Drug delivery devices, components for use within drug delivery devices

Abstract

Drug delivery devices, components for use within drug delivery devices, and methods of operating drug delivery devices are provided. The drug delivery device may include using a real-time clock of the wireless communication module to communicate data with a remote device when the main microcontroller is in a sleep mode. The drug delivery device may include disabling communication between the main microcontroller and the wireless communication module when the main microcontroller is in an injection process. The drug delivery device may include determining an end of the injection process based on data from the insertion drive and the extrusion drive. The drug delivery device may include two proximity sensors with unique thresholds. The drug delivery device may include electrostatic discharge protection and recovery.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 276,384, filed November 5, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices. More particularly, the present disclosure relates to drug delivery devices with improved functionality, components for use within drug delivery devices, and methods of operating drug delivery devices. [Background technology]

[0003] Many pharmaceutical products are manufactured and packaged, for example, in pre-filled syringe (PFS) cartridges for use in drug delivery devices (e.g., autoinjectors (AI), wearable drug delivery devices, etc.). The associated drug delivery devices may comprise a number of electrically actuated components (e.g., an insertion drive, an extrusion drive, a main microcontroller for controlling the injection process, multiple user interfaces, a wireless communication module for communicating drug delivery device configuration data and injection data to and from remote devices, etc.).

[0004] Drug delivery devices often use a real-time clock in the main microcontroller for synchronizing communications with remote devices, so the main microcontroller may need to operate in an active mode whenever a remote device is communicatively connected to the drug delivery device.

[0005] Drug delivery devices often include a main microcontroller configured to control the injection process, so the integrity and data security of the drug delivery device may be compromised during the injection process if a remote device can communicatively connect to the main microcontroller.

[0006] Drug delivery devices often determine the end of the injection process based on data derived from the extrusion drive status (e.g., the plunger rod is retracted from the syringe after injecting the drug), which may result in an erroneous determination of the end of the injection process.

[0007] Drug delivery devices often use proximity sensors configured to assist a user in accurately positioning a proximal end of the drug delivery device near a desired injection site. Multiple proximity sensors can produce erroneous results if a common detection threshold is used for each of the multiple proximity sensors.

[0008] Drug delivery devices often include multiple electrical components that generate electrostatic discharge (ESD) when a user administers an associated medication, and may suffer malfunction and / or damage due to electrostatic discharge (ESD).

[0009] What is needed is a drug delivery device, a component for use within a drug delivery device, and a method of operating a drug delivery device that uses a real time clock in a wireless communication module to communicate data with a remote device when the main microcontroller is in a sleep mode.What is needed is a drug delivery device that disables communication between a main microcontroller and a wireless communication module when the main microcontroller is in an injection process.What is needed is a drug delivery device that determines the end of an injection process based on data from an insertion drive and an extrusion drive.What is needed is a drug delivery device that uses two proximity sensors with unique thresholds.What is needed is a drug delivery device with electrostatic discharge protection and recovery. Summary of the Invention [Means for solving the problem]

[0010] The drug delivery device may include a housing configured to carry a syringe containing a medicament. The drug delivery device may also include an extrusion drive that selectively extrudes the medicament from the syringe in an injection process. The drug delivery device may further include a main microcontroller and a wireless communication module carried by the housing. The main microcontroller and the wireless communication module may be communicatively connected via a communication channel. The main microcontroller may include a first real-time clock. The main microcontroller may be configured to generate injection data based on the first real-time clock. The wireless communication module may include a peripheral interface and a second real-time clock. The peripheral interface may be configured to communicate the injection data to a remote device based on the second real-time clock.

[0011] In another embodiment, a method of operating a drug delivery device may include providing a main microcontroller communicatively coupled to a wireless communication module via a communication channel. The main microcontroller may include a first real-time clock. The main microcontroller may be configured to generate infusion data based on the first real-time clock and control at least a portion of a drug infusion process based on the infusion data. The wireless communication module may include a peripheral interface and a second real-time clock. The method may further include communicating the infusion data via the peripheral interface based on the second real-time clock.

[0012] In a further embodiment, a non-transitory computer readable medium is provided that stores computer readable instructions that, when executed by one or more processors, can cause the one or more processors to receive a first real-time clock signal from a main microcontroller communicatively coupled to the wireless communication module via a communication channel. The main microcontroller can be configured to generate infusion data and control at least a portion of a drug infusion process. Execution of the instructions by the one or more processors can further cause the one or more processors to receive a second real-time clock signal from the wireless communication module. Execution of the instructions by the one or more processors can further cause the one or more processors to communicate the infusion data via a peripheral interface of the wireless communication module based on the second real-time clock.

[0013] In yet another embodiment, the drug delivery device may include a housing configured to carry a syringe containing a medicament. The drug delivery device may also include an extrusion drive to selectively extrude the medicament from the syringe during an injection process. The drug delivery device may further include a main microcontroller communicatively connected to the wireless communication module via a communication channel. The main microcontroller may be configured to control at least a portion of the drug injection process. Communications over the communication channel may be disabled while the main microcontroller controls at least a portion of the drug injection process.

[0014] In a further embodiment, a method of operating a drug delivery device may include controlling at least a portion of a drug injection process by a main microcontroller of the drug delivery device. The method may also include establishing a communication connection between the main microcontroller of the drug delivery device and a wireless communication module. The method may further include disabling communication over the communication connection while the main microcontroller is controlling at least a portion of the drug injection process.

[0015] In another embodiment, a non-transitory computer-readable medium is provided that stores computer-readable instructions that, when executed by one or more processors, can cause the one or more processors to communicatively couple a main microcontroller to a wireless communication module over a communication channel, where the main microcontroller is configured to control at least a portion of a drug infusion process. Further execution of the instructions by the one or more processors can further cause the one or more processors to disable communication over the communication channel while the main microcontroller is controlling at least a portion of the drug infusion process.

[0016] In yet another embodiment, the drug delivery device may include a housing configured to carry a syringe containing a medicament for pushing in the injection process. The drug delivery device may also include an insertion drive system (IDS) configured to insert a needle of the syringe into a patient before pushing the medicament in the injection process and to retract the needle into the housing after pushing the medicament. The drug delivery device may further include an extrusion drive system (EDS) including a plunger rod configured to move through the syringe to push the medicament from the needle in the injection process. The drug delivery device may still further include a microcontroller configured to determine the end of the injection process in the drug delivery device based on the completion of the movement of the plunger rod by the EDS through the syringe in the injection process.

[0017] In yet another embodiment, a method of operating a drug delivery device may include driving an insertion drive system (IDS) to insert an injection needle. The method may also include driving an extrusion drive system (EDS) to advance a plunger rod to expel fluid. The method may further include determining an end of injection in the drug delivery device based on completion of movement of the EDS in advancing the plunger rod to expel fluid.

[0018] In yet a further embodiment, a non-transitory computer readable medium is provided that stores computer readable instructions that, when executed by one or more processors, can cause the one or more processors to drive an insertion drive system (IDS) to insert an injection needle. Execution of the instructions by the one or more processors can cause the one or more processors to drive an extrusion drive system (EDS) to advance a plunger rod to expel fluid. Execution of the instructions by the one or more processors can further cause the one or more processors to determine an end of injection in the drug delivery device based on completion of movement of the EDS in advancing the plunger rod to expel fluid.

[0019] In another embodiment, the drug delivery device may include a housing configured to carry a syringe containing a medicament. The drug delivery device may also include an extrusion drive to selectively extrude the medicament from the syringe in an injection process. The drug delivery device may further include a first capacitance sensor generating a first output. The drug delivery device may still further include a second capacitance sensor generating a second output. The drug delivery device may also include a microcontroller that may be configured to enable the injection process based on a comparison of the first output to a first threshold and a comparison of the second output to a second threshold. The first threshold may be different from the second threshold.

[0020] In a further embodiment, a method of operating a drug delivery device may include generating a first capacitance sensor output by a first capacitance sensor carried by a housing of the drug delivery device. The method may also include generating a second capacitance sensor output by a second capacitance sensor carried by the housing of the drug delivery device. The method may further include enabling the injection process based on a comparison of the first output to a first threshold value and a comparison of the second output to a second threshold value. The first threshold value may be different from the second threshold value.

[0021] In yet another embodiment, a non-transitory computer readable medium is provided that stores computer readable instructions that, when executed by one or more processors, may cause the one or more processors to generate an output of a first capacitance sensor. Execution of the instructions by the one or more processors may further cause the one or more processors to generate an output of a second capacitance sensor. Execution of the instructions by the one or more processors may further cause the one or more processors to enable an injection process based on a comparison of the first output to a first threshold and a comparison of the second output to a second threshold. The first threshold may be different from the second threshold.

[0022] In yet another embodiment, the drug delivery device may include a housing configured to carry a syringe containing a medicament. The drug delivery device may also include an extrusion drive to selectively extrude the medicament from the syringe during an injection process. The drug delivery device may further include a plurality of electronic components. The drug delivery device may still further include at least one electrostatic discharge (ESD) protection device including a watchdog circuit and an ESD recovery module.

[0023] In yet a further embodiment, a method of operating a drug delivery device may include providing at least one drive mechanism. The method may also include providing a plurality of electronic components. The method may further include providing at least one electrostatic discharge protection device including a watchdog circuit and a recovery module.

[0024] In another embodiment, a non-transitory computer-readable medium is provided that stores computer-readable instructions that, when executed by one or more processors, can cause the one or more processors to provide at least one electrostatic discharge protection device including a watchdog circuit and a recovery module to provide ESD protection for at least one drive mechanism and a plurality of electronic components.

[0025] The present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings, in which: Some of the drawings may be simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omission of elements in some of the drawings does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless expressly specified in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0026] [Figure 1A] 1 illustrates an exemplary drug delivery system. [Figure 1B] 1 illustrates an exemplary drug delivery system. [Figure 1C] 1 illustrates an exemplary drug delivery system. [Figure 1D] 1 illustrates an exemplary drug delivery system. [Figure 2A] 1A-1D show various views of an exemplary drug delivery device. [Figure 2B] 1A-1D show various views of an exemplary drug delivery device. [Figure 2C] 1A-1D show various views of an exemplary drug delivery device. [Figure 2D] 1A-1D show various views of an exemplary drug delivery device. [Figure 2E] 1A-1D show various views of an exemplary drug delivery device. [Figure 2F] 1A-1D show various views of an exemplary drug delivery device. [Figure 2G] 1A-1D show various views of an exemplary drug delivery device. [Figure 3A] 1 shows a block diagram of an exemplary drug delivery system and an exemplary method of operating a drug delivery device. [Figure 3B] 1 shows a block diagram of an exemplary drug delivery system and an exemplary method of operating a drug delivery device. [Figure 3C] 1 shows a block diagram of an exemplary drug delivery system and an exemplary method of operating a drug delivery device. [Figure 3D] 1 shows a block diagram of an exemplary drug delivery system and an exemplary method of operating a drug delivery device. [Figure 3E] 1 shows a block diagram of an exemplary drug delivery system and an exemplary method of operating a drug delivery device. [Figure 4A] 1 illustrates an exemplary real-time clock for data communication within a drug delivery device. [Figure 4B] 1 illustrates an exemplary real-time clock for data communication within a drug delivery device. [Diagram 5] 1 illustrates an exemplary data communication disabling device for use within a drug delivery device. [Figure 6A] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6B] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6C] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6D] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6E] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6F] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6G] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6H] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6I] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6J] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6K] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6L] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6M] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6N] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6P] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6Q] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 6R] 1 illustrates an exemplary proximity sensor for use in a drug delivery device. [Figure 7A] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7B] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7C] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7D] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7E] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7F] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 7G] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8A] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8B] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8C] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8D] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8E] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8F]4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8G] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8H] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8I] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8J] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8K] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8L] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8M] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8N] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8P] 1 illustrates exemplary thresholds for use with a proximity sensor of a drug delivery device. [Figure 8Q] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8R] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8S] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8T] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8U] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8V-1] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8V-2] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8W]4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8X-1] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8X-2] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8Y] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 8Z] 4 illustrates exemplary threshold values ​​for use with a proximity sensor of a drug delivery device. [Figure 9A] 1 illustrates an exemplary electrostatic discharge protection for use in a drug delivery device. [Figure 9B] 1 illustrates an exemplary electrostatic discharge protection for use in a drug delivery device. [Figure 9C] 1 illustrates an exemplary electrostatic discharge protection for use in a drug delivery device. [Figure 9D] 1 illustrates an exemplary electrostatic discharge protection for use in a drug delivery device. [Figure 9E] 1 illustrates an exemplary electrostatic discharge protection for use in a drug delivery device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] Drug delivery devices, components for use within drug delivery devices, and methods of operating drug delivery devices are provided. As described herein, the drug delivery device may include using a real-time clock in a wireless communication module to communicate data with a remote device when the main microcontroller is in a sleep mode. This allows the main microcontroller to remain in a sleep mode for a period of time during which the drug delivery device is synchronized with the remote device. The power consumption of the main microcontroller may be less when the microcontroller is in a sleep mode than when the microcontroller is in an active mode.

[0028] As also described herein, the drug delivery device may include disabling communication between the main microcontroller and the wireless communication module when the main microcontroller is in an injection process, thereby allowing the processing resources of the main microcontroller to be dedicated to controlling the injection process, as well as increasing the security of the drug delivery device during the injection process.

[0029] As further described herein, the drug delivery device may include determining the end of an injection process based on data from the insertion drive and the extrusion drive. For example, the drug delivery device may be configured to deliver a particular drug as a single dose, or may be configured to deliver the drug sequentially as a series of individual doses over a period of time. If the drug is delivered sequentially as a series of individual doses, the end of any portion of the associated injection process (i.e., each individual dose) may be based, for example, on the extrusion drive data. If the drug is delivered as a single dose, the end of the associated injection process may be based, for example, on both the extrusion drive data and the insertion drive data.

[0030] As further described herein, the drug delivery device may include, for example, two proximity sensors (e.g., capacitance sensors, etc.) configured to detect when a proximal end of the drug delivery device is in proximity to a desired injection site (e.g., a user's skin surface, etc.). Each sensor may be associated with a unique threshold (e.g., an "in contact" threshold, a "no contact" threshold, etc.). The main microcontroller may determine proximity based on two different thresholds for each of the two sensors (four thresholds in total) configured to provide hysteresis to the output of each sensor.

[0031] As also described herein, the drug delivery device may include protection and recovery against electrostatic discharge (ESD). For example, the drug delivery device may include at least one ESD watchdog circuit configured to detect an ESD event. The drug delivery device may also include an ESD recovery module configured to attempt to recover operation of the drug delivery device based on an output of the ESD watchdog circuit.

[0032] 1A-1D, drug delivery systems 100a-d may include drug delivery devices 110a,c having associated drug cartridges 105a-c. For purposes of illustration, only one drug delivery device 110a,c and one drug cartridge 105a-c are included, but drug delivery systems 100a-d may include any number of drug delivery devices 110a,c and / or drug cartridges 105a-c.

[0033] The drug cartridges 105a-c may include an information label 106a (e.g., printed, near field communication device, bar code, QR code, etc.), a prefilled syringe 107a, and a needle cap 108a-c. The drug delivery devices 110a,c may include handles 111a,b configured to be grasped by a user's hands 103a-d with the user's thumb proximate the distal end 120a. The drug delivery devices 110a,c may include, for example, injection start buttons 112a,d proximate the distal end 120a.

[0034] The drug delivery device 110a,c may include a cartridge receptacle 113a,b and a cartridge receptacle opening device 114a,b. As shown in Figures 1B and 1C, a user may actuate the cartridge receptacle opening device 114a,b to open the cartridge receptacle 113a,b and insert a drug cartridge 105a-c. Once the drug cartridge 105a-c is in the drug delivery device 110a,c, the prefilled syringe 107a may be visible through a viewing window 119a.

[0035] The drug delivery device 110a,c may include a housing portion 115a, a status indicator 121d, a speaker 122d, an error display 123d, an injection progress indicator, and an injection rate switch 125d. Once a user has selected an injection rate via the switch 125d, the user can position the proximal end 118d of the drug delivery device 110a,c by the injection site 104d and press the start injection button 112d to begin the injection.

[0036] The drug delivery systems 100a-d may also include at least one remote site 150a. For purposes of illustration, only one remote site 150a is included in FIG. 1A, but the drug delivery systems 100a-d may include any number of remote sites 150a. Any remote site may include at least one non-transitory computer-readable medium 151a having modules 152a and at least one processor 153a. The modules 152a may include computer-readable instructions that, when executed by the at least one processor 153a, cause the processor 153a to communicate drug delivery device configuration data and / or infusion data between the drug delivery devices 110a,c and the remote site 150a. As described in more detail elsewhere herein, the drug delivery device configuration data may represent, for example, drug cartridge configuration data (e.g., manually entered via a user interface, automatically obtained via a cartridge QR code, automatically obtained via a cartridge bar code, automatically received from a cartridge manufacturer, etc.), real time clock configuration data, communication link configuration data, end of infusion detection configuration data, proximity sensor threshold configuration data, electrostatic discharge (ESD) protection configuration data, etc. The infusion data may represent, for example, a drug, a drug cartridge, an infusion date, an infusion time, an infusion rate, a drug delivery device proximity, a drug delivery device tilt, a request for drug delivery device data from a remote device, a transmission of drug delivery device data to a remote device, an end of delivery, a detection of an ESD event, etc. The drug delivery device data may represent, for example, a subcombination or combination of drug delivery device configuration data and infusion data.

[0037] 1A, the drug delivery devices 110a,c may be communicatively coupled to a network interface 156a via a network 160a, for example, to communicate drug delivery device configuration data and / or infusion data between the drug delivery devices 110a,c and the remote site 150a. The non-transitory computer readable medium 151a having the modules 152a may be embodied in either firmware or computer readable code, by way of example.

[0038] 2A-2G, the drug delivery devices 200a-g may include handles 211b,d. The drug delivery devices 200a-g may also include housing portions 215a,c. The drug delivery devices 200a-g may also include speakers 222a,c. The drug delivery devices 200a-g may also include information displays 224a,c. The drug delivery devices 200a-g may also include proximal ends 218a,b having proximity sensors 229a,b and needle / needle cap openings 228a,b. The drug delivery devices 200a-g may also include distal ends 220a-d having injection start buttons 212c,d. The drug delivery devices 200a-g may also include injection rate selectors 225a,c.

[0039] The drug delivery devices 200a-g may also include a drug cartridge receptacle 213b, d. The drug delivery devices 200a-g may also include a drug cartridge receptacle opening switch 214b, d. The drug delivery devices 200a-g may also include a sound on / off switch 226a, c. The drug delivery devices 200a-g may also include a first viewing window 227a, c. The drug delivery devices 200a-g may also include a second viewing window 219b, c. The drug delivery devices 200a-g may also include a battery 232e. The drug delivery devices 200a-g may also include an insertion drive 243g having an insertion drive position sensor 244g. The drug delivery devices 200a-g may also include a push drive 241e, f having a push drive position sensor 242f. The drug delivery devices 200a-g may also include a distal end cap 220e. The drug delivery devices 200a-g may also include a proximal end cap 230e.

[0040] The drug delivery devices 200a-g may also comprise drug cartridge receptacles 213b, d. The drug delivery devices 200a-g may also comprise electrostatic discharge (ESD) protection, for example, having at least one mechanical solution (e.g., making the device conductive, designing an insulation / ESD shield 233e, and / or distance between the housing and the electronics 298e) and at least one electronic solution (e.g., at least one ESD protection component / circuit 299e on the hardware, at least one Zener diode circuit 999f).

[0041] The drug delivery devices 200a-g may also include an infusion start / status assembly 212e. The drug delivery devices 200a-g may also include a cartridge ejection button assembly 114e. The drug delivery devices 200a-g may also include a first proximity sensor 234e (e.g., a capacitance sensor, etc.). The drug delivery devices 200a-g may also include a second proximity sensor 235e (e.g., a capacitance sensor, etc.). The drug delivery devices 200a-g may also include a proximity sensor attachment. The drug delivery devices 200a-g may also include a lower main printed circuit board 237e. The drug delivery devices 200a-g may also include an upper main printed circuit board 238e. The drug delivery devices 200a-g may also include a progress bar printed circuit board 239e. The drug delivery devices 200a-g may also include a handle printed circuit board 240e.

[0042] 3A-3E, drug delivery systems 300a-e may include drug delivery devices 310a-c in communication with remote devices (e.g., servers) 350a,d,e via a network 360a. Drug delivery devices 310a-c may be similar to, for example, drug delivery devices 110a,c of Figures 1A and 1B, respectively, or drug delivery devices of Figures 2A-2N. Remote devices 350a,d,e may be similar to, for example, remote site 150a of Figure 1A.

[0043] The drug delivery systems 300a-e may facilitate communication between the drug delivery devices 310a-c and remote devices 350a, d, e (e.g., remote servers, cloud-based resources, etc.), for example to provide drug delivery device configuration data and / or infusion data to the drug delivery device database 355a.

[0044] For clarity, only one drug delivery device 310a-c is shown in FIG. 3A. Although FIG. 3A shows only one drug delivery device 310a-c, it should be understood that any number of drug delivery devices 310a-c may be supported. The drug delivery devices 310a-c may comprise a memory 345a and a processor 347a for storing and executing modules 346a, respectively. The modules 346a stored in the memory 345a as a set of computer readable instructions may relate to applications for configuration of the drug delivery device, automatic control of the injection process, and generation of injection data.

[0045] As described in more detail herein, the module 346a may facilitate interactions between the associated drug delivery devices 310a-c and the remote devices 350a,d,e. For example, the processor 347a may further execute the module 346a to facilitate communications between the remote devices 350a,d,e and the drug delivery devices 310a-c via the network interface 348a, the communication link 361a, the network 360a, the remote device communication link 362a, and the remote device network interface 356a.

[0046] The drug delivery devices 310a-c may include an insertion drive 343a, an extrusion drive 341a, a first proximity sensor 334a, a second proximity sensor 335a, an electrostatic discharge (ESD) watchdog circuit 397a, and an ESD protection / recovery 399a. The drug delivery devices 310a-c may include a user interface 322a along with a user input device, which may be any type of electronic display device, such as a touch screen display, a liquid crystal display (LCD), a light emitting diode (LED) display, a plasma display, a cathode ray tube (CRT) display, or any other type of known or suitable electronic display. The user interface 322a may present a user interface (e.g., any of the user interfaces 121d, 123d, 124d, 154a, etc.) that presents a user interface for configuring the drug delivery devices 310a-c to communicate with remote devices 350a, d, e.

[0047] The network interface 360a may be configured to facilitate communication between the drug delivery devices 310a-c and the remote devices 350a,d,e via any wireless communication network 360a, including, for example, a Bluetooth low energy (BLE) device, a wireless LAN, MAN, or WAN, WiFi, the Internet, or any combination thereof. Furthermore, the drug delivery devices 310a-c may be communicatively connected to the remote devices 350a,d,e via any suitable communication system, such as any publicly available or privately owned communication network, including those using wireless communication structures, such as wireless LAN and WAN, wireless communication networks including satellite and cellular communication systems, and the like. The drug delivery devices 310a-c may transmit and store, for example, drug delivery device configuration data and / or infusion data, for example, to the remote devices 350a,d,e, memory 351a, and / or drug delivery device database 355a.

[0048] The remote devices 350a, d, e may include a user interface 354a, a memory 351a, and a processor 353a for storing and executing modules 352a, respectively. The modules 352a stored in the memory 351a as a set of computer readable instructions may facilitate applications related to controlling a drug delivery infusion process. The modules 352a may also facilitate communication between the remote devices 350a, d, e and the drug delivery devices 310a-c via a network interface 356a and a network 360a, as well as other functions and instructions.

[0049] The remote devices 350a, d, e may be communicatively coupled to the drug delivery devices 310a-c. Although the drug delivery device database 355a is shown in FIG. 3A as being communicatively coupled to the remote device 350a, it should be understood that the drug delivery device database 355a may be located in a separate remote server (or any other suitable computing device) communicatively coupled to the remote devices 350a, d, e. Optionally, portions of the drug delivery device database 355a may be associated with memory modules that are separate from one another, such as the memories 345a of the drug delivery devices 310a-c.

[0050] The drug delivery device 310a-c may include, for example, a user interface generation module 346b, a drug delivery device configuration data receiving module 347b, a drug delivery device configuration data generation module 348b, a main microcontroller sleep mode determination module 349b, a remote device communication request receiving module 350b, a real time clock and connection determination module 351b, an injection process progress determination module 352b, a communication link disable module 353b, an insertion drive data generation module 354b, an extrusion drive data generation module 355b, an injection process end determination module 356b, a proximity sensor data receiving module 357b, a drug delivery device proximity data generating module 358b, an electrostatic discharge (ESD) watchdog circuit data receiving module 359b, an ESD protection and recovery data generating module 360b, a drug delivery device data storage module 361b, and a drug delivery device data transmission module 362b stored in memory 345b as a set of computer readable instructions. In either case, modules 346b-362b may be similar to, for example, module 346a of FIG. 3A.

[0051] The method 300c of operating a drug delivery device may be implemented, for example, by a first processor (e.g., processor 347a) executing at least a portion of modules 346b-362b. In particular, processor 347a may execute user interface generation module 346b, causing processor 347a to generate, for example, user interface 322a (block 346c). The user interface may enable a user to input and / or view, for example, drug delivery device configuration data and / or infusion data.

[0052] The processor 347a may execute a drug delivery device configuration data receiving module 347b to cause the processor 347a to receive drug delivery device configuration data, for example, from a remote device (block 347c). The processor 347a may execute a drug delivery device configuration data generating module 348b to cause the processor 347a to generate, for example, drug delivery device configuration data (block 348c). The drug delivery device configuration data may represent, for example, drug cartridge configuration data (e.g., manually entered via a user interface, automatically obtained via a cartridge QR code, automatically obtained via a cartridge barcode, automatically received from a cartridge manufacturer, etc.), real-time clock configuration data, communication link configuration data, end of infusion detection configuration data, proximity sensor threshold configuration data, electrostatic discharge (ESD) protection configuration data, etc.

[0053] The processor 347a may execute the main microcontroller sleep mode determination module 349b to cause the processor 347a to determine, for example, whether the main microcontroller is currently in a sleep mode or an active mode (block 349c). For example, the processor 347a may determine whether the main microcontroller is currently in a sleep mode or an active mode based on data provided by the main microcontroller (block 349c).

[0054] The processor 347a may execute the remote device communication request receiving module 350b to cause the processor 347a to receive, for example, a request from a remote device (block 350c). The processor 347a may execute the real-time clock and connection determination module 351b to cause the processor 347a to determine, for example, a real-time clock (e.g., a real-time clock of a main microcontroller, a real-time clock of a wireless communication module, etc.) to connect to a remote device (block 351c).

[0055] The processor 347a may execute the injection process progress determination module 352b to cause the processor 347a to determine, for example, the progress of a current injection process (block 352c). The processor 347a may execute the communication link disable module 353b to cause the processor 347a to disable, for example, the communication link 361a (block 353c). The processor 347a may execute the insertion drive data generation module 354b to cause the processor 347a to control and / or monitor, for example, the insertion drive (block 354c). The processor 347a may execute the extrusion drive data generation module 355b to cause the processor 347a to control and / or monitor, for example, the extrusion drive (block 355c).

[0056] The processor 347a may execute the injection process end determination module 356b to cause the processor 347a to determine, for example, the end of the injection process (block 356c). For example, the processor 347a may determine the end of the injection process based on the insertion drive data, the extrusion drive data, a combination of the insertion drive data and the extrusion drive data, etc. In the case of an electromechanical autoinjector, determining the end of the autoinjector injection can ensure a safe and effective injection. The determination of the end of the injection relies on the use of algorithms programmed in the software to evaluate signals and data from associated hardware throughout the injection process.

[0057] The autoinjector may include software, a printed circuit board assembly (PCBA), an extrusion drive system (EDS) with a plunger rod for fluid extrusion, and an insertion drive system (IDS) for needle insertion and retraction. After a separate cartridge with a prefilled syringe is inserted into the autoinjector and an injection is started by pressing a button, a typical injection process is as follows: 1) the IDS may be actuated to insert the injection needle; 2) the EDS may be actuated to advance the plunger rod to extrude the fluid; 3) the EDS may partially retract the plunger rod; and 4) the IDS may retract the injection needle.

[0058] Software logic may be used to determine the end of injection after the IDS retracts the needle. Additional software logic / algorithms may be added to determine the end of injection based on the completion of the EDS movement as it advances the plunger rod to expel fluid. The addition of software logic allows the autoinjector to more accurately determine the end of injection compared to determining the end of injection after the IDS retracts the needle.

[0059] The processor 347a may execute a proximity sensor data receiving module 357b to cause the processor 347a to receive, for example, proximity sensor data (block 357c). The processor 347a may execute a drug delivery device proximity data generating module 358b to cause the processor 347a to generate, for example, drug delivery device proximity data (block 358c). The processor 347a may execute an ESD watchdog circuit data receiving module 359b to cause the processor 347a to receive, for example, ESD watchdog data (block 359c). The processor 347a may execute an ESD protection and recovery data generating module 360b to cause the processor 347a to generate, for example, ESD protection and recovery data (block 360c). The processor 347a may execute a drug delivery device data storing module 361b to cause the processor 347a to store, for example, drug delivery device configuration data and / or infusion data (block 361c). The processor 347a may execute a drug delivery device data transmission module 362b to cause the processor 347a to transmit, for example, drug delivery device configuration data and / or infusion data (block 362c).

[0060] The remote device 350a,d may include, for example, a user interface generation module 352d, a drug delivery device configuration data generation module 353d, a drug delivery device configuration data transmission module 354d, a drug delivery device data receiving module 355d, a drug delivery device data storage module 356d, and a drug delivery device data analysis / reporting module 457d stored in a memory 351d as a set of computer readable instructions. In any case, the modules 352d-357d may be similar to, for example, the module 352a of FIG. 3A.

[0061] The method 300e of operating a remote device may be implemented, for example, by a processor (e.g., processor 353a) executing at least a portion of modules 352d through 357d. In particular, processor 353a may execute user interface generation module 352d to cause processor 353a to generate, for example, user interface 354a (block 352e).

[0062] The processor 353a may execute a drug delivery device configuration data generation module 353d to cause the processor 353a to generate, for example, drug delivery device configuration data (block 353e). The processor 353a may execute a drug delivery device configuration data transmission module 354d to cause the processor 353a to generate, for example, drug delivery device configuration data (block 354e). The drug delivery device configuration data may represent, for example, drug cartridge configuration data (e.g., manually entered via a user interface, automatically obtained via a cartridge QR code, automatically obtained via a cartridge barcode, automatically received from a cartridge manufacturer, etc.), real-time clock configuration data, communication link configuration data, end of infusion detection configuration data, proximity sensor threshold configuration data, electrostatic discharge (ESD) protection configuration data, etc.

[0063] The processor 353a may execute a drug delivery device data receiving module 355d to cause the processor 353a to receive, for example, data of a drug delivery device (block 355e). The processor 353a may execute a drug delivery device data storing module 356d to cause the processor 353a to store, for example, data of a drug delivery device (block 356e). The processor 353a may execute a drug delivery device data analysis / reporting module 357d to cause the processor 353a to analyze and report, for example, data of a drug delivery device (block 357e).

[0064] Referring to Figures 4A and 4B, the drug delivery device 400a,b may include a main microcontroller 465a,b having a first real-time clock 466a,b communicatively connected to a wireless communication module 467a,b having a second real-time clock 468a,b via a communication channel 469a,b.

[0065] The real-time clock (RTC) is one of the main components of any embedded device, especially medical devices, and is used to keep track of time and date. Since an autoinjector device is used to deliver medication in a timely manner, it is important to know the correct time on the device. The device's time is set to UTC and there is minimal drift with time to maintain accurate timing. This disclosure relates to the use of a real-time clock in an autoinjector device (ATC). The autoinjector is composed of two embedded components: a main microcontroller (μC) and a BLE module. The main μC has essential peripheral accessories on chip and is called a system on chip (SOC). The real-time clock is one of the embedded sub-components of this SOC. The real-time clock has a crystal oscillator with a crystal oscillator frequency of 32.768KHz, which runs in the active cycle of the main μC to provide live real time. Additionally, the BLE module, which is responsible for Bluetooth connectivity and consumes less power, also has its own RTC. The two components, the main μC and the BLE module, communicate through a serial communication channel (UART). For data exchange between them, both must be running in active mode. An external BLE-enabled device can connect to the device, pair with it, and read the device's time for synchronization.

[0066] If for any reason the autoinjector and therefore the main μC goes into sleep mode in case of a time reading request from an external BLE enabled device, the UART communication between the main μC and the BLE module will be inactive. As a result, live clock time will not be reported to the BLE module and external BLE enabled device, even though the RTC in the main μC is still ticking. To solve this issue, we utilized the RTC clock in the BLE module instead of the RTC in the main μC. The BLE module uses significantly less power compared to the main μC, so it can be kept on in active mode for a long time, while at the same time the main μC and the communication channel between the main μC and BLE can be in sleep mode / inactive. This approach ensures live real time whenever there is a request from an external BLE enabled device.

[0067] Referring to FIG. 5, the drug delivery device 500 may include a main microcontroller 565 communicatively connected to a wireless communication module 567 via a communication channel 569 .

[0068] A medical device may consist of multiple processing modules that are interconnected and communicate data with each other. If any of these modules can connect / communicate outside the system, these interconnections become open channels that may introduce security holes into the system. One example of such a system is an autoinjector, a sensitive device used to administer drugs to patients. During drug administration, it is important to disable external communication channels to ensure that no man-in-the-middle can interfere with the critical function of drug administration.

[0069] In the design architecture of the autoinjector, there can be two microcontrollers, each handling a specific process. One is the main microcontroller of the STM32 family, and the other microcontroller is in the BLE module, which is the nRF52 family. The main microcontroller is responsible for all the critical functions of the autoinjector related to drug administration, such as drug extrusion, needle insertion, and needle retraction. It also serves for all other non-critical functions of the autoinjector. The BLE microcontroller is responsible for the Bluetooth connectivity function and consumes less power compared to the main microcontroller. They can communicate with each other through various communication methods, such as I2C, GPIO, SPI, or UART. In this specific design, UART is utilized for communication between the two. The communication protocol between the two microcontrollers is based on bidirectional asynchronous communication with flow control.

[0070] The BLE module is an open port for interfacing with another BLE-enabled device, such as a mobile device, and is connected to the main microcontroller via UART, so it can send and receive data to and from the main microcontroller, occupying the processing time of the main microcontroller. As the BLE module is the only non-physical communication port to the device, it is vulnerable to man-in-the-middle and unauthorized direct data access (UDDA) cybersecurity attacks. In a cybersecurity attack scenario, the BLE microcontroller can be accessed by a man-in-the-middle, which can flood the main microcontroller with unnecessary requests and occupy the processing bandwidth of the main microcontroller. Such attacks can affect the functionality of the main microcontroller, which processes processes based on interrupt priorities. During the injection process, it is essential to prevent interruptions to the main microcontroller to reduce the risk of device failure and allow the main microcontroller to focus on processing the injection-critical functions. To prevent cybersecurity attack scenarios during injection and ensure proper processing of the injection process by the main microcontroller, we introduced an improvement to disable the communication method between the two microcontrollers, in this case the UAR communication channel between the main microcontroller and the BLE module. The main microcontroller still processes the injection tasks, so there is no impact on the entire injection process. This significantly improves the cybersecurity of the device during injection as the access port is disabled, eliminating the risk of surrendering control of the main microcontroller to a man-in-the-middle, thus ensuring uninterrupted injection.

[0071] With reference to Figures 6A-6N and 6P-6R, the drug delivery device 600a-n, p-r may include two proximity sensors 234e, 235f. With further reference to Figures 7A-7G, the drug delivery device 700a-g may include a threshold for use with the proximity sensor. With further reference to Figures 8A-8N and 8P-8Z, the drug delivery device 700a-g may include a threshold for use with the proximity sensor. Capacitive sensors may be used in medical devices to detect the presence of human skin based on the difference in capacitance observed by the sensor. When detecting skin, it is important to allow flexibility in detection based on variations in normal use by end users or manufacturing variations. Multiple unique capacitive sensor thresholds may be revealed through software to detect skin in an autoinjector built with, for example, an STM32 microcontroller or any chipset utilizing charge transfer acquisition principles for detection of capacitive surfaces.

[0072] The charge transfer acquisition principle consists of charging the sensor capacitor, transferring the stored charge to the sampling capacitor, and repeating until the voltage on the sampling capacitor reaches a maximum voltage. When the sensor detects skin, the capacitance to ground increases, so the signal count and the voltage required to reach the maximum voltage decrease. When these values ​​fall below a defined threshold, the software indicates the detection of skin.

[0073] Skin detection in an autoinjector requires software and hardware components. The hardware consists of a microcontroller that includes a Touch Sensing Controller peripheral (TSC) and utilizes the charge transfer acquisition principle to detect capacitive surfaces. The microcontroller software includes a Touch Sensing Library (TSL) API and is used to process signals and manage signal thresholds based on signals from the hardware.

[0074] The TSL API allows each capacitive sensor channel to be independently tuned. By adjusting individual parameters at the TSC level, TSL allows a unique threshold to be applied to each capacitive sensor channel independently. This allows the capacitive sensor thresholds to be set to potentially compensate for normal end-user use, different skin types or conditions, or variations in manufacturing.

[0075] Figures 6A and 6B show touch sensing, the most important abbreviations are explained below: Acquisition mode is CT (Charge Transfer) acquisition principle. This mode is used in STM microcontrollers. Touch sensing STM32 peripheral is TSC (Touch Sensing Controller) peripheral. Sensor is Touchkey or TKey (Single Channel Sensor). STM32 software is TSL (Touch Sensing Library). Delta is the difference between the measurement value and the reference value. Measurement is the current signal measured on the channel. Reference is a reference signal based on the average value of a sample of measurements.

[0076] The STM32 touch sensing function is based on charge transfer. The surface charge transfer acquisition principle consists in charging a sensor capacitor (Cx) and transferring the accumulated charge to a sampling capacitor (Cs). This sequence is repeated until the voltage across Cs reaches V IH This is repeated until the threshold is reached. The number of charge transfers required to reach the threshold directly represents the size of the electrode capacitance. When the sensor is touched, the sensor capacitance to ground increases. This means that the C voltage drops to V for a small number of counts. IH, which means the measurement drops. When the measurement falls below the threshold, detection is reported by TSL upper statistical thresholds 676_, 678_, 776_, 778_, 876_, and 878_, as used in Figures 6A-8Z, which may represent, for example, that the proximal end of the drug delivery device is 2 mm from the injection site. As used in Figures 6A-8Z, lower statistical thresholds 677_, 679_, 777_, 779_, 877_, and 879_, may represent, for example, that the proximal end of the drug delivery device is 0.5 mm from the injection site.

[0077] With further reference to Figures 8A-8N and 8P-8Z, the described FW modification introduces a new evaluation physical dimension, namely the tilt angle. The evaluation cannot be done with the current DV test fixture. To further test the FW modification, a moving plate fixture was designed. The provided fixture shall aim to measure the distance when the pad detects contact or loss of contact with a moving (conductive) object. The provided fixture shall require that it allows independent measurements on each sensor, pad 1 and pad 2. A graduated scale shall be provided to set a zero reference when the device's capacitive sensor is touching the surface. A handle or mechanism shall be provided to move the conductive surface closer or further away from the device's capacitive sensor. When the device is touching the entire capacitive sensor (display view) on both surfaces, the reference of the fixture shall be set to 0 mm. A: left geometric reference point*, B: right geometric reference point*, r: distance AB**, (*) is the display view, (**) is equal to the width of the nose bottom.

[0078] 9A-9E, electrostatic discharge (ESD) protection 900a-f may include hardware ESD protection 999e, 998d-f, firmware ESD protection 900b, and / or software ESD protection. Electrostatic discharge (ESD) is a common cause of malfunction or damage to portable or wearable electromechanical drug delivery devices, resulting in failed administration or delayed treatment. ESD protection and recovery solutions may be achieved through hardware architecture and firmware logic. This unique design takes into account the device form factor and user interface, which generally makes the device vulnerable due to ESD creep that can electrically damage or destroy the internal semiconductors. This design considers cost, effectiveness, and operational sequence tradeoffs to achieve a feasible and manufacturable solution for most of the typical drug delivery devices.

[0079] There are three factors that cause ESD: movement or friction, non-conductive materials, and dry air. Typical static voltages can reach up to 30KV in dry environments, which can easily affect the stability and lifespan of electronic devices. Portable or wearable drug delivery devices, such as autoinjectors, mini-injectors, patch pumps, or internal syringes, are commonly used in environments with the above three factors, and are therefore subject to interference or damage from ESD. Drug delivery devices consist of an injection site detection part that contacts the patient's skin or body, a needle insertion interface that connects the drug solution to the patient's tissue, a hand-holding area and activation button that contact the patient's hand, and a debug port that connects to test equipment, so all of these ports need to have ESD protection. These ports conduct ESD currents to the device housing. During operation, different areas of the device come into contact with the patient in different time sequences, durations, or with different press pressures (e.g., a patient usually first presses the cassette door eject button to load the cassette, then closes the door before placing the device at the injection site), and therefore require different levels of protection accordingly. The cassette door ejection button requires a higher ESD protection voltage since the injection site is the first to contact the patient. Meanwhile, some areas that do not contact the patient first do not need as high ESD voltage protection to save material costs. Furthermore, based on the patient contact distance to the ESD sensitive internal components, the autoinjector may be provided with different levels of ESD protection with different ESD protection circuits or components for this purpose as well. Furthermore, some areas that are not susceptible to ESD do not need ESD protection. This disclosure documents unique designs from each of the hardware and firmware designs to implement different ESD voltage protection levels to effectively and economically mitigate damage. FIG. 9A shows a hardware protection solution based on ESD voltage analysis and user contact sequence and frequency.Typically, the user interface for device operation, such as the cassette door eject button for loading / unloading, has a higher ESD voltage and the activation button has a lower ESD voltage, which is implemented with different ESD suppression devices to reduce material or (production) costs.

[0080] In many cases, ESD does not permanently damage electronic components, but instead puts semiconductors into the wrong state (binary 0 / 1 inversion), which causes the device to fail or freeze. When this situation occurs, drug delivery devices are designed with logic to recover from the failure. If the user interface portion of the circuit is in a fault state or freeze mode, the main processor attempts to reset or power cycle that portion of the circuit to recover. Once the circuit is recovered, the device resumes the procedure where it left off. The automatic recovery process may take only milliseconds, for example, so that the user is unaware of the recovery process under the hood, and the patient has confidence in the treatment. If any part of the circuit is not recoverable, the event is logged for debugging and analysis purposes, and then it is shut down without incident. Firmware recovery does not add cost to the bill of materials. If the main processor is interrupted or damaged by ESD, a watchdog circuit is activated to reset the entire system and attempt recovery with the same logic that the main processor uses to recover the circuitry related to the user interface.

[0081] FIG. 9B illustrates firmware logic for recovering from an ESD interference event. The main microprocessor starts (block 946b) and a watchdog circuit input may be received (block 947b). If a watchdog read command is not received in block 947b, an OK watchdog timer reset may be generated (block 948b). A watchdog signal (e.g., status in memory, status register, etc.) may be read by the main processor (block 949b). A determination is made regarding the watchdog signal (block 950b). If the peripheral device indicates a response block 950b, the process continues (block 951b). If the peripheral device does not indicate a response block 950b, at least one peripheral device read retry may be attempted (block 952b). As illustrated in FIG. 9B, the "retry" may be attempted at least once before a drug delivery device ESD error is determined (blocks 950b-958b).

[0082] As a specific example, if the main processor reads the status of the watchdog circuit, the watchdog can know that a read has occurred and can then reset the watchdog's timer without triggering a reset signal for the main processor. The main processor can, for example, read the watchdog and indicate to the watchdog that it has been read by the main processor (i.e., it is not intended to read data itself). The watchdog can include a timer. If the watchdog is not read by the main processor within a preset time, the watchdog may send a signal to reset the main processor (i.e., if the watchdog is not read by the main processor within a preset time, it means that the main processor may be frozen, the logic may contain errors, etc.). The watchdog circuit can be constructed as a very simple component. The watchdog circuit can be ESD resistant and not easily damaged or inadvertently interrupted.

[0083] Mechanical ESD protection / recovery solutions may include, for example: making the device conductive or designing insulation / distance between the housing and the electronics. Electronic solutions may include, for example, adding ESD protection components / circuitry on the hardware. Software ESD protection / recovery solutions may include, for example, masking ESD errors by adding watchdog circuits and software recovery.

[0084] The above description describes various devices, assemblies, components, subsystems, and methods for use in conjunction with drug delivery devices, such as pre-filled syringes. The devices, assemblies, components, subsystems, methods, or drug delivery devices (i.e., pre-filled syringes) may further include or be used with drugs, including, but not limited to, the drugs listed below, as well as corresponding generics and biosimilars. As used herein, the term "drug" can be used interchangeably with other synonyms and can be used to refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, bioactive substances and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generics. Non-therapeutic injectables are also included. Drugs may be in liquid, lyophilized, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0085] The drug is contained in a reservoir, for example, in a pre-filled syringe. In some instances, the reservoir is a primary container that is filled or pre-filled with the drug treatment. The primary container may be a vial, a cartridge, or a pre-filled syringe.

[0086] In some embodiments, the reservoir of the drug delivery device may be loaded with or used in conjunction with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0087] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, the term "erythropoietin stimulating protein" refers to any protein that directly or indirectly activates the erythropoietin receptor, for example, by binding to the receptor and causing dimerization. Erythropoietin stimulating proteins include erythropoietin and 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. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), epoetin alfa hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (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.

[0088] Among certain exemplary proteins are the following specific proteins, including fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized 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., which in particular inhibit activities mediated by binding of IL-4 and / or IL-13 to its 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., in particular dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., epratuzumab (CAS Registry No. 501423-23-0 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, including, but not limited to, human CD22 specific IgG antibodies, particularly including, but not limited to, human CD22 specific fully humanized antibodies such as the human CD22 specific fully humanized antibodies of HuMax; IGF-1 receptor specific antibodies, including, but not limited to, anti-IGF-1R antibodies, peptibodies and related proteins; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like, including, but not limited to, those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including, but not limited to, a B7RP specific fully human monoclonal IgG2 antibody, including, but not limited to, a fully human IgG2 monoclonal antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1; IL-15 specific antibodies, such as humanized monoclonal antibodies, peptibodies, related proteins, and the like, including, but not limited to, IL-15 antibodies and related proteins;IFN gamma specific antibodies, including but not limited to, human IFN gamma specific antibodies, including but not limited to, fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF), etc. Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:cMet axis (HGF / SF:c-Met); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; Activin A specific antibodies, peptibodies, proteins, etc.; TGF-beta specific antibodies, peptibodies, related proteins, etc.; Amyloid-beta protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors. , peptibodies, related proteins, etc.; OX40L-specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, new erythropoiesis-stimulating protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® ) (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNF alpha monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; 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 1 fibrogen (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-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); 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).

[0089] In some embodiments, the drug delivery device may contain or be used with sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or used with IMLYGIC® (talimogene laherparepvec) or another oncolyte HSV, including but not limited to OncoVEXGALV / CD, OrienX010, G207, 1716, NV1020, NV12023, NV1034, and NV1042 for the treatment of melanoma or other cancers. In some embodiments, the drug delivery device may contain or be used with an endogenous tissue inhibitor of metalloproteinase (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), another product containing anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or erenumab, for the treatment of migraine headaches. Antagonist antibodies against the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets, can also be delivered by the drug delivery device of the present disclosure.Bispecific T cell engager (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), may also be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ macromolecular agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNF-alpha monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab, for the treatment of autoimmune disease. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used with Parsabiv™ (etelcalcetide hydrochloride, KAI-4169) or another product containing etelcalcetide hydrochloride for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 350), a new bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS. G12C Small molecule inhibitors, or KRAS G12CIt may contain or be used with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product that contains a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160 or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133 or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171 or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176 or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199 or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product that contains AMG 430 or an anti-Jagged-1 monoclonal antibody.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 506 or a multispecific FAPx4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with efavalukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may house or be used in conjunction with another product containing AMG 596 or CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecules. In some embodiments, the drug delivery device may house or be used in conjunction with another product containing AMG 673 or half-life extension (HL. E) The drug delivery device may contain or be used with another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 757 or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0090] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to these embodiments. The detailed description should be construed as merely exemplary and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0091] The detailed description is illustrative only and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be realized that fall within the scope of the claims defining the invention disclosed herein, using either current technology or technology developed after the filing date of this patent. Those skilled in the art will understand that a wide range of modifications, variations, and combinations can be made with respect to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are considered to be within the scope of the inventive concept.

Claims

1. a housing configured to carry a syringe containing a medicament; an extrusion drive for selectively extruding the medication from the syringe during an injection process; a main microcontroller and a wireless communication module carried by said housing; A drug delivery device comprising: the main microcontroller and the wireless communication module are communicatively connected via a communication channel; the main microcontroller includes a first real-time clock; the main microcontroller is configured to generate injection data based on the first real-time clock; the wireless communication module comprises a peripheral interface and a second real-time clock; The drug delivery device, wherein the peripheral interface is configured to communicate the infusion data to a remote device based on the second real-time clock.

2. The drug delivery device of claim 1 , wherein the main microcontroller is configured to automatically control at least a portion of the drug infusion process.

3. The drug delivery device of claim 1 , wherein the second real-time clock is for synchronization with an external wireless device connected to and paired with the peripheral interface.

4. a memory, wherein the main microcontroller is configured to automatically store the injection data in the memory; The drug delivery device according to any one of claims 1 to 3, further comprising:

5. The drug delivery device of claim 4 , wherein the wireless communication module is configured to read the infusion data from the memory.

6. 1. A method of operating a drug delivery device, said method comprising: providing a main microcontroller communicatively connected to a wireless communication module via a communication channel, the main microcontroller includes a first real-time clock; the main microcontroller is configured to generate infusion data based on the first real-time clock and to control at least a portion of a drug infusion process based on drug delivery device configuration data; providing the wireless communication module comprising a peripheral interface and a second real-time clock; communicating the injection data through the peripheral interface based on the second real-time clock; A method comprising:

7. The method of claim 6 , wherein the main microcontroller is configured to automatically control at least a portion of the drug infusion process.

8. The method of claim 6 , wherein the wireless communication module is configured to transmit the injection data to an external wireless device via the peripheral interface.

9. The method of any one of claims 6 to 8, wherein the wireless communication module comprises a Bluetooth low energy (BLE) device.

10. The method of any one of claims 6 to 8, wherein the external wireless device is Bluetooth low energy (BLE) enabled.

11. The method of any one of claims 6 to 8, wherein the timestamp is based on the first real-time clock when the main microcontroller is active.

12. 1. A non-transitory computer-readable medium storing computer-readable instructions that, when executed by one or more processors of a drug delivery device, cause the one or more processors to: receiving a first real-time clock signal from a main microcontroller communicatively coupled to the wireless communication module via a communication channel, the main microcontroller configured to generate infusion data and control at least a portion of a drug infusion process; receiving a second real-time clock signal from the wireless communication module; A non-transitory computer-readable medium that causes the injection data to be communicated via a peripheral interface of the wireless communication module based on the second real-time clock.

13. 13. The non-transitory computer-readable medium of claim 12, wherein the main microcontroller is configured to automatically control at least a portion of the drug infusion process.

14. connecting and pairing an external wireless device with the peripheral interface, wherein the second real-time clock is used for synchronization; The non-transitory computer-readable medium of claim 12 further comprising:

15. automatically storing said injection data in memory using said main microcontroller; The non-transitory computer-readable medium of any one of claims 12 to 14, further comprising:

16. The non-transitory computer-readable medium of any one of claims 12 to 14, wherein the wireless communication module is configured to obtain the injection data from the main microcontroller.

17. 15. The non-transitory computer-readable medium of claim 12, wherein when the main microcontroller is in a sleep mode, at least one of a time read request or a date read request is based on the second real-time clock.

18. 15. The non-transitory computer-readable medium of claim 12, wherein the communication channel is selected from the group comprising a UART channel, an I2C channel, an SPI channel, or a GPIO channel.

19. 15. The non-transitory computer-readable medium of claim 12, wherein the first real-time clock is used to track date stamps and time stamps associated with the injection data.

20. The non-transitory computer-readable medium of any one of claims 12 to 14, wherein the drug delivery device is configured to deliver a medication based on the first real-time clock.

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