Drug delivery device with motion sensing

Abstract

A drug delivery device comprising a sensor for evaluating movement of the device relative to a body to which the device is attached, and at least one processor in communication with the sensor, the at least one processor is programmed or configured to receive data associated with the sensor from the sensor, determine a characteristic associated with the sensor based on the data received from the sensor, determine whether the characteristic associated with the sensor satisfies a threshold, and determine whether the characteristic associated with the sensor satisfies the threshold. And performing an action based on a determination that the data received from the sensor satisfies the threshold.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 349,797, filed on June 7, 2022, and entitled “Drug Delivery Device with Movement Sensing,” the entire disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Medical injectors (e.g., wearable drug delivery systems, wearable injection devices, wearable auto-injectors, on-body injectors (OBIS), on-body delivery systems (OBDS), auto-injectors, intravenous (IV) catheters, IV ports, transdermal delivery patches, etc.) can provide drug therapy to patients when the patient is located away from a clinical facility and / or discretely worn under the patient's clothing. The wearable injector can be applied to the patient's skin and can be configured to automatically or based on the user's command when the wearable injector is applied to (e.g., positioned on) the patient's skin, such as after a delay of a predetermined time period or immediately upon application of the wearable injector. In some cases, the wearable injector can deliver the drug to the patient over a period of time. After the wearable injector delivers the drug composition to the patient, the patient can then remove and dispose of the device.

[0004] In some cases, the wearable injector may move while it is applied to the patient's body. For example, after the wearable injector is applied to a patient's limb, the position of the wearable injector may change based on the movement of the patient's limb. In some cases, the wearable injector and its components (e.g., cannula and / or needle) may shift from the intended position based on the patient's movement. The movement of the wearable injector may disrupt the correct delivery of the drug to the patient. In some cases, if violent movement occurs, the wearable injector may fall off the patient, thereby interrupting the delivery of the drug.

[0005] Therefore, it would be beneficial to determine whether the wearable injector is properly positioned on the patient's body to ensure that the drug is correctly delivered to the patient. Summary of the invention

[0006] Accordingly, improved systems, devices, products, apparatus and / or methods for sensing movement of a drug delivery device are provided.

[0007] Further non-limiting embodiments or aspects are set forth in the following numbered items:

[0008] Article 1: A drug delivery device for delivering a drug to a patient, the drug delivery device comprising: a cannula in fluid communication with a reservoir; at least one sensor; and at least one processor in communication with the sensor. The at least one processor is programmed or configured to: receive data associated with the sensor from the sensor; determine a characteristic associated with the sensor based on the data received from the sensor, wherein the characteristic is relative movement between the drug delivery device and the patient; determine whether the characteristic associated with the sensor satisfies a threshold; and perform an action based on determining that the data received from the sensor satisfies the threshold.

[0009] Clause 2: The drug delivery device of clause 1, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to: receive data from the acceleration sensor associated with the acceleration of the acceleration sensor; wherein when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determine a velocity of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to determine whether the velocity of the acceleration sensor satisfies a velocity threshold; and wherein when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the velocity of the acceleration sensor satisfies the velocity threshold.

[0010] Clause 3: A drug delivery device according to Clause 1, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to: receive data from the acceleration sensor associated with the acceleration of the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to determine an amount of inertial force of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determine whether the amount of inertial force of the acceleration sensor satisfies a force threshold; and wherein, when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the inertial force of the acceleration sensor satisfies the force threshold.

[0011] Clause 4: A drug delivery device according to Clause 3, wherein when determining the amount of the inertial force, the at least one processor is programmed or configured to: determine a first amount of the inertial force in the first direction based on first data associated with the acceleration of the acceleration sensor in the first direction; determine a second amount of the inertial force in the second direction based on second data associated with the acceleration of the acceleration sensor in the second direction. When determining whether the inertial force of the acceleration sensor satisfies the force threshold, the at least one processor is programmed or configured to: determine whether the first amount of the inertial force in the first direction satisfies the first force threshold; determine whether the second amount of the inertial force in the second direction satisfies the second force threshold; and when performing the action, the at least one processor is programmed or configured to: perform the action based on determining that the first amount of the inertial force in the first direction satisfies the first force threshold or the second amount of the inertial force in the second direction satisfies the second force threshold.

[0012] Clause 5: The drug delivery device of clause 1, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data from the acceleration sensor associated with the acceleration of the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determine a first vector value of the acceleration of the acceleration sensor in a first direction based on the data associated with the acceleration of the acceleration sensor; determine a second vector value of the acceleration of the acceleration sensor in a second direction based on the data associated with the acceleration of the acceleration sensor; and determine a composite acceleration vector of the acceleration of the acceleration sensor based on the first vector value of the acceleration of the acceleration sensor in the first direction and the second vector value of the acceleration of the acceleration sensor in the second direction. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to determine whether the composite acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold. When performing the action, the at least one processor is programmed or configured to perform the action based on determining that the resultant acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold.

[0013] Clause 6: The drug delivery device of clause 1, wherein the sensor is an acceleration sensor, wherein the at least one processor is further programmed or configured to determine an orientation of the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to determine the characteristic associated with the acceleration sensor based on the orientation of the acceleration sensor.

[0014] Clause 7: The drug delivery device of Clause 1, wherein the at least one processor and the sensor are positioned on a printed circuit board (PCB).

[0015] Clause 8: The drug delivery device according to Clause 1, further comprising: a housing; and a drug injection system. The at least one processor and the drug injection system are positioned within the housing.

[0016] Clause 9: The drug delivery device of Clause 8, wherein the drug injection system comprises a cannula configured to be inserted into at least one of a blood vessel, dermis, intradermal tissue, subcutaneous tissue, and muscle tissue of a user.

[0017] Clause 10: The drug delivery device of Clause 1, wherein the sensor is a contact sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data from the contact sensor associated with the location of the contact sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determine a condition of the contact sensor regarding the proximity of the contact sensor to the body of a user based on the data associated with the location of the contact sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determine whether the condition of the contact sensor satisfies the threshold associated with the proximity of the contact sensor to the body of the user; and when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the condition of the contact sensor satisfies the threshold associated with the proximity of the contact sensor to the body of the user.

[0018] Clause 11: The drug delivery device of clause 1, wherein the threshold comprises a threshold based on an operating mode of the drug delivery device.

[0019] Article 12: A drug delivery device, the drug delivery device comprising: a housing; a drug injection system; a sensor; and at least one processor in communication with the sensor. The at least one processor, the sensor, and the drug injection system are positioned within the housing; and the at least one processor is programmed or configured to: receive data associated with the sensor from the sensor; determine a characteristic associated with the sensor based on the data received from the sensor; determine whether the characteristic associated with the sensor satisfies a threshold; and perform an action based on determining that the data received from the sensor satisfies the threshold.

[0020] Clause 13: The drug delivery device of Clause 12, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data from the acceleration sensor associated with the acceleration of the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to determine a velocity of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to determine whether the velocity of the acceleration sensor satisfies a velocity threshold; and when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the velocity of the acceleration sensor satisfies the velocity threshold.

[0021] Clause 14: The drug delivery device of Clause 12, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data from the acceleration sensor associated with the acceleration of the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to determine an amount of inertial force of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to determine whether the amount of inertial force of the acceleration sensor satisfies a force threshold; and when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the inertial force of the acceleration sensor satisfies the force threshold.

[0022] Clause 15: The drug delivery device of Clause 12, wherein the sensor is an acceleration sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data associated with the acceleration of the acceleration sensor from the acceleration sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determine a first vector value of the acceleration of the acceleration sensor in a first direction based on the data associated with the acceleration of the acceleration sensor; determine a second vector value of the acceleration of the acceleration sensor in a second direction based on the data associated with the acceleration of the acceleration sensor; and determine a composite acceleration vector of the acceleration of the acceleration of the acceleration sensor based on the first vector value of the acceleration of the acceleration sensor in the first direction and the second vector value of the acceleration of the acceleration sensor in the second direction. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determine whether the composite acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold; and when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the composite acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold.

[0023] Clause 16: The drug delivery device of Clause 12, wherein the sensor is a contact sensor, wherein when receiving the data from the sensor, the at least one processor is programmed or configured to receive data from the contact sensor associated with the location of the contact sensor. When determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determine a condition of the contact sensor regarding the proximity of the contact sensor to the body of a user based on the data associated with the location of the contact sensor. When determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determine whether the condition of the contact sensor satisfies the threshold associated with the proximity of the contact sensor to the body of the user; and when performing the action, the at least one processor is programmed or configured to perform the action based on determining that the condition of the contact sensor satisfies the threshold associated with the proximity of the contact sensor to the body of the user.

[0024] Clause 17: The drug delivery device of Clause 16, wherein the contact sensor comprises at least one of: a proximity sensor; an optical sensor; a conductive sensor; or a measurement circuit.

[0025] Clause 18: The drug delivery device of Clause 17, wherein the proximity sensor is at least one of a capacitive sensor and an ultrasonic sensor.

[0026] Article 19: A drug delivery device, the drug delivery device comprising at least one processor, the at least one processor being programmed or configured to: receive data associated with a sensor from a sensor; determine a characteristic associated with the sensor based on the data received from the sensor; determine whether the characteristic associated with the sensor satisfies a threshold; and perform an action based on determining that the data received from the sensor satisfies the threshold. When performing the action, the at least one processor is programmed or configured to perform at least one of: provide an alarm; provide a notification; stop delivering a drug from the drug delivery device; store data associated with an event; transmit data associated with the event to a remote device; or any combination thereof.

[0027] Article 20: The drug delivery device according to Article 18, further comprising: a housing; a drug injection system; and an adhesive layer; wherein the at least one processor and the drug injection system are positioned within the housing; and wherein the adhesive layer is configured to be positioned on the user's body.

[0028] Clause 21: The drug delivery device of Clause 20, wherein the drug injection system comprises a cannula configured to be inserted into at least one of a blood vessel, dermis, intradermal tissue, subcutaneous tissue, and muscle tissue of a patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Additional advantages and details are explained in more detail below with reference to exemplary embodiments shown in the schematic drawings, in which:

[0030] Figure 1 is an illustration of a non-limiting embodiment of a drug delivery device;

[0031] Figure 2 for Figure 1 Illustrations of non-limiting embodiments or aspects of one or more devices and / or components of one or more systems;

[0032] Figure 3 is a flow chart of a non-limiting embodiment of a process for sensing movement of a drug delivery device;

[0033] Figure 4 is an illustration of a non-limiting embodiment of a drug delivery device;

[0034] Figure 5 is an illustration of a non-limiting embodiment of a drug delivery device;

[0035] Figure 6 is an illustration of a non-limiting embodiment of a drug delivery device;

[0036] Figure 7 is an illustration of a non-limiting embodiment of a drug delivery device;

[0037] Figure 8 is an illustration of a non-limiting embodiment of a drug delivery device;

[0038] Fig. 9 is a perspective view of a non-limiting embodiment of a drug delivery device;

[0039] Fig.10 for Fig. 9 A cross-sectional view of a drug delivery device is shown.

[0040] Fig.11 The top cover is removed Fig. 9 A perspective view of a drug delivery device; and

[0041] Fig.12 yes Fig. 9 Illustration of a drug delivery device. DETAILED DESCRIPTION

[0042] It should be understood that, unless expressly stated to the contrary, the present disclosure may employ various alternative variations and step sequences. It will also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary, non-limiting embodiments or aspects. Therefore, specific dimensions and other physical characteristics associated with the embodiments or aspects disclosed herein should not be considered limiting.

[0043] Hereinafter, for the purpose of description, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the embodiments or aspects as oriented in the accompanying drawings. However, it should be understood that the embodiments or aspects may adopt various alternative variations and step sequences unless otherwise explicitly stated. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely non-limiting exemplary embodiments or aspects. Therefore, unless otherwise indicated, specific dimensions and other physical characteristics associated with the embodiments disclosed herein, or aspects of the embodiments disclosed herein, or aspects disclosed herein should not be considered limiting.

[0044] Unless explicitly described as such, the aspects, parts, elements, structures, actions, steps, functions, and / or instructions used herein, etc., should not be interpreted as critical or necessary. In addition, as used herein, the article "a, an", is intended to include one or more items, and can be used interchangeably with "one or more" and "at least one". As used in the specification and claims, the singular forms "a, an" and "the" include plural references, for example, unless the context clearly stipulates otherwise. In addition, further, as used herein, the terms "set" and "group" are intended to include one or more items (for example, related items, unrelated items, combinations of related items and unrelated items, etc.), and can be used interchangeably with "one or more" or "at least one". In the case of only one item, the term "one (one)" or similar language is used. In addition, as used herein, the terms "have", "have", "with" etc. are intended to be open terms. In addition, unless otherwise clearly stated, the phrase "based on" is intended to mean "at least partially based on". Furthermore, unless expressly stated otherwise, the phrase "based on" is intended to mean "based at least in part on." Furthermore, the phrase "based on" may mean "in response to" and may indicate a condition for automatically triggering a specified operation of an electronic device (e.g., a controller, a processor, a computing device, etc.), as appropriately referred to herein.

[0045] As used herein, the terms "communication" and "communicate" may refer to the reception, receipt, transmission, transfer, and / or provision of information (e.g., data, signals, messages, instructions, and / or commands, etc.). For a unit (e.g., a device, a system, a component of a device or system, and / or a combination thereof, etc.) to communicate with another unit, it means that the unit is able to directly or indirectly receive information from another unit, and / or directly or indirectly send (e.g., transmit) information to another unit. This may refer to a direct or indirect connection that is wired and / or wireless in nature. In addition, even if the data sent between the first unit and the second unit can be modified, processed, relayed and / or routed, the two units can communicate with each other. For example, even if the first unit passively receives information and does not actively send information to the second unit, the first unit can communicate with the second unit. As another example, a first unit may communicate with a second unit if at least one intermediate unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and transmits the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network data packet (e.g., a data packet, etc.) including data.

[0046] Some non-limiting embodiments or aspects may be described herein in conjunction with a threshold value. As used herein, satisfying a threshold value may refer to a value being greater than the threshold value, exceeding the threshold value, being above the threshold value, being greater than or equal to the threshold value, being less than the threshold value, being less than the threshold value, being below the threshold value, being less than or equal to the threshold value, being equal to the threshold value, etc.

[0047] Improved devices, systems, methods, and computer program products for sensing movement of a drug delivery device are provided. Embodiments of the present disclosure may include a drug delivery device comprising at least one sensor and at least one processor in communication with the sensor, wherein the at least one processor is programmed or configured to: receive data associated with the sensor from the sensor, determine a characteristic associated with the sensor based on the data received from the sensor, determine whether the characteristic associated with the sensor meets a threshold, and perform an action based on determining that the data received from the sensor meets the threshold. In some non-limiting embodiments, when performing an action, at least one processor is programmed or configured to perform an action (e.g., provide a notification to a user), request an action to be performed (e.g., reposition the device), stop delivery, and / or provide an alarm. The processor may also be configured to provide additional functionality, such as stopping the delivery of a drug, providing a status signal, wirelessly communicating with a handheld device or a smartphone, and / or storing data associated with an event.

[0048] In certain configurations, the drug delivery device may include, for example, an accelerometer and a second sensor (eg, a pressure sensor that may indicate leakage due to movement of the catheter or cannula).

[0049] In some non-limiting embodiments, the threshold value includes a threshold value based on the operating mode of the drug delivery device. In some non-limiting embodiments, at least one processor is also programmed or configured to determine the orientation of the sensor, and when determining the characteristics associated with the sensor, at least one processor is programmed or configured to determine the characteristics associated with the sensor based on the orientation of the sensor. In some non-limiting embodiments, at least one processor and the sensor are positioned on a printed circuit board (PCB). In some non-limiting embodiments, the drug delivery device also includes a housing and a drug injection system, and at least one processor and the drug injection system are positioned in the housing. In some non-limiting embodiments, the drug injection system includes a cannula configured to be inserted into the dermis, subcutaneous tissue and muscle tissue of the user, and / or in the vascular system of the patient (e.g., the patient).

[0050] In this manner, the present disclosure enables a wearable drug delivery device that determines events (e.g., impact, acceleration, movement, and / or dislodgement) that may cause the device to become misplaced after the device is applied to a patient and before delivery of drug to the patient is terminated.

[0051] In other embodiments of the present disclosure, a wearable drug delivery device is implemented that can determine when the drug delivery device is properly positioned on the user's body to ensure that the drug is correctly delivered to the user.

[0052] Reference now Figure 1 , Figure 1 is a diagrammatic representation of a drug delivery device 100. Figure 1 As shown, the drug delivery device 100 may include a processing device 102, a sensor device 104, and a drug injection system 106. The processing device 102, the sensor device 104, and the drug injection system 106 may be interconnected (e.g., connected for communication, etc.) via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection.

[0053] In some non-limiting embodiments, the drug delivery device 100 can be a wearable automatic injector (e.g., an insulin or bone marrow stimulator delivery device). For example, the drug delivery device 100 can be applied to the user's skin and can be triggered to inject the drug into the user's body. The drug delivery device 100 can be pre-filled with the drug, or can be filled with the drug (e.g., refilled after a previous injection) by the user or other individual (e.g., a medical professional) prior to use.

[0054] The drug delivery device 100 can be configured to deliver a dose of a drug into the user's body by injection at a controlled delivery rate. The controlled delivery rate can include a delivery duration from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the drug delivered by the drug delivery device 100 can be in the range of about 0.1 milliliters to about 10 milliliters, but is not limited to this range. The volume of the drug delivered to the user can be adjusted (e.g., automatically adjusted or manually adjusted).

[0055] In some non-limiting embodiments, the processing device 102 may include a device capable of communicating with the sensor device 104 and / or the drug injection system 106. In some non-limiting embodiments, the processing device 102 may include a device controller (e.g., a microcontroller), a processor, and / or an integrated circuit, etc. In some non-limiting embodiments, the processing device 102 may provide commands (e.g., instructions, signals, etc.) to the drug injection system 106 to cause the drug injection system 106 to deliver the drug to the body of a user (e.g., a patient) on whom the drug delivery device 100 is applied.

[0056] In some non-limiting embodiments, the sensor device 104 may include a device capable of communicating with the processing device 102. In some non-limiting embodiments, the sensor device 104 may include at least one sensor, such as an acceleration sensor and / or a contact sensor. In some embodiments, a second sensor or additional sensor (e.g., a pressure sensor) may also be used to help determine whether a leak or other event has occurred that may cause or has caused the drug delivery device to be misplaced. In some non-limiting embodiments, the acceleration sensor may include an accelerometer (e.g., a three-axis accelerometer). In some non-limiting embodiments, the three-axis accelerometer is capable of detecting acceleration in each direction of a three-dimensional (e.g., xyz) coordinate system. Additionally, the three-axis accelerometer may be capable of detecting the angular rate of acceleration in each direction of the three-dimensional coordinate system. In some non-limiting embodiments, the contact sensor may include a sensor capable of detecting contact with the user's body. For example, the contact sensor may include a proximity sensor, an optical sensor, a conductive sensor, and / or a circuit for measuring a property (e.g., a measurement circuit). In some non-limiting embodiments, the measurement circuit may be a tamper-proof circuit. In some non-limiting embodiments, sensor device 104 may provide data associated with sensor device 104 based on sensor device 104 measuring characteristics of sensor device 104 and / or an environment of sensor device 104 .

[0057] In some non-limiting embodiments, the drug injection system 106 may include a device capable of communicating with the processing device 102. In some non-limiting embodiments, the drug injection system 106 may include a device (e.g., a mechanism, a structure, etc.) capable of delivering a drug into the body of a user on whom the drug delivery device 100 is applied. In some non-limiting embodiments, the drug injection system 106 may automatically deliver the drug to the user's body according to one or more predetermined time intervals. Additionally or alternatively, the drug injection system 106 may automatically deliver the drug to the user's body at a predetermined time period (e.g., a predetermined time period after the drug delivery device 100 is applied to the user's body). In some non-limiting embodiments, the drug injection system 106 may include a cannula, a catheter, and / or a needle configured to be positioned within the user's body. For example, the drug injection system 106 may include a cannula, a catheter, and / or a needle configured to be inserted into the dermis, subcutaneous tissue, or muscle tissue of the user.

[0058] In some non-limiting embodiments, the processing device 102, the sensor device 104, and / or the drug injection system 106 can be positioned on a printed circuit board (PCB) of the drug delivery device 100 (e.g., mounted on the PCB, placed on the PCB, integrated with the PCB, etc.). For example, the processing device 102, the sensor device 104, and / or the drug injection system 106 can be positioned on the same PCB. In some non-limiting embodiments, the PCB on which the processing device 102, the sensor device 104, and / or the drug injection system 106 are positioned can be positioned within the housing of the drug delivery device 100. In this way, the drug delivery device 100 can have a compact form factor that allows the user to wear the drug delivery device 100 with minimal discomfort.

[0059] In some non-limiting embodiments, the drug delivery device 100 may include a mechanism for keeping the drug delivery device 100 in contact with the user's body. In this way, the drug delivery device 100 can be a body-worn device. In one example, the drug delivery device 100 may include an adhesive layer having an adhesive suitable for keeping the drug delivery device 100 on the user's body for a long time. Additionally or alternatively, the drug delivery device 100 may include a belt (e.g., a strip, a waist piece, a wrap, etc.) configured to keep the drug delivery device 100 housing in contact with the user's body. In some non-limiting embodiments, the adhesive layer may be positioned on the surface of the drug delivery device 100, which is located near the user's body when the drug delivery device 100 is applied to the user's body. In addition, the components of the drug injection system 106 may be configured to extend through the adhesive layer to be positioned in the user's body. In some non-limiting embodiments, the components of the drug injection system 106 may be configured to extend through the hole of the adhesive layer. In some non-limiting embodiments, the components of the drug injection system 106 may be configured to penetrate the adhesive layer.

[0060] In some non-limiting embodiments, the drug delivery device 100 may include a device for providing an indication associated with the operation of the drug delivery device 100. For example, the drug delivery device 100 may include one or more devices (e.g., one or more light emitting diodes (LEDs) and / or one or more display screens) that provide visual prompts to the user. Additionally or alternatively, the drug delivery device 100 may include one or more devices (e.g., one or more electroacoustic transducers (e.g., one or more speakers)) that provide audio prompts to the user.

[0061] Reference now Figure 2 , Figure 22 is a diagram of example components of device 200. Device 200 may correspond to one or more components of processing device 102, sensor device 104, and / or drug injection system 106. In some non-limiting embodiments, processing device 102, sensor device 104, and / or drug injection system 106 may include at least one device 200, and / or at least one component of device 200. Figure 2 As shown, the apparatus 200 may include a bus 202 , a processor 204 , a memory 206 , a storage component 208 , an input component 210 , an output component 212 , and a communication interface 214 .

[0062] The bus 202 may include components that allow communication between the components of the device 200. In some non-limiting embodiments or aspects, the processor 204 may be implemented using hardware, software, or a combination of hardware and software. For example, the processor 204 may include the following components that can be programmed to perform functions: a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component (e.g., a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.). The memory 206 may include a random access memory (RAM), a read-only memory (ROM), and / or other types of dynamic or static storage devices (e.g., flash memory, magnetic memory, optical memory, etc.) that store information and / or instructions for use by the processor 204.

[0063] The storage component 208 may store information and / or software related to the operation and use of the device 200. For example, the storage component 208 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid-state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and / or other types of computer-readable media and corresponding drives.

[0064] Input components 210 may include components that allow device 200 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, a camera, etc.). Additionally or alternatively, input components 210 may include sensors for sensing information (e.g., a Global Positioning System (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). Output components 212 may include components that provide output information from device 200 (e.g., a display, a speaker, one or more light emitting diodes (LEDs), etc.).

[0065] The communication interface 214 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables the device 200 to communicate with other devices, for example, via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection. The communication interface 214 may allow the device 200 to receive information from other devices and / or provide information to other devices. For example, the communication interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, Interface, Bluetooth interface, interface and / or cellular network interface, etc.

[0066] The device 200 may perform one or more processes described herein. The device 200 may perform these processes based on the processor 204 executing software instructions stored by a computer-readable medium (e.g., memory 206 and / or storage component 208). Computer-readable media (e.g., non-transitory computer-readable media) are defined herein as non-transitory memory devices. Non-transitory memory devices include storage space located within a single physical storage device or storage space distributed on multiple physical storage devices.

[0067] The software instructions may be read into the memory 206 and / or storage component 208 from other computer-readable media or from other devices via the communication interface 214. The software instructions stored in the memory 206 and / or storage component 208, when executed, may cause the processor 204 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Therefore, the embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

[0068] The memory 206 and / or the storage component 208 may include a data storage or one or more data structures (e.g., a database and / or the like). The device 200 may be capable of receiving information from, storing information in, transmitting information to, or searching for information stored in the data storage or one or more data structures in the memory 206 and / or the storage component 208. For example, the information may include input data, input data, output data, business data, account data, or any combination thereof.

[0069] supply Figure 2 The number and arrangement of the components shown are provided as examples. In some non-limiting embodiments or aspects, Figure 2 The device 200 may include additional components, fewer components, different components, or components arranged differently than the components shown in . Additionally or alternatively, a set of components (e.g., one or more components) of the device 200 may perform one or more functions described as being performed by another set of components of the device 200.

[0070] Reference now Figure 3 , Figure 3 Flowchart of a non-limiting aspect or embodiment of a process 300 for sensing movement of a drug delivery device. In some non-limiting embodiments or aspects, one or more of the functions described with respect to the process 300 may be performed (e.g., completely performed, partially performed, etc.) by the processing device 102. In some non-limiting embodiments or aspects, one or more of the steps of the process 300 may be performed (e.g., completely performed, partially performed, etc.) by another device or group of devices (e.g., sensor device 104 and / or drug injection system 106) separate from and / or including the processing device 102.

[0071] like Figure 3 As shown, at step 302, process 300 may include receiving data associated with a sensor. For example, processing device 102 may receive data associated with sensor device 104 from sensor device 104. In some non-limiting embodiments, data associated with sensor device 104 may include any information (e.g., characteristics, parameters, etc.) determined (e.g., measured, detected, sensed, obtained, etc.) by sensor device 104 during operation of sensor device 104.

[0072] like Figure 3As shown, at step 304, process 300 may include determining a characteristic associated with the sensor. For example, processing device 102 may determine a characteristic associated with sensor device 104 based on data received from sensor device 104. In some non-limiting embodiments, processing device 102 may determine an orientation of sensor device 104. In some non-limiting embodiments, processing device 102 may calibrate sensor device 104 based on the orientation of sensor device 104. In some non-limiting embodiments, processing device 102 may determine a characteristic associated with the sensor based on the orientation of sensor device 104 and / or calibration of sensor device 104.

[0073] like Figure 3 As shown, at step 306, process 300 may include determining whether a characteristic associated with the sensor satisfies a threshold. For example, processing device 102 may determine whether a characteristic associated with sensor device 104 satisfies a threshold. In some non-limiting embodiments, the threshold may include a threshold based on the amount of force. In one example, the threshold may include a threshold based on the peeling force required to move drug delivery device 100 in a particular direction. In another example, the threshold may include a threshold based on the amount of force that deforms the skin to cause movement of the cannula, catheter, and / or needle of drug injection system 106. In such an example, the threshold may be based on the amount of force that deforms the skin to cause movement of the cannula, catheter, and / or needle of drug injection system 106, but does not cause the adhesive that holds drug delivery device 100 to the user's body to peel off. In some non-limiting embodiments, the threshold may include a threshold based on the operating mode of drug delivery device 100. The drug delivery device 100 can have multiple operating modes, including a mode associated with when the user is asleep (e.g., deep sleep), an operating mode associated with preparing to apply the drug delivery device 100 to the user's body, an operating mode associated with the deployment of components of the drug injection system 106 (e.g., cannulas, catheters, and / or needles), and / or an operating mode associated with injecting a drug into the user's body (e.g., when the drug is being delivered). In some non-limiting embodiments, the threshold value can be based on the operating mode, such that the threshold value for a first operating mode can be different from the threshold value for a second operating mode. In some non-limiting embodiments, the threshold value can be different for each of the multiple operating modes of the drug delivery device 100.

[0074] like Figure 3As shown, at step 308 ("Yes"), process 300 may include performing an action based on determining that a characteristic associated with the sensor meets a threshold. For example, processing device 102 may perform an action based on determining that a characteristic associated with sensor device 104 meets a threshold. In some non-limiting embodiments, processing device 102 may compare the characteristic associated with sensor device 104 to a threshold (e.g., a limit value), and if processing device 102 determines that the characteristic associated with sensor device 104 meets the threshold, processing device 102 may perform an action. In some non-limiting embodiments, processing device 102 may perform an action by providing a notification to a user, requesting that an action be performed, repositioning the device, stopping delivery, and / or providing an alarm.

[0075] For example, the processing device 102 may cause (e.g., trigger) the drug delivery device 100 to sound an alarm. In some non-limiting embodiments, the processing device 102 may perform an action by providing a notification. For example, the processing device 102 may cause the drug delivery device 100 to provide a notification, such as a notification based on a visual cue (e.g., a light emitting diode is illuminated), a notification based on an audio cue (e.g., a speaker emits an audible sound, etc.). In some non-limiting embodiments, the processing device 102 may perform an action by storing (e.g., recording) data associated with an event (e.g., an event indicating that a characteristic associated with the sensor device 104 meets a threshold). For example, the processing device 102 may store the data associated with the event in a memory device of the drug delivery device 100.

[0076] like Figure 3 As shown, at step 310 (“No”), process 300 may include abandoning execution of the action based on determining that the characteristic associated with the sensor does not satisfy the threshold. For example, processing device 102 may abandon execution of the action based on determining that the characteristic associated with sensor device 104 does not satisfy the threshold. In some non-limiting embodiments, processing device 102 may compare the characteristic associated with sensor device 104 with the threshold, and if processing device 102 determines that the characteristic associated with sensor device 104 does not satisfy the threshold, processing device 102 may abandon execution of the action.

[0077] about Figures 4 to 8 , the processing device 102 can be programmed or configured to appropriately perform a process based on the particular type of sensor of the drug delivery device of which the processing device 102 is a component. In some non-limiting embodiments, the processing device 102 can be programmed or configured to perform a process that is the same or similar to the process 300 for sensing movement of a drug delivery device.

[0078] Reference now Figure 4 , Figure 44 is a diagram of a drug delivery device 400. In some non-limiting embodiments, the drug delivery device 400 may be the same as or similar to the drug delivery device 100. Figure 4 As shown, the drug delivery device 400 may include a processing device 102, an acceleration sensor 404, a drug injection system 406, and an adhesive layer 410. In some non-limiting embodiments, the acceleration sensor 404 may be the same or similar to the sensor device 104. In some non-limiting embodiments, the acceleration sensor 404 may include an accelerometer. For example, the acceleration sensor 404 may include a three-axis accelerometer (e.g., a three-axis gyroscope). In some non-limiting embodiments, the drug injection system 406 may include a cannula 408. In some non-limiting embodiments, the cannula 408 may include a needle. In some non-limiting embodiments, the cannula 408 may include a catheter, which may be a soft, flexible catheter, a rigid catheter, or a combination thereof. In some non-limiting embodiments, the adhesive layer 410 may include a structural layer (e.g., a substrate, a base plate, etc.) and an adhesive applied to the structural layer. In some non-limiting embodiments, the structural layer may include a flexible polymer foam, a fabric material, and / or a hard plastic material, etc. In some non-limiting embodiments, the adhesive layer 410 may contact the user's body. For example, adhesive layer 410 can be applied to the user's skin. In some non-limiting embodiments, cannula 408 and / or a needle of cannula 408 can be inserted into the user's skin.

[0079] With respect to the drug delivery device 400, the processing device 102 may be programmed or configured to perform a process the same or similar to the process 300 for sensing movement of the drug delivery device based on the acceleration sensor 404. In some non-limiting embodiments, the processing device 102 may receive data from the acceleration sensor 404 associated with the acceleration of the acceleration sensor 404.

[0080] In some non-limiting embodiments, the processing device 102 may determine a characteristic associated with the acceleration sensor 404 based on data associated with the acceleration of the acceleration sensor 404. In some non-limiting embodiments, the processing device 102 may determine a velocity of the acceleration sensor based on data associated with the acceleration of the acceleration sensor 404. For example, the processing device 102 may calculate a velocity value based on a measurement value of the acceleration included in the data associated with the acceleration of the acceleration sensor 404. In some non-limiting embodiments, the processing device 102 may determine an amount of inertial force of the acceleration sensor 404 based on data associated with the acceleration of the acceleration sensor 404. In some non-limiting embodiments, when determining the amount of inertial force of the acceleration sensor 404, the processing device 102 is programmed or configured to determine a first amount of inertial force in a first direction (e.g., one of an x ​​direction, a y direction, or a z direction in an xyz coordinate system) based on first data associated with the acceleration of the acceleration sensor in the first direction, and determine a second amount of inertial force in the second direction based on second data associated with the acceleration of the acceleration sensor in the second direction. In some non-limiting embodiments, the processing device 102 may determine a first vector value of the acceleration of the accelerometer in a first direction based on data associated with the acceleration of the accelerometer, determine a second vector value of the acceleration of the accelerometer in a second direction based on data associated with the acceleration of the accelerometer, and determine a composite acceleration vector of the accelerometer based on the first vector value of the acceleration of the accelerometer in the first direction and the second vector value of the acceleration of the accelerometer in the second direction.

[0081] In some non-limiting embodiments, the processing device 102 may determine whether a characteristic associated with the acceleration sensor 404 satisfies a threshold based on the characteristic associated with the acceleration sensor 404. In some non-limiting embodiments, the processing device 102 may determine whether a velocity of the acceleration sensor satisfies a velocity threshold. In some non-limiting embodiments, the processing device 102 may determine whether an amount of an inertial force of the acceleration sensor 404 satisfies a force threshold. In some non-limiting embodiments, when determining whether an inertial force of the acceleration sensor 404 satisfies a force threshold, the processing device 102 may determine whether a first amount of an inertial force in a first direction satisfies a first force threshold, and whether a second amount of an inertial force in a second direction satisfies a second force threshold. In some non-limiting embodiments, the processing device 102 may determine whether a resultant acceleration vector of the acceleration sensor 404 satisfies an acceleration threshold.

[0082] In some non-limiting embodiments, the processing device 102 may perform an action based on determining that a characteristic associated with the acceleration sensor 404 satisfies a threshold, or may forgo performing an action based on determining that a characteristic associated with the acceleration sensor 404 does not satisfy a threshold. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that a velocity of the acceleration sensor 404 satisfies a velocity threshold, or may forgo performing an action based on determining that a velocity of the acceleration sensor 404 does not satisfy a velocity threshold. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that an inertial force of the acceleration sensor 404 satisfies a force threshold, or may forgo performing an action based on determining that an inertial force of the acceleration sensor 404 does not satisfy a force threshold. In some non-limiting embodiments, when performing an action, the processing device 102 may perform an action based on determining that a first amount of inertial force in a first direction satisfies a first force threshold and / or a second amount of inertial force in a second direction satisfies a second force threshold. In some non-limiting embodiments, when abandoning the execution of the action, the processing device 102 may abandon the execution of the action based on determining that the first amount of the inertial force in the first direction does not satisfy the first force threshold and / or the second amount of the inertial force in the second direction does not satisfy the second force threshold. In some non-limiting embodiments, the processing device 102 may execute the action based on determining that the resultant acceleration vector of the acceleration of the acceleration sensor 404 satisfies the acceleration threshold, or abandon the execution of the action based on determining that the resultant acceleration vector of the acceleration of the acceleration sensor 404 does not satisfy the acceleration threshold.

[0083] about Figures 5 to 8 Each picture in Figures 5 to 8 As shown, the sensor device 104 has been replaced by a contact sensor of the type such as proximity sensor 504, optical sensor 604, conductivity sensor 704, and measurement circuit 804 having electrical trace 814 to detect whether the drug delivery device is in contact with the user's body. With respect to drug delivery device 500, drug delivery device 600, drug delivery device 700, and drug delivery device 800, processing device 102 may be programmed or configured to perform the same or similar process as process 300 for sensing movement of the drug delivery device based on a contact sensor (e.g., proximity sensor 504, optical sensor 604, conductivity sensor 704, and / or measurement circuit 804 having electrical trace 814).

[0084] In some non-limiting embodiments, the processing device 102 may receive data associated with the location of a contact sensor (e.g., a proximity sensor 504, an optical sensor 604, a conductive sensor 704, or a measurement circuit 804 having an electrical trace 814) from the contact sensor. In some non-limiting embodiments, the data associated with the location of the contact sensor may include an indication of whether the contact sensor is adjacent to the user's body (e.g., in contact with the user's body, close to the user's body, within a predetermined distance of the user's body, etc.). In some non-limiting embodiments, the processing device 102 may determine a characteristic associated with the contact sensor. For example, the processing device 102 may determine a condition of the contact sensor regarding the proximity of the contact sensor to the user's body based on the data associated with the location of the contact sensor (e.g., a condition associated with whether the contact sensor is in contact with the user's body, a condition associated with whether the contact sensor is close to the user's body, a condition associated with whether the contact sensor is within a predetermined distance of the user's body, etc.). In some non-limiting embodiments, the processing device 102 may determine whether the contact sensor is adjacent to the user's body based on the data associated with the location of the contact sensor.

[0085] In some non-limiting embodiments, processing device 102 may determine whether a characteristic associated with a contact sensor satisfies a threshold. For example, processing device 102 may determine whether a condition of the contact sensor satisfies a threshold associated with the contact sensor being proximate to a user's body. In some non-limiting embodiments, the threshold includes an indication that the contact sensor is proximate to a user's body. In some non-limiting embodiments, processing device 102 may perform an action based on determining that the condition of the contact sensor satisfies the threshold, or forgo performing an action based on determining that the condition of the contact sensor does not satisfy the threshold.

[0086] Reference now Figure 5 , Figure 5 is a diagram of a drug delivery device 500. In some non-limiting embodiments, drug delivery device 500 may be the same as or similar to drug delivery device 100 and / or drug delivery device 400. Figure 5 As shown, drug delivery device 500 may include processing device 102, proximity sensor 504, drug injection system 406, and adhesive layer 410. In some non-limiting embodiments, proximity sensor 504 may be the same as or similar to sensor device 104. In some non-limiting embodiments, proximity sensor 504 may include a device configured to detect whether the proximity sensor is adjacent to (e.g., in proximity to) a user's body.

[0087] In some non-limiting embodiments, the proximity sensor 504 may include a device configured to detect when the proximity sensor 504 is within a predetermined distance threshold from a surface (e.g., a user's body (e.g., a body appendage) and / or a user's skin). In some non-limiting embodiments, the proximity sensor 504 may include a capacitive proximity sensor, an inductive proximity sensor, an ultrasonic proximity sensor, and / or an optical proximity sensor, etc.

[0088] In some non-limiting embodiments, the proximity sensor 504 may be proximate to the user's body, and the proximity sensor 504 may provide a signal to the processing device 102 indicating that the proximity sensor 504 is proximate to the user's body. In some non-limiting embodiments, the proximity sensor 504 may not be proximate to the user's body, and the proximity sensor 504 may provide a signal to the processing device 102 indicating that the proximity sensor 504 is not proximate to the user's body, or the proximity sensor 504 may not provide a signal to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the proximity sensor 504 is proximate to the user's body based on receiving a signal from the proximity sensor 504 to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the proximity sensor 504 is not proximate to the user's body based on receiving a signal from the proximity sensor 504 to the processing device 102 or based on a failure to receive a signal from the proximity sensor 504. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that the proximity sensor 504 is not proximate to the user's body. In some non-limiting embodiments, the processing device 102 may prevent operation (e.g., activation) of the drug injection system 406 based on determining that the proximity sensor 504 is not adjacent to the user's body. In some non-limiting embodiments, the processing device 102 may allow operation (e.g., operation associated with delivering a drug to the user (e.g., injection)) of the drug injection system 406 based on determining that the proximity sensor 504 is adjacent to the user's body.

[0089] Reference now Figure 6 , Figure 6 is a diagram of a drug delivery device 600. In some non-limiting embodiments, drug delivery device 600 may be the same as or similar to drug delivery device 100, drug delivery device 400, and / or drug delivery device 500. Figure 6 As shown, drug delivery device 600 may include processing device 102, optical sensor 604, drug injection system 406, and adhesive layer 610. In some non-limiting embodiments, optical sensor 604 may be the same or similar to sensor device 104. In some non-limiting embodiments, adhesive layer 610 may be the same or similar to adhesive layer 410.

[0090] In some non-limiting embodiments, the optical sensor 604 may include a device configured to detect when the optical sensor 604 is within a predetermined distance threshold from a surface (e.g., a user's body (e.g., a body appendage) and / or a user's skin) based on light transmitted and received (e.g., received based on reflection) by the optical sensor 604. In some non-limiting embodiments, the optical sensor 604 may include an ambient light optical sensor, an infrared (IR) optical sensor, an ultraviolet optical sensor, etc. In some non-limiting embodiments, the optical sensor 604 may include an emitter (e.g., a light emitter) and / or a receiver for receiving light transmitted by the emitter. Figure 6 As shown, adhesive layer 610 may include apertures 612 that allow light emitted by optical sensor 604 to contact the user's body and be reflected back and received by optical sensor 604 .

[0091] In some non-limiting embodiments, optical sensor 604 may be proximate to the user's body, and optical sensor 604 may provide a signal to processing device 102 indicating that optical sensor 604 is proximate to the user's body. In some non-limiting embodiments, optical sensor 604 may not be proximate to the user's body, and optical sensor 604 may provide a signal to processing device 102 indicating that optical sensor 604 is not proximate to the user's body, or optical sensor 604 may not provide a signal to processing device 102. In some non-limiting embodiments, processing device 102 may determine that optical sensor 604 is proximate to the user's body based on a signal received from optical sensor 604 to processing device 102. In some non-limiting embodiments, processing device 102 may determine that optical sensor 604 is not proximate to the user's body based on a signal received from optical sensor 604 to processing device 102 or based on a failure to receive a signal from optical sensor 604. In some non-limiting embodiments, processing device 102 may perform an action based on determining that optical sensor 604 is not proximate to the user's body. In some non-limiting embodiments, processing device 102 may prevent operation (e.g., activation) of drug injection system 406 based on determining that optical sensor 604 is not adjacent to the user's body. In some non-limiting embodiments, processing device 102 may allow operation (e.g., operation associated with delivering a drug to a user (e.g., injection)) of drug injection system 406 based on determining that optical sensor 604 is adjacent to the user's body.

[0092] Reference now Figure 7 , Figure 7is a diagram of a drug delivery device 700. In some non-limiting embodiments, drug delivery device 700 may be the same as or similar to drug delivery device 100, drug delivery device 400, drug delivery device 500, and / or drug delivery device 600. Figure 7 As shown, drug delivery device 700 may include processing device 102, conductivity sensor 704, drug injection system 406, and adhesive layer 610. In some non-limiting embodiments, conductivity sensor 704 may be the same as or similar to sensor device 104.

[0093] In some non-limiting embodiments, the conductive sensor 704 may include a device configured to detect when the conductive sensor 704 is in contact with a surface, such as a user's body (e.g., skin on the body). In some non-limiting embodiments, the conductive sensor 704 may include a device that measures electrical properties (e.g., current, voltage, resistance, etc.) and determines whether the conductive sensor 704 is in contact with the user's body. In some non-limiting embodiments, the conductive sensor 704 may include a piezoelectric sensor, an ohmmeter, a voltmeter, and / or a current sensor, etc. Figure 7 As further shown, the conductive sensor 704 may include electrical contacts 714. Figure 7 As shown, adhesive layer 610 may include apertures 612 that allow electrical contacts 714 of conductive sensor 704 to contact the user's body.

[0094] In some non-limiting embodiments, the electrical contacts 714 of the conductive sensor 704 may be in contact with the user's body, and the conductive sensor 704 may provide a signal to the processing device 102 indicating that the conductive sensor 704 is adjacent to the user's body. In some non-limiting embodiments, the electrical contacts 714 of the conductive sensor 704 may not be in contact with the user's body, and the conductive sensor 704 may provide a signal to the processing device 102 indicating that the conductive sensor 704 is not adjacent to the user's body, or the conductive sensor 704 may not provide a signal to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the conductive sensor 704 is adjacent to the user's body based on a signal received from the conductive sensor 704 to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the conductive sensor 704 is adjacent to the user's body based on a signal received from the conductive sensor 704 to the processing device 102 or based on a failure to receive a signal from the conductive sensor 704. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that the conductive sensor 704 is not adjacent to the user's body. In some non-limiting embodiments, the processing device 102 may prevent operation (e.g., activation) of the drug injection system 406 based on determining that the conductivity sensor 704 is not adjacent to the user's body. In some non-limiting embodiments, the processing device 102 may allow operation (e.g., operation associated with delivering a drug to the user (e.g., injection)) of the drug injection system 406 based on determining that the conductivity sensor 704 is adjacent to the user's body.

[0095] Reference now Figure 8 , Figure 8 800 is a diagram of a drug delivery device. In some non-limiting embodiments, drug delivery device 800 may be the same as or similar to drug delivery device 100, drug delivery device 400, drug delivery device 500, drug delivery device 600, and / or drug delivery device 700. Figure 8 As shown, the drug delivery device 800 may include the processing device 102, the measurement circuit 804, the drug injection system 406, and the adhesive layer 610. In some non-limiting embodiments, the measurement circuit 804 may be the same as or similar to the sensor device 104. Figure 8 As further shown, the measurement circuit 804 may include a conductive trace 814. Figure 8 As further shown, adhesive layer 610 may include apertures 612 that allow conductive traces 814 of measurement circuit 804 to contact the user's body.

[0096] In some non-limiting embodiments, the measurement circuit 804 may include a device configured to detect when the conductive trace 814 is in contact with a surface, such as a user's body (e.g., skin on the body). In some non-limiting embodiments, the measurement circuit 804 may include a device that measures electrical properties (e.g., current, voltage, resistance, etc.) and determines whether the conductive trace 814 is in contact with the user's body. In some non-limiting embodiments, the measurement circuit 804 may include a device that measures physical properties (e.g., strain) and determines whether the conductive trace 814 is in contact with the user's body. In some non-limiting embodiments, the measurement circuit 804 may include a piezoelectric sensor, an ohmmeter, a voltmeter, a current sensor, and / or a strain gauge, etc. In some non-limiting embodiments, the conductive trace 814 may be positioned within the adhesive layer 610.

[0097] In some non-limiting embodiments, the conductive traces 814 of the measurement circuit 804 may be in contact with the user's body, and the measurement circuit 804 may provide a signal to the processing device 102 indicating that the measurement circuit 804 is adjacent to the user's body. In some non-limiting embodiments, the conductive traces 814 of the measurement circuit 804 may not be in contact with the user's body, and the measurement circuit 804 may provide a signal to the processing device 102 indicating that the measurement circuit 804 is not adjacent to the user's body, or the measurement circuit 804 may not provide a signal to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the measurement circuit 804 is adjacent to the user's body based on a signal received from the measurement circuit 804 to the processing device 102. In some non-limiting embodiments, the processing device 102 may determine that the measurement circuit 804 is adjacent to the user's body based on a signal received from the measurement circuit 804 to the processing device 102 or based on a failure to receive a signal from the measurement circuit 804. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that the measurement circuit 804 is not adjacent to the user's body. In some non-limiting embodiments, the processing device 102 may prevent operation (e.g., activation) of the drug injection system 406 based on determining that the measurement circuit 804 is not adjacent to the user's body. In some non-limiting embodiments, the processing device 102 may allow operation (e.g., operation associated with delivering a drug to the user (e.g., injection)) of the drug injection system 406 based on determining that the measurement circuit 804 is adjacent to the user's body.

[0098] Reference now Figures 9 to 11 , Figures 9 to 11is an illustration of drug delivery device 900. In some non-limiting embodiments, drug delivery device 900 may be the same as or similar to drug delivery device 100, drug delivery device 400, drug delivery device 500, drug delivery device 600, drug delivery device 700, and / or drug delivery device 800. Fig. 9 , Fig. 9 is a perspective view of a drug delivery device 900. Fig. 9 As shown, the drug delivery device 900 may include a drug injection system 902, a housing 904, a substrate 906, and a button 918. In some non-limiting embodiments, the drug delivery device 900 may be a wearable automatic injector. For example, the drug delivery device 900 may be an insulin or bone marrow stimulator delivery device. In some non-limiting embodiments, the drug delivery device 900 may be applied to the user's body (e.g., positioned in contact with the user's body). For example, the drug delivery device 900 may be mounted on the user's skin. In some non-limiting embodiments, the substrate 906 may include an adhesive layer 916. In some non-limiting embodiments, the button 918 may be configured to allow manual operation of the drug injection system 902, so that the drug can be delivered to the user's body based on the user pressing the button 918.

[0099] about Fig.10 , Fig.10 is a cross-sectional view of drug delivery device 900. Fig.10 As shown, the drug delivery device 900 may include a cannula 908 and a reservoir 910. As used herein, the term "reservoir" may include any container for injection, including a capsule, a main container, a syringe body, etc. In some non-limiting embodiments, the cannula 908 may include a needle. In some non-limiting embodiments, the cannula 908 may include a catheter, which may be a soft, flexible catheter, a rigid catheter, or a combination thereof. In some non-limiting embodiments, the cannula 908 may be inserted into the user's skin. For example, the cannula 908 may be inserted into the user's skin, and the needle of the cannula may extend into the user's body. In some non-limiting embodiments, the reservoir 910 may include a drug to be delivered (e.g., injected) into the user's body.

[0100] about Fig.11 , Fig.11 900 is a perspective view of the drug delivery device 900 with the housing 904 removed. Fig.11As shown, the drug delivery device 900 may include a drug injection system 902, a substrate 906, a printed circuit board 912, and a fluid line 914. In some non-limiting embodiments, the printed circuit board 912 may include control electronics (e.g., the processing device 102) for controlling the operation of the drug delivery device 900. In some non-limiting embodiments, the printed circuit board 912 may include sensors (e.g., the acceleration sensor 404, the proximity sensor 504, the optical sensor 604, the conductivity sensor 704, and / or the measurement circuit 804 and the electrical traces 814), the drug injection system 902, and / or a processing device (e.g., the processing device 102) attached to the printed circuit board.

[0101] Reference now Fig.12 , Fig.12 yes Fig. 9 FIG. 9 is a diagram of a drug delivery device 900. Fig.12As shown, the drug delivery device 900 may include a power storage subsystem, an electronics subsystem, and a fluidics subsystem. In some non-limiting embodiments, the power storage subsystem may include a power supply 14. In some non-limiting embodiments, the power supply 14 may include a direct current (DC) power supply, such as one or more batteries. In some non-limiting embodiments, the electronics subsystem may control the actuation of the drug injection system (e.g., drug injection system 902) of the drug delivery device 900. The electronics subsystem may include a processing device 24, a sensing electronics 26, a pump and valve controller 28, a sensing electronics 30, and a deployment electronics 32. In some non-limiting embodiments, the fluidics subsystem may include a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering subsystem 38, which includes a pump and valve actuator 40 and a pump and valve mechanism 42. The fluid subsystem may also include an occlusion sensor 44, a deployment actuator 46, a cannula 48 for insertion into the user's skin, and a fluid line 50 in fluid communication with the reservoir 12 and the cannula 48. In some non-limiting embodiments, the drug injection system 902 may be configured to move the cannula 48 from a retracted position completely within the drug delivery device 900 to an extended position in which the cannula 48 extends outside the drug delivery device 900. In some non-limiting embodiments, the cannula 48 is a catheter, which may be a soft, flexible catheter, a rigid catheter, or a combination thereof. In some non-limiting embodiments, the drug delivery device 900 may operate in the same manner as discussed in U.S. Pat. No. 10,449,292 to Pizzochero et al., the entire contents of which are incorporated herein by reference.

[0102] Although embodiments or aspects have been described in detail for the purposes of illustration and description, it will be understood that such detail is for that purpose only, and that embodiments or aspects are not limited to the disclosed embodiments or aspects, but rather, these embodiments or aspects are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it will be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, many of these features may be combined in ways that are not specifically recited in the claims and / or not specifically disclosed in the specification. Although each dependent claim listed below may be directly dependent on only one claim, the disclosed possible implementations include each dependent claim in combination with each other claim in the claim group.

Claims

1. A drug delivery device, the drug delivery device is used to deliver a drug to a patient, the drug delivery device comprising: a cannula in fluid communication with the reservoir; at least one sensor; as well as at least one processor in communication with the sensor, wherein the at least one processor is programmed or configured to: receiving data associated with the sensor from the sensor; determining a characteristic associated with the sensor based on the data received from the sensor, wherein the characteristic is relative movement between the drug delivery device and the patient; determining whether the characteristic associated with the sensor satisfies a threshold; and An action is performed based on determining that the data received from the sensor satisfies the threshold.

2. The drug delivery device according to claim 1, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a velocity of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the speed of the acceleration sensor satisfies a speed threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the velocity of the acceleration sensor satisfies the velocity threshold.

3. The drug delivery device according to claim 1, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining an amount of inertial force of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the amount of the inertial force of the acceleration sensor satisfies a force threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the inertial force of the acceleration sensor satisfies the force threshold.

4. The drug delivery device according to claim 3, wherein: When determining the amount of inertial force, the at least one processor is programmed or configured to: determining a first amount of inertial force in a first direction based on first data associated with acceleration of the acceleration sensor in the first direction; determining a second amount of inertial force in a second direction based on second data associated with acceleration of the acceleration sensor in the second direction; Wherein, when determining whether the inertial force of the acceleration sensor satisfies the force threshold, the at least one processor is programmed or configured to: determining whether a first amount of the inertial force in the first direction satisfies a first force threshold; determining whether a second amount of the inertial force in the second direction satisfies a second force threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that a first amount of the inertial force in the first direction satisfies the first force threshold or a second amount of the inertial force in the second direction satisfies the second force threshold.

5. The drug delivery device according to claim 1, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a first vector value of acceleration of the acceleration sensor in a first direction based on the data associated with the acceleration of the acceleration sensor; determining a second vector value of acceleration of the acceleration sensor in a second direction based on the data associated with the acceleration of the acceleration sensor; and determining a composite acceleration vector of the acceleration of the acceleration sensor based on the first vector value of the acceleration of the acceleration sensor in the first direction and the second vector value of the acceleration of the acceleration sensor in the second direction; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the resultant acceleration vector of the acceleration of the acceleration sensor satisfies an acceleration threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the resultant acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold.

6. The drug delivery device according to claim 1, wherein: The sensor is an acceleration sensor, wherein the at least one processor is further programmed or configured to: determining an orientation of the acceleration sensor; and wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: The characteristic associated with the acceleration sensor is determined based on the orientation of the acceleration sensor.

7. The drug delivery device according to claim 1, wherein: The at least one processor and the sensor are positioned on a printed circuit board (PCB).

8. The drug delivery device according to claim 1, further comprising: case; as well as Drug injection systems; Wherein, the at least one processor and the drug injection system are positioned within the housing.

9. The drug delivery device according to claim 8, wherein: The drug injection system includes a cannula configured to be inserted into at least one of a blood vessel, dermis, intradermal tissue, subcutaneous tissue, and muscle tissue of a user.

10. The drug delivery device according to claim 1, wherein: The sensor is a contact sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data from the contact sensor associated with a position of the contact sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a condition of the contact sensor regarding proximity of the contact sensor to a body of a user based on the data associated with the position of the contact sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the condition of the contact sensor satisfies a threshold associated with the contact sensor being adjacent to the body of the user; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the condition of the contact sensor satisfies the threshold associated with the contact sensor being adjacent to the body of the user.

11. The drug delivery device according to claim 1, wherein: The threshold value comprises a threshold value based on an operating mode of the drug delivery device.

12. A drug delivery device, comprising: case; Drug injection systems; sensor; as well as at least one processor in communication with the sensor; wherein the at least one processor, the sensor, and the drug injection system are positioned within the housing; and Wherein, the at least one processor is programmed or configured to: receiving data associated with the sensor from the sensor; determining a characteristic associated with the sensor based on the data received from the sensor; determining whether the characteristic associated with the sensor satisfies a threshold; and An action is performed based on determining that the data received from the sensor satisfies the threshold.

13. The drug delivery device according to claim 12, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a velocity of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the speed of the acceleration sensor satisfies a speed threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the velocity of the acceleration sensor satisfies the velocity threshold.

14. The drug delivery device according to claim 12, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining an amount of inertial force of the acceleration sensor based on the data associated with the acceleration of the acceleration sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the amount of inertial force of the acceleration sensor satisfies a force threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the inertial force of the acceleration sensor satisfies the force threshold.

15. The drug delivery device of claim 12, wherein: The sensor is an acceleration sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data associated with acceleration of the acceleration sensor from the acceleration sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a first vector value of acceleration of the acceleration sensor in a first direction based on the data associated with the acceleration of the acceleration sensor; determining a second vector value of acceleration of the acceleration sensor in a second direction based on the data associated with the acceleration of the acceleration sensor; and determining a composite acceleration vector of the acceleration of the acceleration sensor based on the first vector value of the acceleration of the acceleration sensor in the first direction and the second vector value of the acceleration of the acceleration sensor in the second direction; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the resultant acceleration vector of the acceleration of the acceleration sensor satisfies an acceleration threshold; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the resultant acceleration vector of the acceleration of the acceleration sensor satisfies the acceleration threshold.

16. The drug delivery device of claim 12, wherein: The sensor is a contact sensor, wherein upon receiving the data from the sensor, the at least one processor is programmed or configured to: receiving data from the contact sensor associated with a position of the contact sensor; wherein, when determining the characteristic associated with the sensor, the at least one processor is programmed or configured to: determining a condition of the contact sensor regarding proximity of the contact sensor to a body of a user based on the data associated with the position of the contact sensor; Wherein, when determining whether the characteristic associated with the sensor satisfies the threshold, the at least one processor is programmed or configured to: determining whether the condition of the contact sensor satisfies a threshold associated with the contact sensor being adjacent to the body of the user; and Wherein, when performing the actions, the at least one processor is programmed or configured to: The action is performed based on determining that the condition of the contact sensor satisfies the threshold associated with the contact sensor being adjacent to the body of the user.

17. The drug delivery device of claim 16, wherein: The contact sensor includes at least one of the following: Proximity sensor; Optical sensors; Conductive sensor; or Measurement circuit.

18. The drug delivery device of claim 17, wherein: The proximity sensor is at least one of a capacitive sensor and an ultrasonic sensor.

19. A drug delivery device, comprising: at least one processor programmed or configured to: receiving data associated with the sensor from the sensor; determining a characteristic associated with the sensor based on the data received from the sensor; determining whether the characteristic associated with the sensor satisfies a threshold; as well as performing an action based on determining that the data received from the sensor satisfies the threshold; Wherein, when performing the actions, the at least one processor is programmed or configured to perform at least one of the following: Provide alerts; Provide notices; ceasing delivery of drug from the drug delivery device; Store data associated with the event; transmitting data associated with the event to a remote device; or Any combination of them.

20. The drug delivery device of claim 18, further comprising: case; Drug injection systems; Adhesive layer; wherein the at least one processor and the drug injection system are positioned within the housing; and Wherein, the adhesive layer is configured to be positioned on a body of a user.

21. The drug delivery device of claim 19, wherein: The drug injection system includes a cannula configured to be inserted into at least one of a blood vessel, dermis, intradermal tissue, subcutaneous tissue, and muscle tissue of a patient.

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