Wireless communication-enabled drug delivery device and method

Abstract

The present disclosure describes a drug delivery device with communication capabilities, the purpose of which is to transmit information to a user device such as a smart phone while maintaining energy-saving operation. The drug delivery device includes a controller, which is configured to: when operating in an active mode, use one or more sensors to detect that an injection mechanism has performed an injection. The controller is also configured to: generate a data entry in a memory indicating the injection and / or the status of the drug delivery device, and switch to the low power mode after or simultaneously with detecting that the injection mechanism has performed the injection. The drug delivery device also includes a wireless communication module powered by a power supply, which is configured to establish a wireless connection with the user device and transmit messages to the user device when the controller is operating in the low power mode.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 864,014, filed on June 20, 2019, the entire disclosure of which is hereby incorporated by reference herein. Technical Field

[0003] The present disclosure relates generally to drug delivery devices, including those used to administer subcutaneous injections, and more particularly to drug delivery devices having wireless communication capabilities. Background Art

[0004] Drugs can be administered by using drug delivery devices such as automatic injectors and on-body injectors. These devices can replace traditional delivery devices, such as traditional injectors. Automatic injectors and on-body injectors can be used to automate the injection process, thereby simplifying the patient's handling, and in some cases self-administration can be selected. Some automatic drug delivery devices include sensors and other electronic devices used for monitoring devices. The information collected by this sensor can be wirelessly transmitted to external devices such as smart phones, so that the information can be displayed to the user, stored in a memory, or can be used by health care providers such as physicians. It may take some time to establish a wireless connection between a drug delivery device and an external device, especially when these devices are not initially within the range of each other. The time spent by the drug delivery device to search for an external device may put forward a large amount of power requirements for the battery included in the drug delivery device. However, it is not desirable to increase the size of the battery to meet this demand, because this will change the form factor or shape of the drug delivery device, which in turn will affect the operation of the device by the patient performing the injection. Moreover, larger batteries increase the cost of the device, and this increases the cost of medical care.

[0005] As set forth in greater detail below, the present disclosure sets forth systems and methods for wirelessly communicating information utilizing a drug delivery device that embody advantageous alternatives to existing systems and methods, and may address one or more of the challenges or needs set forth above, and provide other benefits and advantages. Summary of the invention

[0006] The present disclosure describes adding communication functionality to a drug delivery device for transmitting information to a user device (e.g., a mobile computing device, such as a smartphone, a personal computer, a server, etc.) while maintaining energy-saving operation. In one aspect, a drug delivery device includes: a reservoir suitable for containing a drug, an injection mechanism coupled to the reservoir to deliver the drug from the reservoir, a power source, one or more sensors, a memory, a controller powered by the power source and having an active mode and a low-power mode. The controller is configured to: when operating in the active mode, use the one or more sensors to detect that the injection mechanism has performed an injection. The controller is also configured to: generate a data entry in the memory indicating the injection and / or the status of the drug delivery device, and switch to the low-power mode after or simultaneously with detecting that the injection mechanism has performed the injection. The drug delivery device also includes a wireless communication module, which is powered by the power source and is configured to: when the controller is operating in the low-power mode, establish a wireless connection with a user device, and transmit a message indicating the injection and / or the status of the drug delivery device to the user device.

[0007] In another aspect, a method of operating a drug delivery device includes detecting, by a controller operating in an active mode and communicatively coupled to one or more sensors, that an injection has been performed using the drug delivery device. The method also includes storing a data entry in a memory indicating the injection and / or a status of the drug delivery device; and switching the controller to a low power mode after or simultaneously with detecting that the injection has been performed. The method includes establishing a wireless connection with a user device via a wireless communication module included in the drug delivery device while the controller is operating in the low power mode. The method also includes transmitting, by the wireless communication module and while the controller is operating in the low power mode, a message to the user device indicating the injection and / or the status of the drug delivery device. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] It is believed that the present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings. Some drawings may be simplified by omitting selected elements in order to more clearly show other elements. The omission of these elements in certain drawings does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless it may be clearly indicated in the corresponding written description. Moreover, all drawings are not necessarily drawn to scale.

[0009] Figure 1 A system including an energy-efficient drug delivery device configured to wirelessly communicate with a user's mobile device is presented.

[0010] Figure 2 An exemplary interaction between a controller and a wireless communication module is shown.

[0011] Figure 3 is an exemplary state diagram depicting four power states of a drug delivery device.

[0012] Figure 4 is a flow chart of an exemplary method for energy efficient operation of a drug delivery device. DETAILED DESCRIPTION

[0013] The present disclosure relates to operating a drug delivery device with wireless communication capabilities in an energy-saving manner. The embodiments described herein provide energy savings by efficiently managing the power consumption of a controller and / or a wireless communication module included in the drug delivery device. When one or both of these components do not contribute to or are unnecessary for the current use or operation of the drug delivery device, the corresponding component can be switched to a low power mode and maintained in the low power mode. Since the user device may not be available or lack proximity, it may take a lot of time to establish a wireless connection with the user device. Therefore, when the wireless communication module attempts to establish a wireless connection, the controller can remain in the low power mode. Moreover, when the wireless communication module is trying to establish a connection, the controller can switch between the active mode and the low power mode independently of the wireless communication module when the user uses the drug delivery device for an additional injection. Various triggering events corresponding to automatic tasks and user actions performed by the drug delivery device can cause switching between power modes, and thus achieve energy-saving operation. Such a configuration enables the drug delivery device according to the present disclosure to have an increased battery life.

[0014] Each of the aforementioned components of the drug delivery device and the method of operating the drug delivery device will now be described in more detail.

[0015] Figure 1A system 100 is shown, which includes an energy-saving drug delivery device 102 configured to wirelessly communicate with a user mobile device 104 (also referred to herein as a "mobile device" or "user device"). According to some embodiments, the drug delivery device 102 can be an automatic injector or other handheld device that is configured to automatically or semi-automatically deliver a dose of injectable material (e.g., a drug, a medication, a vaccine, or another therapeutic substance) to a user (e.g., a patient) via subcutaneous injection. Due to its automation, the drug delivery device 102 can be easier and / or more convenient for the patient to use compared to manual injection devices such as conventional syringes. After contacting the skin at the injection site and receiving input from the user, the drug delivery device 102 can automatically penetrate the skin and deliver the injectable material subcutaneously. The drug delivery device 102 can therefore help overcome the physical and / or psychological difficulties associated with injections, improve the user or patient experience, and / or improve compliance with a prescribed injection regimen. In addition, the drug delivery device 102 can enable automatic record keeping of injections, thereby improving the quality of medical care. To this end, the drug delivery device 102 may include electronic components that record information associated with the injection and transmit the recorded information to the user device 104, thereby making the information available to the patient or healthcare provider, for example, via a software application running on the user device 104. As discussed in more detail below, energy-efficient operation of the drug delivery device 102 can reduce the need to charge or replace batteries of the drug delivery device 102, thereby reducing the cost and environmental impact of operation and further enhancing the user experience. In addition, in some embodiments, the drug delivery device 102 can be reusable in the sense that it can be used to perform multiple injections. However, single-use or disposable embodiments of the drug delivery device 102 are also contemplated.

[0016] like Figure 1As shown, the drug delivery device 102 may include a housing 110, in which or on which are arranged various components, assemblies, and / or structures for delivering an injection and for recording and transmitting data associated with an injection and / or a state (e.g., an operating state) of the drug delivery device 102. Components fixedly or removably arranged within the interior space of the housing 110 may include a power source 114, power connections 116a, 116b, a controller 120, a memory 122, a removable storage device 124, an auxiliary circuit system 126, a bus 128, a wireless communication module 130 (WCM), a mechanical drive 140, a plunger 142, a stopper 144, a reservoir 150 for an injectable material, a needle 152, a cap 154, sensors 160a to 160d, and / or indicators 162a, 162b. The housing 110 may include flexible, hinged, and / or removable parts, such as a door 112, for example, for inserting and / or removing a cartridge including the injectable material reservoir 150. The housing 110 may also include other doors leading to compartments having removable components, as well as openings or windows for providing, for example, visual, audible, and / or tactile access to certain components, assemblies, and / or structures of the drug delivery device 102 .

[0017] The power source 114 of the drug delivery device 102 can be one of the components that is removably attached to the housing 110 and accessible through a door (not shown), or can be fixedly attached to or arranged in a compartment of the housing 110. The power source 114 can be an electrical energy storage device, such as, for example, a rechargeable lithium-ion battery. In other embodiments, the power source 114 includes one or more alkaline or other types of batteries, such as AA, AAA, 9V, button batteries, or any other suitable type of battery. Additionally or alternatively, the power source 114 can include one or more capacitors to increase the power density of the power source 114. In some embodiments, the power source 114 can be arranged outside the housing 110 and mechanically and / or electrically connected to other components of the drug delivery device 102. The power source 114 can include two terminals that maintain a substantially fixed voltage of 1.5, 3, 4.5, 6, 9, 12V or any other suitable terminal voltage when in operation. The power source 114 can store an amount of charge, such as 100, 200, 500, 1000, 2000, 5000, 10000, 20000 mAh, or any other suitable charge that can be delivered as an electric current to one or more power-consuming loads. In some embodiments, the power source 114 is a rechargeable battery configured to be electrically connected to a charging circuit (not shown) that can be at least partially disposed external to the drug delivery device 102.

[0018] The power supply 114 may be electrically connected to the controller 120 via a power connection 116a. Similarly, the power supply 114 may be electrically connected to the wireless communication module 130 via a power connection 116b. The power connections 116a, 116b may enable the controller 120 and the wireless communication module 130, respectively, to draw power, charge, and / or current from the power supply 114. Each of the power connections 116a, 116b may include a switch and / or circuit protection device that may be configured to limit or stop the current drawn by the controller 120 and / or the wireless communication module 130, respectively. The power connections 116a, 116b may also include components for regulating voltage (e.g., a Zener diode, a transistor-based voltage regulator, etc.). Via additional power connections (not shown), the power supply 114 can be electrically connected to and provide power to various other loads, including, for example, the memory 122, a removable storage device 124, an auxiliary circuit system 126, a mechanical drive 140, sensors 160a to 160d, and / or indicators 162a, 162b.

[0019] The controller 120 may include one or more processors, such as a microprocessor (μP), a digital signal processor (DSP), a central processing unit (CPU), a graphics processing unit (GPU), a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), and / or any other suitable electronic processing component. Additionally or alternatively, the controller 120 may include a microcontroller (μC). The controller 120 may be communicatively connected to a memory 122. In some embodiments, the memory 122 may be included in, integrated into, and / or a part of the controller 122. In some of these embodiments, the memory 122 included in the controller 120 may be arranged on the same chip or IC as the processor in a system-on-chip (SoC) configuration. In other embodiments, the memory 122 may be arranged in a package separate from one or more processors of the controller 120. The memory 122 in the controller 120 or in communication with the controller 120 may include one or more electronic memory components, such as one or more registers, a random access memory (RAM), a read-only memory (ROM), an electrically erasable programmable read-only memory (EEPROM), and / or a flash memory. Additionally or alternatively, the controller 120 can be communicatively connected to a removable storage device 124, such as a flash drive, an SD (Secure Digital) card, and / or a microSD card. The controller 120 can be configured to read information from and / or write information to the memory 122 or internal memory. Similarly, the controller 120 can be configured to read information from and / or write information to the removable storage device 124. The controller 120 can be packaged and mounted on a circuit board and can interact with other components of the drug delivery device 102 using a plurality of connectors or pins.

[0020] According to those embodiments in which the controller 120 is defined by a microprocessor or the like, the configuration of the controller 120 may correspond to the programming of the controller.

[0021] The wireless communication module 130 may include a wireless chipset. Whether or not a wireless chipset is used for implementation, the wireless communication module 130 may include one or more processors, such as a microprocessor, a DSP, a CPU, a GPU, an FPGA, an ASIC, and / or any other suitable electronic processing component. The wireless communication module 130 may include one or more memory components, such as one or more registers, RAM, ROM, EEPROM, and / or on-board flash memory, that are communicatively connected to at least one processing component. The wireless communication module 130 may include one or more communication components, which include at least one transmitter and at least one receiver. The transmitter and receiver may be part of a single transceiver unit. The transmitter and receiver may be configured to communicate, for example, at a radio frequency (RF) from 50kHz to 100GHz or using an optical frequency from infrared to ultraviolet. The RF transmitter and receiver may include an oscillator, an amplifier, a filter, and / or an antenna, while the optical transmitter and receiver may include a light emitting diode, a laser, a photodetector, an optical amplifier, an optical fiber, and / or a lens. The wireless communication module 130 may be configured to communicate on an industrial science and medicine (ISM) band. In some embodiments, the wireless communication module 130 is a WiFi, near field communication (NFC), Bluetooth, and / or Bluetooth low energy (BLE) module. The wireless communication module 130 can be packaged and mounted on a circuit board and can interact with other components of the drug delivery device 102 using multiple connectors and / or pins.

[0022] Energy-saving operation of the drug delivery device 102 can extend the life of the power supply 114 and / or reduce the frequency with which the power supply 114 must be charged by reducing the power consumption of some or all loads (such as the controller 120 and the wireless communication module 130). The controller 120 can be configured to operate in multiple modes with different power consumption or current consumption, the multiple modes including at least an active mode and a low power mode. When operating in the active mode, the controller 120 and other electronic components optionally included in the drug delivery device 102 can consume or draw more power from the power supply 114 than when operating in the low power mode. In the active mode, the controller 120 can control the operation of the drug delivery device 102 as described below, and / or can access all or most of the computing resources within the controller 120. Even when the controller 120 is idle, the ready access to computing resources in the active mode may result in considerable power consumption. In contrast, in the low power mode, the controller 120 may have only limited access to the computing resources of the controller 120 to save power. One example of a low power mode of the controller 120 may be when the power to the controller 120 is cut off, for example, by a switch external to the controller 120. Another example may be a so-called "sleep" mode of the controller 120. In some embodiments, in the low power mode, the controller 120 may draw less power from the power source 114 of the drug delivery device 102 than in the active mode. To transition from the low power mode to the active mode, the controller 120 may require a trigger corresponding to an external action, such as, for example, turning on the power or sending a "wake up" signal to the controller 120.

[0023] Similar to the controller 120, the wireless communication module 130 can be configured to operate in multiple modes having different power consumption or current consumption, including an active mode and a low power mode. In addition to enabling access to computing resources within the wireless communication module 130, the active mode of the wireless communication module 130 can also cause the wireless communication resources to substantially contribute to power consumption. Conversely, the low power mode of the wireless communication module 130 can refer to an operating mode in which access to computing resources and / or wireless communication resources is restricted to save power. Like the controller 120, the wireless communication module 130 may require a trigger corresponding to an external action of turning on power or waking up from a sleep mode and transitioning to an active mode. The following is Figure 2 More details about the controller 120 and the wireless communication module 130, and the actions that cause the operating mode transitions, are discussed in the context of FIG. 1 , which illustrates possible interactions between the controller 120 and the wireless communication module 130.

[0024] return Figure 1, the controller 120 and the wireless communication module 130 can be communicatively connected to each other via a communication bus 128. The communication bus 128 can also communicatively connect other components including, for example, the memory 122, the removable storage device 124, the auxiliary circuit system 126, the mechanical drive 140, the sensors 160a to 160d, and / or the indicators 162a, 162b to the controller 120 and / or the wireless communication module 130. The communication interconnection between the components can be implemented using one or more circuit board traces, wires, and / or other electrical, optoelectronic and / or optical connections. The communication interconnection can be configured to carry signals conforming to any one or more of a variety of protocols (such as I2C, SPI and / or other logic) to achieve cooperation of various components, assemblies and / or structures of the drug delivery device 102 when performing the functions of the drug delivery device 102 as described below.

[0025] When operating in the active mode, the controller 120 can read instructions from the memory 122 and execute the instructions to operate the drug delivery device 102. For example, the controller 120 can detect that the conditions for initiating and delivering an injection are met. Meeting the conditions for delivering an injection can include, for example, detecting that a user has activated the finger sensor 160b by pressing, pushing and / or covering the finger sensor 160b. The finger sensor 160b can include a button, a capacitive touch sensor, a light sensor, or any other suitable sensor that can detect the touch or close proximity of a finger, a palm, or another suitable object. Additionally or alternatively, meeting the conditions for delivering an injection can include detecting that the drug delivery device 102 is in contact with the skin using the skin sensor 160d. The skin sensor can include a capacitive sensor, a resistive sensor, an inductive sensor, a pressure sensor, a light sensor, and / or any other suitable sensor configured to detect that the drug delivery device 102 is in contact with the skin at the injection site. Still additionally or alternatively, satisfying the condition for delivering the injection may include detecting, using one or more sensors (e.g., including door sensor 160a and reservoir sensor 160c), that the reservoir 150 for the injectable material is in place and contains the injectable material, and that the door 112 of the housing 110 is closed. In some embodiments, the reservoir 150 is part of a removable cartridge. Satisfying the additional or alternative condition for delivering the injection may include determining, using sensors 160a to 160d and / or additional sensors, that the drug delivery device 102 is in the correct orientation relative to the user and / or the gravitational field. It may also be possible or alternatively necessary to satisfy one or more other suitable conditions before the controller 120 causes the drug delivery device 102 to proceed with the injection.

[0026] After the controller 120 detects that conditions for delivering an injection are met using sensors (e.g., sensors 160a to 160d) when operating in an active mode, the controller 120 may engage or activate the injection mechanism to deliver the injection subcutaneously at an injection site on the user's skin. According to some embodiments, the injection mechanism may correspond to one or more of the driver 140, the plunger 142, or other components included in the drug delivery device 102. The driver 140 may include an electric motor that, when operating, may draw current from the power source 114. In order to deliver the injectable material to the patient, the injection mechanism may be configured to provide power for inserting the needle 152 into the patient's body and / or expelling the injectable material from the reservoir 150 through the needle 152. The needle 152 may be in fluid communication with the reservoir 150, or may be operable to be connected in fluid communication with the reservoir 150 prior to or as a result of the operation of the injection mechanism. The needle 152 can be moved relative to the housing 110 between an initial state or storage state (in which the tip of the needle 152 is disposed within the housing 110) and a delivery state (in which the tip of the needle 152 extends from the opening of the housing 110 beyond the outer surface of the housing 110 for insertion into the patient's body). The injection mechanism can be configured to deliver the injection in two steps: piercing the patient's skin with the needle 152 by moving the needle 152 from the storage state to the delivery state so as to form a fluid path between the reservoir 150 and the subcutaneous tissue at the injection site, and then pressing the injectable material from the reservoir 150 into the subcutaneous tissue of the patient. In an alternative embodiment, the injection mechanism may not provide the power required to move the needle 152 from the storage state to the delivery state, but rather the user may provide such action by manually pushing the retractable needle guard into the interior space of the housing 110 to expose the tip of the needle 152.

[0027] The needle 152 may be a generally tubular member having a sharp tip for piercing the patient's skin and / or other tissue. The needle 152 may have a hollow interior that is in fluid communication with the reservoir 150 or is configured to be moved into fluid communication with the reservoir 150 during operation of the drug delivery device 102. In some embodiments, the needle 152 may be staked to the reservoir 150 so that the needle 152 does not move relative to the reservoir 150. In some such embodiments, the reservoir 150 may be pre-filled with medication by the manufacturer so that the device takes the form of a pre-filled syringe. Alternatively, the reservoir 150 may be filled by the user or patient at the time of care and / or the needle 152 may not be staked to the reservoir 150 initially. In addition, in some embodiments, the reservoir 150 may be included as part of a removable cartridge that may be placed (e.g., by a user) within the housing 110 of the drug delivery device 102 through a door 112 in the housing 110 before injection. In some embodiments, the injection mechanism may include a spring-loaded actuator configured to push the entire cartridge toward the user's skin, thereby causing the needle 152 to penetrate the skin. In some embodiments, the driver 140 actuates the plunger 142 to push the cartridge and / or cause the needle 152 to penetrate the skin. The cartridge or housing of the drug delivery device 102 may include a cap 154 ​​that may cover the needle 152 of the cartridge prior to injection. Prior to injection, the cap 154 ​​may need to be removed (e.g., by the user), and satisfying the conditions for delivering the injection may include: the controller 120 using Figure 1 A sensor not shown in FIG. 1 detects the absence of cap 154 ​​.

[0028] The driver 140 can be configured to actuate a plunger 142, which can be mechanically connected to a stopper 144 disposed within the reservoir 150 or forming a removable wall of the reservoir. In some applications, the stopper 144 can be a component of a cartridge that includes the reservoir 150, and when actuated by the driver 140, the plunger 142 can be in mechanical contact with the stopper 144. The actuated plunger 142 can move the stopper 144 toward the needle 152, thereby forcing the injectable material to be pushed out of the reservoir 150 through the needle 152 and into the tissue. When the desired amount of injectable material is forced out of the reservoir 150 (in some embodiments and / or applications, this includes substantially emptying the reservoir 150), the injection mechanism can retract the needle 152 from the user's skin and return it to the housing. The controller 120 can detect that the injection mechanism has completed the injection while still operating in the active mode and by using one or more sensors (e.g., sensors 160a to 160d). The controller 120 may indicate to the user that the drug delivery device 102 has completed delivering the injection using a visual indicator 162a and / or an audio indicator 162b. The visual indicator 162a may include a light emitting diode (LED), a liquid crystal display (LCD), or any other suitable visual indicator device. The audio indicator 162b may include a speaker, a buzzer, or any other suitable audio indicator device. After receiving the indication that the injection is complete, the user may move the drug delivery device 102 away from the injection site, thereby breaking contact between the drug delivery device 102 and the skin. The controller 120 may use a skin sensor 160d to detect the break in contact with the skin, and in response to detecting the break in skin contact and after a predetermined pause, turn off the indication that the injection is complete.

[0029] The controller 120, still operating in active mode, can create and record digital data entries indicating the injection in the memory 122 and / or on the removable storage device 124. The data entry can greatly enhance the user's experience with the drug delivery device 102 and the user's compliance with the injection regimen. In addition, the data entry can provide valuable clinical information to health service providers, drug manufacturers and / or other stakeholders. In summary, the one or more data entries indicating the injection recorded by the controller 120 can be referred to as an injection log. The data entries in the injection log may include injection time / date, injection status, injection cartridge information, etc. Additionally or alternatively, the controller 120 may create one or more data entries indicating the status of the drug delivery device 102 in the injection log or in a different log (e.g., a maintenance log). The one or more data entries may include error codes generated during the self-test routine, the remaining power of the power supply 114, etc. The controller 120 may generate a data entry in the injection log after and / or in response to detecting that the injection mechanism completes the injection and / or the drug delivery device 102 loses contact with the injection site using one or more sensors (e.g., sensors 160a to 160d). In some embodiments, the controller 120 detects a failed injection attempt using sensors 160a to 160d, and generates a data entry in the injection log in response to the failed injection attempt. After generating the data entry, and after and / or in response to detecting that the injection mechanism completes the injection, the controller 120 may switch to a low power mode. In some embodiments, before switching to the low power mode, the controller 120 communicates with the wireless communication module 130 using, for example, a processor interface. The controller 120 may, for example, transmit to the wireless communication module 130 at least some data indicating the completion or failure of the injection and / or the status of the drug delivery device 102. Additionally or alternatively, as described below, the controller 120 may cause the wireless communication module 130 to switch from the low power mode to the active mode, and / or cause the wireless communication module 130 to communicate with the user device 104.

[0030] In order to make the information in the injection log or the status data of the drug delivery device (which may be stored in the memory 122 and / or the removable storage device 124) more accessible and useful, the drug delivery device 102 may be configured to transmit at least a portion of the information or data to the user device 104. The drug delivery device 102 may establish a wireless connection with the user device 104 using the wireless communication module 130 and transmit one or more messages containing at least a portion of the injection log information via the wireless connection. Additionally or alternatively, the wireless communication module 130 may obtain and transmit unrecorded information indicating the status of the injection and / or drug delivery device 102. In some embodiments and / or scenarios, the user device 104 receives at least some of the information for which a copy is not retained on the drug delivery device 102.

[0031] For example, the drug delivery device 102 can use the wireless communication module 130 to transmit injection status or drug delivery device status data without retaining a record of the transmission or data included in the transmission at the drug delivery device 102. The injection status or drug delivery device status data may include, for example, data indicating the position of the motor or plunger, data indicating the fullness of the reservoir 150, etc. In some embodiments, the drug delivery device 102 can use the wireless communication module 130 to stream the injection status or drug delivery device status data at regular time intervals (e.g., every 1, 10, 100, 1000 ms). In other embodiments, the drug delivery device 102 can use the wireless communication module 130 to send the injection status or drug delivery device status data in response to changes detected by one or more sensors 160a to 160d or other sensors. After receiving the injection status or drug delivery device status data from the drug delivery device 102 via the wireless communication module 130, the user device 104 (described in more detail below) can store the received information and / or generate output to the user. For example, the user device 104 can generate an audio signal (e.g., a beep, a voice command, etc.), a visual signal (e.g., a light emitting diode, a graphic and / or text presented on a display, etc.), or a tactile signal (e.g., a vibration) to indicate relevant information to the user based on the data received from the drug delivery device 102. The signal generated by the user device can, for example, instruct the user to perform an injection. The user can take an action that causes the drug delivery device 102 to change state, triggering a new communication in some embodiments (e.g., pausing, continuing, or correcting an injection step performed by the user). In this way, the wireless communication module 130 can facilitate interactive feedback between the drug delivery device 102 and the user during an injection or during other user-performed actions (e.g., changing batteries, changing cartridges, setting time, etc.).

[0032] The wireless communication module 130 may be configured to complete the transmission of information to the user device 104 in a set of steps that may be performed asynchronously or sequentially when operating in the active mode. The wireless communication module 130 may, for example, establish a wireless connection with the user device 104, obtain at least some data from a data entry indicating the status of the injection and / or drug delivery device 102, and transmit a message indicating or including the obtained data to the user device 104. To establish a wireless connection with the user device 104, the wireless communication module 130 may initiate a series of one or more communication attempts. Each communication attempt may include one or more wireless transmissions, for example, containing certain information identifying the drug delivery device 102 and an indication of an attempt to establish a connection with the user device 104. The communication attempts may be referred to herein as “advertising” operations of the wireless communication module 130.

[0033] To begin advertising, the wireless communication module 130 can detect a trigger event, i.e., a communication trigger or simply a "trigger," and initiate a series of one or more communication attempts in response to detecting the communication trigger. In some embodiments, the controller 120 sends a signal indicating a communication trigger to the wireless communication module 130 via a UART (universal asynchronous receiver / transmitter) or another processor interface. The controller 120 can send a trigger at least in part in response to detecting that the injection mechanism completes an injection and / or detecting a specific user action. For example, a user action for triggering communication can include opening and / or closing the door 112, pressing a button, and / or activating a finger sensor 160b. When the controller 120 is in a low power mode, the wireless communication module 130 can detect a communication trigger based on a user action. For example, the auxiliary circuit system 126 can include digital logic that generates a communication trigger based on detecting a user action using sensors 160a to 160d.

[0034] In some embodiments and / or scenarios, the wireless communication module 130 does not need to receive any trigger signal from the user device 104, but only transmits the message payload as a broadcast. The controller 120 and / or the wireless communication module 130 may encrypt the message using one or more encryption techniques before transmission, for example to protect the privacy of the user. After broadcasting the message one or more times and / or repeating a specified time interval, the wireless communication module 130 may switch to a low power mode. After switching to the low power mode, the wireless communication module 130 may be powered on, activated and / or awakened in response to receiving a wireless activation trigger. The controller 120 may, for example, send a wireless activation trigger to the wireless communication module 130 at least in part in response to detecting that the injection mechanism completes the injection and / or detecting a specific user action. The user action for triggering the wireless activation may include opening and / or closing the door 112, pressing a button, and / or activating the finger sensor 160b. Additionally or alternatively, when the controller 120 is in a low power mode, the wireless communication module 130 may detect a wireless activation trigger based on a user action. For example, the auxiliary circuit system 126 may include digital logic to generate a wireless activation trigger based on detecting a user action using sensors 160a to 160d. The wireless activation trigger may be the same as the communication trigger described above. It is noteworthy that the wireless communication module 130 may detect the wireless activation trigger when operating in the low power mode and switch to the active mode in response to detecting the trigger.

[0035] The wireless communication module 130 may be configured to receive confirmation, validation, and / or other wireless signals transmitted by the user device 104. At least some of the set of steps for establishing communications with the user device 104 and / or transmitting messages to the user device 104 may be responsive to these signals transmitted by the user device 104. Accordingly, the discussion of the user device 104 presented below precedes the continued discussion of the steps performed by the wireless communication module 130 of the drug delivery device 102.

[0036] The user device 104 may also include a wireless communication module 182 configured to communicate with the wireless communication module 130 of the drug delivery device 102 via a wireless link (e.g., radio frequency (RF), optical, acoustic link, etc.). The user device 104 may further include a processor 184, a memory 186, and a display 188. The display 188 may be a touch screen, for example, configured to receive tactile input from a user. The wireless communication module 182 of the user device may be communicatively connected to the processor 184 and / or the memory 186. The processor 184 of the user device 104 may execute instructions stored in the memory 186 of the user device 104. For example, the instructions may include a software application and cause the processor 184 to retrieve and process information transmitted from the drug delivery device 102 to the user device 104. When retrieving information (e.g., data indicating an injection, data indicating a state or condition of the drug delivery device 102, etc.) from the drug delivery device 102, the processor 184 may store at least some of the information (e.g., an injection record) in the memory 186 of the user device 104 and / or another digital storage module (not shown). The processor 184 may then cause the display 188 of the user device 104 to display an information prompt to the user based on the information transmitted from the drug delivery device 102. The information prompt may be an indication of the status of the drug delivery device 102, a record of one or more injections, etc. The user device 104 may process the information received from the drug delivery device 102 to enhance the information available to the user via a user interface presented on the display 188. The displayed information may enable the user to see the time of the last injection, a record of success and / or compliance of previous injections, and / or other useful information.

[0037] In response to detecting the wireless transmission from the wireless communication module 130 of the drug delivery device 102, the wireless communication module 182 of the user device 104 may transmit a response (e.g., a response message or another suitable electronic signal having a particular format). In some embodiments, the wireless communication module 182 of the user device 104 transmits a response based at least in part on information identifying the drug delivery device 102 contained in the transmission from the wireless communication module 130 of the drug delivery device 102. In other embodiments, the user device 104 may transmit an identification signal not in response to any transmission from the drug delivery device 102. For example, the transmission from the user device 104 may be in response to a user action associated with an application running on the user device 104.

[0038] Typically, the transmission of information indicating the status of an injection and / or drug delivery device 102 may be dependent upon authentication of the drug delivery device 102 to the user device 104 and / or authentication of the drug delivery device 102 by the user device 104. As a prerequisite to creating a pairing, user action may be required to establish a first or original authentication between the user device 104 and the drug delivery device 102. If the drug delivery device 102 and the user device 104 are paired, the establishment of communication and the transmission of information between the drug delivery device 102 and the user device 104 may be automatic, i.e., without additional user action. To further explain, the drug delivery device 102 may use the wireless communication module 130 to establish a connection with a paired user device 104 that is within range and available, and may transmit information to the paired user device 104 in response to certain triggering events other than user action (e.g., in response to a signal broadcast by the user device 104).

[0039] The communication between the wireless communication module 130 and the user device 104 can be encrypted using one or more encryption methods. Encryption can use symmetric and / or public keys. The wireless communication module 130 and the user device 104 can use wired equivalent privacy (WEP), Wi-Fi protected access (WPA), and / or WPA2 wireless security protocols. In some embodiments, in order to authenticate the wireless communication module 130 and / or the user device 104, the wireless communication module 130 and / or the user device 104 are connected to an authentication server. Additionally or alternatively, the wireless communication module 130 and / or the user device 104 can use password protection and / or biometric screening to authenticate the user.

[0040] As discussed above, the drug delivery device 102 can transmit information to the user device 104 via the wireless connection established between the corresponding wireless communication modules 130, 188 based on certain triggering events. For example, the controller 120 of the drug delivery device 102 can be configured to detect that the injection mechanism has completed the injection (e.g., by processing the signal generated by one or more of the sensors 160a to 160d). Upon detecting that the injection is complete, the controller 120 can generate a data entry in the memory 122 indicating the injection and trigger the wireless communication module 130 to transmit information associated with the data entry to the user device 104. In some embodiments, the wireless communication module 130 itself can detect the completion of the injection using, for example, one or more of the sensors 160a to 160d and / or the auxiliary circuit system 126. Therefore, the wireless communication module 130 can begin transmitting information to the user device 104 when the injection is complete without receiving any signal (e.g., a trigger and / or any notification) from the controller 120.

[0041] Establishing the wireless connection necessary to transmit information from the drug delivery device 102 may require the presence of a ready user device 104 within a sufficiently close distance (i.e., within range) of the drug delivery device 102. The ready state of the user device 104 may require that the user device 104 is powered on, paired with the drug delivery device 102, and / or running a suitable application. In some scenarios and / or embodiments, the wireless communication module 130 may initiate a series of one or more communication attempts to establish a wireless connection with the user device 104. The wireless communication module 130 may receive a confirmation of the communication attempt from the user device 104. If there is no ready user device 104 within range (e.g., the wireless communication module 130 does not receive a confirmation from the user device 104), the wireless communication module 130 may stop the communication attempt after a predetermined period of time (which may be referred to as a "timeout period"). After the timeout, i.e., after the communication attempt is stopped after the timeout period expires without establishing a connection, the wireless communication module 130 may initiate another series of communication attempts after another period of time (which may be referred to as a "communication pause"). The wireless communication module 130 may continue to time out and restart the cycle of communication attempts for a duration that may be referred to as a "communication time window". The wireless communication module 130 may determine that the communication time window has expired, and in response to determining that the communication time window has expired, stop the communication attempt and switch to low power mode before detecting another triggering event. The duration of the communication time window may be 1, 2, 4, 12, 24, 48, 72 hours, or any other suitable time period. The duration of the timeout period may be 10ms, 100ms, 1s, 10s, 1min, 10min, or any other suitable time period. The duration of the communication pause may be 10s, 1min, 10min, 1 hour, or any other suitable time period. In some embodiments, the wireless communication module 130 determines that the communication time window has expired by determining that a wireless connection with the user device 104 has not been established after a time period greater than a threshold time period equal to the communication time window. Additionally or alternatively, the wireless communication module 130 may determine that the communication time window has expired by determining that a wireless connection with the user device 104 has not been established after the number of attempts is greater than the threshold number of attempts.

[0042] The wireless communication module 130 may also stop the communication attempt and / or switch to the low power mode at least in part in response to determining that the wireless communication module 130 has successfully established a wireless connection with the user device 104. The user device 104 may transmit a confirmation that the wireless connection has been established with the drug delivery device 102. The wireless communication module 130 may then receive the confirmation from the user device 104 when operating in the active mode, and switch to the low power mode at least in part in response to receiving the confirmation. Before switching to the low power mode, and after receiving the confirmation, the wireless communication module 130 may transmit a message. The transmitted message may, for example, indicate at least some data obtained by the wireless communication module 130 from the controller 120, from the memory 122, and / or from the removable storage device 124. The obtained data may include at least some data from a data entry generated by the controller 120, the data entry indicating the state or condition of the injection and / or drug delivery device 102. Regardless of the content of the transmitted message, the user device 104 may transmit a confirmation in response to receiving the transmitted message. In response to receiving the confirmation, the wireless communication module 130 may switch to the low power mode.

[0043] Figure 2 An exemplary interaction 200 between the controller 120 and the wireless communication module 130 of the drug delivery device 102 is shown. In other embodiments, Figure 2 The controller 120 and the wireless communication module 130 of the present invention are used for some other system or device. The interaction 200 can enable the controller 120 and the wireless communication module 130 to exchange information and / or send a trigger signal to switch between the active mode and the low power mode.

[0044] As discussed above, the controller 120 and the wireless communication module 130 can each draw power from the power source 114. Therefore, it may be advantageous to configure the drug delivery device 102 to substantially minimize power consumption by reducing the current consumption of the controller 120 and / or the wireless communication module 130 when the corresponding components are not in use. In addition, it may be advantageous to configure the drug delivery device 102 to substantially minimize the use time of the controller 120 and / or the wireless communication module 130 while providing the desired functionality and a high-quality user experience. Therefore, the controller 120 and / or the wireless communication module 130 can be configured to operate in different operating modes with different power consumption curves. The power consumption of the controller 120 and / or the wireless communication module 130 is substantially proportional to the corresponding current consumption. In the discussion below, unless otherwise specified, the exemplary current consumption is the average current consumption over at least a substantial portion (e.g., greater than 5%) of the time spent in the corresponding operating mode before switching to another mode.

[0045] The controller 120 can be configured to operate in an active mode, for example, while controlling the injection mechanism, monitoring the sensors 160a to 160d, generating signals for the indicators 162a, 162b, writing to or reading from the memory 122 and / or the removable storage device 124, and / or sending signals to the wireless communication module 130. The current consumption of the controller 120 operating in the active mode can be 0.05, 0.1, 0.2, 0.5, 1, 2, 5, 10 mA (milliamps), or any other suitable current consumption. The controller 120 can operate in a low power mode, for example, while using a limited set of resources of the controller 120. The low power mode of the controller 120 can be, for example, a stop mode, a standby mode, a sleep mode, a hibernation mode, or a shutdown mode. In some embodiments, depending on the scenario, the controller 120 is configured to operate in one of the selections of the low power mode. The current consumption of the controller 120 operating in one of the one or more possible low power modes may be 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5, 10, 20 μA (micro amperes), or any other suitable current consumption. The current consumption of the controller 120 operating in the active mode may be 2, 5, 10, 20, 50, 100, 200, 500, 1000, 2000, 5000, 10000, or any other suitable multiplication factor higher than the current consumption of the controller 120 in the low power mode. For example, the controller 120 may draw more than 1 mA in the active mode and less than 10 μA in the low power mode. In some embodiments, the switch is configured to disconnect the controller 120 from the power supply 114, thereby reducing the current consumption of the controller 120 operating in the resulting low power mode to substantially zero.

[0046] The wireless communication module 130 may also be configured to operate in one of different modes having different corresponding current consumptions and therefore different corresponding power consumption values. When operating in the active mode, the wireless communication module 130 may transmit and / or receive wireless signals. Additionally or alternatively, when operating in the active mode, the wireless communication module 130 may, for example, prepare for wireless transmission, retrieve data for wireless transmission from the memory 122 and / or the external storage device 124, monitor sensors 160a to 160d, and / or communicate with the controller 120. In the active mode, the wireless communication module 130 may draw a current of 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, 100, 200, 500mA or any other suitable current when transmitting and / or receiving wireless signals. The wireless communication module 130 may be configured to send and / or receive wireless signals only during a small portion of the time spent operating in the active mode. When operating in active mode without transmitting and / or receiving, wireless communication module 130 may draw 1, 2, 5, 10, 20, 50, 100, 200, 500 μA, or any other suitable current. However, in low power mode, wireless communication module 130 may draw 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5 μA, or any other suitable low current. The current consumption of wireless communication module 130 operating in active mode may be 2, 5, 10, 10, 50, 100, 200, 500, 1000, 2000, 5000, 10000, or any other suitable multiplication factor higher than the current consumption of wireless communication module 130 in low power mode. For example, wireless communication module 130 may draw more than 5 mA in active mode and less than 5 μA in low power mode. In some embodiments, the switch is configured to disconnect the wireless communication module 130 from the power supply 110, thereby reducing the current consumption of the wireless communication module 130 operating in the resulting low power mode to substantially zero. The low power mode of the wireless communication module 130 may be, for example, a standby mode, a stop mode, a sleep mode, a hibernation mode, or a shutdown mode. In the low power mode, the wireless communication module neither transmits nor receives wireless signals.

[0047] The controller 120 and the wireless communication module 130 may be configured to communicate with each other via a processor interface 210. The processor interface 210 may use, for example, a bus 128 or another suitable physical connection. The processor interface 210 may include a parallel or serial interface. In some embodiments, the processor interface 210 includes a UART circuit in the controller 120 and / or the wireless communication module 130. In some embodiments, the UART circuit is configured on a general purpose input / output (GPIO) pin of the controller 120 and / or the wireless communication module 130, or more specifically, on a GPIO pin of one or more processing components of the controller 120 and / or the wireless communication module 130. The processor interface 210 may use a protocol with flow control, which includes a request to send (RTS) signal and a clear to send (CTS) signal as well as a transmit (Tx) signal and a receive (Rx) signal.

[0048] The controller 120 may be configured to notify the wireless communication module 130 that the drug delivery device 102 has completed the injection. In some scenarios or embodiments, the controller 120 initiates communication with the wireless communication module 130, for example, by transmitting an RTS signal through a UART. In response to receiving a CTS signal from the wireless communication module 130 through the UART, the controller 120 may send a message notifying that the injection is complete. The message may include at least some data from the data entry indicating the injection. Additionally or alternatively, the message sent by the controller 120 may include a communication trigger, and the wireless communication module 130 may initiate a series of attempts to connect and / or communicate with the user device 104 in response to detecting the communication trigger. In some scenarios or embodiments, the wireless communication module 130 may request additional information from the controller 120, for example, indicating one or more previous injections, the state or condition of the drug delivery device 102, and / or past user actions. The wireless communication module 130 may initiate the request by transmitting an RTS signal through the UART, and upon receiving a CTS signal from the controller 120, a complete request message may be transmitted. After transmitting the requested information to the wireless communication module 130 , the controller 120 may switch to a low power mode.

[0049] In some embodiments, the controller 120 and the wireless communication module 130 may send a trigger signal to each other via the processor interface 210 to switch the other component from the active mode to the low power mode, and vice versa. For example, the controller 120 may send an activation trigger signal to the wireless communication module 130 via the processor interface 210. The wireless communication module 130, when operating in the low power mode, may detect the activation trigger signal sent by the controller 120 via the processor interface 210, and switch to the active mode in response to detecting the activation trigger signal. Similarly, the wireless communication module 130 may send an activation trigger signal to the controller 120 via the processor interface 210. The controller 120, when operating in the low power mode, may detect the controller activation trigger signal sent by the wireless communication module 130 via the processor interface 210, and in response, switch to the active mode. In some embodiments, the trigger is an RTS signal sent by the controller 120 to the wireless communication module 130, and vice versa.

[0050] In some embodiments, the processor interface 210 is not available for communication when the controller 120 is in low power mode or when the wireless communication module 130 is in low power mode. The controller 120 can switch the wireless communication module 130 from low power mode to active mode by sending a signal via an activation line 212 different from the processor interface 210. Similarly, the wireless communication module 130 can switch the controller 120 from low power mode to active mode by sending a signal via another activation line 214 different from the processor interface 210. The activation line 212 is sometimes referred to as the "wireless communication module activation line" in this article. The activation line 214 is sometimes referred to as the "controller activation line" in this article. The activation lines 212, 214 can be part of the bus 128, a separate circuit board trace, or other communication connection between the controller 120 and the wireless communication module 130. In some embodiments, the controller 120 and / or the wireless communication module 130 can each be configured to detect a trigger signal on a plurality of activation lines. For example, a trigger detected on one of the plurality of activation lines can correspond to one of a plurality of low power modes. Additionally or alternatively, at least some of the activation lines may carry signals sent by sources other than the controller 120 and / or the wireless communication module 130. For example, the auxiliary circuit system 126 may send a trigger signal based on a user action detected using sensors 160a to 160d. Still additionally or alternatively, the activation lines 342, 344 may use digital logic to combine multiple trigger sources, such as the controller 120, the wireless communication module 130, and / or the auxiliary circuit system 126.

[0051] In some embodiments, triggers sent via activation lines 342, 344 use switches to control electrical connectivity between power source 114 and controller 120 and / or wireless communication module 130. For example, controller 120 or auxiliary circuitry 126 may send a trigger to open and / or close a switch in power connection 116a connecting power source 114 to wireless communication module 130. Similarly, wireless communication module 130 or auxiliary circuitry 126 may send a trigger to open and / or close a switch in power connection 116b connecting power source 114 to controller 120 (or 120).

[0052] As discussed above, the controller 120 and / or the wireless communication module 130 may detect a trigger signal received via the activation lines 212, 214 and switch to a corresponding low power mode in response to the detected trigger. In the low power mode, the controller 120 and / or the wireless communication module 130 may monitor a limited set of connections or pins to detect an activation trigger, may remove power from the RAM and / or other peripheral devices, and / or may suspend execution of one or more processes. Additionally or alternatively, the wireless communication module 130 operating in the low power mode may shut down the amplifier and / or other active RF and / or optical components in the transmitter and / or receiver of the wireless communication module 130. The configuration and corresponding power consumption of the low power mode may depend on which low power mode (e.g., standby, sleep, hibernation, radio silence, shutdown, etc.) is selected, for example, by a trigger detected on a corresponding pin. Similarly, in some embodiments, the configuration and corresponding power consumption of the active mode may depend on which active mode is selected, for example, by a trigger detected on a corresponding pin.

[0053] Figure 3 is an exemplary state diagram 300 depicting four power states of the drug delivery device 102, corresponding to two power modes of the controller 120 and two power modes of the wireless communication module 130. Additional or alternative power states may exist for the drug delivery device 102 when, for example, the controller 120 or the wireless communication module 130 has more than two modes with different power consumption. Figure 3The states 310 to 340 in FIG. 3 relate specifically to power states of the drug delivery device 102 and may be part of the states or conditions of the drug delivery device 102 recorded by the controller 120. The “all off” state 310 of the drug delivery device 102 may represent the drug delivery device 102 with the controller 120 operating in a low power mode of the controller 120 and the wireless communication module 130 operating in a low power mode of the wireless communication module 130. The “controller on” state 320 of the drug delivery device 102 may represent the drug delivery device 102 with the controller 120 operating in an active mode of the controller 120 and the wireless communication module 130 operating in a low power mode of the wireless communication module 130. The “all on” state 330 of the drug delivery device 102 may represent the drug delivery device 102 with the controller 120 operating in an active mode of the controller 120 and the wireless communication module 130 operating in an active mode of the wireless communication module 130. The “wireless on” state 340 of the drug delivery device 102 may represent the drug delivery device 102 with the controller 120 operating in a low power mode of the controller 120 and the wireless communication module 130 operating in an active mode of the wireless communication module 130. The drug delivery device 102 may indicate to a user the power states 310 to 340 of the drug delivery device 102 or the transition from one state to another using the indicators 162a, 162b.

[0054] For example, the drug delivery device 102 can be in the fully closed state 310 when refrigerated before first use, between two injections, or when charging the power source 110. A user action detected by one of the sensors 160a to 160d, for example, can cause the drug delivery device 102 to transition to the controller on state 320. In some embodiments, the controller 120 switches to the active mode when it detects that the user has pressed a button (e.g., a power button, a cartridge eject button, etc.) or activated a different type of finger sensor (e.g., finger sensor 160b). In another embodiment, the controller 120 switches to the active mode when it detects that the door 112 is opened and / or the cartridge with the injectable material has been replaced. In yet another embodiment, the controller 120 switches to the active mode when movement of the drug delivery device 102 is detected using, for example, one or more accelerometers and / or other movement or vibration sensors. The drug delivery device 102 can be configured to activate the wireless communication module 130 substantially simultaneously with the activation of the controller 120. Thus, the drug delivery device 102 may transition from the fully off state 310 to the controller on state 320, or in some embodiments, directly to the fully on state 330. In some scenarios, the drug delivery device 102 may also transition directly from the fully off state 310 to the wireless on state 340, as discussed below.

[0055] In some embodiments, the transition to the controller on state 320 or the fully on state 330 causes the controller 120 to run a diagnostic routine or self-test. The diagnostic routine can verify the operational readiness of the drug delivery device 102 by determining the remaining energy and / or charge in the power source 114, and / or by detecting error flags from the controller 120, the wireless communication module 130, and / or the auxiliary circuit system 128. Additionally or alternatively, the diagnostic routine can verify that the sensors 160a to 160d are operable. After completing the diagnostic routine, the controller can generate a data entry indicating the status of the drug delivery device and indicate to the user using the indicators 162a, 162b whether the drug delivery device 102 is ready for normal use or requires troubleshooting. Normal use of the drug delivery device 102 may include delivering an injection to the user, indicating the status or condition of the drug delivery device 102 to the user, and / or sending information to the user device 104.

[0056] In some scenarios, the user can proceed with the injection while the drug delivery device 102 is in the controller open state 320 or the fully open state 330. The user can, for example, load the cartridge, close the door 112, remove the cap 154, bring the drug delivery device 102 into contact with the skin at the injection site, and press a button or engage the finger sensor 160b to cause the controller 120 to activate the injection mechanism, which may include the driver 140 and the plunger 142. After at least some of the user's actions, the controller 120 can detect using the sensors 160a to 160d that the actions were completed correctly, and can use the indicators 162a, 162b to notify the user that the user should proceed to the next step. For example, the controller 120 can detect using the skin sensor 160d that the drug delivery device 102 maintains the injection site contact, and use the indicators 162a, 162b to indicate to the user that the drug delivery device 102 is ready for injection. The controller 120 may be configured to make, or at least initiate, a data entry in a memory 122 external to the controller 120 and / or on a removable storage device 124 following any one user action corresponding to an injection step.

[0057] After activating the injection mechanism, the controller 120, still operating in the active mode, can monitor the sensors 160a to 160d to detect that the injection mechanism has completed the injection. In some embodiments, detecting that the injection mechanism has completed the injection includes detecting that the skin sensor 160d has lost contact with the skin and / or the needle 152 has been fully retracted. Additionally or alternatively, detecting that the injection mechanism has completed the injection may include using the skin sensor 160d to detect that the drug delivery device 102 is in mechanical contact with the skin near the injection site or with the skin for a predetermined duration after activating the injection mechanism. The predetermined duration may correspond to the time it takes for the plunger 142 to travel the distance required to press the injectable material out of the reservoir 150. The predetermined time may depend on the injection speed that may be pre-selected by the user. Additionally or alternatively, detecting that the injection mechanism has completed the injection may include using the reservoir sensor 160c to detect that the reservoir 150 has been substantially emptied of the injectable material. Still additionally or alternatively, detecting that the injection mechanism has completed the injection may include detecting that the user has maintained contact with the finger sensor 160b or another button for a predetermined duration, which may be different from the predetermined duration for maintaining skin contact. In addition, detecting that the injection mechanism completes the injection may include detecting whether the injection is successfully completed, and if not successfully completed, determining the failure mode of the injection. Upon detecting that the injection is successfully or otherwise completed, the controller 120 may cause the door 112 to open, for example, to facilitate removal of a used cartridge.

[0058] After and / or in response to detecting that the injection mechanism has successfully or otherwise completed the injection, the controller 120 can switch to a low power mode of the controller 120, thereby causing a transition from the controller on state 320 or the fully on state 330 to the fully off state 310 or the wireless on state 340, respectively. Before switching to the low power mode and after detecting that the injection is complete, the controller 120 can perform one or more tasks. For example, the controller 120 can generate a data entry in the memory 122 and / or the removable storage device 124 indicating that the injection is complete. In some embodiments, the controller 120 adds to the previously generated data entry after completing the injection. The data entry may include, for example, a timestamp indicating when the injection is completed. Additionally or alternatively, the data entry may include timestamps for the various steps of the injection, information about the injectable material and / or cartridge used in the injection, diagnostic information for the drug delivery device 102, and / or any other suitable information.

[0059] Prior to switching to the low power mode, the controller 120 may generate one or more trigger signals for activating the wireless communication module 130 and / or for causing the wireless communication module 130 to initiate establishing a connection with the user device 104. Additionally or alternatively, prior to switching to the low power mode, the controller 120 may send at least some data from the data entry indicating the state of the injection and / or drug delivery device 102 to the wireless communication module 130 via, for example, the bus 128 and / or the processor interface 210. Thus, in some embodiments, after completing an injection in the controller on state 320, the drug delivery device 102 may transition to the fully on state 330 before the controller 120 switches to the low power mode.

[0060] The wireless communication module 130 may operate in the active mode during the injection, or may switch to the active mode when the injection is completed. In some embodiments, the wireless communication module 130 switches to the active mode when it is powered on, reset and / or initialized. In other embodiments, the wireless communication module 130 is configured to be powered on, reset and / or initialized to a low power mode, such as, for example, a sleep mode. After the injection is completed, the wireless communication module 130 may switch to the active mode in response to a trigger signal generated by the controller 120. Therefore, if the injection mechanism initiates and / or completes the injection in the controller on state 320 of the drug delivery device 102, the drug delivery device 102 may operate in the fully on state 330 for a short period of time after the injection is completed. The short period of operation in the fully on state 330 may be 1 ms, 10 ms, 100 ms, 1 s, or any other suitable period of time, and the wireless communication module 130 may be sufficient to obtain data sent by the controller 120 operating in the active mode.

[0061] In some embodiments, the controller 120 switches to a low power mode after the injection is complete and before the wireless communication module 130 switches to an active mode or detects an activation trigger. Thus, after the injection is complete, the drug delivery device 102 may transition from the controller on state 320 to the fully off state 310. The user action may then cause activation of the wireless communication module 130 and transition of the drug delivery device 102 to the wireless on state 340. For example, in embodiments where the door 112 is open when the injection is complete, the user may close the door to activate the wireless communication module 130. More precisely, the auxiliary circuit system 126, in cooperation with the door sensor 160a, may detect that the door 112 is closed and generate a wireless activation trigger. In some embodiments, the auxiliary circuit system 126 generates a wireless activation trigger when the door 112 is closed only when the reservoir sensor 160c detects that there is no cartridge and / or no injectable material in the reservoir 150. Thus, in some embodiments, the drug delivery device 102 completes an injection, opens the door 112 , transitions to the fully closed state 310 in the controller on state 320 , and does not transition to the wireless on state until the user removes the used cartridge and closes the door 112 .

[0062] When activated, the wireless communication module 130 may access an injection log and / or a status data record of the drug delivery device stored in the memory 122 or from the removable storage device 124. The wireless communication module 130 may obtain at least some data from the data entry indicating the completion of the injection and / or the status of the drug delivery device from the injection log and / or the drug delivery device status data record. In some embodiments, the wireless communication module 130 obtains data from the controller 120, for example, via the bus 128 and / or the processor interface 210. To obtain data from the controller 120, the wireless communication module 130 may first send a controller activation trigger to wake up or activate the controller 120, thereby causing the drug delivery device 102 to transition from the wireless on state 340 to the fully on state 330. After the wireless communication module 130 obtains at least some data indicating the completion of the injection from the data entry, the wireless communication module 130 may initiate an attempt to establish a wireless connection with the user device 104. In some embodiments, the wireless communication module 130 may establish a wireless connection with the user device 104 before obtaining data for transmission to the user device 104, and then obtain the data in response to establishing the wireless connection. Establishing a wireless connection with the user device 104 can be performed in time intervals lasting from less than one second to several hours or days. That is, if the paired user device 104 is within the communication range and is in a state that allows communication to be established (e.g., running a suitable application), the entire process including establishing communication and transmitting information from the drug delivery device 102 to the user device can be completed in, for example, 0.1 to 10 seconds. On the other hand, if the paired user device 104 is not available to establish communication, the wireless communication module 130 can repeatedly attempt to communicate. The series of communication attempts may include a transmission burst from the wireless communication module 130, each burst followed by a radio silence period from the wireless communication module 130. Each transmission burst may include intervals during which the wireless communication module 130 can "listen" for a response from the user device 104. In other words, the communication attempt may include multiple transmissions interspersed with listening periods during which the wireless communication module 130 can receive a response from the user device 104. The wireless communication module 130 may make communication attempts when operating in an "advertising mode", and the associated transmission bursts may be referred to as "advertisements".

[0063] During listening periods of communication attempts, the wireless communication module 130 may consume more power than during radio silence periods between communication attempts. While listening, the wireless communication module 130 may draw power for operating a radio receiver and / or an optical (e.g., infrared) receiver within the wireless communication module 130. However, between communication attempts, the receiver may be turned off. Therefore, the wireless communication module 130 may have more than two active modes with different power consumption levels. For purposes of discussion herein, a low power mode of the wireless communication module 130 may refer to a mode in which the wireless communication module 130 requires an external (generated outside the wireless communication module 130) trigger signal to "wake up" before the processor of the wireless communication module 130 can cause the wireless communication module 130 to transmit or receive wireless communications.

[0064] The controller 120 may independently switch from the low power mode to the active mode when the wireless communication module 130 is operating in the active mode and advertising in an attempt to establish a wireless connection with the user device 104. For example, the auxiliary circuit system 126 may generate a controller activation trigger based on a user action detected using the sensors 160a to 160d (e.g., pressing a button, changing a cartridge, and / or closing the door 112). While the wireless communication module 130 is advertising, the controller 120 may switch to the active mode, activate the driver 140, detect a newly completed injection, generate a new data entry, and / or switch back to the low power mode. Thus, in an exemplary power state transition sequence, the drug delivery device 102 may transition as follows: i) from the fully off state 310 to the controller on state 320 for a first injection, ii) to the fully on state 330 or the fully off state 310 upon completion of the first injection, iii) to the wireless on state 340 to establish a wireless connection with the user device 104, iv) to the fully on state 330 while continuing to establish a wireless connection in preparation for a second injection, v) to the wireless on state 330 after completion of the second injection, and then vi) to the fully off state upon successful establishment of a connection with the user device 104 and transmission of a message indicating the first injection and / or the second injection. In some embodiments, upon establishing a connection with the user device 104, the wireless communication module 130 transmits a controller activation trigger to cause the controller 120 to switch to an active mode. For example, in embodiments where the memory 122 is integrated into the controller 120, the wireless communication module 130 may wake up the controller 120 to request and obtain data stored in the memory 122. In some implementations, the controller 120 and the wireless communication module 130 may complete their respective tasks independently and out of sequence (ie, asynchronously).

[0065] Table 1 below shows an exemplary sequence of user actions, corresponding tasks performed by the controller 120 and / or the wireless communication module 130, and power states of the drug delivery device 102 when the tasks are performed.

[0066] Table 1. Power modes associated with various user actions

[0067]

[0068]

[0069] In step A, prior to any user action, the drug delivery device 102 is in the fully off state 310. In step B, the user may press a button (e.g., a dedicated eject button or a finger sensor 160b) to generate a controller activation trigger, thereby causing the drug delivery device 102 to transition to the controller on state 320. The controller 120 may be configured to perform a self-test or diagnostic routine upon activation and generate a data entry in a memory (e.g., memory 122 and / or removable storage device 124) indicating the state (e.g., operating state) of the drug delivery device 102 and / or the injection. The data entry may include information about, for example, the success status of the injection, the number of successful injections, the timing of the injection, the amount of drug delivered during the injection, the injection speed (e.g., the speed selected by the user), the timing of the self-test, the code of any detected error, the remaining power in the power supply 114, the operating mode of the wireless communication module 130, diagnostic information about the sensors 160a to 160d and the indicators 162a, 162b, and / or other information about the state or condition of the drug delivery device 102 or the nature of the injection. If the controller 120 does not detect an error, the door 112 can be opened to enable the user to insert a cartridge with an injectable material. In step C, the user can insert a new cartridge and close the door 112. The controller 120 can detect, for example, by using a reservoir sensor 160c and a door sensor 160a that a valid cartridge is inserted and the door 112 is closed. In response, the controller 120 can activate audio and / or visual indicators 162a, 162b to indicate to the user to proceed to the next step. In some embodiments and / or scenarios, the user closes the door 112 when there is no cartridge in the drug delivery device 102, so that the controller 120 and / or the auxiliary circuit 126 generate a wireless activation trigger and / or a communication trigger. In response, the wireless communication module 130 can wake up, initiate an advertisement, and transmit a message to the user device 104 when connected to the user device 104.

[0070] With a valid cartridge loaded and door 112 closed, the user can proceed to step D of Table 1 by removing cap 154 ​​from the cartridge. The controller 120 can detect that cap 154 ​​is removed using a cap sensor (not shown) and turn on a target light (not shown) to illuminate the injection site. In step E, the user can touch the drug delivery device 102 to the injection site and maintain contact. When stable injection site contact is detected using skin sensor 160d, the controller 120 can use indicators 162a, 162b to indicate to the user to continue the injection. In step F, the user can press a button (e.g., finger sensor 160b or a dedicated start button). The controller 120 can detect that the button is pressed while maintaining contact and activate the injection mechanism. The injection mechanism can use a driver 140, a plunger 142 and / or other components (not shown) to insert a needle 152 and press the injectable material from the reservoir 150 through the needle 152 to deliver a subcutaneous injection. The injection mechanism can then retract the needle 152, and the controller 120 can update the indicators 162a, 162b to inform the user that it is safe to lift the drug delivery device 102 from the injection site. In step G, the user can lift the drug delivery device 102 off the skin, and the controller 120 can detect using the skin sensor 160d that the drug delivery device 102 is no longer in contact with the skin. In response to detecting the end of the injection and the loss of contact with the skin, the controller 120 can generate a data entry in a memory (e.g., the memory 122 and / or the removable storage device 124) indicating the injection. The data entry may include the injection time, an injection success indication, information about the cartridge or injectable material, etc. The controller 120 can open the door 112 before or after generating the data entry and switch to a low power mode, thereby transitioning the drug delivery device 102 to a fully closed state 310.

[0071] In step H, the user may remove the used cartridge and close the door 112 to cause the auxiliary circuit 126 to generate a wireless activation trigger and / or a communication trigger. In response, the wireless communication module 130 may wake up, causing the drug delivery device 102 to transition to the wireless on state 330. Once in active mode, the wireless communication module 130 may initiate advertising. In step I, the user may bring the drug delivery device 102 sufficiently close to the paired user device 104, or bring the user device 104 sufficiently close to the drug delivery device 102. When the paired user device 104 is within range, the wireless communication module 130 may establish a wireless connection with the user device 104. In some embodiments, when the controller 120 is in a low power mode, the wireless communication module 130 obtains at least some data from the data entry generated by the controller 120 by accessing the memory location of the data entry. In other embodiments, the wireless communication module wakes up the controller 120 to help obtain the data, causing the drug delivery device 102 to transition to the full on state 340. The wireless communication module 130 may obtain the data before or after establishing a wireless connection with the user device 104. Because a series of attempts to establish a connection with the user device 104 may occupy the length of the communication time window (which may be hours or days), the drug delivery device 102 remains available for injection. More specifically, the controller 120 may wake up (as in step B), control one or more additional injections, and / or generate one or more additional data entries in response to a user action while the wireless communication module 130 is advertising. After obtaining at least some data from the one or more data entries and establishing a wireless connection, the wireless communication module 130 may transmit a message indicating the obtained data to the user device 104. While transmitting the data, the wireless communication module 130 may switch to a low power mode, thereby causing the drug delivery device 102 to transition to a fully closed state 310. As described above, similar user actions (e.g., pressing a button or finger sensor 160b, closing the door 112, etc.) may cause or trigger different tasks depending on the scenario. For example, closing the door 112 when a cartridge is in the drug delivery device 102 may be a step in preparing for injection. On the other hand, closing the door 112 when there is no cartridge in the drug delivery device 102 may trigger an attempt to transmit data to the user device 104. Thus, similar user actions may be overloaded with multiple consequences to simplify the design and enable convenient operation of the drug delivery device 102 .

[0072] Figure 4 is a drug delivery device (e.g., Figure 1Flowchart of an exemplary method 400 for energy-saving operation of a drug delivery device 102 ... Additionally or alternatively, the controller and the wireless communication module can switch from a low power mode to an active mode when the other is in either mode, and vice versa. In addition, the method 400 can include performing an injection and establishing a wireless connection with a user device in response to a user action and / or the availability of a user device rather than in a particular order.

[0073] At box 410, method 400 may include: detecting that an injection has been performed with a drug delivery device by a controller operating in an active mode and in communication with one or more sensors (e.g., sensors 160a to 160d). As discussed above, the controller may control the various steps of the injection. After initiating the injection and activating a driver (e.g., driver 140) to press out the injectable material from a reservoir (e.g., reservoir 150) and deliver the material subcutaneously at an injection site on the user's skin, the controller may monitor one or more sensors. In some embodiments and / or scenarios, the sensor may indicate that the injection has been completed at least in part by detecting that the reservoir is empty and the drug delivery device has lost contact with the user's skin. In some embodiments and / or scenarios, method 400 may include detecting a failed injection, i.e., an injection has been initiated but not completed correctly. For example, a sensor may indicate that the drug delivery device has lost contact with the user's skin before the injectable material in the reservoir is emptied. Method 400 may treat a failed injection as a completed (but unsuccessful) injection, and indicate a failure and / or failure mode (discussed below) in the data entry generated at box 420.

[0074] At block 420, method 400 may include generating, by the controller, data entries indicating the status of the injection and / or drug delivery device and storing them in a memory (e.g., memory 122 and / or removable storage device 124). The data entry may indicate the injection time, the injection speed selected by the user, the amount of drug delivered to the patient during the injection, the injection success status, the status of the drug delivery device at the time of the injection, the status of the drug delivery device determined in a self-test routine, and / or other information related to the injection and / or use of the drug delivery device. In some embodiments, the controller begins data entry when an injection is initiated and completes data entry when it detects that the injection is successfully or otherwise completed. One or more data entries may form an injection log and / or a device diagnostic log.

[0075] At block 430, the method 400 may include switching the controller to a low power mode after and / or in response to detecting that an injection has been performed. The low power mode of the controller may be a sleep mode, a hibernation mode, a standby mode, or any other mode that consumes less power than an active mode of the controller by limiting the resources of the controller (e.g., reducing access to inputs and / or outputs, shutting down memory and / or other peripherals, etc.), the speed of a processing element of the controller, and / or a set of operations available to the controller. For example, the operation of the controller in the low power mode may be limited to monitoring a set of inputs on which a wake-up signal (e.g., a controller activation trigger) may be received. In some embodiments, in the low power mode of the controller, the controller is turned off (e.g., disconnected from the power source 114 using a switch in the power connection 116a). Upon detecting that the injection has been completed and before switching to the low power mode, the controller may perform a set of tasks other than generating and storing data entries. In some embodiments, the method 400 includes the controller sending one or more signals and / or messages to the wireless communication module before switching to the low power mode. The controller may send a signal indicating a wireless activation trigger, a signal indicating a wireless communication trigger, and / or a message indicating and / or including at least a portion of a data entry to the wireless communication module. The controller may send a signal and / or a message via a processor interface (e.g., processor interface 210, which may be or may include a UART) and / or via an activation line (e.g., WCM activation line 212 and controller activation line 214). For example, the controller may send a signal via an activation line to trigger the wireless communication module to switch from a low power mode of the wireless communication module to an active mode. The controller may send a message including or based on at least a portion of the data indicating an injection via a processor interface, and / or send a signal for triggering the wireless communication module to initiate one or more communication attempts with a user device (e.g., user device 104).

[0076] The method 400 may include obtaining, by the wireless communication module, at least some of the data from a data entry generated by the controller and / or stored in a memory location. Even when the controller is in a low power mode, the wireless communication module may obtain at least some of the data in the data entry directly from a memory (e.g., memory 122) and / or a removable storage device (e.g., removable storage device 124) that is communicatively connected to both the wireless communication module and the controller. Additionally or alternatively, the wireless communication module may obtain a portion of the data or information indicating the data by communicating with the controller via, for example, a processor interface. To enable the wireless communication module to obtain the data, the method 400 may include the wireless communication module sending a signal indicating a controller activation trigger via a processor interface (e.g., processor interface 210) or an activation line (e.g., controller activation line 214). A controller operating in a low power mode may detect the controller activation trigger and switch to an active mode in response. In the event that the controller operates in the active mode of the controller, the wireless communication module may obtain a portion of the data entry from the controller via the processor interface.

[0077] At block 440, method 400 may include establishing a wireless connection with a user device via a wireless communication module included in the drug delivery device when the controller is in a low power mode (e.g., operating in a low power mode or turned off). The process of establishing a wireless connection with the user device may continue when the controller is operating in a low power mode, operating in an active mode, and / or switching between operating modes. Method 400 may include initiating a series of one or more communication attempts intended to advertise to the user device that the wireless communication module is ready to establish a wireless connection and / or transmit information in response to a communication trigger. The advertising transmission may include information identifying the drug delivery device and / or a user of the drug delivery device. If a user device paired with the drug delivery device is within range and ready to communicate (e.g., with the aid of an application running on the user device), the user device may send a confirmation. The user device may send a confirmation in response to identifying the drug delivery device or user information in the advertising transmission. The confirmation may in turn include information identifying the user device and / or a user of the user device. Method 400 may include establishing a connection in response to the wireless communication module allowing the connection based on identifying the identification information sent by the user device. If the wireless communication module does not establish a connection after a threshold time period, the wireless communication module may cease communication attempts and may begin advertising again after a pause, as discussed in more detail above.

[0078] Method 400 may include, in response to determining that the communication time window has expired, ceasing communication attempts and switching the wireless communication module of the drug delivery device to a low power mode. Determining that the communication time window has expired may include determining that a wireless connection with the user device has not been established after at least one of: i) a time period greater than a threshold time period, or ii) a number of attempts greater than a threshold number of attempts. Determining that a wireless connection with the user device has not been established may further include not receiving any confirmation or validation from the user device.

[0079] When operating in low power mode, the wireless communication module can detect a wireless activation trigger and switch to an active mode in response to receiving the wireless activation trigger. The controller can send a signal indicating the wireless activation trigger via a processor interface and / or an activation line. In some embodiments of method 400, an auxiliary circuit (e.g., auxiliary circuit 126) cooperates with a sensor to generate a wireless activation trigger. For example, a logic circuit within the auxiliary circuit system can be connected to an activation line for the wireless communication module. Therefore, a wireless activation trigger can be detected in response to a user action, such as pressing a button and / or engaging a finger sensor, opening a compartment (e.g., opening door 112), and / or closing a compartment of a drug delivery device. In some embodiments, the wireless activation trigger is also a communication trigger. The wireless communication module can be configured to start advertising in response to switching to an active mode.

[0080] At box 450, method 400 may include: transmitting, by the wireless communication module and when the controller is in low power mode, a message indicating the status of the injection and / or drug delivery device. The message may include, for example, the success status of the injection, the number of successful injections (if multiple injections have been performed since the last data transmission), the timing of the injection, the amount of drug delivered during the injection, the remaining battery power, the injection speed (e.g., the speed selected by the user), the timing of any self-test, the code of any detected error, the results of any diagnostic or self-test routine, and / or other information about other states or conditions of the drug delivery device or the nature of the injection. In some embodiments, an application running on the user device requests certain information from the drug delivery device. For example, the application may save a log of injections and / or injection attempts in a memory (e.g., memory 186) of the user device, and the requested information may allow the application to synchronize the information stored on the user device with the information stored on the drug delivery device. The synchronized information may be presented to the user, for example, via a display (e.g., display 188), or may be shared with a healthcare provider. The user device may also generate one or more information prompts based on the message received from the drug delivery device.

[0081] Some embodiments may further include box 460 and box 470. At box 460, method 400 may include receiving, by the wireless communication module, confirmation that: i) communication with the user device has been established, or ii) the user device has received a message. At box 470, method 400 may include: in response to receiving the confirmation, switching the wireless communication module to a low power mode. In the event of receiving confirmation that communication with the user device has been established, the wireless communication module may be configured to switch to a low power mode only after a predetermined time period sufficient to transmit information to the user device. In some embodiments, the wireless communication module of the drug delivery device and the wireless communication module of the user device are Bluetooth modules and / or Bluetooth low energy (BLE) modules, and therefore follow the Bluetooth protocol and / or BLE protocol to establish a connection. The confirmation of establishing a connection may be part of the Bluetooth or BLE protocol.

[0082] In some embodiments, when the controller of the drug delivery device is operated in an active mode and / or before the injection is completed, the drug delivery device may perform at least some of the actions described with reference to blocks 440 to 470. With respect to method 400, the drug injection device may perform some of the actions in blocks 440 to 470 before block 430. In addition, the drug delivery device may use a wireless communication module to transmit injection status or drug delivery device status data without retaining a record of the transmission or the data included in the transmission (e.g., in a memory of the drug delivery device). In some embodiments, the drug delivery device may use a wireless communication module to stream injection status or drug delivery device status data at regular time intervals (e.g., every 1, 10, 100, 1000 ms), from time to time, when the controller is active. In other embodiments, the drug delivery device may use a wireless communication module to send injection status or drug delivery device status data in response to changes detected by one or more sensors. The user device may store the received information and / or generate output to the user when receiving the injection status or drug delivery device status data (received from the drug delivery device via the wireless communication module). The signal generated by the user device may, for example, guide the user to perform an injection. The user can take actions that cause the drug delivery device to change state, triggering new communications in some embodiments (e.g., pausing, continuing, or correcting injection steps performed by the user). In this way, the wireless communication module can facilitate interactive feedback between the drug delivery device and the user during injection or during other user-performed actions (e.g., changing batteries, changing cartridges, setting time, etc.).

[0083] As discussed above, the controller and the wireless communication module can switch between the corresponding active mode and the low power mode in response to a trigger. Some triggers can be based on tasks automatically performed by the controller and / or the wireless communication module. Other triggers can be based on user actions. In some embodiments and / or scenarios, the same user action generates different triggers. Using different triggers to overload the same user action depending on the scenario can achieve a simplified design and / or operation of the drug delivery device.

[0084] Although the foregoing embodiments of the drug delivery device have been mainly described as an automatic injector or other device that is kept in the hands of a patient or user during the injection process, the scope of the present disclosure is not limited to such handheld devices. In an alternative embodiment, the drug delivery device can be releasably attached to the patient's skin so that the drug delivery device can be worn on the patient's skin during drug delivery, rather than being kept in the patient's hand. In some cases, this drug delivery device is referred to as a portable syringe. When drug delivery is to occur within tens of seconds, minutes, or hours, and / or in the case where it is not feasible to keep the drug delivery device in the hands of the user during the entire injection process, the portable syringe may be useful. In such an embodiment, the outer surface of the housing of the drug delivery device may include an adhesive for adhering to the patient's skin. In addition, in such an embodiment, the drug delivery device may have a generally low-profile shape (e.g., a rectangular box) so that the drug delivery device does not hinder the patient's movement when worn by the patient. By arranging the longitudinal axis of the delivery member or at least the tip of the delivery member to be vertical or otherwise not parallel to the longitudinal axis of the reservoir and / or the longitudinal axis of the housing, a low-profile shape can be facilitated. In addition, for sterile purposes, the housing opening through which the tip of the delivery member extends in the delivery state can be covered by a pierceable septum. In the initial state, the tip of the delivery member may not pierce or only partially pierce the septum; however, in the delivery state, the tip of the delivery member can completely pierce the septum for insertion into the patient. In addition, in the portable syringe configuration of the drug delivery device, the delivery member can be defined by a combination of a hollow or solid trocar and a soft cannula. During operation, the trocar can be deployed to introduce the soft cannula into the patient, and then retracted, thereby leaving the soft cannula in the patient. Unless otherwise required by operational or structural differences, this portable syringe configuration of the injector can include the same or similar power control scheme as described above.

[0085] The above description describes various devices, components, parts, subsystems and methods used in relation to drug delivery devices. Devices, components, parts, subsystems, methods or drug delivery devices may further include drugs or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also included. The drug can be in liquid form, in lyophilized form or in a form that can be reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0086] The drug will be contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug for treatment. The primary container may be a vial, a cartridge, or a pre-filled syringe.

[0087] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor, such as granulocyte colony stimulating factor (G-CSF), or the device can be used with a colony stimulating factor. Such G-CSF agents include, but are not limited to (Pegfilgrastim, Pegylated filgrastim, Pegylated G-CSF, Pegylated hu-Met-G-CSF) and (filgrastim, G-CSF, hu-MetG-CSF).

[0088] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. ESA is any molecule that stimulates erythropoiesis. In some embodiments, ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include but are not limited to (Epoetin α), (darbepoetin alfa), (Epoetine δ), (methoxy polyethylene glycol-epoetin beta), MRK-2578, INS-22, (Epoetin ζ), (Epoetin β), (Epoetin ζ), (Epoetin α), Epoetin α Hexal, (Epoetin α), (Epoetine θ), (Epoetine θ), (Epoetin theta), Epoetin alpha, Epoetin beta, Epoetin iota, Epoetin omega, Epoetin delta, Epoetin zeta, Epoetin theta and Epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0089] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that inhibit activity mediated by binding of IL-4 and / or IL-13 to the receptor; interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; Ang2 Specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., especially human CD22-specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, especially including but not limited to human CD22-specific IgG antibodies, such as a dimer of a human-mouse monoclonal hLL2γ-chain and a human-mouse monoclonal hLL2κ chain connected by a disulfide, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS registration number 501423-23-0; IGF-1 receptor-specific antibodies, peptibodies and related proteins, etc., including ... Not limited to anti-IGF-1R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins, etc. ("B7RP-1", also known as B7H2, ICOSL, B7h and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as, for example, 146B7; IFNγ-specific antibodies, peptide bodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ antibodies; TALL-1-specific antibodies, peptide bodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptide bodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptide bodies, related proteins, etc.; hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of OX40 receptors; (alteplase, tPA); (darbepoetin alfa); (epoetin alfa, or erythropoietin); GLP-1, (interferon beta-1a); (tositumomab, anti-CD22 monoclonal antibody); (interferon-β); (alemtuzumab, anti-CD52 monoclonal antibody); (Epoetin delta); (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); (etanercept, TNF receptor / Fc fusion protein, TNF blocker); (Epoetin alpha); (cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Somatropin, human growth hormone); (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); (Somatropin, human growth hormone); (adalimumab); (panitumumab), (Dinosutumab), (Dinosutumab), (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; (interferon alfacon-1); (Nesiritide; recombinant human B-type natriuretic peptide (hBNP)); (Anakinra); (sargramostim, rhuGM-CSF); (epatuzumab, anti-CD22 mAb); Benlysta TM (lymphostat B, belimumab, anti-BlyS mAb); (tenecteplase, a t-PA analog); (methoxypolyethylene glycol-epoetin beta); (gemtuzumab ozogamicin); (efalizumab); (certolizumab pegol, CDP 870); Soliris TM (eculizumab); pexelizumab (anti-C5 complement); (MEDI-524); (ranibizumab); (17-1A, edrecolomab); (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); (IDM-1); (B43.13); (viciluzumab); cantuzumab mertansine (huC242-DM1); (Epoetin beta); (Opreleukin, human interleukin-11); Orthoclone (Muromonab-CD3, anti-CD3 monoclonal antibody); (Epoetin alpha); (infliximab, anti-TNFα monoclonal antibody); (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); (anti-IL6 receptor mAb); (bevacizumab), HuMax-CD4 (zanolimumab); (rituximab, anti-CD20 mAb); (erlotinib); (interferon alfa-2a); (basiliximab); (lumiracoxib); (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); (natalizumab, anti-α4 integrin mAb); (MDX-1303, anti-anthrax protective antigen mAb); ABthrax TM ; (omalizumab); ETI211 (anti-MRSA mAb); IL-1trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); (daclizumab); (daclizumab, anti-IL-2Rα mAb); (ibritumomab tiuxetan); (ezetimibe); (atacicept, TACI-Ig); anti-CD80 mAb (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001);Anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3). ;

[0090] In some embodiments, the drug delivery device may comprise or be used with a sclerostin antibody, such as, but not limited to, romosozumab, blosozumab, or BPS 804 (Novartis), and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to (evolocumab) and (alirocumab). In other embodiments, the drug delivery device can contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab. In some embodiments, the reservoir of the drug delivery device can be filled with a drug for treating melanoma or other cancers. (talimogene laherparepvec) or another oncolytic HSV, or the device can be used with it, the other oncolytic HSV includes but is not limited to OncoVEXGALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device can contain or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as but not limited to TIMP-3. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptors (such as but not limited to anovimab) and bispecific antibody molecules targeting CGRP receptors and other headache targets can also be delivered using the drug delivery device of the present disclosure. In addition, bispecific T cell engagers Antibodies (such as but not limited to (blinatumomab)) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with an APJ macromolecular agonist, such as but not limited to apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure.

[0091] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, which still fall within the scope of the claims defining the invention disclosed herein.

[0092] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes and combinations may be deemed to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: a reservoir adapted to contain a drug; an injection mechanism coupled to the reservoir to deliver the drug; power supply; one or more sensors; Memory; A controller, the controller being powered by the power supply and having an active mode and a low power mode, the controller being configured to: When operating in the active mode, detecting using the one or more sensors that the injection mechanism has performed an injection, generating in the memory a data entry indicative of a status of the drug delivery device and / or the injection, and switching to the low power mode after or simultaneously with detecting that the injection mechanism has administered the injection; and A wireless communication module, the wireless communication module is powered by the power supply and is configured to: while the controller is operating in the low power mode, establishing a wireless connection with a user device, and A message is transmitted to the user device indicating the status of the drug delivery device and / or the injection.

2. The drug delivery device of claim 1, wherein the wireless communication module is configured to: detecting that a first wireless communication module (WCM) is triggered, and in, Establishing the wireless connection includes initiating a series of one or more communication attempts in response to detecting the first WCM trigger.

3. The drug delivery device of claim 2, wherein: The controller and the wireless communication module are communicatively connected via a processor interface, The controller is configured to send a signal indicating the first WCM triggering via the processor interface, and detecting the first WCM triggering by the wireless communication module includes receiving a signal indicating the first WCM triggering via the processor interface.

4. The drug delivery device of claim 3, wherein the processor interface is a Universal Asynchronous Receiver / Transmitter (UART) interface.

5. The drug delivery device according to any one of claims 3 or 4, wherein: Sending the signal by the controller indicating that the first WCM has been triggered is at least partially responsive to detecting that the injection mechanism has performed the injection.

6. The drug delivery device of claim 2, wherein: Detecting, by the wireless communication module, the first WCM trigger includes detecting a user action using the one or more sensors when the controller is in the low power mode.

7. The drug delivery device of claim 6, comprising: a compartment configured to house a cartridge and / or a button; and Wherein, the user action comprises at least one of: i) opening a compartment of the drug delivery device, ii) closing a compartment of the drug delivery device, or iii) pressing a button of the drug delivery device.

8. The drug delivery device according to any one of claims 1 to 4, wherein the wireless communication module is configured as: receiving a confirmation from the user device while operating in an active mode of the wireless communication module, and In response to receiving the confirmation, switching to a low power mode of the wireless communication module.

9. The drug delivery device of claim 8, wherein: The confirmation includes at least one of: i) confirmation of an established wireless connection, or ii) an indication that the user device has received the message.

10. The drug delivery device of claim 8, wherein the wireless communication module is configured to: Determining the expiration of the communication time window; In response to determining that the communication time window has expired, switching to a low power mode of the wireless communication module.

11. The drug delivery device of claim 10, wherein: Determining that the communication time window expires includes determining that a wireless connection with the user device has not been established after at least one of: i) a time period greater than a threshold time period, or ii) a number of attempts greater than a threshold number of attempts.

12. The drug delivery device of claim 10, wherein the communication time window has a duration of at least one hour.

13. The drug delivery device of claim 8, wherein the wireless communication module is configured to: When operating in a low power mode of the wireless communication module, detecting a second WCM trigger, and In response to detecting the second WCM trigger, switching to an active mode of the wireless communication module.

14. The drug delivery device of claim 13, wherein: The controller and the wireless communication module are communicatively connected via a processor interface or one or more activation lines, The controller is configured to send a signal indicating the triggering of the second WCM via the processor interface or one of the one or more activation lines, and Detecting, by the wireless communication module, the second WCM triggering includes receiving, via the processor interface, or one of the one or more activation lines, a signal indicating the second WCM triggering.

15. The drug delivery device of claim 13, comprising: at least one of i) a compartment configured to contain an injection fluid or ii) a button; Wherein, the wireless communication module detecting the second WCM trigger includes: using the one or more sensors to detect a user action; and The user action includes at least one of: i) opening the compartment, ii) closing the compartment, or iii) pressing the button.

16. The drug delivery device of any one of claims 1 to 4, wherein: The wireless communication module is a Bluetooth Low Energy (BLE) module.

17. The drug delivery device of any one of claims 1 to 4, wherein: The controller is configured to: When operating in a low power mode of the controller, detecting a controller activation trigger, and In response to detecting the controller activation trigger, switching to an active mode of the controller.

18. The drug delivery device of claim 17, wherein: The controller and the wireless communication module are communicatively connected via a processor interface or one or more activation lines, The wireless communication module is configured to send a signal indicating an activation trigger of the controller via the processor interface or one of the one or more activation lines, and Detecting, by the controller, the controller activation trigger includes receiving, via the processor interface, or one of the one or more activation lines, a signal indicative of the controller activation trigger.

19. The drug delivery device of any one of claims 1 to 4, wherein: The controller and the wireless communication module are configured to operate asynchronously.

20. The drug delivery device of any one of claims 1 to 4, wherein: The memory is part of the controller.

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