Drug Delivery Device with Fluid Flow Path Detection

Abstract

A drug delivery device comprising a sensor and at least one processor in communication with the sensor, wherein the at least one processor receives data associated with a fluid flow path from the sensor, determines a characteristic associated with the fluid flow path based on the data received from the sensor, determines whether the characteristic associated with the fluid flow path meets a threshold, and is programmed or configured to perform an action based on determining that the data associated with the fluid flow path meets the threshold. The sensor and the processor analyze data to determine normal deployment of the cannula in the target tissue and detect removal of the cannula from the target tissue.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 349,789, filed on Jun. 7, 2022, entitled “Drug Delivery Device with Fluid Flow Path Sensing”. The entire disclosure of U.S. Provisional Patent Application No. 63 / 349,789 is incorporated herein by reference.

Background Art

[0002] Wearable syringes (e.g., wearable drug delivery systems, wearable injection devices, wearable auto - injectors, on - body syringes (OBES), on - body delivery systems (OBDS), etc.) can provide drug therapy to a patient when the patient is in a location away from a clinical facility and / or while worn under the patient's clothing. A wearable syringe can be attached to the patient's skin and, when the wearable syringe is attached to (e.g., positioned on) the patient's skin, such as after a predetermined time has elapsed since the wearable syringe was attached or immediately after the wearable syringe was attached, can be configured to automatically deliver a dose of a drug (e.g., a pharmaceutical composition, a medicament, etc.) or deliver it based on a user's command. In some examples, a wearable syringe can deliver a drug to a patient for a certain duration. After the wearable syringe has delivered a pharmaceutical composition to the patient, the patient subsequently removes and discards the device.

[0003] Depending on the situation, a wearable syringe may move when attached to a patient's body. For example, after the wearable syringe is attached to a patient's limb, the position of the wearable syringe may change based on the movement of the patient's limb. In some examples, the wearable syringe, as well as components of the wearable syringe such as a cannula and / or a needle, may be displaced from their intended position based on the patient's movement. The movement of the wearable syringe may inhibit the proper introduction of the drug to the patient. In some examples, when a wide range of movement occurs, the components of the wearable syringe may not be properly deployed, interfering with the delivery of the drug to the patient. Further, the movement of the wearable syringe may disrupt the fluid flow path from the reservoir of the wearable syringe to the patient's injection site.

[0004] Therefore, it is advantageous to determine whether the components of the wearable syringe are properly deployed with respect to the patient's body and whether the fluid flow path is functioning properly (e.g., whether the fluid flow path is obstructed, whether the fluid flow path is leaking, whether an indwelling catheter is deployed in the subcutaneous tissue, etc.) to ensure the correct delivery of the drug to the patient. SUMMARY OF THE INVENTION

[0005] Accordingly, improved systems, devices, products, apparatuses, and / or methods are provided for detecting the characteristics of the fluid flow path of a drug delivery device.

[0006] Further non-limiting embodiments or aspects are described in the following numbered clauses.

[0007] 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 receives data associated with the fluid flow path from the sensor for a time corresponding to an operating mode of the drug delivery device, determines a characteristic associated with the fluid flow path based on the data received from the sensor, determines whether the characteristic associated with the fluid flow path meets at least one of a threshold and a characteristic time constant derived from pressure attenuation, and is programmed or configured to perform an action based on determining that the data associated with the fluid flow path meets the threshold before the drug is delivered from the drug delivery device or when the delivery is complete.

[0008] Clause 2. The sensor is a flow sensor. The drug delivery device according to Clause 1.

[0009] Clause 3. The sensor is a pressure sensor. The drug delivery device according to Clause 1.

[0010] Clause 4. The pressure sensor is positioned within the fluid flow path. The drug delivery device according to Clause 3.

[0011] Clause 5. At least one sensor is positioned to be in direct contact with the flow path. The drug delivery device according to Clause 1.

[0012] Clause 6. 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.

[0013] Clause 7. The drug injection system includes a cannula configured to be inserted into a user's subcutaneous or muscular tissue. The drug delivery device according to Clause 6.

[0014] Clause 8. The threshold value includes a threshold value based on the operating mode of the drug delivery device, The drug delivery device according to clause 1.

[0015] Clause 9. The specific working mode of the drug delivery device is at least one of component deployment, drug injection, and dwell time, The drug delivery device according to clause 1.

[0016] Clause 10. A drug delivery device including a housing, a drug injection system, a sensor, and at least one processor that communicates with the sensor. The at least one processor, sensor, and drug injection system are positioned within the housing, and the at least one processor receives data related to the fluid flow path from the sensor, determines a characteristic related to the fluid flow path based on the data received from the sensor, determines whether the characteristic related to the fluid flow path meets a threshold value, and is programmed or configured to perform an action based on determining that the data related to the fluid flow path meets the threshold value before the drug is delivered from the drug delivery device or when the delivery is completed.

[0017] Clause 11. The sensor is a flow sensor. The drug delivery device according to clause 10.

[0018] Clause 12. The sensor is a pressure sensor. The drug delivery device according to clause 10.

[0019] Clause 13. The pressure sensor is positioned within the fluid flow path. The drug delivery device according to clause 12.

[0020] Clause 14. At least one sensor is positioned within the flow path. The drug delivery device according to clause 10.

[0021] Clause 15. The drug delivery device according to clause 10, further comprising a housing and a drug injection system. At least one processor and the drug injection system are positioned within the housing.

[0022] Clause 16. The drug delivery device according to clause 15, wherein the drug injection system includes a cannula configured to be inserted into the subcutaneous or muscular tissue of the user. The drug delivery device according to clause 15.

[0023] Clause 17. The threshold includes a threshold based on the operating mode of the drug delivery device. The drug delivery device according to clause 10.

[0024] Clause 18. The drug delivery device includes at least one processor programmed or configured to receive data related to 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 meets a threshold, and perform an action based on determining that the data associated with the fluid flow path meets 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 an event, or any combination thereof.

[0025] Clause 19. The sensor is positioned within the fluid flow path. The drug delivery device according to clause 18.

[0026] Clause 20. The drug delivery device according to 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 user's body.

[0027] Clause 21. The drug injection system comprises a cannula configured to be inserted into the subcutaneous or muscular tissue of the user. The drug delivery device according to clause 20.

[0028] Clause 22. The action is executed based on a determination that data associated with the fluid flow path meets a threshold either before the drug is delivered from the drug delivery device or when the delivery is completed. The drug delivery device according to clause 18.

Brief Description of the Drawings

[0029] Additional advantages and details are described in detail below with reference to the exemplary embodiments illustrated in the accompanying schematic diagrams.

[0030]

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DETAILED DESCRIPTION OF THE INVENTION

[0031] It should be understood that the present disclosure may assume various alternative variations and step sequences unless the contrary is explicitly stated. Also, it should be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary and non-limiting embodiments or aspects. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments or aspects disclosed herein should not be regarded as limiting.

[0032] For the following description, "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall relate to the embodiment or aspect when following the orientation in the drawings. However, it should be understood that the embodiment or aspect may assume various alternative variations and step sequences unless the contrary is explicitly stated. Also, it should be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary and non-limiting embodiments or aspects. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments or aspects disclosed herein should not be regarded as limiting.

[0033] As used herein, aspects, components, elements, structures, acts, steps, functions, instructions, etc. should not be construed as such unless explicitly described as critical or essential. Also, 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". When used in this specification and the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Additionally, further, 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" and "at least one". The term "one" or similar language is used when only one item is intended. Also, as used herein, terms such as "has", "have", "having", etc. are intended to be open-ended terms. Further, the phrase "based on" is intended to mean "at least partially based on" unless otherwise specified. Further, the phrase "based on" is intended to mean "at least partially based on" unless otherwise specified. Further, the phrase "based on" may mean "in response to" and may indicate conditions for automatically triggering specified operations of an electronic device (e.g., a controller, a processor, a computing device, etc.) as appropriately referenced herein.

[0034] As used herein, the terms "communicate" and "communicating" may refer to the reception, receipt, transmission, transfer, provision, etc. of information (e.g., data, signals, messages, instructions, commands, etc.). For a unit (e.g., a device, a system, a component of a device or system, a combination thereof, etc.) to communicate with another unit means that one unit can receive information directly or indirectly from the other unit and / or can send (e.g., transmit) information directly or indirectly to the other unit. This may refer to a direct or indirect connection having wired and / or wireless characteristics. Additionally, two units can communicate with each other even though the information transmitted can be modified, processed, relayed, and / or routed between the first unit and the second unit. For example, a first unit can communicate with a second unit even though the first unit passively receives information and does not actively send information to the second unit. As another example, a first unit can communicate with a second unit when 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 sends the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet, etc.) containing data.

[0035] Some non-limiting embodiments or aspects may be described herein in relation to a threshold. Meeting a threshold may, as used herein, refer to a value being greater than, more than, higher than, above, less than, fewer than, lower than, below, or equal to the threshold.

[0036] An improved device, system, method, and computer program product are provided for detecting characteristics of a fluid flow path of a drug delivery device. Embodiments of the present disclosure are drug delivery devices including a sensor and at least one processor in communication with the sensor, wherein the at least one processor receives data associated with the fluid flow path from the sensor, determines a characteristic associated with the fluid flow path based on the data received from the sensor, determines whether the characteristic associated with the fluid flow path meets a threshold, and is programmed or configured to perform an action based on determining that the data associated with the fluid flow path meets the threshold. In some non-limiting embodiments, the at least one processor is programmed or configured to provide an alarm, provide a notification, store data associated with an event, and / or stop an operation when performing the action.

[0037] In some non-limiting embodiments, the threshold includes a threshold based on the operating mode of the drug delivery device. In some non-limiting embodiments, by measuring a vacuum pressure below the threshold and by including the characteristic time constant for pressure decay within a defined range, the indwelling catheter is further configured to determine that it is properly deployed within the subcutaneous tissue, and 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 when determining the characteristics associated with the fluid flow path. In some non-limiting embodiments, the pressure pattern or fluid movement pattern characteristics of the catheter withdrawn from the tissue are measured by the sensor and analyzed by the processor to trigger an action such as an alarm or notification or a data logging event. In some non-limiting embodiments, at least one processor and sensor are positioned on a printed circuit board (PCB). In some non-limiting embodiments, the drug delivery device further comprises 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 comprises a cannula configured to be inserted into the subcutaneous tissue, dermis, or muscle tissue of a user (e.g., a patient).

[0038] In this way, embodiments of the present disclosure enable a wearable drug delivery device that can determine whether the components of the wearable syringe are properly deployed with respect to the patient's body and whether the fluid flow path is functioning properly to ensure the correct delivery of the drug to the patient.

[0039] Next, referring to FIG. 1, FIG. 1 is a diagram of a drug delivery device 100. As shown in FIG. 1, 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 via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection (e.g., establishing a connection for communication, etc.).

[0040] In some non-limiting embodiments, the drug delivery device 100 may be a wearable auto-injector such as an insulin or bone marrow stimulant delivery device. For example, the drug delivery device 100 may be attached to the user's skin and triggered to inject a drug into the user. The drug delivery device 100 may be pre-filled with the drug or filled with the drug by the user or another individual (e.g., a medical professional) prior to use (e.g., refilled after the previous injection).

[0041] The drug delivery device 100 may be configured to deliver a dose of drug into the user's body at a controlled delivery rate by subcutaneous injection. The controlled delivery rate may 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 may 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 may be adjustable (e.g., automatically adjusted or manually adjusted).

[0042] 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 a command (e.g., an instruction, a signal, etc.) to the drug injection system 106 to cause the drug injection system 106 to deliver a drug to the body of a user (e.g., a patient) to whom the drug delivery device 100 is attached. In some non-limiting embodiments, the processing device 102 may provide a command (e.g., an instruction, a signal, etc.) to the pump device 112 to cause the pump device 112 to provide a drug from the reservoir 110 to the fluid flow path 114, whereby the drug may be delivered to the body of the user to whom the drug delivery device 100 is attached.

[0043] 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 sensors such as a flow rate sensor, a pressure sensor, a temperature, and / or a pressure-temperature composite sensor. In some non-limiting embodiments, the sensor device 104 may provide data associated with the fluid flow path (e.g., data associated with the flow rate of the fluid in the fluid flow path, data associated with the pressure of the fluid flow path (e.g., the pressure in the fluid flow path), data associated with the temperature measurement in the fluid flow path, data associated with the temperature measurement of the fluid in the fluid flow path, etc.) based on the sensor device 104 that detects (e.g., measures) the characteristics of the fluid flow path.

[0044] In some non-limiting embodiments, the drug injection system 106 may include a device that can communicate with the processing device 102. In some non-limiting embodiments, the drug injection system 106 may include a device (e.g., mechanism, structure, etc.) that can deliver drugs to the body of the user to which the drug delivery device 100 is attached. In some non-limiting embodiments, the drug injection system 106 may automatically deliver drugs to the body of the user according to one or more predetermined time intervals. Additionally or alternatively, the drug injection system 106 may automatically deliver drugs to the body of the user at a predetermined time period such as a predetermined time period after attaching the drug delivery device 100 to the body of the user. In some non-limiting embodiments, the drug injection system 106 may include a cannula, catheter, and / or needle configured to be positioned within the body of the user. For example, the drug injection system 106 may include a cannula, catheter, and / or needle configured to be inserted into the subcutaneous or muscle tissue of the user.

[0045] In some non-limiting embodiments, the reservoir 110 may include a container (e.g., bladder, capsule, etc.) for storing the drug intended to be delivered to the body of the user. 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 single-use). In some non-limiting embodiments, the container may not be configured to be removable and / or replaceable.

[0046] In some non-limiting embodiments, the pump device 112 may include a device that can communicate with the processing device 102. In some non-limiting embodiments, the pump device 112 may include a pump (e.g., a positive displacement pump, an impulse 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 a mechanical action. In a non-limiting embodiment, the pump device 112 may include a power source that enables the operation of the pump device 112.

[0047] In some non-limiting embodiments, the fluid flow path 114 may include any suitable structure for allowing the fluid to flow along a path defined within the drug delivery device 100 and to flow to the user's body. 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., the catheter, cannula, and / or needle of the drug injection system 106) that extends outside the drug delivery device 100 (e.g., extends outside the drug delivery device 100 and into the user's body).

[0048] 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 a base portion (e.g., a base plate, a bottom plate, etc.) or a printed circuit board (PCB) of the drug delivery device 100 (e.g., can be installed on the base portion or the printed circuit board, can be disposed on the base portion or the printed circuit board, can be integrated with the base portion or the printed circuit board, etc.). 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 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, the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112 are positioned can be positioned using the housing of the drug delivery device 100 that covers the processing device 102, the sensor device 104, the drug injection system 106, the reservoir 110, and / or the pump device 112 positioned thereon. In this way, the drug delivery device 100 can have a small form factor that allows a user to wear the drug delivery device 100 with minimal discomfort.

[0049] In some non-limiting embodiments, the drug delivery device 100 may include a mechanism for holding the drug delivery device 100 in contact with the user's body. In this way, the drug delivery device 100 may be a body-worn device. In one example, the drug delivery device 100 may include an adhesive layer having an adhesive suitable for holding 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 band (e.g., a strap, belt, wrap, etc.) configured to hold the drug delivery device 100 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 that is positioned near the user's body when the drug delivery device 100 is affixed to the user's body. Further, the components of the drug injection system 106 may be configured to extend through the adhesive layer to be positioned within the user's body. In some non-limiting embodiments, the components of the drug injection system 106 may be configured to extend through an opening in the adhesive layer. In some non-limiting embodiments, the components of the drug injection system 106 may be configured to penetrate the adhesive layer.

[0050] 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 the operation has stopped, etc.). For example, the drug delivery device 100 may include one or more devices for providing a visual prompt 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 for providing an audible prompt to the user, such as one or more electroacoustic transducers (e.g., one or more speakers).

[0051] Next, referring to FIG. 2, FIG. 2 is a diagram of exemplary 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. As shown in FIG. 2, device 200 may include bus 202, processor 204, memory 206, storage component 208, input component 210, output component 212, and communication interface 214.

[0052] Bus 202 may include components that enable communication between the components of device 200. In some non-limiting embodiments or aspects, processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, 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 functions (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc.). Memory 206 may include random access memory (RAM), 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 used by processor 204.

[0053] The memory component 208 can store information and / or software related to the operation and use of the device 200. For example, the memory component 208 can include a hard disk (e.g., magnetic disk, optical disk, magneto-optical disk, solid state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium, along with the corresponding drive.

[0054] The input component 210 can include components that enable the device 200 to receive information via user input (e.g., touch screen display, keyboard, keypad, mouse, button, switch, microphone, camera, etc.). Additionally or alternatively, the input component 210 can include sensors for detecting information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). The output component 212 can include components that provide output information from the device 200 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).

[0055] The communication interface 214 can include a transceiver-like component (e.g., a transceiver, separate receiver and transmitter, etc.) that enables the device 200 to communicate with other devices via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection. The communication interface 214 can enable the device 200 to receive information from and / or provide information to another device. For example, the communication interface 214 can 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 (registered trademark) interface, a Bluetooth (registered trademark) interface, a Zigbee (registered trademark) interface, a cellular network interface, etc.

[0056] Device 200 may execute one or more processes described herein. Device 200 may execute these processes based on the processor 204 executing software instructions stored by a computer-readable medium such as the memory 206 and / or the storage component 208. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A non-transitory memory device includes a memory space located within a single physical memory device or a memory space spanning multiple physical memory devices.

[0057] The software instructions may be read into the memory 206 and / or the storage component 208 from another computer-readable medium or another device via the communication interface 214. The software instructions stored in the memory 206 and / or the storage component 208, when executed, may cause the processor 204 to execute one or more processes described herein. Additionally or alternatively, wired-connected circuitry may be used instead of or in combination with the software instructions to execute one or more processes described herein. Accordingly, the embodiments described herein are not limited to any particular combination of hardware circuitry and software.

[0058] Memory 206 and / or storage component 208 may include data storage or one or more data structures (such as a database, etc.). Device 200 may receive information from the data storage in memory 206 and / or storage component 208, or one or more data structures, store information in the data storage in memory 206 and / or storage component 208, or one or more data structures, communicate information to the data storage in memory 206 and / or storage component 208, or one or more data structures, or search for information stored in the data storage in memory 206 and / or storage component 208, or one or more data structures. For example, the information may include input data, input data, output data, transaction data, account data, or any combination thereof.

[0059] The number and arrangement of the components shown in FIG. 2 are given as an example. In some non-limiting embodiments or aspects, device 200 may include additional components, fewer components, different components, or components arranged differently than those shown in FIG. 2. Additionally or alternatively, a set of components of device 200 (such as one or more components) may perform one or more functions described as being performed by another set of components of device 200.

[0060] Next, referring to FIG. 3, FIG. 3 is a flowchart of a non-limiting embodiment or aspect of a process 300 for detecting characteristics 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 process 300 may be performed (e.g., fully, partially, etc.) by processing device 102. In some non-limiting embodiments or aspects, one or more of the steps of process 300 may be performed (e.g., fully, partially, etc.) by a device separate from and / or including processing device 102, such as sensor device 104, drug injection system 106, reservoir 110, and / or pump device 112, or by a group of devices separate from and / or including processing device 102, or by a group of devices separate from processing device 102 and / or including those devices.

[0061] As shown in FIG. 3, at step 302, process 300 may include receiving data associated with the 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, the data associated with fluid flow path 114 may include any information (e.g., characteristics, parameters, etc.) regarding fluid flow path 114 determined (e.g., measured, detected, sensed, obtained, etc.) by sensor device 104 during the operation of sensor device 104. In some non-limiting embodiments, the information regarding fluid flow path 114 may include data associated with the flow rate of the fluid within fluid flow path 114, data associated with the pressure within fluid flow path 114, such as the pressure within fluid flow path 114, data associated with a temperature measurement within fluid flow path 114, data associated with a temperature measurement of the fluid within fluid flow path 114, and the like.

[0062] As shown in FIG. 3, in step 304, process 300 may include determining characteristics associated with the fluid flow path. For example, processing device 102 may determine characteristics associated with fluid flow path 114 based on data received from sensor device 104. In some non-limiting embodiments, processing device 102 may determine the 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 characteristics associated with fluid flow path 114 based on the orientation of sensor device 104 and / or the calibration of sensor device 104.

[0063] As shown in FIG. 3, in step 306, process 300 may include determining whether the characteristics associated with the fluid flow path satisfy a threshold. For example, processing device 102 may determine whether the characteristics associated with fluid flow path 114 satisfy a threshold. In some non-limiting embodiments, the threshold may include a threshold based on the flow rate of the fluid and / or a pressure threshold. In one example, the threshold may include a threshold based on a flow rate indicating that the fluid is flowing through fluid flow path 114 at an acceptable flow rate (e.g., a maximum acceptable flow rate, a minimum acceptable flow rate, etc.). Additionally or alternatively, the threshold may indicate a threshold based on a pressure indicating that the pressure in 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 may include a plurality of thresholds (e.g., a threshold profile) including a plurality of predetermined values of flow rate and / or a plurality of predetermined values of pressure. For example, the threshold may include a plurality of predetermined values of flow rate and / or a plurality of predetermined values of pressure at time intervals after the cannula and / or needle of drug injection system 106 is deployed. In some non-limiting embodiments, the threshold may include a plurality of predetermined values of flow rate and / or a plurality of predetermined values of pressure based on the amount of drug stored in reservoir 110 and / or the operation of pump device 112 to provide the amount of drug stored in reservoir 110 to fluid flow path 114.

[0064] In some non-limiting embodiments, the threshold may include a threshold based on the mode of operation of the drug delivery device 100. The drug delivery device 100 may have a plurality of modes including a mode associated with a period in which the user is sleeping (e.g., deep sleep), a mode of operation associated with preparing to attach the drug delivery device 100 to the user's body, a mode of operation associated with deployment of components of the drug injection system 106 (e.g., cannula, catheter, and / or needle), and / or a mode of operation associated with injection of the drug into the user's body (e.g., the time at which the drug is delivered), a mode of operation associated with the dwell period of the device by the patient. In some non-limiting embodiments, the threshold may be based on the mode of operation, whereby the threshold for the first mode of operation may be different from the threshold for the second mode of operation. In some non-limiting embodiments, the threshold may be different for each mode of operation of the plurality of modes of operation of the drug delivery device 100.

[0065] As shown in FIG. 3, in step 310 (“Yes”), process 300 may include performing an action based on determining that a characteristic associated with the fluid flow path meets a threshold. For example, processing device 102 may perform an action based on determining that a characteristic associated with fluid flow path 114 meets a threshold. In some non-limiting embodiments, processing device 102 compares a characteristic associated with fluid flow path 114 to a threshold (e.g., a threshold value), and if processing device 102 determines that the characteristic associated with fluid flow path 114 meets 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 issued 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 drug delivery device 100 to provide a notification (e.g., a notification based on a visual prompt such as a light-emitting diode emitting light, a notification based on an audible prompt such as a speaker emitting an audible sound, etc.). In some non-limiting embodiments, 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 fluid flow path 114 meets a threshold). For example, processing device 102 may store data associated with the event in a memory device of drug delivery device 100. In some non-limiting embodiments, processing device 102 may perform an action by stopping the operation of pump device 112 and / or drug injection system 106.

[0066] As shown in FIG. 3, in step 308 (“No”), process 300 may include not performing an action based on a determination that a characteristic associated with the fluid flow path does not meet a threshold. For example, processing device 102 may not perform an action based on a determination that a characteristic associated with fluid flow path 114 does not meet a threshold. In some non-limiting embodiments, processing device 102 may compare a characteristic associated with fluid flow path 114 to a threshold, and if processing device 102 determines that the characteristic associated with fluid flow path 114 does not meet the threshold, processing device 102 may not perform an action.

[0067] Next, referring to FIG. 4, FIG. 4 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. As shown in FIG. 4, the drug delivery device 400 may include a processing device 102, a flow 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 sensing device 404 may be the same as 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, and the catheter may be a soft and 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 base plate, etc.) and an adhesive applied on the structural layer. In some non-limiting embodiments, the structural layer may include a flexible polymeric foam, a woven fabric, a rigid 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 attached to the user's skin. In some non-limiting embodiments, the cannula 408 and / or the needle of the cannula 408 may be inserted into the user's skin.

[0068] Regarding the drug delivery device 400, the processing device 102 may be programmed or configured to perform a process similar to or the same as the process 300 for detecting the characteristics of the fluid flow path of the drug delivery device 400 based on the flow 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 sensing device 404. In some non-limiting embodiments, the data associated with the fluid flow path 114 may include data associated with the fluid flowing within the fluid flow path 114. For example, the data associated with the fluid flow path 114 may include the flow rate of the fluid flowing within the fluid flow path 114.

[0069]

[0069] 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 the flow rate of the fluid flowing within the fluid flow path 114 based on data associated with the fluid flow path 114.

[0070]

[0070] In some non-limiting embodiments, the processing device 102 may determine whether a characteristic associated with the fluid flow path 114 meets a threshold based on the characteristic associated with the fluid flow path 114. For example, the processing device 102 may determine whether the flow rate of the fluid flowing within the fluid flow path 114 meets a flow rate threshold.

[0071]

[0071] In some non-limiting embodiments, the processing device 102 may execute an action based on determining that a characteristic associated with the fluid flow path 114 meets a threshold, or may not execute an action based on determining that a characteristic associated with the fluid flow path 114 does not meet a threshold. In some non-limiting embodiments, the processing device 102 may execute an action based on determining that the flow rate of the fluid flowing within the fluid flow path 114 meets a flow rate threshold, or the processing device 102 may not execute an action based on determining that the flow rate of the fluid flowing within the fluid flow path 114 does not meet a flow rate threshold.

[0072] Next, referring to FIG. 5, FIG. 5 is a diagram of a drug delivery device 500. In some non-limiting embodiments, the drug delivery device 500 may be the same as or similar to the drug delivery device 100 and / or the drug delivery device 400. As shown in FIG. 5, the drug delivery device 500 may include a processing device 102, a pressure sensing device 504, a drug injection system 406, and an 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 in the fluid flow path 114 (e.g., the pressure within the fluid flow path 114).

[0073] Regarding the drug delivery device 500, the processing device 102 may be programmed or configured to perform a process similar to or the same as process 300 for detecting the characteristics of the 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 the pressure in the fluid flow path 114. For example, the data associated with the fluid flow path 114 may include the pressure measured within the fluid flow path 114 (e.g., the pressure measured within the fluid flow path 114 when fluid is flowing through the fluid flow path 114).

[0074] In some non-limiting embodiments, the processing device 102 may determine the characteristics associated with the fluid flow path 114 based on the data associated with the fluid flow path 114. For example, the processing device 102 may determine the pressure in the fluid flow path 114 based on the data associated with the fluid flow path 114.

[0075] In some non-limiting embodiments, the processing device 102 may determine whether the characteristics associated with the fluid flow path 114 meet a threshold based on the characteristics associated with the fluid flow path 114. For example, the processing device 102 may determine whether the pressure in the fluid flow path 114 meets a pressure threshold.

[0076] In some non-limiting embodiments, the processing device 102 may perform an action based on determining that the characteristics associated with the fluid flow path 114 meet a threshold, or may not perform an action based on determining that the characteristics associated with the fluid flow path 114 do not meet a threshold. The threshold 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 in the fluid flow path 114 meets a pressure threshold, or the processing device 102 may not perform an action based on determining that the pressure in the fluid flow path 114 does not meet a pressure threshold.

[0077] Next, referring to FIGS. 6-8, FIGS. 6-8 are diagrams of a 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. With respect to FIG. 6, FIG. 6 is a perspective view of drug delivery device 900. As shown in FIG. 9, 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, drug delivery device 900 may be a wearable auto-injector. For example, drug delivery device 900 may be an insulin or bone marrow stimulant delivery device. In some non-limiting embodiments, drug delivery device 900 may be attachable (e.g., positioned to contact) to a user's body. For example, drug delivery device 900 may be attached to a user's skin. In some non-limiting embodiments, base 906 may include an adhesive layer 916. In some non-limiting embodiments, adhesive layer 916 may be the same as or similar to adhesive layer 410. In some non-limiting embodiments, button 918 may be configured to enable manual operation of drug injection system 902, whereby a drug may be delivered to the user's body based on the user depressing button 918.

[0078] With respect to FIG. 7, FIG. 7 is a cross-sectional view of drug delivery device 900. As shown in FIG. 7, drug delivery device 900 may include a cannula 908 and a reservoir 910. In some non-limiting embodiments, cannula 908 may include a needle. In some non-limiting embodiments, 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, cannula 908 may be inserted into a user's skin. For example, cannula 908 may be inserted into a user's skin, and the needle of cannula 908 may extend into the user's body. In some non-limiting embodiments, reservoir 110 may contain a drug to be delivered (e.g., injected) into the user's body.

[0079] With respect to FIG. 8, FIG. 8 is a perspective view of drug delivery device 900 with housing 904 removed. As shown in FIG. 8, drug delivery device 900 may include drug injection system 902, base 906, printed circuit board 912, and fluid line 914. In some non-limiting embodiments, printed circuit board 912 may include control electronics (e.g., processing device 102) for controlling the operation of drug delivery device 900. In some non-limiting embodiments, printed circuit board 912 may include sensors (e.g., sensor device 104, flow sensing device 404, pressure sensing device 504, etc.) mounted thereon, drug injection system 902, and / or processing device (e.g., processing device 102).

[0080] Next, referring to FIG. 9, FIG. 9 is a schematic diagram of a drug delivery device 900 shown in FIG. 6. As shown in FIG. 9, 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 source 14. In some non-limiting embodiments, the power source 14 may include a direct current (DC) power source such as one or more batteries. In some non-limiting embodiments, the electronics subsystem may control the operation 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 inlet 36, and a metering subsystem 38, and the metering subsystem 38 may include a pump and valve actuator 40 and a pump and valve mechanism 42. The fluid subsystem may further include an occlusion sensor 44, a deployment actuator 46, a cannula 48 inserted 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 fully positioned within the drug delivery device 900 to an extended position where the cannula 48 extends outside the drug delivery device 900. In some non-limiting embodiments, the cannula 48 is a catheter, and the catheter may be a soft and flexible catheter, a rigid catheter, or a combination thereof. In some non-limiting embodiments, the drug delivery device 900 may operate in a manner similar to that described in U.S. Patent No. 10,449,292 to Pizzochero et al., which is hereby incorporated by reference in its entirety.

[0081] Next, referring to FIG. 10, FIG. 10 is a diagram of an implementation 1000 of a drug injection system 902 of a drug delivery device during an injection procedure. In some non-limiting embodiments, the implementation 1000 may include a user operating the drug injection system 902, whereby the drug may be delivered to the user's body based on the user depressing a button (e.g., button 918) of the drug injection system 902. As shown in FIG. 10, the cannula of the drug injection system 902 may extend away from the drug injection system 902 during the injection procedure based on the user depressing the button. As further shown in FIG. 10, the volume of the fluid flow path may increase and a vacuum pressure may be generated within the fluid flow path. The increase in the volume of the fluid flow path may be based on the movement of the cannula as well as the movement of the needle of the cannula. As further shown in FIG. 10, the needle of the cannula may be retracted as part of the injection procedure. In some non-limiting embodiments, based on the needle being retracted within the cannula, the volume of the fluid flow path may change, whereby a vacuum pressure may occur within the fluid flow path. The movement of the cannula and / or the needle may cause a change in a characteristic associated with the fluid flow path that may be detected by a sensor device (e.g., sensor device 104).

[0082] Next, referring to FIG. 11, FIG. 11 is a diagram of a base portion 1100 of a drug delivery device (e.g., drug delivery device 900). As shown in FIG. 11, the base portion 1100 may include a fluid flow path 1114. As further shown in FIG. 11, the fluid flow path 1114 may be formed within the base portion 1100. In some non-limiting embodiments, the base portion 1100 may include a structure (e.g., a stop, a cavity, etc.), and the structure is sized and configured to enable a sensor device to be positioned within this structure and within the fluid flow path 1114.

[0083] Referring now to FIG. 12 , FIG. 12 is a diagram of a sensor device 1200 of a drug delivery device (e.g., drug delivery device 900). In some non-limiting embodiments, the sensor device 1200 can be the same as or similar to the sensor device 104, the flow sensing device 404, and / or the pressure sensing device 504. As shown in FIG. 12 , the sensor device 1200 can include contact pins 1202. In some non-limiting embodiments, the sensor device 1200 can include contact pins 1202 for connecting (e.g., electrically connecting) the sensor device 1200 to a printed circuit board (PCB). In some non-limiting embodiments, the sensor device 1200 can include a pressure sensor and / or a temperature sensor. In some non-limiting embodiments, the sensor device 1200 can include a pressure sensor that calculates pressure based on a force applied to a contact surface of the sensor device 1200. In some non-limiting embodiments, the sensor device 1200 can include an operating pressure range of 1 square inch (6.4516 cm ). 2 ) and / or a maximum pressure of 65 psi (448159 Pa). In some non-limiting embodiments, the pressure sensor may be an absolute pressure sensor with a reading range of 0-30 bar abs. In some non-limiting embodiments, the pressure sensor may be a gauge pressure sensor. In some non-limiting embodiments, the sensor device 1200 has a temperature range of 20-85° C. In some non-limiting embodiments, the sensor device 1200 is an I / O device paired with a multipoint control unit. 2 In some non-limiting embodiments, the sensor device 1200 may sense (e.g., detect, measure, record, etc.) pressure and / or temperature values ​​in real time.

[0084] Next, referring to FIG. 13, FIG. 13 is a diagram of a sensor device 1200 positioned on a base portion 1100. As shown in FIG. 13, the sensor device 1200 can be positioned in the structure of the base portion 1100, whereby the sensor device 1200 is positioned within the fluid flow path 1114. In some non-limiting embodiments, the sensor device 1200 can be connected (e.g., electrically connected) to the PCB 1316 via contact pins 1202.

[0085] Next, referring to FIG. 14, FIG. 14 is a plan view of a drug delivery device 1400. In some non-limiting embodiments, the drug delivery device 1400 may be the same as or similar to the drug delivery device 100, the drug delivery device 400, the drug delivery device 500, and / or the drug delivery device 900. As shown in FIG. 14, the drug delivery device 1400 can 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 as or similar to the sensor device 104, the flow rate detection device 404, the pressure detection device 504, and / or the sensor device 1200. In some non-limiting embodiments, the drug injection system 1406 may be the same as 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 as or similar to the reservoir 110. In some non-limiting embodiments, the pump device 1412 may be the same as or similar to the pump device 112. 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.

[0086] Embodiments or aspects have been described in detail for purposes of illustration and explanation, but such details are for that purpose only, and the embodiments or aspects are not limited to the disclosed embodiments or aspects. On the contrary, it is intended that modifications and equivalent configurations within the spirit and scope of the appended claims be covered. 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 can be combined with one or more features of any other embodiment or aspect. In short, many of these features can be combined in ways not specifically recited in the claims and / or not disclosed herein. Each of the dependent claims listed below may depend directly on only one claim, but the disclosure of possible implementations includes combinations of each dependent claim with every other claim within the claim set.

Claims

1. A drug delivery device for delivering a drug, comprising at least one sensor, and at least one processor in communication with the at least one sensor, wherein the at least one processor is configured to: receive data associated with a fluid flow path from the sensor for 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 meets at least one of a threshold and a characteristic time constant derived from pressure decay; execute an action based on a determination that the data associated with the fluid flow path meets the threshold before a drug is delivered from the drug delivery device or when the delivery is complete, Drug delivery device.

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

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

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

5. The drug delivery device according to claim 1, wherein the at least one sensor is positioned to be in direct contact with the flow path.

6. The drug delivery device according to claim 1, further comprising a housing and a drug injection system, wherein the at least one processor and the drug injection system are positioned within the housing.

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

8. The drug delivery device according to claim 1, wherein the threshold includes a threshold based on an operating mode of the drug delivery device.

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

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, The at least one processor, Receives data associated with the fluid flow path from the sensor, Determines a characteristic associated with the fluid flow path based on the data received from the sensor, Determines whether the characteristic associated with the fluid flow path meets a threshold, Based on determining that the data associated with the fluid flow path meets the threshold at a time before drug is delivered from the drug delivery device or when delivery is complete, is programmed or configured to perform an action, Drug delivery device. **Claim 11** The sensor is a flow sensor The drug delivery device according to claim 10. **Claim 12** The sensor is a pressure sensor The drug delivery device according to claim 10. **Claim 13** The pressure sensor is positioned within the fluid flow path The drug delivery device according to claim 12. **Claim 14** At least one of the sensors is positioned within the flow path The drug delivery device according to claim 10. **Claim 15** A housing, A drug injection system Further comprising, The at least one processor and the drug injection system are positioned within the housing The drug delivery device according to claim 10. **Claim 16** The drug injection system comprises a cannula configured to be inserted into a user's subcutaneous or muscular tissue The drug delivery device according to claim 15. **Claim 17** The threshold includes a threshold based on an operating mode of the drug delivery device The drug delivery device according to claim 10. **Claim 18** A drug delivery device, comprising At least one processor, Receives data associated with the fluid flow path from a sensor, Determines a characteristic associated with the fluid flow path based on the data received from the sensor, Comprises at least one processor programmed or configured to perform an action based on determining whether the data associated with the fluid flow path meets a threshold, When the at least one processor performs the action, Provides an alarm, Provides a notification, Stores data associated with an event, or Programmed or configured to perform any combination thereof Drug delivery device

19. The sensor is positioned within the fluid flow path The drug delivery device according to claim 18

20. A housing, A reservoir, A pump device, A drug injection system, An adhesive layer And further comprises The at least one processor, the reservoir, the pump device, and the drug injection system are positioned within the housing, The adhesive layer is configured to be positioned on the user's body The drug delivery device according to claim 18

21. The drug injection system comprises a cannula configured to be inserted into the subcutaneous or muscular tissue of the user The drug delivery device according to claim 20

22. The action is performed based on a determination that the data associated with the fluid flow path meets the threshold at a time before the drug is delivered from the drug delivery device or when the delivery is complete The drug delivery device according to claim 18

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