Awakening electronics in injection device

JP2025186578APending Publication Date: 2025-12-23SANOFI SA(FR)
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
JP2025169840
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2019-07-01
Filing Date
2025-10-08
Publication Date
2025-12-23

AI Technical Summary

Benefits of technology

【0011】 本開示の1つまたはそれ以上の実施形態の詳細を、添付図面および本明細書で以下に記載する。本開示の他の構成および利点は、本明細書および図面、ならびに特許請求の範囲から明らかになろう。

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure 2025186578000001_ABST
    Figure 2025186578000001_ABST
Patent Text Reader

Abstract

To provide coupling mechanisms and systems configured for extending the life of electronically enabled injection devices by preventing idle drainage of the energy source.SOLUTION: An injection device (102) includes: an energy source (104) configured to power to an electronic system (105) of the injection device (102); one or more sensors (127a, 127b, 128b) in communication with the energy source (104), the one or more sensors (127a, 127b, 128b) configured to cause an activation signal to be provided to the energy source (104) to cause the energy source (104) to enter a powered state from a sleep state; and a processor (128a) configured to facilitate one or more functions of the injection device (102) when the injection device (102) is in the powered state.SELECTED DRAWING: Figure 1
Need to check novelty before this filing date? Find Prior Art

Description

[Technical Field]

[0001] The present disclosure is directed to waking up electronic devices, and more particularly to waking up electronic devices in injection devices. [Background technology]

[0002] Electronically enabled injection devices can assist users in safely administering medications and can also enable the transmission of treatment data to medical staff. Electronically enabled injection devices include electronic components configured to provide continuous active sensing and connectivity features, functions that require an energy supply. The energy supply can be a battery that powers the electrical components. The configuration of the electronically enabled injection device can limit the capacity of the energy supply, which affects the lifespan of the energy supply.

[0003] The lifespan of an electronically enabled injection device may be limited by the lifespan of its energy source. Some electronically enabled injection devices are stored for long periods of time before being used. Current configurations of electronically enabled injection devices lead to idle drainage of the energy source, which can result in the energy source's lifespan being depleted over long storage periods, even when the electronically enabled injection device is not in use. A low battery condition can lead to device failure or malfunction, an incorrect dose, a missing dose, or even render the electronically enabled injection device unusable by ceasing operation of electronic components. Summary of the Invention [Means for solving the problem]

[0004] Implementations of the present disclosure include coupling mechanisms and systems configured to extend the life of an electronically enabled injection device by preventing idle leakage of the energy source. According to one aspect of the invention, the injection device includes an energy source configured to power an electronic system of the injection device, one or more sensors in communication with the energy source, the one or more sensors configured to cause the energy source to provide a wake-up signal to transition the energy source from a sleep state to a powered state, and a processor configured to facilitate one or more functions of the injection device when the injection device is in the powered state. Implementations can include one or more of the following configurations. In some implementations, the one or more functions include dispensing a medication, determining an amount of medication in the injection device, determining an amount of medication dispensed by the injection device, or communicating with an external device.

[0005] In some implementations, the injection device further includes a cap including a magnet. The one or more sensors are magnetic sensors, and the activation signal is provided in response to a magnetic field strength measured by the one or more sensors falling below a predetermined threshold. In some implementations, the magnetic sensor is a reed switch or a Hall effect sensor. The magnet is located proximate to the one or more sensors when the cap is attached to the injection device.

[0006] In some implementations, the injection device further includes a cap including an electrostatic element. The one or more sensors include an electrode. The electrostatic element and the electrode are configured to contact when the cap is attached to the injection device. The electrostatic element is configured to generate an electrostatic discharge when the electrostatic element rubs against a portion of the injection device, and the electrode detects the electrostatic discharge. and in response thereto, causing the provision of an activation signal to the energy source.

[0007] In some implementations, the one or more sensors include a motion sensor configured to detect a particular motion of the injection device and, in response, cause the energy source to provide an activation signal, the particular motion being a rotation of the injection device.

[0008] In some implementations, the one or more sensors include a vibration sensor configured to detect a particular sound or vibration of the injection device and, in response, cause the energy source to provide an activation signal, the particular sound or vibration occurring during dialing of a dose of medication to be injected by the injection device.

[0009] In some implementations, the injection device is provided in a heat-resistant packaging that includes a temperature sensor configured to trigger provision of an activation signal to an energy source when the packaging is opened and the temperature sensor measures a temperature that meets a predetermined threshold.

[0010] It should be understood that systems according to the present disclosure can include any combination of aspects and configurations described herein, i.e., methods according to the present disclosure are not limited to the combinations of aspects and configurations specifically described herein, but also include any combination of aspects and configurations provided.

[0011] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the specification below. Other features and advantages of the disclosure will become apparent from the specification and drawings, and from the claims. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is an exploded view of an example device according to the present disclosure. [Figure 2] FIG. 1 is an exploded view of an example device according to the present disclosure. [Figure 3] FIG. 1 is an exploded view of an example device according to the present disclosure. [Figure 4]1 is a flowchart illustrating an exemplary process that may be performed to implement operations of the present disclosure. [Figure 5] FIG. 1 is a schematic diagram of an exemplary computer system that can be used to practice implementations of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] Like reference symbols in the various drawings indicate like elements.

[0014] Implementations of the present disclosure are generally directed to controlled activation of an energy source of an injection device to prevent idle leakage of the energy source. More particularly, implementations of the present disclosure are directed to a mechanism configured to receive a trigger signal and, in response to receiving the trigger signal, generate an instantiation signal for activating the energy source of the injection device to an electronic component.

[0015] In some injection devices, the energy source of the injection device may be activated in response to an erroneous trigger signal before the intended use of the injection device, resulting in idle leakage of the energy source. Thus, use of the electronic injection device may be hindered by idle leakage of the energy source. In some injection devices, the activation process of the injection device's energy source may take an extended period of time after the injection device is primed. A prolonged activation process may render the injection device impractical. As described in further detail herein, implementations of the present disclosure address these challenges. For example, according to some implementations, to prevent idle leakage of the energy source: The electronic injection device can be activated rapidly (e.g., within a few seconds) in response to signals generated by reactants that are isolated from each other until a trigger signal is initiated (e.g., during the priming step of drug administration).

[0016] 1-3 show exploded views of exemplary fluid delivery systems 100, 200, 300. With particular reference to FIG. 1, the exemplary fluid delivery system 100 can be configured to assist a user in injecting a fluid (e.g., a medication) and facilitate the sharing of medical data. The exemplary fluid delivery system 100 can include an injection device 102 and an external device 130. The injection device 102 can be an electronically enabled injection device configured to prevent idle leakage of the energy source 104. The injection device 102 can be a pre-filled, disposable injection pen or a reusable injection pen having a replaceable medication reservoir 106. The injection device 102 can be configured to communicate with the external device 130. The injection device 102 can transmit operational data (e.g., data related to the start time of use of the injection device 102, the temperature of the injection device 102 during use and storage, etc.) and corresponding treatment data (e.g., the amount of medication administered, the elapsed time over which the medication is administered by the injection device 102, etc.) to the external device 130. In some implementations, the injection device 102 can be associated with an identifier that is used by the external device 130 to uniquely identify the injection device 102 .

[0017] The injection device 102 may include a housing 110 and a needle assembly 115. The housing 110 may include an energy source 104, an electronic system 105, a drug reservoir 106, a stopper 107, a plunger rod 108, a plunger head 109, a priming component (e.g., a dose knob) 112, a dose window 114, and an injection button 120. The housing 110 may be molded from a medical-grade plastic material, such as a liquid crystal polymer.

[0018] The drug reservoir 106 can be configured to contain a fluid drug. The drug reservoir 106 can be a conventional, generally cylindrical, disposable container, such as a cartridge or syringe used to package prepared fluids, such as medications or anesthetics. The drug reservoir 106 can have a pair of ends, one end having a pierceable membrane that receives the inward end of a needle 113 in sealing engagement. A dose of the contained drug can be expelled from the injection device 102 by turning the dose knob 112, and the selected dose is then displayed through the dose window 114, for example, in multiples of so-called international units (IU), where 1 IU is the bioequivalent of approximately 45.5 micrograms (e.g., 1 / 22 mg) of pure crystalline drug. An example selected dose displayed in the dose window 114 can be, for example, 30 IU, as shown in FIG. 1 . In some implementations, the selected dose can be displayed in another form, for example, by an electronic display (e.g., the dose window 114 can take the form of an electronic display). Turning the dose knob 112 may cause a mechanical click to occur, providing audible feedback to the user. The numbers displayed in the dose window 114 may be printed on a sleeve contained in the housing 110 that mechanically interacts with the plunger head 109, which is secured to the end of the plunger rod 108 and presses against the stopper 107 of the medication reservoir 106.

[0019] The plunger head 109 (e.g., the rear end of the plunger rod 108) can be configured to expel a portion of the fluid by displacing a stopper 107 contained within the drug reservoir 106, the position of the stopper 107 being related to the amount of fluid in the injection device 102. The plunger rod 108 is attached to the plunger head 109, which is attached to the stopper 107.

[0020] The stopper 107 may be a flexible stopper, such as a rubber stopper, or a rigid stopper with a sealing component. The stopper 107 may have an outwardly protruding rim that matches the geometry and dimensions of the energy source 104. The stopper 107 may be long enough so that the stopper 107 does not tear or twist when engaged by the plunger head 109. The stopper 107 may be of sufficient volume to accommodate the detection system 103, which may include the energy source 104 and the electronic system 105, among other components described in more detail below.

[0021] The detection system 103 may include one or more sensors 127a, 127b. Similarly, the electronic system 105 (which may be, for example, part of the detection system 103) may include one or more sensors, such as sensor 128b. The sensors 127a, 127b, 128b may be configured and arranged to detect a characteristic that enables the energy source 104. In other words, one or more of the sensors 127a, 127b, 128b may be configured to wake the injection device 102 (e.g., from a deep sleep state in which no or little energy is consumed by the injection device 102). Each sensor 127a, 127b, 128b may be configured to be powered (e.g., with negligible power) such that it is sufficiently operable to cause the provision of a wake-up signal. In some implementations, the energy source 104 itself may provide a minimum amount of power that allows the sensors 127a, 127b, 128b to operate sufficiently. In some implementations, the sensors 127a, 127b, 128b may have separate power sources or may have their own power sources.

[0022] The type of one or more sensors 127a, 127b, 128b can be based on the particular mechanism employed to detect a particular characteristic indicative of waking the injection device 102. For example, if a magnetic system is employed to wake the injection device 102, one or more of the sensors 127a, 127b, 128b can be a magnetic sensor; if an optical detection system is employed to wake the injection device 102, one or more of the sensors 127a, 127b, 128b can be an optical sensor (e.g., a photodiode or a light-dependent resistor); if multiple detection systems are employed, each capable of waking the injection device 102, multiple types of sensors may be provided.

[0023] Any combination of detection system functions is possible. However, for purposes of illustration, implementations including particular ones of sensors 127a, 127b, 128b will be described with respect to particular systems and / or implementations, and each possible system for detecting a characteristic that wakes up the injection device 102 will be described individually in turn. However, it should be understood that multiple systems may be incorporated into the detection system 103 for waking up the injection device 102 in response to multiple different stimuli, and that multiple and / or different sensors may be employed to achieve the functions described herein. For example, while a particular wake-up technique may be described with respect to sensor 128b, a similar wake-up technique could just as easily be implemented using sensors 127a and / or 127b.

[0024] The detection system 103 may be configured to generate a wake-up signal (e.g., a signal to wake up, power on, or increase power consumption from a sleep / deep sleep state to a power-on state) based on a signal provided by one or more of the sensors 127a, 127b, 128b, and send the signal to the energy source 104 (e.g., directly or indirectly) to cause the electronic system 105 to wake up.

[0025] The energy source 104 can be a disposable or rechargeable battery, such as a 1.5V to 5V silver oxide or lithium battery (e.g., SR626, SR516, SR416) or a supercapacitor. In some implementations, the energy source 104 can include multiple batteries (e.g., two 1.5V batteries). The energy source 104 can be configured to provide energy to the electronic system 105 under certain conditions, such as after receiving a wake-up signal from the detection system 103.

[0026] The electronic system 105 may include one or more electronic components configured to perform and / or assist one or more functions of the injection device 102 (e.g., ejection of medication) when coupled with the energy source 104. For example, the electronic system 105 may include one or more processors 128a, sensors 128b (e.g., as described above and in more detail below), antennas 128c, and motors 128d. The motors 128d may be configured to advance in microstep increments to dispense a specific amount of medication. In some implementations, the sensors 128b may provide a signal (e.g., a voltage) to the one or more processors 128a that is proportional to the amount of medication dispensed or the amount of medication remaining in the medication reservoir 106. Such functionality may be provided in addition to a “wake-up” functionality, described in more detail herein. On the other hand, in some implementations, the electronic system 105 may include multiple sensors, each configured to provide a specific function (e.g., facilitate waking up the energy source 104, facilitate other functions of the injection device 102, etc.).

[0027] The one or more processors 128a can include a microprocessor. In some implementations, the microprocessor is a microcontroller, e.g., a combination of a microprocessor component and other components formed in a single package. The microprocessor can be an arithmetic and / or logic unit array. The one or more processors 128a can process one or more signals received from other electronic components of the electronic system 105 (or from other sensors 127a, 127b) and transmit the signals to the antenna 128c. For example, the one or more processors 128a can be configured to perform processing on the received data to generate output data. The one or more processors 128a can be configured to determine the amount of fluid in the injection device 102 based at least in part on the electrical signals and transmit data including information related to the amount of fluid to the antenna 128c, which can transmit the data to the external device 130.

[0028] The antenna 128c may be a Bluetooth or near field communication (NFC) antenna. The antenna 128c may be configured to transmit signals to one or more of the processor 128a and the external device 130. The signals transmitted by the antenna 128c may include the amount of fluid in the medication reservoir 106, a value measured by the sensor 128b, and an identifier of the injection device 102. The communication field 134 may be a Bluetooth field or an NFC field generated by the external device 130. The external device 130 may include a Bluetooth or RF module, a transmitter, a receiver, and an external processor 132. The external processor 132 may be configured to process data transmitted by the injection device 102. The external device 130 may be configured to display (e.g., via a graphical user interface) data received from the injection device 102 and processed by the external processor 132.

[0029] The needle assembly 115 includes a needle 113 that can be attached to the housing 110. The needle 113 is secured by an inner needle cap 116 and an outer needle cap 117. The outer needle cap 117 may be covered by a cap 118. When the needle 113 is inserted into the skin area of ​​a patient and the injection button 120 is then pressed, the drug dose displayed in the dose window 114 may be expelled from the injection device 102. If the needle 113 of the injection device 102 remains in the skin area for a certain period of time after the injection button 120 is pressed, a high percentage (e.g., greater than 90%) of the dose is actually injected into the patient's body. The expulsion of the drug dose may produce a mechanical clicking sound, which may be different from the sound produced when using the dose knob 112.

[0030] The injection device 102 can be used for several injection processes until the drug reservoir 106 is emptied or the expiration date of the injection device 102 is reached (e.g., 28 days after first use). Before using the injection device 102 for the first time, a priming operation may be required to couple the energy source 104 to the electrical components and / or remove air from the drug reservoir 106 and needle 113. For example, the priming operation may include selecting two units of a drug and pressing the injection button 120 while holding the injection device 102 with the needle 113 pointing up. In some implementations, an impulse generated by selecting two units of a drug or pressing the injection button 120 may trigger electrical coupling between the energy source 104 and the electronic system 105 by mechanical means (e.g., a mechanical switch).

[0031] In some implementations, the electronic components of the electronic system 105 can be incorporated into the housing 110 in a single location or in multiple locations (e.g., within the plunger rod 108 or attached to the plunger rod 108 and in a cavity in the plunger head 109). In some implementations, one or more components of the electronic system 105 can be included in the stopper 107. In some implementations, one or more components of the electronic system 105 can be included in the plunger head 109.

[0032] In some implementations, the location of the energy source 104 and / or the location of one or more electronic components of the electronic system 105 can be selected independently of the coupling of the electronic system 105 to the energy source 104. In some implementations, one or more characteristics of one or more electronic components of the electronic system 105 and / or one or more characteristics of the energy source 104 can be selected to couple and / or decouple the electronic system 105 to and / or from the energy source 104.

[0033] In some implementations, the housing 110 of the injection device 102 can be configured to be separated or divided into multiple segments to provide user access to the energy source 104 and allow for separate disposal of the energy source 104. In some implementations, the drug reservoir 106 to be assembled with the injection device 102 is manufactured with an inserted stopper 107, filled with a fluid drug, and closed with a crimp seal.

[0034] During manufacture and storage of the drug reservoir 106 prior to assembly with the injection device 102, the energy source 104 is not activated (or is in a sleep or deep sleep state, for example). By keeping the energy source 104 deactivated, there is no idle leakage of energy during manufacture and possible long-term storage of the drug reservoir 106. During a subsequent step of device priming (or any other action described herein), the energy source 104 of the injection device 102 is activated (or is, for example, woken up) to power the electronic system 105. In some implementations, the energy source 104 can be connected to the electronic system 105 to enable control of functions of the injection device 102 upon receiving an activation signal. In some implementations, the energy source 104: To ensure proper operation of the injection device 102 and the electronic system 105, they may be temporarily woken up during assembly. Connection to the energy source 104 as a manufacturing process allows the electronic system 105 to wake up and generate a feedback signal that confirms proper system function. After performing such in-process control, the energy source 104 may be disconnected again, or the electronic system 105 may be set to sleep mode by an appropriate software function that reduces energy consumption until a priming step is performed to wake up the electronic system 105, or until some other action occurs.

[0035] In some implementations, one or more of sensors 127a, 127b, 128b may be magnetic sensors. For example, with continued reference to FIG. 1 , sensor 127b may be a magnetic sensor configured to sense a magnetic field and provide a signal corresponding to the sensed magnetic field. Magnetic sensor 127b is in communication with energy source 104. Thus, magnetic sensor 127b may provide a wake-up signal that wakes energy source 104, as described herein. For example, when a magnetic threshold is met (e.g., when the sensed magnetic field strength is below a threshold magnetic value), magnetic sensor 127b may provide a signal that triggers generation of the wake-up signal. In some implementations, magnetic sensor 127b includes one or both of a reed switch or a Hall-effect sensor.

[0036] In an exemplary implementation, a magnet 130 may be provided on / in the cap 118 of the injection device 102. The magnet 130 may be embedded in the cap 118 in a position such that the magnet 130 is in close proximity to the magnetic sensor 127b when the cap 118 is in a closed position (e.g., when the cap 118 mostly covers the drug reservoir 106). When the cap 118 is in the closed position, the magnetic field generated by the magnet 130 is sufficient to cause the magnetic sensor 127b to refrain from issuing an activation signal. In other words, when the cap 118 is closed over the injection device 102, a predetermined magnetic threshold is met. When the cap 118 is removed from the injection device, the magnet 130 moves away from the magnetic sensor 127b, such that the magnetic field sensed by the magnetic sensor 127b no longer meets the magnetic threshold, and the magnetic sensor 127b provides an activation signal to the energy source 104. Additionally, the energy source 104 is instructed to wake up (eg, by electronics incorporated into the energy source 104 that are programmed to wake up in response to such a wake-up signal).

[0037] In some implementations, the magnet 130 and / or the magnetic sensor 127b may be located elsewhere. For example, the magnet 130 may be located where a detachable component of the injection device 102 is present. Such a detachable component may be configured to be removed upon first use of the injection device 102. Thus, a wake-up signal may be provided when the detachable component is removed prior to first use of the injection device 102, thereby preventing the injection device 102 from waking up prematurely (e.g., before energy consumption is required for use). In some implementations, the magnet 130 may be integrated into the inner needle cap 116 and / or the outer needle cap 117, among other locations. In some implementations, the magnet may be located within the packaging of the injection device 102. When the injection device 102 is removed from the packaging, the magnetic threshold is no longer met and the magnetic sensor 127b provides a wake-up signal.

[0038] In some implementations, removal of the cap 118 of the injection device 102 may wake the energy source 104 by other means (e.g., other than receiving a wake-up signal from the magnetic sensor 127b). In some implementations, detection of an electrostatic discharge may wake the energy source 104. FIG. 2 illustrates a configuration of the medication injection system 200. In another example, the injection device 102 includes a cap 218, which includes a component for generating an electrostatic discharge upon interaction with another component of the injection device 102. In particular, the cap 218 includes an electrostatic element 202 located on an inner surface around the periphery of an opening in the cap 218. The electrostatic element 202 is configured to interface with one of the sensors, for example, the sensor 127a of the detection system 103. The sensor 127a may be or include an electrode. The sensor 127a may be suitable for such purpose because it may be exposed through the stopper 107 as shown in FIG. 1 (e.g., a surface of the electrode 127a may be exposed such that the electrode 127a can contact the electrostatic element 202). The electrostatic element 202 may include a metallic material configured to generate an electrostatic discharge when it is rubbed against the electrode 127a. In some implementations, the electrostatic element 202 is configured to generate an electrostatic discharge when it is rubbed against another portion of the injection device 102, and the electrode 127a is configured to detect such an electrostatic discharge. Similarly, in some implementations, the electrode 127a may optionally include a material configured to generate such an electrostatic discharge and may also include functionality for triggering the provision of an activation signal to the energy source 104 when an electrostatic discharge is detected. Such an activation signal may function similarly to the activation signal described above with respect to the magnetic sensor 127b. When the cap 218 is removed from its closed position, the electrostatic element 202 rubs against the electrode 127a, generating an electrostatic discharge. The electrode 127a then instructs the energy source 104a to wake up.

[0039] In some implementations, removal of the cap 118, 218 may also wake the energy source 104 by other means. For example, the force / movement / acceleration required to remove the cap 118, 218 may trigger a wake-up of the energy source 104. In some implementations, one of the sensors (e.g., sensor 128b) may be a motion sensor 128b including one or more accelerometers and / or one or more gyroscopes. The motion sensor 128b is configured to operate in a very low power mode (e.g., standby mode). The motion sensor 128b may be configured to detect a force inherently exerted upon removal of the cap 118, 218. For example, a tactile “click” sensation is generated when the cap 118, 218 is removed. Such a click can be detected by the motion sensor 128b, which may provide a wake-up signal to the energy source 104.

[0040] In some implementations, the motion detected by the motion sensor 128b must sufficiently match a particular profile (e.g., a cap removal profile) for the motion sensor 128b to provide a wake-up signal to the energy source 104. Such a requirement can prevent the energy source 104 from waking up accidentally during transportation, shipping, and / or simple movement of the injection device 102. In some implementations, the profile for cap removal can be predetermined (e.g., by testing, calibration, etc.). A motion profile that matches the “click” generated by cap removal can be identified, and the energy source 104 can be woken up in response thereto.

[0041] In some implementations, the energy source 104 may be woken in response to a particular characteristic movement of the injection device 102. That is, wake-up may be triggered by a special movement made by a patient when using the pen for the first time. In some examples, such movements may include, for example, opening the injection device 102 from the manufacturer's packaging, removing the injection device 102 from a boxed package, priming the injection device 102, and / or dialing the injection device 102 to receive a particular dose of medication. Such movements of the injection device 102 may include, for example, A particular motion profile may be accommodated, and when the injection device 102 performs such motion, the motion sensor 128b may cause the provision of a wake-up signal to the energy source 104. In some implementations, the particular motion is selected such that it is not a motion that occurs before the intended activation of the injection device 102. For example, the particular motion may be sufficiently complex so that the injection device 102 is not accidentally woken up during shipping or unloading.

[0042] In some implementations, the particular movement may include rotation of the injection device 102. For example, the user may be instructed to rotate the injection device 360 ​​degrees axially or 360 degrees along the length of the injection device. Such movement may be difficult to perform during shipping of the injection device 102. The movement sensor 128b may detect such movement and cause the energy source 104 to provide an activation signal.

[0043] As mentioned above, the sensors 127a, 127b, 128b may be configured to receive a minimum power that allows them to operate sufficiently to detect a wake-up event. However, such power is minimal and does not result in excessive power dissipation. The power may be from the energy source 104 in a deep sleep state, but in some implementations, the sensors 127a, 127b, 128b may have a separate power source or their own power source.

[0044] In some implementations, the motion sensor may be located elsewhere to detect removal of the cap 118, 218. For example, the motion sensor may be located in the housing 110 of the injection device 102, the cap 118, 218, etc.

[0045] In some implementations, one of the sensors (e.g., sensor 127a) can be an acoustic sensor (e.g., a microphone) configured to detect a particular characteristic sound emanating from the injection device 102. For example, a particular noise produced by the priming or dialing process can be detected by acoustic sensor 127a, and in response, acoustic sensor 127a can trigger the provision of an activation signal to the energy source 104. In some implementations, the “click” sound generated when a dose is dialed into the injection device 102 can have a particular signature that is detected by acoustic sensor 127a. In some implementations, acoustic sensor 127a can alternatively be a vibration sensor configured to detect vibrations that occur during dose dialing or priming, and the vibration sensor can trigger the provision of an activation signal to the energy source 104 in response to detecting a matching vibration profile. In some implementations, acoustic sensor 127a and / or the vibration sensor can be a MEMS-based piezoelectric element used to provide the minimum power required for the sensor to trigger the generation of the activation signal.

[0046] In some implementations, one of the sensors (e.g., sensor 127a) can be an optical sensor such as photodiode 127a. Sensor 127a may be suitable for photodiode 127a because it may be exposed (e.g., a gap or window in stopper 107 may allow light to pass through to photodiode 127a). Before use, injection device 102 is covered by cap 118, 218. Cap 118, 218 prevents light from reaching photodiode 127a. When cap 118, 218 is removed, light typically reaches photodiode 127a. If the light meets a threshold (e.g., a relatively low threshold because photodiode 127a is normally pitch black), photodiode 127a may provide a signal to energy source 104 to wake it from its sleep state.

[0047] Photodiode 127a receives light directly (e.g., through a gap or window). While described as such, in some implementations the light may be embedded in the stopper 107, and the light may be of a wavelength that can pass through the (e.g., rubber) stopper 107. In other words, the light may have properties that prevent it from passing through the cap 118, 218 but can pass through the rubber stopper 107. In this way, the presence of the cap 118, 218 may prevent the energy source 104 from waking up, but removing the cap 118, 218 and exposing the stopper 107 to light may wake up the energy source 104. In some implementations, the light may be specifically designed to wake the injection device 102. For example, the light may meet the rubber transmission spectrum (e.g., the infrared spectrum), and a special device may be used to apply such light to the injection device 102.

[0048] As briefly mentioned above, in some implementations, the injection device 102 may include packaging configured to assist in the wake-up function of the energy source 104. FIG. 3 shows another example of a fluid delivery system 300 including the injection device 102 and packaging 302 configured to house the injection device 102. The packaging 302 may have a cutout sized and shaped to accommodate the injection device 102 so that the injection device 102 can fit (e.g., snugly) within the packaging 302. The packaging 302 may include wrapping (e.g., paper, plastic, etc.) that must be removed before the package 302 can be opened and the injection device 102 can be removed. In some implementations, the package 302 and / or wrapping may be formed from a material that is resistant to temperature changes. For example, the package 302 may maintain an internal temperature below approximately 7°C. When the package 302 is closed and the wrapping is in place, the injection device 102 may maintain a temperature below 7°C. The use of sufficient insulation in the packaging 302 can prevent the device from accidentally rising to a temperature above 7° C. during transport and prior to the device's intended first use.

[0049] The packaging 302 may include a temperature sensor 312 configured to sense the temperature within the packaging 302 and ensure that the injection device 102 is maintained at a temperature below 7°C. If the temperature rises above 7°C (e.g., when the packaging 302 is opened and the injection device 102 is removed from the packaging 302), the injection device 102 may be configured to wake up (e.g., the temperature sensor 312 is configured to cause the energy source 104 to provide a wake-up signal, thereby waking the injection device 102 from its sleep state). In some implementations, the temperature sensor 302 may be configured to wirelessly communicate with the injection device 102 to enable the temperature sensor 302 to instruct it to generate the wake-up signal. In some implementations, the temperature sensor 302 may be incorporated into the injection device 102 itself (e.g., as one of sensors 127a, 127b, 128b). In this way, the temperature sensor 302 does not need to emit a signal to the energy source 104, but rather the sensors 127a, 127b, 128b can simply provide a direct signal (e.g., via a wired connection) to cause the energy source to receive an activation signal.

[0050] Although various possible techniques for waking the injection device 102 have been described, other techniques are possible. In some implementations, the injection device may include a docking station configured to allow the injection device to be mounted in an upright position. Initial placement of the injection device 102 in the mounting station may trigger the provision of a wake-up signal to the energy source 104. In some implementations, the docking station may also include a detection system 103 and / or an electronic system 105 of the injection device 102, as well as connectivity to a home WiFi network. In some implementations, capacitive means, NFC, a magnetic switch, or other techniques may be implemented to wake the energy source 104, and such interaction may involve two This is easy to implement because multiple devices are allowed to interact.

[0051] In some implementations, a pull tab may be located near the energy source 104, and when in place, prevents full power from flowing through the injection device 102. Prior to first use, the user removes the pull tab, thereby waking the injection device from its sleep state and enabling full functionality.

[0052] In some implementations, a manual switch may be provided on the injection device 102. Before first use, the user can press / flip the switch, which provides a wake-up signal to the energy source 104 and wakes the device from its sleep state. In some implementations, the switch may be a touch button (e.g., a capacitive touch button).

[0053] In some implementations, a separate device (e.g., external device 130 of FIG. 1 ) can be used to wake the energy source 104 from its sleep state. For example, the external device 130 can be a smartphone or tablet that the patient can interact with to wake the injection device 102. The external device can communicate with the injection device via antenna 128c (e.g., via a short-range wireless protocol such as WiFi, NFC, RFID, etc.). In particular, the external device 130 may form a connection with the injection device 102, a user can interact with the external device 130 to instruct the external device 130 to wake the injection device, the external device 130 can provide a wake-up signal to the injection device 102, and the user can then use the injection device for the first time.

[0054] 4 is a flowchart illustrating an exemplary process 400 that may be performed by the devices and systems described with reference to FIGS. 1-3. An instantiation signal is generated (402) by one or more of the techniques described herein. Using a magnetic implementation as an example, a cap with a magnet is removed, causing the magnetic field sensed by the magnetic sensor to fall below a predetermined threshold. Using a light-induced wake-up example, the cap may be removed from the injection device, and a photodiode may be exposed to light. Using an electrostatic discharge example, the cap may be removed from the injection device, and an electrode may sense an electrostatic discharge (e.g., caused in part by the electrode). Using a motion sensor cap removal detection example, a signature that the cap has been removed from the injection device may match a predetermined signature indicative of cap removal.

[0055] The instantiation signal is detected 404 by a detection system including one or more sensors. In some implementations, detecting the instantiation signal can include determining a difference between measurements of two sensors. In some implementations, multiple measurements from multiple sensors combined can be detected.

[0056] It is determined whether the instantiation signal meets one or more requirements (406). In some implementations, the instantiation signal (e.g., measurements from one or more sensors) is compared to a threshold, which may or may not be met. In some implementations, a signature (e.g., readings from a motion or vibration sensor) is compared to a predetermined motion signature or sound / vibration signature. If the comparison indicates that the measurements meet an activation threshold or match a particular signature, process 400 proceeds to the next step (408). If the requirements are not met, process 400 returns to detecting the instantiation signal step (404), and process 400 waits for the generation of another signal from one or more sensors.

[0057] If the comparison indicates that the signal satisfies the requirement, a wake-up signal is generated by the detection system, causing the electronic system to wake up and power (408) the injection device (or wake from, for example, a sleep or deep sleep state). In some implementations, the energy source can be coupled to the electronic component by a mechanism (e.g., a gear mechanism). In some implementations, the mechanism can include one or more components (e.g., plunger rod 108, plunger head 109 described with reference to FIGS. 1-3 ) configured to shift the energy source from one position in which the energy source is electrically decoupled from the electronic component to a second position in which the energy source is electrically coupled to the electronic component. In some implementations, the mechanism can include a switch (e.g., an electronic switch, a relay, a software switch, etc.) configured to be activated to electrically couple the energy source to the electronic component.

[0058] In response to coupling of the energy source to the electronic component, an electrical signal is optionally generated (410). The electrical signal may be generated to assist and / or perform the operation of the injection device (e.g., to control administration of the medication) and / or to measure one or more parameters associated with the injection device (e.g., the amount of medication, the temperature, etc.). The electrical signal may include generating injection device data. The injection device data may include a unique identifier for the injection device, the amount of medication administered, the amount of medication in the cartridge and / or injection device, the medication temperature, a timestamp of coupling the energy source to the electronic component, the location, and / or context-specific data about the injection device. Such a step is optional in the sense that it need not occur immediately, but may occur at a later point in time, after activation.

[0059] FIG. 5 shows a schematic diagram of an exemplary computing system 500. The system 500 can be used for the operations described in connection with the implementations described herein. For example, the system 500 can be included in any or all of the server components discussed herein. The system 500 includes a processor 510, a memory 520, a storage device 530, and an input / output device 540. The components 510, 520, 530, and 540 are interconnected using a system bus 550. The processor 510 can process instructions for execution within the system 500. In one implementation, the processor 510 is a single-threaded processor. In another implementation, the processor 510 is a multi-threaded processor. The processor 510 can process instructions stored in the memory 520 or the storage device 530 to display graphical information for a user interface on the input / output device 540.

[0060] The memory 520 stores information within the system 500. In one implementation, the memory 520 is a computer-readable medium. In one implementation, the memory 520 is a volatile memory unit. In another implementation, the memory 520 is a non-volatile memory unit. The storage device 530 can provide mass storage for the system 500. In one implementation, the storage device 530 is a computer-readable medium. In various different implementations, the storage device 530 can be a floppy disk device, a hard disk device, an optical disk device, or a tape device. The input / output device 540 provides input / output operations for the system 500. In one implementation, the input / output device 540 includes a keyboard and / or a pointing device. In another implementation, the input / output device 540 includes a display unit for displaying a graphical user interface that allows a user to access data related to items collected, stored, and queried as described with reference to FIGS. 1-5 .

[0061] The functions described above can be implemented in digital electronic circuitry, computer hardware, firmware, software, or combinations thereof. An apparatus can be implemented in a computer program product tangibly embodied in an information carrier, such as a machine-readable storage device, for execution by a programmable processor; method steps can be implemented by the programmable processor executing a program of instructions to perform the functions of the implementations described above by manipulating input data and generating output. The functions described above can advantageously be implemented in one or more computer programs executable on a programmable system including at least one programmable processor coupled to receive data and instructions from, and transmit data and instructions to, a data storage system, at least one input device, and at least one output device. A computer program is a set of instructions that can be used directly or indirectly by a computer to perform a particular activity or bring about a particular result. Computer programs can be written in any form of programming language, including compiled or interpreted languages, and can be deployed in any form, such as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

[0062] Processors suitable for executing a program of instructions include, by way of example, both general-purpose and special-purpose microprocessors, and the sole processor or one of multiple processors of any kind of computer. Typically, a processor receives instructions and data from a read-only memory or a random-access memory, or both. The essential elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Typically, a computer also includes, or is operatively coupled to communicate with, one or more mass storage devices for storing data files; such devices include magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including, by way of example, semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and memory may be supplemented by, or incorporated in, application-specific integrated circuits (ASICs).

[0063] To enable interaction with a user, the functionality may be implemented in a computer that has a display device, such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, for displaying information to the user, and a keyboard and pointing device, e.g., a mouse or trackball, that allows the user to provide input to the computer.

[0064] The functionality may be implemented in a computer system that includes back-end components such as data servers, middleware components such as application servers or Internet servers, or front-end components such as client computers with graphical user interfaces or Internet browsers, or any combination thereof. The components of the system may be connected by any form or medium of digital data communication, such as a communications network. Examples of communications networks include, for example, LANs, WANs, and the computers and networks forming the Internet.

[0065] The computer system may include clients and servers. A client and server are generally remote from each other and typically interact through a network, such as that described above. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0066] Furthermore, the logic flows depicted in the figures do not require the particular order or sequence shown to achieve desirable results. Furthermore, other steps may be provided or steps may be eliminated from the flows described above, and other components may be added to or removed from the systems described above. Accordingly, other implementations are within the scope of the following claims.

[0067] The terms "drug" or "pharmaceutical agent" are used herein to describe one or more pharmaceutically active compounds. As described below, a drug or pharmaceutical agent may comprise at least one small molecule or macromolecule, or a combination thereof, in various types of formulations for the treatment of one or more diseases. Exemplary pharmaceutically active compounds may include small molecules, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double- or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, e.g., 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 of these drugs are also contemplated.

[0068] The term "drug delivery device" is intended to include any type of device or system configured to administer a volume of a drug to a human or animal body. The volume can typically range from about 0.5 ml to about 10 ml. Drug delivery devices may include, but are not limited to, syringes, needle-safe systems, pen injectors, auto-injectors, large volume devices (LVDs), pumps, perfusion systems, or other devices configured for subcutaneous, intramuscular, or intravascular delivery of drugs. Such devices often include a needle, which may include a small gauge needle (e.g., larger than about 24 gauge, including 27, 29, or 31 gauge).

[0069] In combination with a particular drug, the devices described herein can also be customized to operate within required parameters, for example, within a particular time period (e.g., about 3 to about 20 seconds for a syringe, about 5 to about 60 minutes for an LVD), with low or minimal discomfort levels, or within specific conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations can arise due to a variety of factors, for example, drugs with viscosities ranging from about 3 cP to about 50 cP.

[0070] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharmaceutically active compounds. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -3°C to about 3°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of the drug or agent prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0071] The drug delivery devices and drugs described in the present invention can be used for the treatment and / or prevention of many different types of disorders. Exemplary disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0072] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or a mixture of any of them. As used herein, the term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to have substantially the same functionality or activity (e.g., therapeutic effect).

[0073] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the 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.

[0074] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; 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. Exemplary GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide / AVE0010 / ZP10 / Lyxumia, exenatide / exendin-4 / Byetta / Bidurion / ITCA650 / AC-2993 (a 39 amino acid peptide produced by the salivary glands of the Japanese giant lemur), liraglutide / Victoza, semaglutide, taspoglutide, synclear / albiglutide, dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, via These are Dol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0075] An exemplary oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen / quinamro for the treatment of familial hypercholesterolemia.

[0076] Exemplary DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0077] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0078] Exemplary polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 / Synvisc, sodium hyaluronate.

[0079] The term "antibody," as used herein, refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region.

[0080] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0081] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0082] Exemplary antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0083] The compounds described herein can be used in pharmaceutical formulations comprising (a) the compound or a pharmaceutically acceptable salt thereof, and (b) a pharmaceutically acceptable carrier. The compounds can also be used in pharmaceutical formulations containing one or more other active pharmaceutical ingredients, or in pharmaceutical formulations in which the compound or a pharmaceutically acceptable salt thereof is the only active ingredient. Thus, the pharmaceutical formulations of the present disclosure encompass any formulation made by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0084] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in the drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, salts having a cation selected from alkali or alkaline earth metals, such as Na, K, or Ca, or ammonium ions N(R)(R)(R)(R), where R to R are independently hydrogen, an optionally substituted C-C alkyl group, an optionally substituted C-C alkenyl group, an optionally substituted C-C aryl group, or an optionally substituted C-C heteroaryl group. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0085] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0086] Although numerous implementations of the present disclosure have been described, it will be understood that various modifications can be made without departing from the spirit and scope of the present disclosure. Accordingly, other implementations are within the scope of the following claims.

Claims

1. An injection device (102) comprising: an energy source (104) configured to power an electronic system (105) of the injection device (102); one or more sensors (127a, 127b, 128b) in communication with the energy source (104), the one or more sensors (127a, 127b, 128b) configured to cause the energy source (104) to provide a wake-up signal to transition the energy source (104) from a sleep state to a powered state; a processor (128a) configured to facilitate one or more functions of the injection device (102) when the injection device (102) is in a powered state; The injection device comprising:

2. 10. The injection device (102) of claim 1, further comprising a cap (118) including a magnet (130), wherein the one or more sensors (127a, 127b, 128b) are magnetic sensors (127b).

3. 3. An injection device (102) according to claim 1 or 2, wherein the activation signal is provided in response to the magnetic field strength measured by one or more sensors (127a, 127b, 128b) falling below a predetermined threshold.

4. An injection device (102) according to any one of claims 1 to 3, wherein the one or more sensors (127a, 127b, 128b) comprise a reed switch or a Hall effect sensor.

5. An injection device (102) according to any one of claims 2 to 4, wherein the magnet (130) is located in proximity to one or more sensors (127a, 127b, 128b) when the cap (118) is attached to the injection device (102).

6. 2. The injection device (102) of claim 1, further comprising a cap (218) including an electrostatic element (202), wherein the one or more sensors (127a, 127b, 128b) include an electrode (127a).

7. 7. An injection device (102) according to claim 6, wherein the electrostatic element (202) and the electrode (127a) are configured to come into contact when the cap (218) is attached to the injection device (102).

8. 8. The injection device (102) of claim 6 or 7, wherein the electrostatic element (202) is configured to generate an electrostatic discharge when the electrostatic element (202) rubs against a part of the injection device (102), and the electrode (127a) is configured to detect the electrostatic discharge and in response thereto cause the provision of an activation signal to the energy source (104).

9. 10. The injection device (102) of claim 1, wherein the one or more sensors (127a, 127b, 128b) include a motion sensor (128b).

10. 10. The injection device (102) of claim 9, wherein the motion sensor is configured to detect a specific motion of the injection device (102) and, in response thereto, cause the provision of an activation signal to the energy source (104).

11. 11. The injection device of claim 10, wherein the specific movement is a rotation of the injection device (102). S (102).

12. 2. The injection device (102) of claim 1, wherein the one or more sensors (127a, 127b, 128b) include a vibration sensor (128b).

13. 14. The injection device (102) of claim 13, wherein the vibration sensor is configured to detect a specific sound or vibration of the injection device (102) and in response cause the provision of an activation signal to the energy source (104), the specific sound or vibration occurring during dialing of a dose of medication to be injected by the injection device (102).

14. 10. The injection device of claim 1, provided in a heat-resistant packaging including a temperature sensor configured to trigger provision of an activation signal to an energy source when the packaging is opened and the temperature sensor measures a temperature that meets a predetermined threshold.

15. 10. The injection device (102) of claim 1, wherein the one or more functions include dispensing a medication, determining an amount of medication in the injection device (102), determining an amount of medication to be dispensed by the injection device (102), or communicating with an external device (130).