Note: Descriptions are shown in the official language in which they were submitted.
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WEARABLE PHYSIOLOGICAL MONITORING SYSTEM
FIELD OF THE INVENTION
[0001] The present invention relates to systems and methods for monitoring
physiological
characteristics of a subject. More particularly, the present invention relates
to apparatus,
systems and methods for determining a plurality of physiological
characteristics; particularly,
respiratory characteristics of a subject and respiratory disorders exhibited
thereby, and
anatomical positions and motions of the subject.
BACKGROUND OF THE INVENTION
[0002] It is well known in the art that approximately 10% of adults are
affected by a
respiratory disorder. Most respiratory disorders are deemed a serious risk
factor because they
can, and often will, have a long-ten-n effect on the cardiovascular system.
Indeed,
sympathetic modulation has been found to be closely related to adverse heart
rate variability,
e.g., cardiac arrhythmia.
[0003] The most common respiratory disorders that affect adults are sleep
apneas and
hypopnea.
[0004] As is well known in the art, sleep apnea is generally classified
into three types
based on respiratory functions. The first type of apnea is obstructive sleep
apnea (OSA),
which occurs when the subject or patient stops breathing continuously due to
an obstructed
upper airway.
[0005] The second type of apnea is central sleep apnea (CEN), which occurs
when the
subject or patient stops breathing continuously due to the inability of the
subject to correctly
modulate respiration, i.e. the brain temporarily fails to transmit appropriate
neurological
signals to the muscles responsible for controlling breathing. Unlike
obstructive sleep apnea,
which can be thought of as a mechanical problem, central sleep apnea is more
of a
communication problem.
[0006] The third type of apnea is generally referred to as mixed apnea,
which is a
combination of obstructive and central sleep apnea. Mixed apnea is generally
characterized
by a lack of respiratory effort without air exchange due to upper airway
obstruction.
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[0007] Hypopnea is a respiratory disorder that is characterized by overly
shallow
breathing or an abnormally low respiration rate, i.e. a decreased amount of
air movement into
the lungs, which can, and often will cause oxygen levels in the blood to drop.
[0008] As is also well known in the art, various abnormal seminal
respiratory parameters
and/or characteristics, such as breathing frequency (e.g., breaths per
minute), tidal volume
(VT), inspiration volume, expiration volume, respiratory minute ventilation
(e.g., inspiration
volume per minute or expiration volume per minute) and/or peak expiratory flow
rate, and
physiological parameters and/or characteristics, such as oxyhemoglobin
saturation and
oxygen desaturation index, are indicative of a sleep apnea and/or hypopnea.
[0009] Various systems and methods have thus been developed to detect one
or more
respiratory parameters and determine a respiratory disorder, such as sleep
apnea, therefrom.
Most of the systems and methods are based on anatomical displacements and the
relationships
thereof to one or more of the above referenced respiratory parameters and
characteristics, e.g.,
breathing frequency, VT and inspiration volume.
[00010] Illustrative are the systems and methods for determining respiratory
parameters
disclosed in U.S. Pat Nos. 8,790,273 and 8,790,274 (hereinafter "McCool
patents"). The
systems disclosed in the referenced McCool patents generally comprise at least
two tuned
pairs of electromagnetic (EM) coils (also referred to herein as
"magnetometers"), where each
pair of EM coils comprise a single-channel transmitter EM coil that is adapted
to transmit a
single, specific high-frequency AC electromagnetic field (i.e. transducer) and
an EM coil (i.e.
receiver) that is adapted to receive the AC electromagnetic field transmitted
by the transmitter
EM coil.
[00011] The transmitter EM coil(s) of the McCool systems are positioned on the
front of a
subject and the receiver EM coils are positioned on the back of the subject.
[00012] The systems disclosed in the McCool patents are configured to
determine at least
one respiratory parameter or characteristic; particularly, tidal volume (VT)
as a function of a
plurality of anatomical distances, e.g., rib cage-anteroposterior distance and
abdomen-
anteroposterior distance, which are detected by the tuned pairs of EM coils,
and a plurality of
predetermined volume-motion coefficients.
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[00013] A major drawback and disadvantage associated with the McCool systems
and
associated methods is the use of single-channel transmitter EM coils that (i)
are limited to one
(1) specific AC electromagnetic field frequency and (ii) are susceptible to
interference from
extraneous electromagnetic fields that negatively impact the voltage output of
the EM coils
and, hence, the consistency of the AC electromagnetic field frequency.
[00014] A further drawback and disadvantage associated with the McCool systems
is that
the McCool systems and associated methods are dependent on the use of complex
algorithms,
which can, and often will, fail to quantitatively account for physiological
differences between
individual subjects. As a result, the McCool systems are incapable of
consistently providing
accurate determinations of seminal physiological parameters and/or
characteristics, such as
tidal volume (VT) and minute ventilation (V-dot).
[00015] Another drawback and disadvantage associated with the McCool systems
is the
extensive amount of cumbersome wiring that is required for the McCool systems
to operate.
[00016] Further systems and methods for determining respiratory parameters and
respiratory disorders associated therewith are disclosed in Applicant's issued
U.S. Pat. Nos.
10,064,570 and 10,314,517.
[00017] In contrast to the McCool systems, the systems disclosed in U.S. Pat.
Nos.
10,064,570 and 10,314,517 comprise at least one permanent magnet coupled with
at least one
magnetometer that is configured to receive the AC electromagnetic field
generated by the
permanent magnet. The magnetometer is positioned on the front of a subject
proximate the
xyphoid process and the permanent magnet is positioned on the back of the
subject proximate
the spine and across from the xyphoid process of the subject.
[00018] The magnetometer of the above noted systems is adapted to detect
strength
variations in the AC magnetic field emitted by the permanent magnet, which
reflect
displacements, i.e. change in distance, by and between the magnetometer and
permanent
magnet and, hence, the axial displacements of the chest wall of the subject.
The systems are
then programmed and configured to determine at least one respiratory parameter
of the
subject as a function of the axial displacements of the subject's chest wall.
[00019] A seminal advantage of the systems disclosed in U.S. Pat. Nos.
10,064,570 and
10,314,517 comprises the use of a permanent rare earth magnet that is capable
of generating
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an AC magnetic field with a substantially higher degree of magnetic field
strength per unit
mass compared to conventional magnetic field transducers.
[00020] Further advantages provided by the permanent rare earth magnet are
that the
permanent magnet is capable of providing an AC magnetic field with (i) a
greater degree of
magnetic field stability over time compared to conventional magnetic field
transducers and
(ii) that is minimally impacted by interference from extraneous
electromagnetic fields
compared to conventional magnetic field transducers. The systems disclosed in
U.S. Pat.
Nos. 10,064,570 and 10,314,517 are thus capable of measuring multiple
respiratory
parameters associated with a user or wearer with a high degree of accuracy,
while minimizing
inference from external sources, such as electromagnetic radiation.
[00021] Further, since permanent rare earth magnets do not require an external
power
source or control module to generate an AC magnetic field, the systems
disclosed in U.S. Pat.
Nos. 10,064,570 and 10,314,517 require substantially less wiring and
electrical power to
operate compared to conventional systems, such as the systems disclosed by
McCool.
[00022] Although the systems disclosed in U.S. Pat. Nos. 10,064,570 and
10,314,517 can
be readily employed to accurately determine multiple respiratory parameters in
real time and
determine respiratory disorders; particularly, apneas and hypopnea therefrom,
it is desirable to
provide an improved system based thereon with enhanced respiratory and
physiological
parameter detection accuracy and, thereby, respiratory disorder determination.
[00023] It is also well known in the art that the anatomical position of a
subject during
sleep can, and in many instances will, induce an adverse action by the
subject, e.g.,
gastrointestinal regurgitation, or exasperate an existing condition of the
subject, e.g., sleep
apnea.
[00024] At present there are few, if any, apparatus and/or systems available
that are
configured to accurately monitor anatomical positions and movements of a
subject during
sleep.
[00025] There is thus a need to provide improved physiological monitoring
systems that
accurately detect and measure respiratory parameters and/or characteristics in
real time based
on anatomical displacements of a monitored subject.
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[00026] There is also a need to provide apparatus and systems that are capable
of
accurately detecting and monitoring anatomical positions and movements of a
subject during
sleep.
[00027] 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.
[00028] It is another object of the present invention 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 a monitored
subject.
[00029] It is another object of the present invention to provide a wearable
physiological
monitoring system that accurately determines anatomical positions of a
subject.
[00030] It is another object of the present invention to provide improved
methods for
determining a respiratory disorder based on detected respiratory and/or
physiological
parameters and/or characteristics.
[00031] It is another object of the present invention to provide improved
methods for
determining sleep apnea and/or hypopnea based on detected abnormal respiratory
and/or
physiological parameters and/or characteristics.
SUMMARY OF THE INVENTION
[00032] The present invention is directed to wearable physiological monitoring
systems
and improved methods for determining (i) respiratory and/or sleep disorders
based on
measured anatomical displacements and measured physiological parameters and/or
characteristics, and (ii) anatomical positions and movement of a subject.
[00033] In a preferred embodiment of the invention, the wearable physiological
monitoring
systems comprise a wearable garment that is configured to cover at least the
chest region and
upper back of a subject (or user).
[00034] In a preferred embodiment of the invention, the wearable physiological
monitoring
systems comprise a respiratory parameter monitoring sub-system, an
electronics, i.e. control-
processing module, and integral signal transmission means associated
therewith.
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[00035] In some embodiments of the invention, the wearable physiological
monitoring
systems further comprise a physiological parameter monitoring sub-system.
[00036] In a preferred embodiment of the invention, the respiratory parameter
monitoring
sub-system comprises at least one transmitter coil and multiple receiver
coils.
[00037] In some embodiments of the invention, the physiological parameter
monitoring
sub-system further comprises an accelerometer that is configured and
positioned to establish
at least one anatomical position of the subject and monitor physical movement
of the subject.
[00038] In a preferred embodiment of the invention, the electronics module
comprises a
multi-channel module that is programmed and configured (i.e. comprises
programs,
parameters, instructions and at least one algorithm) to control the
physiological monitoring
systems.
[00039] In some embodiments of the invention, the electronics module is
preferably
programmed and configured to (i) receive AC magnetic field strength signals
that are
generated and transmitted by the receiver coils, (ii) identify the frequency
of each of the
associated AC magnetic field AC magnetic field strength signals, (iii)
determine the identity
of the receiver coil based on the frequency of the AC magnetic field strength
signals, (iv)
determine at least one respiratory parameter, more preferably, a plurality of
respiratory
parameters associated with the monitored subject as a function of the AC
magnetic field
strength signals, (v) determine at least one respiratory parameter value as a
function of the AC
magnetic field strength signals, and (vi) determine at least one respiratory
disorder as a
function of the determined respiratory parameter and determined value thereof.
[00040] In some embodiments of the invention, the electronics module is
further
programmed and configured to (i) receive at least one respiratory parameter
signal
representing a pre-measured baseline respiratory parameter value, and (ii)
deteimine at least
one respiratory disorder as a function of the pre-measured baseline
respiratory parameter
value and the respiratory parameter and value thereof determined as a function
of the AC
magnetic field strength signals.
[00041] In some embodiments, the electronics module is further programmed and
configured to receive and process physiological parameter signals representing
physiological
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parameter values of a subject that are generated and transmitted by the
physiological
parameter monitoring sub-system, i.e. a physiological parameter sensor
thereof.
[00042] In some embodiments of the invention, the electronics module is
preferably
programmed and configured to (i) receive AC magnetic field strength signals
that are
transmitted by the receiver coils and physiological parameter signal(s)
transmitted by a
physiological parameter sensor, (ii) identify the frequency of each of the AC
magnetic field
strength signals, (iii) determine the identity of the receiver coil based on
the frequency of the
AC magnetic field strength signals, (iv) determine at least one respiratory
parameter, more
preferably, a plurality of respiratory parameters associated with the
monitored subject as a
function of the AC magnetic field strength signals, (v) determine at least one
respiratory
parameter value as a function of the AC magnetic field strength signals, and
(vi) determine at
least one respiratory disorder as a function of the physiological parameter
value, and the
respiratory parameter and value thereof determined as a function of the AC
magnetic field
strength signals.
[00043] In some embodiments, the electronics module is further programmed and
configured to (i) receive accelerometer signals representing the anatomical
position and
movement data of the monitored subject that are generated and transmitted by
an
accelerometer, and (ii) determine at least one respiratory disorder as a
function of the pre-
measured baseline respiratory parameter value, physiological parameter value,
accelerometer
data, and the respiratory parameter and value thereof deteimined as a function
of the AC
magnetic field strength signals.
[00044] In some embodiments, the electronics module is further programmed and
configured to determine at least one anatomical position of the monitored
subject as a
function of the accelerometer data.
[00045] In some embodiments of the invention, the electronics module is also
programmed
and configured to generate and transmit at least one anatomical position
warning signal as a
function of (or in response to) the determined anatomical position and a pre-
determined
anatomical position of the subject, e.g., erect, semi-erect, left lateral
recumbent lying, right
lateral recumbent lying, supine or prone position.
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[00046] In a preferred embodiment, the anatomical position warning signal
induces
excitation or warning events that are configured to prompt a subject to
transition to an
alternative position that is less likely to exacerbate and/or trigger a
symptom of an existing
respiratory or sleep disorder of the subject, e.g., obstructive sleep apnea or
gastroesophageal
reflux disease.
[00047] In some embodiments of the invention, the physiological monitoring
systems
further comprise a vibration device that is configured to receive the
anatomical position
warning signal and generate a vibration at a pre-determined frequency in
response to the
anatomical position warning signal.
[00048] In some embodiments of the invention, the physiological monitoring
systems
further comprise an integral audio device that is configured to receive the
anatomical position
warning signal and generate an audible signal at a pre-determined amplitude in
response to
the anatomical position warning signal.
[00049] In some embodiments of the invention, the physiological monitoring
systems
further comprise a remote audio device that is configured to receive the
anatomical position
warning signal and generate an audible signal at a pre-determined amplitude in
response to
the anatomical position warning signal.
[00050] In some embodiments of the invention, the method for determining a
respiratory
disorder and anatomical position of the subject generally comprises:
(i) providing a wearable physiological monitoring system of the invention;
(ii) positioning the wearable physiological monitoring system on the
subject;
(iii) initiating the wearable physiological monitoring system, wherein AC
magnetic
fields are generated and transmitted by the transmitter coil, the AC magnetic
fields
comprising predetermined frequencies;
(iv) detecting and measuring strengths in the AC magnetic fields with the
receiver
coils;
(v) generating AC magnetic field strength signals representing the measured
AC
magnetic field strengths with the receiver coils;
(vi) measuring accelerometer data with the system accelerometer and
generating
accelerometer signals representing the accelerometer data;
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(vii) transmitting the AC magnetic field strength signals and the
accelerometer
signals to the electronics module;
(viii) determining at least one anatomical displacement of the subject as a
function
of the AC magnetic field strength signals;
(ix) determining at least one respiratory parameter of the subject as a
function of
the deteimined anatomical displacement;
(x) determining a respiratory parameter value as a function of the AC
magnetic
field strength signals;
(xi) determining at least one respiratory disorder as a function of the
determined
respiratory parameter and value thereof; and
(xii) deteimining at least one anatomical position of the subject as a
function of the
accelerometer signals. =
BRIEF DESCRIPTION OF THE DRAWINGS
[00051] Further features and advantages will become apparent from the
following and
more particular description of the preferred embodiments of the invention, as
illustrated in the
accompanying drawings, and in which like referenced characters generally refer
to the same
parts or elements throughout the views, and in which:
[00052] FIGURE 1 is a schematic illustration of one embodiment of a
physiological
monitoring system, in accordance with the invention;
[00053] FIGURE 2 is a schematic illustration of another embodiment of a
physiological
monitoring system, in accordance with the invention;
[00054] FIGURE 3 is a schematic illustration of yet another embodiment of a
physiological
monitoring system, in accordance with the invention;
[00055] FIGURE 4 is a perspective view of one embodiment of a wearable
physiological
monitoring system positioned on a subject showing the position of a
transmitter coil
proximate the xyphoid process and one (1) receiver coil proximate the
umbilicus, in
accordance with the invention; and
[00056] FIGURE 5 is a side view of a subject, showing the position of a
transmitter coil
and three (3) receiver coils in a wearable physiological monitoring system
and, thereby, on
the subject, in accordance with one embodiment of the invention.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[00057] Before describing the present invention in detail, it is to be
understood that this
invention is not limited to particularly exemplified apparatus, systems,
structures or methods
as such may, of course, vary. Thus, although a number of apparatus, systems
and methods
similar or equivalent to those described herein can be used in the practice of
the present
invention, the preferred apparatus, systems, structures and methods are
described herein.
[00058] It is also to 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.
[00059] Unless defined otherwise, all technical and scientific terms used
herein have the
same meaning as commonly understood by one having ordinary skill in the art to
which the
invention pertains.
[00060] Further, all publications, patents and patent applications cited
herein, whether
supra or infra, are hereby incorporated by reference in their entirety.
[00061] As used in this specification and the appended claims, the singular
forms "a, "an"
and "the" include plural referents unless the content clearly dictates
otherwise. Thus, for
example, reference to "an AC magnetic field strength signal" includes two or
more such
signals and the like.
[00062] Further, ranges can be expressed herein as from "about" or
"approximately" one
particular value, and/or to "about" or "approximately" another particular
value. When such a
range is expressed, another embodiment includes from the one particular value
and/or to the
other particular value. Similarly, when values are expressed as
approximations, by use of the
antecedent "about" or "approximately", it will be understood that the
particular value forms
another embodiment. It will be further understood that the endpoints of each
of the ranges are
significant both in relation to the other endpoint, and independently of the
other endpoint.
[00063] It is also understood that there are a number of values disclosed
herein, and that
each value is also herein disclosed as "about" or "approximately" that
particular value in
addition to the value itself. For example, if the value "10" is disclosed,
then "approximately
10" is also disclosed. It is also understood that when a value is disclosed
that "less than or
equal to" the value, "greater than or equal to the value" and possible ranges
between values
are also disclosed, as appropriately understood by the skilled artisan. For
example, if the
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value "10" is disclosed then "less than or equal to 10" as well as "greater
than or equal to 10"
is also disclosed.
Definitions
[00064] The terms "respiratory parameter", "respiratory characteristic" and
"respiration
parameter" are used interchangeable herein, and mean and include a
characteristic associated
with the respiratory system and functioning thereof, including, without
limitation, breathing
frequency, tidal volume, inspiration volume, expiration volume, minute
ventilation,
inspiratory breathing time, expiratory breathing time, and flow rates (e.g.,
rates of change in
the chest wall volume).
[00065] The terms "respiratory parameter", "respiratory characteristic" and
"respiration
parameter" further mean and include parameters associated with ventilation
mechanics from
synchronous or asynchronous movements of the chest wall compartments.
[00066] The terms "physiological parameter" and "physiological
characteristic", as used
herein, mean and include, without limitation, electrical activity of the
heart, electrical activity
of other muscles, electrical activity of the brain, pulse rate, blood
pressure, blood oxygen
saturation level, skin temperature, and core temperature. =
[00067] The term "apnea," as used herein, means and includes abnormal
respiration, as
defined herein, of a subject, which is characterized by at least one
respiratory parameter
and/or physiological characteristic.
[00068] The term "apnea" thus means and includes abnoimal respiration
characterized
by, without limitation, breathing frequency or respiratory rate (f) (e.g.,
breaths per minute),
tidal volume (VT), inspiration volume, expiration volume, respiratory minute
ventilation
(e.g., inspiration volume per minute or expiration volume per minute) and/or
peak
expiratory flow rate.
[00069] The term "apnea" thus means and includes the inability of a subject to
correctly
modulate respiration.
[00070] The term "apnea" also means and includes, without limitation, an
obstruction of
the subject's upper airway.
[00071] The term "apnea" further means and includes abnormal respiration
characterized
by, without limitation, a seminal blood oxygen parameter and/or blood oxygen
characteristic
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including, without limitation, oxyhemoglobin saturation and oxygen
desaturation index of a
subject, e.g., oxyhemoglobin desaturation events per hour.
[00072] The term "apnea" thus means and includes, without limitation, a
reduction of a
subject's oxyhemoglobin saturation level > 5% of the subject's average normal
oxyhemoglobin saturation level.
[00073] The term "apnea" also means and includes, without limitation, counter-
correlated
contraction and expansion of the subject's thoracic and abdominal regions
during at least
one respiration cycle, i.e. the expansion and contraction of the subject's
thoracic and
abdominal cavities are ¨1800 out of phase.
[00074] The term "apnea" also means and includes central sleep apnea and
obstructive
sleep apnea.
[00075] The term "apnea" also means and includes complex sleep apnea or mixed
sleep
apnea, i.e. a combination of central and obstructive sleep apnea.
[00076] The term "apneic event," as used herein, means and includes, without
limitation,
a reduction of a subject's minute ventilation? 30 % of the subject's average
normal minute
ventilation and/or a cessation in the subject's breathing? 10 seconds with an
attendant
reduction in oxyhemoglobin saturation.
[00077] The term "normal respiration" as used herein in connection with
"apnea" means
and includes, without limitation, a "normal" or "healthy" apnea/hypopnea index
(AHI), i.e.
an AHI score < 5 apneic events per hour of a subject's sleep, wherein an
apneic event is
defined as (i) a reduction of the subject's minute ventilation? 30 % of the
subject's average
normal minute ventilation and/or (ii) a cessation in the subject's breathing?
10 seconds
with an attendant reduction in oxyhemoglobin saturation.
[00078] The term "abnormal respiration," as used herein, means and includes,
without
limitation, cessation of a subject's breathing for a period? 10 seconds with
an attendant
reduction in oxyhemoglobin saturation (or oxygen saturation).
[00079] The term "abnormal respiration" further means and includes, without
limitation,
a reduction of a subject's ventilation? 30 % of the subject's average normal
ventilation.
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[00080] The term "abnormal respiration" further means and includes, without
limitation,
a reduction of a subject's minute ventilation (V-dot)? 30 % of the subject's
average normal
minute ventilation.
[00081] The term "abnormal respiration" further means and includes, without
limitation,
a "mild" apnea/hypopnea index (AHI) score in the range of 5 ¨ 15 apneic events
per hour of
a subject's sleep, wherein an apneic event is defined as (i) a reduction of
the subject's
minute ventilation? 30 % of the subject's average normal minute ventilation
and/or (ii) a
cessation in the subject's breathing? 10 seconds with an attendant reduction
in
oxyhemoglobin saturation.
[00082] The term "abnormal respiration" further means and includes, without
limitation,
a "moderate" apnea/hypopnea index (AHI) score in the range of 15 ¨ 30 events
per hour of a
subject's sleep, wherein an apneic event is defined as (i) a reduction of the
subject's minute
ventilation? 30 % of the subject's average normal minute ventilation and/or
(ii) a cessation
in the subject's breathing? 10 seconds with an attendant reduction in
oxyhemoglobin
saturation.
[00083] The term "abnormal respiration" further means and includes, without
limitation,
a "severe" apnea/hypopnea index (AHI) score? 30 events per hour of a subject's
sleep,
wherein an apneic event is defined as (i) a reduction of the subject's minute
ventilation? 30
% of the subject's average normal minute ventilation and/or (ii) a cessation
in the subject's
breathing for a period of at least 10 seconds with an attendant reduction in
oxyhemoglobin
saturation.
[00084] The term "abnormal respiration" further means and includes, without
limitation,
a reduction of a subject's tidal volume (VT) in the range of approximately 5 ¨
30 % of the
subject's average normal VT.
[00085] The terms "sleep disorder" and "respiratory disorder" are used
interchangeably
herein, and mean and include, without limitation, an apnea, sleep apnea,
hypopnea, and
abnormal respiration.
[00086] The term "resting position" as used herein in connection with "apnea"
and "sleep
apnea" means and includes minimal physical activity or motion and/or the
absence of
physical activity or motion, except motion associated with normal breathing.
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[00087] The temis "patient" and "subject" are used interchangeably herein, and
mean and
include warm blooded mammals, humans and primates; avians; domestic household
or farm
animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory
animals, such as
mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the
like.
[00088] The terms "subject" and "patient" also mean and include a wearer or
user of a
respiratory parameter monitoring system or a respiratory-physiological
parameter
monitoring system of the invention.
[00089] The term "comprise" and variations of the term, such as "comprising"
and
"comprises," means "including, but not limited to" and is not intended to
exclude, for
example, other additives, components, integers or steps.
[00090] The following disclosure is provided to further explain in an enabling
fashion the
best modes of performing one or more embodiments of the present invention. The
disclosure
is further offered to enhance an understanding and appreciation for the
inventive principles
and advantages thereof, rather than to limit in any manner the invention. The
invention is
defined solely by the appended claims including any amendments made during the
pendency
of this application and all equivalents of those claims as issued.
[00091] Although the physiological monitoring systems and associated methods
for
determining respiratory and physiological parameters, and respiratory
disorders based
thereon, and anatomical positions and movement of a subject are described
herein in
connection with determining respiratory and physiological parameters, and
respiratory and
sleep disorders based thereon, and anatomical positions and movement of a
human subject, it
is understood that the invention is not limited to such use. Indeed, the
physiological
monitoring systems and associated methods can also be readily employed to
determine
respiratory and physiological parameters, and respiratory and sleep disorders
based thereon,
and anatomical positions and movement of other mammalian bodies.
[00092] The physiological monitoring systems and associated methods of the
invention can
also be employed in non-medical contexts, such as determining volumes and/or
volume
changes in extensible bladders used for containing liquids and/or gasses.
[00093] As indicated above, the present invention is directed to physiological
monitoring
systems and improved methods employing same for determining (i) respiratory
and sleep
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disorders of a subject based on measured variations in AC magnetic field
strengths that are
detected and measured by a plurality of receiver coils as a function of the
dimensional
distances between each receiver coil and at least one magnetic field source,
i.e. a transmitter
coil, and, hence, anatomical displacements based thereon, and, in some
embodiments,
physiological parameters and/or characteristics, and accelerometer data,
and/or (ii) anatomical
positions and movement of the subject.
[00094] As discussed in detail below, in a preferred embodiment, the
monitoring systems
of the invention comprise a wearable gannent that is configured to cover at
least the chest
region and upper back of a wearer (or user).
[00095] In some embodiments of the invention, the monitoring systems comprise
a
respiratory parameter monitoring sub-system, electronics (i.e. control and
processing) module
and integral signal transmission means associated therewith.
[00096] In some embodiments, the monitoring systems similarly comprises a
respiratory
parameter monitoring sub-system, a physiological parameter monitoring sub-
system,
electronics module and integral signal transmission means associated
therewith.
[00097] In some embodiments of the invention, the respiratory parameter
monitoring sub-
system comprises at least one permanent magnet and at least one magnetometer,
such as
disclosed in Applicant's Co-pending U.S. App. No. 16/363,290, which is
incorporated by
reference herein in its entirety.
[00098] In a preferred embodiment of the invention, the respiratory parameter
monitoring
sub-system comprises at least one transmitter coil and multiple receiver
coils, such as
disclosed in Applicant's Co-pending U.S. App. No. 16/363,404, which is
incorporated by
reference herein in its entirety.
[00099] According to the invention, the respiratory parameter monitoring sub-
system can
comprise two (2) transmitter coils. As discussed in detail below, in such
embodiments, one
(1) transmitter coil is positioned proximate the xyphoid process and another
transmitter coil is
positioned proximate the umbilicus.
[000100] In a preferred embodiment of the invention, the respiratory parameter
monitoring
sub-system comprises three (3) receiver coils. According to the invention, the
respiratory
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parameter monitoring sub-system can, however, also comprise more or less than
three (3)
receiver coils.
[000101] In a preferred embodiment of the invention, the transmitter coil(s)
are adapted to
generate and transmit electromagnetic radiation, e.g., AC magnetic fields, in
three dimensions
at multiple, non-harmonic frequencies.
[000102] In a preferred embodiment, the non-harmonic frequencies are less than
10 KHz.
[000103] In some embodiments, the non-harmonic frequencies are less than 5
KHz.
[000104] In some embodiments, the non-harmonic frequencies are in the range of
approximately 5-10 KHz.
[000105] According to the invention, the transmitter coils can comprise any
apparatus or
system that is adapted to generate and transmit electromagnetic radiation at
multiple
frequencies.
[000106] In a preferred embodiment, the receiver coils are configured and
positioned to
detect and measure the field strength in at least one field dimension of at
least one AC
magnetic field at a defined frequency, and generate at least one AC magnetic
field strength
signal representing the field strengths in the detected field dimension of the
AC magnetic
field, and, thereby, anatomical displacements of the monitored subject.
[000107] More preferably, the receiver coils are configured and positioned to
detect and
measure the field strengths in multiple field dimensions of at least one AC
magnetic field at a
defined frequency, and generate a plurality of AC magnetic field strength
signals representing
the field strengths in the field dimensions of the AC magnetic field, and,
thereby, anatomical
displacements of the monitored subject.
[000108] According to the invention, the receiver coils can comprise any
apparatus or
system that is configured to detect and measure field strength in an AC
magnetic field at a
defined frequency, and generate at least one AC magnetic field strength signal
representing
the measured field strength in the AC magnetic field, such as a magnetometer
or Hall Effect
sensor.
[000109] In a preferred embodiment of the invention, the transmitter coil is
positioned at a
first anatomical position proximate the subject's xyphoid process and a first
receiver coil is
positioned at a second anatomical position proximate the umbilicus, a second
receiver coil is
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positioned at a third anatomical position proximate the subject's spine
opposite the transmitter
coil, and a third receiver coil is positioned at a fourth anatomical position
proximate the
subject's spine opposite the umbilicus.
[000110] According to the invention, other receiver coil placement
configurations on a
subject can be employed.
[000111] By way of example, in some embodiments of the invention, the
transmitter coil is
positioned proximate the subject's umbilicus and a first receiver coil is
positioned proximate
the subject's spine opposite the transmitter coil, a second receiver coil is
positioned proximate
the subject's xyphoid process, and a third receiver coil is positioned
proximate the subject's
spine opposite the xyphoid process.
[000112] In some embodiments of the invention, the transmitter coil is
positioned proximate
the subject's spine opposite the xyphoid process and a first receiver coil is
positioned
proximate the xyphoid process, a second receiver coil is positioned proximate
the subject's
umbilicus, and a third receiver coils is positioned proximate the subject's
spine opposite the
umbilicus.
[000113] In a preferred embodiment of the invention, the physiological
parameter
monitoring sub-system comprises at least one physiological parameter sensor
that is
configured to (i) detect and measure a physiological parameter and,
preferably, a value
thereof, and (ii) generate a physiological parameter signal representing the
measured
physiological parameter and, preferably, value thereof
[000114] In some embodiments, the physiological parameter monitoring sensor
comprises a
Sp02 sensor.
[000115] In some embodiments, the physiological parameter monitoring sensor
comprises a
body temperature sensor.
[000116] In some embodiments of the invention, the physiological parameter
monitoring
sub-system further comprises at least one accelerometer that is configured and
positioned to
(i) detect anatomical positions of a monitored subject, and (ii) monitor
physical movement of
the subject.
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[000117] In some embodiments, the accelerometer comprises a conventional three
(3) axis
accelerometer that is configured to detect at least one accelerometer
parameter in an X, Y
and/or Z direction.
[000118] According to the invention, the accelerometer is configured to
generate and
transmit at least one accelerometer signal representing accelerometer data,
including at least
one accelerometer parameter representing an anatomical position of a subject.
[000119] In a preferred embodiment, the accelerometer is configured and
positioned to
generate a plurality of accelerometer signals that are processed and employed
to detennine at
least one anatomical position of the subject, i.e. whether the subject is in
an erect, semi-erect,
left lateral recumbent lying, right lateral recumbent lying, supine or prone
position.
[000120] As indicated above, in a preferred embodiment, the electronics module
comprises
a multi-channel module that is programmed and configured (i.e. comprises
programs,
parameters, instructions and at least one algorithm) to control the monitoring
systems of the
invention.
[000121] In some embodiments of the invention, the electronics module is also
preferably
programmed and configured to (i) receive AC magnetic field strength signals
that are
generated and transmitted by the receiver coils, (ii) identify the frequency
of each of the
associated AC magnetic field AC magnetic field strength signals, (iii)
determine the identity
and, thereby, position of the receiver coil based on the frequency of the AC
magnetic field
strength signals, (iv) determine at least one respiratory parameter, more
preferably, a plurality
of respiratory parameters associated with the monitored subject as a function
of the AC
magnetic field strength signals, (v) determine at least one respiratory
parameter value as a
function of the AC magnetic field strength signals, and (vi) determine at
least one respiratory
disorder as a function of the determined respiratory parameter and determined
value thereof.
[000122] In some embodiments of the invention, the electronics module is
further
programmed and configured to (i) receive at least one respiratory parameter
signal
representing a pre-measured baseline respiratory parameter value, and (ii)
determine at least
one respiratory disorder as a function of the pre-measured baseline
respiratory parameter
value and the respiratory parameter and value thereof determined as a function
of the AC
magnetic field strength signals.
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[000123] In some embodiments of the invention, the electronics module is
further
programmed and configured to receive and process physiological parameter
signals
representing physiological parameter values of a subject that are generated
and transmitted by
the physiological parameter monitoring sub-system, i.e. a physiological
parameter sensor
thereof.
[000124] Thus, in some embodiments, the electronics module is preferably
programmed and
configured to (i) receive the AC magnetic field strength signals that are
transmitted by the
receiver coils and physiological parameter signal(s) transmitted by the
physiological
parameter sensor, (ii) identify the frequency of each of the AC magnetic field
strength signals,
(iii) determine the identity of the receiver coil based on the frequency of
the AC magnetic
field strength signals, (iv) determine at least one respiratory parameter,
more preferably, a
plurality of respiratory parameters associated with the monitored subject as a
function of the
AC magnetic field strength signals, (v) deteimine at least one respiratory
parameter value as a
function of the AC magnetic field strength signals, and (vi) determine at
least one respiratory
disorder as a function of the physiological parameter value, and the
respiratory parameter and
value thereof determined as a function of the AC magnetic field strength
signals.
[000125] In some embodiments, the electronics module is further programmed and
configured to (i) receive accelerometer signals representing the anatomical
position and
movement data of the monitored subject that are generated and transmitted by
an
accelerometer, and (ii) determine at least one respiratory disorder as a
function of the pre-
measured baseline respiratory parameter value, physiological parameter value,
accelerometer
data, and the respiratory parameter and value thereof determined as a function
of the AC
magnetic field strength signals.
[000126] In some embodiments of the invention, the electronics module is also
programmed
to determine a physiological parameter value as a function of the
physiological parameter
signal.
[000127] In some embodiments of the invention, the electronics module is also
programmed
and configured to generate and transmit at least one respiratory disorder
warning signal as a
function of (or in response to) a pre-determined respiratory parameter
threshold value and/or
physiological parameter threshold value.
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[000128] In some embodiments, the electronics module is further programmed and
configured to generate and transmit at least one anatomical position warning
signal as a
function of (or in response to) a determined anatomical position and a pre-
determined
anatomical position of the subject.
[000129] In a preferred embodiment of the invention, the monitoring systems
further
comprise at least one excitation device, such as a vibration, audio or
illuminating device,
which generates or provides at least one excitation event, e.g., vibrations,
in response to the
respiratory disorder warning signal and/or anatomical position warning signal.
[000130] In some embodiments of the invention, the monitoring systems thus
further
comprise a vibration device that is configured to receive the respiratory
disorder warning
signal and/or anatomical position warning signal and generate vibrations at a
pre-deteimined
frequency or frequencies in response to the respiratory disorder warning
signal and/or
anatomical position warning signal.
[000131] According to the invention, the vibration device can comprise various
conventional vibration devices, including, without limitation, piezoelectric
vibrators, eccentric
cam motors and electromagnetic (EM) vibrators.
[000132] In a preferred embodiment of the invention, the vibration device is
capable of
generating vibrations with a frequency in the range of approximately 5 ¨ 50
Hz.
[000133] In some embodiments, the vibration device is configured to generate a
plurality of
vibrations in a series of random or continuous pulses in intervals in the
range of 1 ¨ 30
seconds, more preferably, in intervals in the range of 1 ¨ 3 seconds.
[000134] In some embodiments of the invention, the monitoring systems further
comprise a
remote vibration device that is configured to receive the respiratory disorder
warning signal
and/or anatomical position warning signal and generate the vibrations
referenced above in
response to the respiratory disorder warning signal and/or anatomical position
warning signal.
[000135] According to the invention, the remote vibration device can comprise
various
conventional vibration devices, including, without limitation, piezoelectric
vibrators, eccentric
cam motors and electromagnetic (EM) vibrators.
[000136] In a preferred embodiment of the invention, the remote vibration
device is capable
of vibrating at a frequency in the range of approximately 5 ¨ 50 cycles per
second (Hz).
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[000137] In some embodiments, the remote vibration device is similarly
configured to
generate a plurality of vibrations in a series of random or continuous pulses
in intervals in the
range of 1 ¨ 30 seconds, more preferably, in intervals in the range of 1 ¨ 3
seconds.
[000138] According to the invention, the monitoring systems can comprise a
plurality of
vibration devices that are configured to generate and, hence, transmit the
same or different
vibrations.
[000139] In some embodiments, the monitoring systems comprise a vibration
device that is
in communication with a subject's bed, such as a bed frame or mattress, or
chair.
[000140] In some embodiments of the invention, the monitoring systems further
comprise
an integral audio device that is configured to receive the respiratory
disorder warning signal
and/or anatomical position warning signal and produce an audible signal at a
pre-determined
amplitude in response to the respiratory disorder warning signal and/or
anatomical position
warning signal.
[000141] According to the invention, the integral audio device can comprise
various
conventional audio devices, including, without limitation, piezoelectric audio
devices and
electromagnetic audio devices, e.g., speakers.
[000142] In a preferred embodiment of the invention, the audio device is
capable of
providing an audible signal with an amplitude in the range of approximately 70
¨ 90 dB.
[000143] In a preferred embodiment of the invention, the audio device is
capable of
generating acoustic signals with a frequency in the range of approximately 300
¨ 1200 Hz.
[000144] In some embodiments of the invention, the monitoring systems further
comprise a
remote audio device that is configured to receive the respiratory disorder
warning signal
and/or anatomical position warning signal and produce an audible signal at a
pre-determined
amplitude in response to the respiratory disorder warning signal and/or
anatomical position
warning signal.
[000145] According to the invention, the remote audio device can similarly
comprise
various conventional audio devices, including, without limitation,
piezoelectric audio devices
and electromagnetic audio devices, e.g., speakers.
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[000146] In a preferred embodiment of the invention, the remote audio device
is capable of
generating and transmitting an audible signal with an amplitude in the range
of approximately
70 ¨ 110 dB.
[000147] In a preferred embodiment of the invention, the remote audio device
is capable of
generating and transmitting acoustic signals with a frequency in the range of
approximately
300 ¨ 1200 Hz.
[000148] In some embodiments of the invention, the monitoring systems further
comprise a
remote illuminating device that is configured to receive the respiratory
disorder warning
signal and/or anatomical position warning signal and produce a luminous signal
in response to
the respiratory disorder warning signal and/or anatomical position warning
signal.
[000149] According to the invention, the remote illuminating device can
comprise any
conventional device that is configured to generate light, such as a lamp or
any local light
source.
[000150] In some embodiments of the invention, electronics module of the
monitoring
systems is also programmed and configured to transmit a pre-programmed verbal
notice or
warning in response to the respiratory disorder warning signal and/or
anatomical position
warning signal.
[000151] In some embodiments of the invention, the electronics module is
programmed and
configured to transmit a pre-programmed respiratory disorder verbal warning to
an emergency
person or entity via a wireless link.
[000152] By way of example, in some embodiments, the electronics module is
programmed
to transmit the pre-programmed respiratory disorder verbal warning to an
emergency contact
via a pre-programmed telephone number.
[000153] In some embodiments, the electronics module is programmed to transmit
the pre-
programmed respiratory disorder verbal warning to an emergency service, e.g.,
police or fire
department, via a pre-programmed emergency service telephone number, e.g.,
"911".
[000154] In a preferred embodiment of the invention, the electronics module is
programmed
and configured to provide a plurality of respiratory disorder warning signals
and/or
anatomical position warning signals that induce multi-level excitation or
warning events, i.e.
vibrations of the vibration device at different frequencies, induced audible
signals at different
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amplitudes and verbal warnings to emergency contacts and/or services, and
combinations
thereof, as a function of (or in response to) the respiratory disorder warning
signals and/or
anatomical position warning signals.
[000155] Refening now to Table I, there is shown one embodiment of a single-
level sleep
disorder warning system of the invention. As illustrated in Table I, the
single-level
respiratory disorder warning system preferably comprises at least one
respiratory-
physiological parameter threshold and at least one excitation event relating
thereto.
TABLE I
Alert Respiratory-Physiological Excitation Event
Level Parameter Threshold
Level I "Mild" apnea/hypopnea index A series of ¨5 ¨ 50 Hz vibrations
comprising
(AHI) score in the range of 5 ¨ at least I ¨ 3 pulses per second; preferably,
15 apneic events per hour of a sufficient to fully wake a subject. The
subject's sleep. vibrations transmitted until the subject
wakes or turns off the vibration device.
[000156] Referring now to Table II, there is shown one embodiment of a two-
level
respiratory disorder warning system. As illustrated in Table II, the two-level
respiratory
disorder warning system, preferable comprises a plurality of respiratory-
physiological
parameter thresholds and at least one excitation event relating thereto.
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TABLE II
Alert Respiratory-Physiological Excitation Event
Level Parameter Threshold
Level 1 "Mild" apnea/hypopnea index A series of ¨5 ¨ 50 Hz vibrations
comprising
(AHI) score in the range of 5 at least 1 ¨ 3 pulses per second;
preferably,
¨ 15 apneic events per hour of sufficient to fully wake a subject. The
a subject's sleep. vibrations transmitted until the subject
wakes
or turns off the vibration device.
Level 2 "Moderate" apnea/hypopnea A series of ¨5 ¨ 50 Hz vibrations
comprising
index (AHI) score in the range at least 1 pulse every two (2) seconds;
of 15 ¨30 apneic events per preferably, sufficient to fully wake a
subject
hour of a subject's sleep.
and/or
an audible signal of at least 70 dB produced
by an integral audio device and/or remote
device that steadily increases amplitude to a
maximum of 90 dB until the subject wakes or
turns off the vibration device and/or audible
signal.
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[000157] Referring now to Table III, there is shown one embodiment of a three-
level
respiratory disorder warning system. As illustrated in Table III, the three-
level sleep disorder
warning system similarly preferably comprises a plurality of respiratory-
physiological
parameter thresholds and at least one excitation event relating thereto.
TABLE III
Alert Respiratory-Physiological Excitation Event
Level Parameter Threshold
Level 1 "Mild" apnea/hypopnea index A series of ¨5 ¨ 50 Hz vibrations
comprising
(AHI) score in the range of 5 ¨ at least 1 ¨ 3 pulses per second; preferably,
15 apneic events per hour of a sufficient to fully wake a subject. The
subject's sleep. vibrations transmitted until the subject
wakes or turns off the vibration device.
Level 2 "Moderate" apnea/hypopnea A series of ¨5 ¨ 50 Hz vibrations
comprising
index (AHI) score in the range at least 1 pulse every two (2) seconds;
of 15 ¨ 30 apneic events per preferably, sufficient to fully wake a
subject
hour of a subject's sleep.
and/or
an audible signal of at least 70 dB produced
by an integral audio device and/or remote
device that steadily increases amplitude to a
maximum of 90 dB until the subject wakes
or turns off the vibration device and/or
audible signal.
Level 3 "Severe" apnea/hypopnea Transmittal of a verbal warning to an
index (AHI) score > 30 apneic emergency contact and/or service, e.g., 911.
events per hour of a subject's
sleep.
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[000158] As indicated above, in a preferred embodiment, the accelerometer is
configured
and positioned to (i) detect and monitor anatomical positions and movements of
the monitored
subject, and (ii) generate a plurality of accelerometer signals that are
processed and employed
by the electronics module to determine anatomical positions of the subject.
[000159] As also indicated above, in some embodiments, the electronics module
is also
programmed and configured to generate and transmit at least one anatomical
position warning
signal as a function of (or in response to) a determined anatomical position
and a pre-
determined anatomical position of the subject.
[000160] In a preferred embodiment of the invention, the pre-determined and
determined
anatomical positions include at least semi-erect, left lateral recumbent,
right lateral
recumbent, supine and prone.
[000161] In a preferred embodiment, the anatomical position warning signal
induces
excitation or warning events that are configured to prompt a subject to
transition to an
alternate anatomical position that is less likely to exacerbate and/or trigger
a symptom of an
existing respiratory or sleep disorder of the subject, e.g., obstructive sleep
apnea or
gastroesophageal reflux disease.
[000162] Referring now to Table IV, there is shown one embodiment of a single-
level
anatomical position warning system of the invention. As illustrated in Table
IV, the single-
level anatomical position warning system preferably comprises at least one
undesirable
anatomical position or condition and at least one excitation event relating
thereto.
TABLE IV
Anatomical Condition Excitation Event
Subject sleeping in a supine position. A series of ¨5 ¨ 50 Hz vibrations
comprising
at least 1 ¨ 3 pulses per second; preferably,
sufficient to prompt a subject to transition to a
left lateral recumbent lying position.
The vibrations transmitted until the subject
transitions to a left lateral recumbent lying
position, wakes or turns off the vibration
device.
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[0001631 Referring now to Table V, there is shown another embodiment of a
single-level
anatomical position warning system of the invention. The illustrated
embodiment similarly
comprises at least one undesirable anatomical position or condition and at
least one excitation
event relating thereto.
TABLE V
Anatomical Condition Excitation Event
Subject sleeping in a supine position. A series of'-5 ¨ 50 Hz vibrations
comprising
at least 1 pulse every two (2) seconds until the
subject transitions to a left lateral recumbent
lying position, wakes or turns off the vibration
device
and/or
an audible signal of at least 70 dB produced by
an integral audio device and/or remote device
that steadily increases amplitude to a
maximum of 90 dB until the subject
transitions to a left lateral recumbent lying
position, wakes or turns off the audible device.
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[000164] Referring now to Table VI, there is shown another embodiment of a
single-level
anatomical position warning system of the invention.
TABLE VI
Anatomical Condition Excitation Event
Subject sleeping in a prone position. A series of ¨5 ¨ 50 Hz vibrations
comprising
at least 1 pulse every two (2) seconds until the
subject transitions to a left lateral recumbent
lying position, wakes or turns off the vibration
device
and/or
an audible signal of at least 70 dB produced by
an integral audio device and/or remote device
that steadily increases amplitude to a
maximum of 90 dB until the subject
transitions to a left lateral recumbent lying
position, wakes or turns off the audible device.
[000165] In a preferred embodiment of the invention, the anatomical position
warning
system is thus configured to train a subject to maintain an anatomical
position during sleep
that is less likely to exacerbate and/or trigger a symptom of an existing
respiratory or sleep
disorder of the subject.
[000166] In some embodiments of the invention, the anatomical position warning
system is
specifically configured to continuously train a subject afflicted with
obstructive sleep apnea to
maintain a left or right lateral recumbent lying anatomical position during
sleep.
[000167] In some embodiments, the anatomical position warning system is
specifically
configured to continuously train a subject afflicted with gastroesophageal
reflux disease to
maintain a left lateral recumbent lying anatomical position during sleep.
[000168] According to the invention, the anatomical position warning system
can be
configured to train a subject to maintain an anatomical position during sleep
that is less likely
to exacerbate and/or trigger a symptom of any existing disorder or disease of
a subject.
[000169] In some embodiments of the invention, the electronics module is
further
programmed and configured to continuously monitor the frequency of a subject's
anatomical
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position transition events.
[000170] In some embodiments, electronics module is also programmed and
configured to
determine sleep parameters, e.g., total sleep time (TST), sleep efficiency
(SE) and wake-after-
sleep-onset (WASO), as a function of acquired accelerometer data and
determined respiratory
parameter values.
[000171] Thus, as set forth in detail in priority U.S. Application No.
16/363,404, in one
embodiment of the invention the monitoring systems generally comprise a
wearable garment
that is configured to be removably positioned on a subject, the subject
comprising thoracic
and abdominal regions, a spine, an umbilicus and xyphoid process of the
sternum, wherein
when the wearable garment is positioned on a subject the wearable garment
covers at least the
thoracic and abdominal regions of the subject,
the wearable gatment comprising a respiratory parameter monitoring sub-system
and
an electronics module in communication therewith,
the respiratory parameter monitoring sub-system comprising a transmitter coil
and
first, second and third receiver coils,
the transmitter coil and the first, second and third receiver coils being
positioned on
the wearable garment, whereby, when the wearable garment is positioned on the
subject, the
transmitter coil is positioned proximate the subject's xyphoid process, the
first receiver coil is
positioned at a first anatomical region of the subject proximate the subject's
umbilicus at a
first receiver coil distance from the transmitter coil, the second receiver
coil is positioned at a
second anatomical region of the subject proximate the subject's spine opposite
the subject's
xyphoid process at a second receiver coil distance from the transmitter coil,
the third
magnetometer is positioned at a third anatomical region of the subject
proximate the subject's
spine opposite the subject's umbilicus at a third receiver coil distance from
the transmitter
coil,
the transmitter coil being adapted to generate a first alternating current
(AC) magnetic
field in first, second and third field dimensions, a second AC magnetic field
in fourth, fifth
and sixth field dimensions, and a third AC magnetic field in seventh, eighth
and ninth field
dimensions,
the first, second and third field dimensions of the first AC magnetic field
comprising a
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first field frequency, the fourth, fifth and sixth field dimensions of the
second AC magnetic
field comprising a second field frequency, and the seventh, eighth and ninth
field dimensions
of the third AC magnetic field comprising a third field frequency,
the first field dimension of the first AC magnetic field comprising a first
variable
strength as a function of a first distance of the first receiver coil from the
transmitter coil, the
second field dimension of the first AC magnetic field comprising a second
variable strength
as a function of a second distance of the first receiver coil from the
transmitter coil, and the
third field dimension of the first AC magnetic field dimension comprising a
third variable
strength as a function of a third distance of the first receiver coil from the
transmitter coil,
the fourth field dimension of the second AC magnetic field comprising a fourth
variable field strength as a function of a fourth distance of the second
receiver coil from the
transmitter coil, the fifth field dimension of the second AC magnetic field
comprising a fifth
variable field strength as a function of a fifth distance of the second
receiver coil from the
transmitter coil, and the sixth field dimension of the second AC magnetic
field comprising a
sixth variable field strength as a function of a sixth distance of the second
receiver coil from
the transmitter coil,
the seventh field dimension of the third AC magnetic field comprising a
seventh
variable field strength as a function of a seventh distance of the third
receiver coil from the
transmitter coil, the eighth field dimension of the third AC magnetic field
comprising an
eighth variable field strength as a function of an eighth distance of the
third receiver coil from
the transmitter coil, and the ninth field dimension of the third AC magnetic
field comprising a
ninth variable field strength as a function of a ninth distance of the third
receiver coil from the
transmitter coil,
the first receiver coil being configured to detect and measure the first,
second and third
variable field strengths in the first, second and third field dimensions of
the first AC magnetic
field, the first receiver coil being further configured to generate a first AC
magnetic field
strength signal representing the first variable field strength in the first
field dimension of the
first AC magnetic field, a second AC magnetic field strength signal
representing the second
variable field strength in the second field dimension of the first AC magnetic
field, and a third
AC magnetic field strength signal representing the third variable field
strength in the third
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field dimension of the first AC magnetic field, and transmit the first, second
and third AC
magnetic field strength signals to the electronics module,
the second receiver coil being configured to detect and measure the fourth,
fifth and
sixth variable field strengths in the fourth, fifth and sixth field dimensions
of the second AC
magnetic field, the second receiver coil being further configured to generate
a fourth AC
magnetic field strength signal representing the fourth variable field strength
in the fourth field
dimension of the second AC magnetic field, a fifth AC magnetic field strength
signal
representing the fifth variable field strength in the fifth field dimension of
the second AC
magnetic field, and a sixth AC magnetic field strength signal representing the
sixth variable
field strength in the sixth field dimension of the second AC magnetic field,
and transmit the
fourth, fifth and sixth AC magnetic field strength signals to the electronics
module,
the third receiver coil being configured to detect and measure the seventh,
eighth and
ninth variable field strengths in the seventh, eighth and ninth field
dimensions of the third AC
magnetic field, the third receiver coil being further configured to generate a
seventh AC
magnetic field strength signal representing the seventh variable field
strength in the seventh
field dimension of the third AC magnetic field, an eighth AC magnetic field
strength signal
representing the eighth variable field strength in the eighth field dimension
of the third AC
magnetic field, and a ninth AC magnetic field strength signal representing the
ninth variable
field strength in the ninth field dimension of the third AC magnetic field,
and transmit the
seventh, eighth and ninth AC magnetic field strength signals to the
electronics module,
the electronics module being adapted to receive the first, second and third AC
magnetic field strength signals transmitted by the first receiver coil, the
fourth, fifth and sixth
AC magnetic field strength signals transmitted by the second receiver coil and
the seventh,
eighth and ninth AC magnetic field strength signals transmitted by the third
receiver coil,
the electronics module comprising a processing system that is programmed and
configured to determine at least one respiratory parameter of the subject as a
function of the
first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC
magnetic field strength
signals,
the processing system being further programmed and configured to determine a
value
of the at least one respiratory parameter of the subject as a function of the
first, second, third,
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fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength
signals,
the processing system being further programmed and configured to determine a
value
of the at least one respiratory parameter of the subject as a function of the
first, second, third,
fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength
signals,
the processing system being further programmed and configured to deteintine at
least
one respiratory disorder of the subject as a function of the determined at
least one respiratory
parameter and the determined value thereof.
[000172] In some embodiments of the invention, wherein a baseline respiratory
parameter
value is pre-measured, the processing system is further programmed and
configured to
determine the at least one respiratory or sleep disorder of the subject as a
function of the pre-
measured baseline respiratory parameter value and the detennined at least one
respiratory
parameter and value thereof.
[000173] In a preferred embodiment of the 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.
[000174] As also set forth in detail in priority U.S. Application No.
16/363,404, in another
embodiment of the invention the monitoring systems similarly comprise a
wearable garment
that is configured to be removably positioned on a subject, the subject
comprising a spine, an
umbilicus and xyphoid process of the sternum, wherein when the wearable
garment is
positioned on a subject the wearable garment covers at least a thoracic and
abdominal region
of the subject,
the wearable garment comprising a respiratory parameter monitoring sub-system,
physiological parameter sub-system and an electronics module,
the respiratory parameter monitoring sub-system comprising a transmitter coil
and
first, second and third receiver coils,
the physiological parameter sub-system comprising at least one physiological
parameter sensor,
the transmitter coil and the first, second and third receiver coils being
positioned on
the wearable garment, whereby, when the wearable garment is positioned on the
subject, the
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transmitter coil is positioned proximate the subject's xyphoid process, the
first receiver coil is
positioned at a first anatomical region of the subject proximate the subject's
umbilicus at a
first receiver coil distance from the transmitter coil, the second receiver
coil is positioned at a
second anatomical region of the subject proximate the subject's spine opposite
the subject's
xyphoid process at a second receiver coil distance from the transmitter coil,
the third
magnetometer is positioned at a third anatomical region of the subject
proximate the subject's
spine opposite the subject's umbilicus at a third receiver coil distance from
the transmitter
coil,
the transmitter coil being adapted to generate a first alternating current
(AC) magnetic
field in first, second and third field dimensions, a second AC magnetic field
in fourth, fifth
and sixth field dimensions, and a third AC magnetic field in seventh, eighth
and ninth field
dimensions,
the first, second and third field dimensions of the first AC magnetic field
comprising a
first field frequency, the fourth, fifth and sixth field dimensions of the
second AC magnetic
field comprising a second field frequency, and the seventh, eighth and ninth
field dimensions
of the third AC magnetic field comprising a third field frequency,
the first field dimension of the first AC magnetic field comprising a first
variable
strength as a function of a first distance of the first receiver coil from the
transmitter coil, the
second field dimension of the first AC magnetic field comprising a second
variable strength
as a function of a second distance of the first receiver coil from the
transmitter coil, and the
third field dimension of the first AC magnetic field dimension comprising a
third variable
strength as a function of a third distance of the first receiver coil from the
transmitter coil,
the fourth field dimension of the second AC magnetic field comprising a fourth
variable field strength as a function of a fourth distance of the second
receiver coil from the
transmitter coil, the fifth field dimension of the second AC magnetic field
comprising a fifth
variable field strength as a function of a fifth distance of the second
receiver coil from the
transmitter coil, and the sixth field dimension of the second AC magnetic
field comprising a
sixth variable field strength as a function of a sixth distance of the second
receiver coil from
the transmitter coil,
the seventh field dimension of the third AC magnetic field comprising a
seventh
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variable field strength as a function of a seventh distance of the third
receiver coil from the
transmitter coil, the eighth field dimension of the third AC magnetic field
comprising an
eighth variable field strength as a function of an eighth distance of the
third receiver coil from
the transmitter coil, and the ninth field dimension of the third AC magnetic
field comprising a
ninth variable field strength as a function of a ninth distance of the third
receiver coil from the
transmitter coil,
the first receiver coil being configured to detect and measure the first,
second and third
variable field strengths in the first, second and third field dimensions of
the first AC magnetic
field, the first receiver coil being further configured to generate a first AC
magnetic field
strength signal representing the first variable field strength in the first
field dimension of the
first AC magnetic field, a second AC magnetic field strength signal
representing the second
variable field strength in the second field dimension of the first AC magnetic
field, and a third
AC magnetic field strength signal representing the third variable field
strength in the third
field dimension of the first AC magnetic field, and transmit the first, second
and third AC
magnetic field strength signals to the electronics module,
the second receiver coil being configured to detect and measure the fourth,
fifth and
sixth variable field strengths in the fourth, fifth and sixth field dimensions
of the second AC
magnetic field, the second receiver coil being further configured to generate
a fourth AC
magnetic field strength signal representing the fourth variable field strength
in the fourth field
dimension of the second AC magnetic field, a fifth AC magnetic field strength
signal
representing the fifth variable field strength in the fifth field dimension of
the second AC
magnetic field, and a sixth AC magnetic field strength signal representing the
sixth variable
field strength in the sixth field dimension of the second AC magnetic field,
and transmit the
fourth, fifth and sixth AC magnetic field strength signals to the electronics
module,
the third receiver coil being configured to detect and measure the seventh,
eighth and
ninth variable field strengths in the seventh, eighth and ninth field
dimensions of the third AC
magnetic field, the third receiver coil being further configured to generate a
seventh AC
magnetic field strength signal representing the seventh variable field
strength in the seventh
field dimension of the third AC magnetic field, an eighth AC magnetic field
strength signal
representing the eighth variable field strength in the eighth field dimension
of the third AC
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magnetic field, and a ninth AC magnetic field strength signal representing the
ninth variable
field strength in the ninth field dimension of the third AC magnetic field,
and transmit the
seventh, eighth and ninth AC magnetic field strength signals to the
electronics module,
the electronics module being adapted to receive the first, second and third AC
magnetic field strength signals transmitted by the first receiver coil, the
fourth, fifth and sixth
AC magnetic field strength signals transmitted by the second receiver coil and
the seventh,
eighth and ninth AC magnetic field strength signals transmitted by the third
receiver coil,
the electronics module comprising a processing system that is programmed and
configured to determine at least one respiratory parameter of the subject as a
function of the
first, second, third, fourth, fifth, sixth, seventh, eighth and ninth AC
magnetic field strength
signals,
the processing system being further programmed and configured to deteimine a
value
of the at least one respiratory parameter of the subject as a function of the
first, second, third,
fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength
signals,
the processing system being further programmed and configured to determine a
value
of the at least one respiratory parameter of the subject as a function of the
first, second, third,
fourth, fifth, sixth, seventh, eighth and ninth AC magnetic field strength
signals,
the processing system being further programmed and configured to determine at
least
one respiratory disorder of the subject as a function of the physiological
parameter value, and
the determined at least one respiratory parameter and the detetinined value
thereof.
[000175] In a preferred embodiment of the invention, the transmitter coil and
the first
receiver coil are similarly in a first axial alignment, the transmitter coil
and the second
receiver coil are in a second axial alignment and the transmitter coil and the
third receiver coil
are in a third axial alignment.
[000176] In some embodiments of the invention, wherein a baseline respiratory
parameter
value is pre-measured, the processing system is further programmed and
configured to
determine at least one respiratory disorder of the subject as a function of
the pre-measured
baseline respiratory parameter value, physiological parameter value, and the
determined at
least one respiratory parameter and value thereof.
[000177] As also set forth in priority U.S. Application No. 16/363,404 and
discussed in
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detail above, in some embodiments of the invention, the physiological
parameter sub-system
of the monitoring systems of the invention further comprise an accelerometer
that is
configured detect and monitor anatomical positions and physical movement of
the subject,
and generate and transmit accelerometer signals representing same, including
accelerometer
data representing at least one anatomical position of the subject.
[000178] Thus, in some embodiments of the invention, the processing system is
further
programmed and configured to determine at least one respiratory disorder of
the subject as a
function of the pre-measured baseline respiratory parameter value,
physiological parameter
value, accelerometer data, and the determined at least one respiratory
parameter and value
thereof.
[000179] In some embodiments of the invention, the processing system is also
programmed
and configured to detellnine at least one anatomical position of the subject
as a function of the
accelerometer signals and, hence, accelerometer data embodied in same.
[000180] 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 value thereof or at least one anatomical position of
the subject as a
function of the accelerometer signals and, hence, accelerometer data embodied
in same.
[000181] As also set forth in priority U.S. Application No. 16/363,404, in
some
embodiments of the invention, the method for determining a respiratory
disorder with a
monitoring system of the invention generally comprises:
(i) providing a wearable monitoring system comprising a respiratory
parameter
monitoring sub-system, physiological parameter monitoring sub-system and
electronics
control-processing module, the respiratory parameter monitoring sub-system
comprising one
transmitter coil and three, i.e. first, second and third, receiver coils, the
physiological
parameter monitoring sub-system comprising at least one physiological
parameter monitoring
sensor;
(ii) positioning the monitoring system on the subject, wherein the
transmitter coil
is positioned proximate the subject's xyphoid process and the first receiver
coil is positioned
proximate the umbilicus, the second receiver coil is positioned proximate the
subject's spine
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opposite the transmitter coil, and the third receiver coil is positioned
proximate the subject's
spine opposite the umbilicus, and wherein the physiological parameter
monitoring sensor is
positioned proximate a target physical structure, e.g., the subject's skin;
(iii) initiating the monitoring system, wherein AC magnetic fields are
generated
and transmitted by the transmitter coil, the AC magnetic fields comprising
predetermined
frequencies;
(iv) generating and transmitting AC magnetic fields with the transmitter
coil, the
AC magnetic fields comprising predetermined frequencies;
(v) detecting and measuring strengths in the AC magnetic fields with the
receiver
coils;
(vi) generating AC magnetic field strength signals representing the
measured AC
magnetic field strengths with the receiver coils;
(vii) measuring at least one physiological parameter and value thereof with
the
physiological parameter monitoring sub-system and generating a physiological
parameter
signal representing the physiological parameter and value thereof;
(viii) transmitting the AC magnetic field strength signals and the
physiological
signal to the electronics module;
(ix) determining at least one anatomical displacement of the subject as a
function
of the AC magnetic field strength signals with the electronics module;
(x) determining at least one respiratory parameter of the subject as a
function of
the determined anatomical displacement with the electronics module;
(xi) determining a respiratory parameter value as a function of the AC
magnetic
field strength signals with the electronics module; and
(xii) determining at least one respiratory disorder as a function of the
physiological
parameter value, and determined respiratory parameter and value thereof with
the electronics
module.
[000182] In some embodiments of the invention, the method for determining a
respiratory
disorder and anatomical position of a subject generally comprises:
(i) providing a wearable monitoring system comprising a respiratory
parameter
monitoring sub-system and electronics control-processing module, the
respiratory parameter
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monitoring sub-system comprising one transmitter coil and first, second and
third, receiver
coils, the respiratory parameter monitoring sub-system comprising at least one
physiological
parameter monitoring sensor and an accelerometer;
(ii) positioning the monitoring system on the subject, wherein the
transmitter coil
is positioned proximate the subject's xyphoid process and the first receiver
coil is positioned
proximate the umbilicus, the second receiver coil is positioned proximate the
subject's spine
opposite the transmitter coil, and the third receiver coil is positioned
proximate the subject's
spine opposite the umbilicus, and wherein the physiological parameter
monitoring sensor is
positioned proximate a target physical structure, e.g., the subject's skin;
(iii) initiating the monitoring system, wherein AC magnetic fields are
generated
and transmitted by the transmitter coil, the AC magnetic fields comprising
predetei mined
frequencies;
(iv) detecting and measuring strengths in the AC magnetic fields with the
receiver
coils;
(v) generating AC magnetic field strength signals representing the measured
AC
magnetic field strengths with the receiver coils;
(vi) acquiring accelerometer data with the accelerometer and generating
accelerometer signals representing the accelerometer data, the accelerometer
data including
accelerometer parameters representing anatomical positions and movement of the
subject;
(vii) transmitting the AC magnetic field strength signals and the
accelerometer
signals to the electronics module;
(viii) determining at least one anatomical displacement of the subject as a
function
of the AC magnetic field strength signals with the electronics module;
(ix) determining at least one respiratory parameter of the subject as a
function of
the determined anatomical displacement with the electronics module;
(x) determining a respiratory parameter value as a function of the AC
magnetic
field strength signals with the electronics module;
(xi) determining at least one respiratory disorder as a function of the
acquired
baseline accelerometer data and the determined respiratory parameter and value
thereof with
the electronics module; and
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(xii) determining at least one anatomical position of the subject as a
function of the
accelerometer signals with the electronics module.
[000183] Referring now to Fig. 1, there is shown a schematic illustration of
one embodiment
of a monitoring system of the invention. As illustrated in Fig. 1, the
monitoring system 100
preferably comprises a respiratory parameter monitoring sub-system 2 of the
invention, an
electronics module 6 and signal transmission conductors 8.
[000184] As also illustrated in Fig. 1, the respiratory parameter monitoring
sub-system 2
comprises a transmitter coil 15, first, second and third receiver coils 16a,
16b, 16c.
[000185] As further illustrated in Fig. 1, the respiratory parameter
monitoring system 100
further comprises a power source 10. According to the invention, the power
source 10 can
comprise any device or system configured to provide (or generate) electrical
energy, such as a
battery.
[000186] In a preferred embodiment of the invention, the monitoring system 100
preferably
comprises a wearable garment that is configured to cover at least a portion of
the torso of a
subject, i.e. the thoracic and abdominal regions.
[000187] Referring now to Fig. 2, there is shown a schematic illustration of
another
embodiment of a monitoring system of the invention. As illustrated in Fig. 2,
the monitoring
system 102 similarly preferably comprises a respiratory parameter monitoring
sub-system 2,
an electronics module 6 and signal transmission conductors 8.
[000188] As also illustrated in Fig. 2, the respiratory parameter monitoring
sub-system 2
similarly comprises a transmitter coil 15, first, second and third receiver
coils 16a, 16b, 16c.
[000189] As further illustrated in Fig. 2, the monitoring system 102 further
comprises a
physiological parameter monitoring sub-system 4a of the invention.
[000190] In a preferred embodiment of the invention, the monitoring system 102
similarly
preferably comprises a wearable garment that is configured to cover at least a
portion of the
torso of a subject, i.e. the thoracic and abdominal regions.
[000191] As indicated above, in a preferred embodiment of the invention,
transmitter coil 15
is adapted to generate and transmit electromagnetic radiation, e.g., AC
magnetic fields, in
multiple fields, i.e. a three-dimensional field, at multiple, non-harmonic
frequencies.
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[000192] As indicated above, preferably the non-harmonic frequencies are less
than 10 KHz.
[000193] As also indicated above, in a preferred embodiment, the first, second
and third
receiver coils 16a, 16b and 16c are configured and positioned to detect and
measure field
strength in at least one of the field dimensions of the AC magnetic fields,
and generate AC
magnetic field strength signals representing the field strengths in the AC
magnetic fields, and,
thereby, anatomical displacements of the monitored subject.
[000194] In at least one embodiment, the first and second transmitter coils
are configured
and positioned on a subject, wherein the polarities of the AC magnetic fields
generated by the
transmitter coils that are oriented perpendicular to each other, i.e. at a 90
angle relative to
each other, wherein a net vector field, comprising at least X and Y vectors
(or directions), of
the AC magnetic fields is provided.
[000195] In a preferred embodiment of the invention, at least one receiver
coil is configured
to detect at least one AC magnetic field vector in the X-direction and at
least one receiver coil
is configured to detect at least one AC magnetic field vector in the Y-
direction.
[000196] In the noted embodiments of the invention, wherein two (2)
transmitter coils are
employed, when the AC magnetic field vectors in the X and Y directions are
detected by the
receiver coils, an angle between the X and Y AC magnetic field vectors and a
net AC
magnetic field vector based thereon is determined by the processing system of
an electronics
module. The angle 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.
[000197] As indicated above and illustrated in Fig. 2, in a preferred
embodiment of the
invention, the physiological parameter monitoring sub-system 4a of the
respiratory-
physiological parameter monitoring system 102 comprises at least one
physiological
parameter monitoring sensor.
[000198] As further illustrated in Fig. 2, in some embodiments, the
physiological parameter
monitoring sensor 4a preferably comprises a Spa? sensor 18.
[000199] In some embodiments of the invention, the physiological parameter
monitoring
sub-system 4a comprises at least one additional physiological parameter
monitoring sensor,
such as a temperature sensor (shown in phantom and denoted 19).
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[000200] In a preferred embodiment of the invention, the electronics module 6
preferably
comprises a processing system or module, which is progranu-ned and configured
to control the
respiratory-physiological parameter monitoring system 2 and the function
thereof, and a data
transmission module, which is programmed and configured to control the
transmission and
receipt of signals to and from the respiratory parameter monitoring sub-system
2 and
physiological parameter monitoring sub-system 4a.
[000201] As indicated above, in a preferred embodiment of the invention, the
processing
system comprises at least one algorithm that is programmed and configured to
isolate and
process the AC magnetic field strength signals, and determine at least one
respiratory
parameter (or characteristic) of a subject as a function of the AC magnetic
field strength
signals.
[000202] As set forth in priority U.S. Application No. 16/363,404, the
processing system
algorithm for detellnining a respiratory parameter (or characteristic) as a
function of AC
magnetic field strength signals can comprise various conventional algorithms,
including,
without limitation, a conventional and/or modified multiple-degree of freedom
algorithm,
including, without limitation, a two (2) degree of freedom algorithm and three
(3) degree of
freedom algorithm, a spectral density estimation algorithm using non-
parametric methods,
including, without limitation, singular spectrum analysis, short-time Fourier
transform, cross-
power method, transfer function estimate and magnitude squared coherence, and
frequency
domain algorithm, including, without limitation, a Fourier series algorithm,
Fourier transform
algorithm, Laplace transform algorithm, Z transform algorithm and wavelet
transform
algorithm.
[000203] As also set forth in priority U.S. Application No. 16/363,404, the
processing
system is also 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
detelluined anatomical displacement parameters of a subject.
[000204] Referring now to Table VII, there is shown an illustration of one
embodiment of a
diagnostic data set for a subject. As illustrated in Table VII, the diagnostic
data set preferably
comprises at least an array of measured or determined minute ventilation
values and
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anatomical displacements measured at defined points on a subject during
monitoring with a
respiratory parameter or respiratory-physiological parameter monitoring system
of the
invention.
Table VII
Subject #1
Point No. Minute Ventilation
Anatomical Displacement
(V-dot) (Viii,
V1I2)
0 V-doto (Vmi,Vm2)o
1 V-doti (Vm1,Vm2)1
2 V-dot? (Vm1,Vm2)2
3 V-dot3 (Vmi, Vm2)3
4 V-dot4 (Vm1,Vm2)4
V-dot5 (Wu, Vm2)5
6 V-dot6 (Vmi, VM2)6
[000205] According to the invention, the diagnostic data set shown in Table
VII can be
graphically presented, i.e. minute ventilation on the y-axis and anatomical
displacement on
the x-axis, and linearly interpolated using conventional equations, such as
Eq. 1 shown below.
¨ " v,
Y=
Eq.1
[000206] In a preferred embodiment, the processing system is programmed and
configured
to linearly interpolate a diagnostic data set, such as the diagnostic data set
shown in Table VII,
and determine the presence of at least one apneic event exhibited by a subject
over a
predetermined period of time and, thereby, a sleep disorder.
[000207] According to the invention, the diagnostic data set can be
interpolated using any
applicable methods and/or equations. In some embodiments, processing system is
programmed and configured to interpolate a diagnostic data set using quadratic
polynomial
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interpolation and determine the presence of at least one apneic event
exhibited by a subject
over a predeten-nined period of time and, thereby, a sleep disorder.
[000208] In some embodiments of the invention, a subject's tidal volume (VT)
and
respiratory rate (f) are determined via spirometry. Minute ventilation (V-dot)
can then be
detennined using the equation shown below.
V-dot = VT x f Eq. 2
[000209] In a preferred embodiment of the invention, the processing system is
further
programmed to differentiate between indicia of a sleep disorder, i.e.
respiratory and/or
physiological parameters indicative of a sleep disorder, and extraneous
respiratory events,
such as coughing, hiccups, sneezing, etc. by, for example, comparing the pre-
measured
baseline respiratory and pre-measured baseline physiological parameters of the
subject in a
resting position to pre-determined respiratory and physiological parameter
threshold values
reflecting a respiratory disorder.
[000210] In a preferred embodiment of the invention, the processing system is
further
programmed to detennine a type of sleep apnea, i.e. obstructive sleep apnea,
central sleep
apnea and complex sleep apnea, based on detected anatomical displacements of a
monitored
subject.
[000211] In some embodiments, the processing system determines the type of
sleep apnea of
a subject based on the correlation or synchrony between the expansion and
contraction of the
subject's thoracic and abdominal regions (or chest wall and abdominal wall)
during at least
one respiratory cycle.
[000212] As is well established, when a subject is afflicted with obstructive
sleep apnea, the
subject will exhibit a counter-correlated expansion and contraction of the
thoracic and
abdominal regions, i.e. the expansion and contraction of the thoracic and
abdominal regions
are ¨180 out of phase, during at least one respiratory cycle.
[000213] As is also well established, when a subject is afflicted with central
sleep apnea, the
subject will exhibit a complete absence of thoracic and abdominal region
expansion and
contraction.
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[000214] Thus, according to the invention, when the AC magnetic field strength
signals
reflect counter-correlated expansion and contraction of a subject's thoracic
and abdominal
regions during at least one respiratory cycle, a determination of obstructive
sleep apnea is
provided.
[000215] When the AC magnetic field strength signals reflect the absence of
thoracic and
abdominal region expansion and contraction, a determination of central sleep
apnea is
provided.
[000216] In a preferred embodiment of the invention, the electronics module 6
further
comprises a data transmission sub-system that is programmed and configured to
control the
transmission of signals from the respiratory parameter monitoring sub-system 2
and
physiological parameter monitoring sub-system 4a.
[000217] In some embodiments, the data transmission sub-system is also
preferably
programmed and configured to transmit the respiratory parameter signals to a
remote signal
receiving device, e.g., a base module or a hand-held electronic device, such
as a smart phone,
tablet, computer, etc. In some embodiments, the remote signal receiving device
is
programmed and configured to display received and/or processed signals, e.g.,
respiration
parameter signals, physiological parameter signals and accelerometer data
received from the
electronics module 6.
[000218] As further illustrated in Fig. 2, the respiratory-physiological
parameter monitoring
system 102 also similarly includes signal transmission conductors 8, which
facilitate
connection and, thereby, signal communication by and between the respiratory
parameter
monitoring sub-system 2, physiological parameter monitoring sub-system 4a, and
electronics
module 6.
[000219] Referring now to Fig. 3, there is shown a schematic illustration of
another
embodiment of a respiratory-physiological parameter monitoring system of the
invention. As
illustrated in Fig. 3, the respiratory-physiological parameter monitoring
system 104 similarly
preferably comprises a respiratory parameter monitoring sub-system 2, a
physiological
parameter monitoring sub-system comprising at least one physiological
parameter monitoring
sensor, electronics module 6, signal transmission conductors 8, and a power
source 10, such
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as embodied in the respiratory-physiological parameter monitoring system 102
described
above.
[000220] As further illustrated in Fig. 3, in this embodiment, the
physiological parameter
monitoring sub-system (now denoted "4b") further comprises an accelerometer 20
that is
preferably configured detect and monitor anatomical positions and physical
movement of the
subject, and generate and transmit accelerometer signals representing same,
including
accelerometer data representing at least one anatomical position of the
subject.
[000221] In this embodiment, the processing system of the electronics module 6
is also
programmed to detemiine a respiratory disorder as a function of measured
respiratory and
physiological parameters, and accelerometer data of the subject, and at least
one anatomical
position of the subject as a function of the accelerometer data.
[000222] Referring now to Fig. 4, there is shown an embodiment of a wearable
garment 220
that can incorporate a monitoring system of the invention, including
monitoring systems 100
and 102 shown in Figs. 1-3.
[000223] As indicated above and illustrated in Fig. 4, the wearable garment
220 is
preferably configured to cover at least the upper torso 210, i.e. the thoracic
and abdominal
regions, of a subject 200.
[000224] According to the invention, the wearable garment 220 can, however,
also be
configured to cover other regions of the subject 200, including, without
limitation, the lower
abdominal region.
[000225] As illustrated in Fig. 5, in a prefened embodiment, when the wearable
garment
220 incorporates a monitoring system of the invention (and, hence, forms a
wearable
monitoring system) and is positioned on the upper torso 210 of a subject, the
transmitter coil
15 is preferably positioned proximate the subject's xyphoid process and the
first receiver coil
16a is positioned proximate the umbilicus, the second receiver coil 16b is
positioned
proximate the subject's spine opposite the transmitter coil 15, and the third
receiver coil 16c is
positioned proximate the subject's spine opposite the umbilicus.
[000226] According to the invention, when the noted wearable monitoring system
is
positioned proximate the upper torso 210 of a subject 200 and the monitoring
system is
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initiated, respiratory disorders and anatomical positions of the subject 200
can be accurately
determined.
[000227] As will readily be appreciated by one having ordinary skill in the
art, the present
invention provides numerous advantages compared to prior art methods and
systems for
determining respiratory characteristics and respiratory disorders therefrom,
and anatomical
positions and movement of a subject.
[000228] Among the advantages are the following:
= The provision of wearable physiological monitoring systems that
accurately detect and
measure respiratory parameters and/or characteristics in real time based on
anatomical
displacements of a monitored subject.
= The provision of wearable physiological monitoring systems that that
accurately
determine anatomical positions of a subject.
= The provision of wearable physiological monitoring systems that train a
subject to
maintain an anatomical position during sleep that is less likely to exacerbate
and/or
trigger a symptom of an existing respiratory or sleep disorder of the subject.
= The provision of improved methods for determining a respiratory disorder
based on
detected respiratory and/or physiological parameters and/or characteristics.
= The provision of improved methods for determining sleep apnea and/or
hypopnea
based on detected abnormal respiratory and/or physiological parameters and/or
characteristics.
= The provision of methods for training a subject to maintain an anatomical
position
during sleep that is less likely to exacerbate and/or trigger a symptom of an
existing
respiratory or sleep disorder of the subject.
[000229] Without departing from the spirit and scope of this invention, one of
ordinary skill
can make various changes and modifications to the invention to adapt it to
various usages and
conditions. As such, these changes and modifications are properly, equitably,
and intended to
be, within the full range of equivalence of the following claims.
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