WO2022090369A2 - Système sans fil permettant de déclencher un dispositif médical - Google Patents

Système sans fil permettant de déclencher un dispositif médical Download PDF

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Publication number
WO2022090369A2
WO2022090369A2 PCT/EP2021/079933 EP2021079933W WO2022090369A2 WO 2022090369 A2 WO2022090369 A2 WO 2022090369A2 EP 2021079933 W EP2021079933 W EP 2021079933W WO 2022090369 A2 WO2022090369 A2 WO 2022090369A2
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WO
WIPO (PCT)
Prior art keywords
signal
patient
ventilator
physiological
nfmi
Prior art date
Application number
PCT/EP2021/079933
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English (en)
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WO2022090369A3 (fr
Inventor
Georgios Kokovidis
Original Assignee
Drägerwerk AG & Co. KGaA
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 Drägerwerk AG & Co. KGaA filed Critical Drägerwerk AG & Co. KGaA
Priority to EP21805863.4A priority Critical patent/EP4236786A2/fr
Priority to CN202180074173.6A priority patent/CN116437858A/zh
Publication of WO2022090369A2 publication Critical patent/WO2022090369A2/fr
Publication of WO2022090369A3 publication Critical patent/WO2022090369A3/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/389Electromyography [EMG]
    • A61B5/397Analysis of electromyograms
    • 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022Control means therefor
    • A61M16/024Control means therefor including calculation means, e.g. using a processor
    • 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
    • G16H20/40ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • 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
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B13/00Transmission systems characterised by the medium used for transmission, not provided for in groups H04B3/00 - H04B11/00
    • H04B13/005Transmission systems in which the medium consists of the human body
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B5/00Near-field transmission systems, e.g. inductive or capacitive transmission systems
    • H04B5/20Near-field transmission systems, e.g. inductive or capacitive transmission systems characterised by the transmission technique; characterised by the transmission medium
    • H04B5/24Inductive coupling
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B5/00Near-field transmission systems, e.g. inductive or capacitive transmission systems
    • H04B5/20Near-field transmission systems, e.g. inductive or capacitive transmission systems characterised by the transmission technique; characterised by the transmission medium
    • H04B5/24Inductive coupling
    • H04B5/26Inductive coupling using coils
    • H04B5/266One coil at each side, e.g. with primary and secondary coils
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B5/00Near-field transmission systems, e.g. inductive or capacitive transmission systems
    • H04B5/70Near-field transmission systems, e.g. inductive or capacitive transmission systems specially adapted for specific purposes
    • H04B5/72Near-field transmission systems, e.g. inductive or capacitive transmission systems specially adapted for specific purposes for local intradevice communication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055Simultaneously evaluating both cardiovascular condition and temperature
    • 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/08Other bio-electrical signals
    • A61M2230/10Electroencephalographic signals
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/205Blood composition characteristics partial oxygen pressure (P-O2)
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/30Blood pressure
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/40Respiratory characteristics
    • A61M2230/43Composition of exhalation
    • A61M2230/432Composition of exhalation partial CO2 pressure (P-CO2)
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/50Temperature
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/60Muscle strain, i.e. measured on the user

Definitions

  • the present disclosure generally pertains to medical device utilization for patient care and, more particularly, to a wireless system for medical device triggering.
  • various physiological sensors are typically coupled to a patient. Some of these sensors provide time-critical data to lifesustaining medical devices. Sensors may be coupled to life-sustaining devices via low-latency physical connection (e.g. , wires). However, improved connections that retain the low-latency of physical connections and present less clutter, less restrictions on patient movement, and are more robust to disruption are desirable.
  • low-latency physical connection e.g. , wires
  • FIG. 1 illustrates a system for triggering a medical device via a physiological sensor device according to one or more embodiments.
  • FIG. 2 illustrates a system for triggering a medical device by a surface electromyography (“sEMG”) module via a near-field magnetic induction (“NFMI”) communications link according to one or more embodiments.
  • sEMG surface electromyography
  • NFMI near-field magnetic induction
  • FIG. 3 illustrates the magnetic field coupling associated with the NFMI communications technology utilized in one or more embodiments.
  • FIG. 4 illustrates performance of various placements of a receiver coil relative to a transmitter coil according to one or more embodiments.
  • Embodiments provide a low-latency wireless communication link used to trigger a medical device based on physiological sensor data.
  • NFMI near-field magnetic induction
  • Other implementations and uses are also possible. That is, while the present systems are described with respect to a ventilator, other medical devices (e.g., patient monitors or anesthesia machines) could also be implemented in addition to, or in place of, place of the ventilator.
  • NFMI wireless communications Some advantages of the use of NFMI wireless communications are its high interference rejection capability, privacy of the NFMI communications at short distances, and the ability of the transmissions to pass through a patient’s body with little degradation in signal integrity.
  • NFMI is a short-range radio technology that is well-suited for low latency data streaming applications
  • NFMI has excellent human-body compatibility, which is a function of the radio frequency at which it operates.
  • NFMI operates at about 10.6 MHz, at which frequency the human body appears almost transparent. This is in contrast to other higher frequency RF signals, which are absorbed or impeded by the body.
  • the communication system includes an electromyography (“EMG”) device including electrodes configured to be attached to a patient and generate electrical signals based on respiratory activity of the patient; wherein the EMG device is configured to generate a respiratory effort waveform based on the electrical signals and analyze the respiratory effort waveform; wherein the EMG device includes a first near-field magnetic induction (“NFMI”) transceiver configured to generate at least one transmission signal derived from the analysis of the patient respiratory effort waveform and transmit the at least one transmission signal on at least one NFMI communication channel; and a ventilator configured to provide breathing assistance to the patient, wherein the ventilator includes a second NFMI transceiver configured to receive the at least one transmission signal from the EMG device and a controller configured to adjust the breathing assistance provided to the patient based on the at least one transmission signal.
  • EMG electromyography
  • NFMI near-field magnetic induction
  • One or more embodiments provide a method of wirelessly communicating with a ventilator to provide breathing assistance to a patient.
  • the method includes receiving, by an electromyography (“EMG”) device, electrical signals based on muscular respiratory activity of the patient; generating, by the EMG device, a patient respiratory effort waveform based on the electrical signals; analyzing, by the EMG device, the patient respiratory effort waveform; generating, by the EMG device, at least one near-field magnetic induction (“NFMI”) transmission signal derived from the analysis of the patient respiratory effort waveform; transmitting, by the EMG device, the at least one NFMI transmission signal on at least one NFMI communication channel to the ventilator.
  • EMG electromyography
  • NFMI near-field magnetic induction
  • One or more embodiments provide a system for triggering a medical device.
  • the system includes a physiological sensor device configured to sense and transmit a first physiological signal; a medical device configured to receive and process the first physiological signal to determine the presence of a trigger; and a near-field magnetic induction (“NFMI”) communications link coupling the physiological signal from the physiological sensor device to the medical device with a latency of less than 10 milliseconds, wherein upon determination that the first physiological signal contains a first trigger, the medical device performs a first action.
  • NFMI near-field magnetic induction
  • One or more embodiments provide a method for triggering a medical device.
  • the method includes sensing a first physiological signal from a physiological sensor device; wirelessly coupling the physiological signal to a medical device; receiving the physiological signal at the medical device; determining that the first physiological signal contains a first trigger; and performing a first action upon the determining.
  • One or more embodiments provide an apparatus for coupling a physiological sensor device to a medical device.
  • the apparatus includes a first coil with a first primary winding axis oriented in a first direction; a second coil with a second primary winding axis oriented in a second direction, substantially parallel with the first direction; a driver connected to the first coil, the driver configured to receive a first physiological sensor output signal, amplify the sensor output signal, and energize the first coil with the amplified sensor output signal to create a magnetic field; and a receiver connected to the second coil, the receiver configured to receive a loop current from the second coil when the second coil is proximate the first coil and amplify the current to recover an original sensor output signal.
  • EMG electromyography
  • one or more embodiments provide an electromyography (“EMG”) device, including: one or more electrodes configured to be attached to a patient and generate electrical signals based on muscular respiratory activity of a patient; one or more processors configured to generate a patient respiratory effort waveform based on the electrical signals and analyze the patient respiratory effort waveform; and a first near-field magnetic induction (“NFMI”) transceiver configured to generate at least one transmission signal derived from the analysis of the patient respiratory effort waveform and transmit the at least one transmission signal on at least one NFMI communication channel to a second NFMI transceiver included in a ventilator.
  • EMG electromyography
  • One or more embodiments provide a method for wirelessly triggering a therapy device.
  • the method includes receiving, by a physiological parametermonitoring device, electrical signals based on physiological activity of the patient; generating, by the physiological parameter-monitoring device, a waveform representing the physiological activity of the patient based on the electrical signals; generating, by the physiological parameter-monitoring device, at least one near-field magnetic induction (“NFMI”) transmission signal derived from the waveform; and wirelessly transmitting, by the physiological parameter-monitoring device, the at least one NFMI transmission signal on at least one NFMI communication channel to a therapy device, wherein the at least one NFMI transmission signal is configured to trigger an action performed by the therapy device corresponding to the physiological activity represented in the waveform.
  • NFMI near-field magnetic induction
  • any direct electrical connection or coupling without additional intervening elements may also be implemented by an indirect connection or coupling or vice versa, as long as the general purpose of the connection or coupling, for example, to transmit a certain kind of signal or to transmit a certain kind of information, is essentially maintained.
  • the general purpose of the connection or coupling for example, to transmit a certain kind of signal or to transmit a certain kind of information, is essentially maintained.
  • Features from different embodiments may be combined to form further embodiments.
  • variations or modifications described with respect to one of the embodiments may also be applicable to other embodiments unless noted to the contrary.
  • spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures.
  • the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures.
  • the apparatus may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may likewise be interpreted accordingly.
  • 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.
  • One or more aspects of the present disclosure may be implemented as a non-transitory computer-readable recording medium having stored thereon a program embodying methods/algorithms for instructing the processor to perform the methods/algorithms.
  • a non-transitory computer-readable recording medium may have electronically readable control signals stored thereon, which cooperate (or are capable of cooperating) with a programmable computer system such that the respective methods/algorithms are performed.
  • the non-transitory computer-readable recording medium can be, for example, a compact disc, readonly memory (“CD-ROM”), digital video disc (“DVD”), BLU-RAY® disc, a random- access memory (“RAM”), a read-only memory (“ROM”), a programmable read-only memory (“PROM”), an electrically programmable read-only memory (“EPROM”), an electrically erasable, programable read-only memory (“EEPROM”), a FLASH memory, or an electronic memory device.
  • CD-ROM compact disc
  • DVD digital video disc
  • BLU-RAY® disc a random- access memory
  • RAM random- access memory
  • ROM read-only memory
  • PROM programmable read-only memory
  • EPROM electrically programmable read-only memory
  • EEPROM electrically erasable, programable read-only memory
  • FLASH memory or an electronic memory device.
  • Each of the elements of the present disclosure may be configured by implementing dedicated hardware or a software program on a memory controlling a processor to perform the functions of any of the components or combinations thereof.
  • Any of the components may be implemented as a central processing unit (“CPU”) or other processor reading and executing a software program from a recording medium such as a hard disk or a semiconductor memory device.
  • CPU central processing unit
  • DSP digital signal processor
  • ASIC application-specific integrated circuits
  • FPGAs field programmable logic arrays
  • PLC programmable logic controller
  • processor refers to any of the foregoing structures or any other structure suitable for implementation of the techniques described herein.
  • a controller including hardware may also perform one or more of the techniques of this disclosure.
  • a controller, including one or more processors may use electrical signals and digital algorithms to perform its receptive, analytic, and control functions, which may further include corrective functions.
  • Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various techniques described in this disclosure.
  • a signal processing circuit and/or a signal conditioning circuit may receive one or more signals from one or more components and perform signal conditioning or processing thereon.
  • Signal conditioning refers to manipulating a signal in such a way that the signal meets the requirements of a next stage for further processing.
  • Signal conditioning may include converting from analog to digital (e.g., via an analog-to-digital converter), amplification, filtering, converting, biasing, range matching, isolation and any other processes required to make a signal suitable for processing after conditioning.
  • a signal processing circuit may include an analog-to-digital converter (“ADC”) that converts the analog signal from the one or more sensor elements to a digital signal.
  • ADC analog-to-digital converter
  • DSP digital signal processor
  • FIG. 1 illustrates a system 100 for triggering a medical device via a physiological sensor device according to one or more embodiments. It includes a medical device 102, a physiological sensor device 104 comprising one or more sensors 105, and a low-latency wireless communications link 106 communicatively coupling the physiological sensor device 104 to the medical device 102 via wireless communications transceivers 108 and 110 (e.g., via a communication channel).
  • the latency is preferably less than 10 milliseconds (ms) and, more preferably, 5 milliseconds (ms) or less, thereby transmitting time-critical data from the physiological sensor device or data from the medical device across the wireless communications link 106.
  • one or more signals generated by the sensor 105 are transmitted via the wireless communications transceiver 108 over wireless communications link 106 to the medical device 102 via wireless communications transceiver 110.
  • the sensor 105 may be a physiological sensor.
  • the wireless communication link 106 between the medical device 102 and the physiological sensor device 104 is a bi-directional communications link.
  • the medical device 102 processes the signal to determine if there is any actionable information in the signal that could be used to trigger the medical device 102 to perform an action, such as generate an alert, initiate a medical assistance function, or to modify one of its operating parameters of a currently administered medical treatment while in progress.
  • the sensors 105 may be placed proximate to, on, or inside a patient’s body.
  • the sensors 105 may be electrodes that attach to the patient for reading electrical signals generated by or passed through the patient.
  • the sensors 105 may be configured to measure vital signs, measure electrical stimulation, measure brain electrical activity such as in the case of a electroencephalogram (“EEG”), measure blood oxygen saturation fraction from absorption of light at different wavelengths as it passes through a finger, measure a CO2 level and/or other gas levels in an exhalation stream using infrared spectroscopy, measure oxygen saturation on the surface of the brain or other regions, measure cardiac output from invasive blood pressure and temperature measurements, measure induced electrical potentials over the cortex of the brain, measure blood oxygen saturation from an optical sensor coupled by fiber to the tip of a catheter, and/or measure blood characteristics using absorption of light.
  • EEG electroencephalogram
  • the sensors 105 measure a physiological characteristic of a patient and transmit electrical measurement signals over a wired or wireless link to the physiological sensor device 104.
  • the physiological sensor device 104 is configured to analyze the sensor data received in the measurement signals in order to monitor or otherwise evaluate a condition of the patient.
  • the physiological sensor device 104 may detect a monitored condition of the patient based on the sensor data (e.g., via comparing one or more types of sensor data to one or more thresholds).
  • a monitored condition is a condition that requires medical treatment, assistance, or intervention in order to sustain the life of the patient or otherwise assist in sustaining or improving the health of the patient.
  • first tier monitored condition may correspond to a first treatment level administered by the medical device 102 and a second tier monitored condition may correspond to a second treatment level administered by the medical device 102 that is enhanced with respect to the first treatment level.
  • different operation parameters may be set at the medical device 102 based on the treatment level indicated by the physiological sensor device 104. What constitutes first tier and second tier conditions may be implementation specific, and may depend on factors such as, without limitation, the condition(s) being monitored and the health of the patient.
  • the physiological sensor device 104 is configured to generate a one or more communication signals (e.g., a raw sensor data signal, a control signal, an event signal, a flag signal, and/or a trigger signal), and transmit the one or more communication signals via the wireless communications transceiver 108 across the wireless communications link 106 to the wireless communications transceiver 110 of the medical device 102.
  • the wireless communications transceivers 108 and 110 are induction coils that are capable of transmitting and receiving NFMI communication signals. This allows for bi-directional communication between the physiological sensor device 104 and the medical device 102.
  • the wireless communications transceivers 108 and 110 communicate by coupling a magnetic field between the two devices.
  • the magnetic field may be referred to as a non-propagating magnetic field or an evanescent field and the coupling between the two coils may be referred to as an evanescent coupling or a near-field coupling.
  • the communications concept involves a transmitter coil in one device modulating a magnetic field that is measured by means of a receiver coil in another device.
  • a current passed through the transmitter coil produces a corresponding magnetic field.
  • the magnetic field induces a corresponding voltage across the terminals of the receiver coil via inductive or magnetic coupling that can be detected by the receiver.
  • a modulated current produces a modulated magnetic field.
  • the transceiver that performs a transmission may be referred to as a transmitter comprising the transmitter coil and corresponding transmitter circuitry configured to energize the transmitter coil and modulate the magnetic field that is the communication signal).
  • the transceiver performs the receiving may be referred to as a receiver comprising the receiver coil and corresponding receiver circuitry configured to detect the modulated magnetic field via the receiver coil and demodulate or otherwise decode the communication signal.
  • the medical device 102 is a medical treatment device that is configured to administer medical treatment to a patient.
  • the one or more communication signals from the physiological sensor device 104 is intended to, for example, provide raw sensor data, a control signal, an event signal, a flag signal, and/or a trigger signal to trigger an action, such as a medical assistance function, or a response, including modifying one or more operating parameters corresponding to the medical assistance function, to list a few examples.
  • a communication signal may also indicate a treatment level based on the detected condition of the patient.
  • a transmitter of the physiological sensor device 104 may be configured to modulate the magnetic field and thereby modulate the communication signals transmitted by the wireless communications transceiver 108 based on the information to be transmitted via the corresponding communication signal.
  • the transmitted signal may be modulated by amplitude and/or frequency modulation that is to be decoded by the receiver circuitry at the medical device 102.
  • a communication signal may be a trigger signal that triggers a specific function of the medical device 102. In response to detecting the trigger signal, the medical device is configured to perform the triggered function or action.
  • Another communication signal may include control information that may include control data, instructions, or data indicating an instruction set corresponding to which functions the medical device 102 is to perform and/or which operating parameters are to be set or adjusted by the medical device 102 for administering treatment to a patient.
  • the medical device 102 may transmit, via its wireless communications transceiver 110, an acknowledgement signal to the physiological sensor device 104 indicating that the communication signal was successfully received.
  • the acknowledgement signal may indicate that the trigger signal was successfully received and/or that the operating parameters have been set or adjusted according to the received instructions.
  • the medical device 102 comprises a ventilator and physiological sensor device 104 comprises a surface electromyography (“sEMG”) sensor module or pod.
  • sEMG is a non-invasive procedure involving the detection, recording, and interpretation of the electric activity of groups of muscles at rest and during activity. Electrical measurements for muscles at rest may referred to as “static” and for muscles during activity may be referred to as “dynamic”. The procedure is performed using a single or an array of electrodes placed on the skin surface at different sites and specifically over the muscles to be tested. Electrical activity is assessed by computer analysis of the frequency spectrum, amplitude, or root mean square of the electrical action potential.
  • An sEMG pod via the sensors 105 that are attached in proximity to the chest or abdomen of the patient, may act as a trigger or as a controller for a ventilator, attached to that same patient.
  • the communication signals will be communicated wirelessly, and meet an over-the-air latency requirement of less than 10 milliseconds.
  • the physiological sensor device 104 comprises an sEMG device and the medical device 102 is a ventilator
  • the sEMG device within the physiological sensor device 104 may send communication signals to the ventilator to trigger a function or to adjust one of its breathing assistance parameters in response to electrical activity detected around the musculature of the respiratory system of a patient by the sEMG device.
  • Such adjustments may be made to one or more of the ventilator operating or control settings including but not limited to assist control (“AC”), tidal volume (“TV”), positive end-expiratory pressure (“PEEP”), synchronized intermittent mandatory ventilation (“SIMV”), airway pressure release ventilation (“APRV”), pressure support (“PS”), bi-level positive airway pressure (“BIPAP”), continuous positive airway pressure (“CPAP”), high frequency oscillatory ventilation (“HFOV”), and fraction of inspired oxygen (“F1O2”).
  • the adjustments to these settings may be made in proportion to a patient’s respiratory effort waveform and may be signaled to the ventilator by the sEMG device.
  • the sEMG device and the ventilator are configured to perform proportional breathing assistance such as proportional assist ventilation (“PAV”), and, more specifically, neurally adjusted ventilatory assist (“NAVA”) in order to improve patient-ventilator synchrony.
  • PAV proportional assist ventilation
  • NAVA neurally adjusted ventilatory assist
  • the breathing rhythm of the patient who is actively breathing can be assisted by the ventilator such that the breathing rhythm is synchronized with the muscle activity detected by the sEMG device.
  • the ventilator is configured to respond to changes in a patient's ventilatory demand and to decrease patient breathing effort while the patient is actively breathing by actively regulating gas pressure, volume, and flow.
  • the ventilator does this based on the communication signals received from the sEMG device.
  • the sEMG device generates the communication signals based on an analysis it performs on the sensor data it receives from the sensors 105.
  • the sEMG device triggers and controls the PAV or NAVA functions and operation settings of the ventilator.
  • ventilator pressure, ventilator flow, ventilator volume, inhalation timing, exhalation timing may all be controlled by the sEMG device via communication signals transmitted to the medical device 102 (e.g., the ventilator).
  • the sEMG device controls these parameters based on generating a patient’s respiratory effort waveform and analyzing the waveform to determine the occurrence of one or more events or to determine one or more proportional settings corresponding to ventilator pressure, ventilator flow, ventilator volume.
  • the sEMG device utilizes the measurement of the patient respiratory effort waveform (e.g., the diaphragmatic EMG signal) to control the gas delivery of the ventilator.
  • the patient respiratory effort waveform e.g., the diaphragmatic EMG signal
  • pressure is applied during the inspiratory phase, and as the diaphragm relaxes, airway pressure decreases.
  • Inspiration ends at a specific percentage of the peak EMG activity.
  • the sEMG device may trigger on and cycle off the ventilatory assist. It may also control the inhalation phase duration by triggering an activity starting time of the inhalation phase via an inspiratory ventilation trigger and by triggering an activity stop time of the inhalation phase via an expiratory ventilation trigger.
  • the expiratory ventilation trigger also coincides with a starting time of the exhalation phase of the ventilator.
  • the activity starting time of the inhalation phase coincides with an activity stop time of the exhalation phase of the ventilator.
  • the sEMG device may transmit an event signal to the ventilator on a first transmission channel via the NFMI.
  • the event signal includes a plurality of event flags or event indicators, each of which triggers a specific activity or function of the ventilator and/or may trigger an alarm.
  • an inspiratory ventilation trigger is an event flag or an event indicator that triggers the ventilator to pump air into the lungs of the patient.
  • An expiratory ventilation trigger is an event flag or an event indicator that triggers the ventilator to stop the inspiratory phase and allow the patient to exhale to start the expiratory phase.
  • the event flags may be referred to as discrete event flags as they only occur at discrete time instances when a corresponding event is detected by the sEMG.
  • the sEMG may also transmit a proportional control signal to the ventilator on a second transmission channel via the NFMI.
  • the sEMG device generates the proportional control signal based on the patient’s respiratory effort waveform.
  • the proportional control signal is transmitted continuously during ventilator assist to the ventilator (e.g., as a continuous-time signal or analog signal) to provide dynamic, real-time proportional parameter settings, including a proportional ventilator pressure setting, proportional ventilator flow setting, a proportional ventilator volume setting, or any of the other settings noted above that are derived based on the patient’s respiratory effort waveform.
  • the sEMG device constantly adjusts the proportional parameter settings in proportion to the patient’s respiratory effort waveform throughout an entire duration of the ventilator assist or only during the inspiratory phase of the ventilator assist.
  • the proportional control signal may be triggered and transmitted by the sEMG in response to initializing the inspiratory phase of the ventilator assist, and stopped by the sEMG when the inspiratory phase concludes for a given cycle.
  • the ventilator In response to receiving one or more of the proportional parameter settings, the ventilator applies a corresponding gas pressure, gas flow, or gas volume to the patient throughout inspiration and exhalation.
  • Such proportional parameter settings may be dynamically adjusted during the inspiratory phase or expiratory phase in real-time as the settings are received from the sEMG device.
  • the sEMG device may transmit raw sensor data signal or the patient’s respiratory effort waveform on another transmission channel via the NFMI.
  • the raw sensor data may be raw analog data received from the sensors 105 or raw digital data derived therefrom via, for example, an ADC.
  • the ventilator may be configured to display the sensor data or the patient’s respiratory effort waveform on a display or perform further analysis for regulating the PAV functions, particularly, for regulating and adjusting the activity starting times, activity stopping times, and the proportional parameter settings.
  • the sEMG device is configured to analyze the measurement signals received from the sensors 105 corresponding to the muscular electrical activity and use one or more communication signals to trigger the ventilator to perform an action based on the analysis and/or adjust ventilator parameter settings.
  • the sEMG may be configured to transmit sensor data received from the measurement signals via the communication signal, and the ventilator may be configured to analyze the sensor data to determine a corresponding action.
  • the signal transmissions are wireless, secure, and fast with low latency.
  • FIG. 2 illustrates a system 200 for triggering a ventilator 210 by an sEMG module via a near-field magnetic induction (“NFMI”) communications link using a signal from the sEMG module according to one or more embodiments.
  • the system 200 includes an sEMG module 208 and an NFMI ventilator 210.
  • the sEMG module 208 includes an sEMG sensor device 218, an NFMI wireless transceiver 214 coupled to an NFMI wireless transceiver coil 202, control electronics 212 (e.g., a “CPU”), and sensors (e.g., physiological sensors such as sensors 105 from FIG. 1 , not illustrated in FIG. 2) that may be placed strategically on a patient for monitoring electrical signals associated with muscular activity.
  • a power management unit (“PMU”, not separately shown) manages the power of the sEMG module 208.
  • the sEMG sensor device 218 is configured to assess the sensed electrical activity by computer analysis of the frequency spectrum, amplitude, or root mean square of the electrical action potential.
  • the NFMI ventilator 210 includes an NFMI wireless transceiver 216 that is coupled to an NFMI wireless transceiver coil 204, control electronics 220 (e.g., a “CPU”), and various tubes, pumps, oxygen tanks, and control electronics related to providing breathing assistance to a patient (not illustrated).
  • control electronics 220 e.g., a “CPU”
  • various tubes, pumps, oxygen tanks, and control electronics related to providing breathing assistance to a patient not illustrated.
  • a power management unit (“PMU”, not separately shown) manages the power of the NFMI ventilator 210.
  • sEMG sensor device 218 In operation, electrical activities of a patient’s muscles are detected and analyzed by sEMG sensor device 218.
  • the sEMG sensor device 218 determines data to be transmitted and relays the data to a NFMI wireless transceiver 214.
  • the NFMI wireless transceiver 214 determines a transmission channel based on the data type and creates a modulated magnetic field via the NFMI wireless transceiver coil 202 to transmit the data on the assigned transmission channel.
  • the NFMI wireless transceiver coil 202 is placed within an NFMI communication range of the NFMI wireless transceiver coil 204.
  • the sEMG module 208 along with its NFMI wireless transceiver coil 202, may be placed on one lateral side of a patient’s body and the NFMI ventilator 210, along with its NFMI wireless transceiver coil 204, may be placed on an opposite lateral side of a patient’s body.
  • This set up allows both the sEMG module 208 and the NFMI ventilator 210 to be attached to the patient without their cables, cords, tubes, and the like becoming entangled with one another.
  • the magnetic field generated by one of the transceiver coils is emitted across the patient’s body to the receiving transceiver coil.
  • the communication signal can be transmitted through the patient’s body.
  • the communication signal can be transmitted through the patient’s body with low latency and can fulfill an over-the- air latency requirement of less than 10 milliseconds, and, more preferably, 5 milliseconds (ms) or less.
  • the sEMG module 208 is transmitting signals (e.g., communication data) to the NFMI ventilator 210
  • the modulated magnetic field generated by the NFMI wireless transceiver coil 202 is coupled to the NFMI wireless transceiver coil 204, and sensed and processed by the NFMI wireless transceiver 216 to extract the communication data.
  • the extracted communication data is further processed by control electronics 220 and is used to trigger an operation and/or an adjustment of the operating parameters of the NFMI ventilator 210.
  • breathing assistance may be triggered or initialized by the communication data
  • breathing assistance functions may be triggered according to a triggered timing by the communication data
  • one or more of the ventilator operating settings or control settings may be adjusted based on the communication data.
  • FIG. 3 illustrates the magnetic field coupling associated with the NFMI communications technology utilized in one or more embodiments. It includes a modulated input signal 302 being driven to NFMI wireless transceiver coil 202 (e.g., transmitter coil), a modulated magnetic field 306 associated with the modulated input signal, a coupling 308 (e.g., a wireless link) of the modulated magnetic field 306 into the NFMI wireless transceiver coil 204 (e.g., receiver coil), and the subsequent recovery and output of the received signal 304 that corresponds to the modulated input signal 302.
  • NFMI wireless transceiver coil 202 e.g., transmitter coil
  • a modulated magnetic field 306 associated with the modulated input signal
  • a coupling 308 e.g., a wireless link
  • FIG. 4 illustrates performance of various placements of receiving coils relative to a transmitting coil according to one or more embodiments. It includes a transmitting (“TX”) coil 402, a receiving coil A (“RX A”) 404, a receiving coil B (“RX B”) 406, and a receiving coil C (“RX C”) 408.
  • the RX A 404 exhibits the best coupling because the area of the TX 402 and the RX A 404 are co-axial.
  • the RX B 406 exhibits good coupling since the area of the TX 402 and the RX B 406 are co-planer.
  • the RX C 408 exhibits poor coupling due to the area of the RX C 408 being orthogonal to the area of the TX 402.
  • communication signals are stronger at greater distances for a co-axial arrangement between coils when compared to a co-planar arrangement, and communication signals are stronger at greater distances for the co-planar arrangement between coils when compared to an orthogonal arrangement.
  • the co-axial arrangement is the most sensitive to alignments (or misalignments) between coils given that is has the smallest overlapping area among the three arrangements.
  • the co-planar arrangement is the least sensitive to alignments (or misalignments) between coils given that is has the largest overlapping area among the three arrangements.
  • a misalignment can have a negative effect on the signal strength of the communication signals. It will be appreciated that any of the coil arrangements may be implemented in the embodiments shown FIGS. 2 and 3 as a matter of design choice.
  • At least one of A and B and/or the like generally means A or B or both A and B.
  • such terms are intended to be inclusive in a manner similar to the term “comprising”.
  • first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc.
  • a first element and a second element generally correspond to element A and element B or two different or two identical elements or the same element.

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Abstract

Un système de communication de ventilateur comprend un dispositif d'électromyographie (« EMG ») comprenant des électrodes d'EMG conçues pour générer des signaux électriques sur la base de l'activité respiratoire musculaire du patient, et un ventilateur. Le dispositif d'EMG est conçu pour générer une forme d'onde d'effort respiratoire du patient sur la base des signaux électriques et analyser la forme d'onde d'effort respiratoire du patient. Le dispositif d'EMG comprend un premier émetteur-récepteur d'induction magnétique en champ proche (« NFMI ») conçu pour générer au moins un signal de transmission dérivé de l'analyse de la forme d'onde d'effort respiratoire du patient et transmettre ledit signal de transmission sur au moins un canal de communication NFMI. Le ventilateur est conçu pour fournir une assistance respiratoire au patient, le ventilateur comprenant un second émetteur-récepteur NFMI conçu pour recevoir ledit signal de transmission en provenance du dispositif d'EMG et un dispositif de commande conçu pour ajuster l'assistance respiratoire fournie au patient sur la base dudit signal de transmission.
PCT/EP2021/079933 2020-10-29 2021-10-28 Système sans fil permettant de déclencher un dispositif médical WO2022090369A2 (fr)

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US20110000489A1 (en) * 2007-12-20 2011-01-06 Maquet Critical Care Ab Control unit, method and computer-readable medium for operating a ventilator
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US10667904B2 (en) * 2016-03-08 2020-06-02 Edwards Lifesciences Corporation Valve implant with integrated sensor and transmitter
EP3624681A4 (fr) * 2017-05-18 2021-03-10 Advanced Brain Monitoring, Inc. Systèmes et procédés de détection et de gestion de profils physiologiques
US11437150B2 (en) * 2018-05-31 2022-09-06 Inspire Medical Systems, Inc. System and method for secured sharing of medical data generated by a patient medical device
WO2019236664A1 (fr) * 2018-06-06 2019-12-12 Zoll Medical Corporation Systèmes et procédés de synchronisation de compressions thoraciques avec l'activité myocardique
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