, embodiments of the invention will be illustrated with reference to an insulin drug delivery device. However, the invention is not limited to this application and can also be used well with drug delivery devices that eject other medications.

[0063] In the accompanying drawings, the same elements, elements of the same kind, and elements that function in the same or similar manner may be marked with the same reference numerals. The invention is not limited to the embodiments shown or described.

[0064] Figure 1 This is an exploded view of a drug delivery device. In this example, the drug delivery device is drug delivery device 1, such as a device similar to or the same as the device described in WO 2004 / 078239 A1.

[0065] Figure 1 The drug delivery device 1 is a pre-filled disposable injection pen, which includes a housing 10 and houses an insulin container 14, to which a needle 15 can be attached. The needle is protected by an inner needle cap 16 and an outer needle cap 17 and / or another cap 18.

[0066] By rotating the dosing knob 12, the insulin dose to be dispensed from the drug delivery device 1 can be set or "dialed in," and the currently set dose is then displayed via the dosing window 13, for example, in various units. For instance, when the drug delivery device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), where one IU is the bioequivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units may be used in drug delivery devices used to deliver analog insulin or other medications. It should be noted that the selected dose can also be... Figure 1 The dose window 13 shown in the figure is displayed well, unlike the others.

[0067] The dosage window 13 may be in the form of an aperture in the housing 10, which allows a user to observe a limited portion of the digital sleeve 70, which is configured to move as the dosage knob 12 is turned to provide a visual indication of the currently set dosage. When turned during setting, the dosage knob 12 rotates, for example, in a helical path relative to the housing 10.

[0068] In this example, the dosage knob 12 includes one or more shaped structures 71a, 71b, 71c to facilitate the attachment of the electronic system described below.

[0069] The drug delivery device 1 can be configured such that turning the dosage knob 12 generates tactile and / or acoustic feedback (e.g., a mechanical click) perceptible to the user / patient. The digital sleeve 70 interacts mechanically with a piston in the insulin container 14. When the needle 15 is inserted into the patient's skin and the injection button 11 is subsequently pushed, the insulin dose displayed in the display window 13 is ejected from the drug delivery device 1. While the needle 15 of the drug delivery device 1 remains in the skin for a period of time after the injection button 11 is pushed, virtually the majority of the dose is injected into the patient. The drug delivery device can be configured such that several events in the injection process (e.g., completion) can generate tactile and / or acoustic feedback for the user. For example, the acoustic feedback could be a mechanical click; however, this mechanical click could be different from the sound produced when the dosage knob 12 is used.

[0070] In one embodiment, during insulin dose delivery, the dose knob 12 moves axially (i.e., without rotation) to its initial position, while the digital sleeve 70 rotates to return to its initial position, for example, to display a dose of zero units.

[0071] The drug delivery device 1 can be used for several injection processes until the insulin container 14 is empty or until the expiration date of the drug in the drug delivery device 1 is reached (e.g., 28 days after the first use).

[0072] Furthermore, before using the drug delivery device 1 for the first time, it may be necessary to perform a so-called "initial injection" to remove air from the insulin container 14 and needle 15. This is done, for example, by holding the drug delivery device 1 with the needle 15 facing upwards, selecting two units of insulin, and pressing the injection button 11. For simplicity, it will be assumed below that the ejected volume substantially corresponds to the injected dose, such that, for example, the dose of medication ejected from the drug delivery device 1 is equal to the dose received by the user. However, the difference between the ejected volume and the injected dose (e.g., loss) may need to be considered.

[0073] Figure 2 This is a perspective view of the proximal end of the drug delivery device 1 when attached to the electronic system 20 according to an embodiment of this disclosure. Hereinafter, the term "distal" refers to the direction in which the drug delivery device 1 displaces the drug or agent. Correspondingly, the term "proximal" refers to the opposite direction, as further explained above. The electronic system 20 includes an electronic system housing 21 and a dose information unit. For ease of understanding, the dose information unit will be exemplarily described as a display 22 for presenting dose information 22a. However, other types of visual dose information units may be used, such as analog indicators like markers. Alternatively or additionally, the dose information unit may include means for providing dose information in a non-visual manner (e.g., acoustically or tactilely).

[0074] like Figure 3 As shown, the electronic system 20 also includes a sensing unit 23 and a positioning unit 25. The sensing unit is configured to provide information about the maintenance of the spatial position of the entire electronic system 20 or to monitor the maintenance of the spatial position. The positioning unit 25 is configured to assist in the positioning of the electronic system 20. Additionally, the electronic system 20 includes a processor unit 24, which is operatively connected to the sensing unit 23 and the positioning unit 25. The processor unit 24 may include one or more processors (such as a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc.) and memory units 24.1 and 24.2 (including program memory 24.1 and main memory 24.2), which may store software for execution by the processor unit 24. The electronic system housing 21 at least encloses the sensing unit 23, the positioning unit 25, and the processor unit 24.

[0075] An interface 26 is provided to the drug delivery device 1, such as a sensor arrangement including one or more sensors, wherein the processor unit 24 is operatively connected to the interface 26. Figure 3 In the illustrated example, interface 26 is an optical encoder that includes a light source 26a (e.g., a light-emitting diode (LED)) and a photosensor 26b (e.g., an optical transducer). Interface 26 can be configured to detect the presence of the drug delivery device 1 when the electronic system 20 is attached to the drug delivery device 1. Furthermore, interface 26 is also configured to detect movement of components of the drug delivery device 1 relative to the electronic system 20.

[0076] In addition, a transmission unit 27 is provided, which may be a wireless communication interface for communicating with another device (such as a smartphone, smartwatch and / or tablet computer) via a wireless network (such as Wi-Fi or Bluetooth), or an interface for a wired communication link (such as a socket for receiving a Universal Serial Bus (USB), mini USB or micro USB connector).

[0077] A power switch 28 and a battery 29 are provided. In one example, the power switch 28 is configured to respond to pressure applied to the display 22 by turning the electronic system 20 on or off.

[0078] The depicted electronic system 20 is configured to measure the injection dose and / or other parameters of the drug delivery device 1. Measuring other parameters may include, for example, the expiration date of the drug, the planned injection dose, the type of drug, the temperature of the drug, etc. The electronic system 20 can be used to detect the duration and timing details of the previous dose ejected from the drug delivery device 1, and the corresponding information can be displayed in an application on an external device such as a smartphone, smartwatch, and / or tablet. The electronic system 20 is a reusable attachment that can be repeatedly and detachably attached to the drug delivery device 1. In this example, the electronic system 20 is attached to the injection button 11 at the proximal end of the drug delivery device 1. According to an alternative example, the electronic system 20 is a reusable attachment that can be attached to the housing 10 of the drug delivery device 1. The electronic system 20 can be attached to the housing 10 of the drug delivery device 1 such that the electronic system housing 21 covers the window 13. According to another alternative example, the drug delivery device is an autoinjector. It should also be noted that the electronic system 20 can also be used in reusable components of the drug delivery device. For example, this may refer to a reusable drive unit that can be equipped with different containers or syringes. The electronic system 20 may be an integral or inseparable part of the reusable components of the drug delivery device.

[0079] Regarding the positioning function of the electronic system 20, the electronic system 20 is configured to have a first state and a second state. In the first state, the sensing unit 23, the processor unit 24, and the positioning unit 25 do not operate, and in the second state, the sensing unit 23, the processor unit 24, and the positioning unit 25 operate, as described below. In both the first and second states, the power switch 28 is turned on.

[0080] The change from the first state to the second state can be achieved in various ways. For example, the electronic system 20 can be configured such that when the electronic system is attached to the drug delivery device 1, the electronic system changes from the first state to the second state. In this case, the electronic system 20 can have a mechanical switch that is toggled when the electronic system 20 is attached to the drug delivery device 1. The mechanical switch can be configured such that when the electronic system 20 is detached from the drug delivery device 1, the electronic system 20 remains in the second state, allowing the sensing unit 23, the processor unit 24, and the positioning unit 25 to continue operating, as described below. In this way, even if the electronic system 20 is separated from the drug delivery device 1 and accidentally thrown into the trash, the method for locating the electronic system 20 can still be used.

[0081] Once interface 26 detects for the first time that electronic system 20 is attached to drug delivery device 1, the detection of the presence of drug delivery device 1 by interface 26 can switch electronic system 20 from a first state to a second state. When interface 26 detects that electronic system 20 has been detached from drug delivery device 1, electronic system 20 remains in the second state, allowing sensing unit 23, processor unit 24, and positioning unit 25 to continue operating, as described below.

[0082] According to another example, the electronic system 20 is configured to change from a first state to a second state when the interface 26 detects one or more movements of the components of the drug delivery device 1 relative to each other or relative to the electronic system 20. Such movements may in particular include movement of the plunger, needle cannula, dose dial sleeve, dose knob 12, insulin container 14, needle 15, and / or the stopper in the insulin container.

[0083] Once the electronic system 20 is in the second state, the sensing unit 23 can continuously acquire information about the maintenance of the spatial position of the electronic system 20. For this purpose, the sensing unit 23 may include, for example, inertial sensors, such as accelerometers and / or gyroscopes. Once the information meets predefined criteria, the processor unit 24 instructs the positioning unit 25 to enter a user-recognizable state. If the sensing unit 23 does not detect any motion values ​​indicating user manipulation of the electronic system 20, the predefined criteria are satisfied.

[0084] It should be noted that, instead of inertial sensors, other sensors capable of detecting the manipulation of electronic system 20 can be used. Examples may include vibration sensors, pressure sensors, and / or acoustic sensors.

[0085] Typically, electronic system 20 can be configured such that a predefined criterion is the absence of any detectable kinematic events related to electronic system 20, such as the motion and position of electronic system 20 (in the form of vectors, acceleration values, velocity values, vibration values, etc.). Therefore, sensing unit 23 may include means for acquiring such kinematic events.

[0086] Electronic system 20 can be configured such that a predefined criterion includes the absence of information indicating a predefined kinematic event within a predefined time period. In this case, electronic system 20 may include a timer (not shown) configured to assist processor unit 24 in detecting the elapsed time of the predefined period. The predefined time may be greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 seconds.

[0087] After meeting predefined criteria, the electronic system 20 helps the user identify when the reusable electronic system 20 has been disposed of in the trash. This is facilitated by the positioning unit 25 changing its status from a first state to a second state. In the second state, the positioning unit 25 can emit a physically perceptible signal. Additionally or alternatively, the electronic system 20 can emit a physically imperceptible signal in the second state. For this purpose, Figure 3 The positioning unit 25 shown includes a physically perceptible component 25a and a physically insensible component 25b. In the context of this specification, a physically perceptible component is an output device capable of converting various types of signals into physical phenomena or perceptions. Such an output device may be, for example, a lamp, a speaker, and / or a vibrating element. A physically insensible component is an output device that cannot convert various types of signals into physical phenomena or perceptions. Such an output device may be a transmitter, a receiver, or a transceiver.

[0088] like Figure 3 As shown, the electronic system 20 can be configured, for example, to emit and / or receive detectable signals in a second state via component 25b, wherein such signals are suitable for detection by an external device 50. The external device 50 may, in particular, be a smartphone, smartwatch, and / or tablet computer. The external device 50 can be configured to provide an alarm or warning using an application or software when the external device 50 detects or receives a signal. The alarm or warning may be a user-perceptible notification, such as sound, vibration, or a message displayed on the screen of the external device 50. Alternatively or additionally, the electronic system 20 can be configured, for example, to emit light, vibrate, and / or emit audible signals in a second state via component 25a.

[0089] In the second scenario, physically perceptible component 25a may flash, emit light, vibrate, and / or emit sound, both alerting the user to their erroneous action and assisting the user in locating electronic system 20. Alternatively or simultaneously, physically insensible component 25b may emit detectable signals, such as Bluetooth or WLAN (Wi-Fi) signals. This signal is received from external device 50 (such as the user's smartphone), alerting the user to their erroneous action and helping the user locate electronic system 20.

[0090] According to an exemplary embodiment, the sensing unit 23 includes an accelerometer, wherein the sensing unit 23 can be configured to continuously measure the acceleration of the electronic system 20 in a second state. The processor unit 24 compares the detected acceleration value with an acceleration reference value. The acceleration reference value can be greater than or equal to 1, 2, 3, 4, 5, 6, 7, 8, or 9 m / s². 2If the processor unit 24 detects that the acceleration value detected by the sensing unit 23 matches a reference acceleration value or exceeds a reference acceleration value within a predetermined time interval (e.g., 15, 30, 45, or 60 seconds), the processor unit 24 will not instruct the positioning unit 25 to switch to the second state. However, if no reference acceleration value is measured or no value exceeding the reference acceleration value is measured within the predetermined time interval, the processor unit 24 will instruct the positioning unit 25 to switch to the second state.

[0091] According to another exemplary embodiment, the sensing unit 23 includes a gyroscope sensor, wherein the sensing unit 23 can be configured to continuously measure the angular velocity of the electronic system 20 in the second state. The processor unit 24 compares the detected angular velocity value with a reference angular velocity value. The reference angular velocity value can be greater than or equal to 10, 20, 30, 40, 50, 60, 70, 80, or 90° / s. The processor unit 24 will not instruct the positioning unit 25 to switch to the second state as long as it detects that the angular velocity value detected by the sensing unit 23 matches the reference angular velocity value or exceeds the reference angular velocity value within a predetermined time interval (e.g., 15, 30, 45, or 60 seconds). However, once no reference angular velocity value is measured or no value exceeding the reference angular velocity value is measured within the predetermined time interval, the processor unit 24 instructs the positioning unit 25 to switch to the second state.

[0092] In both exemplary embodiments, switching to the second state may include additional prerequisites. For example, it may be additionally necessary that interface 26 has detected movement of a component of the drug delivery device 1 relative to the electronics 20 before sensing unit 23 begins the measurement process. This helps prevent positioning unit 25 from switching to the second state before the drug delivery device 1 is used for the first time, when the drug delivery device 1 with the electronics 20 attached is intentionally stored for an extended period. For example, in this case, movement of a component of the drug delivery device 1 could be the initial rotation of the dosage dial to set the dose to be dispensed. According to another example, it may be necessary that transmission unit 17 has detected an external signal before sensing unit 23 begins the measurement process. Thus, in conjunction with a corresponding application or software on a smartphone, the user can specifically determine when sensing unit 23 begins the measurement process.

[0093] The comparison of the information detected by the sensing unit 23 with a predefined standard can be performed by the processor unit 24. However, the result of the comparison can also be provided only to the processor unit 24. This can be done, for example, via a processor located outside the electronic system 20 or the drug delivery device 1 and communicating with the electronic system 20, for example, via wireless electronic signals. Therefore, the comparison of the information detected by the sensing unit 23 with a predefined standard can be performed by the processor of a smartphone, smartwatch, and / or tablet computer.

[0094] After the user picks up the electronic system 20, the positioning unit 25 is deactivated, for example, by the user switching the electronic system 20 from the second state to the first state using a mechanical switch. The positioning unit 25 can also be deactivated and the electronic system 20 set to the first state by means of a signal sent by an external device 50. For this purpose, the electronic system 20 may have a corresponding receiver that interacts with the processor unit 24.

[0095] Additionally, Figure 3 The electronic system 20 is configured to output a warning signal when the electronic system 20 is detached from the drug delivery device 1 and when the electronic system 20 is in a second state. Figure 3 In the illustrated exemplary embodiment, the positioning unit 25 is configured to output a warning signal. Alternatively, the electronic system 20 may include a warning unit (not shown) configured to output a warning signal, wherein the warning unit and the positioning unit 25 are separate units, both surrounded by the electronic system housing 21. The electronic system 20 outputs a warning signal when it is in a second state, detached from the drug delivery device 1, and when a predetermined time has elapsed since its detachment from the drug delivery device 1. The predetermined time may be greater than 5 seconds. The predetermined time may be greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 seconds. Furthermore, the electronic system 20 is configured to output a warning signal when it is detached from the drug delivery device 1 and when it is not reattached to the drug delivery device 1 within a predetermined time, or alternatively, when it is not reattached to another drug delivery device different from or equivalent to the drug delivery device 1 within a predetermined time.

[0096] Figure 4 The injection button 11 and dosage knob 12 of the drug delivery device 1 are shown in more detail. In the illustrated embodiment, the injection button 11 includes a cavity 30 on its upper surface, which is configured to receive at least a portion of the electronic system 20. In this embodiment, the sidewall of the cavity 30 includes an aperture 31 through which a portion of the digital sleeve 70 is visible.

[0097] Figure 5 A digital sleeve 70 is depicted. In the illustrated embodiment, a crenellated structure 72 is formed (e.g., molded) at one end of the digital sleeve 70. The crenellated structure 72 at one end of the digital sleeve 70 can act as a light-blocking plate for the light emitted by the light source 26a.

[0098] exist Figure 5 In the illustrated embodiment, twelve crenellated structures 72 are provided. These twelve crenellated structures and the gaps between them have widths selected to provide 24 "edges". Each edge can correspond to a dose increment, allowing a maximum dose of up to 24 units to be displayed on the digital sleeve 70. The crenellated structures 72 are formed using a material with a reflectivity different from that of the inner surface of the injection button 11.

[0099] The digital sleeve 70 is arranged to rotate in one direction when the dose is set into the drug delivery device 1 using the dosing knob 12. The digital sleeve 70 is also arranged to rotate in the opposite direction during drug delivery by the drug delivery device 1.

[0100] Figure 6 This is a cross-sectional view of part of the electronic system 20 and the drug delivery device 1.

[0101] like Figure 6 As shown, the housing 21 of the dosage knob 12 and the electronic system 20 includes cooperatively shaped structures 71a and 73a. In this particular embodiment, these shaped structures take the form of a protrusion 73a provided in the housing 21 of the electronic system 20 and a locking portion 71a provided in the dosage knob 12. Figure 1 As shown, the forming structures 71a, 71b, and 71c have only a limited range, so that the electronic system 20 cannot rotate relative to the dose knob 12 when attached.

[0102] Since the electronic system 20 and the dosage knob 12 cannot rotate relative to each other, they move accordingly when the dosage is set in the drug delivery device 1. This allows for a more ergonomic arrangement, as the electronic system 20 can provide a larger surface that can be gripped and rotated by the user during dosage setting. Alternatively or additionally, the electronic system 20 may have shaped structures on its outer surface to facilitate rotation of the electronic system 20, and thus, rotation of the dosage knob 12.

[0103] In arrangements where the electronic system 20 needs to be releasably attached to the drug delivery device 1, the cooperative forming structures 71a, 73a can provide a form-fitting engagement (e.g., a snap-fit ​​engagement), which allows for easy removal of the electronic system 20. This arrangement can be useful when the electronic system 20 is to be used with the disposable drug delivery device 1, as it allows for easy removal of the electronic system 20 from the drug delivery device 1. This facilitates reuse and allows the user greater flexibility in attaching and removing the electronic system 20 at will.

[0104] Alternatively, the co-forming structures 71a, 73a can be configured to permanently attach the electronic system 20 to the drug delivery device 1, for example, using a snap-fit ​​connection. In other embodiments, the electronic system 20 can be permanently attached in other ways, such as by adhesive. Such permanent attachment can be useful where the injection device 1 is reusable.

[0105] In one embodiment, the number and / or position of the co-forming structures 71a, 73a can be configured such that the electronic system 20 can be attached to the drug delivery device 1 at only one specific location. In this example, the housing 21 of the electronic system 20 may include an aperture 74 through which light emitted by the light source 26a can pass when the electronic system 20 is in place and can be detected by a photodetector 26b. The co-forming structures 71a, 73a can be arranged such that when the electronic system 20 is attached to the drug delivery device 1, the aperture 74 in the housing 21 of the electronic system 20 aligns with the aperture 31 in the sidewall of the cavity 30 in the injection button 11, such as... Figure 6 As shown.

[0106] like Figure 6 As indicated by the arrows, light emitted by light source 26a can therefore pass through orifices 74 and 31 and enter injection button 11. If the crenellated structure 72 of digital sleeve 70 is visible through orifice 31, light will be reflected from the crenellated structure 72 and return through orifices 31 and 74, where it can be detected by photodetector 26b. Since the reflectivity of the crenellated structure 72 is different from that of the inner surface of injection button 11, the amount of light detected by photodetector 26b will depend on how much of the crenellated structure 72 can be observed through orifice 31.

[0107] In some embodiments, interface 26 may be arranged to emit and / or detect only light with specific polarization characteristics in order to mitigate the effects of stray light entering aperture 74.

[0108] Figure 7 It is a graph showing the change in the intensity of light received by the photodetector 26b during the setting and delivery of the drug dosage, while Figure 8This is a graph showing the output that can be generated by interface 26 of this embodiment.

[0109] As described above, when the dose is set into the drug delivery device 1, in Figure 7 and Figure 8 During time period t1, the dose knob 12 and digital sleeve 70 rotate helically. As the electronic system 20 moves in unison with the dose knob 12, the amount of light reflected back toward the photodetector 26b should remain substantially constant because there is little or no relative rotational movement between the digital sleeve 70 and the electronic system 20. The amount of reflected light should also remain substantially constant between the completion of dose setting and the start of injection. Figure 7 As shown in time period t2, this is because the user did not move the digital sleeve 70, the dosage knob 12, and the electronic system 20.

[0110] therefore, Figure 8 The output of the interface 26 shown (which may be sensor arrangement 26) is substantially constant during time periods t1 and t2. During time periods t1 and t2, the actual level of the output will depend on whether the crenellated structure 72 is visible through the aperture 31, and if so, on how much the aperture is covered by the crenellated structure 72.

[0111] During the delivery of medication (such as Figure 7 and Figure 8 (As shown in time period t3), the digital sleeve 70 rotates spirally, but the dosage knob 12 only moves axially and does not rotate. Therefore,

[0112] The digital sleeve 70 rotates relative to the electronic system 20.

[0113] During time period t3, as the digital sleeve 70 rotates relative to the dose knob 12 and the electronic system device 20, the crenellated structure 72 of the digital sleeve 70 will move through the orifice 31, and the intensity of the light received by the photodetector 26b will change accordingly, such as Figure 7 As shown. The reflectivity of the digital sleeve 70 can be higher than that of the inner surface of the injection button 11, and therefore Figure 7 The highest strength level shown can correspond to the position where the amount of the crenellated structure 72 covering the orifice 31 reaches its maximum value.

[0114] During time period t3, the output of photodetector 26b will switch between high and low levels based on the received light intensity, such as... Figure 8 As shown. Since the edges of the bastion-like structure 72 correspond to the increments in the drug dosage, the processor unit 24 can determine the amount of drug delivered by the drug delivery device 1 based on the number of transitions between high and low levels in the output of the sensor arrangement 26.

[0115] The length of time period t3 will depend on the dose administered. Furthermore, the length of time period t3 can depend on the time it takes for drug delivery to complete. When drug delivery is complete, the digital sleeve 70 will stop rotating relative to the dosage knob 12 and the electronic system 20, and the signal from the sensor arrangement 26 will remain at a substantially constant level.

[0116] In some embodiments, processor unit 24 is arranged to monitor the time period elapsed since the last transition or last pulse in the output of interface 26. When the elapsed time period reaches a predefined threshold t4, drug delivery is considered complete, and processor unit 24 continues to determine the drug dosage delivered to the user based on the number of transitions detected in the output of sensor arrangement 26 during time period t3. Figure 7 and Figure 8 In the specific example shown, there are eight transitions. Since the transitions correspond to the edges of the crenellations, and in this specific embodiment, the edges of the crenellations correspond to dose increments, the determined dose is 8 units.

[0117] Processor unit 24 then stores the determined drug dosage in main memory 24.2. Processor unit 24 may also store timestamp information to provide a log recording the delivery of the drug to the user.

[0118] The processor unit 24 can then power off the electronic system 20 in order to save energy.

[0119] When the electronic system 20 is powered on again, for example when the user activates the power switch 28, the processor unit 24 can control the display to show the determined drug dosage information 22a to aid the user's memory. Optionally, the processor unit 24 can monitor the time elapsed since the determined drug dosage was delivered and control the display to also show that elapsed time information. For example, the processor unit 24 can cause the display 22 to periodically switch between displaying the determined drug dosage information 22a and displaying the elapsed time.

[0120] Processor unit 24 can also transmit the determined drug dosage and timestamp information (if determined) to another device, such as... Figure 9 The computer 40 is shown. As described above, the transmission unit 27 can be configured to transmit information using a wireless communication link. Alternatively, the electronic system 20 can be connected to the computer 40 using a wired connection 41 to allow information to be uploaded to the computer 40. The processor unit 24 can be configured to periodically transmit information to the computer 40.

[0121] The specific embodiments described in detail above are intended only as examples of how the invention can be implemented. Many variations in the configuration of the electronic system 20 and / or the drug delivery device 1 are conceivable.

[0122] For example, it is not necessary to provide shaping structures 71a, 71b, 71c on the digital sleeve 70. These shaping structures are not necessarily in the form of crenellated structures 72, nor are the widths of the crenellated structures and the gaps between them necessarily precisely corresponding to individual dose increments, as exemplarily described above.

[0123] While this document exemplarily describes interface 26 as an optical sensing arrangement 26, other types of sensors can also be used in conjunction with optical sensors, or other types of sensors can be used instead of optical sensors. For example, the interface may include a magnetic sensor, such as a Hall effect sensor. In such an example, one or more magnets may be mounted on a digital sleeve such that rotation of the digital sleeve relative to the electronic system results in a changing magnetic field. In another example, a capacitive sensor may be used, wherein elements disposed on the digital sleeve can affect the capacitance between two plates disposed in the electronic system. In other examples, mechanical sensors with mechanical switches and / or tracks may be used to detect relative movement.

[0124] In the foregoing, the injection button 11 is exemplarily described as including a central cavity 30 for receiving at least a portion of the electronic system 20. However, if the structure of the electronic system 20 does not require the central cavity 30, the central cavity may be omitted.

[0125] Although Figure 6 The arrangement shown includes a cooperative molding structure in the form of a locking portion 71a in the dosage knob 12 and a protrusion 73a in the housing 21 of the electronic system 20, but other types of cooperative molding structures or attachment methods may be used.

[0126] While the above embodiments have been described with respect to collecting data from an insulin syringe pen, it should be noted that embodiments of the invention can be used for other purposes, such as monitoring the injection of other medications.

[0127] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0128] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may 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 may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0129] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about 1 month to about 2 years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0130] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and the Merck Index (15th edition).

[0131] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0132] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0133] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0134] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and 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, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0135] Examples of oligonucleotides include, for example, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0136] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0137] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0138] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0139] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0140] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may contain a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and immunoglobulin single variable domains. Further examples of antigen-binding antibody fragments are known in the art.

[0141] The term "immunoglobulin single variable domain" (ISV) is used interchangeably with "single variable domain" and defines an immunoglobulin molecule in which an antigen-binding site is located on and formed by a single immunoglobulin domain. Therefore, an immunoglobulin single variable domain can specifically bind to an antigenic epitope without pairing with another immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Therefore, the antigen-binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0142] Immunoglobulin single variable domains (ISVs) can be heavy chain ISVs, such as VH (derived from conventional four-chain antibodies) or VHH (derived from heavy chain antibodies), including camelified VH or humanized VHH. For example, an immunoglobulin single variable domain can be a (single) domain antibody, a “dAb” or dAb or Nanobody® ISV (such as VHH, including humanized VHH or camelified VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx NV, Inc.]; other single variable domains, or any suitable fragment of any of them.

[0143] The “VHH domain,” also known as VHH, VHH antibody fragment, and VHH antibody, was initially described as a variable domain of a “heavy chain antibody” (i.e., “antibody lacking a light chain”; Hamers-Casterman et al. 1993 Nature 363: 446-448) antigen-binding immunoglobulin. The term “VHH domain” was chosen to distinguish these variable domains from the heavy chain variable domains (referred to herein as “VH domains”) present in conventional 4-chain antibodies and the light chain variable domains (referred herein as “VL domains”) present in conventional 4-chain antibodies. For a further description of VHH, see Muyldermans’ 2001 review article (Reviews in Molecular Biotechnology 74: 277-302).

[0144] For the terms “dAb” and “domain antibody”, see, for example, Ward et al. 1989 (Nature 341:544), Holt et al. 2003 (Trends Biotechnol. 21: 484); and WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of this invention because they are not of mammalian origin, single variable domains can be derived from certain shark species (e.g., the so-called “IgNAR domain,” see, for example, WO 2005 / 18629).

[0145] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0146] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0147] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0148] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0149] Example drug delivery devices may 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 categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0150] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0151] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0152] Any invention described herein is not limited to the description in conjunction with exemplary embodiments. Rather, the invention and the associated disclosure include any new features and any combination of features, particularly any combination of features in the patent claims, even if the features or combinations are not expressly stated in the patent claims or exemplary embodiments.

[0153] Figure Labels

[0154] 1. Drug delivery device

[0155] 10 housing

[0156] 11 Injection Button

[0157] 12 Dosage Knob

[0158] 13 windows

[0159] 14 Insulin Containers

[0160] 15 stitches

[0161] 16 Inner Pin Cap

[0162] 17 outer pin cap

[0163] 18 hats

[0164] 20 Electronic Systems

[0165] 21 Electronic System Housing

[0166] 22 monitors

[0167] 22a Dosage Information

[0168] 23 sensing units

[0169] 24 processor units

[0170] 24.1 Program Memory

[0171] 24.2 Main Memory

[0172] 25 positioning units

[0173] 25a Physically perceptible components

[0174] 25b Components that cannot be physically perceived

[0175] 26-interface

[0176] 26a light source

[0177] 26b photodetector

[0178] 27 teleportation units

[0179] 28 power switches

[0180] 29 batteries

[0181] 30 cavities

[0182] 31-hole

[0183] 40 computers

[0184] 50 external devices

[0185] 70 numbered sleeve

[0186] 71a Forming Structure

[0187] 71b Forming Structure

[0188] 71c forming structure

[0189] 72 crenellated structures

[0190] 73a protrusion

[0191] 74 orifices.

Claims

1. An electronic system (20) for measuring a parameter of a drug delivery device (1), the electronic system comprising: a sensing unit (23) configured to provide information on a maintenance of a spatial position of the electronic system; a positioning unit (25) for assisting a positioning of the electronic system; and a processor unit (24) operatively connected to the sensing unit and to the positioning unit, wherein the processor unit is configured to cause the positioning unit to switch to informing a user on a status of a position of the electronic system, when the information on the maintenance of the spatial position provided by the sensing unit fulfills a predefined criterion based on a comparison of the information provided by the sensing unit with the predefined criterion.

2. The electronic system (20) of claim 1, wherein The predefined criterion comprises an absence of information indicative of a predefined kinematic event for a predefined time.

3. The electronic system (20) according to any one of the preceding claims, wherein, The electronic system comprises an interface (26) configured to detect a movement of an external object relative to the electronic system, wherein the processor unit (24) is operatively connected to the interface, and wherein the predefined criterion comprises an absence of the information indicative of the predefined kinematic event for a predefined time after detecting the movement of the external object relative to the electronic system.

4. The electronic system (20) according to any one of the preceding claims, wherein, The electronic system comprises a transmission unit (27) configured to receive an external signal, wherein the processor unit (24) is operatively connected to the transmission unit (27), and wherein the predefined criterion comprises an absence of the information indicative of the predefined kinematic event for a predefined time after the transmission unit receives the external signal.

5. The electronic system (20) according to any one of the preceding claims, wherein, The sensing unit (23) comprises an inertial sensor.

6. The electronic system (20) according to any one of the preceding claims, wherein, The sensing unit (23) is configured to provide the information on the maintenance of the spatial position of the electronic system by measuring acceleration values and / or angular velocity values.

7. The electronic system (20) according to any one of the preceding claims, wherein, The sensing unit (23) comprises a vibration sensor, a pressure sensor and / or an acoustic sensor.

8. The electronic system (20) according to any one of the preceding claims, wherein, The electronic system comprises an electronic system housing (21), wherein the electronic system housing encloses the sensing unit (23), the positioning unit (25) and the processor unit (24), and wherein the sensing unit is configured to provide the information on the maintenance of the spatial position of the electronic system housing.

9. The electronic system (20) according to any one of the preceding claims, wherein, The positioning unit (25) is configured to be detectable visually, acoustically, haptically and / or electronically in informing the user on the status of the position of the electronic system.

10. The electronic system (20) according to any one of the preceding claims, wherein, The electronic system is a reusable add-on device (20) configured to be repeatedly detachably attachable to a drug delivery device (1).

11. The electronic system (20) of claim 10, wherein, The electronic system is configured to output a warning signal in case the electronic system is detached from the drug delivery device (1) and when a predefined time is exceeded after the electronic system is detached from the drug delivery device.

12. The electronic system (20) according to claim 10 or 11, wherein The electronic system includes an interface (26) configured to detect movement of a component of the drug delivery device (1) relative to the electronic system when the electronic system is attached to the drug delivery device, wherein the processor unit (24) is operatively connected to the interface, and wherein the predefined criteria include information indicating a predefined kinematic event that does not exist within a predefined time period following the detection of movement of a component of the drug delivery device relative to the electronic system.

13. The electronic system (20) according to any one of claims 10 to 12, wherein, The electronic system is configured to have a first state and a second state, wherein in the first state, the sensing unit (23), the processor unit (24), and the positioning unit (25) do not operate, and in the second state, the sensing unit, the processor unit, and the positioning unit operate, wherein the electronic system is configured such that when the electronic system is attached to the drug delivery device, the electronic system changes from the first state to the second state, and wherein when the electronic system is detached from the drug delivery device, the electronic system remains in the second state.

14. A drug delivery device (1) comprising an electronic system (20) according to any one of the preceding claims.

15. The drug delivery device (1) according to claim 14, wherein the drug delivery device is configured to contain a drug container (14) containing a drug, or includes a drug container (14) containing a drug.

16. A method for positioning an auxiliary electronic system (20), the method comprising the steps of: - Provide information on the maintenance of the electronic system's spatial position; - Compare the information regarding the maintenance of the spatial position of the electronic system with predefined criteria; - When the information regarding the maintenance of the spatial location meets the predefined criteria, the electronic system switches to a state where it notifies the user of the system's location.

17. A computer program product, such as a computer program or a computer-readable storage medium, the computer program product comprising instructions that, when executed by a processor, cause an electronic system (20) according to any one of claims 1 to 15 to perform the method according to claim 16.

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