JP7526198B2 - WEARABLE PHYSIOLOGICAL MONITORING SYSTEM AND METHOD FOR OPERATION OF THE MONITORING SYSTEM - Patent application - Google Patents

Description

The present invention relates to systems and methods for monitoring physiological characteristics of a subject. More particularly, the present invention relates to devices, systems, and methods for determining multiple physiological characteristics, in particular the subject's respiratory characteristics and respiratory disorders indicated thereby, as well as the subject's anatomical position and movement.

It is well known in the art that approximately 10% of adults suffer from respiratory disorders. Most respiratory diseases can, and often do, have long-term effects on the cardiovascular system and are therefore considered serious risk factors. Indeed, sympathetic neuromodulation has been found to be closely related to adverse heart rate variability, e.g., cardiac arrhythmias.

The most common respiratory disorders in adults are sleep apnea and hypopnea.

As is well known in the art, sleep apnea is generally classified into three types based on respiratory function. The first type of apnea is obstructive sleep apnea (OSA), which occurs when a subject or patient continuously stops breathing due to an obstruction in the upper airway.

The second type of apnea is central sleep apnea (CEN), which occurs when a subject or patient stops breathing persistently due to an inability to properly regulate their breathing. That is, when the brain temporarily fails to transmit the proper neurological signals to the muscles that control breathing. Unlike obstructive sleep apnea, which is considered a mechanical problem, central sleep apnea is more of a transmission problem.

The third type of apnea is commonly called 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 breathing disorder characterized by very shallow breathing or an abnormally slow respiratory rate; that is, reduced air movement into the lungs, which often leads to low oxygen levels in the blood.

As is well known in the art, various abnormal key respiratory parameters and/or characteristics, such as respiratory frequency (e.g., breaths per minute), tidal volume (V _T ), inspired volume, expired volume, minute ventilation (e.g., inspired volume per minute or expired volume per minute), and/or peak expiratory flow, as well as physiological parameters and/or characteristics, such as oxyhemoglobin saturation and oxygen desaturation index, are indicative of sleep apnea and/or hypopnea.

Accordingly, various systems and methods have been developed to detect one or more respiratory parameters and determine therefrom breathing disorders such as sleep apnea, most of which are based on anatomical displacements and their relationship to one or more of the above-referenced respiratory parameters and characteristics (e.g., respiratory frequency, V _T , and inspired volume, etc.).

A system and method for determining respiratory parameters is described in U.S. Patent 8,790,273 (hereinafter "McCool Patent"). The system disclosed in the McCooll Patent generally includes at least two tuned pairs of electromagnetic (EM) coils (also referred to herein as "magnetometers"), each pair of EM coils comprising a single channel transmitter EM coil adapted to transmit a single specific high frequency AC electromagnetic field (i.e., a transducer) and an EM coil adapted to receive the AC electromagnetic field transmitted by the transmitter EM coil (i.e., a receiver).

The transmitter EM coil of the McCool system is placed in front of the subject, and the receiver EM coil is placed on the subject's back.

The system disclosed in the McCooll patent is configured to determine at least one respiratory parameter or characteristic, in particular tidal volume (V _T ), as a function of a number of anatomical distances, e.g., rib cage-anteroposterior distance and abdomen-anteroposterior distance, which are sensed by synchronized pairs of electromagnetic coils and a number of predefined volumetric motion coefficients.

The main drawbacks and disadvantages associated with the McCoo system and associated methods are the use of a single channel transmitter EM coil, which (i) is limited to one particular AC electromagnetic field frequency, and (ii) is susceptible to interference from external electromagnetic fields that negatively impact the voltage output of the EM coil, thus affecting the consistency of the AC electromagnetic field frequency.

Further drawbacks and disadvantages associated with the McCooI System are that the McCooI System and related methods rely on the use of complex algorithms that cannot quantitatively account for physiological differences between individual subjects. As a result, the McCooI System cannot consistently and accurately determine key physiological parameters and/or characteristics such as tidal volume ( _VT ) and minute ventilation (Vdot).

Another drawback and inconvenience associated with the McCooll system is the large amount of wiring required for it to operate, which can be cumbersome.

Further systems and methods for determining respiratory parameters and associated respiratory disorders are disclosed in Applicant's issued U.S. Patents: 10,064,570 and 10,314,517.

In contrast to the McCooll system, the systems disclosed in U.S. Patents 10,064,570 and 10,314,517 include at least one permanent magnet coupled to at least one magnetometer configured to receive an AC electromagnetic field generated by the permanent magnet. The magnetometer is positioned on the subject's front, adjacent to the xiphoid process, and the permanent magnet is positioned on the subject's back, adjacent to the spine, across the subject's xiphoid process.

The magnetometer of the above-mentioned system is adapted to detect intensity variations of the AC magnetic field emitted by the permanent magnet, which reflect a displacement between the magnetometer and the permanent magnet, i.e., a change in the distance between the magnetometer and the permanent magnet, and thus an axial displacement of the subject's chest wall. The system is then programmed and configured to determine at least one respiratory parameter of the subject as a function of the axial displacement of the subject's chest wall.

A key advantage of the systems disclosed in U.S. Patents 10,064,570 and 10,314,517 is the use of permanent rare earth magnets that can generate AC magnetic fields with substantially higher field strength per unit mass compared to conventional magnetic field transducers.

Further advantages offered by permanent rare earth magnets are that they (i) can provide an AC magnetic field with greater field stability over time compared to conventional magnetic field transducers, and (ii) can be minimized from interference from external electromagnetic fields compared to conventional magnetic field transducers. The systems disclosed in U.S. Patents 10,064,570 and 10,314,517 can thus measure multiple respiratory parameters associated with a user or wearer with high accuracy while minimizing interference from external sources such as electromagnetic radiation.

Furthermore, because permanent rare earth magnets do not require an external power source or control module to generate the AC magnetic field, the systems disclosed in U.S. Patents 10,064,570 and 10,314,517 require substantially less wiring and power to operate as compared to conventional systems such as the system disclosed by McCooll.

The systems disclosed in U.S. Patents 10,064,570 and 10,314,517 can be readily used to accurately determine multiple respiratory parameters in real time and to determine disordered breathing, and in particular, apnea and hypopnea therefrom. However, it would be desirable to provide an improved system that increases the accuracy of respiratory and physiological parameter detection, thereby determining disordered breathing.

It is also well known in the art that the anatomical position of a subject while sleeping can, and often does, induce adverse effects in the subject, such as gastrointestinal reflux, or exacerbate a pre-existing condition in the subject, such as sleep apnea.

Currently, there are few devices and/or systems available that are configured to accurately monitor the anatomical position and movements of a sleeping subject.

Therefore, there is a need to provide an improved physiological monitoring system that accurately detects and measures respiratory parameters and/or characteristics in real time based on anatomical displacements of a monitored subject.

There is also a need to provide devices and systems that can accurately detect and monitor the anatomical position and movement of a subject while sleeping.

It is therefore an object of the present invention to provide a wearable physiological monitoring system that accurately detects and measures respiratory parameters and/or characteristics in real time based on anatomical displacements of a monitored subject.

Another object of the present invention is to provide a wearable physiological monitoring system that accurately detects and measures respiratory and physiological parameters and characteristics in real time based on anatomical displacements of the monitored subject.

Another object of the present invention is to provide a wearable physiological monitoring system that accurately determines a subject's anatomical location.

Another object of the present invention is to provide an improved method for determining disordered breathing based on detected respiratory and/or physiological parameters and/or characteristics.

Another object of the present invention is to provide an improved method for determining sleep apnea and/or hypopnea based on detected abnormal breathing and/or physiological parameters and/or characteristics.

The present invention is directed to a wearable physiological monitoring system and improved methods for (i) determining breathing and/or sleep disorders based on measured anatomical displacements and measured physiological parameters and/or characteristics, and (ii) determining a subject's anatomical position and movement.

In a preferred embodiment of the present invention, the wearable physiological monitoring system includes a wearable garment configured to cover at least the chest and upper back of the subject (or user).

The wearable physiological monitoring system has a respiratory parameter monitoring subsystem and electronic components, i.e. a control processing module and associated integrated signaling means.

In some embodiments of the present invention, the wearable physiological monitoring system further comprises a physiological parameter monitoring subsystem.

In a preferred embodiment of the present invention, the respiratory parameter monitoring subsystem includes at least one transmitter coil and multiple receiver coils.

In some embodiments of the present invention, the physiological parameter monitoring subsystem further comprises an accelerometer configured and arranged to determine at least one anatomical position of the subject and to monitor physical movement of the subject.

In a preferred embodiment of the present invention, the electronic module comprises a multi-channel module that is programmed and configured (i.e., comprises a program, parameters, instructions, and at least one algorithm) to control the physiological monitoring system.

In some embodiments of the invention, the electronic module is preferably programmed and configured to: (i) receive the AC magnetic field strength signals generated and transmitted by the receiver coils; (ii) identify the frequency of each of the associated AC magnetic field strength signals; (iii) determine the ID of the receiver coil based on the frequency of the AC magnetic field strength signals; (iv) determine at least one respiratory parameter, more preferably multiple 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 parameters and the determined values.

In some embodiments of the invention, the electronics module is further programmed and configured to: (i) receive at least one respiratory parameter signal representative of 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 determined as a function of the AC magnetic field strength signal.

In some embodiments, the electronics module is further programmed and configured to receive and process physiological parameter signals representative of the subject's physiological parameter values generated and transmitted by the physiological parameter monitoring subsystem (i.e., its physiological parameter sensors).

In some embodiments of the invention, the electronic module is preferably programmed and configured to: (i) receive the AC magnetic field strength signal transmitted by the receiver coil and the physiological parameter signal transmitted by the physiological parameter sensor; (ii) identify the frequency of each of the AC magnetic field strength signals; (iii) determine the ID of the receiver coil based on the frequency of the AC magnetic field strength signal; (iv) determine at least one respiratory parameter, more preferably multiple respiratory parameters, associated with the monitored subject as a function of the AC magnetic field strength signal; (v) determine at least one respiratory parameter value as a function of the AC magnetic field strength signal; and (vi) determine at least one respiratory disorder as a function of the physiological parameter value, the respiratory parameter determined as a function of the AC magnetic field strength signal and its value.

In some embodiments, the electronic module is further programmed and configured to: (i) receive accelerometer signals representative of the monitored anatomical position and movement data generated and transmitted by the accelerometer; and (ii) determine at least one respiratory disorder as a function of pre-measured baseline respiratory parameter values, physiological parameter values, the accelerometer data, and respiratory parameters and their values determined as a function of the AC magnetic field strength signal.

In some embodiments, the electronics module is further programmed and configured to determine at least one anatomical location of the monitored subject as a function of the accelerometer data.

In some embodiments of the invention, the electronics module is also programmed and configured to generate and transmit at least one anatomical position alert signal as a function of (or in response to) the subject's determined anatomical position and a pre-determined anatomical position (e.g., upright, semi-upright, left lateral, right lateral, supine, or prone position).

In a preferred embodiment, the anatomical location warning signal triggers an excitation or warning event configured to prompt the subject to move to an alternative position that is less likely to exacerbate and/or induce symptoms of the subject's existing breathing or sleep disorder (e.g., obstructive sleep apnea or gastroesophageal reflux disease).

In some embodiments of the present invention, the physiological monitoring system further comprises a vibration device configured to receive the anatomical location alert signal and generate vibrations at a predetermined frequency in response to the anatomical location alert signal.

In some embodiments of the present invention, the physiological monitoring system further comprises an integrated audio device configured to receive the anatomical location alert signal and generate an audible signal at a predetermined amplitude in response to the anatomical location alert signal.

In some embodiments of the invention, the physiological monitoring system further comprises a remote audio device configured to receive the anatomical location alert signal and generate an audible signal at a predetermined amplitude in response to the anatomical location alert signal.

In some embodiments of the invention, a method for determining a breathing disorder and an anatomical location of a subject generally includes:
(i) providing a wearable physiological monitoring system of the present invention;
(ii) placing the wearable physiological monitoring system on a subject;
(iii) initiating the wearable physiological monitoring system, wherein an AC magnetic field including a predetermined frequency is generated and transmitted by a transmitter coil;
(iv) detecting and measuring the strength of the AC magnetic field with a receiver coil;
(v) generating an AC magnetic field strength signal representative of the AC magnetic field strength measured at the receiver coil;
(vi) measuring accelerometer data with a system accelerometer and generating an accelerometer signal representative of the accelerometer data;
(vii) transmitting the AC magnetic field strength signal and the accelerometer signal to an electronic module;
(viii) determining at least one anatomical displacement of the subject as a function of the AC magnetic field strength signal;
(ix) determining at least one respiratory parameter of the subject as a function of the determined anatomical displacement;
(x) determining a respiratory parameter quantity as a function of the AC magnetic field strength signal;
(xi) determining at least one disordered breathing as a function of the determined respiratory parameter and its value;
(xii) determining at least one anatomical position of the subject as a function of the accelerometer signal.

Further features and advantages will become apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings, in which like reference characters generally refer to the same parts or elements throughout the drawings:

FIG. 1 is a schematic diagram of one embodiment of a physiological monitoring system in accordance with the present invention;

1 is a schematic diagram of another embodiment of a physiological monitoring system according to the present invention;

FIG. 2 is a schematic diagram of yet another embodiment of a physiological monitoring system according to the present invention;

FIG. 1 is a perspective view of one embodiment of a wearable physiological monitoring system positioned on a subject, showing the location of a transmitter coil proximate the xiphoid process and one receiver coil proximate the navel, in accordance with the present invention;

1 is a side view of a subject showing the location of a transmitter coil and three receiver coils in a wearable physiological monitoring system and their locations on the subject, according to one embodiment of the present invention.

Before describing the invention in detail, it is to be understood that the invention is not limited to the particularly exemplified devices, systems, structures, or methods, as such may, of course, vary. Thus, although many devices, systems, and methods similar or equivalent to those described herein can be used in the practice of the invention, the preferred devices, systems, structures, and methods are described herein.

It should also be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

Furthermore, all publications, patents, and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety.

In this specification and claims, the singular includes the plural unless the context clearly dictates otherwise. For example, an "alternating magnetic field strength signal" includes two or more such signals.

Additionally, ranges may 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, it is understood that the particular value forms another embodiment by the use of the antecedent "about" or "approximately." The beginning and end points of a range each have a significant meaning in relation to the other point (the end point and the beginning point) and independently of the other point.

It is also understood that there are multiple values disclosed herein, and that each value, in addition to the value itself, is also disclosed as "about" or "approximately" the particular value. For example, if the value "10" is disclosed, then "approximately 10" is also disclosed. It is also understood that if a value is disclosed as "less than or equal to the value," then "greater than or equal to the value" and possible ranges between the values are also disclosed, as would be well understood by one of ordinary skill in the art. For example, if the value "10" is disclosed, then "less than or equal to 10" as well as "greater than or equal to 10" are also disclosed.

<Definition>
The terms "respiratory parameters,""respiratorycharacteristics," and "respiratory parameters" are used interchangeably herein and refer to and include characteristics related to the respiratory system and its function, including, but not limited to, respiratory frequency, tidal volume, inspired volume, expired volume, minute ventilation, inspired breathing time, expired breathing time, and flow rate (e.g., rate of change of chest wall volume).

The terms "respiratory parameters," "respiratory characteristics," and "respiratory parameters" further mean and encompass parameters related to ventilation mechanics from synchronous or asynchronous movement of the chest wall compartments.

As used herein, the terms "physiological parameters" and "physiological characteristics" mean, but are not limited to, cardiac electrical activity, other muscular electrical activity, brain electrical activity, pulse rate, blood pressure, blood oxygen saturation level, skin temperature, and core temperature.

As used herein, the term "apnea" means and includes abnormal breathing, as defined herein, of a subject characterized by at least one respiratory parameter and/or physiological characteristic.

Thus, the term "apnea" means and encompasses, but is not limited to, abnormal breathing characterized by the following: respiratory frequency or rate (f) (e.g., breaths per minute), tidal volume ( _VT ), inspired volume, expired volume, respiratory minute ventilation (e.g., inspired volume per minute or expired volume per minute), and/or peak expiratory flow rate.

The term "apnea" thus refers to and encompasses the inability of a subject to properly regulate breathing.

The term "apnea" also means and includes, but is not limited to, obstruction of a subject's upper airway.

The term "apnea" means and includes, but is not limited to, abnormal breathing characterized by the following: vital blood oxygen parameters and/or blood oxygen characteristics, such as a subject's oxyhemoglobin saturation and oxygen desaturation index, e.g., oxyhemoglobin desaturation events per hour.

The term "apnea" therefore refers to, but is not limited to, a decrease in a subject's oxyhemoglobin saturation level by 5% or more below the subject's normal oxyhemoglobin saturation level.

The term "apnea" also means and includes, but is not limited to, anti-correlated contractions and expansions of the subject's thoracic and abdominal regions during at least one respiratory cycle, i.e., expansions and contractions of the subject's thoracic and abdominal cavities are ∼180° out of phase.

The term "apnea" means and includes central sleep apnea and obstructive sleep apnea.

The term "apnea" means and includes, but is not limited to, complex or mixed sleep apnea, i.e., a combination of central and obstructive sleep apnea.

As used herein, the term "apnea event" means and includes, but is not limited to, a cessation of a subject's breathing for 10 seconds or more accompanied by a decrease in the subject's minute ventilation of 30% or more of the subject's normal minute ventilation and/or a decrease in oxyhemoglobin saturation.

As used herein in relation to "apnea," the term "normal breathing" means and includes, but is not limited to, a "normal" or "healthy" Apnea/Hypopnea Index (AHI), i.e., an AHI score of ≦5 apnea events per hour of sleep for the subject. An apnea event is defined as (i) a decrease in the subject's minute ventilation of 30% or more of the subject's average normal minute ventilation, and/or (ii) a cessation of the subject's breathing for 10 seconds or more accompanied by a decrease in oxyhemoglobin saturation.

As used herein, the term "abnormal breathing" means and includes, but is not limited to, the cessation of a subject's breathing for 10 seconds or more accompanied by a drop in oxyhemoglobin saturation (or oxygen saturation).

The term "abnormal breathing" further means and includes, but is not limited to, a decrease in ventilation of ≥ 30% of the subject's average normal ventilation.

The term "abnormal breathing" further means and includes, but is not limited to, a decrease in a subject's minute ventilation (V-dot) of 30% or more of the subject's average normal minute ventilation.

The term "abnormal breathing" further means and includes, but is not limited to, a "mild" Apnea/Hypopnea Index (AHI) score in the range of 5-15 apnea events per hour of the subject's sleep. An apnea event is defined as (i) a decrease in the subject's minute ventilation of ≥ 30% of the mean normal minute ventilation and/or (ii) a cessation of the subject's breathing for ≥ 10 seconds accompanied by a decrease in oxyhemoglobin saturation.

The term "abnormal breathing" further means and includes, but is not limited to, a "moderate" Apnea/Hypopnea Index (AHI) score in the range of 15-30 events per hour of the subject's sleep. An apnea event is defined as (i) a decrease in the subject's minute ventilation of ≥ 30% of the mean normal minute ventilation and/or (ii) a cessation of the subject's breathing for ≥ 10 seconds accompanied by a decrease in oxyhemoglobin saturation.

The term "abnormal breathing" further means and includes, but is not limited to, "severe" apnea/hypopnea index (AHI) ≧30 events per hour of the subject's sleep. An apnea event is defined as (i) a decrease in the subject's minute ventilation of ≧30% of the subject's normal minute ventilation, and/or (ii) a cessation of the subject's breathing for at least 10 seconds with a concomitant decrease in oxyhemoglobin saturation.

The term "abnormal breath" further means and encompasses, but is not limited to, a reduction in a subject's expiratory volume (V _T ) in the range of about 5-30% of the subject's average normal V _T .

The terms "sleep disorder" and "disordered breathing" are used interchangeably herein and refer to, but are not limited to, apnea, sleep apnea, hypopnea, and abnormal breathing.

As used herein in connection with "apnea" and "sleep apnea," the term "resting position" means and includes minimal and/or no physical activity or movement, other than that associated with normal breathing.

The terms "patient" and "subject" are used interchangeably herein and include warm-blooded mammals, humans and primates; birds; pets or farm animals, such as cats, dogs, sheep, goats, cows, 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 refer to and include the wearer or user of the respiratory parameter monitoring system or respiratory-physiological parameter monitoring system of the present invention.

The term "comprise" and its variations, such as "comprising" and "comprises," mean "including, but not limited to," and are not intended to exclude, for example, other additives, ingredients, integers, or steps.

The following disclosure is provided to further explain in an enabling manner the best mode of carrying out one or more embodiments of the present invention. The disclosure is not provided to limit the invention in any manner, but is further provided to enhance an understanding of the principles of the present invention and its advantages. The present invention is defined solely by the appended claims, including any amendments made during the pendency of this application and all equivalents of the claims as patented.

The physiological monitoring system and associated methods for determining respiratory and physiological parameters, respiratory disorders based thereon, and anatomical location and movement of a subject are described herein in the context of determining respiratory and physiological parameters, respiratory and sleep disorders based thereon, and anatomical location and movement of a human subject, although it will be understood that the invention is not limited to such use. Indeed, the physiological monitoring system and associated methods can readily be used to determine respiratory and physiological parameters, respiratory and sleep disorders based thereon, and anatomical location and movement of other mammalian bodies.

The physiological monitoring systems and related methods of the present invention can be used in non-medical contexts, such as to determine the volume and/or volume change of an expandable bladder used to contain liquids and/or gases.

As discussed above, the present invention is directed to a physiological monitoring system and improved method for determining: (i) a subject's breathing and sleep disorders based on measured variations in AC magnetic field strength detected and measured by a plurality of receiver coils as a function of distance between each receiver coil and at least one magnetic field source, i.e., a transmitter coil, and anatomical displacements therefrom, and, in some embodiments, physiological parameters and/or characteristics, as well as accelerometer data, and/or (ii) the subject's anatomical position and movement.

As discussed in more detail below, in a preferred embodiment, the monitoring system of the present invention comprises a wearable garment configured to cover at least the chest and upper back of a wearer (or user).

In some embodiments, the monitoring system includes a respiratory parameter monitoring subsystem, an electronics (i.e., control and processing) module, and associated integrated signaling means.

In some embodiments, the monitoring system also includes a respiratory parameter monitoring subsystem, a physiological parameter monitoring subsystem, an electronics module, and associated integrated signaling means.

In some embodiments of the present invention, the respiratory parameter monitoring subsystem comprises at least one permanent magnet and at least one magnetometer, as disclosed in applicant's co-pending U.S. patent application Ser. No. 16/363,290, the entirety of which is incorporated herein by reference.

In a preferred embodiment of the present invention, the respiratory parameter monitoring subsystem comprises at least one transmitter coil and multiple receiver coils, as disclosed in applicant's co-pending U.S. patent application Ser. No. 16/363,404, which is incorporated herein by reference in its entirety.

In accordance with the present invention, the respiratory parameter monitoring subsystem can include two transmitter coils. In one embodiment, one transmitter coil is positioned near the xiphoid process and another transmitter coil is positioned near the navel, as described in more detail below.

In a preferred embodiment of the present invention, the respiratory parameter monitoring subsystem includes three receiver coils. However, in accordance with the present invention, the respiratory parameter monitoring subsystem may include more or less than three receiver coils.

In a preferred embodiment of the present invention, the transmitter coil is configured to generate and transmit electromagnetic radiation, e.g., AC magnetic fields, in three dimensions at multiple non-harmonic frequencies.

In a preferred embodiment, the non-harmonic frequencies are less than 10 KHz.

In some embodiments, the non-harmonic frequencies are less than 5 KHz.

In some embodiments, the non-harmonic frequencies are in the range of about 5-10 KHz.

In accordance with the present invention, a transmitter coil may comprise any device or system configured to generate and transmit electromagnetic radiation at multiple frequencies.

In a preferred embodiment, the receiver coil is configured and positioned to detect and measure the magnetic field strength in at least one field dimension of at least one AC magnetic field at a prescribed frequency and generate at least one AC magnetic field strength signal representative of the magnetic field strength in the detected field dimension of the AC magnetic field, thereby generating an anatomical displacement of the monitored subject.

More preferably, the receiver coil is configured and positioned to detect and measure the magnetic field strength in multiple magnetic field dimensions of at least one AC magnetic field at a prescribed frequency and generate multiple AC magnetic field strength signals representative of the magnetic field strength in the magnetic field dimensions of the AC magnetic field, thereby generating an anatomical displacement of the monitored subject.

In accordance with the present invention, the receiver coil may comprise any device or system, such as a magnetometer or Hall effect sensor, configured to detect and measure the magnetic field strength in an AC magnetic field at a defined frequency and generate at least one AC magnetic field strength signal representative of the measured magnetic field strength in the AC magnetic field.

In a preferred embodiment of the invention, the transmitter coil is positioned at a first anatomical location adjacent the subject's xiphoid process, the first receiver coil is positioned at a second anatomical location adjacent the navel, the second receiver coil is positioned at a third anatomical location adjacent the subject's spine opposite the transmitter coil, and the third receiver coil is positioned at a fourth anatomical location adjacent the subject's spine opposite the navel.

Other receiver coil arrangements on the subject may be employed according to the present invention.

As an example, in some embodiments of the invention, a transmitter coil is positioned adjacent to the subject's navel, a first receiver coil is positioned adjacent to the subject's spine opposite the transmitter coil, a second receiver coil is positioned adjacent to the subject's xiphoid process, and a third receiver coil is positioned adjacent to the subject's spine opposite the xiphoid process.

In some embodiments of the invention, a transmitter coil is positioned adjacent to the subject's spine and facing the xiphoid process, a first receiver coil is positioned adjacent to the xiphoid process, a second receiver coil is positioned adjacent to the subject's navel, and a third receiver coil is positioned adjacent to the subject's spine and facing the navel.

In a preferred embodiment of the present invention, the physiological parameter monitoring subsystem comprises at least one physiological parameter sensor configured to: (i) detect and measure a physiological parameter and preferably a value thereof, and (ii) generate a physiological parameter signal representative of the measured physiological parameter and preferably a value thereof.

In some embodiments, the physiological parameter monitoring sensor includes an _SpO2 sensor.

In some embodiments, the physiological parameter monitoring sensor includes a body temperature sensor.

In some embodiments of the present invention, the physiological parameter monitoring subsystem further comprises at least one accelerometer configured and positioned to: (i) detect the anatomical location of the monitored subject, and (ii) monitor the subject's physical movement.

In some embodiments, the accelerometer comprises a conventional three-axis accelerometer configured to detect at least one accelerometer parameter in the X, Y and/or Z directions.

In accordance with the present invention, the accelerometer is configured to generate and transmit at least one accelerometer signal representative of accelerometer data, which includes at least one accelerometer parameter representative of an anatomical position of the subject.

In a preferred embodiment, the accelerometer is configured and arranged to generate a plurality of accelerometer signals that are processed and used to determine at least one anatomical position of the subject, i.e., whether the subject is in an upright, semi-upright, left lateral, right lateral, supine, or prone position.

As noted above, in a preferred embodiment, the electronics module comprises a multi-channel module that is programmed and configured (i.e., comprises a program, parameters, instructions, and at least one algorithm) to control the monitoring system of the present invention.

In some embodiments of the invention, the electronic module is preferably programmed and configured to: (i) receive the AC magnetic field strength signals generated and transmitted by the receiver coils; (ii) identify the frequency of each of the associated AC magnetic field strength signals; (iii) determine the ID of the receiver coil based on the frequency of the AC magnetic field strength signals, thereby determining the location of the receiver coil; (iv) determine at least one respiratory parameter, and more preferably multiple 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 parameters and the determined values.

In some embodiments of the invention, the electronics module is further programmed and configured to: (i) receive at least one respiratory parameter signal representative of 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 its value determined as a function of the AC magnetic field strength signal.

In some embodiments of the invention, the electronic module is further programmed and configured to receive and process physiological parameter signals representative of the subject's physiological parameter values generated and transmitted by the physiological parameter monitoring subsystem (i.e., its physiological parameter sensors).

Thus, in some embodiments, the electronic module is preferably programmed and configured to: (i) receive the AC magnetic field strength signal transmitted by the receiver coil and the physiological parameter signal transmitted by the physiological parameter sensor; (ii) identify the frequency of each of the AC magnetic field strength signals; (iii) determine an ID of the receiver coil based on the frequency of the AC magnetic field strength signal; (iv) determine at least one respiratory parameter, more preferably multiple respiratory parameters, associated with the monitored subject as a function of the AC magnetic field strength signal; (v) determine at least one respiratory parameter value as a function of the AC magnetic field strength signal; and (vi) determine at least one respiratory disorder as a function of the physiological parameter value and as a function of the respiratory parameter and its value determined as a function of the AC magnetic field strength signal.

In some embodiments, the electronic module is further programmed and configured to: (i) receive accelerometer signals representative of the monitored anatomical position and movement data generated and transmitted by the accelerometer; and (ii) determine at least one respiratory disorder as a function of pre-measured baseline respiratory parameter values, physiological parameter values, the accelerometer data, and respiratory parameters and their values determined as a function of the AC magnetic field strength signal.

In some embodiments of the invention, the electronic module is also programmed to determine a physiological parameter value as a function of the physiological parameter signal.

In some embodiments of the invention, the electronics module is also programmed and configured to generate and transmit at least one disordered breathing warning signal as a function of (or in response to) predetermined respiratory parameter thresholds and/or physiological parameter thresholds.

In some embodiments, the electronics module is further programmed and configured to generate and transmit at least one anatomical location alert signal as a function of (or in response to) the determined anatomical location of the subject and the predetermined anatomical location of the subject.

In a preferred embodiment of the present invention, the monitoring system further comprises at least one excitation device, such as a vibration, audio, or lighting device, that generates or provides at least one excitation event (e.g., vibration) in response to the respiratory disorder alert signal and/or the anatomical location alert signal.

Thus, in some embodiments of the invention, the monitoring system further comprises a vibration device configured to receive the breathing disorder warning signal and/or the anatomical location warning signal and to generate vibrations at one or more predetermined frequencies in response to the breathing disorder warning signal and/or the anatomical location warning signal.

In accordance with the present invention, vibration devices include a variety of conventional vibration devices, including, but not limited to, piezoelectric vibrators, eccentric cam motors, and electromagnetic (EM) vibrators.

In a preferred embodiment of the present invention, the vibration device is capable of generating vibrations having a frequency in the range of approximately 5 to 50 Hz.

In some embodiments, the vibration device is configured to generate multiple vibrations in a series of random or sequential pulses at intervals ranging from 1 to 30 seconds, more preferably at intervals ranging from 1 to 3 seconds.

In some embodiments of the invention, the monitoring system further comprises a remote vibration device configured to receive the disordered breathing warning signal and/or the anatomical location warning signal and generate the vibrations referenced above in response to the disordered breathing warning signal and/or the anatomical location warning signal.

In accordance with the present invention, the remote vibration device can comprise a variety of conventional vibration devices, including, but not limited to, piezoelectric vibrators, eccentric cam motors, and electromagnetic (EM) vibrators.

In a preferred embodiment of the present invention, the remote vibration device is capable of vibrating at a frequency in the range of approximately 5 to 50 cycles per second (Hz).

In some embodiments, the remote vibration device is similarly configured to generate multiple vibrations in a series of random or sequential pulses at intervals ranging from 1 to 30 seconds, more preferably at intervals ranging from 1 to 3 seconds.

In accordance with the present invention, a surveillance system may include multiple vibration devices configured to generate and transmit the same or different vibrations.

In some embodiments, the monitoring system includes a vibration device connected to the subject's bed, such as a bed frame or mattress, or a chair.

In some embodiments of the present invention, the monitoring system further comprises an integrated audio device configured to receive the disordered breathing warning signal and/or the anatomical location warning signal and to generate an audible signal at a predetermined amplitude in response to the disordered breathing warning signal and/or the anatomical location warning signal.

In accordance with the present invention, the integrated audio system can include a variety of conventional audio devices, including, but not limited to, piezoelectric audio devices and electromagnetic audio devices (e.g., speakers).

In a preferred embodiment of the present invention, the audio device is capable of providing an audible signal having an amplitude in the range of approximately 70-90 dB.

In a preferred embodiment of the present invention, the audio device is capable of generating an acoustic signal having a frequency in the range of approximately 300-1200 Hz.

In some embodiments of the invention, the monitoring system further comprises a remote audio device configured to receive the disordered breathing warning signal and/or the anatomical location warning signal and to generate an audible signal at a predetermined amplitude in response to the disordered breathing warning signal and/or the anatomical location warning signal.

In accordance with the present invention, the remote audio devices may also comprise a variety of conventional audio devices, including, but not limited to, piezoelectric audio devices and electromagnetic audio devices (e.g., speakers).

In a preferred embodiment of the present invention, the remote audio device is capable of generating and transmitting an audible signal having an amplitude in the range of approximately 70-110 dB.

In a preferred embodiment of the present invention, the remote audio device is capable of generating and transmitting an acoustic signal having a frequency in the range of approximately 300-1200 Hz.

In some embodiments of the invention, the monitoring system further comprises a remote illumination device configured to receive the disordered breathing warning signal and/or the anatomical location warning signal and generate a light emission signal in response to the disordered breathing warning signal and/or the anatomical location warning signal.

In accordance with the present invention, the remote lighting device may comprise any conventional device configured to generate light, such as a lamp or any local light source.

In some embodiments of the present invention, the electronic module of the monitoring system is also programmed and configured to transmit a pre-programmed verbal notification or alert in response to the respiratory disorder alert signal and/or the anatomical location alert signal.

In some embodiments of the present invention, the electronics module is programmed and configured to transmit a pre-programmed disordered breathing verbal alert to an emergency contact or entity via a wireless link.

As an example, in some embodiments, the electronics module is programmed to send a pre-programmed disordered breathing verbal alert to an emergency contact via a pre-programmed phone number.

In some embodiments, the electronics module is programmed to transmit a pre-programmed disordered breathing verbal alert to emergency services (e.g., police or fire department) via a pre-programmed emergency services telephone number (e.g., "911").

In a preferred embodiment of the present invention, the electronics module is programmed and configured to provide multiple disordered breathing and/or anatomical location warning signals that induce multiple levels of excitation or warning events (i.e., vibration device signals at different frequencies, audible signals at different amplitudes, verbal alerts to emergency contacts and/or services, combinations thereof) as a function of (or in response to) the disordered breathing and/or anatomical location warning signals.

With reference to Table 1, one embodiment of a single-level sleep disorder warning system of the present invention is shown. As shown in Table 1, the single-level disordered breathing warning system preferably includes at least one respiratory-physiological parameter threshold and at least one excitation event associated therewith.

With reference to Table 2, one embodiment of a two-level respiratory disorder warning system is shown. As shown in Table 2, the two-level respiratory disorder warning system preferably includes a plurality of respiratory-physiological parameter thresholds and at least one excitation event associated therewith.

Referring now to Table 3, one embodiment of a three-level respiratory disorder warning system is shown. As shown in Table 3, the three-level sleep disorder warning system similarly preferably includes a plurality of respiratory-physiological parameter thresholds and at least one excitation event associated therewith.

As described above, in a preferred embodiment, the accelerometer is configured and arranged to: (i) detect and monitor the anatomical position and movement of the monitored subject, and (ii) generate a plurality of accelerometer signals that are processed and used by the electronic module to determine the anatomical position of the subject.

Also, as described above, in some embodiments, the electronic module is also programmed and configured to generate and transmit at least one anatomical location alert signal as a function (or in response) of the determined anatomical location and the predetermined anatomical location of the subject.

In a preferred embodiment of the present invention, the predetermined and determined anatomical positions include at least semi-upright, left lateral, right lateral, supine, and prone.

In a preferred embodiment, the anatomical location warning signal induces an excitation or warning event configured to prompt the subject to relocate to another anatomical location that is less likely to exacerbate and/or induce symptoms of the subject's existing breathing or sleep disorder (e.g., obstructive sleep apnea or gastroesophageal reflux disease).

With reference to Table 4, one embodiment of a single level anatomical location alert system of the present invention is shown. As shown in Table 4, the single level anatomical location alert system preferably includes at least one undesirable anatomical location or condition and at least one excitation event associated therewith.

Referring to Table 5, another embodiment of the single level anatomical location alert system of the present invention is shown. The illustrated embodiment also includes at least one undesirable anatomical location or condition and at least one excitation event associated therewith.

See Table 6. Another embodiment of the single level anatomical location alert system of the present invention is shown.

Thus, in a preferred embodiment of the present invention, the anatomical position alert system is configured to train the subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or induce symptoms of the subject's existing breathing or sleep disorder.

In some embodiments of the present invention, the anatomical position alert system is specifically configured to continuously train a subject suffering from obstructive sleep apnea to maintain a left or right lateral anatomical position during sleep.

In some embodiments, the anatomical position alert system is specifically configured to continuously train a subject suffering from gastroesophageal reflux disease to maintain a left lateral anatomical position during sleep.

In accordance with the present invention, the anatomical position alert system can be configured to train a subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or induce symptoms of any pre-existing disorder or disease in the subject.

In some embodiments of the present invention, the electronic module is further programmed and configured to continuously monitor the frequency of the subject's anatomical location transition events.

In some embodiments, the electronics module is also programmed and configured to determine sleep parameters (e.g., total sleep time (TST), sleep efficiency (SE), and wake after sleep (WASO)) as a function of the acquired accelerometer data and the determined respiratory parameter values.

Thus, as described in detail in priority U.S. patent application Ser. No. 16/363,404, in one embodiment of the present invention, a monitoring system generally includes a wearable garment configured to be removably placed on a subject, the subject including thoracic and abdominal regions, the spine, the navel, and the xiphoid process of the sternum, the wearable garment covering at least the thoracic and abdominal regions of the subject when the wearable garment is placed on the subject;
the wearable garment comprises a respiratory parameter monitoring subsystem and an electronic module in communication therewith;
the respiratory parameter monitoring subsystem comprises a transmitter coil and first, second and third receiver coils;
the transmitter coil and the first, second and third receiver coils are disposed on a wearable garment such that, when the wearable garment is disposed on the subject, the transmitter coil is disposed proximate to the subject's xiphoid process, the first receiver coil is disposed in a first anatomical region of the subject proximate to the subject's navel at a first receiver coil distance from the transmitter coil, the second receiver coil is disposed in a second anatomical region opposite the subject's xiphoid process proximate to the subject's spine at a second receiver coil distance from the transmitter coil, and the third magnetometer is disposed in a third anatomical region of the subject proximate to the subject's navel at a third receiver coil distance from the transmitter coil;
the transmitter coils are configured to generate a first alternating magnetic field in the first, second and third magnetic field dimensions, a second alternating magnetic field in the fourth, fifth and sixth magnetic field dimensions, and a third alternating magnetic field in the seventh, eighth and ninth magnetic field dimensions;
the first, second, and third field dimensions of the first AC magnetic field have a first magnetic field frequency, the fourth, fifth, and sixth field dimensions of the second AC magnetic field have a second magnetic field frequency, and the seventh, eighth, and ninth field dimensions of the third AC magnetic field have a third magnetic field frequency;
a first field dimension of the first AC magnetic field has a first variable magnitude as a function of a first distance of the first receiver coil from the transmitter coil, a second field dimension of the first AC magnetic field has a second variable magnitude as a function of a second distance of the first receiver coil from the transmitter coil, and a third field dimension of the first AC magnetic field has a third variable magnitude as a function of a third distance of the first receiver coil from the transmitter coil;
a fourth field dimension of the second AC magnetic field having a fourth variable field strength as a function of a fourth distance of the second receiver coil from the transmitter coil, a fifth field dimension of the second AC magnetic field having a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil, and a sixth field dimension of the second AC magnetic field having a sixth variable field strength as a function of a sixth distance of the second receiver coil from the transmitter coil;
a seventh field dimension of the third AC magnetic field having a seventh variable field strength as a function of a seventh distance from the transmitter coil, an eighth field dimension of the third AC magnetic field having an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil, and a ninth field dimension of the third AC magnetic field having 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 is configured to detect and measure first, second, and third variable magnetic field strengths of first, second, and third magnetic field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representative of the first variable magnetic field strength of the first magnetic field dimension of the first AC magnetic field, a second AC magnetic field strength signal representative of the second variable magnetic field strength of the second magnetic field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representative of the third variable magnetic field strength of the third magnetic field dimension of the first AC magnetic field, and configured to transmit the first, second, and third AC magnetic field strength signals to the electronic module;
the second receiver coil is configured to detect and measure fourth, fifth, and sixth variable magnetic field strengths of fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representative of a fourth variable magnetic field strength of the fourth magnetic field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representative of a fifth variable magnetic field strength of the fifth magnetic field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representative of a sixth variable magnetic field strength of the sixth magnetic field dimension of the second AC magnetic field, and configured to transmit the fourth, fifth, and sixth AC magnetic field strength signals to the electronic module;
the third receiver coil is configured to detect and measure seventh, eighth, and ninth variable magnetic field strengths of seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representative of the seventh variable magnetic field strength of the seventh magnetic field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representative of the eighth variable magnetic field strength of the eighth magnetic field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representative of the ninth variable magnetic field strength of the ninth magnetic field dimension of the third AC magnetic field, and to transmit the seventh, eighth, and ninth AC magnetic field strength signals to the electronic module;
the electronics module is configured to receive the first, second and third AC magnetic field strength signals transmitted by the first receiver coil, configured to receive the fourth, fifth and sixth AC magnetic field strength signals transmitted by the second receiver coil, and configured to receive the seventh, eighth and ninth AC magnetic field strength signals transmitted by the third receiver coil;
the electronic module comprises a processing system 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 is further programmed and configured to determine a value of 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 is further programmed and configured to determine a value of 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 is further programmed and configured to determine at least one disordered breathing of the subject as a function of the determined at least one respiratory parameter and its determined value.

In some embodiments of the invention in which baseline respiratory parameter values are pre-measured, the processing system is further programmed and configured to determine at least one breathing or sleep disorder of the subject as a function of the pre-measured baseline respiratory parameter values and the determined at least one respiratory parameter and its value.

In a preferred embodiment of the present invention, 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, and the transmitter coil and the third receiver coil are in a third axial alignment.

As described in detail in priority U.S. patent application Ser. No. 16/363,404, in another embodiment of the present invention, the monitoring system also includes a wearable garment configured to be removably placed on a subject, the subject having a spine, an umbilicus, and a xiphoid process of a sternum, the wearable garment covering at least a thoracic and abdominal region of the subject when the wearable garment is placed on the subject;
the wearable garment comprises a respiratory parameter monitoring subsystem, a physiological parameter subsystem, and an electronic module;
the respiratory parameter monitoring subsystem includes a transmitter coil and first, second, and third receiver coils;
the physiological parameter subsystem comprises at least one physiological parameter sensor;
the transmitter coil and the first, second, and third receiver coils are disposed on a wearable garment such that, when the wearable garment is disposed on the subject, the transmitter coil is disposed proximate to the subject's xiphoid process, the first receiver coil is disposed in a first anatomical region of the subject proximate to the subject's navel at a first receiver coil distance from the transmitter coil, the second receiver coil is disposed in a second anatomical region opposite the subject's xiphoid process proximate to the subject's spine at a second receiver coil distance from the transmitter coil, and the third magnetometer is disposed in a third anatomical region of the subject proximate to the subject's navel at a third receiver coil distance from the transmitter coil;
the transmitter coils are configured to generate a first alternating magnetic field in the first, second and third magnetic field dimensions, a second alternating magnetic field in the fourth, fifth and sixth magnetic field dimensions, and a third alternating magnetic field in the seventh, eighth and ninth magnetic field dimensions;
the first, second, and third field dimensions of the first AC magnetic field have a first magnetic field frequency, the fourth, fifth, and sixth field dimensions of the second AC magnetic field have a second magnetic field frequency, and the seventh, eighth, and ninth field dimensions of the third AC magnetic field have a third magnetic field frequency;
a first field dimension of the first AC magnetic field has a first variable magnitude as a function of a first distance of the first receiver coil from the transmitter coil, a second field dimension of the first AC magnetic field has a second variable magnitude as a function of a second distance of the first receiver coil from the transmitter coil, and the first field dimension of the first AC magnetic field has a third variable magnitude as a function of a third distance of the first receiver coil from the transmitter coil;
a fourth field dimension of the second AC magnetic field having a fourth variable field strength as a function of a fourth distance of the second receiver coil from the transmitter coil, a fifth field dimension of the second AC magnetic field having a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil, and a sixth field dimension of the second AC magnetic field having a sixth variable field strength as a function of a sixth distance of the second receiver coil from the transmitter coil;
a seventh field dimension of the third AC magnetic field having a seventh variable field strength as a function of a seventh distance from the transmitter coil, an eighth field dimension of the third AC magnetic field having an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil, and a ninth field dimension of the third AC magnetic field having 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 is configured to detect and measure first, second, and third variable magnetic field strengths of first, second, and third magnetic field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representative of the first variable magnetic field strength of the first magnetic field dimension of the first AC magnetic field, a second AC magnetic field strength signal representative of the second variable magnetic field strength of the second magnetic field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representative of the third variable magnetic field strength of the third magnetic field dimension of the first AC magnetic field, and to transmit the first, second, and third AC magnetic field strength signals to the electronic module;
the second receiver coil is configured to detect and measure fourth, fifth, and sixth variable magnetic field strengths of fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representative of a fourth variable magnetic field strength of the fourth magnetic field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representative of a fifth variable magnetic field strength of the fifth magnetic field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representative of a sixth variable magnetic field strength of the sixth magnetic field dimension of the second AC magnetic field, and to transmit the fourth, fifth, and sixth AC magnetic field strength signals to the electronic module;
the third receiver coil is configured to detect and measure seventh, eighth, and ninth variable magnetic field strengths of seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representative of the seventh variable magnetic field strength of the seventh magnetic field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representative of the eighth variable magnetic field strength of the eighth magnetic field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representative of the ninth variable magnetic field strength of the ninth magnetic field dimension of the third AC magnetic field, and to transmit the seventh, eighth, and ninth AC magnetic field strength signals to the electronic module;
the electronics module is configured to receive the first, second and third alternating magnetic field strength signals transmitted by the first receiver coil, configured to receive the fourth, fifth and sixth alternating magnetic field strength signals transmitted by the second receiver coil, and configured to receive the seventh, eighth and ninth alternating magnetic field strength signals transmitted by the third receiver coil;
the electronic module comprises a processing system 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 is further programmed and configured to determine a value of 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 is further programmed and configured to determine a value of 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 is further programmed and configured to determine at least one disordered breathing of the subject as a function of the physiological parameter value, the determined at least one respiratory parameter, and the determined value.

In a preferred embodiment of the present invention, the transmitter coil and the first receiver coil are similarly aligned in a first axial direction, the transmitter coil and the second receiver coil are aligned in a second axial direction, and the transmitter coil and the third receiver coil are aligned in a third axial direction.

In some embodiments of the invention in which baseline respiratory parameter values are pre-measured, the processing system is further programmed and configured to determine at least one respiratory disorder in the subject as a function of the pre-measured baseline respiratory parameter values, the physiological parameter values, and the determined at least one respiratory parameter and its value.

As described in priority U.S. patent application Ser. No. 16/363,404 and discussed in detail above, in some embodiments of the monitoring system of the present invention, the physiological parameter subsystem of the monitoring system of the present invention further comprises an accelerometer configured to detect and monitor the anatomical position and physical movement of the subject, and to generate and transmit an accelerometer signal including accelerometer data representative of at least one anatomical position of the subject.

Thus, in some embodiments of the invention, the processing system is further programmed and configured to determine at least one respiratory disorder in the subject as a function of the pre-measured baseline respiratory parameter values, the physiological parameter values, the accelerometer data, and the determined at least one respiratory parameter and its value.

In some embodiments of the invention, the processing system is also programmed and configured to determine at least one anatomical position of the subject as a function of the accelerometer signal (and thus the accelerometer data embedded therein).

In some embodiments of the invention, 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 its value, or selectively determine at least one anatomical location of the subject as a function of the accelerometer signal (and thus the accelerometer data incorporated therein).

As also described in priority U.S. patent application Ser. No. 16/363,404, in some embodiments of the present invention, a method for determining disordered breathing using a monitoring system of the present invention generally includes:
(i) providing a wearable monitoring system comprising a respiratory parameter monitoring subsystem, a physiological parameter monitoring subsystem, and an electronic control processing module, the respiratory parameter monitoring subsystem comprising one transmitter coil and three (i.e., first, second, and third) receiver coils, and the physiological parameter monitoring subsystem comprising at least one physiological parameter monitoring sensor;
(ii) positioning a monitoring system on a subject, wherein a transmitter coil is positioned proximate to the subject's xiphoid process, a first receiver coil is positioned proximate to the navel, a second receiver coil is positioned proximate to a spine of the subject opposite the transmitter coil, and a third receiver coil is positioned proximate to the spine of the subject opposite the navel, and a physiological parameter monitoring sensor is positioned proximate to a target physical structure, e.g., the skin of the subject;
(iii) initiating the monitoring system, where an AC magnetic field is generated and transmitted by a transmitter coil, the AC magnetic field comprising a predetermined frequency;
(iv) generating and transmitting an AC magnetic field comprising a predetermined frequency by a transmitter coil;
(v) detecting and measuring the strength of the alternating magnetic field with a receiver coil;
(vi) generating an AC magnetic field strength signal representative of the AC magnetic field strength measured at the receiver coil;
(vii) measuring at least one physiological parameter and its value using the physiological parameter monitoring subsystem and generating a physiological parameter signal representative of the physiological parameter and its value;
(viii) transmitting the AC magnetic field strength signal and the physiological signal to an electronic module;
(ix) determining, by the electronic module, at least one anatomical displacement of the subject as a function of the AC magnetic field strength signal;
(x) determining at least one respiratory parameter of the subject as a function of the determined anatomical displacement using the electronic module;
(xi) determining a respiratory parameter value as a function of the AC magnetic field strength signal using the electronic module;
(xii) determining by the electronic module at least one respiratory disorder as a function of the physiological parameter value, the determined respiratory parameter and its value.

In some embodiments of the invention, a method for determining a breathing disorder and an anatomical location of a subject generally includes:
(i) providing a wearable monitoring system comprising a respiratory parameter monitoring subsystem and an electronics control and processing module, the respiratory parameter monitoring subsystem comprising a transmitter coil and first, second and third receiver coils, the respiratory parameter monitoring subsystem comprising at least one physiological parameter monitoring sensor and an accelerometer;
(ii) positioning a monitoring system on a subject, wherein a transmitter coil is positioned proximate to the subject's xiphoid process, a first receiver coil is positioned proximate to the navel, a second receiver coil is positioned proximate to the subject's spine opposite the transmitter coil, a third receiver coil is positioned proximate to the subject's spine opposite the navel, and physiological parameter monitoring sensors are positioned proximate to a target physical structure, e.g., the skin of the subject;
(iii) initiating the monitoring system, where an AC magnetic field is generated and transmitted by a transmitter coil, the AC magnetic field comprising a predetermined frequency;
(iv) detecting and measuring the strength of the alternating magnetic field by a receiver coil;
(v) generating an AC magnetic field strength signal representative of the AC magnetic field strength measured by the receiver coil;
(vi) acquiring accelerometer data with an accelerometer and generating an accelerometer signal representative of the accelerometer data, the accelerometer data including accelerometer parameters representative of anatomical position and movement of the subject;
(vii) transmitting the AC magnetic field strength signal and the accelerometer signal to an electronic module;
(viii) determining, by the electronic module, at least one anatomical displacement of the subject as a function of the AC magnetic field strength signal;
(ix) determining at least one respiratory parameter of the subject as a function of the anatomical displacement determined by the electronic module;
(x) determining, by the electronic module, respiratory parameter values as a function of the AC magnetic field strength signal;
(xi) determining at least one disordered breathing as a function of the acquired baseline accelerometer data and the determined respiratory parameters and their values using the electronic module;
(xii) determining, using the electronic module, at least one anatomical position of the subject as a function of the accelerometer signal.

Referring now to FIG. 1, a schematic diagram of one embodiment of a monitoring system of the present invention is shown. As shown in FIG. 1, the monitoring system 100 preferably includes a respiratory parameter monitoring subsystem 2 of the present invention, an electronic module 6, and a signal transmission conductor 8.

As also shown in FIG. 1, the respiratory parameter monitoring subsystem 2 includes a transmitter coil 15 and first, second and third receiver coils 16a, 16b and 16c.

As further shown in FIG. 1, the respiratory parameter monitoring system 100 further comprises a power source 10. In accordance with the present invention, the power source 10 may comprise any device or system configured to provide (or generate) electrical energy, such as a battery.

In a preferred embodiment of the present invention, the monitoring system 100 comprises a wearable garment, preferably configured to cover at least a portion of the subject's torso, i.e., the chest and abdominal regions.

Referring now to FIG. 2, there is shown a schematic diagram of another embodiment of the monitoring system of the present invention. As shown in FIG. 2, the monitoring system 102 also preferably includes a respiratory parameter monitoring subsystem 2, an electronic module 6, and a signal transmission conductor 8.

As shown in FIG. 2, the respiratory parameter monitoring subsystem 2 similarly includes a transmitter coil 15 and first, second and third receiver coils 16a, 16b and 16c.

As further shown in FIG. 2, the monitoring system 102 further includes a physiological parameter monitoring subsystem 4a of the present invention.

In a preferred embodiment of the present invention, the monitoring system 102 also preferably includes a wearable garment configured to cover at least a portion of the subject's torso, i.e., the chest and abdominal regions.

As described above, in a preferred embodiment of the present invention, the transmitter coil 15 is configured to generate and transmit electromagnetic radiation, e.g., AC magnetic fields, in multiple fields, i.e., three-dimensional fields, at multiple harmonic frequencies.

As mentioned above, preferably the non-harmonic frequencies are less than 10 KHz.

Also, as described above, in a preferred embodiment, the first, second, and third receiver coils 16a, 16b, and 16c are configured and positioned to detect and measure the field strength in at least one of the magnetic field dimensions of the AC magnetic field and generate an AC magnetic field strength signal representative of the field strength in the AC magnetic field, thereby generating the anatomical displacement of the monitored subject.

In at least one embodiment, first and second transmitter coils are constructed and positioned on the subject. The polarities of the AC magnetic field are generated by the transmitter coils oriented perpendicular to each other, i.e., at a 90° angle relative to each other. A net vector field is provided that includes at least the X and Y vectors (or directions) of the AC magnetic field.

In a preferred embodiment of the invention, at least one receiver coil is configured to detect at least one AC magnetic field vector in an X direction, and at least one receiver coil is configured to detect at least one AC magnetic field vector in a Y direction.

In the above-described embodiment of the present invention, when two transmitter coils are employed and AC magnetic field vectors in the X and Y directions are detected by the receiver coils, the angles between the X and Y AC magnetic field vectors and the resulting net AC magnetic field vector are determined by the processing system of the electronics module. The angles between the X and Y AC magnetic field vectors and the net AC magnetic field vector are then used to determine at least one net AC magnetic field strength vector.

As described above and shown in FIG. 2, in a preferred embodiment of the present invention, the physiological parameter monitoring subsystem 4a of the respiratory-physiological parameter monitoring system 102 includes at least one physiological parameter monitoring sensor.

As further shown in FIG. 2, in some embodiments, the physiological parameter monitoring sensor 4 a preferably comprises an SpO ₂ sensor 18 .

In some embodiments of the present invention, the physiological parameter monitoring subsystem 4a includes at least one additional physiological parameter monitoring sensor, such as a temperature sensor (shown in phantom and designated 19).

In a preferred embodiment of the present invention, the electronic module 6 preferably comprises a processing system or module programmed and configured to control the respiratory-physiological parameter monitoring system 2 and its functions, and a data transmission module programmed and configured to control the transmission and reception of signals between the respiratory parameter monitoring subsystem 2 and the physiological parameter monitoring subsystem 4a.

As described above, in a preferred embodiment of the present invention, the processing system includes at least one algorithm programmed and configured to separate and process the AC magnetic field strength signal and determine at least one respiratory parameter (or characteristic) of the subject as a function of the AC magnetic field strength signal.

As described in priority U.S. patent application Ser. No. 16/363,404, processing system algorithms for determining respiratory parameters (or characteristics) as a function of the AC magnetic field strength signal include, but are not limited to, conventional algorithms such as: conventional and/or modified multi-degree-of-freedom algorithms, including two-degree-of-freedom and three-degree-of-freedom algorithms, spectral density estimation algorithms using non-parametric methods, such as singular spectrum analysis, short-time Fourier transform, cross power methods, transfer function estimation and magnitude-squared coherence, frequency domain algorithms including Fourier series algorithms, Fourier transform algorithms, Laplace transform algorithms, Z-transform algorithms and wavelet transform algorithms.

As also described in priority U.S. patent application Ser. No. 16/363,404, the processing system is preferably programmed and configured to generate and continuously update at least one diagnostic data set. Preferably, 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 the subject.

Referring to Table 7, a diagram of one embodiment of a diagnostic dataset for a subject is shown. As shown in Table 7, the diagnostic dataset preferably includes at least an array of measured or determined minute ventilation and anatomical displacements measured at defined points on the subject during monitoring with a respiratory parameter or respiratory-physiological parameter monitoring system of the present invention.

In accordance with the present invention, the diagnostic data set shown in Table 7 can be presented graphically, i.e., as minute ventilation on the y-axis and anatomical displacement on the x-axis, and linearly interpolated using conventional equations such as Equation 1 shown below.

In a preferred embodiment, the processing system is programmed and configured to linearly interpolate a diagnostic dataset, such as the diagnostic dataset shown in Table 7, to determine the presence of at least one apnea event exhibited by the subject over a predetermined period of time, thereby determining a sleep disorder.

In accordance with the present invention, the diagnostic data set may be interpolated using any applicable method and/or formula. In some embodiments, the processing system is programmed and configured to interpolate the diagnostic data set using second order polynomial interpolation to determine the presence of at least one apnea event exhibited by the subject over a predetermined period of time, thereby determining a sleep disorder.

In some embodiments, the subject's tidal volume ( _VT ) and respiratory rate (f) are determined by spirometry. The minute ventilation (Vdot) can then be determined using the formula shown below:

In a preferred embodiment of the present invention, the processing system is further programmed to distinguish between symptoms of a sleep disorder, i.e., respiratory and/or physiological parameters indicative of a sleep disorder, and extraneous respiratory events such as coughing, sneezing, etc., for example, by comparing the pre-measured baseline respiratory and pre-measured baseline physiological parameters of the subject in a resting position to predetermined respiratory and physiological parameter thresholds reflective of a breathing disorder.

In a preferred embodiment of the present invention, the processing system is further programmed to determine the type of sleep apnea, i.e., obstructive sleep apnea, central sleep apnea, and mixed sleep apnea, based on the detected anatomical displacement of the monitored subject.

In some embodiments, the processing system determines the type of sleep apnea of the 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.

As is well established, when a subject suffers from obstructive sleep apnea, the subject exhibits anti-correlated expansion and contraction of the thoracic and abdominal regions during at least one respiratory cycle; that is, the expansion and contraction of the thoracic and abdominal regions are ∼180° out of phase.

As is also well established, when a subject suffers from central sleep apnea, the subject presents with a complete lack of expansion and contraction of the thoracic and abdominal regions.

Thus, in accordance with the present invention, obstructive sleep apnea is determined when the AC magnetic field strength signal reflects inverse expansion and contraction of the subject's thoracic and abdominal regions during at least one respiratory cycle.

Central sleep apnea is determined when the AC magnetic field strength signal reflects a lack of expansion and contraction of the thoracic and abdominal regions.

In a preferred embodiment of the present invention, the electronic module 6 further comprises a data transmission subsystem programmed and configured to control the transmission of signals from the respiratory parameter monitoring subsystem 2 and the physiological parameter monitoring subsystem 4a.

In some embodiments, the data transmission subsystem is also programmed and configured to transmit the respiratory parameter signals to a remote signal receiving device, e.g., the base module or a handheld electronic device such as a smartphone, tablet, computer, etc. In some embodiments, the remote signal receiving device is programmed and configured to display the received and/or processed signals, e.g., the respiratory parameter signals, the physiological parameter signals, and the accelerometer data received from the electronic module 6.

As further shown in FIG. 2, the respiratory-physiological parameter monitoring system 102 also includes signal transmission conductors 8 that facilitate connection and thereby signal communication with and between the respiratory parameter monitoring subsystem 2, the physiological parameter monitoring subsystem 4a, and the electronics module 6.

Referring now to FIG. 3, a schematic diagram of another embodiment of the respiratory-physiological parameter monitoring system of the present invention is shown. As shown in FIG. 3, the respiratory-physiological parameter monitoring system 104 similarly preferably comprises a respiratory parameter monitoring subsystem 2 and a physiological parameter monitoring subsystem. The physiological parameter monitoring subsystem comprises at least one physiological parameter monitoring sensor, an electronic module 6, a signal transmission conductor 8, and a power source 10 as implemented in the respiratory-physiological parameter monitoring system 102 described above.

As further shown in FIG. 3, in this embodiment, the physiological parameter monitoring subsystem (herein designated "4b") further comprises an accelerometer 20 configured to detect and monitor the anatomical position and physical movement of the subject, and generate and transmit an accelerometer signal representative thereof (including accelerometer data representative of at least one anatomical position of the subject).

In this embodiment, the processing system of the electronic module 6 is also programmed to determine respiratory disturbances as a function of the measured respiratory and physiological parameters and the subject's accelerometer data, and to determine at least one anatomical location of the subject as a function of the accelerometer data.

Referring now to FIG. 4, there is shown an embodiment of a wearable garment 220 that can incorporate the monitoring systems of the present invention, including the monitoring systems 100 and 102 shown in FIGS. 1-3.

As described above and shown in FIG. 4, the wearable garment 220 is preferably configured to cover at least the upper torso 210, i.e., the chest and abdominal regions, of the subject 200.

However, in accordance with the present invention, the wearable garment 220 may also be configured to cover other areas of the subject 200, including but not limited to the lower abdominal region.

As shown in FIG. 5, in a preferred embodiment, when a wearable garment 220 incorporates the monitoring system of the present invention (thus forming a wearable monitoring system) and is placed on a subject's upper body 210, the transmitter coil 15 is preferably placed near the subject's xiphoid process, the first receiver coil 16a is placed near the navel, the second receiver coil 16b is placed adjacent to the subject's spine opposite the transmitter coil 15, and the third receiver coil 16c is placed adjacent to the subject's spine opposite the navel.

In accordance with the present invention, the wearable monitoring system described above is placed adjacent to the upper torso 210 of the subject 200, and when the monitoring system is initiated, the respiratory disorder and anatomical location of the subject 200 can be accurately determined.

As will be readily appreciated by those skilled in the art, the present invention provides numerous advantages over prior art methods and systems for determining respiratory characteristics and therefrom respiratory disorders, as well as the anatomical position and movement of a subject.

Among the advantages are:
- To provide a wearable physiological monitoring system that accurately detects and measures respiratory parameters and/or characteristics in real time based on anatomical displacements of the monitored subject.
-Provides a wearable physiological monitoring system that accurately determines a subject's anatomical location.
- Providing a wearable physiological monitoring system that trains a subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or induce symptoms of the subject's existing breathing or sleep disorder.
- Providing an improved method for determining disordered breathing based on detected respiratory and/or physiological parameters and/or characteristics.
- Providing an improved method for determining sleep apnea and/or hypopnea based on detected abnormal breathing and/or physiological parameters and/or characteristics.
- Providing a method for training a subject to maintain an anatomical position during sleep that is less likely to exacerbate and/or induce symptoms of the subject's existing breathing or sleep disorder.

Without departing from the spirit and scope of the present invention, those skilled in the art may make various changes and modifications to the present invention in order to adapt it to various applications and conditions. Accordingly, it is intended that these changes and modifications be properly, equitably, and within the full scope of equivalents of the following claims.

Claims (16)

1. A wearable surveillance system, comprising:
a wearable garment configured to be removably placed on a subject , the subject having thoracic and abdominal regions, a spine, an umbilicus, and a xiphoid process of a sternum, the wearable garment covering at least the thoracic and abdominal regions of the subject when the wearable garment is placed on the subject ;
the wearable garment comprising a respiratory parameter monitoring subsystem; an electronic module in communication with the respiratory parameter monitoring subsystem;
the respiratory parameter monitoring subsystem comprises a transmitter coil and first, second and third receiver coils;
the transmitter coil and the first, second and third receiver coils are disposed on the wearable garment such that, when the wearable garment is disposed on the subject, the transmitter coil is disposed proximate to the subject's xiphoid process, the first receiver coil is disposed in a first anatomical region of the subject proximate to the subject's navel at a first receiver coil distance from the transmitter coil, the second receiver coil is disposed in a second anatomical region of the subject proximate to the subject's spine opposite the subject's xiphoid process at a second receiver coil distance from the transmitter coil, and the third receiver coil is disposed in a third anatomical region of the subject proximate to the subject's spine opposite the subject's navel at a third receiver coil distance from the transmitter coil;
the transmitter coils are configured to generate a first alternating current (AC) magnetic field in a first, second, and third magnetic field dimension, a second AC magnetic field in a fourth, fifth, and sixth magnetic field dimension, and a third AC magnetic field in a seventh, eighth, and ninth magnetic field dimension;
the first, second, and third field dimensions of the first AC magnetic field have a first magnetic field frequency, the fourth, fifth, and sixth field dimensions of the second AC magnetic field have a second magnetic field frequency, and the seventh, eighth, and ninth field dimensions of the third AC magnetic field have a third magnetic field frequency;
the first field dimension of the first AC magnetic field has a first variable field 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 has a second variable field strength as a function of a second distance of the first receiver coil from the transmitter coil, and the third field dimension of the first AC magnetic field has a third variable field 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 has 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 has a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil, and the sixth field dimension of the second AC magnetic field has 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 has a seventh variable field strength as a function of a seventh distance from the transmitter coil to the third receiver coil, the eighth field dimension of the third AC magnetic field has an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil, and the ninth field dimension of the third AC magnetic field has 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 is configured to detect and measure first, second, and third variable magnetic field strengths in the first, second, and third magnetic field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representative of the first variable magnetic field strength in the first magnetic field dimension of the first AC magnetic field, a second AC magnetic field strength signal representative of the second variable magnetic field strength in the second magnetic field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representative of the third variable magnetic field strength in the third magnetic field dimension of the first AC magnetic field, and to transmit the first, second, and third AC magnetic field strength signals to the electronic module;
the second receiver coil is configured to detect and measure fourth, fifth, and sixth variable magnetic field strengths in the fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representative of the fourth variable magnetic field strength in the fourth magnetic field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representative of the fifth variable magnetic field strength in the fifth magnetic field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representative of the sixth variable magnetic field strength in the sixth magnetic field dimension of the second AC magnetic field, and to transmit the fourth, fifth, and sixth AC magnetic field strength signals to the electronic module;
the third receiver coil is configured to detect and measure seventh, eighth, and ninth variable magnetic field strengths in the seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representative of the seventh variable magnetic field strength in the seventh magnetic field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representative of the eighth variable magnetic field strength in the eighth magnetic field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representative of the ninth variable magnetic field strength in the ninth magnetic field dimension of the third AC magnetic field, and to transmit the seventh, eighth, and ninth AC magnetic field strength signals to the electronic module;
the electronic module is configured to receive the first, second and third AC magnetic field strength signals transmitted by the first receiver coil, the electronic module is configured to receive the fourth, fifth and sixth AC magnetic field strength signals transmitted by the second receiver coil, and the electronic module is configured to receive the seventh, eighth and ninth AC magnetic field strength signals transmitted by the third receiver coil;
the electronic module comprising a processing system 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 is 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 is further programmed and configured to determine disordered breathing of the subject as a function of the determined at least one respiratory parameter and the determined value. the transmitter coil and the first receiver coil are aligned in a first axial direction, the transmitter coil and the second receiver coil are aligned in a second axial direction, and the transmitter coil and the third receiver coil are aligned in a third axial direction.
The monitoring system of claim 1. the first, second, and third variable magnetic field strengths of the first, second, and third magnetic field dimensions of the first AC magnetic field represent a displacement of a first anatomical region of the subject relative to the xiphoid process of the subject.
The monitoring system according to claim 2. the fourth, fifth, and sixth variable magnetic field strengths of the fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field represent a displacement of a second anatomical region of the subject relative to the xiphoid process of the subject.
The monitoring system according to claim 2. the seventh, eighth, and ninth variable magnetic field strengths of the seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field represent a displacement of a third anatomical region of the subject relative to the xiphoid process of the subject.
The monitoring system according to claim 2. the wearable garment further comprising a physiological parameter monitoring subsystem.
The monitoring system of claim 1. the physiological parameter monitoring subsystem comprises at least one physiological parameter sensor configured to measure a physiological parameter of the subject and to transmit a physiological parameter signal representative of the physiological parameter and its value;
The monitoring system according to claim 6. the electronic module is further configured to receive the physiological parameter signal transmitted by the physiological parameter sensor;
the electronic module is further programmed to determine the respiratory disorder of the subject as a function of the determined at least one respiratory parameter and its determined value and a value of the physiological parameter.
The monitoring system according to claim 7. the wearable garment further comprising a physiological parameter monitoring subsystem;
the physiological parameter monitoring subsystem comprises at least one physiological parameter sensor configured to measure a physiological parameter of the subject and to transmit a physiological parameter signal representative of the physiological parameter and its value;
the physiological parameter monitoring subsystem comprising at least one accelerometer configured to measure accelerometer data representative of anatomical displacements of the subject and to generate and transmit an accelerometer parameter signal representative of the measured accelerometer data;
The monitoring system of claim 1 . the electronic module is further adapted to receive the physiological parameter signal transmitted by the physiological parameter sensor and the accelerometer parameter signal transmitted by the accelerometer;
the electronic module is further programmed to determine the disordered breathing of the subject as a function of the determined at least one respiratory parameter and its determined value, the value of the physiological parameter, and the accelerometer data.
The monitoring system of claim 9. The monitoring system of claim 1, wherein the respiratory disorder includes apnea. 1. A method of operating a monitoring system for determining respiratory disorder and anatomical location of a subject, comprising:
(i) the monitoring system comprises a wearable physiological monitoring system configured to be removably placed on a subject, the subject having thoracic and abdominal regions, a spine, an umbilicus, and a xiphoid process of a sternum, the physiological monitoring system covering at least the thoracic and abdominal regions of the subject when the physiological monitoring system is placed on the subject ;
the physiological monitoring system includes a respiratory parameter monitoring subsystem, a physiological parameter subsystem, and an electronic module in communication with the physiological parameter subsystem;
the physiological parameter subsystem comprising an accelerometer configured to detect anatomical position and movement of the subject and generate and transmit accelerometer signals representative thereof;
the respiratory parameter monitoring subsystem comprises a transmitter coil and first, second and third receiver coils;
the transmitter coil and the first, second and third receiver coils are disposed on the wearable garment such that, when the wearable garment is disposed on the subject, the transmitter coil is disposed proximate to the subject's xiphoid process, the first receiver coil is disposed in a first anatomical region of the subject proximate to the subject's navel at a first receiver coil distance from the transmitter coil, the second receiver coil is disposed in a second anatomical region of the subject proximate to the subject's spine opposite the subject's xiphoid process at a second receiver coil distance from the transmitter coil, and the third receiver coil is disposed in a third anatomical region of the subject proximate to the subject's spine opposite the subject's navel at a third receiver coil distance from the transmitter coil;
the transmitter coils are configured to generate a first alternating current (AC) magnetic field in a first, second, and third magnetic field dimension, a second AC magnetic field in a fourth, fifth, and sixth magnetic field dimension, and a third AC magnetic field in a seventh, eighth, and ninth magnetic field dimension;
the first, second, and third field dimensions of the first AC magnetic field have a first magnetic field frequency, the fourth, fifth, and sixth field dimensions of the second AC magnetic field have a second magnetic field frequency, and the seventh, eighth, and ninth field dimensions of the third AC magnetic field have a third magnetic field frequency;
the first field dimension of the first AC magnetic field has a first variable field 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 has a second variable field strength as a function of a second distance of the first receiver coil from the transmitter coil, and the third field dimension of the first AC magnetic field has a third variable field 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 has 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 has a fifth variable field strength as a function of a fifth distance of the second receiver coil from the transmitter coil, and the sixth field dimension of the second AC magnetic field has 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 has a seventh variable field strength as a function of a seventh distance from the transmitter coil to the third receiver coil, the eighth field dimension of the third AC magnetic field has an eighth variable field strength as a function of an eighth distance of the third receiver coil from the transmitter coil, and the ninth field dimension of the third AC magnetic field has 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 is configured to detect and measure first, second, and third variable magnetic field strengths in the first, second, and third magnetic field dimensions of the first AC magnetic field, the first receiver coil being further configured to generate a first AC magnetic field strength signal representative of the first variable magnetic field strength in the first magnetic field dimension of the first AC magnetic field, a second AC magnetic field strength signal representative of the second variable magnetic field strength in the second magnetic field dimension of the first AC magnetic field, and a third AC magnetic field strength signal representative of the third variable magnetic field strength in the third magnetic field dimension of the first AC magnetic field, and to transmit the first, second, and third AC magnetic field strength signals to the electronic module;
the second receiver coil is configured to detect and measure fourth, fifth, and sixth variable magnetic field strengths in the fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field, the second receiver coil being further configured to generate a fourth AC magnetic field strength signal representative of the fourth variable magnetic field strength in the fourth magnetic field dimension of the second AC magnetic field, a fifth AC magnetic field strength signal representative of the fifth variable magnetic field strength in the fifth magnetic field dimension of the second AC magnetic field, and a sixth AC magnetic field strength signal representative of the sixth variable magnetic field strength in the sixth magnetic field dimension of the second AC magnetic field, and to transmit the fourth, fifth, and sixth AC magnetic field strength signals to the electronic module;
the third receiver coil is configured to detect and measure seventh, eighth, and ninth variable magnetic field strengths in the seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field, the third receiver coil being further configured to generate a seventh AC magnetic field strength signal representative of the seventh variable magnetic field strength in the seventh magnetic field dimension of the third AC magnetic field, an eighth AC magnetic field strength signal representative of the eighth variable magnetic field strength in the eighth magnetic field dimension of the third AC magnetic field, and a ninth AC magnetic field strength signal representative of the ninth variable magnetic field strength in the ninth magnetic field dimension of the third AC magnetic field, and to transmit the seventh, eighth, and ninth AC magnetic field strength signals to the electronic module;
the electronic module is configured to receive the first, second and third AC magnetic field strength signals transmitted by the first receiver coil, the electronic module is configured to receive the fourth, fifth and sixth AC magnetic field strength signals transmitted by the second receiver coil, and the electronic module is configured to receive the seventh, eighth and ninth AC magnetic field strength signals transmitted by the third receiver coil;
the electronic module comprising a processing system 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 is 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 is further programmed and configured to determine disordered breathing of the subject as a function of the determined at least one respiratory parameter and the determined value;
The processing system is further programmed and configured to determine an anatomical position of the subject as a function of the accelerometer signal ;
The method includes, when the monitoring system is positioned on a first subject,
(iii) when the monitoring system is activated, the transmitter coil generating and transmitting the first, second, and third AC magnetic fields comprising the first, second, and third magnetic field dimensions;
(iv) the first receiver coil detecting and measuring the first, second, and third variable magnetic field strengths in the first, second, and third magnetic field dimensions of the first AC magnetic field;
(v) the second receiver coil detecting and measuring the fourth, fifth, and sixth variable magnetic field strengths in the fourth, fifth, and sixth magnetic field dimensions of the second AC magnetic field;
(vi) the third receiver coil detecting and measuring the seventh, eighth, and ninth variable magnetic field strengths in the seventh, eighth, and ninth magnetic field dimensions of the third AC magnetic field;
(vii) the first receiver coil generating the first, second, and third AC magnetic field strength signals;
(viii) the second receiver coil generating the fourth, fifth, and sixth AC magnetic field strength signals;
(ix) the third receiver coil generating the seventh, eighth, and ninth AC magnetic field strength signals;
(x) the accelerometer measuring accelerometer data and generating the accelerometer signal representative of the accelerometer data;
(xi) the first receiver coil transmitting the first, second, and third AC magnetic field strength signals to the electronic module;
(xii) the second receiver coil transmitting the fourth, fifth, and sixth AC magnetic field strength signals to the electronic module;
(xiii) the third receiver coil transmitting the seventh, eighth, and ninth AC magnetic field strength signals to the electronic module;
(xiv) the accelerometer transmitting the accelerometer signal to the electronic module;
(xv) the electronic module determining at least one anatomical displacement of the first subject as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth AC magnetic field strength signals;
(xvi) the electronic module determining at least one respiratory parameter as a function of the at least one anatomical displacement;
(xvii) the electronic module determining respiratory parameter values of the respiratory parameters as a function of the first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth AC magnetic field strength signals;
(xviii) the electronic module determining a first respiratory disorder of the first subject as a function of the determined at least one respiratory parameter and its determined value;
(xix) the electronic module determining a first anatomical position of the first subject as a function of the accelerometer signal;
The method according to claim 1, The method of claim 12, wherein the first respiratory disorder of the first subject includes apnea. The method includes pre-measuring a first baseline respiratory parameter of the first subject prior to the step of providing the wearable garment to determine a first baseline respiratory parameter value for the first subject.
13. The method of claim 12. the first respiratory disorder of the first subject is determined as a function of the first baseline respiratory parameter value and the determined at least one respiratory parameter and its determined value.
15. The method of claim 14. The processing system is further programmed and configured to: generate a diagnostic data set comprising an array of minute ventilations and anatomical displacements of the first subject measured at predetermined anatomical points of the first subject; determine at least one apnea event as a function of the diagnostic data set; and determine the disordered breathing as a function of the at least one apnea event.
13. The method of claim 12.

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