WO2020197978A1 - Système de surveillance physiologique portable - Google Patents

Système de surveillance physiologique portable Download PDF

Info

Publication number
WO2020197978A1
WO2020197978A1 PCT/US2020/023787 US2020023787W WO2020197978A1 WO 2020197978 A1 WO2020197978 A1 WO 2020197978A1 US 2020023787 W US2020023787 W US 2020023787W WO 2020197978 A1 WO2020197978 A1 WO 2020197978A1
Authority
WO
WIPO (PCT)
Prior art keywords
magnetic field
subject
field
field strength
receiver coil
Prior art date
Application number
PCT/US2020/023787
Other languages
English (en)
Inventor
Robert T Stone
Original Assignee
Medical Design Solutions, Inc.
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
Priority claimed from US16/363,404 external-priority patent/US10993638B2/en
Priority claimed from US16/419,358 external-priority patent/US11191452B2/en
Application filed by Medical Design Solutions, Inc. filed Critical Medical Design Solutions, Inc.
Priority to JP2021557317A priority Critical patent/JP2022527068A/ja
Priority to EP20776824.3A priority patent/EP3946045A4/fr
Priority to CA3133993A priority patent/CA3133993A1/fr
Publication of WO2020197978A1 publication Critical patent/WO2020197978A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording 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, mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording 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, mobility of a limb
    • A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • 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
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A61B5/6805—Vests
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0223—Magnetic field sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0826—Detecting or evaluating apnoea events
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4561—Evaluating static posture, e.g. undesirable back curvature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7405—Details of notification to user or communication with user or patient ; user input means using sound
    • A61B5/741—Details of notification to user or communication with user or patient ; user input means using sound using synthesised speech
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7455—Details of notification to user or communication with user or patient ; user input means characterised by tactile indication, e.g. vibration or electrical stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0022—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the tactile sense, e.g. vibrations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0027—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the hearing sense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0044—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the sight sense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0272—Electro-active or magneto-active materials
    • A61M2205/0294—Piezoelectric materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/332—Force measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/08—Other bio-electrical signals
    • A61M2230/10—Electroencephalographic signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/42—Rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/60—Muscle strain, i.e. measured on the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/62—Posture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity

Definitions

  • the present invention relates to systems and methods for monitoring physiological characteristics of a subject. More particularly, the present invention relates to apparatus, systems and methods for determining a plurality of physiological characteristics; particularly, respiratory characteristics of a subject and respiratory disorders exhibited thereby, and anatomical positions and motions of the subject.
  • sleep apnea is generally classified into three types based on respiratory functions.
  • the first type of apnea is obstructive sleep apnea (OSA), which occurs when the subject or patient stops breathing continuously due to an obstructed upper airway.
  • OSA obstructive sleep apnea
  • the second type of apnea is central sleep apnea (CEN), which occurs when the subject or patient stops breathing continuously due to the inability of the subject to correctly modulate respiration, i.e. the brain temporarily fails to transmit appropriate neurological signals to the muscles responsible for controlling breathing.
  • CEN central sleep apnea
  • obstructive sleep apnea which can be thought of as a mechanical problem
  • central sleep apnea is more of a communication problem.
  • the third type of apnea is generally referred to as mixed apnea, which is a combination of obstructive and central sleep apnea.
  • Mixed apnea is generally characterized by a lack of respiratory effort without air exchange due to upper airway obstruction.
  • Hypopnea is a respiratory disorder that is characterized by overly shallow breathing or an abnormally low respiration rate, i.e. a decreased amount of air movement into the lungs, which can, and often will cause oxygen levels in the blood to drop.
  • various abnormal seminal respiratory parameters and/or characteristics such as breathing frequency (e.g., breaths per minute), tidal volume (VT), inspiration volume, expiration volume, respiratory minute ventilation (e.g., inspiration volume per minute or expiration volume per minute) and/or peak expiratory flow rate, and physiological parameters and/or characteristics, such as oxyhemoglobin saturation and oxygen desaturation index, are indicative of a sleep apnea and/or hypopnea.
  • breathing frequency e.g., breaths per minute
  • VT tidal volume
  • inspiration volume e.g., inspiration volume per minute or expiration volume per minute
  • respiratory minute ventilation e.g., inspiration volume per minute or expiration volume per minute
  • peak expiratory flow rate e.g., oxyhemoglobin saturation and oxygen desaturation index
  • McCool patents Illustrative are the systems and methods for determining respiratory parameters disclosed in U.S. Pat Nos. 8,790,273 and 8,790,274 (hereinafter“McCool patents”).
  • the systems disclosed in the referenced McCool patents generally comprise at least two tuned pairs of electromagnetic (EM) coils (also referred to herein as“magnetometers”), where each pair of EM coils comprise a single-channel transmitter EM coil that is adapted to transmit a single, specific high-frequency AC electromagnetic field (i.e. transducer) and an EM coil (i.e. receiver) that is adapted to receive the AC electromagnetic field transmitted by the transmitter EM coil.
  • EM electromagnetic
  • the transmitter EM coil(s) of the McCool systems are positioned on the front of a subject and the receiver EM coils are positioned on the back of the subject.
  • the systems disclosed in the McCool patents are configured to determine at least one respiratory parameter or characteristic; particularly, tidal volume (VT) as a function of a plurality of anatomical distances, e.g., rib cage-anteroposterior distance and abdomen- anteroposterior distance, which are detected by the tuned pairs of EM coils, and a plurality of predetermined volume-motion coefficients.
  • VT tidal volume
  • a major drawback and disadvantage associated with the McCool systems and associated methods is the use of single-channel transmitter EM coils that (i) are limited to one (1) specific AC electromagnetic field frequency and (ii) are susceptible to interference from extraneous electromagnetic fields that negatively impact the voltage output of the EM coils and, hence, the consistency of the AC electromagnetic field frequency.
  • a further drawback and disadvantage associated with the McCool systems is that the McCool systems and associated methods are dependent on the use of complex algorithms, which can, and often will, fail to quantitatively account for physiological differences between individual subjects. As a result, the McCool systems are incapable of consistently providing accurate determinations of seminal physiological parameters and/or characteristics, such as tidal volume (VT) and minute ventilation (V-dot).
  • VT tidal volume
  • V-dot minute ventilation
  • 10,064,570 and 10,314,517 comprise at least one permanent magnet coupled with at least one magnetometer that is configured to receive the AC electromagnetic field generated by the permanent magnet.
  • the magnetometer is positioned on the front of a subject proximate the xyphoid process and the permanent magnet is positioned on the back of the subject proximate the spine and across from the xyphoid process of the subject.
  • the magnetometer of the above noted systems is adapted to detect strength variations in the AC magnetic field emitted by the permanent magnet, which reflect displacements, i.e. change in distance, by and between the magnetometer and permanent magnet and, hence, the axial displacements of the chest wall of the subject.
  • the systems are then programmed and configured to determine at least one respiratory parameter of the subject as a function of the axial displacements of the subject’s chest wall.
  • a seminal advantage of the systems disclosed in U.S. Pat. Nos. 10,064,570 and 10,314,517 comprises the use of a permanent rare earth magnet that is capable of generating an AC magnetic field with a substantially higher degree of magnetic field strength per unit mass compared to conventional magnetic field transducers.
  • the permanent rare earth magnet is capable of providing an AC magnetic field with (i) a greater degree of magnetic field stability over time compared to conventional magnetic field transducers and (ii) that is minimally impacted by interference from extraneous electromagnetic fields compared to conventional magnetic field transducers.
  • Nos. 10,064,570 and 10,314,517 are thus capable of measuring multiple respiratory parameters associated with a user or wearer with a high degree of accuracy, while minimizing inference from external sources, such as electromagnetic radiation.
  • physiological monitoring system that accurately detects and measures respiratory parameters and/or characteristics in real time based on anatomical displacements of a monitored subject.
  • the present invention is directed to wearable physiological monitoring systems and improved methods for determining (i) respiratory and/or sleep disorders based on measured anatomical displacements and measured physiological parameters and/or characteristics, and (ii) anatomical positions and movement of a subject.
  • the wearable physiological monitoring systems comprise a wearable garment that is configured to cover at least the chest region and upper back of a subject (or user).
  • the wearable physiological monitoring systems comprise a respiratory parameter monitoring sub-system, an electronics, i.e. control- processing module, and integral signal transmission means associated therewith.
  • the wearable physiological monitoring systems further comprise a physiological parameter monitoring sub-system.
  • the respiratory parameter monitoring sub-system comprises at least one transmitter coil and multiple receiver coils.
  • the physiological parameter monitoring sub-system further comprises an accelerometer that is configured and positioned to establish at least one anatomical position of the subject and monitor physical movement of the subject.
  • the electronics module comprises a multi-channel module that is programmed and configured (i.e. comprises programs, parameters, instructions and at least one algorithm) to control the physiological monitoring systems.
  • the electronics module is preferably programmed and configured to (i) receive AC magnetic field strength signals that are generated and transmitted by the receiver coils, (ii) identify the frequency of each of the associated AC magnetic field AC magnetic field strength signals, (iii) determine the identity of the receiver coil based on the frequency of the AC magnetic field strength signals, (iv) determine at least one respiratory parameter, more preferably, a plurality of respiratory parameters associated with the monitored subject as a function of the AC magnetic field strength signals, (v) determine at least one respiratory parameter value as a function of the AC magnetic field strength signals, and (vi) determine at least one respiratory disorder as a function of the determined respiratory parameter and determined value thereof.
  • the electronics module is further programmed and configured to (i) receive at least one respiratory parameter signal representing a pre-measured baseline respiratory parameter value, and (ii) determine at least one respiratory disorder as a function of the pre-measured baseline respiratory parameter value and the respiratory parameter and value thereof determined as a function of the AC magnetic field strength signals.
  • the electronics module is further programmed and configured to receive and process physiological parameter signals representing physiological parameter values of a subject that are generated and transmitted by the physiological parameter monitoring sub-system, i.e. a physiological parameter sensor thereof.
  • the electronics module is preferably programmed and configured to (i) receive AC magnetic field strength signals that are transmitted by the receiver coils and physiological parameter signal(s) transmitted by a physiological parameter sensor, (ii) identify the frequency of each of the AC magnetic field strength signals, (iii) determine the identity of the receiver coil based on the frequency of the AC magnetic field strength signals, (iv) determine at least one respiratory parameter, more preferably, a plurality of respiratory parameters associated with the monitored subject as a function of the AC magnetic field strength signals, (v) detennine at least one respiratory parameter value as a function of the AC magnetic field strength signals, and (vi) detennine at least one respiratory disorder as a function of the physiological parameter value, and the respiratory parameter and value thereof determined as a function of the AC magnetic field strength signals.
  • the electronics module is further programmed and configured to (i) receive accelerometer signals representing the anatomical position and movement data of the monitored subject that are generated and transmitted by an
  • the electronics module is further programmed and configured to detennine at least one anatomical position of the monitored subject as a function of the accelerometer data.
  • the electronics module is also programmed and configured to generate and transmit at least one anatomical position warning signal as a function of (or in response to) the determined anatomical position and a pre-detennined anatomical position of the subject, e.g., erect, semi-erect, left lateral recumbent lying, right lateral recumbent lying, supine or prone position.
  • anatomical position warning signal as a function of (or in response to) the determined anatomical position and a pre-detennined anatomical position of the subject, e.g., erect, semi-erect, left lateral recumbent lying, right lateral recumbent lying, supine or prone position.
  • the anatomical position warning signal induces excitation or warning events that are configured to prompt a subject to transition to an alternative position that is less likely to exacerbate and/or trigger a symptom of an existing respiratory or sleep disorder of the subject, e.g., obstructive sleep apnea or gastroesophageal reflux disease.
  • the physiological monitoring systems further comprise a vibration device that is configured to receive the anatomical position warning signal and generate a vibration at a pre-determined frequency in response to the anatomical position warning signal.
  • the physiological monitoring systems further comprise an integral audio device that is configured to receive the anatomical position warning signal and generate an audible signal at a pre-determined amplitude in response to the anatomical position warning signal.
  • the physiological monitoring systems further comprise a remote audio device that is configured to receive the anatomical position warning signal and generate an audible signal at a pre-determined amplitude in response to the anatomical position warning signal.
  • the method for determining a respiratory disorder and anatomical position of the subject generally comprises:
  • FIGURE 1 is a schematic illustration of one embodiment of a physiological monitoring system, in accordance with the invention.
  • FIGURE 2 is a schematic illustration of another embodiment of a physiological monitoring system, in accordance with the invention.
  • FIGURE 3 is a schematic illustration of yet another embodiment of a physiological monitoring system, in accordance with the invention.
  • FIGURE 4 is a perspective view of one embodiment of a wearable physiological monitoring system positioned on a subject showing the position of a transmitter coil proximate the xyphoid process and one (1) receiver coil proximate the umbilicus, in accordance with the invention.
  • FIGURE 5 is a side view of a subject, showing the position of a transmitter coil and three (3) receiver coils in a wearable physiological monitoring system and, thereby, on the subject, in accordance with one embodiment of the invention.
  • ranges can be expressed herein as from “about” or“approximately” one particular value, and/or to "about” or“approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about” or“approximately”, it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • respiratory parameter means and include a characteristic associated with the respiratory system and functioning thereof, including, without limitation, breathing frequency, tidal volume, inspiration volume, expiration volume, minute ventilation, inspiratory breathing time, expiratory breathing time, and flow rates (e.g., rates of change in the chest wall volume).
  • respiratory parameter means and include parameters associated with ventilation mechanics from synchronous or asynchronous movements of the chest wall compartments.
  • physiological parameter and “physiological characteristic”, as used herein, mean and include, without limitation, electrical activity of the heart, electrical activity of other muscles, electrical activity of the brain, pulse rate, blood pressure, blood oxygen saturation level, skin temperature, and core temperature.
  • respiration means and includes abnormal respiration, as defined herein, of a subject, which is characterized by at least one respiratory parameter and/or physiological characteristic.
  • respiration thus means and includes abnormal respiration characterized by, without limitation, breathing frequency or respiratory rate (/) (e.g., breaths per minute), tidal volume (V T ), inspiration volume, expiration volume, respiratory minute ventilation (e.g., inspiration volume per minute or expiration volume per minute) and/or peak expiratory flow rate.
  • respiratory rate e.g., breaths per minute
  • V T tidal volume
  • inspiration volume e.g., inspiration volume per minute or expiration volume per minute
  • respiratory minute ventilation e.g., inspiration volume per minute or expiration volume per minute
  • peak expiratory flow rate characterized by, without limitation, breathing frequency or respiratory rate (/) (e.g., breaths per minute), tidal volume (V T ), inspiration volume, expiration volume, respiratory minute ventilation (e.g., inspiration volume per minute or expiration volume per minute) and/or peak expiratory flow rate.
  • the term“apnea” thus means and includes the inability of a subject to correctly modulate respiration.
  • the term“apnea” also means and includes, without limitation, an obstruction of the subject’s upper airway.
  • abnormal respiration characterized by, without limitation, a seminal blood oxygen parameter and/or blood oxygen characteristic including, without limitation, oxyhemoglobin saturation and oxygen desaturation index of a subject, e.g., oxyhemoglobin desaturation events per hour.
  • the term“apnea” thus means and includes, without limitation, a reduction of a subject’s oxyhemoglobin saturation level > 5% of the subject’s average normal
  • the term“apnea” also means and includes, without limitation, counter-correlated contraction and expansion of the subject’s thoracic and abdominal regions during at least one respiration cycle, i.e. the expansion and contraction of the subject’s thoracic and abdominal cavities are -180° out of phase.
  • apnea also means and includes central sleep apnea and obstructive sleep apnea.
  • apnea also means and includes complex sleep apnea or mixed sleep apnea, i.e. a combination of central and obstructive sleep apnea.
  • the term“apneic event,” as used herein, means and includes, without limitation, a reduction of a subject’s minute ventilation > 30 % of the subject’s average normal minute ventilation and/or a cessation in the subject’s breathing > 10 seconds with an attendant reduction in oxyhemoglobin saturation.
  • normal respiration as used herein in connection with“apnea” means and includes, without limitation, a“normal” or“healthy” apnea/hypopnea index (AHI), i.e. an AHI score ⁇ 5 apneic events per hour of a subject’s sleep, wherein an apneic event is defined as (i) a reduction of the subject’s minute ventilation > 30 % of the subject’s average normal minute ventilation and/or (ii) a cessation in the subject’s breathing > 10 seconds with an attendant reduction in oxyhemoglobin saturation.
  • AHI a“normal” or“healthy” apnea/hypopnea index
  • abnormal respiration means and includes, without limitation, cessation of a subject’s breathing for a period > 10 seconds with an attendant reduction in oxyhemoglobin saturation (or oxygen saturation).
  • the term“abnormal respiration” further means and includes, without limitation a reduction of a subject’s ventilation > 30 % of the subject’s average normal ventilation.
  • the term“abnormal respiration” further means and includes, without limitation, a reduction of a subject’s minute ventilation (Y-dot) > 30 % of the subject’s average normal minute ventilation.
  • abnormal respiration further means and includes, without limitation, a“mild” apnea/hypopnea index (AHI) score in the range of 5 - 15 apneic events per hour of a subject’s sleep, wherein an apneic event is defined as (i) a reduction of the subject’s minute ventilation > 30 % of the subject’s average normal minute ventilation and/or (ii) a cessation in the subject’s breathing > 10 seconds with an attendant reduction in
  • AHI hyperpneic index
  • abnormal respiration further means and includes, without limitation, a“moderate” apnea/hypopnea index (AHI) score in the range of 15 - 30 events per hour of a subject’s sleep, wherein an apneic event is defined as (i) a reduction of the subject’s minute ventilation > 30 % of the subject’s average normal minute ventilation and/or (ii) a cessation in the subject’s breathing > 10 seconds with an attendant reduction in oxyhemoglobin saturation.
  • AHI hyperpneic event
  • abnormal respiration further means and includes, without limitation, a“severe” apnea/hypopnea index (AHI) score > 30 events per hour of a subject’s sleep, wherein an apneic event is defined as (i) a reduction of the subject’s minute ventilation > 30 % of the subject’s average normal minute ventilation and/or (ii) a cessation in the subject’s breathing for a period of at least 10 seconds with an attendant reduction in oxyhemoglobin saturation.
  • AHI hyperpneic index
  • abnormal respiration further means and includes, without limitation, a reduction of a subject’s tidal volume (VT) in the range of approximately 5 - 30 % of the subject’s average normal VT.
  • VT tidal volume
  • sleep disorder and“respiratory disorder” are used interchangeably herein, and mean and include, without limitation, an apnea, sleep apnea, hypopnea, and abnormal respiration.
  • the term“resting position” as used herein in connection with“apnea” and“sleep apnea” means and includes minimal physical activity or motion and/or the absence of physical activity or motion, except motion associated with normal breathing.
  • the terms "patient” and“subject” are used interchangeably herein, and mean and include warm blooded mammals, humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like.
  • the terms“subject” and“patient” also mean and include a wearer or user of a respiratory parameter monitoring system or a respiratory-physiological parameter
  • physiological monitoring systems and associated methods for determining respiratory and physiological parameters, and respiratory disorders based thereon, and anatomical positions and movement of a subject are described herein in connection with determining respiratory and physiological parameters, and respiratory and sleep disorders based thereon, and anatomical positions and movement of a human subject, it is understood that the invention is not limited to such use. Indeed, the physiological monitoring systems and associated methods can also be readily employed to determine respiratory and physiological parameters, and respiratory and sleep disorders based thereon, and anatomical positions and movement of other mammalian bodies.
  • physiological monitoring systems and associated methods of the invention can also be employed in non-medical contexts, such as determining volumes and/or volume changes in extensible bladders used for containing liquids and/or gasses.
  • the present invention is directed to physiological monitoring systems and improved methods employing same for determining (i) respiratory and sleep disorders of a subject based on measured variations in AC magnetic field strengths that are detected and measured by a plurality of receiver coils as a function of the dimensional distances between each receiver coil and at least one magnetic field source, i.e. a transmitter coil, and, hence, anatomical displacements based thereon, and, in some embodiments, physiological parameters and/or characteristics, and accelerometer data, and/or (ii) anatomical positions and movement of the subject.
  • the monitoring systems of the invention comprise a wearable garment that is configured to cover at least the chest region and upper back of a wearer (or user).
  • the monitoring systems comprise a respiratory parameter monitoring sub-system, electronics (i.e. control and processing) module and integral signal transmission means associated therewith.
  • the monitoring systems similarly comprises a respiratory parameter monitoring sub-system, a physiological parameter monitoring sub-system, electronics module and integral signal transmission means associated therewith.
  • the respiratory parameter monitoring subsystem comprises at least one permanent magnet and at least one magnetometer, such as disclosed in Applicant’s Co-pending U.S. App. No. 16/363,290, which is incorporated by reference herein in its entirety.
  • the respiratory parameter monitoring sub-system comprises at least one transmitter coil and multiple receiver coils, such as disclosed in Applicant’s Co-pending U.S. App. No. 16/363,404, which is incorporated by reference herein in its entirety.
  • the respiratory parameter monitoring sub-system can comprise two (2) transmitter coils. As discussed in detail below, in such embodiments, one (1) transmitter coil is positioned proximate the xyphoid process and another transmitter coil is positioned proximate the umbilicus.
  • the respiratory parameter monitoring sub-system comprises three (3) receiver coils.
  • the respiratory parameter monitoring sub-system can, however, also comprise more or less than three (3) receiver coils.
  • the transmitter coil(s) are adapted to generate and transmit electromagnetic radiation, e.g., AC magnetic fields, in three dimensions at multiple, non-harmonic frequencies.
  • the non-harmonic frequencies are less than 10 KHz.
  • the non-harmonic frequencies are less than 5 KHz.
  • the non-harmonic frequencies are in the range of approximately 5-10 KHz.
  • the transmitter coils can comprise any apparatus or system that is adapted to generate and transmit electromagnetic radiation at multiple frequencies.
  • the receiver coils are configured and positioned to detect and measure the field strength in at least one field dimension of at least one AC magnetic field at a defined frequency, and generate at least one AC magnetic field strength signal representing the field strengths in the detected field dimension of the AC magnetic field, and, thereby, anatomical displacements of the monitored subject.
  • the receiver coils are configured and positioned to detect and measure the field strengths in multiple field dimensions of at least one AC magnetic field at a defined frequency, and generate a plurality of AC magnetic field strength signals representing the field strengths in the field dimensions of the AC magnetic field, and, thereby, anatomical displacements of the monitored subject.
  • the receiver coils can comprise any apparatus or system that is configured to detect and measure field strength in an AC magnetic field at a defined frequency, and generate at least one AC magnetic field strength signal representing the measured field strength in the AC magnetic field, such as a magnetometer or Hall Effect sensor.
  • the transmitter coil is positioned at a first anatomical position proximate the subject’s xyphoid process and a first receiver coil is positioned at a second anatomical position proximate the umbilicus, a second receiver coil is positioned at a third anatomical position proximate the subject’s spine opposite the transmitter coil, and a third receiver coil is positioned at a fourth anatomical position proximate the subject’s spine opposite the umbilicus.
  • receiver coil placement configurations on a subject can be employed.
  • the transmitter coil is positioned proximate the subject’s umbilicus and a first receiver coil is positioned proximate the subject’s spine opposite the transmitter coil, a second receiver coil is positioned proximate the subject’s xyphoid process, and a third receiver coil is positioned proximate the subject’s spine opposite the xyphoid process.
  • the transmitter coil is positioned proximate the subject’s spine opposite the xyphoid process and a first receiver coil is positioned proximate the xyphoid process, a second receiver coil is positioned proximate the subject’s umbilicus, and a third receiver coils is positioned proximate the subject’s spine opposite the umbilicus.
  • the physiological parameter monitoring sub-system comprises at least one physiological parameter sensor that is configured to (i) detect and measure a physiological parameter and, preferably, a value thereof, and (ii) generate a physiological parameter signal representing the measured physiological parameter and, preferably, value thereof.
  • the physiological parameter monitoring sensor comprises a Sp0 2 sensor.
  • the physiological parameter monitoring sensor comprises a body temperature sensor.
  • the physiological parameter monitoring sub-system further comprises at least one accelerometer that is configured and positioned to (i) detect anatomical positions of a monitored subject, and (ii) monitor physical movement of the subject.
  • the accelerometer comprises a conventional three (3) axis accelerometer that is configured to detect at least one accelerometer parameter in an X, Y and/or Z direction.
  • the accelerometer is configured to generate and transmit at least one accelerometer signal representing accelerometer data, including at least one accelerometer parameter representing an anatomical position of a subject.
  • the accelerometer is configured and positioned to generate a plurality of accelerometer signals that are processed and employed to determine at least one anatomical position of the subject, i.e. whether the subject is in an erect, semi-erect, left lateral recumbent lying, right lateral recumbent lying, supine or prone position.
  • the electronics module comprises a multi-channel module that is programmed and configured (i.e. comprises programs, parameters, instructions and at least one algorithm) to control the monitoring systems of the invention.
  • the electronics module is also preferably programmed and configured to (i) receive AC magnetic field strength signals that are generated and transmitted by the receiver coils, (ii) identify the frequency of each of the associated AC magnetic field AC magnetic field strength signals, (iii) determine the identity and, thereby, position of the receiver coil based on the frequency of the AC magnetic field strength signals, (iv) determine at least one respiratory parameter, more preferably, a plurality of respiratory parameters associated with the monitored subject as a function of the AC magnetic field strength signals, (v) determine at least one respiratory parameter value as a function of the AC magnetic field strength signals, and (vi) determine at least one respiratory disorder as a function of the determined respiratory parameter and determined value thereof.
  • the electronics module is further programmed and configured to (i) receive at least one respiratory parameter signal representing a pre-measured baseline respiratory parameter value, and (ii) determine at least one respiratory disorder as a function of the pre-measured baseline respiratory parameter value and the respiratory parameter and value thereof determined as a function of the AC magnetic field strength signals.
  • the electronics module is farther programmed and configured to receive and process physiological parameter signals representing physiological parameter values of a subject that are generated and transmitted by the physiological parameter monitoring sub-system, i.e. a physiological parameter sensor thereof.
  • the electronics module is preferably programmed and configured to (i) receive the AC magnetic field strength signals that are transmitted by the receiver coils and physiological parameter signal(s) transmitted by the physiological parameter sensor, (ii) identify the frequency of each of the AC magnetic field strength signals, (iii) determine the identity of the receiver coil based on the frequency of the AC magnetic field strength signals, (iv) determine at least one respiratory parameter, more preferably, a plurality of respiratory parameters associated with the monitored subject as a function of the AC magnetic field strength signals, (v) determine at least one respiratory parameter value as a function of the AC magnetic field strength signals, and (vi) determine at least one respiratory disorder as a function of the physiological parameter value, and the respiratory parameter and value thereof determined as a function of the AC magnetic field strength signals.
  • the electronics module is further programmed and configured to (i) receive accelerometer signals representing the anatomical position and movement data of the monitored subject that are generated and transmitted by an
  • accelerometer and (ii) determine at least one respiratory disorder as a function of the premeasured baseline respiratory parameter value, physiological parameter value, accelerometer data, and the respiratory parameter and value thereof determined as a function of the AC magnetic field strength signals.
  • the electronics module is also programmed to determine a physiological parameter value as a function of the physiological parameter signal.
  • the electronics module is also programmed and configured to generate and transmit at least one respiratory disorder warning signal as a function of (or in response to) a pre-determined respiratory parameter threshold value and/or physiological parameter threshold value.
  • the electronics module is further programmed and configured to generate and transmit at least one anatomical position warning signal as a function of (or in response to) a determined anatomical position and a pre-determined anatomical position of the subject.
  • the monitoring systems further comprise at least one excitation device, such as a vibration, audio or illuminating device, which generates or provides at least one excitation event, e.g., vibrations, in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • excitation device such as a vibration, audio or illuminating device, which generates or provides at least one excitation event, e.g., vibrations, in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the monitoring systems thus further comprise a vibration device that is configured to receive the respiratory disorder warning signal and/or anatomical position warning signal and generate vibrations at a pre-determined frequency or frequencies in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the vibration device can comprise various components
  • conventional vibration devices including, without limitation, piezoelectric vibrators, eccentric cam motors and electromagnetic (EM) vibrators.
  • EM electromagnetic
  • the vibration device is capable of generating vibrations with a frequency in the range of approximately 5 - 50 Hz.
  • the vibration device is configured to generate a plurality of vibrations in a series of random or continuous pulses in intervals in the range of 1 - 30 seconds, more preferably, in intervals in the range of 1 - 3 seconds.
  • the monitoring systems further comprise a remote vibration device that is configured to receive the respiratory disorder warning signal and/or anatomical position warning signal and generate the vibrations referenced above in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the remote vibration device can comprise various conventional vibration devices, including, without limitation, piezoelectric vibrators, eccentric cam motors and electromagnetic (EM) vibrators.
  • piezoelectric vibrators including, without limitation, piezoelectric vibrators, eccentric cam motors and electromagnetic (EM) vibrators.
  • EM electromagnetic
  • the remote vibration device is capable of vibrating at a frequency in the range of approximately 5 - 50 cycles per second (Hz).
  • the remote vibration device is similarly configured to generate a plurality of vibrations in a series of random or continuous pulses in intervals in the range of 1 - 30 seconds, more preferably, in intervals in the range of 1 - 3 seconds.
  • the monitoring systems can comprise a plurality of vibration devices that are configured to generate and, hence, transmit the same or different vibrations.
  • the monitoring systems comprise a vibration device that is in communication with a subject’s bed, such as a bed frame or mattress, or chair.
  • the monitoring systems further comprise an integral audio device that is configured to receive the respiratory disorder warning signal and/or anatomical position warning signal and produce an audible signal at a pre-determined amplitude in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the integral audio device can comprise various conventional audio devices, including, without limitation, piezoelectric audio devices and electromagnetic audio devices, e.g., speakers.
  • the audio device is capable of providing an audible signal with an amplitude in the range of approximately 70 - 90 dB.
  • the audio device is capable of generating acoustic signals with a frequency in the range of approximately 300 - 1200 Hz.
  • the monitoring systems further comprise a remote audio device that is configured to receive the respiratory disorder warning signal and/or anatomical position warning signal and produce an audible signal at a pre-determined amplitude in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the remote audio device can similarly comprise various conventional audio devices, including, without limitation, piezoelectric audio devices and electromagnetic audio devices, e.g., speakers.
  • the remote audio device is capable of generating and transmitting an audible signal with an amplitude in the range of approximately 70 - 110 dB.
  • the remote audio device is capable of generating and transmitting acoustic signals with a frequency in the range of approximately 300 - 1200 Hz.
  • the monitoring systems further comprise a remote illuminating device that is configured to receive the respiratory disorder warning signal and/or anatomical position warning signal and produce a luminous signal in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the remote illuminating device can comprise any conventional device that is configured to generate light, such as a lamp or any local light source.
  • electronics module of the monitoring systems is also programmed and configured to transmit a pre-programmed verbal notice or warning in response to the respiratory disorder warning signal and/or anatomical position warning signal.
  • the electronics module is programmed and configured to transmit a pre-pro grammed respiratory disorder verbal warning to an emergency person or entity via a wireless link.
  • the electronics module is programmed to transmit the pre-programmed respiratory disorder verbal warning to an emergency contact via a pre-programmed telephone number.
  • the electronics module is programmed to transmit the pre programmed respiratory disorder verbal warning to an emergency service, e.g., police or fire department, via a pre-programmed emergency service telephone number, e.g.,“911”.
  • an emergency service e.g., police or fire department
  • a pre-programmed emergency service telephone number e.g.,“911”.
  • the electronics module is programmed and configured to provide a plurality of respiratory disorder warning signals and/or anatomical position warning signals that induce multi-level excitation or warning events, i.e. vibrations of the vibration device at different frequencies, induced audible signals at different amplitudes and verbal warnings to emergency contacts and/or services, and combinations thereof, as a function of (or in response to) the respiratory disorder warning signals and/or anatomical position warning signals.
  • a plurality of respiratory disorder warning signals and/or anatomical position warning signals that induce multi-level excitation or warning events, i.e. vibrations of the vibration device at different frequencies, induced audible signals at different amplitudes and verbal warnings to emergency contacts and/or services, and combinations thereof, as a function of (or in response to) the respiratory disorder warning signals and/or anatomical position warning signals.
  • the single-level respiratory disorder warning system preferably comprises at least one respiratory- physiological parameter threshold and at least one excitation event relating thereto.
  • the two-level respiratory disorder warning system preferable comprises a plurality of respiratory-physiological parameter thresholds and at least one excitation event relating thereto.
  • the three-level sleep disorder warning system similarly preferably comprises a plurality of respiratory-physiological parameter thresholds and at least one excitation event relating thereto.
  • the accelerometer is configured and positioned to (i) detect and monitor anatomical positions and movements of the monitored subject, and (ii) generate a plurality of accelerometer signals that are processed and employed by the electronics module to determine anatomical positions of the subject.
  • the electronics module is also programmed and configured to generate and transmit at least one anatomical position warning signal as a function of (or in response to) a determined anatomical position and a pre determined anatomical position of the subject.
  • the pre-determined and determined anatomical positions include at least semi-erect, left lateral recumbent, right lateral recumbent, supine and prone.
  • the anatomical position warning signal induces excitation or warning events that are configured to prompt a subject to transition to an alternate anatomical position that is less likely to exacerbate and/or trigger a symptom of an existing respiratory or sleep disorder of the subject, e.g., obstructive sleep apnea or gastroesophageal reflux disease.
  • the single-level anatomical position warning system preferably comprises at least one undesirable anatomical position or condition and at least one excitation event relating thereto.
  • Table V there is shown another embodiment of a single-level anatomical position warning system of the invention.
  • the illustrated embodiment similarly comprises at least one undesirable anatomical position or condition and at least one excitation event relating thereto.
  • the anatomical position warning system is thus configured to train a subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or trigger a symptom of an existing respiratory or sleep disorder of the subject.
  • the anatomical position warning system is specifically configured to continuously train a subject afflicted with obstructive sleep apnea to maintain a left or right lateral recumbent lying anatomical position during sleep.
  • the anatomical position warning system is specifically configured to continuously train a subject afflicted with gastroesophageal reflux disease to maintain a left lateral recumbent lying anatomical position during sleep.
  • the anatomical position warning system can be configured to train a subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or trigger a symptom of any existing disorder or disease of a subject.
  • the electronics module is further programmed and configured to continuously monitor the frequency of a subject’s anatomical position transition events.
  • electronics module is also programmed and configured to determine sleep parameters, e.g., total sleep time (TST), sleep efficiency (SE) and wake-after- sleep-onset (WASO), as a function of acquired accelerometer data and determined respiratory parameter values.
  • sleep parameters e.g., total sleep time (TST), sleep efficiency (SE) and wake-after- sleep-onset (WASO)
  • the monitoring systems generally comprise a wearable gannent that is configured to be removably positioned on a subject, the subject comprising thoracic and abdominal regions, a spine, an umbilicus and xyphoid process of the sternum, wherein when the wearable garment is positioned on a subject the wearable garment covers at least the thoracic and abdominal regions of the subject,
  • the wearable garment comprising a respiratory parameter monitoring sub-system and an electronics module in communication therewith,
  • the respiratory parameter monitoring sub-system comprising a transmitter coil and first, second and third receiver coils
  • the transmitter coil and the first, second and third receiver coils being positioned on the wearable garment, whereby, when the wearable garment is positioned on the subject, the transmitter coil is positioned proximate the subject’s xyphoid process, the first receiver coil is positioned at a first anatomical region of the subject proximate the subject’s umbilicus at a first receiver coil distance from the transmitter coil, the second receiver coil is positioned at a second anatomical region of the subject proximate the subject’s spine opposite the subject’s xyphoid process at a second receiver coil distance from the transmitter coil, the third magnetometer is positioned at a third anatomical region of the subject proximate the subject’s spine opposite the subject’s umbilicus at a third receiver coil distance from the transmitter coil,
  • the transmitter coil being adapted to generate a first alternating current (AC) magnetic field in first, second and third field dimensions, a second AC magnetic field in fourth, fifth and sixth field dimensions, and a third AC magnetic field in seventh, eighth and ninth field dimensions,
  • AC alternating current
  • the first, second and third field dimensions of the first AC magnetic field comprising a first field frequency
  • the fourth, fifth and sixth field dimensions of the second AC magnetic field comprising a second field frequency
  • the seventh, eighth and ninth field dimensions of the third AC magnetic field comprising a third field frequency
  • the first field dimension of the first AC magnetic field comprising a first valuable strength as a function of a first distance of the first receiver coil from the transmitter coil
  • the second field dimension of the first AC magnetic field comprising a second valuable strength as a function of a second distance of the first receiver coil from the transmitter coil
  • the third field dimension of the first AC magnetic field dimension comprising a third variable strength as a function of a third distance of the first receiver coil from the transmitter coil
  • the fourth field dimension of the second AC magnetic field comprising a fourth variable field strength as a function of a fourth distance of the second receiver coil from the transmitter coil
  • the fifth field dimension of the second AC magnetic field comprising a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil
  • the sixth field dimension of the second AC magnetic field comprising a sixth variable field strength as a function of a sixth distance of the second receiver coil from the transmitter coil
  • the seventh field dimension of the third AC magnetic field comprising a seventh variable field strength as a function of a seventh distance of the third receiver coil from the transmitter coil
  • the eighth field dimension of the third AC magnetic field comprising an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil
  • the ninth field dimension of the third AC magnetic field comprising a ninth variable field strength as a function of a ninth distance of the third receiver coil from the transmitter coil
  • the first receiver coil being configured to detect and measure the first, second and third variable field strengths in the first, second and third field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representing the first variable field strength in the first field dimension of the first AC magnetic field, a second AC magnetic field strength signal representing the second variable field strength in the second field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representing the third variable field strength in the third field dimension of the first AC magnetic field, and transmit the first, second and third AC magnetic field strength signals to the electronics module,
  • the second receiver coil being configured to detect and measure the fourth, fifth and sixth variable field strengths in the fourth, fifth and sixth field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representing the fourth variable field strength in the fourth field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representing the fifth valuable field strength in the fifth field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representing the sixth variable field strength in the sixth field dimension of the second AC magnetic field, and transmit the fourth, fifth and sixth AC magnetic field strength signals to the electronics module,
  • the third receiver coil being configured to detect and measure the seventh, eighth and ninth variable field strengths in the seventh, eighth and ninth field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representing the seventh variable field strength in the seventh field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representing the eighth variable field strength in the eighth field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representing the ninth variable field strength in the ninth field dimension of the third AC magnetic field, and transmit the seventh, eighth and ninth AC magnetic field strength signals to the electronics module,
  • the electronics module being adapted to receive the first, second and third AC magnetic field strength signals transmitted by the first receiver coil, the fourth, fifth and sixth AC magnetic field strength signals transmitted by the second receiver coil and the seventh, eighth and ninth AC magnetic field strength signals transmitted by the third receiver coil, the electronics module comprising a processing system that is programmed and configured to determine at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals,
  • the processing system being further programmed and configured to determine a value of the at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals, the processing system being further programmed and configured to determine a value of the at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals,
  • the processing system being further programmed and configured to determine at least one respiratory disorder of the subject as a function of the determined at least one respiratory parameter and the determined value thereof.
  • the processing system is further programmed and configured to determine the at least one respiratory or sleep disorder of the subject as a function of the premeasured baseline respiratory parameter value and the determined at least one respiratory parameter and value thereof.
  • the transmitter coil and the first receiver coil are in a first axial alignment
  • the transmitter coil and the second receiver coil are in a second axial alignment
  • the transmitter coil and the third receiver coil are in a third axial alignment.
  • the monitoring systems similarly comprise a wearable garment that is configured to be removably positioned on a subject, the subject comprising a spine, an umbilicus and xyphoid process of the sternum, wherein when the wearable garment is positioned on a subject the wearable garment covers at least a thoracic and abdominal region of the subject,
  • the wearable garment comprising a respiratory parameter monitoring sub-system, physiological parameter sub-system and an electronics module,
  • the respiratory parameter monitoring sub-system comprising a transmitter coil and first, second and third receiver coils
  • the physiological parameter sub-system comprising at least one physiological parameter sensor
  • the transmitter coil and the first, second and third receiver coils being positioned on the wearable garment, whereby, when the wearable garment is positioned on the subject, the transmitter coil is positioned proximate the subject’s xyphoid process, the first receiver coil is positioned at a first anatomical region of the subject proximate the subject’s umbilicus at a first receiver coil distance from the transmitter coil, the second receiver coil is positioned at a second anatomical region of the subject proximate the subject’s spine opposite the subject’s xyphoid process at a second receiver coil distance from the transmitter coil, the third magnetometer is positioned at a third anatomical region of the subject proximate the subject’s spine opposite the subject’s umbilicus at a third receiver coil distance from the transmitter coil,
  • the transmitter coil being adapted to generate a first alternating current (AC) magnetic field in first, second and third field dimensions, a second AC magnetic field in fourth, fifth and sixth field dimensions, and a third AC magnetic field in seventh, eighth and ninth field dimensions,
  • AC alternating current
  • the first, second and third field dimensions of the first AC magnetic field comprising a first field frequency
  • the fourth, fifth and sixth field dimensions of the second AC magnetic field comprising a second field frequency
  • the seventh, eighth and ninth field dimensions of the third AC magnetic field comprising a third field frequency
  • the first field dimension of the first AC magnetic field comprising a first variable strength as a function of a first distance of the first receiver coil from the transmitter coil
  • the second field dimension of the first AC magnetic field comprising a second variable strength as a function of a second distance of the first receiver coil from the transmitter coil
  • the third field dimension of the first AC magnetic field dimension comprising a third variable strength as a function of a third distance of the first receiver coil from the transmitter coil
  • the fourth field dimension of the second AC magnetic field comprising a fourth variable field strength as a function of a fourth distance of the second receiver coil from the transmitter coil
  • the fifth field dimension of the second AC magnetic field comprising a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil
  • the sixth field dimension of the second AC magnetic field comprising a sixth variable field strength as a function of a sixth distance of the second receiver coil from the transmitter coil
  • the seventh field dimension of the third AC magnetic field comprising a seventh variable field strength as a function of a seventh distance of the third receiver coil from the transmitter coil
  • the eighth field dimension of the third AC magnetic field comprising an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil
  • the ninth field dimension of the third AC magnetic field comprising a ninth variable field strength as a function of a ninth distance of the third receiver coil from the transmitter coil
  • the first receiver coil being configured to detect and measure the first, second and third variable field strengths in the first, second and third field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representing the first variable field strength in the first field dimension of the first AC magnetic field, a second AC magnetic field strength signal representing the second variable field strength in the second field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representing the third variable field strength in the third field dimension of the first AC magnetic field, and transmit the first, second and third AC magnetic field strength signals to the electronics module,
  • the second receiver coil being configured to detect and measure the fourth, fifth and sixth variable field strengths in the fourth, fifth and sixth field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representing the fourth variable field strength in the fourth field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representing the fifth variable field strength in the fifth field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representing the sixth variable field strength in the sixth field dimension of the second AC magnetic field, and transmit the fourth, fifth and sixth AC magnetic field strength signals to the electronics module,
  • the third receiver coil being configured to detect and measure the seventh, eighth and ninth variable field strengths in the seventh, eighth and ninth field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representing the seventh variable field strength in the seventh field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representing the eighth variable field strength in the eighth field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representing the ninth variable field strength in the ninth field dimension of the third AC magnetic field, and transmit the seventh, eighth and ninth AC magnetic field strength signals to the electronics module,
  • the electronics module being adapted to receive the first, second and third AC magnetic field strength signals transmitted by the first receiver coil, the fourth, fifth and sixth AC magnetic field strength signals transmitted by the second receiver coil and the seventh, eighth and ninth AC magnetic field strength signals transmitted by the third receiver coil, the electronics module comprising a processing system that is programmed and configured to determine at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals,
  • the processing system being further programmed and configured to determine a value of the at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals,
  • the processing system being further programmed and configured to determine a value of the at least one respiratory parameter of the subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength signals,
  • the processing system being further programmed and configured to determine at least one respiratory disorder of the subject as a function of the physiological parameter value, and the determined at least one respiratory parameter and the determined value thereof.
  • the transmitter coil and the first receiver coil are similarly in a first axial alignment
  • the transmitter coil and the second receiver coil are in a second axial alignment
  • the transmitter coil and the third receiver coil are in a third axial alignment.
  • the processing system is further programmed and configured to determine at least one respiratory disorder of the subject as a function of the pre-measured baseline respiratory parameter value, physiological parameter value, and the determined at least one respiratory parameter and value thereof.
  • the physiological parameter sub-system of the monitoring systems of the invention further comprise an accelerometer that is configured detect and monitor anatomical positions and physical movement of the subject, and generate and transmit accelerometer signals representing same, including accelerometer data representing at least one anatomical position of the subject.
  • the processing system is further programmed and configured to determine at least one respiratory disorder of the subject as a function of the pre-measured baseline respiratory parameter value, physiological parameter value, accelerometer data, and the determined at least one respiratory parameter and value thereof.
  • the processing system is also programmed and configured to determine at least one anatomical position of the subject as a function of the accelerometer signals and, hence, accelerometer data embodied in same.
  • the processing system is further programmed and configured to selectively determine at least one respiratory disorder of the subject as a function of the physiological parameter value and the determined at least one respiratory parameter and value thereof or at least one anatomical position of the subject as a function of the accelerometer signals and, hence, accelerometer data embodied in same.
  • the method for determining a respiratory disorder with a monitoring system of the invention generally comprises:
  • a wearable monitoring system comprising a respiratory parameter monitoring sub-system, physiological parameter monitoring sub-system and electronics control-processing module, the respiratory parameter monitoring sub-system comprising one transmitter coil and three, i.e. first, second and third, receiver coils, the physiological parameter monitoring sub-system comprising at least one physiological parameter monitoring sensor;
  • the method for determining a respiratory disorder and anatomical position of a subject generally comprises:
  • a wearable monitoring system comprising a respiratory parameter monitoring sub-system and electronics control-processing module, the respiratory parameter monitoring sub-system comprising one transmitter coil and first, second and third, receiver coils, the respiratory parameter monitoring sub-system comprising at least one physiological parameter monitoring sensor and an accelerometer;
  • the monitoring system 100 preferably comprises a respiratory parameter monitoring sub-system 2 of the invention, an electronics module 6 and signal transmission conductors 8.
  • the respiratory parameter monitoring sub-system 2 comprises a transmitter coil 15, first, second and third receiver coils 16a, 16b, 16c.
  • the respiratory parameter monitoring system 100 further comprises a power source 10.
  • the power source 10 can comprise any device or system configured to provide (or generate) electrical energy, such as a battery.
  • the monitoring system 100 preferably comprises a wearable garment that is configured to cover at least a portion of the torso of a subject, i.e. the thoracic and abdominal regions.
  • the monitoring system 102 similarly preferably comprises a respiratory parameter monitoring sub-system 2, an electronics module 6 and signal transmission conductors 8.
  • the respiratory parameter monitoring sub-system 2 similarly comprises a transmitter coil 15, first, second and third receiver coils 16a, 16b, 16c.
  • the monitoring system 102 further comprises a physiological parameter monitoring sub-system 4a of the invention.
  • the monitoring system 102 similarly preferably comprises a wearable garment that is configured to cover at least a portion of the torso of a subject, i.e. the thoracic and abdominal regions.
  • transmitter coil 15 is adapted to generate and transmit electromagnetic radiation, e.g., AC magnetic fields, in multiple fields, i.e. a three-dimensional field, at multiple, non-harmonic frequencies.
  • electromagnetic radiation e.g., AC magnetic fields
  • the non-harmonic frequencies are less than 10 KHz.
  • the first, second and third receiver coils 16a, 16b and 16c are configured and positioned to detect and measure field strength in at least one of the field dimensions of the AC magnetic fields, and generate AC magnetic field strength signals representing the field strengths in the AC magnetic fields, and, thereby, anatomical displacements of the monitored subject.
  • the first and second transmitter coils are configured and positioned on a subject, wherein the polarities of the AC magnetic fields generated by the transmitter coils that are oriented perpendicular to each other, i.e. at a 90° angle relative to each other, wherein a net vector field, comprising at least X and Y vectors (or directions), of the AC magnetic fields is provided.
  • At least one receiver coil is configured to detect at least one AC magnetic field vector in the X-direction and at least one receiver coil is configured to detect at least one AC magnetic field vector in the Y-direction.
  • the physiological parameter monitoring sub-system 4a of the respiratory- physiological parameter monitoring system 102 comprises at least one physiological parameter monitoring sensor.
  • the physiological parameter monitoring sensor 4a preferably comprises a SpCb sensor 18.
  • the physiological parameter monitoring sub-system 4a comprises at least one additional physiological parameter monitoring sensor, such as a temperature sensor (shown in phantom and denoted 19).
  • the electronics module 6 preferably comprises a processing system or module, which is programmed and configured to control the respiratory-physiological parameter monitoring system 2 and the function thereof, and a data transmission module, which is programmed and configured to control the transmission and receipt of signals to and from the respiratory parameter monitoring sub-system 2 and physiological parameter monitoring sub-system 4a.
  • the processing system comprises at least one algorithm that is programmed and configured to isolate and process the AC magnetic field strength signals, and determine at least one respiratory parameter (or characteristic) of a subject as a function of the AC magnetic field strength signals.
  • the processing system algorithm for determining a respiratory parameter (or characteristic) as a function of AC magnetic field strength signals can comprise various conventional algorithms, including, without limitation, a conventional and/or modified multiple-degree of freedom algorithm, including, without limitation, a two (2) degree of freedom algorithm and three (3) degree of freedom algorithm, a spectral density estimation algorithm using non-parametric methods, including, without limitation, singular spectrum analysis, short-time Fourier transform, cross- power method, transfer function estimate and magnitude squared coherence, and frequency domain algorithm, including, without limitation, a Fourier series algorithm, Fourier transform algorithm, Laplace transform algorithm, Z transform algorithm and wavelet transform algorithm.
  • a conventional and/or modified multiple-degree of freedom algorithm including, without limitation, a two (2) degree of freedom algorithm and three (3) degree of freedom algorithm
  • a spectral density estimation algorithm using non-parametric methods including, without limitation, singular spectrum analysis, short-time Fourier transform, cross- power method, transfer function estimate and magnitude squared coherence
  • frequency domain algorithm including, without limitation, a Fourier series algorithm, Four
  • the processing system is also preferably programmed and configured to generate and continuously update at least one diagnostic data set.
  • the diagnostic data set correlates at least one array of measured or determined respiratory parameters with at least one array of measured or determined anatomical displacement parameters of a subject.
  • the diagnostic data set preferably comprises at least an array of measured or determined minute ventilation values and anatomical displacements measured at defined points on a subject during monitoring with a respiratory parameter or respiratory-physiological parameter monitoring system of the invention.
  • the diagnostic data set shown in Table VII can be graphically presented, i.e. minute ventilation on the y-axis and anatomical displacement on the x-axis, and linearly interpolated using conventional equations, such as Eq. 1 shown below.
  • the processing system is programmed and configured to linearly interpolate a diagnostic data set, such as the diagnostic data set shown in Table VII, and determine the presence of at least one apneic event exhibited by a subject over a predetermined period of time and, thereby, a sleep disorder.
  • a diagnostic data set such as the diagnostic data set shown in Table VII
  • the diagnostic data set can be interpolated using any applicable methods and/or equations.
  • processing system is
  • a sleep disorder programmed and configured to interpolate a diagnostic data set using quadratic polynomial interpolation and determine the presence of at least one apneic event exhibited by a subject over a predetennined period of time and, thereby, a sleep disorder.
  • a subject tidal volume (V T ) and respiratory rate (/) are determined via spirometry. Minute ventilation (V-dot) can then be determined using the equation shown below.
  • V-dot VT X / Eq. 2
  • the processing system is further programmed to differentiate between indicia of a sleep disorder, i.e. respiratory and/or physiological parameters indicative of a sleep disorder, and extraneous respiratory events, such as coughing, hiccups, sneezing, etc. by, for example, comparing the pre-measured baseline respiratory and pre-measured baseline physiological parameters of the subject in a resting position to pre-determined respiratory and physiological parameter threshold values reflecting a respiratory disorder.
  • a sleep disorder i.e. respiratory and/or physiological parameters indicative of a sleep disorder
  • extraneous respiratory events such as coughing, hiccups, sneezing, etc.
  • the processing system is further programmed to determine a type of sleep apnea, i.e. obstructive sleep apnea, central sleep apnea and complex sleep apnea, based on detected anatomical displacements of a monitored subject.
  • a type of sleep apnea i.e. obstructive sleep apnea, central sleep apnea and complex sleep apnea
  • the processing system determines the type of sleep apnea of a subject based on the correlation or synchrony between the expansion and contraction of the subject’s thoracic and abdominal regions (or chest wall and abdominal wall) during at least one respiratory cycle.
  • the electronics module 6 further comprises a data transmission sub-system that is programmed and configured to control the transmission of signals from the respiratory parameter monitoring sub-system 2 and physiological parameter monitoring sub-system 4a.
  • the data transmission sub-system is also preferably programmed and configured to transmit the respiratory parameter signals to a remote signal receiving device, e.g., a base module or a hand-held electronic device, such as a smart phone, tablet, computer, etc.
  • a remote signal receiving device e.g., a base module or a hand-held electronic device, such as a smart phone, tablet, computer, etc.
  • the remote signal receiving device is programmed and configured to display received and/or processed signals, e.g., respiration parameter signals, physiological parameter signals and accelerometer data received from the electronics module 6.
  • the respiratory-physiological parameter monitoring system 102 also similarly includes signal transmission conductors 8, which facilitate connection and, thereby, signal communication by and between the respiratory parameter monitoring sub-system 2, physiological parameter monitoring sub-system 4a, and electronics module 6.
  • the respiratory-physiological parameter monitoring system 104 similarly preferably comprises a respiratory parameter monitoring sub-system 2, a physiological parameter monitoring sub-system comprising at least one physiological parameter monitoring sensor, electronics module 6, signal transmission conductors 8, and a power source 10, such as embodied in the respiratory-physiological parameter monitoring system 102 described above.
  • the physiological parameter monitoring sub-system (now denoted“4b”) further comprises an accelerometer 20 that is preferably configured detect and monitor anatomical positions and physical movement of the subject, and generate and transmit accelerometer signals representing same, including accelerometer data representing at least one anatomical position of the subject.
  • the processing system of the electronics module 6 is also programmed to determine a respiratory disorder as a function of measured respiratory and physiological parameters, and accelerometer data of the subject, and at least one anatomical position of the subject as a function of the accelerometer data.
  • FIG. 4 there is shown an embodiment of a wearable gannent 220 that can incorporate a monitoring system of the invention, including monitoring systems 100 and 102 shown in Figs. 1-3.
  • the wearable garment 220 is preferably configured to cover at least the upper torso 210, i.e. the thoracic and abdominal regions, of a subject 200.
  • the wearable gannent 220 can, however, also be configured to cover other regions of the subject 200, including, without limitation, the lower abdominal region.
  • the transmitter coil 15 is preferably positioned proximate the subject’s xyphoid process and the first receiver coil 16a is positioned proximate the umbilicus, the second receiver coil 16b is positioned proximate the subject’s spine opposite the transmitter coil 15, and the third receiver coil 16c is positioned proximate the subject’s spine opposite the umbilicus.
  • the present invention provides numerous advantages compared to prior art methods and systems for determining respiratory characteristics and respiratory disorders therefrom, and anatomical positions and movement of a subject.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Acoustics & Sound (AREA)
  • Psychology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un système de surveillance de respiration portable ayant une bobine émettrice qui est adaptée pour générer et pour émettre des champs magnétiques CA à fréquences multiples, une pluralité de bobines de réception adaptées pour détecter les forces variables des champs magnétiques CA et générer des signaux de force de champ magnétique CA représentant les déplacements anatomiques d'un sujet surveillé, et au moins un accéléromètre qui est configuré pour détecter et surveiller les positions anatomiques et le mouvement du sujet, et générer et émettre des signaux d'accéléromètre les représentant. Le système de surveillance portable comprend en outre un module électronique qui est adapté pour recevoir les signaux de force de champ magnétique CA et les signaux d'accéléromètre, et déterminer au moins un trouble respiratoire comme une fonction des signaux de force de champ magnétique CA et au moins une position anatomique du sujet comme une fonction des signaux d'accéléromètre.
PCT/US2020/023787 2019-03-25 2020-03-20 Système de surveillance physiologique portable WO2020197978A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2021557317A JP2022527068A (ja) 2019-03-25 2020-03-20 装着可能な生理学的監視システム
EP20776824.3A EP3946045A4 (fr) 2019-03-25 2020-03-20 Système de surveillance physiologique portable
CA3133993A CA3133993A1 (fr) 2019-03-25 2020-03-20 Systeme de surveillance physiologique portable

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US16/363,404 US10993638B2 (en) 2013-04-01 2019-03-25 Wearable monitoring system and methods for determining respiratory and sleep disorders with same
US16/363,404 2019-03-25
US16/419,358 US11191452B2 (en) 2013-04-01 2019-05-22 Wearable physiological monitoring system
US16/419,358 2019-05-22

Publications (1)

Publication Number Publication Date
WO2020197978A1 true WO2020197978A1 (fr) 2020-10-01

Family

ID=72609054

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/023787 WO2020197978A1 (fr) 2019-03-25 2020-03-20 Système de surveillance physiologique portable

Country Status (4)

Country Link
EP (1) EP3946045A4 (fr)
JP (1) JP2022527068A (fr)
CA (1) CA3133993A1 (fr)
WO (1) WO2020197978A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107438774B (zh) * 2015-04-20 2021-08-24 瑞思迈传感器技术有限公司 多传感器射频检测

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2289403A1 (fr) 2009-09-01 2011-03-02 Adidas AG Procédé et système pour la surveillance des caractéristiques de performance physiologique et athlétique d'un sujet
US20120179005A1 (en) 2011-01-07 2012-07-12 Mccool Franklin Dennis Non-invasive method for measuring changes in body position and respiration
US8790273B2 (en) 2008-09-05 2014-07-29 Adidas Noninvasive method and system for measuring pulmonary ventilation
US20140296651A1 (en) * 2013-04-01 2014-10-02 Robert T. Stone System and Method for Monitoring Physiological Characteristics
WO2017184129A1 (fr) * 2016-04-20 2017-10-26 Medical Design Solutions, Inc. Système et procédé de surveillance de la respiration
US20180184735A1 (en) * 2015-08-24 2018-07-05 Gianluigi LONGINOTTI-BUITONI Physiological monitoring garments with enhanced sensor stabilization
US10064570B2 (en) 2013-04-01 2018-09-04 Medical Design Solutions, Inc. Respiration monitoring system and method

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8790273B2 (en) 2008-09-05 2014-07-29 Adidas Noninvasive method and system for measuring pulmonary ventilation
EP2289403A1 (fr) 2009-09-01 2011-03-02 Adidas AG Procédé et système pour la surveillance des caractéristiques de performance physiologique et athlétique d'un sujet
US20120179005A1 (en) 2011-01-07 2012-07-12 Mccool Franklin Dennis Non-invasive method for measuring changes in body position and respiration
US8790274B2 (en) 2011-01-07 2014-07-29 Franklin Dennis McCool Non-invasive method for measuring changes in body position and respiration
US20140296651A1 (en) * 2013-04-01 2014-10-02 Robert T. Stone System and Method for Monitoring Physiological Characteristics
US10064570B2 (en) 2013-04-01 2018-09-04 Medical Design Solutions, Inc. Respiration monitoring system and method
US10314517B2 (en) 2013-04-01 2019-06-11 Medical Design Solutions, Inc. Respiration monitoring system and method
US20180184735A1 (en) * 2015-08-24 2018-07-05 Gianluigi LONGINOTTI-BUITONI Physiological monitoring garments with enhanced sensor stabilization
WO2017184129A1 (fr) * 2016-04-20 2017-10-26 Medical Design Solutions, Inc. Système et procédé de surveillance de la respiration

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3946045A4

Also Published As

Publication number Publication date
CA3133993A1 (fr) 2020-10-01
EP3946045A1 (fr) 2022-02-09
EP3946045A4 (fr) 2022-12-21
JP2022527068A (ja) 2022-05-30

Similar Documents

Publication Publication Date Title
US9826903B2 (en) Multi modal method and system for transmitting information about a subject
JP5841716B2 (ja) 生理学的情報、パフォーマンス情報および状況情報を解釈および分析するための方法およびシステム
US6893404B2 (en) Breathing movement measurements and apparatus
US20150208949A1 (en) Apparatus and method for continuous noninvasive measurement of respiratory function and events
US8790274B2 (en) Non-invasive method for measuring changes in body position and respiration
US20100305466A1 (en) Incentive spirometry and non-contact pain reduction system
US10314517B2 (en) Respiration monitoring system and method
WO2008135985A1 (fr) Suivi, prévision et traitement d'épisodes cliniques
CN113473910A (zh) 睡眠监测系统和方法
US11957449B2 (en) Wearable physiological monitoring system
US11191451B2 (en) Wearable monitoring system and methods for determining respiratory and sleep disorders with same
WO2017184129A1 (fr) Système et procédé de surveillance de la respiration
US10993638B2 (en) Wearable monitoring system and methods for determining respiratory and sleep disorders with same
WO2020197978A1 (fr) Système de surveillance physiologique portable
CA3100475C (fr) Appareil et procede de surveillance d'un patient pendant son sommeil
TWI476723B (zh) 基於腹部肌群機能之個人化腹式呼吸訓練評估方法與其系統
CN104755016B (zh) 用于呼吸率测量的系统和方法
CN219250156U (zh) 一种睡眠监测产品的性能验证装置
Jia Unobtrusive vital sign detection through ambient physical vibrations
WO2022113027A1 (fr) Systèmes et procédés permettant d'identifier une position corporelle d'utilisateur pendant une thérapie respiratoire

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20776824

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 3133993

Country of ref document: CA

ENP Entry into the national phase

Ref document number: 2021557317

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020776824

Country of ref document: EP

Effective date: 20211025