Drug delivery device with fluid flow path sensing

Abstract

A drug delivery device includes a sensor and at least one processor in communication with the sensor, where the at least one processor is programmed or configured to receive data associated with a fluid flow path from the sensor, determine a characteristic associated with the fluid flow path based on the data received from the sensor, and transmit the determined characteristic to the sensor. It is determined whether a characteristic associated with the fluid flow path satisfies a threshold, and an action is performed based on a determination that the data associated with the fluid flow path satisfies the threshold. A sensor and a processor analyze the data to determine successful deployment of the cannula in the target tissue and detect removal of the cannula from the target tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 349,789, filed on June 7, 2022, entitled “Drug Delivery Device with Fluid Flow Path Sensing,” the entire disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] A wearable injector (e.g., a wearable drug delivery system, a wearable injection device, a wearable auto-injector, an on-body injector (OBIS), an on-body delivery system (OBDS), etc.) can provide medication therapy to a patient while the patient is at a location away from a clinical facility and / or while being discreetly worn under the patient's clothing. The wearable injector can be applied to the patient's skin and can be configured to deliver a dose of medication (e.g., a pharmaceutical composition, a drug, etc.) automatically or based on a user's command when the wearable injector is applied to (e.g., positioned on) the patient's skin (e.g., such as after a delay of a predetermined period of time or immediately upon application of the wearable injector). In some cases, the wearable injector can deliver the medication to the patient over a period of time. After the wearable injector delivers the pharmaceutical composition to the patient, the patient can then remove and discard the device.

[0004] In some cases, the wearable injector may move while the wearable injector 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 (such as a cannula and / or needle) may deviate from the intended position based on the patient's movement. The movement of the wearable injector may interfere with the proper introduction of the drug to the patient. In some cases, if a large range of movement occurs, the components of the wearable injector may not be properly deployed, thereby interrupting the delivery of the drug to the patient. In addition, the movement of the wearable injector may interfere with the fluid flow path from the reservoir of the wearable injector to the injection site of the patient.

[0005] Thus, determining whether the components of the wearable injector are properly deployed relative to the patient's body and whether the fluid flow path is functioning properly (e.g., whether the fluid flow path is not blocked, whether the fluid flow path is not leaking, whether the indwelling catheter is deployed in the subcutaneous tissue, etc.) is beneficial for ensuring proper delivery of the drug to the patient. Summary of the invention

[0006] Thus, improved systems, devices, products, apparatus and / or methods are provided for sensing characteristics of a fluid flow path of a drug delivery device.

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

[0008] Clause 1. A drug delivery device for delivering a drug, comprising 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 a fluid flow path from the sensor during a time corresponding to an operating mode of the drug delivery device, determine a characteristic associated with the fluid flow path based on the data received from the sensor, determine whether the characteristic associated with the fluid flow path satisfies at least one of a threshold value and a characteristic time constant derived from pressure decay, and perform an action at a time before or upon completion of drug delivery from the drug delivery device based on determining that the data associated with the fluid flow path satisfies the threshold value.

[0009] Clause 2. The drug delivery device of clause 1, wherein the sensor is a flow sensor.

[0010] Clause 3. The drug delivery device of clause 1, wherein the sensor is a pressure sensor.

[0011] Clause 4. The drug delivery device of clause 3, wherein the pressure sensor is positioned within the fluid flow path.

[0012] Clause 5. The drug delivery device of clause 1, wherein the at least one sensor is positioned in direct contact with the fluid path.

[0013] Clause 6. The drug delivery device of 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.

[0014] Clause 7. The drug delivery device of clause 6, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

[0015] Clause 8. The drug delivery device of clause 1, wherein the threshold value comprises a threshold value based on an operating mode of the drug delivery device.

[0016] Clause 9. The drug delivery device of clause 1, wherein the specific operating mode of the drug delivery device is at least one of deployment of the component, injection of the drug, and dwell time.

[0017] Clause 10. A 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 wherein the at least one processor is programmed or configured to receive data associated with a fluid flow path from the sensor, determine a characteristic associated with the fluid flow path based on the data received from the sensor, determine whether the characteristic associated with the fluid flow path satisfies a threshold, and perform an action at a time before or upon completion of drug delivery from the drug delivery device based on determining that the data associated with the fluid flow path satisfies the threshold.

[0018] Clause 11. The drug delivery device of clause 10, wherein the sensor is a flow sensor.

[0019] Clause 12. The drug delivery device of clause 10, wherein the sensor is a pressure sensor.

[0020] Clause 13. The drug delivery device of clause 12, wherein the pressure sensor is positioned within the fluid flow path.

[0021] Clause 14. The drug delivery device of clause 10, wherein the at least one sensor is positioned within the fluid path.

[0022] Clause 15. The drug delivery device of clause 10, further comprising a housing and a drug injection system. The at least one processor and the drug injection system are positioned within the housing.

[0023] Clause 16. The drug delivery device of clause 15, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

[0024] Clause 17. The drug delivery device of clause 10, wherein the threshold value comprises a threshold value based on an operating mode of the drug delivery device.

[0025] Clause 18. A drug delivery device comprising at least one processor programmed or configured to receive data associated with a fluid flow path from a sensor, determine a characteristic associated with the fluid flow path based on the data received from the sensor, determine whether the characteristic associated with the fluid flow path satisfies a threshold, and perform an action based on the determination that the data associated with the fluid flow path satisfies the threshold. When performing the action, the at least one processor is programmed or configured to provide an alarm, provide a notification, store data associated with the event, or any combination thereof.

[0026] Clause 19. The drug delivery device of clause 18, wherein the sensor is positioned within the fluid flow path.

[0027] Clause 20. The drug delivery device of clause 18, further comprising a housing, a reservoir, a pump device, a drug injection system, and an adhesive layer. The at least one processor, the reservoir, the pump device, and the drug injection system are positioned within the housing, and the adhesive layer is configured to be positioned on the body of a user.

[0028] Clause 21. The drug delivery device of clause 20, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

[0029] Clause 22. The drug delivery device of clause 18, wherein the action is performed at a time prior to or upon completion of drug delivery from the drug delivery device based on determining that data associated with the fluid flow path satisfies a threshold. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Additional advantages and details are explained in more detail below with reference to exemplary embodiments shown in the accompanying schematic drawings, in which:

[0031] Figure 1 is a diagram of a non-limiting embodiment of a drug delivery device;

[0032] Figure 2 yes Figure 1 diagrams of non-limiting embodiments of one or more devices and / or components of one or more systems;

[0033] Figure 3 is a flow chart of a non-limiting embodiment of a process for sensing a characteristic of a fluid flow path of a drug delivery device;

[0034] Figure 4 is a diagram of a non-limiting embodiment of a drug delivery device;

[0035] Figure 5 is a diagram of a non-limiting embodiment of a drug delivery device;

[0036] Figure 6 is a perspective view of a non-limiting embodiment of a drug delivery device;

[0037] Figure 7 yes Figure 6 A cross-sectional view of a drug delivery device shown in;

[0038] Figure 8 yes Figure 6 A perspective view of a drug delivery device with the housing removed;

[0039] Fig. 9 yes Figure 6 Schematic diagram of a drug delivery device;

[0040] Fig.10is a diagram of a non-limiting example of an embodiment of a drug injection system of a drug delivery device during an injection procedure;

[0041] Fig.11 is a diagram of a non-limiting embodiment of a base portion of a drug delivery device;

[0042] Fig.12 is an illustration of a non-limiting embodiment of a sensor device;

[0043] Fig.13 yes Fig.12 A diagram of a non-limiting embodiment of a sensor device shown in FIG. 1 , the sensor device being positioned at Fig.11 within the base portion shown in ; and

[0044] Fig.14 is a bottom view of a non-limiting embodiment of a drug delivery device. DETAILED DESCRIPTION

[0045] It should be understood that the present disclosure may take various alternative variations and step sequences, unless otherwise expressly provided. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary and 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.

[0046] For ease of description below, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to an embodiment or aspect as oriented in the accompanying drawings. However, it shall be understood that an embodiment or aspect may employ various alternative variations and step sequences unless expressly provided otherwise. It shall also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely non-limiting exemplary embodiments or aspects. Therefore, unless otherwise stated, specific dimensions and other physical characteristics associated with the embodiments or aspects of the embodiments or aspects disclosed herein shall not be considered limiting.

[0047] Unless explicitly described as such, no aspect, component, element, structure, action, step, function, instruction, etc. used in this document should be construed as critical or essential. Moreover, as used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more" and "at least one." As used in the specification and claims, the singular forms of "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Furthermore, as used herein, the terms "set" and "group" are intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." In the case where only "a" and "a" are intended, the term "set" and "group" are intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." Figure 1 In the case of an item, the term "one" or similar language is used. Moreover, as used herein, the terms "having" and the like are intended to be open-ended terms. Additionally, unless expressly provided otherwise, the phrase "based on" is intended to mean "based at least in part on." Additionally, the phrase "based on" is intended to mean "based at least in part on," unless expressly provided otherwise. Additionally, unless expressly provided otherwise, the phrase "based on" may mean "in response to" and 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.

[0048] As used herein, the terms "communication" and "convey" may refer to the reception, receipt, transmission, transfer, provision, etc. of information (e.g., data, signals, messages, instructions, commands, etc.). A unit (e.g., a device, a system, a component of a device or system, a combination thereof, etc.) communicating with another unit means that one unit is able to directly or indirectly receive information from another unit and / or 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, two units may communicate with each other, even if the transmitted information may be modified, processed, relayed, and / or routed between the first and second units. For example, a first unit may communicate with a second unit, even if the first unit passively receives information and does not actively transmit information to the second unit. As another example, 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, then the first unit may communicate with the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet, etc.) including data.

[0049] 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 greater than a threshold value, more than a threshold value, higher than a threshold value, greater than or equal to a threshold value, less than a threshold value, less than a threshold value, lower than a threshold value, less than or equal to a threshold value, equal to a threshold value, etc.

[0050] Improved devices, systems, methods, and computer program products for sensing characteristics of a fluid flow path of a drug delivery device are provided. Embodiments of the present disclosure may include a drug delivery device that includes a 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 fluid flow path from the sensor, determine the characteristics associated with the fluid flow path based on the data received from the sensor, determine whether the characteristics associated with the fluid flow path meet a threshold, and perform an action based on determining that the data associated with the fluid flow path meets the threshold. In some non-limiting embodiments, when performing an action, the at least one processor is programmed or configured to provide an alarm, provide a notification, store data associated with the event, and / or cause the operation to stop.

[0051] In some non-limiting embodiments, the threshold value includes a threshold value based on the working mode of the drug delivery device. In some non-limiting embodiments, at least one processor is also programmed or configured to determine the correct deployment of the indwelling catheter in the subcutaneous tissue by measuring the vacuum pressure below the threshold and the characteristic time constant of the pressure decay is included in the defined range, and when determining the characteristics associated with the fluid flow path, at least one processor is programmed or configured to determine the characteristics associated with the fluid flow path based on the vacuum measured by the sensor. In some non-limiting embodiments, the pressure pattern or fluid movement pattern characteristics of the catheter being pulled out of the tissue are measured by the sensor and analyzed by the processor to trigger an action, such as an alarm or notification or data logging event. 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 within the housing. In some non-limiting embodiments, the drug injection system includes a cannula configured to be inserted into the subcutaneous tissue, dermis or muscle tissue of a user (e.g., a patient).

[0052] In this manner, embodiments of the present disclosure allow for a wearable drug delivery device that can determine whether the components of the wearable injector are properly deployed with respect to the patient's body and whether the fluid flow pathways are functioning properly to ensure proper delivery of the drug to the patient.

[0053] Reference now Figure 1 , Figure 1 is a diagram of a drug delivery device 100. Figure 1As shown in , the drug delivery device 100 may include a processing device 102, a sensor device 104, a drug injection system 106, a reservoir 110, and a pump device 112. The processing device 102, the sensor device 104, the drug injection system 106, the reservoir 110, and the pump device 112 may be interconnected (e.g., establish a connection for communication, etc.) via a wired connection, a wireless connection, or a combination of a wired and wireless connection.

[0054] In some non-limiting embodiments, the drug delivery device 100 can be a wearable automatic injector, such as an insulin or bone marrow stimulant delivery device. For example, the drug delivery device 100 can be applied to the user's skin and 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 another individual (e.g., a medical professional) before use.

[0055] The drug delivery device 100 can be configured to deliver a dose of a drug to a user via subcutaneous injection at a controlled delivery rate. The controlled delivery rate can include a duration of delivery ranging from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume range of the drug delivered by the drug delivery device 100 can range from 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 or manually).

[0056] 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, 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) applying the drug delivery device 100. In some non-limiting embodiments, the processing device 102 may provide commands (e.g., instructions, signals, etc.) to the pump device 112 to cause the pump device 112 to provide the drug from the reservoir 110 to the fluid flow path 114 so that the drug can be delivered to the body of the user applying the drug delivery device 100.

[0057] 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 a sensor, such as a fluid flow sensor, a pressure sensor, a temperature sensor, and / or a combined pressure and temperature sensor. In some non-limiting embodiments, the sensor device 104 may provide data associated with the fluid flow path (e.g., data associated with a flow rate of a fluid in the fluid flow path, data associated with a pressure of the fluid flow path (e.g., a pressure within the fluid flow path), data associated with a temperature measurement in the fluid flow path, data associated with a temperature measurement of the fluid in the fluid flow path, etc.) based on the sensor device 104 sensing (e.g., measuring) a characteristic of the fluid flow path.

[0058] 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 to the body of a user to 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 within a predetermined time period, such as within 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 subcutaneous tissue or muscle tissue of the user.

[0059] In some non-limiting embodiments, the reservoir 110 may include a container (e.g., a sac, a capsule, etc.) that stores the medication to be delivered to the user's body. In some non-limiting embodiments, the container may be refillable. In some non-limiting embodiments, the container may be configured to be removable and / or replaceable. In some non-limiting embodiments, the container may not be refillable (e.g., the container may be a disposable container). In some non-limiting embodiments, the container may not be configured to be removable and / or replaceable.

[0060] In some non-limiting embodiments, the pump device 112 may include a device capable of communicating with the processing device 102. In some non-limiting embodiments, the pump device 112 may include a pump (e.g., a positive displacement pump, a pulse pump, a speed pump, a gravity pump, a valveless pump, etc.) that moves a fluid (e.g., a drug stored in the reservoir 110) based on mechanical action. In some non-limiting embodiments, the pump device 112 may include a power source that allows operation of the pump device 112.

[0061] In some non-limiting embodiments, the fluid flow path 114 may include any suitable structure for allowing fluid to flow along a path defined in the drug delivery device 100 and to the body of the user. In some non-limiting embodiments, the fluid flow path 114 may include a defined channel. In some non-limiting embodiments, the fluid flow path 114 may include a tube (e.g., a pipe, a hose, etc.). In some non-limiting embodiments, the fluid flow path 114 may include a catheter, a cannula, and / or a needle (e.g., of the drug injection system 106) that extends to the exterior of the drug delivery device 100 (e.g., extends to the exterior of the drug delivery device 100 and into the body of the user).

[0062] In some non-limiting embodiments, the processing device 102, the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112 can be positioned on (e.g., mounted on, placed on, integrated with, etc.) a base portion (e.g., a substrate, a bottom plate, etc.) or a printed circuit board (PCB) of the drug delivery device 100. For example, one or more of the processing device 102, the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112 can be positioned on the same base portion or PCB. In some non-limiting embodiments, the PCB on which the processing device 102, the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112 are positioned can be positioned within the housing of the drug delivery device 100. Additionally or alternatively, the base portion on which the processing device 102, sensor device 104, drug injection system 106, reservoir 110, and / or pump device 112 are positioned can be positioned with a housing of the drug delivery device 100 that covers the processing device 102, sensor device 104, drug injection system 106, reservoir 110, and / or pump device 112 positioned thereon. In this manner, the drug delivery device 100 can have a compact form factor that allows a user to wear the drug delivery device 100 with minimal discomfort.

[0063] 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 an extended period of time. Additionally or alternatively, the drug delivery device 100 may include a belt (e.g., a belt, a waistband, a wrap, etc.) configured to keep the drug delivery device 100 in contact with the user's body. In some non-limiting embodiments, when the drug delivery device 100 is applied to the user's body, the adhesive layer may be positioned on the surface of the drug delivery device 100 close 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.

[0064] 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 (e.g., an indication of proper operation, an indication of improper operation, an indication that operation has ceased, etc.). For example, the drug delivery device 100 may include one or more devices that provide visual cues to the user, such as one or more light emitting diodes (LEDs) and / or one or more display screens. Additionally or alternatively, the drug delivery device 100 may include one or more devices that provide audible cues to the user, such as one or more electroacoustic transducers (e.g., one or more speakers).

[0065] Reference now Figure 2 , Figure 2 200. The device 200 may correspond to one or more components of the processing device 102, the sensor device 104, and / or the drug injection system 106. In some non-limiting embodiments, the processing device 102, the sensor device 104, and / or the drug injection system 106 may include at least one device 200 and / or at least one component of the device 200. Figure 2 As shown in , device 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 .

[0066] The bus 202 may include components that allow communication between components of the device 200. In some non-limiting embodiments or aspects, the processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, the processor 204 may include 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 that can be programmed to perform a function (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 another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions for use by the processor 204.

[0067] 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 disk (CD), a digital versatile disk (DVD), a floppy disk, a cassette, a magnetic tape, and / or another type of computer-readable medium, and a corresponding drive.

[0068] Input components 210 may include components that allow device 200 to receive information, such as via a user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, buttons, switches, 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.).

[0069] The communication interface 214 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmission source, etc.) that enables the device 200 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of a wired and wireless connection. The communication interface 214 may allow the device 200 to receive information from another device and / or provide information to another device. 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, a Wi-Fi® interface, a Bluetooth® interface, a Zigbee® interface, a cellular network interface, etc.

[0070] Device 200 can perform one or more processes described herein. Device 200 can perform these processes based on processor 204 executing software instructions stored by computer-readable media (such as 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 memory space located within a single physical storage device or memory space distributed across multiple physical storage devices.

[0071] The software instructions may be read into the memory 206 and / or storage component 208 from another computer-readable medium or from another device via the communication interface 214. When executed, the software instructions stored in the memory 206 and / or storage component 208 may cause the processor 204 to perform one or more processes described herein. In addition, or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, the embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

[0072] The memory 206 and / or storage component 208 may include a data storage device or one or more data structures (e.g., a database, etc.). The device 200 may be capable of receiving information from, storing information in, communicating information to, or searching for information stored in the data storage device or one or more data structures in the memory 206 and / or storage component 208. For example, the information may include input data, input data, output data, transaction data, account data, or any combination thereof.

[0073] supply Figure 2 The number and arrangement of components shown in FIG. 2 are provided as examples. In some non-limiting embodiments or aspects, the device 200 may include: Figure 2 More components, fewer components, different components, or differently arranged components than those shown in . In addition, or alternatively, a collection of components of device 200 (e.g., one or more components) can perform one or more functions described as being performed by another collection of components of device 200.

[0074] Reference now Figure 3 , Figure 3300 for sensing a characteristic of a fluid flow path 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, partially, 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, partially, etc.) by another device or group of devices (such as the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112) that is separate from and / or includes the processing device 102.

[0075] like Figure 3 As shown in , at step 302, process 300 may include receiving data associated with a fluid flow path. For example, processing device 102 may receive data associated with fluid flow path 114 from sensor device 104. In some non-limiting embodiments, data associated with fluid flow path 114 may include any information (e.g., characteristics, parameters, etc.) about fluid flow path 114 determined (e.g., measured, detected, sensed, obtained, etc.) by sensor device 104 during operation of sensor device 104. In some non-limiting embodiments, information about fluid flow path 114 may include data associated with a flow rate of a fluid in fluid flow path 114, data associated with a pressure of fluid flow path 114 (such as a pressure within fluid flow path 114), data associated with a temperature measurement in fluid flow path 114, data associated with a temperature measurement of the fluid in fluid flow path 114, etc.

[0076] like Figure 3 As shown in , at step 304, process 300 may include determining a characteristic associated with a fluid flow path. For example, processing device 102 may determine a characteristic associated with fluid flow path 114 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 fluid flow path 114 based on the orientation of sensor device 104 and / or calibration of sensor device 104.

[0077] like Figure 3As shown in , at step 306, the process 300 may include determining whether a characteristic associated with the fluid flow path satisfies a threshold value. For example, the processing device 102 may determine whether a characteristic associated with the fluid flow path 114 satisfies a threshold value. In some non-limiting embodiments, the threshold value may include a threshold value based on a threshold value of a flow rate and / or pressure of the fluid. In one example, the threshold value may include a threshold value based on a flow rate indicating that the fluid flows at an acceptable flow rate (e.g., a maximum acceptable flow rate, a minimum acceptable flow rate, etc.) within the fluid flow path 114. Additionally or alternatively, the threshold value may include a threshold value based on a pressure indicating that the pressure of the fluid flow path 114 is an acceptable pressure (e.g., a maximum acceptable pressure, a minimum acceptable pressure, etc.). In some non-limiting embodiments, the threshold value may include a plurality of threshold values ​​(e.g., a distribution of threshold values), which include a plurality of predetermined flow rate values ​​and / or a plurality of predetermined pressure values. For example, the threshold value may include a plurality of predetermined flow rate values ​​and / or a plurality of predetermined pressure values ​​at certain time intervals after the cannula and / or needle of the drug injection system 106 are deployed. In some non-limiting embodiments, the threshold value may include multiple predetermined flow rate values ​​and / or multiple predetermined pressure values ​​based on the amount of drug stored in the reservoir 110 and / or the operation of the pump device 112 to provide the amount of drug stored in the reservoir 110 to the fluid flow path 114.

[0078] In some non-limiting embodiments, the threshold value may include a threshold value based on the operating mode of the drug delivery device 100. The drug delivery device 100 may have multiple operating modes, including a mode associated with a period of sleep (e.g., deep sleep) of the user, 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 (e.g., cannula, catheter and / or needle) of the drug injection system 106, and / or an operating mode associated with injecting the drug into the user's body (e.g., the time of drug delivery), an operating mode associated with the period of time the device stays in the patient's body. In some non-limiting embodiments, the threshold value may be based on the operating mode, so that the threshold value for the first operating mode may be different from the threshold value for the second operating mode. In some non-limiting embodiments, the threshold value may be different for each of the multiple operating modes of the drug delivery device 100.

[0079] like Figure 3As shown in , at step 310 (“yes”), process 300 may include performing an action based on determining that a characteristic associated with the fluid flow path satisfies a threshold. For example, processing device 102 may perform an action based on determining that a characteristic associated with fluid flow path 114 satisfies a threshold. In some non-limiting embodiments, processing device 102 may compare a characteristic associated with fluid flow path 114 to a threshold (e.g., a threshold value), and if processing device 102 determines that a characteristic associated with fluid flow path 114 satisfies the threshold, processing device 102 may perform an action. In some non-limiting embodiments, processing device 102 may perform an action by providing an alarm. For example, processing device 102 may cause (e.g., trigger) an alarm to be emitted by drug delivery device 100. In some non-limiting embodiments, processing device 102 may perform an action by providing a notification. For example, processing device 102 may cause a notification to be provided by drug delivery device 100 (e.g., a notification based on a visual cue (such as a light emitting diode being illuminated), a notification based on an audio cue (such as a speaker emitting a sound), etc.). In some non-limiting embodiments, the processing device 102 may perform an action by storing (e.g., logging) data associated with an event (e.g., an event indicating that a characteristic associated with the fluid flow path 114 satisfies 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. In some non-limiting embodiments, the processing device 102 may perform an action by causing the pump device 112 and / or the drug injection system 106 to cease operation.

[0080] like Figure 3 As shown in , at step 308 ("No"), process 300 may include abandoning execution of the action based on determining that the characteristic associated with the fluid flow path does not satisfy the threshold. For example, processing device 102 may abandon execution of the action based on determining that the characteristic associated with fluid flow path 114 does not satisfy the threshold. In some non-limiting embodiments, processing device 102 may compare the characteristic associated with fluid flow path 114 to the threshold, and if processing device 102 determines that the characteristic associated with fluid flow path 114 does not satisfy the threshold, then processing device 102 may abandon execution of the action.

[0081] Reference now Figure 4 , Figure 4 4 is a diagram of a drug delivery device 400. In some non-limiting embodiments, drug delivery device 400 may be the same as or similar to drug delivery device 100. Figure 4As shown in , the drug delivery device 400 may include a processing device 102, a flow rate sensing device 404, a reservoir 110, a pump device 112, a drug injection system 406, and an adhesive layer 410. In some non-limiting embodiments, the flow rate sensing device 404 may be the same or similar to the sensor device 104. 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 base portion, such as a bottom 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 woven material, a hard plastic material, etc. In some non-limiting embodiments, the adhesive layer 410 may be in contact with the user's body. For example, the adhesive layer 410 may be applied to the user's skin. In some non-limiting embodiments, cannula 408 and / or a needle of cannula 408 may be inserted into the skin of a user.

[0082] With respect to the drug delivery device 400, the processing device 102 may be programmed or configured to perform a process the same as or similar to the process 300 for sensing a characteristic of a fluid flow path of the drug delivery device 400 based on the flow rate sensing device 404. In some non-limiting embodiments, the processing device 102 may receive data associated with the fluid flow path 114 from the flow rate sensing device 404. In some non-limiting embodiments, the data associated with the fluid flow path 114 may include data associated with a fluid flowing in the fluid flow path 114. For example, the data associated with the fluid flow path 114 may include a flow rate of the fluid flowing in the fluid flow path 114.

[0083] In some non-limiting embodiments, the processing device 102 may determine a characteristic associated with the fluid flow path 114 based on data associated with the fluid flow path 114. For example, the processing device 102 may determine a flow rate of a fluid flowing in the fluid flow path 114 based on data associated with the fluid flow path 114.

[0084] In some non-limiting embodiments, the processing device 102 may determine whether a characteristic associated with the fluid flow path 114 satisfies a threshold value based on the characteristic associated with the fluid flow path 114. For example, the processing device 102 may determine whether a flow rate of the fluid flowing in the fluid flow path 114 satisfies a threshold value for the flow rate.

[0085] In some non-limiting embodiments, the processing device 102 may perform an action based on a determination that a characteristic associated with the fluid flow path 114 satisfies a threshold value, or may forgo performing an action based on a determination that a characteristic associated with the fluid flow path 114 does not satisfy a threshold value. In some non-limiting embodiments, the processing device 102 may perform an action based on a determination that a flow rate of the fluid flowing in the fluid flow path 114 satisfies a threshold value for the flow rate, or may forgo performing an action based on a determination that a flow rate of the fluid flowing in the fluid flow path 114 does not satisfy a threshold value for the flow rate.

[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 in , the drug delivery device 500 may include the processing device 102, the pressure sensing device 504, the drug injection system 406, and the adhesive layer 410. In some non-limiting embodiments, the pressure sensing device 504 may be the same as or similar to the sensor device 104. In some non-limiting embodiments, the pressure sensing device 504 may include a device configured to detect the pressure of the fluid flow path 114 (e.g., the pressure within the fluid flow path 114).

[0087] With respect to the drug delivery device 500, the processing device 102 may be programmed or configured to perform a process that is the same as or similar to the process 300 for sensing a characteristic of a fluid flow path of the drug delivery device 500 based on the pressure sensing device 504. In some non-limiting embodiments, the processing device 102 may receive data associated with the fluid flow path 114 from the pressure sensing device 504. In some non-limiting embodiments, the data associated with the fluid flow path 114 may include data associated with a pressure of the fluid flow path 114. For example, the data associated with the fluid flow path 114 may include a pressure measured within the fluid flow path 114 (e.g., a pressure measured within the fluid flow path 114 when a fluid is flowing in the fluid flow path 114).

[0088] In some non-limiting embodiments, the processing device 102 may determine a characteristic associated with the fluid flow path 114 based on data associated with the fluid flow path 114. For example, the processing device 102 may determine a pressure of the fluid flow path 114 based on data associated with the fluid flow path 114.

[0089] In some non-limiting embodiments, processing device 102 may determine whether a characteristic associated with fluid flow path 114 satisfies a threshold value based on the characteristic associated with fluid flow path 114. For example, processing device 102 may determine whether a pressure of fluid flow path 114 satisfies a threshold value for pressure.

[0090] In some non-limiting embodiments, the processing device 102 may perform an action based on determining that a characteristic associated with the fluid flow path 114 satisfies a threshold value, or forgo performing an action based on determining that a characteristic associated with the fluid flow path 114 does not satisfy a threshold value. The threshold value may be a static value, a dynamic change in a pressure value, a characteristic time constant (e.g., a pressure decay time constant), or a combination thereof. In some non-limiting embodiments, the processing device 102 may perform an action based on determining that the pressure of the fluid flow path 114 satisfies a threshold value for pressure, or the processing device 102 may forgo performing an action based on determining that the pressure of the fluid flow path 114 does not satisfy a threshold value for pressure.

[0091] Reference now Figure 6-8 , Figure 6-8 is 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, and / or drug delivery device 500. Figure 6 , Figure 6 is a perspective view of drug delivery device 900. Fig. 9 As shown in , the drug delivery device 900 may include a drug injection system 902, a housing 904, a base 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 it). For example, the drug delivery device 900 may be mounted on the user's skin. In some non-limiting embodiments, the base 906 may include an adhesive layer 916. In some non-limiting embodiments, the adhesive layer 916 may be the same or similar to the adhesive layer 410. 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.

[0092] about Figure 7 , Figure 7 is a cross-sectional view of drug delivery device 900. Figure 7As shown in , the drug delivery device 900 may include a cannula 908 and a reservoir 910. 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 908 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.

[0093] See also Figure 8 , Figure 8 900 is a perspective view of the drug delivery device 900 with the housing 904 removed. Figure 8 As shown in , the drug delivery device 900 may include a drug injection system 902, a base 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 sensor device 104, the flow rate sensing device 404, the pressure sensing device 504, etc.), the drug injection system 902, and / or a processing device (e.g., the processing device 102) attached thereto.

[0094] Reference now Fig. 9 , Fig. 9 yes Figure 6 Schematic diagram of a drug delivery device 900 is shown in FIG. Fig. 9As shown in , the drug delivery device 900 may include a power storage subsystem, an electronics subsystem, and a fluid 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 a 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 fluid subsystem may include a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering subsystem 38, the metering subsystem including 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 skin of a user, 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 can be configured to move the cannula 48 from a retracted position completely positioned 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 can be a soft, flexible catheter, a rigid catheter, or a combination thereof. In some non-limiting embodiments, the drug delivery device 900 can operate in the same manner as discussed in U.S. Pat. No. 10,449,292 to Pizzochero et al., which is incorporated herein by reference in its entirety.

[0095] Reference now Fig.10 , Fig.10 is a diagram of an embodiment 1000 of a drug injection system 902 of a drug delivery device during an injection procedure. In some non-limiting examples, the embodiment 1000 may include a user operating the drug injection system 902 such that a drug may be delivered to the user's body based on the user pressing a button (e.g., button 918) of the drug injection system 902. Fig.10 As shown in , the cannula of the drug injection system 902 can be extended from the drug injection system 902 based on the user pressing a button during the injection procedure. Fig.10 As further shown in FIG. 1 , the volume of the fluid flow path can increase and cause a vacuum pressure in the fluid flow path. The increase in the volume of the fluid flow path can be based on the movement of the cannula and the movement of the needle of the cannula. Fig.10As further shown in , the needle of the cannula can be retracted as part of the injection procedure. In some non-limiting embodiments, the volume of the fluid flow path can change based on the needle retracting into the cannula, which can cause vacuum pressure in the fluid flow path. Movement of the cannula and / or needle can cause changes in characteristics associated with the fluid flow path, which can be detected by a sensor device (e.g., sensor device 104).

[0096] Reference now Fig.11 , Fig.11 is a diagram of a base portion 1100 of a drug delivery device (eg, drug delivery device 900). Fig.11 As shown in , the base portion 1100 may include a fluid flow path 1114. Fig.11 As further shown in FIG. 1 , a fluid flow path 1114 can be formed in the base portion 1100. In some non-limiting embodiments, the base portion 1100 can include a structure (e.g., a stopper, a cavity, etc.) that is sized and configured to allow a sensor device (such as a pressure sensor) to be positioned within the structure and within the fluid flow path 1114.

[0097] Reference now Fig.12 , Fig.12 1 is an illustration of a sensor device 1200 of a drug delivery device (e.g., drug delivery device 900). In some non-limiting embodiments, sensor device 1200 may be the same as or similar to sensor device 104, flow rate sensing device 404, and / or pressure sensing device 504. Fig.12 As shown in , the sensor device 1200 may include contact pins 1202. In some non-limiting embodiments, the sensor device 1200 may include contact pins 1202 to connect (e.g., electrically connect) the sensor device 1200 to a printed circuit board (PCB). In some non-limiting embodiments, the sensor device 1200 may include a pressure sensor and / or a temperature sensor. In some non-limiting embodiments, the sensor device 1200 may include a pressure sensor that calculates pressure based on the force applied to the contact surface of the sensor device 1200. In some non-limiting embodiments, the sensor device 1200 may have an operating pressure range of 4.3-17.4 pounds per square inch (psi) and / or a maximum pressure of up to 65 psi. In some non-limiting embodiments, the pressure sensor may be an absolute pressure sensor with a reading range of 0-30 bar absolute pressure. In some non-limiting embodiments, the pressure sensor may be a gauge pressure sensor. In some non-limiting embodiments, the sensor device 1200 may include a temperature range of -20 to 85 degrees Celsius. In some non-limiting embodiments, the sensor device 1200 may communicate via a serial communication interface, such as an I2C interface, that is paired with a multipoint control unit. 2C interface. In some non-limiting embodiments, the sensor device 1200 can sense (eg, detect, measure, record, etc.) pressure and / or temperature values ​​in real time.

[0098] Reference now Fig.13 , Fig.13 1 is a diagram of a sensor device 1200 positioned in a base portion 1100. Fig.13 As shown in FIG. 1 , sensor device 1200 may be positioned in a structure of base portion 1100 such that sensor device 1200 is positioned within fluid flow path 1114. In some non-limiting embodiments, sensor device 1200 may be connected (eg, electrically connected) to PCB 1316 via contact pins 1202.

[0099] Reference now Fig.14 , Fig.14 1 is a plan view of drug delivery device 1400. In some non-limiting embodiments, drug delivery device 1400 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 900. Fig.14 As shown in , the drug delivery device 1400 may include a drug injection system 1402, a sensor device 1404, a reservoir 1410, a pump device 1412, a fluid flow path 1414, and a PCB 1416. In some non-limiting embodiments, the sensor device 1404 may be the same or similar to the sensor device 104, the flow rate sensing device 404, the pressure sensing device 504, and / or the sensor device 1200. In some non-limiting embodiments, the drug injection system 1406 may be the same or similar to the drug injection system 106, the drug injection system 406, the drug injection system 506, and / or the drug injection system 902. In some non-limiting embodiments, the reservoir 1410 may be the same or similar to the reservoir 110. In some non-limiting embodiments, the pump device 1412 may be the same or similar to the pump device 112. As shown in FIG. Fig.14 As further shown in FIG. 14 , the sensor device 1404 can be positioned within the fluid flow path 1414. In some non-limiting embodiments, one or more of the sensor device 1404, the drug injection system 1406, the reservoir 1410, and / or the pump device 1412 can be positioned on the PCB 1416 or the base portion 1418.

[0100] Although embodiments or aspects have been described in detail for purposes of illustration and description, it should 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, on the contrary, are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should 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, any of these features may be combined in a manner not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed below may be directly dependent on one claim, the disclosure of possible implementations includes each dependent claim in combination with each other claim in the claim set.

Claims

1. A drug delivery device for delivering a drug, comprising: 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 fluid flow path from the sensor during a time corresponding to an operating mode of the drug delivery device; determining a characteristic associated with the fluid flow path based on data received from the sensor; determining whether a characteristic associated with the fluid flow path satisfies at least one of a threshold value and a characteristic time constant derived from a pressure decay; and An action is performed at a time prior to or upon completion of drug delivery from the drug delivery device based on determining that data associated with the fluid flow path satisfies a threshold.

2. The drug delivery device of claim 1, wherein the sensor is a flow sensor.

3. The drug delivery device of claim 1, wherein the sensor is a pressure sensor.

4. The drug delivery device of claim 3, wherein the pressure sensor is positioned within the fluid flow path.

5. The drug delivery device of claim 1, wherein the at least one sensor is positioned in direct contact with the fluid path.

6. The drug delivery device of 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.

7. The drug delivery device of claim 6, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

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

9. The drug delivery device of claim 1, wherein the specific operation mode of the drug delivery device is at least one of deployment of a component, injection of a drug, and dwell time.

10. 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, sensor, and drug injection system are positioned within the housing; and wherein the at least one processor is programmed or configured to: receiving data associated with a fluid flow path from a sensor; determining a characteristic associated with the fluid flow path based on data received from the sensor; determining whether a characteristic associated with the fluid flow path satisfies a threshold; and An action is performed at a time prior to or upon completion of drug delivery from the drug delivery device based on determining that data associated with the fluid flow path satisfies a threshold.

11. The drug delivery device of claim 10, wherein the sensor is a flow sensor.

12. The drug delivery device of claim 10, wherein the sensor is a pressure sensor.

13. The drug delivery device of claim 12, wherein the pressure sensor is positioned within the fluid flow path.

14. The drug delivery device of claim 10, wherein the at least one sensor is positioned within a fluid path.

15. The drug delivery device of claim 10, 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.

16. The drug delivery device of claim 15, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

17. The drug delivery device of claim 10, wherein the threshold comprises a threshold value based on an operating mode of the drug delivery device.

18. A drug delivery device comprising: at least one processor programmed or configured to: receiving data associated with a fluid flow path from a sensor; determining a characteristic associated with the fluid flow path based on data received from the sensor; determining whether a characteristic associated with the fluid flow path satisfies a threshold; as well as performing an action based on determining that data associated with the fluid flow path satisfies a threshold; Wherein, when performing the actions, the at least one processor is programmed or configured to: Provide alerts; Provide notices; store data associated with the event; or Any combination thereof.

19. The drug delivery device of claim 18, wherein the sensor is positioned within the fluid flow path.

20. The drug delivery device of claim 18, further comprising: case; Liquid reservoir; Pump equipment; Drug injection systems; as well as Adhesive layer; wherein the at least one processor, reservoir, pump device, and 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 20, wherein the drug injection system comprises a cannula configured to be inserted into subcutaneous tissue or muscle tissue of a user.

22. The drug delivery device of claim 18, wherein the action is performed at a time prior to or upon completion of drug delivery from the drug delivery device based on determining that data associated with the fluid flow path satisfies a threshold.

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