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WO2025076491A1 - Suite de capteurs intégrés pour surveillance médicale - Google Patents

Suite de capteurs intégrés pour surveillance médicale Download PDF

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Publication number
WO2025076491A1
WO2025076491A1 PCT/US2024/050146 US2024050146W WO2025076491A1 WO 2025076491 A1 WO2025076491 A1 WO 2025076491A1 US 2024050146 W US2024050146 W US 2024050146W WO 2025076491 A1 WO2025076491 A1 WO 2025076491A1
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WO
WIPO (PCT)
Prior art keywords
sensor
patient
thoracic
sensing system
peripheral
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/US2024/050146
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English (en)
Inventor
Steve Xu
Claire SORENSON
Anne-Severine LIMA PIMENTA
Kristen BEAN
Zach BURCHMAN
Jong YOON LEE
Sean COHEN
Ha Uk CHUNG
Kelly CAO
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Sibel Inc
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Sibel Inc
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Publication of WO2025076491A1 publication Critical patent/WO2025076491A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0024—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system for multiple sensor units attached to the patient, e.g. using a body or personal area network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2503/00—Evaluating a particular growth phase or type of persons or animals
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    • A61B2503/04—Babies, e.g. for SIDS detection
    • A61B2503/045—Newborns, e.g. premature baby monitoring
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    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02416—Measuring pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A—HUMAN NECESSITIES
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    • A61B5/026—Measuring blood flow
    • A61B5/029—Measuring blood output from the heart, e.g. minute volume
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
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    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
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    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
    • A61B5/1115—Monitoring leaving of a patient support, e.g. a bed or a wheelchair
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    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
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    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
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    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
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    • A61B5/6814—Head
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    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A—HUMAN NECESSITIES
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches

Definitions

  • the present disclosure pertains to medical monitoring of patient physiological parameters and, more particularly, to a communicatively integrated sensing system.
  • a communicatively integrated sensing system for use medical physiological parameter monitoring comprises a sensor suite including a scalable thoracic multisensor and a peripheral multi-sensor.
  • the scalable thoracic multi-sensor is designed to sense a plurality of physiological parameters of a patient.
  • a physically scalable thoracic multi-sensor comprises a plurality of modules; a flexible, conduct link; a plurality of sensors; and a wireless communications interface.
  • the modules each house one or more sensing devices.
  • the flexible, conductive link structurally engages the plurality of modules with each other.
  • the sensors in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface by which the thoracic multi-sensor communicates the acquired patient data off-sensor.
  • a peripheral multi-sensor comprises a hardened sculpted shell, a soft, curved interior surface, a paired photodiode and light emitting diode, a plurality of electronics, and a wireless communications interface.
  • the shell is fabricated of a first material, the shell defining a pair of wings extending from a base of the shell.
  • the interior surface is fabricated of a second material, the curvature of the interior surface snugging against a patient’s body surface when in use.
  • the paired photodiode and light emitting diode are disposed on the interior surface of the wings opposite one another.
  • the electronics are housed in the shell and include a plurality of detectors that, in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface is used by the peripheral multisensor to communicate the acquired patient data off-sensor.
  • a communicatively integrated sensing system for use medical physiological parameter monitoring comprises a sensor suite, a medical device, a central monitoring station, a communications interface, and a relay.
  • the sensor suite further comprises a thoracic multi-sensor designed to sense a plurality of physiological parameters of a patient and a peripheral multi-sensor.
  • the sensor suite is designed to communicate patient data acquired from the patient to the medical device and to the central monitoring station.
  • the communications interface is coupled to the sensor suite and the sensor suite communicates patient data acquired from the patient to the medical device.
  • the communications interface is external to and structurally distinct from the sensor suite.
  • the sensor suite is designed to communicate patient data acquired from the patient to the central monitoring station through the relay.
  • a communicatively integrated sensing system for use medical physiological parameter monitoring substantially is as shown and described.
  • a method for monitoring physiological parameters of a patient substantially is as shown and described.
  • a thoracic multi-sensor substantially is as shown and described.
  • a method for monitoring physiological parameters of a patient using a thoracic multi-sensor substantially is as shown and described.
  • a peripheral multi-sensor substantially is as shown and described.
  • FIG. 1 conceptually depicts a communicatively integrated sensing system for use in medical physiological parameter monitoring according to one or more embodiments.
  • FIG. 2A, FIG. 2B, and FIG. 2C illustrate one particular embodiment of a thoracic multi-sensor as may be used to implement the thoracic multi-sensor of FIG. 1 in perspective, top plan, and side views, respectively.
  • FIG. 3A, FIG. 3B, and FIG. 3C illustrate an example electronic architecture for the thoracic multi-sensor in FIGs. 2A to 2C.
  • FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, and FIG. 4E illustrate one particular embodiment of a peripheral multi-sensor as may be used to implement the peripheral multi-sensor of FIG. 1 in top, bottom, first end, side, and second end views, respectively.
  • FIG. 5A, FIG. 5B depict the peripheral multi-sensor of FIG. 4A-FIG. 4E deployed on an adult patient’s hand and a neonatal patient’s foot, respectively.
  • FIG. 6A, FIG. 6B, and FIG. 6C illustrate an example electronic architecture for the peripheral multi-sensor in FIG. 2.
  • FIG. 7 illustrates one example of a communication flow for the network in the system of FIG. 1.
  • FIG. 8 illustrates one example of a communication flow for a tablet in the system of FIG. 1.
  • FIG. 9 illustrates one example of a communication flow among sensors in the system of FIG. 1 in accordance with one or more embodiments.
  • FIG. 10A, FIG. 10B depict examples physiological waveforms acquired through the thoracic multi-sensor in FIG. 2A-FIG. 2C and the peripheral multi-sensor of FIG. 4A-FIG. 4E in accordance with one or more embodiments.
  • FIG. 11 depicts an example display of acquired data on a bedside patient monitor in accordance with one or more embodiments.
  • FIG. 12 depicts an example display of acquired data on a centralized monitoring station in accordance with one or more embodiments.
  • FIG. 13A, FIG. 13B depict one particular embodiment of the thoracic multi-sensor in FIG. 1 in assembled and exploded views, respectively, and from opposite viewpoints.
  • FIG. 14A, FIG. 14B, and FIG. 14C depict the embodiment of the thoracic multisensor first shown in FIG. 13A-FIG. 13B in additional exploded and assembled views.
  • FIG. 15 depicts placement of the embodiment of the thoracic multi-sensor first shown in FIG. 13A-FIG. 13B on a neonatal patient.
  • FIG. 16 depicts one particular embodiment of the thoracic multi-sensor in FIG. 1 in an assembled view.
  • FIG. 17 depicts placement of the embodiment of the thoracic multi-sensor first shown in FIG. 16 on a neonatal patient, including placement on the head in addition to the chest.
  • FIG. 18 depicts representative data that may be acquired by placement of the embodiment first shown in FIG. 16 on the chest of the neonatal patient as shown in FIG. 17.
  • FIG. 19A, FIG. 19B depict one particular embodiment of the thoracic multi-sensor in FIG. 1 in an assembled top view and an assembled bottom view, respectively.
  • FIG. 20 depicts placement of the embodiment of the thoracic multi-sensor first shown in FIG. 19A, FIG. 19B on a neonatal patient.
  • FIG. 21 A, FIG. 21 B depict another embodiment of the thoracic multi-sensor in FIG.
  • FIG. 22A, FIG. 22B depict placement ofthe embodiment of the thoracic multi-sensor first shown in FIG. 21 A, FIG. 21 B on the belly and a limb of a neonatal patient.
  • FIG. 23A, FIG. 23B depict one particular embodiment of the thoracic multi-sensor in FIG. 1 in an assembled, top, perspective view and an assembled side view, respectively.
  • FIG. 24A, FIG. 24B illustrate how the electronics of the thoracic multi-sensor first shown in FIG. 1 may be encapsulated in accordance with one or more embodiments.
  • FIG. 25A, FIG. 25B, FIG. 25C, and FIG. 25D illustrate the electronics for embodiments of the thoracic multi-sensor first shown in FIG. 1 may be encapsulated in accordance with one or more embodiments, some disposable and some reusable.
  • FIG. 26 graphically illustrates alternative implementations of the communications interface of the system in FIG. 1 as well as a sensing system in accordance with one or more embodiments.
  • the sensor suite 105 is shown including only two sensors. However, the technique disclosed herein is not so limited. The number and identity of the sensors that comprise the sensor suite 105 may vary in other embodiments. For instance, FIG. 9 discloses an embodiment in which the sensor suite includes three sensors identified as a primary sensor, or a thoracic multi-sensor, and two secondary, or limb, sensors. Those in the art having the benefit of this disclosure will be able to appreciate still more variations in the implementation of the sensor suite 105 in this respect.
  • the medical device 120 and the centralized monitoring station 125 are what may be considered for this disclosure to be “third party equipment’’ for most embodiments.
  • the present disclosure contemplates that the sensor suite 105, or even the thoracic multi-sensor 110 and the peripheral multi-sensor 115 individually, may be used with installed equipment already in use in medical care facilities.
  • the thoracic multi-sensor 110 and the peripheral multi-sensor 115 made be manufactured and/or offered by a party different from the one who makes or uses the rest of the sensing system 100.
  • the thoracic multi-sensor 110 and the peripheral multi-sensor 115 may be offered as part of an overall sensing system 100.
  • the third-party equipment has a higher likelihood of being communicatively incompatible with the sensors 110, 115 of the sensor suite 105.
  • Communicative incompatibility may arise from any of a number of factors, frequently in combination.
  • a communicatively incompatible device (whether medical or computational) may use incompatible protocols or technologies for communication or signaling. Or, perhaps, a communicatively incompatible device may use incompatible connectors for cabling.
  • a communicatively incompatible device may use incompatible connectors for cabling.
  • Those skilled in the art having the benefit of this disclosure may appreciate still other ways in which a device can be “communicatively incompatible” with the sensors 110, 115 of the sensor suite 105.
  • equipment from the same manufacturer as the sensors 110, 115 and the sensor suite 105 may also be communicatively incompatible. This consequence is not limited to third party equipment.
  • the presently disclosed technique addresses this communicative incompatibility through the communications interface 130.
  • the communications interface 130 is an addition to the sensing system 100 that modifies either the communications from the sensor suite 105 or the communicatively incompatible equipment so that communications can occur.
  • Several options for implementing the communications interface are discussed below in connection with FIG. 26. However, other embodiments are not limited to the solutions presented herein and may use still other solutions.
  • the communications among the components of the sensing system may occur over various kinds of computing systems.
  • Many healthcare facilities include one or more private networks over which medical information is transferred.
  • some communications may occur over public networks, as between the medical device 120 and an offsite computational center, such as a cloud or an offsite physician’s office.
  • the communications are properly secured to meet legal and regulatory requirements.
  • the sensing system 100 may be considered to include certain computational devices used to implement such computing systems over which communications occur.
  • the thoracic multi-sensor 200 is designed to be worn comfortably on the chest by all age groups, neonates to pediatrics and may be extended to adults, similar to a patch, and so is scalable across these differently sized potential patients.
  • the design connects a plurality of modules, or “pucks”, via a flexible cable.
  • the device is manufactured with different lengths of the cable to facilitate application on patients of different sizes and ages.
  • the disclosed sensor utilizes a multitude of dry electrodes minimizing discomfort and skin irritation.
  • the sensor also is made from biocompatible and waterproof materials to ensure durability and safety.
  • module is used in this disclosure in accordance with the accustomed usage and understanding of that term. That is, the term “module” is used to identify a set of hardware and/or software, or combination thereof responsible for implementing an associated functionality. Thus, in this disclosure, the modules comprise hardware and software as discussed below that implement the functionality ascribed to the thoracic multi-sensor.
  • the thoracic multi-sensor 200 uses a high-fidelity electrocardiogram (“ECG”) signal acquisition with noise reduction algorithms.
  • ECG electrocardiogram
  • a plurality of detectors includes a noise canceling microphone array for measurement of heart, lung, and other anatomical sounds. Also included are a body temperature sensor, an inertial measurement, and a barometric pressure for seismocardiogram activity, and fall detection.
  • the thoracic multi-sensor 200 also includes rechargeable battery for a power source, connectivity resources, and localization resources. Connectivity is provided by Bluetooth® and WI-FI® capabilities for seamless data transmission to mobile devices and centralized storage.
  • the thoracic multi-sensor 200 also uses near field connectivity (“NFC”) for tap to pair and as a charging source. Localization is provided by Ultra Wide Band (“UWB”) for patient or asset tracking.
  • NFC near field connectivity
  • UWB Ultra Wide Band
  • the thoracic multi-sensor 200 includes an accompanying software app for real-time monitoring, data visualization, and alerts.
  • Data warehouse integration is provided by secure on premises or cloud storage for long-term data analysis and sharing with healthcare providers.
  • the thoracic multi-sensor 200 machine learning. More particularly, the thoracic multi-sensor 200 integrates machine learning algorithms with sensor fusion for predictive analytics and early detection of anomalies.
  • thoracic multi-sensor 200 further comprises a plurality of modules 205, each module 205 housing one or more sensing devices not shown in FIG. 2A to FIG. 2C but that will be discussed below.
  • a flexible, conductive link 210 structurally engages the plurality of modules 204 with each other.
  • the flexible, conductive link 210 is a wire or cable.
  • the flexible, conductive link 210 may have other constructions employing other kinds of materials. One such alternative is discussed below.
  • the two-module design of FIGs. 2A-2C allows for wider electrode spacing, increasing the accuracy of the sensed data.
  • the spaced electrodes in the two modules provide less motion artifact in the electrocardiogram (“ECG”) data, and also help achieve quality respiratory rate data collection as the spacing allows a larger voltage potential from the body.
  • ECG electrocardiogram
  • This design may also be used for an older patient population of ages twelve and over by simply extending the length of the cable.
  • FIG. 3A-FIG. 3C illustrate an example electronic architecture 300 for the thoracic multi-sensor 200 in FIGs. 2A-2C.
  • the electronic architecture 300 includes a power subsystem 305, a BLUETOOTH® system-on-a-chip 310, and a memory 315. Also included are a red-green-blue (“RGB”) light emitting diode (“LED”) 320 that may be used for communicating visual signals or, for example, to provide a blue light dosimeter to assess phototherapy dosing.
  • the BLUETOOTH® system-on-a-chip 310 includes a wireless communications interface 311 by which the thoracic multi-sensor 200 wirelessly communicates as described herein. There are also a plurality of detectors 325 through which the multi-sensor 200 acquires physiological data from a patient. All the components shown in FIG. 3A communicate with one another over a bus system 330.
  • the power subsystem 305 includes a wireless power source 335, a charge controller 336, a power management module 337, and fuel gauge 338.
  • the power subsystem 305 includes a wireless power source 335, a charge controller 336, a power management module 337, and fuel gauge 338.
  • a haptic device may be used for stimulation during apneic events.
  • the multi-sensor 200 includes a number of sensing devices 325 shown as a part of the electronic architecture 300 as shown in FIG. 3A. These sensing devices include one or more microphones 341 , one or more temperature sensors 342, an ECG analog front end 343, a barometric pressure sensor 344, and a motion subsystem 345. An example of the motion subsystem 345 is shown in FIG. 3C and includes an accelerometer 351 and a gyroscope 352.
  • the thoracic multi-sensor 200 measures, for example and without limitation, a single lead electrocardiography (“ECG”), bioimpedance (“BioZ”), abdominal/thoracic electromyography, temperature, acoustic signatures of heart, lung, and other body sounds, and a combination of movement and positional data via Inertial measurement.
  • ECG electrocardiography
  • BioZ bioimpedance
  • abdominal/thoracic electromyography temperature
  • the thoracic multi-sensor 200 is designed to be fully flexible and conformably mountable around neonates’, infants’, and toddlers’ abdomen and chest associated with a highly skin-safe adhesives that adheres safely to the fragile skin of this population.
  • the electronics, detectors, hardware, and software illustrated in FIG. 3A-FIG. 3C, as disposed in the housing shown in FIG. 2A-FIG. 2C, comprise the modules 205.
  • the electronics, detectors, hardware, and software may be distributed across the two (or more) modules 205 in manner that will be implementation specific. Note, however, that for some functionalities, detectors may be distributed across both modules 205. For example, a single-lead ECG will include a detector in each of the modules 205.
  • the thoracic multi-sensor 200 detects patient physiological parameters through the ECG analog front end 343 from which a single-lead ECG for neonates may be performed. Additionally, heart rate measurement (“HR”), arrythmias detection, pacemaker detection, defibration protection may be performed using the data collected through the ECG analog front end 343.
  • HR heart rate measurement
  • arrythmias detection in some embodiments is arrhythmias 60601-2-27 &; -47 and EC57 certified compliant.
  • the motion subsystem 345 functions as an Inertial Measurement Unit (“IMU”). Data collected through the motion subsystem 345 may further be used to detect/determine Respiratory Rate (“RR”), apnea detection, physical activity, fall count, core body position (e.g., turn time), and Kangaroo Care. The listed examples are neither exhaustive nor exclusive. Respiratory rate data is captured also using EKG, electromyography (“EMG”), and the digital microphone 341. The ability to place the sensor over the chest and/or abdomen also ensures that the abdominal breaths, the primary mechanism of breath in neonates, are fully captured. By using three methods of capturing respiratory data, there is a significantly decreased incidence of missed respiratory events (i.e., apneic periods) or inaccurate respiratory rates.
  • IMU Inertial Measurement Unit
  • the thoracic multi-sensor 200 is also capable of obtaining PPG data such as continuous non-invasive blood oxygenation (“SpO2”) on chest, chest Pulse Rate (“PR”), and desaturation. Again, the listed examples are neither exhaustive nor exclusive.
  • PPG data such as continuous non-invasive blood oxygenation (“SpO2”) on chest, chest Pulse Rate (“PR”), and desaturation.
  • SpO2 continuous non-invasive blood oxygenation
  • PR chest Pulse Rate
  • desaturation desaturation
  • the sensor also contains PPG capabilities to measure SpO2; meaning this sensor can collect all key vital signs in a single sensor.
  • the sensor also has the ability to measure Near Infrared spectroscopy (“NIRS”) to determine the oxygen consumption of the brain or somatic organs and to measure tissue perfusion and blood volume.
  • NIRS Near Infrared spectroscopy
  • This thoracic multi-sensor 200 also has two microphones 341 to detect respiratory and abdominal sounds. This is relevant for detecting extubation, wheezing and other abnormal breath sounds, crying, swallowing, gastric tube placement, and bowel sounds.
  • the microphones 341 may also detect swallow, cardiac shunting, high frequency oscillation ventilation, breath sounds, and crying.
  • the thoracic multi-sensor 200 includes a blue light dosimeter to evaluate the dose of blue light phototherapy being administered to the patient for elevated bilirubin levels.
  • a blue light dosimeter to evaluate the dose of blue light phototherapy being administered to the patient for elevated bilirubin levels.
  • the dose of blue light phototherapy is not routinely monitored in current practice despite the potential for adverse effects. Prolonged exposure to high doses of blue light phototherapy can lead to dehydration, skin burns or lesions, temperature changes, and alterations to blood counts. This capability may utilize, for example, the RGB LED 320 shown in FIG. 3A.
  • the various embodiments and implementations of the thoracic multi-sensor 200 lend themselves to numerous use cases. For example, there are strong uses in neonatal and pediatric monitoring in healthcare and home settings: The absence of long cables eliminates risk of entanglement. The sensor’s small size, flexibility, and comfort give a specific advantage in monitoring neonatal and pediatric patients. Remote patient monitoring is another use case for patients with chronic heart conditions requiring continuous monitoring in the clinical care facility or at home. So is ambulatory care, since the device is untethered, thereby allowing patients to maintain their daily activities while being monitored. Preventive healthcare is another use case since the sensor can be used for early detection of potential heart issues in at-risk populations.
  • the thoracic multi-sensor 200 may come in rechargeable, reusable and disposable options. It may be used in twenty-two-week neonates through age twelve-year-old children. As noted above, it can also be used for twelve and over by adjusting the length of the flexible, conductive link 210, shown in FIGs. 2A-2C.
  • the thoracic multi-sensor 200 environments such as General Care Nurseries, Level ll-IV Neonatal Intensive Care Units (“NICUs”), neonatal wards, Pediatric Intensive Care Units (“PICUs”), pediatric wards, Emergency Departments and transport, general pediatric units treating neonatal, infant, and toddler patients, general hospital admissions, cardiology clinics, home healthcare, and fitness and wellness. These environments are examples, and the list is neither exhaustive nor exclusive.
  • the design of the thoracic multi-sensor 200 overcomes a number of disadvantages found in conventional practice.
  • the two relatively small modules are used to distribute mass and reduce the footprint. These modules are connected via thin, coated wiring.
  • the length of the wire can be varied to accommodate various patient sizes. This also allows for multiple placement positions allowing each module to be placed in the area of anatomical significance for targeting the specific diagnostic intent, such as the abdomen of a neonate vs the chest of an adult for respiratory monitoring.
  • the ideal placement locates the first module just below the supra sternal notch and the second module placed in the left side mid axillary region along the subcostal border.
  • the location of these modules also contributes to minimal impact on patient positioning.
  • the sensor may remain in place for targeted radiographic exams but may be removed for a complete chest/abdomen exam in some cases.
  • the modules are thinner than many other sensors; this, coupled with the placement of the modules, minimizes the risk of pressure injury.
  • the multi-sensor disclosed herein also does not interfere with patient movement, the patient being held, or - most notably - neonatal patient receiving Kangaroo or skin-to-skin care.
  • Many other sensors experience interference in the sensor data being transmitted during holding or skin-to-skin contact due to the proximity of the neonate wearing the sensor and the caregiver holding the neonate and the low power signals from the sensor to the monitor.
  • the Bluetooth 2.4 gigahertz signal of most traditional sensors is not capable of transmitting well through the body due to the high quantity of water in body composition. Therefore, when the neonate is being held or cradled, the traditional sensors are unable to transmit sensor data through the caregiver’s body to the monitor and clinicians will note significant signal dropout.
  • the current sensor structure and design using two modules, each containing an antenna will significantly decrease signal blockage, improve signal quality and transmission, and decrease signal dropout.
  • the apparatus and method disclosed herein include a wearable device designed to provide continuous multi-parameter monitoring.
  • the device is compact, lightweight, adapts to the patient’s size thanks to the variable length of the wire and uses advanced dry electrode technology to ensure comfort and reduce skin irritation. It features wireless connectivity for real-time data transmission to healthcare providers, including clinical and technical alarms and alerts, enabling timely intervention and management of medical conditions.
  • the apparatus and method disclosed herein furthermore provide continuous multi-parameter monitoring; neonatal and pediatric vital signs monitoring; light, soft, flexible, wireless, wearable medical devices, mindful of the skin’s sensitivity; and ECG, SCG, auscultation sensor fusion.
  • the peripheral multi-sensor 115 is also generally applicable to neonatal and pediatric populations as well as adults.
  • the form factor is small, lightweight, flexible, and has multiple placement locations.
  • Predicate devices have a flexible sensor but are limited in use due to the required wires and cords that create risk of tangling, strangulation, and disconnection.
  • FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, and FIG. 4E illustrate one particular embodiment of a peripheral multi-sensor 400 as may be used to implement the peripheral multisensor of FIG. 1 in top, bottom, first end, side, and second end views, respectively.
  • the peripheral multi-sensor 400 includes a hardened, sculpted shell 405 and a soft, curved, interior surface 410.
  • the shell 405 includes a pair of wings 415 extending from the base 416 of the shell 405 and houses the electronics, which shall be discussed further below.
  • One functionality implemented in the peripheral multi-sensor 400 is pulse oximetry.
  • An LED 420 and a photodiode 425 used in the pulse oximetry are mounted in the interior surface 410 from the shell 405.
  • the peripheral multi-sensor 400 is described as “peripheral” as it is designed to be deployed to peripheral, as opposed to central, parts of the patient’s body.
  • Examples of “peripheral” parts of the body include, but are not limited to, digits, hands, feet, etc.
  • the primary advantage of the design is its curved interior surface that sits snugly against the body surface, ensuring close contact and minimal light pollution, thereby improving the signal quality and data acquisition.
  • the sensor can be comfortably worn on an ankle or wrist (premature neonate), hand or food (neonate and infant), digit, thumb, or great toe (toddler, child, and adult).
  • the wings 415 ensure that the photodiode 425 and LED 420 remain positioned across from one another for accurate positioning and signal collection.
  • the portion 430 of the sensor 400 that contains the bulk of the electronics rests against a more substantial body part, for example, when the sensor 400 is positioned around a premature infant’s ankle, the hub lays against the neonate’s calf.
  • the ability to place the sensor in multiple locations, the curved design, wraparound wings, and consideration for the hub placement decrease the risk of pressure injury while preserving the signal quality.
  • FIG. 6A-FIG. 6C illustrate an example electronic architecture 600 for the peripheral multi-sensor 400 in FIG. 5.
  • the electronic architecture 600 includes a power subsystem 605, a BLUETOOTH® system-on-a-chip 610, and a memory 615. Also included are a red-green-blue (“RGB”) light emitting diode (“LED”) 620.
  • the BLUETOOTH® system-on-a-chip 610 includes a wireless communications interface 611 by which the thoracic multi-sensor 200 wirelessly communicates as described herein.
  • the power subsystem 605 includes a wireless power source 635, a charge controller 636, a power management module 637, and fuel gauge 638.
  • the power subsystem 605 includes a wireless power source 635, a charge controller 636, a power management module 637, and fuel gauge 638.
  • a haptic device may be used for stimulation during apneic events.
  • the peripheral multi-sensor 400 includes a number of sensing devices 625 shown as a part of the electronic architecture 600 as shown in FIG. 6A. These sensing devices include one or more microphones 641 , one or more temperature sensors 642, an ECG analog front end 643, a barometric pressure sensor 644, and a motion subsystem 645.
  • An example of the motion subsystem 645 is shown in FIG. 6C and includes an accelerometer 651 and a gyroscope 652.
  • the motion subsystem 645 functions as an Inertial Measurement Unit (“IMU”).
  • IMU Inertial Measurement Unit
  • the peripheral multi-sensor 400 measures PPG, pulse index, and pulse rate.
  • PPG includes continuous non-invasive blood oxygenation (“SpO2”), Pulse Rate (“PR”), Perfusion Index (“PI”).
  • the peripheral multi-sensor 400 also includes a temperature probe to monitor peripheral temperature which can be used to evaluate the risk of sepsis or other deterioration.
  • Additional capabilities of the peripheral multi-sensor 400 include alerts and alarms using, for example, LED visual indication.
  • Wireless communication is implemented using BLUETOOTH® (“BT”), NFC, and UWB.
  • BT BLUETOOTH®
  • NFC NFC
  • UWB Universal Serial Bus
  • a single antenna design is used and is side located to ensure seamless data transmission during Kangaroo Care.
  • Wireless charging uses NFC WLC 2.0 specifications and data communication enabled.
  • Ultrawide Band provides location information, pair, and communicate between sensors and monitoring hardware.
  • WIFI® in the sensor is used for communication directly with the cloud and/or central monitoring.
  • Long term evolution (“LTE”) or other cellular telephony made be used for communication directly with a cloud and/or central monitoring.
  • the wearable peripheral multi-sensor 400 therefore is designed for continuous monitoring of blood oxygen saturation (“SpO2”) and pulse rate in neonates, infants, toddlers, as well as children and adults of all ages.
  • the device is lightweight, non-invasive, and uses advanced sensor technology to provide accurate readings even during motion and low perfusion conditions. It features wireless connectivity for real-time data transmission to healthcare providers, ensuring prompt medical response when needed.
  • the peripheral multi-sensor 400 provides comfort in the form of a soft, adjustable band and lightweight design ensure comfort for neonates during prolonged use.
  • the peripheral multi-sensor 400 employs advanced sensor technology and noise reduction algorithms provide accurate readings even during motion and low perfusion. Wireless data transmission enables real-time monitoring and timely medical intervention.
  • the peripheral multi-sensor 400 is suitable for various use cases, including NICUs, nurseries, PICUs, pediatric wards, home healthcare, and out-of-hospital births.
  • the peripheral multi-sensor 400 is designed to be worn comfortably on the patient’s hand or foot, wrist or ankle, or great toe or finger/thumb using a soft, adjustable band.
  • the curvature provides a snug fit against body for comfortable wear and accurate measurement.
  • Body temperature is monitored and an inertial measurement unit measures activity and fall detection.
  • the peripheral multi-sensor 400 utilizes advanced optical sensors that are sensitive enough to detect SpO2 and pulse rate accurately in neonates.
  • the peripheral multi-sensor 400 is furthermore made from biocompatible, hypoallergenic, and waterproof materials to ensure safety and durability.
  • a rechargeable battery is provided as a power source.
  • Connectivity is provided by BLUETOOTH® and WIFI® for seamless data transmission to mobile devices and centralized storage.
  • NFC is used for tap to pair and as a charging source. Localizations is implemented using Ultra Wide Band for patient or asset tracking.
  • the peripheral multi-sensor 400 includes a software app for real-time monitoring, data visualization, and alerts.
  • Data warehouse integration is provided by secure, on premises or cloud storage, for long-term data analysis and sharing with healthcare providers.
  • Machine learning algorithms are integrated with sensor fusion for predictive analytics and early detection of anomalies.
  • peripheral multi-sensor 400 lend themselves to numerous use cases. Neonatal and pediatric monitoring in healthcare and home settings is indicated by the absence of long cables eliminates risk of entanglement.
  • the sensor s small size, flexibility, and comfort give a specific advantage in monitoring neonatal and pediatric patients. Remote patient monitoring for patients with chronic heart conditions, for example, requiring continuous monitoring in the clinical care facility or at home.
  • the sensor is useful for preventive healthcare as it can be used for early detection of potential heart issues in at-risk populations.
  • the peripheral multi-sensor 400 may find use in a wide variety of environments. For example, use in neonatal wards, NICU, pediatric wards and PICU for continuous monitoring of patient vital signs.
  • Emergency transport is another example, for use in continuous monitoring of patient vital signs. Hospitals, clinics, and other health care facilities for continuous monitoring of patient vital signs and location. Home healthcare for remote monitoring of at-risk patients and neonates born in out-of-hospital settings are also implicated. Neonates can be monitored to ensure timely detection of hypoxemia.
  • the present disclosure contemplates that the sensor suite 105, or even the thoracic multi-sensor 110 and the peripheral multi-sensor 115 individually, may be used with installed equipment already in use in medical care facilities or other environments.
  • the role of the communications interface 130 is to facilitate communications between the sensors and the third-party equipment.
  • the present disclosure admits variation in how the communications interface 130 may be implemented as is graphically illustrated in FIG. 26.
  • the communications interface 130’ in FIG. 26 is an electronic module (hardware, software, or a combination thereof) that can be integrated into third party equipment such as bedside or transport monitors, neonatal warmers and incubators and mobile devices.
  • It provides the ability to adapt existing equipment to be compatible with the wireless connectivity to use the sensors 110, 115 of the sensor suite 105. It includes BLUETOOTH® for communicating data from the sensors wirelessly, Ultrawide Band (“UWB”) for sensor location, pairing, and communication data, and Near Field Communication (“NFC”) for pairing to sensors in a secure and efficient way (tap and go).
  • BLUETOOTH® for communicating data from the sensors wirelessly
  • Ultrawide Band (“UWB”) for sensor location
  • NFC Near Field Communication
  • the communications interface 130’ may be implemented in a pod 2605 with a cable (not shown) connectable to the third-party equipment.
  • a cable (not shown) connectable to the third-party equipment.
  • the biggest benefit of this version is that it mitigates the challenges of placing the communications interface 130’ inside of a third-party equipment while providing optimal location for NFC pairing.
  • the pod 2605 is self-contained and external to the equipment, it can easily be moved into close proximity with a sensor to pair, even if the sensor is already attached to the patient.
  • a card or board 2610 may be installed in the third-party equipment. This limits or reduces the amount of equipment at the patient’s bedside including cables and cords. However, it is anticipated that third party equipment manufacturers may be reluctant to exercise this option. Hence, the pod 2605 is provided as an option.
  • the communications interface may be implemented in a gateway (not shown).
  • the gateway is a headless, standalone device that pairs with one or more sensors using any of the aforementioned mechanisms (BLUETOOTH®, UWB, NFC, etc.) and is used to transmit data to the receiving station without requiring a patient monitor.
  • the gateway device wirelessly pairs to multiple sensors via BLUETOOTH® and simultaneously streams data from the sensors to a receiving station using a longer range network infrastructure such as WIFI®, ethernet, or cellular.
  • Each of the three versions employ BLUETOOTH® 5 or higher, an NFC reader (Full protocols; ISO/IEC 14443, 15693, 18000), and a radio frequency (“RF”) range extender.
  • Each version Supports Universal Asynchronous Receiver/Transmitter (“UART”) and RS-232; various connectors types such as DB9, RJ45.
  • the second version using the card or board 2610 supports one or more additional NFC Readers/Taggers in case the board is installed in a location not accessible for NFC authentication.
  • Each version supports data/signal streaming of the sensors in the sensor suite 105. These may include thoracic, limb, and other compatible sensors original equipment manufacturer (“OEM”) and third-party sensors.
  • Each version provides wireless connectivity and connectors for serial communication and power supply.
  • FIG. 7 illustrates one example of a communication flow 700 for the network in the system of FIG. 1.
  • the sensors are establishing connection with third party equipment in a network (not shown).
  • the flow starts (at 703) by tapping the sensor to the network (at 706).
  • the sensors communicate with the third part equipment for a connection confirmation (at 709). If a connection has not been established (at 712), then the flow 700 is ended (at 715). If a connection has been established (at 712), then the network connects with the sensors and begins streaming data (718). The streaming continues (at 718) until the third-party equipment as requested disconnection (at 721). If there has been a request to disconnect (at 721), the network disconnects with the sensors (at 724) and the flow ends (at 715).
  • the sensor connection is checked (at 727) to see if the connection has been lost. If not, the network connects with the sensors (at 718) to continue streaming data. If the connection is lost (at 727), the network attempts to reconnect with the sensors (at 730). If reconnection is successful (at 733), the network connects with the sensors and streams data (at 718). If reconnection is unsuccessful (at 733), then the network again attempts to reconnect with the sensors (at 730).
  • FIG. 8 illustrates one example of a communication flow 800 for a tablet in the system of FIG. 1.
  • the flow 800 is very similar to the flow 700 discussed immediately above.
  • the sensors are establishing connection with third party equipment in a network (not shown).
  • the flow starts (at 803) by tapping the sensor to the network (at 806).
  • the sensors communicate with the third part equipment for a connection confirmation (at 809). If a connection has not been established (at 812), then the flow 800 is ended (at 815). If a connection has been established (at 812), then the network connects with the sensors and begins streaming data (818). The streaming continues (at 818) until the third-party equipment as requested disconnection (at 821). If there has been a request to disconnect (at 821), the network disconnects with the sensors (at 824) and the flow ends (at 815).
  • the sensor connection is checked (at 827) to see if the connection has been lost. If not, the network connects with the sensors (at 818) to continue streaming data. If the connection is lost (at 827), the network attempts to reconnect with the sensors (at 830). If reconnection is successful (at 833), the network connects with the sensors and streams data (at 818). If reconnection is unsuccessful (at 833), then the network again attempts to reconnect with the sensors (at 830).
  • FIG. 9 illustrates one example of a communication flow 900 among sensors in the system of FIG. 1 in accordance with one or more embodiments.
  • the thoracic multi-sensor 905 serves as a “primary” sensor through which other, “secondary” limb sensors 910, 915 transmit information.
  • a tablet 920 establishes connection with the thoracic multi-sensor 905 and the limb sensor 910.
  • the connection is established using proprietary protocols, transmitting an address and a security key to each of the sensors 905, 910.
  • the limb sensor 915 will establish a connection with the tablet 920 as well. However, for purposes of this example, either the limb sensor 915 has never established connection or an established connection has been lost.
  • the sensors that have an established connection with the tablet 920 authenticate with each other using the address and security key earlier provided by the tablet 920. They also time sync using a master clock. These devices may stream data directly to the table 920 over the established connection as discussed above.
  • the limb sensor 915 cannot since it has no established connection to the tablet 920. The limb sensor 915 therefore streams its data to the thoracic multi-sensor 905 which then relays the streamed data to the tablet 920 over the limb sensor 910.
  • FIG. 10A, FIG. 10B depict examples physiological waveforms acquired through the thoracic multi-sensor 200 in FIG. 2A-FIG. 2C and the peripheral multi-sensor 400 of FIG. 4A-FIG. 4E in accordance with one or more embodiments.
  • Physiological waveforms are displayed on clinician interfaces such as a mobile device, patient bedside monitors, and the central monitoring station. Data is captured and transmitted by the sensors 200, 400 of the sensor suite 105 as described above.
  • the thoracic multi-sensor 200 provides an EKG waveform 1000, the EKG-derived heart rate 1005, as well as respiratory rate 1010, and patient temperature (not shown).
  • Arrhythmia monitoring is provided with a continuous processing algorithm.
  • Body position, fall count, blue light dosimeter data, and NIRS data can also be collected and displayed.
  • the peripheral multi-sensor 400 collects data that is displayed on the monitors, including the plethysmography waveform 1025, as well as the SpO2 level 1026, pulse rate 1027, and perfusion index 1028.
  • the peripheral multi-sensor 400 also can measure and transmit data points including body temperature 1030 and peripheral temperature 1035. Note also the presence of motion relate data 1040 including number of falls and number of steps.
  • the waveforms can be displayed or hidden based upon the clinician’s preferences and needs.
  • FIG. 11 depicts an example display of acquired data on a bedside patient monitor 1100 in accordance with one or more embodiments.
  • the patient monitoring screen is the default view for the bedside patient monitor. This is displayed, in some embodiments, on a wireless tablet that can easily be transported with the patient to various care settings.
  • the sensors can be paired to the patient bedside monitor through Bluetooth, NFC tap, or UWB perimeter detection.
  • the patient monitoring screen displays patient demographic information, such as patient type and bed location. It also displays sensor status, including connection and battery life.
  • the patient monitoring screen also has the ability to display and trend early warning scores for patient deterioration detection and to display vital signs trending over time.
  • the patient monitoring screen includes audio and visual alerts and alarms that are pushed to the central monitoring station(s).
  • the patient monitoring system is also compatible with many OEM sensors, including non-invasive blood pressure cuffs, thermometers, and so on.
  • Some embodiments may include a patient/family view screen (not shown).
  • the patient/family view screen is intended to provide patients and families with a user-friendly interface to quickly view patient status. This includes an indication of vital signs status, intake and output, and tasks that include the family, such as skin-to-skin care, developmental milestones, and discharge planning. Patients and families can access educational information provided by the healthcare organization to better understand the patient’s care.
  • the patient/family view also allows patients and families to input their own activities to increase patient and family engagement, thereby improving patient and family satisfaction. This view is highly customizable to the patient population and healthcare organization needs.
  • FIG. 12 depicts an example display of acquired data on a centralized monitoring station 1200 in accordance with one or more embodiments.
  • the central station aggregates real time as well as stored data from all the patients of a ward or a section within a healthcare facility. Data includes vital measurements such as waveforms, parameters as well as alarms and alerts. It gives clinicians the ability to get in one glance information on the status of all their patients and act accordingly. Clinicians can also zoom in on a given patient’s data to visualize all real-time information as well as stored data.
  • the central station interfaces as well with the healthcare’s information technology (“IT”) infrastructure to share bi-directionally any data requested by the central or healthcare applications.
  • IT information technology
  • FIG. 13A-FIG. 13B depict one particular embodiment 1300 of the thoracic multisensor 110 in FIG. 1 in assembled and exploded views, respectively, and from opposite viewpoints.
  • the thoracic multi-sensor 1300 measures a single lead electrocardiography (“ECG”), amplitude integrated electroencephalography (“aEEG”), bioimpedance (“BioZ”), abdominal electromyography, temperature, chest oximetry (“SpCh”), forehead near-infrared spectroscopy (“NIRS”) and acoustic signatures of lung sound.
  • ECG electrocardiography
  • aEEG amplitude integrated electroencephalography
  • BioZ bioimpedance
  • SpCh chest oximetry
  • NIRS forehead near-infrared spectroscopy
  • the same sensor will measure vital signs when mounted on the chest and key neurodevelopment signals (EEG and NIRS) when mounted on the forehead.
  • the thoracic multi-sensor 1300 is designed to be fully flexible and conformably mountable around neonates’ belly, chest area, and forehead associated with a highly skin-safe adhesives that adheres safely to the fragile skin of premature babies.
  • the thoracic multi-sensor 1300 may be rechargeable and reusable and may be usable in 22-week neonates and above.
  • the sensor performs single-lead ECG for neonates, heart rate measurement (“HR”), IEC 60601-2-27 & -47 certified, pacemaker detection, and defibration protection.
  • the thoracic multi-sensor 1300 also includes an IMU that acquires data from which can be extracted respiratory rate (“RR”) and that can be used in apnea detection, physical activity monitoring, fall count, core body position (turn time), and in Kangaroo Care.
  • RR extracted respiratory rate
  • PPG parameters such as continuous non-invasive blood oxygenation (“SpO2”) on chest, chest Pulse Rate (“PR”) or data from which these parameters may be extracted may be acquired.
  • BIOZ parameters such as continuous RR, intermittent BIA/BIS for tidal volume, stroke volume, cardiac output, fluid level/responsivity.
  • Temperature measurements may be acquired, including skin temperatures with 0.1 °C accuracy.
  • the thoracic multi-sensor 1300 may provide alerts and alarms, such as LED visual indication or a haptic indication of a condition.
  • Wireless communications employ BT and NFC.
  • a side located dual antenna design ensures seamless data transmission during Kangaroo Care.
  • Wireless charging complies with NFC WLC 2.0 specifications and data communication is enabled.
  • Haptic device may be included for stimulation during apneic events.
  • Microphone(s) may detect extubation, swallowing, and/or cardiac shunting.
  • NIRS sensors may also be included.
  • the thoracic multi-sensor 130 may be used to detect head/neck alignment, necrotizing enterocolitis indicators, and nNaso/orogastric tube placement.
  • a communications interface to third party equipment may include a hardware board that can be integrated into the third-party equipment such as neonatal warmer and incubator and provide the wireless connectivity to the sensors of the sensor suite. It contains a Bluetooth for communicating data from the sensors wirelessly and Near Field Communication (“NFC”) for pairing to sensors in a secure and efficient way (tap and go).
  • NFC Near Field Communication
  • the communications interface may also be a pod with a cable connectable to third party equipment.
  • the biggest benefit of the pod is that it reduces the challenges of placing the hardware board inside of a third-party equipment for optimal location to do NFC tagging. Instead, the pod can be easily grabbed by a user and brought into sensors for tagging to connect or disconnect even when the sensor is already attached on a patient.
  • Both the board and the pod include Bluetooth 5 or higher, NFC Reader (Full protocols; ISO/IEC 14443, 15693, 18000), and RF range extender. They both support UART and RS-232, various connectors: DB9, RJ45, additional NFC Reader I Tagger in case the board is installed in a location not accessible for NFC authentication, and data/signal streaming of sensors. Both are also equipped with wireless connectivity and connectors for serial communication and power supply, while ANNE Pod contains the ANNE Net with enclosure and added functionality.
  • a thoracic multi-sensor 1300 is shown in assembled and exploded views, respectively, and from opposite viewpoints.
  • the thoracic multi-sensor 1300 comprises a top layer 1305, a board assembly with battery 1310, a bottom layer 1315, and adhesive 1318 for each of two electrodes 1321.
  • FIG. 14A-FIG. 14C depict the embodiment of the thoracic multi-sensor first shown in FIG. 13A-FIG. 13B in additional exploded and assembled views.
  • the thoracic multi-sensor 1300 comprises bottom clear liners 1400, hydrogels 1403, pads 1406 for the hydrogels 1403, a base Mepitac 1409, pads 1412 for hydrogels 1415, a Silicon gel layer 1418, a sensor liner 1421 , a flap line 1424, pads 1427 for the Mepitac flaps 1430.
  • FIG. 15 depicts placement of the embodiment of the thoracic multi-sensor 1300 first shown in FIG. 13A-FIG. 13B on a neonatal patient 1500. Note the belly placement and the side positioning of the antenna. Note also the relatively large distance between the modules 1505 separated by the flexible, conductive link 1510, relative to the body of the patient 1500.
  • FIG. 16 depicts one particular embodiment 1600 of the thoracic multi-sensor 110 in FIG. 1 in an assembled view.
  • FIG. 17 depicts placement of the thoracic multi-sensor 1600 first shown in FIG. 16 on a neonatal patient 1700, including placement on the head in addition to the chest.
  • FIG. 18 depicts representative data that may be acquired by placement of the thoracic multi-sensor 1600 first shown in FIG. 16 on the chest of the neonatal patient 1700 as shown in FIG. 17.
  • the representative data includes waveforms for an EEG 1803, an ECG 1806, an SCG 1809, a PPG 1812, respiration 1815, limb temperature 1818, and chest temperature 1821.
  • FIG. 19A, FIG. 19B depict one particular embodiment 1900 of the thoracic multisensor 110 in FIG. 1 in an assembled top view and an assembled bottom view, respectively.
  • FIG. 20 depicts placement of the embodiment 1900 of the thoracic multi-sensor first shown in FIG. 19A, FIG. 19B on a neonatal patient.
  • FIG. 21A, FIG. 21 B depict another embodiment 2100 of the thoracic multi-sensor 110 in FIG. 1 in an assembled top view and an assembled bottom view, respectively.
  • FIG. 22A, FIG. 22B depict placement of the embodiment 2100 of the thoracic multi-sensor first shown in FIG. 21 A, FIG. 21 B on the belly and a limb of a neonatal patient.
  • FIG. 23A, FIG. 23B depict one particular embodiment 2300 of the thoracic multisensor 110 in FIG. 1 in an assembled, top, perspective view and an assembled side view, respectively.
  • FIG. 24A, FIG. 24B illustrate how the electronics of the thoracic multi-sensor first shown in FIG. 1 may be encapsulated in accordance with one or more embodiments.
  • FIG. 25A, FIG. 25B, FIG. 25C, and FIG. 25D illustrate the electronics for embodiments of the thoracic multi-sensor first shown in FIG. 1 may be encapsulated in accordance with one or more embodiments, some disposable and some reusable. More particularly, the embodiment FIG. 25A is reusable while the embodiments of FIG. 25B and FIG. 25C are disposable. FIG. 25D illustrates a pin connection between the encapsulated electronics and the band.
  • sensing system 2600 is shown. Some aspects of the sensing system 2600 are discussed above. However, additionally, note that the sensing system 2600 streams data acquired from the sensors to a variety of third-party devices 2615 (only one indicated), including a central monitoring station 2620, and to a cloud 2625. Computing resources such as for processing and storage may be allocated from the cloud 2625 to process and store the streamed data. For example, the streamed data may be stored in a patient’s electronic health record (“EH ”) 2630.
  • EH electronic health record
  • the current designs for the thoracic multi-sensor overcomes the disadvantages and provides several new and unobvious advantages over known conventional sensors.
  • the first advantage is the structure and shape design of the thoracic multi-sensor.
  • the physical form is long, skinny, and flexible, allowing the thoracic multi-sensor to bend so that it matches the neonatal patient’s belly/chest contour. This provides a very conformable sensor positioning on any area of the neonatal patient’s chest or abdomen, but the thoracic multi-sensor design disclosed herein is especially beneficial when being used on the medical default or preferred sensor area of the neonatal patient’s belly in a flipped smile position, as this position and configuration provides the most accurate sensing with the most comfort for the neonatal patient.
  • One advantage of this structure and placement of the thoracic multi-sensor is that medical staff can avoid having to remove the thoracic multi-sensor during chest x-ray events.
  • sensors would occupy quite a lot of area in the upper chest region and that's most common x-ray target location for neonatal patients, but now the structure of the present sensor allows medical staff to move the sensor location down to the area around the belly, which gives both more accurate sensor readings and no longer impedes the common x-ray region of neonatal patients.
  • Another advantage of the structure and design of the thoracic multi-sensor disclosed herein being long and skinny and very flexible is that it gives a much better (wider) electrode spacing, which increases accuracy of the sensed data.
  • the spaced electrodes provide a more noise-free motion, less motion artifact ECG data, also helping to get better respiratory rate data collection as the spacing allows a bigger sort of a voltage potential from the body.
  • Kangaroo care is basically mother or father holding their neonatal patient in skin-to-skin contact configuration. What happens with other, conventional wireless sensors for measuring the chest is that significant interference occurs in the sensor data being transmitted due to the proximity of both bodies and the challenge in transmitting low power signals from the sensor to the monitor.
  • the Bluetooth 2.4 gigahertz signal of most traditional sensors is not capable of transmitting well throughout the body because body is basically the water. But if one actually holds the neonatal patient completely, then one is surrounding 660-degree, which prevents traditional sensors from being able to transmit sensor data to a monitor. In this scenario you will experience a lot of data dropout.
  • the antenna is in the side near the end of the sensor structure so that when an adult holds a neonatal patient, the antenna is actually located sideways and near the edge of the neonatal patient’s chest or belly cavity so that you have a more room to have better transmission and less dropout.
  • Still another advantage of the currently disclosed thoracic multi-sensor is on the belly side of the sensor.
  • the sensor captures the respiratory rate through basically three mechanisms. One is based on ECG. Two is based on bio impedance, and then third is oximeter, and then neonatal patient's belly breather. Neonatal patients do not breathe like adults. When their chest is moving, their belly is moving really repeatedly. Because the thoracic multi-sensor disclosed herein may be placed on the neonatal patient’s belly it better measures physiological parameters for the respiratory recalculation.
  • the thoracic multi-sensor disclosed herein also makes significant improvements over the prior art in terms of conductivity.
  • the conductive material between the patient’s skin and the detector for measuring the ECG is typically hydrogel in conventional practice
  • the downside of hydrogel is once it absorbs the sweat and humidity, which is very common procedure in incubator, adhesion starts to weaken. Or, by absorbing too much of skin as well as the heat, it will develop a more adhesion overtime. So, potentially, skin irritation possibility goes up.
  • hydrogel becomes basically slimy, and then it will be become slippery over the skin surface.
  • Another problem with the heat involved is that it actually dries out but then becomes a very sticky because although the water content dries out the contents remain.
  • the pure hydrogel, which is very common in 6M electrodes is not very ideal.
  • Mepitac is another proven material for NICU and is used in tape, but it is not conductive. Mepitac is actually a Silicon tape used to secure things to a patient’s skin.
  • the present design includes a very specific stack up using the meek on the bottommost layer. The design uses stackup of the adhesive that the Mepitac layer provides a very safe bonding to the skin. Some embodiments do also have a very tiny hydrogel area for making the conductive pathway, but that amount is very minimal. And then other materials are usually not very sticky to the silicone encapsulation, silicone material because silicone is naturally inert material.
  • the present embodiments use a silicone gel material for the top side so that it has a good contact to our silicone-based sensor.
  • the disclosed thoracic multi-sensor is therefore designed to be providing a very safe skin coupling to the neonatal patient while also providing secure contact to the sensor as well as necessary conductive pathway to measure good ECG signal.
  • Another advantage of the disclosed design of the current sensor is it has a flat design.
  • One of the big issues in the neonatal patient is having a very large curvature, the bending radius is large, so even if the sensor is flexible enough, it can still have some delamination.
  • the presently disclosed sensor is overcoming that large bending radius by having the flap design so that the flap is basically pushing out so that the contact remains good all the time.
  • Another advantage is the ability to measure all the key vital signs from a single sensor. This includes ECG and the chest area cardiopulmonary from one sensor and then using the peripheral multi-sensor to measure SpO2. There also is a PPG in the chest sensor. The technique disclosed herein can actually technically measure the chest P, PG and then derive chest SpO2, i.e., photoplethysmography (“PPG”) from a single chest sensor.
  • PPG photoplethysmography
  • the thoracic multi-sensor 110 and peripheral multi-sensor 115 of the sensor suite may communicate with the medical device 120 and/or the centralized monitoring station 125, sometimes through the communications interface 130.
  • These and other devices may communicate directly or indirectly with one another as well as other devices not shown.
  • the communicating devices disclosed herein may communicate with one or more computing networks and devices, workstations, consoles, computers, monitoring equipment, alert systems, and/or mobile devices (e.g., a mobile phone, tablet, or other hand-held display device). It is generally contemplated that the communicating devices include the hardware and software needed or useful for implementing these communications capabilities.
  • the communications interfaces for these devices may include various network cards, interfaces, communication channels, cloud, antennas, and/or circuitry to permit wired and wireless communications with such computing networks and devices.
  • the communications interfaces may be used to implement, for example, a BLUETOOTH® connection, a cellular network connection, and/or a WIFI® connection with such other computing/communicating networks and devices.
  • Example wireless communication connections implemented using the communication interfaces may include wireless connections that operate in accordance with, but are not limited to, IEEE802.11 protocol, a Radio Frequency For Consumer Electronics (“RF4CE”) protocol, and/or IEEE802.15.4 protocol (e.g., ZigBee® protocol). In essence, any wireless communication protocol may be used.
  • the communications interfaces may permit direct (i.e., device-to- device) communications (e.g., messaging, signal exchange, etc.) such as from, for example, a universal serial bus (“USB”) connection or other communication protocol interface.
  • the communications interfaces may also permit direct device-to-device connection to other devices such as to a tablet, computer, or similar electronic device; or to an external storage device or memory.
  • the thoracic multi-sensor 110 and peripheral multi-sensor 115 of the sensor suite may communicate with the medical device 120 and/or the centralized monitoring station 125, as well as any other computing device employed in the scenario 200, includes electronic components, software, and/or electronic computing devices operable to receive, transmit, process, store, and/or manage data and information associated performing the functions of the system as described herein.
  • This contemplation encompasses any suitable processing device adapted to perform computing tasks consistent with the execution of computer-readable instructions stored in a memory or a computer-readable recording medium.
  • the BLUETOOTH® system on a chip 610 in FIG. 6A and the BLUETOOTH® system on a chip 610 in FIG. 6A both include one or more processors (not separately shown) whose operation imparts the described functionality to their respective sensors.
  • the one or more processors may be any suitable processor-based resource.
  • the one or more processors may comprise a processor chipset including, for example and without limitation, one or more co-processors.
  • the functionality of the respective sensors 110, 115 is imparted by the one or more processors executing programmed instructions stored in memories (also not separately shown).
  • the memories are, in the disclosed embodiments, a part of the respective BLUETOOTH® system on a chip.
  • the memories may be single memory devices or one or more memory devices at one or more memory locations that may include, without limitation, one or more of a random-access memory (“RAM”), a memory buffer, a hard drive, a database, an erasable programmable read only memory (“EPROM”), an electrically erasable programmable read only memory (“EEPROM”), a read only memory (“ROM”), a flash memory, hard disk, various layers of memory hierarchy, or any other non-transitory computer readable medium.
  • RAM random-access memory
  • EPROM erasable programmable read only memory
  • EEPROM electrically erasable programmable read only memory
  • ROM read only memory
  • flash memory hard disk, various layers of memory hierarchy, or any other non-transitory computer readable medium.
  • the memories may be on-chip or off-chip depending on the implementation of the one or more processors.
  • the memories may be used to store any type of instructions associated with algorithms, processes, or operations for controlling the general functions and operations of the sensors 110, 115.
  • the instructions may be any form of software, including, without limitation, firmware, executable applications, etc. Execution of the instructions by the respective one or more processors will impart the functionalities of the sensors 110, 115 associated with the presently disclosed technique as discussed below.
  • processors and memories applies to any of the devices in the sensing system 100. This would include the medical device 120, the centralized monitoring station 125 and any other computational/medical device in the sensing system 100. Thus, the medical device 120 and the centralized monitoring station 125 both include one or more processors programmed by instructions stored on memories and those processors and memories may be implemented as described above.
  • each computational/medical device may mitigate for certain implementations over others.
  • the sensors 110, 115 are designed to be small and light. This mitigates for small and simple implementations such as a processor with an on-chip memory, an ASIC, an FGPA, or an EEPROM.
  • the medical device 120 and the centralized monitoring station 125 are not particularly as concerned with these considerations such that their design permits greater latitude in implementing the one or more processors and memory.
  • the thoracic multi-sensor 110 in each of the embodiments disclosed herein is readily scalable to accommodate the size of different patients.
  • the term “scalable” means that the thoracic multi-sensor 110 can be modified without changing the physical form factor except for dimensions.
  • neonatal patients have a greater bend radius in their chest and belly than do adult patients.
  • the thoracic multi-sensor 110 is scalable to accommodate this variation in bending radius, primarily by lengthening or shortening the flexible conductive link.
  • a communicatively integrated sensing system for use in medical physiological parameter monitoring comprises a sensor suite including a scalable thoracic multi-sensor and a peripheral multi-sensor.
  • the scalable thoracic multi-sensor is designed to sense a plurality of physiological parameters of a patient.
  • the peripheral multisensor designed to perform at least a pulse oximetry.
  • the communicatively integrated sensing system of the first embodiment further comprises a medical device.
  • the communicatively integrated sensing system of the second embodiment wherein the medical device is a communicatively incompatible device further comprises a communications interface coupled to the sensor suite and through which the sensor suite communicates patient data acquired from the patient to the medical device, the communications interface being external to and structurally distinct from the sensor suite.
  • the communicatively integrated sensing system of the second embodiment further comprises a central monitoring station to which the sensor suite is designed to communicate patient data acquired from the patient.
  • the communicatively integrated sensing system of the first embodiment further comprises a relay through which the sensor suite is designed to communicate patient data acquired from the patient to a bedside monitor, a central monitoring station, or both.
  • the communicatively integrated sensing system of the first embodiment further comprises a communications interface communicatively coupled to the sensor suite through which the sensor suite communicates patient data acquired from the patient, the communications interface being external and structurally distinct from the sensor suite.
  • the communicatively integrated sensing system of the first embodiment further comprises a central monitoring station to which the sensor suite is designed to communicate patient data acquired from the patient.
  • the communicatively integrated sensing system of the first embodiment further comprises a relay through which the sensor suite is designed to communicate patient data acquired from the patient to a bedside monitor, a central monitoring station, or both.
  • the physically scalable thoracic multi-sensor comprises a plurality of modules, a flexible, conductive link, a plurality of sensors, and a wireless communications interface.
  • the plurality of modules each house one or more sensing devices.
  • the flexible, conductive link structurally engages the plurality of modules with each other.
  • the plurality of sensors in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface by which the thoracic multi-sensor communicates the acquired patient data off-sensor.
  • the communicatively integrated sensing system of the first embodiment wherein the peripheral multi-sensor comprises a hardened sculpted shell, a soft, curved interior surface, a photodiode, a light emitting diode, a plurality of electronics, and a wireless communications interface.
  • the shell is fabricated of a first material, the shell defining a pair of wings extending from a base of the shell.
  • the soft, curved interior surface is fabricated of a second material, the curvature of the interior surface snugging against a patient’s body surface when in use.
  • the photodiode is disposed on the interior surface of a first one of the wings.
  • a physically scalable thoracic multi-sensor comprises a plurality of modules; a flexible, conduct link; a plurality of sensors; and a wireless communications interface.
  • the modules each house one or more sensing devices.
  • the flexible, conductive link structurally engages the plurality of modules with each other.
  • the sensors in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface by which the thoracic multi-sensor communicates the acquired patient data off-sensor.
  • the physically scalable thoracic multi-sensor of the eleventh embodiment comprises a wire or cable.
  • the flexible conductive link comprises a stackup of flexible materials.
  • the physically scalable thoracic multi-sensor of the eleventh embodiment further comprises an adhesive structure to secure the multi-sensor to the patient’s skin.
  • the adhesive structure includes a piece of adhesive Silicon tape to secure the multi-sensor to the patient’s skin; and a relatively small spot of hydrogel to assist the adhesive Silicon tape to secure the multi-sensor and to provide a conductive pathway between the patient’s skin and one or more of the detectors.
  • “relatively small” means small relative to the amounts of hydrogel used in conventional devices and relative to the adhesive structure.
  • the plurality of detectors includes one or more digital microphones, or one or more temperature sensors, or an electrocardiogram front end, or a barometric pressure sensor, or an inertial measurement unit, or a combination thereof.
  • a peripheral multi-sensor comprises a hardened sculpted shell, a soft, curved interior surface, a paired photodiode and light emitting diode, a plurality of electronics, and a wireless communications interface.
  • the shell is fabricated of a first material, the shell defining a pair of wings extending from a base of the shell.
  • the interior surface is fabricated of a second material, the curvature of the interior surface snugging against a patient’s body surface when in use.
  • the paired photodiode and light emitting diode are disposed on the interior surface of the wings opposite one another for pulse oximetry.
  • the electronics are housed in the shell and include a plurality of detectors that, in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface is used by the peripheral multi-sensor to communicate the acquired patient data off-sensor.
  • the detectors include one or more temperature detectors, or a photoplethysmography front end, or an inertial measurement unit, or a combination thereof.
  • a communicatively integrated sensing system for use in medical physiological parameter monitoring comprises a sensor suite, a medical device, a central monitoring station, a communications interface, and a relay.
  • the sensor suite further comprises a thoracic multi-sensor designed to sense a plurality of physiological parameters of a patient and a peripheral multi-sensor.
  • the sensor suite is designed to communicate patient data acquired from the patient to the medical device and to the central monitoring station.
  • the communications interface is coupled to the sensor suite and the sensor suite communicates patient data acquired from the patient to the medical device.
  • the communications interface is external to and structurally distinct from the sensor suite.
  • the sensor suite is designed to communicate patient data acquired from the patient to the central monitoring station through the relay.
  • the physically scalable thoracic multi-sensor comprises a plurality of modules; a flexible, conductive link, a plurality of sensors, and a wireless communications interface.
  • the modules each house one or more sensing devices.
  • the flexible, conductive link structurally engages the modules with each other.
  • the sensors in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface by which the thoracic multi-sensor communicates the acquired patient data off-sensor.
  • the peripheral multi-sensor comprises a hardened sculpted shell; a soft, curved interior surface, a photodiode, a light emitting diode, a plurality of electronics, and a wireless communications interface.
  • the shell is fabricated of a first material and defines a pair of wings extending from a base of the shell.
  • the interior surface is fabricated of a second material and the curvature of the interior surface snugging against a patient’s body surface when in use.
  • the photodiode is disposed on the interior surface of a first one of the wings and the light emitting diode is disposed on the interior surface of a second one of the wings opposite the photodiode.
  • the electronics are housed in the shell and include a plurality of sensors that, in use, acquire data from a patient representative of a plurality of physiological parameters of the patient.
  • the wireless communications interface by which the peripheral multi-sensor communicates the acquired patient data off-sensor.
  • a method for monitoring physiological parameters of a patient substantially is as shown and described.
  • a thoracic multi-sensor substantially is as shown and described.
  • a method for monitoring physiological parameters of a patient using a thoracic multi-sensor substantially is as shown and described.
  • a peripheral multi-sensor substantially is as shown and described.
  • top means that part of the sensor that, in use, contacts the patient’s skin.
  • bottom means that part of the sensor that, in use, contacts the patient’s skin.
  • top therefore means that portion of the sensor that, in use, is opposite the “bottom”, or that part of the sensor that is opposite the part that contacts the patient’s skin in use.
  • side is used relative to the terms “top”, and “bottom” as just described.
  • the article “a” is intended to have its ordinary meaning in the patent arts, namely “one or more.”
  • the term “about” when applied to a value generally means within the tolerance range of the equipment used to produce the value, or in some examples, means plus or minus 10%, or plus or minus 5%, or plus or minus 1 %, unless otherwise expressly specified.
  • the term “substantially” as used herein means a majority, or almost all, or all, or an amount with a range of about 51 % to about 100%, for example.
  • examples herein are intended to be illustrative only and are presented for discussion purposes and not by way of limitation.
  • to "provide” an item means to have possession of and/or control over the item. This may include, for example, forming (or assembling) some or all of the item from its constituent materials and/or, obtaining possession of and/or control over an already-formed item.
  • expressions including ordinal numbers may modify various elements.
  • such elements are not limited by the above expressions.
  • the above expressions do not limit the sequence and/or importance of the elements.
  • the above expressions are used merely for the purpose of distinguishing an element from the other elements.
  • a first box and a second box indicate different boxes, although both are boxes.
  • a first element could be termed a second element, and similarly, a second element could also be termed a first element without departing from the scope of the present disclosure.
  • a sensor refers to a component which converts a physical quantity to be measured to an electric signal, for example, a current signal or a voltage signal.
  • the physical quantity may for example comprise electromagnetic radiation (e.g., photons of infrared or visible light), a magnetic field, an electric field, a pressure, a force, a temperature, a current, or a voltage, but is not limited thereto.
  • Use of the phrases “capable of,” “capable to,” “operable to,” “configured to,” or “programmed to” in one or more embodiments refers to some apparatus, logic, hardware, and/or element designed in such a way to enable the use of the apparatus, logic, hardware, and/or element in a specified manner.
  • the phrase “designed to” is, like the phrase “capable of” and variations thereon an acknowledgment that some functionalities of the variously recited components of the claimed subject matter are only realizable when deployed, supplied with power, and activated.
  • the phrase means that some apparatus, logic, hardware, and/or element designed in such a way to enable the use of the apparatus, logic, hardware, and/or element in a specified manner. That is, the design of the apparatus, logic, hardware, and/or element involved choices and decisions driven by the goal of implementing the recited functionality in the apparatus, logic, hardware, and/or element.
  • a measured value could be higher than a pre-determined threshold (e.g., an upper threshold), or lower than a pre-determined threshold (e.g., a lower threshold).
  • a pre-determined threshold range defined by an upper threshold and a lower threshold
  • the use of the phrase “exceed” in one or more embodiments could also indicate a measured value is outside the pre-determined threshold range (e.g., higher than the upper threshold or lower than the lower threshold).
  • the subject matter of the present disclosure is provided as examples of apparatus, systems, methods, circuits, and programs for performing the features described in the present disclosure. However, further features or variations are contemplated in addition to the features described above. It is contemplated that the implementation of the components and functions of the present disclosure can be done with any newly arising technology that may replace any of the above-implemented technologies.

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Abstract

L'invention concerne un système de détection intégré en communication destiné à la surveillance de paramètres physiologiques médicaux qui comprend une suite de capteurs comprenant un multi-capteur thoracique adaptable et un multi-capteur périphérique. Le multi-capteur thoracique adaptable est conçu pour détecter une pluralité de paramètres physiologiques d'un patient.
PCT/US2024/050146 2023-10-06 2024-10-05 Suite de capteurs intégrés pour surveillance médicale Pending WO2025076491A1 (fr)

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US20170296070A1 (en) * 2013-03-15 2017-10-19 Venture Gain L.L.C. Wearable Wireless Multisensor Health Monitor with Head Photoplethysmograph
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US20230293047A1 (en) * 2022-03-20 2023-09-21 Sibel Health Inc. Closed-loop wearable sensor and method

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US20210161442A1 (en) * 2009-07-20 2021-06-03 Masimo Corporation Wireless patient monitoring system
US20170296070A1 (en) * 2013-03-15 2017-10-19 Venture Gain L.L.C. Wearable Wireless Multisensor Health Monitor with Head Photoplethysmograph
KR20160014567A (ko) * 2013-06-01 2016-02-11 헬스와치 리미티드 섬유 전극을 구비한 웨어러블 태아 모니터링 시스템
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US20230293047A1 (en) * 2022-03-20 2023-09-21 Sibel Health Inc. Closed-loop wearable sensor and method

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