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WO2025231022A1 - Système de capteur d'écoulement - Google Patents

Système de capteur d'écoulement

Info

Publication number
WO2025231022A1
WO2025231022A1 PCT/US2025/026876 US2025026876W WO2025231022A1 WO 2025231022 A1 WO2025231022 A1 WO 2025231022A1 US 2025026876 W US2025026876 W US 2025026876W WO 2025231022 A1 WO2025231022 A1 WO 2025231022A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
flow sensor
syringe
medical device
base
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/026876
Other languages
English (en)
Inventor
Austin Jason Mckinnon
Jack Balji
Amir Mohammad TAHMASEBI MARAGHOOSH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025231022A1 publication Critical patent/WO2025231022A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16MFRAMES, CASINGS OR BEDS OF ENGINES, MACHINES OR APPARATUS, NOT SPECIFIC TO ENGINES, MACHINES OR APPARATUS PROVIDED FOR ELSEWHERE; STANDS; SUPPORTS
    • F16M13/00Other supports for positioning apparatus or articles; Means for steadying hand-held apparatus or articles
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16MFRAMES, CASINGS OR BEDS OF ENGINES, MACHINES OR APPARATUS, NOT SPECIFIC TO ENGINES, MACHINES OR APPARATUS PROVIDED FOR ELSEWHERE; STANDS; SUPPORTS
    • F16M11/00Stands or trestles as supports for apparatus or articles placed thereon ; Stands for scientific apparatus such as gravitational force meters

Definitions

  • the present disclosure relates generally to a flow sensor system and, in some nonlimiting embodiments or aspects, to a flow sensor system for sensing a flow of a fluidic medicament.
  • a system including: a flow sensor including a sensor to detect a property of a medical device received by the system; and a base configured to receive the flow sensor, wherein the base includes: a stabilizing surface; a monitoring surface rotatable at least 90 degrees relative to the stabilizing surface, the monitoring surface including a reflective portion; and a sensor mount rotatable at least 90 degrees relative to the monitoring surface and including: means to secure the flow sensor to the sensor mount; and a sensor channel adapted provide a field of detection for the sensor through the sensor mount toward the reflective portion.
  • the flow sensor includes a mobile computing device and the sensor includes a camera.
  • the means to secure the flow sensor includes a high friction material.
  • the base further includes a medical device receiver configured to hold a medical device in view of the reflective portion.
  • the flow sensor includes a processor configured by specific instructions stored on a memory device to perform one or more of the methods or processes described.
  • the flow sensor includes a network communication device, and wherein the flow sensor is configured to transmit information detected by the sensor via the network communication device.
  • system further includes a server configured by specific instructions stored on a memory device to perform one or more of the methods or processes described.
  • the flow sensor includes a display device, and wherein the flow sensor is configured to: determine a status of the medical device based on information received from the sensor; and present, via the display, the status of the medical device.
  • the status of the medical device includes a volume of fluid delivered from the medical device, wherein the medical device includes a syringe, and wherein determining the status includes: identifying a type of the syringe; determining, based on first information from the sensor, a starting location of a plunger of the syringe; determining, based on second information from the sensor, a current location of the plunger of the syringe; and generating the volume based on a comparison between the starting location and the current location.
  • the starting location of the syringe is identified by a tag affixed to the syringe.
  • the status of the medical device includes a volume of fluid delivered from the medical device, wherein the medical device includes a syringe, and wherein determining the status includes: identifying a type of the syringe; determining, based on first information from the sensor, a bottom of the syringe, wherein, when a plunger of the syringe is at the bottom of the syringe, the syringe is substantially emptied of the fluid; determining, based on second information from the sensor, a current location of the plunger of the syringe; and generating the volume based on a comparison between the starting location and the current location.
  • the bottom of the syringe is identified by a tag affixed to the syringe.
  • a base for a flow sensor including: a stabilizing surface; a monitoring surface rotatable at least 90 degrees relative to the stabilizing surface, the monitoring surface including a reflective portion; and a sensor mount rotatable at least 90 degrees relative to the monitoring surface and including: means to secure the flow sensor to the sensor mount; and a sensor channel adapted provide a field of detection for a sensor of the flow sensor through the sensor mount toward the reflective portion.
  • a system comprising: a flow sensor including a sensor to detect a property of a medical device received by the system; and a base configured to receive the flow sensor, wherein the base includes: a stabilizing surface; a monitoring surface rotatable at least 90 degrees relative to the stabilizing surface, the monitoring surface including a reflective portion; and a sensor mount rotatable at least 90 degrees relative to the monitoring surface and including: means to secure the flow sensor to the sensor mount; and a sensor channel adapted provide a field of detection for the sensor through the sensor mount toward the reflective portion.
  • Clause 4 The system of any of clauses 1-3, wherein the base further comprises a medical device receiver configured to hold a medical device in view of the reflective portion.
  • Clause 5. The system of any of clauses 1-4, wherein the flow sensor includes a processor configured by specific instructions stored on a memory device to perform one or more of the methods or processes described.
  • Clause 7. The system of any of clauses 1-6, further comprising a server configured by specific instructions stored on a memory device to perform one or more of the methods or processes described.
  • Clause 8. The system of any of clauses 1-7, wherein the flow sensor includes a display device, and wherein the flow sensor is configured to: determine a status of the medical device based on information received from the sensor; and present, via the display, the status of the medical device.
  • Clause 9 The system of any of clauses 1-8, wherein the status of the medical device comprises a volume of fluid delivered from the medical device, wherein the medical device comprises a syringe, and wherein determining the status comprises: identifying a type of the syringe; determining, based on first information from the sensor, a starting location of a plunger of the syringe; determining, based on second information from the sensor, a current location of the plunger of the syringe; and generating the volume based on a comparison between the starting location and the current location.
  • Clause 10 The system of any of clauses 1-9 wherein the starting location of the syringe is identified by a tag affixed to the syringe.
  • the status of the medical device comprises a volume of fluid delivered from the medical device, wherein the medical device comprises a syringe, and wherein determining the status comprises: identifying a type of the syringe; determining, based on first information from the sensor, a bottom of the syringe, wherein, when a plunger of the syringe is at the bottom of the syringe, the syringe is substantially emptied of the fluid; determining, based on second information from the sensor, a current location of the plunger of the syringe; and generating the volume based on a comparison between the starting location and the current location.
  • a base for a flow sensor comprising: a stabilizing surface; a monitoring surface rotatable at least 90 degrees relative to the stabilizing surface, the monitoring surface including a reflective portion; and a sensor mount rotatable at least 90 degrees relative to the monitoring surface and including: means to secure the flow sensor to the sensor mount; and a sensor channel adapted provide a field of detection for a sensor of the flow sensor through the sensor mount toward the reflective portion.
  • FIG. 1 is a diagram of non-limiting embodiments or aspects of an environment in which systems, devices, products, apparatus, and/or methods, described herein, may be implemented;
  • FIG. 2 is a diagram of non-limiting embodiments or aspects of components of one or more devices and/or one or more systems of FIG. 1;
  • FIG. 3 is a diagram of non-limiting embodiments or aspects of one example of a flow sensor system in a first configuration
  • FIG. 4 is a diagram of non-limiting embodiments or aspects of the example flow sensor system of FIG. 3 but in a second configuration
  • FIG. 5 is a diagram of non-limiting embodiments or aspects of a side view of the example flow sensor system of FIG. 3 but in the first configuration;
  • FIG. 6 is a diagram of an example image captured by the flow sensor system of FIG. 3.
  • FIG. 7 is a flow chart of a non-limiting embodiment or aspect of a process for using a flow sensor system.
  • proximal shall refer to a part or direction located away or furthest from a patient (upstream), while distal shall refer to a part or direction towards or located nearest to a patient (downstream).
  • a drug substance is used herein in an illustrative, nonlimiting manner to refer to any substance injectable into the body of a patient for any purpose.
  • Reference to a patient may be to any being, human or animal.
  • Reference to a clinician may be to any person or thing giving treatment, e.g., a nurse, doctor, machine intelligence, caregiver, or even self-treatment.
  • the terms “communication” and “communicate” refer to the receipt or transfer of one or more signals, messages, commands, or other type of data.
  • one unit e.g., any device, system, or component thereof
  • to be in communication with another unit means that the one unit is able to directly or indirectly receive data from and/or transmit data to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature.
  • two units may be in communication with each other even though the data transmitted may be modified, processed, relayed, and/or routed between the first and second unit.
  • a first unit may be in communication with a second unit even though the first unit passively receives data and does not actively transmit data to the second unit.
  • a first unit may be in communication with a second unit if an intermediary unit processes data from one unit and transmits processed data to the second unit. It will be appreciated that numerous other arrangements are possible.
  • satisfying a threshold may refer to a value being greater than the threshold, more than the threshold, higher than the threshold, greater than or equal to the threshold, less than the threshold, fewer than the threshold, lower than the threshold, less than or equal to the threshold, equal to the threshold, etc.
  • the term “computing device” or “computer device” may refer to one or more electronic devices that are configured to directly or indirectly communicate with or over one or more networks.
  • the computing device may be a mobile device, a desktop computer, or the like.
  • the term “computer” may refer to any computing device that includes the necessary components to receive, process, and output data, and normally includes a display, a processor, a memory, an input device, and a network interface.
  • An “application” or “application program interface” (API) refers to computer code or other data sorted on a computer-readable medium that may be executed by a processor to facilitate the interaction between software components, such as a client-side front-end and/or server- side back-end for receiving data from the client.
  • An “interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, touchscreen, etc.).
  • GUIs graphical user interfaces
  • server may refer to or include one or more processors or computers, storage devices, or similar computer arrangements that are operated by or facilitate communication and processing for multiple parties in a network environment, such as the Internet, although it will be appreciated that communication may be facilitated over one or more public or private network environments and that various other arrangements are possible. Further, multiple computers, e.g., servers, or other computerized devices, directly or indirectly communicating in the network environment may constitute a “system”. As used herein, the term “data center” may include one or more servers, or other computing devices, and/or databases.
  • the term “mobile device” may refer to one or more portable electronic devices configured to communicate with one or more networks.
  • a mobile device may include a cellular phone (e.g., a smartphone or standard cellular phone), a portable computer (e.g., a tablet computer, a laptop computer, etc.), a wearable device (e.g., a watch, pair of glasses, lens, clothing, and/or the like), a personal digital assistant (PDA), and/or other like devices.
  • PDA personal digital assistant
  • client device and “user device,” as used herein, refer to any electronic device that is configured to communicate with one or more servers or remote devices and/or systems.
  • a client device or user device may include a mobile device, a network-enabled appliance (e.g., a network-enabled television, refrigerator, thermostat, and/or the like), a computer, and/or any other device or system capable of communicating with a network.
  • a network-enabled appliance e.g., a network-enabled television, refrigerator, thermostat, and/or the like
  • an “application” or “application program interface” refers to computer code, a set of rules, or other data sorted on a computer-readable medium that may be executed by a processor to facilitate interaction between software components, such as a client-side front-end and/or server-side back-end for receiving data from the client.
  • An “interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, etc.).
  • GUIs graphical user interfaces
  • environment 100 may include flow sensor system 150 including flow sensor 160 and base 180, medical device 102 (e.g., a syringe, etc.) including one or more of an identification tag 104, IV line 106, communications network 108, or remote computing device 110.
  • medical device 102 e.g., a syringe, etc.
  • Medical device 102 may be configured to physically connect to flow sensor 160 or base 180 as described in more detail herein.
  • Identification tag 104 may be attached to or integrated with medical device 102 as described in more detail herein.
  • identification tag 104 may include an optically scannable tag such as a barcode or a quick-read code.
  • identification tag 104 may include one or more computing devices, chips, contactless transmitters, contactless transceivers, near field communication (NFC) transmitters/receivers, radio frequency identification (RFID) transmitters/receivers, contact based transmitters/receivers, or the like.
  • NFC near field communication
  • RFID radio frequency identification
  • the identification tag 104 can include one or more devices capable of transmitting or receiving information to or from the flow sensor 160 via a short-range wireless communication connection (e.g., a communication connection that uses NFC protocol, a communication connection that uses RFID, a communication connection that uses a Bluetooth® wireless technology standard, or the like).
  • a short-range wireless communication connection e.g., a communication connection that uses NFC protocol, a communication connection that uses RFID, a communication connection that uses a Bluetooth® wireless technology standard, or the like.
  • Flow sensor 160 may be configured to be removably, physically, and/or electrically connected to base 180 as described in more detail herein. Further details regarding non-limiting embodiments or aspects of flow sensor 160 are provided below with reference to FIGS. 3-7.
  • Base 180 may be configured to be removably, physically, and/or electrically connected to flow sensor 160 as described in more detail herein.
  • the base 180 provides a support structure for mounting the flow sensor 160 to monitor the medical device 102. Additional features may be implemented via base 180 to support or extend functionality of the flow sensor 160.
  • the base 180 may include one or more devices capable of receiving information or data from remote computing device 110 (e.g., via communication network 108, etc.) or communicating information and/or data to remote computing device 110 (e.g., via communication network 108, etc.).
  • base 180 includes one or more computing devices, chips, contactless transmitters, contactless transceivers, NFC transmi tters/receivers, RFID transmitters/receivers, contact based transmitters/receivers, or the like.
  • base 180 can include one or more devices capable of transmitting and/or receiving information to and/or from short-range wireless communication tag 104 or flow sensor 160 via a short- range wireless communication connection (e.g., a communication connection that uses NFC protocol, a communication connection that uses Radio-frequency identification (RFID), a communication connection that uses a Bluetooth® wireless technology standard, and/or the like).
  • a short- range wireless communication connection e.g., a communication connection that uses NFC protocol, a communication connection that uses Radio-frequency identification (RFID), a communication connection that uses a Bluetooth® wireless technology standard, and/or the like.
  • base 180 includes an integrated power source (not shown), such as a battery, wired power, or the like.
  • the base 180 may include a connection point to receive the flow sensor 160.
  • the connection point may be a physical connection element to hold the flow sensor 160 in a fixed position.
  • the connection point may include conductive elements to facilitate the exchange of data or power between the flow sensor 160 and the base 180.
  • Communication network 108 may include one or more wired and/or wireless networks.
  • communication network 108 may include a cellular network (e.g., a long-term evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation network (5G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., the public switched telephone network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, a fiber optic-based network, a cloud computing network, and/or the like, and/or a combination of these or other types of networks.
  • LTE long-term evolution
  • 3G third generation
  • 4G fourth generation
  • 5G fifth generation network
  • CDMA code division multiple access
  • PLMN public land mobile network
  • LAN local area network
  • Remote computing device 110 may include one or more devices capable of receiving information or data from base 180 or flow sensor 160 (e.g., via communication network 108, etc.) or communicating information or data to base 180 or flow sensor 160 (e.g., via communication network 108, etc.).
  • remote computing device 110 may include a computing device, a server, a group of servers, a mobile device, a group of mobile devices, or the like.
  • FIG. 1 The number and arrangement of devices and systems shown in FIG. 1 is provided as an example. There may be additional devices or systems, fewer devices or systems, different devices or systems, or differently arranged devices or systems than those shown in FIG. 1. Furthermore, two or more devices or systems shown in FIG. 1 may be implemented within a single device or system, or a single device or system shown in FIG. 1 may be implemented as multiple, distributed devices or systems. Additionally, or alternatively, a set of devices or systems (e.g., one or more devices or systems) of environment 100 may perform one or more functions described as being performed by another set of devices or systems of environment 100.
  • a set of devices or systems e.g., one or more devices or systems of environment 100 may perform one or more functions described as being performed by another set of devices or systems of environment 100.
  • FIG. 2 is a diagram of example components of a device 200.
  • Device 200 may correspond to flow sensor 160, base 180, or remote computing device 110.
  • flow sensor 160, base 180, or remote computing device 110 may include at least one device 200 or at least one component of device 200.
  • device 200 may include bus 202, processor 204, memory 206, storage component 208, input component 210, output component 212, or communication interface 214.
  • Bus 202 may include a component that permits communication among the components of device 200.
  • processor 204 may be implemented in hardware, firmware, or a combination of hardware and software.
  • 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 (e.g., a field-programmable gate array (FPGA), an application- specific integrated circuit (ASIC), etc.), and/or the like, which can be programmed to perform a function.
  • 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., a flash memory, a magnetic memory, an optical memory, etc.) that stores specific information or instructions for use by processor 204.
  • RAM random-access memory
  • ROM read only memory
  • static storage device e.g., a flash memory, a magnetic memory, an optical memory, etc.
  • Storage component 208 may store information or software related to the operation and use of device 200.
  • storage component 208 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid-state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, or another type of computer-readable medium, along with a corresponding drive.
  • Input component 210 may include a component that permits device 200 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, etc.). Additionally, or alternatively, input component 210 may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, an NFC sensor, an RFID sensor, an optical sensor, a bar code reader, etc.). Output component 212 may include a component that provides output information from device 200 (e.g., a display, a speaker, one or more lightemitting diodes (LEDs), etc.).
  • LEDs lightemitting diodes
  • Communication interface 214 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmission source, etc.) that enables device 200 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections.
  • Communication interface 214 may permit device 200 to receive information from another device and/or provide information to another device.
  • 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 cellular network interface, and/or the like.
  • RF radio frequency
  • USB universal serial bus
  • Device 200 may perform one or more processes described herein. Device 200 may perform these processes based on processor 204 executing software instructions stored by a computer-readable medium, such as memory 206 or storage component 208.
  • a computer- readable medium e.g. , a non-transitory computer-readable medium
  • a memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.
  • Software instructions may be read into memory 206 or storage component 208 from another computer-readable medium or from another device via communication interface 214. When executed, software instructions stored in memory 206 or storage component 208 may cause processor 204 to perform one or more processes described herein. Additionally, or alternatively, hardwired circuitry may be used in place of or in combination with specific software instructions to perform one or more processes described herein. Thus, embodiments or aspects described herein are not limited to any specific combination of hardware circuitry.
  • Memory 206 or storage component 208 may include data storage or one or more data structures (e.g., a database, etc.). Device 200 may be capable of receiving information from, storing information in, communicating information to, or searching information stored in the data storage or one or more data structures in memory 206 or storage component 208.
  • data structures e.g., a database, etc.
  • device 200 may include additional components, fewer components, different components, or differently arranged components than those shown in FIG. 2. Additionally, or alternatively, a set of components e.g., one or more components) of device 200 may perform one or more functions described as being performed by another set of components of device 200.
  • FIG. 3 is a diagram of non-limiting embodiments or aspects of one example of a flow sensor system in a first configuration.
  • the flow sensor system 300 may include a base 380 and a flow sensor 360. As shown in FIG. 3, the flow sensor 360 is a mobile communication device.
  • the first configuration of the flow sensor system 300 facilitates the monitoring of medical device 102. The monitoring may include capturing an image of medical device 102 such as the image shown in FIG. 6.
  • Base 380 includes a first portion 382 that includes a first hinge 384 to couple with a second portion 386.
  • the first portion 382 serves as a stabilizing surface for the base 380.
  • the second portion 386 may be formed as a monitoring surface that includes a second hinge 390 to couple with a third portion 392 (e.g., sensor mount).
  • a third hinge 396 may be included to couple the third portion 392 with a fourth portion 394.
  • the first portion 382 may serve as a stabilizing element of base 380. As shown in FIG. 3, the first portion 382 is shaped to sit on a surface.
  • the first portion 382 may include a clamp or other anchoring device to secure base 380 for medical device monitoring.
  • Second portion 386 may include a reflective surface 388 with a field of view covering at least a portion of the first portion 382.
  • the reflective surface 388 may be within a field of view of the flow sensor 360 when received on the third portion 392.
  • the third portion 392 may include a hole or other cutaway portion (e.g., a sensor channel, etc.) to allow a camera of the flow sensor 360 to capture images of the reflective surface 388. In this way, when medical device 102 is secured to the base, a reflected image can be captured by the flow sensor 360.
  • FIG. 5 shows a side view of the optical layout of flow sensor system 300.
  • the fourth portion 394 may be omitted and an alternate means for securing the flow sensor 360 may be provided.
  • the alternate means may include a high friction material such as rubber that will retain the flow sensor 360 on the third portion 392 even if the third portion 392 is not parallel to the ground.
  • a high friction material such as rubber that will retain the flow sensor 360 on the third portion 392 even if the third portion 392 is not parallel to the ground.
  • Another example of the means for securing include a clamp or post that may be affixed to the third portion 392 to engage and secure the flow sensor 360 when received.
  • the hinges in FIG. 3 may be tension hinges configured to move at least one surface 90 degrees relative to another surface joined at the hinge. The tension may hold the surfaces in a fixed position.
  • FIG. 4 is a diagram of non-limiting embodiments or aspects of the example flow sensor system of FIG. 3 but in a second configuration.
  • the base 380 In the second configuration, the base 380 is folded into a compact configuration and the flow sensor 360 is not shown. In the second configuration, the base 380 may be moved to a different clinical setting to be used for tracking a different medical device or administration.
  • FIG. 5 is a diagram of non-limiting embodiments or aspects of a side view of the example flow sensor system of FIG. 3 but in the first configuration.
  • a first field of view or detection 502 affords a camera or other optical device of the flow sensor 360 to capture an image or series of images of the reflective surface 388.
  • the reflective surface 388 provides a second field of view or detection 504 including a medical device placed on the first portion 382.
  • the medical device 102 may be received by the base 382 at an angle that corresponds to the angle of the reflective surface 388 such that the medical device 102 and reflective surface 388 are at or nearly parallel to each other.
  • FIG. 6 is a diagram of an example image captured by the flow sensor system of FIG. 3.
  • medical device 102a, 102b, and 102c are syringes.
  • Medical device 102d is a manifold. Each medical device may be tracked independently or collectively by the flow sensor 360.
  • Tags 104a through 104f may be used to track the medical device(s).
  • a tag may include information identifying the medical device or its contents. The distance between tag 104a and 104b may be calculated to estimate the total volume of medication within medical device 102a.
  • a physical characteristic of a medical device, such as stopper 106 or markings on the medical device such as the numbers, may be used to track the medical device(s).
  • the distance from tag 104e to the stopper 106 may be calculated to determine how much medication was expelled from medical device 102c.
  • the image may be further processed to identify potential errors. For example, if medical device 102a is not properly connected to the manifold 102d, the image may capture evidence of leaking. As another example, if medical device 102a includes a crack or other defect, the image may capture evidence of the defect. As another example, in some instances, particulates may be drawn into a syringe. These particulates can be harmful to a patient but may be detected by an image captured by the flow sensor system 150. An image processing system on the flow sensor 360 or connected therewith may analyze images to detect such anomalies. The image processing system may include object detection, image classifiers, or other machine learning or artificial intelligence guided image processing to efficiently and accurately identify administration events of interest.
  • FIG. 7 is a flow chart of a non-limiting embodiment or aspect of a process for using a flow sensor system.
  • the process 700 may be implemented in whole or in part using one or more of the devices shown and described in this application.
  • a device may be configured to perform or guide a user through the steps of the process 700.
  • the guidance may be provided via a user interface or other human perceivable means (e.g., voice guidance, light guidance).
  • the base of a flow sensor system is secured.
  • the securing of the base may include unfolding a base or clamping a base to a surface. Securing the base ensures that the base is stabilized for steady capturing of medication administration information.
  • securing the base may include connecting power or data to the base.
  • the base may include a port to receive a wired connection that can provide one or more of power or data connectivity.
  • a port is a USB-C port.
  • a sensor may be coupled with the base.
  • coupling the sensor to the base may include placing the sensor on the base in a position to detect medication administration via one or more medical devices.
  • coupling the sensor to the base may include a physical clamping or affixing of the sensor to the base. Coupling the sensor to the base may include aligning the sensor (or device integrated therewith such as a camera) to provide a field of detection to monitor medication administration.
  • a medical device may be received by the flow sensor system.
  • Receiving the medical device may include clipping, clamping, or otherwise affixing a manifold at the base such that the flow sensor has a field of detection to monitor the medical device and medication administered therefrom.
  • the flow sensor system may calibrate one or more fields of detection.
  • Calibration of the fields of detection may include adjusting the base or portions thereof to ensure a reflective surface is optimally aligned with the field of detection for the flow sensor.
  • the optimal alignment may include adjusting the angle or height of a portion of the base such that the medical device is aligned with a marking on the reflective surface.
  • the reflective surface may include fiduciary markings that indicate a field of detection for the flow sensor.
  • manipulating the position of the base or portions thereof can change what image is reflected by the reflective surface. The manipulation may be manual or performed using actuators that adjust the portions or pivots of the base.
  • Calibrating the fields of detection at block 708 may also include adjusting the position of the sensor to ensure the medication administration events of interest are within the detection field of the sensor.
  • the calibration may include adjusting the position of the sensor to ensure the field of view of the camera captures an area of interest such as the reflective surface.
  • Calibration may include automatically adjusting settings of the sensor such as panning, zooming, or adjusting lighting levels to best capture an area of interest.
  • a fiducial marking on the base may be used to calibrate lighting conditions, color levels, angle of capture, or other information that can be known prior to monitoring and used to process images or other data captured by the sensor.
  • the monitoring session may be associated with a patient.
  • the mobile device may include scanning technology to scan patient information.
  • the patient information can be used to associate data captured by the sensor with a patient.
  • the mobile device may include a user interface or other input mechanism to allow identification of a patient associated with the medication administration to be monitored.
  • the association may be based on information stored in or on the medical device.
  • a tag on a syringe may include information that can be used by the system to associate the events monitored by the sensor with a specific patient. Examples of such information include order identifier or patient identifier or container identifier.
  • the system can begin capturing events.
  • the sensor is capturing images of the events.
  • the sensor may alternatively or additional capture sonic readings of the events, weight readings of the events, non-visible images of the events (e.g., thermal readings), or the like.
  • Capturing the event image may include processing the event data. For example, an image may be processed to determine how far the syringe has been pressed to determine how much medication as administered therefrom. As another example, an image may be processed to identify errors or malfunctions with the medical device such as a leak, particulates, air bubbles, broken devices, or the like.
  • the image processing may include object detection or image classifiers to generate information about the event.
  • the image processing may be performed by the sensor or image may be transmitted via a network to a service that can perform the image processing. In such instances, the service may provide a response including information about any event detected via the image.
  • the event may be documented.
  • Documenting the event may include transmitting the event data to a patient’s medical record in association with their identifier.
  • Documenting the event may include maintaining a log that can later be provided to a central record system.
  • the log may be used to monitor not just patient safety but also performance of the clinician and adherence to clinical practices (e.g., how fast to administer fluids, syringe technique, aseptic techniques, administration sequencing techniques, or the like).
  • the event data may include or be augmented with time or date information indicating when the event occurred.
  • Some events may be routine or not interesting (e.g., administering or waiting to administer) while another event may be an event of interest (EOI) such as a safety event.
  • EOI event of interest
  • the event is evaluated to determine if the event is an EOI.
  • the rules for EOI may be established based on the clinical care area, physical site, clinician administering the medication, or other factor available to the system. As events are identified or classified, the classification or specific identifying features may be compared with a list of classifications or features of interest.
  • the event may be an EOI and the process at block 718 may present an alert.
  • Presenting an alert may include providing a human perceivable output to draw attention to the event.
  • Presenting the alert may include adjusting a user interface to provide information about the event.
  • the system may provide a suggested corrective action for the event. For example, if a leak is detected, the sensor may present the image captured of the medical device with the potential leak area highlighted.
  • the corrective action may be a prompt such as “Slow down the rate of injection” or “Adjust the position of the sensor to improve monitoring.”
  • the process 700 may proceed to block 720.
  • the process determines whether the medication administration session is complete. Determining a session is complete may be based on one or more of: removing the sensor, activating a button or other control element (physical or virtual) on the flow sensor system to terminate the session, detecting removal of the medical device (e.g., via the flow sensor or a sensor on the base (e.g., button that can indicate when the medical device is attached to the base), unsecuring the base, or the like.
  • Completing the session may include transmitting a completion message or storing a log entry indicating the time the session was completed. The completion of the session may trigger uploading of the events or log thereof. If the determination at block 720 is negative, the medication administration monitoring continues by returning to block 712 as described above.
  • Flow sensor system 150 may reduce medication error at bedside during bolus delivery.
  • Flow sensor system 150 may provide a record of and electronically measure bolus delivery, which allows monitoring bolus delivery and automatic documentation of bolus delivery as part of a patient's health record.
  • Flow sensor system 150 may provide alerts when bolus delivery inconsistent with a patient's medical record is about to occur.
  • base 180 may include one or more processors 204, a base electrical contact 192 in electrical communication with the one or more processors 204, a short-range wireless communication device (e.g., communication interface 214, a near-field communication (NFC) receiver, etc.), or a display 194 (e.g., input component 210, output component 212, a touchscreen display configured to receive user input from a user, etc.).
  • a flow sensor electrical contact may be in electrical communication with a corresponding base electrical contact when the flow sensor 160 is connected (e.g., connected, attached, mounted, etc.) to the base 180.
  • the one or more processors 204 may be programmed or configured to automatically detect a connection of flow sensor 160 to base 180. For example, when a user attaches flow sensor 160 to reader base 180, reader base 180 automatically detects flow sensor 160 installation. As an example, a mechanical button or switch on base 180 in electrical communication with the one or more processors may be actuated by connection/disconnection of flow sensor 160 to base 180 to send a signal to the one or more processors 204 indicating the connection/disconnection state of flow sensor 160 to base 180.
  • the one or more processors 204 are programmed or configured to automatically detect a connection of a medical device 102, such as a syringe or manifold, to the base 180.
  • a medical device 102 such as a syringe or manifold
  • base 180 or flow sensor 160 may automatically detect the connection of the syringe and initiate decoding of tag 104 (e.g., via the short-range wireless communication device, etc.) to record information contents of tag 104 (e.g., medication information, etc.).
  • flow sensor system 150 may include an electronic and mechanical interface that interacts with medical device 102 when received by the base 180 to detect the presence of the medical device 102 upon insertion by the user.
  • a mechanical button or switch on flow sensor 160 or base 180 in electrical communication with the one or more processors may be actuated by connection/disconnection of medical device 102 to send a signal to the one or more processors 204 indicating the connection/disconnection state of medical device 102 to flow sensor system 150.
  • tag or label 104 which may include an NFC tag embedded in the tag or label 104, may be manually placed on a body of syringe 102 using a standard label printer.
  • a label printer can be used to encode the NFC tag at the time of printing.
  • NFC encoding can be performed using a separate NFC tag encoding unit.
  • the short-range wireless communication device is configured to automatically communicate with the short-range wireless communication tag 104 on medical device 102 via a short-range wireless communication connection when the short-range wireless communication tag 104 is brought within a communication range of the short-range wireless communication device.
  • the short-range wireless communication device is configured to automatically communicate with the short-range wireless communication tag 104 on the medical device 102 via a short-range wireless communication connection in response to the base 180 or flow sensor 160 detecting a connection of the syringe 102 to the fluid injection port 165.
  • the tag 104 may be detected by using NFC when placed radially adjacent to an antenna of the short-range wireless communication device in base 180 or flow sensor 160.
  • base 180 and flow sensor 160 may include an integrated NFC antenna positioned radially to record syringe label tag 104 and read and decode encoded information therefrom.
  • the NFC antenna and label tags are optimized to eliminate false detection of adjacently positioned syringes with NFC tag labels (e.g., an NFC antenna mounted radially in the flow sensor system 150 and label tag 104 on the syringe barrel of medical device 102 can be used to transmit encoded label information from the tag 104 to the flow sensor system 150, etc.).
  • base 180 includes an optical scanner configured to read a barcode label (e.g., a patient wristband barcode label, a barcode label on flow sensor 160, etc.).
  • a barcode label e.g., a patient wristband barcode label, a barcode label on flow sensor 160, etc.
  • base 180 includes a wireless communication device configured to communicate information associated with the at least one attribute of the fluid in the medical device 102 to remote computing device 110.
  • base 180 may communicate information or data with remote computing device 110 to document drug delivery occurrences into patient medical records (e.g., patient medical records associated with a patient wristband bar code label scanned by the optical scanner, etc.).
  • non-limiting embodiments or aspects of a process for using a flow sensor system may enable more steps to be performed at ae site of care with a patient in view which provides advantages over methods that require interaction with EMR screens. Further, non-limiting embodiments or aspects of a process for using a flow sensor system may enable a patient to be associated with the smart consumable that is attached to the patient IV line rather than the electronics (e.g., base 180, etc.) alone, which provides for higher confidence that the device data is linked to the proper patient as the smart IV consumable is directly attached to the patient (through the IV), and which may enable the smart device to be swapped with another that can be associated to the patient by a scan of the smart consumable as opposed to being required to re-scan the patient wristband.
  • the electronics e.g., base 180, etc.

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Abstract

La présente invention concerne un système qui peut comprendre un capteur d'écoulement et/ou une base. Le capteur d'écoulement peut comprendre un capteur pour détecter une propriété d'un dispositif médical reçu par le système. La base peut être conçue pour recevoir le capteur d'écoulement. La base peut comprendre une surface de stabilisation ; une surface de surveillance pouvant pivoter d'au moins 90 degrés par rapport à la surface de stabilisation, la surface de surveillance comprenant une partie réfléchissante ; et un support de capteur pouvant pivoter d'au moins 90 degrés par rapport à la surface de surveillance et comprenant : un moyen pour fixer le capteur d'écoulement au support de capteur ; et un canal de capteur conçu pour fournir un champ de détection pour le capteur à travers le support de capteur vers la partie réfléchissante.
PCT/US2025/026876 2024-04-30 2025-04-29 Système de capteur d'écoulement Pending WO2025231022A1 (fr)

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US63/640,398 2024-04-30

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